Encouraging AWaRe-ness and discouraging inappropriate antibiotic use—the new 2019 Essential Medicines List becomes a global antibiotic stewardship tool

The AWaRe groups are now explicitly linked to the WHO Priority Pathogens List.7 New antibiotics eligible for the Reserve category must be active, at least in vitro, against organisms of critical or high priority on the Priority Pathogens list.7 Fourth-generation cephalosporins in the AWaRe list were reclassified from the Reserve group to the Watch group, but were removed from the EML as they were not recommended by the Expert Committee as first-choice or second-choice therapies in any of 26 infectious syndromes reviewed.4,8 Similarly, other antibiotics such as aztreonam, ceftaroline, daptomycin, and tigecycline were removed because they were not deemed to be of sufficiently high priority for multidrug-resistant infections (aztreonam and tigecycline), because of safety concerns (eg, tigecycline has a black-box warning from the US Food and Drug Administration), or because EML-listed alternatives were available, such as linezolid for meticillin-resistant Staphylococcus aureus and vancomycin-resistant enterococci (ceftaroline and daptomycin). Recognising the need to stop the inappropriate use of antibiotics, the EML Committee recommended that WHO add a group to the AWaRe classification tool for antibiotics that are not used on the basis of sound evidence or recommended in high-quality international guidelines, particularly for fixed-dose combinations of multiple broad-spectrum antibiotics. The EML Committee noted that there was “very limited clinical trial evidence” comparing the efficacy of the newly added antibiotics against infections caused by carbapenem-resistant bacteria and their approval was based on small individual clinical studies.4 The Committee was very concerned that the current regulatory approval process for new drugs targeting the Critical group of the Priority Pathogens does not adequately meet the major public health need for clear evidence-based guidance on the optimal management of carbapenem-resistant infections.