国内外药品不良反应报告质量评价方法的研究进展  

Research progress on quality evaluation methods for adverse drug reaction reports at home and abroad

作　　者：王欣[1] 刘琛[2] 张艳红[1] 冀冰心[1] 蔡晧东 Wang Xin;Liu Chen;Zhang Yanhong;Ji Bingxin;Cai Haodong(Department of Medical Affairs,Xuanwu Hospital,Capital Medical University,Beijing 100053,China;Department of Pharmacy,Xuanwu Hospital,Capital Medical University,Beijing 100053,China;Adverse Drug Reactions Journal Agency,Beijing 100053,China)

机构地区：[1]首都医科大学宣武医院医务处,北京100053 [2]首都医科大学宣武医院药学部,北京100053 [3]药物不良反应杂志社,北京100053

出　　处：《药物不良反应杂志》2023年第11期683-689,共7页Adverse Drug Reactions Journal

摘　　要：开展药品不良反应个例报告质量评价,获得准确、客观和科学的数据资料,关系到整个药品不良反应监测工作的水平和质量,是药品监管部门制定安全监管措施的重要依据。本文通过文献检索了解国外药品不良反应(ADR)报告质量评价方法学的研究进展及应用现状,主要纳入了来自世界卫生组织乌普萨拉不良反应监测中心、荷兰和澳大利亚的3类不同评价方法(WHO质量评价方法、临床文档工具、ADR报告质量算法)。我国目前有2版ADR报告质量评价方法,分别在2005和2012版的《药品不良反应报告和监测工作手册》附录中。不同的ADR报告质量评价方法评价条目有不同的侧重点,需要制定适合我国的科学评价方法,为ADR报告的质量监督管理提供参考。Conducting quality evaluation of adverse drug reaction(ADR)case report and obtaining accurate,objective and scientific data is related to the level and quality of the entire monitoring work,and is an important basis for drug regulatory departments to formulate safety regulatory measures.The research progress and application status of the methodology of quality evaluation of ADR reports abroad were inves⁃tigated through literature search in this paper.It mainly includes 3 different evaluation methods(WHO quality evaluation method,clinical documentation tool,ADR report quality algorithm)from Uppsala Monitoring Centre,Netherlands and Australia.There are currently 2 versions of ADR report quality evaluation methods in China,which are included in the appendices of the 2005 and 2012 editions of the"Adverse Drug Reaction Reporting and Monitoring Work Manual".Different ADR report quality evaluation methods have different focus points,and it is necessary to develop a scientific evaluation method suitable to provide reference for the quality supervision and management of ADR in China.

关 键 词：药物相关副作用和不良反应 药物不良反应报告系统 因果关系 质量控制 评价方法 

分 类 号：R95[医药卫生—药学]