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美国食品和药物管理局如何解决处方药短缺问题。

How the US Food and Drug Administration can solve the prescription drug shortage problem.

机构信息

Department of Health Policy and Management, University of California Los Angeles Fielding School of Public Health, Los Angeles, CA 90095-1772, USA.

出版信息

Am J Public Health. 2013 May;103(5):e10-4. doi: 10.2105/AJPH.2013.301239. Epub 2013 Mar 14.

Abstract

Drug shortages are threatening care quality and cost-containment efforts. I describe the pharmaceutical marketplace changes that have caused the problem, and propose new policies to solve it, through changing incentives for producers and purchasers. I propose a grading scheme for the Food and Drug Administration when it inspects manufacturing facilities in the United States and abroad. The inspections' focus would change from closing unsafe plants to improving production process quality, reducing the likelihood that plants will be closed-the most frequent cause of drug shortages.

摘要

药品短缺威胁着医疗质量和成本控制工作。我描述了导致这一问题的药品市场变化,并通过改变生产者和购买者的激励措施,提出了解决这一问题的新政策。我建议美国食品和药物管理局(FDA)在检查国内外制药厂时采用一种评级方案。检查的重点将从关闭不安全的工厂转变为提高生产过程的质量,从而降低工厂关闭的可能性——这是造成药品短缺的最常见原因。

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