A pharmacist-led educational and audit & feedback strategy to reduce antibiotic prescription in primary care: the AFA study.

Introduction: The increasing emergence of bacteria resistant to antibiotic treatments has become a global public health concern and one of the leading causes of death worldwide. This growing threat demands urgent and coordinated action from health systems across the globe. A key driver of antimicrobial resistance is the inappropriate and excessive use of antibiotics, which accelerates the development of resistant strains. At the same time, the lack of new antibiotics in development exacerbates the crisis. In this context, promoting the appropriate and prudent use of antibiotics is essential to limit the emergence and spread of resistance.

Methods: A randomized, multicentre, parallel-group clinical trial with a hybrid type I (effectiveness-implementation) design to reduce antibiotic prescriptions in primary care. General practitioners from three regional health systems in Spain will be randomly assigned (1:1) to an intervention or active control group. The intervention includes a monthly Audit & Feedback report, pharmacist-led consultations, clinical messages, patient information sheets, and an online training module. The primary outcome is the rate of antibiotic prescriptions per 100 patient visits at 12-month follow-up. Implementation outcomes will be assessed using the RE-AIM framework. All analyses will follow the intention-to-treat principle.

Ethics and dissemination: The study was approved by the Balearic island, Valencia and IDIAP Jordi Gol Ethical Committee, follows the Declaration of Helsinki, Good Clinical Practice guidelines, and applicable national and European regulations concerning clinical trials and data protection.

Trial registration: ISRCTN11175879, registration date: 11/12/2024.