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Bundesgesundheitsblatt Gesundheitsforschung Gesundheitsschutz. 2019 May 29. doi: 10.1007/s00103-019-02968-0. [Epub ahead of print]

[Interim analysis of the survey accompanying insurance-covered prescriptions of cannabis-based medicines in Germany].

[Article in German]

Author information

1
Bundesinstitut für Arzneimittel und Medizinprodukte, Kurt-Georg-Kiesinger-Allee 3, 53175, Bonn, Deutschland. Gabriele.Schmidt-Wolf@bfarm.de.
2
Bundesinstitut für Arzneimittel und Medizinprodukte, Kurt-Georg-Kiesinger-Allee 3, 53175, Bonn, Deutschland.

Abstract

In Germany, medical doctors who prescribe cannabis medicines at the expense of the statutory health insurance are obliged to take part in a noninterventional survey on the use of these cannabis medicines. The survey collects and evaluates anonymized treatment data and runs until 31 March 2022. Amongst other things, the results of the accompanying survey are the basis on which the Joint Federal Committee (G-BA) regulates the future assumption of treatment costs in the context of a therapy with cannabis medicines in accordance with the Social Code (SGB) V. The transmission of the data for the survey takes place via an online portal operated by the Federal Institute for Drugs and Medical Devices (BfArM). The first data transmission takes place after a treatment period of one year or, if the treatment discontinued before the end of one year, directly after discontinuation of therapy.At the time of the interim evaluation, 01 February 2019, there were 4153 complete datasets collected. Most frequently, the symptom "pain" was treated (69%), followed by spasticity (11%), and anorexia/wasting (8%). The observed adverse reactions correspond with those listed in the product information for the two cannabis-based proprietary medicinal products, Sativex® (GW Pharma Ltd, Salisbury, Wiltshire, UK) and Canemes® (AOP Orphan Pharmaceuticals AG, Vienna, Austria). Most often, insufficient effect was the reason for a discontinuation of treatment. The main indication of pain was already apparent in the licensing procedure for the acquisition of cannabis for medical purposes between the years 2005 and 2016. Further evaluations and subgroup analysis will be carried out when higher case numbers are available.

KEYWORDS:

Adverse reactions; Medical cannabis; Noninterventional survey; Preliminary results; Treated symptoms

PMID:
31143965
DOI:
10.1007/s00103-019-02968-0

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