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information for German pharmacists

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In Germany, cannabinoid-containing medicines can be prescribed by doctors of all disciplines for suitable indications if they and the patients expect treatment to be successful.

It should be noted that statutory health insurance companies only cover such a therapy if several requirements according to Social Security Code V (SGB V) are met. Due to their broad symptomatic effect profile (use of cannabis in medicine), cannabis medicinal products are used in everyday medical practice to control and alleviate various – especially therapy-resistant – complaints. They represent a way out for sick people, especially in the event of treatment failure or contraindications to conventional therapy options.

 

As an alternative to conventional medicines, cannabis can also enable a dose reduction or the complete discontinuation of, for example, painkillers.

 

However, the study situation on medical cannabis does not yet allow a final assessment of the potential effect. This can be attributed, for example, to the relatively small group of subjects and/or short study periods. The range of variation in the measurable results, both within studies and across multiple studies, is high. There is reason to believe that these heterogeneous results are partly due to the fact that some people are non-responders.

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Information on drug manufacture

In order to ensure patient safety and uniform quality, cannabis therapeutics are manufactured on the basis of monographs in the German Pharmacopoeia (DAB) and the German Drug Codex (DAC) as well as in accordance with NRF recipe specifications. The following monographs on cannabis medicinal products and cannabinoids exist:

  • Cannabis flowers DAB

  • Discontinued cannabis extract DAB

  • Cannabidiol (C-052)

  • Dronabinol (D-100)

 

Prescription medicines containing cannabinoids can be manufactured at the pharmacy in accordance with the following NRF prescriptions:

  • Dronabinol Capsules 2.5mg | 5mg | 10 mg (NRF 22.7.)

  • Oily dronabinol drops 25 mg/ml (NRF 22.8.)

  • Cannabidiol oily solution 50 mg/ml | 100 mg/ml (NRF 22.10.)

  • Oily cannabis oil resin solution 25 mg/ml dronabinol (NRF 22.11.)

  • Cannabis flowers for inhalation after vaporization (NRF 22.12.)

  • Single-dose cannabis flowers for inhalation after vaporization (NRF 22.13.)

  • Cannabis flowers for tea preparation (NRF 22.14.)

  • Cannabis flowers in single doses of 0.25 g | 0.5g | 0.75g | 1.0 g for tea preparation (NRF 22.15.)

  • Dronabinol ethanol solution 10 mg/ml for inhalation (NRF 22.16.)

Information on the billing of cannabinoid-containing products

Prescription products within the framework of the current regulation

The National Association of Statutory Health Insurance Funds and the German Association of Pharmacists have laid down changed rules for the taxation of medicinal products containing cannabis with the new Annex 10 to the auxiliary tax retroactive to March 1, 2020. Specific rules now apply to the billing of prescription drugs containing dronabinol, cannabis flowers and cannabis extracts. In addition, the fee is taxed with the usual surcharges of 90 or 100 percent on packaging and the fee for documentation in accordance with the Narcotics Ordinance (BtM documentation). In the case of preparations, the formulation surcharge, the fixed surcharge of EUR 8.35 and the purchase prices and surcharges for excipients are also included in the assessment.

Billing of cannabis flowers

Based on the new price regulation, a uniform purchase price of EUR 9.52 per gram can be billed for cannabis blossoms. If a pharmacy buys at a higher price, it has to bear the corresponding loss of margin. Fixed surcharges based on the delivery quantity are added to the billing:

  • EUR 9.52 per gram for the first 15 grams when selling cannabis blossoms unchanged, sales price in accordance with Section 4 of the Drug Price Ordinance (AMPreisV). PZN for unchanged cannabis flowers: 06460694

  • 8.56 euros per gram for the first 15 grams for cannabis flowers used in preparations, sales price according to § 5 AMPreisV. PZN for cannabis flowers in preparations: 06460665

  • 3.70 euros per gram from 16 grams to 30 grams

  • 2.60 euros per gram for every gram in excess of 30 grams.

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Answers to common questions about medicinal cannabis

How is cannabis flower identity verified?

The identification of cannabis blossoms is based on the DAB monograph for cannabis blossoms and includes an organoleptic or visual examination, a microscopic examination and thin-layer chromatography to detect tetrahydrocannabinol (THC) and/or cannabadidiol (CBD) using reference substances.

How many patients in Germany are treated with medical cannabis products?

 

Unfortunately, due to the high number of self-payers, there is little reliable and up-to-date data. In 2018 there were an estimated 60,000 medical cannabis patients in Germany (source: Prohibition Partners). In 2018, 95,000 prescriptions for medicines containing cannabinoids were issued, 60 percent of which were reimbursed by health insurance companies.

Is there anything special that needs to be considered when dispensing cannabis products to patients?

In principle, there are no legal requirements that go beyond the Narcotics Act (BtMG) when selling cannabis products. Cannabis medicinal products can be prescribed by doctors of all disciplines except dentists and veterinarians. A declaration of assumption of costs by the health insurance company is not necessary. However, in order to protect the pharmacy from reimbursements, it can be advisable to inform the patient before dispensing the preparation of the need to obtain a promise to assume the costs in the case of prescriptions via statutory health insurance.

What information must be on a cannabis prescription?

Cannabis therapeutics are prescribed via a Narcotics Ordinance (BtM Ordinance) in accordance with § 9 Narcotics Prescription Ordinance (BtMVV) and must include the following information:

  • First name, last name and address of the patient

  • date of issue

  • unique drug designation, e.g. B. Cannabis Flos Stratus Indica

  • Prescription amount in grams, milliliters or number of items, e.g. B. 30 grams

  • Instructions for use with single and daily dosage or reference to the written instructions available to the patient, e.g. B. 4 x daily 0.25 g

  • Specification of the dosage form, e.g. B. vaporize and inhale

  • Delivery form, e.g. B. not crushed (in the case of cannabis blossoms, further processing can alternatively be ordered, e.g. according to NRF 22.12.)

  • Name, job title, address and telephone number of the doctor

  • Signature of the doctor

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