中国药物警戒 ›› 2019, Vol. 16 ›› Issue (11): 654-661.
DOI: 10.19803/j.1672-8629.2019.11.03

• 药品上市许可持有人制度专栏 • 上一篇    下一篇

药品生产企业直接报告不良反应能力调查研究

王丹1, 李馨龄1, 董铎1, 熊玮仪1, 刘翠丽1, 朱兰1, 耿凤英2, 廖剑波2, 杨月明2, 兰姗3, 吕小琴4, 王彤春5, 赵霞6, 王雯7   

  1. 1 国家药品不良反应监测中心,北京 100022;
    2 辽宁省检验检测认证中心,辽宁 沈阳110036;
    3 四川省药品不良反应监测中心, 四川 成都610017;
    4 浙江省药品不良反应监测中心,浙江 杭州310012;
    5 上海市药品和医疗器械不良反应监测中心,上海200040;
    6 无锡市药品不良反应监测中心,江苏 无锡214000;
    7 华西医科大学循证医学中心,四川 成都610041
  • 收稿日期:2019-11-27 修回日期:2019-11-27 出版日期:2019-11-20 发布日期:2019-11-27
  • 作者简介:王丹,女,硕士,主任药师,药品不良反应监测与评价。

Investigation of Pharmaceutical Manufacturers’ Ability of Direct Reporting of Drug Adverse Reactions

WANG Dan1, LI Xinling1, DONG Duo1, XIONG Weiyi1, LIU Cuili1, ZHU Lan1, GENG Fengying2, LIAO Jianbo2, YANG Yueming2, LAN Shan3, LV Xiaoqin4, WANG Tongchun5, ZHAO Xia6, WANG Wen7   

  1. 1 China National Center for ADR Monitoring , Beijing 100022, China;
    2 Liaoning Inspection, Examination & Certification Centre, Shenyang Liaoning 110036, China;;
    3 Sichuan Center for ADR Monitoring, Chengdu Sichuan 610017, China;
    4 Zhejiang Center for ADR Monitoring, Hangzhou Zhejiang 310012, China;
    5 Shanghai Monitoring Center For Drug and Medical Device Adverse Reactions Shanghai 200040, China;
    6 Wuxi ADR Monitoring Center, Wuxi Jiangsu 214000, China;
    7 Chinese Evidence-based Medicine Center, West China Hospital, Sichuan University, Chengdu Sichuan 610041, China
  • Received:2019-11-27 Revised:2019-11-27 Online:2019-11-20 Published:2019-11-27

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摘要： 目的 调查我国制药行业药品不良反应监测工作现状及存在问题,提出提高药品生产企业不良反应报告能力的措施。方法 采取定性和定量相结合的调查方法。定性调查包括座谈会和实地考察;定量调查为向全国16个省份的药品生产企业发放问卷进行调查。结果 我国药品生产企业在不良反应监测体系建设、不良反应收集报告、分析评价和风险控制方面都存较多问题,技术监督和行政监管也存在需要改进的地方。结论 药品生产企业、药品不良反应监测机构、药品监督管理部门应认真落实《国家药品监督管理局关于药品上市许可持有人直接报告不良反应事宜的公告》,采取有效措施从整体上提高我国制药行业药品安全性意识和不良反应监测工作水平。

关键词: 药品不良反应监测, 药品不良反应直接报告制度, 调查研究

Abstract: Objective To investigate the status quo of and existing problems with ADR monitoring in the pharmaceutical industry in China, so as to propose measures to improve the ADR reporting ability of manufacturers.Methods Personnel interviews and questionnaires were used. Personnel interviews were conducted in the form of symposiums and on-the-spot investigation, using qualitative analysis Method. Questionnaire surveys were conducted among more than 1 000 manufacturers in 16 provinces, using qualitative analysis Method.Results There were many problems with the construction of ADR monitoring systems as well as with the collection, reporting, analysis and evaluation, and control of ADRs by drug manufacturers. Technical supervision and administrative supervision needed to be improved.Conclusion Drug manufacturers, ADR monitoring centers and drug regulatory authorities should implement the Notice of the NMPA on Direct Reporting Adverse Reactions by MAHs to the letter so as to improve the awareness of safety and the level of ADR monitoring in the pharmaceutical industry as a whole.

Key words: ADR monitoring, ADR Direct Reporting System, investigation and study

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