"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."
www.pharmawatch.net
Reporting adverse drug reactions: Giving a voice to
consumers dyos.med.mun.caviewnews.phpOpen ↗
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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 implementaion was
"deadly slow." While on a partial sabbatical in
Victoria, BC, in 2002 he directed a student to improve
the the responsiveness of the technology and structured
the database so that all personally identifieable 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 acessing 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 world-wide. 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 probablility 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 is a widely-prescribed
Johnson and Johnson drug used to prevent acid reflux and
nighttime heartburn, in some people it causes life-
threatening heart rythmn 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 roughtly 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."
mun.ca2003Open ↗
2004/mar18/newspage8.html
Posted: 2004-03-24