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药物到此为止:解决药品短缺危机的公共卫生框架。

The drugs stop here: a public health framework to address the drug shortage crisis.

作者信息

Hoffman Sharona

出版信息

Food Drug Law J. 2012;67(1):1-21, i.

PMID:24624646
Abstract

Drug shortages are emerging as a major public health threat. Grave concern has been expressed by the medical community and government officials, and the crisis has been highlighted in recent media stories. Nevertheless, little has been written to date in the legal literature about the drug shortage crisis, and this timely article begins to fill this gap. It provides a thorough analysis of the origins and implications of the drug shortage problem and formulates a multi-layered approach to addressing it. The article argues that drug shortages result from a combination of market failures and regulatory constraints. It proposes a blend of legislative, regulatory, and private-sector interventions that should deter undesirable conduct on the part of manufacturers and provide appropriate incentives to combat the drug shortage phenomenon.

摘要

药品短缺正成为一个重大的公共卫生威胁。医学界和政府官员已表达了严重关切,近期媒体报道也突出了这一危机。然而,迄今为止法律文献中关于药品短缺危机的论述甚少,而这篇及时的文章开始填补了这一空白。它对药品短缺问题的根源及影响进行了全面分析,并制定了一个多层次的应对方法。文章认为,药品短缺是市场失灵和监管限制共同作用的结果。它提出了一系列立法、监管及私营部门干预措施,这些措施应能遏制制造商的不良行为,并提供适当激励以应对药品短缺现象。

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The drugs stop here: a public health framework to address the drug shortage crisis.药物到此为止:解决药品短缺危机的公共卫生框架。
Food Drug Law J. 2012;67(1):1-21, i.
2
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Drug shortages: the cycle of quantity and quality.药品短缺:数量与质量的循环。
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J Pharm Health Care Sci. 2021 Apr 2;7(1):14. doi: 10.1186/s40780-021-00200-3.
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Quantifying the persisting orphan-drug shortage public health crisis in the United States.量化美国持续存在的孤儿药短缺公共卫生危机。
J Mark Access Health Policy. 2016 Dec 23;5(1):1269473. doi: 10.1080/20016689.2017.1269473. eCollection 2017.
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The Impact of Shortages on Medication Prices: Implications for Shortage Prevention.
短缺对药品价格的影响:对短缺预防的启示。
Drugs. 2016 Oct;76(16):1551-1558. doi: 10.1007/s40265-016-0651-7.
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Medicine shortages in Australia: causes, impact and management strategies in the community setting.澳大利亚的药品短缺:社区环境中的原因、影响及管理策略
Int J Clin Pharm. 2016 Oct;38(5):1133-41. doi: 10.1007/s11096-016-0342-1. Epub 2016 Jul 6.
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Chemotherapy drug shortages in pediatric oncology: a consensus statement.化疗药物在儿科肿瘤学中的短缺:共识声明。
Pediatrics. 2014 Mar;133(3):e716-24. doi: 10.1542/peds.2013-2946. Epub 2014 Feb 2.
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Ethical considerations for the clinical oncologist in an era of oncology drug shortages.肿瘤药物短缺时代临床肿瘤学家的伦理考虑
Oncologist. 2014 Feb;19(2):186-92. doi: 10.1634/theoncologist.2013-0301. Epub 2014 Jan 21.