我国建立计算机化药品不良反应/事件报告质量评估体系的构想

中国药物警戒 ›› 2017, Vol. 14 ›› Issue (11): 674-679.

我国建立计算机化药品不良反应/事件报告质量评估体系的构想

陈嘉音, 袁丽, 杨悦^*

沈阳药科大学工商管理学院/沈阳药科大学国际食品药品政策与法律研究中心,辽宁沈阳 110016

收稿日期:2017-12-26 修回日期:2017-12-26 出版日期:2017-11-20 发布日期:2017-12-26
通讯作者: *杨悦,女,博士,教授·博导,药事法规与药品政策研究。E-mail：yyue315@vip.126.com
作者简介:陈嘉音,女,在读硕士,药事管理。

Conception of Establishing Computerized Quality Assessment System of Adverse Drug Reaction/Event Report in China

CHEN Jia-yin, YUAN Li, YANG Yue^*

School of Business Administration, Shenyang Pharmaceutical University, International Food and Drug Policy and Law Research Center,Shenyang Pharmaceutical University, Liaoning Shenyang 110016, China

Received:2017-12-26 Revised:2017-12-26 Online:2017-11-20 Published:2017-12-26

摘要/Abstract

摘要： 目的为我国药品不良反应报告质量评估体系建设提出计算机化识别构想。方法引进世界卫生组织药品监测中心的警戒分级法和警戒数据库管理方法,对药品不良反应/药品不良反应事件（ADR/ADE）报告质量评估标准和算法加以详细说明。结果警戒分级法按照结构化格式录入数据,根据对因果关系判定重要性不同,对评估维度信息赋予不同减分比例,以乘法连续计算。报告完整性评分范围为0.07至1,视完整性评分大于0.8为良好报告。结论建议我国采用结构化报告格式,建立计算机化识别的ADR/ADE质量评估体系,注重评估信息维度,依信息重要性赋分,以乘法取代加减分的计算方式。

关键词: 药物警戒, 警戒分级法, 质量评估, 计算机化

Abstract: Objective To put forward a conception of computerized identification for quality assessment system of adverse drug reaction/event report in China. Methods By introducing the World Health Organization drug monitoring center's vigiGrade and VigiBase management Methods, ADR/ADE report quality assessment standards and algorithms were described in detail. Results The vigiGrade inputs data in structured format. For each information dimension, a penalty is detracted which varies with causality assessment. The vigiGrade completeness score ranges from 0.07 to 1. We classified reports with C>0.8 as well-documented. Conclusion It is suggested that computerized identification for quality assessment system of adverse drug reaction/event report should be established by using structured report format, each information dimension should be evaluated according to its importance, and the method of addition and subtraction should be replaced by multiplication.

Key words: pharmacovigilance, vigiGrade, quality assessment, computerized

中图分类号:

R994.11

陈嘉音, 袁丽, 杨悦. 我国建立计算机化药品不良反应/事件报告质量评估体系的构想[J]. 中国药物警戒, 2017, 14(11): 674-679.

CHEN Jia-yin, YUAN Li, YANG Yue. Conception of Establishing Computerized Quality Assessment System of Adverse Drug Reaction/Event Report in China[J]. Chinese Journal of Pharmacovigilance, 2017, 14(11): 674-679.

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