药品不良反应监测年度报告十年趋势分析  

Trend Analysis of Ten-year Annual Reports on Adverse Drug Reaction Monitoring

作　　者：王丹 任经天 董铎 彭丽丽 刘巍 WANG Dan;REN Jingtian;DONG Duo;PENG Lili;LIU Wei(Center for Drug Reevaluation,NPMA,Beijing 100022)

机构地区：[1]国家药品监督管理局药品评价中心,北京100022

出　　处：《中国药物警戒》2020年第5期276-283,共8页Chinese Journal of Pharmacovigilance

基　　金：国家科技重大专项项目(2017ZX09101001-001-003):药品再评价政策法规及实施策略研究。

摘　　要：目的分析近十年我国药品不良反应监测数据的变化趋势,提出值得关注的问题。方法对2009至2018年国家药品监督管理部门发布的《药品不良反应监测年度报告》中的相关数据进行合并分析,探究变化趋势并分析原因。结果近十年我国药品不良反应报告数量、质量快速提高,监测网络覆盖面不断扩大,对风险的识别和控制能力不断增强,但同时也存在值得关注和需要改进的问题。结论药品监管部门和药品不良反应技术监测机构应根据监测数据提示的风险和多年积累的经验开展深入研究,有针对性地调整工作重心,着力提高监测工作水平。Objective To analyze the pattern of change of ADR monitoring data in China over the past ten years so as to point out some issues worthy of attention.Methods The data in the annual report on ADR monitoring issued by the state drug regulatory agencies from 2009 to 2018 was analyzed,the trend of change explored and the reasons were analyzed.Results The number and quality of ADR reports in China have been improved rapidly in the past decade,the coverage of monitoring networks has been expanding,and the ability of risk identification and control has been enhanced.However,there are still some problems worthy of attention and the need for improvement.Conclusion Drug regulatory agencies and ADR monitoring centers should conduct in-depth research based on the risk highlighted by the monitoring data and on the experience accumulated over the years,shift priorities and work hard to improve the level of monitoring.

关 键 词：药品不良反应监测 年度报告 趋势分析 

分 类 号：R951[医药卫生—药学]