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Medicare-based system proposed to track safety, effectiveness of medications

Ambulatory Safety Monitor, June 9, 2005

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The head of Medicare has proposed a Medicare-based system that could help reduce the number of serious side effects for new medications, but Food and Drug Administration (FDA) officials are hesitant to commit to a new approach.

The system, proposed by Mark McClellan, a doctor, economist, and current head of Medicare, would take billing data from the prescription program, which will begin in January, and combine this information with healthcare information collected when Medicare beneficiaries submit claims for doctor and hospital care, according to the Los Angeles Times.

By cross-referencing the information, the data pool would be significantly larger than the current FDA reporting system, so problems could be detected more effectively than they are now, McClellan reportedly said.

The proposal comes after news about suspected links between Viagra and cases of vision loss, or heart attacks connected with Vioxx use. The current system detects no more than 10% of serious drug reactions, according to the Times.

"One of the main frustrations with Vioxx was that it was on the market for a number of years and used by millions of people, and only later was there a possible association with problems," McClellan reportedly said in an interview.

"There is a legitimate reason for the public to be concerned. In an era when we should be depending on electronic systems, it should not take five years and millions of patients before we get to a potential problem."

FDA officials responded by saying it was too early to commit to a new system, and that the agency would explore the proposal, according to the Times.

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