Abstract

Background: The data pertaining to Adverse drug reactions is very limited especially in India. Adverse drug reactions are known to cause mortality and increased morbidity and hence increase the burden of disease. Therefore this study was done over a period of 18 months to assess the causality of adverse drug reactions, nature of their seriousness and to know if they could have been prevented or not. Materials and Methods: A number of spontaneous reports of ADRs were included in the study over a period of 18 months from June 2015 to December 2016 reported from different clinical Departments of ANIIMS, Port Blair. The World Health Organization (WHO) definition of an ADR and its seriousness was adopted. The organ system involvement was labeled by WHO-ADR terminology. ADRs were analyzed for causality by Naranjos algorithm. Results: A Total of 200 reactions were reported in this time period, and out of these, most common Adverse drug reactions were Hypersensitivity reactions accounting for more than half of cases ie 54 %. A look at the causative agents revealed antimicrobials as the commonest agents causing these ADRs 48%, followed by drugs affecting GIT 20%, then autacoids 10%. Of these, about two-thirds of the reactions i.e. almost 65% were classified as probable and one-tenth were classified as preventable. Serious ADRs were 0.25 per 1000 patients. Conclusion: Most of the ADRs were caused by Antimicrobial Agents, and further large sample size studies are needed to confirm the association of particular Drugs with the ADRs.