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http://ssrn.com/abstract=940447
 
 

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


Amar Gupta


Pace University - The Seidenberg School of Computer Science and Information Systems

Igor Crk


SIUE; University of Arizona - College of Engineering

Surendra Sarnikar


University of Arizona - Eller College of Management

Bipin Karunakaran


University of Arizona - Eller College of Management

October 30, 2006

Eller College of Management Working Paper No. 1037-06

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.

Number of Pages in PDF File: 30

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

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Date posted: November 16, 2006  

Suggested Citation

Gupta, Amar and Crk, Igor and Sarnikar, Surendra and Karunakaran, Bipin, The Drug Effectiveness Reporting and Monitoring System: Discussion and Prototype Development (October 30, 2006). Eller College of Management Working Paper No. 1037-06. Available at SSRN: http://ssrn.com/abstract=940447 or http://dx.doi.org/10.2139/ssrn.940447

Contact Information

Amar Gupta (Contact Author)
Pace University - The Seidenberg School of Computer Science and Information Systems ( email )
163 William Street
New York, NY 10038
United States
Igor Crk
SIUE ( email )
Department of Computer Science
School of Engineering
Edwardsville, IL 62026-1656
United States
University of Arizona - College of Engineering ( email )
Tucson, AZ 85721
United States
Surendra Sarnikar
University of Arizona - Eller College of Management ( email )
McClelland Hall
P.O. Box 210108
Tucson, AZ 85721-0108
United States
Bipin Karunakaran
University of Arizona - Eller College of Management ( email )
McClelland Hall
P.O. Box 210108
Tucson, AZ 85721-0108
United States
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