Two major government health agencies that have traditionally operated as self-contained bureaucratic fiefdoms announced a joint venture Thursday that promises to improve prescription drug safety for all Americans, while potentially reducing wasteful spending on medications.
The Food and Drug Administration and Medicare agreed on rules for using information from Medicare's giant claims databases to create a computerized early-warning network for problems with medications and medical devices that come to light after they go on the market.
Though Medicare will not turn over individual patients' data to the FDA, the two agencies' computers will now be able to talk to each other, in effect, to pose and answer questions that may reveal potentially risky side effects in new drugs. Since pre-market testing usually involves a limited number of patients, serious problems sometimes become evident only after hundreds of thousands of people begin using a product.
The new system, called the Sentinel Initiative, will eventually include private insurers as well, to fill in information gaps about drugs that elderly patients don't use, such as contraceptives.
The FDA's current early-warning system is nowhere near as comprehensive as the new system is expected to be. It relies on self-reporting by drug makers, hospitals and doctors, and is believed to capture only 1% to 10% of problems. Since the elderly are the major consumers of medications, Medicare's trove of inpatient, outpatient and prescription plan data is considered particularly rich.
Health and Human Services Secretary Mike Leavitt compared the FDA's current safety system to "looking at the stars from your backyard with the naked eye." The new system will provide a precise telescope, he added, and "you will see the stars trying to send you messages."
Setting up the network will not entail any major new expense for technology, officials said. Instead, the main task involves getting data experts from both agencies to work together under a mutually agreed-on framework.
Sentinel could save money, said Kerry Weems, acting administrator of the U.S. Centers for Medicare and Medicaid Services, citing estimates that the cost of treating preventable drug reactions in the elderly is as high as $900 million a year.
