Cannabis products in the pilot programme
Doctors can prescribe the cannabis products included in the pilot programme that the companies have made available for prescribers and the pharmacies’ subsequent preparation and dispensing.
The doctor can write out a prescription for a so-called cannabis end-product based on which the pharmacy prepares and dispenses the cannabis end-product.
The pharmacy uses a cannabis intermediate product to prepare the cannabis end-product.
The cannabis intermediate product is manufactured by an intermediate product manufacturer based on a cannabis primary product. It is the intermediate product manufacturer who has applied for inclusion of this cannabis intermediate product in the pilot programme.
Information about the cannabis intermediate products admitted to the pilot programme is available from the following sources:
- on the list of cannabis intermediate products on the website of the Danish Medicines Agency, including product sheet and patient information sheet, if any, for each intermediate product.
- in the medical practice systems
- on Medicinpriser.dk (medicine prices)
Below, we go through the product-specific information available from each of the above sources.
List of admitted cannabis intermediate products
The list of admitted cannabis intermediate products gives doctors an overview of the cannabis intermediate products comprised by the programme.
This list describes the name, strength, product form and pack size of each product.
The product sheet is completed by the company (intermediate product manufacturer). The information in the product sheet reflects the information on the packaging of the cannabis intermediate product. Accordingly, the product sheet contains the following information:
- Name of the cannabis intermediate product
- Declaration of active ingredients
- Product form
- Pack size
- Method of administration
- Method of preparation. Instructions on how to prepare the product are relevant if the product must be prepared before use – consumed as a tea for example.
- Storage conditions
- Shelf life
- Name and address of the intermediate product manufacturer
- Date of completion/revision by the intermediate product manufacturer
- Product number
Patient information sheet
The patient information sheet is prepared by the intermediate product manufacturer if the required information on use, preparation method and/or declaration of excipients and any related warnings cannot be written on the packaging. The patient information sheet must be supplied with the package of the cannabis intermediate product.
You can find the product sheets and patient information sheets of admitted cannabis intermediate products on the website of the Danish Medicines Agency.
Medicinpriser.dk (medicine prices)
The inclusion of a cannabis product in the pilot programme does not necessarily mean that it is currently available for prescribers.
The manufacturer might, for example, be affected by supply difficulties making a cannabis product unavailable for a certain period of time.
Doctors can use www.medicinpriser.dk to look up the cannabis products currently available for prescription in their medical practice systems.
The front page of medicinpriser.dk links to a list of all the cannabis products that you may expect pharmacies to be able to prepare and dispense. Use this link to go directly to the overview.
From the list, you can click on each of the cannabis products and see particulars about the product’s:
- pack sizes
- intermediate product manufacturer
If you click on a specific pack size, information about any substitutable cannabis products will appear.
Medical practice systems
The various types of medical practice systems provide information about the cannabis products. The information available may vary between the systems used by the doctors. In the medical practice system, you will be able to see the specific cannabis product’s:
- pack size
- route of administration
- the indications covered by the Danish Medicines Agency’s guideline for doctors on the medicinal cannabis pilot programme.
If a doctor wants to prescribe a cannabis intermediate product for other indications than those appearing from the guideline, they may be able to select indications from an extended list in their medical practice system. However, not all medical practice systems make this list available.
It is also possible to write the indication in a free-text field, but this field is to be used only if the prescriber cannot find a matching indication in the available indication list.
Dosage recommendations will not be available for doctors through the medical practice system. This is because the intermediate product manufacturer is not required to provide dosage information.
This means that the individual doctor must determine the dose that is right for the patient based on the expression of strength, product form, route of administration and their knowledge of the active ingredients and the concerned patient’s disease, age, co-administered drugs, etc.