Medicinal cannabis

01 March 2022
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What is medicinal cannabis?

Medicinal cannabis has become a catch-all term for dried cannabis flowers, cannabis oils, capsules, tablets, oromucosal spray and so on. What all these products have in common is that they contain either parts of the cannabis plant, active substances from the plant or synthetic cannabinoids, and that people use them to ease symptoms of disease.

Cannabis sativa L is a plant of the Cannabaceae family, commonly referred to as hemp. Cannabis sativa L contains substances capable of producing beneficial medical effects, but also unintended side effects. It is the same plant that is used to manufacture euphoriant substances such as hash, marijuana, “skunk” and pot.

A range of other cannabis species contain very low contents of the euphoriant substance THC and can be used to produce industrial hemp fibres, e.g. for yarn or insulation material.

It is legal and possible to obtain cannabis-based medicines in Denmark. But you can only get it if your doctor has prescribed it to you and you buy it from a pharmacy.

Doctors in Denmark have several routes to prescribe cannabis-based products:

There are two authorised cannabis-based medicines in Denmark: Sativex® and Epidyolex®.

Sativex is an oromucosal spray based on extracts of cannabis containing the substances THC (dronabinol) and CBD (cannabidiol). Sativex is authorised for symptom improvement in adult patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who demonstrate clinically significant improvement in spasticity related symptoms during an initial trial of therapy. Sativex can be prescribed by medical specialists in neurology and/or neuromedicine.

Epidyolex is an oral solution containing CBD from the cannabis plant. Epidyolex is authorised in the EU for the treatment of the forms of epilepsy called Dravet syndrome and Lennox-Gastaut syndrome. The authorisation of Epidyolex covers only these two indications that the company has applied for and only in combination with clobazam, another authorised medicine for the treatment of epilepsy. Epidyolex can be prescribed by medical specialists in neurology and/or paediatrics.

Both Sativex and Epidyolex have been authorised through the official procedures for medicines licensing. This means they have been tested in controlled laboratory trials, animal trials as well as in real people (trial subjects). The manufacturers have submitted all data from these trials to the authorities, which have assessed that the benefits of these medicines outweigh the risk of side effects. As a result, Sativex and Epidyolex are authorised medicines in Denmark.

Marinol and Nabilone are two products authorised in the USA and other countries. They contain synthetically manufactured cannabinoids. The manufacturers of Marinol and Nabilone have not applied for authorisation in Denmark. Consequently, they are not marketed as authorised medicines in Denmark.

Medicines are not authorised in Denmark at the request of the Danish Medicines Agency but at the request of the pharmaceutical companies through an application procedure. Doctors who wish to prescribe Marinol or Nabilone to specific patients can apply to the Danish Medicines Agency for a compassionate use permit even if the medicine is not approved in Denmark. The compassionate use programme allows Marinol or Nabilone to be imported from, for example, the USA if the Danish Medicines Agency accepts the doctor’s application to prescribe either of these medicines to a specific patient.

Doctors can also prescribe magistral preparations of cannabis-based products. A magistral preparation is made by a pharmacy for a specific patient according to the doctor's instructions. The magistral preparation scheme was established to meet the needs of patients who cannot be treated sufficiently with the standard range of authorised medicines. In such cases, a pharmacist will prepare a medicine using the exact ingredients (active substances) that the patient needs according to the prescription issued by the doctor. In this way, a doctor may lawfully write out a prescription for, say, THC or CBD (some of the active ingredients of the cannabis plant). Doctors can prescribe different formulations of the medicine such as oil or capsules.

When pharmacies prepare magistral preparations of medicines, they must follow certain rules. This does not mean that the medicine becomes "authorised" in the traditional sense since it has not been subjected to thorough testing in controlled trials like authorised medicines. So, we do not have the same knowledge of efficacy and side effects of magistral preparations of medicines as we do with authorised medicines.

Since January 2018, doctors in Denmark have been allowed to prescribe new types of cannabis products under the medicinal cannabis pilot programme. Under this programme, doctors can prescribe products that are neither authorised medicines nor magistral preparations of medicines.

The products comprised by the pilot programme are called medicinal cannabis, and they may be in the form of dried cannabis flowers, cannabis oils, capsules, tablets, etc.

The products in the pilot programme must meet established requirements for cultivation of the plant and for the manufacturing of the cannabis product. It is also required that the cannabis product is standardised, meaning that the manufacturer must be able to document the product’s ingredients to ensure the strength and quantity are the same for all packages. The products of the pilot programme are not tested in terms of effects and side effects in controlled trials as authorised medicines are. The Danish Medicines Agency has issued guidelines for doctors to help them with their prescription. Since there is only limited knowledge about the individual products in the pilot programme, the guidelines consider the general knowledge available on the effects of THC and CBD.

The pilot programme will be evaluated throughout its duration to determine whether or not it should be made permanent. 

Watch out for illegal cannabis-containing medicine

Sadly, some people sell illegal cannabis-containing medicines, often under the names of cannabis oils, CBD oils, etc. Most of these oils are sold illegally online, but sometimes also from physical shops. Sellers often promote them as legal products or food supplements although this is rarely the case. Fact is, the oils cannot be compared to the lawful forms of cannabis-containing medicines, which are standardised and controlled products.  

There is great uncertainty about how the illegal cannabis medicines have been produced and what is actually in them. The products might contain something quite different from what the label says, just as the content may vary from bottle to bottle. Neither the products nor the manufacturing processes are controlled, which makes it impossible to predict the effects and side effects with certainty. Taking unknown substances is dangerous, especially if you are ill since neither you nor a doctor has any way of predicting how the unknown substances will affect your disease or interact with any other medicines you take. You might end up getting sicker than you were.

Please put your health first and never buy illegal medicines. Especially children should under no circumstances be exposed to uncontrolled cannabis products.

Talk to your doctor to find the treatment most suitable for you.