Characteristics and Requirements of Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Databases

Abstract

Abstract: Pharmacoepidemiologic studies play an important role in evaluating the interrelationship between drugs and adverse events. With the development of the electronic healthcare databases, the traditional method of pharmacoepidemiologic study cannot completely meet the needs of the pharmacovigilance today. Based on the understanding of the electronic healthcare databases and of the FDA related guidelines, this paper proposes to introduce the general characteristics of pharmacoepidemiologic safety studies using electronic healthcare databases and the requirements of the data collection put forward by FDA, which aims to provide relevant technical reference to our country's pharmacoepidemiologic studies and pharmacovigilance.

Key words: pharmacoepidemiologic safety studies, electronic healthcare databases, pharmacovigilance

CLC Number:

R994.11

ZHU Tian-tian, YE Xiao-fei, GUO Xiao-jing, ZHANG Tian-yi, WANG Jing, SHI Wen-tao, HE Jia. Characteristics and Requirements of Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Databases[J]. Chinese Journal of Pharmacovigilance, 2014, 11(7): 413-315.

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https://zgywjj.magtechjournal.com/EN/Y2014/V11/I7/413

References

[1] Paul E. Stang, Hong Qiu, Jesse A. Berlin. 药物流行病学与电子健康档案数据库[J].中国药物警戒,2009,6(9):574-576.
[2] Ispe. Guidelines for good pharmacoepidemiology practices(GPP)[J]. Pharmacoepidemiology and drug safety,2008,17(2):200-208.
[3] The European network of centres for pharmacoepidemiology and pharmacovigilance(ENCePP). Guide on methodological standards in pharmacoepidemiology(Revision 1)[EB/OL].(2013-02-08)[2014-04-08].http://www.encepp.eu/ standards and guidances.
[4] Takahashi Y, Nishida Y, Asai S. Utilization of health care databases for pharmacoepidemiology[J].European Journal of Clinical Pharma-cology,2012,68(2):123-129.
[5] Strom B L(ed).PHARMACOEPIDEMIOLOGY[M]. 4th Edition,2005. West Sussex, England:John Wiley&Sons, Ltd., ISBN:978-0-470-86681-8.
[6] Hennessy S. Use of health care databases in pharmacoepidemiology[J]. Basic & clinical pharmacology & toxicology,2006,98(3):311-313.
[7] Schneeweiss S, Avorn J. A review of uses of health care utilization databases for epidemiologic research on therapeutics[J]. Journal of clinical epidemiology,2005,58(4):323-337.
[8] Strom B L, Carson J L, Halpern A C, et al. Using a claims database to investigate drug-induced Stevens-Johnson syndrome[J]. Statistics in medicine,1991,10(4):565-576.
[9] Cox E, Martin B C, Van Staa T, et al. Good research practices for comparative effectiveness research: approaches to mitigate bias and confounding in the design of nonrandomized studies of treatment effects using secongdary data sources: the International Society for Pharmacoeconomics and Outcomes Research Good Research Practices for Retrospective Database Analysis Task Force Report-part I[J]. Value Health, 2009, 12(8):1053-1061.
[10] Esposito D, Wahl P, Daniel G, et al. Results of a Retrospective Claims Database Analysis of Differences in Antidepressant Treatment Persistence Associated With Escitalopram and Other Selective Serotonin Reuptake Inhibitors in the United States[J]. Clinical Therapeutics,2009,31(3):644-656.
[11] SilvermanSL. FromRandomizedControlledTrials toObservational Studies[J]. American Journal of Medicine,2009,122(2):114-120.
[12] Wong I CK,MurrayML. The potential of UK clinical databases in enhancing paediatric medication research[J]. British journal of clinical pharmacology,2005,59(6):750-755.
[13] 许军, 黄东. 浅谈区域性电子病历信息共享[J].电子设计工程,2012,20(5):61-63.
[14] 陈奕轩.医院HIS 系统网络数据质量控制与管理方法[J]. 信息系统工程, 2013(10):62-62.

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