TBO.com - TBO is Tampa Bay Online

Program To Watch Medicare Drug Use

ADVERTISEMENT

The Associated Press

Published: May 23, 2008

WASHINGTON - Federal health officials will use new regulatory authority to monitor prescription drug use by millions of Medicare participants for potential safety problems with medicines and medical devices.

The Food and Drug Administration has been under increasing pressure to develop a comprehensive drug surveillance system since the painkiller Vioxx was pulled from the market in 2004 after it was linked to increased risk of stroke and heart attack.

New regulations announced Thursday by the Health and Human Services Department will enable federal agencies, states and academic researchers to screen Medicare claims data.

Personal identity information will stay inside the Medicare agency and will not be part of the information that the FDA and others look at.

Medicare beneficiaries use an average of 28 prescriptions a year, and those who consider themselves in poor health have an average of 45 prescriptions annually, giving health officials a huge database of health records to tap.

Officials said they would no longer have to wait years to see how a drug or medical device affects millions of people.

"The era of wait and see is going to become the era of tell me right now," said the FDA commissioner, Andrew von Eschenbach.

The Institute of Medicine recommended creation of such a surveillance system in 2006.

The FDA currently relies on physicians and patients to report suspected adverse effects. Often, it takes a number of cases before someone at the agency detects a pattern that's worth investigating, then it conducts an investigation to determine whether the side effects were indeed caused by the drug. At the first hint of trouble, the FDA will now be able to query databases involving tens of millions of patients. It will not only be able to see the medications used, but also whether a patient had lab work done or whether they had to be hospitalized.

The first batch of records the agency will have at its disposal will be from 25 million Medicare beneficiaries. Later, private companies will contribute medical data, said Health and Human Services Secretary Mike Leavitt.

"We're moving from a reactive dependence on voluntary reporting of product safety concerns to a proactive surveillance of medical products currently on the market," Leavitt said.

Share this:

Loading Comments...

Email Print

ADVERTISEMENT