By Ann Neuer

Oct. 6, 2008 | As part of its strengthening focus on product safety, the FDA is rolling out the Sentinel Initiative, a new effort that creates an integrated electronic system known as the Sentinel System for monitoring marketed medical products throughout their entire lifecycle.

Rachel Behrman, FDA’s Associate Commissioner for Clinical Programs, explains that the Sentinel System will enable FDA to conduct product safety queries proactively from multiple existing data sources from remote locations, such as electronic health record systems, medical claims databases, and possibly clinical trial databases if they overlap with those of marketed products. “Data sources will be maintained by their owners and will remain behind the firewall of the data owner. We are not creating one big database,” she says.

To conduct the queries, the Sentinel System will operate using a public-private partnership model with stakeholders, such as pharmaceutical, biologics and medical device manufacturers, insurance plans, the Veterans Health Administration, Medicare, academics, and patient organizations. Queries, such as how many patients taking a specific antibiotic had a certain adverse event, will be constructed centrally, and data owners who house such information will be solicited to participate in the query voluntarily. The results will then be returned to FDA for analysis. No personal information will be transferred.

Because the Sentinel Initiative launched in May, it is very much in the formative stages. “Currently, we are working on what the governance structure will look like,” says Behrman. “The system will rely heavily on data standards and we expect to work with existing standards organizations.” She says that the agency started with a series of stakeholder meetings to convey the agency’s vision. “We are looking to have preliminary documents available shortly for discussion.”

How organizations become stakeholders and how the Sentinel System will work from an IT perspective has not been fleshed out, but will be more fully defined as the governance structure is developed. As envisioned, the Sentinel System can be achieved with minimal transfer of data and will build upon investments made by The Department of Health and Human Services (HHS) in health information technology programs that have already been launched.

A key feature of the Sentinel System is that it will operate proactively. Once fully operational, Sentinel will enable FDA to evaluate massive amounts of information generated from the point of care and allow researchers to learn as much as possible from data that yields firm understandable answers, instead of partial information, mis-information or mis-interpretable information. This is an important differentiation from MedWatch, FDA’s safety information and adverse event reporting system.

MedWatch operates by receiving and then disseminating safety reports from healthcare professionals and consumers about adverse events they suspect are associated with drugs and medical devices. Often these reports contain limited or incomplete information about a single event that cannot be put in a larger context. For example, did the reported event happen to one consumer out of 100 or one consumer out of 10,000? Furthermore, many adverse events are never reported to MedWatch. By comparison, the Sentinel System is being designed to handle large queries and will not rely on the reporting of suspected adverse events. Ultimately, a report sent to MedWatch could be evaluated using the Sentinel System.

To start, there are several pilot projects and most recently, FDA granted eight contracts to external organizations such as Harvard Pilgrim Health Care, IMS Government Solutions, and Booz Allen Hamilton.

Behrman says, “This is the future. This won’t be easy, so our stakeholders are cautiously optimistic. FDA is well positioned to take a leadership role and we’ve gotten active participation from our outreach efforts.”
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