Plebon-Huff Sieara, Aziz Nadia, Cavar Marko, Hassan Safia, Aoun Maria, Perwaiz Shahid, Abramovici Hanan
Office of Cannabis Science and Surveillance, Strategic Policy Directorate, Controlled Substances and Cannabis Branch, Health Canada, 150 Tunney's Pasture Driveway, Ottawa, ON, K1A 0T6, Canada.
J Cannabis Res. 2025 Aug 12;7(1):56. doi: 10.1186/s42238-025-00310-x.
The cannabis control framework implemented by Canada in October 2018 established a robust post-market surveillance system for cannabis products, adopting tools and practices from the existing pharmacovigilance system for pharmaceuticals and health products. The cannabis vigilance system relies on spontaneous reporting of adverse reactions, allowing Health Canada to collect, monitor and assess health effects involving cannabis. In this study, we examine trends in adverse reaction reports involving legal cannabis products since legalization and regulation in Canada.
Unique case reports of adverse reactions involving cannabis were collected through the Canada Vigilance Program. Case details were extracted from each report involving legal cannabis as a suspected product. Each case was also assessed for causality to determine the likelihood of association between the cannabis product(s) and the reported event(s). The case data was then aggregated and descriptively analyzed to identify adverse reaction case patterns, including the demographic profiles and use patterns of individuals reporting adverse reactions to cannabis.
Overall, individuals reporting an adverse reaction to a cannabis product (n = 698) were 56.0 ± 20.0 years of age. 45.4% of reporting individuals were female, and 67.5% of individuals self-reported using cannabis for medical purposes, with pain management as the most cited reason for medical use. Most cases were reported as serious (62.3%), citing "other medically important condition" as the primary reason for seriousness (58.6%), and 68.8% of all cases involved cannabis extracts. Frequently reported events included hallucination, headache, nausea, dizziness and dyspnea. Some events were more frequently reported with products containing a greater concentration of tetrahydrocannabinol to cannabidiol, whereas others were more frequently reported with products containing a greater concentration of cannabidiol to tetrahydrocannabinol. Causality was assessed for 668 events; most were assessed as being "possibly" associated with the reported cannabis product.
The post-market adverse reaction reporting system for cannabis products has provided valuable safety information about cannabis products available for legal retail sale in Canada. The data collected through this framework have helped identify emerging risks associated with legal cannabis products; contributed to international data about cannabis effects and risks; informed the development of communication materials related to new and emerging risks; and provided evidence to inform regulatory decisions.
加拿大2018年10月实施的大麻管制框架为大麻产品建立了一个强大的上市后监测系统，采用了现有药品和保健品药物警戒系统的工具和做法。大麻警戒系统依赖于不良反应的自发报告，使加拿大卫生部能够收集、监测和评估涉及大麻的健康影响。在本研究中，我们调查了加拿大将大麻产品合法化并进行监管后，涉及合法大麻产品的不良反应报告趋势。
通过加拿大警戒计划收集涉及大麻的不良反应独特病例报告。病例细节从每份涉及合法大麻作为可疑产品的报告中提取。还对每个病例进行因果关系评估，以确定大麻产品与报告事件之间关联的可能性。然后汇总病例数据并进行描述性分析，以确定不良反应病例模式，包括报告大麻不良反应的个人的人口统计学特征和使用模式。
总体而言，报告大麻产品不良反应的个人（n = 698）年龄为56.0±20.0岁。45.4%的报告个人为女性，67.5%的个人自我报告使用大麻用于医疗目的，疼痛管理是最常被提及的医疗用途原因。大多数病例报告为严重（62.3%），将“其他具有医学重要性的病症”作为严重程度的主要原因（58.6%），所有病例中有68.8%涉及大麻提取物。经常报告的事件包括幻觉、头痛、恶心、头晕和呼吸困难。一些事件在含有更高浓度四氢大麻酚与大麻二酚的产品中报告得更频繁，而其他事件在含有更高浓度大麻二酚与四氢大麻酚的产品中报告得更频繁。对668起事件进行了因果关系评估；大多数被评估为“可能”与报告的大麻产品有关。
大麻产品的上市后不良反应报告系统提供了有关加拿大合法零售的大麻产品的宝贵安全信息。通过该框架收集的数据有助于识别与合法大麻产品相关的新出现风险；为有关大麻影响和风险的国际数据做出了贡献；为与新出现风险相关的宣传材料的制定提供了信息；并为监管决策提供了证据。
