Retrospective Analysis of Adverse Drug Reactions at South Indian Tertiary Care Teaching Hospital

Background: Adverse drug reaction (ADR) is an appreciably harmful reaction from an intervention related to the use of the medicinal product, which predicts hazard from future administration and specific treatment, or alteration of the dosage regimen, or withdrawal of the product. This study aimed to analyze ADRs retrospectively to understand their nature at the study site. Methods: Retrospective analysis of the ADRs reported over 6 months was conducted at a South Indian Tertiary Care Teaching Hospital.We analyzed Patient characteristics, Causality, Severity,Dechallenge, Rechallenge, Management, Outcomes, Department, Drug Class, and Organ system involved related adverse events. Results: Out of 116 ADRs females developed 51.72 % of reactions, and ADRs are more common in the adult population (73.2 %), followed by geriatrics (11.2 %). Antibiotics were the most frequently used medication class and also lead to the majority of reactions (16.3%). A total of 55 ADRs were assessed for causality, and 31 (57.4%) reactions were possibly linked to the implicated medications. At the time of reporting, 41 (35.6 %) patients had recovered from the reaction, 37 % of ADRs were non-serious, and no deaths had been reported. Conclusions: The majority of ADRs were minor, and patients were able to recover from them after discontinuing the implicated medicine. We were unable to estimate the severity of the ADRs using this reporting form, and the majority of ADRs lacked a causation assessment, which is not a mandatory condition for reporting any suspected ADR. Keywords: ADRs, Retrospective study, Causality assessment, HCPs, Pharmacovigilance program of India