The BfArM's Federal Opium Agency keeps a register on behalf of the "Laender" with data on the prescription of substitute drugs (Substitution Register). The legal basis for this is Section 13 sub-section 3 of the German Narcotic Drugs Act ("Betäubungsmittelgesetz", BtMG) in conjunction with Section 5a of the Narcotic Drugs Prescription Ordinance ("Betäubungsmittel-Verschreibungsverordnung", BtMVV).
Any physician prescribing a substitute drug for a patient addicted to opioids shall immediately report the following data to the BfArM's Federal Opium Agency:
- the patient code,
- the date of the first prescription,
- the substitute drug prescribed,
- the date of the last prescription,
- the name and address of the prescribing physician,
- the name and address of the consulted physician.
Furthermore, the medical associations shall inform the Federal Opium Agency every year by 31 March and 30 September which physicians meet the minimum qualification requirements for addiction therapy.
The main functions of the Substitution Register include
- preventing as early as possible multiple prescriptions of a substitute drug by several physicians for the same patient,
- checking compliance of the substituting physicians with the minimum qualification requirements for addiction therapy,
- transmitting statistical evaluations to the competent monitoring authorities and highest health authorities of the "Laender".
As a national monitoring instrument and supplier of data, the Substitution Register contributes significantly to the protection of patients and to the safety and control of substitution treatments on a federal, state, and local level.