Data_Sheet_3_Surveillance of Resistance to New Antibiotics in an Era of Limited Treatment Options.docx

As with any health threat, our ability to respond to the emergence and spread of antimicrobial resistance depends on our ability to understand the scale of the problem, magnitude, geographical spread, and trends over time. This is especially true for resistance emergence to newer antibiotics coming to the market as last-resort treatments. Yet current antibiotic surveillance systems are limited to monitoring resistance to commonly prescribed drugs that have been on the market for a long time. This qualitative study determined the essential elements and requirements of antimicrobial resistance surveillance for new antibiotics based on literature review, interviews and expert consensus. After an extensive mapping exercise, 10 experts participated in a modified Delphi consultation to identify consensus on all elements required for surveillance of resistance to novel antibiotics. The main findings indicate that there is a need for a two-phase system; an early alert system transitioning to routine surveillance, led by the public sector to gather and share essential data on resistance to newer antibiotics in a transparent manner. The system should be decentralized, run largely from national level, but be coordinated by an arm of an existing international public health institution. Priority should be given to monitoring emergence of resistance among already multi-drug resistant pathogens causing infections, over a broader selection of pathogens to maximize clinical impact. In conclusion, we cannot rely on current AMR surveillance systems to monitor resistance emergence to new antibiotics. A new, public system should be set-up, starting with a focus on detecting resistance emergence, but expanding to a more comprehensive surveillance as soon as there is regional spread of resistance to the new antibiotic. This article provides a framework based on expert agreement, which could guide future initiatives.

鉴于任何健康威胁，我们应对抗微生物耐药性出现及传播的能力，依赖于我们理解问题规模、强度、地理分布以及随时间推移的趋势。对于市场中新出现的、作为最后手段治疗的抗生素产生的耐药性，这一点尤为重要。然而，现行的抗生素监测系统仅限于对已在市场上长期存在的常见药物耐药性的监测。本研究通过文献综述、访谈和专家共识，确定了针对新抗生素抗微生物耐药性监测的基本要素和需求。经过广泛的映射练习后，10位专家参与了改进的德尔菲咨询，以确定对新型抗生素耐药性监测所需所有要素的共识。主要发现表明，有必要建立一个两阶段系统；一个早期警报系统过渡到常规监测，由公共部门主导，以透明的方式收集和共享关于新抗生素耐药性的关键数据。该系统应实行地方化，主要从国家层面运行，但需由现有国际公共卫生机构的一个部门进行协调。应优先监测对多重耐药病原体（引起感染）的耐药性出现，覆盖更广泛的病原体选择，以最大化临床影响。总之，我们无法依赖当前的抗微生物耐药性监测系统来监测新抗生素的耐药性出现。应建立一个新的公共系统，首先集中于检测耐药性出现，一旦新抗生素的耐药性在地区范围内扩散，便扩展到更全面的监测。本文提供了一个基于专家共识的框架，可指导未来的行动计划。