| 赵霞,冷美玲,席晓宇,王朋,曹璐娟,彭楠.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[J].中国药事,2019,33(6):717-724 |
| 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 |
| Investigation and Analysis into the Current Status of Communications on Adverse Drug Reaction Information Between Medical Institutions in Wuxi and MAHs |
| 投稿时间：2019-01-08 |
| DOI：10.16153/j.1002-7777.2019.06.017 |
| 中文关键词: 药品上市许可持有人 ADR 直报制度 医疗机构 现状调查 |
| 英文关键词: marketing authorization holder adverse drug reaction(ADR) direct reporting system medical institution investigation of current status |
| 基金项目:江苏省食品药品监督管理局2017-2018年度科研项目（编号20170109）；2018年度药品不良反应监测中心委托项目《药品上市许可持有人从医疗机构获取药品不良反应信息的现状调查和对策研究》（编号20180801） |
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| 中文摘要: |
| 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。 |
| 英文摘要: |
| 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. |
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