ADVERSE DRUG REACTION ANALYSIS IN A TERTIARY CARE HOSPITAL: PHARMACOVIGILANCE PERSPECTIVE

Amudavalli K. and Amudhan Arvind E.*

ABSTRACT

Introduction: Pharmacovigilance (PV) is defined as the detection, assessment, understanding and prevention of Adverse Drug Reactions (ADRs) when a drug is used. In many countries, ADRs ranks among the top ten leading cause of morbidity and mortality. There is a lack of proper protocol for monitoring and reporting of ADRs in India in most of places with rate of ADR reporting rate is as less as 1% as compared to 5% in other part of world. Aim: To undertake ADR monitoring in various departments of a tertiary care government hospital and to cultivate the culture of ADR reporting among fellow physicians and interns. Materials and Methods: This is an observational, retrospective study conducted by analysing the spontaneous ADR forms, collected over a period of 6 months (March 2017 to August 2017) at Government Dharmapuri Medical College by Department of Pharmacology. Results: During the period of one year, around 200 ADR forms were collected from inpatients of the hospital. Male: Female ratio was 1.44:1.Geriatric age group was most commonly affected and most of the cases were from general medicine department. Antibiotics were the most common drug which caused reactions followed by analgesics. Gastritis was most common adverse effect.Most of the patients recovered from adverse effect in course of treatment. Conclusion: ADR reporting is an ongoing and continuous process. Studies from the institute helps to identify and rectify the problems related to ADR reporting. The lacunae in reporting can be cleared by creating awareness among physicians and interns there by improving the ADR reporting among them.

Keywords: ADR reporting, Drugs, Pharmacovigilance, Pharmacovigilance program of India.