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15. May 2019 Top News0

 

 

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:

 

Download PDF

 

 


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10. May 2019 Top News

 

Since 1 April 2019, new special codes have been in force for the billing of cannabinoids and cannabinoid formulations for pharmacists. The new indicators have been included in Technical Annex 1 to the Drug Settlement Agreement. Technical Annex 1 to the Agreement on the Transfer of Data in the Framework of Drug Accounting pursuant to Section 300 of the German Social Code (SGB V) previously listed three special PZNs for cannabis preparations. Since April 1, 2019, version 31list five.

According to this, now only preparations from cannabis blossoms are to be accounted under the special PZN 06460665. Until now this PZN was generally valid for cannabis-containing recipes. Two new special numbers will be added: For cannabinoid-containing substances or ready-to-use medicines in preparations, PZN 06460748 must now be used. Substances containing cannabinoids in their unchanged state are covered by the special PZN 06460754.

Cannabis blossoms in unchanged state will continue to be charged with PZN 06460694. For cannabinoid-containing ready-to-use medicines without PZN, PZN 06460671 continues to apply.


An overview of the special codes valid since April 2019:


06460665

Cannabis blossoms in preparations

06460694
Cannabis blossoms in unaltered state

06460748
Substances containing cannabinoids or ready-to-use medicinal products in preparations

06460754
Substances containing cannabinoids in unaltered state

06460671
Ready-to-use medicinal products containing cannabinoids without pharmaceutical central number

In addition, the DAP work aids on cannabis blossoms and cannabinoids were updated on 1 April 2019:

 

https://www.deutschesapothekenportal.de/rezept-retax/dap-retax-arbeitshilfen/betaeubungsmittel/btm-rezepte-korrekt-beliefern/

https://www.gkv-datenaustausch.de/media/dokumente/leistungserbringer_1/apotheken/technische_anlagen_aktuell/TA1_031_20181204.pdf

 

 

 

 

 

 


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