UBC Reports | Vol.
51 | No. 2 |
Feb. 3, 2005
Boosting Drug Safety for Children
A new national surveillance network will help find adverse
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
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
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
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.