May 22, 2008, HHS Secretary Mike Leavitt announced new FDA/CMS efforts that will complement each other to improve patient safety and the quality of medical care.(1) Read more about the big picture and how CBO sees the Federal government's Activities fit in at CBO's Report, pp24-27(2) and Supra Paul Gillan's post of yesterday on CBO below.
This [FDA] initiative will tremendously increase the FDA's capacity to monitor the use of medical products on the market...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.(1)A new FDA white paper describes the proposed Sentinel System and calls for a public-private collaboration to develop and implement it.(3) The system would enable 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. FDA Commissioner Andrew C. von Eschenbach, M.D. explains:
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...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 VA 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.CMS Acting Administrator Kerry Weems states:
There's a clear nexus between the data collected through Medicare's prescription drug program and the FDA's role in protecting the public from adverse events.For example:CMS's most recent survey of beneficiaries indicates that people with Medicare use more than twice as many medications in a year as do other Americans. Medicare beneficiaries use an average of 28 prescriptions in a year, while those who consider themselves in poor health have about 45 prescriptions in a year (source: Medicare current beneficiary survey, 2004). In contrast, other Americans use about 13 prescriptions a year, according to a 2007 study by the Agency for Healthcare Research and Quality.(4) Medicare beneficiaries' high usage of medications, coupled with numerous chronic health conditions, puts this population segment at higher risk of adverse drug events than other Americans and makes them the group most likely to see benefits from the FDA's new Sentinel Initiative.
(1)http://www.hhs.gov/news/press/2008pres/05/20080522a.html
(2)http://www.cbo.gov/ftpdocs/91xx/doc9168/05-20-HealthIT.pdf
(3) FDA's report is available at: http://www.fda.gov/oc/initiatives/advance/reports/report0508.html.
"The Sentinel Initiative -- A National Strategy for Monitoring Medical Product Safety"
(4)http://www.ahrq.gov/news/nn/nn051607.htm
(5)The press release notes that a CMS final regulation published today will make it possible for federal agencies, states, and academic researchers to use claims data from the Medicare prescription drug program (Part D) -- 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. Read the Fact Sheet athttp://www.cms.hhs.gov/PrescriptionDrugCovGenIn/Downloads/PartDClaimsDataFactSheet.pdf