Cannabis for medical purposes: dynamic surrounding conditions – appropriate information

In March 2017, cannabis medications were generally made available to all patients for medical purposes in Germany with the “Act amending narcotics and other regulations”. Decisive for this were not new scientific findings on the medical use of cannabis, but decisions of supreme courts, as can be seen from the introductory article on the history of the law. For the first time, cannabis medicines can be prescribed under certain conditions at the expense of the statutory health insurance, even if these medicines are not legally approved as finished medicinal products. A system break.

A reproducible pharmaceutical grade is the prerequisite for a safe supply of cannabis medicines. Cannabis flowers, like other herbal drugs and extracts, must be of appropriate pharmaceutical grade as the starting pharmaceutical ingredients used in the manufacture of medicines. Corresponding quality standards are described in the individual monographs of the German Pharmacopoeia (DAB). In his contribution, D. Manns presents the development of the cannabis blossom monograph for the DAB and reports on the state of development of monographs for the European Pharmacopoeia.

In addition to the monographs of the pharmacopoeias, the Federal Association of German Pharmacist Associations (ABDA) in the German Pharmaceutical Codex / New Formulation Formium issues both monographs on the quality of cannabinoid-containing starting materials and recipe prescriptions, as A. Kiefer explains in his article. It highlights the challenges faced by the medical profession in issuing cannabis extract and flower recipes, as well as the pharmacy requirements for testing the pharmaceutical grade of precursors and the production of standardized prescription medicines that are essential for adequate patient care.

In 1964, the isolation of Δ-9-tetrahydrocannabinol (THC), the main active ingredient of the cannabis plant, was achieved for the first time. It contains more than 500 individual substances. After the discovery of the endocannabinoid system in the late 1980s, research expanded. The current state of research on cannabinoid receptors can be found in the article by C. E. Müller.

We have already pointed out the systemic failure in the medical supply of cannabis medicines. It is all the more important to compile scientific data on efficacy and safety, as it might be. a. in the research project “Cannabis: Potential and Risks. A scientific analysis “(CaPRis) has happened. In her article, E. Hoch presents the results of the medical application. The application areas pain, spasticity in multiple sclerosis, nausea and loss of appetite are in the foreground, whereby the effects were often only small.

Since chronic pain, nausea, vomiting and weight loss are common in cancer patients, the use of cannabis medicines is near. However, no clear recommendation can be derived from the literature available so far. Thus, T. Rasche also concludes in his contribution that therapy with cannabinoids for cancer pain and weight gain should only be considered if other therapies are not sufficiently effective.

The therapy of pain is in the foreground when using cannabis medicines. This has already been the case with patients who until the beginning of 2017 were in possession of an exemption permit for the acquisition of cannabis for the purpose of medically accompanied self-therapy. Following the amendment, more than two-thirds of prescriptions for cannabis medicines will be issued to pain patients. What is missing are randomized and controlled efficacy and safety studies. The current state and the difficulties in the interpretation of study results is W. Hauser in his article dar.

With the follow-up survey running until 31.03.2022, the Federal Institute for Drugs and Medical Devices (BfArM) is now systematically collecting data on the use of cannabis medicines for the first time. First interim results are included in the article by G. Schmidt-Wolf. Such a survey can not replace clinical trials, and yet it provides clues as to what to look for when using cannabis medicines and which therapeutic areas are most likely to have positive effects. The very common side effects should not be underestimated.Since many of the unwanted effects are related to vigilance, it is important to alert patients to possible side effects.

Worldwide, there is a very dynamic development regarding the legal regulations on cannabis medicines for medical use. This becomes clear in the concluding article in this issue, which deals in particular with the situation in the Netherlands.

This dynamic has not only captured the use of cannabis in medicine. The use as a stimulant also takes place. Canada, for example, legalized cannabis as a stimulant at the end of 2018. A development that we consider with concern.And not only because the legalization violates the globally recognized unitary convention on narcotics. But this would require another issue of cannabis as a stimulant.

The first step is to ensure the medical care of patients who are currently dependent on cannabis medicines. A significant contribution to this is made by the BfArM-based cannabis agency. In the days leading up to this editorial, the BfArM was able to award the outstanding orders for the cultivation of cannabis for medical purposes in Germany. A milestone in safe patient care and reducing dependence on cannabis imports.

For all efforts made after the o. G. In order to make cannabis medicines available, a professional goal should not lose sight of one goal: In the medium term, the care of patients must be carried out with approved and drug-approved finished medicinal products.

We are pleased that the present issue helps to disseminate appropriate information and to stimulate the professional discussion on cannabis as a medicine.

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Dr. Peter Cremer-Schaeffer

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Prof. Dr. Werner Knoss