Abstract

Background: Reporting adverse drug reaction (ADRs) through Pharmacovigilance program of India is very important for effectiveness of drug treatment. It allows professionals to detect, assess, monitor and derive ways to reduce the incidence of ADRs.

Aims and Objectives: The aim of the study was to study the patterns of ADRs reported in a tertiary care teaching hospital.

Material and Methods: This study was conducted for a period of 10 months. We included all the forms of ADRs caused by drugs which were sent to the Pharmacovigilance cell, Department of Pharmacology. The reports were analyzed for age group, anatomical therapeutic classification, organ system involvement, type, severity, and the causality assessment.

Results: A total of 104 ADRs form were analyzed. The highest percentage 59.6% of ADRs was seen in 19–59 years of age group. Females were reported more reactions. The most common class of drugs involved was antimicrobial agents (51.9%). Major organ system affected was skin constituted a major component (73.0%). Our study showed that 75% reactions were predictable while 13.4% were unpredictable reactions. About 51.9% of reactions were moderate according to severity grading. The WHO causality assessment showed that 37.5% reactions were probable/likely and 32.6% were possible. About 75.9% of patients suffered from temporary harm and require intervention while 17.3% requires hospitalization. About 53.8% of reactions were from definitely preventable category and 43.2% were probably preventable.

Conclusion: The results suggest that staff of our hospital is reporting ADR according to the guidelines. There will be increase in spontaneous reporting and decrease in number of ADRs with further reinforcement. The data generated from Pharmacovigilance department will also help in finding ways for safer use of drugs in our hospital.

Key words: Pharmacovigilance; Adverse Drug Reaction Pattern; Causality Assessment; Severity Index