The article caused irritation. From the first line, or even in the title, the term “Mitgabe”—i.e. issuing, or dispensing—is used. This implies a hospital or surgery’s dispensing a substitute drug to be taken by the patient under his/her own responsibility. This is not provided for within the Narcotic Drugs Prescription Ordinance (Betäubungsmittel-Verschreibungsverordnung, BtMVV) (§ 5) and therefore not permitted within the framework of the German law governing the prescription of medicines.
The guideline of the German Medical Association dated 19 February 2010, No 9, 3rd sentence, is (suggest, for clarity’s sake: “also”) unequivocal: “Eine Mitgabe von Substitutionsmitteln aus dem Praxisbestand ist hingegen strafbar [providing substitution medication from the practice’s own dispensary is a punishable offense].”
Furthermore the authors report that patients from 20 psychiatric hospitals participated in their study. Providing take home medication from the hospital’s dispensary is legally not permitted, and professional and ethical regulatory guidelines naturally also apply to the inpatient setting.
Regarding the methods, the authors wrote: “5032 patients were registered at the Berlin Medical Association as being on maintenance treatment.”
According to § 5a section 2 of the German Narcotics Law, any doctor prescribing substitution medication is under obligation to report immediately the start and end date of every case of substitution treatment in coded form to the substitution registry held at the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) in Bonn.
Ignoring this rule is a regulatory offense under §17 of the narcotics law. On the basis of this obligation, the BfArM is able to determine the number of registered cases of substitution treatment at federal and state levels.
Hence none of the 5032 described patients are registered with a medical association. The deficiencies described unfortunately limit the value of the overall conclusion. Further remarks are unfortunately not possible in view of the space restrictions imposed by Deutsches Ärzteblatt’s instructions for authors.
Kassenärztliche Vereinigung Berlin
|1.||Gutwinski S, Bald LK, Heinz A, Müller CA, Schmidt AK, Wiers C, Bermpohl F, Gallinat J: Take home maintenance medication in opiate dependence. Dtsch Arztebl Int 2013; 110(23–24): 405–12 VOLLTEXT|