ArticlePharmacoepidemiology and drug safety2026
Reported Dosing-Related Medication Errors Involving Systemic Antibiotics in the Brazilian Pharmacovigilance Database (2018-2025): Distribution Across the WHO AWaRe Classification.
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Abstract
purposeAppropriate antibiotic dosing is essential to minimise treatment failure and reduce selective pressure that may contribute to antimicrobial resistance. This study characterised antibiotic medication-error drug-event pairs (MEPs) reported to the medicines Individual Case Safety Reporting (ICSR) system, VigiMed and assessed the distribution of dosing-related error drug-event pairs (DEPs) across World Health Organization (WHO) AWaRe (Access, Watch, and Reserve) antibiotic classes.
methodsWe conducted an exploratory cross-sectional analysis of reports involving systemic antibiotics (Anatomical Therapeutic Chemical, ATC Classification System as J01 - antibacterials for systemic use) from Brazil's open-access pharmacovigilance database (VigiMed) from 2018 to 2025. MEPs were identified using the Standardised MedDRA Query for Medication Error; within this group, Preferred Terms (PTs) related to dose amount, timing, frequency, duration, or rate of administration were classified as DEPs (32 PTs). Descriptive analyses and modified Poisson regression were used to examine demographic and reporting characteristics associated with MEP classification and, among MEPs, the association between AWaRe class and DEP classification.
resultsThe adjusted prevalence of MEP classification was higher among neonates (PR 3.90), infants (PR 1.78) and older adults (PR 1.70) than among adults. DEPs accounted for 31.7% of MEPs (n = 2587; 61 antibiotics), with dose omission (51.4%) and dosing regimen problems (16.7%) as the leading error subtypes. Among DEPs, 35.9% involved Access, 56.7% Watch and 7.1% Reserve antibiotics. In adjusted analyses, Watch (PR 1.14; 95% CI 1.07-1.22) and Reserve (PR 1.31; 95% CI 1.16-1.49) antibiotics showed a higher prevalence of DEPs than Access antibiotics.
conclusionsThis study analyses pharmacovigilance data on antibiotic dosing-related medication errors, highlighting potential opportunities for antimicrobial stewardship.
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