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The German Medical Association ’ s Revised Directive for Opiod Substitution Treatment (OST):

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

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The German Medical Association ’ s Revised Directive for Opiod Substitution Treatment (OST):

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

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

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

  4. Scientific Rationale of the GMA-Directive Expert Committee RCTs International Guidelines / Regulations Reviews Observational Studies Hearing with Medical Community

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

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

  7. 2. General Treatment Prerequisites – see §5 Sect.12 Nr.2 BtMVV • Assessment of opioid dependence according to ICD 10 - F10 • Dependence as a result of illegal opioid use • OST also possible after temporarily enforced abstinence (ICD 10 - F11.21) Lisbon Addictions Oct. 25, 2017

  8. 2. General Treatment Prerequisites – see §5 Sect.12 Nr.2 BtMVV Lisbon Addictions Oct. 25, 2017 • Assessment of potential contraindications: • Relevant 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

  9. 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

  10. 3. Treatment Plan – see §5 Sect. 12 Nr.3 BtMVV • 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

  11. 3b. Integration of Supportive Psychosocial Services – see §5 Sect. 12 Nr.3c BtMVV • 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

  12. 3c. Treatment Evaluation and Monitoring– see §5 Sect. 12 Nr.3d BtMVV 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

  13. Treatment Termination 3c. Treatment Evaluation and Monitoring - continued– see §5 Sect. 12 Nr.3d BtMVV • 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

  14. 3d. Prerequisites for Self-administered Medication – see §5 Sect. 12 Nr.3b BtMVV 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 3rd parties assessed and weighted upon • No violation of clinic rules Overall considerations: • Increased risk for diversion and abuse • Increase of intervals according to patient stability Lisbon Addictions Oct. 25, 2017

  15. Improvements by revised Narcotic Drugs Prescription Ordinance (BtMVV) 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

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

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