Cannabis as prescription

With the Act Amending Narcotics Law and Other Regulations, which came into force on 10 March 2017, the legislator has expanded the options for prescribing cannabis medicines.

What must be considered before prescribing a cannabis medicine for the first time? When prescribing the approved finished medicinal products Sativex® or Canemes® outside the approved indications or cannabis flowers, cannabis extracts not approved as finished medicinal products or dronabinol at the expense of the SHI, the patient must submit an application for approval of cost coverage to the competent health insurance fund before the first prescription. For this purpose, reference is made to § 31 paragraph 6 of the Fifth Book of the German Social Code. In each of the aforementioned cases, the patient must be informed that a companion survey has been carried out .

How must cannabis medicinal products be prescribed? Cannabis medicinal products must be prescribed on a narcotic prescription. All cannabis medicinal products are narcotics listed in Schedule III to Section 1(1) of the Narcotics Act. Schedule III narcotics must be prescribed on a narcotic prescription.

Who may prescribe cannabis medicinal products? In principle, all persons authorised to practise medicine are entitled to prescribe narcotics (including cannabis extracts and flowers, dronabinol and nabilone) on a narcotic prescription. Dentists and veterinarians, however, are not entitled to prescribe cannabis. The generally applicable regulations on the prescription of narcotics must be observed whenever cannabis medicinal products are prescribed.

Will there be different varieties of cannabis products? There will be different varieties of cannabis flowers and extracts. The respective varieties will be clearly identifiable by their name and defined by their THC and CBD content. The content of ingredients will vary.

How can I ensure safety in therapy? As with other natural products, the content of ingredients in each product will fluctuate. However, the range of variation is limited by the definition in the monograph on cannabis. Since cannabis has a relatively high therapeutic breadth according to scientific information available to date, fluctuations in the active ingredient content in the acceptance range should have little, if any, effect on the efficacy and safety of therapy with these products.

Where can I get information about the available varieties? The BfArM assumes that corresponding suppliers will make the available varieties known to the professional circles.

Where can I get information on dosage? With regard to the finished medicinal products Sativex®(thick extracts of cannabis), Marinol®(active ingredient: dronabinol) and Canemes®(active ingredient: nabilone), we refer to the respective expert information. Scientific information on the dosage of non-approved cannabis medicinal products (especially flowers) is only available to a very limited extent. Further information can be found, among others, on the website of the Canadian authority Health Canada under the title "Information for Health Care Professionals". The BfArM accepts no responsibility for the completeness and accuracy of this information.

What must be written on the narcotic prescription (BtM prescription)? Am I allowed to prescribe cannabis medicinal products even if the health insurance company does not agree to cover the costs? The current legal framework allows the prescription of cannabis medicinal products in all justified cases. The assumption of costs by the health insurance funds is not a mandatory condition for the prescription.

Since, with the exception of Sativex®, no finished cannabis-based medicinal products are available at present, extracts and flowers are dispensed as prescription medicinal products in pharmacies. The prescription of cannabis medicinal products is also permissible in the case of patient care via narcotics requisition notes.

1. https://www.bfarm.de/DE/Bundesopiumstelle/Cannabis/_node.html