A Diagnostics & Imaging Week

The task of keeping an eye on drug and device safety sometimes seems more than one agency can handle, and the Department of Health and Human Services has decided to put the job in the hands of two agencies at HHS.

HHS Secretary Mike Leavitt reported efforts undertaken jointly by FDA and the Centers for Medicare & Medicaid Services that will "complement each other to improve patient safety and the quality of medical care," according to the accompanying press release, which described the plan as the Sentinel Initiative.

The Sentinel Initiative "will include the development of a new electronic system that will enable FDA to query a broad array of information to identify possible post-market adverse events," according to the HHS statement. The system "will be created through public-private partnerships and will capitalize on existing large electronic claims and medical records data sources maintained by private and government entities," the statement said.

In the accompanying white paper, FDA chief Andrew von Eschenbach, MD, said that despite the agency's efforts to track drugs and devices, "uncertainties about the safety of medical products regulated by the FDA will always remain." He added that any electronic system "would need to have the capability to draw data from sources like electronic health records and medical claims" from public and private sources and "should strengthen the ability of the FDA to query other systems quickly and securely ... within appropriate privacy guidelines."

According to the white paper titled "The Sentinel Initiative A National Strategy for Monitoring Medical Product Safety," Leavitt queried FDA in 2005 about "the possibility of building on the capabilities of multiple data systems to augment the agency's data query capability" in such a way as to create a public/private partnership and make use of the greater availability of large electronic databases. The discussion also included making use of both emerging technology and existing systems rather than putting together a system from scratch.

The Food and Drug Administration Amendments Act of 2007 (FDAAA) put congressional weight behind the initiative, specifically calling for HHS "to develop methods to obtain access to disparate data sources and to establish a post-market risk identification and analysis system to link and analyze healthcare data from multiple sources," according to the white paper. FDAAA set a goal of giving the Sentinel database access to data from 25 million patients by July 2010 and another 75 million two years later. This, of course, requires "FDA to work closely with partners from public, academic, and private entities," the white paper notes.

As one might expect, a number of hurdles stand between the plan and its completion. The white paper cites privacy among these, but also says that the governance structure of the initiative will also be key.

Data collection will, of course, be at the heart of the effort, and the white paper acknowledges that problems of interoperability of the varying computer systems will surely create a lot of work. Still, the planners are optimistic, stating that "efforts already underway elsewhere in the private and public sectors ... and the standards efforts that have been advanced and supported by HHS should facilitate the interoperability necessary."

The paper notes that FDA has a number of memoranda of understanding for data sharing with a number of other agencies, including Veteran's Health and the Department of Defense, both of which were signed last year. The Center for Devices and Radiological Health is working with the Dartmouth Center for the Evaluative Clinical Sciences (Hanover, New Hampshire) on a pilot study to evaluate whether Medicare Part A and Part B claims data can help with post-market surveillance of treatments related to abdominal aortic aneurysms. The Sentinel effort will require the development and validation of data mining software as well.

Leavitt said in the HHS statement that the initiative moves FDA "from reactive dependence on voluntary reporting of safety concerns to proactive surveillance of medical products on the market" and noted that "Medicare data on prescription drug use will be available to help government agencies and academic researchers improve the safety, quality and efficiency of healthcare services."

As for CMS's Medicare database, the word massive sounds stingy. HHS said that Medicare beneficiaries use an average of 28 prescriptions a year, a sharp contrast to the 13 that is typical of the rest of American society. That trove of information could provide data on as many as 25 million Americans, which would cover the statutorily imposed numeric requirement for 2010. The white paper described Part D data as including about a billion claims a year, which will "provide the FDA, other agencies, and researchers with a powerful new tool to investigate potential drug safety problems and questions about health outcomes."

Among the private sector data sources cited in the white paper for potential use and incopration into the Sentinel System is the Regenstreif Medical Record System, which boasts a database of more than three million patients and 32 million patient orders.