Drug effectiveness reporting and monitoring systems: discussion and prototype development

Amar Gupta, Igor Crk, Surendra Sarnikar, Bipin Karunakaran
2009 International Journal of Technology Management  
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
more » ... 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 FDA's approach are poor quality of submitted reports, duplicate reporting of events, underreporting of adverse events capturing only a small fraction of the actual events, and absence of denominator or baseline information required to make meaningful conclusions from the data. We propose a system that features a per-drug customizable baseline and follow-up survey interface, elimination of duplicate reports, and continuous monitoring of patients. After the introduction of a drug into the market, a bi-directional flow of information related to drug usage, interactions, adverse effects, and treatment outcomes needs to take place between the drug companies, FDA, healthcare professionals and the patients. Timely and effective information flows should occur between the drug companies and FDA, on one side, and between physicians, pharmacists and patients, on the other. This information should incorporate newly detected adverse events, drug interactions, side effects, and recall information. Continuous monitoring is essential (Bates, Cohen, Leape, et al., 2001) ; further, the presentation of on-line statistical analysis of collected data that may also be presented to pharmacists would facilitate quicker discovery of adverse effects and patient notification.
doi:10.1504/ijtm.2009.024121 fatcat:thds5n7nv5g6fpaofwvlhkqefy