Detection of Adverse Drug Reaction Signals in the Thai FDA Database: Comparison between Reporting Odds Ratio and Bayesia
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Woronee Buncbuoiluo, BPbarm, PhD candidate Department of Community Pharmacy, Faculty of Pharmacy, Silpakorn University. Nakhon Pathom. Thailand; Department of Tropical Hygiene, Faculty of Tropical Medicine. Mahidol University, Bangkok. Thailand Ilene H. Zrckermon, PhornD, PhD Department of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy. Baltimore. Maryland Vitboyo Kulsomboon, PhD Department of Social and Administrative Pharmacy, Faculty of Pharmaceutical Sciences. Chulalongkorn University. Bangkok. Thailand Wimon Suwonkesowong, BSc (Pbarm), MA Health Products Vigilance Center, Thai Food and Drug Administration, Nonthaburi, Thailand Protop Singhasironon, MBBS, DTMLH (Bangkok), DrPH (Epidemiology), MPH Department of Tropical Hygiene, Faculty of Tropical Medicine, Mahidol University. Bangkok, Thailand Joranit Koewkmgwol, PhD Department of Tropical Hygiene. Faculty of Tropical Medicine. Mahidol University. Bangkok. Thailand Key Words Adverse drug reaction; Spontaneous reporting; Signal detection; ROR; BCPNN Correspondence Address Waranee Bunchuailua, Department of Community Pharmacy, Faculty of Pharmacy, Silpakorn University. Sanamchantra Palace Campus, Muang, Nakhon Pathom 73000 (email: [email protected]).
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Detection of Adverse Drug Reaction Signals in the Thai FDA Database: Comparison Between Reporting Odds Ratio and Bayesian Confidence Propagation Neural Network Methods The study aimed to compare performance between the reporting odds ratio (ROR) and the Bayesian confidence propagation neural network (BCPNN)methods in identifiing serious adverse drug reactions (ADRs) using the Thai FDA spontaneous database. The two methods were retrospectively applied to identifi new, serious ADRs reported with antiretroviral therapy (ART) drugs using the data set between 1990 and 2006.We plotted the ROR and the information component against time to compare the differential timing of signal detection
INTRODUCTION Advances in antiretroviral therapy (ART), especially the use of highly active antiretroviral therapy (HAART), have resulted in significant reductions in morbidity and mortality associated with HIV infection (1-3). As a combination regimen of three different classes of drugs (nucleoside analog reverse transcriptase inhibitors, NRTls; nonnucleoside reverse transcriptase inhibitors, NNRTIs; and protease inhibitors), HAART has the ability to effectively suppress HIV-1 viral replication (4,5).However, the treatment is associated with a number of adverse effects that have short-term and long-term consequences ranging from mild to severe (6). Adverse reactions were reported in up to 50% of patients treated with ART, including gastrointestinal, metabolic, neurologic, and dermatologic effects (7). Moreover, some adverse effects may result in increased morbidity and represent additional risk factors for future complications that require treatment interruptions along with therapeutic drug monitoring for management (8). Studies have indicated that adverse effects of ART are a major cause of trea
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