Unknown effects from medications putting Canadian children at risk

A small effort could make a big difference in child drug safety

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By Terry Klassen
Expert Advisor
and Martin Offringa
Professor of Paediatrics
University of Toronto

WINNIPEG, MB and TORONTO, ON Sept. 14, 2015/ Troy Media/ – Almost a year has passed since an important report was released on ways Canada can improve medicines for children.

The report was commissioned, by Health Canada and undertaken by the Council of Canadian Academies, after experts sounded alarms because there wasn’t enough knowledge on possible side-effects of certain medications.

The truth is one that is rarely declared publicly: Canadian children are often treated with drugs in the absence of evidence.

What the reportImproving Medicines for Children in Canada, confirmed was what pediatricians in the field already know – 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.

The report also noted that children respond to medications differently from adults, which means that medicines must be both studied in children and formulated for children. The good news is that there are precedents. In the United States and the European Union, pediatric medicines research is encouraged, required, and monitored in ways that offer lessons for Canada.

What such precedents teach us is that studying medicines in children is always possible and is in their best interests. The report rightly emphasizes that pediatric medicines research is a Canadian strength, but it requires reinforcement and sustained capacity and infrastructure to realize its full potential.

Unfortunately, little has been done since this landmark report.

Although the report flags the fact that Canada is uniquely positioned to engage in collaborative disease-specific networks that have been established internationally; this first critical step still needs to be taken. To do this, we need our federal government to help us set this in motion by working with Health Canada, provincial counterparts, universities, and children’s hospitals to implement a proposed national network for the study of medicines in children.

What would this mean for Canadian kids?

A Canadian network working in collaboration with global partners could support rapid delivery of studies on new children’s medicines that we cannot deliver alone, and bring medicines for children to market more quickly. It would also allow critical Canadian participation in global health, economic, and other international studies so that pharmaceutical pricing can reflect needs in our country.

The wheels are in motion. The Canadian government is studying a comprehensive proposal for a child health drug research network prepared by the joint children’s hospitals in our country – a unique Canadian development in which child health leaders choose to collaborate rather than compete. At the same time, international pharmaceutical companies are promoting a plan to develop a Global Pediatric Clinical Trials Network involving national networks of the best children’s hospitals in more than 20 countries in the world.

Instead of a single children’s hospital building up a local or provincial infrastructure to answer one drug research question at a time, then breaking it down; Canada would benefit immensely from a sustainable network, taking on multiple questions, working with multiple partners, led by Canada’s reputable clinicians and scientists.

Of course, whichever way we move forward, the child and family should be put first for all decisions made. This will guarantee that only ethical, relevant research proposals are adopted by the network.

Can we really afford not to be part of this global development and miss having our national infrastructure organized? It’s time Health Canada made progress on the recommendations of a report that they, themselves, commissioned — and for the federal government to set the course.

As the report stipulates, only a small investment is needed to align existing resources and send a strong international signal. If we don’t, Canada will lose its competitive advantage to engage pharmaceutical companies. Worse, Canadian families will be at further risk of failing to benefit from emerging scientific breakthroughs.

Terry P. Klassen is an adviser with EvidenceNetwork.ca, a pediatric emergency physician and clinical epidemiologist. He is CEO and Scientific Director of the Children’s Hospital Research Institute of Manitoba and Head of Pediatrics, University of Manitoba. Martin Offringa is a Professor of Paediatrics at the University of Toronto, a practising neonatologist and a Senior Scientist in Child Health Evaluative Sciences at The Hospital for Sick Children. Both authors served, with many others, as experts on the Council of Canadian Academies committee that looked into Therapeutic Products in Children.

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