Abstract：
OBJECTIVE: The use of cannabis-based medicine (CBM) as a therapeutic has surged in Australia over the past 5 years. Historically, the United Nations Single Convention on Narcotic Drugs (1961) prohibited cannabis use in Europe, the USA, the UK and Australia, leading to legislative resistance and limited preclinical data on CBM. Existing safety monitoring systems for CBM are poorly structured and do not integrate well into the workflows of busy health professionals. As a result, postmarketing surveillance is inconsistent. This review aims to evaluate international systems for monitoring CBM side effects and adverse events.
METHODS: To undertake a scoping review with a systematic approach, we used the Population, Intervention, Comparison, Outcome (PICO) framework to develop keyword elements, and two search queries to maximise search sensitivity and specificity.
METHODS: Search queries were entered into Embase and Scopus for peer-reviewed literature, and additional searches for grey literature were conducted on 23 June 2023.
METHODS: We included 54 full-text articles in the review: 39 from peer-reviewed searches, 8 from grey literature and 7 from citations of relevant texts.
METHODS: Our search yielded two main forms of monitoring systems: databases and registries. Out of the 24 monitoring systems identified, there were 10 databases and 14 registries, with databases often created by regulatory authorities. Systems differed in methods of causality assessment, level of detail collected, terminology and affiliations.
RESULTS: Within the monitoring systems with enough published data for analysis, all except one remain active at the time of this review. VigiBase is the largest centralised monitoring system, receiving international case reports, however data heterogeneity persists.
CONCLUSIONS: Our study emphasises the need for a centralised, consistent and accessible system for the postmarketing surveillance of side effects and adverse events associated with medicinal cannabis use.
METHODS: To undertake a scoping review with a systematic approach, we used the Population, Intervention, Comparison, Outcome (PICO) framework to develop keyword elements, and two search queries to maximise search sensitivity and specificity.
METHODS: Search queries were entered into Embase and Scopus for peer-reviewed literature, and additional searches for grey literature were conducted on 23 June 2023.
METHODS: We included 54 full-text articles in the review: 39 from peer-reviewed searches, 8 from grey literature and 7 from citations of relevant texts.
METHODS: Our search yielded two main forms of monitoring systems: databases and registries. Out of the 24 monitoring systems identified, there were 10 databases and 14 registries, with databases often created by regulatory authorities. Systems differed in methods of causality assessment, level of detail collected, terminology and affiliations.
RESULTS: Within the monitoring systems with enough published data for analysis, all except one remain active at the time of this review. VigiBase is the largest centralised monitoring system, receiving international case reports, however data heterogeneity persists.
CONCLUSIONS: Our study emphasises the need for a centralised, consistent and accessible system for the postmarketing surveillance of side effects and adverse events associated with medicinal cannabis use.
摘要：
目的：在过去5年中，澳大利亚使用大麻药物（CBM）作为治疗药物的数量激增。历史上,《联合国麻醉品单一公约》（1961年）禁止在欧洲使用大麻，美国,英国和澳大利亚,导致立法阻力和有限的CBM临床前数据。现有的CBM安全监控系统结构不佳，无法很好地集成到繁忙的卫生专业人员的工作流程中。因此,上市后的监督是不一致的。这篇综述旨在评估监测CBM副作用和不良事件的国际系统。
方法：要用系统的方法进行范围审查，我们利用人口，干预,比较,开发关键字元素的结果(PICO)框架，和两个搜索查询，以最大限度地提高搜索灵敏度和特异性。
方法：将搜索查询输入Embase和Scopus以获取同行评审的文献，2023年6月23日进行了更多的灰色文献搜索。
方法：我们在评论中包含了54篇全文文章：39篇来自同行评审的搜索，8来自灰色文献，7来自相关文本的引用。
方法：我们的搜索产生了两种主要形式的监测系统：数据库和登记册。在确定的24个监测系统中，有10个数据库和14个登记册，通常由监管机构创建的数据库。系统在因果关系评估方法上有所不同，收集的细节水平，术语和从属关系。
结果：在具有足够的已发布数据进行分析的监测系统中，在这次审查时，除了一个人之外，所有人都保持活跃。Vigibase是最大的集中式监控系统，接收国际病例报告，然而，数据异质性仍然存在。
结论：我们的研究强调了集中化，一致和可访问的系统，用于药物大麻使用相关的副作用和不良事件的上市后监测。
方法：要用系统的方法进行范围审查，我们利用人口，干预,比较,开发关键字元素的结果(PICO)框架，和两个搜索查询，以最大限度地提高搜索灵敏度和特异性。
方法：将搜索查询输入Embase和Scopus以获取同行评审的文献，2023年6月23日进行了更多的灰色文献搜索。
方法：我们在评论中包含了54篇全文文章：39篇来自同行评审的搜索，8来自灰色文献，7来自相关文本的引用。
方法：我们的搜索产生了两种主要形式的监测系统：数据库和登记册。在确定的24个监测系统中，有10个数据库和14个登记册，通常由监管机构创建的数据库。系统在因果关系评估方法上有所不同，收集的细节水平，术语和从属关系。
结果：在具有足够的已发布数据进行分析的监测系统中，在这次审查时，除了一个人之外，所有人都保持活跃。Vigibase是最大的集中式监控系统，接收国际病例报告，然而，数据异质性仍然存在。
结论：我们的研究强调了集中化，一致和可访问的系统，用于药物大麻使用相关的副作用和不良事件的上市后监测。
