Rapid Leaning to Improve Drug Safety in the USA.

The US Food and Drug Administration has announced a very important data mining initiaitive.

F.D.A. to Expand Scrutiny of Risks From Drugs After They’re Approved for Sale

By GARDINER HARRIS

WASHINGTON — Chastened by repeated instances in which popular medicines proved deadly, federal health officials announced a major effort on Thursday to use information on Medicare claims to assess the risks of drugs already on the market.

The new system, called the Sentinel Initiative, will allow officials from the Food and Drug Administration for the first time to monitor almost immediately how drugs affect health. As it stands now, months or even years must pass before officials learn of unexpected side effects that can cost dozens or even thousands of lives.

“It will be a quantum leap forward in F.D.A.’s capacity to monitor the use of medical products that are currently on the market,” said Health and Human Services Secretary Michael O. Leavitt.

In two news conferences, officials made repeated assurances that the agency and other researchers would not have access to any of the personal information of Medicare beneficiaries.

Researchers praised the government initiative, but many said its fruits would take years to realize. And several said the Bush administration’s policy of delivering the Medicare drug benefit through myriad private plans made the effort that much more difficult.

“This is going to take a lot of work,” said Dr. Bruce Psaty, a professor of medicine and epidemiology at the University of Washington.

Mr. Leavitt said “the power of this is in the capacity to take disparate databases and use it in a productive way.” Dr. Janet Woodcock, director of the F.D.A.’s drug center, agreed that much work remains to be done.

The Sentinel Initiative has been in the works for years. In 2005, Mr. Leavitt asked the F.D.A. to explore the creation of such a system. In 2006, the Institute of Medicine recommended one, and last fall Congress voted to require the agency to create such a system.

The agency now relies on an unsystematic system in which doctors, patients and manufacturers report problems with drugs and medical devices when they deem them important. One doctor might see an infection following the use of a drug as important to report while another might not. The agency estimates that it receives reports for only a fraction of actual drug effects.

More here:

http://www.nytimes.com/2008/05/23/washington/23fda.html?_r=1&ref=health&oref=slogin

Another report regarding the same initiative is here:

Program Aims for Drug, Device Safety

By Rob Stein

Washington Post Staff Writer

Friday, May 23, 2008; A02

Federal health officials yesterday announced plans to begin mining the medical records of millions of patients to try to identify safety problems from drugs and medical devices more quickly.

The Sentinel Initiative will enable the Food and Drug Administration and others to analyze the growing number of databases of health records compiled by the government, health insurers and HMOs to try to identify drug- and device-related problems sooner than does the current system, which relies primarily on voluntary reporting by individual doctors.

"It will be a quantum leap forward in the FDA's capacity to monitor the use of medical products that are currently on the market," said Health and Human Services Secretary Mike Leavitt. "We are moving from reactive dependence on voluntary reporting of product-safety concerns to proactive surveillance of medical products that are currently on the market. The result will be much improved safety."

The agency plans to start by analyzing data collected about the more than 25 million people enrolled in the new Medicare prescription drug program. State agencies and academic researchers will also have access to the data under a new federal regulation that will go into effect in 30 days, officials said.

"The FDA will eventually be able to query databases of tens of millions of patients almost simultaneously," Leavitt said.

The officials stressed that the system will protect patient privacy by keeping all identifying information confidential.

"FDA will not receive information that identifies individual patients, so patient privacy will remain protected," Leavitt said.

More here:

http://www.washingtonpost.com/wp-dyn/content/article/2008/05/22/AR2008052203918.html

This is a great initiative as not only will it help identify issues with new medicines in the post marketing phase for citizens in the USA but it will also provide valuable information as to what potential problems our TGA should be alert to. That is of course until they get a similar system operational in Australia.

I am sure they have it planned and are just awaiting funding! (I hope).

David.