Characteristics and Predictors of Serious Adverse Drug Reactions Reported to the Pharmacovigilance Unit, Anbar General Health Directorate, Iraq (2020–2025)
Keywords:
Adverse drug reactions, Anbar, Pharmacovigilance, SeriousnessAbstract
Background: Seriousness classification under ICH E2A criteria determines which adverse drug reaction (ADR) reports receive expedited regulatory attention; this has not previously been assessed in Iraqi regional pharmacovigilance data. Objectives: To characterize the proportion, clinical basis, and independent predictors of serious ADR reporting among individual case safety reports (ICSRs) submitted to the pharmacovigilance section within the Anbar General Health Directorate, 2020–2025. Methods: A retrospective analysis was conducted involving all ICSRs submitted through the VigiFlow platform. A case was classified as serious if at least one reaction met an ICH E2A criterion. Suspected medicines were harmonized to International Nonproprietary Names and classified by ATC level-1 group. Associations with seriousness were assessed using multivariable logistic regression, with adjusted odds ratios (aORs) and 95% confidence intervals reported. Results: Of 3264 submitted reports, 3164(96.9%) had a recorded seriousness status, of which 978(30.9%) were serious (30% of all submitted reports). Life-threatening reactions were the commonest criterion (49.3%); 3.6% resulted in death. Anti-infectives were the leading ATC group among serious reports (36.1%), and ceftriaxone was the leading suspected medicine. Blood/blood-forming products, antineoplastic/immunomodulating agents, “various” products, and neonatal and infant age showed the strongest independent associations with seriousness (aORs=2.4–4.0), followed by nervous-system medicines, physician reporting, and increasing numbers of suspected drugs and reaction terms. Conclusions: Nearly one-third of ICSRs submitted to the Anbar pharmacovigilance section met formal seriousness criteria. Blood products, antineoplastic agents, nervous-system medicines, and infant age were associated with seriousness, supporting risk-based pharmacovigilance and targeted safety monitoring in western Iraq.
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