Prescription drug trials for children a necessity, researchers say
Medicines must be studied in children and formulated for them, panel advises Health Canada
Canadian children are put at risk when they take prescription medications that in most cases aren’t tested or approved for use in pediatric patients, a policy that eminent researchers say needs to change.
Each year about half of Canada’s seven million children use at least one prescription drug, but much of the time, the prescription is "off label" or differs from an authorized use, which creates potential health risks.
Health Canada asked an expert panel to analyze the gaps, opportunities and challenges of prescription drug use in children. On Thursday, the Council of Canadian Academies’ expert panel released its report.
"It's clearly unacceptable to go on treating 20 or 30 per cent of the population with therapies that have not been validated in a scientific fashion that's been required for 50 years in the adult world," said Dr. Stuart MacLeod, a pediatrics professor at the University of British Columbia, who led the expert panel.
Children should be protected through research, not protected from it, he said.
The panel’s findings include:
- Children take many medications that have not been proven safe and effective for their use.
- Children respond to medications differently from adults and may need liquids instead of pills. When that's not available, adapting existing forms of medication based on evidence-based standards would make them safer.
- Health Canada can’t compel drug manufacturers to study their products in children and youth, while in the U.S. and the European Union, pediatric medicine research is encouraged, required and monitored.
- Strong adverse drug reaction databases are needed with more active surveillance.
The U.S. and Europe have done studies in children for years to determine the safety, effectiveness and proper dosages, said Dr. Anne Junker of BC Children’s Hospital and scientific director of the Canadian Child & Youth Health Coalition.
Junker called it unacceptable that only 14 per cent of clinical trials are specifically designed for use in children.
Junker and MacLeod said Canada has the expertise and a network of children's hospitals that could conduct more pediatric research if the government updates regulations.
Dr. Noni MacDonald is a pediatrics professor at Dalhousie University in Halifax, who sits on a Health Canada advisory committee. MacDonald said the pediatric research doesn't have to be done in Canada but the dosing information for children should be available rather than have doctors "guessing in the dark."
Health Canada thanked the council and its expert panel for the report, which it said will be reviewed closely.
"Work to address some of the challenges raised is already well underway," the department said in an email that referred to Vanessa's Law.
"If passed, the legislation will enable the government to compel companies to do further product testing, including when issues emerge with at-risk populations such as children. It would also enable Health Canada to compel companies to revise drug labels to clearly reflect health risk information, including updates for health warnings for children."
With files from CBC's Pauline Dakin