北京市2004年《药品不良反应/事件报告表》质量分析  

Analysis on quality of《Adverse drug reaction/event report form》received by Beijing in 2004

作　　者：张京航[1] 张俊[1] 张黎明[1] 

机构地区：[1]北京市药品不良反应监测中心,北京100024

出　　处：《中国药物警戒》2005年第4期204-206,共3页Chinese Journal of Pharmacovigilance

摘　　要：目的分析2004年北京市药品不良反应监测中心收集的北京市医疗机构《药品不良反应,事件报告表》的质量情况,针对存在的问题,提出解决办法,以提高报告质量。方法对2004年北京市药品不良反应监测中心收到医疗机构上报的7868份《药品不良反应/事件报告表》质量进行统计分析。结果报表总体质量偏低,北京市部分三级医疗机构报表质量影响全市药品不良反应报告的整体质量。结论提高部分三级医疗机构上报《药品不良反应/事件报告表》的质量是保证北京市整体报告质量的关键；提高药品不良反应报告质量,是做好上市药品安全性、有效性再评价的基础。Objective This text was to test the quality of 《Adverse drug reaction/event report form》 from the medical organization in Beijing, put forward method to solve existed problem in order to improve quality of the forms. Method Statistical analyze the quality of 7868 share report forms received by Beijing Center for ADR Monitoring in 2004. The forms were reported by medical organization in Beijing. Results The overall quality of the forms is relatively low. Quality of some forms reported by tertiary hospital in Beijing influences the quality of all the forms. Conclusion We must improve the quality of forms which was reported by some tertiary hospital. This is the sticking point to ensure the quality of all the forms. Improve the quality of forms is a basic job to revaluate the security ,validity of post-marketing medicine.

关 键 词：《药品不良反应/事件报告表》质量 存在问题 解决问题方法 

分 类 号：R954[医药卫生—药学]