Ibel C Fredy
PES College of Pharmacy, India
Title: Adverse Drug Reaction Reporting – A Retrospective Analysis
Biography
Biography: Ibel C Fredy
Abstract
INTRODUCTION: Pharmacovigilance also known as drug safety is defined as the science and activities relating to the collection, detection, assessment, monitoring and prevention of adverse effects or any other drug-related problems. The occurrence of adverse drug reaction is a price that patients have to pay for the benefits produced by modern medicine. METHODOLOGY: The study was a retrospective observational study. Each documented ADRs was assessed for its causality by using the Naranjo’s scale. The severity by modified Hartwig and Siegel scale. Preventability by modified Shamrock and Thornton scale. Results were analyzed using Microsoft Excel RESULTS: Our study showed that gender predominance occurs based on the population included under study and common age groups affected were above 40 yrs. most of the ADR’s was probable, followed possible and less of highly probable and unlikely. Adverse drug reactions reported were commonly moderate followed by mild with a few severe reactions. Majority of the reactions was not preventable followed by probably preventable with only less number of them were definitely preventable. Commonly associated drugs with ADRs were Analgesics, Cephalosporins, followed by chemotherapeutic agents and Quinolones. Retrospective analysis of ADRs reported from 2009-2015 shows significant variations in number of ADRs reported which was maximum during the active pharmacovigilance studies. CONCLUSION: This study strongly suggests that there is greater need for streamlining of hospital based ADR reporting and monitoring system to create awareness, to promote the reporting of ADRs among healthcare professionals and to encourage ADR based studies in hospital which have significant outcome in the ADR reporting.