ArticleCMAJ open
Pediatric drug data in Canadian drug monographs: a descriptive analysis.
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Article in CMAJ open. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.
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Who cites it
5 citing papers in PubMed, 7 citations in OpenAlex.
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- Reforming Paediatric Drug Regulations in Canada: A Clinical and an Access Imperative.Healthcare policy = Politiques de sante · 2023Article
- Drug Prescriptions Requiring Compounding at a Canadian University Affiliated Pediatric Hospital: A Cross-Sectional Study.Children (Basel, Switzerland) · 2023Article
- High-Cost Drug Policies in Canadian Children's Hospitals: An Exploratory Study.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2023Article
- Time for a regulatory framework for pediatric medications in Canada.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2022Article
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Authors and funding
10 authors at 4 institutions in 3 countries.
Preeya RajaDepartment of Pharmacy (Raja), Hamilton Health Sciences; Departments of Pediatrics (Duffett), and Health Research Methods, Evidence, and Impact (Duffett), McMaster University, Hamilton, Ont.; Department of Emergency Medicine (Mazer-Amirshahi), MedStar Washington Hospital Center, Washington, DC; Faculty of Health Sciences (Patel), McMaster University, Hamilton, Ont.; The Rosalind & Morris Goodman Family Pediatric Formulations Centre of the Sainte-Justine University Hospital Center (Gilpin, Litalien), Montréal, Que.; Division of Pediatric Hematology/Oncology (Chan), McMaster Children's Hospital, McMaster University, Hamilton, Ont.; Division of Clinical Pharmacology (van den Anker), Department of Pediatrics, Children's National Health System, Washington, DC; Division of Paediatric Pharmacology and Pharmacometrics (van den Anker), University of Basel Children's Hospital, Basel, Switzerland; Division of Neonatology (Lacaze-Masmonteil), Department of Pediatrics, University of Calgary, Alberta Children's Hospital, Calgary, Alta.; Division of Neonatology (Samiee-Zafarghandy), Department of Pediatrics, McMaster Children's Hospital, McMaster University, Hamilton, Ont.
Mark DuffettDepartment of Pharmacy (Raja), Hamilton Health Sciences; Departments of Pediatrics (Duffett), and Health Research Methods, Evidence, and Impact (Duffett), McMaster University, Hamilton, Ont.; Department of Emergency Medicine (Mazer-Amirshahi), MedStar Washington Hospital Center, Washington, DC; Faculty of Health Sciences (Patel), McMaster University, Hamilton, Ont.; The Rosalind & Morris Goodman Family Pediatric Formulations Centre of the Sainte-Justine University Hospital Center (Gilpin, Litalien), Montréal, Que.; Division of Pediatric Hematology/Oncology (Chan), McMaster Children's Hospital, McMaster University, Hamilton, Ont.; Division of Clinical Pharmacology (van den Anker), Department of Pediatrics, Children's National Health System, Washington, DC; Division of Paediatric Pharmacology and Pharmacometrics (van den Anker), University of Basel Children's Hospital, Basel, Switzerland; Division of Neonatology (Lacaze-Masmonteil), Department of Pediatrics, University of Calgary, Alberta Children's Hospital, Calgary, Alta.; Division of Neonatology (Samiee-Zafarghandy), Department of Pediatrics, McMaster Children's Hospital, McMaster University, Hamilton, Ont.
Maryann Mazer-AmirshahiDepartment of Pharmacy (Raja), Hamilton Health Sciences; Departments of Pediatrics (Duffett), and Health Research Methods, Evidence, and Impact (Duffett), McMaster University, Hamilton, Ont.; Department of Emergency Medicine (Mazer-Amirshahi), MedStar Washington Hospital Center, Washington, DC; Faculty of Health Sciences (Patel), McMaster University, Hamilton, Ont.; The Rosalind & Morris Goodman Family Pediatric Formulations Centre of the Sainte-Justine University Hospital Center (Gilpin, Litalien), Montréal, Que.; Division of Pediatric Hematology/Oncology (Chan), McMaster Children's Hospital, McMaster University, Hamilton, Ont.; Division of Clinical Pharmacology (van den Anker), Department of Pediatrics, Children's National Health System, Washington, DC; Division of Paediatric Pharmacology and Pharmacometrics (van den Anker), University of Basel Children's Hospital, Basel, Switzerland; Division of Neonatology (Lacaze-Masmonteil), Department of Pediatrics, University of Calgary, Alberta Children's Hospital, Calgary, Alta.; Division of Neonatology (Samiee-Zafarghandy), Department of Pediatrics, McMaster Children's Hospital, McMaster University, Hamilton, Ont.
Ashaka PatelDepartment of Pharmacy (Raja), Hamilton Health Sciences; Departments of Pediatrics (Duffett), and Health Research Methods, Evidence, and Impact (Duffett), McMaster University, Hamilton, Ont.; Department of Emergency Medicine (Mazer-Amirshahi), MedStar Washington Hospital Center, Washington, DC; Faculty of Health Sciences (Patel), McMaster University, Hamilton, Ont.; The Rosalind & Morris Goodman Family Pediatric Formulations Centre of the Sainte-Justine University Hospital Center (Gilpin, Litalien), Montréal, Que.; Division of Pediatric Hematology/Oncology (Chan), McMaster Children's Hospital, McMaster University, Hamilton, Ont.; Division of Clinical Pharmacology (van den Anker), Department of Pediatrics, Children's National Health System, Washington, DC; Division of Paediatric Pharmacology and Pharmacometrics (van den Anker), University of Basel Children's Hospital, Basel, Switzerland; Division of Neonatology (Lacaze-Masmonteil), Department of Pediatrics, University of Calgary, Alberta Children's Hospital, Calgary, Alta.; Division of Neonatology (Samiee-Zafarghandy), Department of Pediatrics, McMaster Children's Hospital, McMaster University, Hamilton, Ont.
Andrea GilpinDepartment of Pharmacy (Raja), Hamilton Health Sciences; Departments of Pediatrics (Duffett), and Health Research Methods, Evidence, and Impact (Duffett), McMaster University, Hamilton, Ont.; Department of Emergency Medicine (Mazer-Amirshahi), MedStar Washington Hospital Center, Washington, DC; Faculty of Health Sciences (Patel), McMaster University, Hamilton, Ont.; The Rosalind & Morris Goodman Family Pediatric Formulations Centre of the Sainte-Justine University Hospital Center (Gilpin, Litalien), Montréal, Que.; Division of Pediatric Hematology/Oncology (Chan), McMaster Children's Hospital, McMaster University, Hamilton, Ont.; Division of Clinical Pharmacology (van den Anker), Department of Pediatrics, Children's National Health System, Washington, DC; Division of Paediatric Pharmacology and Pharmacometrics (van den Anker), University of Basel Children's Hospital, Basel, Switzerland; Division of Neonatology (Lacaze-Masmonteil), Department of Pediatrics, University of Calgary, Alberta Children's Hospital, Calgary, Alta.; Division of Neonatology (Samiee-Zafarghandy), Department of Pediatrics, McMaster Children's Hospital, McMaster University, Hamilton, Ont.
Catherine LitalienDepartment of Pharmacy (Raja), Hamilton Health Sciences; Departments of Pediatrics (Duffett), and Health Research Methods, Evidence, and Impact (Duffett), McMaster University, Hamilton, Ont.; Department of Emergency Medicine (Mazer-Amirshahi), MedStar Washington Hospital Center, Washington, DC; Faculty of Health Sciences (Patel), McMaster University, Hamilton, Ont.; The Rosalind & Morris Goodman Family Pediatric Formulations Centre of the Sainte-Justine University Hospital Center (Gilpin, Litalien), Montréal, Que.; Division of Pediatric Hematology/Oncology (Chan), McMaster Children's Hospital, McMaster University, Hamilton, Ont.; Division of Clinical Pharmacology (van den Anker), Department of Pediatrics, Children's National Health System, Washington, DC; Division of Paediatric Pharmacology and Pharmacometrics (van den Anker), University of Basel Children's Hospital, Basel, Switzerland; Division of Neonatology (Lacaze-Masmonteil), Department of Pediatrics, University of Calgary, Alberta Children's Hospital, Calgary, Alta.; Division of Neonatology (Samiee-Zafarghandy), Department of Pediatrics, McMaster Children's Hospital, McMaster University, Hamilton, Ont.
Anthony K ChanDepartment of Pharmacy (Raja), Hamilton Health Sciences; Departments of Pediatrics (Duffett), and Health Research Methods, Evidence, and Impact (Duffett), McMaster University, Hamilton, Ont.; Department of Emergency Medicine (Mazer-Amirshahi), MedStar Washington Hospital Center, Washington, DC; Faculty of Health Sciences (Patel), McMaster University, Hamilton, Ont.; The Rosalind & Morris Goodman Family Pediatric Formulations Centre of the Sainte-Justine University Hospital Center (Gilpin, Litalien), Montréal, Que.; Division of Pediatric Hematology/Oncology (Chan), McMaster Children's Hospital, McMaster University, Hamilton, Ont.; Division of Clinical Pharmacology (van den Anker), Department of Pediatrics, Children's National Health System, Washington, DC; Division of Paediatric Pharmacology and Pharmacometrics (van den Anker), University of Basel Children's Hospital, Basel, Switzerland; Division of Neonatology (Lacaze-Masmonteil), Department of Pediatrics, University of Calgary, Alberta Children's Hospital, Calgary, Alta.; Division of Neonatology (Samiee-Zafarghandy), Department of Pediatrics, McMaster Children's Hospital, McMaster University, Hamilton, Ont.
John van den AnkerDepartment of Pharmacy (Raja), Hamilton Health Sciences; Departments of Pediatrics (Duffett), and Health Research Methods, Evidence, and Impact (Duffett), McMaster University, Hamilton, Ont.; Department of Emergency Medicine (Mazer-Amirshahi), MedStar Washington Hospital Center, Washington, DC; Faculty of Health Sciences (Patel), McMaster University, Hamilton, Ont.; The Rosalind & Morris Goodman Family Pediatric Formulations Centre of the Sainte-Justine University Hospital Center (Gilpin, Litalien), Montréal, Que.; Division of Pediatric Hematology/Oncology (Chan), McMaster Children's Hospital, McMaster University, Hamilton, Ont.; Division of Clinical Pharmacology (van den Anker), Department of Pediatrics, Children's National Health System, Washington, DC; Division of Paediatric Pharmacology and Pharmacometrics (van den Anker), University of Basel Children's Hospital, Basel, Switzerland; Division of Neonatology (Lacaze-Masmonteil), Department of Pediatrics, University of Calgary, Alberta Children's Hospital, Calgary, Alta.; Division of Neonatology (Samiee-Zafarghandy), Department of Pediatrics, McMaster Children's Hospital, McMaster University, Hamilton, Ont.
Thierry Lacaze-MasmonteilDepartment of Pharmacy (Raja), Hamilton Health Sciences; Departments of Pediatrics (Duffett), and Health Research Methods, Evidence, and Impact (Duffett), McMaster University, Hamilton, Ont.; Department of Emergency Medicine (Mazer-Amirshahi), MedStar Washington Hospital Center, Washington, DC; Faculty of Health Sciences (Patel), McMaster University, Hamilton, Ont.; The Rosalind & Morris Goodman Family Pediatric Formulations Centre of the Sainte-Justine University Hospital Center (Gilpin, Litalien), Montréal, Que.; Division of Pediatric Hematology/Oncology (Chan), McMaster Children's Hospital, McMaster University, Hamilton, Ont.; Division of Clinical Pharmacology (van den Anker), Department of Pediatrics, Children's National Health System, Washington, DC; Division of Paediatric Pharmacology and Pharmacometrics (van den Anker), University of Basel Children's Hospital, Basel, Switzerland; Division of Neonatology (Lacaze-Masmonteil), Department of Pediatrics, University of Calgary, Alberta Children's Hospital, Calgary, Alta.; Division of Neonatology (Samiee-Zafarghandy), Department of Pediatrics, McMaster Children's Hospital, McMaster University, Hamilton, Ont.
Samira Samiee-ZafarghandyDepartment of Pharmacy (Raja), Hamilton Health Sciences; Departments of Pediatrics (Duffett), and Health Research Methods, Evidence, and Impact (Duffett), McMaster University, Hamilton, Ont.; Department of Emergency Medicine (Mazer-Amirshahi), MedStar Washington Hospital Center, Washington, DC; Faculty of Health Sciences (Patel), McMaster University, Hamilton, Ont.; The Rosalind & Morris Goodman Family Pediatric Formulations Centre of the Sainte-Justine University Hospital Center (Gilpin, Litalien), Montréal, Que.; Division of Pediatric Hematology/Oncology (Chan), McMaster Children's Hospital, McMaster University, Hamilton, Ont.; Division of Clinical Pharmacology (van den Anker), Department of Pediatrics, Children's National Health System, Washington, DC; Division of Paediatric Pharmacology and Pharmacometrics (van den Anker), University of Basel Children's Hospital, Basel, Switzerland; Division of Neonatology (Lacaze-Masmonteil), Department of Pediatrics, University of Calgary, Alberta Children's Hospital, Calgary, Alta.; Division of Neonatology (Samiee-Zafarghandy), Department of Pediatrics, McMaster Children's Hospital, McMaster University, Hamilton, Ont. samiees@mcmaster.ca.
Hamilton Health Sciences · CAUniversity Children’s Hospital Basel · CHChildren's National · USMedStar Washington Hospital Center · US
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundOptimal drug therapy in children relies on the availability of pediatric-specific information. We aimed to describe the current status of pediatric pharmacotherapy data in monographs of new drugs approved by Health Canada.
methodsIn this descriptive analysis, we reviewed the quality and quantity of monographs of new drugs approved by Health Canada between Jan. 1, 2007, and Dec. 31, 2016. We excluded drugs withdrawn from the Canadian market and drugs with primary indications irrelevant to pediatrics. We determined the percentage of included drug monographs that listed pediatric-specific information.
resultsDuring this study period, Health Canada approved 281 drugs, 270 of which met our inclusion criteria. Pediatric-specific information and indication were present in 127 (47.1%) and 75 (27.8%) of the drug monographs, respectively. Of all pediatric age groups, neonates had the lowest number of indications listed in the product monographs (7, 2.6%). Only 9 (60%) oral drugs indicated for children 6 years of age or younger were available in child-friendly, age-appropriate dosage forms.
interpretationMost of the new drugs approved by Health Canada do not contain pediatric or neonatal indications in their product monographs, and therefore, are used "off-label." Regulatory mechanisms are required to promote both neonatal and pediatric drug development and submission of available pediatric data by manufacturers to Health Canada.
Indexed as
Dosage FormsCanadaChildChild, PreschoolDrug ApprovalDrug DevelopmentDrug IndustryDrug TherapyFemaleHumansInfantInfant, NewbornMaleOff-Label UsePediatricsDosage Forms
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