A Retrospective Analysis of Adverse Drug Reactions at a Tertiary Care Center–patterns, Causality, Predictability, and Preventability

Background: Adverse drug reactions (ADRs) are associated with significant morbidity and mortality. They can negatively impact healthcare resources and cause financial burden on patients. Objectives: This study aimed to assess the causality, severity, predictability, and preventability of reported ADRs as per standard scales. Methods: A retrospective observational study was conducted in KRIMS, Karwar, from April 2018 to August 2019. All suspected ADRs reported by outpatients and inpatients of various clinical departments were collected and analyzed. Results: A total of 159 ADRs were reported in 136 patients. Most patients were adults aged 18-65 years (88.2%). A female preponderance was observed. The skin and central nervous system (CNS) were the predominant organ systems affected (29.6% each). The most common ADRs reported were rashes (14.5%) followed by sedation (8.2%). Antibiotics were the most commonly used drug class (38.5%). Among the individual drugs, β-lactam antibiotics were the most commonly implicated (16%). Most drugs causing ADRs were administered orally (67.5%). The causality of the reported ADRs was probable in 64.2%. Most of the reported ADRs were non-serious (91.2%). A total of 61% of patients experiencing ADRs recovered completely. Of the ADRs, 83.6% were mild, 51.6% were predictable, and 85.5% were not preventable. Most ADRs subsided after withdrawing the offending drug (66.7%). Conclusion: Early detection of the causal relationship between drugs and adverse reactions is crucial for their effective management and prevention.