Pharmacovigilance and Adverse Drug Reactions Reporting in Bhutan: A Review of Current Status

Bhutan is a small country located in the eastern Himalayas situated between China and India. Bhutan's road to modern health system began in 1961. Essential Drugs Program under the Ministry of Health introduced pharmacovigilance to the pharmacy professionals before the establishment of the Drug Regulatory Authority. Legislations and relevant guidelines for pharmacovigilance activities are developed and health professionals are sensitized on adverse drug reaction reporting system. Bhutan became a member to the World Health Organization Program for International Drug Monitoring in 2014. National Pharmacovigilance Center takes necessary regulatory actions based on the degree of adverse reactions reported. Pharmacovigilance centers set up in five major hospitals collect, assess and report adverse drug reactions. Currently, only healthcare professionals are involved in reporting of adverse drug reactions. Adverse drug reaction reports are assessed and uploaded through VigiFlow database. Pharmacovigilance in Bhutan is still at its nascent stage and a lot more lies ahead for improvement. More health professionals must be trained to promote adverse drug reaction reporting.