Policymakers' and patient advocates' continued call to keep patients safe has stimulated innovations targeting quality and safety improvements across health care. The Sentinel Initiative, a result of the Food and Drug Administration's Amendments Act of 2007, is designed to be such an improvement.
Launched in 2008, the electronic Sentinel System monitors the safety of new medical products. It enables the FDA to pose targeted safety questions to data partners in academic medical centers, health systems and health insurance companies to improve understanding of medical product safety.
Having met its first milestone last July, the FDA now has access to electronic health care data for more than 25 million patients. The agency is on track to hit its next major milestone—100 million patients—by July 2012, according to the initiative's project director,
"Unlike existing FDA surveillance systems, Sentinel's active surveillance capabilities will enable the FDA to use existing electronic health care data in near real time, a key advantage for evaluating and understanding safety issues," she adds.
"Nothing like this has ever been done," says Thomas Gross, M.D., deputy director in the FDA's Office of Surveillance and Biometrics at the Center for Devices and Radiological Health. In the past, the FDA relied primarily on spontaneous surveillance systems, collecting voluntary reports from clinicians or manufacturers, which limited its ability to get real-time information. The Sentinel System will augment that approach with a greater quantity of information.
The law requires the FDA to develop partnerships with academic, public and private entities to access multiple data sources, such as administrative data, pharmacy dispensing data and electronic health records. Harvard Pilgrim Health Care Institute, which is affiliated with the Harvard Medical School in Boston, created a mini-sentinel system to develop and test protocols that should aid the larger program.
"We're increasing the size of the population we can evaluate, as well as adding new kinds of data from the electronic health record," says Richard Platt, M.D., professor of population medicine at Harvard Medical School.
The Sentinel System will allow the FDA to monitor the safety of patients in several significant ways, explains Platt. For example, the FDA will have the ability to quickly identify groups exposed to a product that has come into question to determine if patients have experienced similar events.
"Having the ability to look forward when the FDA has a reason to look, and look back quickly, if necessary, is key," says Platt, also stressing the need to interpret findings appropriately and consider that patients taking certain medications already may be at higher risk for various complications.
"The industry is looking forward to having additional data about the post-market experience," says Jeff Secunda, vice president of technology and regulatory affairs and Sentinel System point person for the Advanced Medical Technology Association. He cautions that data aggregated from a number of sources may be a "sentinel for a potential problem," but not confirmation of a real problem.
"FDA officials have said they will not take action solely on findings from this data, but rather use it to investigate further or do a focused follow-up study," says Secunda. "If findings were made public before a complete study could be performed, the public and media could draw conclusions on their own."