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UBC Reports | Vol. 51 | No. 2 | Feb. 3, 2005

Boosting Drug Safety for Children

A new national surveillance network will help find adverse drug reactions

By Hilary Thomson

Last year’s recall of the arthritis pain drug, Vioxx®, left a big question in the mind of Bruce Carleton.

An associate professor of pharmaceutical sciences, Carleton specializes in evaluating the effectiveness and safety of medications. The recall left him wondering why government-mandated drug safety surveillance programs worldwide didn’t capture the risks associated with the popular medication.

Post-marketing surveillance involves manufacturers, health-care professionals and consumers reporting adverse drug reactions. But if the system failed to detect the life-threatening cardiovascular risks posed by Vioxx®, despite millions of prescriptions issued, are patients really being protected from potential adverse reactions, Carleton asks.

As director of the Pharmaceutical Outcomes Program at Vancouver’s Children’s & Women’s Health Centre, he is especially interested in how well surveillance programs work to identify adverse drug outcomes among children.

In the U.S. alone, approximately 26,500 children die every year from adverse drug reactions, according to a 1998 study published in the Journal of the American Medical Association.

Carleton and renowned UBC geneticist Michael Hayden aim to change that through a three-year, $8.4 million project funded by Genome Canada. Called the Genotype-specific Approaches to Therapy in Childhood (GATC) program, the project officially gets underway this month.

The program will test a novel surveillance system and explore genetic influences in adverse drug reactions.

The researchers will establish a national network of “detectives” -- nurses, pharmacists and other clinicians with expertise in identifying adverse drug reactions. The sleuths will work in pediatric hospitals across Canada specifically to find and report adverse drug reactions in children.

In addition, the GATC network will collect DNA samples from patients to help understand causes of adverse reactions. The genetic information and other data will form a central data registry concerning drug effectiveness and safety.

“Our goal is to understand why a drug is safe for one child but not another, so that we can reduce adverse reactions,” says Hayden, who directs Vancouver’s Centre for Molecular Medicine and Therapeutics (CMMT). “We want to develop diagnostic tests to determine a child’s genetic fingerprint. Once we can predict a child’s risk, we can offer personalized dosing recommendations for some commonly used drugs. We want to be able to do this within five years.”

Carleton is confident that a permanent national surveillance network operating in hospitals at a grassroots level would make a huge difference in our knowledge of drug effectiveness and safety.

About 95 per cent of adverse drug reactions go unreported world wide, he says, but failure to report won’t be fixed by imposing a mandatory reporting system.

He says the problem is that physicians don’t necessarily recognize when drugs may be the culprits in adverse outcomes. An adverse reaction to drugs is often interpreted as another symptom of illness, requiring treatment with -- you guessed it -- more drugs.

“It can be next to impossible to sort out if the disease is getting worse or the drugs are having an adverse effect,” Carleton says. “When patients are on more than one drug at the same time, it’s even more difficult.”

The GATC program will bring together experts in a variety of disciplines including pharmacogenomics (study of how an individual’s genetic inheritance affects the body’s response to drugs), pediatric pharmacology and genetics. This expertise combined with a focused, hospital-based monitoring system is expected to give researchers the information they need to reduce fatal and disabling adverse drug reactions in children.

For more information about drug safety, visit http://www.fda.gov/opacom/hpchoice.html.

Genome Canada is the primary funding and information resource relating to genomics and proteomics in Canada.

Children’s & Women’s Health Centre of British Columbia is an agency of the Provincial Health Services Authority, and includes BC Children’s Hospital and Sunny Hill Health Centre for Children, and BC Women’s Hospital & Health Centre.

The CMMT, a centre of the B.C. Research Institute for Children’s & Women’s Health, is a multidisciplinary centre focused on determining genetic contributions to different illnesses and developing new approaches to therapy.

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Last reviewed 22-Sep-2006

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