我国药品不良反应公众报告模式研究

中国药物警戒 ›› 2017, Vol. 14 ›› Issue (7): 407-412.

• 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模式研究

吴世福¹, 王玲², 李玉基¹, 田月洁^1*, 刘红亮², 王晓骏¹, 常虹³, 王成岗⁴, 路长飞¹, 许莉莉¹, 赵玉娟¹, 赵惠荣⁵

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 济宁市食品药品检验检测中心,山东济宁272100;
4 山东中医药大学,山东济南 250355;
5 蓬莱市中医医院,山东蓬莱265600

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: 田月洁,男,硕士,主任药师,药品不良反应监测与评价。E-mail:tianyuejie@sdfda.gov.cn
作者简介:吴世福,男,硕士,主任药师,药品不良反应监测与评价。
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

Research on the Public Reporting Model for Adverse Drug Reactions in China

WU Shi-fu¹, WANG Ling², LI Yu-ji¹, TIAN Yue-jie^1,*, LIU Hong-liang², WANG Xiao-jun¹, CHANG Hong³, WANG Cheng-gang⁴, LU Chang-fei¹, XU Li-li¹, ZHAO Yu-juan¹, ZHAO Hui-rong⁵

1 Shandong Center for ADR Monitoring, Shandong Jinan 250014, China;
2 Center for Drug Reevaluation, CFDA, Beijing 100045, China;
3 Jining Institute for Food and Drug Control, Shandong Jining 272100, China;
4 Shandong university of Traditional Chinese Medicine, Shandong Jinan 250355, China;
5 Traditional Chinese Medicine Hospital of Penglai, Shandong Penglai 265600, China

Received:2017-08-16 Revised:2017-08-16 Online:2017-07-20 Published:2017-08-16

摘要/Abstract

摘要： 目的研究建立我国药品不良反应公众报告模式。方法采用文献检索的方法,研究发达国家药品不良反应公众报告现状,分析公众报告的作用和特点。利用问卷调查的方式,了解我国公众和药品不良反应监测机构的需求。结果药品不良反应公众报告是发达国家自愿报告系统的重要组成部分,具有降低漏报率、完善报告信息、发现和增强风险信号等作用。我国鼓励公众报告药品不良反应,已有监测机构探索开展了相关工作。提出了建立多种途径报告、分级审核评价的公众报告模式。结论我国应重视药品不良反应公众报告的作用,加强相关法律法规、技术规范、信息化平台和人才队伍建设,分阶段稳步推进药品不良反应公众报告工作。

关键词: 药品不良反应, 公众报告, 药物警戒, 研究

Abstract: Objective To establish a public reporting model for adverse drug reactions in China. Methods Analyze the roles and characteristics of public reporting by retrieve the situation of public reporting of adverse drug reactions in developed countries, and carry out a questionnaire survey to understand the needs of the public and adverse drug reaction monitoring institutions in China. Results Public reporting of adverse drug reactions is an important part of the voluntary reporting system in developed countries, with the effect of reducing the rate of omission, supplementing the report of professionals and enhancing the strength of the risk signal. It's encouraged for the public to report adverse drug reactions in China. Several monitoring agencies had explored and carried out relevant works. The public reporting model with a variety of ways to report and grading audit evaluation was established. Conclusion We should pay attention to the roles of public reporting of adverse drug reactions, and steadily promote the public reporting with strengthening the construction of the relevant laws and regulations, technical specifications, information platform and the talent team.

Key words: adverse drug reactions, public reporting, pharmacovigilance, research

中图分类号:

R994.11

吴世福, 王玲, 李玉基, 田月洁, 刘红亮, 王晓骏, 常虹, 王成岗, 路长飞, 许莉莉, 赵玉娟, 赵惠荣. 我国药品不良反应公众报告模式研究[J]. 中国药物警戒, 2017, 14(7): 407-412.

WU Shi-fu, WANG Ling, LI Yu-ji, TIAN Yue-jie, LIU Hong-liang, WANG Xiao-jun, CHANG Hong, WANG Cheng-gang, LU Chang-fei, XU Li-li, ZHAO Yu-juan, ZHAO Hui-rong. Research on the Public Reporting Model for Adverse Drug Reactions in China[J]. Chinese Journal of Pharmacovigilance, 2017, 14(7): 407-412.

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我国药品不良反应公众报告模式研究

Research on the Public Reporting Model for Adverse Drug Reactions in China

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