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Are age-appropriate antibiotic formulations missing from the WHO list of essential medicines for children? A
Verica Ivanovska1,2, Hubert G Leufkens1,3, Carin Ma Rademaker4
1Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.
Insights
This study identified additional pediatric antibiotic formulations beyond the WHO Essential Medicines List for Children (EMLc). These formulations offer improved administration and dosing accuracy, crucial for children in diverse settings.
Area of Science:
- Pediatric Pharmacology
- Global Health
- Antimicrobial Stewardship
Background:
- Global demand for child-appropriate antibiotic formulations is high.
- Paediatric antibiotics are a key public health concern.
- Existing Essential Medicines List for Children (EMLc) may lack optimal formulations.
Purpose of the Study:
- Identify clinically relevant paediatric antibiotic formulations not on the EMLc.
- Evaluate the added clinical value and costs of these formulations.
Main Methods:
- Compared four medicines lists against the EMLc.
- Analyzed paediatric antibiotic formulations by administration route, dosage form, and strength.
- Assessed clinical benefits and costs of additional formulations.
Main Results:
- Seven oral and two parenteral formulations were deemed clinically relevant.
- Oral formulations addressed unmet needs and offered administration/supply advantages.
- Specific injectable formulations could simplify neonatal/infant dosing but target narrow groups.
Conclusions:
- Additional paediatric antibiotic formulations offer benefits for low-resource settings.
- Simplified administration and improved dosing accuracy are key advantages.
- Procurement and management complexities of multiple formulations require consideration.
Objective:
There is a global call for formulations, which are better suited for children of different age categories and in a variety of settings. One key public health area of interest is age-appropriate paediatric antibiotics. We aimed to identify clinically relevant paediatric formulations of antibiotics listed on pertinent formularies that were not on the WHO Essential Medicines List for Children (EMLc).
Methods:
We compared four medicines lists versus the EMLc and contrasted paediatric antibiotic formulations in relation to administration routes, dosage forms and/or drug strengths. The additional formulations on comparator lists that differed from the EMLc formulations were evaluated for their added clinical values and costs.
Results:
The analysis was based on 26 EMLc antibiotics. Seven oral and two parenteral formulations were considered clinically relevant for paediatric use. Frequently quoted benefits of oral formulations included: filling the gap of unmet therapeutic needs in certain age/weight groups (phenoxymethylpenicillin and metronidazole oral liquids, and nitrofurantoin capsules), and simplified administration and supply advantages (amoxicillin dispersible tablets, clyndamycin capsules, cloxacillin tablets, and sulfamethoxazole+trimethoprim tablets). Lower doses of ampicillin and cefazolin powder for injection could simplify the dosing in newborns and infants, reduce the risk of medical errors, and decrease the waste of medicines, but may target only narrow age/weight groups.
Conclusions:
The identified additional formulations of paediatric antibiotics on comparator lists may offer clinical benefits for low-resource settings, including simplified administration and increased dosing accuracy. The complexity of both procuring and managing multiple strengths and formulations also needs to be considered.