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中国医药导刊 ›› 2023, Vol. 25 ›› Issue (4): 355-361.

• 监管科学 • 上一篇    下一篇

中美药品安全性主动监测实践对比研究

葛斯羿, 梁毅*   

  1. 中国药科大学国际医药商学院, 江苏 南京 211198
  • 收稿日期:2023-01-04 修回日期:2023-05-10 出版日期:2023-04-28 发布日期:2023-04-28

Comparative Study on Active Drug Safety Surveillance Practice of China and the United States

  1. School of International Pharmaceutical Business,China Pharmaceutical University, Jiangsu Nanjing 211198, China
  • Received:2023-01-04 Revised:2023-05-10 Online:2023-04-28 Published:2023-04-28

摘要: 目的:比较不同时期中美两国开展的药品安全性主动监测实践,为我国药品安全性主动监测的发展提供一定启发。 方法:通过中国知网、PubMed等数据库和BCDSP、Sentinel、中国医院药物警戒系统等官方网站检索中美两国不同时期药品安全性主动监测实践相关的文献和资料,从主动监测开展的形式、规模等多个方面探究不同阶段中美两国药品安全性主动监测实践的共性和差异。结果与结论:中美两国药品安全性主动监测实践的发展路径基本一致,都经历了从医院集中监测走向主动监测系统建设的过程,但不同时期两国开展主动监测的规模、规范性等方面有较大差距。造成这种差距的原因是多方面的,两国的医药产业发展水平、法律与规范完善程度、政策支持力度、信息基础设施条件等都是影响主动监测发展水平的重要因素。因此,在借鉴美国先进经验的基础上,应积极探索出一条符合我国实际的药品安全性主动监测发展路径,不断提高药品安全监管能力。

关键词: font-size:medium, ">主动监测;集中监测;主动监测系统;哨点计划;中国医院药物警戒系统

Abstract: Objective: To provide some inspiration for the development of active drug safety surveillance in China by comparing the active drug safety surveillance practices of China and the United States in different periods. Methods:The literature and data related to the active drug safety surveillance practices of China and the United States in different periods were retrieved through databases such as CNKI, PubMed, and the official website of BCDSP, Sentinel, CHPS, and the similarities and differences between China and the United States practices in the form, scale and other aspects of active drug safety surveillance at different periods were analyzed. Results and Conclusion:The development path of active drug safety surveillance practices of China and the United States is basically the same. Both countries have experienced the process from centralized monitoring in hospitals to the construction of active surveillance systems. However, there is a large gap in the scale and standardization of active surveillance in different periods between the two countries.The reasons for this disparity are manifold, the development level of pharmaceutical industry, the perfection of laws and regulations, the strength of policy support and the condition of information infrastructure are all important factors that affect the development level of active drug safety surveillance. Therefore, on the basis of learning from advanced experience of the United States, a development path of active drug safety surveillance in line with the reality of China should be actively explored,to continuously improve the capacity of drug safety supervision.

Key words: font-size:medium, ">Active surveillance; Centralized monitoring; Active surveillance; Sentinel initiative; CHPS

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