University of Miami Miller School of Medicine and Humana Launch Drug Safety Surveillance Program
MIAMI -- The University of Miami Miller School of Medicine and Humana Inc. today announced the launch of a new Pharmacovigilance Initiative at the Universityâ€™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.
â€œIt is estimated that about 2 million people in this country experience a serious adverse drug reaction each year,â€ said University of Miami President Donna E. Shalala. â€œClearly, 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.â€
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.
â€œPharmacovigilance 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,â€ said Jonathan Lord, M.D., Humanaâ€™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.
â€œRight 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,â€ said Pascal J. Goldschmidt, M.D., senior vice president for medical affairs and dean of the Miller School of Medicine. â€œThis new initiative between the Miller School of Medicine and Humana is the right thing to do for the patient, at the right time.â€
Further complicating the risks of adverse drug events, roughly 21 percent of all medications are prescribed â€œoff label,â€ 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.
â€œWe will be looking at a wide range of medications to track trends in side effects and potential adverse events,â€ said William J. Oâ€™Neill, M.D., executive dean for clinical affairs and medical director of the Pharmacovigilance Initiative. â€œFor example, we are analyzing the outcomes of 41,000 diabetics in Humanaâ€™s population, including Avandia users.â€
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.
Humana Inc., headquartered in Louisville, Kentucky, is one of the nationâ€™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 â€“ through traditional and consumer-choice plans â€“ to employer groups, government-sponsored plans, and individuals.
Humana is one of Floridaâ€™s leading health benefits companies with nearly 1 million medical members statewide, and is the University of Miamiâ€™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 companyâ€™s Web site at http://www.humana.com.