STUDY OF ADVERSE DRUG REACTION PROFILE IN A TERTIARY CARE HOSPITAL: A RETROSPECTIVE OBSERVATIONAL STUDY

Shaik Rabia Basri*, Basavaraj C. Kotinatot, Shaik Nazia Nazneen and Harsha Naikwad

ABSTRACT

Introduction: ADR can increase the hospital stay, cost of treatment and also decreases the quality of life. Reporting of ADR ensures safe use of a drug. Present study was conducted to study the ADR profile in a tertiary care hospital. Objectives: 1. To study the Adverse Drug Reactions (ADRs) profile. 2. To assess the seriousness, causality, severity and outcome of ADRs. Methods: A retrospective observational study was conducted in a tertiary care hospital, BIMS, Belagavi among outpatients and inpatients with suspected ADR. After the approval by Institutional ethics committee, the recorded data of each patient in various departments was collected based on inclusion and exclusion criteria and then evaluated. The data regarding demographic details of patients, drugs and adverse drug reactions was entered in a specially designed proforma and later into MS excel sheet. Results: A total of 380 ADRs were analyzed out of which males and females showed an equal distribution of 50%. Majority of the patients were in the age group of 21-30(24%). Majority i.e., 192(28%) subjects had minor severity, followed by 78 (68%) subjects had moderate severity. Maximum ADRs were due to Anti TB drugs.(26%).Casualty assessment showed 187(66%) were probable, 93(33%) were possible and 2(1%) were certain. Cutaneous ADRs (51%) were the most common followed by CNS(22%) and musculoskeletal (12%)ADRs. Out of the 380 patients 155(55%) recovered, 86(30%) were recovering, 40(14%) had not recovered and one ADR had a fatal outcome. Conclusion: Most of the ADR’s in the study were due to Anti-TB drugs which resulted in prolonged hospitalization and increased economic burden. To avoid the ADR’s, it is important to identify and avoid the risk factors of ADR’s and follow rational drug usage.

Keywords: Adverse drug reactions, Casualty, Profile, Severity, Suspected drugs.