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Sentinel Initiative is a long-term effort by the U.S. Food and Drug Administration (FDA) to create a national electronic system for monitoring medical product safety. It will strengthen FDA's ability to track how drugs and other medical products perform once they go on the market and, ultimately, facilitate the development of tools to strengthen the agency's ability to communicate safety information to the public.
The Sentinel Initiative will include the development of a new electronic system, called the Sentinel System, that will enable FDA to gather information about medical products by posing targeted queries (consistent with strict privacy and security safeguards) of patient registry data, insurance claims data, and other large health care information databases.
As the name implies, the system will help the FDA stand guard over the nation's vast supply of medical products. The Sentinel Initiative will give FDA other, more proactive, tools to monitor the safe use of medical products after they are approved for marketing.
FDA's current postmarket surveillance programs generate very important new risk information, but health care professionals and patients must first recognize an association between an adverse effect and a medical product, and then report it to FDA or the manufacturer. Most adverse events are never reported, and when they are, the information provided may be incomplete.
Once the Sentinel System is up and running, FDA will have the tools to query specific adverse event data in large databases, like the Medicare database and in claims data and electronic health information maintained by private and federal entities who volunteer to participate in the Sentinel System. Creating an advanced surveillance system like Sentinel was one of the recommendations made by the Institute of Medicine in its 2006 report on ways to improve the safe use of drugs.
Let's say that clinical trial data suggest there's a possible risk of cardiac effects from a device. Or after a drug goes on the market, we get reports of possible adverse event that might be linked to the drug. We would set up targeted queries with participating Sentinel partners so we can monitor for these possible links and see if the data they have in their system show the same types of reports.
No. If FDA is looking into possible adverse events related to the use of a particular drug or other medical product, the agency will query the databases of the organizations that volunteer to be a part of the Sentinel System.
People will benefit because FDA will have better, more robust tools to do its job. We will be able to identify potential problems sooner, better understand those problems, and ultimately, help health professionals and patients use medical products more safely.
After careful analyses by FDA, confirmed findings will be communicated through one of the various methods currently available to the agency, such as changing a product's labeling, issuing alerts to health care professionals, or issuing a press release.
Ensuring the protection of privacy and preserving the control of information is very important to patients, and we've made it an important part of this initiative. As the Sentinel System is currently envisioned, the data will remain with its data holders who will continue to manage the data in accordance existing privacy and security safeguards. FDA will be able to query those data holders who participate in the Sentinel System. The data holders will evaluate their data and send the results of their evaluations to FDA for further analysis.
Medicare Part D will be handled in a slightly different way. With the new Medicare Part D regulation, CMS will be able to, for the first time, link medication data (Part D) with hospital and physician data (Parts A and B). Under the Sentinel Initiative, this new, much larger dataset would be available to FDA for analysis with, among others, the following privacy safeguards in place: only information without patient names and other identifying information will be received.
No. The system will analyze large sets of data; it won't access individual medical records. In the case of Medicare data, only de-identified data will be accessed, meaning that only information without patients' names and other identifying information will be accessed. When we're working with other federal and private entities, we would ask a question or questions, and the data holders would conduct the query and then provide the information to FDA which we can then analyze in aggregate.
A new federal regulation makes 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. FDA is planning to use this Medicare data as part of the Sentinel System, as well as data from other government and private health care organizations that volunteer to participate.
The budget impact of theSentinel Initiative for FDA will largely involve the time and effort of current FDA scientists and researchers to conduct the initial planning and analysis of the initiative and to coordinate input that FDA receives from stakeholders.