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Providing Suitable Pediatric Formulations for Canadian Children: A Call for Action.

Catherine Litalien1, Julie Autmizguine2, Antoine Carli3

  • 1, MD, FRCPC, is with the Rosalind & Morris Goodman Family Pediatric Formulations Centre, the Department of Medical Biology, and the Research Centre of the CHU Sainte-Justine, Montréal, Quebec. She is also with the Department of Pediatrics and the Department of Pharmacology and Physiology, Université de Montréal, Montréal, Quebec.

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Canada lags in providing age-appropriate pediatric drug formulations, with nearly half of compounded medications available elsewhere. This highlights a critical need for improved pediatric drug availability and access in Canada.

Keywords:
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Area of Science:

  • Pediatric Pharmacology
  • Drug Formulation Science
  • Regulatory Affairs

Background:

  • Many medications for children lack commercially available, age-appropriate formulations.
  • This necessitates compounding, increasing risks of dosing errors, adverse events, and poor adherence.
  • Taste issues and suboptimal dosing can lead to therapeutic failure in pediatric patients.

Purpose of the Study:

  • To identify drugs requiring compounding for pediatric oral administration in a Canadian hospital.
  • To assess the availability of licensed pediatric oral formulations for these drugs in the US and EU.
  • To compare regulatory status and excipient safety of available formulations.

Main Methods:

  • Retrospective analysis of compounded liquid oral medications dispensed in 2015 at a Canadian pediatric hospital.
  • Searched Health Canada, FDA, EMA, and UK MHRA databases for licensed pediatric formulations.
  • Evaluated excipient safety based on EMA guidelines for specific ingredients.

Main Results:

  • Of 56 compounded drugs, 27 (48%) had suitable child-friendly formulations available outside Canada.
  • These drugs had been on the Canadian market for a median of 35 years.
  • Nearly half (48%) of the compounded drugs had a documented pediatric indication in Canada.

Conclusions:

  • Canada demonstrates a significant lag in providing accessible, age-appropriate pediatric drug formulations compared to the US and EU.
  • Factors contributing to this gap include small market size, regulatory hurdles, and inadequate reimbursement policies.
  • Urgent implementation of pediatric-sensitive regulations, incentives, and reimbursement strategies is required to address these unmet needs.