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This report is a slightly revised version of the following journal article:

Sarnikar S, Woosley RL, Gupta A. An information technology architecture for drug effectiveness reporting and post-marketing surveillance. International Journal of Healthcare Information Systems and Informatics. July-September 2007, 2(3) pp. 65-80.

Abstract

Adverse drug events impose a large cost on the society in terms of lives and healthcare costs. In this paper, we propose an information technology architecture for enabling the monitoring of adverse drug events in an outpatient setting as a part of the post marketing surveillance program. The proposed system architecture enables the development of a web based drug effectiveness reporting and monitoring system that builds on previous studies analyzing the involvement of community pharmacies in identifying and reporting adverse drug events. We define the key requirements of such a monitoring and reporting system, identify the critical factors that influence the successful implementation and use of the system, and propose information technology solutions that satisfy these requirements.