(HHS: Washington, D.C.) -- Efforts are underway at the U.S. Food and Drug Administration and the Centers for Medicare & Medicaid Services (CMS) to improve patient safety and the quality of medical care through a plan called “The Sentinel Initiative—A National Strategy for Monitoring Medical Product Safety.” The FDA white paper, calls for a public and private collaboration to develop and implement a system that would enable the FDA to analyze significantly more information by tapping into vast databases of health information to detect early signs of emerging safety problems.
“This initiative will tremendously increase the FDA’s capacity to monitor the use of medical products on the market,” says Mike Leavitt, Health and Human Services secretary. “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.””The Sentinel Initiative,” a white paper published May 22, 2008, will include the development of a new electronic system that will enable the FDA to query a broad array of information to identify possible post-market adverse events. That Sentinel system will be created through public and private partnerships and will capitalize on existing large electronic claims and medical records data sources maintained by private and government entities that agree to participate in this nationwide effort.
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 for public health and safety research, quality initiatives, care coordination, and other research and analysis.
“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 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.”
Creating an active surveillance system such as the Sentinel system was one of the recommendations made by the Institute of Medicine in a 2006 report on ways to improve the safe use of drugs. The recently passed Food and Drug Administration Amendments Act of 2007 (FDAAA) includes provisions that call for the development of such a system.
For further information, visit www.hhs.gov/news/press/2008pres/05/20080522a.html.
Add new comment