国外制药企业药物警戒数据库建设现状及启示

中国药物警戒 ›› 2015, Vol. 12 ›› Issue (10): 590-592.

国外制药企业药物警戒数据库建设现状及启示

张渊, 叶小飞, 张天一, 朱田田, 史文涛, 贺佳

第二军医大学卫生统计学教研室,上海200433

收稿日期:2015-05-19 修回日期:2015-12-07 出版日期:2015-10-08 发布日期:2015-12-07
通讯作者: 贺佳，女，博导，药物流行病学及新药评价的统计分析。E-mail：hejia@smmu.edu.cn
作者简介:张渊，男，在读硕士，药物流行病学。
基金资助:
国家自然科学基金(81202285);国家自然科学基金(81373105);上海市自然科学基金(12ZR1453700)。

Foreign Pharmaceautical Enterprises' Pharmacovigilance Databases Overview and Enlightenments

ZHANG Yuan, YE Xiao-fei, ZHANG Tian-yi, ZHU Tian-tian, SHI Wen-tao, HE Jia

Department of Health Statistics, Second Military Medical University, Shanghai 200433, China

Received:2015-05-19 Revised:2015-12-07 Online:2015-10-08 Published:2015-12-07

摘要/Abstract

摘要： 部分国外制药企业已经建立了成熟的药物警戒数据库，通过对这些数据库的数据来源、数据收集流程以及信号检测等情况进行介绍，并找出国外制药企业药物警戒数据库建设的优点。结合我国本土制药企业实际情况和国外制药企业的经验，为我国本土制药企业药物警戒数据库的建设提出建议。

关键词: 制药企业, 药物警戒数据库, 启示

Abstract: Some foreign pharmaceautical enterprises have owned mature pharmacovigilance databases.This article mainly introduced the sources of data, the process of data collection, the algorithm of signal detection about these databases and found out their advantages. Furthermore,this article proposed recommendations on the development of pharmacovigilance database of pharmaceautical enterprises in our country based on the experience of foreign pharmaceutical enterprises and the actual situation of China's domestic pharmaceutical enterprises.

Key words: pharmaceautical enterprise, pharmacovigilance database, enlightenment

中图分类号:

张渊, 叶小飞, 张天一, 朱田田, 史文涛, 贺佳. 国外制药企业药物警戒数据库建设现状及启示[J]. 中国药物警戒, 2015, 12(10): 590-592.

ZHANG Yuan, YE Xiao-fei, ZHANG Tian-yi, ZHU Tian-tian, SHI Wen-tao, HE Jia. Foreign Pharmaceautical Enterprises' Pharmacovigilance Databases Overview and Enlightenments[J]. Chinese Journal of Pharmacovigilance, 2015, 12(10): 590-592.

参考文献

[1] FDA. Guidance for Industry Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment[EB/OL].(2005-03-22)[2015-05-12].www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126834.pdf.
[2] Pfizer Ltd.Safety of medicines[EB/OL].(2015-03-01)[2015-05-12].http://www.pfizer.co.uk/content/safety-medicines.
[3] Head Office and Registered Office,GlaxoSmithKline plc.GSK Annual Report 2014 [EB/OL].(2015-05-15)[2015-08-02].http://www.gsk.com/media/603031/annual-report-2014.pdf.
[4] Hammond I W, Gibbs T G, Seifert H A, et al. Database size and power to detect safety signals in pharmacovigilance[J]. Expert opinion on drug safety, 2007, 6(6): 713-721.
[5] Van Holle L, Bauchau V. Signal detection on spontaneous reports of adverse events following immunisation: a comparison of the performance of a disproportionality-based algorithm and a time-to-onset-based algorithm[J]. Pharmacoepidemiology and Drug Safety, 2014, 23(2): 178-185.
[6] Candore G, Juhlin K, Manlik K, et al. Comparison of Statistical Signal Detection Methods Within and Across Spontaneous Reporting Databases[J]. Drug Safety, 2015,38(6):577-587.
[7] ARISGLOBAL. ARISgTM. The Drug Safety Software Most Used by Pharmaceutical Companies[EB/OL].(2015-03-15)[2015-05-12].http://arisglobal.com/total-safety/arisg/.
[8] SAYERS J. Implementing a quality management system in a global pharmacovigilance processing centre[J]. The Quality Assurance Journal, 2001, 5(2): 71-75.
[9] Camberidge Healthtech. 2010 Best Practices Competition Basic Research and Drug Discovery[EB/OL].(2010-06-15).[2015-05-12].
www.chicorporate.com/uploadedfiles/bio-it_world/best_practices/2010/rnd-comp.pdf.
[10] 石琴, 魏晶. 简述外资制药企业在中国建立药品不良反应监测系统[J]. 中国医药指南,2015,5(13): 286-287.
[11] 张建华, 王清理, 孔蕊. 影响药物不良反应监测的因素探讨[J]. 中国现代药物应用, 2012,6(13): 75-76.

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