中国药物警戒 ›› 2017, Vol. 14 ›› Issue (7): 402-406.

• 药品不良反应公众报告专栏 • 上一篇    下一篇

我国药品不良反应公众报告的需求调研及思考

王成岗1, 王东芳1, 许莉莉2, 王晓骏2, 吴世福2*, 王玲3, 田月洁2, 李玉基2, 刘红亮3, 路长飞2   

  1. 1 山东中医药大学,山东 济南 250355;
    2 山东省药品不良反应监测中心,山东 济南 250014;
    3 国家食品药品监督管理总局药品评价中心,北京 100045
  • 收稿日期:2017-08-16 修回日期:2017-08-16 出版日期:2017-07-20 发布日期:2017-08-16
  • 通讯作者: 吴世福,男,硕士,主任药师,药品不良反应监测与评价。E-mail:wushifu@sdfda.gov.cn
  • 作者简介:王成岗,男,博士,副教授,药物流行病学。
  • 基金资助:
    国家食品药品监督管理总局药品评价中心课题：我国公众药械化妆品不良反应报告模式研究

Investigation and Reflection on the Demand of Public Reporting of Adverse Drug Reaction in China

WANG Cheng-gang1, WANG Dong-fang1, XU Li-li2, WANG Xiao-jun2, WU Shi-fu2,*, WANG Ling3, TIAN Yue-jie2, LI Yu-ji2, LIU Hong-liang3, LU Chang-fei2   

  1. 1 Shandong University of Traditional Chinese Medicine, Shandong Jinan 250355, China;
    2 Shandong Center for ADR Monitoring, Shandong Jinan 250014, China;
    3 Center for Drug Reevaluation,CFDA, Beijing 100045, China
  • Received:2017-08-16 Revised:2017-08-16 Online:2017-07-20 Published:2017-08-16

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摘要： 目的 调研我国公众发生药品不良反应的现况,分析我国实施药品不良反应公众报告的必要性和可行性。方法 采取配额抽样的方法,选择公众和不良反应监测人员进行问卷调查,了解不良反应发生现况、处理方法和公众报告需求,采用统计图、统计表、卡方检验和秩和检验进行统计分析。结果 共收到有效公众调查表5 394份,监测人员调查表185份。调查对象及家人发生过药品不良反应的2 032人（占37.7%）。若发生不良反应,直接向药品不良反应监测机构或食品药品监督管理部门报告者占17.5%,16.2%的人不知道报告途径。2015年公众主动报告数量仅占总数的0.11%。有78.0%的监测机构和87.0%的公众认为应建立药品不良反应公众报告系统,有47.5%的省级监测机构表示有能力承担该工作。结论 我国应开展广泛宣传,提高公众对不良反应的认知度和自我保护意识;同时完善不良反应监测的法律法规体系,逐步建立药品不良反应公众报告机制。

关键词: 药品不良反应, 公众报告, 必要性, 可行性, 现况研究

Abstract: Objective To investigate the prevalence of adverse drug reactions (ADR) in public, and to analyze the necessity and feasibility of implementing public reports of adverse reactions in China. Methods By quota sampling, questionnaire survey was used in public and ADR monitoring staff in order to obtain information about the current situation , treatment Methods and public reporting demands of adverse reactions. Statistical Methods such as statistical tables, statistical graphs, chi-square test and rank sum test were used to deal with the data. Results 5 394 public questionnaires and 185 monitoring staff questionnaires were received. 2 032 (37.7%) of the respondents or his family had occurred ADR. If adverse reactions occur, only 17.5% of the respondents directly reporttoinstitutions of ADR monitoring or FDA, and other 16.2%did not know the reporting Methods. In 2015, public reports accounted for only 0.11% of all adverse reactions reported. 78.0% of the monitoring institutions and 87.0% of the public that thought a public reporting system for adverse reactions necessary,with 47.5% of the provincial monitoring institutions indicate they can undertake this work. Conclusion we should pay more attention to the propaganda of the public reports of adverse reactions to improve the public awareness of adverse reactions and self-protection awareness. And at the same time we should perfect the legal system of adverse reaction monitoring, and gradually establish a public reporting mechanism for adverse reactions.

Key words: adverse drug reactions, public reporting, necessity, feasibility, prevalence study

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