What is medicinal cannabis?
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Cannabis sativa L is a plant of the family Cannabaceae, commonly referred to as hemp. Cannabis sativa L contains substances that may produce a beneficial medicinal effect, but it may also produce unintended side effects. The same plant is used to manufacture euphoriant substances such as hash, marihuana, skunk and pot. Sometimes, another species is used, Cannabis indica Lam.
A range of other cannabis species contain very low contents of the euphoriant substance THC. It is used for industrial hemp, e.g. for the production of yarn or insulation material.
Today, medicinal cannabis is a catch-all term for anything from dried cannabis flowers, cannabis oils, capsules, tablets, oromucosal spray and so on. But common to all of these product types is that they contain either parts of the cannabis plant, active substances from the plant or synthetic cannabinoids, and that they are used to alleviate illness.
It is both legal and possible to obtain cannabis-based medicines today, 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 possibilities of prescribing cannabis-based products:
- Authorised medicine
One cannabis-based medicine has been authorised in Denmark. The medicine is called Sativex and is an oromucosal spray that is used to treat spasms in multiple sclerosis. Sativex contains cannabis extracts and may be prescribed by neurologists to patients with multiple sclerosis. Because it is an authorised medicine, we know exactly what is in it, how it works, and how it is made. Sativex has gone through the official authorisation procedure, which means it has been tested in controlled laboratory trials, animal trials and human trials. The company behind the product has submitted all data from the trials to the authorities, and the authorities found that the benefits of the medicine outweigh the risk of side effects. And that is why Sativex is an authorised medicine in Denmark. Sativex is manufactured by GW Pharmaceuticals, a pharmaceutical company that carries out research with other types of cannabis-based medicines as well.
- Non-authorised medicine by issue of a compassionate use permit
The USA and other countries have authorised the products Marinol and Nabilone. They contain synthetically manufactured cannabinoids. The manufacturers of Marinol and Nabilone have not applied for authorisation of the products in Denmark, and they are therefore not sold as authorised medicines in Denmark. The Danish Medicines Agency is not the initiator when medicines are authorised – it is something the companies have to apply for. If a doctor wants to prescribe Marinol or Nabilone to specific patients, he or she can apply for a compassionate use permit from the Danish Medicines Agency even though these medicines are not approved in Denmark. The compassionate use scheme means that Marinol or Nabilone can be imported from for example the USA if the Danish Medicines Agency accepts a doctor’s application to prescribe either products to a specific patient.
- Magistral preparations of cannabis
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 common range of authorised medicines. In such cases, a pharmacy will prepare the medicine with the specific active substances that will benefit the patient according to the prescription issued by the doctor. In this way, a doctor may lawfully write out a prescription for, say, THC or CBD which are 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. But the medicine is not "authorised" in the strict sense because it does not go through the same thorough tests in controlled trials like authorised medicines do. So, we do not have the same knowledge about efficacy and side effects of magistral preparations of medicines compared to authorised medicines.
- Medicinal cannabis pilot programme
From 1 January 2018, doctors can prescribe a new type of cannabis product. A pilot programme will run for a four-year period, and during this time doctors will be allowed to 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 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 content of the product, so that the strength and quantity are the same for all packages. The products of the pilot programme are not tested in regard to effects and side effects in controlled trials in the same way as authorised medicines. The Danish Medicines Agency has issued guidelines for doctors to help them with prescription of the medicines. 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 if it should be extended or perhaps made permanent.
Watch out for illegal cannabis-containing medicine
Regrettably, some people are selling illegal cannabis-containing medicines, often called cannabis oils, CBD oils, etc. Most of these oils are sold 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 legal forms of cannabis-containing medicines, which are standardised and controlled products.
There is great uncertainty about how the illegal cannabis medicines have been made, and what the products actually contain. The products could 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 process are controlled, which makes it impossible to predict with certainty the effects and side effects. Taking unknown substances is dangerous, especially if you are ill since neither you or a doctor has any way of predicting how the unknown substances will affect the disease or interact with any other medicines you are taking. You might end up getting sicker than you were.
Please put your health first and do not buy illegal medicines. Especially children should under no circumstances be exposed to uncontrolled cannabis products.
Talk to your doctor to find the treatment that is best for you.