国际药物警戒系统评估指标研究进展  

Research progress on evaluation indicators of international pharmacovigilance system

作　　者：刘丽 李莉 张涛 丁长玲[4] LIU Li;LI Li;ZHANG Tao;DING Changling(Traditional Chinese Medicine Hospital of Wudu District Longnan City,Longnan 746000,China;New Drug Evaluation Center,Shandong Academy of Pharmaceutical Sciences,Jinan 250101,China;Department of Pharmacy,Shandong Electric Power Central Hospital,Jinan 250001,China;Binzhou Medical University Hospital,Binzhou 256603,China)

机构地区：[1]陇南市武都区中医医院,甘肃陇南746000 [2]山东省药学科学院新药评价中心,山东济南250101 [3]山东电力中心医院药学部,山东济南250001 [4]滨州医学院附属医院,山东滨州256603

出　　处：《药学研究》2023年第11期949-952,共4页Journal of Pharmaceutical Research

基　　金：山东省医药卫生科技发展计划项目(No.2014WS0488);陇南市社会化出资科技计划项目(No.2023-S·SZ-38)。

摘　　要：药物警戒是国际通行的对上市后药品安全性进行监管的手段。为评价药物警戒系统的效能,国际上研究并建立了对药物警戒系统能力进行评估的指标。本文系统分析了国际药物警戒系统评估指标研究进展,以及利用相关评估指标开展药物警戒系统评估的实例,以期为我国建立药物警戒系统评估指标体系提供思路。Pharmacovigilance is an internationally accepted means of regulating the safety of post-marketing drugs.In order to evaluate the effectiveness of pharmacovigilance systems,indicators for evaluating the capacity of pharmacovigilance systems have been studied and established internationally.In this paper,the research progress of international pharmacovigilance system evaluation indicators and the use of relevant evaluation indicators to carry out pharmacovigilance system evaluation were systematically analyzed,in order to provide ideas for the establishment of pharmacovigilance system evaluation indicator system in China.

关 键 词：药物警戒 药品不良反应监测 评估指标 监管科学 

分 类 号：R95[医药卫生—药学]