中国药物警戒 ›› 2017, Vol. 14 ›› Issue (7): 413-418.

• 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途径和报告内容调研和思考

王晓骏1, 路长飞1, 赵玉娟1, 吴世福1, 王玲2, 田月洁1, 李玉基1, 刘红亮2, 丁长玲3, 王东芳4, 王成岗4*   

  1. 1 山东省药品不良反应监测中心,山东 济南 250014;
    2 国家食品药品监督管理总局药品评价中心,北京 100045;
    3 滨州医学院附属医院,山东 滨州256603;
    4 山东中医药大学,山东 济南 250355
  • 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: 王成岗,男,博士,副教授,药物流行病学。E-mail:wangchg1268@163.com
  • 作者简介:王晓骏,男,本科,工程师,信息化。
  • 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 Way and Content of Public Reporting of Adverse Drug Reactions in China

WANG Xiao-jun1, LU Chang-fei1, ZHAO Yu-juan1, WU Shi-fu1, WANG Ling2, TIAN Yue-jie1, LI Yu-ji1, LIU Hong-liang2, Ding Chang-ling3, WANG Dong-fang4, WANG Cheng-gang4,*   

  1. 1 Shandong Center for ADR Monitoring, Shandong Jinan 250014, China;
    2 Center for Drug Reevaluation, CFDA, Beijing 100045, China;
    3 Binzhou Medical University affiliated Hospital, Shandong Binzhou 256603, China;
    4 Shandong university of Traditional Chinese Medicine, Shandong Jinan 250355, 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 分析适合我国的药品不良反应公众报告途径、报告内容及反馈方式,为我国建立药品不良反应公众报告模式提供参考。方法 选择全国省级不良反应监测机构和部分市县级监测机构人员,并采取配额抽样的方法选择山东省的公众进行问卷调查,调查对我国建立药品不良反应公众报告途径、报告内容及反馈方式等的需求。结果 公众优先选择电话（74.2%）、微信公众号（68.7%）和互联网网站（66.0%）为报告途径,54.6%的监测机构认为应选择互联网网站报告。在报告内容方面,愿提供除身份证号码外个人基本信息的公众占42.6%;47.6%的监测机构认为身份证号不是必报内容,97.9%的监测机构认为应提供报告人或联系人电话号码。公众能提供伤害表现的比例为80.2%,而能提供产品名称、生产批号、批准文号、规格型号和生产厂家等产品信息（占34.2%）和伤害表现、伤害过程或事件描述、伤害部位、照片等伤害信息（占24.3%）的比例较低。需要信息反馈的公众占30.5%。结论 开展药品不良反应公众报告工作时,应建立电话、微信公众号、互联网等多种报告途径;报告内容应该根据公众特点设计易于获取且是分析评价必需的参数;应向报告人做好信息反馈工作。

关键词: 药品不良反应, 公众报告, 报告途径, 报告内容, 现况研究

Abstract: Objective To find the proper reporting Methods, reporting contents and feedback ways of public reporting of adverse drug reactions(ADR) in China, so as to provide reference for the establishment of a public reporting model of ADR. Methods Questionnaire survey was carried out in public and the ADR monitoring staff by quota sampling. Results For reporting Methods, the public tended by telephone (74.2%), WeChat official account (68.7%) and Internet site (66.0%); and 54.6% of the monitoring agency chosen the Internet site to report. For reporting contents, 42.6% of the public was willing to provide personal information except the ID number. 47.6% of the monitoring agencies considered that the ID number was not required, and 97.9% of agencies thought that the telephone number of the reporter or contact person was necessary. 80.2% of the public could provide injury performance, but only 34.2% could provide product information such as product name, batch, manufacturer and 24.3% of injury information. 30.5% of the public need information feedback. Conclusion A variety of reporting ways, such as the phone, WeChat public number, and Internet should be provided when public reporting of ADR is working. The contents of the report should be designed to be easy to obtain and necessary parameters for analysis and evaluation according to the characteristics of public. The relevant information should be fed back to the public.

Key words: adverse drug reactions, public reporting, reporting pathway, report content, prevalence study

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