COMPREHENSIVE PHARMACOVIGILANCE STUDY IN PATIENTS WITH ASTHMA AT A TERTIARY CARE TEACHING HOSPITAL

Abstract

Background: Asthma is a chronic inflammatory airway disorder requiring long-term pharmacotherapy, often involving multiple drug classes. This increases the risk of adverse drug reactions (ADRs), making pharmacovigilance essential for ensuring patient safety and optimizing therapeutic outcomes.

Objective: To evaluate the incidence, pattern, causality, and severity of ADRs associated with asthma therapy in a tertiary care teaching hospital.

Methods: A prospective observational study was conducted at Teerthankar Mahaveer tertiary care hospital in Moradabad, Uttar Pradesh, India, involving 238 patients diagnosed with asthma. Data on patient demographics, drug therapy, and ADRs were collected using the Pharmacovigilance Programme of India (PvPI) reporting format. ADRs were assessed for causality using Naranjo’s scale, severity using the Hartwig scale, and preventability using the Schumock and Thornton criteria. Descriptive statistics were applied using MS Excel/SPSS. Ethical approval was obtained, and informed consent was secured from all participants.

Results: A total of 55 ADRs were reported, indicating a notable occurrence among the study population. The mean age of patients was 37.53±1.27 years, with a male predominance (55%). ADRs were more common in younger age groups (≤30 years), accounting for approximately 58% of total reactions. Polypharmacy was associated with a higher ADR incidence (24.81%) compared to non-polypharmacy (20.95%). Most ADRs were classified as “probable” (58.18%) according to Naranjo’s scale, followed by “possible” (29.09%). Severity assessment revealed that the majority were moderate (58.18%), while 32.72% were mild and 9.09% were severe. Bronchodilators were the most frequently implicated drug class (38.2%), followed by antibiotics (20%) and corticosteroids. Among individual drugs, salbutamol, amoxicillin, and prednisolone were commonly associated with ADRs.

Conclusion: ADRs are relatively common in asthma pharmacotherapy, particularly among patients receiving polypharmacy and bronchodilator-based regimens. Most reactions are moderate and probable, suggesting that they are predictable and potentially preventable. Strengthening pharmacovigilance systems, promoting rational drug use, and enhancing clinician awareness can significantly improve patient safety and therapeutic outcomes in asthma management.