Tag Archive: Buprenorphin


Los 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.

108 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

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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

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

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.

Am 02.12.1999 fand in der Psychiatrischen Klinik der Universität
München unter dem Vorsitz von PD Dr. M. Soyka
eine Konsensus-Konferenz zur Anwendung von Buprenorphin
in der Substitutionsbehandlung opiatabhängiger Patienten
statt. An ihr nahmen Experten aus Deutschland, Österreich
und der Schweiz teil (Teilnehmerliste am Ende des Beitrags).
Hintergrund war die kurz bevorstehende Einführung von
Buprenorphin in der Substitutionsbehandlung Drogenabhängiger
in Deutschland. Ziel der Konsensus-Konferenz war es,
praktische Hinweise für den Einsatz von Buprenorphin zu
geben, um mögliche Indikationen und Kontraindikationen herauszuarbeiten.
Dabei war es hilfreich, daß die Substanz in
Österreich und der Schweiz schon in einigen Therapiezentren
eingesetzt wurde. Im übrigen liegen breite Erfahrungen, vor
allem aus Frankreich, aber auch den USA vor.
Die von den Experten vorgenommene Einschätzung ist Basis
des erarbeiteten Konsensuspapiers gewesen. Einige wenige Punkte
sollen hervorgehoben werden, da sie im Rahmen der Konferenz
etwas breiter diskutiert wurden. Dies betrifft zum einen
die in der Substitutionsbehandlung mit Buprenorphin gewählte
Eingangsdosis. Während in vielen Publikationen und Therapieempfehlungen
eine Dosis von 2 mg Buprenorphin initial für ausreichend
gehalten wird, deuten insbesondere die Erfahrungen
aus Österreich und der Schweiz darauf hin, daß in Regel 4 mg,
gelegentlich sogar 8 mg Buprenorphin eine geeignete Eingangsdosis

sein könnte. Zu niedrige Dosierungen führen offensichtlich

gehäuft zum Abbruch einer solchen Therapie. Als wenig

problematisch wurde die Applikation von Sublingualtabletten

angesehen, die nach den vorliegenden Erfahrungen von Patienten
gut toleriert werden. Auch wenn in den meisten Fällen das
Vorliegen einer Schwangerschaft sowie Stillen eine Kontraindikation
für eine Substitutionsbehandlung darstellt, so haben doch
Erfahrungen, insbesondere aus Österreich, gezeigt, daß in Einzelfällen
die Gabe von Buprenorphin auch bei Stillenden und
Schwangeren indiziert sein kann. Die diesbezüglich vorliegenden
klinischen Erfahrungen sind offensichtlich gut, allerdings
liegen hier noch keine kontrollierten klinischen Prüfungen vor.
Insofern ist die üblicherweise angegebene Gegenanzeige für die
Behandlung mit Buprenorphin „Stillen von Neugeborenen“ mit
einem gewissen Fragezeichen zu versehen.
Buprenorphin stellt heute, zumindest in Frankreich, das Mittel
der Wahl in der Behandlung Drogenabhängiger dar. In Deutschland
sollen in den nächsten Jahren breiter angelegte Studien zum
Einsatz von Buprenorphin, das im Sicherheitsprofil einige Vorteile
gegenüber reinen Opioidagonisten aufweist, durchgeführt
werden. Dies betrifft auch den Einsatz bei speziellen Subgruppen,
wie zum Beispiel bei Frauen oder Patienten mit komorbiden
psychischen Störungen. Nach der erst wenige Monate zurückliegenden,
erheblichen Revision der „Richtlinien über die Einführung
neuer Untersuchungs- und Behandlungsmethoden und
über die Überprüfung erbrachter vertragsärztlicher Leistungen“
(vormals NUB-Richtlinien) in Deutschland stellt die Einführung
von Buprenorphin eine weitere Neuerung in der Therapie Drogenabhängiger
dar. Sie wird hoffentlich zu einer Diversifizierung
und Verbesserung des therapeutischen Angebots bei Drogenabhängigen
führen. Das erarbeitete Konsensus-Papier soll dabei
die Basis oder genauer gesagt einen Leitfaden für dessen klinischen
Einsatz sein.

Weiter geht es mit den link:

636

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

Wie stellt sich die aktuelle Situation der Substitutionsbehandlung in Österreich dar? Im Rahmen einer umfangreichen Querschnittstudie erörterten Univ.Prof. Dr. Alfred Springer, Pionier der österreichischen Suchtforschung, und Dr. Alfred Uhl, Koordinator des Forschungsbereiches „Epidemiologie / Sozialwissenschaften“ sowie des Bereiches „Suchtpräventionsdokumentation – Alkohol“ am Anton Proksch Institut (API) in Wien, Themen wie das Ausbildungsniveau und die Arbeitsweise der Ärzte, die Zufriedenheit der Patienten sowie die Bewertung der verschiedenen Substanzen, die für die Substitution zur Verfügung stehen. Die Daten repräsentieren signifikant die Situation des Landes: Die Ergebnisse beruhen auf den Aussagen von etwa zwei Drittel der gesamten Substitutionspatienten in Österreich. Im Gespräch mit drogensubstitution.at bietet Alfred Springer Einblick in die wichtigsten Erkenntnisse der Studie.

Wie steht es aktuell um die Substitutionsbehandlung in Österreich?

Springer: Im Großen und Ganzen lässt sich aus der Studie ableiten, dass die Substitutionsbehandlung sowohl aus der Sicht der Ärzte wie auch der Patienten recht gut und zufriedenstellend funktioniert. Allerdings konnte keine Information darüber gewonnen werden, in wie viel Fällen die Substitution nicht angenommen wurde oder abgebrochen wurde. Die zur Verfügung stehenden Mittel werden differenziert und diversifiziert eingesetzt, wobei im Zeitraum in dem die Untersuchung stattfand, bereits die Verschreibungsregeln der neuen Substitutionsverordnung umgesetzt wurden.

Welche Substanz wurde am häufigsten verschrieben?

Springer: Die zumeist verschriebenen Substanzen waren Morphinzubereitungen mit verzögerter Freisetzung der Wirksubstanz gefolgt von Methadon und Buprenorphin. Die Morphinpräparate wurden sowohl von den Ärzten wie auch den Patienten am positivsten bewertet. Allerdings wurde ihnen von den Ärzten ein relativ hohes Missbrauchspotential zugeordnet. Das geringste derartige Risiko wurde dem Buprenorphin zugeschrieben. Methadon schnitt sowohl in der Bewertung durch die Patienten wie auch durch die Ärzte am schlechtesten ab.

Unter welchen Bedingungen wurde welche Substanz eingesetzt?

Springer: Die positiven Bewertungen ergaben ein differenziertes Bild. Die Ärzte gaben an, dass sie das Morphin insbesondere bei somatisch kranken Patienten, schweren psychischen Komorbiditäten und langer Substitutionsdauer bevorzugten, während das Buprenorphin vorrangig jüngeren Patienten mit relativ kurzer Suchtanamnese verordnet wurde. Auffallend war, dass Methadon überzufällig häufig in niedriger Dosierung verschrieben wurde. Die Bedingung einer täglich oder mehrmals wöchentlich kontrollierten Einnahme wurde am häufigsten im Falle der Morphin-Verschreibungen umgesetzt.

Welche Kritik üben die Patienten?

Springer: Kritik wurde von den Patienten hauptsächlich an den Mitgaberegeln geäußert, wobei diese Kritik auch in der Bewertung der Substanz Niederschlag fand. Der Wunsch nach Umstellung des Mittels wurde am häufigsten von Methadon-Substituierten geäußert, am seltensten von den Morphin-Klienten.

Was bedeuten die Ergebnisse für die Praxis der Substitutionsbehandlung?

Springer: Wie auch aus internationalen Studien bekannt ist, funktioniert die Substitutionsbehandlung besser, wenn nur solche Regeln den Behandlungsablauf beeinflussen, die sowohl für den Arzt wie für die Patienten verständlich und notwendig sind. Auch unsere Ergebnisse sprechen dafür, dass eine patientengerechte Dosierung und eine minimal beschränkende Mitgaberegelung zu höherer Patientenzufriedenheit führen und damit sicherlich auch zu besserer Compliance beitragen. Aufklärungsbedarf besteht, warum Methadon so häufig in niedriger Dosierung (eventuell sogar unterdosiert) verschrieben wird. Eine Begriffsklärung scheint notwendig, was für Ärzte als „Missbrauchspotential“ bedeutet. Wird darunter lediglich die Bereitschaft zu verschreibungswidrigem intravenösem Gebrauch verstanden, oder gibt es weitergehende ordnungs- und sicherheitspolitische Bedenken? Ohne eine derartige Begriffsklärung wird man wohl kaum zu Maßnahmen gelangen, die eine Optimierung der Situation versprechen.

Im Gegensatz zu Morphin retard und Buprenorphin schneidet Methadon in der Bewertung sowohl bei den Ärzten, als auch bei den Patienten schlechter ab.

Springer: Methadon schneidet in der Bewertung schlechter ab, allerdings sind die Unterschiede auch wieder nicht so gravierend, weil die Zufriedenheit mit der Substitutionsbehandlung auch bei Methadonklienten überwiegt. Überhaupt sollte man dieses Phänomen differenziert und nicht auf Substanzniveau allein beschränkt untersuchen. Die Bewertung einer Substanz hängt nicht nur von ihren pharmakologischen Eigenschaften ab, sondern ist weitgehend auch von den Bedingungen ihrer Abgabe und anderen sozialen und psychologischen Faktoren mitbestimmt.

Was kann die Politik in Hinsicht auf das aktuelle Suchtmittelgesetz daraus lernen?

Springer: Für die politische Bewertung ist sicher wichtig, dass sich erweist, dass die Ärzte differenziert und problembewusst handeln. Die neu geschaffenen Konditionen und Restriktionen haben gegriffen, allerdings leider nicht nur zu den erwünschten Ergebnissen geführt. Insbesondere ist der Beigebrauch nicht unter Kontrolle gebracht worden und scheint insbesondere bei Methadonklienten eine recht hohe Bereitschaft zu bestehen, andere Opioide, die illegal erworben werden, zu gebrauchen. Genauere Forschung müsste sich der Frage widmen, ob diese Bereitschaft auch etwas mit der Zubereitung der Substanz zu tun hat. Zu hinterfragen ist auch, ob die Erschwerung, Methadon intravenös zu gebrauchen, dazu führt, dass andere Substanzen für den intravenösen Gebrauch erworben werden. Dieser Missbrauchssituation kann offenkundig weder durch Verbote noch durch restriktive Verschreibung und der Forderung nach Weiterbildung des Arztes wirksam begegnet werden.

Auf jeden Fall sprechen die Ergebnisse dafür, dass eine hohe Kompetenz der substituierenden Ärzte besteht, die Behandlungsmethode gut etabliert ist und von jener Klientel, die sich mit den Bedingungen, unter denen sie umgesetzt wird, abfindet, gut angenommen wird. In  der Zukunft  sollte dafür gesorgt werden, dass die Kompetenz genutzt wird und dass die drogenpolitische Regulierung den Zugang zur Substitutionsbehandlung erleichtert. Es sollte ein flächendeckendes Angebot ermöglicht werden, das auch für jene Teilpopulation der Morphinabhängigen attraktiv ist, die bis jetzt nicht den Zugang zu dieser Versorgung gefunden hat.

Herzlichen Dank für das Gespräch.

Die Studie zum Downloaden: (PDF, Querschnittstudie)

source: http://www.drogensubstitution.at/expertenmeinung/aktuelle-situation-der-substitutionsbehandlung-in-oesterreich-eine-querschnittstudie.htm

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.

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.

1) Indikation von Buprenorphin: Buprenorphin wird einerseits zur
Opiatsubstitutionsbehandlung sowie andererseits i.R. eines
Opiatentzuges verwendet. Im Übrigen wird Buprenorphin in Form von
Temgesic ®, Transtec ®)) als Analgetikum in der Behandlung von
starken Schmerzen eingesetzt.
2) Wirkungen von Buprenorphin:
Rezeptorprofil: Buprenorphin ist ein partieller Opioidagonist an den
mü-Opioidrezeptoren sowie ein Antagonist an den Kappa-
Opioidrezeptoren. Damit erzeugt Buprenorphin eine im Vergleich mit
Morphin maximal 60%-ige Aktivität an den mü-Opioidrezeptoren. Der
antagonistischen Wirkung am Kappa-Rezeptor wird eine positive
Beeinflussung von dysphorischen Verstimmungszuständen
zugeschrieben.
Einnahmeart: Aufgrund eines ausgeprägten enterohepatischen
Kreislaufes führt eine orale Einnahme von Buprenorphin zu einer nur
unzureichenden Wirkungsstärke (ca. 16%-ige biologische
Wirksamkeit). Subutextabletten müssen deshalb sublingual
eingenommen werden (ca. 50%-ige biologische Wirkungsamkeit).
Die Sublingualtabletten sollen ca. 3-5 Minuten unter der Zunge
vergehen lassen werden.
Intrinsische Sicherheit: Aufgrund der nur maximal 60%-igen mü-
Aktivität ist die Gefahr einer möglichen Intoxikation mit letalen Folgen
unter Buprenorphin bei Monokonsum praktisch ausgeschlossen. Eine
atemdepressive Wirkung fehlt weitgehend. Buprenorphin weist
deshalb eine hohe intrinsische Sicherheit und therapeutische Breite
auf (Auch bei Personen mit vollständig fehlender Opiattoleranz ist
eine Intoxikation mit letalem Ausgang auch unter hohen
Buprenorphindosen nicht möglich, Überdosierungen von 10-20-fach
erhöhter Dosis wurden ohne ausgeprägte Nebenwirkungen
überstanden (In Frankreich wurden allerdings vereinzelte Todesfälle
bei sehr hohen Buprenorphindosen und gleichzeitiger Einnahme von
Alkohol und Benzodiazepinen festgestellt).
Bei einer Dosis von 32mg und mehr kommt es zu einem sogenannten
„Ceiling Effect“, d.h. einem Wirkungsplateau bzw. einer maximalen
Opioidwirkung.
Aufgrund einer nur langsamen Resorption fehlt eine entsprechende
Rauschwirkung auch bei hohen Buprenorphindosen weitgehend.
Opioidrezeptoraffinität: Buprenorphin zeigt eine sehr starke
Opioidrezeptoraffinität, die diejenige von Methadon, Heroin,
Morphin, Codein, Dihydrocodein sowie Naltrexon und Naloxon
(letztere beide reine Opioidantagonisten) klar übertrifft. Dies erklärt,
weshalb unter vorgängiger Einnahme eines der oben genannten
Opioide und darauffolgender Einnahme von Buprenorphin ein
Opioidentzugssyndrom ausgelöst werden kann. Gleichzeitig lässt sich
die Opioidwirkung von Buprenorphin nur sehr schwer antagonisieren:
Die dafür notwendige Dosis beträgt das 10-30-fache der sonst
üblichen Morphindosis.
Rezeptordissoziationskinetik: Buprenorphin weist eine sehr langsame
Dissoziationskinetik an den Opioidrezeptoren auf. Dies führt einerseits
im Falle eines buprenorphingestützten Opiatentzuges zu geringeren
Entzugserscheinungen als dies bei schrittweiser Dosisreduktion mit
Methadon der Fall ist. Andererseits führt dies zu einer im Vergleich zu
Methadon und Heroin verlängerten Halbwertszeit am Rezeptor.
Dieser Effekt der verlängerten Wirkung wird durch die hohe Lipophilie
mit Speicherung von Buprenorphin im Fettgewebe und nur
langsamer Freisetzung noch verstärkt.
Wirkungszeit: Eine weitere Besonderheit von Buprenorphin ist seine
dosisabhängige Wirkungszeit: Mit Zunahme der Dosis (von 16-
32mg/die) kommt es weniger zu einer Zunahme der Wirkungsstärke
als mehr zu einer Verlängerung der Wirkungszeit (Wirkungsdauer
unter 2-4mg: bis zu 12 Stunden, unter 16-32mg bis zu 48-72 Stunden).
Dies ermöglicht bei Erhöhung der Dosis eine Ausweitung des
Dosisintervalles auf eine 2 bis sogar 3-tägliche Einnahme.
Metabolismus: Buprenorphin wird in der Leber von Mikrosomen NDealkyliert
und später glukoronidiert. Im Vergleich zum Metabolismus
des Methadons ist die Beteiligung des Zytochrom P450-
Enzymsystemes beim Buprenorphin nur sehr gering. Es wird zu 80%
über die Fäzes und 20% renal ausgeschieden.
Weitere Vorteile: Buprenorphin hat ein im Vergleich mit Methadon
geringeres Abhängigkeitspotenzial. Buprenorphin wird eine
antidepressive Wirkung zugeschrieben, was es bei gleichzeitigen
depressiven Zuständen als sinnvoll erscheinen lässt.
Bei gleichzeitig vorhandener Kokainabhängigkeit konnte eine
positive Wirkung in Bezug auf das Craving nach Kokain
nachgewiesen werden, was im Vergleich mit Methadon zu einer
stärkeren Verminderung des Kokainkonsumes und erhöhter
Kokainabstinenzrate führte.
Unter Buprenorphin waren die im Vergleich zu unter Methadon
gehäuft auftretenden Nebenwirkungen wie Schwitzen, Potenz- und
Libidostörungen, Obstipation und Gefühl der Affektabflachung
deutlich geringer.
Unter Buprenorphin fühlen sich die Patienten im Vergleich zu
Methadon oft wacher und nehmen intensivere Gefühle jeder Art
wahr. Letzteres kann für die Patienten sowohl ein Vor- wie auch ein
Nachteil bedeuten: Bei Patienten mit gewissen komorbiden
psychiatrischen Störungen (PTSD, Borderline Persönlichkeitsstörung
etc.) kann der stimmungsausgleichende Effekt von Methadon
(„Gefühle wie in Watte verpackt“) gegenüber Buprenorphin ein
Schutz vor ausgeprägten Stimmungsschwankungen / negativen
Gefühlszuständen bedeuten und deshalb eine Umstellung von
Methadon auf Buprenorphin kontraindiziert sein!
3.Umstellungen von Heroin / Methadon auf Buprenorphin:
Heroin auf Buprenorphin: Für eine Umstellung von Heroin auf
Buprenorphin wird eine Wartezeit von ca. 8 Stunden mit Auftreten
von leicht bis mittelgradiger Opiatentzugssymptomatik gefordert, um
so die Gefahr eines sogenannten „forzierten Entzuges“ zu vermeiden
(„forzierter Enzug“ : Unter der Wirkung von Heroin / Methadon und
gleichzeitiger Einnahme von Buprenorphin kommt es zu einem
Entzugssyndrom, da Buprenorphin das Heroin / Methadon aufgrund
seiner stärkeren Rezeptoraffinität aus den mü-Rezeptoren verdrängt
und selbst eine im Vergleich zu Heroin und Methadon geringere
Opioidaktivität aufweist. Eine Umstellung von Heroin auf
Buprenorphin ist i.a. bei niedrig bis mittleren Heroindosen
erfolgversprechend. Bei hohen Heroindosen ist die durch
Buprenorphin ausgeübte Opiatwirkung teilweise zu gering.
Methadon auf Buprenorphin: Vor einer Umstellung wird i.a. eine
vorgängige Reduktion der Methadondosis bis auf 30mg und weniger
empfohlen. Sodann nach Wartezeit von 24-36 Stunden erfolgt die
Umstellung nach Auftreten eines mittelgradigen Entzugssyndromes.
Eine Umstellung von Methadon im Bereich zwischen 30-60mg/die ist
ebenfalls möglich, dabei sollte jedoch ein ausgeprägtes
Entzugssyndrom vorliegen, um die Gefahr eines forzierten Entzuges zu
vermeiden. Bei Methadondosen höher als 60mg/die wird von einer
Umstellung auf Buprenorphin abgeraten.
Einstellung der Buprenorphindosis: Es wird am 1.Tag mit einer Erstdosis
zwischen 4-8mg Subutex begonnen. Dabei wird mit dem Patient
nach 3 Stunden eine erneute Kurzkonsultation vereinbart. Im Falle
von dann noch bestehenden Entzugserscheinungen erfolgt eine
weitere Gabe von 2-8mg Subutex am gleichen Tag. Der Patient
erscheint in der Folge am 2. und am 3.Tag zu einer Kurzkonsultation,
in welcher pro Tag eine weitere Dosissteigerung von 2-8mg
vorgenommen wird. Tagesdosen von mehr als 32mg erbringen i.d.R.
keine zusätzliche Opiatwirkung.
Bezugsunterbrüche: Bei Bezugsunterbrüchen von 72 Stunden und
mehr kann von einer fehlenden Buprenorphinwirkung ausgegangen
werden. Um einen allfälligen forzierten Entzug bei vorgängigem
Heroinkonsum und erneuter Buprenorphingabe zu vermeiden, ist
deshalb durch den zuständigen Therapeuten eine individuelle
Beurteilung der Drogenzwischenanamnese (letzter Heroinkonsum,
allfälliger Mischkonsum von anderen sedierenden Substanzen) des
Patienten und Planung einer Dosisneueinstellung vorzunehmen.
4) Buprenorphingestützter Opiatentzug: Ein Opiatentzug mit
Buprenorphin kann im Vergleich zu einem methadongestüzten
Opiatentzug, welcher mindestens mehrere Wochen dauert, oft
deutlich schneller durchgeführt werden: Grund für im Vergleich mit
Methadon geringere Entzugssymptomatik ist die langsamere
Rezeptordissoziationskinetik von Buprenorphin.
Ein Buprenorphingestützter Opiatentzug kann grundsätzlich in 5
Tagen gemäss folgendem Schema durchgeführt werden:
1.Tag 16mg Subutex
2. Tag 8mg Subutex
3.Tag 4mg Subutex
4. Tag 2mg Subutex
5.Tag 1mg Subutex
6.Tag Subutex stoppen
Alternativ kann der Patient jedoch auch individuell die Dauer seines
Opiatentzuges und die damit verbundenen Dosisreduktionsintervalle
festlegen.
5) Interaktionen von Buprenorphin mit anderen Pharmaka:
Besondere Vorsicht ist bei der gleichzeitigen Verordnung von
antiviralen Medikamenten bei HIV-positiven Patienten unter Therapie
mit Buprenorphin geboten: Protease-Inhibitoren wie Ritonavir,
Indinavir und Saquinavir blockieren in vitro Untersuchungen an 13
humanen Lebermikrosomen den Abbau von Buprenorphin. Da sich
beide Substanzgruppen in ihrer Metabolisierung durch die
Leberenzyme P450 3A4 behindern, steigt damit das Risiko einer
Überdosierung.
Weitere Interaktionen von Buprenorphin sind mit folgenden
Medikamenten möglich:
Analgetika: Oxycodon: verstärkender atemdepressiver Effekt
Alfentanil: Wirkungsverstärkung
Anxiolytika: Alprazolam (Xanax®), Diazepam (Valium ®, Paceum ®),
bzw. jegliche Arten von Benzodiazepinen: Buprenorphimissbrauch in
Kombination mit Benzodiazepinen führte zu Todesfällen in Frankreich!
Antipsychotika: Chlorprothixen (Truxal ®), Triflupromazin (Psyquil ®):
Hypotension, verstärkter atemdepressiver Effekt; bzw. jegliche
sedierende Neuroleptika
Anticholinergika: Biperiden (Akineton ®): verstärkter atemdepressiver
Effekt
Hypnotika: Flurazepam (Dalmadorm ®), Flunitrazepam (Rohypnol ®),
Phenobarbital (Luminal ®): verstärkter atemdepressiver Effekt
Bei nur geringer Metabolisierung durch das Zytochrom P450-System
sind die potenziellen Medikamenteninteraktionen im Vergleich mit
Methadon geringer. Trotzdem sind Pharmaka, welche nicht oder nur
in geringem Ausmasse über das Zytochrom P450-Oxydase-System
metabolisiert werden gegenüber Pharmaka mit ausgeprägter
Beteiligung des Zytochrom P450-System vorzuziehen.

siehe Anhang: Opioide Umrechnen

Diese Tabelle erhaelt unheimlich viel zulauf,

ich bitte jedoch folgendes zu beachten, „man kann Opioide nicht einfach umrechnen“!

Methadone and Other Opioids Not Always

Equivalent,


Conversion Can Be Lethal!

In a comprehensive literature review of poisoning deaths involving opioids from 1999 – 2009, the deaths involving methadone were found to be disproportionately high.
(Edit by me: to get a inside-view via the „GAO-Report“)

Methadone represented less than five percent of all opioid prescriptions but is responsible for a third of the deaths. After four years of investigation, the major underlying cause was found to be fundamental misunderstandings about the properties of the medicine — a „knowledge deficit“ — especially when converting patients from other opioids.

After a rapid increase of opioid-related deaths was reported in Utah, then president of the Utah Academy of Pain Medicine, Dr. Lynn Webster decided to find out why, and then find a solution. By reviewing state and federal sources as well as PubMed, he was able to assess demographics, prevalence, and other risk factors related to this significant increase in poisoning deaths involving opioids.

Webster found that methadone deaths had more to do with misunderstandings about when to prescribe it, how to convert patients to it from other pain medicines, and how to inform patients about its risks. The research also showed that one-third of the deaths occurred within five days after a dosage change — also suggesting that unfamiliarity with the medicine could lead to accidental deaths.

Webster then brought this information to a consensus conference sponsored by the LifeSource Foundation where a panel of colleagues helped him determine root causes of the problem. After reviewing and discussing the data, the panel identified the following as probable causes underlying the spike: physician error due to knowledge deficits, patient non-adherence to medication regimen, unanticipated medical and psychiatric co-morbidities (including substance abuse), and payer policies that mandate methadone as a first-line coverage.

„Not all pain medicines — even within a class — and not all patients — are created equally,“ said Dr. Webster. „Methadone is a safe and effective opioid with pharmacokinetics and pharmacodynamics unlike other opioids, so knowledge about it and how it may affect a specific patient is paramount to a positive clinical outcome. Education about pain medicine is the best safeguard against the unintended deaths and side effects we’ve seen with methadone in the last decade.“

According to Webster, simple conversion from one opioid twice a day to another twice a day is not safe. Patient pharmacogenetics (a patient’s unique response to medicine based on his or her genetics), especially when converting between opioids, along with the properties of the medicine, must be taken under advisement to determine appropriate therapy.

In addition, he advises that switching a patient to methadone must be done slowly and over time: start with a low dose, and titrate from there in increments that make sense for the patient and the pain condition.

Source: PRNewswire.com — February 4, 2010

The National Institute on Drug Abuse (NIDA) supports most of the world’s research on drug abuse and addiction.
NIDA-funded research enables scientists to apply the most advanced techniques available to the study of every aspect of
drug abuse, including:
• genetic and social determinants of vulnerability and response to drugs;
• short- and long-term effects of drugs on the brain, including addiction;
• other health and social impacts of drug abuse, including infectious diseases and economic costs;
• development and testing of medication and behavioral treatments for abuse and addiction; and
• development and evaluation of effective messages to deter young people, in particular, from abusing drugs.
Included in this document are selections of topic-specific articles reprinted from NIDA’s research newsletter,
NIDA Notes. Six times per year, NIDA Notes reports on important highlights from NIDA-sponsored research,
in a format that specialists and lay readers alike can read and put to use. Selections like the current one are intended to remind regular NIDA Notes readers and inform other readers of important research discoveries during the periods they cover.

.A_Collection_of_Articles_That_Address_Heroin_Prevention,_Treatment_and_Research