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Published on: October 17, 2019
Essential and forgotten antibiotics: An inventory in low- and middle-income countries
Gianpiero Tebano1, Grace Li2, Bojana Beovic3
1Department 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.
Background:
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.
Objective:
To investigate which WHO-EML 'access' and 'forgotten' antibiotics are approved at national level in a sample of low- to middle-income countries (LMICs).
Methods:
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.
Results:
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.
Conclusions:
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.
Insights
Essential antibiotics from the World Health Organization list are widely approved in low- and middle-income countries. However, many valuable
Area of Science:
- Global health
- Infectious disease management
- Pharmaceutical policy
Background:
- The World Health Organization Essential Medicines List (WHO-EML) identifies crucial 'access' antibiotics for common infections.
- A separate category of 'forgotten' antibiotics, often older and off-patent, holds significant value for specific indications.
- Antimicrobial stewardship programs highlight the importance of both essential and specialized antibiotic classes.
Purpose of the Study:
- To determine the national approval status of WHO-EML 'access' and 'forgotten' antibiotics in selected low- and middle-income countries (LMICs).
- To assess the availability of specific antibiotic formulations, including paediatric options, within these countries.
Main Methods:
- A consensus procedure identified 26 WHO-EML 'access' and 15 'forgotten' antibiotics for evaluation.
- An internet-based survey was distributed to representatives in 40 LMICs, with 28 countries participating.
- Antibiotic approval was defined by licensing from official drug regulatory agencies or national ministries of health.
Main Results:
- Nine WHO-EML 'access' antibiotics were approved in all surveyed countries, and all 26 'access' antibiotics were approved in over two-thirds of them.
- Conversely, only one of the 15 'forgotten' antibiotics was approved in more than two-thirds of the countries.
- Six common paediatric antibiotic formulations were approved in over two-thirds of the surveyed LMICs.
Conclusions:
- WHO-EML 'access' antibiotics and essential paediatric formulations are predominantly approved in the surveyed LMICs.
- Many 'forgotten' antibiotics, vital for combating multi-drug-resistant bacteria, lack widespread national approval.
- This disparity highlights potential gaps in access to critical, albeit specialized, antimicrobial agents in LMICs.
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