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Web-based Drug
Withdrawal Warnings |
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Doctors Develop New
Approach To Web-based Drug Withdrawal Warnings
Other Topics:
Medical Informatics Management
Solutions, Computer
Personalized Medical Treatment,
Regenerative Medicine,
Cancer Genome Atlas
University of Cincinnati
October 2, 2006
The University of Cincinnati (UC) has developed a faster
approach for informing consumers online when the Food and Drug
Administration (FDA) withdraws a medication.
Peter Embi, MD, and Mark McCuistion, developed a new, faster
approach to communicate FDA drug withdrawals via health Web
sites. (Image courtesy of University of Cincinnati)
The new approach works with NetWellness.org, a commercial-free,
consumer health Web site produced by Ohio’s three medical
research universities—UC, Case Western Reserve University and
Ohio State University. |
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“Information about drug withdrawals may not reach patients
quickly enough to prevent potentially dangerous side effects,”
explains Peter Embi, MD, lead author on the UC-based study
published in the most recent online edition of the Journal of
Medical Internet Research. “Given the public’s growing use of
the Web for health information, it’s important that Web-based
consumer health content is kept up to date, particularly that
involving withdrawal of a potentially harmful medicine.
“However,” says
Embi, assistant professor of medicine and a researcher at UC's
Institute for the Study of Health, “it’s been shown that many
sites don’t update their content for days, or even weeks,
following an FDA drug withdrawal.
“Our new approach,” he says, “allows just one person to modify
affected Web pages in less than an hour and within just hours of
an FDA drug withdrawal announcement.”
Embi says he hopes this new method will encourage those
responsible for other Web sites carrying critical consumer
health information to adopt a similar 24-hour response standard
to drug withdrawals.
“There’s evidence that patients continue to use medications for
some time after their withdrawal, which occasionally causes
harmful effects,” Embi explains, “so it’s important to inform
the public as quickly as possible.”
Before developing the new approach, Embi and his team evaluated
NetWellness’ previous update process following the FDA’s
withdrawal of the painkilling, anti-inflammatory drug Vioxx (rofecoxib)
on Sept. 30, 2004.
Notified of the Vioxx withdrawal, NetWellness staff searched
their site for the drug and related terms. References to Vioxx
information were temporarily pulled and evaluated by medical
experts. Content was either changed and reposted or permanently
removed.
The researchers found that while this original process was
ultimately effective, it took nearly three weeks and
considerable human input to complete NetWellness content changes
after the Vioxx withdrawal.
To improve on this, the research team developed their new
approach and then tested it following FDA withdrawal of the
anti-inflammatory drug Bextra (valdecoxib) on April 7, 2005. The
results were significantly better than with the previous
approach, they say. In just 18 hours after the drug recall, all
instances of Bextra on NetWellness were updated and active, says
Embi.
The new method, initiated by the FDA’s automated MedWatch E-List
alert and combined with modified technology and people
processes, allows updates of all relevant NetWellness pages with
minimal manual input and within 24 hours of a drug recall.
Now when the FDA announces a drug withdrawal, the NetWellness
team receives an alert by MedWatch E-List and immediately checks
the site’s database for instances of the drug name, including
trade and generic names. Instances are then hyperlinked using an
automated find-and-replace function built into the site’s
content management system.
Simultaneously, pages containing these references receive a
hyperlinked warning box indicating the availability of important
information about the withdrawn drug.
All hyperlinks point directly to a new NetWellness “warning”
page containing information about the FDA alert and to
additional links to either the FDA or the drug manufacturer’s
Web site.
A recent study in the Journal of the American Medical
Informatics Association reports that the majority of Web-based
sources, including the popular consumer health site WebMD.com,
took several days to update the Bextra drug information. A
subscription-based health information Web site for health
professionals, PDR.net, took 268 days to update Bextra content.
Embi plans to further automate this new update method and
develop similar responses to other types of FDA health warnings
relevant to consumers.
Study coauthors included Mark McCuistion, Charles Kishman, Doris
Haag and Steven Marine, all from UC, and Prasad Acharya, from
Wright State University. |
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