以国际药品不良反应监测为引领的我国化妆品不良反应报告质量评估标准方法的研究与建立  

Research and Establishment of the Quality Assessment Standard Method of Cosmetic Adverse Reaction Reporting in China Based on the International ADR Monitoring

作　　者：沈璐 Shen Lu(Center for Drug Reevalution,NMPA,Beijing 100076,China)

机构地区：[1]国家药品监督管理局药品评价中心<国家药品不良反应监测中心>,北京100076

出　　处：《中国药事》2024年第12期1387-1398,共12页Chinese Pharmaceutical Affairs

摘　　要：目的:国际药品不良反应监测发展多年,已形成成熟的药品报告质量评估方法,而化妆品不良反应报告质量在国内甚至国际一直未有科学、系统、量化的评估方法。为提高化妆品不良反应报告质量,夯实分析评价、风险预警的基础,笔者借鉴国际药品不良反应监测经验,首次研究建立了化妆品不良反应报告质量评估标准方法。方法:基于国际药品不良反应报告质量评估方法,研究建立并运用“人工抽样赋分累加法”以及“计算机逐例连乘权重减分法”,使我国化妆品报告质量评估方法实现了从无到有、从有到优的跨越。结果:应用报告质量评估方法后,通过得分掌握全国报告质量的现状和水平,通过研究分析失分项,找出监测工作存在的问题和不足,进而有针对性地采取制定技术指南、开展培训指导等措施,提高了报告质量。结论:不良反应报告是不良反应监测工作的基础,通过量化的方法评估报告质量,发现问题和不足,持续提升报告质量,为后续分析评价和风险预警提供了真实、完整、准确的信息依据,为我国化妆品监管及公众健康安全提供有力的技术支撑。Objective:International ADR monitoring has developed for many years,and a mature drug reporting quality assessment method has been formed,but there has never been a scientific,systematic,and quantitative evaluation method for the quality of cosmetics adverse reaction reports,both domestically and internationally.In order to improve the quality of cosmetic adverse reaction report,strengthen the analysis evaluation,the basis of risk early warning,a standard method for assessing the quality of adverse reaction reports for cosmetics was established for the first time by drawing on international experience in monitoring adverse drug reactions.Methods:Based on the international quality assessment method of ADR reporting,this study established and operated the"manual sampling score addition"and"computer case-by-case multiplication weight reduction method",which enabled the method of cosmetics report quality assessment in China to achieve a leap from scratch and from existence to excellence.Results:After the application of the report quality evaluation method,the status quo and level of the report quality across the country were mastered by scoring,and the problems and deficiencies of the monitoring work were found out,and then targeted measures such as formulating technical guidelines and providing training guidance were taken to improve the quality of the report.Conclusion:Adverse reaction report is the foundation of adverse reaction monitoring work.Through quantitatively evaluating report quality,identifying the problems and deficiencies,continuously improving the quality of report,a true,complete and accurate information basis is provided for the subsequent analysis evaluation and risk early warning,which provide strong technical support for China's cosmetics regulation and public health safety.

关 键 词：药品不良反应监测 化妆品不良反应报告质量 评估方法 人工抽样赋分累加法 计算机逐例连乘权重减分法 实践与成效 

分 类 号：R95[医药卫生—药学]