ADVERSE DRUG REACTION MONITORING IN A TERTIARY CARE HOSPITAL: A PRELIMINARY APPROACH TO ENHANCE REPORTING

Background: Adverse drug reaction (ADR) evaluation and monitoring is key for safe medication use. This study aimed to initiate, enhance reporting and support the Pharmacovigilance program of India. Methodology: This prospective observational study on the evaluation of adverse drug reactions was carried out for 6 months with the approval of ethics committee. Using standard tools, data was collected in the Standard suspected ADR reporting form and assessed for causality, severity, and preventability. Complete data were collected until the discharge of the patient. Results: A total of 31 cases were recorded with 33 ADRs. The incidence of ADRs was predominant among the elderly (38.7%). ADRs were more prevalent in females (54.83%) than males. Hypertension was the commonly observed  co-morbidity among the patients enrolled in the study. The most common suspected drug class was antibiotics (48.48%) followed by anti-hypertensive agents (12.12%). Type B adverse reactions were predominant (69.69%) with a higher incidence of cutaneous manifestations (51.61%). On Causality assessment using the WHO-UMC scale, the majority of the ADRs were Probable (83.87 %) and 6.45% were possible. Most of the ADRs were moderate (87.09%) in severity (Hartwig’s scale), and the majority of ADRs were not Preventable (96.77%). Conclusion: This study provides a database of ADRs, which will help the healthcare professionals for optimum and safe use of the drugs.