Improving Patient Safety: New Format for Drug Labels
The FDA has unveiled a major revision to the format of drug labels (package inserts) to give health care professionals clearer and more concise prescribing information. The plan also includes a government database that allows people to search for information online.
The format is being revised for the first time in more than 25 years. FDA officials said that one goal was to ensure that doctors would not overlook essential safety information, which is often buried deep in the document.
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The labels will include (1) the date of initial U.S. approval, (2) recent changes to information about the drug, (3) a toll-free phone number for patients or doctors to report suspected side effects to the FDA, (4) drug interactions discussed in one place, and (5) a section prompting doctors on keys facts to relay to patients. The format also includes a summary of important information at the top (“Highlights”), a “table of contents,” a section on patient counseling, and greater prominence of essential prescribing information.
These changes are to take effect by the spring for new drugs and their new approved uses.
