| アブストラクト | OBJECTIVES: 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. DESIGN: 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. DATA SOURCES: Search queries were entered into Embase and Scopus for peer-reviewed literature, and additional searches for grey literature were conducted on 23 June 2023. ELIGIBILITY CRITERIA: 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. DATA EXTRACTION AND SYNTHESIS: 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. |
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| ジャーナル名 | BMJ open |
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| 投稿日 | 2024/7/19 |
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| 投稿者 | Wang, Rebecca Qi; Bonomo, Yvonne Ann; Hallinan, Christine Mary |
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| 組織名 | Department of General Practice and Primary Care, The University of Melbourne,;Parkville, Victoria, Australia.;Melbourne Medical School, The University of Melbourne, Parkville, Victoria,;Australia.;Addiction Medicine, The University of Melbourne Faculty of Medicine Dentistry and;Health Sciences, Parkville, Victoria, Australia.;Australia hallinan@unimelb.edu.au.;HaBIC R2, Department of General Practice and Primary Care, The University of;Melbourne, Parkville, Victoria, Australia. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/39025811/ |
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