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AMA. 2010;304(14):1612-1614. doi:10.1001/jama.2010.1496

Illicit drug use is a major cause of morbidity and mortality worldwide. In the United States, the 2009 National Survey on Drug Use and Health documented that 8.7% of individuals older than 12 years reported past month illicit drug use.1 Illicit opioid use is an important contributor to health problems, including human immunodeficiency virus and hepatitis C infection and overdose-related deaths. While historically heroin has been most commonly abused, nonmedical use of prescription opioid pain relievers is now the dominant form of opioid abuse in the United States. In 2009, more than 5.3 million Americans reported past month prescription opioid abuse1 and the 2009 Monitoring the Future Study demonstrated that among 12th-graders, 9.7% reported abuse of hydrocodone and 4.9% reported abuse of oxycodone in the past year.2 Thus, illicit opioid use is a critical national health issue that requires creative approaches to prevention and treatment.

Opioid dependence is characterized by physical dependence, medical and psychological problems, and social dysfunction. Treatment strategies include counseling and pharmacotherapy. Medications have been particularly effective for treating opioid dependence given the unique effects of opioids on the brain and the availability of medications that can modulate these effects. Opioid agonist treatment has been demonstrated to most effectively decrease craving and drug use and improve health and social outcomes; furthermore, sustained medication maintenance is much more effective than short-term detoxification.3 Methadone maintenance has been the gold standard treatment since it was described by Dole and Nyswander in JAMA in 1965.4 Since then, dozens of studies have reaffirmed the effectiveness of methadone although it has not been without controversy, including potential toxicities and the strict regulatory restrictions on its use.5 Other agonist medications such as levo-alpha-acetylmethadol (LAAM) and diacetylmorphine (heroin)6 have been examined, but none has gained significant acceptance.

The newest medication treatment for opioid dependence is the partial opioid agonist buprenorphine. When used alone, or in combination with naloxone (buprenorphine-naloxone) in a sublingual tablet formulation, buprenorphine improves drug use–related outcomes in a manner similar to methadone7 with an improved safety profile. The naloxone component is not significantly absorbed sublingually but is included to block opioid effects if intravenous use is attempted. Buprenorphine was approved by the US Food and Drug Administration (FDA) in 2002 and its use has increased considerably. Along with enhanced safety, buprenorphine has the advantage of being available through prescription by trained generalist and specialty physicians in their offices, thus expanding the availability of maintenance treatment outside the confines of licensed programs.8 Subsequent research has expanded knowledge on how9 and in whom10 buprenorphine can be used most effectively.

Despite these advantages, buprenorphine use has been limited by the small (but increasing) number of trained physicians, concerns about diversion, and its high cost relative to methadone. In addition, buprenorphine typically requires daily supervised or self-administration. Thus, particularly in office-based treatment where medication administration is generally unsupervised, effectiveness relies on patient adherence. Efforts to improve adherence have been investigated, including less than daily dosing and electronic compliance monitoring; however, these approaches are seldom used.

Thus, the study of subdermal buprenorphine implants reported by Ling and colleagues11 in this issue of JAMA is an important addition to the literature because this method of medication administration may address limitations of sublingual buprenorphine, in particular adherence and diversion. Patients from 18 addiction treatment centers were randomly assigned to receive buprenorphine or placebo implants and were followed up for 24 weeks. Efforts to blind treatments and assessments were used and meaningful outcomes were selected. Along with the primary outcome of percentage of illicit opioid–negative urine samples, treatment retention, study completion, craving, and withdrawal and dependence severity were assessed. Safety and pharmacokinetic assessments are particularly important when new medication technologies are examined and these were also performed.

The manner in which treatment was provided has important implications regarding study limitations and clinical utility. Both groups received buprenorphine induction with sublingual buprenorphine-naloxone tablets, implant insertion, and up to twice-weekly counseling. In addition, supplemental sublingual buprenorphine-naloxone was provided based on patient-reported withdrawal and craving, and otherwise when requested. Thus, this treatment is not without complexity (eg, the implantation/removal procedures) or resource intensity (eg, specialized counseling). The need to use supplemental medication indicates that risk of diversion is not completely eliminated, especially if its use is unsupervised as is common in practice. Moreover, because this study was performed in treatment centers with specialized counseling and close medication supervision, it provides relatively little information about how implants might be used in office practice.

With these caveats in mind, Ling et al demonstrated that implant buprenorphine was more effective than placebo implants for the primary and major secondary outcomes.11 It is certainly not surprising that buprenorphine implants performed better than placebo implants and one could argue a control group other than placebo should have been used given the established efficacy of buprenorphine. However, attention to patient safety along with the need to carefully assess this new delivery method in a definitive manner, the availability of “rescue” buprenorphine for all patients, and the 2:1 randomization ratio moderate this concern. Despite the superior urine toxicology results noted with buprenorphine implants, more than 50% of urine samples were positive, suggesting that even the active treatment had significant limitations. This, along with the relatively low buprenorphine plasma levels noted in these patients and the degree to which they required supplemental buprenorphine, suggests that further improvement in the implant delivery system may be warranted. However, the meaning of low drug plasma levels is not entirely clear clinically because effective buprenorphine plasma concentrations are likely to vary considerably between individuals.12 Ultimately, a direct comparison of implant to sublingual administration that examines pharmacokinetics and drug use is required to better understand the pharmacology and effectiveness of implant buprenorphine and to ensure that effectiveness is not sacrificed for convenience.

The study by Ling et al11 should be viewed in the context of what has been learned about opioid dependence treatment over the past 50 years. While counseling is critical for all substance abuse treatment, opioid dependence is uniquely susceptible to pharmacologic therapy. Patients and their physicians are often tempted to use “quick fix” detoxification in which short-term medication treatment is provided rather than longer-term maintenance. However, for most opioid-dependent patients there is no quick fix. Detoxification has been conclusively demonstrated to have exceedingly high long-term failure rates13 and is not nearly as effective as opioid maintenance.3, 10 Extensive research on the effectiveness of methadone maintenance is irrefutable and research on buprenorphine maintenance has followed suit.

The question of where to provide buprenorphine has been the subject of extensive research that has allowed treatment to expand from the maintenance clinic to the physician’s office. Ling et al are addressing the question of how to provide buprenorphine. Intramuscular buprenorphine has been available for many years for pain management and a sublingual liquid formulation was initially used in investigational studies prior to FDA approval for treating opioid dependence. Buprenorphine was subsequently formulated in sublingual tablet forms in combination with naloxone (buprenorphine-naloxone) to discourage diversion. In addition, sublingual film buprenorphine has been developed,14 a version of which was approved by the FDA in 2010. The use of much longer-acting depot and implant medications has a long history and has demonstrated utility in enhancing adherence in the treatment of conditions such as schizophrenia and as an approach to providing hormonal contraception. A small study of depot injection buprenorphine demonstrated low plasma levels and pharmacologic activity over 6 weeks after one injection.15 The use of implant buprenorphine in this study suggests that a promising new approach to long-acting buprenorphine administration may be close at hand.

The study by Ling et al11 represents a potentially important step forward in the effort to improve and expand the treatment options for opioid dependence. Further research is needed to assess how this treatment compares with current opioid maintenance treatment prior to the widespread use of implant buprenorphine in clinical practice. If further research suggests that this buprenorphine implant is as good as or better than current treatment approaches, then the study by Ling et al would represent a major advance in the substantial and continued progress that has occurred in the treatment of opioid dependence since methadone maintenance began in the 1960s.

Despite these advances, significant challenges remain. As new and potentially better medications are developed, promoting access to treatment for opioid-dependent patients continues to be a major concern. In addition, physicians must be more knowledgeable about addiction and embrace their responsibility to care for individuals with, or at risk for, substance use disorders so that more patients can be identified and offered treatment. Treatments also need to be carefully designed so that medication effectiveness is maximized and counseling therapies are tailored to meet the needs of individual patients in a cost-effective manner.

Context Limitations of existing pharmacological treatments for opioid dependence include low adherence, medication diversion, and emergence of withdrawal symptoms.

Objective To determine the efficacy of buprenorphine implants that provide a low, steady level of buprenorphine over 6 months for the treatment of opioid dependence.

Design, Setting, and Participants A randomized, placebo-controlled, 6-month trial conducted at 18 sites in the United States between April 2007 and June 2008. One hundred sixty-three adults, aged 18 to 65 years, diagnosed with opioid dependence. One hundred eight were randomized to receive buprenorphine implants and 55 to receive placebo implants.

Intervention After induction with sublingual buprenorphine-naloxone tablets, patients received either 4 buprenorphine implants (80 mg per implant) or 4 placebo implants. A fifth implant was available if a threshold for rescue use of sublingual buprenorphine-naloxone treatment was exceeded. Standardized individual drug counseling was provided to all patients.

Main Outcome Measure The percentage of urine samples negative for illicit opioids for weeks 1 through 16 and for weeks 17 through 24.

Results The buprenorphine implant group had significantly more urine samples negative for illicit opioids during weeks 1 through 16 (P = .04). Patients with buprenorphine implants had a mean percentage of urine samples that tested negative for illicit opioids across weeks 1 through 16 of 40.4% (95% confidence interval [CI], 34.2%-46.7%) and a median of 40.7%; whereas those in the placebo group had a mean of 28.3% (95% CI, 20.3%-36.3%) and a median of 20.8%. A total of 71 of 108 patients (65.7%) who received buprenorphine implants completed the study vs 17 of 55 (30.9%) who received placebo implants (P < .001). Those who received buprenorphine implants also had fewer clinician-rated (P <.001) and patient-rated (P = .004) withdrawal symptoms, had lower patient ratings of craving (P <.001), and experienced a greater change on clinician global ratings of severity of opioid dependence (P<.001) and on the clinician global ratings of improvement (P < .001) than those who received placebo implants. Minor implant site reactions were the most common adverse events: 61 patients (56.5%) in the buprenorphine group and 29 (52.7%) in the placebo group.

Conclusion Among persons with opioid dependence, the use of buprenorphine implants compared with placebo resulted in less opioid use over 16 weeks as assessed by urine samples.

Dependence on opioids, in the form of heroin or prescription pain medications, is a significant health concern.1-3 Methadone maintenance treatment for opioid dependence reduces morbidity, mortality, and the spread of infectious diseases4 but is restricted to licensed specialty clinics in the United States, requires frequent clinic visits, and has a risk of mortality with overdose.5 These issues have led to increased use of buprenorphine, and numerous studies support the efficacy of sublingually administered buprenorphine.6 In the United States, buprenorphine can be prescribed in office-based physician practice.7 Because it is a partial agonist, buprenorphine has less risk of overdose than methadone.8 However, there are concerns about diversion and nonmedical use of sublingual buprenorphine, even when a buprenorphine-naloxone combination (designed to reduce misuse) is used.9-11 Poor treatment adherence, resulting in craving and withdrawal symptoms that increase the likelihood of relapse, is also a concern with sublingual buprenorphine.12

To address these problems with adherence, diversion, and nonmedical use, an implantable formulation of buprenorphine has been developed. This implant is a polymeric matrix composed of ethylene vinyl acetate and buprenorphine that delivers buprenorphine over 6 months. Following an initial pulse release, a constant and low level of buprenorphine is released, avoiding plasma peaks and troughs observed with sublingual administration. A preliminary open-label phase 2 study reported favorable results with this implant in opioid-dependent patients.13

The present study reports results of a phase 3 multicenter, randomized, placebo-controlled investigation of buprenorphine implants for treatment of opioid dependence.

Participants

Patients were recruited for the study from 6 academic, 3 Veterans Affairs, and 9 nonprofit community addiction treatment centers in the United States between April 2007 and June 2008. The study was approved by institutional review boards at each site, and written informed consent was obtained from all participants.

To be eligible for the study, men or nonpregnant women, aged 18 to 65 years, were required to meet Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) (DSM-IV) diagnosis of current opioid dependence at a screening visit as determined by the Mini International Neuropsychiatric Interview.14 Exclusion criteria were AIDS, met DSM-IV criteria for current dependence on psychoactive substances other than opioids or nicotine, currently using nonprescribed benzodiazepines, had received medication treatment for opioid dependence within the previous 90 days, or had a current diagnosis of chronic pain that required opioid treatment. Patients were also excluded if they had any of the following: aspartate aminotransferase (AST) levels at least 3 times higher than the upper limit of normal, alanine aminotransferase (ALT) levels at least 3 times the upper limit of normal, total bilirubin levels of at least 1.5 times the upper limit of normal, or creatinine levels at least 1.5 times the upper limit of normal.

Demographics and history were collected by patient self-report based on a list of choices.

Study Intervention and Randomization

Eligible patients entered into an open-label induction phase designed to ensure that buprenorphine could be safely administered. Patients were required to complete induction within 10 days of screening and receive a fixed dose of 12 to 16 mg/d sublingual buprenorphine-naloxone tablets for at least 3 consecutive days immediately before randomization. Patients were excluded from participation if during the induction phase they had reported significant withdrawal symptoms, defined as more than 12 on the Clinical Opiate Withdrawal Scale,15 or significant cravings for opioids, defined as more than 20 mm on a 100-mm opioid craving visual analog scale (VAS).

At the end of the induction phase, patients were randomized (stratified by sex and site) at a 2:1 ratio to double-blind treatment with either 4 buprenorphine implants (80 mg each) or 4 placebo implants. The 2:1 ratio was used to reduce patient exposure to placebo implants. The implants (26 mm in length x 2.5 mm in diameter) were placed in the subdermal space (2-3 mm below the skin) all at the same time in the inner side of the nondominant arm by a physician who had participated in a 1-day training in implant insertion and removal or who had prior similar experience. No sutures are required for implantation (sutures were used at removal). The physicians who placed and removed the implants were from various medical specialties (eg, family practice, psychiatry, dermatology, obstetrics and gynecology) and had surgical training but did not serve as the site investigator. The implants were removed after 6 months.

After implant placement, patients could receive supplemental sublingual buprenorphine-naloxone tablets, beginning with 4 mg and increasing in 2-mg increments as clinically necessary and tolerated up to 12 to 13 mg, if they experienced significant withdrawal symptoms or significant craving or if they had requested a dose increase that the treating physician judged to be appropriate. The supplemental sublingual buprenorphine-naloxone tablets were administered at the clinic under observation, except for weekends and holidays, for which participants received a maximum of 3 days of dosing to take at home. Patients could receive an additional implant if they required 3 or more days per week of any supplemental sublingual buprenorphine-naloxone tablets for 2 consecutive weeks, or 8 or more days of any supplemental buprenorphine-naloxone tablets over 4 consecutive weeks.

Because the placebo implants had a slightly different appearance than buprenorphine implants, steps were taken to maintain the blind: (1) the physician and staff involved in the implant insertion and removal procedures did not participate in efficacy evaluations or discuss with other study staff any information regarding a patient’s implants, (2) surgical draping prevented patients from viewing the implants during insertion or removal procedures, (3) staff not involved in implant insertion and removal procedures were forbidden from asking those involved in these procedures about the rod’s appearances, (4) each implant was sealed in an opaque, foil-lined pouch that hid the contents from view and was only opened by those involved with the implanting procedures.

All patients received manual-guided individual drug counseling.16 Sessions were held twice a week during the first 12 weeks and then weekly for the subsequent 12 weeks. If a patient missed 6 consecutive counseling sessions, this was judged to be clinically meaningful nonadherence, causing the patient to be withdrawn from the study. Because experienced drug counselors at each site who were familiar with the drug-counseling treatment model provided services, they received no formal training.

Urine samples were obtained 3 times per week throughout the entire 6-month treatment period. Drug screens were performed by a central laboratory and study staff, and patients remained blind to results. If a patient did not provide 9 consecutive urine samples, they were considered nonadherent and withdrawn (ie, 3 weeks was considered a clinically important interval). Participants could continue in the study regardless of test results. Urine toxicology samples were verified at collection by measurement of urine temperature. Patients provided another sample if a urine sample was outside of a valid temperature range. If the second sample was outside of the temperature range, the sample was designated as missing.

Efficacy Assessments

The primary outcome measure was the percentage of the 48 urine samples that were negative for illicit opioids during the first through 16th week of the trial. This 16-week period was selected because of the interest in examining early-treatment response in the context of this longer-term treatment.

The secondary outcome measure was assessed as the percentages of the 24 urine samples that were negative for illicit opioids during weeks 17 through 24. Additional outcomes measured included the proportion of treatment failures, the proportion of study completers, the patient-report and clinician-report withdrawal scales, a craving scale, and clinician severity and improvement ratings.

Treatment failure was defined as receiving a fifth implant and subsequently requiring 3 or more days per week of supplemental sublingual buprenorphine-naloxone treatment for 2 consecutive weeks or 8 or more days of supplemental sublingual buprenorphine-naloxone treatment over 4 consecutive weeks at any time after the implant dosage increase. Patients who met this definition of treatment failure were withdrawn from the study.

Patient report of withdrawal symptoms was assessed by the Subjective Opiate Withdrawal Scale.17 Clinician report of withdrawal symptoms was measured with the Clinical Opiate Withdrawal Scale, administered by the investigator or other qualified clinical staff. Craving for opioids was measured using a 100-mm VAS: 0 indicates no cravings; and 100, the maximum craving experienced. All 3 measures were obtained at baseline and at weeks 1, 4, 8, 12, 16, 20, and 24. The clinician-rated Clinical Global Impressions-Severity (CGI-S)18 (of opioid dependence) and Improvement scales (CGI-I)18 were obtained at baseline and at weeks 16 and 24 (or end point).

Safety and Pharmacokinetic Assessments

Vital signs, blood and urine laboratory tests (hematology, liver function tests, coagulation, pregnancy test), and electrocardiograms were obtained at regular study visits. The assessment protocol required that study investigators visually inspect the surgical implant location of each participant during each study visit. Levels of plasma buprenorphine were obtained and analyzed from blood samples taken at baseline and monthly thereafter.

Statistical Analyses

Baseline variables were compared across treatment groups using {chi}2 for categorical variables and t tests for continuous variables.

The primary analysis was conducted using an intention-to-treat approach that included all randomized patients. The primary statistical analysis specified in the study protocol was a van Elteren Wilcoxon rank sum test,19 stratified by sex and treatment site, comparing study groups on the distributions of the percentages of urine samples that tested negative for illicit opioids over 16 weeks. Sample size determination was conducted using a 2-sided {alpha} of .05 and 80% power to detect a shift of 20% (a difference deemed to be clinically relevant) between the placebo and buprenorphine groups on the distributions of the percentage of urine samples negative for illicit opioids over 16 weeks. Approximately 150 patients were required, taking into account the 2:1 randomization scheme, normal distributions without stratification with a common standard deviation of 30% as a conservative powering model, and an attrition rate of approximately 40%.

The denominator for the primary end point was all possible urine samples that could have been collected from implantation through week 16. Missed samples were considered positive for opioids. After a patient was withdrawn from the study, urine samples from the point of withdrawal onward were also considered positive.

A secondary analysis examined the percentage of urine samples over weeks 17 through 24 (using a van Elteren Wilcoxon test stratified for sex and site). Hypothesis testing for the primary analysis and the first secondary analysis was conducted using a fixed-sequence testing procedure. First, the primary hypothesis was tested using a 5% {alpha} level. Only if the null hypothesis was rejected for the primary analysis did testing proceed to the first secondary analysis. In accordance with this procedure, no {alpha} adjustment for multiple tests is required and the accepted alternative hypotheses may be claimed significant at the 5% level. An additional van Elteren Wilcoxon rank sum test examined the percentage of urine samples negative for the full 24-week period (72 samples per patient).

The proportions of participants who completed the study (defined as completing 24 weeks) were compared between treatment groups with a Cochran Mantel-Haenszel test, stratified by sex and site. The clinical and subjective withdrawal scales and the craving VAS were analyzed using a mixed-effects repeated-measure analysis of covariance using all available assessments and adjusting for sex, site, and baseline value. A spatial power law correlation structure was specified for these analyses. This covariance structure was used because it is appropriate for modeling data when the measurement time points are continuous (unequally spaced) rather than discrete categories, and the correlations decline as a function of the time difference. The CGI-I and CGI-S were analyzed as categorical variables using a Cochran Mantel-Haenszel test stratified by sex and site.

The incidence of specific adverse events was compared across treatment groups using {chi}2 tests. All statistical analyses were performed using SAS software version 8.2 (SAS Institute Inc, Cary, North Carolina).


Figure 1

 

Treatment Exposure

The median number of weeks of exposure to the implants (before they were removed) was 24 (range, 0-43 weeks) for buprenorphine and 16.6 (range, 3-34 weeks) for placebo. Additional implants were received by 20.3% (22 of 108) of those in the buprenorphine group and 58.2% (32 of 55) of those in the placebo group. During weeks 1 through 16, 64 of 108 participants (59%) in the buprenorphine implant group received supplemental sublingual buprenorphine-naloxone tablets for a median of 7.5 days for emergent withdrawal or craving, whereas 50 of the 55 patients in the placebo group (91%) received the buprenorphine-naloxone tablets for a median of 19.5 days. The buprenorphine implant group received a mean dose of 94.1 mg (95% confidence interval [CI], 71.3-117.0 mg) for the weeks 1 through 16 and received an average daily dose of 9.8 mg (95% CI, 8.8-10.8 mg), whereas the placebo group received a mean of 208.3 mg (95% CI, 163.1-253.5 mg) for an average daily dose of 10.4 mg (95% CI, 9.3-11.4 mg). For weeks 17 through 24, 12% (13 of 108) in the buprenorphine implant group received a mean dose of 56.9 mg (95% CI, 29.2-84.6 mg) and an average daily dose of 12.7 mg (95% CI, 10.1-15.2 mg) for a median of 3 days, whereas 20% (11 of 55) in the placebo group received a mean of 175.8 mg (95% CI, 21.0-330.6 mg) and an average daily dose of 12.8 mg (95% CI, 9.8-15.8 mg) for a median of 7 days.

The most frequent reasons for early discontinuation in the buprenorphine implant group were nonadherence with the protocol and being lost to follow-up. In the placebo group, patients most frequently withdrew early because of treatment failure or nonadherence (Figure 1).

Of those who discontinued because of protocol nonadherence, 2 participants in the buprenorphine implant group and 1 in the placebo group missed 6 consecutive counseling sessions and were therefore withdrawn. There was no evidence of unscheduled implant removal or attempted removal.

Efficacy

A mean of 40.4% (95% CI, 34.2%-46.7%; median, 40.7%) of the 48 urine samples taken for each patient in the buprenorphine group during the first 16 weeks of the study tested negative for opiate use vs a mean 28.3% (95% CI, 20.3%-36.3%; median, 20.8%) in the placebo group (P = .04). The distributions of the percentage of 24 urine samples taken from week 17 through 24 that tested negative for opioid use also showed a statistically significant difference (P < .001). For the full 24-week treatment period for a total of 72 urine samples from each patient, the buprenorphine group had a mean 36.6% (95% CI, 30.5%-42.6%; median, 29.9%) of urine samples that tested negative for opioids vs 22.4% (95% CI, 15.3%-29.5%; median, 13.9%) for the placebo group (P = .01).

A mean of 42.9 (44.0%) urine samples were actually provided by patients for weeks 1 through 16 and 17.5 (31.1%) for weeks 17 through 24 for the buprenorphine group vs 31.9 (43.2%) for weeks 1 through 16 and 8.5 (14.1%) for weeks 17 through 24 for the placebo group. Retention in the study is shown in Figure 2.


Figure 2

 

reatment group differences were also evident on additional efficacy measures (Table 2). During weeks 1 through 16, 88 of 108 (81.5%) in the buprenorphine implant group remained in the study vs 28 of 55 (50.9%) in the placebo group (P < .001). A significant difference (P < .001) was also evident in completion rates for the full 24-week study period: 71 of 108 (65.7%), buprenorphine implant group; 17 of 55 (30.9%), placebo group. The buprenorphine implant group had lower scores for clinical (P < .001) and subjective (P = .004) opiate withdrawal and for opioid craving (P < .001) than those in the placebo group across 24 weeks of treatment. At week 24, there were significant differences between the treatment groups on the CGI-S (P <.001) and CGI-I (P < .001) rating scales favoring buprenorphine (Table 2).

 

No patients in the buprenorphine implant group met the definition of treatment failure; 30.9% (17of 55) of placebo patients were classified as treatment failures.

Safety

Ninety-three (86.1%) of those in the buprenorphine implant group had at least 1 adverse event vs 45 (81.8%) of those in the placebo group (Table 3). Implant site adverse events were the most common; these events were normal and expectable consequences of the surgical procedure (not due to difficulties with insertion or removal).

 

mong adverse events not related to implant site, headache and insomnia were the most common in the buprenorphine group. No significant treatment group differences were apparent for adverse events that occurred with 10% or greater frequency (Table 3). No adverse events resulted in discontinuation of treatment in the placebo group. In the buprenorphine group, 3.7% of the patients experienced adverse events for which they were discontinued. These adverse events were implant site pain and infection (2 cases), implant site pain, and elevated liver enzymes. Two patients (1.9%) in the buprenorphine implant group experienced serious adverse events compared with 4 (7.3%) in the placebo group. One patient with a history of pulmonary embolism and chronic obstructive pulmonary disease in the buprenorphine group had a pulmonary embolism and an exacerbation of chronic obstructive pulmonary disease, and these events were judged as possibly related to treatment (because of the effect of opioids on respiratory function). The other patient experienced a burn injury. In the placebo group, 1 patient experienced suicidal ideation, another had pneumonia and cellulitis (related to implant site), another had a relapse of opioid dependence resulting in hospitalization, and another had respiratory failure. The patient with pneumonia and cellulitis was hospitalized for 1 day, during which time an incision and drainage were performed on the infected site, and the patient was treated with intravenous and oral antibiotics.

There were no clinically meaningful changes from baseline in vital signs, physical examinations, or electrocardiograms. No clinically significant changes from baseline were observed in hematology or coagulation values in either group. There was a minor increase in mean ALT and mean AST levels in the buprenorphine group, which was attributable to 1 patient who had significant increases in ALT and AST levels that were likely related to a hepatitis C infection and history of alcohol and drug use.

Pharmacokinetics

Mean (SD) steady state plasma buprenorphine concentrations over weeks 4 through 24 were 941 (832) pg/mL vs 495 (720) pg/mL in the placebo group, and the respective medians were 775 pg/mL (range, 378-8070 pg/mL) vs 237 pg/mL (range, 0-3070 pg/mL). The plasma buprenorphine in the placebo group can be attributed to use of rescue sublingual buprenorphine-naloxone tablets and possibly buprenorphine obtained from outside the study.

his study demonstrated that buprenorphine implants are effective in the treatment of opioid dependence over a 24-week period following implantation. Of particular clinical importance are the favorable urinalysis toxicology results and the good patient retention—with 65.7% of patients who received the active implants completing 24 weeks of treatment without experiencing craving or withdrawal symptoms that necessitated withdrawal from the study. In contrast, a recent study reported a median duration of 40 days for individuals who received sublingual buprenorphine in clinical settings.12 Available 6-month trials of sublingual buprenorphine have reported retention rates of 35%,20 38%,21 and 35%.22

The improved retention rate was found in the current study despite the buprenorphine implants resulting in relatively low plasma concentrations of buprenorphine. Given the known pharmacokinetics of buprenorphine,23 the steady state plasma concentration levels are consistent with a constant buprenorphine release of 1 to 1.3 mg/d from 4 to 5 buprenorphine implants. Results from the prior phase 2 study showed that average plasma concentrations of buprenorphine implants were lower than trough plasma concentrations of sublingual buprenorphine measured in the same patients (prior to implants) and that the initial pulse of buprenorphine in the 24 hours following implant insertion was less than half of peak plasma concentration observed with sublingual buprenorphine prior to implant insertion.13 Extrapolating from the low buprenorphine plasma concentrations, it is possible that a higher number of implants would result in greater efficacy. However, no patients in the buprenorphine implant group exceeded the criterion for treatment failure based on the need for sublingual buprenorphine-naloxone tablets. Thus, it appears that 4 or 5 implants are sufficient to control most cravings and withdrawal symptoms.

Minor implant site reactions were common. However, only 1 patient in the placebo group experienced a major implant site reaction (cellulitis). There was no evidence of unscheduled implant removal or attempted removal. Thus, diversion of the buprenorphine implants appears unlikely.

Several limitations of this study are important to consider: (1) All patients received psychosocial counseling in addition to implants. The extent to which the efficacy of the implants is dependent on this ancillary counseling is not known, although this is the standard of care in addiction treatment. (2) Placebo patients had an average buprenorphine plasma concentration that was almost half that of the active implant group due to the need for rescue buprenorphine-naloxone treatment. The use of rescue buprenorphine-naloxone treatment complicates the interpretation of study results, particularly the plasma buprenorphine levels. (3) The current trial was not statistically powered to examine efficacy within subgroups of patients. The number of implants and extent of supplemental sublingual buprenorphine-naloxone treatment may need to vary depending on initial severity of opioid dependence, duration of opioid dependence, or type of opioid. (4) Attrition was high because of the regulatory requirement to include a placebo control.

In summary, this study found that the use of buprenorphine implants compared with placebo resulted in less opioid use over 16 weeks and also across the full 24 weeks.

os Angeles – Subkutane Implantate könnten die Compliance der Opiatabhängigen bei der Buprenorphin-Substitution verbessern und einen Schwarzmarkt verhindern. Eine Phase-III-Studie im US-amerikanischen Ärzteblatt JAMA 2010; 304: 1576-1583) attestiert dem Präparat eines US-Herstellers jetzt eine passable Wirksamkeit. In der Substitutionstherapie von Heroinabhängigen ist Buprenorphin eine attraktive Alternative zu Methadon. Denn der partielle Opiat-Agonist ist weniger anfällig gegenüber Überdosierungen und auch außerhalb der großen Substitutionszentren verfügbar. In vielen Ländern ist die sublinguale Buprenorphin-Substitution deshalb sehr beliebt.

Es lässt sich allerdings kaum verhindern, dass das starke Opiat auf den Schwarzmarkt gelangt – selbst wenn es in vielen Ländern mit dem Antagonisten Naloxon versetzt ist. Bei einer unzuverlässigen Einnahme kommt es außerdem schnell zu Entzugssymptomen und die Rückfallquote der Patienten ist deshalb hoch.

Beide Probleme könnten durch subkutane Implantate gelöst werden, die den Wirkstoff über mehrere Monate kontrolliert freisetzen. Das Präparat eines US-Herstellers wurde jetzt an 18 Behandlungszentren des Landes in einer Phase-III-Studie untersucht.

 

08 Patienten – zu zwei Drittel Heroin-, zu einem Drittel Medikamentenabhängige – wurden jeweils vier 26 mm lange und 2,5 mm dicke Implantate in 2 bis 3 mm Tiefe ins Unterhautfettgewebe am Arm eingebracht.

Wenn notwendig konnten die Probanden ein fünftes Implantat erhalten. Nach 6 Monaten wurden alle Implantate entfernt, was einen kleinen chirurgischen Eingriff erfordert, der eine kurze Narbe hinterlässt. In einer Vergleichsgruppe von 55 Patienten wurden Implantate mit Placebo implantiert, was ethisch gerechtfertigt war, weil die Patienten in beiden Gruppen bei Bedarf zusätzlich Sublingualtabletten mit Buprenorphin erhalten konnten.

Wie Walter Ling von der Universität Los Angeles und Mitarbeiter berichten, erhöhten die Buprenorphin-Implantate den Anteil der negativen Urinkontrollen – als Hinweis auf einen fortgesetzten Drogenkonsum – von durchschnittlich 28,3 auf 40,4 Prozent.

Auch in den sekundären Endpunkten wurde eine Wirksamkeit nachgewiesen: Insgesamt 65,7 gegenüber 30,9 Prozent nahmen bis zum Schluss an der Studie teil. Auch die Häufigkeit von Entzugssymptomen wurde ebenfalls signifikant gesenkt.

Im Buprenorphin-Arm gab es keine Therapieversager: Alle kamen mit vier oder fünf Implantaten aus. Im Placebo-Arm wurden 30,9 Prozent der Patienten als Therapieversager eingestuft, weil sie häufiger als dreimal in der Woche Sublingualtabletten nachfragten.

Die Implantate lösten nur geringe Lokalreaktionen aus, wobei es zwischen Buprenorphin und Placebo keine Unterschiede gab. Der Hersteller führt derzeit eine zweite Phase-3-Studie durch und will sich nach deren Abschluss um eine Zulassung in den USA und in Europa bemühen. © rme/aerzteblatt.de

Die Krankenkassen haben die Behandlung von schwer Opiatabhängigen zur Regelleistung erklärt. Diamorphin darf nur in speziellen Einrichtungen verabreicht werden.

Hamburg. Die Behandlung schwerstkranker opiatabhängiger Patienten mit Diamorphin ist als Regelleistung der gesetzlichen Krankenkassen in den Leistungskatalog aufgenommen worden. Für Hamburg haben Verbände der gesetzlichen Krankenkassen mit der Kassenärztlichen Vereinigung Hamburg (KVH) eine entsprechende Honorarvereinbarung geschlossen, wie die Krankenkassen am Donnerstag in einer gemeinsamen Erklärung mitteilten. Zuvor hatte der Gemeinsame Bundesausschuss (G-BA) diese Behandlung geprüft und insbesondere die Erfahrungen in den Modellversuchen unter anderem in Hamburg ausgewertet.

Bei Diamorphin handelt es sich den Angaben zufolge um synthetisches Heroin. Schwerstkranke opiatabhängige Patienten erhalten das Medikament, wenn sie mit herkömmlichen Methoden nicht therapierbar sind. Für diese Behandlung kommen laut G-BA-Beschluss ausschließlich schwerstabhängige Patienten infrage. Diese müssen seit mindestens fünf Jahren abhängig sein, zwei erfolglos beendete beziehungsweise abgebrochene Suchtbehandlungen hinter sich und das 23. Lebensjahr vollendet haben.

Die Regelung sieht zudem vor, dass eine begleitende psychosoziale Betreuung mit einer Dauer von mehr als sechs Monaten stattfindet. Die Behandlung mit Diamorphin darf nur in speziell dafür geeigneten Einrichtungen vorgenommen werden. In Hamburg ist dies die Ambulanz Altona der Abteilung für Abhängigkeitserkrankungen der Asklepios Klinik Nord. (dapd/abendblatt.de)

Fensterlose Räume mit Sicherungen wie in einer Bank, verdeckt installierte Überfallmelder – so sollen die Zentren aussehen, in denen in Baden-Württemberg künftig Diamorphin abgegeben wird.

STUTTGART (fst). Das Landeskabinett in Stuttgart hat nach langem internen Widerstand Mitte Juni den Rechtsrahmen für die Umsetzung der diamorphingestützten Substitution in Baden-Württemberg vorgelegt. Das entsprechende Bundesgesetz ist bereits seit Juli 2009 in Kraft.

Mappus galt als rigoroser Kritiker des Projekts

Doch als Stefan Mappus (CDU) im Februar zum Ministerpräsidenten gewählt wurde, hielt man im Sozialministerium die Luft an: Mappus war – wie viele CDU-Kollegen im Südwesten –  als rigoroser Kritiker der Diamorphinabgabe in Erscheinung getreten. “Wir sind nicht bereit, finanziell in die Bresche zu springen”, sagt der damalige CDU-Fraktionschef noch im Oktober 2008, als es um eine Anschlussfinanzierung für die Karlsruher Heroinambulanz ging.

Mit dem Kabinettsbeschluss hat Mappus zähneknirschend zugestimmt. Doch die administrativen Hürden sind hoch – Experten meinen: zu hoch. Das Sicherheitskonzept für die vermutlich zehn Standorte, an denen Diamorphin abgegeben werden soll, ist aufwändig. “Die baulichen Anforderungen sind – gelinde gesagt – übertrieben”, sagt Dr. Gisela Dahl, Vorstandsmitglied bei der KV Baden-Württemberg. Das Beste sei, man kaufe für die Einrichtungen “eine alte Bank”, meint Dahl. Denn das sechsseitige Sicherheitskonzept verlangt quasi den Bau eines Hochsicherheitstrakts für Lagerung und Abgabe des Diamorphins – Überfall- und Einbruchmeldeanlage mit Direktschaltung zur Polizei inklusive. Weil diese Infrastruktur kein Arzt alleine stemmen kann, zahlt das Land für jeden Standort einen Investitionszuschuss von 100 000 Euro.

Die politischen Debatten im Vorfeld hat KV-Vorstand Dahl nie verstanden: “Es geht um eine medizinische Behandlung, nicht um ein Politikum.” Die Suchtmedizinerin Dr. Inge Hönekopp, die in Mannheim eine Methadon-Schwerpunktpraxis leitet, erinnert an den Modellversuch, der dem Beschluss des Bundestags im Juli 2009 vorausgegangen ist: “Die Begleitforschung zum Modellprojekt über die heroingestützte Behandlung Opiatabhängiger hat klar ergeben, dass diese Behandlungsform medizinisch und ökonomisch für Patienten, die GKV und die Gesellschaft insgesamt vorteilhaft ist.” Der Kreis der in Frage kommenden Suchtkranken werde sehr klein sein. “In Mannheim werden es 15 bis 30 Personen sein. Ich denke, dass sich diese Zahl aber noch erhöhen wird”, sagt Hönekopp. Insgesamt wird landesweit mit bis zu 300 Teilnehmern gerechnet.

Wahrscheinlich werden im laufenden Jahr nur die Standorte Karlsruhe und Stuttgart an den Start gehen. Dahl hofft, dass bis Ende 2011 auch Einrichtungen in Mannheim, Freiburg, Heilbronn, Tübingen/Reutlingen, Singen, Ulm und Ravensburg den Betrieb aufnehmen können.

Honorierung der Ärzte ist noch ungewiss

Aus Sicht des KV-Vorstands ist nicht ausgemacht, ob sich genügend Ärzte für die Arbeit in den Spezial-Einrichtungen finden. Denn unklar ist auch noch die Honorierung der Ärzte. Anfang Juli wird dazu im Bewertungsausschuss eine Entscheidung erwartet. Dass in der Politik das Misstrauen gegenüber substituierenden Ärzten noch längst nicht passé ist, zeigte im Dezember 2009 ein Papier der baden-württembergischen Landesregierung zur Honorierung der Diamorphin-Abgabe. Werde die Substitution “zu schlecht bezahlt, finden sich keine qualifizierten Ärzte, wird sie zu gut bezahlt, wird der Wechsel auf andere Substitutionsmittel erschwert”, heißt es. Für KV-Vorstand Dahl eine befremdliche Sichtweise: “Ich gebe doch nicht Heroin ab, weil ich damit mehr Geld verdiene.”

Diamorphingestützte Substitution

Mit dem Gesetz zur diamorphingestützten Substitution hat der Bundestag im Juli 2009 einen Rechtsanspruch für Schwerstabhängige auf entsprechende Behandlung geschaffen.
Allerdings gelten für potenzielle Teilnehmer strenge Voraussetzungen: Die Betroffenen müssen unter anderem mindestens 23 Jahre alt und seit fünf Jahren opiatabhängig sein sowie mindestens zwei erfolglose Therapieversuche mit Methadon oder Subutex hinter sich haben. Anders als bei der Methadon-Substitution ist eine Take-home-Regelung verboten. Außerdem gilt ein Sondervertriebsweg, bei dem das Diamorphin vom Hersteller direkt zu den substituierenden Einrichtungen transportiert wird.
Der Gemeinsame Bundesausschuss hat zudem Mitte Juni festgelegt, dass Patienten, die Diamorphin erhalten, in den ersten sechs Monaten psychosozial betreut werden. Hoch sind auch die Anforderungen an die Einrichtungen. Sie müssen mindestens drei Ärzte in Vollzeit beschäftigen und die Behandlung täglich über zwölf Stunden sicherstellen. Alle beteiligten Ärzte müssen über suchttherapeutische Qualifikationen verfügen oder sie müssen mindestens sechs Monate beim Modellprojekt zur heroingestützten Behandlung tätig gewesen sein.

Diamorphinabgabe im Südwesten nach strengen Regeln

STUTTGART (fst). Das baden-württembergische Landeskabinett hat nach langem internen Streit eine Grundlage für die diamorphingestützte Substitution geschaffen. Sozialministerin Monika Stolz (CDU) betonte, man setze den Rechtsanspruch für Schwerstabhängige “mit der gebotenen Sorgfalt um”. Dabei solle der Missbrauch von Diamorphin “sicher ausgeschlossen” werden.

Für Baden-Württemberg wird mit 200 bis 300 Teilnehmern gerechnet. Um eine Zulassung zu erhalten, müssen die Träger in das örtliche System der Suchtkrankenhilfe eingebunden sein. Im Gespräch sind Standorte in Mannheim, Karlsruhe, Freiburg, Heilbronn, Stuttgart, Tübingen/Reutlingen, Singen, Ulm und Ravensburg. Die Einrichtungen sollen Investitionszuschüsse von 100 000 Euro erhalten, um die strengen Sicherheitsvorschriften erfüllen zu können.

Erwartet wird, dass Karlsruhe als erster Standort einen Genehmigungsantrag stellen wird. Auch in Stuttgart seien die Planungen “recht weit fortgeschritten”. Für alle anderen genannten Städte erwartet Stolz einen Start erst im kommenden Jahr.
Das vom Bundestag verabschiedete Gesetz zur diamorphingestützten Substitution ist am 21. Juli 2009 in Kraft getreten.

Methods and definitions

1. EMCDDA definition

‘Drug-related death’ is the term used by the EMCDDA to refer to deaths happening shortly after consumption of one or more psychoactive drugs, and directly related to this consumption. Often these deaths are referred as ‘overdoses’, although equivalent concepts are also ‘deaths directly related to drug use’, ‘poisonings’ or ‘drug-induced deaths’.

Most national statistics refer to these deaths, which are usually recorded through general mortality registries or special registries (forensic or police).

The EMCDDA has developed a common definition, in agreement with national experts (see below summary definition and also the DRD-Standard protocol) focusing on those deaths directly related to consumption of illegal substances (although alcohol or psychoactive medicines are also found frequently in the toxicological analysis).

At present, national statistics are improving in most countries and their definitions are becoming the same, or relatively similar, to the common EMCDDA definition. Some countries still include cases due to psychoactive medicines or non-overdose deaths, generally as a limited proportion (Drug-related deaths: ‘National definitions’ specifies in detail the definition of drug-related death used in each Member State).

In addition, there are still differences between countries in procedures of recording cases, and in the frequency of post-mortem investigation (including autopsy rates). In some countries information exchange between general mortality registries and special registries (forensic or police) is insufficient or lacking, which compromise the quality of information.

Direct comparisons between countries in the numbers or rates of drug-related deaths should be made with caution; but if methods are maintained consistently within a country, the trends observed can give valuable insight when interpreted together with other drug indicators.

In addition to deaths directly related to the use of drugs, also deaths indirectly related to drug use (e.g. AIDS, accidents, suicides, violence) should also be taken into account from a public health perspective, although their estimation requires different methodologies and data sources. The EMCDDA Report CT.00.RTX.22 presents an example of methodology to estimate the ‘total burden of mortality’ related to drug use that includes both deaths directly and indirectly related to drugs (Annex 1, pages 47 to 53).

The EMCDDA definition of drug-related deaths

The EMCDDA definition of drug-related death in the Key Indicator ‘Drug-related deaths and mortality among drug users’ refers to those deaths that are caused directly by the consumption of drugs of abuse. These deaths occur generally shortly after the consumption of the substance(s).

The cases are selected as follows:

  1. The preferred method to estimate the number of deaths is to extract cases from existing general mortality registries according to the following criteria:

based on the WHO International Classification of Diseases, 9th edition -ICD-9-

Cases will be counted when their underlying cause of death was drugs psychoses, drug dependence, nondependent drug abuse, accidental poisoning, suicide and self-inflicted poisoning, and poisoning with undetermined intent.

Cases will be included when the death was due to a standard list of specific drugs: opiates, cocaine, amphetamines and derivates, cannabis, and hallucinogens.

The precise ICD-9 codes to be selected are the following:

Category of drug-related death

Selected ICD-9 code(s)

Drug psychoses

292

Drug dependence

304.0, 304.2-9

Nondependent drug abuse

305.2-3, 305.5-7, 305.9

Accidental drug poisoning

E850.0, E850.8 (1), E854.1-2, E855.2, and E858.8 (1)

Suicide and self-inflicted drug poisoning

E950.0 (1) , E950.4 (1)

Drug poisoning undetermined intent

E980.0 (1), E980.4 (1)

(1) In combination with N-codes (N965.0, and/or N968.5, and/or N969.6, and/or N969.7

This selection was agreed by the EMCDDA expert group on drug-related deaths. It was called ‘Selection B’ for general mortality registries based on ICD-9.

based on the WHO International Classification of Diseases, 10th edition -ICD-10-

Case will be counted when their underlying cause of death was mental and behavioural disorders due to psychoactive substance use (see list of substances below) or poisoning accidental, intentional or undetermined intent (see list of substances below)

  • Harmful use, dependence, and other mental and behavioural disorders due to:

    • opioids (F11)

    • cannabinoids (F12)

    • cocaine (F14)

    • other stimulants (F15)

    • hallucinogens (F16)

    • multiple drug use (F19)

  • Accidental poisoning (X41, X42), intentional poisoning (X61, X62), or poisoning by undetermined intent (Y11, Y12) by:

    • opium (T40.0)

    • heroin (T40.1)

    • other opioids (T40.2)

    • methadone (T40.3)

    • other synthetic narcotics (T40.4)

    • cocaine (T40.5)

    • other and unspecified narcotics (T40.6)

    • cannabis (T40.7)

    • lysergide (T40.8)

    • other and unspecified psychodysleptics (T40.9)

    • psychostimulants (T43.6)

The T-codes are to be selected in combination with the respective X-codes and Y-codes.

Underlying cause of death

Selected ICD-10 code(s)

Disorders

F11-F12, F14-F16, and F19

Accidental poisoning

X42 (1), X41 (2)

Intentional poisoning

X62 (1), X61 (2)

Poisoning undetermined intent

Y12 (1), Y11 (2)

(1) in combination with the T-codes: T40.0-9

(2) in combination with T code: T43.6.

This selection was agreed by the EMCDDA expert group on drug-related deaths. It was called ‘Selection B’ for general mortality registries based on ICD-10.

  1. An alternative method is to estimate the number of deaths by extracting cases from existing special registers (forensic or police registries). The method based on the special registries will be applied in countries where the preferred method cannot be implemented, but also will be used whenever possible as a backup estimate for the general mortality registries.

Cases will be counted when the death was due to poisoning by accident, suicide, homicide, or undetermined intent.

Cases will be included when the death was due to opiates, amphetamines, cocaine (or crack), cannabis, hallucinogens, solvents, or synthetic designer drugs like amphetamine derivates.

The precise groups of deaths are the following:

Category of drug-related death

Selected groups

Poisoning by accident, suicide, homicide, or undetermined intent

Opiates only (excluding methadone only)

Methadone only

Poly-substances including opiates

Poly-substances excluding opiates

Unspecified/unknown

- ‘poly-substances’ should include at least one of the above mentioned substances

- ‘unspecified/unknown’ will be included when it is assumed to include one of the above mentioned substances

This selection was agreed by the EMCDDA group of experts. It was called ‘Selection D’ for special registries

For more information on EMCDDA work on drug-related deaths see:

http://www.emcdda.eu.int/?nnodeid=1419.

For the EMCDDA protocol ‘DRD-Standard Protocol’ see:

http://www.emcdda.eu.int/?nnodeid=1837.

2. Drug-related deaths: ‘National definitions’

Definitions of ‘acute drug-related death’ in EU Member States, as used to report cases for the EMCDDA annual report

(It is recommended that for reporting to the EMCDDA, the national definitions are in line with the EMCDDA definition)

Austria

Case definition

EMCDDA standard definition for special registries (‘Selection D’)

Technical information

‘Selection D’ is described in the protocol EMCDDA-DRD Standard, version 3.0 (for special registries)

Data collection procedure

Cases are reported by the police and hospitals to the Federal Ministry of Health and Women, which orders and checks the results of forensic examinations.

Reference

Suchtgiftbezogene Todesfälle-Statistik; Federal Ministry of Health and Women

Remarks

Belgium

Case Definition

EMCDDA definition for general mortality registries(‘Selection B’ for ICD-9)

Technical information

‘Selection B’ is described in the protocol EMCDDA-DRD Standard, version 3.0 (for general mortality registries)

Data collection procedure

Cases are reported by health authorities of the French and Flemish Communities that collect death certificates filled by physicians. The National Institute of Statistics centralises the morbidity statistics of the two communities

Reference

National Institute of Statistics. General mortality registry: personal communication (ad-hoc data extraction for REITOX national focal point for the 2002 National Report).

Remarks

Since 1998, cases will be selected by ICD-10 codes

Denmark

Case definition

A death is included in the statistics, if the death is caused by poisoning and also non-overdose deaths, such as for example accidents and suicides. The definition includes deaths due to all forms of narcotic substances.

OR

A death is included in the statistics, if

(1) the dead is causes by poisoning (or)

(2) there is a strong causal relation between use of drugs and death

Technical information

If no report from autopsy is available, the case is decided on available information of the deceased and circumstances of death.

Data collection procedure

Cases are reported from forensic institutes to the National Commission of Police.

Reference

www.politi.dk

Remarks

Finland

Case definition

From 1988 through 1995 (ICD-9, Finnish adaptation), deaths due to identified drugs by:

  • Diseases (dependence, harmful use, substance induced brain syndrome);

  • accidental poisoning;

  • events of undetermined intent.

From 1996 onwards, EMCDDA definition for general mortality registries(‘Selection B’ for ICD-10)

Technical information

From 1988 through 1995 cases selected by ICD-9 (Finnish adaptation. See Finnish National Report 2003, Appendix 7)

From 1996 onwards, ‘Selection B’ for ICD10, which is described in the protocol EMCDDA-DRD Standard, version 3.0 (for general mortality registries)

Data collection procedure

Collection and processing of causes of death statistics at Statistics Finland.

Reference

STAKES. General mortality registry. Personal communication (Ad-hoc data extraction for REITOX national focal point for the 2004 National Report)

Remarks

The Finnish adaptation of ICD-9 did not allow the implementation of ‘Selection B’ of DRD standard protocol. For these reason, Selection B is only available from 1996 onwards, where ICD-10 was implemented.

The breach of trends observed between 1995 and 1996 could be in part due to change from ICD-9 to ICD-10 and to change from national definition to Selection B

France

Case definition

  • Deaths due to overdose in the strictest sense of the term.

  • Deaths occurring directly and immediately after consumption of drugs.

Technical information

Data collection procedure

After investigations following suspicious death, which generally include an autopsy and a toxicological analysis, cases are reported by the police and the Gendarmerie to the Office Central pour la Répression du Traffic Illicite de Stupéfiants (OCRTIS) at the Ministry of the Interior.

Reference

Office central pour la répression du trafic illicite des stupéfiants (2004) Usage et trafic des produits stupéfiants en France en 2003, OCRTIS, Nanterre

Remarks

Deaths due to poisoning by psychoactive medicines are included but, in practice, case definition is an approximation to ‘Selection D’ (only 10 cases of difference in 2003)

Germany

Case definition

  • Deaths following intentional or unintentional overdose.

  • Deaths as a result of long-term abuse.

  • Deaths due to suicide resulting from despair about the circumstances of life or the effects of withdrawal symptoms.

  • Deaths due to fatal accidents suffered by people under the influence of drugs

Technical information

Data collection procedure

Cases are reported by local police units that are working jointly with the forensic physicians, to the National Police Department, the Federal Criminal Police Office (BKA) that records the information.

Reference

Bundeskriminalamt OA21 (2004). Bundeslagebild Rauschgift 2003. Wiesbaden: Bundekriminalamt

Remarks

  • From 1985 through 1990, the figures only refer to the former West Germany (the old Länder).

Since 1991, the figures refer to the reunited Germany, which includes the old and the new Länder.

Greece

Case definition

EMCDDA standard definition for special registries (‘Selection D’)

In national terms:

  • Deaths caused by overdose.

  • Deaths caused by the synergic activity of different drugs.

Technical information

‘Selection D’ is described in the protocol EMCDDA-DRD Standard, version 3.0 (for special registries)

Data collection procedure

Cases of sudden death are notified to the police who refer the cases to the forensic department for autopsy and toxicology, which notifies the police of the results. Cases are then reported by local police units to Section C of the Directory of Public Security at the Ministry of Public Order (Hellenic Police). Statistics are reported by the National Anti-Drug Co-ordinative Unit, National Anti-Drug Intelligence Unit, Joint Secretariat.

Reference

Hellenic Police, 2004. Reference for 2003 data: http://www.ydt.gr

Remarks

Ireland

Case definition

  • Deaths due to drug dependence.

  • Deaths due to poisoning by opiates and related narcotics.

Technical information

Cases selected by ICD-9 codes

- 304 (drug dependence)

- 965.0 (poisoning by opiates and related narcotics)

Data collection procedure

Cases are reported by regional registrars of births and deaths, who collect information from doctors, the police, and coroners, to the general mortality register at the Central Statistics Office (CSO).

Reference

Central Statistics Office, Vital Statistics Section

Remarks

The increase between 1995 and 1997 is (partly) due to an increased awareness of the need for more accurate information and reporting.

Italy

Case definition

EMCDDA standard definition for special registries (‘Selection D’)

In national terms:

Deaths directly attributed to drug misuse (acute intoxication, overdose) and reported by local and special police units to the Central Drugs Directorate.

Technical Information

‘Selection D’ is described in the protocol EMCDDA-DRD Standard, version 3.0 (for special registries

Data collection procedure

Cases are reported by local and special police units to the Central Drugs Directorate at the Ministry of the Interior.

Reference

Relazione Annuale 2003. Direzione Centrale per i Servizi Antidroga (DCSA), Ministero dell’Interno

Remarks

Luxembourg

Case definition

Deaths caused by acute/direct reaction to the use of illegally acquired high risk consume (HRC) drugs.

Technical information

Fatal (accidental, intentional or of undetermined intention) intoxication caused by

the use of at least one illicitly acquired drug or

other drug(s) in case the victim has been known as a persistent user of illicitly acquired drugs.

Death is due to the acute pharmacological and or toxicological effects(s) of the consumed substances(s)

Data collection procedure

All suspected deaths require a judicial enquiry, and after forensic evidence from autopsy, cases are reported by the local police to the special drug section (SDU) of the judicial police.

Reference

Origer, A.(in press). National report on the state of the drugs problem -RELIS 2003. NFP – CRP-Santé. Luxembourg

Remarks

Netherlands

Case definition

EMCDDA definition for general mortality registries(‘Selection B’)

From 1985 through 1995, based on ICD-9

Since 1996, based on ICD-10

Technical information

‘Selection B’ is described in the protocol EMCDDA-DRD Standard, version 3.0 (for general mortality registries)

Data collection procedure

Cases are reported by municipal registrars, who collect information from physicians and coroners, to the causes of death statistics at Statistics Netherlands.

Reference

Causes of death statistics, Statistics Netherlands

Remarks

Only persons retrievable in the Dutch population register are included

Norway

Case definition

Death due to misuse of illegal drugs (Drug dependence or poisoning).

mental and behavioural disorders due to drug use

accidental or undetermined poisoning by drugs of abuse

Technical information

  • Up to 1996, cases were selected by ICD-8 and ICD-9 codes (304).

  • Since 1996, the ICD-10 codes used (underlying causes) are:

F11-F12, F14-16, F19,

X42 and Y12 in combination with T40.0-9

X41 and Y11 in combination with T43.6.

Data collection procedure

Registry of causes of death, from Statistics Norway. Data from Statistics Norway are manly based on autopsy reports from the National Institute of Forensic medicine.

Reference

Statistics Norway

Remarks

National definition is an approximation to ‘Selection B’ for ICD-10 but excluding ‘intentional poisoning’ (X61 and X62)

Portugal

Case definition

A person whose post-mortem toxicological analysis is positive for any illicit drug of abuse (whatever was the cause of death.

Technical information

  • The proportion of cases with positive toxicology and information on presumed cause of death suspected to be acute drug-related deaths were: 44 % (2003), 58 % (2002) and 73 % (2001)

  • The cases refer to Lisbon, Oporto and Coimbra regions

Data collection procedure

Cases are reported to the delegations at the three forensic institutes of the Ministry of Justice.

Reference 2003

Relatório Anual do IDT- 2003. Lisboa

Remarks

Due to under-reporting in previous annual reports, more cases are reported in the annual report since 1995.

Spain

Case definition

Deaths due to acute reaction following non-medical use of psychoactive substances

Technical information

  • From 1985 through 1995: Deaths due to acute reactions following opiate or cocaine consumption.

  • Since 1996: Deaths due to acute reactions following consumption of any psychoactive drug.

  • The cases refer to five large cities Barcelona, Bilbao, Madrid, Valencia, and Zaragoza.

Data collection procedure

Cases are reported by medical pathologists for the Mortality Indicator at the Delegación del Gobierno para el Plan Nacional Sobre Drogas (DGPNSD).

Reference 2003

1990 to 1995 State Information System on Drug Abuse (SEIT) Reports.

1996 to 2002 Unpublished reports

Remarks

Deaths due to poisoning by psychoactive medicines are included, but in practice, case definition is an approximation to ‘Selection D’ (only 1 case of difference in 2002)

A small breach of trend took place in 1996 due to a change from reporting only on opiate and cocaine cases to all psychoactive substances.

Sweden

Case definition

EMCDDA definition for general mortality registries(‘Selection B’ for ICD-10)

Cases codified with T40.4 are excluded (in Sweden are mainly due to dextropropoxifen poisonings)

Technical information

‘Selection B’ is described in detail in the protocol EMCDDA-DRD Standard, version 3.0 (for general mortality registries)

Data collection procedure

Cases are reported by physicians to the cause of death register at Statistics Sweden and are reported and published by the Epidemiological Centre of the National Board of Health and Welfare (NBHW).

Reference

National Death Cause Registry (Run by the Epidemiological Centre, at the NBHW)

Remarks

In 2003 ‘national case definition’ was adapted to the EMCDDA definition (Selection B) with the exception described

United Kingdom

Case definition

  • Deaths due to drug dependence.

  • Deaths due to nondependent abuse.

  • Deaths due to accidental, suicidal, or undetermined poisonings.

Technical information

  • England and Wales, Northern Ireland and Scotland (‘ONS standard definition’)

Based on ICD-9 Classification:

292 (Drug psychoses),

304 (Drug dependence),

305.2 – 9 (Non-dependent abuse of drugs),

E850 – E858 (Accidental poisoning by solid or liquid substances – drugs, medicaments, and biologicals),

E950.0 – 5 (Suicide and self-inflicted poisoning by solid or liquid substances – drugs and medicaments),

E980.0 – 5 (Poisoning by solid or liquid substances, undetermined whether accidentally or purposely inflicted – drugs and medicaments),

E962.0 (Assault by poisoning – drugs and medicaments).

Scotland (From 2000) and England & Wales and N Ireland (From 2001) (‘ONS standard definition’

Based on ICD-10 Classification:

F11-F16, F18, F19,

X40-X44 (accidental poisoning),

X60-X64 (intentional self poisoning),

Y85 (assault by drugs, medicaments and biological substances),

Y10-Y14 (poisoning undetermined intent).

Data collection procedure

Cases from England and Wales are reported to the Office for National Statistics (ONS), cases for Northern Ireland are reported to the General Register Office (Northern Ireland) and cases for Scotland are reported to the General Register Office (Scotland).

Reference 2003

See Health Statistics Quarterly, Nos 5, 7, 9, 11, 13, 17 & 21, ONS 2000, 2001, 2002, 2003 & 2004

Remarks

Drug Strategy Definition

Recently it has been developed an additional national definition that in this reports is referred as ‘UK Drug Strategy Definition’.

The UK Drug Strategy Definition is a more restrictive extract from the ONS description that focuses on drugs controlled under the Misuse of Drugs Act of 1971. Drugs controlled by the Misuse of Drugs Act include class A, B and C drugs.

A description of this definition is given in the Annexed Box 1) ‘UK Drug Strategy Definition’.

This definition produces estimates approximated to the EMCDDA Standard ‘Selection B’.

Figures reported on the basis of this definition are presented separately in Table DRD-2 part (ii).

National Programme on Substance Abuse Deaths (np-SAD)

In addition, in the UK there is a special registry on drug-related deaths within the National Programme on Substance Abuse Deaths (np-SAD). This registry is based on data submitted voluntarily by coroners.

This registry can produce estimates for the EMCDDA Standard ‘Selection D’.

A description of this special registry is given in the Annexed Box (2) ‘UK np-SAD’.

Notes:

1) ICD-9, ICD-10 = International Classification of Diseases, edition 9, edition 10, established by the World Health Organisation (WHO).

2) In some countries, traditional definitions of ‘drug-related deaths’ used at national level are different from those presented here and may also include cases related to medicines, or some other deaths indirectly related to drug use (e.g. diseases, accidents).

(1) Annexed Box ‘UK Drug Strategy Definition’

UK Drug Strategy definition

Extract from ONS description (based on ICD-9)

A) Deaths where the underlying cause of death has been coded to the following categories:

Drug psychoses (292);

Drug dependence (304.0 -.5 and 304.7-.9);

Nondependent abuse (305.2 -.9)

B) Deaths coded to the following categories and where a drug controlled under the Misuse of Drugs Act 1971 was mentioned on the death record:

- Accidental poisoning by drugs, medicaments and biologicals (E850-E858);

- Undetermined whether accidentally or purposely inflicted (E980.0-E980.5);

- Assault by poisoning – drugs and medicaments (E962.0)

- Dependence on other drugs (304.6).

Notes:

1. Deaths coded to opiate abuse which resulted from the injection of contaminated heroin have been included in the indicator. This is opposite to the approach taken in Scotland, where these deaths have been excluded for 2000.

2. Specific rules were adopted for dealing with compound analgesics which contain relatively small quantities of drugs listed under the Misuse of Drugs Act, the major ones being dextropropoxyphene, dihydrocodeine and codeine. Where these drugs are present on a death record, they have been ignored if they are part of a compound analgesic (such as co-proxamol, co-dydramol or co-codamol) or cold remedy. Dextropropoxyphene has been ignored on all occasions. However, codeine or dihydrocodeine mentioned alone were included in the indicator.

3. Drugs controlled under the Misuse of Drugs Act 1971 include class A, B and C drugs.

Extract from ONS description (based on ICD-10)

a) deaths where the underlying cause of death was

F11; F12; F13; F14; F15; F16; and F19.

b) deaths coded to the following categories and where a drug listed under the Misuse of Drugs Act (1971) was known to be present in the body at the time of death:

accidental poisoning (X40 – X44);

intentional self-poisoning by drugs, medicaments and biological substances (X60 – X64);

assault by drugs, medicaments and biological substances (X85); and

event of undetermined intent, poisoning (Y10 – Y14)

Notes

Deaths excluded:

deaths coded to F10 (alcohol), F17 (tobacco) and F18 (volatile substances);

deaths coded to drug abuse which were caused by secondary infections and related complications

deaths from AIDS where the risk factor was believed to be the sharing of needles;

deaths from road traffic and other accidents which occurred under the influence of drugs; and

deaths where a drug listed under the Misuse of Drugs Act was present because it was part of a compound analgesic or cold remedy: examples are: Co-proxamol Co-dydramol and co-codamol. Dextropropoxyphene has been ignored on all occasions. However, deaths involving codeine or dihydrocodeine alone have been included.

(2) Annexed Box ‘National Programme Substance Abuse Deaths’

Special registry np-SAD

The National Programme on Substance Abuse Deaths (np-SAD), based in the Department of Addictive Behaviour and Psychological Medicine at St George’s Hospital Medical School in London, collects data from inquests held on drug-related deaths submitted voluntarily by coroners.

The electronic database’s current coverage is about four-fifths of all coroners’ jurisdictions in England and Wales. Recently coverage was extended to Scotland and Northern Ireland.

A ‘case’ is defined as a drug-related death where any of the following criteria are met at an inquest or fatal accident inquiry:

one or more psychoactive substances directly implicated in death;

history of dependence or abuse of psychoactive drugs; or

presence of controlled drugs at post-mortem.

New Member States and candidate countries

Note:

Reported separately in this edition of the statistical bulletin to highlight the developments of these countries.

Czech Republic

Case definition

Deaths due to poisoning caused by psychoactive substances (drugs of abuse and psychoactive medicines).

Technical information

Selection D of EMCDDA standard definition (drugs of abuse) PLUS deaths due to poisonings by psychoactive medicines

Data collection procedure.

Special semiautomated electronic registry run by national focal point and Society of Forensic Medicine and Toxicology.

Reference

Special mortality register – drug-related deaths in 2003. Prague: National Monitoring Centre for Drugs and Drug Addiction. Unpublished

Remarks

In 2003, according to the national definition, 167 cases out of a total of 222 were due to psychoactive medicines

Since the practice in Czech Republic does not allow to include into the GMR any examination newer than 3 days after the death, this registry is not observed for the purposes of drug epidemiology as appropriate.

Estonia

Case Definition

Cases according to the EMCDDA definition for general mortality registries(‘Selection B’ for ICD-9 classification):

Technical information

‘Selection B’ is described in detail in the protocol EMCDDA-DRD Standard, version 3.0 (for general mortality registries)

Data collection procedure

Reference

Ad hoc data extraction by national focal point from general mortality registry for the 2004 Reitox National Report

Remarks

Cyprus

Case definition

The EMCDDA standard definition for special registries (‘Selection D’) will be used.

Technical information

Data collection procedure

Reference 2003

Remarks

Not information provided yet.

Latvia

Case definition

Cases according to the EMCDDA definition for general mortality registries(‘Selection B’ for ICD-9 classification)

Technical information

‘Selection B’ is described in detail in the protocol EMCDDA-DRD Standard, version 3.0 (for general mortality registries)

Data collection procedure

Reference

Ad hoc data extraction from Forensic Medical Institute 2003

Remarks

Lithuania

Case definition

Cases according to the EMCDDA definition for general mortality registries(‘Selection B’ for ICD-9 classification):

Technical information

‘Selection B’ is described in detail in the protocol EMCDDA-DRD Standard, version 3.0 (for general mortality registries)

Data collection procedure

Reference

Ad hoc data extraction by national focal point from general mortality registry for the 2004 Reitox National Report

Remarks

Hungary

Case definition

Cases according to the EMCDDA definition for general mortality registries(‘Selection B’ for ICD-9 classification

Technical information

‘Selection B’ is described in detail in the protocol EMCDDA-DRD Standard, version 3.0 (for General Mortality Registries)

Data collection procedure

Reference

Ad hoc data extraction by national focal point from general mortality registry for the 2004 Reitox National Report

Remarks

Malta

Case definition

Cases according to the EMCDDA definition for general mortality registries(‘Selection B’ for ICD-10 classification)

Technical information

‘Selection B’ is described in detail in the protocol EMCDDA-DRD Standard, version 3.0 (for general mortality registries)

Data collection procedure

Reference

Dept of Health Information. Malta National Mortality Registry

Remarks

Poland

Case definition

Technical information

Data collection procedure

Reference

Remarks

Slovenia

Case definition

Deaths due to drug abuse; that means deaths happening during the time drugs is affecting the organism (accidental poisonings, intentional poisonings, poisonings of undetermined intent)

Technical Information

National definition takes into account the ICD-10 codes of the EMCDDA definition, but without exact implementation of Selection B or selection D

Data collection procedure

From 2002 onwards cases were obtained by linkage of four different databases: i) general mortality registry, ii) police database, iii) first treatment demand database and iv) toxicology department at the Institute of forensic medicine

Reference

Ad hoc data extraction by national focal point from general mortality registry for the 2004 Reitox National Report

Remarks

Information of the GMR is completed with forensic and toxicology data, with police data and with first treatment demand data

Slovakia

Case definition

Technical information

Data collection procedure

Reference 2003

Remarks

Bulgaria

Case definition

Cases of death which underlying cause of death is drug psychosis, drug addiction, drug abuse, accidental poisoning

Technical information

The cases are selected according to the ICD-9 codes

292, drug psychosis

304, drug dependence

305, drug abuse

E854, accidental poisoning with other psychrotropic substances

E939, psychotropic substances

Data collection procedure

Death certificates filled in by family doctors do not specify the substance even if they have reasonable doubts. Deaths occurring in hospitals are followed by toxicological examination.

Reference

Ad hoc data extraction by national focal point from general mortality registry for the 2004 Reitox National Report

Remarks

- ICD-10 will be implemented in 2003

- There are difference in number of cases obtained from the general mortality registry (15) and from police reports (56) in 2003

Romania

Case definition

Drug-related deaths refers to those deaths that are caused directly by the consumption of drugs of abuse

Technical information

Cases extracted according to codes X62 in combination to T40.1

Data collection procedure

Reference

Ad hoc data extraction by national focal point from general mortality registry for the 2004 Reitox National Report

Remarks


Konzeptionelle Fragen betreffend „drogenbedingte Todesfälle”
Der Begriff „drogenbedingter Todesfall” ist nicht leicht einzugrenzen. Es ist wichtig, sowohl direkte („Überdosis”) als auch indirekte (Aids, Unfälle usw.) drogenbedingte Todesfälle zu berücksichtigen. Es sind sehr unterschiedliche Methoden und Datenquellen erforderlich, um die verschiedenen mit dem Drogenkonsum verbundenen Todesursachen zu bewerten.
Die EBDD-Definition für drogenbedingte Todesfälle
Die EBDD-Definition für drogenbedingte Todesfälle im Schlüsselindikator „Drogenbedingte Todesfälle und Mortalität von Drogenkonsumenten” bezieht sich auf jene Todesfälle, die direkt durch den Konsum von Missbrauchsdrogen verursacht werden. Diese Todesfälle ereignen sich im Allgemeinen kurz nach dem Konsum der Substanz/en.

Praktisch werden die Fälle wie folgt ausgewählt:

(1) Die bevorzugte Methode zur Schätzung der Zahl der Todesfälle besteht darin, die Fälle den vorhandenen allgemeinen Todesursachenregistern gemäß folgenden Kriterien auf der Grundlage der Internationalen Klassifikation der Krankheiten der Weltgesundheitsorganisation, 9. Ausgabe –ICD-9 – zu entnehmen (ICD-10 siehe weiter unten).
Es werden Fälle berücksichtigt, bei denen die eigentliche Todesursache Drogenpsychose, Medikamenten- oder Drogenabhängigkeit, Drogenkonsum ohne Abhängigkeit, unbeabsichtigte Vergiftung, Selbstmord und selbst zugefügte Vergiftung oder Vergiftung unter unbestimmten Umständen ist.

Es werden Fälle berücksichtigt, bei denen die Todesursache auf in einer Standardliste aufgeführte spezifische Drogen zurückzuführen ist: Opiate, Kokain, Amphetamine und zugehörige Derivate, Cannabis und Halluzinogene.

Im Einzelnen sind die folgenden ICD-9-Codes zu verwenden:

Kategorie drogenbedingter Todesfälle Ausgewählte(r) ICD-9-Code(s)
Drogenpsychose 292
Medikamenten- und Drogenabhängigkeit 304.0, 304.2–9
Drogen- und Medikamentenmissbrauch ohne Abhängigkeit 305.2–3, 305.5–7, 305.9
Unbeabsichtigte Drogenvergiftung E850.0, E850.8 (1), E854.1-2, E855.2 und E858.8 (1)
Tod durch Selbstmord und selbst zugefügte Drogenvergiftung E950.0 (1),E950.4 (1)
Drogenvergiftung, unklar, ob unbeabsichtigt oder vorsätzlich E980.0 (1), E980.4 (1)
(1) In Verbindung mit den N-Codes (N965.0 und/oder N968.5 und/oder N969.6 und/oder N969.7).

Diese Auswahl wurde von der EBDD-Expertengruppe für drogenbedingte Todesfälle vereinbart. Sie heißt „Auswahl B”.

Was die 10. Ausgabe der Internationalen Klassifikation der Krankheiten anbelangt, wird die Auswahl in enger Absprache mit Experten von Eurostat und der WHO entwickelt, wobei die Arbeiten schon recht weit fortgeschritten sind, und von der EBDD-Expertengruppe im Laufe des Monats Juni 2002 erörtert.

Die (zur Diskussion gestellte) vorläufige Auswahl der ICD-10-Codes für die Schätzung der Zahl der drogenbedingten Todesfälle sieht wie folgt aus:

  • Schädlicher Gebrauch, Abhängigkeit oder andere psychische Störungen oder Verhaltensstörungen aufgrund von:
    • Opioiden (F11)
    • Cannabinoiden (F12)
    • Kokain (F14)
    • anderen Stimulanzien (F15)
    • Halluzinogenen (F16)
    • multiplem Substanzgebrauch (F19).
  • unbeabsichtigte Vergiftung (X41, X42), vorsätzliche Selbstvergiftung (X61, X62) oder Vergiftung, Umstände unbestimmt (Y11, Y12) durch:
    • Opium (T40.0)
    • Heroin (T40.1)
    • andere Opioide (T40.2)
    • Methadon (T40.3)
    • Wird noch erörtert: andere synthetische Betäubungsmittel (T40.4)
    • Kokain (T40.5)
    • Wird noch erörtert: andere, nicht spezifizierte Betäubungsmittel (T40.6)
    • Cannabis (T40.7)
    • Lysergid (T40.8)
    • Wird noch erörtert: andere, nicht spezifizierte Psychodysleptika (T40.9)
    • Psychostimulanzien (T43.6)

Die T-Codes sind in Verbindung mit den jeweiligen X-Codes und Y-Codes auszuwählen.

(2) Eine alternative Methode besteht darin, die Zahl der Todesfälle dadurch zu schätzen, dass man die Fälle den vorhandenen (gerichtsmedizinischen oder polizeilichen) Spezialregistern entnimmt. Die auf den Spezialregistern beruhende Methode wird in Ländern angewandt, in denen die bevorzugte Methode nicht durchgeführt werden kann, wobei sie aber auch – wann immer möglich – herangezogen wird, um mit den entsprechenden Schätzungen die allgemeinen Todesursachenregister zu untermauern.
Es werden Fälle berücksichtigt, wenn der Tod durch unbeabsichtigte Vergiftung, in Selbstmordabsicht oder unter unbestimmten Umständen verursacht wurde.

Es werden Fälle berücksichtigt, wenn der Tod durch Opiate, Amphetamine, Kokain (oder Crack), Cannabis, Halluzinogene, Lösungsmittel oder synthetische Designerdrogen wie Amphetaminderivate verursacht wurde.

Es gibt im Einzelnen die folgenden Gruppen von Todesfällen:

Kategorie drogenbedingter Todesfälle Ausgewählte Gruppen
Vergiftung durch Unfall, in Selbstmordabsicht oder unter unbestimmten Umständen Nur Opiate (nur Methadon ausgenommen)
Nur Methadon Polysubstanzen, einschließlich Opiaten
Polysubstanzen, ausgenommen Opiate Nicht spezifiziert/unbekannt
Anmerkungen:

— In der Kategorie „Polysubstanzen” sollte mindestens eine der oben genannten Substanzen enthalten sein.

— Die Kategorie „nicht spezifiziert/unbekannt” wird verwendet, wenn angenommen wird, dass eine der oben erwähnten Substanzen darin enthalten ist.

Diese Auswahl wurde von der Expertengruppe der EBDD vereinbart. Sie heißt „Auswahl D”.

quelle: http://ar2002.emcdda.europa.eu/de/popups/olbox09-de.html

The production of opium — the raw material for heroin and a major source of revenue for the Taliban insurgency — has halved in Afghanistan due to crop infection this year, but prices have tripled, a UN report released on Thursday said. The sharp drop in output is largely due to bad weather and a plant infection hitting the major poppy-crop growing provinces of Helmand and Kandahar particularly hard, the UN Office on Drugs and Crime (UNODC) said.

“As a result of the damage, yield fell 48 per cent to 29.2 kilograms per hectare, from 56.1 kilograms per hectare compared with the previous year,” it said.

The report said the area of land under poppy cultivation remained stable in 2010 at 123,000 hectares.

Some 98 per cent of the all opium poppy was cultivated in nine provinces in the country’s western and southern regions, it said, adding, “Helmand and Kandahar took the lion’s share with Helmand alone accounting for 53 per cent of total opium cultivation in Afghanistan.” The two provinces, where Taliban are most active, are the focus of a US military surge this year, with the bulk of 30,000 extra US troops moved to Afghanistan this year deployed to Helmand and Kandahar.

“These regions are dominated by insurgency and organized crime networks,” UNODC executive director Yury Fedotov said in a statement.

“This underscores the link between opium poppy cultivation and insecurity in Afghanistan, a trend we have observed since 2007.” Taliban militants are believed to fund their insurgency against the Afghan government and the 150,000 US and NATO troops by collecting tax from opium money.

Fedotov cautioned against “false optimism” because of the drop in production, saying the rising price for opium might make the market again lucrative for growers.

In 2010, the average farm-gate price of dry opium at harvest time was recorded at USD 169 per kilogram, a 164-per-cent increase over 2009, when the price was USD 64 per kilogram, the report found.

The rising prices could also prompt former poppy farmers to think twice about having switched to wheat, an important alternative crop in Afghanistan, Fedotov said.

He said also that any meaningful fight against Afghan opium production would also require the international community to curb demand in the region and western countries. “As long as demand drives this market, there will always be another farmer to replace one we convince to stop cultivating, and another trafficker to replace one we catch.” Afghanistan supplies more than 90 per cent of the world’s opium.

Thursday’s report said that the forced eradication programme led by the government was at its lowest level this year. Afghan forces eradicated 2,316 hectares of poppy crops, more than half of them in Helmand province.

NATO has also stepped up its targeting of opium convoys and traffickers, arresting dozens of suspects and seizing thousands of tons of the illicit drug.

On Wednesday, Baz Mohammed Ahmadi, the deputy interior minister, said nearly 8 tons of opium, heroin and hashish had been seized by Afghan forces in the past six months.

  • Disease keeps prices high despite drop in production
  • Number of households involved in farming drug on rise
  • Industry supports Taliban insurgency against 150,000 troops

The Taliban made £65million last year from Afghanistan’s opium trade despite the presence of thousands of British troops, a damning UN report has found.

In a startling indication that the war on poppy growing is having little effect, insurgents are still reaping the benefits despite the loss of life and huge amounts of money being thrown at the problem.

The report for the United Nations ominously warns that the illegal trade will grow even more.

High: while disease cut the amount of opium produced in Afghanistan by almost half this year compared to last, there was no fall in the number of poppy fields under cultivation and farmers earned far more for their crops
High: while disease cut the amount of opium produced in Afghanistan by almost half this year compared to last, there was no fall in the number of poppy fields under cultivation and farmers earned far more for their crops
Big score: Afghanistan produces 90 per cent of the world's opium, which, in turn, produces heroin
Big score: Afghanistan produces 90 per cent of the world’s opium, which, in turn, produces heroin
Killing fields: Some £63 million is earned by insurgents per year through the opium trade - it helps fund the Taliban's war efforts
Killing fields: Some £63 million is earned by insurgents per year through the opium trade – it helps fund the Taliban’s war efforts

Helmand province, where 9,500 British soldiers are battling the Taliban, produced 53 per cent of the country’s opium, the raw ingredient to make heroin.

The insurgents receive about $100million (£65million) a year from Afghanistan’s illegal opium trade. the report said.

The cash bonanza will continue to fund their fight against British and NATO troops. In the last 12 months, 92 UK servicemen have lost their lives in the country.

This is despite the U.S. and its coalition allies spending more than $250million (£190million) on counter-narcotics programmes in the war-ravaged nation.

In total the amount of poppy cultivated last year was 304,000 acres – the same as in 2009.

The figures are a damaging blow for Britain, whose deployment to the Taliban heartland of Helmand in 2006 intended to smash poppy cultivation and production.

Stash: Though some opium is seized, these latest figures offer are not expected to deter other farmers from cultivating
Stash: Though some opium is seized, these latest figures offer are not expected to deter other farmers from cultivating
Come down: While opium production has decreased, the price has increased so much that farmers are earning more now than they were last year with less stock
Come down: While opium production has decreased, the price has increased so much that farmers are earning more now than they were last year with less stock

Since then the UK death toll has risen to 337 since military action began in 2001.

Afghanistan produces 90 per cent of the world’s opium, said the UN’s Office on Drugs and Crime.

Before the 2001 invasion, the Taliban had managed to drastically reduce the poppy crop.

But since being toppled it has backed poppy growing to finance its insurgency.

Cultivation of the multibillion-dollar crop in 2010 was the same as in 2009 after falling in the previous two years.

Opium production dropped 48 per cent to 3,600 metric tons, mainly due to the spread of a disease that damaged poppy plants.

But low harvest yields caused by blight is likely to lead to an increase in poppy prices – encouraging more poverty-stricken farmers to plant the crop.

In 2009, the average price per kilogram of dry opium at harvest was $64 (£41) per kilogram. It is now about $169 (£114) per kilogram.

UN officials warned three years ago that ‘frightening levels’ of poppy production was threatening the very survival of Afghanistan.

The coalition has poured money into the country to try to stem opium production as part of an effort to undercut funding for insurgent groups fighting the 150,000 coalition forces in the country.

The disappointing figures come despite years of programmes aimed at reducing the poppy crop, by giving farmers subsidised seeds for other crops and vouchers for farmers.

The wheat-distribution programme, where famers receive bags of cereal seeds to persuade them to quit growing narcotics, will begin shortly.

Experts said that if Afghanistan’s discredited government can provide security there would be less incentive for farmers to plant opium to survive.

Robert Watkins, the deputy UN envoy in Afghanistan, said: ‘If there is not going to be security in Afghanistan across the entire country, we are not going to be able to eliminate this problem.’

This is despite the U.S. and its coalition allies spending more than $250million (£190million) on counter-narcotics programmes in the war-ravaged nation.

In total the amount of poppy cultivated last year was 304,000 acres – the same as in 2009.

The figures are a damaging blow for Britain, whose deployment to the Taliban heartland of Helmand in 2006 intended to smash poppy cultivation and production.

Stash: Though some opium is seized, these latest figures offer are not expected to deter other farmers from cultivating
Stash: Though some opium is seized, these latest figures offer are not expected to deter other farmers from cultivating
Come down: While opium production has decreased, the price has increased so much that farmers are earning more now than they were last year with less stock
Come down: While opium production has decreased, the price has increased so much that farmers are earning more now than they were last year with less stock

Since then the UK death toll has risen to 337 since military action began in 2001.

Afghanistan produces 90 per cent of the world’s opium, said the UN’s Office on Drugs and Crime.

Before the 2001 invasion, the Taliban had managed to drastically reduce the poppy crop.

But since being toppled it has backed poppy growing to finance its insurgency.

Cultivation of the multibillion-dollar crop in 2010 was the same as in 2009 after falling in the previous two years.

Opium production dropped 48 per cent to 3,600 metric tons, mainly due to the spread of a disease that damaged poppy plants.

But low harvest yields caused by blight is likely to lead to an increase in poppy prices – encouraging more poverty-stricken farmers to plant the crop.

In 2009, the average price per kilogram of dry opium at harvest was $64 (£41) per kilogram. It is now about $169 (£114) per kilogram.

UN officials warned three years ago that ‘frightening levels’ of poppy production was threatening the very survival of Afghanistan.

The coalition has poured money into the country to try to stem opium production as part of an effort to undercut funding for insurgent groups fighting the 150,000 coalition forces in the country.

The disappointing figures come despite years of programmes aimed at reducing the poppy crop, by giving farmers subsidised seeds for other crops and vouchers for farmers.

The wheat-distribution programme, where famers receive bags of cereal seeds to persuade them to quit growing narcotics, will begin shortly.

Experts said that if Afghanistan’s discredited government can provide security there would be less incentive for farmers to plant opium to survive.

Robert Watkins, the deputy UN envoy in Afghanistan, said: ‘If there is not going to be security in Afghanistan across the entire country, we are not going to be able to eliminate this problem.’

Read more: http://www.dailymail.co.uk/news/article-1316562/Taliban-rakes-63m-heroin-crops-despite-British-troops-crackdown.html#ixzz11T9wBYG8

Berlin (ots) – Die Deutsche AIDS-Hilfe e.V. (DAH) widerspricht negativen und fachlich teilweise falschen Berichten zur Substitutionsbehandlung von Opiatkonsumenten in der Ärztezeitung und in Medien der WAZ-Gruppe (“Junkies nehmen Heroin und dealen mit Methadon”). Zum wiederholten Mal entsteht in der Öffentlichkeit durch solche Berichte der Eindruck, viele Substituierte würden weiterhin Heroin konsumieren und ihr Substitut auf dem Schwarzmarkt weiterverkaufen. Dieses pauschale Bild entspricht nicht der Wirklichkeit. Substitution ist die weltweit erfolgreichste Behandlungsform für Heroinabhängige und rettet in Deutschland Zehntausenden das Leben.

Silke Klumb, Geschäftsführerin der DAH erklärt hierzu: “Substitutionspatienten werden in diesen Berichten diskreditiert, indem sie als Dealer und Betrüger dargestellt werden. Die positiven Effekte der Substitutionsbehandlung fallen unter den Tisch. Substitution ermöglicht den Betroffenen den Ausstieg aus der Drogenszene und die Wiedereingliederung in die Gesellschaft. Viele können zum Beispiel wieder arbeiten.”

Die WAZ-Medien zitieren einen FDP-Landtagsabgeordneten, der sich auf nicht näher bezeichnete Studien bezieht. Die Ärztezeitung nimmt in ihrem Bericht Bezug auf die bekannte ZIS-Studie, zieht aber falsche Schlüsse. Bereits nach Veröffentlichung der Studie im Jahr 2009 erläuterten die Autoren: “Bei den befragten 806 Personen handelt es sich zum großen Teil um sozial desintegrierte, schwer kranke Personen, die im Umfeld von Drogenkonsumräumen kontaktiert wurden, und nicht um reguläre, integrierte Substitutionspatienten.” Die Wissenschaftler reagierten damit auf fehlerhafte Berichte über die Studie, unter anderem im Spiegel.

Das Thema Beikonsum (Drogenkonsum zusätzlich zum Medikament, das die Droge ersetzt) wird immer wieder falsch dargestellt. Indem etwa Kokain, Medikamente und Alkohol in einem Atemzug mit Heroin genannt werden, entsteht der Eindruck, viele Substituierte würden weiter Heroin konsumieren. Das kommt aber nur relativ selten vor.

Dazu Dirk Schäffer, DAH-Referent für Drogen und Strafvollzug: “Drogenabhängige konsumieren oft viele Substanzen. Die Substitutionsmedikamente wirken ausschließlich gegen die Opiatabhängigkeit. Der missbräuchliche Konsum anderer Substanzen wird nicht beeinflusst. Hier werden unrealistische Erwartungen an die Substitutionsbehandlung gerichtet.”

Auch der reflexartige Ruf nach mehr Kontrolle der Substitutionsbehandlung verkennt die Realität. Substitution ist bereits heute so engmaschig reglementiert, dass viele Ärzte den Aufwand scheuen und aus dieser Behandlungsform aussteigen. Ein Höchstmaß an Regeln und Kontrollen erschwert zugleich vielen Abhängigen den Einstieg in die Behandlung.

Statt Substitution in Frage zu stellen, muss es darum gehen, die Palette der zur Verfügung stehenden Medikamente zu erweitern, um noch mehr Heroinkonsumenten eine für sie passende Behandlung anbieten zu können. Nach den Ergebnissen der “Heroinstudie” in Deutschland profitieren sowohl bisher nicht erreichte Heroinkonsumenten als auch so genannte “Substitutionsversager” von einer Behandlung mit Diamorphin (pharmazeutisch reines Heroin).

Darüber hinaus gilt es, den Wiedereinstieg in Arbeit und Beschäftigung weiter zu erleichtern und damit die Fähigkeit zur Eigenverantwortung zu stärken. Beikonsum kann auf diesem Weg reduziert werden.

Unter www.aidshilfe.de finden Sie Links zu den genannten Presseberichten. Dort steht auch die zitierte Stellungnahme von den Autoren der ZIS-Studie online.

Den Artikel haben Wir hier:


Beikonsum bei jedem zweiten Methadon-Patienten in NRW?

ESSEN (nös). In Nordrhein-Westfalen gibt es offenbar erhebliche Probleme mit Beikonsum in der Methadon-Substitution. Experten schätzten, dass jeder zweite Substitutionspatient in NRW zusätzlich illegale Betäubungsmittel konsumiert, berichten die Zeitungen der WAZ-Gruppe am Montag.
Beikonsum bei jedem zweiten Methadon-Patienten in NRW? Zitiert wird der FDP-Landtagsabgeordnete und Arzt Dr. Stefan Romberger, der sich auf Studienveröffentlichungen beruft. Diese hätten gezeigt, dass jeder Zweite zusätzlich auf dem Schwarzmarkt beschafftes Heroin oder andere "weiche" Drogen konsumiert. Defizite macht Romberger dem Bericht zufolge in Arztpraxen aus: "Da wird viel zu wenig hingeschaut, insbesondere in den Praxen, die Methadon ausgeben." In Nordrhein-Westfalen befinden sich derzeit dem Bericht zufolge rund 38 000 Menschen in einer Substitutionsbehandlung.
Laut WAZ ist auch die Deutsche Hauptstelle für Suchtfragen (DHS) alarmiert. "Beigebrauch ist ein Riesenproblem", sagte Jost Leune vom DHS-Vorstand der Mediengruppe. Er fordert "viel mehr Kontrolle und zweitens eine bessere Betreuung der Patienten." Dies sei in der Realität bislang aber nur die Ausnahme. "Die Kassen zahlen diese Betreuung nicht, also findet sie auch selten statt", wird der Leiter der Düsseldorfer Drogenhilft, Joachim Alxnat, zitiert. Eine Studie aus dem vergangen Jahr kam zu ähnlichen Ergebnissen, wie sie jetzt von der WAZ berichtet wurden. 46 Prozent der Methadon-Substituierten konsumierten auf dem Schwarzmarkt besorgtes Heroin, berichtete das Zentrum für Interdisziplinäre Suchtforschung der Uni Hamburg (ZIS) im Juli 2009. Bei der Ersatzbehandlung mit Buprenorphin seien es 43,4 Prozent. Das ZIS kam damals außerdem zu dem Schluss, dass zwei Drittel der Süchtigen bereits illegal Substitutionspräparate konsumiert haben. Mit knapp 60 Prozent rangierte Methadon dort an erster Stelle. Etwas mehr als 40 Prozent gaben an, Levomethadon illegal konsumiert zu haben. In Deutschland befinden sich rund etlichen zehntausend Drogenabhängige in einer Substitutionstherapie. In ihrem jüngsten "Jahrbuch Sucht" zählt die Deutsche Hauptstelle für Suchtfragen 72 000 im Substitutionsregister erfasste Patienten (Stichtag 1. Juli 2008). Im Vorjahreszeitraum lag die Zahl laut DHS bei 68 800. Zur Behandlung wird in fast 60 Prozent aller Fälle Methadon einsetzt. An zweiter und dritter Stelle folgen Levomethadon und Buprenorphin mit jeweils rund 20 Prozent. Codein und Diamorphin haben in der Therapie nur einen Stellenwert als Außenseiter.

Viele Jahre stand die liberale Frankfurter Drogenpolitik in der Kritik – doch sie hat sich durchgesetzt.
Ab heute übernehmen nun sogar die Krankenkassen die Kosten der kontrollierten Abgabe von Heroin.
Die Stadt spart dadurch viel Geld.

Von hr-Reporterin Silja Tietz

Wie alle, die in der Frankfurter Heroinambulanz gelandet sind, hat Klaus (Name geändert) einen langen Leidensweg hinter sich. Über 30 Jahre nahm er Drogen, auch Heroin. Er konnte einfach nicht ohne. Durch die Behandlung in der Heroinambulanz im Frankfurter Ostend kam für ihn mit Anfang 50 aber die Zuversicht zurück: “Das ist das erste Mal, dass ich mich so stabil fühle, dass ich mir vorstellen kann, ein normales Leben zu führen, mit Arbeit, unabhängig und selbstständig”. In der Heroinambulanz bekommen schwerstabhängige Menschen wie Klaus künstlich hergestelltes Heroin vom Arzt – so genanntes Diamorphin.

Zurzeit kommen 104 schwerstabhängige Menschen regelmäßig in die Heroinambulanz, keine Therapie half ihnen bislang aus dem Drogensumpf. Drei Mal am Tag bekommen sie von einem Arzt Diamorphin. So sollen sie es schaffen, wieder ein normales Leben zu führen, so Wilfried Köhler, der Leiter der Heroinambulanz. “Viele Menschen kommen von der Straße, allen sozialen Bezügen entrissen. Nach einer Woche sagen sie ‘Guten Tag’ und ‘Danke schön’. Das klingt banal – aber es illustriert, was für ein Prozess in Gang kommt.”

Nun übernehmen die Krankenkassen die Kosten für die Behandlung. Das hat der Bundestag im Frühjahr so entschieden. Nach langen Kämpfen hat sich damit die Idee der Heroinambulanz durchgesetzt. Für einige wenige Schwerstabhängige, die mehrere erfolglose Therapien hinter sich haben, ist der kontrollierte Drogenkonsum der einzige Weg zurück zu einem halbwegs normalen Leben. Für die Krankenkassen fallen Kosten von jährlich rund 11.500 Euro pro Patient an. Damit habe sich auch die liberale Frankfurter Drogenpolitik durchgesetzt, so Gesundheitsdezernentin Manuela Rottmann (Grüne). “Es war uns immer klar, dass wir einen kleinen Teil der Ausstiegswilligen mit anderen Programmen nicht erreichen. Für diese kleine Gruppe ist die Diamorphinabgabe der Weg in ein normales Leben.”

Krankenkassen müssen 1,5 Millionen Euro zahlen

Noch im Herbst 2007 drohte der Heroinambulanz im Ostend das Aus. Das auf vier Jahre angelegt Modellprojekt war zu Ende. Die Bundesregierung wollte die Drogenabgabe nicht mehr zulassen. Nach viel Überzeugungsarbeit von Politikern aller Parteien in Frankfurt kam es aber anders. Durch die Bundestagsentscheidung gehört die Abgabe künstlichen Heroins an Schwerstabhängige nun sogar zum Leistungskatalog der Krankenkassen. Die Stadt Frankfurt spart damit 1,5 Millionen Euro im Jahr.

Das sind Kosten, die nun die Krankenkassen tragen müssen. Meinhard Johannidis vom hessischen Verband der Ersatzkassen sieht das kritisch. “Wir sind der Auffassung, dass die Behandlung mit Diamorphin nicht nur Aufgabe der Krankenkassen ist, sondern eine gesamtgesellschaftliche Aufgabe.”

Manche schaffen den Sprung in ein drogenfreies Leben

Für die Schwerstabhängigen in der Frankfurter Heroinambulanz gibt es nun aber eine dauerhafte Perspektive. Die bisherigen Erfolge in Frankfurt machen Gesundheitsdezernentin Rottmann auch für die Zukunft zuversichtlich. “Die soziale Situation der meisten hat sich ganz schnell verbessert, viele sind obdachlos und isoliert und das ändert sich ganz schnell.” Auch den kompletten Ausstieg schaffen manche: Im vergangenen Jahr hätten immerhin fünf Patienten den Absprung in ein drogenfreies Leben geschafft.

Zitat:

Die Aufnahme in den Regelkatalog der Krankenkassen bedeutet
das Menschen nun das Anrecht auf diese Behandlung haben,
Patienten koennen diese nun einklagen

quelle: http://www.hr-online.de/website/rubriken/nachrichten/indexhessen34938.jsp?rubrik=36082&key=standard_document_39860123

CNRS-Wissenschaftler des Pasteur Instituts und ein Wissenschaftler-Team des Forschungszentrums für Neuropsychopharmakologie und angewandte Ethologie ETAP (Vandoeuvre-lès-Nancy, Lothringen) haben bei Tieren die schmerzstillenden und antidepressiven Eigenschaften von Opiorphin gemessen. Das Molekül lindert Schmerzen so gut wie Morphium, weist jedoch deutlich weniger Nebenwirkungen auf. Des Weiteren wirkt es genauso gut wie das Antidepressivum Imipramin, aber gänzlich ohne Nebenwirkungen. Die Ergebnisse wurden in der Fachzeitschrift Journal of Physiology and Pharmacology veröffentlicht [1].

Opiorphin – ein im menschlichen Speichel vorkommendes Endorphin (körpereigenes Opioid) – wurde 2006 von Catherine Rougeot und ihrem Team “Struktur- und Zellbiochemie” des Pasteur Instituts entdeckt. Die Pariser Wissenschaftler konnten kürzlich, in Zusammenarbeit mit dem ETAP-Team vom Technopol Nancy-Brabois, in vivo nachweisen, dass Opiorphin, in identischer Dosierung, die gleiche schmerzstillende Wirkung wie Morphium zeigt und sowohl bei thermischen und mechanischen Schmerzen als auch bei tonischen und chronischen Schmerzen wirkt. Die Nebenwirkungen des Opiorphins sind deutlich geringer als die des Morphiums: Keine Gewöhnung (die Dosis muss nicht progressiv erhöht werden), keine Verstopfung und nur eine geringe Suchtgefahr bzw. psychologische Abhängigkeit.

Auch als Antidepressivum erwies es sich als sehr wirksam. Bei Tierversuchen zeigte das Molekül bei identischer Dosierung die gleiche Wirksamkeit wie Imipramin, ein zur Behandlung depressiver Syndrome eingesetzter Wirkstoff. Opiorphin verursacht jedoch keine Übererregbarkeit, keine sedative Wirkung und keine Auswirkung auf das Langzeitgedächtnis, wie es zuweilen bei Antipressiva der Fall ist.

Schmerzen und Depressionen sind oft miteinander verbunden: Depressive Patienten sind oft besonders schmerzempfindlich und umgekehrt verursachen chronische Schmerzen oft Depressionen. Die Wissenschaftler hoffen nun, ein auf diesem Molekül basierendes Arzneimittel herstellen zu können, das beide Syndrome gleichzeitig behandeln könnte. Im Hinblick auf eine therapeutische Anwendung arbeiten die Forscher nun an der Optimierung ihres synthetisch hergestellten Opiorphins, mit dem Ziel einer größeren Bioverfügbarkeit und einer längeren Wirkungsdauer. Erst im Anschluss an diese notwendigen Schritte können die ersten klinischen Studien durchgeführt und das therapeutische Potenzial von Opiorphin evaluiert werden.

[1] Veröffentlichungen: – “Human Opiorphin is a naturally occurring antidepressant acting selectively on enkephalin-dependant delta-opioid pathways”, Javelot , Messaoudi, Garnier, Rougeot – Journal of Physiology and Pharmacology – 2010, 61(3): 355-362. – “Systemically active human Opiorphin is a potent yet non-addictive analgesic without drug tolerance effects”, Rougeot, Robert, Menz, Bisson & Messaoudi – Journal of Physiology and Pharmacology – 2010, 61(4): 483-490.

Quelle: “Antidouleur, antidépresseur: une molécule tout-en-un”, Pressemitteilung des CNRS – 01.09.2010 <http://www2.cnrs.fr/presse/communique/1966.htm?debut=0&gt;

September 28, 2010 (Las Vegas, Nevada) — A transdermal application system containing the partial μ-opioid receptor agonist buprenorphine showed analgesic efficacy in the treatment of low back pain in opioid-naive patients, according to clinical trial results presented here at the American Academy of Pain Management 21st Annual Clinical Meeting. Buprenorphine is commonly used for the treatment of acute pain and, in the United States, for opioid dependence. A new transdermal delivery system of the drug (Butrans, Purdue Pharma LP) provides continuous delivery of this drug during a 7-day period and also effectively controls lower back pain, researchers announced. The US Food and Drug Administration recently approved the product for the management of moderate to severe chronic pain in patients requiring an around-the-clock opioid analgesic for an extended period. Purdue reports Butrans is scheduled to be marketed in January 2010. “Butrans is a class 3 opioid and the only 7-day opioid patch on the market,” said Deborah J. Steiner, MD, medical director at Purdue Pharma LP. The transdermal drug carries a boxed warning and requires a Risk Evaluation and Mitigation Strategy as part of its approval. The double-blind, multicenter, 12-week study involved 1024 opioid-naive patients with moderate to severe chronic lower back pain. Patients received open-label transdermal buprenorphine (BTDS) during a run-in period, and 541 patients who both tolerated and responded to treatment were then randomized to receive either BTDS, 10 μg/h (BTDS 10; n = 120), or BTDS, 20 μg/h (BTDS 20; n = 137), or matching placebo patches (n = 284). The primary efficacy outcome was the “average pain over the last 24 hours” scores at the end of the 12-week, double-blind phase. Response to treatment was evaluated according to the percentage of improvement in pain scores compared with screening values. The results showed an average improvement in pain in the last 24 hours at week 12 of −0.58 in favor of those treated with the BTDS compared with placebo (P = .0104). On the basis of a responder analysis, the proportion of patients with pain score improvement of 30% or more and 50% or more was larger in the BTDS group compared with the placebo group, Dr. Steiner noted. “We conducted responder analyses, which showed a larger percentage of patients treated with [transdermal buprenorphine] had both a greater than or equal to 30% and 50% improvement in pain from baseline,” she said. Treatment-emergent adverse events (occurring in ≥5% patients) included nausea, application site rash, and headache. Serious adverse events occurred in 1.2% of BTDS-treated patients and 0.7% of placebo patients. There were no deaths or safety concerns arising from clinical laboratory tests. A treatment for chronic pain that requires only a once-a-week application should represent an important new option in the marketplace, said Perry G. Fine, MD, a professor of anesthesiology at the University of Utah School of Medicine in Salt Lake City. “I think it will be a very welcome addition to the formulary for chronic pain for a number of reasons, not the least of which is the fact that, in terms of a once-a-week treatment for people with some degree of disabling and opioid-responsive pain, there currently is no such thing,” said Dr. Fine, who is president-elect of the American Academy of Pain Medicine. “The fact that [transdermal buprenorphine] is a low-dose formulation is also good thing, because there are a lot of patients who don’t need high-dose opioid therapy but who need something potent to help beyond drugs that pose other potential dangers, such as acetaminophen in higher doses. “[The patch] could be especially useful in older populations with osteoarthritis who have pain that seriously interferes with either the quality of life or sleep,” he noted. “So I think this is really a positive event that is a long time coming.” The study was supported by Purdue Pharma LP. Dr. Steiner is medical director at Purdue Pharma LP. Dr. Fine’s disclosures include that he is on the advisory boards for companies including Alpharma, Forest Laboratories, Ortho McNeil, Purdue Pharma, Endo, Lilly, Cephalon, and King Pharmaceuticals. American Academy of Pain Management (AAPM) 21st Annual Clinical Meeting: Poster Abstract 29. Presented September 23, 2010.

001_ButransPI (This is a File about what it is)

Abwässer der Pharmaindustrie belasten die Umwelt stärker als bislang angenommen. Das ist bedenklich. So können Antibiotika in den Gewässern dazu beitragen, dass Krankheitserreger resistent werden.

Egal ob Antidepressiva oder Zytostatika – vieles aus dem verschreibungspflichtigen Sortiment der Pharmaindustrie gibt es längst rezeptfrei im Badesee. Mehr als 150 verschiedene Arzneiwirkstoffe haben Wissenschaftler mittlerweile in Seen und Flüssen, Sedimenten, Grundwasser und Böden nachgewiesen, berichtet das Umweltbundesamt (UBA) in Dessau. Immer wieder werden sogar im Trinkwasser Medikamente entdeckt, wenn auch in geringen Mengen.

KLÄRANLAGE STUTTGART-MÜHLHAUSEN Bild vergrößern Mehr als 150 verschiedene Arzneiwirkstoffe haben Wissenschaftler in Seen und Flüssen, Sedimenten, Grundwasser und Böden nachgewiesen. (© DPA)

Abwässer der Pharmaindustrie tragen offenbar weit mehr zu dieser flächendeckenden Umweltbelastung bei, als bisher vermutet. Das zeigt eine Studie des US Geological Survey, einer Forschungseinrichtung des US-Innenministeriums (Environmental Science and Technology, Bd.44, S.4910, 2010).

Ein Forscherteam um den Hydrologen Patrick Phillips verglich zwei New Yorker Kläranlagen, die jeweils zu einem Fünftel ihrer Kapazität Abwässer von Arzneimittelherstellern aufnehmen, mit Anlagen aus New York und anderen Bundesstaaten, in die keine Abwässer der Pharmaindustrie fließen.

Wasser aus den Klärwerken, die Abwässer von Arzneimittelherstellern aufbereiten, enthält bis zu 1000-mal so hohe Medikamentenkonzentrationen wie Wasser aus anderen Anlagen. Wohlgemerkt: nach der Klärung.

Die US-Forscher hatten zwischen 2004 und 2009 den Auslauf von insgesamt 26 Klärwerken in den USA auf sieben verschiedene Medikamente untersucht. Am häufigsten entdeckten sie das Barbiturat Butalbital, das in mehr als 80 Prozent aller Proben auftauchte. Gut die Hälfte der Wasserproben enthielt das Opioid Oxycodon, an dritter Stelle folgte ein Mittel zur Muskelentspannung namens Carisoprodol. Bei allen Kläranlagen ohne Pharmaindustrie-Abwässer blieb die Konzentration der einzelnen Substanzen jeweils unter einem Mikrogramm pro Liter.

Anlagen, die auch Abwässer aus Krankenhäusern aufbereiteten, wiesen am Auslauf etwas höhere Arzneimittelrückstände auf als andere, aber der Unterschied war statistisch nicht bedeutsam. Dagegen entließen die beiden Anlagen, die von Arzneimittelherstellern mitbenutzt wurden, je nach Substanz zehn- bis 1000-fach höhere Konzentrationen an Medikamenten in die Umwelt.

Für das Opioid Oxycodon beispielsweise wurden Werte bis zu 1700 Mikrogramm pro Liter gemessen. Würde ein Mensch anderthalb Liter dieses Wasser trinken, hätte er damit schon mehr von dem Schmerzmittel geschluckt, als die kleinste Tablette des Präparats enthält, heißt es in einem Bericht über die Studie im Fachjournal Environmental Health Perspectives.

Nun stillt wohl kaum jemand seinen Durst aus dem Auslauf einer Kläranlage. Flussabwärts verdünnt sich das Opiat bald, und so taugt das Flusswasser weder als Schmerzmittel noch macht es süchtig. Auch alle anderen entdeckten Wirkstoffe werden so stark verdünnt, dass das Wasser keinesfalls verschreibungspflichtig wäre.

Dennoch gelten Medikamentenrückstände in Gewässern als äußerst bedenklich. So können Antibiotika in der Umwelt dazu beitragen, dass Krankheitserreger resistent werden. Das Psychopharmakon Fluoxetin ist hochgiftig für Wasserorganismen. Andere Arzneistoffe beeinflussen deren Fortpflanzung, weil sie ähnlich wie Hormone wirken.

Ein besonderes Risiko für die Umwelt stellen Medikamente zur Krebstherapie dar, die das Erbgut schädigen können. Auch geringste Mengen von weniger als einem hundertstel Mikrogramm pro Liter können eine Umweltgefahr darstellen, daher sind für solche Mittel gesonderte Risikobewertungen nötig, betonten Wissenschaftler des Universitätsklinikums Freiburg im vergangenen Jahr in einer Studie für das Umweltbundesamt.

Die jetzt in den USA durchgeführten Messungen ergaben für eine Reihe von Medikamenten weit höhere Werte, als Modellrechnungen vorhergesagt hatten, erklären Patrick Phillips und seine Kollegen. Denn alle Berechnungen gingen bislang davon aus, dass Medikamente entweder mit Ausscheidungen von Patienten in Gewässer gelangen oder durch Medikamentenreste, die nach einer überstandenen Erkrankung in Haushalten sorglos in die Toilette geschüttet werden.

Dass die Pharmaindustrie Flüsse und Seen erheblich mit Medikamenten belastet, war bisher nur aus Schwellenländern bekannt geworden. So hatten schwedische Forscher im indischen Hyderabad im Jahr 2007 extrem hohe Konzentrationen von Antibiotika und anderen Medikamenten im geklärten Abwasser von Arzneimittelherstellern entdeckt.

Wie stark Abwässer von Pharmafirmen in Deutschland die Gewässer belasten, ist allerdings unbekannt. Dieser Frage ist nach Auskünften des Umweltbundesamtes bisher noch niemand nachgegangen. “Bei der Zulassung von Arzneimitteln werden zwar auch Umweltgesichtspunkte betrachtet”, erläutert Bettina Rechenberg, Leiterin des Fachgebietes Umweltrisikobewertung von Arzneimitteln im UBA. Doch beziehe sich dies nur auf die Anwendung, nicht aber auf die Produktion. “Wenn es also gilt zu bewerten, ob kritische Umweltkonzentrationen erreicht werden oder nicht, bleibt die Produktion ausgenommen.”

Auch hierzulande ging man also bisher davon aus, dass Ausscheidungen von Patienten und die unsachgemäße Entsorgung von Arzneimittelresten weit stärker ins Gewicht fallen als die Abwässer der Pharmaindustrie. “Allerdings gibt es keine systematischen Daten, die diese Annahme belegen”, gesteht Rechenberg. Bei einem Monitoring-Programm Ende der 1990er-Jahre seien viele Arzneimittelrückstände gefunden worden, in abwasserbelasteten Flüssen mehr als in Flüssen ohne solche Einleitungen.

“Es wurde aber nicht rückverfolgt, woher die Abwässer stammten, ob es sich also um kommunale oder industrielle Abwässer handelte”, bedauert Rechenberg. Angesichts der nun veröffentlichten Daten aus den USA sagt sie: “Es wäre durchaus sinnvoll, dem auch in Deutschland nachzugehen und zu prüfen, ob Einleitungen aus der Pharmaindustrie tatsächlich zu vernachlässigen sind.”

quelle ist: http://www.sueddeutsche.de/wissen/umweltverschmutzung-medikamente-aus-der-klaeranlage-1.997961

It is often easy to assume the war on drugs is centered on men, when in truth it is affecting an untold number of women. According to an Alertnet article, the rate of female imprisonment has increased by nearly 800 percent since 1977, and this number is still rising. Much of this increase is attributed to the war on drugs.

The Bureau of Justice Statistics shows that 40 percent of criminal convictions leading to incarceration of women at the turn of this century were for drug-related crimes. The latest victims are mothers, sisters and daughters, suffering in a system bent on punishment instead of rehabilitation.

Drug Czar Gil Kerlikowske has said it is time to evaluate how U.S. policies affect the women of this country. The gravity of the economic and social costs for such policies is essential, especially given the fact that more than 75 percent of women in prison are mothers.

There are some who argue that the incarceration for a drug-related crime should result in the termination of parental rights. The Adoption and Safe Families Act of 1997 dictates the initiation of the termination of parental rights proceedings if a child has been placed in foster care for 15 of the last 22 months.

A study by the U.S. General Accounting Office shows the median prison sentence for women is 60 months and as a result, the majority of mothers in prison lose their parental rights. More than 75 percent of women incarcerated in federal prisons are there on nonviolent drug offenses.

A study issued by the Sentencing Project showed that 1,706,600 minor children had an incarcerated parent in 2007, and half of these children were under the age of 10. Based on current statistics, many of these children will be incarcerated as juvenile offenders.

source: http://addictiontreatmentmagazine.co…pacting-women/

The Study can be found here: Admin_Documents_publications_inc_incarceratedparents

There are significant differences between men and women with substance use disorders across all realms — from biology to historical and current psychosocial stressors. These differences account for many gender-specific needs in both treatment and attempts to sustain recovery from substance use. They also reflect both the socialization differences between males and females in our culture as well as the inherent biological differences between men and women. All such factors present multiple challenges and barriers to treatment and recovery for women since research and treatment have been traditionally based upon the experiences of men. Since the 1970s, however, more has become known about the growth and development of women in general and substance treatment providers have increasingly focused more upon gender-specific information about the illness of addiction itself as well as the treatment and recovery needs of each gender.

Research and clinical experience have long validated the progression of addictive illness as occurring with a faster development of severe health consequences for women than for men. While women typically begin use with lower amounts of substance than do men, they tend to become substance dependent more quickly and to progress through the stages of dependence more quickly as well. Not only do women become ‘sicker quicker’, but they also appear to have a higher rate of relapse than men. Women tend to enter treatment with more acute psychiatric needs than men and to have more difficulty remaining abstinent with periods of sobriety often undermined by psychiatric symptoms and the stress of various psychological and social factors that men do not typically share.

One of the chief complications for women in both illness development and attempted sobriety is a history of trauma. Generally, women with substance use disorders typically report having experienced trauma such as physical, emotional and sexual abuse. While both men and women with substance disorders are apt to have had such experiences, it appears that women in treatment continue to report these more frequently and to have more acute symptoms of trauma upon entering treatment. For many women, a problematic use of substances seems to begin as a pursuit to manage and ‘numb’ trauma related feelings, thoughts and memories. Such attempts to self-medicate can, over the course of substance use, prolong and intensify trauma symptoms as well as create extreme discomfort in abstinence when they are experienced without the ‘medicinal’ effects of substance use. Such discomfort is often the precipitant to relapse.

Overall, there appears to be a significant correlation between the severity of trauma symptoms and a tendency for women to begin and relapse to substance use. Further, it is more common that women will report having begun substance use in order to cope with the stress of a traumatic event. Men, on the other hand, tend to describe having had more interest in intoxication rather than in managing a stress reaction at the onset of use. For these reasons, many women will require appropriate support to address and manage trauma symptoms in order to successfully navigate periods of abstinence and recovery.

Additionally, the typical social roles and cultural expectations placed upon women result in very specific stigma and stereotyping with regard to substance use. For example, women often assume (or are expected to assume) care giving roles in all their relationships — as mother, partner and daughter. Consequently, an addictive illness and related impairments are frequently viewed as personal failures with significant and negative stereotyping. Women are likely to be perceived as failing morally when experiencing a substance-related illness — for example, to be a “bad” woman, mother, wife or daughter. Such stigma affects the behavior of women in need of treatment and can lead to difficulty maintaining sobriety. Shame in reaction to social and cultural stereotyping is an obstacle for many women who want and need substance treatment.

Women often report having delayed treatment because they believed a disclosure of substance use would result in severe social consequences. This is particularly true for women who have children. The cultural expectations of mothers are generally more exacting than for men who are parents. It is less ‘acceptable’, for example, for women to leave their children for prolonged periods and even treatment stays can be perceived as periods of ‘abandonment’. Overall, addicted women are more apt to have remained intricately involved in their children’s lives as primary caregivers than are addicted men. Women who have children report much shame and guilt about ‘failing’ as mothers when ill with an addiction and in treatment for it. They also report fear of having their children removed from their care by family members or child protection agencies.

Women with children who do enter treatment face multiple challenges. Single mothers, for example, are often unable to secure childcare long enough for inpatient stays. Many also report difficulty attending recovery support groups in the community due to lack of childcare and lack of transportation. Realistically, addicted women do face the risk of having their children removed by child protection agencies with reunification dependent upon a significant period of sustained recovery. All of these issues leave substance dependent women prone to conceal their addictions and to postpone seeking help. Men with substance use disorders are not typically concerned with such issues when considering treatment and tend to report less guilt and shame related to their parental roles than do addicted women.

Relationships with partners can also greatly complicate recovery efforts for women. Addicted women are apt to be financially dependent upon their partners and are more likely than men to be involved with partners who also use substances. Therefore, many women must leave these relationships and achieve financial independence in order to successfully recover. Along with the usual rigors of early sobriety, these tasks can be overwhelming. Halfway houses are stepping stones to independence, but these are not always viable options for women with children. Further, addicted women are likely to have fewer job skills with which to obtain gainful employment and financial independence. Many women with children report that they cannot successfully support themselves and their children without relying upon a partner.

Ironically, women in our culture tend to be defined by their relationship roles more so than men, but women with substance use disorders tend to have a high degree of social isolation. They are more likely, for example, to use in the home as opposed to the more social environment of a bar as men do. Women are also likely to have fewer people to rely upon in treatment and early recovery especially if their partners continue to use substances. Sabotage of treatment efforts by partners who are substance users takes many forms: threats of abandonment, withdrawal of financial support and manipulation of the woman’s feelings, particularly guilt and shame. Consequently, recovery efforts such as inpatient stays and time in halfway houses are sometimes refused or aborted due to this lack of support. Social isolation and financial dependency can also leave women vulnerable for making impulsive and self-sabotaging relationships while in treatment and early recovery.

Women in treatment settings have many specific treatment needs that set them apart from their male counterparts during the course of treatment. For example, gender-specific groups allow a more in-depth and forthcoming exploration of significant relationship issues and trauma. Given that abuse in both childhood and adulthood, particularly sexual abuse/assault and domestic violence, are prevalent among women with substance disorders, treatment groups must provide a safe emotional and psychological atmosphere in which to address these. Because women who have been victimized are likely to have been victimized by men, the presence of men in treatment groups can trigger more acute trauma symptoms for women as well as impede disclosures and processing of these events.

Additionally, a shame-based sexuality is often an integral part of an addicted lifestyle and many women will find it necessary to process such issues in order to fully recover. Difficult sexual experiences during use often bring related sexual difficulties during recovery. Demeaning and/or traumatic events such as engaging in sex for drugs and having experienced miscarriages and abortions are common. Prostitution and other sex-related work, relationships with multiple partners or sexual activity that may have violated a woman’s own usual standards of conduct are not easily addressed in mixed gender groups. Further, the cultural phenomenon of male privilege and status is often exaggerated in addicted lifestyles and can continue in treatment settings. All of these issues can complicate the appropriate processing of experiences in which women have been objectified, demeaned, devalued and dominated before entering treatment. The discussion of sexual concerns that would facilitate a healthy sexuality in recovery can also be hindered in mixed gender groups.

Co-ed treatment groups can also present other challenges for women in treatment due to the differences in socialization of men and women. For example, women will tend to nurture men who are present in their therapy groups. While this additional support often benefits the men who receive enhanced support and encouragement in mixed gender groups, women are likely to be diverted away from stating their own needs and exploring their own issues as they ‘take care’ of male group members. Women are more prone to ‘internalize’ while men will more typically assert themselves or display more aggressive traits in addressing issues. This difference in communication and expressive styles creates an atmosphere in which women will frequently take a ‘backseat’ to the needs of male group members who will be prone to dominate the process and work of therapy groups.

Source: http://addictiontreatmentmagazine.co…bstance-users/

I was driving up the Massachusetts Turnpike one evening last February when I knocked over a bottle of water. I grabbed for it, swerved inadvertently–and a few seconds later found myself blinking into the flashlight beam of a state trooper. “How much have you had to drink tonight, sir?” he demanded. Before I could help myself, I blurted out an answer that was surely a new one to him. “I haven’t had a drink,” I said indignantly, “since 1981.”

It was both perfectly true and very pertinent to the trip I was making. By the time I reached my late 20s, I’d poured down as much alcohol as normal people consume in a lifetime and plenty of drugs–mostly pot–as well. I was, by any reasonable measure, an active alcoholic. Fortunately, with a lot of help, I was able to stop. And now I was on my way to McLean Hospital in Belmont, Mass., to have my brain scanned in a functional magnetic-resonance imager (fMRI). The idea was to see what the inside of my head looked like after more than a quarter-century on the wagon.

Back when I stopped drinking, such an experiment would have been unimaginable. At the time, the medical establishment had come to accept the idea that alcoholism was a disease rather than a moral failing; the American Medical Association (AMA) had said so in 1950. But while it had all the hallmarks of other diseases, including specific symptoms and a predictable course, leading to disability or even death, alcoholism was different. Its physical basis was a complete mystery–and since nobody forced alcoholics to drink, it was still seen, no matter what the AMA said, as somehow voluntary. Treatment consisted mostly of talk therapy, maybe some vitamins and usually a strong recommendation to join Alcoholics Anonymous. Although it’s a totally nonprofessional organization, founded in 1935 by an ex-drunk and an active drinker, AA has managed to get millions of people off the bottle, using group support and a program of accumulated folk wisdom.

While AA is astonishingly effective for some people, it doesn’t work for everyone; studies suggest it succeeds about 20% of the time, and other forms of treatment, including various types of behavioral therapy, do no better. The rate is much the same with drug addiction, which experts see as the same disorder triggered by a different chemical. “The sad part is that if you look at where addiction treatment was 10 years ago, it hasn’t gotten much better,” says Dr. Martin Paulus, a professor of psychiatry at the University of California at San Diego. “You have a better chance to do well after many types of cancer than you have of recovering from methamphetamine dependence.”

That could all be about to change. During those same 10 years, researchers have made extraordinary progress in understanding the physical basis of addiction. They know now, for example, that the 20% success rate can shoot up to 40% if treatment is ongoing (very much the AA model, which is most effective when members continue to attend meetings long after their last drink). Armed with an array of increasingly sophisticated technology, including fMRIs and PET scans, investigators have begun to figure out exactly what goes wrong in the brain of an addict–which neurotransmitting chemicals are out of balance and what regions of the brain are affected. They are developing a more detailed understanding of how deeply and completely addiction can affect the brain, by hijacking memory-making processes and by exploiting emotions. Using that knowledge, they’ve begun to design new drugs that are showing promise in cutting off the craving that drives an addict irresistibly toward relapse–the greatest risk facing even the most dedicated abstainer.

“Addictions,” says Joseph Frascella, director of the division of clinical neuroscience at the National Institute on Drug Abuse (NIDA), “are repetitive behaviors in the face of negative consequences, the desire to continue something you know is bad for you.”

Addiction is such a harmful behavior, in fact, that evolution should have long ago weeded it out of the population: if it’s hard to drive safely under the influence, imagine trying to run from a saber-toothed tiger or catch a squirrel for lunch. And yet, says Dr. Nora Volkow, director of NIDA and a pioneer in the use of imaging to understand addiction, “the use of drugs has been recorded since the beginning of civilization. Humans in my view will always want to experiment with things to make them feel good.”

That’s because drugs of abuse co-opt the very brain functions that allowed our distant ancestors to survive in a hostile world. Our minds are programmed to pay extra attention to what neurologists call salience–that is, special relevance. Threats, for example, are highly salient, which is why we instinctively try to get away from them. But so are food and sex because they help the individual and the species survive. Drugs of abuse capitalize on this ready-made programming. When exposed to drugs, our memory systems, reward circuits, decision-making skills and conditioning kick in–salience in overdrive–to create an all consuming pattern of uncontrollable craving. “Some people have a genetic predisposition to addiction,” says Volkow. “But because it involves these basic brain functions, everyone will become an addict if sufficiently exposed to drugs or alcohol.”

That can go for nonchemical addictions as well. Behaviors, from gambling to shopping to sex, may start out as habits but slide into addictions. Sometimes there might be a behavior-specific root of the problem. Volkow’s research group, for example, has shown that pathologically obese people who are compulsive eaters exhibit hyperactivity in the areas of the brain that process food stimuli–including the mouth, lips and tongue. For them, activating these regions is like opening the floodgates to the pleasure center. Almost anything deeply enjoyable can turn into an addiction, though.

Of course, not everyone becomes an addict. That’s because we have other, more analytical regions that can evaluate consequences and override mere pleasure seeking. Brain imaging is showing exactly how that happens.Paulus, for example, looked at methamphetamine addicts enrolled in a VA hospital’s intensive four-week rehabilitation program. Those who were more likely to relapse in the first year after completing the program were also less able to complete tasks involving cognitive skills and less able to adjust to new rules quickly. This suggested that those patients might also be less adept at using analytical areas of the brain while performing decision-making tasks. Sure enough, brain scans showed that there were reduced levels of activation in the prefrontal cortex, where rational thought can override impulsive behavior. It’s impossible to say if the drugs might have damaged these abilities in the relapsers–an effect rather than a cause of the chemical abuse–but the fact that the cognitive deficit existed in only some of the meth users suggests that there was something innate that was unique to them. To his surprise, Paulus found that 80% to 90% of the time, he could accurately predict who would relapse within a year simply by examining the scans.

Another area of focus for researchers involves the brain’s reward system, powered largely by the neurotransmitter dopamine. Investigators are looking specifically at the family of dopamine receptors that populate nerve cells and bind to the compound. The hope is that if you can dampen the effect of the brain chemical that carries the pleasurable signal, you can loosen the drug’s hold.

One particular group of dopamine receptors, for example, called D3, seems to multiply in the presence of cocaine, methamphetamine and nicotine, making it possible for more of the drug to enter and activate nerve cells. “Receptor density is thought to be an amplifier,” says Frank Vocci, director of pharmacotherapies at NIDA. “[Chemically] blocking D3 interrupts an awful lot of the drugs’ effects. It is probably the hottest target in modulating the reward system.”

But just as there are two ways to stop a speeding car–by easing off the gas or hitting the brake pedal–there are two different possibilities for muting addiction. If dopamine receptors are the gas, the brain’s own inhibitory systems act as the brakes. In addicts, this natural damping circuit, called GABA (gamma-aminobutyric acid), appears to be faulty. Without a proper chemical check on excitatory messages set off by drugs, the brain never appreciates that it’s been satiated.

As it turns out, vigabatrin, an antiepilepsy treatment that is marketed in 60 countries (but not yet in the U.S.), is an effective GABA booster. In epileptics, vigabatrin suppresses overactivated motor neurons that cause muscles to contract and go into spasm. Hoping that enhancing GABA in the brains of addicts could help them control their drug cravings, two biotech companies in the U.S., Ovation Pharmaceuticals and Catalyst

Pharmaceuticals, are studying the drug’s effect on methamphetamine and cocaine use. So far, in animals, vigabatrin prevents the breakdown of GABA so that more of the inhibitory compound can be stored in whole form in nerve cells. That way, more of it could be released when those cells are activated by a hit from a drug. Says Vocci, optimistically: “If it works, it will probably work on all addictions.”

Another fundamental target for addiction treatments is the stress network. Animal studies have long shown that stress can increase the desire for drugs. In rats trained to self-administer a substance, stressors such as a new environment, an unfamiliar cage mate or a change in daily routine push the animals to depend on the substance even more.

Among higher creatures like us, stress can also alter the way the brain thinks, particularly the way it contemplates the consequences of actions. Recall the last time you found yourself in a stressful situation–when you were scared, nervous or threatened. Your brain tuned out everything besides whatever it was that was frightening you–the familiar fight-or-flight mode. “The part of the prefrontal cortex that is involved in deliberative cognition is shut down by stress,” says Vocci. “It’s supposed to be, but it’s even more inhibited in substance abusers.” A less responsive prefrontal cortex sets up addicts to be more impulsive as well.

Hormones–of the male-female kind–may play a role in how people become addicted as well. Studies have shown, for instance, that women may be more vulnerable to cravings for nicotine during the latter part of the menstrual cycle, when the egg emerges from the follicle and the hormones progesterone and estrogen are released. “The reward systems of the brain have different sensitivities at different points in the cycle,” notes Volkow. “There is way greater craving during the later phase.”

That led researchers to wonder about other biological differences in the way men and women become addicted and, significantly, respond to treatments. Alcohol dependence is one very promising area. For years, researchers had documented the way female alcoholics tend to progress more rapidly to alcoholism than men. This telescoping effect, they now know, has a lot to do with the way women metabolize alcohol. Females are endowed with less alcohol dehydrogenase–the first enzyme in the stomach lining that starts to break down the ethanol in liquor–and less total body water than men. Together with estrogen, these factors have a net concentrating effect on the alcohol in the blood, giving women a more intense hit with each drink. The pleasure from that extreme high may be enough for some women to feel satisfied and therefore drink less. For others, the intense intoxication is so enjoyable that they try to duplicate the experience over and over.

But it’s the brain, not the gut, that continues to get most of the attention, and one of the biggest reasons is technology. It was in 1985 that Volkow first began using PET scans to record trademark characteristics in the brains and nerve cells of chronic drug abusers, including blood flow, dopamine levels and glucose metabolism–a measure of how much energy is being used and where (and therefore a stand-in for figuring out which cells are at work). After the subjects had been abstinent a year, Volkow rescanned their brains and found that they had begun to return to their predrug state. Good news, certainly, but only as far as it goes.

“The changes induced by addiction do not just involve one system,” says Volkow. “There are some areas in which the changes persist even after two years.” One area of delayed rebound involves learning. Somehow in methamphetamine abusers, the ability to learn some new things remained affected after 14 months of abstinence. “Does treatment push the brain back to normal,” asks NIDA’s Frascella, “or does it push it back in different ways?”If the kind of damage that lingers in an addict’s learning abilities also hangs on in behavioral areas, this could explain why rehabilitation programs that rely on cognitive therapy–teaching new ways to think about the need for a substance and the consequences of using it–may not always be effective, especially in the first weeks and months after getting clean. “Therapy is a learning process,” notes Vocci. “We are trying to get [addicts] to change cognition and behavior at a time when they are least able to do so.”

One important discovery: evidence is building to support the 90-day rehabilitation model, which was stumbled upon by AA (new members are advised to attend a meeting a day for the first 90 days) and is the duration of a typical stint in a drug-treatment program. It turns out that this is just about how long it takes for the brain to reset itself and shake off the immediate influence of a drug. Researchers at Yale University have documented what they call the sleeper effect–a gradual re-engaging of proper decision making and analytical functions in the brain’s prefrontal cortex–after an addict has abstained for at least 90 days.

This work has led to research on cognitive enhancers, or compounds that may amplify connections in the prefrontal cortex to speed up the natural reversal. Such enhancement would give the higher regions of the brain a fighting chance against the amygdala, a more basal region that plays a role in priming the dopamine-reward system when certain cues suggest imminent pleasure–anything from the sight of white powder that looks like cocaine to spending time with friends you used to drink with. It’s that conditioned reflex–identical to the one that caused Ivan Pavlov’s famed dog to salivate at the ringing of a bell after it learned to associate the sound with food–that unleashes a craving. And it’s that phenomenon that was the purpose of my brain scans at McLean, one of the world’s premier centers for addiction research.

In my heyday, I would often drink even when I knew it was a terrible idea–and the urge was hardest to resist when I was with my drinking buddies, hearing the clink of glasses and bottles, seeing others imbibe and smelling the aroma of wine or beer. The researchers at McLean have invented a machine that wafts such odors directly into the nostrils of a subject undergoing an fMRI scan in order to see how the brain reacts. The reward circuitry in the brain of a newly recovering alcoholic should light up like a Christmas tree when stimulated by one of these alluring smells.

I chose dark beer, my absolute favorite, from their impressive stock. But I haven’t gotten high for more than a quarter-century; it was an open question whether I would react that way. So after an interview with a staff psychiatrist to make sure I would be able to handle it if I experienced a craving, I was fitted with a tube that carried beer aroma from a vaporizer into my nose. I was then slid into the machine to inhale that still familiar odor while the fMRI did its work.

Even if the smells triggered a strong desire to drink, I had long since learned ways to talk myself out of it–or find someone to help me do so. Like the 90-day drying-out period that turns out to parallel the brain’s recovery cycle, such a strategy is in line with other new theories of addiction. Scientists say extinguishing urges is not a matter of getting the feelings to fade but of helping the addict learn a new form of conditioning, one that allows the brain’s cognitive power to shout down the amygdala and other lower regions. “What has to happen for that cue to extinguish is not for the amygdala to become weaker but for the frontal cortex to become stronger,” says Vocci.

While such relearning has not been studied formally in humans, Vocci believes it will work, on the basis of studies involving, of all things, phobias. It turns out that phobias and drugs exploit the same struggle between high and low circuits in the brain. People placed in a virtual-reality glass elevator and treated with the antibiotic D-cycloserine were better able to overcome their fear of heights than those without benefit of the drug. Says Vocci: “I never thought we would have drugs that affect cognition in such a specific way.”

Such surprises have even allowed experts to speculate whether addiction can ever be cured. That notion goes firmly against current beliefs. A rehabilitated addict is always in recovery because cured suggests that resuming drinking or smoking or shooting up is a safe possibility–whose downside could be devastating. But there are hints that a cure might not in principle be impossible. A recent study showed that tobacco smokers who suffered a stroke that damaged the insula (a region of the brain involved in emotional, gut-instinct perceptions) no longer felt a desire for nicotine.

That’s exciting, but because the insula is so critical to other brain functions–perceiving danger, anticipating threats–damaging this area isn’t something you would ever want to do intentionally. With so many of the brain’s systems entangled with one another, it could prove impossible to adjust just one without throwing the others into imbalance.

Nevertheless, says Volkow, “addiction is a medical condition. We have to recognize that medications can reverse the pathology of the disease. We have to force ourselves to think about a cure because if we don’t, it will never happen.” Still, she is quick to admit that just contemplating new ideas doesn’t make them so. The brain functions that addiction commandeers may simply be so complex that sufferers, as 12-step recovery programs have emphasized for decades, never lose their vulnerability to their drug of choice, no matter how healthy their brains might eventually look.

I’m probably a case in point. My brain barely lit up in response to the smell of beer inside the fMRI at McLean. “This is actually valuable information for you as an individual,” said Scott Lukas, director of the hospital’s behavioral psychopharmacology research laboratory and a professor at Harvard Medical School who ran the tests. “It means that your brain’s sensitivity to beer cues has long passed.”

That’s in keeping with my real-world experience; if someone has a beer at dinner, I don’t feel a compulsion to leap across the table and grab it or even to order one for myself. Does that mean I’m cured? Maybe. But it may also mean simply that it would take a much stronger trigger for me to fall prey to addiction again–like, for example, downing a glass of beer. But the last thing I intend to do is put it to the test. I’ve seen too many others try it–with horrifying results.

Habe  ich hier: att_93236_DE_EMCDDA_AR2009_DE

Das ist uerigens der gesamte Bericht, lesenswerte Statistiken, wie immer!

Drogenbedingte Infektionskrankheiten

Eine der besonders schwerwiegenden gesundheitlichen Folgen des Konsums illegaler Drogen und insbesondere des injizierenden Drogenkonsums ist die Übertragung von HIV und anderen Infektionskrankheiten, vor allem Hepatitis C und B. Der Zusammenhang zwischen injizierendem Drogenkonsum und der Übertragung von Infektionskrankheiten ist eindeutig belegt. Die Eindämmung des injizierenden Drogenkonsums und der gemeinsamen Nutzung von Spritzenbestecken ist daher mittlerweile ein primäres Ziel drogenorientierter Maßnahmen im Bereich der öffentlichen Gesundheit. Ferner weisen Studien auf einen Zusammenhang zwischen Drogenkonsum und hochriskanten sexuellen Verhaltensweisen hin. Daraus wird die zunehmende Notwendigkeit deutlich, Maßnahmen zur Bekämpfung des Drogenkonsums mit Strategien im Bereich der öffentlichen Gesundheit zu verknüpfen, die auf die Sexualgesundheit abzielen. Was die Beobachtung auf europäischer Ebene betrifft, so werden Daten über Infektionskrankheiten durch reguläre Meldequellen, wobei der injizierende Drogenkonsum als Risikofaktor erfasst werden kann, sowie im Zuge spezieller Studien über Drogenkonsumenten in unterschiedlichen Settings erhoben.

HIV und Aids

Jüngste Tendenzen bei den neu gemeldeten HIV-Fällen

Derzeit melden die meisten Ländern niedrige Raten neu diagnostizierter HIV-Infektionen, die mit dem injizierenden Drogenkonsum in Verbindung gebracht werden. Anhand der Länder, die kontinuierlich niedrige HIV-Infektionsraten unter injizierenden Drogenkonsumenten (IDU) melden, kann untersucht werden, welche Faktoren hierfür verantwortlich sein könnten. Diese Frage wird im laufenden EU-Drogenaktionsplan thematisiert und bildet einen der Schwerpunkte einer von der EBDD koordinierten Studie. In diesem Zusammenhang darf man sich jedoch keinen Illusionen hingeben. Weder Spanien noch Italien, die beide HIV-Epidemien unter IDU zu beklagen hatten, stellen nationale Berichtsdaten über HIV-Fälle zur Verfügung, was erhebliche negative Auswirkungen auf den Wert dieser Daten für die Darstellung des Gesamtbildes in der EU hat. Darüber hinaus geben die Daten aus einigen Ländern Anlass zu der Befürchtung, dass die Zahl der HIV-Infektionen steigen könnte, zumindest in bestimmten Teilgruppen der IDU.

In Frankreich, wo HIV-Fälle erst seit 2003 erfasst werden, ist die HIV-Inzidenz unter IDU (wenn auch ausgehend von einem niedrigen Niveau) von schätzungsweise 2,3 Fällen je 1 Millionen Einwohner im Jahr 2003 auf 2,9 Fälle im Jahr 2004 gestiegen. Dies steht zwar insgesamt im Einklang mit den verfügbaren Erhebungsdaten (siehe unten), es ist jedoch daran zu erinnern, dass neue Meldesysteme in der Anfangsphase häufig instabil sind. In Portugal wird der zuvor verzeichnete scheinbare Rückgang der neu diagnostizieren HIV-Fälle unter IDU durch die Daten des Jahres 2004 in Frage gestellt, die mit 98,5 Fällen je 1 Million Einwohner die EU-weit höchste HIV-Inzidenz belegen (186). Im Vereinigten Königreich ist die HIV-Inzidenz unter IDU langsam gestiegen, bleibt gegenwärtig aber bei jährlich knapp unter 2,5 Fällen je 1 Million Einwohner stabil. In Irland stieg die Inzidenz Ende der 90er Jahre auf einen Spitzenwert von 18,3 Fällen je 1 Million Einwohner im Jahr 2000, fiel anschließend auf 9,8 Fälle je 1 Million Einwohner im Jahr 2001 und stieg dann auf 17,8 Fälle je 1 Million Einwohner im Jahr 2004 an.

Zu HIV-Ausbrüchen im Zusammenhang mit dem injizierenden Drogenkonsum kam es auch in jüngerer Zeit, so zum Beispiel 2001 in Estland und Lettland sowie 2002 in Litauen. Seitdem sind die Raten stark zurückgegangen. Nach einer ersten epidemischen Phase ist in der Regel ein Rückgang der Zahl der neu gemeldeten Fälle zu erwarten, wenn sich ein endemisches Infektionsniveau einstellt (siehe unten).

HIV-Seroprävalenz bei getesteten injizierenden Drogenkonsumenten

Seroprävalenzdaten von injizierenden Drogenkonsumenten (prozentualer Anteil der Infizierten in Stichproben von IDU) stellen eine wichtige Ergänzung zu den Berichten über HIV-Fälle dar. Wiederholte Seroprävalenz-Studien sowie die regelmäßige Überwachung der Daten aus diagnostischen Tests können die aus den Daten der Fallberichterstattung gezogenen Schlussfolgerungen untermauern und detailliertere Informationen über bestimmte Regionen und Settings bereitstellen. Die Prävalenzdaten stammen jedoch aus den unterschiedlichsten Quellen und sind in einigen Fällen unter Umständen schwer vergleichbar; daher sollten sie mit Bedacht interpretiert werden.

Die jüngsten in den Berichten einiger Länder über HIV-Fälle verzeichneten Anstiege werden zumeist durch die verfügbaren Seroprävalenzdaten bestätigt, die jedoch belegen, dass eine erhöhte Wachsamkeit nicht nur in diesen Ländern geboten ist.

In den baltischen Staaten zeigen die verfügbaren Seroprävalenzdaten, dass die Übertragung unter IDU unter Umständen noch immer nicht unter Kontrolle ist (Abbildung 10). In Estland geht aus einer kürzlich durchgeführten Studie hervor, dass die Prävalenz unter IDU in einer Region steigt (Tallinn: von 41 % einer Stichprobe von 964 IDU im Jahr 2001 auf 54 % einer Stichprobe von 350 IDU im Jahr 2005) und in einer anderen außergewöhnlich hoch ist (Kohtla-Järve: 90 % einer Stichprobe von 100 IDU). In Lettland zeigen zwei Zeitreihen von Seroprävalenzdaten unter IDU einen kontinuierlichen Anstieg bis 2002/2003, während eine dritte Reihe einen Rückgang seit dem Höhepunkt im Jahr 2001 belegt. In Litauen zeigen die Daten für das Jahr 2003 einen Anstieg der Zahl der positiv auf HIV getesteten IDU in Drogentherapien, Nadelaustauschprogrammen und Krankenhäusern von zwischen 1,0 % und 1,7 % im Zeitraum 1997 bis 2002 auf 2,4 % (27 von 1 112) im Jahr 2003.


Abbildung 10:  HIV-Prävalenz bei getesteten injizierenden Drogenkonsumenten im Zeitraum 2003/2004

Abbildung 10

Anmerkung:

Die Angaben in (Klammern) sind lokale Daten. Die Farben markieren die mittleren Werte der nationalen Daten bzw., sofern diese nicht verfügbar sind, der lokalen Daten.

In den Daten für Italien und Portugal werden nicht injizierende Drogenkonsumenten berücksichtigt; dies führt wahrscheinlich zu einer Unterschätzung der Prävalenz bei injizierenden Drogenkonsumenten.

* Die Daten wurden teilweise oder vollständig vor dem Jahr 2003 (Spanien 2002/2003; Frankreich 2002/2003; Lettland 2002/2003; Niederlande 2002) bzw. im Jahr 2005 (Estland) erhoben.

Quellen:

Nationale Reitox-Knotenpunkte. Primärquellen, Einzelheiten zu den Studien sowie Daten für den Zeitraum vor 2003 oder nach 2004 sind der Tabelle INF-8 im Statistical Bulletin 2006 zu entnehmen.

Drucken


In den Ländern, die in der Vergangenheit hohe Raten von HIV-Infektionen unter IDU verzeichnet haben (Spanien, Frankreich, Italien, Polen und Portugal) gibt es neue Anzeichen für eine fortgesetzte Übertragung auf nationaler Ebene, in bestimmten Regionen oder in bestimmten Teilgruppen von IDU (187). Es muss darauf hingewiesen werden, dass die infolge der umfangreichen Epidemien der 80er und 90er Jahre hohe Hintergrundprävalenz in diesen Ländern die Wahrscheinlichkeit erhöht, das hochriskantes Verhalten zu einer Infektion führt.

Für Spanien und Italien stehen keine nationalen Daten aus der Fallberichterstattung zur Verfügung. Daten aus routinemäßigen diagnostischen Tests sind schwer zu interpretieren, da bei ihnen unterschiedliche Auswahlverzerrungen auftreten können; jedoch geben sie in diesen Ländern Anlass zur Besorgnis. In Spanien blieb die HIV-Prävalenz unter jungen IDU (unter 25 Jahren), die während der Drogenbehandlung getestet wurden, bis 2002 bei über 12 % stabil, während sie unter neuen IDU (definiert als IDU, die seit weniger als zwei Jahren injizieren) im Zeitraum 2000/2001 von 15 % auf 21 % gestiegen ist, was für das Jahr 2002 auf eine hohe Inzidenz schießen lässt. In Italien weisen die einzelnen Regionen sehr unterschiedliche Tendenzen bei IDU auf, wobei in einigen Regionen auch in der letzten Zeit weitere erhebliche Zunahmen der HIV-Prävalenz festgestellt wurden (Bozen, Ligurien, Molise, Toskana und Umbrien).

In Polen deutet die in lokalen Untersuchungen festgestellte hohe Prävalenz unter jungen IDU darauf hin, dass sich HIV zumindest bis vor kurzem weiter ausgebreitet hat (in einer Region lag die Prävalenz im Jahr 2002 bei 15 %, in zwei weiteren Regionen im Jahr 2004 bei 4 % bis 11 %). In der Erhebung des Jahres 2002 wurden vier Fälle (9 %) von HIV unter den 45 neuen injizierenden Konsumenten der Stichprobe gemeldet. Jedoch wurden in der Erhebung des Jahres 2004 bei den 20 neuen IDU der Stichprobe keine Fälle festgestellt.

Schließlich weisen in einigen Ländern, in denen niemals umfangreiche Epidemien unter IDU beobachtet wurden, einige der jüngsten Prävalenzdaten darauf hin, dass Wachsamkeit angezeigt ist. Dies ist offenbar in Luxemburg, Österreich und dem Vereinigten Königreich der Fall, obwohl der Anstieg der HIV-Prävalenz in diesen Ländern begrenzt bleibt und nicht durch Daten aus der Fallberichterstattung untermauert wird.

Länder mit niedriger HIV-Prävalenz

Hinsichtlich der HIV-Prävalenz unter getesteten IDU bestehen nach wie vor große Unterschiede zwischen den EU-Mitgliedstaaten (Abbildung 10). In einer Reihe von Ländern ist die HIV-Prävalenz unter IDU in jüngster Zeit gestiegen oder bleibt seit vielen Jahren auf hohem Niveau stabil. Dagegen blieb die HIV-Prävalenz unter IDU in mehreren anderen Ländern im Zeitraum 2003/2004 sehr niedrig: Die HIV-Prävalenz lag in der Tschechischen Republik, Griechenland, Ungarn, Malta und Slowenien (basierend auf nationalen Erhebungen) sowie in der Slowakei, Bulgarien, Rumänien, der Türkei und Norwegen (basierend auf subnationalen Erhebungen) unter oder bei etwa 1 %. Einige dieser Länder (z. B. Ungarn) wiesen sowohl bei der HIV-Prävalenz als auch bei der Prävalenz des Hepatitis-C-Virus (HCV) die europaweit niedrigsten Raten auf, was auf niedrige Raten injizierender Drogenkonsumenten hinweist (siehe „Hepatitis B und C“). Jedoch gibt es in einigen Ländern (z. B. Rumänien) Belege für eine steigende Prävalenz von Hepatitis C.

Geschlechtsspezifische Unterschiede hinsichtlich der HIV-Prävalenz zwischen den getesteten IDU

Die verfügbaren Daten für den Zeitraum 2003/2004 zeigen, dass hinsichtlich der Seroprävalenz bei den getesteten IDU Unterschiede zwischen Männern und Frauen festgestellt wurden (188). Die kombinierten Daten aus Belgien, Estland (2005), Spanien (2002), Frankreich, Italien, Luxemburg, Österreich, Polen und Portugal ergaben eine Stichprobe von insgesamt 124 337 Männern und 20 640 Frauen, die vorwiegend in Drogenbehandlungszentren oder anderen Drogendiensten getestet wurden. Die Gesamtprävalenz betrug bei den Männern 13,6 % und bei den Frauen 21,5 %. Zwischen den Ländern wurden erhebliche Unterschiede beobachtet: Während in Estland, Spanien, Italien, Luxemburg und Portugal die höchsten Anteile der Frauen im Verhältnis zu den Männern festgestellt wurden, verzeichnete Belgien mit höheren Raten unter den Männern eine umgekehrte Tendenz.

AIDS-Inzidenz und Verfügbarkeit von HAART

Da die seit 1996 verfügbare hochaktive antiretrovirale Therapie (HAART) dem Ausbruch von AIDS bei HIV-Infizierten wirksam vorbeugt, sind die AIDS-Inzidenzdaten als Indikator für die Übertragung von HIV weniger geeignet als in der Vergangenheit. Sie belegen jedoch nach wie vor die Gesamtraten der symptomatischen Erkrankungen und stellen einen wichtigen Indikator für die Einführung und das flächendeckende Angebot von HAART für IDU dar.

Schätzungen der WHO zufolge hatte im Jahr 2003 in den westeuropäischen Ländern ein Großteil der behandlungsbedürftigen Menschen (über 70 %) Zugang zu HAART, während der Erfassungsgrad dieser Therapieform in den meisten osteuropäischen Ländern, darunter in Estland, Litauen und Lettland, stärker begrenzt war (189). Jüngere Daten über den Erfassungsgrad von HAART zeigen, dass sich die Lage erheblich gebessert hat und gegenwärtig in allen EU-Mitgliedstaaten und Kandidatenländern mindestens 75 % der behandlungsbedürftigen Menschen Zugang zu HAART haben. Spezifische Daten über die Verfügbarkeit von HAART für IDU liegen jedoch nicht vor, und es bleibt festzustellen, ob der verbesserte Erfassungsgrad zu einem Rückgang der AIDS-Inzidenz unter IDU in Estland und Lettland führen wird.

Was die vier westeuropäischen Länder mit der höchsten AIDS-Inzidenz betrifft, d. h. Spanien, Frankreich, Italien und Portugal, so ist die Inzidenz in den drei erstgenannten Ländern seit 1996 und in Portugal erst seit 1999 zurückgegangen. Portugal ist mit 31 Fällen je 1 Million Einwohner im Jahr 2004 nach wie vor das EU-Land mit der höchsten AIDS-Inzidenz unter IDU. In Lettland ist jedoch die Inzidenz mit 30 Fällen je 1 Million Einwohner fast genauso hoch.

Die von EuroHIV vorgelegten Daten bis 2004 (korrigiert um Meldeverzögerungen) zeigen, dass die AIDS-Inzidenz unter IDU sowohl in Estland als auch in Lettland steigt (190).

Hepatitis B und C

Hepatitis C

Die Prävalenz von Antikörpern gegen das Hepatitis-C-Virus (HCV) unter injizierenden Drogenkonsumenten ist EU-weit im Allgemeinen außerordentlich hoch, wobei es jedoch große Unterschiede innerhalb der Länder und zwischen den einzelnen Ländern gibt. Für die Jahre 2003/2004 werden aus Belgien, Dänemark, Deutschland, Griechenland, Spanien, Irland, Italien, Polen, Portugal, dem Vereinigten Königreich, Rumänien und Norwegen Prävalenzraten von über 60 % bei Stichproben von injizierenden Drogenkonsumenten gemeldet, während Belgien, die Tschechische Republik, Griechenland, Zypern, Ungarn, Malta, Österreich, Slowenien, Finnland und das Vereinigte Königreich über Stichproben mit Prävalenzraten unter 40 % berichten (191).

Daten über die HCV-Antikörper-Prävalenz unter jungen IDU (unter 25 Jahren) sind aus 14 Ländern verfügbar, beruhen jedoch zum Teil auf kleinen Stichproben. Die Ergebnisse weisen große Unterschiede auf, wobei einige Länder sowohl hohe als auch niedrige Zahlen aus unterschiedlichen Stichproben melden. Im Zeitraum 2003/2004 wurden die höchsten Prävalenzraten unter jungen injizierenden Drogenkonsumenten (über 40 %) in Stichproben aus Belgien, Griechenland, Österreich, Polen, Portugal, der Slowakei sowie dem Vereinigten Königreich und die niedrigsten Prävalenzraten (unter 20 %) in Stichproben aus Belgien, Griechenland, Zypern, Ungarn, Malta, Österreich, Slowenien, Finnland, dem Vereinigten Königreich und der Türkei ermittelt. Berücksichtigt man ausschließlich auf nationaler Ebene durchgeführte Erhebungen unter jungen IDU, wurden die höchsten Prävalenzraten (über 60 %) in Portugal und die niedrigsten (unter 40 %) in Zypern, Ungarn, Malta, Österreich und Slowenien festgestellt. Obwohl die verwendeten Stichprobenverfahren zu einer Verzerrung zugunsten der chronischen Patienten geführt haben könnten, ist die in einer nationalen Stichprobe in Portugal festgestellte hohe HCV-Antikörper-Prävalenz (67 % von 108 IDU unter 25 Jahren) dennoch beunruhigend und könnte auf fortgesetzte hochriskante Verhaltensweisen unter jungen IDU hinweisen (siehe auch „Jüngste Tendenzen bei den neu gemeldeten HIV-Fällen“).

Zwar liegen Daten über die HCV-Antikörper-Prävalenz unter neuen injizierenden Drogenkonsumenten (die seit weniger als zwei Jahren injizieren) nur in begrenztem Umfang vor und stammen aus kleinen Stichproben, dennoch können sie einen besseren Ersatzindikator für die jüngsten Inzidenzraten darstellen als die Daten über junge IDU. Aus den für die Jahre 2003/2004 verfügbaren Informationen geht hervor, dass in Stichproben aus Griechenland, Polen, dem Vereinigten Königreich und der Türkei die höchsten (über 40 %) und in Stichproben aus Belgien, der Tschechischen Republik, Griechenland, Zypern und Slowenien die niedrigsten (unter 20 %) Prävalenzraten unter neuen IDU festgestellt wurden. Niedrige Prävalenzraten wurden in kleinen, jedoch auf nationaler Ebene erhobenen Stichproben neuer IDU in Zypern (nur zwei von 23 IDU wurden positiv auf HCV-Antikörper getestet, das entspricht einem Anteil von 9 %) und Slowenien (zwei von 32 IDU, bzw. 6 % wurden positiv getestet) festgestellt.

Hepatitis B

Auch bei der Prävalenz der Marker für das Hepatitis-B-Virus (HBV) gibt es große Unterschiede sowohl innerhalb der Länder als auch zwischen den einzelnen Ländern. Die vollständigsten Daten liegen für den Marker Anti-HBc vor, der auf Infektionen in der Vergangenheit hinweist. Für den Zeitraum 2003/2004 wurden IDU-Stichproben mit Prävalenzraten über 60 % aus Italien und Polen gemeldet, während Belgien, Irland, Zypern, Österreich, Portugal, Slowenien, die Slowakei und das Vereinigte Königreich über Stichproben mit Prävalenzraten unter 20 % berichteten. Für die Länder, aus denen Meldedaten bezüglich Hepatitis B verfügbar sind, belegen diese für den Zeitraum 1992 bis 2004 ein sehr uneinheitliches Bild (192). In den skandinavischen Ländern betreffen die allermeisten gemeldeten Fälle akuter Hepatitis B injizierende Drogenkonsumenten, und in mehreren Ländern korreliert die Zahl der Ausbrüche von Hepatitis B mit der Zunahme des injizierenden Drogenkonsums. Beispielsweise belegen die Daten für Norwegen, dass die Inzidenz der Hepatitis-B-Infektionen unter IDU zunächst zwischen 1992 und 1998 stark gestiegen und anschließend gesunken ist. In Finnland sind die Meldungen über Hepatitis B unter IDU in den letzten Jahren drastisch zurückgegangen, was möglicherweise auf Impfprogramme und ein umfassendes Nadel- und Spritzenaustauschprogramm zurückzuführen ist.

Prävention von Infektionskrankheiten

Wirksame Maßnahmen

Eine Reihe von Maßnahmen im Bereich der öffentlichen Gesundheit hat sich hinsichtlich der Reduzierung der Verbreitung von Infektionskrankheiten unter Drogenkonsumenten als wirksam erwiesen, und es besteht zunehmend Einigkeit darüber, dass ein umfassendes Konzept für die Erbringung von Leistungen in diesem Bereich die größten Erfolgschancen hat. In der Vergangenheit konzentrierte sich die Diskussion auf die Prävention von HIV-Infektionen unter injizierenden Drogenkonsumenten. Gegenwärtig wird jedoch zunehmend auch die Notwendigkeit wirksamer Maßnahmen zur Verhinderung der Verbreitung von Hepatitis sowie der Prävention der Verbreitung von Infektionskrankheiten unter nicht injizierenden Drogenkonsumenten anerkannt.

Es ist darauf hinzuweisen, dass für die Wirksamkeit der Prävention von HIV-Infektionen unter injizierenden Drogenkonsumenten die meisten Belege verfügbar sind. Eine tragfähige Basis verfügbarer Evidenzdaten zeigt, dass die Maßnahmen als wirksam bewertet werden können und der Zugang zu allen Therapieformen zum Schutz der Drogenkonsumenten beiträgt (Farrell et al., 2005; WHO, 2005). Seit Mitte der 90er Jahre werden im Rahmen der europäischen Maßnahmen zunehmend Drogentherapien angeboten (siehe Kapitel 2), die offenbar insgesamt zu dem recht ermutigenden Bild beigetragen haben, das gegenwärtig hinsichtlich der epidemischen Verbreitung von HIV unter injizierenden Drogenkonsumenten in Europa zu beobachten ist.

Die Behandlung ist nur ein Teil eines umfassenden Konzepts zur HIV-Prävention. Ein solches Konzept muss außerdem eine Reihe von Informations-, Schulungs- und Kommunikationstechniken, freiwillige Beratungen über Infektionskrankheiten und entsprechende Tests, Impfungen, die Ausgabe steriler Spritzenbestecke sowie andere vorbeugende Maßnahmen umfassen. Gemeinsam mit dem Angebot einer medizinischen Versorgung in niedrigschwelligen Diensten oder sogar auf der Straße können diese Maßnahmen dazu beitragen, die Kommunikation mit aktiven Drogenkonsumenten und ihren Sexualpartnern über die Risiken und die Prävention gesundheitlicher Folgen des Drogenkonsums herzustellen oder zu verbessern.

Eine grundsätzliche Verpflichtung zu einem umfassenden Konzept impliziert nicht, dass alle diese Leistungen auf nationaler Ebene in gleichem Umfang entwickelt oder unterstützt werden. Jedoch zeichnet sich offenbar ein gewisser Konsens ab. In einer Erhebung unter den nationalen Knotenpunkten nannten drei von vier Befragten die Kombination von Nadel- und Spritzenaustauschprogrammen mit Information und Beratung als eine Priorität der nationalen Politik zur Bekämpfung der Verbreitung von Infektionskrankheiten unter injizierenden Drogenkonsumenten (Abbildung 11). Die Tatsache, dass gegenwärtig so viele Länder explizit die Bedeutung der Bereitstellung sauberer Spritzenbestecke als Teil ihrer HIV-Präventionsstrategie anerkennen, zeigt, dass sich diese Form von Leistungen in Europa erfolgreich durchgesetzt hat und nicht länger in den meisten Ländern kontrovers diskutiert wird. Das bedeutet jedoch nicht, dass ein einhelliger Konsens über die Vorteile dieser Angebote besteht. So wurden sie beispielsweise in Griechenland und Schweden nicht als politische Priorität eingestuft. Insgesamt zeichnet sich aber hinsichtlich der Durchführung von Maßnahmen in diesem Bereich EU-weit ein recht homogenes Bild ab (193): Alle Länder mit Ausnahme Zyperns berichten über die Existenz von Programmen für den Austausch von Spritzenbestecken oder die Ausgabe steriler Nadeln und Spritzen (194).

Formen von Nadel- und Spritzenaustauschprogrammen in europäischen Ländern

Zwar werden in den meisten europäischen Ländern sterile Spritzenbestecke ausgegeben, jedoch gibt es zwischen den Ländern Unterschiede hinsichtlich der Art und der Reichweite dieser Angebote. Am weitesten verbreitet ist ein Modell, bei dem diese Leistung an einem bestimmten Ort, in der Regel bei einem spezialisieren Drogendienst, angeboten wird, wobei dies jedoch häufig durch mobile Dienste ergänzt wird, die versuchen, Drogenkonsumenten in Gemeindeeinrichtungen zu erreichen. In acht Ländern (195) werden neben den verfügbaren Nadel- und Spritzenaustauschdiensten auch Automaten für den Austausch oder Verkauf von Spritzen bereitgestellt. Dieses Angebot ist aber offenbar auf einige wenige Orte begrenzt, und nur Deutschland und Frankreich berichten über erhebliche Aktivitäten in diesem Bereich (etwa 200 bzw. 250 Automaten). Spanien ist das einzige EU-Land, in dem Nadel- und Spritzenaustauschprogramme regelmäßig in Haftanstalten angeboten werden: Hier war dieses Angebot im Jahr 2003 in 27 Haftanstalten verfügbar. Als einziges weiteres EU-Land berichtet Deutschland über Tätigkeiten in diesem Bereich, wobei jedoch das Angebot auf eine Haftanstalt beschränkt ist.


Kasten 15: Ist die flächendeckende Versorgung mit Spritzen in Europa ausreichend?

Zwar berichten fast alle Mitgliedstaaten über eine gewisse Verfügbarkeit von Nadel- und Spritzenaustauschprogrammen, jedoch ist die Wirkung dieser Maßnahmen davon abhängig, ob der Versorgungsgrad geeignet ist, den Bedarf der injizierenden Drogenkonsumenten zu decken.

Jüngere Schätzungen über die Zahl der injizierenden Drogenkonsumenten und über die Zahl der an diese ausgegebenen Spritzen liegen aus neun europäischen Ländern vor. Ausgehend von diesen Daten kann eine grobe Schätzung der Zahl der jedem injizierenden Konsumenten jährlich zur Verfügung stehenden Spritzen vorgenommen werden (1). Den jüngsten verfügbaren Daten zufolge gibt es hinsichtlich des Versorgungsgrads der Nadel- und Spritzenaustauschprogramme erhebliche Unterschiede zwischen den Ländern: Die Zahl der je injizierendem Drogenkonsumenten ausgegebenen Spritzen reicht von 2 bis 3 Spritzen in Griechenland über 60 bis 90 in der Tschechischen Republik, Lettland, Österreich und Portugal bis hin zu etwa 110 in Finnland, 210 in Malta und über 250 Spritzen in Luxemburg und Norwegen. Darüber hinaus sind auch in Apotheken Spritzen erhältlich, und die Daten aus der Tschechischen Republik und Finnland weisen darauf hin, dass von einer schätzungsweise flächendeckenden Verfügbarkeit von Spritzen ausgegangen werden kann. Unter Berücksichtung sowohl der Ausgabe- als auch der Verkaufsdaten ergibt sich der Schluss, dass jeder injizierende Drogenkonsument in der Tschechischen Republik durchschnittlich 125 Spritzen und in Finnland 140 Spritzen jährlich erhält.

Bekanntermaßen beeinflussen viele Faktoren die Injektionshäufigkeit der Drogenkonsumenten, darunter die Konsummuster, der Grad der Abhängigkeit und die Art der konsumierten Droge. Bei einer vor kurzem durchgeführten Studie über den Zusammenhang zwischen der HIV-Prävalenz und dem Versorgungsgrad der Spritzenverteilungsprogramme wurde festgestellt, dass bestimmte Verhaltensweisen, z. B. die Injektionshäufigkeit und die Wiederverwendung von Spritzen durch den Einzelnen, starken Einfluss darauf haben, welcher Versorgungsgrad erreicht werden muss, um einen substanziellen Rückgang der HIV-Prävalenz zu erzielen (Vickerman et al., 2006).

Die Bemessung des Grads der Versorgung mit Spritzen ist ein wichtiger Faktor für das Verständnis der wahrscheinlichen Auswirkungen der Spritzenverteilung auf die Prävention von Erkrankungen und für die Beurteilung des ungedeckten Bedarfs. Es ist jedoch wichtig, bei der Interpretation dieser Daten sowohl die Verfügbarkeit von Spritzen im Rahmen des Verkaufs in Apotheken (Preise, Dichte der Apothekennetze) als auch die Verhaltensmuster der injizierenden Drogenkonsumenten sowie Milieufaktoren zu berücksichtigen. Dieses Thema wird im Statistical Bulletin 2006 weiter erörtert.

(1) Methodische Einzelheiten sind dem Statistical Bulletin 2006 zu entnehmen.


Die Einbeziehung von Apotheken in Austauschprogramme trägt ebenfalls dazu bei, die geografische Reichweite des Angebots zu erweitern, und auch durch den Verkauf sauberer Spritzen in Apotheken könnte die Verfügbarkeit dieser Spritzen verbessert werden. Der Verkauf von Spritzen ohne Rezept ist mit Ausnahme Schwedens in allen EU-Ländern erlaubt, obwohl einige Apotheker nicht dazu bereit sind und einige sogar Drogenkonsumenten aktiv den Zutritt zu ihren Geschäftsräumen verwehren. In neun europäischen Ländern (in Belgien, Dänemark, Deutschland, Spanien, Frankreich, den Niederlanden, Portugal, Slowenien und im Vereinigten Königreich) gibt es formal organisierte Apotheken-Netze für den Austausch oder die Ausgabe von Spritzen, wobei es jedoch hinsichtlich der Beteiligung an diesen Programmen beträchtliche Unterschiede gibt: Sie reicht von fast der Hälfte der Apotheken (45 %) in Portugal bis unter 1 % in Belgien. In Nordirland erfolgt der Austausch von Nadeln und Spritzen gegenwärtig ausschließlich in Apotheken.

Der Erwerb von Spritzen in Apotheken könnte für einige injizierende Drogenkonsumenten eine gute Chance bieten, mit dem Gesundheitswesen in Berührung zu kommen, und es besteht eindeutig die Möglichkeit, diese Kontaktstellen als Anlaufpunkte für die Vermittlung in andere Betreuungsdienste zu nutzen. Die Motivation und Unterstützung der Apotheker bei der Erweiterung ihrer Leistungen auf Drogenkonsumenten könnten einen wichtigen Beitrag zur Ausweitung der Rolle der Apotheken leisten, jedoch werden offenbar nur in Frankreich, Portugal und im Vereinigten Königreich entsprechende Anstrengungen unternommen.

Mortalität und drogenbedingte Todesfälle

Mortalität unter problematischen Drogenkonsumenten

Die meisten Informationen über die Mortalität unter problematischen Drogenkonsumenten in Europa beziehen sich auf Opioidkonsumenten. Über die Mortalität im Zusammenhang mit anderen Formen des Drogenkonsums liegen weniger Informationen vor, sie stellt jedoch nach wie vor im Bereich der öffentlichen Gesundheit ein wichtiges Thema dar.

In einer im Rahmen eines EBDD-Projekts durchgeführten Gemeinschaftsstudie wurde die Mortalität unter in Behandlung befindlichen Opioidkonsumenten in acht europäischen Ländern bzw. Städten untersucht (196). Dabei wurde festgestellt, dass die Mortalitätsrate unter Opioidkonsumenten wesentlich höher ist als unter den Angehörigen derselben Altersgruppe in der Allgemeinbevölkerung: Die Mortalität unter Opioidkonsumenten ist bei Männern sechs bis 20 Mal, bei Frauen zehn bis 50 Mal höher. In sechs Städten (Amsterdam, Barcelona, Dublin, London, Rom und Wien) können schätzungsweise 10 % bis 23 % aller Todesfälle unter Erwachsenen im Alter zwischen 15 und 49 Jahren mit dem Konsum von Opioiden in Verbindung gebracht werden, vor allem mit Überdosen, AIDS und externen Ursachen (Unfälle, Selbstmorde). Etwa ein Drittel dieser drogenbedingten Todesfälle war auf Überdosen zurückzuführen, wobei dieser Anteil in Städten mit einer niedrigen Prävalenz von HIV-Infektionen unter injizierenden Drogenkonsumenten höher war und vermutlich steigen wird, sobald die hochaktive antiretrovirale Therapie (HAART) flächendeckender angeboten wird.

Bei einer in der Tschechischen Republik durchgeführten Kohortenstudie zur Mortalität wurde festgestellt, dass die Mortalität unter den Konsumenten von Stimulanzien vier bis sechs Mal (standardisierte Sterblichkeitsrate) und unter den Opioidkonsumenten neun bis zwölf Mal höher war als in der Allgemeinbevölkerung. Eine französische Kohortenstudie unter Menschen, die wegen des Konsums von Heroin, Kokain oder Crack festgenommen worden waren, ergab bei Männern eine fünf Mal höhere und bei Frauen eine 9,5 Mal höhere Mortalität als in der Allgemeinbevölkerung, wobei allerdings auch eine rückläufige Tendenz festgestellt wurde.

Mit dem zunehmenden Alter der Opiatkonsumenten kommen zu den Todesfällen durch externe Ursachen (d. h. den nicht durch eine Überdosis verursachten Todesfällen) wie Selbstmord und Gewalt auch Todesfälle aufgrund chronischer Krankheiten (Zirrhose, Krebs, Atemwegserkrankungen, Endocarditis, AIDS) hinzu (nationale Berichte der Niederlande 2004 und 2005, Daten des städtischen Gesundheitsamtes Amsterdam). Die Lebensbedingungen der Drogenkonsumenten (z. B. Obdachlosigkeit, psychische Erkrankungen, Gewalt, Mangelernährung usw.) können ebenfalls erheblich zu der hohen Mortalität in dieser Bevölkerungsgruppe beitragen.

Im Jahr 2002 wurden darüber hinaus 1 528 Aids-Todesfälle gemeldet (197), die mit dem intravenösen Drogenkonsum in Verbindung gebracht wurden. Dabei dürfte es sich jedoch um eine Unterschätzung handeln. Andere Ursachen für drogenbedingte Todesfälle wie Krankheiten (z. B. Hepatitis), Gewalt und Unfälle sind schwerer zu beurteilen. Es ist jedoch wahrscheinlich, dass sie für eine erhebliche Zahl von Todesfällen verantwortlich sind. Schätzungsweise können 10 % bis 20 % der Todesfälle unter jungen Erwachsenen in europäischen Städten mit dem Konsum von Opioiden in Verbindung gebracht werden (siehe oben). Darüber hinaus sollten die Todesfälle im Zusammenhang mit anderen Formen des Drogenkonsums berücksichtigt werden, die jedoch sehr schwer zu beziffern sind.

Drogenbedingte Todesfälle

Der Begriff der drogenbedingten Todesfälle ist komplex. In einigen Berichten werden damit ausschließlich Todesfälle bezeichnet, die unmittelbar durch die Wirkung psychoaktiver Substanzen verursacht werden, während in anderen Fällen auch Todesfälle mit eingeschlossen werden, bei denen der Drogenkonsum eine indirekte oder begleitende Rolle gespielt hat (Verkehrsunfälle, Gewalt, Infektionskrankheiten). In einem kürzlich vorgelegten Bericht, in dem die Formen der im Vereinigten Königreich durch den Konsum illegaler Drogen verursachten Schäden analysiert wurden, kamen die Autoren zu der Einschätzung, dass drogenbedingte Todesfälle die häufigsten durch den Drogenkonsum verursachten Schäden darstellen (MacDonald et al., 2005).

In diesem Abschnitt sowie im EBDD-Protokoll bezeichnet der Begriff „drogenbedingte Todesfälle“ jene Fälle, in denen der Tod unmittelbar durch den Konsum einer oder mehrerer Drogen verursacht wurde und in der Regel kurz nach der Einnahme der Substanz(en) eingetreten ist. Diese Fälle werden unter anderem auch als „Überdosis“, „Vergiftung“, „drogeninduzierte Todesfälle“ oder „akute drogenbedingte Todesfälle“ bezeichnet (198).

Zwischen 1990 und 2003 meldeten die EU-Länder jährlich 6 500 bis über 9 000 solcher Todesfälle, insgesamt also über 113 000 Fälle. Diese Zahlen sind als Minimalschätzungen anzusehen, da wahrscheinlich in vielen Ländern nicht alle Fälle gemeldet werden (199).

Mit Raten zwischen 0,2 und über 50 Todesfällen (durchschnittlich 13) je 1 Million Einwohner verzeichneten die europäischen Länder sehr unterschiedliche Mortalitätsraten im Zusammenhang mit drogenbedingten Todesfällen. In den meisten Ländern bewegt sich diese Zahl in der Spanne zwischen sieben und 30 Todesfällen je 1 Million Einwohner, wobei in Dänemark, Estland, Luxemburg, Finnland, dem Vereinigten Königreich und Norwegen Raten von über 25 Fällen ermittelt wurden. Unter Männern im Alter zwischen 15 und 39 Jahren sind die Mortalitätsraten in der Regel drei Mal so hoch (durchschnittlich 40 Todesfälle je 1 Million Einwohner), wobei sieben Länder Raten von über 80 Todesfällen je 1 Million Einwohner melden. Im Zeitraum 2003/2004 waren 3 % aller Todesfälle unter Europäern im Alter zwischen 15 und 39 Jahren drogenbedingte Todesfälle, wobei ihr Anteil in Dänemark, Griechenland, Luxemburg, Malta, Österreich, dem Vereinigten Königreich und Norwegen bei über 7 % lag. Diese Zahlen sind als Mindestschätzungen zu betrachten. Darüber hinaus sollte berücksichtigt werden, dass ungeachtet der vorgenommenen Verbesserungen noch immer erhebliche Qualitätsunterschiede in der Berichterstattung der einzelnen Länder bestehen und somit direkte Vergleiche mit Bedacht anzustellen sind (200).

Opioidbedingte Todesfälle

Bei den meisten in der EU gemeldeten „akuten drogenbedingten Todesfällen“, die auf illegale Substanzen zurückzuführen sind, spielen Opioide eine Rolle, obwohl in zahlreichen Fällen bei der toxikologischen Untersuchung auch andere Substanzen nachgewiesen wurden, insbesondere Alkohol, Benzodiazepine und, in einigen Ländern, Kokain. In Europa werden die meisten opioidbedingten Todesfälle mit Heroin in Verbindung gebracht, es werden jedoch auch andere Opioide festgestellt (siehe unten) (201).

Eine Überdosierung mit Opioiden ist eine der häufigsten Todesursachen bei jungen Menschen in Europa, vor allem unter Männern in städtischen Gebieten. Derzeit sind Überdosierungen bei Opioidkonsumenten EU-weit die häufigste Todesursache, insbesondere in Ländern mit einer niedrigen HIV-Prävalenz unter injizierenden Drogenkonsumenten (siehe „Mortalität unter problematischen Drogenkonsumenten“).

Am häufigsten werden Überdosen von männlichen Drogenkonsumenten eingenommen (202): In 65 % bis 100 % der Fälle sind Männer betroffen, wobei dieser Anteil in den meisten Ländern zwischen 75 % und 90 % liegt. In der Tschechischen Republik, Polen und Finnland werden die höchsten und in Griechenland, Italien und Zypern die niedrigsten Anteile von Frauen gemeldet. Diese Ergebnisse müssen im Zusammenhang mit den unterschiedlichen Raten des Opioidkonsums und des injizierenden Drogenkonsums bei Männern und Frauen interpretiert werden.

Die meisten Opfer einer Überdosis stehen im Alter zwischen 20 und 40 Jahren, wobei das Durchschnittsalter in den meisten Ländern bei Mitte 30 liegt (die Spanne reicht jedoch von 20 bis 44 Jahre). Das niedrigste Durchschnittsalter der Opfer von Überdosierungen wird aus Estland, Slowenien, Bulgarien und Rumänien, das höchste aus der Tschechischen Republik, den Niederlanden, Polen und Finnland gemeldet. Für die Altersgruppe unter 15 Jahren werden nur sehr wenige Todesfälle durch Überdosierungen gemeldet (17 Fälle von insgesamt 7 516 Todesfällen, basierend auf den jüngsten verfügbaren Daten der einzelnen Länder), wobei in den Berichten möglicherweise nicht alle drogenbedingten Todesfälle in dieser Altergruppe erfasst werden. Die Daten der EBDD beinhalten einige Todesfälle von Erwachsenen im Alter von über 65 Jahren, wobei nur sieben Länder berichten, dass diese Altersgruppe mehr als 5 % der Fälle ausmacht (203).

In einigen neuen Mitgliedstaaten (Estland, Zypern, Lettland und Slowakei) sowie in den Kandidatenländern Bulgarien und Rumänien ist das Durchschnittsalter zum Todeszeitpunkt vergleichsweise niedrig. In diesen Ländern ist der Anteil der Opfer einer Überdosis im Alter von unter 25 Jahren hoch, was darauf schließen lässt, dass die Heroinkonsumenten in diesen Ländern im Durchschnitt jünger sind. Das hohe Durchschnittsalter in der Tschechischen Republik ist darauf zurückzuführen, dass hier zahlreiche Todesfälle infolge der Einnahme psychoaktiver Arzneimittel einbezogen werden (Abbildung 12).

In vielen Mitgliedstaaten ist zu beobachten, dass die Opfer einer Überdosis älter werden, woraus der Schluss gezogen werden kann, dass weniger junge Menschen Heroin konsumieren. Diese Tendenz ist seit Anfang der 90er Jahre in allen EU-15-Mitgliedstaaten festzustellen, wobei sie jedoch in Schweden und dem Vereinigten Königreich weniger ausgeprägt ist. Auch in den neuen Mitgliedstaaten ist die Tendenz weniger deutlich, und in vielen Fällen ist sogar ein sinkendes Durchschnittsalter zu beobachten (204).

Durch Methadon verursachte Todesfälle

In ihren Reitox-Berichten 2005 meldeten mehrere Länder, dass bei einem erheblichen Anteil der drogenbedingten Todesfälle Methadon nachgewiesen wurde. Die einzelnen Länder verwenden unterschiedliche Terminologien, und in einigen Fällen kann kaum festgestellt werden, inwieweit Methadon als Todesursache eine Rolle gespielt hat.

Dänemark berichtet, dass Methadon (alleine oder in Kombination mit anderen Substanzen) in 44 % der Todesfälle (95 von 214 Fällen im Jahr 2004) die Ursache der Vergiftung war, was ungefähr dem im Jahr 2003 festgestellten Anteil entspricht, jedoch einen deutlichen Anstieg seit 1997 darstellt. Deutschland gibt an, dass 345 Fälle mit „Substitutionsmitteln“ in Verbindung gebracht wurden (im Jahr 2004 wurden in 46 Fällen ausschließlich Substitutionsmittel und in 299 Fällen Substitutionsmittel in Kombination mit anderen Suchtstoffen nachgewiesen), was einem deutlichen Rückgang seit 2002 entspricht. Aus dem Vereinigten Königreich werden 216 Fälle gemeldet, bei denen Methadon „erwähnt“ wurde (England und Wales im Jahr 2003), was ebenfalls einen deutlichen Rückgang seit 2002 bedeutet. Spanien berichtet über wenige Fälle von Überdosierungen, die ausschließlich mit Methadon in Verbindung gebracht wurden (2 %), jedoch über zahlreiche opioidbedingte (42 %) und kokainbedingte (20 %) Todesfälle, in denen auch Methadon nachgewiesen wurde. Andere Länder meldeten keine oder nur sehr wenige Todesfälle im Zusammenhang mit Methadon. Es ist unklar, welche Faktoren für diese Unterschiede verantwortlich sind und ob in einigen Ländern nicht alle Fälle gemeldet werden (205).

Die Forschungen belegen zwar, dass Substitutionstherapien das Risiko einer tödlichen Überdosierung verringern, dennoch ist es wichtig, im Rahmen der Qualitätssicherung von Substitutionsprogrammen auch die Zahl der mit Methadon in Verbindung gebrachten Todesfälle und die jeweiligen Begleitumstände (die Herkunft der Substanz, ob sie in Kombination mit anderen Substanzen konsumiert wurde, das Therapiestadium, in dem es zu der Vergiftung kam) zu beobachten.

Todesfälle im Zusammenhang mit Buprenorphin und Fentanyl

Die Tatsache, dass es offenbar nur selten zu Todesfällen infolge einer Vergiftung durch Buprenorphin kommt, wird auf die pharmakologischen Eigenschaften dieser agonistisch-antagonistisch wirksamen Droge zurückgeführt. Dennoch wurden aus den europäischen Ländern einige Todesfälle gemeldet.

In den nationalen Berichten 2005 nannten lediglich Frankreich und Finnland Todesfälle, die mit dieser Substanz in Verbindung gebracht wurden. In Finnland wurde 2004 bei 73 drogenbedingten Todesfällen Buprenorphin nachgewiesen, das entspricht der bereits 2003 gemeldeten Zahl. Dabei wurde die Droge in der Regel in Kombination mit Benzodiazepinen, Sedativa oder Alkohol eingenommen. Diese hohen Angaben gehen mit einer zunehmenden Zahl von Buprenorphintherapien in Finnland einher, wobei hier jedoch die Zahl der mit Buprenorphin behandelten Patienten wesentlich geringer ist als in Frankreich, wo schätzungsweise 70 000 bis 85 000 Menschen eine Buprenorphintherapie erhalten. Interessanterweise meldet Frankreich im Jahr 2004 jedoch nur vier Fälle von Buprenorphin-Überdosen (gegenüber acht Fällen im Jahr 2003). Selbst wenn man eine mögliche Dunkelziffer von Vergiftungen in Frankreich berücksichtigt, ist dieser immense Unterschied frappierend. Neben Frankreich und Finnland werden aus drei weiteren Ländern (jeweils nur zwei oder drei Fälle je Land) Todesfälle gemeldet, die mit Buprenorphin in Verbindung gebracht wurden, wobei die Substanz jedoch nicht als primäre Todesursache nachgewiesen wurde.

Während die Ostseeanrainerländer in den vorangegangenen Jahren noch Todesfälle im Zusammenhang mit Fentanyl gemeldet hatten, wurden in den nationalen Berichten 2005 keine solchen Todesfälle angegeben.

Entwicklungstendenzen bei akuten drogenbedingten Todesfällen

Aus den nationalen Tendenzen bei drogenbedingten Todesfällen können einige Rückschlüsse auf die Entwicklungen der Muster des problematischen Drogenkonsums in den einzelnen Ländern, beispielsweise im Hinblick auf Heroinepidemien und hochriskante Verhaltensweisen (z. B. injizierender Drogenkonsum), auf die Bereitstellung von Behandlungen und selbst auf die unterschiedliche Verfügbarkeit des Heroins gezogen werden. Diese Tendenzen können selbstverständlich auch auf erfolgreiche Verfahrensweisen der medizinischen Notfalldienste zur Verhinderung tödlicher Überdosierungen zurückzuführen sein (206).

Die für die EU verfügbaren Daten weisen auf einige allgemeine Tendenzen bei drogenbedingten Todesfällen hin. In den EU-15-Mitgliedstaaten wurde in den 80er und frühen 90er Jahren eine drastische Zunahme beobachtet, die möglicherweise mit der Verbreitung des Heroinkonsums und des injizierenden Heroinkonsums einherging. Zwischen 1990 und 2000 stieg die Zahl der drogenbedingten Todesfälle weniger schnell, aber kontinuierlich an (Abbildung 13). Die jährliche Zahl der drogenbedingten Todesfälle stieg in den Mitgliedstaaten, aus denen entsprechende Daten vorliegen (die meisten alten und neuen Mitgliedstaaten) zwischen 1995 und 2000 um 14 % von insgesamt 8 054 auf 9 392 Fälle an.


Abbildung 13:  Langfristige Tendenzen bei akuten drogenbedingten Todesfällen, 1985 bis 2004

Anmerkung:

In diesen Daten sind die neuen Mitgliedstaaten und die Kandidatenländer nicht berücksichtigt, da für diese in den meisten Fällen keine retrospektiven Daten vorliegen.

Die Zahl der Todesfälle in den einzelnen Ländern sowie Anmerkungen zur Methodik sind Tabelle DRD-2 im Statistical Bulletin 2006 zu entnehmen.

Für das Jahr 2004 haben zehn Länder Angaben zur Verfügung gestellt, während aus sechs Ländern keine Daten vorliegen. Daher ist die Angabe für das Jahr 2004 vorläufig und basiert auf einem Vergleich der Daten aus 2003 und 2004 lediglich der Länder, die für beide Jahre Daten übermittelt haben.

Quellen:

Nationale Reitox-Berichte 2005, auf der Grundlage von allgemeinen Todesursachenregistern oder (gerichtsmedizinischen bzw. polizeilichen) Spezialregistern.

Drucken


Seit 2000 berichten viele EU-Länder über einen Rückgang der Zahl der drogenbedingten Todesfälle, was möglicherweise auf die bessere Verfügbarkeit von Behandlungen und vermehrte Maßnahmen zur Schadensminimierung zurückzuführen ist, wobei jedoch auch die sinkende Prävalenz des Drogenkonsums eine wichtige Rolle spielen könnte. Auf europäischer Ebene ist die Zahl der drogenbedingten Todesfälle 2001 um 6 %, 2002 um 13 % und 2003 um 7 % gesunken. Trotz dieser Verbesserungen wurden 2003 noch immer fast 7 000 drogenbedingte Todesfälle gemeldet (aus Belgien, Spanien und Irland liegen keine Daten vor). In den 19 Ländern, die im Jahr 2004 Daten vorgelegt haben, wurde ein geringer Anstieg um 3 % ermittelt. Zwar sollten für das Jahr 2004 nur vorsichtige Rückschlüsse gezogen werden, jedoch weisen 13 der 19 Berichte auf einen gewissen Anstieg hin.

Hinsichtlich der Zahl der drogenbedingten Todesfälle unter jungen Menschen im Alter von unter 25 Jahren ist eine starke Diskrepanz zwischen den Tendenzen in den alten und neuen Mitgliedstaaten zu beobachten. In den EU-15-Mitgliedstaaten ist seit 1996 ein kontinuierlicher Rückgang festzustellen, was auf eine sinkende Zahl junger injizierender Opioidkonsumenten schließen lässt. Dagegen wurde in den neuen Mitgliedstaaten bis zum Zeitraum 2000 bis 2002 ein deutlicher Anstieg beobachtet, der erst im Jahr 2003 von einem merklichen Rückgang abgelöst wurde (207).

Darüber hinaus sind auch Unterschiede zwischen den Geschlechtern auszumachen. Bei den Männern ist die Zahl der Todesfälle zwischen 1990 und 2000 nach und nach gestiegen und anschließend deutlich zurückgegangen (bis 2003 um 30 %), während bei den Frauen die Zahl der gemeldeten Todesfälle zwischen 1990 und 2000 bei jährlich 1 700 bis 2 000 Fällen in etwa stabil geblieben und seitdem um nur 15 % gesunken ist. Dies könnte auf eine Reihe von Faktoren zurückzuführen sein, unter anderem auf eine unterschiedliche Wirksamkeit der Maßnahmen oder auf verschiedene Risikofaktoren bei Männern und Frauen (208).

In Ländern, für die längere Datenreihen vorliegen, können bei drogenbedingten Todesfällen unterschiedliche Muster festgestellt werden. In einigen Ländern erreichte die Zahl der drogenbedingten Todesfälle Anfang der 90er Jahre ihren Höhepunkt und ging anschließend zurück, beispielsweise in Deutschland, wo der Höhepunkt im Zeitraum 1991/92 erreicht wurde, sowie in Spanien (1991), Frankreich (1994) und Italien (1991). In anderen Ländern, z. B. in Griechenland, Irland, Portugal, Finnland, Schweden und Norwegen, erreichte die Zahl der drogenbedingten Todesfälle ihren Höhepunkt erst später, zwischen 1998 und 2001, und ging anschließend wieder zurück. In wieder anderen Ländern war ein weniger deutliches Muster erkennbar oder die Zahlen blieben stabil. Obwohl aufgrund der relativ geringen Zahl der drogenbedingten Todesfälle in einigen Ländern nur vorsichtige Rückschlüsse gezogen werden sollten, könnten diese Muster auch mit den Tendenzen beim injizierenden Heroinkonsum in Verbindung gebracht werden (209).

Todesfälle in Verbindung mit Ecstasy und Amphetaminen

Todesfälle in Verbindung mit Ecstasy werden aus den europäischen Ländern seit den 90er Jahren gemeldet, als sich der Konsum der Droge verbreitete. Diese Todesfälle sind besonders besorgniserregend, da häufig völlig unerwartet sozial integrierte junge Menschen betroffen sind.

Es liegen nur in begrenztem Umfang Informationen über Todesfälle im Zusammenhang mit Ecstasy vor, jedoch weisen die Daten der nationalen Reitox-Berichte 2005 darauf hin, dass derartige Todesfälle im Vergleich zu opioidbedingten Todesfällen nach wie vor relativ selten sind. In einigen Ländern ist ihre Zahl jedoch nicht zu vernachlässigen. Insgesamt wurden in Europa 77 Todesfälle in Verbindung mit Ecstasy gemeldet, wobei dies als Mindestschätzung betrachtet werden sollte (210). Über Todesfälle wurde aus Dänemark (2), Deutschland (20), Frankreich (4), Ungarn (3) und dem Vereinigten Königreich (48 „Erwähnungen“ von Ecstasy, davon 33 in England und Wales) berichtet, was vermutlich auf bessere Meldesysteme in diesen Ländern zurückzuführen ist. In Spanien wurde bei 2,5 % der Vergiftungen durch Drogen Ecstasy nachgewiesen.

Das Thema der mit dem Ecstasykonsum verbundenen Risiken wurde häufig angesprochen. Dividiert man die Zahl der festgestellten Todesfälle durch die Zahl der jährlich erfassten Konsumenten (211) (potenziell gefährdete Menschen), ergeben sich in den beiden Ländern, für die diese Berechnung vorgenommen werden kann, Raten von fünf bis acht Fällen bzw. zwei bis fünf Fällen je 100 000 Konsumenten. Dabei sind jedoch die Fehlerspanne der auf Erhebungen basierenden Prävalenzschätzungen und die Schwierigkeiten bei der Meldung drogenbedingter Todesfälle zu berücksichtigen.

Todesfälle in Verbindung mit Amphetaminen werden ebenfalls nur selten gemeldet. In der Tschechischen Republik wurden jedoch im Jahr 2004 16 Todesfälle mit Pervitin (Methamphetamin) in Verbindung gebracht, nahezu doppelt so viele wie im Vorjahr. Dies stand im Einklang mit einem Anstieg der geschätzten Zahl problematischer Pervitinkonsumenten und der Behandlungsnachfragen. Einzelheiten zu Todesfällen im Zusammenhang mit GHB sind Kapitel 4 zu entnehmen.

Todesfälle in Verbindung mit Kokain

Es herrscht zunehmend Besorgnis über die Gesundheitsrisiken des Kokainkonsums, da in einigen Ländern ein steigender Kokainkonsum in der Freizeit beobachtet wird, und zwar bei jungen Menschen, bei in Behandlung befindlichen Drogenabhängigen und in Randgruppen.

Kokain wird häufig von Opioidkonsumenten eingenommen, und in der Regel werden in Fällen einer Überdosierung von Opioiden bei der toxikologischen Analyse Kokain sowie andere Substanzen wie Alkohol und Benzodiazepine festgestellt. Kokain wird häufig gemeinsam mit Alkohol konsumiert, was eine erhöhte Toxizität zur Folge haben kann.

Derzeit sind in Europa nur in begrenztem Umfang Statistiken verfügbar, und aufgrund von Veränderungen bei den Kriterien zur Ermittlung kokainbedingter Todesfälle sind die Angaben nicht vergleichbar. Darüber hinaus werden einige kokainbedingte Todesfälle unter Umständen nicht erkannt oder bleiben ungemeldet, was sich in einer unvollständigen Berichterstattung niederschlägt. Den vorliegenden Daten zufolge werden bei zahlreichen Todesfällen, bei denen Kokain eine Rolle spielt, auch Opioide nachgewiesen.

Die Länder, die Daten zur Verfügung gestellt haben, meldeten in ihren nationalen Berichten 2005 insgesamt mehr als 400 Todesfälle im Zusammenhang mit Kokain. Hierbei handelt es sich um eine Mindestschätzung. In den meisten dieser Fälle wurde die Todesursache offenbar mit Kokain in Verbindung gebracht, wobei dies aus den Berichten nicht immer eindeutig hervorgeht. In den Berichten aus neun Ländern wurden weder Todesfälle im Zusammenhang mit Kokain genannt, noch wurde explizit darauf hingewiesen, dass keine derartigen Todesfälle verzeichnet wurden. 0 % bis 20 % der gemeldeten akuten drogenbedingten Todesfälle wurden mit Kokain in Verbindung gebracht, wobei dieser Anteil in Deutschland, Spanien, Frankreich, den Niederlanden und dem Vereinigten Königreich zwischen 10 % und 20 % lag. Todesfälle, bei denen die Todesursache mit Kokain in Verbindung gebracht wurde (alleine oder in Kombination mit anderen Substanzen), wurden aus Frankreich (14), Deutschland (166), Spanien (53), den Niederlanden (20) und dem Vereinigten Königreich (142 „Erwähnungen“ von Kokain, davon 113 in England und Wales) gemeldet. Neun weitere Länder meldeten zwischen null und zwei Fällen. Zudem wird Kokain in einigen Ländern häufig bei der toxikologischen Analyse in Fällen einer Überdosierung von Opioiden nachgewiesen. Anhand der wenigen verfügbaren Daten können kaum zuverlässige Tendenzen ermittelt werden, jedoch scheint sich in allen Ländern, die über größere Zahlen von Todesfällen im Zusammenhang mit Kokain berichten, eine zunehmende Tendenz abzuzeichnen, d. h. in Deutschland, Spanien, Frankreich, den Niederlanden und dem Vereinigten Königreich, wobei jedoch in den Niederlanden die Zahlen in den letzten zwei Jahren nicht mehr gestiegen sind.

Darüber hinaus kann Kokain bei Todesfällen aufgrund von Herzkreislaufproblemen (Arrhythmie, Myokardinfarkt und zerebrale Hämorrhagie) eine Rolle spielen, insbesondere bei Drogenkonsumenten mit entsprechender Prädisposition, bei Vorliegen bestimmter Risikofaktoren (Rauchen, Bluthochdruck, Angiome) sowie bei älteren Menschen. Gegenwärtig bleiben möglicherweise viele dieser Fälle unbemerkt, da man sich dieser Problematik nicht ausreichend bewusst ist. In diesem Bereich sind weitere Forschungsarbeiten erforderlich.

Reduzierung drogenbedingter Todesfälle

Wirksame Maßnahmen

Eine Aufklärung über die Risiken des Drogenkonsums und den Umgang mit diesen Risiken sowie eine Vermittlung zu Diensten, darunter auch zu Therapien, sind nur möglich, wenn versucht wird, Drogenkonsumenten zu erreichen, die noch nicht in Behandlung sind, und geeignete Kommunikationskanäle geschaffen werden.

Die bei der Untersuchung der Begleitumstände von Überdosierungen gewonnenen Erkenntnisse wurden bei der Erarbeitung gezielter Maßnahmen für hochriskante Situationen und stark gefährdete Risikopersonen berücksichtigt. Diese Maßnahmen könnten zu einer deutlichen Reduzierung der unmittelbar durch den Konsum von Drogen verursachten Todesfälle beitragen. Die Bedeutung der unterschiedlichen Maßnahmen für die Verringerung akuter drogenbedingter Todesfälle durch Überdosierung wurde in einem Briefing der EBDD zur Drogenpolitik zusammenfassend dargestellt (EBDD, 2004d).

Da bei den meisten Todesfällen durch Überdosierung in Europa Heroin eine Rolle spielt, kann die Erhöhung des Anteils der in Behandlung befindlichen Heroinkonsumenten durchaus als eine Maßnahme zur Prävention von Überdosierungen betrachtet werden. Für die in letzter Zeit in einigen Mitgliedstaaten zu beobachtende ansatzweise Umkehrung der Tendenzen bei Todesfällen durch Überdosierung könnten mehrere Faktoren verantwortlich sein, darunter sinkende Prävalenzraten und ein Rückgang des injizierenden Drogenkonsums, verstärkte Präventionsbemühungen, verbesserte Verfügbarkeit und Inanspruchnahme von Therapien, ein zunehmender Verbleib in der Behandlung und möglicherweise auch ein vermindertes Risikoverhalten.

Maßnahmenprofile

In den meisten Ländern wird in Fachkreisen im Hinblick auf den Einsatz unterschiedlicher Präventionsstrategien die Auffassung vertreten, dass die opioidgestützte Substitutionstherapie das erfolgversprechendste Konzept darstellt, um eine Reduzierung der Todesfälle durch Überdosierung zu erreichen (212). In Ungarn und Schweden ist diese Therapieform zwar verfügbar, wird jedoch nicht als Instrument für die Verringerung der drogenbedingten Todesfälle betrachtet. In Estland und Polen wiederum hat das geringe Angebot von Substitutionstherapien zur Folge, dass in diesen Ländern die methadongestützte Substitutionsbehandlung gegenwärtig nicht als wichtige Maßnahme zur Reduzierung der Todesfälle durch Überdosierung gilt.

Darüber hinaus werden in den meisten europäischen Ländern informations-, aufklärungs- und kommunikationsorientierte Strategien als wichtig erachtet. In 19 Ländern werden Botschaften zur Verbesserung des Risikobewusstseins und Anweisungen zum Umgang mit Überdosierungen häufig oder größtenteils durch speziell erarbeitetes Informationsmaterial oder über andere Medien (Flyer, Websites, Kampagnen in den Medien) verbreitet. In sieben Ländern (Estland, Frankreich, Irland, Lettland, Ungarn, Malta und Finnland) kommen derartige Maßnahmen selten und in einem Land (Schweden) überhaupt nicht zum Einsatz.

Den Angaben der nationalen Knotenpunkte zufolge ist das Konzept einer systematischen Einbeziehung individueller Risikobewertungen in die Beratungs- und Behandlungsverfahren sowie der Risikoaufklärung und Vermittlung von Informationen über den Umgang mit den Risiken in Gruppensitzungen für Drogenkonsumenten weniger verbreitet.

Eine weit gefasste Kategorie von Aktivitäten kann als „entlassungsvorbereitende Maßnahmen“ bezeichnet werden. Diese reichen von einfachen Informationen über Beratungen zu Risiken und Prävention von Überdosierungen bis hin zur Einleitung oder Fortführung von Substitutionsbehandlungen in Haftanstalten. Jedoch werden derartige Maßnahmen in 13 Ländern nur selten und in weiteren fünf Ländern (Lettland, Ungarn, Polen, Rumänien und Schweden) überhaupt nicht durchgeführt. In Spanien, Italien und im Vereinigten Königreich jedoch gehören Maßnahmen in Haftanstalten zu den gängigsten Strategien zur Verringerung der akuten drogenbedingten Todesfälle.

Die mit dem injizierenden Drogenkonsum in der Öffentlichkeit verbundenen lokalen Risiken haben dazu geführt, dass in vier EU-Ländern und Norwegen (213) professionell überwachte Drogenkonsumräume eingerichtet wurden. Diese sollen vor allem jenen stark ausgegrenzten und risikofreudigen Drogenkonsumenten zur Verfügung stehen, die Drogen auf der Straße injizieren (EBDD, 2004c).


SOUTH SAN FRANCISCO, Calif., Sept. 22 /PRNewswire-FirstCall/ — Titan Pharmaceuticals, Inc. (OTC Bulletin Board: TTNP) today announced that patient enrollment is now complete in the confirmatory, Phase 3 clinical study of Probuphine for the treatment of opioid addiction.  This placebo and active controlled Phase 3 study is being conducted at 20 sites in the United States and the results are expected in the second quarter of 2011, about three months ahead of the original schedule. This study is part of a registration-directed program intended to obtain marketing approval of Probuphine for the treatment of opioid addiction in the United States and Europe.

“We are very encouraged by the excellent response to recruitment for this trial.  Thanks to the ongoing dedication of the Probuphine Consortium of clinical investigators and their staff, we expect to report the results of this important trial significantly ahead of schedule, in the second quarter of next year,” said Dr. Katherine L. Beebe, Senior Vice President, Clinical Development and Medical Affairs and Principal Investigator of the study.

This study is partially supported by a two-year $7.6 million, Research and Research Infrastructure Grand Opportunities grant through the American Reinvestment and Recovery Act of 2009 (ARRA),  and the second year allocation of approximately $2 million has recently been approved by the National Institutes of Health (NIH). The grant is administered by the National Institute on Drug Abuse (NIDA).

Initial safety and effectiveness of treatment for opioid addiction with Probuphine has been demonstrated in a series of clinical studies. Probuphine also has the potential to reduce limitations currently associated with daily oral buprenorphine therapy, including poor compliance, withdrawal and craving symptoms associated with variable blood levels and diversion and non-medical use of the drug. Results of the Probuphine development program to date will be presented during a symposium titled “Buprenorphine Implant for the Long-Term Treatment of Opioid Dependence,” on October 6, 2010 in Milan, Italy at the 2010 International Society of Addiction Medicine (ISAM) conference.  The 90-minute symposium is co-chaired by Dr. Beebe of Titan and Dr. Ivan Montoya of NIDA, Division of Pharmacotherapies and Medical Consequences of Drug Abuse (DPMCDA),  and will cover all aspects of the Probuphine development program from early non-clinical studies to pharmacokinetic and clinical studies demonstrating the safety and effectiveness of Probuphine.  Further information about the scientific program may be found on the ISAM website at http://www.isam2010.medicina.unimib.it/scientific_program/day6/

The World Health Organization estimates that 2.8 million individuals in the U.S. and Europe are addicted to illicit opiates such as heroin, and more than 2.0 million individuals in the U.S. alone are addicted to prescription opioid medications.  It is estimated that about twenty percent of this population are currently receiving pharmacological treatment.

About Probuphine

Probuphine is designed to deliver six months of continuous round-the-clock, long-term therapeutic levels of the drug buprenorphine following a single subcutaneous treatment. Buprenorphine, an approved agent for the treatment of opioid addiction, is currently available mainly in the form of a sublingual tablet formulation. The safety and effectiveness of treatment with Probuphine has been initially established in the three Phase 3 studies conducted to date, specifically, a 163 patient placebo controlled study which demonstrated clinically meaningful and statistically significant treatment with Probuphine over a 24 week period, an open label 24 week retreatment study in 62 patients who had successfully completed six months of treatment in the controlled study, and a relative bioavailability study in 9 patients treated with Suboxone® and then switched to Probuphine treatment for 60 days.

Probuphine was developed using ProNeura, Titan’s continuous drug delivery system that consists of a small, solid rod made from a mixture of ethylene-vinyl acetate (EVA) and a drug substance. The resulting product is a solid matrix that is placed subcutaneously, normally in the upper arm in a simple office procedure, and is removed in a similar manner at the end of the treatment period. The drug substance is released slowly, at continuous levels, through the process of diffusion. This results in a constant rate of release similar to intravenous administration.

Research and Research Infrastructure Grand Opportunities Program

The purpose of the Research and Research Infrastructure Grand Opportunities program is to support high impact ideas and large-scale research projects that accelerate critical breakthroughs, early and applied research on cutting-edge technologies, and new approaches to improve the synergy and interactions among multi and interdisciplinary research teams.

This initiative is being offered to help fulfill the goals of the American Recovery and Reinvestment Act to help stimulate the economy through support of biomedical and behavioral research. The ARRA will provide economic stimulus to the nation while furthering the NIH mission to uncover new knowledge that will lead to better health for everyone.

For more information on ARRA funding, visit grants.nih.gov/recovery. To track the progress of Health and Human Services activities funded through the recovery act, visit www.hhs.gov/recovery. To track all federal funds provided through the recovery act, visit http://www.recovery.gov/.

About Titan Pharmaceuticals

For information concerning Titan Pharmaceuticals, Inc., please visit the Company’s website at www.titanpharm.com.

The press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to the Company’s development program and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in development, testing, regulatory approval, production and marketing of the Company’s drug candidates, adverse side effects or inadequate therapeutic efficacy of the Company’s drug candidates that could slow or prevent product development or commercialization, the uncertainty of patent protection for the Company’s intellectual property or trade secrets, and the Company’s ability to obtain additional financing. Such statements are based on management’s current expectations, but actual results may differ materially due to various factors, including those risks and uncertainties mentioned or referred to in this press release.

At anytime, drugs were seized, ceasefire groups were often stereotyped as the producers and the owners of the products, especially nowadays, because the groups are at loggerheads with Burma’s ruling military junta over the junta’s run border guard force (BGF) program, said a ranking Wa official from Panghsang, on the Sino-Burma border.

“Whenever there is a drug seizure, almost everyone would report most of the time that it comes from the ceasefire groups, particularly the Wa, because we are in need for arms and ammo for our defense against the Burma Army,” said the officer who requested not to be named.

The United Wa State Army (UWSA) has been dubbed as a terrorist organization with connections to drug trafficking by the United States. Most of its leaders are also wanted by both Thailand and US.

“It is our turn to be the fall guys, like Khun Sa (late leader of the defunct Mong Tai Army) did for us in the past,” he said. “During Khun Sa’s days drugs seized were said to have come from him even though they actually come from the Wa. At that time he was a scapegoat for the Wa.”

“Now all fingers are upon us whether or not the drugs come from us.  Maybe we are repaying for what we had done to Khun Sa.”

Meanwhile, the UWSA and its southern ally National Democratic Alliance Army (NDAA) better known as Mongla have been launching a joint operation against drug traders in their controlled regions since 1 August 2010, according to sources from Mongla and Panghsang.

“In August, Mongla alone arrested over 300 people ,” said the source returning from Mongla.

Likewise, Panghsang has so far seized over 30 different types of cars mostly owned by Chinese businessmen suspected as drug dealers, according to a source from Panghsang.

“I saw the cars gathered at the Weluwan monastery in Panghsang. Some owners were arrested by the Wa and some escaped,” he said.

A businessman from Shan State East speaking to the Shan Herald Agency for News (SHAN), said anyone who wants to sell any kind of drugs must seek the assistance of the junta-backed militia units since the Burma Army’s relations with the Wa had turned sour over its BGF program outlined in April 2009. Since then the Burma Army had showered its favor on local militia units.

“The tables have turned now. Not only other dealers but the Wa as well have to pay militia units for the safe passage of their goods,” he said. “Now most of the drugs (pills, Ice and heroin) are manufactured by militia men. All their yaba pills are copying famous Wa brands.”

A long drug user in Shan State East’s Tachilek, opposite Thailand’s Mae sai said the quality of yaba (methamphetamine) is different even though similar in appearance.

“If it is militias’ products, the color will be lighter, the pill is softer, has much ash and not so strong. Moreover, the smell is not so fragrant as the Wa’s,” he said.

According to him, the price between the militias and the Wa’s products is also different in Tachilek markets. One pill of Yaba (methamphetamine) made by Wa is sold between Baht 42-43 ($1.4-1.43) and the militias’ pill is between Baht 30-33 ($1-1.1).

According to a SHAN’s source, prices of heroin and ice have also dropped during these days. “Only few people are asking to buy and sell heroin,” he said. “The rage now is Ice (crystal methamphetamine).”

Last year heroin price Baht 330,000 ($10,000) for 1 Jin (700 gm) and now has dropped to Baht 280,000-290,000 ($9,100.34-9,425.36). “It may be also related to the drop in the dollar price,” he said.

The most hit and best selling product now is “ice”, he said, whose price used to be Baht 800,000- 1 million ($26,000.98-32,501.22) per kilogram, now it is about Baht 520,000 ($16,900.64). “The Ice price in Bangkok is double Tachilek and ten times in Hong Kong and Taiwan.

According to him, King Roman Casino, opened in September 2009, on the Thai-Lao border has become where drug entrepreneur meet to make deals. “The areas around here are controlled by Naw Kham. Everyone must pay him protection money to get their goods across. No one dares to touch him because top Burma Army officers are behind him.”

SHAN will be releasing its 2009-2010 drug report next week, according to its editor Khuensai Jaiyen.

My career in Addiction Medicine began more than 40 years ago when I founded the Haight Ashbury Free Medical Clinic during the “Summer of Love” following my training at the University of California at San Francisco. As “Young Doctor Smith,” I dealt with young people who came for the Bay Area counterculture seeking “Drugs, Sex and Rock & Roll” and “Better Living through Chemistry,” only to see my neighborhood go from fantasy of psychedelics to a nightmare of speed. We dealt primarily with bad trips and methamphetamine psychosis with its associated medical and psychiatric problems (Brokaw, 2008; Owen, 2006).

Although our practice was based on the assumption that addiction was a disease and the addict had a right to treatment, consistent with the clinicís founding philosophy that “Health Care is a Right, not a Privilege,” our understanding of addiction and recovery was limited and conformed primarily to the 12-step fellowships of Alcoholics Anonymous and Narcotics Anonymous. Our relationship with law enforcement was confrontational as they often conflicted with our goal of treating the addict as a patient with a disease, rather than criminalizing them for using an illicit substance (Brokaw, 2008; Owen, 2006).

As “Old Doc Smith” I have returned to my roots, operating as Medical Director of Center Point in Northern California where I treat troubled young people being diverted to long-term treatment in a six-month therapeutic community. I have also taken the role of Chief of Addiction Medicine at Newport Academy in Southern California, a long-term adolescent addiction treatment program for young women.

Addiction medicine is now a mainstream medical specialty recognized by the American Medical Association, and our relationship with law enforcement is more cooperative, as evidenced by the use of Drug Court diversion to treatment initiatives. Knowledge of addiction as a brain disease and its long-term treatment has increased exponentially over this 40-year period.

The publicity given the drug problems of the late 1960s ultimately led to a skewed perception by the general public that the drug epidemic in the United States was basically over. Unfortunately, the problem of adolescent addiction with associated co-occurring disorders is much greater and more widespread now than ever. However, it appears that this dual diagnosis disorder occurs primarily in patients that have a pre-existing psychiatric disorder. In addition to exacerbating psychotic symptoms, marijuana has been reported to worsen mania in patients with bipolar disorders. The chronic cannabis-dependent adolescent also has a high incidence of underlying depression and may in fact be self-medicating that depression as a major comorbid factor in the development of cannabis dependence (Gurley, 1998).

Various investigators confirm that in adolescent and young adult populations, nonmedical use of prescription drugs is the most prevalent form of substance use, after marijuana and alcohol. For prescription analgesics and prescription stimulants, exposure opportunity and lifetime prevalence increase dramatically in the first two years of college, with prescription stimulants having the greatest proportional increase. Marijuana continues to be the most prevalent drug used among this population, with nearly one-third of teens reporting having ever tried marijuana in their lifetime. In chronic marijuana users, 15 percent reported clinical depression and psychotic symptoms (CESAR, 2009).

The next two most prevalent substances abused, however, are substances that are not illegal when used as directed, and are often readily available in teens’ households. Nearly one in five (an estimated 4.7 million) teens have abused inhalants, and the same number report abusing prescription drugs. In addition, 10 percent of teens (an estimated 2.5 million) have abused over-the-counter cough medicines—approximately the same percentage who have used crack/cocaine or ecstasy (see Figure 1). Abuse of inhalants and OTC cough medicine is defined as using the substance to get high and abuse of prescription drugs is defined as use without a doctor’s prescription. Per­ceived risk and availability may help explain the prevalence of prescription drug abuse — ­41 percent of teens thought that prescription drugs are much safer to use than illegal drugs and 61 percent reported that prescription drugs are easier to get than illegal drugs (CESAR, 2009).

The most prevalent cause of adolescent morbidity and mortality is drug and alcohol abuse. Only 10 percent of the estimated 1.4 million adolescents (aged 12 to 17 years) with an illicit drug problem receive treatment (Brannigan, 2004). Adolescent addiction is a developmental disorder with peak onset between 15 and 21 years of age. Statistically, if addictive disease onset is before 15 years of age, severity and duration of disability with addiction is prolonged (NIDA, 1999, 2008). Additional risk factors for early onset addiction may include: genetic predisposition to addiction in first order relatives; childhood trauma; disruptive or addictive child rearing environments; and co-occurring disorders preceding the onset of addiction. The management of addictive disease and co-occurring disorders in a continuing care model of treatment must include consideration of the possibilities of dual diagnosis disorders, the level of detoxification, relapse prevention, depression, ADHD, and/or eating disorders, based on American Society of Addition Medicine (ASAM) treatment criteria (ASAM, 2003; Rawson, 2008; Zweben, 2003).

Early onset is highly correlated with non-medical use of drugs, including prescription psychostimulants, as well as being linked with co-occurring disorders. Studies have shown an increase in adolescents using non-prescribed pain relievers at least once in their lifetime. These youths are significantly more likely to report poly-drug abuse than those who did not use nonprescriptive pain relievers. The use falls into a myriad of classes: prescription pain killers, psychostimulants, benzodiazepine sedative hypnotics and barbiturate sedative hypnotics. In a recent study obtained by the Center for Substance Abuse Research, more teens report abusing prescription drugs and inhalants than any other illicit drug except marijuana. The nature of the drug problem in adolescents has changed, with the biggest increase being nonmedical misuse of prescription drugs diverted from the medical system mixing with street drugs, blurring the line between legal and illegal drug cultures (Arria, 2008).

Co-occurring disorders and addiction in adolescents

In working with high risk and traumatized adolescents a very careful clinical approach is necessary. The challenge is to treat both the trauma and the addiction in an integrated fashion. Traum­atized adolescents with addictive disorders often have great difficulties with learning recovery skills as their attention is focused on family conflicts (Rothman, 2008; Joslyn, 2008; Joslyn, 2008).

Dr. Marc Schuckit, at a recent UCSF conference on the genetics of alcoholism, stressed that early onset alcoholism in high risk genetically pre-disposed youth is characterized by an altered initial response to alcohol coupled with “inborn tolerance,”or the ability to drink large quantities of alcohol to achieve intoxication and the gravitation to an adolescent peer group that also drinks heavily (University of California, San Francisco lecture, 3/23/09; Joslyn, 2008; Joslyn, 2008).

Recent efforts in the trauma field have focused on the difficulties that youth have to self-soothe, to literally calm themselves and their inner turmoil. This self-soothing inability explains why many of these traumatized youth turn to alcohol and other drugs in an attempt to quiet their inner thoughts and emotions. This population of adolescents with trauma that predated the onset of their substance abuse has a high incidence of co-occurring disorders, including depression and eating disorders. The experience of multiple chronic prolonged and developmentally adverse traumatic events of an interpersonal nature with early life onset requires an intensive, multifaceted pretreatment approach that addresses the issues in the context of the family, socialization and education (Rothman, 2008).

Adolescents need a somewhat different treatment model than adults. The adolescent model focuses on habilitation, emphasizing the teaching of new psycho-social recovery skills, whereas the adult rehabilitation model focuses on returning to pre-existing recovery skills while simultaneously learning new skills. Early onset addiction with co-occurring disorders has many characteristics that are different from adult treatment, and treatment has to be implemented early in the treatment cycle (NIDA, 1999, 2008). Inpatient residential treatment ranges from short-term to long-term in residential facilities, to sober living residences, which need to be age-differentiated (Rawson, 2008).

Alcohol and other drug addictions are increasing in adolescent girls, and necessitates gender-specific treatment. Evidence suggests that the shortcomings of the treatment system with regard to the unique needs of women and girls have resulted in a female death rate from alcoholism that is now 50 to 100 percent higher than in men. Other issues arguing for gender-specific treatment include physical and sexual abuse reported by 75 to 89 percent of addicted women, and sexual abuse reported by up to 70 percent of drug-using girls (more than 80 percent had at least one addicted parent) (Miller, 2003).

Early intervention is critical for treatment success with girls. Women rarely enter into treatment until late-stage addiction is upon them. Girls tend to move from experimentation to problematic drug use more quickly than boys; they have higher rates of binge drinking than boys; and they have higher rates of illicit drug use while pregnant than their adult counterparts (Miller, 2003).

Eating disorders are common in substance-abusing women; however, assessment and integrated treatment for these disorders are rare in most treatment programs. Eating disorders can co-exist with substance abuse, and drug use may mask or facilitate the disorder. For example, heroin use facilitates vomiting. Stimulants can suppress appetite, while creating a sense of power. Alcohol can provide a feeling of release and diminish the shame that follows an eating episode (Brannigan, 2004; Zweben, 2003).

The best model for treating addictive disease in adults is the integration of pharmacotherapy and psychosocial recovery. However, treatment protocols in pharmacotherapy for adolescent addition are not well established and there are very few studies involving co-occurring eating disorders. One of the difficulties in prescribing Serotonin Selective Re-uptake Inhibitors (SSRIs) for adolescent substance abusers with eating disorders is its increased propensity for weight gain, which leads to medication non-compliance by patients. Suboxone is the most promising new pharmaco-therapy for opioid addiction, but there are very few studies looking at its use for adolescents with prescription narcotic addiction. Therefore, the role of pharmaco-therapy in an integrated adolescent addiction program focusing on patients with co-occurring disorders has to be individualized and implemented by a skilled addiction psychiatrist with the cooperation of a trained clinical staff (Harris, 2008; NIDA, 1999, 2008; Rawson, 2008).

Research has shown significant differences between the treatment needs of male and female adolescent drug users. Programs designed to serve women can provide many services which more directly address womenís issues. They can increase effectiveness in addressing eating disorders and plan for nutritional stabilization to focus strategies to stop aberrant eating disorders. In addition, more appropriate models than the 12-step model can be created. Women-specific programs also can provide more careful inquiry during initial assessment, with specialized training, and encourage psychotherapy earlier in the recovery process (Nelson-Zlupko, 1995; Zweben, 2003).

Addictive and mental­ disorders often occur in the same individual and need to be treated in an integrated manner. Patients presenting for either condition need to be assessed and treated for co-occurrence of the other disorder (NIDA, 2008).
Effective adolescent substance abuse treatment programs provide the broader range of treatment necessary to address all aspects of adolescent life. They also meet the more challenging treatment needs of adolescents, who have a higher rate of dual diagnosis than adults. Developmentally appropriate programming targeted at adolescents is necessary.

Factors in treatment effectiveness include a strong motivation to facilitate the treatment process. A mix of sanctions or enticements from personal, professional and/or legal relationships can increase treatment entry and retention rates, as well as the success of interventions (ASAM, 2003; NIDA, 2008).

Denial among adolescents about drug problems is high and few seek treatment on their own. One of the most essential aspects of treatment is a positive alliance between the adolescent, the counselor and the staff. Programs need to focus on creative treatment techniques to engage and retain adolescents while they navigate their recovery. Gender-specific sessions offer a forum to address issues that may be difficult to discuss in mixed groups. Barbara Nosal, PhD, MFT, Newport Academy Clinical Director, an adolescent addiction treatment program for young women with co-occurring disorders, will publish the crucial criteria for same-sex treatment in a future issue of Counselor Magazine.

There is a critical need for adolescent treatment to be more effective and respond to the growing addiction problem in this high risk age group. It clearly will have to incorporate new evidence-based strategies, including gender-
specific modalities.

David E. Smith, MD, FASAM, FAACT Dr. Smith is recognized as a national leader in the areas of the treatment of addictive disease, the psychopharmacology of drugs, new research strategies in the management of drug abuse problems, and proper prescribing practices for physicians. He is the Founder of the Haight Ashbury Free Clinics in San Francisco, which treats over 160,000 client visits per year in 23 sites in the San Francisco Bay area.

References

American Society of Addiction Medicine. (2003). Treatment Criteria. In Principles of Addiction Medicine, 3rd Edition. Chevy Chase MD: ASAM. pp. 1591-1600.
Brannigan, R., Schackman, B.R., Falco, M. and Millman, R.B. (2004). The Quality of Highly Regarded Adolescent Substance Abuse Treatment Programs. Arch. Pediatric Adolescent Med., 158, 904-909.
Arria, A.M, Caldeira, K.M., OíGrady, K.E., Vincent, K.B., Fitzelle, D.B., Johnson, E.P. and Wish, E.D. (2008). Drug Exposure Opportunities and Use Patterns Among College Students: Results of a Longitudinal Prospective Cohort Study. Substance Abuse, 29(4), 19-38.
Brokaw, T. (2007). Somethingís Happening Here: Dr. David Smith. In Boom. New York: Random House. pp. 243-249.
CESAR FAX. (2009). ìMarijuana, Inhalants, and Prescription Drugs are Top Three Substances Abused by Teens.î Adapted from The Partnership for a Drug-Free America, The Partnership Attitude Tracking Study (PATS): Teens 2008 Report, 2009. (available online at http://www.drugfree.org/Files/full_report_teens_2008). 18(9), 3/9/09.
Gurley, R.J., Aranow, R., Katz, M. (1998). Medical Marijuana: A Comprehensive Review. Journal of Psychoactive Drugs. 30(2), 137-148.
Harris, G. (2008). Use of Antipsychotics In Children Is Criticized. New York Times, 11/19/08.
Joslyn, G., Brush, G., Robertson, M., Smith, T. L., Kalmijn, J., Schuckit, M., and White, R.L. (2008) Chromosone 15q25.1 Genetic Markers Associated with Level of Response to Alcohol in Humans. Nature, online 12/7/08.
Joslyn, G., Brush, G., Robertson, M., Smith, T.L., Kalmijn, J., Schuckit, M., and White, R.L. (2008) Chromosone 15q25.1 Genetic Markers Associated with Level of Response to Alcohol in Humans. Proc.
Nat. Acad. Sci., online 12/8/2008, doi = 10.1073/
pnas.0810970105.
Miller, N. (2003). Consideration of Gender Specific Factors in the Development of Adolescent Alcohol and Other Drug Interventions and Treatment. White Paper, New Hampshire Task Force on Women and Recovery, Manchester, NH. 20pp. http://nhtwr.org/publicationsadogirls6-29-04_copyright.pdf
Nelson-Zlupko, L., Kauffman, E. and Morrison Dore, M. (1995). Gender Differences in Drug Addiction and Treatment: Implications for Social Work Intervention with Substance-Abusing Women. Social Work. 40(1),
45-54.
NIDA. (1999, 2008). Principles of Drug Addiction: A Research-Based Guide. NIH/US Department of Health and Human Services. NIH Publication No. 08-4180.
Owen, F. (2006). The Dark Side of the Summer of Love: How Meth and Madness Destroyed the Hippie Dream. Playboy, July. pp.56-60, 122-128.
Rawson, R.A. (2008). What is Substance Abuse Treatment and What is It Supposed to Do? Addiction Medicine Review course.
Rothman, B., OíGorman, P. (2008). Working With Traumatized and Addicted Adolescents. Counselor, 9(6), 24-29.
Zweben, J. (2003). Special Issues in Treatment: Women. In Principles of Addiction Medicine, 3rd Edition. Chevy Chase MD: ASAM. pp. 569-580.

This article is published in Counselor, The Magazine for Addiction Professionals, June 2009, v.10, n.3, pp.42-46.

There has been a growing awareness in recent years of the importance of gender in medical treatment and research. While much past research in addiction focused on men, there is now recognition that biologic and psychosocial differences between men and women influence the prevalence, presentation, comorbidity, and treatment of substance use disorders. For instance, Greenfield and colleagues1 conducted an extensive review of the literature published from 1975 to 2005 on substance abuse treatment in women. They found a tremendous increase in attention to gender differences in the literature during the past 15 years; 90% of the articles discussing gender had been published since 1990.

This increase in awareness of gender-specific issues is also seen in the clinical sector, with about 40% of substance abuse treatment facilities now providing special programs or groups for women.2 In this article, we summarize and discuss the findings of various studies that have looked at the epidemiology; relationship of comorbidity and victimization; diagnostic and screening issues; course of illness; psychosocial and biologic influences; and treatment of substance abuse in terms of the influence of female gender.

Epidemiology
A number of epidemiologic survey studies have demonstrated that the prevalence rates of drug and alcohol use disorders are consistently higher among men than among women.3,4 The most recent of these studies, the National Institute on Alcohol Abuse and Alcoholism’s National Epidemiologic Survey on Alcohol and Related Conditions (NESARC), surveyed more than 40,000 adults and found that men are twice as likely as women to meet lifetime DSM-IV criteria for any drug use disorder (13.8% of men vs 7.1% of women).5 Twelve-month prevalence rates of alcohol abuse are almost 3 times as high among men as they are among women (6.9% of men vs 2.6% of women).6 These ratios are consistent with the findings of other past epidemiologic surveys, showing that the gender differential for alcohol use disorders is higher than that for drug use disorders.3,7

In contrast, prescription drug abuse in women closely approaches that of men. The National Survey on Drug Use and Health reported 12-month prevalence rates of abuse or dependence for nonmedical use of pain relievers to be 1.4% for men and 1.1% for women 18 to 25 years old, and 0.5% for men and 0.4% for woman 26 years and older.8 The differential for tobacco use and dependence is substantially less than for any other drug of abuse; only slightly more men than women report tobacco use (13.5% men vs 10.2% women) and meet criteria for tobacco dependence (31% men vs 27% women).3,9

Psychiatric comorbidity and victimization
One area that has received considerable attention is gender differences in psychiatric comorbidity. Both epidemiologic studies and studies of treatment-seeking patients indicate that gender differences in the patterns of comorbid psychiatric disorders in substance users follow the same patterns seen in the general population, with women more likely to meet criteria for anxiety, depression, eating disorders, and borderline personality disorder and men more likely to meet criteria for antisocial personality disorder.10,11 However, a number of studies indicate that for women, the onset of the psychiatric disorder is more likely to antedate the onset of the substance use disorder. This suggests gender differences in the relationship between psychiatric and substance use disorders.12

One study exploring gender differences in the onset of major depression episode (MDE) and alcohol dependence using the Epidemiologic Catchment Area data set found that women with MDE were more than 7 times as likely as women without MDE to have alcohol dependence at a 2-year follow-up point. However, men with MDE were not at any enhanced risk for the development of alcohol dependence.13

Gender differences in comorbidity are also particularly important in nicotine dependence. A number of studies have demonstrated that persons with depression are more likely to smoke cigarettes and are less successful in smoking cessation attempts. This relationship appears to be particularly strong for women. Indeed, a recent study demonstrated that women with a history of MDE were twice as likely to relapse to smoking at 1-year follow-up as women without MDE.14

Converging lines of evidence suggest that a relationship between trauma, posttraumatic stress disorder, and substance use disorders also may be particularly important for women. Early life stress, particularly sexual abuse, is more common in girls than in boys and is associated with a risk of substance use disorders.15 Women exposed to violence in adulthood also demonstrate a higher risk for drug and alcohol dependence. Moreover, alcohol and drug abuse place women at risk for repeated victimization, thus perpetuating the cycle of victimization and substance use.16 Animal studies have demonstrated that uncontrollable stress increases drug self-administration and that neurobiologic correlates of stress appear to mediate this response.17 Gender differences in the neurobiologic response to stress may be especially important in understanding the relationship between trauma and substance use disorders for women.

Diagnostic and screening issues
Even though general awareness of addiction in women has increased, limitations in the identification and treatment of substance use disorders in women still remain. Women tend to seek treatment at mental health or primary care clinics, rather than addiction treatment programs.18 Thus, it is important to screen for substance abuse among women in those settings.

Several studies have examined the use of brief surveys or single items that can be embedded within other health surveys at primary care and obstetrics clinics to screen for substance use problems.19-21 These studies have demonstrated that substance abuse and psychiatric conditions are typically undetected and untreated in substantial numbers of women (19% of women with substance abuse problems and 26% with psychiatric conditions).21 Studies show that the addition of a single question about the last episode of drinking can help increase detection of problematic use among men and women in primary care settings.19 As such, brief surveys or screening items may be useful to prompt more in-depth assessment of patients’ treatment needs.

Course of illness
One of the most reproducible findings in studies of women with substance use disorders is an increased vulnerability to adverse consequences of substance use, abuse, and dependence.22-26 In general, females advance more rapidly than males from use to regular use to first treatment episode.25,27-29 In addition, when they enter treatment, in spite of fewer years of use and smaller quantities of substances used, their substance abuse symptom severity is generally equivalent to that of males; and females average more medical, psychiatric, and adverse social consequences of substance use than do males.25,26,28,29 This phenomenon has been called the “telescoping” of substance use disorders in women, and it is likely that both biologic and psychosocial factors contribute to this phenomenon.

Psychosocial influences
Social factors—primarily family environment—also appear to influence women’s substance use. Women with alcohol dependence are more likely than men with alcohol dependence to have role models in their nuclear families and/or spouses who are also alcohol-dependent.30,31 A study by Cavallo and colleagues32 in adolescent smokers indicated a positive relationship between female smokers and perception of smoking as a weight control strategy as well as concerns about gaining weight on quitting. In addition, women are more likely to cite stressful life experiences and interpersonal stressors as reasons for substance use and relapse, while men are more likely to report external temptation situations as precursors to relapse.

Biologic influences
There are a number of biologic factors that are likely to contribute to the telescoping of substance use disorders in women as described above. Women become intoxicated after drinking smaller amounts of alcohol than men. Women also achieve higher blood alcohol concentrations after drinking equivalent amounts of alcohol, mainly because they have less total body water30,33 and a lower concentration of gastric dehydrogenase, an enzyme responsible for alcohol metabolism.34 These findings provide a biologic basis for the increased vulnerability of women to the physiologic and psychological consequences of drinking. Recent neuroimaging studies have confirmed this finding by demonstrating equivalent brain atrophy in men and women despite less consumption by women.26

There also is accumulating evidence from preclinical and clinical studies indicating that hormonal fluctuation during the menstrual cycle can impact response to and craving for drugs. For example, estrogen augments behavioral responses to cocaine in female rats by modulating the mesocorticolimbic dopamine system.35-37 In humans, this may explain increased responsiveness to cocaine cues or more severe use of cocaine at intake in women.38,39 The most recent study by Evans and Foltin40 has shown that administration of progesterone to women during the follicular phase of the menstrual cycle attenuated the positive subjective effects of cocaine, indicating that progesterone may reduce the response to cocaine in women.41

In a study by Sofuoglu and coinvestigators,42 women reported lower ratings of “feeling high” on cocaine during the luteal phase than women in the follicular phase or men. Thus, ovulating women may be more vulnerable to relapse during the follicular phase, when progesterone levels are lower, than in the luteal phase.43 This is an area of active investigation that could have important implications for treatment.

Neuroimaging techniques have provided important information about the neural processes underlying gender differences in the area of substance abuse. During a stress imaging task, female cocaine users showed greater brain activation than males.44 Using positron emission tomography to compare men and women during cue-induced cocaine craving, Kilts and coauthors45 found greater activation in women than in men in the dorsal striatum and anterior cingulate cortices and lower activity in the amygdala, which assesses the pleasure of an experience and connects it with its consequences. The gender differential in brain activation by stress and drug cues provides important information about gender differences in reasons for drug use, with clear implications for treatment.44

Gender differences in treatment
A number of studies indicate that women are less likely than men to enter treatment.1 Reasons for lower rates of treatment entry may include sociocultural factors (eg, stigma, lack of partner/family support to enter treatment), socioeconomic factors (eg, child care), pregnancy, fears concerning child custody issues, and complexities associated with increased rates of co-occurring psychiatric disorders and the availability of appropriate dual-diagnosis treatments.1,30,46 Furthermore, as previously stated, many women seek treatment at settings or clinics other than substance abuse clinics (eg, primary care, mental health).18

Those women who do enter substance abuse treatment receive similar benefits to those received by men. There are few, if any, consistent gender differences in treatment outcome, retention rates, or relapse rates across various types of substances, treatment settings, and types of treatment.1,47,48 In studies that have found gender differences, women typically have better outcomes than men. For example, women have been found to have higher rates of abstinence at 6-month follow-up (79.3% of women vs 54% of men) and at 5 years (odds ratio, 1.9).24,49,50 Women also demonstrate greater improvement in other domains (eg, medical problems51), have shorter relapse episodes,52 and are more likely to seek help following a relapse.52,53

It is still unclear whether women-focused or gender-specific treatments are more effective than standard substance abuse treatments.1,54-56 Some data suggest that women-focused outpatient or residential treatments produce higher rates of treatment completion than traditional programs.57,58 Data also suggest that residential programs that allow women to be accompanied by their children result in higher rates of retention, an important factor in predicting treatment outcome.59,60

In summary, the converging data suggest that women are less likely to enter substance abuse treatment, but once they do they are at least as likely as men to complete and benefit from treatment. There is a paucity of research—in particular randomized clinical trials—addressing issues of gender-specific treatment. However, programs that address barriers to treatment that are specific to women (eg, child care) and provide careful psychiatric assessment and treatment are likely to be more effective. More research is needed to determine the benefits of such treatments and to identify potential subgroups of women (eg, pregnant women, women with comorbid eating disorders) for whom women-focused treatments may be especially useful.

Conclusions
There are important gender differences in substance use disorders that are meaningful for screening, diagnosis, and course of illness, as well as treatment. Fortunately, gender differences have been a focus of increased attention in recent studies. This line of investigation will be important in helping shape prevention and treatment efforts for both men and women.

Dr Back is assistant professor, Dr Contini is a postdoctoral fellow, and Dr Brady is professor and director, division of clinical neuroscience, Medical University of South Carolina, Charleston. The authors report no conflicts of interest regarding the subject matter of this article.

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source: http://www.psychiatrictimes.com/print/article/10168/46496?printable=true

Heroin and methadone users who’ve ever been diagnosed with AIDS are at dramatically higher risk of bone loss as they get older, according to a study published in the September 24 issue of AIDS.

Potent combination antiretroviral (ARV) therapy has significantly cut the death rate and led to longer life spans in people with HIV. This means that people are now living into older age, when additional health problems typically strike. In fact, experts project that by 2015 more than half of all people with HIV in the United States will be older than 50.

A growing concern is bone mineral loss—called osteopenia when it is mild and osteoporosis when it is more severe. Numerous studies have found higher rates of bone mineral loss among people with HIV than their HIV-negative counterparts. This is particularly true of HIV-positive men.

A further risk factor for decreased bone mineral density (BMD) is use of opiates, including heroin and methadone. Both drugs have been associated with osteopenia and osteoporosis. Since a significant number of people with HIV are current or former drug users, Anjali Sharma, MD, MS, and her colleagues from the State University of New York Downstate Medical Center in Brooklyn set out to measure bone health within this population.

Sharma’s team enrolled 389 men in the Bronx, New York, ages 49 and older who were HIV positive or at risk for infection. In total, 230 were HIV positive, and 159 were HIV negative. The men’s average age was 56, and most were of average height and weight. More than half of the HIV-positive men had been positive for at least 10 years, and 77 percent of them reported using protease inhibitors. More than half were African American, roughly one quarter were Latino, and the remainder were white or another race. The median CD4 count among the HIV-positive men was 398, and 42 percent had a history of an AIDS diagnosis.

All of the men underwent extensive interviews to determine their behavioral and medical histories. Each of them also underwent dual energy X-ray absorptiometry (DEXA) scans to measure their bone health in the thigh, hip and lower back, both at the time they entered the study and roughly three years later.

Risk factors associated with diminished BMD were common: 88 percent had a history of cocaine use, almost all had a history of smoking (64 percent were current smokers), 47 percent had evidence of alcoholism, and 47 percent had low serum testosterone.

At time of first DEXA, 46 percent of the men overall had normal BMD, while 42 percent had osteopenia, and 12 percent had osteoporosis. Of the men who initially had a normal BMD, 14 percent progressed to osteopenia, and 86 percent continued to have healthy bones. The risk for developing osteopenia among this group was nearly three times higher in the HIV-positive men. Of those who were initially diagnosed with osteopenia, roughly 12 percent progressed to osteoporosis. The rate of progression here was the same for HIV-positive men as for HIV-negative men.

Most of the typical factors for reduced BMD were associated with bone loss in this study, including, age, race, use of corticosteroids or testosterone, and hepatitis C virus (HCV) infection.

Sharma’s team, however, found a powerful interaction between use of heroin and a history of an AIDS diagnosis, such that the people with the greatest bone loss were heroin users who’d ever received an AIDS diagnosis. This held up after adjusting for all other risk factors. HCV status and current methadone use were also highly predictive. CD4 count and types of ARVs did not affect BMD.

Oddly, cigarette smoking was not significantly associated with bone loss. However, the authors comment that “the lack of an independent association of BMD loss with cigarette smoking might be due in part to the fact that nearly 90 percent of participants in the cohort were current or former smokers.”

“Taken together, these data suggest that HIV-infected opioid-using men may be at particular risk of bone loss as they age, as a result of comorbid disease such as hepatitis C infection, opioid substitution treatment with methadone, ongoing heroin use, progression to AIDS, or a combination of these factors,” the authors concluded.

“An improved understanding of factors associated with ongoing bone loss and fracture risk is needed,” they continued, “to help guide thresholds for assessment of BMD and for osteopenia treatment in HIV-infected persons and opioid users.”

source: http://www.aidsmeds.com/articles/hiv_opiate_bone_1667_19073.shtml

Von Frank Krause, aktualisiert am 17.09.2010 um 18:15
Elfjähriger Heroindealer erneut gefasst
Foto: dpa

Stuttgart – Die Versorgung von schwerstabhängigen Drogensüchtigen mit künstlich hergestelltem Heroin wird sich weiter verzögern. Zwar hat nach dem Bund nun auch das Land die rechtlichen Voraussetzungen geschaffen, aber die Kassenärztliche Vereinigung (KV) wird die neun geplanten Schwerpunktpraxen im Land nicht auf einmal ausweisen. “Unser Ziel ist es, noch dieses Jahr oder spätestens Anfang 2011 in Stuttgart eine Praxis zu eröffnen. Danach werden wir sukzessive die anderen Standorte im Land angehen. Alle auf einmal geht nicht”, sagte ein KV-Sprecher am Freitag unserer Zeitung. Man müsse “erst einmal Erfahrungen in Stuttgart” sammeln.

Jahrelang hatte die Politik darum gerungen, wie man schwerstabhängigen Süchtigen hilft und sie aus der Beschaffungskriminalität holt. Während SPD, Grüne, FDP und Kommunen für die Therapie mit Diamorphin warben, stellte sich die CDU lange quer. Inzwischen hat die Union auf Bundesebene eingelenkt, das baden-württembergische Sozialministerium hat nun die entsprechende Verwaltungsvorschrift erlassen. Damit haben rund 200 bis 300 Schwerstabhängige im Land, bei denen alle anderen Therapien gescheitert waren, das Anrecht auf das sogenannte Heroin auf Krankenschein.

Im Land sollen speziell ausgestattete Schwerpunktpraxen an den Standorten Stuttgart, Mannheim, Freiburg, Heilbronn, Tübingen/Reutlingen, Singen, Ulm und Ravensburg eingerichtet werden; in Karlsruhe gibt es bereits eine Praxis. Die Genehmigung müssen das jeweilige Regierungspräsidium sowie die KV erteilen. Wann die anderen Arztpraxen betriebsbereit sind, ist unklar. “Der Aufwand an Sicherheitsvorkehrungen ist sehr hoch”, so der KV-Sprecher.

Das Land hat für die einzelnen Standorte einen Investitionszuschuss von jeweils 100000 Euro signalisiert. Der Städtetag begrüßte die Verwaltungsvereinbarung des Sozialministeriums. “Land und Kommunen haben ihre Hausaufgaben gemacht. Jetzt ist die kassenärztliche Vereinigung am Zug”, sagte Städtetagssprecher Manfred Stehle unserer Zeitung . Das “jahrelange Bohren eines dicken Brettes” habe zu einem “letztlich befriedigenden Ergebnis” geführt, zumal wenn die Therapie in die örtliche Suchtkrankenhilfe integriert werde. Der Städtetag warnte zugleich davor, die Ausweisung der Arztpraxen hinauszuzögern. Nachdem das Gesetz nun in Kraft sei, könnten Drogenabhängige die Therapie einklagen.

quelle: http://www.stuttgarter-nachrichten.de/inhalt.anfang-2011-heroin-auf-krankenschein-verzoegert-sich.c809404d-76ea-4fbf-bbca-88cacb866f42.html

Commonly Prescribed Medications and Potential False-positive Urine Drug Screens

Purpose.
The implications of potential false-positive urine drug screen (UDS) results for patients receiving commonly prescribed medications were evaluated.

Summary. A comprehensive literature review was conducted to identify false-positive UDSs associated with all clinic formulary medications, as well as common nonprescription medications. The references of each report describing a medication whose use was associated with false-positive UDS results were also reviewed. If a class effect was suspected, additional agents in the category were searched. A total of 25 reports of false-positive UDS results were identified. Categories of medications included antihistamines, antidepressants, antibiotics, analgesics, antipsychotics, and nonprescription agents. Reports of false-positive results were found for the following formulary and nonprescription medications brompheniramine, bupropion, chlorpromazine, clomipramine, dextromethorphan, diphenhydramine, doxylamine, ibuprofen, naproxen, promethazine, quetiapine, quinolones (ofloxacin and gatifloxacin), ranitidine, sertraline, thioridazine, trazodone, venlafaxine, verapamil, and a nonprescription nasal inhaler. False-positive results for amphetamine and methamphetamine were the most commonly reported. False-positive results for methadone, opioids, phencyclidine, barbiturates, cannabinoids, and benzodiazepines were also reported in patients taking commonly used medications. The most commonly used tests to screen urine for drugs of abuse are immunoassays, even though false-positive results for drugs of abuse have been reported with a number of these rapid-screening products. Results from such tests should be confirmed using additional analytical methods, including gas chromatography–mass spectrometry.

Conclusion. A number of routinely prescribed medications have been associated with triggering false-positive UDS results. Verification of the test results with a different screening test or additional analytical tests should be performed to avoid adverse consequences for the patients.

Introduction
The potential for false-positive urine drug screen (UDS) results for substances of abuse presents a therapeutic selection dilemma for the treating health care professional. While this problem is reported with specific medications, the extent of the problem in a clinic serving indigent patients and the medically underserved has not been evaluated. In particular, the use of medications with the potential for false-positive UDS results may present a significant liability for individuals required to undergo random or periodic UDSs as a component of a recovery or court-ordered monitoring program[1,2] or as a condition of employment.[1,3,4] In addition, false-positive UDS results may affect the clinician–patient relationship by raising issues of trust.[5] This article identifies commonly used medications associated with reports of false-positive UDSs.

Literature Review
A comprehensive literature review was conducted for all medications on the formulary of Bedlam Clinic, a free evening clinic for the medically indigent or working poor, offered by the University of Oklahoma School of Community Medicine in Tulsa. The English-language literature was reviewed, utilizing databases for Ovid MEDLINE, International Pharmaceutical Abstracts, the Excerpta Medica Database, the Cochrane Database of Systematic Reviews, ACP Journal Club, Database of Abstracts of Reviews of Effects, Cochrane Central Register of Controlled Trials, Health Technology Assessment Database, and NHS Economic Evaluation Database. The search strategy was developed by a medical librarian combining the terms false positive results, urine, and substance abuse testing and the generic names of 116 medications. When possible, MeSH terms were used and expanded upon. Truncation was employed for a maximum number of results. In addition, the references for each medication with a reported false-positive UDS were reviewed.

Reports of false-positive UDS results were found for 25 (21.5%) of 116 formulary medications. The potential for false-positive UDS results was identified for the following medication classes on the clinic formulary: antihistamines, antidepressants, antibiotics, analgesics, antipsychotics, and nonprescription agents. Specific immunologic reagent tests have been identified with these reactions, and, in some cases, the concentrations needed to elicit the reaction were provided.

Examples of specific medications with false-positive reports are listed in Table 1 and included brompheniramine,[6,7] bupropion,[8,9] chlorpromazine,[10,11] clomipramine,[10] dextromethorphan,[12–14] diphenhydramine,[11,15] doxylamine,[16] ibuprofen,[14] naproxen,[4] promethazine,[17] quetiapine,[5,18,19] quinolones[1,3] (ofloxacin[20] and gatifloxacin[21]), ranitidine,[22,23] sertraline,[24,25] thioridazine,[10] trazodone,[26] venlafaxine,[27–29] verapamil,[2] and a nonprescription nasal inhaler.[30]
Amphetamine or methamphetamine was the most commonly reported false-positive UDS result. Given the structural similarity between agents, such as ephedrine and amphetamine, this finding was not unexpected,[31,32] and such cross-reactivity has been previously reported.[17,30,33] However, cross-reactivity was reported with a structurally dissimilar agent: ranitidine. Ranitidine use resulted in false-positive results for amphetamine and methamphetamine using monoclonal antibody technology, EMIT d.a.u. (Syva Company, Palo Alto, CA).[22,23] Ranitidine is available without a prescription (75 and 150 mg) and with a prescription (150 and 300 mg). In a review by the assay manufacturer, the most commonly reported dosage range associated with false-positive reports was 150–300 mg daily.[23] The manufacturer obtained multiple urine samples from eight subjects, five of whom had at least one false-positive result within nine hours of the last dose. The same dosage range (150–300 mg daily) was used in another study (n = 23) to determine the urine concentration associated with a false-positive result and the time frame for this interaction after drug administration. The study revealed that urine concentrations exceeding 91 mg/L were needed to elicit a false-positive result (subject urine concentration range, 7–271 mg/L) within a short time frame after drug administration (i.e., first two voids). Of the 63 urine samples analyzed, 12 revealed false-positive results, and the urine concentration of one sample was 91 mg/L. False-positive results were not reported with polyclonal EMIT d.a.u. or TDx (Abbott Laboratories) amphetamine/methamphetamine II assays.[23]

False-positive reports for other nonprescription products were reviewed. Information on the prevalence of nonprescription medication use in the working poor was not found. Cold and cough medications accounted for 8.5% of the nonprescription products used by other populations, such as residents in assisted living facilities.[34] Common ingredients in nonprescription products may cross-react with products in commercially available methamphetamine test kits. Huang et al.[6] performed a systematic determination of the effect on various nonprescription product ingredients using eight methamphetamine test kits (AbuSign, accuPINCH, AccuSign, I.D. Block, Medi-Mate, QuikPac, SureStep, and Visualine) on components (e.g., brompheniramine, chlorpheniramine, ephedrine, guaifenesin, phenylephrine, pheniramine) commonly found in nonprescription cold products. As previously reported, products structurally related to amphetamines interfered with the assay reagents and yielded false-positive results. Brompheniramine produced a positive result for amphetamine with I.D. Block at a concentration of ≥1 mg/L. In a separate case report, the use of phenylpropanolamine and brompheniramine caused a false-positive result for amphetamine with EMIT monoclonal and polyclonal products.[7] Confirmatory results with gas chromatography (GC) and thin liquid chromatography were negative.[7] Since the concentrations of phenylpropanolamine were not adequate to interfere with the test and no previous reports of false-positive results secondary to β-blocker use were found, the investigators theorized that the metabolites of brompheniramine might have interfered with assay results, producing a false-positive result.

Dextromethorphan is frequently included in nonprescription products as a cough suppressant. It is a congener of levorphanol, a narcotic analgesic,[14] yet reports of its effect on false-positive opioid results were not found. False-positive phencyclidine results were possible, however. In a case report of psychosis secondary to a dextromethorphan overdose, no immunoassay product was identified.[13] The authors recommended GC and mass spectrometry (GC–MS) to differentiate between phencyclidine and dextromethorphan. Marchei and colleagues[14] reported a false-positive phencyclidine result with the Instant-View multitest (Alfa Scientific Designs, Po-way, CA) in a pediatric patient. The dextromethorphan concentration of 5000 µg/L yielded a positive result. The patient’s urine dextromethorphan concentration was 5100 µg/L. The same investigators reported a case of a false-positive test result for phencyclidine with ibuprofen.[14] One pediatric patient’s urine specimen taken after ibuprofen ingestion yielded a false-positive result for phencyclidine using the Instant-View multitest. The test solution concentration needed for detection was 4 × 106 µg/L. Although the patient’s urine concentration was lower than that of the test solution (3.3 × 104 µg/L), two factors were considered as contributors to the false-positive result: (1) the two major metabolites of ibuprofen and (2) the amount ingested. The authors theorized that cross-reactivity with the antiphencyclidine antibodies caused the false-positive test result.

Rollins and colleagues[4] sought to determine if episodic or chronic use of ibuprofen, naproxen, or fenoprofen could cause false-positive results. Urine samples from consenting volunteers (n = 120) were tested with Abuscreen, EMIT d.a.u., and TDx for cannabinoids, barbiturates, and benzodiazepines. Although the investigators reported that the risk for false-positive results was low with acute or chronic ibuprofen use and chronic naproxen use, false-positive results for cannabinoids and barbiturates were reported. Naproxyn, at therapeutic doses, produced one false-positive result for cannabinoids and barbiturates. Chronic ibuprofen use was associated with one false-positive result for cannabinoids and barbiturates and acute use with one false-positive result for cannabinoids. The investigators were unable to correlate the false-positive results with urine drug concentration levels, since higher levels were previously documented for these subjects and the immunoassays had not produced false-positive results for those samples. Of the immunoassays used, only the enzyme-mediated immunoassay (e.g., EMIT d.a.u.) was associated with false-positive cannabinoid results, and the fluorescence polarization immunoassay technology, used by TDx, was associated with false-positive barbiturate results. No false-positive benzodiazepine results were reported. Metabolites for ibuprofen and naproxyn were not believed to compete for cannabinoid binding sites. The investigators theorized that enzyme-reaction interference, errors in absorbance reading, or the presence of an endogenous substance may have contributed to the results. Overall, they opined that ibuprofen use (acute or chronic) and chronic naproxen use were not regularly associated with false-positive results but did recommend secondary confirmation with GC–MS.

False-positive methadone results with diphenhydramine[15] and doxylamine[16] also have been reported. Daily doses of 100–200 mg of diphenhydramine resulted in false-positive UDS results for three patients.[15] The urine drug concentration needed to show a positive result was 10 mg/L. Doxylamine intoxication resulted in false-positive results for both methadone and opiates when urine samples were checked using EMIT d.a.u (methadone) and EMIT st (opiates) on admission.[16] Opiates were not detected with Abuscreen radioimmunoassay (Roche Diagnostic Systems, Inc., Montclair, NJ) testing. The urine drug concentrations reported were 50 mg/L (for methadone) and 800 mg/L (for opiates).

A nonprescription nasal in-haler containing the active in-gredient l-methamphetamine (l-desoxyephedrine) yielded false-positive results for amphetamine.[30,35] The extent of the problem was systematically evaluated by Poklis and Moore.[30] In a small study (n = 6), four volunteers used the inhaler per manufacturer directions for five consecutive days, while two used twice the recommended dose for three consecutive days. Use of the inhaler according to the prescribing information and double the recommended dose did not have false-positive results using EMIT d.a.u. and EMIT II monoclonal amphetamine and methamphetamine assays. However, when the amphetamine class assay (EMIT d.a.u. without the monoclonal designation) was used, both groups produced positive UDS results because the EMIT d.a.u. nonmonoclonal assay detects metabolites of phenylisopropylamine, in addition to d-amphetamine and d-methamphetamine.

False-positive UDS results for opiates also have been reported with the use of quinolones.[1] Thirteen available agents were tested for false-positive results using five commercially available test kits (AxSym, CEDIA, EMIT II, Roche, and Synchron). The opiate test solution was morphine at concentrations of 0, 225, 300, and 375 ng/mL. Solutions of various concentrations were evaluated with the different assays. If a positive result was obtained, additional dilution was performed to determine the lowest concentration associated with a positive test. In addition, subjects (n = 6) were given a single dose of either levofloxacin or ofloxacin, and urine samples were collected over the next 48 hours. At least one assay yielded false-positive results related to the use of nine quinolones. False-positive results were obtained from all six volunteers, with urine samples obtained every 6 hours. Using the EMIT II system, detectable opiate levels ranged from >375 to 225 ng/mL for 20–25 hours. The investigators also recognized the potential additive effects of other substances (specifically poppy seeds) and potential consequences for false-positive results, as did other investigators.[3,21]

False-positive opiate results were reported with the EMIT II for three inpatients (therapeutic doses) and two volunteers (single dose) receiving ofloxacin: urine concentrations of 200 mg/L were sufficient to exceed the morphine threshold of 300 µg/L needed for a false-positive result.[20] No false-positive results were seen in patients receiving ciprofloxacin (n = 3) or norfloxacin (n = 3). A case report of a false-positive result secondary to gatifloxacin use was reviewed.[21] The patient was participating in a substance abuse residential treatment program, a setting similar to the population that may seek care at the free evening clinic. The urine sample, originally assayed with the Beckman Synchron, was retested with GC–MS; no opiates were detected.

Rifampin is another antiinfective that may be used by medically under-served patients and was reported to be associated with false-positive UDS results. Three cases of false-positive opiate results with rifampin were reported.[36] The original immunoassay used for the first case report was the Syva RapidTest. During follow-up, the Syva RapidTest, Triage, and Genix RapidTech were used on two patients receiving rifampin. One hour post-dose, urine samples assayed with the Syva RapidTest and Genix RapidTech were positive. Confirmatory GC–MS was negative for opiate use. Both of these immunoassays are one-step processes with a cutoff concentration of 300 mg/L.

Another category of medication associated with false-positive UDS results is phenothiazines. One frequently prescribed agent from this class, promethazine, is used for a variety of indications. One large metropolitan emergency department evaluated UDS results for all admitted patients within an 11-month period if two criteria were met: serum promethazine presence and the performance of a UDS (n = 22).[17] Of these patients, 36% had false-positive urine results for amphetamines using the EMIT II Plus monoclonal amphetamine/methamphetamine immunoassay. Although this detection product was reported to have greater specificity for amphetamines and methamphetamine, false-positive results were also identified for an antipsychotic (chlorpromazine[37]) and antidepressant (bupropion[9]). In this evaluation, the authors theorized that the false-positive results were secondary to promethazine metabolites.[17]

The urine samples of 104 subjects were evaluated for false-positive amphetamine/methamphetamine results with the EMIT II monoclonal assay.[37] Subjects’ medications included chlorpromazine (n = 6) and promethazine (n = 20). Negative results were reported with the Syva polyclonal EMIT d.a.u. assay and positive results were observed with the EMIT II assay. Supplementnaive urine samples (n = 7) of chlorpromazine intake of <100 mg daily were associated with false-positive results, with one case showing a false positive with a 25-mg daily dosage. Promethazine dosages of ≥50 mg daily produced positive results in 3 of 18 cases. The investigators theorized that the majority of the results were secondary to phenothiazine structures and that the parent compound, chlorpromazine, may have had some effect.

The potential for psychotropic medications to cause false-positive results for methadone was also evaluated.[10] Kinetics Interaction of Microparticles in Solution (KIMS, Roche), a monoclonal antibody assay, identified possible false-positive results for chlorpromazine, clomipramine, and thioridazine. No cross-reactivity was found for other typical antipsychotics (trifluoperazine, fluphenazine, loxapine) or atypical antipsychotic agents (clozapine, olanzapine, risperidone). No false-positive methadone results were found for citalopram, paroxetine, sertraline, or venlafaxine.[10] Quetiapine was associated with false-positive UDS results for methadone in an adolescent population (testing method not provided).[5] Quetiapine monotherapy in three patients was associated with false-positive results for methadone using the Cobas Integra Methadone II test kit (Roche Diagnostics, USA).[19] However, no information on quetiapine metabolites was included.

Antidepressant use also resulted in false-positive results for amphetamine in two case reports involving bupropion, an aminoketone antidepressant structurally related to phenylethylamines, a class that includes stimulants.[8,9] In these cases, the EMIT U Amp (Dade Behring, Inc., Newark, DE)[8] and EMIT II[9] monoclonal immunoassays were used, but follow-up confirmation with liquid chromatography was negative. This interaction was attributed to one or more of the metabolites; when compared with the calibrating solution of methamphetamine, several of the metabolites, alone and in combination, resulted in concentrations sufficient for positive results.[9] Both the need to include the possible false-positive UDS information in the testing product information[9] and implications for employment or insurance screening were discussed.[8]

False-positive results for benzodiazepines were reported for three inpatients on an adolescent unit prescribed sertraline, a selective serotonin reuptake inhibitor antidepressant.[24] The results were considered valid without a further confirmatory test and therefore caused the loss of privileges and additional consequences for the patient. Daily sertraline doses of ≥150 mg could result in false-positive UDS results.[24] In a separate evaluation, Nasky and colleagues[25] retrospectively reviewed patients’ UDS results that were positive for benzodiazepines while taking sertraline (n = 522) and negative with GC–MS. Using this method, 26 (26.5%) of 98 records were identified as false-positive results with >69% accuracy of the assay tests (the Aeroset and Architect c8000 Systems, Abbott Laboratories, Irving, TX). This interaction was subsequently addressed in a revised package insert of the tests.

Although less frequently used than other antidepressants, selegiline yielded false-positive amphetamine and methamphetamine results.[38] Selegiline is a monoamine oxidase inhibitor used for the treatment of Parkinson’s disease. As two of its three major metabolites are l-amphetamine and l-methamphetamine, a random screen was positive for amphetamine and methamphetamine.[38] GC–MS confirmed the results with high concentrations. A number of follow-up methods determined that only l-isomers were involved in the positive UDS results. Additional specimens (n = 4) were analyzed, and all samples had methamphetamine concentrations of >500 µg/mL. The authors suggested that the ratio of amphetamine:methamphetamine be identified and that the concentration of specific isomers be considered when interpreting UDS results.
Use of trazodone, a triazolopyridine antidepressant, yielded one false-positive amphetamine result.[26] No quantification information was included in the report. In addition, one report of a false-positive result associated with a trazodone overdose was found.[33] Use of venlafaxine, a serotonin and norepinephrine reuptake inhibitor, resulted in a number of false-positive reports for phencyclidine.[27–29] Although venlafaxine is structurally dissimilar to phencyclidine, the combination of parent compound and active metabolite, primarily O-desmethylvenlafaxine, was theorized to cause false-positive results secondary to cross-reactivity with the antiphencyclidine antibodies.[29] Testing was performed with the following systems: Syva RapidTest d.a.u.,[29] AxSym (Abbott Laboratories),[27] and Instant-View (Alpha Laboratories) multidrug screen urine test.[28]

False-positive results for methadone with verapamil metabolites were also reported.[2] Subsequent to this report, the manufacturer confirmed the results and included this product in its monoclonal antimethadone antibody screen.[39] No additional reports of false-positive results with verapamil were found.

The most commonly used UDS tests are immunoassays, as they allow large-scale screenings with rapid detection at minimal expense.[40] The disadvantage of immunoassays, when compared with the use of GC–MS (“the gold standard”), is false-positive results.[7] A false-positive result for individuals with court-ordered or work-related screening can lead to legal interventions, workplace disruptions, or questions of honesty. A more specific confirmatory test should be conducted prior to releasing the initial screening results.[8]

Accounts of false-positive UDS results for drugs of abuse have been reported with a number of rapid-screening immunoassay products. After receiving positive results for illicit or abused substances, additional confirmatory testing was done in some cases. This included more detailed patient interviews and secondary analysis with GC–MS to more precisely identify the offending substances. Awareness of the potential for false-positive results and confirmatory follow-up information are particularly important for the patients who seek care at the Bedlam evening clinic. Patients may be unaware of potential false-positive reactions when they use prescribed medications and of the correct follow-up procedures to properly resolve the situation. Health care delivery may be provided for the working poor by additional resources, such as the Department of Health or other service providers.

UDS sample timing was found to be important in several of the reports.[2,3,15,17,27] In other reports, the presence of metabolites with different structures, pharmacokinetics, or pharmacodynamic properties may have been factors in the results.[10,26] Reagent specificity or sensitivity is another concern.[1,6,41] Patient-specific factors, such as the physiological effects of weight or diet (as they apply to urine acidity or alkalinity) were not included in this review of formulary agents. Based on the reports reviewed, no single reagent was identified with false-positive results. The ranges of the results were developed for the adult, not pediatric, population.[32]

With the increased availability of onsite drug testing and the variety of products associated with reports of false-positive results in the literature, confirmation of results is needed. Failure to follow up to determine if a false positive may have occurred could result in unnecessary adverse consequences for the patient (e.g., incarceration, employment denial, loss of privileges).

Conclusion:
A number of routinely prescribed medications have been associated with triggering false-positive UDS results. Verification of the test results with a different screening test or additional analytical tests should be performed to avoid adverse consequences for the patients.

source is: http://www.medscape.com/viewarticle/726897 

The Flower contrasts a utopian society that freely farms and consumes a pleasure giving flower with a society where the same flower is illegal and its consumption is prohibited. The animation is a meditation on the social and economic costs of marijuana prohibition.

Objectives: The objective of the study was to analyse the practice of giving take-home dosages of opioid medications to patients
with reference to the reasons for and the quantity of the medications given as additional or extra take-home dosages. Methods: All
the patients were checked regarding the kind of medication, urine samples, reasons for extra take-home dosages and their quantity.
Results: Of the 150 patients selected for the group in the programme, 27 needed one or more extra take-home dosages in 2007. 10
(11*) of those patients had negative urine samples for all illicit drugs and never used alcohol at any stage of the year of the study. 7
patients used marijuana, benzodiazepines or alcohol only once or just occasionally in that year. 10 patients used other illicit drugs or
used alcohol and benzodiazepines more often. Among the reasons for extra take-home dosages, hard physical work was listed 7 times,
vomiting because of the bad taste of the medication 3 times, difficulties in intiating medical therapy after entering the programme 3
times, vomiting as a part of illness twice and lowering the dosage too quickly twice. Other reasons were listed once each. Altogether,
the percentage of the overall quantity of medications received by patients during the year as extra take-home dosages was: 0.47% for
methadone, 0.75% for buprenorphine and 0.10% for SR morphine. Conclusions: Reviewing the fairly good results of treatment at the
centre, therapeutic decisions to give additional take-home dosages to the patients have proved to be reasonable and usually correct.
Throughout this study a continual therapeutic wish to achieve a better understanding of opioid addiction as just one among other
chronic diseases has been made evident.

1. Introduction
Take-home dosages of opioid medications are a matter of
delicate balance in the therapist – client relationship. There
are various important reasons for the therapist to worry about
the destiny of the medication that has been handed over to
the patient. Some medications (methadone, SR morphine)
can ‘kill’ the person who has not adapted to the medication
or the dosage.
Treatment education for patients, medical training for
prescribers and the right choice of pharmaceutical forms
appear to be means that need to be developed simultaneously
to optimize treatment [1].
Opioid medications are also present on the Slovenian
black market. In 2005, 6 of 45 drug-related death cases
involved methadone, usually combined with other drugs
and alcohol [8].
The decision whether to hand the medication over to an
opioid-dependent patient is a difficult one, as it involves a
risk of misuse. In 2004 there were 2,944 arrests/reports for
drug offences (use and/or possession) in Slovenia; 42 of
these involved methadone. There was a total of 545 cases
of drug-related dealing/trafficking and 20 of those referred
to methadone; the numbers recorded for drug-related use
and trafficking was 94 in all and 2 of those referred to
methadone [9] .
In 2005, out of a total of 45 cases of victims of a drugrelated
death in Slovenia, methadone was involved in 6; in a
majority of these cases, methadone overdose was diagnosed
as accidental, not as suicide [8]. According to the Slovenian
Therapeutic Agreement, in centres for the prevention and
treatment of drug addiction (CPTDA) only “trustworthy”
patients can get the medication into their own hands. Take-

home dosages are generally a bonus that patients can get by
showing good and stable behaviour [10]. In the international
inquiry into the quality of work in Slovenian CPTDAs in
the year 2007, it was stressed that “leakage is difficult to
control, and it is hard to prevent someone from selling his/
her medication” [10]. Patients can get their first take-home
dosages after 3 to 6 months of negativization of urine samples
for illicit drugs – with the debatable exception of marijuana.
After 6 to 12 months of negative samples, they can get takehome
dosages for the whole week or, in case of holidays, for
10 days. However, the “actual rules” for giving take-home
dosages differ from one centre to another, as the inquiry
showed [10]. The numbers and the motivation of staff play
a role in these decisions [10].
In Slovenia the percentage of the medications used in CPTDAs
in 2007 was 81% for methadone, 13% for buprenorphine
and 6% for SR morphine [4]. Compared with medications for
other chronic diseases, opioid-dependent patients sometimes
need additional (extra) dosages of medications even when
they are clinically perceived as being stable. According to
the National Therapeutic Agreement, they have no right to
get extra dosages. This decision was made by the Coordination
Committee of CPTDA therapists to prevent misuse of
the medication. On the other hand, clinical work showed the
need for a better understanding of patients’ problems, and,
therefore, the appropriateness of giving extra take-home
dosages for a variety of therapeutically sound reasons.
In France, because of positive outcomes maintenance
treatments were not officially questioned [2]. A national
evaluation of maintenance treatment in France showed
that the decrease of 80% in fatal overdoses and of 67% in
arrests for heroin use (1994–1999) were directly related to
treatment accessibility [2]. Once the authorities decided to
implement control measures over patients, the innovations
approved might make access to treatment more difficult. The
effectiveness of substitution treatment could be affected as
a result [2].
One general objective of this study was to provide an
important practical tool for improving the quality of the
work carried out by the CPTDA in Logatec. The therapists
give extra take-home dosages to implement a motivational
approach as a powerful resource in enhancing staff-client
interactions, quality of services and programme functioning
as a whole [7].

The specific aims of this study were:
a) to check the topic of so-called »therapeutic reasons« for
giving extra take-home dosages;
b) to check the therapeutic status of patients at the moment
when they receive extra take-home dosage;
c) to find out the amount of extra take-home dosages for
each medication with reference to the quantity taken over
one whole year and the percentage of total medication
distributed in this way.

2. Methods
At the centre the data were collected from the protocols
on giving medications to patients. The research involved
included the collection of the following data:
a) dosages given to patients at the centre to be used under
close observation by the nurse
b) dosages given to patients as their take-home dosages
c) dosages given to patients as their extra take-home dosages
The number and proportion of all dosages for each of these
three types of medication were calculated from the written
dispensary protocols (i.e. the nurse’s book and the computer
programme setting out the regime for giving medications).
The reasons for extra take-home dosages were taken
from the therapist’s protocol for each patient. For all extra
take-home dosages there were two descriptions, of the
psychosocial and somatic status of the patient and the »reasons
« for prescribing extra take-home dosages. The first was
selected by the therapist herself in writing the protocol, and
the second was chosen by the patient at home and added to
that protocol, together with the patient’s application for extra
take-home dosage or dosages.
As one of the measures for discovering the therapeutic
stability of the patients, their urine samples were used. The
results were taken from the documentation on each patient.
In descriptions of the frequency of drug use, the word »occasionally
« meant the use of a substance more than once but
less than four times during the year.

2.2 Description of the patients
On the question of extra take-home dosages, the population
of all 150 opioid-substituted patients attending the centre (29
females and 121 males) in 2007 was checked. 101 patients
(19 females and 82 males) were receiving methadone; 32 (7
females and 25 males) were being treated with buprenorphine,
and 17 patients (3 females and 14 males) with SR morphine.
At the centre, mean daily dosages were 101.9 mg for
methadone, 14.2 mg for buprenorphine and 672.3 mg for
SR morphine.
Mean age of patients who got extra take-home dosages
was 28.6 years (min. 20 years, max. 39 years) for methadone
(3 F and 18 M); the ages of the buprenorphine patients (all
men) who got extra take-home dosages were 25, 27 and 31.
The one patient (a man) who was given extra take-home
dosages of SR morphine was 25.
Mean duration of the opioid treatment of the patients with
extra take-home dosages was 5.43 years (min. duration was
1 year and max. was 11 years).
Most of the patients that needed extra take-home dosages
were working (17/25): 12 of them had a regular job with a
working contract, 3 were working regularly but without a
contract, 2 were working without a contract and at the same
time going to school, and 4 patients were working occasion

ally to earn some money. Only 4 patients out of 25 (16%)
had no organized work or school.
At the time when they needed extra take-home dosages
the patients were coming to the centre at varying frequencies,
depending on the therapeutic agreement, the duration
of treatment and their therapeutic stability: 2 came once
every 2 weeks, 14 once a week, 2 twice a week and 2 three
times per week. Two thirds (2/3) of them were travelling to
the centre, 20 to 40 km one way. Others were living nearer.

3. Results
In 2007 at least one or sometimes more extra take-home
dosages of the medication were given to 27 patients out of
150 (15.3%) . Extra methadone was given to 20.7% of the
methadone patients, to 12% of buprenorphine patients and
to 5.08% of SR morphine-substituted patients.
Regarding urine samples in the year of the research, 10 of
the patients (10/27) who got extra take-home dosages (10/27)
were negative for all illicit drugs and with complete abstinence
from alcohol throughout the year. For 1 patient who needed
extra take-home SR morphine, abstinence was very likely
but impossible to confirm – because of the cross-reactivity
of the tests. 4 patients had once or only occasionally positive
THC in urine, 1 had THC and BZO in urine occasionally. 1
had THC occasionally in the urine samples and was drinking
alcohol occasionally. Altogether, 17 patients used no other
illicit substances or used marijuana, benzodiazepines or
alcohol once or only occasionally (table 1).
The most frequent reason for extra take-home dosages
was a heavier physical or sometimes psychological burden
at the workplace. The following reasons were cited regarding
a) physical status of the patient, b) characteristics of the
medication and c) the patient’s social environment. (Table 2).
The total quantity of all medications given to the patients
attending the centre in 2007 as extra take-home dosages was
calculated. The percentages of the medications given to all
patients as extra take-home dosages were as follows: 0.49%
of the total quantity of methadone taken; 0.75% of the total
quantity of buprenorphine; 0.1 % of the total quantity of SR
morphine. (Table 3)

4. Discussion
Most patients responded well to methadone maintenance,
whereas about one in four tends not to respond well to treatment
[6] .
From the very start of the programme in the CPTDA in
Logatec, in 1995, the therapists at the centre have been trying
to get the most complete picture possible of the centre’s
therapeutic situation. In 2005, when the centre celebrated its
10th anniversary together with its history of using methadone
as the only medication for opioid addiction, an overview of
the treatment in the centre was published in the Journal of
Slovenian Medical Association: “Before starting methadone
treatment the detoxification without medical help was accomplished
by 37% of the patients, 15% were hospitalized
in psychiatric clinics for the purpose of detoxification, 6%
were treated in the therapeutic communities, 3.9% in the
therapeutic community Project “Človek” (man). 11% of the

patients spent a part of their youth in juvenile correctional
facilities. 13% experienced imprisonment. At the time of their
therapy in the centre 79% were working or/and attending
school. 30.8% of them had children and they had a partner
included in methadone treatment in 23%” [8].
In 2005 a study on one-year abstinence was published:
“In the group of 61 patients treated in CPTDA with methadone
for at least one year, in the last year of treatment in the
centre 67.2% didn’t use heroin, 34.4% didn’t smoke marihuana,
72.1% didn’t use cocaine, 85.2% didn’t use ecstasy
and 65.6% didn’ t use any medications of benzodiazepines
type. Alcohol was not used at all in the last year by 21.3%
of patients. Only 3% of them didn’t smoke tobacco. Chronic
infection with hepatitis C viruses was present in 16.4% of
patients. None was infected by HIV”[4] .
These results give a fairly good overview of the patient
population of the centre and the level of treatment success.
Intractable problems in substitution therapy include the
distance to be travelled in reaching the centres (18 centres
cover an area of 20,256 km2) and their working hours. The
CPTDA in Logatec must meet the needs of a region of 13,000
people. Its premises are shared with the primary health centre,
and it has the same opening hours as other medical departments,
while operating under the same regime; that means

it is open every weekday for half the day: Mon Wed Fri 6.30
a.m.-1.30 p.m. and Tue Thu 1 p.m.-8 p.m. The centre can
count on contributions from 5 family doctors, 1 paediatrician,
1 school doctor, 5 stomatologists, 1 part-time gynecologist
and 1 part-time specialist for occupational medicine. The
centre sometimes uses the help of its GPs for exceptional
distribution of take-home dosages to patients outside the
working hours of the centre (during other weekday hours,
plus Saturdays, Sundays and holidays). For patients who are
obliged to take their medication daily – including Saturdays
and Sundays – and for stabilized patients in situations that
prevent their coming to the centre during opening hours,
their dosages are left in the refrigerator of the emergency
department by the nurse at the centre. She arranges this in
agreement with the doctor at the centre, the patient and the
staff of the emergency department.
All medications that are given under control at the centre
are prepared and delivered by the nurse or by the doctor at
the centre. Take-home dosages of buprenorphine and SR
morphine are prepared by the nurse for each patient separately
at the time of the patient’s visit to the centre. Take-home
dosages of methadone are prepared by the pharmacy on the
basis of a doctor’s prescription for all take-home dosages at
the centre on Thursday afternoons, applying the Soundex
code for each patient. This allows the patient to get his/her
own exact take-home dosages for some days or for the whole
week ahead. The nurse brings all the take-home dosages of
methadone solution mixed with orange juice in 100ml plastic
bottles from the pharmacy to the refrigerator at the centre.
She gives them to each patient in the centre according to his/
her take-home regime as ordered by the doctor.
In the year of the study, a majority of patients who got
extra take-home dosages needed only one or few extra dosages.
There was an exception: a 26-year-old girl in the year
of the study started to encounter difficult family problems
caused by her extremely aggressive father. She lived near
her primary home with her old and sick grandparents and
with her mother, who was seeking this girl patient’s help.
Before these family troubles reached a climax, this girl was
abstinent from all illicit drugs and had drunk no alcohol for
three years in our programme. She was working morning,
afternoon and night shifts and was living more than 20 km
from the centre. Her grandparents and her parents visited the
centre at the very beginning of the treatment, but stopped
doing so afterwards. During that whole period, she refused
to tell them about her taking methadone. She was receiving
take-home dosages of methadone to last one week at a time.
Apart from the distress experienced at home, she also split
with her boyfriend. In those days she started to use cocaine
for the first time in her life. Because she was taking extra
dosages of methadone and due to her stressful personal
situation, her tolerance grew. The therapists slowly raised
the daily dosage to 230 mg. She became stable again and
stopped using cocaine. She has managed to keep her job,
which is very demanding. Her employer is satisfied with
her work. This year she was promoted to a more demanding
position. Unfortunately, she got infected by hepatitis C at the
time when she was using cocaine. A month ago she started
treatment with interferon and ribavirin.
The National Therapeutic Agreement in Slovenia is very
demanding. To ensure successful therapy, some therapists
decide to provide take-away dosages even before some
patients have actually qualified to receive their bonus. Such
a decision is always a question of “sailing between Scylla
and Charybdis”, besides raising the eternal questions of
right and wrong.

Doctors have to help people live, and primum nil nocere
has to be the rule. But there is always the question of how
each doctor applies these solutions in treating individual
patients. Less frequent visits to the centre may create an
opportunity to work better with those who come. In some
ways it also prevents patients from grouping around the
centre. Unduly strict regulations can be harmful in another
way. We can learn this from the German experience, where
the official reaction to the troubles emerging in an organization
providing ongoing opioid treatment was to tighten the
regulations; most of the primary care physicians responded
by giving up their work. “When therapy was predominantly
offered by special maintenance centres, strong concentration
of these specific patients took place.”[11]
Having discussed the results of urine testing compared
with the patient’s real abstinence, we are aware of well-known
difficulties. The frequency of urine testing in the centre varies
from 2 or 3 times per week for some patients to once in
3 or even 6 months for the few of them who are stable and
abstinent in the opinion of the therapist. Besides testing
devices for drugs in urine, saliva test devices are sometimes
used. For the assessment of drinking habits, a saliva test and
quite often the AUDIT and CAGE questionnaires are used.
Each year the therapists at the centre carry out some research.
Patients are asked to fill in a patient satisfaction questionnaire
yearly. The philosophy of the centre aims for an attitude of
“listening, understanding and acceptance” towards patients
or, as the expression goes, of “dancing with clients”.. [1]
This attitude of therapists provides an explanation for giving
extra take-home dosages, as most patients mostly do not
misuse the therapist’s trust. Each difficult situation is used
as a convenient moment to discuss with a patient his/her
decisions in life, his/her feelings and troubles, worries or
anger. After such discussions the patients usually feel better.
At the beginning of the study, the therapists were afraid
of taking on the task of calculating what had previously been
an unknown (potentially large?) quantity of extra take-home
medications that had been supplied to their patients. But the
top priority of the therapists in carrying out this inquiry was
an honest check on the work they were doing. At the end of
the study therapists have reached a strong conviction that this
has been a positive experience in improving the medical and

social status of their patients, partly through the distribution
of additional take-home dosages; this outcome makes it is
worth discussing the risks involved in not always obeying
the rules set by the National Therapeutic Agreement. Not
giving extra take-home dosages would mean putting the
patient in the position of lacking a required medication. He
or she would have to search for the medication on the black
market or have to buy a certain amount of heroin. A relapse
would be the inevitable result.
The explanations for such therapeutic decisions are easy to
understand in diabetes patients, when dietary mistakes have
been made or when these patients have an acute illness, or
in allergic asthma patients who need more inhaled corticosteroids
when an attack of asthma has been exacerbated by
visiting an old friend who owns a cat or a rabbit.

5. Conclusion
In reviewing the fairly good results for abstinence and
employment in all the years during which the CPTDA in
Logatec has provided treatment, and its continual objective
of achieving a better understanding of opioid addiction as
just one of many chronic diseases, the therapists at the centre
view their decisions to give extra take-home dosages to their
patients as having been mostly correct.

read more:Rupnik 12(2)2010 2

Inhaltsverzeichnis……………………………………………………………………………………………….1
Abbildungs- und Tabellenverzeichnis……………………………………………………………………1
1 Einleitung und Fragestellung…………………………………………………………………………3
2 Methodik…………………………………………………………………………………………………….3
2.1 Durchführung………………………………………………………………………………………4
2.2 Auswertung………………………………………………………………………………………….4
3 Ergebnisse…………………………………………………………………………………………………..4
3.1 Die Untersuchungsgruppe……………………………………………………………………..5
3.2 Gesundheit…………………………………………………………………………………………..9
3.3 Konsummuster……………………………………………………………………………………12
3.3.1 Prävalenz des Drogenkonsums………………………………………………………13
3.3.2 Applikationsformen……………………………………………………………………..15
3.3.3 Konsumentengruppen…………………………………………………………………..16
3.4 Risikoverhalten………………………………………………………………………………………..19
3.5 Hilfebedarf und Hilfenutzung……………………………………………………………….22
3.6 Konsum in Haft………………………………………………………………………………….31
4 Fazit…………………………………………………………………………………………………………32
Literatur………………………………………………………………………………………………………….36
Abbildungs- und Tabellenverzeichnis
Abbildung 1: Anzahl der Befragten pro Stadt…………………………………………………………5
Abbildung 2: Durchschnittalter nach Stadt…………………………………………………………….6
Abbildung 3: Migrationshintergrund nach Stadt……………………………………………………..6
Tabelle 1: Schulabschluss…………………………………………………………………………………….7
Abbildung 4: Arbeitssituation………………………………………………………………………………7
Tabelle 2: Wohnsituation…………………………………………………………………………………….7
Abbildung 5: Substituierte nach Stadt……………………………………………………………………8
Abbildung 6: HIV-Infektion nach Stadt…………………………………………………………………9
Abbildung 7: HCV-Infektion nach Stadt………………………………………………………………10
Tabelle 3: Körperlicher und psychischer Zustand………………………………………………….10
Abbildung 8: Einschätzung des körperlichen Zustands nach Stadt…………………………..10
Abbildung 9: Einschätzung des psychischen Zustands nach Stadt…………………………..11
1
Abbildung 10: Anzahl Krankheitssymptome nach Stadt………………………………………..11
Tabelle 4: Körperliche und psychische Probleme………………………………………………….12
Abbildung 11: Prävalenz Drogenkonsum…………………………………………………………….13
Abbildung 12: Konsummuster von Männern und Frauen……………………………………….14
Abbildung 13: Heroin-, Kokain- und Crackkonsum nach Städten……………………………14
Abbildung 14: Prävalenzen nicht-verschriebener Substitutionsmittel nach Städten……15
Abbildung 15: Konsumformen……………………………………………………………………………15
Abbildung 16: Konsumgruppen nach Clusteranalyse…………………………………………….16
Abbildung 17: Konsummustergruppen nach Stadt…………………………………………………17
Abbildung 18: Wichtigkeit der Hilfsangebote nach Konsumgruppen………………………18
Abbildung 19: Spritzen- oder Utensilien-Teilen nach Konsumgruppe……………………..19
Abbildung 20: Risikoverhalten……………………………………………………………………………20
Abbildung 21: Verwendungshäufigkeit von Spritzen nach Städten………………………….20
Abbildung 22: Gemeinsames Nutzen von Spritzen oder Utensilien…………………………21
Abbildung 23: Drogen aus einer Spritze mit anderen geteilt…………………………………..21
Abbildung 24: Gemeinsame Nutzung der Crackpfeife…………………………………………..22
Tabelle 5: Gründe für den Aufenthalt auf der Szene………………………………………………22
Abbildung 25: Gründe für Szeneaufenthalt nach Stadt…………………………………………..23
Abbildung 26: Wichtigkeit von Hilfeangeboten……………………………………………………24
Abbildung 27: Wichtigkeit von Hilfeangeboten nach Stadt…………………………………….24
Abbildung 28: Häufigkeit des Besuchs der Einrichtung…………………………………………25
Abbildung 29: Häufigkeit des Besuchs der Einrichtung nach Stadt…………………………25
Abbildung 30: Besuch anderer Einrichtungen………………………………………………………26
Abbildung 31: Nutzung der Hilfsangebote……………………………………………………………26
Abbildung 32: Nutzung von Beratung…………………………………………………………………27
Abbildung 33: Nutzung des Konsumraumes…………………………………………………………28
Abbildung 34: Besuch anderer Konsumräume nach Stadt………………………………………28
Abbildung 35: Nutzung von Konsumräumen durch Substituierte……………………………29
Abbildung 36: Orte des Konsums……………………………………………………………………….29
Abbildung 37: Gründe für öffentlichen Konsum…………………………………………………..30
Abbildung 38: Grund für öffentlichen Konsum nach Stadt…………………………………….31
Abbildung 39: Drogenkonsum in Haft…………………………………………………………………32

Meine geliebten Statistiken:AbschlussberichtSzenebefragung

quelle: INSTITUT FÜR INTERDISZIPLINÄRE SUCHT- UND DROGENFORSCHUNG – ISD, HAMBURG Träger: Förderverein interdisziplinärer Sucht-
und Drogenforschung (FISD) e.V.
http://www.isd-hamburg.de

Psychiaterin: Therapie eines Opiatabhängigen ist vergleichbar mit der Therapie anderer chronischer Erkrankungen

Wien – 22.000 bis 33.000 Menschen haben in Österreich einen problematischen Drogenkonsum, vor allem geht es um das regelmäßige Injizieren von Suchtgiften (Opiate). Im Vergleich zu anderen Erkrankungen ist die Zahl der Betroffenen gering, doch Stigmatisierung und Diskriminierung sind dafür umso höher. Um zu einer Feinabstimmung der Strategien in der Behandlung von Abhängigen in Österreich zukommen, gibt es morgen, Donnerstag, eine international besetzte Enquete im Gesundheitsministerium. Vor allem auf eine möglichst umfassende Betreuung der Patienten auf der Basis wissenschaftlicher Erkenntnisse komme es an, hieß es bei einer Pressekonferenz in Wien.

“Den Einen ist die Behandlung zu liberal, die Anderen meinen, man soll alle einsperren. Der Oberste Sanitätsrat hat Süchtige immer als Schwerkranke gesehen, die behandelt gehören”, fasste der Vorsitzende des OSR, Ernst Wolner, pointiert die oft ideologisch und politisch überfrachteten Diskussionen rund um Sucht und Abhängigkeit zusammen.

Gabriele Fischer, Leiterin der OSR-Unterkommission zur Qualitätssicherung in der Betreuung von Suchterkrankungen und Chefin der Drogenambulanz am Wiener AKH: “Es kommt niemand mit einem genetischen Defekt auf die Welt, der ihn später zum Opiatabhängigen macht. Es ist nichts Lasterhaftes, es ist keine Verhaltensproblematik. (…) Abhängigkeit ist eine schwere psychiatrische Erkrankung. Die Therapie eines Opiatabhängigen ist vergleichbar mit der Therapie anderer chronischer Erkrankungen, mit der eines Diabetikers. Die Medikamentenkosten sind die geringsten Kosten.” Rückfälle und Missbrauch von Arzneimitteln – den Opioid-Substitutionsmitteln – seien krankheitsimmanent.

Entzug nicht sinvoll

Gerade bei Opiatsüchtigen ist die Drogensubstitution mit Medikamenten wie Methadon, retardierten Morphinen, Buprenorphin etc. der Stand der modernen Medizin. Die Psychiaterin: “Es wird immer wieder thematisiert, dass man Abhängige (stationär, Anm.) aufnehmen soll, es sollte entzogen werden – dann wäre die Problematik vorbei. Diese singuläre Intervention funktioniert überhaupt nicht. Wir haben es mit einer chronischen Erkrankung zu tun. Die Detoxifikation entspricht nicht mehr dem ‘State of the Art’.”

Trotzdem gibt es immer wieder heftige Debatten über Art und Weise der Substitutionstherapie, die verwendeten Mittel, Mitgaberegelungen etc. Hier soll die Enquete die notwendigen Informationen für eine Feinabstimmung in Österreich liefern. Prinzipiell, so Gabriele Fischer, seien alle Substitutionsmittel gute Medikamente, sie müssten nur optimal und kontrolliert verschrieben werden. Aber, so die Expertin: “Wir haben (in Österreich, Anm.) nur 15 Prozent Verschreibungen auf Methadon, 60 Prozent auf retardierte Morphine, die restlichen auf Buprenorphin und Kombinationspräparate. Das ist meines Erachtens ein Missverhältnis.” 80 Prozent der Drogentoten sind nicht in Substitutionstherapie, die meisten Todesfälle gehen auf das Konto von Mischkonsum mit Benzodiazepinen und Alkohol.

30 Prozent in Substitutionsbehandlung

In Österreich dürften rund 11.000 Menschen in Opiat-Substitutionstherapie sein. Das wären 30 Prozent der potenziell vorhandenen Patienten. In der EU ist das eine Position im Mittelfeld. Wie regional unterschiedlich die Betreuungsdichte aber ist, erweist sich an dem Umstand, dass allein 7.000 Substitutionspatienten in Wien betreut werden.

Es gibt – so Gabriele Fischer – durchaus Verbesserungsmöglichkeiten: “Ganz besondere Sorge macht die hohe Verschreibungsrate von Benzodiazepinen. 70 Prozent der Substitutionspatienten bekommen auch Benzodiazepine. Ein Drittel der Patienten ist bei Allgemeinmedizinern hervorragend aufgehoben. Das Problem ist, was mit den anderen zwei Dritteln geschieht. Ein Drittel müsste in Spezialeinrichtungen in sehr enger Anbindung versorgt werden.” Hier benötige man wahrscheinlich mehr Einrichtungen. Österreich habe aber auch einen Mangel an Psychiatern – und psychiatrische Abteilungen und Schwerpunktkrankenhäuser dürften sich nicht der Behandlung von Abhängigen entziehen. (APA)

quelle: http://derstandard.at/1271375971587/Substitutionstherapie-Drogentherapie-Substitution-statt-Entzug

“The secret of grand fortunes without apparent cause is a crime forgotten, for it was properly done.” These are the words of renowned French author, Honore de Balzac in his book, Pere Goriot. While Balzac is often quoted, never were the words so timely as those quoted above. In an astonishingly overlooked article published in the U.K. newspaper, the Guardian in December 2009, the head of the United Nations Office on Drugs and Crime declared that billions of dollars in illicit drug money sustained the global financial system during the zenith of the worldwide recession.

Antonio Maria Costa reported to the Guardian that he has seen convincing evidence that the cash profits made from the global trafficking of drugs were “the only liquid investment capital” available to many of the world’s largest banks during 2008. He inferred from this information that much of the $352 billion derived from these illegal activities percolated through these legitimate banks and into the fiscal streams of most of the nations of the world.

“In many instances,” Costa said, “the money from drugs was the only liquid investment capital. In the second half of 2008, liquidity was the banking system’s main problem and hence liquid capital became an important factor.” These accusations arouse many questions regarding the participation, whether tacit or direct, of the leaders of the world and the world’s banks in the systematic laundering of drug money through the washing machines of legitimate enterprise.

The principal channel through which this dirty money flowed, according to Costa, is loans made among financial institutions. “Inter-bank loans were funded by money that originated from the drugs trade and other illegal activities,” he asserted. When asked by the reporter at the Guardian to identify the banks or countries that he believed conducting this sort of business, Costa declined. He refused to point the finger of blame, but assured the paper that the intelligence received by his office inculpated the entire “official system.”

Rather than go bankrupt or be subject to rampant craze of nationalization, many of the world’s banks, according to Costa’s story, consented to accept the enormous cash deposits from cartels that would normally have been hidden in offshore accounts until they were converted into property or otherwise disposed of. These banks gobbled up the specie handed it by organized crime syndicates and passed it around among themselves to stave off insolvency. Just a little crooked cash to tide them over until the traditional and legitimate streams of income started flowing again.

The question begged, then, is who gave the green light for these otherwise illegal deposits to be made? Which high-level official picked up the phone and assented to cooperate with the world’s most despicable criminals? And, furthermore, did those high-level officials look for an approving nod from governmental leaders who would also be required to turn a blind eye to the collusion? These questions have never been asked of Barack Obama or Gordon Brown or David Cameron or any of the world’s leaders with ostensible oversight of the banking infrastructure of their nations.

If one were to accept, in arguendo, the testimony of Costa and crunch the numbers he supplies, then as much as 20 percent of the world’s “legitimate” economy is buttressed by the bricks and mortars of international organized crime. These notorious and powerful kingpins have injected their decadent dollars into the accounts of the world’s banks and used cash to hide a multitude of sins. If such enormous sums have truly been infused into the white market by the black hats of the world, then where, the citizens of the world should ask, were the reputable bank presidents and elected political leaders when this exchange was being made? Were they idly, though willingly, holding the coats of these drug lords while they walked in through the lobbies of legitimacy and deposited millions?

All of this intrigue and intercourse between officialdom and racketeers may sound like the plot of a vacation thriller. In fact, it is. Best-selling novelist, John LeCarre has written a new book entitled Our Kind of Traitor. In his story, the Russian mob is in cahoots with the British upper crust of the House of Lords, and together they wash the filth right out of the profits derived from the smuggling of drugs and human beings.

LeCarre insists that his book was written long before Antonio Maria Costa made public his allegations. This only makes the truth, if it is indeed true, so much stranger than fiction.

Many do not doubt the veracity of Costa’s assertions. In fact, most forensically minded accountants insist that when it comes to the billions of dollars generated by the criminal cartels of the world, Presidents, Prime Ministers, and parliaments are content to “catch the minnows while leaving the sharks to roam free.” The minnows in the analogy are the millions of dollars seized in highly-publicized drug busts, while the sharks are the billionaire kingpins who are always handy to have around when the banking industry needs a quick billion or two to maintain the illusion of “economic recovery.”

Hector Meredith, the cynical spy with the heart of gold in LeCarre’s new novel, as quoted in the story in the Guardian, said it best: “A chap’s laundering a couple of million? He’s a bloody crook. Call in the regulators, put him in irons. But a few billion? Now you’re talking. Billions are a statistic.” The statistics that indicate the global economy is on the brink of collapse are apparently music to the ears of cash rich mega-criminals who are pleased as punch to turn over bushels of the fruit of their evil endeavors to the bankers and bureaucrats who will turn them into delicious pies of money to be sliced up and eaten by the global community.

source: http://www.thenewamerican.com/index.php/usnews/crime/4556-drug-money-props-up-banks-during-recession

by: Albrecht Ernst

Your viral load is the amount of specific viruses that you have, in a given volume of your blood (usually 1 milliliter = 1 cubic centimeter). More precisely, it means that the amount of Hep C genetic material found in your blood corresponds to as many Hep C viruses as the given number says. Therefore the given number denotes “viral equivalents.”

There appears to be no significant correlation between HCV RNA levels and ALT values or histological activity in patients untreated by anti-viral therapies (Interferon). Viral load varies between infected individuals but is not a useful prognostic indicator nor does it measure the severity of virus-induced liver disease.

WHAT DOES NEGATIVE OR “NOT DETECTED” MEAN?

The viral load can range from “not detected” to hundreds of millions. The meaning of “not detected” or “negative” differs, depending on the test used. In one lab, the detection limit for the *quantitative* HCV RNA test by *PCR* is 200 virus equivalents/ml (and with the *qualitative* test they can detect down to 10 virus equivalents/ml). The less expensive quantitative *bDNA* test has a detection limit of about 200,000 virus equivalents/ml. So it is less sensitive, but above its detection limit it is more accurate than the PCR test.

So, when you are “negative”, maybe you have no Hepatitis C virus in your blood. But maybe also, you do have Hepatitis C virus in your blood, but the number of viruses is lower than the detection limit. {Example: If the less expensive quantitative *bDNA* has been used, and the detection limit is 200,000 virus equivalents/ml, any number less than this would register as “negative” or “not detected”, when in fact, the viral load could be present, but less than this detection limit.} Your lab can tell you which testing measure is used, and your doctor can explain what it means in your case.

WHAT DOES “POSITIVE” MEAN?

When you get back the result of your HCV RNA quantitative test, and when the lab was able to determine the amount of virus in your blood, then it is important to write down not only the number, but also in what units this number is given.

I) Volume

The volume of blood, that the number refers to, is usually one milliliter.

But some labs give the number for 20 microliters = 1/50 milliliter. So in these cases you have to multiply the result of the viral load by 50 to get the number for 1 milliliter.

II) Amount of Virus

Unfortunately, there are several ways to express the viral load. So, in order to be able to compare different results, you have to know how to convert these numbers to some standard format, which let’s say is just the plain number of viruses per milliliter, like 1.5 Million/ml, or 1,500,000/ml. (both of these numbers are the same).

a) Measure by weight

Sometimes, the lab reports the amount of genetic material found by its weight. 1 pg (pico-gram) of genetic material corresponds to about 1 million virus equivalents, so, if your lab result is given in picograms, just multiply the lab result by 1,000,000, and you have the number of viruses.

b) Measure by virus count

i) Plain numbers

Often the virus count is expressed as a plain number, like 1.73 million, or 1,730,000 or 1730000. Millions sometime are abbreviated by the prefix “M” (Mega). So when you see 1.73 Meq/ml, it means 1.73 Mega-equivalents/ml or again 1730000 equivalents/ml..

ii) Exponential format

Large numbers are often expressed in exponential form, that means a number, multiplied by 10 with an exponent. To convert this to normal numbers, append as many zeroes to a “1” as the exponent says, and multiply this with the number. In some lab report, the viral load was “Hep C RNA Quant 17.3 x 10(exp) 5 equivalents/ml”. So, with 5 as exponent, you have to append 5 zeroes to a “1”, that gives 100000, and multiply this with the number 17.3, that gives 1730000 as the viral load. Normally this would be written 1.73×10(exp)6, or 1.73×106 , (which are again the same number).

17.3×105 = 1.73×106 = 1,730,000

iii) Logarthmic format

Now, recently some people express these numbers also in logarithmic form (logarithmic transformed number).

log(1730000)=6.24

6.24 is the logarithmic transformed number of the viral load of our above example. A result of 3.5 for a viral load, that someone reported, seems to be such a number (unless he forgot to write down a “10” and an exponent). You need a calculator to convert this. You have to use the function 10x , where you have to replace x with the logarithmic number, in the above case 3.5. The result would be: 103.5 = 3162 virus equivalents per milliliter.

When you take the logarithmic number from the first example, 6.24, you have to calculate 106.24 = 1730000 , and here we have the original number of virus equivalents again. If you don’t have a calculator, you can estimate the order of magnitude of a viral load expressed as a logarithmic number. From the logarithmic number, you take the first digit (left of the point) and add 1 to this number. This gives you the number of digits that your viral load has (expressed as a plain number).

Example: Logarithmic number 6.24

Left of the point is “6”. 6+1 = 7

The number that gives the viral load is 7 digits long, that means it is between 1,000,000 and 9,999,999 (digit # 1 234 567)

The next digit (right of the point of the logarithmic number) shows whether you are high or low in the range.

In case you have a logarithmic number *and* a blood volume other than 1 ml, you have to convert the logarithmic number to a plain number *first*, and then correct it to correspond to 1 ml !

Therefore it is important to have a close look at your lab report and see in what units the result is given!


There is still no general agreement on what Viral Load is considered low and what is high in Hepatitis C. This interpretation makes sense for people not currently being treated – for someone who is 6 months into an INF + RIBA trial, even 200,000 could be considered a high titer.

(Numbers are Virus Equivalents per Milliliter)

below 200,000 very low (undetectable by *bDNA* test)

200,000 to 1,000,000 low

1,000,000 to 5,000,000 medium

5,000,000 to 25,000,000 high

above 25,000,000 very high

Once again, please note that this information is not written by an MD or medical expert. Nothing can (or should) take the place of appropriate medical care.

See also the “Viral Load Chart” http://www.hepatitis-central.com/hcv/hepatitis/loadchart.html

t is much easier to talk of the Hepatitis C virus as if it is a single organism but in fact it is a range of viruses, similar enough to be called Hepatitis C virus, yet different enough to be classified into subgroups.

Viruses are microscopic and no person could ever see them with the naked eye. Indeed, HCV is so small that there’s been no confirmed actual sighting of it using any type of microscope yet developed.

Consequently, a better way to understand the terms HCV ‘genotypes’ and ‘subtypes’ is to compare them to things that we can more readily relate to.

Genotypes

The group of birds we call ‘raptors’ (birds of prey) have evolved into different main types. Imagining raptors as being Hepatitis C viruses, you could take one major raptor type, such as eagles, and imagine these as being one of HCV’s main types (genotypes).

Subtypes

But eagles as a group are made up of different sub types such as the American Bald Eagle and Australia’s Wedge Tailed Eagle and Sea Eagle. You could imagine each of these as being one of the HCV subtypes that make up an HCV genotype.

Quasispecies

Within each of above particular types of eagles, there are further differences. All Wedge Tailed Eagles, for example, differ from each other in regard to wing span, weight, color, beak size, etc. Similarly, within a Hepatitis C sub-type, individual viruses differ from each other ever so slightly. Such viral differences are not significant enough to form another sub-type but instead form what’s known as quasi-species. It is believed that within an HCV sub-type, several million quasispecies may exist. Scientists predict that people who have Hepatitis C, have billions of actual viruses circulating within their body. Although there may be one or two predominant sub-types, the infection as a whole is not a single entity and is composed of many different quasispecies.

Classifications

Biologists are generally not known for creativity when it comes to naming things – hence Hepatitis C virus. The most commonly used classification of Hepatitis C virus has HCV divided into the following genotypes (main types): 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 and 11. As we’ve highlighted, HCV genotypes can be broken down into sub-types, some of which include:

1a, 1b, 1c
2a, 2b, 2c
3a, 3b
4a, 4b, 4c, 4d, 4e
5a
6a
7a, 7b
8a, 8b
9a
10a
11a

Genotype patterns

It is believed that theHhepatitis C virus has evolved over a period of several thousand years. This would explain the current general global patterns of genotypes and subtypes:

1a – mostly found in North & South America; also common in Australia
1b – mostly found in Europe and Asia.
2a – is the most common genotype 2 in Japan and China.
2b – is the most common genotype 2 in the U.S. and Northern Europe.
2c – the most common genotype 2 in Western and Southern Europe.
3a – highly prevalent here in Australia (40% of cases) and South Asia.
4a – highly prevalent in Egypt
4c – highly prevalent in Central Africa
5a – highly prevalent only in South Africa
6a – restricted to Hong Kong, Macau and Vietnam
7a and 7b – common in Thailand
8a, 8b & 9a – prevalent in Vietnam
10a & 11a – found in Indonesia

It’s believed that of the estimated 160,000 Australians with HCV, approx. 35% have subtype ‘1a’, 15% have ‘1b’, 7% have ‘2’, 35% have ‘3’ (mostly being 3a). The remaining people would have other genotypes.

Genotype and treatment

Current scientific belief is that factors such as duration of a person’s HCV infection, their HCV viral load, age, grade of liver inflammation or stage of fibrosis may play an important role in determining response to interferon treatment. Recent studies have suggested that a person’s HCV subtype (or subtypes) may influence their possible response to interferon, or interferon-ribavirin combination treatment. Worldwide trials are being conducted which will soon shed more light on this belief. We’ll publish any reports as they come to hand.

Genotypes and Genetic Variation of Hepatitis C Virus by G. Maerterns & L. Stuyver,
reviewed by Dr Greg Dore of the National Centre in HIV Epidemiology & Clinical Research.
From The Hep C Review; Ed 23, December 1998; Paul Harvey

Treatment guidelines are considered to be an important tool in steering patients to medical treatment. Thisstudy was conducted to analyze guidelines for the treatment of hepatitis C virus (HCV) infection in injectiondrug users (IDUs) in the European Union (EU) countries as a component of treatment access. National and
international databases, expert contacts, professional societies, and health administrations were approachedto acquire guidelines. According to their quality standard, guidelines were divided into expert opinions, semiofficial guidelines, official guidelines, and consensus processes. Recommendations for the treatment ofHCV infection in IDUs vary substantially, from lack of recommendations and outright treatment disapproval to recommendations for treatment under specified circumstances. Recent guidelines that apply qualified processprocedures that include literature research tend to be more permissive.

Qualified guideline processes in each
EU country and subsequently renewed pan-European guidelines are needed.

Chronic infection with hepatitis C virus (HCV) is considered
to be a major burden, both to those infected
and to the public health system [1]. Besides alcoholism,
chronic HCV infection is the major cause of liver cirrhosis
and end-stage liver disease and the main reason
for liver transplantation [2]. Moreover, chronic HCV
infection is associated with increased rates of depression
and fatigue and leads to impaired quality of life [3, 4].
The future health costs in 10 European Union (EU)
countries for 1 year of drug-related HCV, hepatitis B
virus, and HIV infection were estimated at i1.89 billion,
with HCV accounting for nearly 40% [5]. Within the
EU countries, the prevalence of HCV infection in the
general population is as high as 3%; among injection
drug users (IDUs), the prevalence of HCV infection is
30%–98% [6–8]. The introduction of antiviral com-
bination therapy with ribavirin and pegylated IFN has
led to sustained virological response in 150% of patients;
however, rates depend on the HCV genotype [9,
10]. Nevertheless, treatment of HCV infection in IDUs
is still the subject of controversy. Reasons for withholding
antiviral therapy from IDUs may include the
assumption of poor adherence, fear of adverse effects,
and the risk of reinfection [11]. There is evidence that
IDUs can adhere to medical protocols in the same manner
as do non-IDUs [12], and early pilot studies showed
that antiviral treatment of chronic HCV infection in
IDUs is both safe and effective [13–17]. Rates of reinfection
in IDUs may not necessarily be higher than
in non-IDU populations [18]. Despite these promising
results, IDUs may face barriers when trying to gain
access to treatment for chronic HCV infection. Treatment
guidelines have an increasing effect on the provision
of therapies, because, in times of limited resources,
allocation of even these limited resources
follows, among other considerations, the recommendations
of guidelines. In addition, treatment guidelines
may have an effect on the provision of qualifications
for professionals and on the willingness of sponsors to pay for
treatment and of professionals to provide treatment [19, 20].
This study was undertaken to analyze guidelines for the treatment
of HCV infection as applied in the EU countries with
regard to treatment accessibility for IDUs.

METHODS
Guidelines for the treatment of HCV infection were retrieved
by researching international databases and requesting information
from professional societies and experts. The MEDLINE
database (http://www.ncbi.nlm.nih.gov/entrez/query.fcgi) was
used with the keywords “guidelines,” “management,” “guidance,”
and “treatment”—in combination with the terms “hepatitis,”
“hepatitis C,” and “HCV.” The first 200 publications
that were presented for each keyword were considered.
Publications from non-EU countries except for Norway were
not taken into account. Authors of relevant references were
screened for further publications about these topics. Internet
home pages of international and national professional societies
in the areas of addiction medicine, gastroenterology, and
hepatology were screened for guidelines and experts. Experts,
as identified by the European Monitoring Centre for Drugs and
Drug Addiction (http://www.emcdda.eu.int) and the Centre for
Interdisciplinary Addiction Research of the University of
Hamburg (http://www.zis-hamburg.de), were asked to provide
both guidelines and expert contacts in their country. In addition,
we contacted experts and/or institutions discovered via
the European Society for the Study of the Liver (EASL; http:
//www.easl.ch), European Network for HIV/AIDS and Hepatitis
Prevention in Prisons, and European Information Network
on Drugs and Drug Addiction (http://www.emcdda.eu
.int/index.cfm?fuseactionppublic.Content&nNodeIDp403&s
LanguageISOpEN). To assess quality levels, guidelines were
divided into consensus papers, official guidelines, semiofficial
guidelines, and expert opinions. To qualify as a consensus paper,
guidelines had to follow, at least partially, recommendations
for development in the areas “scope and purpose,” “stakeholder
involvement,” “rigor of development,” “clarity of presentation,”
“applicability,” and “editorial independence,” as suggested by
the Appraisal of Guidelines Research and Evaluation collaboration
[21]. To qualify as official guidelines, guidelines had to
be authored by a professional organization; to qualify as semiofficial
guidelines, the authorship of at least 3 experts on the
topic was required. Recommendations by single experts on the
topic were rated as expert opinions.

RESULTS
The results of this research are presented by country, guideline
quality level, and content analysis.
EU. The latest consensus paper of the EASL was published
in 1999. It states that “Active intravenous drug users should
not be treated due to the risk of reinfection. In addition, compliance
with treatment is poor in patients in whom alcoholism
has not been interrupted and in whom drug addiction continues”
[22, p. 958].

Austria. The Austrian Society of Gastroenterology and Hepatology
published in 1998 official guidelines for the treatment
of viral hepatitis. This publication states, “For persons actively
injecting drugs and/or drinking alcohol antiviral treatment is
absolutely contraindicated. Patients after successful detoxification
and/or patients in methadone maintenance therapy may
receive antiviral treatment” [23, p. 25]. A group of 7 authors
who are specialists in addiction medicine published guidelines
for treatment of chronic hepatitis C in drug users in Austria
from the point of view of addiction medicine, which was categorized
as semiofficial guidelines [24]. These authors indicate
that patients are eligible for treatment after at least 6 months
of abstinence or, in case of substitution treatment, without
additional drug use or, in case of drug use, no injection drug
use or intoxication and few psychosocial deficits. Patients definitely
not eligible for treatment are characterized by periodically
or continuously uncontrolled drug use or by injection
drug use without applying safer-use criteria. Patients undergoing
substitution treatment who follow safer-use criteria when
injecting intravenously or IDUs who follow safer-use criteria
are possibly eligible for treatment. Recently, Ferenci [25] published
his expert opinion, which is largely in concordance with
the 1998 recommendations of the Austrian Society for Gastroenterology
and Hepatology.

Belgium. The Steering Committee of the Belgian Association
for the Study of the Liver published official guidelines
[26]; however, these guidelines lack recommendations for patients
with drug-related problems. A group of 4 authors published
guidelines categorized as semiofficial, which stated that
“…current studies support that the anti-HCV therapy of
IVDUs [IDUs] should be the same as in other HCV-infected
patients” but excluded certain IDUs by saying that “Patients
with uncontrolled active intravenous drug use are not candidates
for medical treatment due to lack of compliance and a
high risk of re-infection” [27, p. 99].

Denmark. One expert opinion was acquired in Denmark.
It was reported that most Danish treatment centers adhere to
the EASL consensus report. “[Being an] IDU is not a reason
for exclusion and certainly substitution treatment is not. Most
centres would however not treat IDUs actively injecting” (B.
P. Christensen, personal communication).

Finland. Two semiofficial guidelines were acquired for Finland.
In the guidelines from the year 2002 it is assumed that
IDUs “…even if drug dependence does not exist any longer,
cannot profit from therapy” [28, p. 1261]. The other guidelines,
published in 2003, states that “…long-term intravenous
consumption…represents a clear contra-indication of therapy…”
[29, p. 525].

France. The French consensus paper states that “occasional
intravenous drug use by an otherwise stabilized patient does
not contraindicate treatment” [30, p. 306]. Expert opinions and
literature research constituted an integral component of the
consensus process. An expert mapped out that a nonstabilized
IDU with ongoing drug use must not be treated [31]; on behalf
of the bibliographic group, a case-by-case decision was recommended
[32].

Germany. One official guidelines and 2 semiofficial guidelines
exist. The author of the official guidelines is the German
Society of Digestive and Metabolic Diseases. This publication
states that “an interferon-based therapy should not be initiated
in active drug and/or alcohol users. Drug users should be abstinent
before initiation of interferon-based therapy for at least
twelve months, alcoholics for at least six months. No consensus
exists as to treatment of patients in methadone maintenance
programs” [33, p. 981]. Semiofficial guidelines authored by the
president of the German Society of Addiction Medicine recommends
postponing treatment in cases of !12 months of
abstinence in drug users or in cases of substantial alcohol intake
[34]. A second semiofficial guidelines was authored by 8 experts
on the topic under the auspices of the German Ministry of
Health and the Robert Koch Institute. This publication recommends
treatment of IDUs within a methadone maintenance
program, restricts treatment of IDUs after detoxification to
specialized centers, and recommends treatment of abstinent
IDUs in general in close collaboration with experts in addiction
medicine (U. Marcus, Ministry of Health and Social Security,
personal communication).

Greece. No data were acquired.

Ireland. No data were acquired.

Italy. An expert on the topic stated that there are no specific
guidelines for the treatment of HCV infection in IDUs (G.
Rezza, personal communication). Guidelines of the Italian Association
for the Study of the Liver will be published soon (M.
Strazzabosco, personal communication).

Luxembourg. No data were acquired.

The Netherlands. According to an expert opinion, treatment
for HCV infection is offered to IDUs within a special
treatment program [35], although inclusion criteria remain
unclear.

Norway. According to guidelines classified as semiofficial,
“Patients addicted to alcohol should not be treated. The same
applies to those addicted to other substances, although heroin
addicted sometimes are successfully treated. Drug addicts
treated with methadone are in exceptional cases also treated
with IFN and ribavirin. Until now, six months abstinence before
initiating HCV-therapy has been required” [36, p. 927].

Portugal. No data could be acquired.

Spain. Two official guidelines, authored by the Spanish
College of Hospital Pharmacists and the Society of Primary
Care Physicians, respectively, do not address the problem of
treatment for HCV infection in IDUs [37, 38]. Two semiofficial
guidelines, each authored by a group of 6 experts, do not consider
injection drug use as a treatment contraindication [39,
40]. An expert opinion promoted by the Spanish Association
for the Study of the Liver (http://www.aeeh.org) does not specifically
address the topic of treatment of HCV among IDUs.

On this Web page, consensus papers of the National Institutes
of Health [41] and the EASL [22] are also presented. Therefore,
the official position of this professional society remains unclear.
In the autonomous region of Catalonia, official guidelines published
by the Department of Health and Social Security [42]
considers injection drug use a contraindication for the treatment
of HCV infection.

Sweden. Official guidelines authored by 19 experts considers
“ongoing or recent drug or alcohol abuse” a contraindication
for treatment [43]. The official guidelines of the Swedish
Medical Products Agency considers “ongoing or recent drug
use” a relative contraindication for treatment [44].

United Kingdom. The official guidelines of the Royal College
of Physicians of London and the British Society of Gastroenterology
states that “current IVDUs should not be treated
although in selected cases ex-IVDUs taking regular oral methadone
may be considered for treatment” [45, p. i7]. The official
guidelines of the National Institute for Clinical Excellence states
that “treatment of people who continue to use drugs intravenously
is often not indicated due to the high probability of
reinfection, presumed likelihood of relatively high levels of noncompliance
and the possibility of drug interactions. Cessation
of intravenous drug use before starting antiviral treatment is
therefore important. Combination therapy is not contra-indicated
for former intravenous drug users whose drug use has
been stabilized on oral methadone or other products such as
buprenorphine” [46].

Scotland. The official guidelines of the Scottish Executive
states that “treatment is not recommended for drug users who
continue to inject, where drug interactions, compliance and the
possibility of reinfection are issues. This will need to be assessed
on a case-by-case basis” [47, p. 7]. Table 1 encapsulates the
findings described above.

CONCLUSION
This study was conducted to provide an overview on the guidelines
for treatment of chronic HCV infection in IDUs. Because
of the disabling potential of HCV infection and its high prevalence
among IDUs, it is considered to be a major burden to
both the public and the individual. Treatment guidelines have
an effect of allocation of resources and provision of therapy in
terms of finances, qualification, and outreach. Therefore
ment access is influenced by guidelines. Treatment guidelines
allowing for or even recommending treatment of a specific
disease can facilitate access to treatment [19, 20].

Data were gathered in Austria, Belgium, Denmark, Finland,
France, Germany, Italy, The Netherlands, Norway, Spain including
Catalonia, Sweden, and the United Kingdom (including
Scotland). Contacts were established in Greece, Ireland, Luxembourg,
and Portugal as well, but data quality and sources
remain unclear yet and are therefore not considered. According
to their quality level, guidelines were categorized into expert
opinions, semiofficial guidelines, official guidelines, and consensus
papers (table 1). Taking into account only guidelines
with the highest level, the EU and French guidelines met criteria
of consensus papers; in Austria, Belgium, Germany, Spain (including
the autonomous region of Catalonia), Sweden, and the
United Kingdom (including Scotland), guidelines met the criteria
of official guidelines; semiofficial guidelines were found
for Finland and Norway; and expert opinions were retrieved
in Denmark (P. Christensen, personal communication), Italy
(M. Strazzabosco and G. Rezza, personal communications), and
The Netherlands [22, 23, 26, 28, 29, 30, 33, 36, 41–43, 45–47].

Treatment of HCV infection in active IDUs is allowed under
specific circumstances according to the French consensus;
methadone maintenance was regarded as a treatment requirement
by the official guidelines of Austria and the United Kingdom
and the expert opinion from Finland (M. Fa¨rkkila¨ and
H. Nuutinen, personal communication) [23, 30, 45, 46]. Abstinence
was a pretreatment prerequisite in the EU consensus,
in the official guidelines of Germany, Sweden, Scotland, and
Catalonia, in the semiofficial guidelines of Finland and Norway,
and in the expert opinion of Denmark (P. B. Christensen, personal
communication) [22, 28, 29, 33, 36, 42, 43, 47]. Treatment
recommendations were lacking in the official guidelines from
Belgium and Spain as well as in the expert opinion from Italy
(M. Strazzabosco and G. Rezza, personal communications) [26,
41].

Treatment recommendations remain unclear in the expert
opinion from The Netherlands [35]. Publication dates of guidelines
vary from 1997 to 2003 and therefore cannot consider
the evidence published thereafter. Besides mentioned guidelines
which qualify for the highest level of quality in the respective
country, additional and more recent guidelines with a lower
level of quality exist in Austria, Belgium, Germany, and Spain.
Two of these guidelines [25, 34] are as restrictive as and 5 are
more permissive than the older and higher-level guidelines in
the respective country (U. Marcus, personal communication)
[24, 27, 39, 40]. Overall, treatment guidelines qualifying for a
higher quality level and/or published more recently are more
likely to allow for treatment of IDUs under specific conditions
and/or under methadone maintenance therapy (U. Marcus,
personal communication) [24, 27, 30, 39, 40]. First clinical
studies showing that treatment of HCV infection in IDUs is as
safe and effective as in non-IDUs [13–17] and that rates of
reinfection are not necessarily higher than in non-IDU populations
[18] may have contributed to this process. Generally,
it is desirable to implement a structured high-quality guideline
process in each country to improve acceptance. An update of
the EU consensus [22] would be helpful in establishing widely
accepted state-of-the-art guidelines. The problem of HCV infection
in IDUs is recognized in most EU countries. Guidelines
represent 1 component in enabling access to treatment, accompaniment
by implementation of outreach programs, qualification
of professionals, and adequate funding.

Full File, Source, links and more information in the attachment

HepatitisCVirusInfection

INHALTSVERZEICHNIS
1. Erhöhte Leberwerte……………………………………………………………………………………….1
2. Das ABC der Virushepatitis…………………………………………………………………………….1
3. Epidemiologie, Übertragung und natürlicher Verlauf der HCV-Infektion………………3
4. Therapie der Hepatitis C – Update 2009 …………………………………………………………..4
5. Therapie der Hepatitis C beim Drogenabhängigen …………………………………………….9
6. HCV-Therapie bei psychiatrischen Begleiterkrankungen …………………………………..10
7. Hepatitis C und Drogengebrauch – optimierte Patientenbetreuung durch
Netzwerke in Österreich……………………………………………………………………………….10
8. Das Schweizer Hepatitis Netzwerk…………………………………………………………………12
9. Hepatitis B, Übertragung, Prophylaxe und natürlicher Verlauf ……………………………13
10.Therapie der chronischen Hepatitis B …………………………………………………………….15
11.Chronische Hepatitis D…………………………………………………………………………………16
12.Koinfektion mit HBV und HCV bei HIV-infizierten Patienten……………………………….17
13.Hepathitis C – rechtliche Aspekte ………………………………………………………………….18
14.Interdisziplinäres Patientenmanagement –
ein Erfahrungsbericht vom Projekt „Interfall“ ……………………………………………………19
15.HCV-Therapie bei Drogenabhängigen –
Erfahrungen aus einer Schwerpunktpraxis………………………………………………………19
16.Frühintervention als Maßnahme der Hepatitis-C- Prävention bei
Drogengebrauchern …………………………………………………………………………………….20

Lest den ganzen Bericht, denn Wissen ist Macht:Syllabus_18.08.2009_neu

Und noch die Statistik der EU ueber europaeische IDU:stattab16-en

WASHINGTON — The FDA has approved a new sublingual film formulation of the opioid dependence treatment combination buprenorphrine/naloxone (Suboxone).

The new formulation will be released in the same 2 mg buprenorphrine/0.5 mg naloxone and 8 mg buprenorphrine/2 mg naloxone doses as the drug’s sublingual tablet form.

“During clinical tests, Suboxone sublingual film was shown to be faster dissolving than Suboxone sublingual tablets,” Shaun Thaxter, president of manufacturer Reckitt Benckiser Pharmaceuticals, said in a prepared statement.

Drug approval included a risk evaluation and mitigation strategy program, which requires the company to monitor patients to determine whether potential treatment benefits outweigh potential risks, especially with accidental overdose, misuse, and abuse of the film, the brief said.

The drug can be abused in ways similar to other opioids. Healthcare professionals should monitor patients for proper use, the company said in the statement.

Buprenorphrine reduces patient opioid cravings and withdrawal symptoms, and also blocks the effects of other opioids. Naloxone triggers withdrawal symptoms in patients who crush and inject the drug, but has limited bioavailability when taken sublingually, and should cause no adverse events.

Chronic use of the drug may result in physical dependence and a sudden or rapid decrease in dose may result in withdrawal symptoms, though the symptoms are milder and more delayed than those occurring with full opioid agonists, the brief said.

Patients taking the film, particularly if injected or through other improper means and with central nervous system depressants, may experience life-threatening respiratory depression or death. Healthcare professionals should consider a reduced dose of the central nervous system depressant, the combination, or both when prescribing buprenophrine/naloxone, the statement said.

Pediatric patients taking the drug may have severe, potentially fatal respiratory depression.

Those taking the film should have liver function monitored before and during drug treatment.

Patients who take the drug prior to use or abuse of other full agonists, such as heroin or oxycodone, may experience withdrawal symptoms due to interactions with the drug’s naloxone.

Healthcare professionals should only prescribe pregnant or nursing patients the drug combination if potential gain outweighs potential risk, due to possible neonatal withdrawal symptoms associated with the drug, according to the manufacturer.

The drug is contraindicated in patients hypersensitive to buprenophrine or naloxone.

Adverse events associated with the film include numb mouth, sore tongue, mouth redness, headache, nausea, vomiting, sweating, constipation, insomnia, pain, swelling of limbs, attention disturbance, palpitations, blurred vision, cytolytic hepatitis, jaundice, and anaphylactic shock.

We read of it nearly every day: Mexico appears to be imploding. Murders, assassinations of local politicians, kidnappings. A war between the drug cartels which acted with what appeared — from the outside at least — to be governmental neglect if not permission, and the presidency of Felipe Calderon who has taken them on. In August, 72 migrants were slaughtered, apparently by one or more drug cartels (a lone survivor said they identified themselves as the Zetas drug cartel) and President Calderon said “the drug gangs are carrying out more extortions and kidnappings of migrants as their resources and recruits dwindle.” He also said that government crackdowns on the cartels have significantly weakened them. Perhaps, but it appears to me that Mexico, with its dismal crime solution numbers — local populations do not even call the police — is on the verge of massive unrest if not open insurrection. This is a terrifying prospect to those unfortunate Mexican citizens who have to live with it, and it is to some extent, the fault of the United States. We are their customers, and we create the demand. In a country as economically deprived as Mexico, it is no surprise that “companies” — cartels — have sprung up to reap the rewards of the enormous profit in illegal drug sales.

I recently wrote about the prison industrial complex, and talked about the economic incentives to incarcerate, among other things. And there are economic incentives to make this “war” on drugs — there is profit in it for a lot of people. Have we learned nothing from our experiment with prohibition of alcohol? As Professor Duke tells us in his article about drug prohibition, what our government told us when it imposed drug prohibition isn’t true at all. In fact “most illegal recreational drugs have no pharmacological properties that produce violence or other criminal behavior. Heroin and marijuana diminish rather than increase aggressive behavior. Cocaine-or cocaine withdrawal-occasionally triggers violence but usually does not. Very little crime is generated by the mere use of these drugs, especially in comparison to alcohol, which is causally related to thousands of homicides and hundreds of thousands of assaults annually. The major linkages between illegal drugs and crime must be found elsewhere — in prohibition.” (From Volume 27 of the Connecticut Law Review)

When we banned the sale of alcohol during prohibition, there was anarchy in the streets, crime rose alarmingly, people drank anyway, and criminals made a fortune. That is what is happening now, on our streets where drugs are sold, in Mexico, and the halls of our high schools, and I fear our junior high schools too. Many terrorist organization function based on illegal drug trade profits. Drug prohibition hasn’t worked, will not work and is destroying us from within.

I am not alone in this view. The former president of Mexico, Vicente Fox, has spoken about it. So has a group of law enforcement officers: Law Enforcement Against Prohibition (LEAP). LEAP is an organization which, while it does not promote the use of drugs and is deeply concerned about the extent of drug abuse worldwide, is also deeply concerned with the destructive impact of violent drug gangs and cartels everywhere in the world. LEAP’s position is that neither problem is remedied by the current policy of drug prohibition. Indeed, drug abuse and gang violence flourish in a drug prohibition environment, just as they did during alcohol prohibition in the US.

I know that there are people reading this who may say to themselves that legalizing drugs puts the government’s stamp of approval on drug abuse, but that’s not true. Legalizing drugs will put the black market out of business; it will tax and regulate those drugs. We could funnel money from prohibition enforcement to treatment and use our law enforcement resources to solve other crimes.

And, frankly, I would prefer if it were as difficult for a ten-year-old child to purchase cocaine as it is a beer. At least she should have to have a fake ID and be able tall enough to reach over the counter

source: http://www.huffingtonpost.com/andrea-lyon/prohibition-and-civil-unr_b_701261.html

Objective: To present a summary of the existing literature on syringe exchange programs (SEPs) and to discuss the potential role of pharmacists in providing support for injection drug users (IDUs) and such programs.
Data sources: To identify relevant articles published since 2000, a search of PubMed and Medline was conducted using syringe exchange programs and needle exchange programs as search terms. A manual review of each article’s citation list was also conducted.
Data extraction: By the authors.
Data synthesis: Information is presented in four categories: state and federal support of SEPs, characteristics of SEP users, epidemiological studies, and social reluctance for SEP support. The information summarized in these sections is then used as a foundation for a review of the potential role of the pharmacist.
Conclusion: SEPs have demonstrated a clear effect in improving the health outcomes of IDUs by decreasing the transmission of blood-borne disease and lowering high-risk injecting behaviors. Despite conflicting support for SEPs at both the federal and local levels, pharmacists can play a pivotal role in the health of IDUs by providing sound medical advice and, in some states, acting as an alternative channel for obtaining clean syringes. Efforts should continue to focus on educating pharmacists about this role and how their individual actions can benefit the health of the entire population.

Introduction

Injection drug users (IDUs) represent a population that is disproportionately affected by the human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS), hepatitis B virus (HBV), and hepatitis C virus (HCV). In 2006, approximately 19% of all people living with HIV/AIDS acquired the virus through injection drug use. In that same year, 54% of people with confirmed HBV and approximately 50% of those with acute HCV reported injection drug use.[1] Because sharing of contaminated syringes is a major route of transmission for diseases such as these, providing access to and encouraging the use of sterile injection equipment is believed to be a central strategy in the effort to reduce the transmission of HIV and other blood-borne pathogens.[2] Based on the philosophy of harm reduction, syringe exchange programs (SEPs) allow IDUs to obtain sterile syringes and other injection equipment at little to no cost and to safely dispose of used injection equipment. Many of the programs require participants to exchange used syringes for sterile ones, which results in the safe disposal of used equipment and a reduction in the number of syringes disposed of improperly in the community. With the primary goal of reducing the spread of infectious disease among IDUs, their sexual partners and children, and the public at large, many national organizations and government bodies support the establishment of SEPs.[2,3] Specifically, the Centers for Disease Control and Prevention recommends that IDUs use a sterile syringe for each injection.[2] Another means to increasing access to clean equipment is the sale of syringes by pharmacists. Accordingly, pharmacists are presented with the opportunity to provide patient counseling or referrals to other health-related services and to help expand access to care and supplement the work of SEPs, particularly in areas in which SEPs have not been established.[4]

In the early 1980s, HBV and HCV rates among IDUs sparked concern among health care providers. The need for supplying sterile syringes to this patient population was first recognized during this period. However, it was not until the HIV/AIDS pandemic that the importance of these programs was accepted worldwide and the rapid establishment of SEPs began.[5] In the United States, the first SEPs were established in New York City (NYC), Oregon, San Francisco, and Washington in the late 1980s.[6] By 2005, 28 states had operating SEPs, for a total of 166 programs nationwide.[7] According to the North American Syringe Exchange Network (NASEN), at least 211 SEPs currently exist in 36 states and territories.[8] Table 1 shows the states with SEPs as publicly listed on the NASEN website.

Table 1. States with active syringe exchange programs[8]

Alaska District of Columbia Illinois Maine North Carolina Oregon Washington
Arizona Delaware Indiana Michigan New Jersey Pennsylvania Wisconsin
California Florida Louisiana Minnesota New Mexico Rhode Island
Colorado Georgia Massachusetts Missouri New York Texas
Connecticut Hawaii Maryland Montana Ohio Vermont

These states allowed the North American Syringe Exchange Network to list their contact information on its website.

The benefits of SEPs extend to both IDUs and other members of the community. Most importantly, SEPs protect the health of the public by reducing the spread of blood-borne infections, directly through decreased sharing of syringes or accidental contact with contaminated syringes by individuals in the community and indirectly through sexual contact. However, in addition to the exchange and safe disposal of used syringes and injection equipment, SEPs also offer a greater public health benefit by providing a range of additional services, including but not limited to health education and counseling; free sharps containers and condoms; on-site HIV testing and screening for HBV, HCV, and tuberculosis; referrals to substance abuse treatment; and other medical and social services.[3,6] These additional services are invaluable, especially in rural communities and for individuals with limited access to health care. Much debate and controversy surrounds the social policy of SEPs. Perceptions of the effectiveness, importance, and appropriateness of these programs vary among IDUs, health care professionals, and policy makers. In the United States, a ban preventing federal funding for SEPs was lifted in December 2009. This change may result in greater overall acceptance and support of the establishment of SEPs nationwide; however, this change may develop slowly and/or be met with resistance because of deep-rooted controversy and lack of awareness and education. Therefore, as health care professionals, pharmacists must remain aware of the evidence surrounding the effectiveness of SEPs. Evidence has demonstrated that SEPs are associated with declines in the incidence and prevalence of HIV, HBV, and HCV and of high-risk injecting behaviors (e.g., needle sharing between HIV-negative and -positive IDUs).[3,9]

Objective

The goal of the current work is to present a summary of the existing literature surrounding SEPs in the United States. This summary will address the outcomes of SEPs in the IDU population, including rates of disease transmission and injection risk behaviors. High-risk injection behaviors can include injecting with a used syringe, giving used syringes to other IDUs, sharing injection paraphernalia such as cotton or cookers, reusing a syringe more than once, or not bleaching a used syringe before injecting. We also address the potential role of pharmacists and how their support and work can further the public health benefits of SEPs. Because the success of SEPs depends in part on the sale of syringes by pharmacists—a considerable change in the practice of pharmacy—data addressing the personal beliefs of pharmacists regarding this policy are discussed. A review of past and current U.S. regulations and funding issues is also presented.

Search Strategy

PubMed and Medline were searched using the terms syringe exchange programs and needle exchange programs. The selection was restricted to English-language articles outlining the outcomes of SEPs in the United States after 2000. A total of 657 studies were identified. Articles were excluded if they focused on data from outside the United States, were restricted to SEPs in correctional facility populations, and did not specifically address the impact of SEPs or the role of pharmacists. All articles considered potentially applicable were reviewed by the authors independently before being included in the final review. As a result, 33 articles were identified for inclusion. A manual review of each article’s citation list was conducted to identify any other applicable articles. Additional articles were used to supplement these findings as appropriate.

State and Federal Support of SEPs

Despite the evidence supporting the public health benefit of SEPs, financial support for these programs varies on the federal and state levels. In 1988, a federal ban on funding for SEPs was enacted and has been subsequently restated and supported.[10] In 1998, this ban was nearly lifted by the Clinton Administration; however, the final outcome was to allow local communities to determine whether such programs should be instituted, and if so, funding had to be acquired from nonfederal sources.[10] Then, on December 13, 2009, Congress voted (57 to 35) in favor of ending the ban. The new bill, titled the Consolidated Appropriations Act of 2010, required an additional vote by the House of Representatives, which had previously passed the bill in July 2009. The updated bill, which passed the House on December 10, removed earlier provisions requiring a minimum distance of 1,000 feet between an SEP and any daycare, pool, school, playground, and youth center. With the distance requirement removed, the bill now allowed SEPs to exist in any location, as long as local public health or law enforcement authorities did not object to their placement. The act was signed into law by President Barack Obama on December 16, 2009.[12] The passing of the bill was a crucial development that will provide states and communities with the resources needed to ensure sufficient SEP coverage. Additionally, the act further supports the importance of pharmacists in taking a more active role in participating or providing education regarding syringe safety and exchange activities.[11–15]

Current Laws in Place

According to a review of 16 states, recommendations for the safe disposal of used syringes vary greatly and are derived from or regulated by a variety of agencies.[16] The review concluded that communities need to develop low-cost and easy-to-use systems by which IDUs can safely dispose of used syringes; developing SEPs was one suggestion for accomplishing this.[16]

The topic of SEPs highlights an unfortunate dichotomy in priorities for a government that seeks to curb illicit drug use but also supports the safe use of injectable drugs to prevent the spread of disease. These same issues exist on the state level, with conflicting priorities between public health departments and law enforcement agencies.[16] In 2002, 47 states had drug paraphernalia laws in place with criminal penalties for possessing or selling syringes for the purpose of injection drug use.[16,17] These laws may impose penalties for the sale, distribution, or possession of syringes and as a result may promote fear of arrest and criminal punishment among IDUs.[17] This may cause IDUs to be reluctant to store used syringes for future disposal at an SEP.[16] As of 2008, eight states had syringe prescription laws that prohibited the dispensing or possession of syringes without a valid medical prescription.[18] A total of 21 states had pharmacy regulations or practice guidelines regulating the sale of syringes.[18] The current work demonstrates the varied degrees of support for SEPs at both the state and federal levels.

Characteristics of SEP Users

Studies have indicated that participants of SEPs have higher rates of injection frequency, unemployment, jail time, homelessness, cigarette use, and alcohol use compared with IDUs who do not participate in SEPs. This suggests that IDUs who participate in SEPs represent a distinct and higher-risk sub-population of injectors.[19] Numerous studies have shown that, in general, minority men represent the largest portion of participants of SEPs.[4,9,19] Data also reveal that women are underrepresented among SEP participants, as the majority of studies of SEP clients evaluate predominantly male populations.[9,20]

As one of the largest SEPs in the United States, the Chicago Recovery Alliance (CRA) found that considerable variation existed in terms of participant demographics by geographic location and hours of operation among its multiple sites throughout the city. During a 4-year period (1994–1998), a total of 11,855 IDUs, with a median age of 41 years and the majority being men (73.5%), visited CRA at least once. One-half (50%) of the participants during this time were black, 37.6% white, 10.3% Puerto Rican, and 2.2% “other” (Latin American or Native American). When analyzed in terms of geographic location, results revealed that younger (<30 years), white, and Puerto Rican IDUs were attracted to certain sites, whereas older participants (>30 years), who tended to be black, were attracted to others. At the time of the study, CRA had nine sites that were open only during the daytime and participants were predominately black (60.9%) and the proportion of participants 30 years or younger was less than 9.8%. In contrast, for the 10 sites that were open only at night, participants were predominately white (46.2%) and Puerto Rican (32.2%) and the proportion of participants 30 years or younger was 21.9%. Results also revealed that women tended to frequent sites that were open both during the day and at night.[9]

The findings discussed above indicate that SEPs do not attract all types of IDUs; a subset of the population might prefer not to participate in or does not have access to SEPs. For these individuals, obtaining clean syringes through other channels may be challenging. As noted previously, some states permit the sale of syringes by pharmacists without a legal prescription. Although a portion of the population will purchase syringes for medical reasons such as diabetes, we focus specifically on the impact of syringe sales by pharmacists in the IDU population. According to a small study of 62 individuals purchasing nonprescription syringes at pharmacies in NYC and Albany, NY, 74% of participants reported purchasing syringes for injection drug use and 36% for medical use. Additionally, participants who purchased for drug use were significantly more likely to be black or Hispanic than to be white (P < 0.001). Regarding injection practice, 60% of participants reported reusing the same syringe, 26% had shared syringes in their lifetime, and 10% had shared syringes in the previous month. No differences were observed in sharing or reuse of syringes by race/ethnicity, gender, or age.[4] The study showed that sharing and reuse of syringes is a common practice among all IDUs, regardless of demographics.

With varying characteristics among IDUs and, as evidence has shown, among IDUs who participate in SEPs, pharmacists have a valuable role in their communities. One-on-one and telephone interactions with IDUs and their family members provide pharmacists with opportunities to help and support both patients and SEPs. Awareness of provided services and hours of operations of local SEPs allows pharmacists to refer patients appropriately. In addition, pharmacists may be able to provide feedback and/or information regarding unmet needs of the community directly to SEPs. For pharmacists practicing in states that do not permit the sale of syringes at a pharmacy, becoming familiar with these programs and building relationships with them is equally important.

Epidemiological Studies

The main goal of SEPs is to decrease the incidence of blood-borne diseases such as HIV, HBV, and HCV. As mentioned previously, SEPs represent a method for achieving this goal by decreasing the circulation of contaminated syringes in and beyond the IDU community.[21] Numerous studies have examined the impact of SEPs on a variety of endpoints, and the most recent and clinically relevant studies are reviewed below. Specific endpoints examined include seroconversion rates of HIV, HBV, and HCV, high-risk behavior among IDUs, and how these differ between SEP and non-SEP users.

Impact of SEPs on HIV, HBV, and HCV Transmission Rates

A large number of studies have examined the correlation between HIV and, to a lesser extent, HBV and HCV infection rates and SEPs. Although some of these studies have found a lower risk of infection transmission in SEP participants, results from other studies have reported either a negative effect or no effect. A 1995 study by Hagan et al.[22] found that not participating in an SEP led to a five times greater risk of HBV infection and a seven times greater risk of HCV infection. In a literature review article, Gibson et al.[23] examined 42 studies from 1989 to 1999 that evaluated the effectiveness of SEPs. Although the focus of their review was the United States, it also contained data from Canada, the United Kingdom, and the Netherlands. Of these 42 studies, 28 found a positive effect of SEPs on HIV risk behavior and seroconversion, 2 found a negative association, and 14 found either no difference or a mix of positive and negative effects. It has been hypothesized that these 14 studies failed to find an association as a result of dilution or selection bias.[23] These two types of bias are a common occurrence in SEP studies. Dilution bias arises when both the SEP and non-SEP IDU population have equivalent access to sterile syringes. This bias has been seen in studies conducted in cities where non-SEP IDUs had access to sterile syringes through the legal sale by a pharmacist or as a result of IDUs participating in an SEP that provides them with sterile syringes.

Conversely, selection bias relates to the observed phenomenon that SEP IDUs tend to be less socially integrated and more prone to excessively high baseline risk behaviors, therefore creating a disproportionate concentration of high-risk IDUs among SEP users.[24] This bias was reported in a study by Riley et al.[25] that compared the characteristics of IDUs using standalone SEPs with those using pharmacy-based SEPs. Standalone SEPs attracted a greater majority of high-frequency injection users. Hagan et al.[26] also explored this phenomenon of selection bias by examining the characteristics of an IDU cohort (n = 2,027) that began or stopped participating in a Seattle SEP during a 12-month period. The study reported that IDUs with certain high-risk characteristics such as daily injection (risk ratio 1.6 [95% CI 1.1–2.1]), injecting with heroin (1.8 [1.2–2.7]), syringe sharing (1.5 [1.1–2.1]), and backloading (i.e., practice of squirting drug solution from one syringe to another; 1.6 [1.1–2.1]) were more likely to initiate SEP use and that these same characteristics also made it more likely to continue the use of SEP services. The authors concluded that the SEP examined tended to attract IDUs who had a much higher baseline risk for blood-borne infections and that IDUs who stopped frequenting the SEP included a large number who were at low risk. Fischer et al.[27] further examined selection bias in a study that assigned IDUs (n = 600) to either an Alaskan SEP or a pharmacy for syringe purchase. The results demonstrated that IDUs who were assigned to and used the SEP tended to have a higher injection frequency and were also more likely to have shared injection paraphernalia. Both of these characteristics placed the SEP IDUs at higher risk for blood-borne infections.

If either or both of these biases are present, the study results will tend to be skewed away from supporting an association between SEP use and a decrease in transmission rates. An example of this is a study by Holtzman et al.[28] that examined the effect of SEP participation on high-risk injection behavior and HCV infection rates. Data were collected from two observational cohort studies and one randomized behavioral intervention trial from 1993 to 2004. The study reported that of the entire population (n = 4,663), approximately 46% reported SEP participation. When HCV infection rates were examined, no significant associations between SEP participation and infection rates were found. From the pool of patients who tested negative for HCV at baseline (n = 1,288), 12% became positive at the 3-, 6-, or 12-month follow-up period. The authors attributed the lack of an association between SEP use and a decrease in the HCV infection rates to both dilution and selection bias.[28]

In contrast, Neaigus et al.[29] reported a positive benefit of SEPs and pharmacy syringe sales on HIV, HBV, and HCV rates. The study examined the effect of legal SEPs and syringe pharmacy sales in NYC compared with Newark, NJ, where, during the study period, distributing syringes for drug injection was illegal. The rates of HIV (26.1% vs. 5.2%; adjusted odds ratio [AOR] 3.2 [95% CI 1.6–6.1], P = 0.0007), HBV (69.6% vs. 27.1%; 4.4 [2.8–6.9], P < 0.0001), and HVC (82.4% vs. 53.4%; 3.0 [1.8–4.9], P < 0.0001) were significantly higher in the New Jersey (n = 214) than in the NYC (n = 312) population. Additionally, only 4.7% of New Jersey participants reported obtaining syringes from a legal source compared with 92.6% of NYC IDUs. This trend continued, as New Jersey residents were also twice as likely to inject with a used syringe (19.2% vs. 8%; 2.32 [1.07–5.04]) and three times as likely to reuse their own syringe (37.9% vs. 13.5%; 2.99 [1.63–5.50]). New Jersey IDUs also were more than five times as likely to inject multiple times with the same syringe if it was new and sealed (5.43 [2.86–10.30]). The study demonstrated the positive health implications that legal SEPs and legal pharmacy syringe sales can have on transmission rates of HIV, HBV, and HCV and on syringe-sharing behaviors.

Effect of SEPs on IDU Behavior

The impact of SEP participation on IDU behavior has also been examined. Reducing high-risk behaviors is often thought to lead to the SEP’s protective effect rather than the SEP participation itself.[28] As demonstrated previously, the majority of IDUs who participate in SEPs tend to have a higher number of injections per day and higher baseline risk behaviors than IDUs who do not use SEPs. This is thought to be partly a result of SEP participants being less socially integrated than their non-SEP counterparts.[28] However, the results of these studies have shown that SEP participants share syringes and other drug paraphernalia less frequently than their non-SEP counterparts. The study by Gibson et al.[23] reinforces this viewpoint, as the review also found that not only were SEPs associated with a decrease in transmission rates but also in preventing behaviors associated with a higher risk of HIV transmission. Results from a study conducted by Longshore et al.[30] among IDUs in Providence, RI, who attended an SEP (n = 248) also reinforce a decreased risk in the sharing of syringes and other injection equipment with an increased frequency of visits to an SEP. The study demonstrated that lower frequency of SEP attendance was associated with a greater likelihood of syringe sharing, as indicated by the AOR for IDUs attending two to four times per month (2.04, P = 0.02) and for those attending no more than once per month (3.20, P = 0.01). Regarding the sharing of injection equipment, the results demonstrated that lower frequency of SEP attendance was associated with a greater likelihood of sharing cookers (IDUs attending two to four times per month: AOR 2.00, P = 0.02; IDUs attending no more than once per month: AOR 2.55, P = 0.04).[30]

In addition to examining HCV rates, Holtzman et al.[28] examined the effect of SEP participation on high-risk injection behavior. The study reported a significant correlation between more recent SEP participation and daily injection drug use among IDUs. However, this same IDU population, despite injecting more frequently, was significantly less likely to share syringes (AOR 0.77 [95% CI 0.67–0.88]) compared with non-SEP IDUs.

Regarding younger IDUs, Bailey et al.[31] surveyed 700 IDUs aged 18 to 30 years from 1997 to 1999. The majority of participants were younger than 26 years (64%), and almost two-thirds (65%) had not used an SEP in the 6 months before baseline. Additionally, on average, only 13% had used an SEP more than once per month. The study assessed risk factors based on the frequency of SEP visits (no visits, one to six visits, or seven or more visits). Participants who had visited SEPs seven times or more had the highest injection frequency rate (AOR 2.88 [95% CI 1.69–4.91], P < 0.001) but also the highest percent of not sharing syringes (0.32 [0.19–0.54], P < 0.001). This high–SEP use group was also the most likely to inject only once per syringe (0.25 [0.13–0.45], P < 0.001) and the least likely to share various injection paraphernalia such as cookers and cotton (0.51 [0.30–0.85], P = 0.013) and to backload (0.39 [0.19–0.81], P = 0.21). Finally, IDUs with the highest SEP use were also the most likely to use condoms with both regular and casual sex partners; however, only the regular partners comparison was significant (2.95 [1.56–5.56], P = 0.001). This study further reinforces the trend that although SEP users have a tendency to inject more frequently than those with less SEP frequency, overall they exhibit less high-risk drug behavior. However, the study also exposed a particular subgroup of IDUs who did not appear to use SEPs to a great extent (i.e., those aged 18–30 years).

Huo and Ouellet[32] also reported an observed decrease in injection risk behaviors for SEP users in a Chicago IDU population (n = 901). Compared with non-SEP users, IDUs who frequented SEPs injected drugs more frequently and were more likely to be HIV positive; however, this was expected because the SEP was located in an area with the highest HIV prevalence. However, the results of the study demonstrated that relative to non-SEP users, SEP-using IDUs were less likely to share syringes (odds ratio [OR] 0.33 [95% CI 0.23–0.46]), lend a used syringe (0.55 [0.41–0.75]), share other drug paraphernalia like cotton filters and cookers (0.70 [0.52–0.95]), and reuse their own syringes (0.18 [0.10–0.30]) and more likely to bleach syringes used by others before injecting (2.28 [1.37–3.80]). Additional evidence from a cohort study by Hagan and Thiede[33] and a meta-analysis by Ksobiech[34] also reported that IDUs who used an SEP were less likely to inject with a used syringe than non–SEP-using IDUs.

Gibson et al.[35] followed 338 IDUs and examined the effect of SEP participation on HIV risk behavior. Follow-up interview time from baseline was 10.7 months. At baseline, 31% and 33% of all participants reported using SEPs and having a high risk, respectively. IDUs were determined to be low risk if they only used unsterilized syringes with a regular sex partner they believed was HIV negative or if they bleached used syringes before injecting with them. High-risk IDUs were those who shared syringes with nonregular sex partners or with a regular partner whose HIV status was unknown or positive. The study evaluated whether SEP participation provided any protective benefit against HIV risk behavior. The results of the study showed that no significant difference existed in frequency of injections per month between IDUs who used and did not use SEPs. However, borrowing sterile (27% vs. 50%) or unsterile (17% vs. 35%) syringes occurred significantly less frequently in SEP users. Additionally, the rate of high-risk behavior was also significantly higher in the non-SEP group (12% vs. 24%). It was also shown that SEP use provided a more than twofold protective effect on HIV risk behavior (OR 0.45 [95% CI 0.21–0.92]). When access to other sources of syringes was evaluated along with SEP access, the odds of HIV risk behavior decreased sixfold if IDUs did not have syringe access beyond SEPs. The study once again demonstrated the evident protective effect of SEPs on HIV infection prevention.

Bluthenthal et al.[36] examined the effect of SEPs on 340 high-risk IDUs from 1992 to 1996. All patients reported sharing syringes at baseline. The study then followed these participants after the opening of an SEP in their community, and the results were based on two follow-up interviews 6 months apart. Overall, 60% (204 of 340) of the participants at follow-up reported that they had quit sharing syringes. Starting and continuing SEP participation was associated with syringe-sharing cessation. Patients who had steady sex partners who were also IDUs were found to be less likely to stop sharing syringes compared with those who did not have steady sex partners (52.1% vs. 67.2%). Furthermore, to determine whether SEP participation was independently associated with syringe-sharing cessation, the authors conducted a multivariate analysis that controlled for a number of variables (e.g., total number of interviews, age, presence of a steady sex partner). The results of the study demonstrated that IDUs who started SEP use (AOR 2.68 [95% CI 1.35–5.33], P = 0.005) and IDUs who continued SEP use (1.98 [1.05–3.75], P = 0.003) were both associated with ceasing syringe sharing, but independently of each other. The study further highlights the positive benefit of SEPs on syringe sharing.

Huo and Ouellet[37] studied the positive effect of SEPs on injection behavior and high-risk sexual behavior. Their study examined the impact of SEPs on IDU sexual risk behaviors in 889 IDUs in Chicago between 1997 and 2000. Of participants, 717 used SEPs. The study examined three aspects of sexual risk behaviors: number of partners, frequency of condom use, and number of unprotected sex acts. Patients were interviewed at baseline with three additional annual follow-up visits. The results of the study showed that no difference occurred in the number of sexual partners between the two study groups across time (P = 0.40). The number of unprotected sex acts also was not different between the two groups at baseline; however, the number decreased by 26% per year in the SEP group and only 10% in the non-SEP group (P = 0.02). Additionally, SEP users were more likely to use condoms consistently with their main partners (P = 0.001). However, no difference between the two groups was reported in condom use with casual or commercial sex partners. The study concluded that use of SEPs may encourage less high-risk sexual behavior, which in turn could lead to a decrease in blood-borne viral transmission.

Results from the studies discussed above demonstrate the significant amount of evidence supporting the positive health aspects of SEPs; however, the location of an SEP and whether it affects the overall health benefits achieved has not been addressed. Hospital-based SEPs are common in countries such as Canada and the United Kingdom but are not widespread in the United States. This type of SEP would be advantageous because IDUs tend to frequent hospital emergency departments for their regular source of care, which is extremely costly. A randomized-controlled trial by Masson et al.[38] examined this specific topic. The study compared the effectiveness of hospital- and community-based SEPs on IDU health status and injection practices. The study enrolled 166 people during a 2-year period. Patients were randomly assigned to receive syringes from either hospital- or community-based SEPs, with follow-up assessments at 6 and 12 months. The study reported that SEP location had no significant effect on either injection behaviors or health status. However, both groups reported a decrease in high-risk behavior and an improvement in overall physical health. Additionally, IDUs assigned to the hospital SEP had 83% more inpatient admissions and 22% more ambulatory care visits than those in the community SEPs. The study demonstrated that the location of an SEP did not lead to a difference in reducing high-risk injection behavior; however, hospital-based SEPs had the additional advantage of providing easy access to outpatient care services for IDUs.

Sustainability of the Effects of SEPs

The current work provides considerable clinical evidence demonstrating the positive effect of SEPs on high-risk injecting behavior and transmission rates. However, little evidence exists indicating whether this positive SEP effect can be sustained over time. Braine et al.[39] interviewed IDUs at the Tacoma Syringe Exchange Program in 1997 (n = 197) and again in 2001 (n = 326). The study examined change in injection risk behavior of SEP participants over time. The authors found that in 1997, 987,000 syringes were exchanged and, by 2001, the total had increased to 1.44 million. The frequency of injections per day did not change significantly over time, with the majority of patients in both periods injecting two or more times per day (54%, 1997; 65%, 2001). Change in injection risk behaviors was also examined during the 4 study years. These behaviors included backloading with used syringes, giving a used syringe to someone else, and self-injection with a known used syringe. For all three behaviors, the frequency of backloading (18% vs. 22%), giving a used syringe (23% vs. 30%), and injecting with a used syringe (23% vs. 27%) did not significantly decrease from 1997 to 2001. Factors that affected injecting with a used syringe in both time periods included having depressive symptoms 30 days before the study interview and the combination of being younger than 35 years and coinjecting with amphetamines. Other factors that affected used syringe sharing changed from year to year. In 1997, more women shared syringes than men, but by 2001 this trend had reversed. Finally, the researchers examined the HIV incidence rate in 12 new injectors who had been IDUs for 5 years or less. They found that none of the 12 IDUs were HIV positive. Although injection risk behavior did not decrease over time, the study demonstrated that injection risk behavior among Tacoma Syringe Exchange Program participants remained stable from 1997 to 2001. Additionally, the frequency of injection did not increase significantly during the period of study. This demonstrates the sustainability of the impact of SEPs and again reinforces the benefit of SEPs in the IDU population.

Although IDUs who frequent SEPs tend to have a higher injection rate frequency, these programs also lead to a substantial decrease in high-risk drug behavior among participants. IDUs who participate in SEPs also exhibit safer sex practices. Further, some studies have shown that SEP participants have lower rates of HIV, HCV, and HBV. However, a considerable number of barriers regarding SEPs and IDUs remain. As seen in the study by Bailey et al.,[31] the percent of young IDUs who used SEPs was very low. This appears to be a segment of the IDU population in which additional education and outreach on the benefits of SEPs are needed. Additionally, the potential benefit of SEPs that are integrated in the hospital setting represents another avenue that should be further examined. It is common for IDUs to use the emergency department as their primary source of care. Given that this population tends to have a number of chronic medical conditions, having access to inpatient care, along with access to SEPs, would be beneficial in the long term as well. Finally, legal issues surrounding SEPs in the United States, as well as support at the state level, also play a major role in decreasing transmission and high-risk behavior.

Social Reluctance for SEP Support

With the relatively low number of SEPs currently operating in the United States and conflicting support at both the state and federal levels, considering available alternatives for IDUs is important. Without SEPs, IDUs could obtain syringes either through unauthorized channels or at the pharmacy, with or without a prescription depending on state regulations.[40] As previously described, state laws differ in view on the over-the-counter sale of syringes to IDUs in pharmacies.[17] Although this may not be an option in all places, pharmacies provide an ideal setting for this method of distribution for several reasons, including convenient location in the community, counseling and referral to additional resources by pharmacists when necessary, and protection of IDUs’ privacy if they are unwilling to identify themselves through use of an SEP.[40,41]

Research on pharmacists’ personal beliefs regarding SEPs is limited; however, reports of their personal beliefs on the sale of syringes at the pharmacy are readily available. Looking specifically at the legality of selling syringes, many pharmacists are uncertain how to interpret laws and policies. In many states, the laws and pharmacy regulations may not provide pharmacists with clear answers regarding the legality of the sale of syringes. Many of these laws and regulations allow the sale of syringes for a legitimate medical purpose, but that is another concept that is loosely defined and open to interpretation.[42] For example, some individuals may feel that distributing clean needles to prevent the spread of disease is a legitimate medical purpose, whereas others may feel that it simply furthers drug abuse. Regardless of state laws or regulations or how pharmacists interpret them, for the sale of syringes to IDUs, the final decision to sell belongs to the individual pharmacist. Although often a controversial topic, it has been shown that this decision is greatly dependent on the beliefs and perceptions of the individual pharmacist.[41,43–46]

Surveys have been conducted to better identify specific barriers that would deter a pharmacist from making this type of sale. Several structural and individual barriers that prevent pharmacists from selling syringes to IDUs have been reported. A qualitative study conducted among a sample of pharmacists from Atlanta, GA, sought to identify and classify some of these barriers.[41] The analysis found that pharmacists’ concerns and hesitations to sell syringes could be categorized into three groups: personal attitudes and beliefs about drug users and HIV/AIDS, concerns about deception, and concerns about legality. Pharmacists who viewed drug addiction as a personal choice and a matter of personal responsibility were less likely to sell syringes to an IDU. Some pharmacists were hesitant to sell syringes to IDUs because of their concern that the syringes would not be disposed of properly and might be found in the community. However, individuals who viewed access to sterile syringes as a strategy to prevent HIV were more willing to sell syringes to IDUs. For some pharmacists, the hesitation to make such a sale was based on the discomfort that comes with being lied to. Some pharmacists reported that they were more willing to sell syringes if the individual was honest about how they were going to use them. Most of the pharmacists surveyed admitted having a limited knowledge of the state laws and board of pharmacy regulations that governed the sale of syringes without a prescription. Among those that were aware of these laws and regulations, the interpretation varied greatly. This demonstrates that in addition to the conflicting levels of support among state and federal organizations, understanding of the issue on the individual level varies considerably.

Another analysis compared the opinions of pharmacists in rural versus urban locations in and between four states (Colorado, Connecticut, Kentucky, and Missouri).[43] The analysis demonstrated that individual opinions vary not just from state to state but also based on the location of the pharmacy and the population that the pharmacy serves. The results demonstrated that location can play a substantial role in pharmacists’ decision to sell syringes to IDUs depending on the important issues in that particular region. For example, pharmacists located in areas where production and abuse of methamphetamine are common were less likely to sell syringes to IDUs. These pharmacists reported that in their community, fighting this rampant drug abuse was more important than preventing the spread of blood-borne disease.

Discussion: Roles for Pharmacists

Several barriers exist surrounding pharmacist acceptance of the value of increasing syringe access in the IDU population; however, the role of the pharmacist is an important element of combating the spread of blood-borne viruses and infections in the IDU population. Therefore, it is important to examine steps that can be taken at the pharmacy level to change these negative perceptions and encourage a proactive view for the pharmacist when dealing with IDUs seeking sterile syringes.

Pharmacists have the potential to play a key role in preventing the transmission of major blood-borne viruses in the IDU population through the provision of sterile syringes and injection equipment, patient counseling (e.g., substance abuse treatment, safe injecting practices, safe disposal practices, safe sex practices), and support of local SEPs.[47] The sale of syringes by pharmacists supplements the work of SEPs by operating in locations that lack SEPs, operating during hours during which SEPs might be closed, and appealing to a subpopulation of IDUs who may be less likely to participate in SEPs. Despite the benefits of supplemental syringe access at the pharmacy level, data from a study among IDUs in Harlem and the Bronx, NY, demonstrate that even with pharmacy-based expanded access to syringes, SEPs remained the most frequently used source of syringes.[48] This further emphasizes the importance of the support needed for SEPs from other health care professionals, including pharmacists.

Surveys of various populations of pharmacists regarding their attitudes about selling syringes without a prescription to IDUs have repeatedly highlighted that, as a result of both individual and structural barriers, pharmacists can be divided into three groups: one that strongly favors the sale of syringes, a second that strongly opposes such sales, and a third that is unsure.[41,43,44,47] Individual barriers included pharmacists’ personal attitudes and beliefs about drug abuse and HIV/AIDS and concerns of deception. Structural barriers included state laws and regulations that addressed the sale of syringes without a prescription, as well as pharmacy regulations and practice guidelines.[41] Because pharmacies represent an important and convenient alternative to SEPs for IDUs to obtain sterile syringes, examining how some of these barriers can be addressed is necessary.

Many of the personal barriers that were identified may be related to misconceptions that can be changed by exposing pharmacists to additional education surrounding the issue. Although changing state laws and regulations regarding the sale of syringes may not be possible, current laws and regulations can be clarified and education on their proper interpretation can be provided. The ultimate decision to sell syringes without a prescription belongs to the individual pharmacist. Unfortunately, pharmacists may be reluctant to perform the sale simply because they do not truly understand the proper interpretation of laws, regulations, and policies.[49] Outreach efforts to educate pharmacists on these laws and regulations can help ensure that they have a similar understanding of the meaning of the laws and regulations for their specific state(s) and are better informed in making a decision on performing the sale of a syringe without a prescription. In addition, this also lends to a more consistent practice among pharmacists regarding the sale of syringes. Increasing educational efforts targeted at these issues could increase pharmacists’ willingness to sell syringes to IDUs and their willingness to support and participate in SEPs.

Education of pharmacists is particularly important when laws and regulations change. After syringe sales were deregulated in four states (Minnesota, New Mexico, New York, and Washington), outreach efforts were made to inform and promote the acceptance of the new laws among both the IDU and pharmacy communities.[47] One study conducted in New Mexico found that pharmacists were generally not well informed about recent changes in pharmacy laws or about SEPs. The study concluded that an educational outreach supported by the department of health was well received and that similar programs in other states may be beneficial to help increase pharmacist knowledge and acceptance of the issues surrounding increased access to clean syringes for IDUs.[50] Sustained promotional efforts may be necessary, as the reluctance to sell syringes to IDUs and to buy them from pharmacies is rooted in decades of laws and regulations.[47]

Conclusion

The IDU population has a greater risk of contracting bloodborne diseases such as HIV, HCV, and HBV through the sharing and reuse of syringes. Ensuring that IDUs have access to sterile syringes can help reduce this risk and the corresponding risk of spreading diseases to others. SEPs have demonstrated a clear effect in improving the health outcomes of IDUs. Opponents of SEPs believe that such programs imply societal condoning of illicit drug use. However, many IDUs either will not stop injecting drugs or cannot get into substance abuse treatment programs; therefore, the need to provide IDUs with this support is crucial for them and for the public at large. SEPs have demonstrated a clear effect in improving the health outcomes of IDUs, which ultimately benefits overall public health. Participation in SEPs has been shown to decrease the transmission of blood-borne disease and high-risk injecting behaviors. In addition to SEPs, in some states, IDUs have the option of purchasing syringes without a prescription. Although pharmacists play a pivotal role in the health of IDUs by providing an alternative channel for obtaining clean syringes, acknowledging that they can play a pivotal role simply by being aware of and supporting active SEPs is important. Pharmacists are knowledgeable and accessible sources of health information and can counsel IDUs regarding syringe access and disposal and addiction treatment programs. Therefore, pharmacists should be aware of SEPs in their community and provide the appropriate information to IDUs when requested.

Efforts are needed to educate pharmacists about their roles in syringe access and how their actions can benefit the health of the entire population. Concerns or misconceptions that pharmacists have about IDUs, SEPs, blood-borne diseases, and the interpretation of state and federal laws regarding syringe sales must be addressed. Providing this education will help increase pharmacist participation in this crucial public health activity.

Sidebar

At a Glance

Synopsis: The current work provides a summary of the literature on syringe exchange programs (SEPs) and discusses roles for pharmacists in providing support for injection drug users (IDUs) and SEPs. IDUs have an increased risk of contracting blood-borne diseases such as human immunodeficiency virus, hepatitis B virus, and hepatitis C virus through the sharing and reuse of syringes. Ensuring that IDUs have access to sterile syringes can help reduce this risk and the risk of spreading diseases to others. SEPs have demonstrated a clear effect in improving the health outcomes of IDUs. Because pharmacists are knowledgeable and accessible sources of health information and can counsel IDUs regarding syringe access and disposal and addiction treatment programs, they should be aware of operating SEPs in their community and provide the appropriate information to IDUs when requested.

Analysis: Although IDUs who frequent SEPs tend to have a higher injection rate frequency, these programs also lead to a considerable decrease in the highrisk drug behavior of participants. The ultimate decision to sell syringes without a prescription belongs to the individual pharmacist; however, pharmacists may be reluctant to perform the sale because they lack a complete understanding of the proper interpretation of laws, regulations, and policies. Increasing educational efforts targeted at these issues could increase pharmacists’ willingness to sell syringes to IDUs and their willingness to support and participate in SEPs.

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To the Editor: Beyond numerous studies examining suicide attempts and completions, the examination of broader types of self-harm behavior among various clinical samples has been fairly limited (eg, eating disorders,1 gastric bypass patients2). In this regard, we are aware of no studies examining various self-harm behaviors in patients seeking buprenorphine treatment—the focus of this study.
Method. The study was conducted from October 2006 to August 2008. Participants were men and women, aged 18 years or older, who presented for admission to a subacute detoxification unit (eg, 24-hour care facility) for opioid dependence in which buprenorphine is the standardized treatment. Exclusion criteria were cognitive (eg, delirium), medical (eg, acute withdrawal), or psychiatric (eg, psychosis) impairment that would preclude the successful completion of a survey booklet; these were assessed by the recruiter (P.W.). A total of 117 consecutive candidates were approached; 112 agreed to participate, for a response rate of 95.7%.
Of the 112 respondents, 53.6% were male and 46.4% were female, ranging in age from 18 to 59 years (mean = 32.9, SD = 9.1). Most participants were white/Caucasian (92.0%); 4 participants were African American, 3 Hispanic, 1 Asian, and 1 Native American. With regard to educational attainment, 85.7% had at least graduated high school; 9.8% had earned a college degree.
All participants completed a 5-page research booklet, which took about 15 minutes. The cover page of the research booklet contained the elements of informed consent, and completion of the research booklet was assumed to be implied consent for participation. After providing demographic information (eg, age, sex, race/ethnicity, marital status, education), respondents completed the Self-Harm Inventory,3 a 22-item, yes/no, self-report measure. Each item in the inventory is preceded by the statement, “Have you ever intentionally, or on purpose,…” Individual items include, “overdosed,” “cut yourself on purpose,” “burned yourself on purpose,” and “hit yourself.” Each endorsement is in the pathologic direction. The Institutional Review Boards of the community hospital and local university approved this project.
Results. The response profile of participants is shown in Table 1. As expected, the abuse of prescription medications (87%) and alcohol (71%) was very prevalent. In addition, nearly one-third of participants acknowledged either suicide attempts or intentional overdoses. Other intentional self-defeating behaviors in which at least one-quarter of the respondents reported having engaged included sexual promiscuity, losing a job on purpose, torturing oneself with self-defeating thoughts, distancing oneself from God, head-banging, setting oneself up in a relationship to be rejected, hitting oneself, cutting oneself, and making medical situations worse.

Table 1
Table 1

Lifetime Self-Harm Behaviors Reported by Patients in a Buprenorphine Treatment Program (N = 112)
In previous analyses of this study population, we confirmed high rates of borderline personality disorder4 and childhood trauma.5 These variables are likely to be partially mediating the notably high rates of self-harm behavior that we observed in this study population of patients in treatment with buprenorphine.
The limitations of this study include the small sample size, self-report nature of the data, and limited ability to generalize the data to other types of populations. However, this is the only study of which we are aware that has examined broad self-harm behaviors in an opioid-dependent population; findings indicate notable rates.
REFERENCES
1. Sansone RA, Levitt JL. The prevalence of self-harm behavior among those with eating disorders. In: Levitt JL, Sansone RA, Cohen L, editors. Self-Harm Behavior and Eating Disorders: Dynamics, Assessment and Treatment. New York, NY: Brunner-Routledge; 2004. pp. 3–13.
2. Sansone RA, Wiederman MW, Schumacher DF, et al. The prevalence of self-harm behaviors among a sample of gastric surgery candidates. J Psychosom Res. 2008;65(5):441–444. [PubMed]
3. Sansone RA, Wiederman MW, Sansone LA. The Self-Harm Inventory (SHI): development of a scale for identifying self-destructive behaviors and borderline personality disorder. J Clin Psychol. 1998;54(7):973–983. [PubMed]
4. Sansone RA, Whitecar P, Wiederman MW. The prevalence of borderline personality among buprenorphine patients. Int J Psychiatry Med. 2008;38(2):217–226. [PubMed]
5. Sansone RA, Whitecar P, Wiederman MW. The prevalence of childhood trauma among those seeking buprenorphine treatment. J Addict Dis. 2009;28(1):64–67. [PubMed]

A new list of Interactions between Methadone and HIV Medications, Tuberculosis Medications, Other Infections, Antidepressants, Antipsychotics, Anxiolytics, Anticonvulsants and Psychostimulant Medications

PCSS-M_Methadone_drug_interactions_updated_07.2010

What Britain could learn from Portugal’s drugs policy

A decade ago Portugal took a radical new approach to illegal drugs by treating users as people with social problems rather than as criminals. Could it work in the UK?


  • A cannabis smoker in Porto, Portulgal, during a march in favour of legalising drugs
  • A cannabis smoker in Porto, Portugal, during a march in favour of legalising drugs Photograph: Estela Silva/EPASusannah is being treated in the physiotherapy unit of the Centro das Taipas, a vast, pink former mental institutution close to Lisbon’s airport, where she is having hot towels pressed on to her lower back. Built during the second world war, the wards of wing 21B are these days committed to the treatment of drug addiction.

    Susannah is a long-term drug user and is intelligent but troubled. She first smoked cannabis at 13. At 17, she began taking heroin with the father of her children. Now 37, she has been dependent on drugs – mostly heroin – for almost two decades.

    “I lived in Spain for a while,” she tells me. “And London for a year, working in the restaurants with a friend. I went there to try to get off drugs but ended up on crack.” These days, however, Susannah, who also suffers from a bipolar disorder, is one of the beneficiaries of Europe’s most tolerant drug regime. For in Portugal, where Susannah lives, drugs have not only been decriminalised for almost a decade, but users are treated as though they have a health and social problem. Addicts such as Susannah are helped by the law, not penalised and stigmatised by it.

    In the midst of the recently resurgent debate in Britain about whether our drug laws are working – or require a major overhaul – the experience of Portugal has become a crucial piece of evidence in favour of a radical approach that has confounded the expectations of even its conservative critics, so much so that in the last month British officials have asked their Portuguese counterparts for advice, with the only caveat being that they avoid mentioning the word “decriminalise”.

    It is, perhaps, an unnecessary sensitivity. For the reality is that, despite liberalising how it regards drug possession – now largely an administrative problem rather than a criminal offence – Portugal has not become a magnet for drug tourists like Amsterdam, as some had predicted.

    British officials are not the only ones who have made the pilgrimage to Portugal in recent years – health specialists, officials and journalists from around the world have all made the journey to see what Portugal is doing right, even as their own countries are still struggling.

    Nor has it seen its addict population markedly increase. Rather it has stabilised in a nation that, along with the UK and Luxembourg, once had the worst heroin problem in Europe.

    For Susannah – as for the many long-term addicts now on methadone replacement and other programmes, and for the country’s health professionals – the country’s recent social history is divided into what the world of addiction and drug use was like before Law 30 was approved in November 2000, and what it is like now.

    Before the law, which decriminalised (or depenalised) possession of drugs but still prohibited their use, the story of drug addiction in Portugal was a familiar one. More than 50% of those infected with HIV in Portugal were drug addicts, with new diagnoses of HIV among addicts running at about 3,000 a year. These days, addicts account for only 20% of those who are HIV infected, while the number of new HIV diagnoses of addicts has fallen to fewer than 2,000 a year.

    Other measures have been equally encouraging. Deaths of street users from accidental overdoses also appear to have declined, as – anecdotal evidence strongly suggests – has petty crime associated with addicts who were stealing to maintain their habits. Recent surveys in schools also suggest an overall decrease in drug experimentation.

    At the same time, the number of those in treatment for their addiction problems has risen by about a third from 23,500 in 1998 to 35,000 today – helped by a substantial increase in available beds, facilities and medical support – with many going on to methadone replacement programmes. The consequence is that perhaps as much as €400m (£334m) has been taken out of the illegal drugs market.

    But decriminalisation, as Portuguese officials and others who have observed the country’s experience are at pains to point out, was only the most obvious part of what happened 10 years ago in the midst of a similar debate on drugs to the one now going on in the UK.

    Then, in a moment of grand vision powered by an inquiry which recommended a wholesale overhaul of Portugal’s anti-drugs policy in 1998, the government opted to make wholesale changes to the way Portugal dealt with the issue, giving a huge boost in resources to everything from prevention to harm reduction, treatment and reintegration – creating an entirely joined-up approach to drug abuse under the auspices of a single unit in the ministry of health.

    It marked an acceptance that for many, living drug-free was neither realistic nor possible and that what society needed to do was mitigate the risk individuals posed to themselves and a wider population at large by helping them manage their problems.

    Susannah’s doctor, the head of treatment at the Centro das Taipas, is Dr Miguel Vasconcelos. He frames Portuguese drug laws in a way that I hear repeated several times. Within certain clearly defined limits – an amount equivalent to 10 days’ normal use of any particular drug, ranging from amphetamines and cannabis to heroin – possession, he explains, is now considered similar to a traffic offence. It is a notion I find later described in the Portuguese drug strategy document as a “humanistic” approach.

    Vasconcelos, 51, is old enough to remember what it was like before, in a country which, two decades ago, barely had a methadone replacement programme at all. In his office, decorated with artworks by his clients, Vasconcelos says: “Critics from the conservative parties were concerned that the new law would make Portugal a place like Amsterdam, but that did not happen.

    “You have to remember,” he says, “that the substances are still illegal; it is the consequences that are different.” And for those arrested in possession of drugs for personal use, that means not a court appearance but an invitation to attend a “dissuasion board” that can request – but not insist upon – attendance at facilities such as the Centro das Taipas for assessment and treatment. “They evaluate if someone is ill or a recreational user, if a person uses sporadically,” says Vasconselos. “Even then people have a choice. People can refuse to attend the dissuasion board.”

    For many, he believes, the experience can be cathartic and he admits being surprised by how open many of the clients who have come to his facility via that system have been .

    If there has been a problem with the Portuguese experiment, he believes that it has been one largely of perception – outside Portugal – where decriminalisation has been misunderstood by some as legalisation or a step on the road to it.

    Rather, Vasconcelos believes that decriminalisation is a natural consequence of a gradual shift from regarding addicts as social delinquents to regarding them as people in need of help, a view reiterated by Dr Manuel Cardoso, a board member at the Instituto da Droga e da Toxicodependência at Portugal’s health ministry, which now co-ordinates the country’s approach to drug abuse.

    At the centre of Portugal’s deeply pragmatic approach are the dissuasion boards. Lisbon’s board – which deals with 2,000 cases a year – sits in a modest office on the second floor of a block above a pretty park. There are no lawyers (although they can attend) and no clerks in robes. No uniforms at all.

    Last Friday, on one side of the table were Nadia Simoes and Nuno Portugal Capaz, both members of the commission. On the other was a 19-year-old barman in a white T-shirt who allowed the Observer to observe the confidential process but asked not to be named.

    Stopped by police with 5.2 grams of cannabis, he is marginally over the limit of what can be dealt with by the dissuasion board alone and has had to appear in court as well. It is the young man’s first offence. He looks nervous. But it quickly becomes clear that this is a non-confrontational process, as Simoes explains that while possession of drugs for personal use is not a criminal offence, it is still forbidden.

    The man nods his understanding. Simoes explains the risks of smoking cannabis, including schizophrenia, and the sanctions the board can impose for second offences, including a fine or community service. Licences crucial to employment can also be revoked. As the process concludes, the barman looks relieved and promises to stop smoking. As he leaves, Capaz stands up and shakes his hand. The whole thing has lasted less than 10 minutes.

    A sociologist by training, Capaz is a vice-president on the board. He believes that far from Portugal becoming more lenient, the reality is that the state intervenes far more than it did before Law 30 and the other associated legislation was introduced. Before, he explains, police would often not pursue drug users they had arrested, interested only in the dealers. “People outside Portugal believe we had a tougher approach under the old law, but in reality it is far tougher now.”

    Now everyone who is caught with drugs must go before one of the 20 boards in the country to be categorised as either a recreational user, someone with a developing problem, or an addict. And while some 30% choose to refuse to appear at the first summons, most – when threatened with a fine for disobedience – eventually attend.

    Capaz has been involved since the very beginning and is struck by two things. The first is how Portuguese society has come to accept that addicts and drug users should be treated as a social rather than a criminal problem. The second, he explains, is that under the old criminal system all of those caught were supposed to be equal before the law. “With this system,” he explains, “We do it the other way. We can apply the law in a way that fits the individual.”

    Indeed, the law recognises that for addicts certain sanctions are not appropriate. While recreational users can be fined, the law prevents addicts from having a financial penalty imposed for fear that in trying to raise the fine they might be driven to commit a crime.

    But not everyone is totally convinced. Not even among the people who have dedicated their lives to assisting addicts. Francisco Chaves runs a modern shelter for street addicts close to Casal Vendoso, a place once notorious for its drug problems. “I want to explain first that this is not my profession but a vocation,” he explains by way of introduction. He wants, however, to pose a “rhetorical question” which turns out to be more passionate intervention than a debating point.

    He is concerned that under the “humanistic approach” enshrined in Portugal’s decade-old laws – in its concern for the human rights of the addict – perhaps too much pressure to change may have been taken off addicts. “I worry that it has become too easy being an addict now,” he says. “They can say: ‘I’ve got clean clothes. I’ve got food. Support. So why should I change?'”

    He says this sadly, because he agrees that addicts should be treated properly but cannot avoid “the paradox of the situation”. “I say it is a rhetorical question because places like this are required. It is a personal, philosophical question.” But it is one without any obvious answer.

    Outside his office in the large, bright space where addicts are lolling on the sofa, eating or watching television, I encounter Fernando Almeida, 31, who has been a heroin addict since he was 19. A thief – who stole to support his habit – he was recently released from prison and found a place at this centre.

    When he arrived six months ago, he weighed 55 kilos. These days he weighs 73kg and appears both lucid and motivated. “In the old days I used to get hassled by the police. Now the police don’t interfere with me,” he says. “I used to steal. Now I’m not going to steal anymore. For me the solution is to stop. I’ve discovered food and small things like taking a walk and having a coffee. I’m learning how to work.”

source: http://www.guardian.co.uk/world/2010/sep/05/portugal-drugs-debate

Patients who stay in methadone treatment for 12 months or longer have better therapeutic outcomes — yet most drop out within the critical first year. According to a recent study funded by the National Institute on Drug Abuse (NIDA), a major factor is a clinic’s views of its patients.

Clinics perceiving methadone patients as “consumers” who spend time and often money on treatment for opioid addiction generally try to attract patients by providing services such as child care, flexible hours, and help with housing and transportation. Clinics with the classic view of patients as “beneficiaries,” for whom treatment is considered a privilege, may offer patients fewer options and focus on the needs of the program rather than those of the patient. The authors suggest that by viewing patients as consumers of services, rather than beneficiaries, methadone clinics can retain patients in treatment longer and improve therapeutic outcomes.

Participants in the study were 42 patients prematurely discharged from six methadone programs in metropolitan Baltimore, Maryland. The study spanned 18 months, ending in June 2006, and was based on in-depth, semi-structured interviews. About 64 percent of participants were black, the remainder white. Average age of participants was 40 years. About 60 percent were men. Approximately 74 percent of participants reported injecting heroin. The average length of treatment was 124 days, and the group had an average of three prior drug-treatment episodes.

Reasons for Premature Discharge

Of the 42 patients, 17 left early for program-related reasons, 16 because of incarceration, 5 in order to become free of all addictions, and 4 because of life events or logistics. As discussed below, the somewhat rigid “beneficiary” thread ran through patients’ dissatisfaction and departure.

Conflicting Views of Reasons for Discharge

Counselors had to select a reason for discharge from eight categories. “Left before completing treatment” was the counselors’ most common reason, even for incarcerated patients. According to the authors, this suggested unawareness of the true reasons, but an alternate explanation could be that staff do not necessarily consider paperwork to be related to treatment. Yet the discharge summary report can be important, because ideally it accompanies the patient to any subsequent programs, possibly influencing the patient’s later attempts at recovery.

Specific Program-Related Factors

  • Disagreement with program rules. Some participants were frustrated with program policies and procedures that they believed were applied inconsistently or continuously changed, hindering their ability to improve their lives. For example, a homeless patient had a specific plan for regaining a construction job, but his counselor put other projects in his way, then complained he lacked stable housing. “So I was really bummed.” He left the program.
  • Conflicts with staff. Some conflicts with counselors led to confrontations and discharge from the program. Program directors sometimes refused patients’ requests for a different counselor. Some patients saw counselors as disrespecting patients’ “street” education. A patient complained that he didn’t need anyone, because he was “a grown man.”
  • “Feetox.” Rapid detoxification and discharge because of late payment or nonpayment of fees evoked strong reactions. “It’s all about money,” said an exasperated patient who was feetoxed after falling less than a week behind during the first month of treatment.
  • Scheduling conflicts. Many patients tried to cope with schedules, public transportation problems, family obligations, and job-seeking. A “beneficiary” working a 12-hour shift couldn’t get to the clinic while it was open. Another found a good job, but the commute was an hour and a half. Both chose work over treatment. The authors did not comment on the possibility that without treatment, relapse and possible job loss might occur

Desire to be Free of Addiction

Despite a generally positive view of methadone, more than 10 percent of discharged patients left treatment primarily to be free of all medication. Some were “scared of becoming dependent” on methadone. A patient said that trying to work and get to the clinic during the time the clinic was open “became like a schedule,” letting yet another drug — methadone — control his life.

Chairs

Discussion

The authors note that while studies indicate that the clinic director sets clinic policies, the counselor usually has to interpret and enforce the rules, which can create a conflict with their role as therapists. The authors believe that rules regarding take-home doses, missed doses, hours of operation, and children’s presence at the clinic may be critical factors in patient satisfaction and retention.

The authors identify several current problems:

  • A short supply of methadone treatment in the Baltimore area, limiting patients’ choices and putting some in a dependent relationship with a program.
  • Inability of some patients to negotiate clinic rules.
  • Decreased funding for methadone programs for the past several decades, increasing counselors’ case loads, making individualized attention difficult, and decreasing the variety of patient services.
  • Financial pressures may lead to “feetoxing” patients. The authors note that data appear to refute the idea that contributing fees is “therapeutic,” even for indigent patients. Heroin-addicted individuals given free treatment are more likely to enter and remain in therapy than those required to pay.

Suggestions for Staff to Increase Retention

  • Clearly explain program rules to patients
  • Have an appeal system offering a patient advocate
  • Allow patients to switch counselors if conflicts cannot be resolved
  • Consider having clinical experts review each patient’s case before discharge
  • Instruct counselors to document patients’ reasons for leaving treatment
  • Separate counselors’ rule-enforcement and counseling functions

Study Limitations

Because of social desirability, or lack of insight, reasons patients gave may not be accurate. Moreover, elapsed time may have altered patients’ memory of events. Nevertheless, the data may help programs improve their approaches and their outcomes.

Source:

Reisinger HS, Schwartz RP, Mitchell SG, et al. Premature discharge from methadone treatment: Patient perspectives. J Psychoactive Drugs. 2009; 41(3):285-296

Research on the association of vitamin D status with pain conditions continues to accumulate. In this latest study, a multinational European group of researchers found in a large sample of men that having musculoskeletal pain, particularly chronic widespread pain, was significantly influenced by low levels of vitamin D.

As part of the extensive European Male Ageing Study (EMAS), men 40 to 79 years of age completed a mailed pain assessment questionnaire and attended a clinical assessment that included measurement of vitamin D status signified by 25-hydroxyvitamin D3, or 25(OH)D, levels [McBeth et al. 2010]. Subjects were classified according to 25(OH)D levels as “normal” (≥15 ng/ml) or “low” (<15 ng/ml). Of 3,075 male participants included in the analysis (mean age 60 years, primarily Caucasian), 1,262 (41.0%) were pain-free, 1,550 (50.4%) reported “other pain” that did not satisfy criteria for chronic widespread pain (CWP), and 263 (8.6%) reported CWP. Compared with patients who were pain-free, those with “other pain” and those with CWP had significantly lower 25(OH)D levels (p<0.05).

After adjusting for age, men having “other pain” were 30% more likely to have low 25(OH)D, and having CWP was associated with a 50% greater likelihood of low 25(OH)D. These relationships persisted after adjusting for physical activity levels as a surrogate marker for sunshine exposure; however, after adjusting for additional lifestyle factors (such as smoking and alcohol use) the relationship of pain and low 25(OH)D was somewhat decreased — although, those with low vitamin D levels were still 20% more likely to also have pain.

COMMENTARY: In this large study, “other pain” was defined as any pain lasting one day or more in the past month and CWP was based on established criteria for diagnosing fibromyalgia. The total sample mean 25(OH)D level was 25 ng/mL, which could be considered overall as somewhat inadequate, and using a cut-off level of 15 ng/mL to separate “normal” versus “low” values is unusual, since many of those classified as normal still would have deficient levels (<20 ng/mL). It is interesting to note that the significant prevalence of CWP in this population of men was fairly equally distributed across 25(OH)D levels extending from <10 ng/mL to 30+ ng/mL. This suggests that there is a wide range of vitamin D deficiency and insufficiency that might influence CWP, including higher levels that many would otherwise consider as quite adequate 25(OH)D (ie, >30 ng/mL).

In the study population, men who were depressed, smoked cigarettes, and/or reported more frequent alcohol use were more likely to have low 25(OH)D levels. We have previously reported on the negative effects of tobacco and alcohol on 25(OH)D status in our review of vitamin D and pain [see PDF of paper here, page 25]. The investigators also examined levels of serum calcium and parathyroid hormone and found no significant differences between men with or without pain; therefore, clinically evident osteomalacia due to insufficient vitamin D may not have been a major influence (however, there also can be subclinical manifestations of difficult-to-detect osteomalacia).

Of further interest, an earlier published study, from the UK, similarly examined a large but mixed-gender population with and without CWP [reported in our blogpost 8/1/09]. In this study, 11% of men and 12.5% of women had CWP; however, an association of low 25(OH)D levels and pain was found in the women but not the men, and this was not accounted for by differences in lifestyle, anxiety, depression, or diet (although, persons with either high or low body mass index were more adversely affected by deficient vitamin D status). The present study, covering a larger and more diverse European population of men, supports the likelihood that CWP may be equally influenced by vitamin D status in both men and women.

As usual, however, we must caution that cross-sectional studies such as these from Europe and the UK do not confirm a direct cause-effect relationship between pain and low vitamin D status, and there appear to be certain potentially confounding factors. Furthermore, none of the researchers reported on clinical outcomes achieved via vitamin D supplementation in their subjects with pain, and this is a common shortcoming of much research in this field of inquiry that needs to be corrected.

REFERENCE: McBeth J, Pye SR, O’Neill TW, et al. Musculoskeletal pain is associated with very low levels of vitamin D in men: results from the European Male Ageing Study. Ann Rheum Dis. 2010;69:1448-1452 [abstract here].

Abstract
This retrospective study aims to determine whether
there is a difference in the additional consumption of
alcohol between addicts treated with methadone or dihydrocodeine
(DHC) and untreated addicts injecting heroin.
1,685 patients admitted for opioid withdrawal between
1991 and 1997 were reviewed. Cross-reference tables
and multiple logistic regression analyses were carried
out. 28% of patients take more than 40 g of alcohol daily
(on average 176 g). We found that patients who are
treated with methadone or DHC drink alcohol significantly
more often daily than the heroin-dependent patients
(p ! 0.01). Using multiple regression analyses, the results
were confirmed. Additionally, we found that co-abuse of
alcohol was predicted by male gender, longer duration
of drug use, additional daily consumption of tetrahydrocannabinol
and daily consumption of benzodiazepines.

Alcohol consumption by opioid-addicted patients
treated with methadone or DHC presents a serious medical
problem. Co-abuse of alcohol will receive more attention.

Introduction
Consumption of other psychotropic substances during
substitution treatment of opioid addicts with methadone
and dihydrocodeine (DHC) may have a substantial impact
on morbidity, mortality and clinical course. While
consumption of illegal drugs is usually reduced during
substitution treatment, additional consumption of legal
psychotropic substances, especially of alcohol, has not
been examined in such detail. Chronic alcohol consumption
leads to a variety of somatic effects and diseases.
Therefore, where a high prevalence of regular or severe
alcohol consumption exists among patients in substitution
programs, the advantages and risks should be carefully
weighed up. Further, to the consumption of respirantdepressive
opioids, additional complications and dangers
are involved when taking other psychotropic substances
with respiration-depressive effects, such as alcohol, benzodiazepines
or barbiturates. 62–72% of the patients, who
had been treated for overdosing, had consumed various
substances [1, 2], of which 23–35% comprised alcohol. In
cases of fatal overdosing, abuse with multiple substances
was reported in 71–92% of patients [3–7]. In 41–51% of
these deaths, alcohol was identified. In addition to the

acute risk of an overdose from combined consumption of

a number of psychotropic substances, the consumption of

alcohol, in contrast to opioids, leads to chronic permanent
damage and disease concerning almost all aspects of medicine
[8–11].
On the one hand, a number of studies have ascertained
that the supplementary consumption of illegal drugs such
as heroin and cocaine may be reduced by methadone
maintenance treatment programs [12–15] and codeine
maintenance programs [16]. On the other hand, it has
often been reported that about 30% of the patients in
methadone maintenance treatment programs have an
alcohol problem or are even alcoholics [17–19]. It is not
clear, however, whether the patients already had alcohol
problems before their entry into the methadone maintenance
treatment. The North Rhine Westphalia study on
the efficacy of outpatient medical rehabilitation with
methadone maintenance indicated that over time the
number of patients being abstinent of alcohol increased
during treatment [20].
In Germany, the critical dose is often stated as 60 g for
men and 40 g for women [21]. More than 8,000 deaths of
people aged 15–29 years in Europe in 1999 were attributable
to alcohol [22].
In addition to the risk of overdosing, alcoholism for
example leads to an increased risk of long-term secondary
physical sicknesses [8, 9]. With regard to narcotics fatalities,
toxicological data from southern Bavaria – the same
area as in our study – indicate that alcohol is a frequent
covariant in drug-related deaths and in patients treated
with codeine (27% each) and that it is less frequent in
methadone patients (16%) [23].
Those studies concerned with supplementary consumption
within methadone and codeine maintenance
treatment programs have mainly focused on the supplementary
consumption of illegal drugs. We further consider
that in Germany, and especially Bavaria, where alcohol
is everywhere easily available and where alcohol consumption
is well established (e.g. the ‘Oktoberfest’), heroin
addicts consider alcohol consumption analogous to a
‘normal’ individual’s regular consumption of alcohol, and
more so when heroin becomes more difficult to obtain.
We thus present our hypothesis that those patients treated
with methadone or DHC drink less alcohol than the
untreated patients injecting illegal heroin.
Subjects and Methods
Sample
All drug-addicted patients voluntarily admitted to inpatient detoxification
treatment between April 1991 and December 1996, in
whom, according to ICD-10 criteria, an opioid or multiple-substance

addiction had been diagnosed, were included in the study. Of all
patients enrolled in the treatment program between April 1991 and
December 1996, those subjects coming for a second or third detoxification
visit within this time period had to be excluded, except for the
first visit, otherwise the assumption of independent observations
would have been violated. Patients could come in of their own volition,
and previous contact with a counsellor or physician was not
necessary. The treatment strategy called ‘qualified detoxification’ has
been described elsewhere [24].
Measures
On the day of admission, the daily intake of psychotropic substances
over the preceding 6 months was established. The patients
were questioned individually regarding their intake of opioids, especially
heroin, codeine/DHC and methadone (D, L-methadone, levomethadone),
and of other psychotropic substances such as nicotine,
benzodiazepines, barbiturates, cocaine, cannabis, amphetamines/
amphetamine derivatives and alcohol. The alcohol intake
was noted in grams of alcohol per day. 500 ml beer was calculated as
20 g alcohol, 500 ml cognac (40%) or vodka (40%) as 160 g alcohol
[21]. The declarations were verified by an immunoassay urine test
(Triage®) and a KIMS test (kinetic interaction of microparticles in a
solution).
The patients were divided into 3 groups according to the preferred
opioid of each individual. Those who daily received methadone
or levomethadone (summarized as methadone) were included
in group 1, those who took codeine or DHC daily (summarized as
DHC) in group 2 and those daily consuming heroin in group 3. If
primarily two opioids were taken daily, then the priority sequence of
heroin before methadone before DHC was decisive. If none of the
opioids were taken daily, but rather several of them alternatively,
then these patients were not introduced into any of the 3 groups.
Data concerning the daily intake of other psychotropic substances
were collected for each group, as well as the gender of the patient,
duration of addiction, age at first opioid use, age, marital status, history
of imprisonment, history of suicide attempts and employment.
Alcohol was separated and selected as a dependent variable (co-abuse
of alcohol). Co-abuse of alcohol was defined as consumption of more
than 40 g alcohol per day. The 40-gram value was chosen since it is
the stated critical dose of alcohol per day in most other published
reports [21, 22, 25, 26].
Statistics
After cross-tabulation and bivariate analysis, a logistic regression
model was established. Bivariate analyses were performed for the
variable of interest and all further potentially relevant variables.
Since preliminary analysis indicated nonlinear associations involving
type of opioid dependency, age, duration of drug use, age at first
opioid use, marital status and history of imprisonment, these variables
were transformed from ordinal to categorical variables. Results
are summarized by reporting a ‘full model’ that includes all investigated
variables regardless of their statistical significance. Tests for
interactions were used as a check on the uniformity assumption
under which multiple regression estimates are derived.

Results
During the observation period from April 1991 to
December 1996, 1,656 patients were voluntarily admitted
to stationary qualified withdrawal treatment, 36% women
and 64% men. 537 of these were patients readmitted
within the given time frame. Of these patients only the
first admission was included in the study in order not to
violate the assumption of independent observations. 49
patients were not included since they had daily consumed
several different opioids. 137 patients, 36% women and
64% men, who daily received methadone, were included
in group 1. 658 patients, 34% women and 66% men, due
to their daily intake of codeine/DHC were placed into
group 2. 275 patients, 39% women and 61% men, daily
consuming heroin formed group 3. The average age was
30.7 years in group 1, 28.9 years in group 2 and 28.3 years
in group 3. The average duration of addiction to opioids
was substantiated as 10.5 years in group 1, 8.9 years in
group 2 and 8.2 years in group 3.
301 patients consumed more than 40 g alcohol per day.
These were evaluated as positive for the dependent variable
‘co-abuse of alcohol’. On average, alcohol consumption
was 176 g/day (table 1).
Contrary to our hypothesis, the bivariate analysis indicated
that patients who are in a methadone or DHC maintenance
treatment program daily drink alcohol significantly
more often than the heroin-dependent patients (p !
0.01). Fewer patients who were treated with DHC
(31.3%) drink alcohol than patients who were treated with
methadone (36.5%). Table 2 presents bivariate analyses
on the key variable and possible confounding variables
predicting co-abuse of alcohol. As shown, co-abuse of
alcohol was predicted by male gender, older age, longer
duration of drug use, additional daily consumption of
tetrahydrocannabinol (THC), daily consumption of barbiturates
and daily consumption of benzodiazepines.
Table 3 shows the results of a multiple logistic regression
analysis. The key finding that patients consuming
heroin drink less alcohol than patients who were treated
with DHC or methadone persists even when all investigated
variables regardless of their statistical significance
were included in the model. Age and daily consumption
of barbiturates turned out not to be a significant predictor
of co-abuse of alcohol. None of the other previously
entered significant variables like gender (odds ratio, OR,
0.61, 95% confidence interval, CI, 0.44–0.84, p ! 0.01),
duration of drug use (OR 0.19, 95% CI 0.05–0.74, p !
0.05), daily consumption of benzodiazepines (OR 0.52,
95% CI 0.38–0.71, p ! 0.001) and daily consumption of
Table 1. Consumption of alcohol by opioid patients consuming
more than 40 g of alcohol per day (defining ‘co-abuse of alcohol’)
Quantity of alcohol
g/day
Patients (n = 301)
%
40–60 12.0
61–120 23.9
121–180 27.2
181–240 13.3
More than 240 23.6
Total 100
THC (OR 0.67, 95% CI 0.47–0.95, p ! 0.05) became
insignificant, even though our variable of interest ‘type of
opioid dependency’ remained only marginally significant
(OR 2.38, 95% CI 1.42–4.00, p ! 0.001; table 3).
Discussion
The aim of this study was to investigate the association
between the consumption of alcohol and the daily preferred
opioid (methadone, DHC or heroin). The results
indicate that patients consuming heroin drink less alcohol
on a regular basis. In comparison to the patients who consume
DHC, patients in a methadone maintenance program
drink alcohol more often (36.5% of the methadone
patients vs. 31.3% of the DHC patients). The hypothesis
had therefore to be rejected. One explanation might be
due to the effect of the substance, i.e. that heroin is the one
substance with which the desired effect according to the
addicts may best be attained. Other opioids such as methadone
and DHC do not completely produce the desired
effect so that other additional substances, e.g. alcohol, are
consumed. In published reports, problematic alcohol consumption
by opiate users is given as varying between 12%
[27], 32% [18, 28] and 42% [27]. In this spectrum, the
individual subgroups of our study are found, with 16%
problem drinkers in the heroin group, 31.3% in the
codeine group and 36.5% in the methadone group. It is
becoming increasingly possible in Europe to use various
opioids as substitutes. This is understandable when one
considers the high mortality rate of drug addicts, which,
in a meta-analysis, was found to be more than 13 times
greater than in the average populations’ equivalent age
group [29]. Researchers and practitioners are therefore
required to re-evaluate indication positions and to annotate
advantages and disadvantages of each substance. An

important target criterion should be the parallel consumption
of further psychotropic substances, especially alcohol.
It is known that alcohol has a toxic effect on all
organic systems and that therefore chronic consumption
of alcohol causes many severe illnesses. If the patients
now begin to drink alcohol during the methadone or DHC
substitution treatment, then a serious responsibility falls
upon the physicians to recognize, and where necessary to
prevent, the injurious alcohol consumption being caused
perhaps partly by the substitution treatment itself. Further
studies had to be conducted to prove the association
between methadone or other substitutes and drinking
alcohol, and to investigate how long patients can be
treated with methadone before the risk of excessive alcohol
consumption increases significantly. A previous study
showed that 29% of the patients initially began to drink
during the course of methadone maintenance treatment
programs and that they are younger in comparison to nonopioid-
addicted alcoholics [30]. Numerous studies continue
to substantiate that patients during substitution
treatment with methadone consume fewer illegal drugs,
that the risk of HIV infection is reduced and that drugrelated
crime rates fall [20, 31–33]. DHC, which is frequently
prescribed in Germany, appears to improve the
addicts’ situation just as well as methadone [16]. In all
these studies, the illicit drug co-abuse but not alcohol was
a target criterion. In a new study, it was reported that only
one third of the patients in methadone maintenance treatment
abstained from alcohol at the intake and follow-up
[34]. It is known that with a lower dosage of methadone,
co-abuse is higher [35]. Apparently, patients who discover
they are hepatitis C positive, reduce their alcohol con

sumption considerably [28]. In principle it should be taken
into consideration that in Germany alcohol is culturally
accepted. Possibly the results would be somewhat different
in a more abstinence-oriented culture.
Independently of the preferred daily opioid the following
variables were associated with co-abuse of alcohol:
(1) in the total population, males more often have an alcohol
problem than females [36–38] – so it was not surprising
that male opioid addicts more often had drunk alcohol
daily than female opioid addicts; (2) that older patients,
consuming drugs over a longer period, drink more alcohol
seems realistic since the drug alone no longer appears to
have the desired effect; (3) this would be an analogous
explanation of the significantly higher benzodiazepine
and cannabis consumption. Barbiturates are consumed
(in total) in such small quantities that its use is difficult to
assess with certainty. The subgroup of cocaine users is
also so small that an assessment here appears to be of little
practical value.
The multiple logistic regression analysis result proves
that patients who have been treated with methadone or
have taken DHC drink quite significantly more than
patients who have injected heroin intravenously. To our
knowledge this has not yet been described thus in any other
literature. It is nevertheless necessary to consider that
this concerns a retrospective study. Being male, additional
consumption of benzodiazepines and THC was also
confirmed as independent predictor for alcohol co-abuse.
Increased age was not asserted as an independent predictor,
but duration of drug use was. This may be explained
by the fact that increased age implies a longer period of
drug use, since drug addicts in this study on average first
began injecting heroin at 20 years of age. In the first year
of opioid consumption, it appeared that the opioid itself
achieved the desired effect. Not quite every sixteenth
patient drinks alcohol additionally. Already from the second
year onward every fourth patient drinks alcohol daily.
From the sixth to the tenth year, the proportion was
30%, from the eleventh to the fifteenth year 40%. The
effect of the opioid itself no longer appears to be sufficient.
With an opioid consumption of more than 15 years,
slightly fewer patients drank alcohol daily (32.4%). This is
comparable to a British study in which a 32% harmful
daily alcohol consumption has been diagnosed, where the
average duration of opioid dependence was 17 years and
the average age was 39 [28].
The results of this study suggest that co-abuse of alcohol
should receive more attention in further studies of the
effectiveness of substitution treatment programs with various
substitution drugs. Particularly, a comparison between
heroin and methadone should prove very interesting.
More longitudinal studies are still needed.
Acknowledgements
This study was supported by the ‘Modellprogramm Kompakttherapie
im Verbund der Drogenhilfe 1990–1995’ from the Department
of Health of the Federal Republic of Germany. The authors
would like to thank the staff of the detoxification unit ‘villa’ for their
help with data collection and entry.

Read the whole Material here: alcoholConsumption.in.methadone

Psychisch Kranke und süchtige Menschen zählen in fast allen Ländern zu den am meisten stigmatisierten Bevölkerungsgruppen. Wie sich die Diskriminierung psychisch Kranker reduzieren lässt, hat jetzt das Aktionsbündnis für Seelische Gesundheit im Auftrag des Bundesgesundheitsministeriums (BMG) untersucht. (AST – AntiSTigma – HUMAN RIGHTS)

Die AOK Bayern überprüft Beigebrauch von Substitutionspatienten, dies meldet der DGS Newsletter für September. Ein empfehlenswerter Newsletter, für Personen mit Interesse an der Drogenpolitik. Um die Schnüffelaktion zu ermöglichen erhielt Dr.Franz-Josef Bentele, substituierender Arzt und DGS-Mitglied aus Neu-Ulm, kürzlich Post von der AOK-Bayern. Die AOK forderte ihn darin auf, Patienten dazu zu drängen, ihren behandelnden Arzt von der Schweigepflicht gegenüber der Krankenkasse zu entbinden.

Der Vorgang ist nicht einmalig: Auch aus Hessen und Baden-Württemberg teilen Mitglieder der DGS mit, dass die regionalen AOK-Verbände ähnliche Ansinnen geäußert hätten.

dgs-info veröffentlichte die Anfrage der AOK-Bayern und bittet die substituierende Ärzteschaft, mit Dr.Bentele eine Diskussion aufzunehmen, wie man sich in einem solchen Fall am besten verhalten solle. Eine Zusammenfassung der Debatte werde im nächsten DGS-Rundbrief veröffentlichen.

Unsere Meinung dazu:

Nur der behandelnde Arzt muss wissen, ob ein Substitutionspatient einen Beigebrauch von anderen Mitteln hat. Dies ist wichtig, um zum Beispiel Überdosierungen zu vermeiden. Die AOK hat sich aus den Ärzte-Patienten Vertrauensverhältnis ‘rauszuhalten. Es besteht keine medizinische Notwendigkeit, dass die Krankenkasse darüber bescheid weis. Der einzige trifftige Grund für das Vorgehen der Krankenkasse ist, Menschen mit Beigebrauch aus ihren Therapieprogrammen zu nehmen und dadurch auf Kosten derer Geld zu sparen.

WASHINGTON, Aug 20 (Reuters) – Between 1971, when Richard Nixon launched the war on drugs, and 2008, the latest year for which official figures are available, American law enforcement officials made more than 40 million drug arrests. That number roughly equals the population of California, or of the 33 biggest U.S. cities.

Forty million arrests speak volumes about America’s longest war, which was meant to throttle drug production at home and abroad, cut supplies across the borders, and keep people from using drugs. The marathon effort has boosted the prison industry but failed so obviously to meet its objectives that there is a growing chorus of calls for the legalization of illicit drugs.

In the United States, that brings together odd bedfellows. Libertarians in the tea party movement, for example, and Law Enforcement Against Prohibition (LEAP), an organization of former police officers, narcotics agents, judges and prosecutors who favor legalizing all drugs, not only marijuana, the world’s most widely-used illicit drug.

In Mexico, President Felipe Calderon has proposed a debate on the legalization of drugs – an implicit admission that the war he launched against his country’s drug cartels in 2006 cannot be won by force alone. (The death toll has just risen above 28,000 and keeps climbing). Calderon’s predecessor, Vicente Fox, followed up by declaring that since prohibition strategies had failed, Mexico should consider legalizing “the production, sale and distribution of drugs.”

It’s difficult to see how that could work without parallel moves in the United States, the main market for Mexican drugs, and it’s equally difficult to imagine Congress or state legislatures signing off on the regulated sale of cocaine, heroin or methamphetamine.

But there is growing acceptance that marijuana should be treated differently. Support for less rigid policies spans the political spectrum and has come from unexpected quarters. Sarah Palin, the darling of the American right, recently stepped into the debate on marijuana by describing its use as a “minimal problem” which should not be a priority for law enforcement.

That’s a view widely shared. Last year, a blue-ribbon panel chaired by three former Latin American presidents (Ernesto Zedillo of Mexico, Cesar Gaviria of Colombia and Fernando Henrique Cardoso of Brazil) published a report that rated the drug war a failure and urged governments to look into “decriminalizing” the possession of marijuana for personal use.

THE BEGINNING OF THE END?

“Taking all this together, there is reason to believe that we are at the beginning of the end of the drug war as we know it,” says Aaron Houston, a veteran Washington lobbyist for marijuana policy reform.

Far-fetched? Perhaps. But how many people in the late 1920s, at the height of the government’s fight against the likes of Al Capone, would have foreseen that alcohol prohibition would end in just a few years? Prohibition lasted from 1920 to 1933 and is now considered a failed experiment in social engineering.

Alcohol and marijuana prohibition have much in common: both in effect handed production, sales and distribution of a commodity in high demand to criminal organizations, both filled the prisons (America’s population behind bars is now the world’s largest), both diverted the resources of law enforcement, and both created millions of scoff-laws.

According to government estimates, up to 100 million Americans have tried marijuana at least once and the list of prominent citizens who admit having smoked it at one point or another is impressive. It includes President Barack Obama, his predecessor, George W. Bush, Supreme Court Judge Clarence Thomas, California Governor Arnold Schwarzenegger, New York Mayor Michael Bloomberg, Senator John Kerry, former Speaker of the House Newt Gingrich and former Vice President Al Gore. Not to forget Bill (I didn’t inhale) Clinton.

The argument for making marijuana legal is straightforward: it is thought to account for around 60 percent of the profits of international drug cartels, estimated at up to $60 billion annually. Take almost two thirds of that business away and the cartels’ power to corrupt and confront the state, as they do in Mexico, will decline sharply.

How close (or far) the United States is to an end to marijuana prohibition will become clear on November 2, when voters in California decide on a ballot initiative known as Proposition 19. Its official title, the Regulate, Control and Tax Cannabis Act of 2010, reflects what marijuana reform advocates around the country have long campaigned for – treat it like alcohol and tobacco.

The act would allow Californians over 21 to own, cultivate or transport up to an ounce of marijuana for personal use. This is distinct from marijuana for medical purposes, which is already legal in California and 13 other states, as well as the District of Columbia.

Public opinion polls on the proposition so far give no clear picture. A yes vote would be virtually certain to hasten changes elsewhere — California is not only America’s most populous state, it also has a long track record for setting trends. (You can contact the author at Debusmann@Reuters)

Die USA befinden sich nicht nur im Irak und in Afghanistan im Krieg. Sie sind auch in den Drogenkampf in Mexiko involviert – einen Konflikt direkt vor ihrer Haustür, der buchstäblich mit ihren eigenen Waffen ausgetragen wird: 90 Prozent der Gewehre und Granaten stammen aus den USA.

Von Ralph Sina, WDR-Hörfunkstudio Washington

Drogenkrieg in Ciudad Juarez (Foto: AP) Großansicht des Bildes

[Bildunterschrift: Eine Szene wie aus einem Kriegsgebiet: Patrouille vor einer Bar in Ciudad Juarez. ]
Er ist in den US-Nachrichtensendungen ständig präsent: der Krieg der mexikanischen Drogenbanden, nur wenige Meilen entfernt von der Grenze zu den Bundesstaaten Kalifornien, Arizona, Texas und New Mexiko. Immer mehr US-Bürger ahnen: Ihr Land ist nicht nur in die Kriege im Irak und in Afghanistan verwickelt, sondern in einen noch viel blutigeren Konflikt direkt vor ihrer Haustür, ausgefochten mit regelrechten Kriegswaffen.

Großteil der Waffen stammt aus US-Produktion

Waffen (Foto: dpa) Großansicht des Bildes

[Bildunterschrift: 90 Prozent der im Drogenkrieg eingesetzten Waffen stammen aus den USA. ]
90 Prozent dieser Waffen – darunter Maschinengewehre, Granaten und ferngezündete Bomben – stammen aus US-amerikanischer Produktion und wurden von Mittelsmännern der Drogenbanden auf dem Territorium der USA gekauft. Für die 7000 staatlich lizensierten US-Waffenläden entlang der amerikanisch-mexikanischen Grenze ist der eskalierende Krieg ein höchst profitables Geschäft. Wie der US-Fernsehsender NBC berichtet, versorgen diese Waffenläden Mexikos Mörderbanden buchstäblich mit allem – einschließlich schwerer Maschinengewehre, für die es ja dank einer Entscheidung des US-Kongresses und der ehemaligen Bush-Administration kein Verkaufsverbot mehr gibt.

28.000 Tote in dreieinhalb Jahren

„Ich denke, das ist ein Fehler“, gibt US-Außenministerin Hillary Clinton zu, als sie nach den US-Waffenlieferungen an Mexikos Drogen dealende Massenmörder gefragt wird. 28.000 Menschen starben in den letzten dreieinhalb Jahren im Kugelhagel rivalisierender mexikanischer Banden, darunter auch mehrere US-Bürger. Die Obama-Regierung fürchtet, der mexikanische Nachbar könne schon bald ein ‘failed state’ werden, ein anarchisches Gebilde mit unkalkulierbaren Folgen für die direkt angrenzenden US-Bundesstaaten. Doch die Waffenlobby der USA sorgt dafür, dass der Verkauf von Kriegsgerät an Privatpersonen weiterhin möglich ist – und damit auch der Export an Mexikos Drogenmilizen.

Die versprochene Hilfe lässt auf sich warten

Dennoch behauptet US-Präsident Barack Obama, die mexikanische Regierung könne bei ihrem Kampf gegen die Drogenmafia auf die volle Unterstützung des nördlichen Nachbarn zählen. Fast alle Güterzüge Richtung Süden würden zum Beispiel von US-Sicherheitsbehörden genau überprüft. Als Partner gebe man der mexikanischen Regierung eben, was sie zum Erfolg im Drogenkrieg brauche.

Drogenkrieg in Ciudad Juarez (Foto: AP) Großansicht des Bildes
[Bildunterschrift: Ein vermummter Polizeibeamter vor einem Hotel in Ciudad Juarez.]
Drogenkrieg in Ciudad Juarez (Foto: AP) Großansicht des Bildes
[Bildunterschrift: Soldaten überwachen die Vernichtung von Drogen im Feuer.]

Doch das sind nur schöne präsidiale Worte. Die 1,3 Milliarden Dollar, die der US-Kongress bereits 2008 zur Bekämpfung des Drogenschmuggels bewilligt hatte, liegen immer noch auf US-Staatskonten. Verzweifelt warten die mexikanischen Drogenbekämpfer auf die von den USA seit Langem versprochenen Helikopter, Überwachungsflugzeuge und Drohnen. Man werde den mexikanischen Behörden bei der Bekämpfung der Geldwäsche durch Drogendealer helfen, versprachen die USA.

Waffen für Drogen

Doch bisher ist kaum etwas geschehen – obwohl mexikanische Drogenkartelle mittlerweile auch in den USA zu den größten kriminellen Vereinigungen zählen, so der Fernsehsender NBC. Kein Wunder: Die USA sind nicht nur der Hauptlieferant der Waffen, sondern auch der Hauptabnehmer der Drogen.

Man werde jetzt neue Programme zur Bekämpfung der Drogennachfrage in den USA umsetzen, verspricht Obama. Doch das dürfte eher eine stumpfe Waffe im Kampf gegen Mexikos Drogenbarone bleiben. Die morden in letzter Zeit gerne mit ferngezündeten Autobomben, wie jüngst im mexikanischen Bundesstaat Tamaulipas – ganz nach dem Vorbild von Al Kaida.

“Depressive illness was described by Hippocrates in ancient Greece, but effective therapeutic agents did not emerge until the 1950s. Today, almost all antidepressant Drugs in clinical use increase levels of certain neurotransmitters in the brain, in particular norepinephrine and serotonin. Although these medications are beneficial, a sizeable minority of patients remain resistant to their therapeutic effects. Moreover, in most patients, there is a delay of weeks to months before the drugs take full effect. As a result, there is an urgent need to develop faster-acting drugs,” writes John F. Cryan, Senior Lecturer, School of Pharmacy, Department of Pharmacology and Therapeutics, Alimentary Pharmabiotic Centre, University College Cork, Ireland, in this week’s journal of Science.

Major Depressive Disorder (MDD), afflicts about 17% of the population at some point in their lives, and is frequently a disabling disorder . Those who suffer from MDD more often than not do not get any relief from the initial medication prescribed. Thus begins what can be a frustrating journey of side-effects and delayed relief due to the fact that most antidepressant drugs take weeks or months to produce the therapeutic effect intended.

Ronald Duman, Professor of Psychiatry and Pharmacology Director, Division of Molecular Psychiatry and Abraham Ribicoff Research Facilities, Yale University, and senior author of a recent study, reportedly have found that a single dose of the drug ketamine can produce an antidepressant effect within hours and lasting up to a week.

Ketamine, which can produce psychotic episodes, cause damage to brain function with long-term use, and kill in high doses, is not a great candidate for ongoing therapy. However, researchers noted that ketamine has shown to be effective as a rapid way to treat people with suicidal thoughts; many suicidal patients respond weeks later with traditional drugs.

Yale researchers discovered that in rats, ketamine restored connections between brain cells damaged by chronic stress and quickly improved depression-like behavior. Investigating exactly how the drug works, scientists found that ketamine activates a signaling pathway in the brain called the mammalian target of rapamycin pathway (mTOR), suggesting new therapeutic targets for antidepressant drug development.

“The pathway is the story. Understanding the mechanism underlying the antidepressant effect of ketamine will allow us to attack the problem at a variety of possible sites within that pathway,” says George Aghajanian, Professor of Psychiatry, Yale School of Medicine.

Other antidepression drugs do not appear to activate this mTOR pathway. Based on investigation of a few different classes, serotonin selective reuptake inhibitors (SSRI), the tricyclic antidepressants, and even electroconvulsive seizure, similar effects with those classes of antidepressants have not been evidenced.

The August 20 issue of the journal Science, report that the new findings should hasten the development of a safe and easy-to-administer form of the anti-depressant ketamine. Ketamine use has a proven track record in remarkably effecting severelydepressed patients.

“It’s like a magic drug—one dose can work rapidly and last for seven to 10 days,” said Duman.

In an interview, Duman said “There are two major findings, I think, of the paper. A single dose of this NMDA, antagonist, ketamine, produces an increase in the number of connections in a part of the brain—the prefrontal cortex—that’s known to be involved in depression and treatment response. This is a really dramatic finding that a drug can increase the connections between neurons within a relatively short timeframe.”

“To put that into perspective, there are quite a few studies in the field that have demonstrated that stress and depression—models of depression in preclinical studies—produce the opposite effect – they actually cause atrophy of neurons and decrease the size of the dendritic or processes of neurons. So, here’s a drug that’s able to rapidly reverse the actions of and produce the opposite actions of what is occurring with chronic stress or depression.”

He cites the second major finding, “related to the mechanism and the signaling pathways that
underlie that effect. Ketamine can rapidly increase a signaling cascade that regulates
translation of proteins at the synapse or at the contact site of neurons, that’s known to be involved in control of protein synthesis. It’s been implicated in models of learning and memory, and is required for protein synthesis–dependent long-term memory.”

Duman admits that studying something like depression or any psychiatric illness in rodents is difficult. Behavioral tests have been devised modeling certain aspects of depression, such as
helplessness or confusion enabling testing as to whether or not ketamine can produce an antidepressant response. The mTOR pathway, is identical in all mammals, therefore the same in rats and humans.

Reporting in Science Magazine, Nanxin Li, Laboratory of Molecular Psychiatry, Center for Genes and Behavior, Departments of Psychiatry and Neurobiology, Yale University School of Medicine cites, “The rapid antidepressant response after ketamine administration in treatment-resistant depressed patients suggests a possible new approach for treating mood disorders compared to the weeks or months required for standard medications. Our results demonstrate that these effects of ketamine are opposite to the synaptic deficits that result from exposure to stress and could contribute to the fast antidepressant actions of ketamine.”

‘The dissociative anesthetic effects of ketamine have also been applied within the realm of postoperative pain management. Low doses of ketamine have been found to significantly reduce morphine consumption as well as reports of nausea following abdominal surgery.’ The Medscape Journal of Medicine (2008).

Other possible illnesses that could benefit from treatment with ketamine are bi-polar depression and post-traumatic stress disorder (PTSD). It is also used widely in veterinary medicine.

Treatment of Alcohol addiction and drug addiction in Germany, using Ketamine, psychotherapy and group therapy, resulted in successful withdrawal and continued abstinence for more than one year.

Developed early in the 1960’s, Ketamine was commonly used as an anaesthetic for soldiers in Vietnam. Recreational use began as early as 1967 when it was referred to as “mean green” and “rockmesc”. Gaining in popularity and known as “K”, “Ket”, “Special K” and “Vitamine, the ‘party drug’ use increased through the ’90’s, prompting it’s placement in Schedule II of the United States Controlled Substance Act in August, 1999.

Recreational use (abuse) of Ketamine produces profound psychological effects, characterised by a sense of detachment from one’s physical body and external world, which mimic schizophrenia. Psychotic reactions, intense hallucinations, perception of falling and flying and a complete dissociation from the real world occur during the state of unconsciousness.

The effect on the mind is so dibilitating that users may not remember their own names or know they are human, or what that means. The process of returning to reality is slow; movement is extremely difficult and recognizing their surroundings or being aware of their body can take hours. The long term neurological damaging effects of Ketamine are not completely clear, however premature death has been linked to reacreational use of the drug.

Believing the use of this new information about how Ketamine works could be developed into a pill form of the drug, that is much safer and more convenient, for the treatment of severe depression.

Laura Lamp King

source: http://www.foodconsumer.org/newsite/…320100217.html

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