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加拿大药品短缺的相关因素:一项回顾性队列研究。

Factors associated with drug shortages in Canada: a retrospective cohort study.

作者信息

Zhang Wei, Guh Daphne P, Sun Huiying, Lynd Larry D, Hollis Aidan, Grootendorst Paul, Anis Aslam H

机构信息

Centre for Health Evaluation and Outcome Sciences (Zhang, Guh, Sun, Lynd, Anis), St. Paul's Hospital; School of Population and Public Health (Zhang, Anis) and Faculty of Pharmaceutical Sciences (Lynd), University of British Columbia, Vancouver, BC; Department of Economics (Hollis), University of Calgary, Calgary, Alta.; Leslie Dan Faculty of Pharmacy (Grootendorst), University of Toronto, Toronto, Ont.

出版信息

CMAJ Open. 2020 Aug 31;8(3):E535-E544. doi: 10.9778/cmajo.20200036. Print 2020 Jul-Sep.

Abstract

BACKGROUND

To monitor the magnitude of the drug shortage problem in Canada, since 2017, Health Canada has required manufacturers to report drug shortages. This study aimed to identify the factors associated with drug shortages in Canada.

METHODS

We conducted a retrospective cohort study of all prescription drugs available on the market between Mar. 14, 2017, and Sept. 12, 2018, in Canada. All drugs of the same active ingredient, dosage form, route of administration and strength were grouped into a "market." Our main outcome was shortages at the market level, determined using the Drug Shortages Canada database. We used logistic regression to identify associated factors such as market structure, route or dosage form, and Anatomic Therapeutic Chemical (ATC) classification.

RESULTS

Among the 3470 markets included in our analysis, 13.3% were reported to be in shortage. Markets with a single generic manufacturer were more likely to be in shortage than other markets. Markets with oral nonsolid route or dosage form were more likely to be in shortage than those that were oral solid with regular release (odds ratio [OR] 1.66, 95% confidence interval [CI] 1.11 to 2.49). Markets for sensory organs were more likely to be in shortage than most other ATC classes. Markets with a higher proportion of drugs covered by public insurance programs were more likely to be in shortage (OR 1.03, 95% CI 1.00 to 1.05 per 10% increase).

INTERPRETATION

Markets with a single generic manufacturer were most likely to be in shortage. To ensure the security of drug supply, governments should be vigilant in monitoring markets with a single generic manufacturer, with complex manufacturing processes, with higher demand from public programs or those that are in certain ATC classes.

摘要

背景

为监测加拿大药品短缺问题的严重程度,自2017年起,加拿大卫生部要求药品制造商报告药品短缺情况。本研究旨在确定与加拿大药品短缺相关的因素。

方法

我们对2017年3月14日至2018年9月12日在加拿大市场上可获得的所有处方药进行了一项回顾性队列研究。所有具有相同活性成分、剂型、给药途径和强度的药物被归为一个“市场”。我们的主要结局是市场层面的短缺情况,通过加拿大药品短缺数据库确定。我们使用逻辑回归来确定相关因素,如市场结构、给药途径或剂型以及解剖治疗学化学(ATC)分类。

结果

在我们分析的3470个市场中,有13.3%被报告存在短缺。单一仿制药制造商的市场比其他市场更有可能出现短缺。具有口服非固体给药途径或剂型的市场比普通释放的口服固体剂型市场更有可能出现短缺(优势比[OR]为1.66,95%置信区间[CI]为1.11至2.49)。感觉器官类药物的市场比大多数其他ATC分类的市场更有可能出现短缺。公共保险计划覆盖药物比例较高的市场更有可能出现短缺(每增加10%,OR为1.03,95%CI为1.00至1.05)。

解读

单一仿制药制造商的市场最有可能出现短缺。为确保药品供应安全,政府应警惕监测单一仿制药制造商、生产工艺复杂、公共项目需求较高或属于某些ATC分类的市场。

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