Acting Senior Scientific Evaluator Health Canada, Canada
Background: Health Canada’s (HC) Vigilance Framework for Cannabis Products allows for the detection, collection, monitoring, and assessment of adverse reactions (ARs) to support decision-making, knowledge translation and communication of the risks of cannabis products to the public. With more than a quarter of Canadians aged 16 years and older reporting use of cannabis for non-medical purposes in the previous year, it is important to continue to monitor any potential ARs arising from the use of cannabis and cannabis products particularly given that consumers have differing risk profiles that may increase the risk of ARs.
Objectives: To introduce HC’s Vigilance Framework for Cannabis Products and summarize ARs suspected as being associated with cannabis products received by HC since the coming into force of the Cannabis Act and its Regulations.
Methods: Adverse reaction reports are submitted to HC by consumers and healthcare professionals on a voluntary basis, and by licence holders who are obligated to report serious ARs according to Section 248 of the Cannabis Regulations. Reports are received and coded in the Canada Vigilance Database by the Marketed Health Products Directorate. The Office of Cannabis Science and Surveillance is responsible for the detection, monitoring, prioritization, evaluation and risk management of cannabis ARs.
A descriptive analysis of all cases involving legal cannabis products in a suspected role and received from October 17, 2018 to December 31, 2022 was conducted to better understand case patterns by demographic and use characteristics since the coming into force of the Cannabis Act and its Regulations.
Results: A total of 577 AR cases involving legal cannabis products were reported to HC during the reference period. Most cases were serious (65%) and involved females (47%; males: 36%; not reported: 17%), cannabis use for self-reported medical purposes (69%) and cannabis extracts (71%). The most frequently reported events were hallucination, headache, nausea, dizziness, and malaise. Of the cases assessed, most were assigned a causality of ‘Possible’ meaning the product may have contributed to the AR but that the contribution of other factors could not be ruled out.
Conclusions: This analysis has identified several patterns in AR cases reported to HC involving legal cannabis products. Health Canada will continue to monitor and analyze trends in cannabis ARs and publish public-facing surveillance reports of ARs annually. These data will help inform educational and outreach resources for consumers, healthcare professionals and other reporters of ARs, in addition to informing other activities, such as potential risk communications.
