(HHS: Washington, D.C.) -- The U. S. Department of Health and Human Services stated that efforts are underway between the U.S. Food and Drug Administration and the Centers for Medicare and Medicaid Services (CMS) to improve patient safety and the quality of medical care.
“This initiative will tremendously increase the FDA’s capacity to monitor the use of medical products on the market,” says HHS secretary Mike Leavitt. “We are moving from reactive dependence on voluntary reporting of safety concerns, to proactive surveillance of medical products on the market. In addition, Medicare data on prescription drug use will be available to help government agencies and academic researchers improve the safety, quality and efficiency of health care services.”In The Sentinel Initiative: A National Strategy for Monitoring Medical Product Safety (May 2008), the system would enable the FDA to analyze significantly more information than it can today by tapping into vast databases of health information to detect early signs of emerging safety problems.
“With the Sentinel System we will no longer have to wait years to see how a drug or medical device is affecting millions of people,” says FDA commissioner Andrew C. von Eschenbach, M.D. “The era of ‘wait and see’ is going to become the era of ‘tell me right now.’ By harnessing the world’s most powerful information technologies, and by partnering with CMS, the Department of Veterans Affairs, and DoD, and an array of private health care organizations, we will have the ability to monitor a product’s performance in millions of patients in real time. The Sentinel System will give us an unprecedented ability to detect problems as they first begin to surface.”
A CMS final regulation will make it possible for federal agencies, states, and academic researchers to use claims data from the Medicare prescription drug program—subject to protections for beneficiary privacy and commercially sensitive data—for public health and safety research, quality initiatives, care coordination and other research and analysis.
For more information, visit www.hhs.gov/news/press/2008pres/05/20080522a.html.
To view the report, visit www.fda.gov/oc/initiatives/advance/reports/report0508.html.
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