Analysis of adverse drug reactions reported to national pharmacovigilance center of Bhutan

Abstract

Introduction: Medicines prescribed for diseases often causes adverse drug reactions in patients ranging from mere inconvenience to permanent disability and death. This is because, most of the adverse drug reactions especially the serious and latent ones may not have occurred during the clinical trials and vulnerable populations like children, pregnant women and the elderly are not all included in clinical trial studies considering the ethical and safety issues.

Objectives: To study the demographic characteristics, types of adverse drug reactions and common drugs causing these reactions from the adverse drug reaction reports received by the national pharmacovigilance of Bhutan.

Methods: A total of 222 adverse drug reactions were received at the national pharmacovigilance center from January 2016 to May 2018 were analyzed retrospectively. The Drug Regulatory Authority is the national pharmacovigilance center of Bhutan and is a member to the International Drug Monitoring Program since 2014.

Results: 73% of adverse drug reactions occurred in adults while 13.5% occurred each in children and elderly. 48.7% of the total adverse drug reactions reports were caused by antibiotics out of which penicillin was the most common causal drug (32.4%). The most commonly reported adverse drug reactions was rashes (36.5%) followed by gastro-intestinal system disorder (14.9%).

Conclusions: Antibiotics are common causal drugs for adverse drug reactions. All categories of health professional must be encouraged to report adverse drug reactions. Active surveillance for drug safety monitoring especially for those of patients who are on antibiotics is recommended.