Prescription drug insert information made clearer

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Prescription drug insert information made clearer

The Food and Drug Administration is making prescription drug information easier to understand.

What happened: On Jan. 18, 2006, the Food and Drug Administration (FDA) issued new guidelines designed to make the printed information included with prescription drugs easier for doctors and consumers to understand.

This material, called package inserts, provides information on the usage and risks of medications — including warnings, side effects, contraindications and interactions with other drugs. The FDA says it is concerned that the old format plus information overload mean that some of the information may not be getting through to doctors and consumers, resulting in thousands of "preventable adverse events" every year.

The FDA says the new guidelines provide for "clear and concise information" in the package inserts, with the information to be presented in a standardized graphical format. The most notable change, according to the FDA, is the addition of a summary — labeled "Highlights" — outlining the most important information. The new labels will be phased in gradually on a voluntary basis.

What does this mean to you? You've no doubt seen them many times — those multiply folded, small-type, hard-to-understand pieces of paper that are included when you pick up a prescription.

Now, as the new labeling requirements are gradually phased in, the information should be presented in a way that's easier to read and understand. The FDA is hoping that the new regulations will make clearer the benefits and risks of medications, thereby reducing medical errors and adverse events.

Last Updated: 01/20/2006
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