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USING ELECTRONIC HEALTHCARE RECORDS TO GET DATA
ON ADVERSE DRUG EVENTS -- VA is leading the way
as
the private healthcare sector seeks better
solutions.
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Using EHRs to extract data on adverse drug
events
By: Andis Robeznieks / HITS staff writer
During the opening reception at the National Patient Safety Foundation's
annual conference in San Francisco last May, patient-safety pioneer
Lucian Leape was holding court and talking about how electronic health
records could be used to automatically capture data on any adverse
reactions or side effects of new drugs on the market. If such a system
were in place, the Harvard University adjunct professor of health policy
said, information that now takes years to gather could be collected in a
matter of months. Other experts also see the potential of using EHRs for
post-market drug safety surveillance.
This has been one of the big missing links in the patient-safety
movement, and it could prevent a lot of harm and a lot of costs,” says
Michael Cohen, president of the Institute for Safe Medication Practices.
"That was always part of the vision of having a fully integrated
electronic health record—you suddenly have access to this information in
close to real time," says Kenneth Kizer, a physician who is chairman of
the board and chief executive officer of Medsphere Systems Corp., a
clinical information systems developer. Kizer is also former president
and CEO of the National Quality Forum, a not-for-profit standards
consensus development organization. "Drug reactions are the most common
untoward event that happens in healthcare and, while a significant
amount are because of errors," they also can occur via adverse reactions
or side effects, he says.
As undersecretary for health in the Veterans Affairs Department from
1994 to 1999, Kizer promoted using health IT to improve quality and
safety. Building a national health information network would not be
necessary to conduct the needed surveillance, Kizer says.
Instead, he says an effective sentinel network could be created by
linking the Veterans Health Administration with about six of the largest
health systems that use IT extensively. "Just think of the data you
could accrue in a short period of time," Kizer says.
While the VA conducts its own adverse drug event surveillance, the Food
and Drug Administration's MedWatch program, established in 1993, is the
federal government's main post-market drug safety effort. MedWatch, a
repository of voluntary reports on adverse drug events, has long been
criticized for its ineffectiveness.
“It’s better than nothing, but I think most people view it as anemic,”
Kizer says. "Certainly, the completeness of reporting leaves a lot to be
desired. You’re basically waiting for something to come across the
transom."
Landen Bain, the healthcare liaison for the Austin, Texas-based Clinical
Data Interchange Standards Consortium, or CDISC, went further and called
it "abysmal," and says the MedWatch adverse drug event reporting form is
so cumbersome that "I wouldn’t fill it out at gunpoint."
In addition to the troubles of getting information into the system, it's
also tough to get anything out of it, Cohen says. "When physicians
participate in a voluntary effort, they want to get something out of
it," he says. "In order to get information (from MedWatch), you need to
file a Freedom of Information Act request, and people just don’t want to
do that."
Jonathan Nebeker, associate director of the Informatics, Decision
Enhancement and Surveillance Center at the VA Medical Center in Salt
Lake City, notes that the drug companies assemble reports for MedWatch,
which raises some concern. "A lot of times, it is easier to report
things to industry directly, so industry helps collect information," he
says. "I'm not saying it's all bad. It's just filtered." The FDA defends
MedWatch, but notes that it has heard the criticism. "We do get 450,000
adverse event reports a year," says Paul Seligman, FDA associate
director for safety policy and communication. "We're always cognizant of
the fact that it takes pharmacists, physicians and nurses a moment out
of their day to report to us."
The FDA has scheduled a public meeting for March 7-8 in Rockville, Md.,
to discuss linking private and public sector post-market drug
surveillance efforts to create an integrated electronic Sentinel
Network. An FDA spokeswoman says the new network would not replace
MedWatch. Instead, she says it would serve as a way to leverage all
available resources toward the goal of improving drug safety.
On Jan. 30, the FDA also announced (registration required) a series of
initiatives to improve its drug and medical-device safety programs,
including working with the VA to improve post-market tracking of adverse
drug events and posting MedWatch findings in an online newsletter.
Others, however, are not waiting. Bain’s organization teamed up with IT
vendor Allscripts Healthcare Solutions and pharmaceutical manufacturer
Pfizer on a "retrieve form for data capture" demonstration project that,
if put in place, could make reporting on adverse drug events much
easier.
The demonstration had its "dress rehearsal" last month at the
Integrating the Healthcare Enterprise Connectathon—an event that gets
competing IT vendors to work together on improving the interoperability
of their products. The CDISC-Allscripts-Pfizer team will reassemble in
New Orleans for the Interoperability Showcase, which will be part of the
Healthcare Information and Management Systems Society’s annual
conference Feb. 25-March 1.
The concept involves an easily retrievable electronic form that a
physician can access, fill out and send to the FDA or Centers for
Disease Control and Prevention. Bain says retrieval of the form is
instantaneous, but the real time savings comes from not having to exit
the EHR a physician might be working on at the time.
"It’s not rocket science—it’s not brilliant or sexy—but I personally
feel it could make a great difference in public safety by making it much
easier to report and improve the quality of the reporting," says Michael
Ibara, Pfizer information resources director. "At HIMSS, it will be one
of the most technologically simple things that will be showed there, but
that doesn't mean it won't have a great effect."
This story initially appeared in this week's edition of Modern
Healthcare magazine.
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Larry Scott --
