中国药物警戒 ›› 2019, Vol. 16 ›› Issue (4): 215-218.

• 法规与管理研究 • 上一篇    下一篇

检查视角下生产企业药品不良反应报告与监测的问题及思考

桑媛1, 吴世福2, 路长飞2, 谢彦军2, 崔小康2, 许莉莉2, 刘文文2, 霍艳飞2   

  1. 1威海市药品不良反应监测中心,山东 威海264200;
    2山东省药品不良反应监测中心,山东 济南 250014
  • 收稿日期:2019-05-09 修回日期:2019-05-09 出版日期:2019-04-20 发布日期:2019-05-09
  • 作者简介:桑媛,女,副主任药师,药品不良反应监测与评价。

Problems and Thoughts on Reporting and Monitoring of Adverse Drug Reactions in Drug Manufacturers

SANG Yuan1, WU Shifu2, LU Changfei2, XIE Yanjun2, CUI Xiaokang2, XU Lili2, LIU Wenwen2, HUO Yanfei2   

  1. 1Weihai Center for ADR Monitoring, Shandong Weihai 264200, China;
    2Shandong Center for ADR Monitoring, Shandong Jinan 250014, China
  • Received:2019-05-09 Revised:2019-05-09 Online:2019-04-20 Published:2019-05-09

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摘要： 目的 通过对药品不良反应报告和监测检查发现的不符合项目和检查人员建议的分析,探讨生产企业药品不良反应报告与监测存在的主要问题,为推动药品生产企业履行药品安全主体责任提供建议。方法 对近期开展11家企业药品不良反应报告和监测检查发现的不符合项目和检查人员的建议进行汇总,分类,归纳缺陷项目,对药品生产企业开展药品不良反应报告与监测中存在问题及其原因进行分析。结果与结论 目前,生产企业开展药品不良反应报告和监测工作初见成效,但部分企业仍然不同程度存在对药品安全主体责任认识不到位,风险信息收集能力不高,对开展药品安全风险管理的理念和方法掌握不全面,对反馈数据分析利用能力不高等问题,需要从监管政策层面强化政策引导,加强教育和培训,强化监督检查,推动药品生产企业履行药品安全主体责任。

关键词: 药品不良反应, 检查, 问题思考, 药物警戒, 风险管理

Abstract: Objective To discuss the main problems of the reporting and monitoring of adverse drug reactions in drug manufacturers, to provide suggestions for promoting drug manufacturers to fulfill the responsibility of drug safety through the analysis of the inspection findings on adverse drug reaction reporting and monitoring. Methods To classify and summarize the defect items for the non-compliance and recommendations of the 11 manufacturers which were inspected recently, and analyze the problems and causes on the adverse drug reaction reporting and monitoring of drug manufacturers. Results & Conclusion At present, drug manufacturers have improved adverse drug reaction monitoring work, but there are still varying degrees of problems as following in some companies: the awareness of the main responsibility for drug safety is not in place, the risk information collection capacity is not high, the understanding to carry out drug safety risk management concepts and methods is incomplete, the feedback data analysis and utilization capacity is not high and so on. It needs to intensify policy guidance from the regulatory level, enhance education and training, strengthen supervision and inspection, and promote drug manufacturers to fulfill the main responsibility for drug safety.

Key words: drug adverse reaction, inspection, analysis of problem, pharmacovigilance, risk management

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