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By Sharon Gray
A researcher in Memorial’s Faculty of Medicine has developed
a Web-based technology to report adverse drug reactions for
the consumer advocacy group PharmaWatch, Canada.
Dr. Ted Hoekman, Medical Informatics, has a long-standing interest
in online reporting of adverse drug reactions using a Web interface.
He began working on this about three years ago, quickly realizing
that while the concept was elegant, his initial implementation
was “deadly slow.” While on a partial sabbatical
in Victoria, BC, in 2002 he directed a student to improve the
responsiveness of the technology and structured the database
so that all personally identifiable data would remain anonymous.
The refining of the technology continues with other student
programmers from MUN Computer Science Department.
“We have used a strategy to make the process of accessing
the report site sufficiently challenging and information rich,
to discourage people from making casual, non-informative reports,”
explained Dr. Hoekman. “To use the reporting facility
you have to register – we maintain completely separate
databases for registrations and reports. Unless you choose to
report in an identified fashion no name will associated with
the report.”
Initially Dr. Hoekman developed the technology with the idea
of producing a tool targeted at healthcare professionals. While
in British Columbia he heard about PharmaWatch. “It was
a bright idea just starting to happen – they were interested
in developing direct consumer reporting of adverse drug reactions.
I already had this in the back of my mind because my study of
the literature revealed a major under-reporting of adverse drug
reactions worldwide. Most optimistically, serious studies show
that perhaps five to eight per cent of adverse reactions are
being reported. Hence, if a particular reaction is a regular,
but relatively rare, and dangerous event, the probability of
picking it up before many people are killed or injured is very
small.
The issue came to public attention in March, 2000, when 15-year
old Vanessa Young of Ontario died after taking the prescription
drug Propulsid. This was a widely-prescribed Johnson and Johnson
drug used to prevent acid reflux and night time heartburn –
but in some people it causes life-threatening heart rhythm abnormalities,
even in those with no heart disease. Propulsid had already been
associated with 80 deaths and hundreds of injuries, many among
children, before Vanessa’s death. Propulsid was ordered
off the market in the U.S. just three days after Vanessa’s
death, yet her family had no warning that the drug was regarded
as dangerous.
“I heard a talk by Terence Young, Vanessa’s father,
and he is convinced that there are many times as many people
who have died from Propulsid as have been reported,” said
Dr. Hoekman. “It shows how insensitive our reporting system
is for events that happen relatively rarely but are dangerous.
If we can improve frequency reporting, we can save lives.
“It has been shown in comparative studies that consumer
reporting is roughly equivalent to health professional reporting
in detecting important drug reaction issues. Achieving an improvement
in health professional reporting has been difficult –
partly because these people are frequently overworked and submitting
these reports is a time-consuming (and un-compensated) activity.
In addition, the methodology used to report adverse drug reactions
is cumbersome. Health Canada’s strategy is for the reporter
to download a PDF form from their Web site, print it, fill it
out by hand and mail or fax it to a reporting centre. Typically
several weeks or months can pass between the time the report
is submitted and its transcription into the data base where
it has the possibility of triggering a warning.”
While the PharmaWatch Web site – which is being designed
by Memorial’s Computing and Communication – is not
yet up and running, its launch is imminent. The URL will be
www.pharmawatch.net.
“The long-term plan is that anyone who registers with
PharmaWatch, whether they report or not, will be able to query
the database and receive a summary of reactions to drugs of
interest,” said Dr. Hoekman. “My vision is that
it will be a transparent public resource for health professionals,
caregivers and patients.” |
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issue: April 8, 2004
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