The World Health Organization (WHO) compiles and disseminates the WHO Essential Medicines List for children (EMLc) to guide the selection of medicines for use in children ages 0 to 12. Essential medications are defined as those necessary to prevent, treat, or manage the most prevalent diseases in a population. The EMLc is an important tool; for most low- and middle-income countries, the list serves as a template for national drug formularies. But a study published in Archives of Diseases in Childhood documents that most essential enteral medications listed in both the 2011 and 2019 EMLc couldn’t be considered age-appropriate for children under age 6.
The study sought to determine the appropriateness of all enteral formulations on the EMLc by assessing two important characteristics: swallowability and dose adaptability. Researchers defined age-appropriate formulations as ones which “a child of a specified age or age-group would have the natural ability to use (either directly or indirectly) without the product having to be altered from its original presentation before administration.” Two pharmacists evaluated each of the recommended medications for each of the five age-groups under age 12 and ranked them as 1 (not age-appropriate), 2 (possibly age-appropriate), or 3 (age-appropriate) for those two characteristics.
When assessing swallowing ability, they used certain criteria to gain consistency in their evaluations:
Liquids, oral powders/granules, dispersible tablets: appropriate from birth, with dose volumes under 10 mL being acceptable under age 5
Crushed tablets, sprinkle capsules: appropriate from age 6 months, or the age at which a child can swallow solids
Chewable tablets, dispersible tablets: appropriate from age 2, or the age at which a child can safely chew and swallow tablets
Conventional tablets and capsules: not appropriate for those under age 5; children this age are incapable of swallowing the medication safely
Effervescent tablets: not appropriate for those under age 5, because of the need for large volumes, typically in excess of 100 to 200 mL.
To examine dose adaptability, the evaluators compared the recommended doses in mg/kg body weight or mg/m2 BSA for each essential medicine, as given in the WHO formulary, to the mean body weight or BSA for each age-group. They determined whether the volume of a liquid or size/amount of a solid form was appropriate to deliver the recommended dose to a given age-group.
The evaluation found that, in the 2011 edition of the EMLc, 77% of formulations were appropriate for older children (older than age 6). But for younger children, those percentages dropped: 34% were age-appropriate for preschoolers (ages 3 to 5), 30% were age-appropriate for toddlers (ages 1 to 2), 22% were age-appropriate for infants (ages 28 days to 11 months), and 15% were age-appropriate for neonates (ages 0 to 27 days). Overall, these proportions held true for EMLc 2019. The researchers further found that 55% of the active pharmaceutical ingredients were available in a variety of formulations that resulted in the drug being appropriate for all age-groups and that at least 47% had, at the minimum, one formulation (usually an oral liquid) that was considered appropriate for all age groups. But in practice, especially in low-income countries, the whole range of formulations aren’t readily commercially available. For example, only 33% of drugs on the 2011 EMLc were available in Nigeria in formulations suitable for younger children, significantly lower than the 52% to 57% availability seen in countries like the United States, the United Kingdom, and France.
Going forward, all formulations included in the EMLc should be assessed for age-appropriateness, and that assessment should be a guide to development of new products or alternative administration strategies. Ensuring that age-appropriate formulations are actually available can help support decisions and strategies intended to provide access to essential medicines. (Orubu, E. S., Duncan, J., et al. (2022). WHO essential medicines for children 2011-2019: Age-appropriateness of enteral formulations. Arch Dis Child, 107, 317–322. Retrieved March 2022 from https://adc.bmj.com/content/107/4/317)
Released: April 2022
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