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Samira Samiee-Zafarghandy led an analysis of pediatric information available in Canadian drug product monographs.
September 1, 2020

More info needed on medication dosages for children

Samira Samiee-Zafarghandy hopes that an analysis she prepared in partnership with expert colleagues in pediatric drugs will lead to increased safety when it comes to prescribing medications to children.

In Canada, there’s a need for more detailed pediatric information on monographs, said Samiee-Zafarghandy, assistant professor of pediatrics at McMaster University and a neonatologist and pediatric clinical pharmacologist at HHS’ McMaster Children’s Hospital.

Monographs are the written descriptions of medications that help health professionals like doctors and pharmacists determine appropriate uses and dosages for patients.

Committed to bringing change

Improved information on drug product monographs will help keep children safer, says Samiee-Zafarghandy, the paper’s senior and corresponding author. The findings were published today in Canadian Medical Association Journal (CMAJ) Open.

“It’s important to ensure all available pediatric data reaches Health Canada.”

“Canadian regulatory mechanisms are needed to ensure submission of pediatric data by manufacturers when use in children is anticipated,” said Samiee-Zafarghandy.

“For some drugs, manufacturers need to complete a pediatric study. For others, the data might be available in other countries. For example, the U.S. and Europe are far ahead of Canada when it comes to developing rules and legislation aimed at increasing access to pediatric drug data. It’s important to ensure all available pediatric data reaches Health Canada.”

Kids aren’t tiny adults

Drug dosage recommendations are based on adult bodies. The current and long-time practice in pediatrics in most countries, including Canada, when it comes to prescribing medications for children is to calculate dosages based on weight, with children receiving smaller dosages than an adult would receive.

“Their bodies metabolize drugs differently.”

“But it’s important to remember that children aren’t just tiny adults,” said Samiee-Zafarghandy. “Their bodies metabolize drugs differently, so children might get over exposed or under exposed due to their different metabolisms which may depend on their developmental stage.”

Children also can’t be lumped into one category because their bodies are so different. “You can’t compare the body of a newborn with a toddler, or a toddler with a teenager.”

Numbers tell the story

The research team manually reviewed monographs of all new drugs approved by Health Canada between 2007 and 2016. During this time, Health Canada approved 281 drugs, 270 of which had clear benefit for children.

“The result may be inadequate treatment or increased side effects.”

“Although we were aware that information present in the drug labels are usually more focused on adult patients, the extent of the absence of prescribing information available for children was much, much greater than we anticipated,” said Samiee-Zafarghandy.

“We were also confounded by how many drugs used in critical conditions for pediatric and newborn patients did not have any information for their proper use in these children,” she said. “Many of these drugs are being prescribed to children anyway, and the lack of pediatric data in their monograph can make it difficult for physicians and pharmacists to optimize treatment. The result may be inadequate treatment or increased side effects.”

Parents can still feel confident

While there is significant room for improvement, Samiee-Zafarghandy said that parents should still feel confident in their children’s physicians and pharmacists.

“This is a historical issue for Canada and much of the world,” she said. “It’s how the system has always operated and the medical community has developed best practices, but there’s still significant room for improvement. There’s only so much that medical professionals can do when detailed information isn’t provided on the monographs. Without change, the door does remain open for inconsistencies.”

Samiee-Zafarghandy said that regulatory mechanisms to require the submission of pediatric data by manufacturers to Health Canada are urgently needed to promote both neonatal and pediatric drug development.

“Our study is the first to report this severe lack of necessary information in labeling of Canadian drugs for pediatric patients,” she said. “The results of this study will serve as a foundation for future comparisons of pediatric drug information availability between Canadian drug labels and drug labels of medications approved in the U.S. and Europe.”