Assessment of triggering tools and risk factors of adverse drug reactions at a tertiary care hospital

Vollständiger Abstract

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Background: Adverse drug reactions are a significant cause of morbidity, mortality, and healthcare burden, making their identification, reporting, and prevention critical. This study aimed to assess the incidence, risk factors, causality, severity, and preventability of adverse drug reactions in a tertiary care hospital using standardized pharmacovigilance tools. Methods: A prospective observational study was conducted among inpatients across multiple departments. Data were analyzed using the World Health Organization-Uppsala Monitoring Centre causality scale, Hartwig’s severity scale, and the Thornton and Schumock preventability scale. Clinical grading was performed using the common terminology criteria for adverse events version 5.0 to determine associations between risk factors and adverse outcomes. Results: A total of 258 adverse drug reactions were identified from 313 suspected drugs. Adults comprised 57.7% of cases and elderly patients 37.2%, with females accounting for 51.9%. Antibiotics were the leading cause at 25.5%. Analysis showed that 88.3% of reactions were serious, with 62.01% requiring hospitalization or extended stay. Clinical recovery was observed in 86% of patients. Causality assessment classified 77.5% of reactions as probable. Approximately 55.03% of events were probably and definitely preventable, primarily linked to errors in dosing or administration. Polypharmacy and multiple comorbidities were identified as the primary risk factors for serious outcomes. Conclusions: Adverse drug reactions are frequent among adults and the elderly, with antimicrobials most commonly implicated. The high proportion of serious events emphasizes the need for rational prescribing, continuous monitoring, and active pharmacovigilance to enhance patient safety.