Abstract

An adverse drug reaction ADR as defined by World Health Organization WHO is a noxious unintended effect of a drug occurring at normal doses in humans for prophylaxis diagnosis or therapy of disease or for the modification of physiological function ADRs are considered as the fourth to sixth leading cause of death among hospitalized patients About 2 9-5 6 of all admissions are caused by adverse related events and approximately 35 hospitalized patients experience an ADR Objective To identify the ADR by chart review method to determine the causality of the ADR by Naranjo s algorithm to analyze the severity of the ADR by modified Hartwig method and to motivate the health care professionals to report ADRs in Nephrology ward of Gauhatu Medical College and Hospital GMCH Guwahati Preventability of ADR is done by Schumock Thortonpreventibility scale Materials and methods A prospective observational and hospital based case control study June 2011-May 2012 was carried out in the Nephrology ward of GHMC including both out-patient and in- patient departments All the values are statistically determined using parametric t-test and nonparametric fisher s exact test or chi-square tests Results Out of 850 patient records thecommonly occurring ADRs were moon face n 16 18 6 followed by hypersensitivity n 9 10 4 and hepatotoxicity n 4 4 65 Gastrointestinal ADRs were highest in number followed by the hypersensitivity Prednisolone was found to be the most offending drug followed by Nimesulide and Diclofenac It is very clear that 12 7 ADRs were preventable Conclusion Renal dysfunction plays a significant role in occurrence of serious and multiple ADRs Poly-pharmacy comorbidity and number of diagnosis were found to be risk factors for ADRs