Presentation (CTI)

OBJECTIVES: To describe the burden of reported adverse drug reactions (ADRs) associated with oral World Health Organization (WHO) AWaRe Watch-category antibiotics using VigiAccess data and estimate potential healthcare cost savings achievable through optimized prescribing practices.
METHODS: A retrospective descriptive study was conducted using publicly available data from VigiAccess, the WHO pharmacovigilance database. Reports of ADRs related to oral antibiotics classified under the WHO AWaRe Watch category were identified and summarized. Average direct healthcare costs associated with antibiotic-related ADRs were obtained from published health economic studies and applied to reported ADR frequencies to estimate the potential economic burden. Scenario analyses modeled potential cost savings assuming 10%, 20%, and 30% reductions in ADR occurrence following optimized prescribing practices.
RESULTS: Oral Watch-category antibiotics accounted for a substantial number of reported ADRs within the VigiAccess database. Based on published literature, estimated direct healthcare costs per antibiotic-related ADR ranged from approximately USD 400 for outpatient-managed reactions to more than USD 12,000 for severe reactions requiring hospitalization or intensive medical management. Economic modeling demonstrated that reductions in ADR occurrence through optimized prescribing could generate meaningful healthcare cost savings.
CONCLUSIONS: ADRs associated with oral WHO AWaRe Watch antibiotics represent an important and potentially avoidable economic burden. Optimized prescribing practices and strengthened antimicrobial stewardship strategies targeting Watch-category antibiotics may reduce ADR occurrence and improve healthcare resource utilization. Integrating pharmacovigilance data with economic modeling may support safer and more cost-effective antibiotic use.