Sept. 18, 2014 – 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
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, according to a statement from the Council
of Canadian Academies.
"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
The panel's key findings are:
· 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.
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,
the Council said.
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 in relation 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.
For more information or to download a copy of the panel's report, visit the Council of Canadian Academies' website, www.scienceadvice.ca.
Council of Canadian Academies is an independent, not-for-profit
organization that began operation in 2005. The Council undertakes
independent, authoritative, science-based, expert assessments that
inform public policy development in Canada.
conducted by independent, multidisciplinary panels of experts from
across Canada and abroad. Panel members serve free of charge and many
are Fellows of the Council's Member Academies.
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