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A retrospective study of serious adverse drug reactions and associated risk factors in a tertiary care hospital

Background: Serious adverse drug reactions (ADRs) cause physical, psychological and economic harm to patients and society. This study was undertaken to understand serious ADRs in a tertiary care hospital and risk factors associated with it. Methods: The serious adverse reactions that occurred over a one-year period were assessed. The serious adverse drug reactions, action taken, outcome, predictability, suspect drug, causality, patient demographics and risk factors for the reaction was collected. Chi-square test was applied for observing relationships of predisposing factors for serious ADRs. Results: Out of a total of 984 reported adverse drug reactions, 94 (9.55%) were serious. Hematological disorders (41.05%) were the common serious ADRs followed by electrolyte disturbances (18.94%). Anticancer agents were the suspect drugs for majority of serious ADRs. Serious ADRs contributed to 39 (0.05%) admissions in the hospital. Recovery occurred in 97.87% of the patients. The causality was possible in 91.48% (n=86) and probable in 8.51% (n=8) of the serious adverse drug reactions. Males, patients even with a single concomitant disease and those with more than 2 concomitant medications were at increased risk (p<0.05) for developing serious ADRs. Conclusions: Serious ADRs are a significant problem in health care. Measures should be taken to detect and treat them at the earliest to reduce suffering of the patient.