Most medications prescribed to children have not been adequately studied
By Martin Offringa and Terry P. Klassen EvidenceNetwork.caNews
June 23, 2014 – A version of this commentary appeared in the Globe and Mail, the Huffington Post and the Hamilton Spectator
The development of new therapies has provided our health care system with enormous advances, such as insulin for diabetes, antibiotics for infections or chemotherapy for many cancers. Yet these therapies may also cause potential harm, even death, so the benefits have to be carefully weighed against the risks.
But how do you strike a balance when treating children with drugs in the
absence of such evidence? Most people might be surprised to learn that
much of the medications given to children in Canada have never been
adequately studied or even formally approved for the conditions they are
commonly prescribed to treat.
Pediatricians in our country face
this dilemma every day. Sometimes we end up using medications for our
young patients even when we have no evidence whether a child will
benefit from the treatment. In other cases, we may not use medication
that could benefit a child because studies have not been done to
demonstrate this. And sometimes it is necessary to prescribe medications
for serious medical conditions where the potential risks for children
are not yet known.
Yet when things go badly, such as the recent
baby deaths from a mom nursing her baby while taking codeine, there is —
understandably — a public outcry that such tragedies should never
happen. We know that ADHD medication is one of the fastest growing drug
categories for children. Yet the Toronto Star has reported as many as
600 serious, sometimes fatal side effects caused by ADHD medication in
the past 10 years.
How can doctors continue to prescribe or deny
medications to children without knowing the possible consequences first?
Such is the current situation in Canada.
Sadly, we are trailing
our global neighbours on the issue of drug safety and efficacy for
children. Other countries have recognized this serious risk to children
and invested in national research networks that are providing the much
needed evidence to fill the current knowledge gap. The United Kingdom
has the most marked example, when in 2006 they created the Medicines for
Children Research Network by making a significant investment and
commitment to children’s health. The effect has been spectacular: the
number of studies into the safety and efficacy of medicines for children
has doubled to 300 studies in a two-year time span.
and the United States, legislative changes have incentivized the
undertaking of studies specific to children’s health treatments. Yet
much work still has to be done to move away from the current situation
where children commonly receive medicines not geared for their needs.
problem has been recognized by experts in Canada as well, and there may
be a light in the distance. Health Canada has commissioned a report to
be released in September of this year on Therapeutic Products in
Children, undertaken by the Council of Canadian Academies. This report
will examine the best methods for establishing the safety and
effectiveness of new therapeutic products in children. It will also
examine Canada’s position in the context of other developments around
The report will just be the first step in a series of necessary actions.
Harper government has made it clear that mothers and children are a
priority for this government, and so it has a unique opportunity to
invest in evidence, best practices and improved regulations to better
the health of our children. Such an investment by the federal government
in children’s health in Canada will result in significant knowledge
being created — and new investment being drawn to Canada.
know from the UK experience that investing in a network infrastructure
for doing clinical research will draw in investment both from the
pharmaceutical industry and publically funded research. Implementing the
results of all of this work into the daily practice of health care
providers will result in better health outcomes for sick children.
is uniquely positioned to make best use of this investment through
collaborative disease specific networks that have already been
established. There is also unparalleled cooperation and coordination
among various organizations that have as their chief mandate the health
With an investment now, Canada could leap from last
to first: to leading the world in creating new knowledge about
therapeutic products used by our children and youth.
Offringa is a Professor of Paediatrics at the University of Toronto, a
practicing neonatologist and a Senior Scientist in Child Health
Evaluative Sciences at The Hospital for Sick Children.
Klassen is an advisor with EvidenceNetwork.ca, a pediatric emergency
physician and clinical epidemiologist who is currently the CEO and
Scientific Director of the Manitoba Institute of Child Health. He was
the founding chair of Pediatric Emergency Research of Canada.
authors serve, with many others, as experts on the Council of Canadian
Academies committee that looks into Therapeutic Products in Children.
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