[Opioid Substitution Treatment in Germany: Physicians' View on the Effects of the 3rd Revision of the Narcotic Drugs Prescription Ordinance]. / Die Substitutionstherapie Opioidabhängiger in Deutschland: Auswirkungen der 3. BtMVVÄndV aus der Sicht substituierender Ärztinnen und Ärzte.

STUDY AIM: Opioid substitution treatment (OST) is the most effective drug treatment for opioid dependence worldwide. This form of therapy is also well established in Germany. Nevertheless, there are gaps in the provision of care, especially in rural areas and some states, due to a decreasing number of physicians involved in implementing the substitution programs. The 3rd revision of the Narcotic Drugs Prescription Ordinance (NDPO), which came into force in 2017, transferred medical therapeutic tasks of OST to the policy-making power of the German Medical Association. This comprehensive reform of the general conditions for OST led to greater legal certainty for this form of treatment. The present study aimed to analyze the effects of the 3rd revision of the Narcotic Drugs Prescription Ordinance from the providers' perspective. METHODS: Between August and December 2019, a questionnaire on individual experiences with the changes implemented in 3rd revision of the Narcotic Drugs Prescription Ordinance was sent by the Federal Opium Agency and the Associations of Statutory Health Insurance Physicians of the chosen federal states to 2,503 physicians implementing the substitution program in Germany as well as 563 physicians in Hamburg, Bavaria, North Rhine-Westphalia and Saxony who were not or no longer involved in this field of medical practice.The evaluation distinguished between physicians with and without further training in addiction medicine and between urban and rural districts. RESULTS: The response rate of physicians was 34.1%. The average age was 57.9 (±8.7) years, and 64.5% were male. The most relevant changes of the NDPO revision were found to be no time limit for achieving opioid abstinence (85.3%), new assessment and treatment using additional psychotropic substances (71.0%), extending take-home regulation to a maximum of 30 days (70.0%) and greater legal certainty (66.2%). Widening of consultative care up to 10 patients met with little approval (14.8%); 36.7% did not believe that care of substituted patients was assured either now or in the future. CONCLUSIONS: The NDPO revisions were considered to be relevant in terms of increased legal certainty and treatment liberties. Information was needed in rural areas, among physicians who carried out substitution therapy without advanced training in addiction medicine and physicians no longer involved in substitution therapy.

'South Asian cocktail'--the concurrent use of opioids, benzodiazepines and antihistamines among injecting drug users in Nepal and associations with HIV risk behaviour.

BACKGROUND: Data of the Central Bureau of Statistic of Nepal from 2008 show a total of more than 46,000 illegal drug users, out of which 61% are injecting drug users (IDU). An injecting mix of medicines like opioids, benzodiazepines and antihistamines (the so-called South Asian cocktail) was prevalent. Furthermore, it is estimated that about 70,000 people are living with human immunodeficiency virus (HIV). The government of Nepal has started realizing and recognizing drug use and HIV as significant health and social issues. Harm reduction programs such as needle syringe exchange and opioid substitution treatment are being implemented. METHODS: The aim of this study is to obtain specific knowledge on the drug use behaviour and the health status of drug users with a focus on HIV in drug users with concurrent injection of opioids, benzodiazepines and antihistamines. After an initial mapping of Kathmandu Valley, 300 drug users in contact with different treatment and counselling centres were randomly chosen for the interviews. The research questionnaire was designed according to the European Addiction Severity Index (EuropASI) and Maudsley Addiction Profile standards. RESULTS: Ninety-one percent of the respondents are male and 9% female. Mean age is 28.7 years. Ninety-five percent are injecting drug users with a mean of 8.7 years of drug use history. Eighty-six percent are injecting different 'cocktails', usually made of buprenorphine, diazepam, promethazine and/or other substances (30-day prevalence). Similarly, 48% use heroin, whereas only 2% take cocaine/crack. Among those tested for HIV (N = 223), 33% are positive (25% of the sample population). Compared to the other drug users (mainly heroin), the cocktail users show a higher HIV infection rate and more co-infections. Furthermore, risk behaviour, as e.g. needle sharing, is much more common among the cocktail users. CONCLUSION: Currently, the mixture of medicines, opioids, benzodiazepines and antihistamines, is the predominant drug in Nepal; the pharmaceutical drugs needed to prepare the cocktail are less expensive than heroin and relatively easy to acquire. The cocktail users show a higher risk behaviour regarding the transmission of HIV than heroin drug users. It needs to be considered which HIV prevention measures are necessary to target the specific needs of drug users who inject a mixture of opioids, benzodiazepines and antihistamines, since the available services (such as needle syringe exchange) do not seem to cover their specific needs (high percentage of needle sharing).

The effects of racemic D,L-methadone and L-methadone in substituted patients--a randomized controlled study.

AIMS: To test the hypothesis that switching from L-methadone to D,L-methadone is associated with more frequent withdrawal symptoms and side-effects than switching from D,L-methadone to L-methadone. DESIGN: Stratified, randomized 2 x 2 crossover study design over a time-period of 8 weeks. At study entry, every second patient was switched from the pre-study substance to the other medication, after 4 weeks all patients were subject to a (re-)switch. SETTING: The study was conducted as a multi-centre trial in three methadone maintenance therapy (MMT) clinics. PARTICIPANTS: Seventy-five patients previously treated with either D,L-methadone or L-methadone for at least 1 year took part in the study. MEASUREMENTS: Intra-individual changes in withdrawal symptoms (Short Opiate Withdrawal Scale, SOWS) and side-effects were defined as primary outcome criteria. Secondary outcome measures included necessity for methadone dose adjustment. FINDINGS: Complete data were available for 68 patients (91%). Sample strata were unbalanced at baseline: 15 patients (22%) were treated with L-methadone and 43 with D,L-methadone (78%). Thirty-five patients were randomized into the group treated with L-methadone and 33 into the group treated with D,L-methadone during the first 4 weeks. There were no significant differences in intra-individual change of withdrawal symptoms and side-effects between groups after crossover. However, patients treated with levomethadone tended to feel less withdrawal symptoms than patients treated with d,l-methadone. CONCLUSIONS: D,L-methadone and L-methadone can safely be replaced by each other on a 2:1 ratio. Withdrawal symptoms or side-effects due to conversion are of transient nature only.