Raja Preeya, Duffett Mark, Mazer-Amirshahi Maryann, Patel Ashaka, Gilpin Andrea, Litalien Catherine, Chan Anthony K, van den Anker John, Lacaze-Masmonteil Thierry, Samiee-Zafarghandy Samira
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.
CMAJ Open. 2020 Aug 31;8(3):E522-E529. doi: 10.9778/cmajo.20200010. Print 2020 Jul-Sep.
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.
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 We excluded drugs withdrawn from the Canadian market and drugs with primary indications irrelevant to pediatrics.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.
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.
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.
儿童的最佳药物治疗依赖于儿科专用信息的可得性。我们旨在描述加拿大卫生部批准的新药说明书中儿科药物治疗数据的现状。
在这项描述性分析中，我们回顾了2007年1月1日至2016年12月31日期间加拿大卫生部批准的新药说明书的质量和数量。我们排除了已从加拿大市场撤出的药物以及主要适应症与儿科无关的药物。我们确定了列出儿科专用信息的纳入药物说明书的百分比。
在本研究期间，加拿大卫生部批准了281种药物，其中270种符合我们的纳入标准。药物说明书中分别有127份（47.1%）和75份（27.8%）包含儿科专用信息和适应症。在所有儿科年龄组中，新生儿在产品说明书中列出的适应症数量最少（7种，2.6%）。对于6岁及以下儿童适用的口服药物，只有9种（60%）有适合儿童的、符合年龄的剂型。
加拿大卫生部批准的大多数新药在其产品说明书中不包含儿科或新生儿适应症，因此属于“超说明书用药”。需要监管机制来促进新生儿和儿科药物的开发，并促使制造商向加拿大卫生部提交现有的儿科数据。
