HHS Set to Launch Drug Data Tracking System

A new electronic data mining system that will allow federal and state agencies and academic researchers to use existing medical records and claims information to more effectively track the postmarketing safety profile of various drugs and medical devices is expected to launch in June.

The Sentinel System will allow FDA researchers access to CMS data from more than 25 million Medicare drug benefit beneficiaries. The researchers will use the system to pull specific information from those patients' records, with the goal of tracking drug side effects that did not show up in premarketing clinical trials.

HHS and FDA officials also are speaking to private insurers about including data from their plans in Sentinel. Indianapolis-based WellPoint Inc., which serves some 35 million members, already has thrown its support behind the system.

The current system for monitoring drug and medical device safety after these products have hit the U.S. market is tied largely to voluntary reports, with physicians and other health care providers reporting on drug side effects via the MedWatch program, a joint project of the FDA and CDC. However, many such events go unreported, according to FDA officials, and the current system lacks the sophisticated data mining tools the new program offers.

In the Sentinel System, if FDA researchers have concerns about the side effects of a particular drug in patients older than age 65, for example, they could first pose a data query to see how many Medicare patients use the drug in question. They then could use the system to determine how many of those patients have sought care for a certain medical problem, such as a heart attack. Researchers then could drill further into the data to determine if the heart attack appeared to be closely related to the drug.

The result might be new drug safety warnings or more detailed package labeling to alert physicians about potential side effects in certain types of patients.

"With the Sentinel System, we will no longer have to wait years to see how a drug or medical device is affecting millions of people," FDA Commissioner Andrew Eschenbach, M.D., said in a May 22 HHS news release. "The era of 'Wait and see' is going to become the era of 'Tell me right now.'"

FDA officials said that the system includes safeguards so information that could identify patients would be separated from the data collected to preserve patients' privacy.

In addition to improving patient safety, the system is expected to provide information that would enable government payers to make better decisions about how to reimburse for certain drugs or other therapies; it also could aid in determinations about whether payers should cover certain drugs or emphasize their use.