Collection, Detection, Assessment, Monitoring and Prevention of Adverse Drug Reactions in the Nephrology Department of Gauhati Medical College and Hospital, Assam, India
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
