Catherine Litalien1, Julie Autmizguine2, Antoine Carli3, Denis Giroux3, Denis Lebel4, Jean-Marie Leclerc5, Yves Théorêt6, Andrea Gilpin7, Sophie Bérubé3. 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. 2. , MD, FRCPC, MSc, 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. 3. , BPharm, MSc, is with the Rosalind & Morris Goodman Family Pediatric Formulations Centre of the CHU Sainte-Justine, Montréal, Quebec. 4. , BPharm, MSc, FCSHP, is with the Rosalind & Morris Goodman Family Pediatric Formulations Centre and the Department of Pharmacy, CHU Sainte-Justine, Montréal, Quebec. 5. , MD, FRCPC, is with the Rosalind & Morris Goodman Family Pediatric Formulations Centre and the Department of Medical Biology of the CHU Sainte-Justine, Montréal, Quebec. He is also with the Department of Pediatrics, Université de Montréal, Montréal, Quebec. 6. ê, BPharm, PhD, 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. He is also with the Department of Pharmacology and Physiology, Université de Montréal, Montréal, Quebec. 7. , PhD, is with the Rosalind & Morris Goodman Family Pediatric Formulations Centre of the CHU Sainte-Justine, Montréal, Quebec.
Abstract
BACKGROUND: Many medications given to children have no commercially available, age-appropriate formulations. This leads to manipulation of dosage forms designed for adults (compounding), which can result in an increased risk of dosing errors and adverse events, lack of medication adherence because of taste issues, and suboptimal dosing with therapeutic failure. OBJECTIVES: To determine which drugs required compounding for oral administration to children in a Canadian hospital and, for each compounded drug, to determine whether it was available as licensed oral pediatric formulations in the United States or the European Union. METHODS: Drugs requiring compounded liquid formulations for oral administration, dispensed from January 1 to December 31, 2015, at a Canadian university-affiliated tertiary pediatric hospital, and prepared in a quantity exceeding 0.5 L per year, were retrospectively identified. The online drug databases of Health Canada, the US Food and Drug Administration, the European Medicines Agency (EMA), and the UK Medicines and Healthcare Products Regulatory Agency were searched to determine the availability of child-friendly oral formulations for these drugs. The regulatory status in each jurisdiction was also compared. For licensed formulations with potential concerns about excipient safety, EMA guidelines for sorbitol, propylene glycol, ethanol, and sodium benzoate were used to determine pediatric suitability. RESULTS: Of the 56 compounded drugs investigated, 27 (48%) had a suitable commercialized child-friendly formulation available outside Canada. Overall, these drugs had been on the Canadian market for a median of 35 years, and almost half (27 [48%]) had a pediatric indication in Canada. CONCLUSIONS: Canada is lagging behind the United States and the European Union in ensuring availability of and access to suitable pediatric formulations. Potential explanations for this gap include small market size, regulatory uncertainties, and reimbursement shortcomings. Steps must be taken to implement pediatric-sensitive regulations and incentives, as well as reimbursement policies, to address these unmet needs. 2020 Canadian Society of Hospital Pharmacists. All content in the Canadian Journal of Hospital Pharmacy is copyrighted by the Canadian Society of Hospital Pharmacy. In submitting their manuscripts, the authors transfer, assign, and otherwise convey all copyright ownership to CSHP.
BACKGROUND: Many medications given to children have no commercially available, age-appropriate formulations. This leads to manipulation of dosage forms designed for adults (compounding), which can result in an increased risk of dosing errors and adverse events, lack of medication adherence because of taste issues, and suboptimal dosing with therapeutic failure. OBJECTIVES: To determine which drugs required compounding for oral administration to children in a Canadian hospital and, for each compounded drug, to determine whether it was available as licensed oral pediatric formulations in the United States or the European Union. METHODS: Drugs requiring compounded liquid formulations for oral administration, dispensed from January 1 to December 31, 2015, at a Canadian university-affiliated tertiary pediatric hospital, and prepared in a quantity exceeding 0.5 L per year, were retrospectively identified. The online drug databases of Health Canada, the US Food and Drug Administration, the European Medicines Agency (EMA), and the UK Medicines and Healthcare Products Regulatory Agency were searched to determine the availability of child-friendly oral formulations for these drugs. The regulatory status in each jurisdiction was also compared. For licensed formulations with potential concerns about excipient safety, EMA guidelines for sorbitol, propylene glycol, ethanol, and sodium benzoate were used to determine pediatric suitability. RESULTS: Of the 56 compounded drugs investigated, 27 (48%) had a suitable commercialized child-friendly formulation available outside Canada. Overall, these drugs had been on the Canadian market for a median of 35 years, and almost half (27 [48%]) had a pediatric indication in Canada. CONCLUSIONS: Canada is lagging behind the United States and the European Union in ensuring availability of and access to suitable pediatric formulations. Potential explanations for this gap include small market size, regulatory uncertainties, and reimbursement shortcomings. Steps must be taken to implement pediatric-sensitive regulations and incentives, as well as reimbursement policies, to address these unmet needs. 2020 Canadian Society of Hospital Pharmacists. All content in the Canadian Journal of Hospital Pharmacy is copyrighted by the Canadian Society of Hospital Pharmacy. In submitting their manuscripts, the authors transfer, assign, and otherwise convey all copyright ownership to CSHP.
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