The Drug Effectiveness Reporting and Monitoring System: Discussion and Prototype Development

Abstract

Medication errors occur commonly in healthcare facilities resulting in adverse drug events. These types of errors and their consequences have been previously observed and studied and it has been shown that simple tracking systems can help to significantly decrease occurrences and consequences of such events. We have found a need for similar monitoring for drugs that have just entered the market and whose potential adverse events are not yet known. Current techniques for post-approval monitoring are not adequate for timely discovery of as-of-yet unknown adverse events. FDA's current approach to identifying drugs with serious adverse effects, the MedWatch system, is inherently slow to identify the culprit drugs and to remove them from the market. Between 1997 and 2005, the system was successful in helping to identify 15 drugs with toxic side-effects. However, on average, it took 5.9 years for the identification phase and the subsequent phase for the removal from of the drug from the market. We propose a system that could help reduce this time by a significant amount. The proposed approach involves a simple on-line surveying system coupled with continuous monitoring by participating pharmacists. We have developed a concept demonstration prototype system and provide recommendations for further work related to the scalability, security, and data consistency aspects of our approach. In addition, we analyze how advances in semantic web and ontology development could be used to populate the database of the proposed system.

Keywords: Adverse event reporting, community pharmacy safety network, post-marketing surveillance, heterogeneous information systems, heterogeneous database systems, healthcare information integration, drug effectiveness reporting, drug effectiveness monitoring