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美国和加拿大药品短缺情况的差异。

Differences in Drug Shortages in the US and Canada.

作者信息

Tadrous Mina, Callaway Kim Katherine, Hernandez Inmaculada, Rothenberger Scott D, Devine Joshua W, Hershey Tina B, Maillart Lisa M, Gellad Walid F, Suda Katie J

机构信息

Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario, Canada.

Division of General Internal Medicine, Department of Medicine, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.

出版信息

JAMA. 2024 Dec 10;332(22):1912-1922. doi: 10.1001/jama.2024.17688.

Abstract

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.

摘要

重要性

药品短缺是一个长期存在的公共卫生问题,在新冠疫情期间有所增加。美国和加拿大都遵循类似的监管标准,并要求报告可能导致短缺的药品相关供应链问题。然而,尚不清楚与严重短缺(定义为药品供应显著减少)相关的比例是多少,以及加拿大和美国之间是否存在差异。

目的

比较美国和加拿大药品相关供应链问题报告与药品短缺相关的频率。

设计、背景和参与者:2023年1月至2024年3月进行的纵向横断面研究,使用2017年至2021年加拿大和美国间隔少于180天的药品相关供应链问题报告。使用艾昆纬跨国综合数据分析数据库的数据评估短缺情况,该数据库涵盖美国89%和加拿大100%的药品采购。

暴露因素

国家(加拿大与美国)、报告发布时间(新冠疫情之前与之后)以及药品相关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、剂型、每单位价格、药品获批超过20年以及治疗替代方案数量)。

主要结局和测量指标

相对于向美国或加拿大报告系统报告供应链问题前6个月的平均采购单位,12个月内出现药品短缺(每月采购的标准化药品单位减少≥33%)。

结果

在两国104份药品相关供应链问题报告中,美国有49.0%(95%CI,39.3%-59.7%)与药品短缺相关,而加拿大为34.0%(95%CI,25.0%-45.0%)(调整后风险比[HR],0.53[95%CI,0.36-0.79])。加拿大药品短缺风险低于美国,在新冠疫情之前(调整后HR,0.47[95%CI,0.30-0.75])和疫情之后(调整后HR,0.31[95%CI,0.15-0.66])均如此。合并两国供应链问题报告后,独家生产药品的短缺风险加倍(调整后HR,2.58[95%CI,1.57-4.24]),加拿大3级药品(中度风险)的短缺风险几乎减半(调整后HR,0.56[95%CI,0.32-0.98])。

结论和意义

与美国相比,加拿大药品相关供应链问题报告导致严重药品短缺的可能性低约40%。这些发现凸显了各国之间开展国际合作以遏制药品短缺影响并提高药品供应链弹性的必要性。

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本文引用的文献

1
COVID-19's Limited Impact on Drug Shortages in Canada.新冠疫情对加拿大药品短缺的影响有限。
Can Public Policy. 2020 Oct 1;46(Suppl 3):S307-S312. doi: 10.3138/cpp.2020-107.
2
Drug Shortages Prior to and During the COVID-19 Pandemic.药品短缺:新冠疫情前后
JAMA Netw Open. 2024 Apr 1;7(4):e244246. doi: 10.1001/jamanetworkopen.2024.4246.
6
Pharmaceutical security for Canada.加拿大的药品安全。
CMAJ. 2022 Aug 22;194(32):E1113-E1116. doi: 10.1503/cmaj.220324.
9
Drug Shortage: Causes, Impact, and Mitigation Strategies.药品短缺:原因、影响及缓解策略
Front Pharmacol. 2021 Jul 9;12:693426. doi: 10.3389/fphar.2021.693426. eCollection 2021.
10
Supply chain transparency and the availability of essential medicines.供应链透明度与基本药物的可及性。
Bull World Health Organ. 2021 Apr 1;99(4):319-320. doi: 10.2471/BLT.20.267724. Epub 2021 Jan 21.

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