Opinion

New drug labels: Easing information overload

The American Medical Association applauds the Food and Drug Administration's attempt to make medication package inserts easier for physicians to digest.

Posted March 13, 2006.

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Each year the Food and Drug Administration approves more than 100 new drug applications, including about 30 medications never before marketed in any form. The agency also gives the nod to more than 100 new or expanded uses for existing medications.

On top of that, special black-box warnings are attached to some drugs' labeling information. The agency is currently pondering adding such an alert to the package inserts for drugs that treat attention-deficit/hyperactivity disorder. Hundreds of medications have these special warnings.

Keeping up to date on this ever-changing prescription drug landscape is overwhelming for physicians.

Ironically, the package inserts that come with these medications have become so dense, lengthy and complicated that they are almost impossible to navigate, let alone absorb. Instead of serving the original intent as a tool to give doctors information they need about a medication, package inserts have become largely a legal document aimed protecting drugmakers.

Fortunately, the FDA has recognized the problem and is trying to do something about it. The agency last month came out with new rules for prescription drug labels -- the first revision in more than 25 years.

The American Medical Association, which long encouraged the agency to update the package insert to make it more user-friendly for doctors, has applauded the move. The Association has testified before Congress and the FDA about the need for these improvements and adopted policy in 2005 urging the agency to publish final drug label rules.

The FDA took a practical approach by adopting an "easy-to-read" format that it hopes will make the contents more memorable for physicians. At the top of the updated package insert will be a new highlights section. This will give a brief outline of the most important information about the medication, including boxed warnings, indications and usage, dosage and administration, and any substantive changes in the past year. This summary will typically run half a page, the agency predicts.

The new labels also will include a table of contents, which will make them easier to navigate. The section giving full prescribing information will be reorganized to give greater prominence to the most important and commonly referenced materials.

Patients are demanding more information than ever from physicians about the drugs they are prescribing. The FDA aims to ease communication between the two with a new section in the package insert called Patient Counseling Information. It is designed to help physicians advise patients about the important uses of medications, as well as their limitations and risks.

The agency hopes all these changes to medications' packaging materials will improve patient safety. Research shows that prioritizing warning information helps reduce adverse events, the FDA states.

The new rules go into effect June 30 for new drugs. Medications approved in the last five years will be phased in gradually. Makers of older drugs aren't required to change their labels but can do so voluntarily.

U.S. Surgeon General Richard H. Carmona, MD, MPH, got it right when he said Americans had "hit a point of information overload." The old legalistic drug package inserts were part of the problem, he said when the new rules were announced.

The medication label changes will help doctors out of the swamp of drug data and will equip them better to assist patients in traversing this difficult terrain.

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External links

Food and Drug Administration's new requirements for prescribing information (link)

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