FDA and CMS launch new initiative to improve drug safety

FDA and CMS launch new initiative to improve drug safety

The Department of Health and Human Services (HHS) announced recently that the Food and Drug Administration (FDA) and the Centers for Medicare and Medicaid Services (CMS) will begin efforts to improve drug safety and medical care through a new proactive approach called the Sentinel Initiative. The FDA will use a number of public and private databases to monitor millions of patient records and alert officials to possible adverse effects from medical products sooner than the current system allows. The FDA will work closely with the CMS using data from its 25 million beneficiaries through the Medicare prescription drug program, as well as information from a number of other government and private health care organizations. While patient privacy will continue to be protected, the data will also be made available to state agencies and academic researchers in order to improve various health care services. The idea for the initiative began as a recommendation from the Institute of Medicine outlined in a 2006 report. For information, go to http://www.hhs.gov/news/press/2008pres/05/20080522a.html.

Source: AAMC STAT, May 26, 2008