中国药物警戒 ›› 2018, Vol. 15 ›› Issue (11): 652-657.

• 药品上市许可持有人直接报告药品不良反应制度专栏 • 上一篇    下一篇

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

赵霞1, 冷美玲2, 王朋1, 李馨龄3, 曹璐娟1, 田春华3, *, 刘翠丽3   

  1. 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
  • 收稿日期:2019-01-09 修回日期:2019-01-09 出版日期:2018-11-20 发布日期:2019-01-09
  • 通讯作者: 田春华,女,硕士,副主任药师,上市后药品安全监测。E-mail: lixinling@cdr-adr.org.cn
  • 作者简介:赵霞,女,硕士,副主任药师,上市后药品安全监测。
  • 基金资助:
    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）

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

ZHAO Xia1, LENG Meiling2, WANG Peng1, LI Xinling3, CAO Lujuan1, TIAN Chunhua3, *, LIU Cuili3   

  1. 1 Center for ADR Monitoring of Wuxi, Jiangsu Wuxi 214000, China;
    2 China Pharmaceutical University, Jiangsu Nanjing 211198, China;
    3 Center for Drug Reevaluation, CFDA, Beijing 100022, China
  • Received:2019-01-09 Revised:2019-01-09 Online:2018-11-20 Published:2019-01-09

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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。

关键词: 药品生产企业, 直报制度, 医疗机构, 现状调查

Abstract: 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.

Key words: drug manufacturers, direct reporting system, medical institutions, current status investigation

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