1. 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
2nd European Conference on Addictive Behaviours and Dependencies Oct. 2017

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

3. Legal Framework of GMA Directive
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)
Lisbon Addictions
Oct. 25, 2017

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
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
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
Lisbon Addictions
Oct. 25, 2017

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
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
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

14. 3d. Prerequisites for Self-administered Medication. – see §5 Sect
3d. Prerequisites for Self-administered Medication – see §5 Sect. 12 Nr.3b BtMVV
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 3rd parties assessed and weighted upon
No violation of clinic rules
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