First findings from the substitution register of the BfArM

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Since the legislative changes in March 2017, physicians have been able to prescribe cannabis-based drugs. In addition, the BfArM has been mandated to conduct a non-interventional substitution register on the use of medications based on cannabis. For this purpose, doctors transmit certain data relating to cannabis therapy to the BfArM in anonymised form.

Last week at the German Anaesthesia Congress in Leipzig, the BfArM presented the first results of the substitution register.

The data made available by the BfArM refer in particular to the diagnosis of pain, which was the reason for the treatment of the respective patients in approx. 69% of the 4774 data records submitted by April 2019. With more than 3100 cases, an initial overview of certain variables was possible with regard to the symptomatology of pain. After the diagnosis of pain, spasticity (11%), anorexia (8%) as well as nausea and vomiting (4%) followed. Depression follows (3%), ADHD (2%). Lack of appetite, inflammatory bowel diseases, epilepsy or Tic disorders result in 1%. Restless legs syndrome, restlessness and sleep disorders account for less than 1% of prescriptions. Further data from the substitution register are expected to be published in the Federal Health Gazette in July 2019. The anonymous substitution register will continue until 2022. According to the authority, the findings obtained to so far from the substitution register largely show results that could have been expected.

The data published by the BfArM can be viewed here:

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