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HHSC study: Canada lags when it comes to information on prescription drugs for children

A report prepared by a team led by Dr. Samira Samiee-Zafarghandy   says drug manufacturers need to pay more attention to the affects of new drugs on kids. According to the study, less than one-third of drugs approved by Health Canada over a recent 10-year period contain sufficient information on dosage and the clinical effects of the drugs on children, especially neonatal babies. More than half of the approved drugs failed to provide any information regarding children at all. The study showed that 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.

“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.”

“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.”

The report said Canada lags behind the United States and Europe when it comes to evaluating the use of new drugs on kids and neonates. It recommends more legislative control.

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