Expert panel report on the state of therapeutic products for infants, children and youth; © panthermedia.net/Monkeybusiness Images
A new expert panel report, Improving Medicines for Children in Canada, released today by the Council of Canadian Academies, addresses the importance of developing safe and effective medicines for children. Each year about half of Canada's seven million children use at least one prescription drug. Much of this prescribing is done off-label (i.e. the prescription differs from the authorized use), creating potential health risks.
Children have historically been excluded in drug research and development, including clinical trials. As a result, there is a knowledge gap about medicines and how they will affect children at different ages and stages of development. Today a paradigm shift is taking place with a view that children's participation is important for ensuring better health care.
"Overall, our 14-member expert panel determined that children should be protected through research, rather than from it," said Dr. Stuart MacLeod, Chair of the Expert Panel. "There is an opportunity for Canada to move forward with innovative policies and regulations that will allow for a greater knowledge base and ultimately improved health care for the youngest members of our society."
The Panel's key findings are:
1. Children take medications, many of which have not been proven safe and effective for their use.
2. Children respond to medications differently from adults; thus, medicines must be studied in children and formulated for children.
3. Studying medicines in children is always possible and is in their best interests.
4. In the United States and the European Union, pediatric medicines research is encouraged, required, and monitored in ways that offer lessons for Canada.
5. Pediatric medicines research is a Canadian strength, but it requires reinforcement and sustained capacity and infrastructure to realize its full potential.
Currently, Canada is very active in drug safety monitoring and in the field of pediatric clinical trials. Internationally, Canadians are working to develop leading-edge health standards, provide meaningful tools, and share knowledge that will improve the care and treatment for sick children. Recognizing Canada's strengths and the need for better information, Health Canada requested the Council assemble an expert panel that could provide a comprehensive and up-to-date analysis of the gaps, opportunities, and challenges that exist related to prescription drug use in children. The resulting report will serve as an important resource for policy-makers, regulators, health care professionals and researchers in the years to come.
MEDICA.de; Source: Council of Canadian Academies