Tag Archive: suboxone



Zitat:
Abstract

BACKGROUND: In Finland, buprenorphine (Subutex) is the most abused opioid. In order to curb this problem, many treatment centres transferred („forced transfer“) their buprenorphine patients to the buprenorphine plus naloxone (Suboxone) combination product in late 2003.

METHODS: Data from a retrospective study involving five different treatment centers, examining the effects of switching patients to Suboxone, were gathered from 64 opioid-dependent patients who had undergone the medication transfer.

RESULTS: Most patients (90.6%) switched to Suboxone at the same dose of buprenorphine that they had been receiving as Subutex (average 22 mg). The majority of these patients (71.9%) were maintained at the same dose of Suboxone throughout the 4-week study period. During the first 4 weeks, 50% of the patients reported adverse events and at the four month time point, 26.6% reported adverse events. However, due to adverse events one patient only discontinued treatment with Suboxone during the 4-week study period, and five during the four month follow-up period. Of the 26 patients in the follow-up period, Suboxone was misused intravenously once each by 4 patients and twice by 1 patient. These 5 patients all reported that injecting Suboxone was like injecting „nothing“ with any euphoria, or that it was a bad experience.

CONCLUSION: We conclude that when patients are transferred from high doses (> 22 mg) of buprenorphine to the combination product, dose adjustments may be necessary especially in the later phase of the treatment. We recommend that a transfer from Subutex to Suboxone should be carefully discussed and planned in advance with the patients and after the transfer adverse events should be regularly monitored. With regard of buprenorphine IV abuse, the combination product seems to have a less abuse potential than buprenorphine alone.


Source:
http://www.ncbi.nlm.nih.gov/pubmed/18559110

Versus

Zitat:
Abstract

Abuse and misuse of pharmacological therapies represent major challenges in the healthcare system, particularly in patients receiving long-acting opioid drugs for the treatment of heroin or opioid addiction. The partial mu-opioid receptor agonist buprenorphine is used to treat opioid dependence, but diversion and misuse may occur.

The sublingual combination formulation of buprenorphine and the opioid receptor antagonist naloxone (buprenorphine/naxolone) is associated with a reduced abuse potential, and has been shown to have promising efficacy for the treatment of opioid dependence. This observational study assessed the safety and efficacy of sublingual buprenorphine/naloxone combination therapy in patients with opioid dependence after therapeutic switch from buprenorphine monotherapy. A total of 94 patients being treated with buprenorphine monotherapy (average dose 8 mg/day; mean duration of therapy 840 days) were switched to buprenorphine/naloxone combination therapy. Patients were asked to rate their level of satisfaction with buprenorphine/naloxone combination treatment with respect to the management of withdrawal symptoms, and urinary toxicology tests were carried out before and 14 days after switching to combination therapy. Within 3 months, 75/94 patients (80%) previously treated with buprenorphine monotherapy had switched to sublingual buprenorphine/naloxone combination treatment (average dose buprenorphine 8 mg).

Among patients receiving combination treatment for >3 months, 83% were receiving medication either weekly or fortnightly, based on the results of toxicological testing. A reduction in positive urinary toxicology tests was observed in patients within two weeks after being switched to combination treatment (before switch: 28, 9 and 2 positive tests for heroin, cocaine and heroin + cocaine, respectively vs 11, 3 and 1 after switch) and a total of 64 patients of the 75 who switched to combination therapy (85%) were satisfied with the management of withdrawal symptoms during buprenorphine/naloxone treatment.

Few adverse events were reported and no patients dropped out of treatment. This study shows that switching from buprenorphine monotherapy to sublingual buprenorphine/naloxone combination therapy is effective and well tolerated, and associated with good control of withdrawal symptoms in the majority of patients. In addition, combination therapy reduced illicit drug use (based on negative urinary toxicology texts) and allowed the time between clinic visits to be increased.

Source: http://www.ncbi.nlm.nih.gov/pubmed/20450243

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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.

10.000 Drogenkranke werden in Österreich mit Ersatzdrogen therapiert. Ein Millionengeschäft für nur sehr wenige Anbieter von Substitutions-Mitteln, die sich nun ein Match um Marktanteile liefern.

Wien. 30.000 Österreicher sind süchtig nach Opiaten wie beispielsweise Heroin. 9828 davon befanden sich Ende 2008 in einer sogenannten Substitutionstherapie mit Ersatzdrogen. Statt den Stoff von der Straße (mit allen seinen Nebenwirkungen) konsumieren die Patienten vom Arzt verschriebene Medikamente. Weil nun durchsickerte, dass im Gesundheitsministerium einmal mehr darüber nachgedacht wird, ob bestimmte Medikamente anderen vorzuziehen und wieder andere gar zu verbieten wären, ist zwischen den Herstellern der Präparate ein Kampf um Marktanteile ausgebrochen.

Es geht ums Geld. Ein Millionen-Euro-Geschäft um eine sichere, weil süchtige Kundschaft, um das nur eine Handvoll Anbieter rittert. Vereinfacht dargestellt verläuft die Frontlinie zwischen den beiden Unternehmen Mundipharma (Jahresumsatz 2007: 25 Mio. Euro) und Aesca Pharma (59 Mio.). Das Mundipharma-Produkt Substitol hat in Österreich einen Marktanteil von 62 Prozent (Quelle: Agentur für Gesundheit und Ernährungssicherheit, Ages) und beschert dem Unternehmen ein Drittel des Umsatzes. Aesca kommt mit seinen Produkten Subutex und Suboxone zusammen auf 21 Prozent. Den Rest teilen sich Compensan von Lannacher (16 Prozent) und Kapanol von GlaxoSmithKline (ein Prozent). Weil Methadon direkt in Apotheken abgemischt wird, liegen der Ages dafür keine Zahlen zum Marktanteil vor. Insgesamt gaben die Sozialversicherungen 2007 20 Millionen Euro für Ersatzdrogen aus.Aesca stört nun, dass Österreichs Ärzte ihren Suchtpatienten nach wie vor häufig Substitol und Compensan, zwei sogenannte „retardierte Morphine“, verschreiben. Und das, obwohl ihre eigenen Produkte mit dem Wirkstoff Buprenorphin von der derzeit gültigen Verordnung des Gesundheitsministeriums als „Mittel erster Wahl“ bezeichnet werden.

Offenbar in der Hoffnung, mithilfe von medialem Druck in der geplanten Neufassung der Verordnung retardierte Morphine überhaupt zu verbieten, füttert Aesca über die Vermittlung einer PR-Agentur seit einiger Zeit Journalisten mit „Hintergrunddossiers“ über die Vorzüge der eigenen und die Nachteile der Konkurrenzprodukte von Mundipharma und Lannacher. Zum Teil mit Erfolg. In manchen Medien werden retardierte Morphine bereits als „Problemdrogen“ dargestellt. Im Zentrum der Kritik steht das relativ hohe Missbrauchspotenzial von retardierten Morphinen, die wegen möglicher Mehrfachverschreibungen von Ärzten und ihrer „kick“-ähnlichen Wirkung von Süchtigen gerne am Schwarzmarkt ver- und gekauft werden.

Dabei ist objektiv keines der genannten Medikamente besser oder schlechter, gefährlicher oder sicherer als das andere: Das sagt zumindest Marcus Müllner, Bereichsleiter für Arzneimittelsicherheit bei der Ages, die regelmäßig Ärzteberichte, Studien, Fachartikel und Pressemeldungen zum Thema analysiert. Interessant am Ages-Bericht ist auch, dass 2008 nur zwei ärztliche Meldungen über (geringfügige) Nebenwirkungen von Ersatzdrogen einlangten. Beide betrafen Suboxone von Aesca.

Ein der „Presse“ bekannter Arzt, der zahlreiche Suchtpatienten betreut, erinnert sich in diesem Zusammenhang an eine „seltsame Strategieänderung“ der Aesca-Vertreter, die ihn in den vergangenen Jahren regelmäßig aufsuchten, um die Vorzüge der eigenen Medikamente zu bewerben. Nachdem man jahrelang die angebliche Sicherheit von Subutex gegenüber den retardierten Morphinen in den Vordergrund gestellt hatte, legten die Vertreter dem Arzt bei ihrem letzten Besuch Studien vor, die plötzlich das hohe Missbrauchspotenzial von Subutex beschrieben und gleichzeitig die Vorzüge des direkten Nachfolgers Suboxone priesen.

Ärztekritik an Politvorschriften

Während die Politik die Entscheidung über bevorzugte Medikamente (und damit Marktanteile) hinausschiebt, wollen sich die Ärzte nicht mehr verunsichern lassen. Die Österreichische Gesellschaft für arzneimittelgestützte Behandlung von Suchtkrankheit (ÖGABS) hat daher ein (noch nicht veröffentlichtes) Grundsatzpapier erstellt, das auf Grundlage unabhängiger Studien feststellt, dass keines der am Markt befindlichen Medikamente generell besser oder schlechter ist als das andere.

Der Wiener Allgemeinmediziner Horst Schalk, der auch Drogenpatienten betreut, beschreibt das dann so: „Die Patienten sind verschieden und sprechen auf unterschiedliche Medikamente unterschiedlich an. Ein Arzt sollte seinen Patienten daher die Präparate verschreiben, auf die der Patient am besten anspricht

quelle:diepresse.com/home/panorama/oesterreich/477270/index.do

Bridget M. Kuehn

JAMA. 2010;304(3):261-263. doi:10.1001/jama.2010.963

When patients with HIV infection also are addicted to opioids, treating both disorders simultaneously may help improve outcomes and reduce the spread of HIV or other infections transmitted through needle sharing or risky sexual behaviors associated with injection drug use. But accessing such integrated care has sometimes been a challenge for such patients, who generally had to seek care for opioid abuse at addiction treatment centers and primary HIV care elsewhere. This could be logistically difficult and often led to delays in receiving care.

Now, however, buprenorphine prescribing by HIV clinicians is offering patients the option of receiving treatment for both opioid addiction and HIV infection, an approach that a growing body evidence indicates benefits individual patients and public health.

Figure 05072FA
There are currently about 19 000 US physicians certified to prescribe buprenorphine, but experts urge more physicians, particularly those in HIV primary care, to become certified to meet the demand for opioid addiction treatment.

Since 2002, buprenorphine, a partial opioid agonist, has been available in the United States as an office-based treatment for opioid dependence. Physicians who wish to prescribe the drug may under go a training program and become certified through the Substance Abuse and Mental Health Services Administration (SAMHSA) to prescribe buprenorphine (http://buprenorphine.samhsa.gov/). Methadone, a full opioid agonist, remains available through highly regulated, specialized treatment programs.

„Buprenorphine has definitely expanded access [to addiction care],“ said Amina Chaudhry, MD, MPH, an HIV clinician in Baltimore who prescribes buprenorphine. Chaudhry, who is also a medical officer at SAMHSA’s Center for Substance Abuse Treatment in Rockville, Md, explained that even in cities like Baltimore, where there may be specialty addiction programs nearby, the demand for such care often exceeds the available slots. And rural areas may have no specialty addiction programs at all within a reasonable distance.

IMPROVED OUTCOMES


Studies have suggested that patients with HIV infection and untreated opioid addiction often receive HIV treatment later in the course of their illness, may be less adherent to their antiretroviral therapy regimen, and may engage in behaviors such as unprotected sex or injection drug use that put themselves and others at risk of new infections. But treating patients for both HIV and drug use can improve such outcomes. Although much of this research has focused on the effects of methadone, emerging evidence suggests that buprenorphine has similar benefits and may have a few advantages over methadone treatment for patients with HIV.

A recent randomized trial found that office-based care can improve addiction-related outcomes for patients with HIV and opioid addiction and may lead to faster treatment for addiction (Lucas GM et al. Ann Intern Med. 2010;152[11]:704-711). Gregory M. Lucas, MD, PhD, of Johns Hopkins University School of Medicine in Baltimore, and colleagues randomized 93 patients at a Baltimore HIV clinic to receive buprenorphine therapy at the clinic or to receive a referral to specialty addiction treatment elsewhere. Patients randomized to clinic-based opioid agonist treatment with buprenorphine entered addiction treatment much more quickly (84% had initiated such care at 2 weeks compared with 11% in the referral group). During the 12-month trial, participation in opioid addiction treatment was significantly greater in the clinic-based care group (74% participated in such treatment vs only 41% in the referral group). Patients receiving buprenorphine in the clinic also had significantly fewer urine test results that were positive for opioids or cocaine and visited their HIV primary care clinicians more frequently.

However, the researchers did not find differences in HIV-treatment participation or HIV treatment effects between the clinic-based vs referral groups. The authors concluded that the improvements in addiction treatment may have been driven by streamlined access to care because patients referred to outside specialty addiction care may have experienced a delay in treatment initiation. The small sample size may have precluded identifying clinically significant differences in HIV treatment outcomes, they also noted.

The study was part of the Health Resources and Services Administration’s (HRSA’s) Buprenorphine in HIV Primary Care National Evaluation and Support Center (BHIVES; http://www.bhives.org). An analysis of pooled data from 10 sites participating in the HRSA program is under way.

David A. Fiellin, MD, associate professor of medicine at Yale School of Medicine and co-investigator on BHIVES, noted that the program is also probing which approaches to primary care delivery work best in HIV clinics. So far, he and his colleagues have demonstrated in a pilot study that an approach that uses a nurse or other staff member to help coordinate buprenorphine care by overseeing such tasks as urine testing, drug counseling, and medication monitoring can help to reduce drug use among HIV patients, has good retention rates, improves patient function, and promotes patient satisfaction (Sullivan LE et al. Clin Infect Dis. 2006;43[suppl 4]:S184-S190).

Previous studies had suggested that physicians‘ concerns about adherence to antiretroviral treatment by injection drug users with HIV played a role in the likelihood that such patients would be offered highly active antiretroviral therapy or at least experience a delay in receiving such treatment. But results of a French study suggest that integrated treatment of HIV and opioid addiction could allay such concerns. The study found that retention in opioid substitution therapy, either buprenorphine or methadone, is associated with improved virologic outcomes in patients treated with highly active antiretroviral therapy and who had opioid use disorders (Roux P et al. Clin Infect Dis. 2009;49[9]:1433-1440). The study included 53 patients receiving buprenorphine, 28 receiving methadone, and 32 who were not receiving opioid substitution therapy. The median duration of opioid substitution treatment was 25 months.

„Having one-stop shopping for patients means one less barrier to accessing care,“ Chaudhry said.

Buprenorphine also appears to have fewer interactions with antiretroviral drugs than methadone. Elinore F. McCance-Katz, MD, PhD, professor of psychiatry at the University of California, San Francisco, and her colleagues published an article reviewing drug interactions involving methadone and buprenorphine and other medications, including antiretroviral therapies (McCance-Katz EF et al. Am J Addict. 2009;19[1]:4-16). Two HIV medications in particular, efavirenz and nevirapine, have been documented to trigger opiate withdrawal in patients taking methadone but not in patients taking buprenorphine, despite observations of reduced levels of both methadone and buprenorphine when these antiretrovirals were given to patients receiving these opioid therapies, noted McCance-Katz in an interview. A possible reason for the observed differences may be that methadone is metabolized to an inactive substance while buprenorphine is metabolized to norbuprenorphine, which also has opioid effects and may protect patients from experiencing opiate withdrawal, McCance-Katz said.

„It’s very difficult to effectively treat patients [with HIV] if they are in withdrawal,“ she said. „They simply don’t comply with antiretroviral therapy if they are in withdrawal.“

Elevated concentrations of buprenorphine have been documented in patients with opioid dependence and HIV taking atazanavir; such elevated levels were associated with cognitive impairment in a few HIV patients in one case study, while another study in non–HIV-infected patients found only increased drowsiness (Bruce RD and Altice FL. AIDS. 2006;20[5]:783-784 and McCance-Katz EF et al. Drug Alcohol Depend. 2007;91[2-3]:269-278). Such elevations of methadone concentrations have not been documented with atazanavir.

„In general, buprenorphine has fewer interactions with HIV medications, but neither drug has been looked at extensively with many other medications,“ she said, adding that many patients with HIV may be taking a number of medications in addition to antiretroviral drugs.

Integrating buprenorphine treatment into the HIV care setting has another potential advantage: it may be easier for clinicians to spot interactions between addiction and HIV therapies when patients receive buprenorphine treatment at their primary HIV clinic, McCance-Katz said. For example, if a patient receives methadone at one clinic and antiretroviral therapy at another, there may be limited communication between clinicians at the 2 sites and adverse events may not be identified.


CLINICIAN ACCEPTANCE


About 19 000 US physicians are certified to prescribe buprenorphine and about 640 000 patients are receiving the prescriptions compared with about 4500 certified prescribers and a little more than 100 000 patients in 2005, according to Nicholas Reuter, MPH, senior public health analyst at SAMHSA. But access to buprenorphine therapy in the HIV primary care setting in the United States may be limited. Reuter noted that psychiatrists and physicians specializing in addiction treatment were early adopters of office-based buprenorphine prescribing. Today, 31% of the prescribers are classified as general or family practitioners, 21% as psychiatrists, 15% as internal medicine specialists, and the remaining third are other specialists who are not HIV clinicians, according to Reuter. (SAMHSA doesn’t track the number of HIV/AIDS specialists who are certified to prescribe buprenorphine.)

A survey of about 500 HIV clinicians (49.7% response rate) who attended International AIDS Society conferences in the United States in 2006 found that only 85 (17%) worked in offices that prescribe buprenorphine. Of the 323 physicians who responded, only 67 (21%) were certified to prescribe the drug, and only 19 (6%) had ever done so (Kunins HV et al. Fam Med. 2009;41[10]:722-728). Additionally, when presented with a vignette of an opioid-addicted patient with HIV, only 16% of the respondents endorsed primary care buprenorphine treatment as the best option for the patient compared with 49% who endorsed buprenorphine treatment in a substance abuse treatment program and 31% who endorsed methadone treatment in a specialty program.

Fiellin noted that other BHIVES efforts have found that clinicians may feel they do not have adequate training and resources to provide addiction treatment but are interested in receiving additional training. The clinics that have implemented primary care buprenorphine care as part of BHIVES have received technical support during implementation, and over time their satisfaction with and sophistication at providing buprenorphine care have improved, he noted.

Another program offering resources to buprenorphine-prescribing physicians is SAMHSA’s Physician Clinical Support System (PCSS), which is directed by Fiellin and includes McCance-Katz as among the clinical experts who work with the program. PCSS helps match new buprenorphine prescribers to more experienced mentors who work in similar settings, including HIV primary care. The program also has drafted a guidance document for buprenorphine prescribing to patients with HIV (http://www.pcssbuprenorphine.org/pcss/documents2/PCSS_OpioidTherapiesHIVDrugInteractions_022808.pdf).

SAMHSA is also working with primary care physicians at federally qualified health centers who may be treating many HIV-infected patients. Reuter explained that the agency would like these centers to offer both buprenorphine and methadone, although the latter would require a center to be licensed as an opioid treatment clinic. He noted that SAMHSA’s goal is to make sure there are as many physicians as possible qualified to provide care to opioid-dependent patients, who may require long-term or recurrent care. For example, the average duration of methadone treatment is 6.8 years. „Our concern is that as long as patients remain engaged in treatment they do very well,“ he said. „A number of patients discontinue and the relapse rate is very high.“

Chaudhry emphasized that primary care buprenorphine treatment is not necessarily a replacement for specialty addiction treatment with methadone or buprenorphine. For example, she noted that some patients may prefer to keep their addiction treatment separate from their HIV care.

„The more treatment choices that providers have to offer the better,“ she said.

A Role for Buprenorphine in Prevention?Between 2004 and 2007, of the 152 917 US individuals in 34 states diagnosed with new HIV infections, 13% of them (n = 19 687) were injection drug users, according to the US Centers for Disease Control and Prevention (MMWR Morb Mortal Wkly Rep. 2009;58[46]:1291-1295). For those who are already infected with HIV, buprenorphine treatment may reduce the likelihood they will spread the infection to others through needle sharing or unprotected sexual activity. And for opioid-dependant individuals who are not already HIV-infected, primary care buprenorphine treatment may reduce risky behaviors that put them at risk of HIV infection, according to a recent study.

Lynn E. Sullivan, MD, and colleagues from the Yale University School of Medicine in New Haven, Conn, compared drug-related and sex-related risk behaviors in 166 buprenorphine-treated individuals at baseline, 12 weeks, and 24 weeks (Sullivan LE et al. J Subst Abuse Treat. 2008;35[1]:87-92). Reports of intravenous drug use among the individuals declined over time, from 37% at baseline to 12% at 12 weeks, to 7% at 24 weeks. The researchers also found a decline in reports of sex while the patient or their partner was high between baseline (64%) and 12 weeks (13%), although such reports increased to 15% a 24 weeks, and inconsistent condom use with a regular partner remained unchanged.

Such benefits may be particularly important in regions of the world where HIV transmission is driven primarily by injection drug use. In Eastern Europe and Central Asia, for example, the Joint United Nations Programme on HIV/AIDS estimates that more than 80% of all HIV infections are caused by contaminated injection equipment (http://www.unaids.org/en/PolicyAndPractice/KeyPopulations/InjectDrugUsers/).

The HIV Prevention Trials Network, an international clinical trials network funded by the National Institute of Allergy and Infectious Diseases, currently has a phase 3 randomized trial under way in China and Thailand to assess whether buprenorphine in combination with naloxone (to reduce the abuse potential) decreases drug use and HIV-related risk behaviors (http://www.hptn.org/research_studies/HPTN058.asp). The trial, which is enrolling about 1500 HIV-uninfected injection drug users, will randomize individuals to receive either buprenorphine plus naloxone for 1 year or detoxification with buprenorphine plus naloxone for up to 18 days (with a second detoxification if necessary). Both groups will also receive counseling for HIV risk reduction. The study will assess cumulative HIV incidence and death and frequency of drug use and drug-related and HIV-related risk behaviors in the 2 groups.—B.M.K.

Methadone & Pregnancy
“Is methadone safe for my baby?” is usually the first question  we hear           from women.
Pregnant women have been treated with methadone for more than  25  years          and neither methadone or other opiates have not been  shown to  directly          cause birth defects. However, your baby may  experience some side  effects          from methadone. The most common  are smaller-than-normal head  size, low          birth weight, and  withdrawal symptoms. As babies born dependent  on methadone           grow, they usually will fall in the normal range for size and   development.

Methadone is not the only thing that can cause these symptoms.   Smoking          cigarettes, drug use, your biological makeup,  nutrition, and how  well          you take care of yourself are just a  few examples of things that  can affect          the health of your  baby.
Whether or not you are pregnant, you only get the benefits of   methadone          if you are stable on your dose. There is no ‘magic  number’ of  milligrams          to stay below. If you feel any  withdrawals or cravings to use,  make sure          you talk to your  counselor about adjusting your dose. When you  feel withdrawals,           so does your baby and that can lead to complications and even   miscarriage.

Research does not necessarily show any connection between a mother’s dose and withdrawal symptoms in the baby.

It might seem that the more milligrams a mother is taking, the worse the withdrawal symptom s will be, however this is not the case. That’s why we encourage you to focus on finding a dose that works for you and not to worry about the amount of milligrams. If you are tapering, most clinics will stop your taper and keep you at your current dose. Some women ask about tapering off methadone while they are pregnant. The Government’s Center for Substance Abuse Treatment says this: “Medical withdrawal of the pregnant women from methadone is not indicated or recommended.” and here at methadoneandpregnancy.com agree with them. Remember- If you were not ready to taper before you were pregnant, you are not ready to taper because you are pregnant. Medically, pregnant women have been safely tapered off of methadone, but it’s only been done on an inpatient basis where they can monitor the fetus for any distress. You should never try to detox yourself. This can be very dangerous to you and your baby. This can also put your recovery in jeopardy. Usually when women learn more about methadone use during pregnancy and see other healthy babies at the clinic with their moms, they decide to continue methadone treatment. It’s not uncommon to need a dose increase during your pregnancy. By the third trimester the amount of blood in your body just about doubles! Because of this your dose of methadone may need to be increased to help keep you and your baby free from withdrawal symptoms. In fact, an increase in methadone (if you need it) during this time can help improve growth and reduce risk of premature delivery. We cannot stress it enough; make sure you are stable on your dose! If for some reason you aren’t able to make it to the clinic for one day make sure you call the clinic and let them know you aren’t able to make it in. Do your best to get there the next day as early as possible. If you’re having problems with transportation, talk to your counselor. They will help you to figure out how you can get to the clinic every day. Many people wonder: does methadone use during pregnancy increase the chance of my child becoming an addict? There are not many studies that have looked at long-term effects of babies born depended on methadone. The other problem is that there are so many factors influencing drug use, it would be difficult to pinpoint methadone as the ‘cause’ if a child did start using drugs. We do know that there is a genetic component to addiction, so regardless if you are in methadone treatment or not, if you or the baby’s father has had substance abuse problems, the child may be at an increased risk of being an addict or having problems with drug use. While you are pregnant some clinics require that you meet with the Nurse Practitioner (NP) or other medical staff at least once per month. The medical staff wants to check in with you to make sure your pregnancy is going smoothly and ask about your prenatal visits. This is an excellent time to ask any medical questions. If you have any questions at anytime feel free to talk to your counselor or medical staff at the clinic. Your questions are important and deserve to be answered! Clinic staff may ask you to sign a release so we can speak with your prenatal providers. The release is needed so we can talk with your prenatal provider about your treatment at the clinic. It’s also important to have a release in place so if there are any medical concerns the clinic will be able to assist you. Medications such as Suboxone, Nubain, and Stadol could cause you to have severe withdrawal symptoms if you are taking methadone. Be cautious of medications that you are prescribed or given. You should always check with your medical providers before taking any medication. You should never take anyone else’s prescription medication. And be careful about taking any medications, even if it’s offered to you from a friend or family member. Some people store more than one type of medication in a bottle and you might be given something that could harm you, your pregnancy, or cause you to have a positive drug screen. All of your providers are here to support you and want to help you to have a healthy and safe pregnancy! Let us know what you need and how we can help. 1. Methadone maintenance treatment Methadone maintenance treatment (MMT) is the treatment of choice for opioid dependant pregnant women 2. Methadone is a long-acting opioid that enables women to cease or reduce their heroin use and related behaviours, in accordance with a harm minimization philosophy. MMT throughout pregnancy is associated with improved fetal development, infant birth weight, and reduces the risk of perinatal and infant mortality in heroin dependant women (level III 2, 1). The aims of methadone maintenance treatment are to:
  • Reduce or eliminate illicit heroin and other drug use
  • Improve the health and wellbeing of those in treatment
  • Facilitate social rehabilitation
  • Reduce the spread of blood borne diseases
  • Reduce the risk of death associated with opioid use
  • Reduce the level of crime associated with opioid use 2
  • Withdrawal from heroin, without MMT is associated with risks to the fetus and a high risk of relapse2. Women should be informed of these risks, and if it is to be attempted it should ideally be done in the 2nd trimester, supervised in a specialist unit (Consensus,1). While inpatient supervision of withdrawal is not available at the Women's, WADS clinicians are able to provide outreach services to pregnant women undergoing withdrawal in specialist detoxification units.
2. Methadone stabilisation program Heroin dependant women should have priority access to methadone treatment, which includes admission to an inpatient obstetric unit for stabilization and rapid dose titration, with respite from the external environment (Consensus,1). This service is offered at the Women's, under the supervision of WADS care coordination team inpatient stabilisation brochure, at any gestation. Admission is for 5 days (Monday to Friday). Inpatient admission is necessary as rapid induction onto methadone is required. Legislative requirements must be met, including obtaining a permit for prescribing methadone from DHS before commencing, as per the Women's CPG: Methadone and Buprenorphine Dosing Procedures. Care in pregnancy should be provided as per CPG: Care of Women with Alcohol and Drug Issues in Pregnancy. 2.1 Criteria for methadone stabilisation program Women will be assessed as being
  • dependent on opioids
  • motivated to undertake induction onto MMT
  • willing to comply with the whole program and methadone regime.
Women not suitable for treatment with methadone3:
  • Severe hepatic impairment
  • Hypersensitivity to methadone
  • Unable to give informed consent (eg. Major psychiatric illness) or age under 18, consider jurisdictional requirements for obtaining legal consent
Specialist advice should be sought for clients with severe respiratory depression, acute asthma, acute alcoholism, head injury and raised intracranial pressure, ulcerative colitis, biliary and renal tract spasm, patients receiving monoamine oxidase inhibitors. 3. Methadone induction procedure Women should commence on a dose of methadone that should be titrated to the woman's symptoms with rapid increases1. The starting dose should be 20mg, and is reviewed at 4 hourly intervals or earlier if required. At each review, if the woman has objective signs of withdrawal (eg. Pupils dilated, restless, see short opiate withdrawal scale in appendix of National clinical guidelines for the management of drug use during pregnancy, birth and the early development years of the newborn), then give an additional 5-10mg. If there are no signs of withdrawal no extra dose is given until the next scheduled review. The maximum dose in the first 24 hours should not exceed 50mg. Extreme caution should be exercised when assessing the woman's requirements on subsequent days if a dose of over 30mg is used on day 1, in order to prevent accumulation and possible toxicity from methadone. The same process should be repeated on day 2 (when the woman will almost certainly require less methadone), commencing again with 20mg and giving additional doses of 2.5 to 10mg as required, with a maximum dose increase of 50mg. If at any time the woman becomes sedated (small pupils, drowsiness), increase frequency of observation and ensure no further methadone is administered until sedation is reversed. Women should be encouraged to remain on the ward for 30-60 minutes post dose, for observation. Women should be cautioned regarding the use of other drugs whilst on methadone. Urine drug screening is not routine, but may sometimes be requested if there are concerns about harmful concurrent drug use. 3.1 Vomiting Vomiting is a serious concern in pregnant women on methadone. Vomiting of a methadone dose may lead to withdrawal in both mother and fetus (consensus,1). If a methadone dose is vomited (consensus,1):
  • Within 10 minutes of dosing - consider giving a repeat dose
  • Within 10-60 minutes of dosing - consider giving half a repeat dose
  • More than 60 minutes after dosing - consider half a repeat dose if withdrawal occurs
Prevention of vomiting (consensus,1):
  • Women should be discouraged from ingesting methadone on an empty stomach
  • Women should be encouraged to sip their dose slowly
  • If the dose consistently causes vomiting, consider splitting the dose or giving rectal prochlorperazine 30-60 minutes before dosing
  • If woman vomits constantly not in relation to dose, assess and treat according to the Women's CPG: Hyperemesis Gravidarum.
sources: http://www.thewomens.org.au/Methadon...ioninPregnancy Health Conditions of Drug-exposed Infants Birth weight Birth weight is an important factor associated with children’s overall health and development. Children who weigh under five-and-one-half pounds at birth are more likely to have serious medical problems and to exhibit developmental delays. Drug-exposed infants often do not exhibit normal development. Prematurity The risk of prematurity (birth at less than thirty-seven weeks) is higher in drug-exposed infants. Other complications can include an increase in acute medical problems following birth, and extended periods of hospitalization. Birth weight under three pounds has been associated with poor physical growth and poor general health status at school age. Low Birth weight infants also have an increased risk of neurosensory deficits, behavioral and attention deficits, psychiatric problems, and poor school performance. Premature infants may have experienced bleeding of the brain tissue, hydrocephalus, bronchial problems, eye disease, and interferences with the normal ability to feed. Small for Gestational Age (SGA) This term is used to describe infants whose Birth weight is below the third percentile for their gestational age (i.e., 97% of infants the same age are heavier than the SGA infant). It is common for women who abuse cocaine to experience decreased appetite and provide inadequate nutrition for themselves and their baby. Failure to Thrive (FTT) Infants who were exposed to alcohol and/or drugs may exhibit this disorder, which is characterized by a loss of weight, or slowing of weight gain, and a failure to reach developmental milestones. This can be due to medical and/or environmental factors. The infant’s behavior includes poor sucking, difficulty in swallowing, and distractibility. Many of these children live in chronically dysfunctional families which places them at greater risk of parental neglect. Neurobehavioral symptoms Within seventy-two hours after birth, many infants who were exposed prenatally to drugs experience withdrawal symptoms, including tremors and irritability. Their skin may be red and dry; they may have a fever, sweating, diarrhea, excessive vomiting, and even seizures. Such infants may require medication for calming. Other infants exposed to stimulants show a pattern of lethargy during the first few days after birth, are easily overstimulated, and may go from sleep to loud crying within seconds. These behaviors usually decrease over time and subside in toddlerhood. Infectious diseases Infants with prenatal drug exposure may be exposed prenatally or postnatally to infectious and/or sexually transmitted diseases contracted by their mothers. The most common infectious diseases seen in infants are chlamydia, syphilis, gonorrhea, hepatitis B, HIV, and AIDS. Sudden Infant Death Syndrome (SIDS) Children who have been exposed prenatally to alcohol and/or drugs have an increased risk of dying from sudden infant death syndrome. The causes of SIDS are unknown and its occurrence is almost impossible to predict. Apnea/cardiac monitoring is recommended for these infants. Fetal Alcohol Syndrome Mothers who consume large quantities of alcohol during pregnancy may have babies who are born with Fetal Alcohol Syndrome (or FAS). A diagnosis of FAS is based on three factors: 1) prenatal and postnatal growth retardation; 2) central nervous system abnormalities, and, 3) abnormalities of the face. Many of these children display significant disabilities, learning disorders, and emotional problems as they mature. Each of the above conditions associated with prematurity or drug exposure has programmatic implications for caregivers; the children who exhibit these conditions are often referred to as "medically fragile". Developmental Outcomes There are many unknowns involved in trying to predict the outcomes of infants and children exposed to drugs. While we know that there are certain physical problems that may remain with the child, in a structured and nurturing environment, many of these children are able to grow and develop quite normally. A small percentage of children have been found to have moderate to severe developmental problems. But regardless of their health status, all children who have a history of prenatal substance exposure should receive developmental evaluations on a regular basis: at least once during the first six months; at twelve months; and at least every year thereafter until school age. Early identification of social, language, cognitive, and motor development problems is essential. Developmental Patterns in Children Exposed Prenatally to Drugs Birth to fifteen months
  • Unpredictable sleeping patterns
  • Feeding difficulties
  • Irritability
  • Atypical social interactions
  • Delayed language development
  • Poor fine motor development
Toddlers from sixteen months to thirty-six months
  • Atypical social interactions
  • Minimal play strategies
Preschool children from age three to five While average preschoolers are beginning to share and take turns, demonstrate language skills, and increase their attention spans in a group setting, the drug-exposed toddler may be hyperactive, have a short attention span, lose control easily, have mood swings and problems moving from one activity to another. These children may also experience difficulties processing auditory or visual information/instructions. School and teenage years There has not been sufficient research into the long-term biological effects of drug exposure on older children and teenagers, however, we do know that children with the behaviors described above are at greater risk of abuse and neglect, learning disabilities, and behavioral problems. Obviously, it becomes imperative to identify these problems at a very early age, access the necessary resources for the child, and build a team of professionals who regularly monitor the progress of each child. Supporting a drug-exposed child in the course of his life may require advocating vigorously for specialized educational services; providing recreational and employment opportunities that allow a measure of success; educating parents; and providing counseling. Techniques in Working with Drug-exposed Infants and Young Children Respite and crisis care programs working with drug-exposed infants and children may not know the exact drugs to which each child was exposed. A combination of substances, including alcohol and tobacco, may be involved. There are a few techniques, however, which can be used in a general plan of care that may be individualized to meet the specific problems of each child:
  1. Provide a calm environment: low lighting; soft voices; slow transition from one activity to another.
  2. Be aware of signs of escalated behavior and frantic distress states before they occur, e.g., increased yawns, hiccoughs, sneezes, increased muscle tone and flailing, irritability, disorganized sucking, and crying.
  3. Use calming and special care techniques on a regular basis, such as
    • swaddling blankets tightly around the infant
    • using a pacifier even when the infant is not organized enough to maintain a regular suck
    • rocking, holding, or placing the infant in a swing, or Snuggly™ carrier
    • massaging the child
    • bathing in a warm bath, followed by a soothing application of lotion
    • rubbing ointment on diaper area to prevent skin breakdown
  4. Encourage developmental abilities when the infant is calm and receptive using only one stimulus at a time. Look for signs of infant distress and discontinue the activity if this occurs.
  5. Gradually increase the amount and time of daily developmental activities; encourage the child to develop self-calming behaviors and self control of his own body movements.
Behavior Descriptions and Suggested Strategies Feeding problems Feed the baby more often; feed smaller amounts at one time; allow the infant to rest frequently during feeding. Place the infant upright for feeding; after feeding, place the child on his side or stomach to prevent choking; if vomiting occurs, clean the skin immediately to prevent irritation. Irritability/unresponsive to caregiver Reduce noise in the environment; turn down lights; swaddle the infant: wrap snugly in a blanket with arms bound close to the body. Hold the infant closely; put the infant in a bunting-type wrapper and carry it close to your body. Rock the infant slowly and rhythmically, either horizontally or with its head supported vertically, whichever soothes. Place the child in a front-pack carrier; walk with the infant; offer the infant a pacifier or place it in an infant swing. Goes from one adult to another, showing no preference for a particular adult Respond to specific needs of child with predictability and regularity.

May have poor inner controls/frequent temper tantrums


Use  books,  pictures, doll play, and conversation to help the child explore  and express a range of feelings.

Ignores  verbal/gestural  limit setting
Talk  the child  through to the consequence of the action.

Shows decreased   compliance with simple, routine commands
Provide  the child  with explicitly consistent limits of behavior.

Exhibits tremors  when  stacking or reaching
Observe  the child  and note the onset of tremors, their duration, and how the  child compensates for them; provide a variety of materials to enhance  development and refinement of small motor skills, e.g., blocks, stacking  toys, large Leggos™, and puzzles with large pieces. Sand and water play  are soothing and appropriate.

Unable to end or let  go  of preferred object or activity
Provide  attention  and time to children who are behaving appropriately; provide  child with an opportunity to take turns with peers and adults.

Delayed receptive  and  expressive language
Create  a stable  environment where the child feels safe to express feelings,  wants, and needs; use stories/records/songs; use hands-on activities to  reinforce the child’s language abilities.

Expresses wants,  needs,  and fears by having frequent temper tantrums
Remove  and help  calm the child; redirect the child’s attention; verbalize the  expected behavior; reflect the child’s feelings. Praise attempts toward  adaptive behavior. Set consistent limits.

Difficulty with  gross  motor skills (e.g. swinging, climbing, throwing, catching,  jumping, running, and balancing)
Provide  appropriate  motor activities through play, songs, and equipment. Offer  guidance, modeling, and verbal cues as needed.

Over-reacts to  separation  of primary caregiver
Offer  verbal  reassurance; be consistent, and help the child learn to trust  adults.

Withdraws and seems  to  daydream or not be there
Provide   opportunities for contact; move close to the child, make eye contact,  use verbal reassurance; allow, identify, and react to the child’s  expressions of emotions.

Frequent temper  tantrums
Understand  that a  tantrum is usually a healthy release of rage and frustration;  protect the child from harm; remove objects from the child’s path if he  is rolling on floor. Some children do not want to be held during a  tantrum and doing so can cause more frustration. Remain calm, using a  soothing voice; anger will only escalate the child’s frustration. Do not  shout or threaten to spank the child–the adult needs to be in control.  Help the child to use words to describe emotions. Read stories about  feelings. Help the child gain control by making eye contact, sitting  next to the child, giving verbal reassurance, and offering physical  comfort (rubbing back, etc.). Note the circumstances that provoked the  tantrum, and try to avoid such confrontations when possible. Provide a  neutral area for the child to work through the tantrum, (e.g., a large  cushion or bean bag chair). Some children want to work through a tantrum  alone; keep the child in sight, but do not interact until he is calm.

Parent  Involvement
It is critical to the  success  of the drug-exposed infant that the eventual caregiver (parent,  relative, foster parent, respite provider, adoptive parent) learn the  care routine, control techniques, and background of the children for  whom they will be providing care. Understanding the etiology of  drug-exposure, the types of medical problems that arise, the  developmental patterns, and the techniques for handling drug-exposed  infants and toddlers is imperative.

Program social workers,  case  managers, child care staff, and nursing staff must all work  together with the caregiver to offer parent education ("hands-on"  opportunities to provide care under the guidance of professionals), and  encouragement for families who undertake the care of a drug-exposed  infant. The caregiver’s understanding of the child’s behavior, physical  "cues," and developmental problems, goes a long way in helping the  drug-exposed infant, toddler, and teen succeed. It also assists the  caregiver in setting realistic expectations for children who enter the  world battling the the effects of their parent’s addiction.

Many children who were   prenatally exposed to drugs will grow and develop without unusual  problems. However, for those infants who have physical indicators, the  respite and crisis care provider can make a difference by providing,  perhaps, the first stable, nurturing environment. Here, the child can be  observed, positive routines for care can be established, and parents  can receive the critically necessary education and support to enable  them to care for an alcohol or drug-exposed child.

Summary
Staff training, caregiver   training, and parent education are all critical elements of any program  that will be successful with these children. Physical elements of the  environment (lighting, noise, and space) may need to be adjusted to  accommodate their care. The inclusion of medical support, i.e., nurses  and physicians who are familiar with the problems of these children, is  essential. In summary, the care of alcohol and drug-exposed children is a  team effort that requires coordination, case management, special care  techniques, and education to be successful in any respite or crisis care  situation. With these components in place, agencies and families can  witness the positive growth and development of children who have been  greatly at risk.

About the Author: Jeanne Landdeck-Sisco, MSW, is the Executive Director of Casa de los  Niños  in Tucson, Arizona, which was the first crisis nursery in the  U.S., established in 1973. Ms. Landdeck-Sisco served as the first  President of the ARCH National Advisory Committee for Respite and Crisis  Care Programs from 1991-93 and remained on the committee until 1996.
Resources
Center for Substance Abuse   Prevention National Resource Center for the Prevention of Perinatal  Abuse of Alcohol and Other Drugs, 9302 Lee Highway, Fairfax, VA 22031,  (800) 354-8824.
National Organization on  Fetal  Alcohol Syndrome, 1815 H Street, N.W., Suite 710, Washington, DC  20006, (202) 785-4585.
References
Besharov, Douglas J. When   Drug Addicts Have Children. Washington, DC: Child Welfare League  of America, 1994.
Hargrove, Elisabeth, et  al. Resources Related  to Children and Their Families Affected by  Alcohol and Other Drugs. Chapel Hill, NC: NEC*TAS, 1995.

Special acknowledgment is  given to Rosemarie Dyer, R.N., Nursing Supervisor at Casa  de los Niños, who has developed the agency’s program for drug- and  alcohol-exposed infants and from whose training material many of the  techniques and caregiver responses have been drawn; and to Anna  Binkiewicz, M.D., Casa de los Niños Board Member and Medical  Director, who has provided on-site medical treatment of Casa’s medically  fragile children.

Table of contents
EXECUTIVE SUMMARY…………………………………………………………………………..1
INTRODUCTION ……………………………………………………………………………………..2
Medico-legal issues …………………………………………………………………………………………………………………….. 2
OPIOID DEPENDENCE AND PREGNANCY……………………………………………….3
Opioid use during pregnancy ………………………………………………………………………………………………………. 3
Pregnancy outcomes…………………………………………………………………………………………………………………. 3
Neonatal abstinence …………………………………………………………………………………………………………………. 5
OPIOID SUBSTITUTION IN PREGNANCY …………………………………………………6
Objectives of opioid substitution ………………………………………………………………………………………………….. 6
Opioid substitution during pregnancy………………………………………………………………………………………….. 6
Objectives of opioid substitution in pregnancy……………………………………………………………………………… 7
Management of opioid substitution during pregnancy and perinatally ………………………………………….. 8
Assessment of pregnant women………………………………………………………………………………………………….. 8
Maintenance treatment ………………………………………………………………………………………………………………. 8
Breastfeeding ………………………………………………………………………………………………………………………….. 9
Other management approaches for the treatment of heroin dependence during pregnancy………….. 10
BUPRENORPHINE ………………………………………………………………………………..11
Registration and listing of buprenorphine ………………………………………………………………………………….. 11
Literature summary: clinical studies of buprenorphine and pregnancy……………………………………….. 13
Concerns regarding the use of buprenorphine in pregnancy ……………………………………………………….. 17
Monitoring of women for pregnancy while on buprenorphine programs……………………………………… 19
Use of buprenorphine in pregnancy……………………………………………………………………………………………. 20
Transfer from buprenorphine to methadone………………………………………………………………………………. 22
Management with buprenorphine during pregnancy ………………………………………………………………….. 23
Management of dependence……………………………………………………………………………………………………… 23
Management of opiate dependence with buprenorphine……………………………………………………………. 23
Notification of buprenorphine pregnancy ……………………………………………………………………………….. 23
Frequency of review………………………………………………………………………………………………………… 23
Management of heroin use ……………………………………………………………………………………………….. 24
Dose adjustments……………………………………………………………………………………………………………. 24
Monitoring…………………………………………………………………………………………………………………….. 24
Dose reductions or detoxification during pregnancy…………………………………………………………….. 24
Turing Point Alcohol and Drug Centre and The Royal Women’s Hospital
______________________________________________________________________________
ii
Frequency of dosing ………………………………………………………………………………………………………… 24
Use of other substances ……………………………………………………………………………………………………. 24
Dispensing Issues ……………………………………………………………………………………………………………. 25
Poor progress on buprenorphine ……………………………………………………………………………………………. 25
Direct transfer from methadone to buprenorphine……………………………………………………………………… 26
Induction onto buprenorphine after diagnosis of pregnancy ……………………………………………………….. 26
Management of obstetric care ……………………………………………………………………………………………………. 27
Management of ante-natal care …………………………………………………………………………………………………. 27
Frequency of review ……………………………………………………………………………………………………………. 27
Multidisciplinary team approach …………………………………………………………………………………………… 27
Monitoring of pregnancy ……………………………………………………………………………………………………… 27
Timing of delivery ………………………………………………………………………………………………………………. 27
Care in labour………………………………………………………………………………………………………………………… 28
Induction …………………………………………………………………………………………………………………………… 28
Analgesia during labour and caesarean section ……………………………………………………………………….. 28
During labour ………………………………………………………………………………………………………………… 28
Postpartum…………………………………………………………………………………………………………………….. 29
Caesarean section ……………………………………………………………………………………………………………. 29
Use of buprenorphine post-partum…………………………………………………………………………………………….. 29
Management of neonatal care ……………………………………………………………………………………………………. 30
Neonatal Withdrawal Syndrome ……………………………………………………………………………………………….. 30
Breast feeding and buprenorphine……………………………………………………………………………………………… 32
Recommendations ………………………………………………………………………………………………………………….. 32
Prescribing requirements………………………………………………………………………………………………………….. 33
APPENDIXES………………………………………………………………………………………..34
APPENDIX 1: PATIENT CONSENT FORM FOR BUPRENORPHINE
TREATMENT DURING PREGNANCY / BREASTFEEDING ………………………..35
APPENDIX 2: LETTER FROM OBSTETRIC SERVICE TO GENERAL
PRACTITIONERS…………………………………………………………………………………..36
APPENDIX 3: NEONATAL ABSTINENCE SCORE – FINNEGAN SCORE…….36
APPENDIX 4: ISSUES FOR CLINICAL DISCUSSION………………………………..38
APPENDIX 5: CONTACT PHONE NUMBERS …………………………………………..39
REFERENCES ………………………………………………………………………………………41

Please read more:CTG_Bup_Pregnancy_060104

Pharmacists have the unique knowledge, skills and responsibilities for assuming an important role in substance abuse prevention education and assistance…  Pharmacists, as health care providers, should be actively involved in reducing the negative effects that substance abuse has on society, health systems and the pharmacy profession.

— American Society of Health-System Pharmacists (2003)

Competency framework

Unless they have taken special training, most pharmacists are unaware of the clinical and practice issues surrounding methadone and their impact on client safety because they have had little or no exposure to them during their undergraduate pharmacy education.

The role of the pharmacist in MMT is unusual and there is no similar model in other therapeutic areas. Daily interactions with clients, along with direct clinical assessments, supervised dose administration and close monitoring do not usually occur in other types of pharmacy care. Pharmacists require a set of key competencies to ensure client safety in methadone maintenance treatment.

The panel recommends that:

15. Pharmacy managers/owners, hospital pharmacy directors and the Ontario College of Pharmacists support and encourage pharmacists providing methadone services to have education in and/or demonstrate knowledge and skills in core competency areas. These areas include:

a. Substance use disorders, including opioid dependence. [IV]

b. The varied models of substance abuse treatment, including harm reduction and its implications for pharmacy. [IV]

c. The impact of attitudes and stigma on client care. [III]

d. Methadone maintenance treatment clinical guidelines and their rationale, particularly with respect to practices to protect client safety, including:

  • assessing initial and increased doses for appropriateness
  • assessing methadone-dosing histories (for missed doses and irregularities in pattern of pickup) before dispensing a dose of methadone to a client
  • ensuring the safe provision of “carries” (take-home doses) to clients
  • dealing with intoxicated clients, including understanding the risks of polysubstance abuse. [IV]

Pharmacists need to understand substance use disorders, particularly addiction, and to understand the difference between “use” and “use disorders.” Pharmacists need to be able to identify individuals with substance use disorders and to help motivate them to seek change and treatment. As one of the most accessible health care professionals, the pharmacist can play an important role and refer patients to appropriate services and substance use treatment programs. Many MMT clients have concurrent substance use disorders with substances such as alcohol, benzodiazepines or cocaine. Pharmacists should understand the risks associated with polysubstance use and the risk of toxicity.

Although pharmacists may already be involved in harm reduction, for example, by providing sterile needles and syringes to people who use injection drugs, further involvement could include offering advice to people with substance use problems about health issues and how to minimize health risks. A random survey of 2,017 Canadian pharmacists by Myers et al. (1998) found that while more than 88 per cent of pharmacists were comfortable with the harm reduction role in providing needles and syringes, this comfort did not extend to providing methadone services. This may be due to a misunderstanding of the benefits of methadone maintenance treatment and its role as a harm reduction approach. Educational initiatives need to address such misunderstandings and other negative attitudes or misperceptions that may be held by pharmacists.

Pharmacists must have a good understanding of the critical safety issues associated with methadone. Methadone has a unique pharmacological profile that makes it useful in the treatment of opioid dependence; however, it is different from other opioids and the implications of its long half-life can lead to risks of accumulation contributing to methadone overdose and deaths.

The initiation phase of methadone treatment can be a time of high risk for toxicity and pharmacists’ understanding of dosing recommendations is critical at this stage. Pharmacists need to exercise particular vigilance in monitoring client dosing for appropriateness. For example, where clients have missed several doses (defined as three or more), or fewer (one or two) during periods of methadone dose escalation, pharmacists must understand the concept of loss of tolerance and risks to clients if the usual regular methadone dose is administered (CPSO, 2005).

Pharmacists also have to understand the safety issues associated with “carries.” Having a written carry agreement with the client is one way to help the client understand these issues as well. Pharmacists should be aware of some of the signs that indicate a formerly stable client on a high level of carries is relapsing to instability (e.g., missing observed dosing days, lost carries) (CPSO, 2005).

Pharmacists in Ontario need to be familiar with the CPSO’s most recent Methadone Maintenance Guidelines (2005), the OCP’s Policy for Dispensing Methadone (2006), and CAMH’s Methadone Maintenance: A Pharmacist’s Guide to Treatment (Isaac et al., 2004).

Understanding the risks of polysubstance use and knowing how to deal with intoxicated clients are particularly important core competency areas for pharmacists, with significant safety implications. The pharmacist should have an understanding of the impact that polysubstance use (for example, use of benzodiazepines, alcohol and cocaine) can have on the client taking MMT. Through dialogue and checking for signs of excessive dosing or substance use such as sedation, slurring of speech, smelling of alcohol and unsteady gait, the pharmacist should be able to assess if a client is intoxicated before dosing.

Recommendations from the coroner have highlighted the need for assessing clients for intoxication because deaths have occurred through combination of methadone and other drugs, including alcohol (OCP, 2008).

In an Australian survey (Peterson et al., 2007), pharmacists identified the risk of overdose associated with methadone alone and in combination with other psychoactive drugs as the greatest problematic issue for pharmacists in deciding to provide a methadone service.

In a survey of 148 pharmacists in Australia (Koutroulis et al., 2000), when asked about how they would respond to clients who presented intoxicated for their methadone dose, 44 per cent said they would withhold the dose and inform the client of this. This is the desirable course of action. However, 32 per cent of pharmacists said they would provide the usual dose, 16 per cent would dispense a reduced dose without the client knowing and nine per cent said they would blind the dose with a placebo. Only two per cent of the pharmacists indicated that they would breathalyse an intoxicated client.

Pharmacists who withheld the methadone dose were more likely to inform the prescriber (74 per cent) than pharmacists who dispensed the usual or modified dose. In a focus group, the reasons for dispensing to an intoxicated client were categorized as follows:

  • insufficient communication between prescriber and pharmacist
  • downplaying the risk of toxicity
  • personal beliefs and values
  • fear of what the client would do if dose refused
  • difficulty in recognizing intoxication and lack of education and training.

Further, Koutroulis et al.’s survey suggested that pharmacists who had more than 10 methadone clients were more likely to provide the usual methadone dose than pharmacists with 10 or fewer clients.

Educational offerings

Many physicians and pharmacists don’t think they see addicts in their practice. The reality is they probably are treating them for other disorders, but the patient just hasn’t been identified as an addict. This also means that dependence treatment needs to become part of regular pharmacy practice as well.

— Open discussion, physicians and pharmacists (Raisch et al., 2005)

The panel recommends that:

16. All pharmacy students receive education on substance abuse, including opioid dependence, its treatment and practical intervention strategies, in their undergraduate curriculum. [IV]

Future pharmacists need to be adequately educated on substance use so that they are prepared upon graduation to care for patients with substance abuse disorders. In particular, opioid dependence and its treatment should be required components in the curriculum. Pharmacists who have had education in this area are likely to feel more comfortable providing pharmaceutical care to this group of clients.

Currently there are two faculties of pharmacy in Ontario, at the University of Toronto and at the University of Waterloo. The Waterloo faculty initiated their program in January 2009; therefore, their plans for curriculum on substance abuse education are still in the development phase.

At Toronto’s Faculty of Pharmacy, pharmacy students receive a rigorous scientific and clinical education over four years but receive little or no education on substance abuse and its treatment. Since the early 1990s, an elective fourth-year problem-based course has been offered (Busto et al., 1994). This course has one 2-hour segment on opioid abuse and treatment. It includes a didactic component, as well as an MMT client interview and discussion of stigma and attitudes. The course is elective and only a small proportion of the fourth-year class has taken this course offering.

Over the last five years enrolment in this elective has increased from 9.7 per cent of the class (13/134 students) in 2003–2004 to 34.2 per cent of the class (79/231 students) in 2008–2009 (personal communication, Dr. B. Sproule, April 29, 2009). Clearly, most future pharmacists have no exposure to substance use, opioid dependence and treatment with methadone.

The lack of specific undergraduate educational activities about substance abuse results in a missed opportunity to positively influence the knowledge, skills and attitudes of future pharmacists in this area.

As the most accessible of all health care professionals, pharmacists have an important role to play to help prevent and treat substance abuse disorders in their clients (Tommasello, 2004). Preparation for this role should begin in the undergraduate pharmacy training.

Experiential learning and other innovative teaching methods, for example, involving real patients (or simulated cases), audiovisual vignettes or other online modules may enhance pharmacy students’ understanding of substance dependence issues and attitudes.

One college of pharmacy in the United States, in addition to a required substance abuse course, offers an elective to illustrate addiction recovery principles. Students taking the elective are asked to give up a habit that is causing them problems for six weeks and they meet weekly to discuss the addiction recovery process. This course has been offered for 15 years and 50 per cent of the substance abuse course students are enrolled (Baldwin, 2008).

From the client consultation interviews

Clients’ need for pharmaceutical care
“I would have liked to know more about methadone before I started. It would have helped me make a better decision. You shouldn’t just tell a sick person ‘this will make you better.’ ”

“There has been a lack of care and communication and confusion with my HIV meds. The methadone wasn’t holding me due to medication interactions.”

“I felt sick for weeks and didn’t know it was because my dose was too high.”

The panel recommends that:

17. Professional organizations, addiction and mental health agencies and pharmacists’ employers promote the development of, and provide encouragement for all practising pharmacists to participate in, educational events on substance abuse and opioid dependence, including the growing problem of prescription opioid abuse. [III]

Most pharmacists receive little training on opioid dependence and treatment in their undergraduate experience, and it is important that all pharmacists further their knowledge in this area, even if they are not yet providing MMT services. There are indications that abuse and dependence on prescription opioids is increasing in Ontario and Canada. There was an increased number of patients addicted to prescription opioids entering the CAMH methadone maintenance program following the rapid expansion in the availability of MMT in Ontario in the 1990s (Brands et al., 2002; Brands et al., 2000). More recently, the number of individuals seeking detoxification treatment from controlled-release oxycodone at CAMH has also increased significantly (Sproule et al., 2009). In addition, in a cohort study of illicit opioid users, the proportion using prescription opioids increased from the year 2002 to 2005, with regional differences noted across Canada (Fischer et al., 2006). Pharmacists need to increase their knowledge base in prescription opioid addiction, particularly to understand the difference between addiction and physical dependence. Continuing education programs on pain treatment rarely (or inadequately) discuss the issue of opioid abuse and dependence.

A survey in British Columbia of 257 pharmacists (Cohen & McCormick, 2008) found that a slight majority reported training on how to identify signs of prescription drug misuse or abuse. This training was more common in younger pharmacists. The mean amount of training was 13.6 hours. Many pharmacists learned to identify prescription drug misuse through personal experience: they detected multi-doctoring using the provincial PharmaNet prescription drug profile or by recognizing early refills of prescriptions. Most intervened by calling the physician to confirm prescriptions or by confronting the customer directly. The primary reason they gave for not intervening was concern over how the customer might react (i.e., they were afraid that the client would be confrontational or they feared for their own safety). Pharmacists recommended additional training on prescription drug misuse.

Jones et al. (2005) surveyed 42 community pharmacists in Wales and found that at one month after a structured educational evening event there was little maintained change in attitudes. This suggests that changing attitudes is a long-term process. There is a need for reinforcing changes through continuing education.

Practising pharmacists (484) in Florida were surveyed while attending continuing education programs (Lafferty et al., 2006). Of the respondents, 67.5 per cent reported participating in two or fewer hours of addiction/ substance abuse education in pharmacy school and 29.2 per cent said they had received no addiction education. Pharmacists who had more education counselled clients more frequently and felt more confident in dealing with substance abuse clients. Of those surveyed, 53 per cent reported they had never referred a patient to substance abuse treatment in their whole career.

Brooks et al. (2001) conducted a survey in the United States of 556 pharmacists, comparing those who had taken training in addiction treatment to those who had not, and found that those who had taken training would more likely refer clients to community resources and be more involved in working with their chemically dependent clients.

The panel recommends that:

18. The Ontario College of Pharmacists revise the current requirements for pharmacies providing MMT services to mandate earlier training to promote safety. The designated manager and one pharmacist must complete the training within six months of starting to dispense methadone. [IV]

19. CAMH or another approved provider of methadone training develop a brief electronic document (e.g., one page) outlining the key safety features of providing MMT services that can be made available for immediate use by pharmacies initiating MMT services. [IV]

20. CAMH produce an electronic version of its most recent pharmacist’s guide to methadone maintenance treatment that can be purchased online and downloaded immediately so that pharmacies initiating MMT services can access it without delay. [IV]

21. CAMH make the online component of its Opioid Dependence Treatment Course available immediately upon enrolment to pharmacists new to providing MMT services, with the stipulation that these pharmacists attend the workshop component within six months of beginning the course. [IV]

22. CAMH or another approved provider of methadone training monitor and respond to waiting lists for training programs by, for example, offering the training more frequently or by exploring other delivery methods, such as webinars or video conferencing, to help meet the needs of pharmacists in remote areas. [IV]

Since undergraduate training on substance abuse and opioid dependence is lacking, most pharmacists do not have an adequate knowledge base from which to provide MMT services safely.

Having the most essential knowledge and references easily accessible and as early as possible will help facilitate pharmacies starting a methadone service and assist those who are deciding whether to provide MMT.

The online component of the CAMH Opiate Dependence Treatment Interprofessional Education Program would provide a good introduction to providing service, and a brief methadone information sheet would complement this program. The methadone information sheet could include some of the key points in providing MMT service, for example, observing dosing, diluting dose in orange drink, identifying the client, assessing the client for intoxication and informing the prescriber of missed doses.

Having a current version of the CAMH Pharmacist’s Guide available in a downloadable format would enable pharmacists to have this mandatory reference as soon as they need it. The other two references pharmacists dispensing methadone require, the CPSO Methadone Maintenance Guidelines and the OCP Policy for Dispensing Methadone, are currently available electronically.

The panel recommends that:

23. The Ontario College of Pharmacists and providers of methadone training collaborate on ongoing training requirements based on needs identified during the College’s pharmacy inspection process. [IV]

The Ontario College of Pharmacists undertakes regular inspections of community pharmacy practice in the province. Practice issues related to methadone service provision identified during these inspections could be shared with educational service providers for consideration in future training initiatives. This would be an effective mechanism for updating methadone training to reflect current practice issues in the field.

The panel recommends that:

24. CAMH or another approved provider of methadone education deliver methadone training in a manner consistent with interprofessional education principles. [IV]

Since MMT practice is best delivered in a collaborative manner (Health Canada, 2002), a multidisciplinary approach in education will prepare pharmacists to work effectively with other health professionals as a team.

The panel recommends that:

25. The Ontario College of Pharmacists and community colleges providing pharmacy technician training develop core competency requirements for regulated pharmacy technicians providing MMT services. [IV]

Pharmacy technicians are important members of the pharmacy team. They may be involved with preparing and dispensing methadone, and interact with MMT clients in the pharmacy. Core competencies should be developed and educational programs designed to optimize the role of pharmacy technicians in the safe delivery of methadone services. This issue may be particularly important in view of the new regulated status for pharmacy technicians that will be implemented soon in Ontario, where pharmacy technicians will be able to take more responsibility for dispensing.

The panel recommends that:

26. CAMH or another approved provider of methadone education undertake a needs assessment of pharmacists who have participated in the initial MMT training, and then use this information to develop an updated or advanced MMT course for pharmacists. [IV]

27. Professional pharmacy organizations, the Ontario College of Pharmacists, pharmacy managers/owners and hospital pharmacy directors encourage pharmacists to take courses on motivational interviewing, intervention strategies to use with difficult patients, and concurrent disorders, to enhance pharmacists’ skills in dealing with opioid-dependent clients. [IV]

Pharmacists who are already in MMT practice and have taken initial MMT training may wish to update and improve their skills. Since pharmacist training is recommended by the Ontario College of Pharmacists every five years, a new, higher level course would meet the needs of this experienced group of providers. Pharmacists who have taken initial MMT training should be surveyed for their input about topics to include within this higher level course. This advanced training could include, for example, methadone use in pregnancy, in patients with concurrent disorders (e.g., pain, psychiatric disorders, HIV) and in other special populations.

Any interaction with a client has therapeutic potential. Pharmacists using motivational techniques in their interactions with clients may enhance clients’ treatment. The issue of dealing with difficult, demanding clients has been identified by pharmacists as an area in which they would like more training (Cohen & McCormick, 2008). Training in de-escalation techniques to avoid potentially unsafe interactions could help pharmacists achieve greater satisfaction in their practice, as well as improve client outcomes.

The panel recommends that:

28. Drug information service providers ensure that staff is trained on and familiar with common issues in MMT treatment and have a mechanism to refer to experts when necessary. [IV]

Pharmacies must subscribe to a drug information provider service. The staff at the drug information provider should be able to respond to general questions on MMT and substance abuse. To do this they would require training in MMT to understand the patient safety issues and relevant guidelines. For more complex questions, the drug information service should have an arrangement with expert service providers to assist in consultation.

The panel recommends that:

29. Professional pharmacy organizations develop a mechanism in conjunction with the Ontario College of Pharmacists to ensure that pharmacists dispensing methadone are informed in a timely fashion of new educational resources available. [IV]

A timely direct communication via e-mail from the Ontario College of Pharmacists, the Ontario Pharmacists’ Association or another professional pharmacy organization is recommended when any new methadone-related item is posted on the website of either the OCP or the CPSO.

The panel recommends that:

30. Professional pharmacy organizations, CAMH and funding agencies develop a mentorship program to link new methadone service providers with experienced providers. [IV]

31. Professional pharmacy organizations and CAMH promote the CAMH Addiction Clinical Consultation Service to pharmacists providing MMT services. [IV]

The Addiction Clinical Consultation Service (ACCS) is a service provided by CAMH. It is designed to serve health and social service professionals, including pharmacists, who have client-specific questions related to substance abuse. The accs is not designed to deal with health emergencies or immediate or legal issues. The health care worker calls a central phone number and, depending on the question, accs may provide referral to a consultant team member (physician, therapist/counsellor or pharmacist) who will communicate with the health care worker within four hours. Awareness of the service should be promoted to support pharmacists providing methadone services.

Very few studies have considered heroin users’ views on substitute prescribing, in
particular with regards to subutex. The aim of this study was to conduct detailed
qualitative analysis, using the Grounded theory approach, on heroin users’ views on
substitute prescribing, paying specific attention to methadone and subutex. Semistructured
interviews were conducted with nine subjects recruited from an
abstinence-based, structured day care treatment program. All of the subjects were
either currently on a subutex prescribing program, or had remained abstinent from
illicit substances following the completion of a subutex treatment program. Five major
themes emerged from the analysis. These were reasons for obtaining a methadone
prescription, experiences with methadone programs, views on methadone, views on
subutex and views on an ideal opioid treatment program. Most of the findings were
supported by previous qualitative studies such as that of Neale (1999a) and Fischer
and colleagues (2002). However, there does appear to be some discrepancies
between qualitative and quantitative research with regards to consumer satisfaction
of methadone, in comparison to subutex, as a substitute drug. This study clearly
highlights the need for further research into users’ views on substitute prescribing,
with emphasis being placed on qualitative research considering users’ experiences
with subutex.

Read the full File: methadoneversussubutex kopie

1. ALLGEMEIN 2
2. RECHTSGRUNDLAGE 2
3. SUBSTITUTION 2
3.1 Voraussetzungen für die Substitution 2
3.2 Durchführung der Substitution 3
3.2.1 Der behandelnde Arzt 3
3.2.2 Die Suchtberatungsstelle 3
4. BEWILLIGUNGSVERFAHREN 3
4.1 Ordentliches Verfahren (definitive Bewilligung) 3
4.2 Eilverfahren (provisorische Bewilligung) 3
4.3 Verlängerung der Bewilligung 3
4.4 Beendigung der Substitutionsabgabe 3
4.5 Entzug der Bewilligung 4
5. PERSONENDATENSCHUTZ 4
6. EVALUATION 4
7. INKRAFTTRETEN / ÜBERGANGSREGELUNG 4
8. ANHÄNGE 5
8.1 Anhang: Ablaufschema bei einer Erst-Bewilligung 5
8.2 Anhang: Ablaufschema bei einer Verlängerung der Bewilligung (jährlich) 6
8.3 Anhang: Antrags-/Eintrittsfragebogen 7
8.4 Anhang: Verlaufs-/Abschlussberichtsfragebogen 9
8.5 Anhang: Empfehlungen für die Methadonbehandlung 11
8.6 Anhang: Empfehlungen für die Buprenorphinbehandlung 14
8.7 Anhang: Behandlungsvertrag 17

Volle Fassung:ao_bm_substitutionsrichtlinie

Buprenorphine interactions

Although there is significant confusion in the literature, buprenorphine is most commonly classified as a (partial) mu agonist/kappa antagonist. There is consensus that in the relatively ‘low doses’ used in clinical pain management, (5-100 mcg per hour), buprenorphine behaves like a ‚full‘ mu agonist. The partial agonist/antagonist effects seem only to become relevant for analgesia in very high doses used to treat opioid addiction (8-32 mg per day).

In patients on ‘analgesic doses’ of buprenorphine (eg transdermal), one can continue to use opioid analgesics for breakthrough pain in the usual way with good effect. The partial agonist/antagonist effect on supplemental opioid analgesia is not a major clinical issue. Other alternatives include sublingual buprenorphine or tramadol.

When treating acute pain after major surgery or trauma in patients on ‘high dose’ sublingual buprenorphine for addiction, continue the buprenorphine, using maximal multimodal analgesia including ketamine and neural blockade, supplemented with opioid PCA (using higher bolus doses) and monitoring the patient closely for adverse effects. In our experience, many patients undergoing major emergency surgery seem to do well with continuation of high dose sublingual buprenorphine and PCA fentanyl or morphine in appropriate doses. Conversion to standard opioids is complicated and often unnescessary.

Methadone interactions

Because methadone ‘saturates’ CYP450 (3A4) at low plasma levels (low hepatic clearance) compared with other opioids, it’s very ’susceptible‘ to;

  • The effects of a 30-fold variation in CYP450 enzyme activity between patients (fast, medium or slow methadone metabolisers), thus explaining the wide range of t1/2 (5-150 hours) and in part, highly variable clinical responses to methadone loading.
  • ‘Plasma accumulation‘, as the dose or frequency increases (the ’saturated‘ CYP450 can’t ‚burn off‘ the excess methadone):
  • Complex interactions with many drugs that share CYP450 for metabolism, particularly anticonvulsants, antidepressants, anti-microbial and antiretrovirals.

When prescribing methadone, always think about drug interactions at CYP450. Interactions are complex, with either induction (eg. phenytoin, rifamycins) or suppression (eg. fluvoxamine, fluoroquinalones, macrolides) of enzyme activity affecting methadone clearance, sometimes resulting in either withdrawal or accumulation respectively.

Methadone is highly-bound to plasma acute phase reactants (a1-acid glycoprotein), with the free methadone concentration decreasing when the level of phase reactants is raised (the free methadone is ‘mopped up’) such as in cancer or sepsis, leading to reduced analgesia or in rare cases withdrawal.

There are also substantial risks of over-sedation when methadone is combined with benzodiazepines, alcohol or THC.

Methadone, prolongs the QT interval in a dose dependent fashion (usually in doses greater than 200 mg per day) with case reports of Torsades de Pointes and VT. Check an ECG before commencing methadone, keep doses low and consider potential interaction with other drugs and conditions that prolong the QT interval.