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WHO essential medicines for children 2011-2019: age-appropriateness of enteral formulations
Ebiowei Samuel F Orubu1, Jennifer Duncan2, Catherine Tuleu3
1Biomedical Engineering, Boston University, Boston, Massachusetts, USA sforubu@bu.edu.
Insights
Most essential enteral medicines on the WHO Essential Medicine List for children (EMLc) are not age-appropriate for young children. This lack of age-appropriate formulations requires manipulation, potentially impacting medicine safety and efficacy.
Area of Science:
- Pediatric Pharmacology
- Pharmaceutical Sciences
- Public Health
Background:
- The World Health Organization Essential Medicine List for children (EMLc) aims to improve access to essential medicines for pediatric populations.
- Age-appropriateness of enteral formulations is critical for safe and effective pediatric dosing, considering factors like swallowability and dose adaptability.
- There is limited data on the age-appropriateness of enteral medicines listed in the EMLc.
Purpose of the Study:
- To evaluate the age-appropriateness of enteral (oral and rectal) formulations included in the WHO Essential Medicine List for children (EMLc).
Main Methods:
- Assessed age-appropriateness of enteral formulations from the 3rd to 7th editions (2011-2019) of the EMLc for children under 12 years.
- Stratified children into five age groups and evaluated formulations based on swallowability and dose adaptability.
Main Results:
- Enteral formulations were generally more age-appropriate for older children (6-11 years) than for younger age groups.
- For younger children, age-appropriateness decreased significantly with decreasing age, with only 15% of formulations suitable for neonates (0-27 days).
- Formulations for specific diseases like HIV and tuberculosis showed higher age-appropriateness in the 7th edition.
Conclusions:
- A majority of recommended enteral essential medicines in the EMLc (2011 and 2019) are not age-appropriate for children under six years old.
- Non-age-appropriate formulations necessitate manipulation, potentially compromising medicine safety and efficacy.
- Evaluating formulation age-appropriateness for EMLc inclusion can enhance future access to suitable pediatric medicines.
Introduction:
The WHO Essential Medicine List for children (EMLc) is used for promoting access to medicines. The age-appropriateness of enteral (oral and rectal) formulations for children depend on their adaptability/flexibility to allow age-related or weight-related doses to be administered/prescribed and the child's ability to swallow, as appropriate. There is scant information on the age-appropriateness of essential enteral medicines for children.
Objective:
To evaluate the age-appropriateness of enteral essential medicines.
Materials And Methods:
Age-appropriateness of all enteral formulations indicated and recommended in the EMLc 3rd to 7th (2011-2019) editions were determined by assessing swallowability and/or dose adaptability for children under 12 years, stratified into five age groups.
Results:
Enteral formulations in the EMLc were more age-appropriate for older children aged 6-11 years than for younger children. In the 3rd edition, for older children, 77%, n=342, of formulations were age-appropriate. For younger children, age-appropriateness decreased with age group: 34% in those aged 3-5 years, 30% in those aged 1-2 years, 22% among those aged 28 days to 11 months and 15% in those aged 0-27 days. Overall, similar proportions were found for the 7th edition. In contrast, the majority of medicines in the 7th list were age-appropriate in targeted diseases like HIV and tuberculosis.
Conclusion:
Most recommended enteral essential medicines in EMLc 2011 and 2019 were not age-appropriate for children <6 years. Medicines which are not age-appropriate must be manipulated before administration, leading to potential issues of safety and efficacy. Evaluation of the age-appropriateness of formulations for medicines to be included in EMLc could improve access to better medicines for children in the future.
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