FAERS数据库建设与应用启示

Implications from the Construction and Application of the FAERS Database

目的为我国药物警戒相关数据库的建设提供参考。方法分析美国食品和药物管理局不良事件报告系统(FAERS)数据库的数据来源、建设结构、内容与应用,提出关于我国药物警戒相关数据库建设的思考。结果FAERS数据库为季度数据,涵盖患者的基本信息和用药信息,需要用关系型数据库和标准化工具规整数据,常用的信号检测方法为多项伽马-泊松分布缩减算法(MGPS)。结论需不断完善我国药物警戒工作相关法律法规,强化企业药品安全的主体责任,增设公众报告端口,扩大不良事件报告收集来源,提高全民安全用药意识。

Objective To provide a reference for the construction of pharmacovigilance-related databases.Methods The construction structure,content,and application of the Food and Drug Administration Adverse Event Reporting System(FAERS)database were analyzed,and the considerations for the construction of pharmacovigilance-related databases were proposed.Results The FAERS database is a quarterly data,covering the patients'basic information and medication information.The data needs to be adjusted with relational databases and standardized tools.The common signal detection method is Multi-Item Gamma Poisson Shrinker(MGPS).Conclusion It is necessary to improve relevant laws and regulations of China's pharmacovigilance work,strengthen the subject responsibility in drug safety of the marketing authorization holder(MAH),add public reporting ports,expand the collection sources of adverse event reports,and improve people's awareness of drug safety.