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Substitution - what doctors need to consider

The legislature has regulated the legal requirements for substitution-based treatment of drug addicts in Sections 5 and 5a of the Narcotics Prescription Ordinance (BtMVV). In the Narcotics Prescription Ordinance, it is pointed out in several places that the "generally recognized state of the art of medical science" must be observed for substitution treatment.

In its "Guidelines of the German Medical Association for the Implementation of Substitution-Based Treatment of Opiate Addicts", the German Medical Association established the "generally recognized state of medical science".

The Federal Joint Committee (in Germany the highest body of joint self-administration in the health care system) has in the guidelines on the evaluation of medical examination and treatment methods (BUB guidelines, now: Guidelines for methods of contract medical care ") according to § 135 para. 1 SGB V die Prerequisites for carrying out substitution-based treatment in the case of manifest opiate addicts are regulated within the framework of statutory health care.

The addiction medicine qualification of the doctors is a prerequisite for the authorization to prescribe substitution drugs.

Only those doctors who have acquired specific addiction medicine qualifications are allowed to prescribe substitution drugs. The German Medical Association has stipulated that evidence of additional training (previously: specialist knowledge) "basic addiction medicine" or an equivalent qualification is required.

Obligation to report for substitution treatment

Since July 1, 2002, the obligation to report for substitution-based treatments has been in effect. This measure is intended to prevent possible double prescriptions from different doctors. The doctor must immediately report every patient for whom he prescribes a substitute drug to the Federal Institute for Drugs (BfArM) in anonymised form.

Report to the BfArM that doctors are entitled to substitution treatment

The medical associations are obliged to continuously report those doctors who have acquired the authorization to prescribe substitution drugs to the Federal Institute for Drugs (BfArM). The messages are compared there. Anyone who prescribes substitution drugs without reporting this or without having the authorization must expect a fine.
Exception: A doctor may treat up to three patients with substitution support even without the required qualification if he works closely with a consultant who has the necessary qualifications.

Take-home regulations and taking substitute drugs with you when you are abroad

As a rule, the substitution agent must be taken daily by the patient in the doctor's office under supervision. Only after the course of treatment has stabilized (stable dose setting, no hazardous additional use, no injecting drugs - more details on this in the BÄK guidelines) can the patient take the substitution agent for a certain period of time (a maximum of 7 days) on his own responsibility, including a prescription for the necessary Amount is given by the doctor (take-home rule).

In the case of a planned stay abroad, the doctor may prescribe a larger amount of the substitution drug for the patient, but only if the usual take-home requirements are met. These prescriptions cannot exceed the 30-day amount within a year. In the case of a prescription for more than 7 days, the doctor must immediately notify the responsible state authority. In Berlin, the State Office for Health and Social Affairs (LAGeSo) is the competent authority for monitoring traffic with narcotics:

State Office for Health and Social Affairs (LAGeSo), Unit IB
P.O. Box 310 929
10639 Berlin
Tel .: 030 90125521

Certificates for taking a substitute substance abroad

A patient who travels abroad must carry a certificate from his doctor with him during the trip stating that he needs the drug for health reasons. For details depending on the country / region, among other things the Institute for the Promotion of Qualified Drug Research, Accepting Drug Work and Rational Drug Policy e. V. Within the states that have signed the Schengen Agreement, a "Certificate for the carriage of narcotics for medical treatment - Article 75 of the Schengen Implementation Agreement" must be carried. This certificate can also be obtained from Indro e. V. to download.

This certificate must be completed, signed and stamped by the attending physician. The patient must have the signature certified by the state authority. Responsible in Berlin is:

State Office for Health and Social Affairs (LAGeSo), Section I A 45
Fehrbelliner Platz 1
10707 Berlin
Tel .: 030 90125096 (prior appointment by phone required!)

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