Dr Wilfried Kunstmann German Medical Association Berlin The

Dr. Wilfried Kunstmann - German Medical Association Berlin The German Medical Association’s Revised Directive for Opiod Substitution Treatment (OST): Legal Framework, Treatment Regulations and Scientific Rationale Lisbon Addictions 2017 2 nd European Conference on Addictive Behaviours and Dependencies 24 -26 Oct. 2017

The German Medical Association’s Revised Directive for OST: Legal Framework, Treatment Regulations and Scientific Rationale Contents: 1. Areas of OST regulated by GMA Directive 2. Scientific rationale for Directive regulations 3. What has changed? Lisbon Addictions Oct. 25, 2017 2

Legal Framework of GMA Directive Narcotic Drugs Prescription Ordinance (Bt. MVV) determines: • Areas of OST regulated by GMA Directive (§ 5 Sect. 12 Bt. MVV): 1. Additional treatment goals 2. General treatment prerequisites 3. Treatment plan including a. selection of treatment medication b. integration of psychosocial support c. Treatment evaluation and monitoring d. prerequisites for self-administered substitution/medication 4. Required documentation • Regulations to be based on current state of medical science (§ 5 Sect. 12 ) • Approval by Federal Ministry of Health (§ 5 Abs. 14 Bt. MVV) Lisbon Addictions Oct. 25, 2017 3

Scientific Rationale of the GMA-Directive Expert Committee Inte rnat s CT R Re vie ws iona Reg l Guide ulat ions lines / Observational Studies Hearing with Medical Community 4

Areas of OST - regulated by GMA Directive: 1. Treatment Goals (§ 5 Sect. 2 & Sect. 12 Nr. 1 Bt. MVV) Narcotic Drugs Prescription Ordinance: Additional Goals – GMA Directive: • Securing of patients survival (s. § 5 Abs. 2 Nr. 1 Bt. MVV) • Reduction of harmful drug-use behavior • Reduction of illegal opioid use • Stabilization and improvement of patients • Reduced consumption of other illegal drugs general health (s. § 5 Abs. 2 Nr. 2 Bt. MVV) • Supportive treatment of somatic and psychiatric comorbidity • Improvement of health-related quality of life • Reduction of criminal behavior (s. § 5 Abs. 2 Nr. 4 Bt. MVV) • Improvement of social and occupational • Abstinence from illegal opioids, (s. § 5 Abs. 3 functioning Nr. 3 Bt. MVV) • Reduction of addiction-related prenatal and postpartum risks (s. § 5 Abs. 2 Nr. 5 Bt. MVV) Lisbon Addictions Oct. 25, 2017 5

1. Treatment Goals (§ 5 Sect. 12 Nr. 1 Bt. MVV) - continued Narcotic Drugs Prescription Ordinance: GMA Directive: Overall Goal (§ 5 Abs. 2 S. 1 Bt. MVV) • „In OST abstinence from opioids should be pursued. “ Abstinence to be addressed as a therapeutic option • To be documented in the patient file Ordinance rationale: • Goal to be addressed in a motivational interview • In accordance with patient´s motivation and potentials Lisbon Addictions Oct. 25, 2017 6

2. General Treatment Prerequisites – see § 5 Sect. 12 Nr. 2 Bt. MVV Ø Assessment of opioid dependence according to ICD 10 - F 10 Ø Dependence as a result of illegal opioid use Ø OST also possible after temporarily enforced abstinence (ICD 10 - F 11. 21) Lisbon Addictions Oct. 25, 2017 7

2. General Treatment Prerequisites – see § 5 Sect. 12 Nr. 2 Bt. MVV Assessment of potential contraindications: ØRelevant pre-existing conditions (esp. cardiac, respiratory conditions, diseases of the liver, psychiatric comorbidity, polydrug use, reduced opioid tolerance) => Treatment risks to be weighed up against risks of uncontrolled drug consumption Lisbon Addictions Oct. 25, 2017 8

2. Prerequisites: Special Patient Groups 1. Adolescents / Patients with a short history of drug abuse • Special care when determining treatment indication 2. Pregnant women: • OST as treatment standard 3. Imprisoned patients: • • • In and out of prison: continuity of care to be secured OST also after temporarily enforced abstinence Increased caution for dosing Lisbon Addictions Oct. 25, 2017 9

3. Treatment Plan – see § 5 Sect. 12 Nr. 3 Bt. MVV • Required before treatment initiation • Ongoing review and adjustment Elements of Treatment Plan: • Proof of valid indication according to ICD diagnosis • Identification of patient-specific therapeutic goals • Selection and dosing of medication • Integration of psychosocial support and other services – according to patients needs Lisbon Addictions Oct. 25, 2017 10

3 b. Integration of Supportive Psychosocial Services – see § 5 Sect. 12 Nr. 3 c Bt. MVV • Psychosocial support to be recommended regularly • Type and extent of psychosocial support according to patients situation and treatment progress • Psychosocial support as an integrated part of OST for adolescents Lisbon Addictions Oct. 25, 2017 13

3 c. Treatment Evaluation and Monitoring – see § 5 Sect. 12 Nr. 3 d Bt. MVV Measures to handle concomitant drug use: • Dose adjustment according to test results • Exploration of reasons • Treatment of coexisting drug dependencies Lisbon Addictions Oct. 25, 2017 15

3 c. Treatment Evaluation and Monitoring - continued – see § 5 Sect. 12 Nr. 3 d Bt. MVV Treatment Termination Regular termination: • Termination with consent from doctor and patient Premature termination: • Existing serious contraindications • Continued heavy use of psychotropic drugs • Continued violation of clinic rules Caveats of premature treatment termination: • Search for reasons of treatment non-compliance • Adjustment of treatment plan • Securing of appropriate continuity of care Lisbon Addictions Oct. 25, 2017 16

3 d. Prerequisites for Self-administered Medication – see § 5 Sect. 12 Nr. 3 b Bt. MVV Overall considerations: • Increased risk for diversion and abuse • Increase of intervals according to patient stability Criteria: • Regular clinic-attendance • Stable doses of opioid-medication • No critical concomitant drug use • Supervised medication once a week • Psychosocial stability • Potential risks for patients and 3 rd parties assessed and weighted upon • No violation of clinic rules Lisbon Addictions Oct. 25, 2017 17

Improvements by revised Narcotic Drugs Prescription Ordinance (Bt. MVV) and GMA-Directive • Treatment goals according to patient´s abilities • Extended treatment settings • Extended options for self-administered medication • Therapeutic aspects transferred to GMA Directive for regulation • Concomitant drug use becomes subject of treatment • Psychosocial treatment according to treatment progress and individual needs • Improved continuity of care between settings • Reduced threat of legal sanctions Lisbon Addictions Oct. 25, 2017 18

Thank you for your attention! Lisbon Addictions Oct. 25, 2017 19