Department of Infectious Diseases, Pitié-Salpêtrière Hospital, AP-PH, Paris, France; Sorbonne University, UPMC Univ Paris 06, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique (IPLESP UMRS 1136), Paris, France.
Paediatric Infectious Diseases Research Group, St George's University of London, London, UK.
Int J Antimicrob Agents. 2019 Sep;54(3):273-282. doi: 10.1016/j.ijantimicag.2019.06.017. Epub 2019 Jun 28.
The World Health Organization Essential Medicines List (WHO-EML) includes 'access' antibiotics, judged essential to treat common infections. The European Society of Clinical Microbiology and Infectious Diseases Study Group for Antimicrobial Stewardship defined a list of 'forgotten' antibiotics, some old and often off-patent antibiotics, which have particular value for specific indications.
To investigate which WHO-EML 'access' and 'forgotten' antibiotics are approved at national level in a sample of low- to middle-income countries (LMICs).
The Scientific Committee used a consensus procedure to select 26 WHO-EML 'access' and 15 'forgotten' antibiotics. Paediatric formulations were explored for 14 antibiotics. An internet-based questionnaire was circulated to 40 LMIC representatives. Antibiotics were defined as approved if an official drug regulatory agency and/or the national ministry of health licensed their use, making them, at least theoretically, available on the market.
Twenty-eight LMICs (11 in Africa, 11 in Asia and six in America) were surveyed. Nine WHO-EML 'access' antibiotics (amoxicillin, ampicillin, benzylpenicillin, ceftriaxone, clarithromycin, ciprofloxacin, doxycycline, gentamicin and metronidazole) were approved in all countries, and all 26 'access' antibiotics were approved in more than two-thirds of countries. Among the 15 'forgotten' antibiotics, only one was approved in more than two-thirds of countries. The median number of approved antibiotics per country was 30 (interquartile range 23-35). Six of 14 paediatric formulations (amoxicillin, amoxicillin-clavulanic acid, oral antistaphylococcal penicillin, cotrimoxazole, erythromycin and metronidazole) were approved in more than two-thirds of countries.
WHO-EML 'access' antibiotics and the most frequently used formulations for paediatrics were approved in the vast majority of the 28 surveyed LMICs. This was not the case for many of the 'forgotten' antibiotics, despite their important role, particularly in areas with high prevalence of multi-drug-resistant bacteria.
世界卫生组织基本药物清单（WHO-EML）包括被认为对治疗常见感染至关重要的“可获得”抗生素。欧洲临床微生物学和传染病学会抗菌药物管理研究组定义了一系列“被遗忘”的抗生素，其中一些是旧的、经常是专利过期的抗生素，对于特定适应症具有特殊价值。
调查在一组中低收入国家（LMICs）中，WHO-EML 的“可获得”和“被遗忘”抗生素中有哪些在国家层面获得批准。
科学委员会采用共识程序选择了 26 种 WHO-EML“可获得”和 15 种“被遗忘”抗生素。为 14 种抗生素探索了儿科制剂。向 40 个 LMIC 代表分发了一份基于互联网的问卷。如果官方药品监管机构和/或国家卫生部批准了抗生素的使用，那么就将其定义为批准，这至少在理论上使它们在市场上可用。
对 28 个 LMIC 进行了调查（11 个在非洲，11 个在亚洲，6 个在美洲）。9 种 WHO-EML“可获得”抗生素（阿莫西林、氨苄西林、苄青霉素、头孢曲松、克拉霉素、环丙沙星、强力霉素、庆大霉素和甲硝唑）在所有国家均获得批准，26 种“可获得”抗生素在三分之二以上的国家获得批准。在 15 种“被遗忘”抗生素中，只有一种在三分之二以上的国家获得批准。每个国家批准的抗生素数量中位数为 30 种（四分位距 23-35）。14 种儿科制剂中有 6 种（阿莫西林、阿莫西林-克拉维酸、口服抗葡萄球菌青霉素、复方磺胺甲噁唑、红霉素和甲硝唑）在三分之二以上的国家获得批准。
在调查的 28 个 LMIC 中，WHO-EML“可获得”抗生素和最常用于儿科的制剂在绝大多数国家获得批准。然而，许多“被遗忘”的抗生素并非如此，尽管它们具有重要作用，特别是在多药耐药菌流行率高的地区。
