Due to concerns about their vulnerability, children have historically been neglected in drug research and development, including clinical trials. But the reality is that children need medicines and are taking them. Data shows that each year, about half of Canadian children use at least one prescription drug. Much of this prescribing is done off-label (i.e., the prescription differs from the authorized use) or without adequate age-related information, a practice that may introduce unnecessary risk of harm to children who need medicine.
Recognizing the importance of developing safe and effective medicines specifically for children, the Minister of Health, on behalf of Health Canada, asked the Council of Canadian Academies to provide an evidence-based and authoritative assessment of the state of research and regulations leading to the approval of medicines for children, in Canada and abroad. The Panel, chaired by Dr. Stuart MacLeod, Professor of Pediatrics, Faculty of Medicine, University of British Columbia, considered the current Canadian landscape, how drugs are used by children, the state of knowledge of clinical pharmacology, and lessons learned from international experiences.
The final report focuses on the ethical development of safe and effective medicines for children; examines gaps in the current state of knowledge regarding the relationships among clinical pharmacology, human development, and pediatric drug investigations; and identifies opportunities for strengthening knowledge of safe and effective pediatric medicines. The Expert Panel’s work provides key insights that will support Canadian decision-makers as they consider policies in support of children’s health.
The Panel identified five key findings that serve to answer the charge put forward by Health Canada:
Children take medications, many of which have not been proven safe and effective for their use.
Children respond to medications differently from adults; thus, medicines must be studied in children and formulated for children.
Studying medicines in children is always possible and is in their best interests.
In the United States and the European Union, pediatric medicines research is encouraged, required, and monitored in ways that offer lessons for Canada.
Pediatric medicines research is a Canadian strength, but it requires reinforcement and sustained capacity and infrastructure to realize its full potential.
What is the state of clinical pharmacology, in Canada and abroad, that can be applied to the ethical development of safe and effective pharmaceuticals and biologics labeled as therapies for infants, children and youth?
Report and Related Products
Improving Medicines for Children in Canada
Report in Focus (abridged version)
The Expert Panel on the State of Therapeutic Products for Infants, Children, and Youth was chaired by Dr. Stuart MacLeod, Professor of pediatrics at the University of British Columbia in Vancouver. For a complete list of panel members visit the Expert Panel on the State of Therapeutic Products for Children page.
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