A Landscaping Assessment and Call-to-Action to Improve Access to Novel Reserve Antibiotics in 14 Low- and Middle-Income Countries.

Background: Antimicrobial resistance (AMR) presents a significant global mortality burden which particularly affects the low- and middle-income countries (LMICs). Enhancing diagnostics to identify drug-resistant infections and improving appropriate access to novel Reserve antibiotics in LMICs can address AMR-related morbidity, mortality and healthcare costs. This article characterizes the AMR landscape across 14 LMICs and describes an introductory pathway for novel Reserve antibiotics. Methods: This mixed-method study was completed in 14 LMICs in Africa, the Americas, Asia and Europe through a combination of qualitative interviews with physicians and public health experts (PHEs), and a quantitative survey of physicians, supported by an assessment of secondary materials relating to antibiotic introduction and AMR burden. Results: A total of 54 physicians and 17 PHEs were interviewed, and 209 physicians participated in the survey. Top unmet needs across public and private settings were as follows: access to new antibiotics to better manage drug-resistant infections; affordability; adequate safety profile for prescribed antibiotics. Access to diagnostics and antibiotic susceptibility testing was noted as a barrier, with large tertiary and private centres experiencing better access. Implementation of antibiotic stewardship programmes was variable and limited by insufficient funding, shortage of infectious disease physicians, poor AMR education and lack of restrictions to limit antibiotic use. Antibiotic access varies by sector, centre type, location and strength of individual state procurement systems. In particular, private sector facilities have better access to Reserve products. In most countries, most Reserve antibiotics included in WHO's Essential Medicines List (EML) were not included in national EMLs or not registered in countries. Conclusion: This study has helped to identify common barriers and pathways to Reserve antibiotic access, irrespective of the level of preparedness of countries. The data offer insights into possible solutions to improve access and highlight opportunities to strengthen access pathways and expedite access, for example, by identifying priority antibiotics based on national public health need. A six-step introductory pathway for novel Reserve antibiotics is described.