New Package Inserts For Prescription Medications

U.S. health officials announced Wednesday a major overhaul of the package inserts that accompany prescription drugs.

It's hoped that the changes, designed to be easier to read and understand, will benefit not only doctors and other health-care workers, but consumers as well, officials said at a news conference.

"We see this as a platform whereby we can build much better consumer information," said Dr. Janet Woodcock, deputy commissioner for operations at the U.S. Food and Drug Administration. "This is just one step in getting better prescribing information to the people who need it."

The revisions, the first since 1975, will require that package inserts include a "prominently displayed summary of key information including indications, usage, dosage and administration," said FDA acting commissioner Dr. Andrew von Eschenbach. This summary, or "Highlights" section, will be about half a page in length, he said.

Health-care professionals can also expect to see a table of contents, patient-consulting information to ease communication between doctor and patient, as well as a toll-free number and Internet reporting information for suspected side effects. Drug manufacturers will also be required to provide a list of all substantive changes made to the product during the past year.

I hope they also make the print larger. It's just too tiny now.

More info here.

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