无锡市医疗机构与MAH沟通药品不良反应信息的现状调查与分析
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摘要
目的:对无锡市医疗机构与药品上市许可持有人(MAH)沟通药品不良反应(ADR)信息的现状进行调查与分析,为推动直报制度实施提供现实依据。方法:对医疗机构和MAH分别展开问卷调查,从无锡市正常开展ADR报告的医疗机构中抽取46家,从江苏省MAH中抽取15家,调查对象为各级各类监测人员,共发放问卷413份,对回收问卷进行统计分析,并对药物警戒各领域专家进行深度访谈。结果:目前,MAH从医疗机构获取ADR信息的整体水平并不高,无论是收集信息的类型还是途径均有进一步提升空间,MAH与医疗机构双方都应该做出改进。结论:为促进MAH切实履行ADR报告的主体责任,医疗机构、MAH和政府部门均应采取相应措施,共同推动直报制度顺利落地实施。
Objective: To investigate and analyze the current status of communications on adverse drug reaction(ADR) information between medical institutions in Wuxi and marketing authorization holders(MAHs), so as to lay a realistic basis for promoting the implementation of direct reporting system. Methods: Questionnaire surveys were conducted among medical institutions and MAHs respectively. 46 medical institutions that normally performed ADR reporting tasks in Wuxi were selected, and 15 MAHs were selected from Jiangsu Province.The survey targets were various types of monitoring personnel at all levels. A total of 413 questionnaires were distributed. Questionnaires were recovered and analyzed statistically. At the same time, in-depth interview with experts in various fields of pharmacovigilance was conducted. Results: Currently, the overall level of MAHs' access to ADR information from medical institutions is not so optimistic. There is room for further improvement,either in the type of information collected or the way of collecting information. Both MAHs and medical institutions should make improvements. Conclusion: In order to promote MAHs to fulfill their substantial responsibilities for ADR reporting, medical institutions, MAHs and government departments should take corresponding measures to jointly promote the smooth implementation of the direct reporting system.
Objective: To investigate and analyze the current status of communications on adverse drug reaction(ADR) information between medical institutions in Wuxi and marketing authorization holders(MAHs), so as to lay a realistic basis for promoting the implementation of direct reporting system. Methods: Questionnaire surveys were conducted among medical institutions and MAHs respectively. 46 medical institutions that normally performed ADR reporting tasks in Wuxi were selected, and 15 MAHs were selected from Jiangsu Province.The survey targets were various types of monitoring personnel at all levels. A total of 413 questionnaires were distributed. Questionnaires were recovered and analyzed statistically. At the same time, in-depth interview with experts in various fields of pharmacovigilance was conducted. Results: Currently, the overall level of MAHs' access to ADR information from medical institutions is not so optimistic. There is room for further improvement,either in the type of information collected or the way of collecting information. Both MAHs and medical institutions should make improvements. Conclusion: In order to promote MAHs to fulfill their substantial responsibilities for ADR reporting, medical institutions, MAHs and government departments should take corresponding measures to jointly promote the smooth implementation of the direct reporting system.
引文
[1]卫生部.卫生部令81号药品不良反应报告和监测管理办法[S]. 2011.
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[6]沈梦秋,李明,马丹华,等. 2016年江苏省药品不良反应报告和监测检查缺陷分析[J].药学与临床研究,2017,25(6):553-556.
[7]张雪梅,郭佳栋,冯变玲,等.药品生产企业药品不良反应工作的调查研究[J].医药导报,2016,35(8):902-905.
[2]国家食品药品监管总局.关于印发药品不良反应报告和监测检查指南(试行)的通知[EB/OL].(2015-07-02)[2019-04-11]. http://samr.cfda.gov.cn/WS01/CL0844/124221. html.
[3]国家药品监督管理局.关于发布个例药品不良反应收集和报告指导原则的通告2018年第131号[EB/OL].(2018-12-19)[2019-04-11]. http://www.nmpa.gov.cn/WS04/CL2138/334011.html.
[4]国家食品药品监管总局.中华人民共和国药品管理法[EB/OL].(2015-04-24)[2019-04-11]. http://www.nmpa.gov.cn/WS04/CL2076/300564.html.
[5]彭丽丽,范燕,李馨龄.浅议生产企业如何履行药品上市后安全第一责任人的职责[J].中国药物警戒,2016,13(3):159-161.
[6]沈梦秋,李明,马丹华,等. 2016年江苏省药品不良反应报告和监测检查缺陷分析[J].药学与临床研究,2017,25(6):553-556.
[7]张雪梅,郭佳栋,冯变玲,等.药品生产企业药品不良反应工作的调查研究[J].医药导报,2016,35(8):902-905.