A study on adverse drug reactions and to monitor the incidence of ADRs in a pulmonary medicine department in teaching tertiary care hospital: a hospital-based study

Abstract

Background: Adverse drug reactions (ADRs) are a significant clinical problem and an essential aspect of patient care and evaluation. ADRs are a leading cause of morbidity, especially among hospitalized patients with respiratory diseases due to polypharmacy. Approximately 2% of all hospitalizations are linked to ADRs. Medications with a narrow therapeutic index require special ADR management. Research on ADRs is crucial to assess their frequency among medical inpatients, evaluate their impact on hospital admissions, classify the types of ADRs, identify potential risk factors, and calculate the costs of ADRs in terms of prolonged hospital stays. Theophylline, used for asthma and chronic obstructive pulmonary disease (COPD), is associated with ADRs like palpitations, anorexia, and nausea, occurring in 4.71% of cases.Objective: To evaluate the incidence, pattern, and causality of ADRs in the pulmonary medicine department of a tertiary care hospital. Methods: A prospective observational study was conducted over six months in the Pulmonary Medicine Department. ADRs were identified, documented, and analyzed using WHO causality assessment and Naranjo’s scale.Results: Among 320 patients, 60 ADRs were reported (38 male, 22 female). First-line TB drugs caused the most ADRs, followed by corticosteroids. Causality was highly probable, and ADR severity was mild. Conclusion: Anti-tubercular drugs were the primary cause of ADRs. Regular monitoring and effective pharmacovigilance are essential to reduce ADR-related burdens in respiratory patients.