Adverse Drug Reaction (ADR) Monitoring at the Eastern Regional Pharmacovigilance Centre, Nepal.

Background Adverse Drug Reaction is any unintended drug consequence. It is often preventable. In developed countries, it is among the top ten leading causes of morbidity and mortality. However, it's monitoring is largely unexplored in developing countries like Nepal. Objective To identify and characterize the pattern of Adverse Drug Reactions at BP Koirala Instittue of Health Science (BPKIHS), the Eastern Regional Pharmacovigilance Centre of Nepal. Method It was an observational study among the patients presented to different Clinical Departments of BPKIHS. Study duration was between July 2012 to July 2015. Adverse Drug Reactions were documented in a structured questionnaire and analysis done, in the department of Clinical Pharmacology and Therapeutics, using Microsoft 2013 Excel. Result There were total 150 Adverse Drug Reactions documented mostly in the age range of 19-40 years (61.4%) with female preponderance (56.7%). Maximum Adverse Drug Reactions were collected from Psychiatry (60.7%) followed by Dental surgery (17.3%) and Internal Medicine (10.7%). Most frequent Adverse Drug Reactions were seen with drugs primarily affecting CNS (64.7%), followed by steroids (18.0%) and Antimicrobial drugs (12.0%). Among CNS drugs, Antidepressants (93.6%) accounted for most documentation. Weight gain (20.1%), Fatigue (12.4%), Rash (8.1%), Acid peptic disorder (7.7%), Headache (7.2%) and Puffiness of face (7.2%) were the most frequently encountered Adverse Drug Reactions. Conclusion Most reported Adverse Drug Reactions were from young (18-40) female presented to the department of Psychiatry. Weight gain was the most common side effect.