Cannabisdispensariesuses
Experimentation with Cannabis dispensaries for medical use will be launched in the second half of 2020. The main objective of this experimental phase is to assess in real-life the prescription and dispensing circuit as well as the adherence of healthcare professionals and patients to these. conditions. read this article.
Its secondary objective is to collect the first French data on efficacy and safety.
The most important elements of this framework are aimed at ensuring the best possible security for prescribing and monitoring patients:
Prescription security : treatment can only be initiated by doctors who practice in reference centers / structures and in the indicated indications throughout the territory. Participation will be on a voluntary basis; prescribing physicians must have been previously trained to be able to prescribe cannabis;
Secure patient follow-up : setting up of a comprehensive electronic national register which will also collect the first French clinical data on efficacy and safety.
Thus, the ANSM recommends the following methods of making cannabis available for therapeutic purposes during this experimental phase:
Medicines available, modes of administration, ratios and dosages
provision of medicines based on dried cannabis flowers and full spectrum extracts
provision of immediate and long-
acting forms : - immediate-effect forms: provision of sublingual and inhaled forms (oil and dried flowers for vaporization, etc.)
- long-acting forms: provision of oral forms (solution drinkable and oil capsules…).
provision of the following 5 THC / CBD ratios: THC 1: 1 CBD, THC 1: 20 CBD, THC 1: 50 CBD, THC 5: 20 CBD and THC 20: 1 CBD
dose adjustment by titration by the doctor until the minimum effective dose and / or side effects tolerable by the patient are obtained.
Prescription and dispensing conditions
initiation of treatment reserved for doctors practicing in reference centers / structures supporting the 5 indications listed below, throughout the territory
prescription made by the doctor at the referral center / structure until the patient stabilizes
indications retained for the experimental phase in the event of insufficient relief or poor tolerance (undesirable effects) of medicinal or inaccessible therapies and in particular Cannabis dispensaries products based on cannabis or cannabinoids already available, taking into account the recommendations of good practice: pain neuropathic refractory to accessible therapies (medicinal or not), certain forms of drug-resistant epilepsy, in certain rebellious symptoms in oncology (such as nausea, vomiting, anorexia, etc.), in palliative situations, in painful spasticity in multiple sclerosis or other pathologies of the central nervous system
participation in the experiment, centers and doctors, on a voluntary basis
possible relay in town medicine, once the patient's treatment has stabilized, and after prior agreement between the two doctors
compulsory preliminary training for prescribers (e-learning platform)
mandatory information by physicians of a national electronic patient monitoring register set up by the ANSM
dispensing by pharmacies for internal use (PUI) and in pharmacies
dispensing possible by the pharmacist only if the prescriber has followed the training and filled in the register when prescribing
maintaining access to the drugs used throughout the experimental phase for patients with a favorable benefit / risk.
Contraindications and precautions for use
contraindication in pregnant and breastfeeding women
implementation of effective contraception for women of childbearing potential
warning about the ability to drive and use machines
prescription possible regardless of age if the benefit is assumed to be favorable given the severity of the disorder.
Patient follow-up and evaluation of adverse effects
establishment of the electronic national registry to monitor patients treated with cannabis for therapeutic purposes
collection and analysis of registry data including adverse effects and initial efficacy data for Cannabis dispensaries for therapeutic purposes
The main purpose of the patient follow-up register will be to evaluate the experiment.