EVALUATION OF ADVERSE DRUG REACTIONS AND PHARMACOVIGILANCE OUTCOMES IN T2DM PATIENTS

Abstract

Background: Type 2 Diabetes Mellitus 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 that demand active pharmacovigilance to enhance drug safety and patient adherence. Methods: A prospective observational study was carried out over duration of 2 years at a tertiary care teaching hospital located in Central India. ADRs were identified through clinical evaluation and assessed for causality, severity, and preventability. Chi-square tests and logistic regression were utilized for statistical evaluation. Results: ADRs were reported in 231 patients. Hypoglycemia (notably with sulfonylureas) and gastrointestinal disturbances (mainly with metformin) were the most common ADRs. The Naranjo assessment categorized 7.36% of ADRs were classified probable, 83.55 % possible, 9.09 % doubtful and 0% definite with  88.7 % mild, 10.4% moderate and only two severe reactions (0.9 % ) classified in severity. According to Schumock and Thornton criteria, 27.27 % were definitely preventable, 54.98% probably preventable and 17.75% not preventable. Conclusion: This research underscores a significant prevalence of ADRs in patients with T2DM, with many being preventable. Sulfonylureas 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.