国际药品不良反应公众报告现状的分析与思考

中国药物警戒 ›› 2017, Vol. 14 ›› Issue (7): 419-423.

• 药品不良反应公众报告专栏 • 上一篇下一篇

国际药品不良反应公众报告现状的分析与思考

常虹¹, 田月洁², 刘红亮³, 吴世福^2*, 王玲³, 李玉基², 王晓骏², 王冰洁⁴, 赵汝民⁵, 赵惠荣⁶, 张云端⁷

1 济宁市食品药品检验检测中心,山东济宁 272100;
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;
4 淄博市药品不良反应监测中心,山东淄博 255000;
5 滨州市药品不良反应监测中心,山东滨州 256600;
6 蓬莱市中医医院,山东蓬莱 265600;
7 青岛市黄岛区人民医院,山东青岛 266400

收稿日期:2017-06-06 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:常虹,女,硕士,主管药师,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

Analysis and Reflection on the Current Situation of International Public Reporting of Adverse Drug Reactions

CHANG Hong¹, TIAN Yue-jie², LIU Hong-liang³, WU Shi-fu^2,*, WANG Ling³, LI Yu-ji², WANG Xiao-jun², WANG Bing-jie⁴, ZHAO Ru-min⁵, ZHAO Hui-rong⁶, ZHANG Yun-duan⁷

1 Jining Institute for Food and Drug Control, Shandong Jining 272100, China;
2 Shandong Center for ADR Monitoring, Shandong Jinan 250014, China;
3 Center for Drug Reevaluation, CFDA, Beijing 100045,China;
4 Zibo Center for ADR Monitoring, Shandong Zibo 255000,China;
5 Binzhou Center for ADR Monitoring, Shandong Binzhou 256600, China;
6 Traditional Chinese Medicine Hospital of Penglai, Shandong Penglai 265600, China;
7 People's Hospital of Huangdao District, Shandong Qingdao 266400, China

Received:2017-06-06 Revised:2017-08-16 Online:2017-07-20 Published:2017-08-16

摘要/Abstract

摘要： 我国已经建立较为完善的药品不良反应监测体系,并鼓励公众主动报告不良反应,但历年来公众报告数量很少。本文分析了国际发达国家,主要是美国、加拿大、澳大利亚和英国药品不良反应公众报告的现状,总结了在法律法规、报告途径、报告表格设计等方面的模式,为我国建立药品不良反应公众报告模式提供参考。

关键词: 国际, 药品不良反应监测, 自发报告, 公众报告

Abstract: A relatively perfect adverse drug reactions monitoring system has been established in China. The public was encouraged to report adverse drug reactions in our country while the number of the public reports was very small over the years. To provide reference for the establishment of public reporting model of adverse drug reactions in China, current situations of the public reporting of adverse drug reactions in the developed countries mainly including the United States, Canada, Australia and the UK was analyzed, and the laws and regulations, the reporting ways and the reporting forms were summarized.

Key words: international, adverse drug reactions monitoring, spontaneous reporting, public reporting

中图分类号:

R994.11

常虹, 田月洁, 刘红亮, 吴世福, 王玲, 李玉基, 王晓骏, 王冰洁, 赵汝民, 赵惠荣, 张云端. 国际药品不良反应公众报告现状的分析与思考[J]. 中国药物警戒, 2017, 14(7): 419-423.

CHANG Hong, TIAN Yue-jie, LIU Hong-liang, WU Shi-fu, WANG Ling, LI Yu-ji, WANG Xiao-jun, WANG Bing-jie, ZHAO Ru-min, ZHAO Hui-rong, ZHANG Yun-duan. Analysis and Reflection on the Current Situation of International Public Reporting of Adverse Drug Reactions[J]. Chinese Journal of Pharmacovigilance, 2017, 14(7): 419-423.

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国际药品不良反应公众报告现状的分析与思考

Analysis and Reflection on the Current Situation of International Public Reporting of Adverse Drug Reactions

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