A 'One Health' cross-sectional analysis of reports of potential antibiotic resistance cases in international pharmacovigilance databases.

Introduction: Antibiotic resistance is a global health problem that requires 'One Health' interventions encompassing human, animal, and environmental health. Pharmacovigilance databases have been previously discussed as a potential supplement to traditional antibiotic resistance surveillance, but they have not been explored from a 'One hHealth' perspective. Methods: This study searched VigiBase-the WHO global database of adverse event reports-and EudraVigilance Veterinary, an animal health pharmacovigilance database maintained and managed by the European Medicines Agency, to identify reports related to antibiotic resistance across the 'One Health' domains. The searches were performed on all reports received up to February 21st, 2024, for VigiBase and EudraVigilance Veterinary. Results: A total of 29,667 and 5,217 reports were identified in VigiBase and EudraVigilance Veterinary, respectively. A further search for all antibiotic reports with an environment-related reported adverse event identified 52 reports from both databases, but none of these were related to antibiotic resistance. The reports on potential human and animal antibiotic resistance were increasing in number over time and received from across the globe, despite the differences in scopes of the databases. Discussion: Pharmacovigilance databases have the capability to capture reports from across the globe. However, limitations remain, particularly a lack of a global database for animal-based pharmacovigilance. For environment-related outcomes there is a scarcity of reports and no database designed to collect them.