Background/Aim: Type 2 diabetes mellitus (T2DM) is a chronic condition that frequently necessitates prolonged pharmacological treatment and is frequently complicated by polypharmacy and comorbid conditions. These components elevate the likelihood of adverse drug reactions (ADRs) that demand active pharmacovigilance to enhance drug safety and patient adherence. This study aimed to generate actionable insights to improve prescribing practices, strengthen pharmacovigilance infrastructure and enhance patient safety in chronic disease management by systematically evaluating the incidence, severity, causality and preventability of ADRs in T2DM patients attending a tertiary care hospital in Central India. Methods: A prospective observational study was carried out over duration of 12 months at a tertiary care teaching hospital located in Central India. A total of 964 adults diagnosed with type 2 diabetic patients were enrolled. Data on demographics, comorbidities and drug prescriptions were recorded. Adverse events were identified through clinical evaluation and assessed for causality, severity and preventability. Chi-square tests and logistic regression were utilised for statistical evaluation. Binary logistic regression determined independent predictors of adverse events, with findings presented as adjusted odds ratios (OR) and 95 % confidence intervals (CI). Results: Among 964 patients (mean age 46.9 ± 12.4 years), the highest prevalence was observed in the 41-50 age group (32.6 %). Adverse events were reported in 231 patients (23.96 %). Hypoglycaemia (notably with sulfonylureas, p 0.01) and gastrointestinal disturbances (mainly with metformin) were the most common adverse event. The Naranjo assessment categorised 62.3 % of adverse events as probable, with 89.1 % classified as mild-to-moderate in severity. According to Schumock and Thornton criteria, 54.5 % of adverse events were preventable. Logistic regression revealed polypharmacy (OR = 2.73, p 0.01) and kidney dysfunction (OR = 2.21, p 0.01) as significant predictors of adverse events. Conclusion: This research underscores a significant prevalence of adverse events in patients with T2DM, with many being preventable. Sulfony-lureas and metformin were frequently implicated. Strengthening pharmacovigilance practices and promoting rational drug use are necessary for improving patient safety and therapeutic results in diabetes management.
Rathore et al. (Thu,) studied this question.