The role of the pharmacies

Updated 11 March 2022

Both pharmacies and branch pharmacies are part of the supply chain and must therefore assist in the supply of cannabis end-products prescribed by doctors to patients.

For information specific to hospital pharmacies and hospital branch pharmacies, please see below.

Both pharmacies and branches must:

  • accept prescriptions for cannabis end-products;
  • check prescriptions for cannabis end-products;
  • inform patients about substitution and the cheapest pack size available and must otherwise provide general guidance; and
  • dispense cannabis end-products to patients.

The procedures involved in the dispensing of prescriptions for cannabis end-products are very similar to those involved in the dispensing of prescribed medicines. The advice given about cannabis end-products must be based on the information that intermediate product manufacturers and the Danish Medicines Agency have made available about the cannabis end-products in the programme. It is the pharmacies and hospital pharmacies that are responsible for producing the cannabis end-product, but it is the pharmacy owner who decides if branch pharmacies should offer this service as well or if they should order cannabis end-products from the main pharmacy for dispensing at the branch pharmacy.  

The executive order on the pharmacies’ production of cannabis end-products (Danish title: Bekendtgørelse om apotekers fremstilling af cannabisslutprodukter) specifies the conditions under which the production must take place. Details are provided below.

Cannabis end-products must be dispensed to the patient as quickly as possible – usually within two operating days. If the prescription is handed in to a branch pharmacy, usually three days are allowed to supply the cannabis end-product if the branch does not produce the product itself.

The reason it takes so long is because the product has to be produced in accordance with a doctor’s prescription for a specific patient. This procedure is fundamental to the operation of the pilot programme.

The role of hospital pharmacies

Hospital pharmacies, private hospital pharmacies and their associated branch hospital pharmacies can supply their own hospitals with cannabis end-products for the treatment of specific patients. 

Both hospital pharmacies and hospital branch pharmacies may:

  • receive requisitions for cannabis end-products; and
  • dispense cannabis end-products to their own hospitals.

Hospital pharmacies and hospital branch pharmacies must check and process medicine requisitions according to the provisions of part V of the Act on a Medicinal Cannabis Pilot Programme (Danish title: Lov om forsøgsordning med medicinsk cannabis). See the heading Hospital pharmacies (Sygehusapoteker).

These paragraphs include additional rules applicable to hospital pharmacies regarding the processing of prescriptions and handling, specifying the details to be included in a requisition, the circumstances under which a requisition can be accommodated, when errors must be corrected and the requirements for the establishment of procedures and workflows.

How are cannabis end-products produced from cannabis intermediate products?

The production of a cannabis end-product must follow a statutory procedure, requiring the product to be labelled with warnings and certain details for the patient and information to be provided to the patient, etc. (section 18 of the above-mentioned act). This includes:

  • labelling the product with the text “To be kept out of the reach of children”;
  • labelling the product with a warning triangle if covered by the executive order on euphoriant substances;
  • labelling the product with the patient’s name;
  • labelling the product with the name of the pharmacy and the date of processing;
  • labelling the product with information about the active substances;
  • labelling the product with indication, dosage and use, according to the prescription;
  • enclosing information encouraging patients to tell their doctor about side effects; and
  • handing out a standard measuring device if not provided with the intermediate product.

The production procedure is fundamental to the operation of the pilot programme.

Requirements when pharmacies and hospital pharmacies produce cannabis end-products

The executive order on the pharmacies’ production of cannabis end-products provides the detailed rules for the production of cannabis end-products by pharmacies and hospital pharmacies. The executive order sets out requirements for quality assurance and documentation, organisation and staff, premises and equipment, the production, documentation of the production and for self-inspection.

A distinction is made between the person producing the product and the responsible person (authorised person with overall responsibility for all aspects of the production process).

  • Both pharmacists and pharmaconomists can produce cannabis end-products. 
  • The responsible person must have a scientific academic background and relevant experience. This means that a pharmaconomist cannot have overall responsibility for the production process including the release of the specific product.

Supervision and control

The Danish Medicines Agency supervises and controls the pharmacies’ and hospital pharmacies’ processing of prescriptions and medicine requisitions and the production of cannabis end-products.