In early August 2020, the Federal Minister of Health granted an exemption under the Controlled Drugs and Substances Act(CDSA) to four terminally ill Canadians to use psilocybin in their end of life care.
Psilocybin is one of the active ingredients/chemicals in “magic mushrooms,” the other is psilocin. Both psilocybin and psilocin are controlled substances under Schedule III of the CDSA. The sale, possession, production, etc. are prohibited unless authorized for clinical trial or research purposes under Part J of the Food and Drug Regulations. Both have been illegal in Canada since 1974. According to Health Canada, there are no approved therapeutic products containing psilocybin in Canada. However, the purified active ingredient, i.e. psilocybin, is being studied in supervised clinical settings for its potential to treat various conditions such as anxiety and depression.
The Minister’s exemption marks the first time a legal exemption has been granted in Canada for patients to access psychedelic substances for treatment. The four individuals suffer from terminal cancer and have experienced anxiety etc. that have not responded to conventional psychotherapy treatments. They applied for an exemption under compassionate grounds under section 56(1) of the CDSA.
Subsection 56(1) of the CDSA allows the Minister of Health to exempt any person or class of persons or any controlled substance or precursor or class thereof from the application of all or any provisions of the Act or the regulations if, in the opinion of the Minister, the exemption is necessary for a medical or scientific purpose or is otherwise in the public interest.
Health Canada’s policy regarding exemptions for scientific purposes (e.g.clinical research) indicates that the applicant must ensure that the controlled substance is an integral part of the protocol and that the use and storage of the controlled substance will not contribute to the diversion or abuse of the substance. It is not clear what the considerations are for individual exemptions, but we expect Health Canada will delineate a policy as the decision is likely to spark more applications.
While we can expect more exemptions in the future, physicians and psychotherapists are reminded of their respective College obligations. Of course, unless there is authorized use of psilocybin (as in these four individual exemptions), health professionals will not be able to prescribe the psychedelic substance. This, however, brings back the discussion surrounding cannabis for medical purposes top of mind.
Medical cannabis is subject to different rules than recreational cannabis. The production and sale of medical cannabis is regulated exclusively by the federal government, while provincial governments are responsible for some of the regulations for recreational cannabis.
The College of Physicians and Surgeons of Ontario (CPSO) has a policy on Cannabis for Medical Purposes that was last updated in January 2019. As with any treatment, physicians are not obligated to prescribe cannabis if they do not believe it is clinically appropriate for the patient. Particular care must be taken if a physician is prescribing cannabis for patients under the age of 25. Unlike more ‘conventional prescriptions,’ the policy advises physicians to require their patients to sign a written treatment agreement that, at minimum, specifies that the patient agrees that they will:
The agreement should also include a clause that specifies that in case of a breach of the agreement, the physician may decide not to continue prescribing cannabis to the patient. For further detail, physicians are encouraged to review the policy on Cannabis for Medical Purposes as well as the CPSO’s Prescribing Drugs policy.Disclaimer: A blog post is never a substitute for legal advice specific to your circumstances, particularly when surrounding circumstances are changing rapidly or novel.
Like other professionals, pharmacists have been adjusting to an expanded scope of practice as all health professionals work to combat the COVID-19 pandemic. We wrote about some of these changes in our previous blog posts.
Last week, the Minister of Health made additional changes to the Regulated Health Professions Act relevant to pharmacy professionals. Now, members of the Ontario College of Pharmacists — including pharmacists, interns, registered pharmacy students, or pharmacy technicians — can administer coronavirus vaccines by injection. These individuals must be certified to administer vaccines and must do so while being engaged by an organization that has an agreement with the Minister governing the administration of the vaccine (e.g., a hospital).