Disproportionality Analysis and Characterisation of Medication Errors in EudraVigilance: Exploring Findings on Sexes and Age Groups: Medication Errors in Eudravigilance

• Published in: Drug safety 2025, Vol.48 (1), p.59-74
• Main Authors: Pera, Victor, Kors, Jan A., van Mulligen, Erik M., de Wilde, Marcel, Rijnbeek, Peter R., Verhamme, Katia M. C.
• Format: Article
• Language: English
• Subjects: Drug Safety and Pharmacovigilance; Medicine; Medicine & Public Health; Original Research Article; Pharmacology/Toxicology
• ISSN: 0114-5916; 1179-1942
• DOI: 10.1007/s40264-024-01478-6

Background While medication errors (MEs) have been studied in the European Medicines Agency’s EudraVigilance, extensive characterisation and signal detection based on sexes and age groups have not been attempted. Objectives The aim of this study was to characterise all ME-related individual case safety reports in EudraVigilance and explore notable signals of disproportionate reporting (SDRs) among sexes and age groups for the 30 most frequently reported drugs. Methods Individual case safety reports were used from EudraVigilance reported between 2002 and 2021. An ME was defined as any Preferred Term from the narrow Standardised Medical Dictionary for Regulatory Activities ® Query. Signals of disproportionate reporting were selected based on a lower boundary of the 95% confidence interval ≥ 1 of the reporting odds ratio, and at least 3 individual case safety reports. Analysed subgroups were female individuals, male individuals, and age groups 0–1 month, 2 months to 2 years, 3–11 years, 12–17 years, 18–64 years, 65–85 years, and >85 years. Heatmaps were utilised as a visual aid to identify striking SDRs. Results Of the 9,662,345 EudraVigilance reports, 267,262 (2.8%) contained at least one ME, with a total of 300,324 MEs, for 429,554 drugs. The most reported ME was “Inappropriate schedule of product administration” (52,646; 17.5%), followed by “Incorrect dose administered” (32,379; 10.8%) and “Wrong technique in product usage process” (26,831; 8.9%). Individual case safety reports with MEs were most frequently related to female individuals (148,009; 55.4%), most often submitted by healthcare professionals (155,711; 58.3%), originated predominantly from the USA (98,716; 36.9%), followed by France (26,678; 10.0%), and showed a median reported age of 50 years (interquartile range: 26–68). Most ME individual case safety reports (158,991; 59.5%) were associated with a serious health outcome. A total of 847 SDRs were identified, based on the entire EudraVigilance database; for subgroups, the number of SDRs ranged from 84 for the age group 0–1 month to 749 for female individuals. Signals of disproportionate reporting for female individuals and male individuals were very similar. Most MEs were reported for the vaccine against human papillomavirus (Anatomical Therapeutic Chemical [ATC]: J07BM01; 11,086 MEs, 57% being “inappropriate schedule of product administration”), with reporting odds ratios that range from 1.5 to 47.0 among age groups. The SDR for the live-attenu