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A Data Warehouse Based Retrospective Post-marketing Surveillance Method: A Feasibility Test with Fluoxetine

Other Title
임상 데이터 웨어하우스 기반 후향적 시판 후 부작용조사: Fluoxetine 대상 적용 가능성 연구
박, 만영; 박, 래웅; 김, 은엽; 이, 영호; 김, 우재; 감, 혜진; 최, 종필; 한, 태화; 강, 운구
Taehan Ŭiryo Chŏngbo Hakhoe chi, 15(2):191-199, 2009
Journal Title
Taehan Ŭiryo Chŏngbo Hakhoe chi; Journal of Korean Society of Medical Informatics; 대한의료정보학회지
Objective :Post-marketing surveillance (PMS) is an adverse events monitoring practice of pharmaceutical drugs on the market. Traditional PMS methods are labor intensive and expensive to perform, because they are largely based on manual work including phone-calling, mailing, or direct visits to relevant subjects. The objective of this study was to develop and validate a PMS methodology based on the clinical data warehouse (CDW).

Methods :We constructed a archival DB using a hospital information system and a refined CDW from three different hospitals. Fluoxetine hydrochloride, an antidepressant, was selected as the target monitoring drug. Corrected QT prolongation on ECG was selected as the target adverse outcome. The Wilcoxon signed rank test was performed to analyze the difference in the corrected QT interval before and after the target drug administration.

Results :A refined CDW was successfully constructed from three different hospitals. Table specifications and an entity-relation diagram were developed and are presented. A total of 13 subjects were selected for monitoring. There was no statistically significant difference in the QT interval before and after target drug administration (p=0.727).

Conclusion :The PMS method based on CDW was successfully performed on the target drug. This IT-based alternative surveillance method might be beneficial in the PMS environment of the future.
Post-marketing SurveillanceClinical Data WarehouseFluoxetineQT Prolongation
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Journal Papers > School of Medicine / Graduate School of Medicine > Medical Informatics
AJOU Authors
박, 래웅한, 태화
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