A Prospective Study on Adverse Drug Reactions in an Indian Hospital – Pages 149-162

A Prospective Study on Adverse Drug Reactions in an Indian Hospital – Pages 149-162
Sivanandy Palanisamy, Kottur S.G. Arul Kumaran and Aiyalu Rajasekaran
Department of Pharmacy Practice, KMCH College of Pharmacy, Coimbatore-48, India
DOI: http://dx.doi.org/10.6000/1927-5951.2013.03.02.6

Abstract: Background:ADRs have a major impact on public health, reducing patients’ quality of life and imposing a considerable financial burden on the health care systems.

Objectives: The main objectives were to analyze the pattern and extent of occurrence of ADRs in the hospital, identify co-morbidities, past and present illness, assess causality and identify the offending drugs, assess the severity and preventability of adverse drug reactions.

Methods:Prospective, observational, spontaneous, reporting study with both active and passive methods.

Results:Thestudy was carried out from January 2009 to August 2012. A total of 950 ADRs were accepted from 1227 reported ADRs. Female patients experienced more number of ADRs when compared to male patients. Fever was the most commonly observed reason for admission. Maculopapular skin rashes were the commonly observed ADR in the study population. Amoxicillin and clavulenic acid combination implicated more number of ADRs in the antibiotic category than others. Sixty one percent of the ADRs were moderate in severity followed by minor and severe ADRs. Most of the reactions in this study population were managed by withdrawing the offending drug and rechallenge was performed in few subjects. Most of the ADRs were definitely preventable (40%) and were predictable in nature. Eighty percent of the reactions were probably related to offending drugs, 758 reactions were likely to cause ADRs. Twenty five percent ADRs were treated symptomatically in the study population.

Keywords: Adverse drug reactions, Pharmacovigilancce, Spontaneous reporting, Allergic reactions, Observational study.