药品不良反应报告质量评价与控制的探讨  

Study of the Evaluation and Control for Quality of Adverse Drug Reaction Reports

作　　者：田月洁[1] 周勇[1] 黄琳[1] 冯巧巧[1] 谢彦军[1] 孔庆衍 

机构地区：[1]山东省药品不良反应监测中心,山东济南250013

出　　处：《中国药物警戒》2009年第2期90-95,共6页Chinese Journal of Pharmacovigilance

摘　　要：药品不良反应报告质量的评价与控制是药品不良反应监测工作的基本要求。科学规范的评价机制与控制措施有利于报告质量的评价及提高报告质量。山东省通过建立二级审核和评价员制度,加强对药品不良反应报告的质量控制。同时,借鉴国内外对药品不良反应报告质量评价经验,建立对报告质量日常化评价的量化标准,为我国药品不良反应报告质量的提高提供了参考经验。The evaluation and control for adverse drug reaction （ADR） reports quality are basic require- ments for ADR monitoring. Scientific and standardized evaluation mechanism and control measures are conducive to evaluating and improving ADR reports quality. Two-level audit and evaluation system established in Shandong Province have strengthened the quality control of ADR reports. At the same time, the quantitative criteria for the conventional reports evaluation have been developed on the basis of learning from experience of reports quality evaluation at home and abrod. All the practices have provided references for improving ADR reports quality in China.

关 键 词：药品不良反应 质量 评价 控制 

分 类 号：R954[医药卫生—药学]