药品生产企业药物警戒实践与探讨

Pracitice and Discussion on Pharmacovigilance in Drug Manufacturers

目的:探讨如何构建有效的药品生产企业药物警戒体系。方法:通过回顾药物警戒体系的现状和要素,结合本企业药物警戒工作,从组织机构、制度与文件、日常实施、关键指标设计和信息挖掘等方面进行实例分析与探讨。结果与结论:药品生产企业应主动实施药物警戒体系建设工作,可将企业生产信息与药物警戒信息关联设计药物警戒信号指标,从而获得药品真实世界的警戒能力;建议相关监管机构能够提供和共享更多的药物警戒信息。

Objective:To discuss how to construct an effective pharmacovigilance(PV)system in drug manufacturing.Methods:Cases were analyzed from the following aspects,such as organization,system and documents,daily implementation,key index design and information mining through reviewing current status,key elements of PV system and the PV practice.Results and Conclusion:Drug manufacturers should take the initiative to implement the construction of PV system,which can correlate production information with PV information to design alert PV signal indicators so as to obtain the PV ability.It is recommended that more PV information should be provided and shared by regulators timely.