An Information Technology Architecture for Post-Marketing Surveillance: The Drug Effectiveness Reporting and Monitoring System

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 system for monitoring adverse drug events in an outpatient setting that can form a part of the post marketing surveillance program. The proposed system architecture 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 factors that influence the successful implementation and use of the system, and propose information technology solutions that satisfy these requirements.

Keywords: Adverse event reporting, community pharmacy safety network, post-marketing surveillance