我国药品不良反应报告质量评估现状的分析与思考  

Study on the Evaluation for Quality of Adverse Drug Reaction Reports in China

作　　者：刘巍[1] 李馨龄[1] 程刚[1] 沈璐[1] 董铎[1] 刘翠丽[1] 王亚丽[1] 

机构地区：[1]国家食品药品监督管理总局药品评价中心,北京100045

出　　处：《中国药物警戒》2014年第9期561-563,566,共4页Chinese Journal of Pharmacovigilance

摘　　要：目的分析药品不良反应报告质量评估工作的现状。方法对目前国内药品不良反应个案报告表质量和药品不良反应数据库整体质量评估工作的历史和现状进行回顾和总结。结果对每份个案报告表质量的评估能发现报告表填写、评价审核中存在的细节问题,而药品不良反应数据库整体质量评估则能发现监测工作在方法、导向以及趋势等方面相对宏观的问题。二者互为补充,对推动监测工作健康发展具有积极作用。结论药品不良反应报告质量提高工作是药品不良反应监测工作的重要内容,亟待建立针对药品不良反应个案报告表和药品不良反应数据库建立科学、可操作的评估体系和方法。Objective To review the progress of the evaluation for the quality of the adverse drug reactions （ADR） in China. Methods Progress of the evaluation for the quality of the ICSRS and the ADR database in China were reviewed and summarized. Results By the evaluation for the quality of the ICSRS, the detail problems such as spelling could be found. By the evaluation for the quality of the ADR database, the macroscopic problems such as the method and the trend could be found. They complement each other and play a positive role for the healthy development of ADR monitor-ing. Conclusion The quality of ADR report is an important content of the ADR monitoring, so it is very necessary to establish scientific and operable evaluation system and methods.

关 键 词：个案报告表 数据库 质量 评估 

分 类 号：R95[医药卫生—药学]