22.08.2007 14:00:00
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University of Miami Miller School of Medicine and Humana Launch Drug Safety Surveillance Program
The University of Miami Miller School of Medicine and Humana Inc. (NYSE:
HUM) today announced the launch of a new Pharmacovigilance Initiative at
the University’s medical campus in Miami. The
new program will focus on prescription drug safety -- in particular, the
science of detecting and understanding adverse drug events.
"It is estimated that about 2 million people
in this country experience a serious adverse drug reaction each year,”
said University of Miami President Donna E. Shalala. "Clearly,
something in our system is not working properly, and this new program
will track the problem and offer solutions based on good science and
research.”
The new Pharmacovigilance Initiative will be undertaken by the
University of Miami-Humana Health Services Research Center, a
public-private partnership established in 2005 to focus on health
services and health behavior research with an emphasis on improving
health outcomes for individual patients.
"Pharmacovigilance represents yet another area
where the University and Humana have a unique opportunity to bridge the
research gap between the bench and the bedside and give consumers a real
time, transparent view into the health care system,”
said Jonathan Lord, M.D., Humana’s Chief
Innovation Officer.
Although the Center works with a number of entities today to design and
produce cutting edge research on conditions like metabolic syndrome,
obesity, heart disease and diabetes, the new Pharmacovigilance
Initiative will be an independent pursuit aimed at protecting the health
and safety of the public, supporting better clinician decision making
through reporting on the comparative effectiveness of pharmaceuticals,
and contributing to the ongoing dialogue in Washington around drug
safety.
"Right now, the reporting of adverse drug
events to the U.S. Food and Drug Administration is strictly voluntary,
and the recent drug recalls and stepped-up black box warnings would
suggest something more needs to be done to protect patient safety,”
said Pascal J. Goldschmidt, M.D., senior vice president for medical
affairs and dean of the Miller School of Medicine. "This
new initiative between the Miller School of Medicine and Humana is the
right thing to do for the patient, at the right time.”
Further complicating the risks of adverse drug events, roughly 21
percent of all medications are prescribed "off
label,” or for uses other than what they were
approved for by the FDA. Little is known about clinical and cost impacts
of off-label use.
"We will be looking at a wide range of
medications to track trends in side effects and potential adverse events,”
said William J. O’Neill, M.D., executive dean
for clinical affairs and medical director of the Pharmacovigilance
Initiative. "For example, we are analyzing
the outcomes of 41,000 diabetics in Humana’s
population, including Avandia users.”
Avandia is the diabetes drug that recently came under fire because of a
reported increase in heart attack risk.
The Center will be appointing a multi-disciplinary Advisory Board,
including a medical ethicist, to provide guidance on the clinical
domains of exploration and communicating findings to the public. Beyond
Avandia and several other targeted analyses, the University of Miami and
Humana expect the Pharmacovigilance Initiative to begin communicating
through public releases and a consumer Website a large volume of
research findings in early 2008.
About Humana
Humana Inc., headquartered in Louisville, Kentucky, is one of the nation’s
largest publicly traded health benefits companies, with approximately
11.3 million medical members. Humana offers a diversified portfolio of
health insurance products and related services –
through traditional and consumer-choice plans –
to employer groups, government-sponsored plans, and individuals.
Humana is one of Florida’s leading health
benefits companies with nearly 1 million medical members statewide, and
is the University of Miami’s health benefits
provider.
Over its 46-year history, Humana has consistently seized opportunities
to meet changing customer needs. Today, the company is a leader in
consumer engagement, providing guidance that leads to lower costs and a
better health plan experience throughout its diversified customer
portfolio.
More information regarding Humana is available to investors via the
Investor Relations page of the company’s Web
site at http://www.humana.com.
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