Journal of Korean Society of Medical Informatics  2009;15(2):191-199

doi:10.4258/jksmi.2009.15.2.191

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

Man Young PARK 1 ; Young Ho LEE ; Eun Yeob KIM ; Woo Jae KIM ; Hye Jin KAM ; Jong Pill CHOI ; Tae Hwa HAN ; Un Gu KANG ; Rae Woong PARK

Affiliations

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Keywords

Post-marketing Surveillance; Clinical Data Warehouse; Fluoxetine; QT Prolongation

Country

Republic of Korea

Language

Korean

Abstract

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.