PHARMACOVIGILANCE IN PRACTICE: ASSESSMENT OF REPORTED SERIOUS ADVERSE DRUG EVENTS IN NINEVEH HEALTH INSTITUTIONS

Abstract

Introduction: Serious adverse drug reactions (SADRs) cause significant morbidity and mortality. This study describes SADRs reported to the Nineveh pharmacovigilance system and evaluates patient demographics, implicated drugs, affected organ classes, and clinical outcomes. Methods: This cross-sectional study analyzed spontaneous serious individual case safety reports (ICSRs) in the Nineveh VigiFlow. database during 2025. Data were coded using MedDRA and ATC classifications, with causality assessed via the WHO-UMC system. Results: Of 1,300 ICSRs, 419 (32.2%) met WHO seriousness criteria, encompassing 897 SADRs. Most reports involved females (70.2%) and adults aged 18–64 (62.3%). Skin/subcutaneous (15.5%) and respiratory/thoracic (13.8%) disorders were the most affected organ classes, with dyspnea (11.0%) being the most frequent presentation. Antineoplastics (45.7%) and systemic anti-infectives (23.9%, predominantly ceftriaxone) were the most implicated drug classes. Most reactions were life-threatening (31.5%) or required hospitalization (27.5%). While 64.7% of patients recovered, three fatalities (0.7%) occurred following parenteral cephalosporin administration. Causality was deemed probable in 49.6% and possible in 40.4% of cases. Conclusion: Antineoplastics and systemic antibiotics (especially ceftriaxone) are primarily linked to reported SADRs in Nineveh, frequently presenting as skin and respiratory hypersensitivity reactions. These findings emphasize the need for enhanced pharmacovigilance training, rational antimicrobial prescribing, and targeted medication-error prevention.