药品安全性监测数据综合分析标准与规范的研究  

Study on Standards and Norms of Drug Safety Monitoring Data and Comprehensive Analysis

作　　者：黄传海[1] 李泮海[1] 田月洁[1] 刘巍[2] 金少鸿[2] 

机构地区：[1]山东省药品不良反应监测中心,山东济南250013 [2]国家食品药品监督管理局药品评价中心,北京100045

出　　处：《中国药物警戒》2010年第1期25-28,共4页Chinese Journal of Pharmacovigilance

基　　金：十一五国家科技支撑计划项目(2006BAI14B03)"安全用药监测研究与预警技术系统的研究及应用"

摘　　要：药品安全性监测是药物警戒的基本内容,监测数据的综合分析是药物警戒的关键环节,也是最复杂、最困难的步骤,至今仍无统一的国际国内标准。通过对药品安全性监测数据的评价和分析利用进行系统研究,分析我国药品安全性监测数据的特点,借鉴国际经验,结合我国国情,制订药品安全性监测数据综合分析的标准与规范,可有效提高评价分析的规范化,降低因人员因素而导致的结果偏倚,有利于提升药品安全性信息的分析利用水平,完善药品安全监测系统,降低药品安全事件的发生和影响。Drug safety monitoring is the basic content of pharmacovigilance.Comprehensive analysis on monitor-ing data which is the most complex and most difficult step, is a key step in pharmacovigilance. No unified standards in the world update. With the analyzed characteristics of drug safety monitoring data through systematic research in China, drawing on international experience, combining with our national conditions, development of drug safety monitoring data, a comprehensive analysis of standards and norms, the standardization of evaluation and analysis were improved effectively, and the result Of bias due to human factors is reduced, and contribute to enhancing drug safety analysis of information utilization levels, to improve drug safety monitoring system, and also to reduce the incidence of drug safety and impact.

关 键 词：药品安全性监测 评价分析 标准 规范 

分 类 号：R956[医药卫生—药学]