A Prospective Pharmacovigilance Study in the Respiratory Tract Infections in Pulmonary Medicine Department of a Tertiary Care Hospital

Background: Adverse drug reactions (ADR) are the known dangers of any medicinal therapy. They are not only responsible for increasing the mortality and morbidity but also for multiplying the health care expenditure. The aim of this study was Identify the utilization pattern of different drugs, monitoring, reporting and management of ADRs in Pulmonary Medicine Department of a Tertiary Care Hospital Methods: The study was prospective observational study which was carried out for a period of Three Month (April – June 2025) study in Tertiary Care Hospital. Patients included in the Pulmonary Medicine Department in respiratory disease Proportion of ADRs and patient characteristics were investigated. Causality was evaluated by the Naranjo algorithm, severity was determined using the Hartwig classification and preventability was assessed using the Schumock and Thornton scale. Results: One hundred and Five numbers (105) of ADRs were seen out of 150 patients of the study population. The occurrence of ADR was found slightly higher in males i.e., 55% as compared to females i.e., 45%. Most of the patients are affected with tuberculosis about 42 patients, asthma are 31 patients and acute pulmonary edema 19 patients. Causality assessment of ADR is identified According to naranjo scale. ADR were classified as is (0%) doubtful, (28%) probable (54%) possible and (18%) definite. ADRs observed yellow eyes (17%), nausea & allergy (15%), Palpitation which occurred in 14 cases i.e., 20.29%. Among 28 ADRs i.e., 43% belonged to the mild category,46% moderate category and Severe 11% was found in the study. Conclusion: A routine patient follow-up is needed for the early detection and prevention of ADRs in order to improve patient adherence to drug therapy and provide improved drug therapy by avoiding associated morbidity and mortality.