世界卫生组织药品不良反应数据库全球信号管理方法简述

Methods for signal management using the global safety database VigiBase

世界卫生组织(WHO)药品不良反应病例报告数据库(VigiBase)自1978年起由乌普萨拉监测中心(UMC)开发和维护。目前VigiBase保存着超过3900万份匿名的患者疑似药品和疫苗不良反应报告(截至2024年6月)。为支持世界卫生组织国际药物监测计划(WHO PIDM)成员国制定、实施和加强安全监测计划,UMC开发了多个系统、工具和方法,以促进VigiBase的使用。本文描述了6种vigi方法(vigiMethods):vigiGrade、vigiMatch、vigiRank、vigiPoint、vigiGroup和vigiVec。VigiBase数据来源依靠主动报告的药品不良反应,但药品不良反应漏报是一个主要问题。为提高大型数据库(如VigiBase)中病例处理的效率、质量和能力,人工智能增强方法正在不断发展,以满足管理日益增长的数据量需求。继续开发现有的和新的方法,将VigiBase和其他数据库中的报告内容转化为有价值的信息,对于全球所有国家的患者更安全地使用药物和疫苗至关重要。

The WHO database of adverse event reports for medicines and vaccines,VigiBase,has been developed and maintained by UMC since 1978.VigiBase now holds over 39 million anonymised reports of suspected adverse effects of medicines and vaccines suffered by patients(as of June 2024).To support of members of the WHO Programme for International Drug Monitoring(WHO PIDM)in developing,implementing,and strengthening safety surveillance programmes,UMC has developed several systems,tools and methods to facilitate the use of VigiBase.This paper describes six such vigiMethods;vigiGrade,vigiMatch,vigiRank,vigiPoint,vigiGroup,vigiVec.VigiBase depends on unsolicited reporting of adverse drug effects and,regretfully,underreporting of adverse drug effects continues to be a major issue.Artificial intelligence methods for augmentation to increase efficiency,quality,and capability of case processing in the large databases such as VigiBase are evolving to meet the higher demands to manage the increasing volume of safety data.Continued development of existing and new methods to translate the information in the reports in VigiBase and other databases into valuable knowledge will be paramount for safer use of medicines and vaccines for patients in all countries globally.