J Korean Soc Med Inform.  2009 Jun;15(2):191-199. 10.4258/jksmi.2009.15.2.191.

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

• Park MY
• Lee YH
• Kim EY
• Kim WJ
• Kam HJ
• Choi JP
• Han TH
• Kang UG
• Park RW

• KMID: 2211388
• DOI: http://doi.org/10.4258/jksmi.2009.15.2.191

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.

Keyword

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

MeSH Terms

Electrocardiography
Fluoxetine
Hospital Information Systems
Postal Service
Retrospective Studies
Fluoxetine

Figure

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  Figure 1 Process of making a specialized CDM for PMS

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  Figure 2 ER-Diagram for the integrated CDW

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