Drug safeguards to be bolstered

April 20, 2006|By JONATHAN D. ROCKOFF | JONATHAN D. ROCKOFF,SUN REPORTER

WASHINGTON -- The Food and Drug Administration announced yesterday another step toward making sure doctors have the most accurate information about prescription drugs.

Starting June 30, the agency will require manufacturers to provide the approved uses and serious side effects of their products in computer code that can be easily sent to physicians' computers and hand-held devices.

Frustrated with the complexity of official sources of drug information, many physicians have turned to private services that present the information in an easy-to-use format.

FDA officials, worried about the accuracy of material from private sources, are taking steps to reduce the estimated 300,000 medical errors that are made each year.

In January, the agency said it was simplifying the wording and organization of drug package inserts, most notably in a new "highlights" section.

The latest announcement builds on that effort by ordering drug manufacturers to provide the highlights material in a standardized electronic format. That should make it easier for private services -- along with federal health agencies and large health systems that have databases for doctors to use -- to quickly transfer the information to their systems.

"We want that information more accessible," said Dr. Randy Levin, the FDA's director for health and regulatory standards.

The next step is for the private information suppliers and health care companies to incorporate the material.

Linda Fischetti, a technology official at the federal Veterans Health Administration, said the agency wants to pass along the data to its doctors and nurses at patients' bedsides but did not know when that might begin.

jonathan.rockoff@baltsun.com

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