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如何应对药品短缺:来自 24 个国家的横断面研究结果。

How to address medicines shortages: Findings from a cross-sectional study of 24 countries.

机构信息

WHO Collaborating Centre for Pharmaceutical Pricing and Reimbursement Policies, Pharmacoeconomics Department, Gesundheit Österreich (GÖG / Austrian National Public Health Institute), 1010 Vienna, Austria.

出版信息

Health Policy. 2020 Dec;124(12):1287-1296. doi: 10.1016/j.healthpol.2020.09.001. Epub 2020 Sep 21.

Abstract

Shortages of medicines have become a major public health challenge. The aim of this study was to survey national measures to manage and combat these shortages. A questionnaire survey was conducted with public authorities involved in the Pharmaceutical Pricing and Reimbursement Information (PPRI) network. Reponses relating to measures as of March / April 2020 were received from 24 countries (22 European countries, Canada and Israel). In 20 countries, manufacturers are requested to notify - usually on an obligatory basis - upcoming and existing shortages, which are recorded in a register. Further measures include a regular dialogue with relevant stakeholders (18 countries), financial sanctions for manufacturers in cases of non-supply and/or non-compliance with reporting or stocking requirements (15 countries) and simplified regulatory procedures (20 countries). For defined medicines, supply reserves have been established (14 countries), and legal provisions allow the issuing of export bans (10 countries). Some measures have been introduced since the end of 2019 and countries are planning and discussing further action. While governments reacted by taking national measures, the COVID-19 crisis might serve as an opportunity to join forces in cross-country collaboration and develop joint (e.g. European) solutions to address the shortage issue in a sustainable manner. A practical first step could be to work on a harmonisation of the national registers.

摘要

药品短缺已成为一个主要的公共卫生挑战。本研究旨在调查管理和应对这些短缺的国家措施。我们对参与药品定价和报销信息(PPRI)网络的公共机构进行了问卷调查。截至 2020 年 3 月/4 月,收到了来自 24 个国家(22 个欧洲国家、加拿大和以色列)的回复。在 20 个国家,制造商被要求通知(通常是强制性的)即将发生和现有的短缺情况,这些情况将被记录在一个登记册中。其他措施包括与相关利益攸关方定期对话(18 个国家)、对不供应和/或不遵守报告或储备要求的制造商进行财务制裁(15 个国家)以及简化监管程序(20 个国家)。对于某些定义明确的药物,已经建立了供应储备(14 个国家),法律规定允许发布出口禁令(10 个国家)。自 2019 年底以来,一些措施已经出台,各国正在计划和讨论进一步的行动。虽然各国政府通过采取国家措施做出了反应,但 COVID-19 危机可能是一个机会,可以在跨国合作中联合力量,制定联合(如欧洲)解决方案,以可持续的方式解决短缺问题。一个实际的第一步可以是努力协调国家登记册。

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