Improving the regulation of medical cannabis in Canada to better serve pediatric patients.

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From: CMAJ: Canadian Medical Association Journal(Vol. 193, Issue 41)
Publisher: CMA Joule Inc.
Document Type: Article
Length: 2,878 words
Lexile Measure: 1890L

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Children with chronic debilitating illness and pain are increasingly using cannabis for medical purposes, particularly when conventional treatment options have limited benefit or substantial adverse effects. Caregivers are becoming aware of evidence that suggests medical cannabis provides benefit for children with conditions that include drug-resistant epilepsy, cancer pain and autism. (1,2) At present, children and youth aged 18 years and younger (henceforth referred to as children) access medical cannabis through a framework regulated by Health Canada. In 2018, the Cannabis Act (Bill C-45) created separate medical and recreational streams for purchasing cannabis. (3,4) Under the law, cannabis treatment for children must be authorized by a physician or nurse practitioner, which provides an opportunity for patient counselling. Strict production and labelling requirements that limit contaminants and create some consistency in cannabinoid concentrations have been instituted, which is good for pediatric cannabis users. (5) However, requirements for physician authorization are outdated and do not reflect the needs of pediatric patients, and product labelling remains inadequate, as does surveillance for adverse drug reactions in children. Improvements in regulation are needed.

Under current regulations, health care providers must specify the quantity of cannabis authorized for patients in grams of dried cannabis per day. In the latter half of 2018, cannabis extracts--preparations that have been extracted from the leaves and flowers (inflorescence) of Cannabis sativa--accounted for 67% of cannabis authorized for medical purposes in Canada. (6) Although no pediatric-specific data exist, clinical experience indicates that extracts, not dried product, are predominantly used for children. If patients use extracts, providers must calculate a dosage conversion to complete the authorization form. The cannabinoid content of the dried cannabis used to produce extracts varies, which complicates the daily dosage conversion from milligrams of the desired cannabinoid to grams of dried cannabis. Furthermore, different processes for extracting cannabinoids from dried cannabis plant material have the potential to give the resultant extract a distinctive cannabinoid, terpenoid and residual solvent profile. (7) Individual licensed cannabis producers may have interbatch variability within the same product. Dose calculation is further complicated if the patient uses more than 1 formulation.

Although licensed producers must use validated methods to measure the concentrations of cannabinoids, Health Canada requires only that they label the total concentrations of cannabidiol (CBD) and tetrahydrocannabinol (THC), combining carboxylated and decarboxylated (activated) forms. (5) This variability in CBD and THC content, along with other undisclosed cannabinoids and terpenes, threatens safety and efficacy, deters health care providers from prescribing cannabis and prevents cannabis extracts from being placed on provincial and territorial drug formularies or covered by many private health insurance plans. (8) Consequently, medical cannabis extracts are prohibitively expensive for many caregivers of children, which often leads them to turn to the recreational market or produce homemade extracts that may be unsafe. (8)

Research on medical cannabis use among children in Canada is hampered by inadequate national data. Health Canada reports statistics on medical cannabis use, yet these are currently not stratified by age. Health Canada also maintains a system for reporting adverse...

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Gale Document Number: GALE|A678710298