Preeya Raja1, Mark Duffett1, Maryann Mazer-Amirshahi1, Ashaka Patel1, Andrea Gilpin1, Catherine Litalien1, Anthony K Chan1, John van den Anker1, Thierry Lacaze-Masmonteil1, Samira Samiee-Zafarghandy2. 1. Department 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. 2. Department 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.
Abstract
BACKGROUND: Optimal 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. METHODS: In 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. RESULTS: During 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. INTERPRETATION: Most 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. Copyright 2020, Joule Inc. or its licensors.
BACKGROUND: Optimal 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. METHODS: In 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. RESULTS: During 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. INTERPRETATION: Most 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. Copyright 2020, Joule Inc. or its licensors.
Authors: Praveen Kumar; Jennifer K Walker; Kristin M Hurt; Kimberly M Bennett; Neal Grosshans; Michael A Fotis Journal: J Pediatr Date: 2007-10-22 Impact factor: 4.406