The French government has published a long -awaited decree detailing how a limited experience of medical cannabis will be carried out.
The first prescriptions should now take place in March 2021.
It has also been confirmed that up to 3,000 patients have been selected and 700 of them suffer from chronic pain. It is important to know that chronic pain affects 5 % of the population. This clinical trial is important to them. If the results are conclusive, these new THC and CBD mixing drugs will relieve them on a daily basis.
The experience will be limited in time - two years from the first prescription.
The first results of the clinical trial expected after 6 months
The decree also determined that the Ministry of Health and Solidarity is responsible for the execution of the project. The Minister, with the opinion of the Director General of the French Agency for the Safety of Medicines and Health Products (ANSM), will decide:
The characteristics, the composition, the pharmaceutical form and the technical specifications of cannabis medical products.
The pharmaceutical form
Medical cannabis during experimentation will be presented either in the form of flowers, oils and capsules, full spectrum extracts
Flowers for inhalation by vaporization will be part of the experience, as well as extracts - capsules or oils - with different THC and CBD ratios.
- - Forms with an immediate effect: provision of sublingual and inhaled shapes (oil and dried flowers for vaporization, etc.)
- - Prolonged effect forms: provision of oral forms (oral solution and oil capsules, etc.)
Vaporization is the only acceptable route of administration for flowers.
CBD / THC ratio
Provision of the 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
Dosological adaptation by the doctor by the doctor until the minimum effective dose is obtained and/or adverse effects tolerable by the patient.
Only patients with the following qualification conditions will be able to participate in the trial
- Refractory neuropathic pain.
- Certain forms of drug resistant epilepsy
- Certain insoluble symptoms in oncology linked to cancer or anti -cancer treatment. (such as nausea, vomiting, anorexia, etc.)
- Palliative situations.
- Painful spasticity due to multiple sclerosis or other pathologies of the central nervous system.
Contraindications and precautions for use
- Contraindication in pregnant and breastfeeding women
- Effective contraception for women of childbearing age
- a warning concerning the ability to drive vehicles and to use machines
- Possible prescription regardless of age if the benefit is deemed favorable given the severity of the disease.
Patient monitoring and side effects assessment
- Creation of the national electronic register for monitoring patients treated with cannabis for therapeutic purposes
- Collection and analysis of registry data, including undesirable effects and initial efficiency data of therapeutic cannabis
- The primary purpose of the patient monitoring register will be to assess the experience.
Questions on the experimentation of cannabis for medical use
How to be included in the experience? Who should I contact?
Inclusion is only carried out by hospital services (reference structures) which oversee one of the 5 indications used for experience. The list of these structures is being finalized and publication by the ANSM.
If you are not followed in one of these structures, you will need to contact your general practitioner or the specialist who follows you so that he can direct you towards a listed reference structure.
Can I be followed by my doctor during the experience?
After being involved in experimentation through a reference structure, your doctor may take care of your follow -up care, provided they have followed the preparatory and compulsory training in the prescription of medical cannabis.
How to get my cannabis prescription for medical use?
Like all drugs, medical cannabis is prescribed on a safe prescription which should not be renewed more than 28 days.
The prescription must be presented at the hospital pharmacy where the prescription has been issued or at the city's pharmacy of your choice. The pharmacist must also be trained in the distribution of cannabis for medical use.
What data is collected during the experience?
Inclusion in experience implies the collection of personal data in a national electronic surveillance register. The objective of this register is to assess the prescription and dispensation cycle and collect the first French data on the efficiency and safety of the use of cannabis in medical areas.
Your personal information is protected and will not be published.
It is being drafted by the ANSM and its implementation is subject to the approval of the CNIL (National Commission for Data Protection).
What are the precautions for use?
Cannabis and THC, one of its active ingredients, are narcotics.
Cannabis can considerably affect vigilance. It is also potentially addictive and can lead to dependence (a physiological phenomenon which requires increasing the dose regularly to obtain the same effect).
In addition, cannabis is contraindicated for medicinal purposes as a precaution for pregnant and lactating women. The prescribing doctor will require effective contraception for women of childbearing age during the first consultation.
A collection and analysis of adverse events for all patients followed in experience is planned. Analysis of the undesirable effects is carried out by the networks of CRPV (Regional Pharmacovigilance Centers) and CEIP (Evaluation and information centers on pharmacodependence - Addictavigilance - Evaluation and information centers on pharmacodependence - Addictavigilance ).
source :
https://www.ansm.sante.fr/Dossiers/Cannabis-a-usage-medical/Appel-a-candidatures-fourniture-et-distribution-de-medicaments-a-base-de-cannabis-pour-l-experimentation/(offset)/0
