| 王胜鹏,王翀,张弛,朱炯.美国近期短缺药品管理策略与启示[J].中国药事,2020,34(10):1191-1199 |
| 美国近期短缺药品管理策略与启示 |
| On U.S. Current Management Strategy for Drug Shortage and Its Enlightenment |
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| DOI：10.16153/j.1002-7777.2020.10.011 |
| 中文关键词: 短缺药品 管理策略 经验启示 应急管理 |
| 英文关键词: drug shortage management strategy experience and inspiration emergency management |
| 基金项目: |
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| 中文摘要: |
| 目的：研究美国短缺药品管理策略，为我国短缺药品管理提供参考。方法：检索FDA官方网站等政府网站查找短缺药品管理相关文件与法规，统计2010-2018年美国短缺药品数据，对美国短缺药品管理策略进行研究。结果：美国组建跨部门短缺药品应对工作组以探索短缺药品应对长效机制，更新了短缺药品管理的政策与程序手册，采取加强药品质量管理、维护市场竞争、确保供应链稳定、机构协作和提倡社会共治等应对措施，注重运用法治思维和法治方式提高短缺药品管理水平。结论：美国短缺药品管理策略和应对计划，对完善我国短缺药品供应保障具有参考价值。 |
| 英文摘要: |
| Objective: To study the key points of American drug shortage management strategy and provide references for the drug shortage management of China. Methods: The official websites of FDA were retrieved to find related documents, laws and regulations, and the drug shortage data between 2010-2018 were summarized. The drug shortage regulatory strategy was analyzed. Results: An Interagency Drug Shortage Task Force was established to come up with long-term solutions to prevent shortages, and the CDER's Manual of Policies and Procedures for drug shortage management was renewed. Such countermeasures as strengthening drug quality management, maintaining market competition, reassuring supply chain stability, making multi-institutional collaborations and advocating social co-governance, have been taken by the regulatory agency. The application of legal thinking and legal methods to improve the level of drug shortage management was emphasized. Conclusion: The American drug shortage management strategy and the countermeasures are useful in improving the drug shortage management of China. |
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