- The Washington Times - Wednesday, January 18, 2006

The U.S. Food and Drug Administration yesterday previewed major changes for warning labels and package inserts of prescription drugs with the hope of reducing errors in medication use.

Each year, about 300,000 preventable mistakes occur in U.S. hospitals, many as a result of confusing medical information, Surgeon General Dr. Richard H. Carmona said during a press conference at which the changes were announced.

In the past decade, the prescribing information for newly approved drugs has become increasingly complicated, and specific information is often difficult to locate.

“Prescription drug information often reads more like legal disclaimers than useful health information,” the surgeon general said.

Dr. Andrew von Eschenbach, acting commissioner of the FDA, said the changes, planned since 2000, will be required for all prescription drugs approved in the past five years. He and officials also voiced the hope that drug makers voluntarily adopt the revisions for older drugs as well.

The newly designed package insert will provide the most up-to-date information about a drug in an easy-to-read format designed to draw a physician’s attention to the most vital data before a drug is prescribed.

“This is the first major overhaul of prescription drug information in a quarter century, and the changes will enable the revolution in electronic prescribing of medications” that has already begun to be adapted, said Dr. Janet Woodcock, the FDA’s deputy commissioner of operations.

But no one foresees 25 more years without further changes.

“Today’s initiative is one major step, with other steps to follow,” Dr. von Eschenbach said.

As part of the overall modifications, Dr. Woodcock said, “we are launching a totally new look for prescription labels,” because research shows that prioritizing the warning information about a drug has a major effect in decreasing its improper usage.

With the changes, there will be a reorganization of critical drug information, so doctors can find it more easily.

Some of the most significant changes in prescription information include:

• A highlights section, complete with “black box” warning information. Dosage, drug interactions, information about patients who should never receive the drug and its most common and serious side effects.

• A table of contents for easy reference to detailed safety information.

• The date of initial product approval, making it easier to know how long a drug has been on the market.

cA toll-free number and Internet reporting information for suspected adverse reactions to encourage more widespread reporting of potential side effects.

Numbers will be provided both for the FDA and for the drug’s manufacturer.

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