Analysis of the Adverse Drug Reactions and Associated Cost Burden on the Patients in a South Indian Teaching Hospital

Objectives: To analyse the adverse drug reactions (ADR) and related economic burden on the health care system and health seekers

Methods: A prospective observational study was conducted in a South Indian tertiary care teaching hospital from July 2016 – December 2018.ADRs were analyzed for their causality, severity, predictability, and preventability through standard scales and were reported to the Pharmacovigilance Program of India (PvPI) through a specified updated Indian Pharmacopoeia Commission (IPC) suspected ADR reporting form. The total cost burden including both direct and indirect were calculated by assessing the ADR management including the clinical investigations done. The indirect cost was calculated based on the per capita analysis by using the Gross Domestic Product (GDP) of our study area.

Results: Among 458 ADRs, 81.88% were reported in Adult population with an almost same incidence in both the genders, majority were probable (41.70%) and Antibiotics were most commonly involved (16.18%). Around 60% ADRs were treated with at least one drug, 27% ADRs required either hospitalization or increased length of Hospitalization. A total of 989164.5 Indian Rupee (INR) was spent by the hospital and the patients for the management of ADRs, of which 79% was direct cost and 21% was indirect cost.

Conclusion: In this hospital, 26.88% of patients were identified with ADRs that were associated with high direct costs, due to hospitalization/extended hospitalizations, which resulted in an extra economic burden to the healthcare sector and seekers for the management of ADRs.