美国和加拿大药物短缺的差异。

IF 63.1 1区 医学 Q1 MEDICINE, GENERAL & INTERNAL Jama-Journal of the American Medical Association Pub Date : 2024-10-31 DOI:10.1001/jama.2024.17688
Mina Tadrous, Katherine Callaway Kim, Inmaculada Hernandez, Scott D Rothenberger, Joshua W Devine, Tina B Hershey, Lisa M Maillart, Walid F Gellad, Katie J Suda
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引用次数: 0

摘要

重要性:药品短缺是一个长期存在的公共卫生问题,在 COVID-19 大流行期间这一问题更加严重。美国和加拿大都遵循类似的监管标准,要求报告可能导致药品短缺的药品供应链相关问题。然而,目前尚不清楚有多大比例的药品短缺(定义为药品供应量大幅减少)与真正意义上的短缺有关,也不清楚加拿大和美国之间是否存在差异:比较美国和加拿大与药品相关的供应链问题报告与药品短缺相关的频率:纵向横断面研究于 2023 年 1 月至 2024 年 3 月进行,使用的是 2017 年至 2021 年期间加拿大和美国相隔不到 180 天的与药品相关的供应链问题报告。短缺情况使用来自 IQVIA 跨国综合数据分析数据库的数据进行评估,其中包括 89% 的美国药品采购和 100% 的加拿大药品采购:暴露:国家(加拿大与美国)、报告发布时间(COVID-19大流行之前与之后)、与药品相关的供应链问题报告之前的供应链特征(包括世界卫生组织基本药物地位、加拿大卫生部3级药物[中度风险分类]、药品是否为独家生产、配方、单位价格、药品批准时间≥20年以及治疗替代品的数量):与向美国或加拿大报告系统报告供应链问题前 6 个月的平均购买量相比,12 个月内出现药品短缺(每月购买的标准化药品单位减少≥33%):在两国 104 份与药品相关的供应链问题报告中,美国有 49.0%(95% CI,39.3%-59.7%)的报告与药品短缺有关,而加拿大有 34.0%(95% CI,25.0%-45.0%)的报告与药品短缺有关(调整后危险比 [HR],0.53 [95% CI,0.36-0.79])。在 COVID-19 大流行之前(调整后的危险比为 0.47 [95% CI, 0.30-0.75])和之后(调整后的危险比为 0.31 [95% CI, 0.15-0.66]),加拿大与美国相比药物短缺的风险较低。合并两国的供应链问题报告后,单一来源药品的短缺风险增加了一倍(调整后 HR,2.58 [95% CI,1.57-4.24]),而加拿大三级药品(中度风险)的短缺风险减少了近一半(调整后 HR,0.56 [95% CI,0.32-0.98]):与美国相比,加拿大与药品相关的供应链问题报告导致重大药品短缺的可能性要低 40%。这些发现突出表明,各国之间需要开展国际合作,以遏制药品短缺的影响并提高药品供应链的应变能力。
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Differences in Drug Shortages in the US and Canada.

Importance: Drug shortages are a persistent public health issue that increased during the COVID-19 pandemic. Both the US and Canada follow similar regulatory standards and require reporting of drug-related supply chain issues that may result in shortages. However, it is unknown what proportion are associated with meaningful shortages (defined by a significant decrease in drug supply) and whether differences exist between Canada and the US.

Objective: To compare how frequently reports of drug-related supply chain issues in the US vs Canada were associated with drug shortages.

Design, setting, and participants: Longitudinal cross-sectional study conducted from January 2023 to March 2024 using drug-related reports of supply chain issues from 2017 to 2021 that were less than 180 days apart in Canada and the US. Shortages were assessed using data from the IQVIA Multinational Integrated Data Analysis database, comprising 89% of US and 100% of Canadian drug purchases.

Exposure: Country (Canada vs US), timing of report issuance (before vs after the COVID-19 pandemic), and characteristics of the supply chain prior to the reports of drug-related supply chain issues (including World Health Organization essential medicine status, Health Canada tier 3 medicine [moderate risk classification], whether there was sole-source manufacturing of the drug, the formulation, the price per unit, ≥20 years since drug approval, and the number of therapeutic alternatives).

Main outcomes and measures: A drug shortage (a decrease of ≥33% in monthly purchased standardized drug units) within 12 months, relative to the average units purchased during the 6 months prior to the report of supply chain issues to a US or Canadian reporting system.

Results: Among the 104 drug-related reports of supply chain issues in both countries, 49.0% (95% CI, 39.3%-59.7%) were associated with drug shortages in the US vs 34.0% (95% CI, 25.0%-45.0%) in Canada (adjusted hazard ratio [HR], 0.53 [95% CI, 0.36-0.79]). The lower risk of drug shortages in Canada vs the US was consistent before the COVID-19 pandemic (adjusted HR, 0.47 [95% CI, 0.30-0.75]) and after the pandemic (adjusted HR, 0.31 [95% CI, 0.15-0.66]). After combining reports of supply chain issues in both countries, the shortage risk was double for sole-sourced drugs (adjusted HR, 2.58 [95% CI, 1.57-4.24]) and nearly half for Canadian tier 3 medicines (moderate risk) (adjusted HR, 0.56 [95% CI, 0.32-0.98]).

Conclusions and relevance: Drug-related reports of supply chain issues were 40% less likely to result in meaningful drug shortages in Canada compared with the US. These findings highlight the need for international cooperation between countries to curb the effects of drug shortages and improve resiliency of the supply chain for drugs.

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来源期刊
CiteScore
48.20
自引率
0.90%
发文量
1569
审稿时长
2 months
期刊介绍: JAMA (Journal of the American Medical Association) is an international peer-reviewed general medical journal. It has been published continuously since 1883. JAMA is a member of the JAMA Network, which is a consortium of peer-reviewed general medical and specialty publications.
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