我国药品生产企业从医疗机构收集药品不良反应信息的现状调查及对策研究  

Research on Current Status and Countermeasures of Information Collection on Adverse Drug Reactions by Drug Manufacturers from Medical Institutions in China

作　　者：赵霞 冷美玲 王朋 李馨龄[3] 曹璐娟 田春华[3] 刘翠丽[3] ZHAO Xia;LENG Meiling;WANG Peng;LI Xinling;CAO Lujuan;TIAN Chunhua;LIU Cuili(Center for ADR Monitoring of Wuxi,Jiangsu Wuxi 214000,China;China Pharmaceutical University,Jiangsu Nanjing 211198,China;Center for Drug Reevaluation,CFDA,Beijing 100022,China)

机构地区：[1]无锡市药品不良反应监测中心,江苏无锡214000 [2]中国药科大学,江苏南京211198 [3]国家食品药品监督管理总局药品评价中心,北京100022

出　　处：《中国药物警戒》2018年第11期652-657,共6页Chinese Journal of Pharmacovigilance

基　　金：国家药品不良反应监测中心2018年度调研项目:提升企业药品不良反应报告能力;江苏省食品药品监督管理局2017-2018年度科研项目(20170109)

摘　　要：目的通过调查了解医疗机构对建立以药品生产企业为主体的直报制度的态度和现阶段企业从医疗机构获取药品不良反应(ADR)信息的现状,为提高企业ADR报告能力提供参考。方法在全国选取6个代表性省份/直辖市,分别从中抽取一、二、三级医疗机构各1家,对其医务人员进行企业收集ADR信息方面的问卷调查和访谈,并就调查结果进行统计和分析。结果医疗机构对实施直报制度喜忧参半,企业也将面临诸多挑战。目前企业从医疗机构收集ADR信息并不顺畅,存在诸多问题,现状不容乐观。结论为提高企业药品不良反应报告能力,需医疗机构、企业和政府部门三方面同时发力,共同推动直报制度顺利实施。Objective To provide reference for improving adverse drug reactions(ADR)reporting capabilities of drug manufacturers by investigating the medical institutions'attitude towards establishing a direct reporting system based on drug manufacturers and the current status of information collection on ADR by drug manufacturers from medical institutions.Methods Six representative provinces/municipalities were selected nationwide,and one medical institution of each was selected from each of the three grades.Questionnaires and interviews on the collection of ADR information by enterprises were conducted with the medical staff,and the results were counted and analyzed.Results Medical institutions suffered mixed fortunes in the implementation of the direct reporting system,and enterprises would face many challenges.At present,the collection of ADR information by enterprises from medical institutions was not smooth,and the status was not optimistic.Conclusion In order to improve the ADR reporting capacity of drug manufacturers,it is necessary for medical institutions,enterprises and government departments to simultaneously exert efforts to jointly promote the smooth implementation of the direct reporting system.

关 键 词：药品生产企业 直报制度 医疗机构 现状调查 

分 类 号：R95[医药卫生—药学]