Most Medications Prescribed to Children Have Not Been Adequately Studied

Canada is falling behind other countries on drug safety for children

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.

In Europe 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.

The 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 globe.

The report will just be the first step in a series of necessary actions.

The 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.

Why? We 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.

Canada 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 of children.

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.

By Martin OKlassen_Terryffringa and Terry P. KlassenOffringa_Martin

Martin 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. 

Terry P. Klassen is an advisor with, 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.

Both authors serve, with many others, as experts on the Council of Canadian Academies committee that looks into Therapeutic Products in Children.