The role of the pharmacies
Both pharmacies and branch pharmacies are part of the supply chain and must therefore assist in the supply of cannabis 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 products,
- check prescriptions for cannabis products,
- inform patients about substitution and the cheapest pack size available and must otherwise provide general guidance,
- Dispense cannabis products to patients.
The procedures of preparing and giving out prescribed cannabis products are very similar to the procedures for preparing and giving out prescribed medicines. Advice about cannabis products must be based on the information about the cannabis products that are part of the programme made available by the intermediate product manufacturers and the Danish Medicines Agency. Only pharmacies and hospital pharmacies can prepare cannabis products. The executive order on the preparation of cannabis products by pharmacies lays down the framework required to be in place to prepare the products. Details are provided below.
When a branch pharmacy receives a prescription, it must re-direct it to the pharmacy it is associated to. The finished cannabis product can then be dispensed to the patient from the branch once the pharmacy has prepared it.
Cannabis products must be dispensed to the patient as quickly as possible – usually within two opening days. When a prescription is handed in to a branch pharmacy, usually three days are allowed for delivery.
It takes some time to deliver the product because it is prepared in accordance with a prescription by a doctor to a specific patient. This is absolutely fundamental to 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 products to treat specific patients.
Both hospital pharmacies and hospital branch pharmacies may:
- receive requisitions for cannabis products,
- dispense cannabis 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 the medicinal cannabis pilot programme under the heading Hospital pharmacies (the act is in Danish only).
The passage describes, among other things, which of the rules governing the pharmacies’ processing of prescriptions and handling also apply to hospital pharmacies, 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.
When a branch hospital pharmacy receives a requisition, it must re-direct the requisition to the hospital pharmacy it is associated to. The finished cannabis product can then be dispensed to the hospital or the department from the branch hospital pharmacy once the hospital pharmacy has prepared it.
How are cannabis products prepared from cannabis intermediate products?
The preparation of a cannabis product must follow a statutory procedure, requiring the product to be labelled with warnings, patient details, information for the patient, etc. (section 18 of the act).
- To be kept out of the reach of children
- Warning triangle if covered by the executive order on euphoriant substances
- The name of the patient
- The name of the pharmacy and the date of service
- Active substances
- Indication, dosage and use, according to the prescription
- Advice about informing the doctor about side effects
- Hand out relevant measuring device for the medicine
The preparation procedure is fundamental to the pilot programme.
Requirements when pharmacies and hospital pharmacies prepare cannabis products
The executive order on pharmacies’ and hospital pharmacies’ preparation of cannabis products lays down the requirements to be satisfied when pharmacies and hospital pharmacies prepare cannabis products. There are requirements for quality assurance and documentation, organisation and staff, premises and equipment, the preparation, documentation of the preparation and for self-inspection.
A distinction is made between the person preparing the product and the responsible person:
- Both pharmacists and pharmaconomists are permitted to prepare cannabis products.
- The responsible person must have a scientific academic background and relevant experience. This means that a pharmaconomist cannot be responsible for the preparation 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 preparation of cannabis products.