FDA revises package inserts to improve safety.(News)

Prescription drug package inserts will soon have a new format that U.S. Food and Drug Administration officials believe will reduce the risk of medical errors.

A goal of the "major revisions" announced by the FDA is to prioritize warning information and provide user-friendly access to the most important prescribing information. The new inserts will contain a "Highlights" section prominently displayed at the top of the first page, Dr. Andrew von Eschenbach, acting FDA commissioner, explained during a press briefing sponsored by the agency.

The new format will provide the most up-to-date information in a clearly organized, concisely written, easily accessed format so doctors can convey this vital information to patients, he said. Other key features of the new inserts will include a table of contents that provides reference to detailed safety and efficacy information, the date of initial product approval and information about any changes to the label in the past year, a patient counseling information section, and a toll-free number and Web site for reporting adverse events.

The revisions also were designed to make prescription information more accessible via the Internet: Information will be updated in real time to DailyMed, an interagency online health information clearinghouse, which can be accessed at http://dailymed.nlm.nih.gov, Dr. Scott Gottlieb, FDA's deputy commissioner of medical and scientific affairs, said during the briefing. This information will also be made available soon at a new Web site called Facts@FDA, which will provide comprehensive information about all FDA-regulated products, he noted. Some of the information also is available at Drugs@FDA, a consumer-oriented site (www.accessdata.fda.gov/scripts/cder/drugsatfda).

The electronic capability aspects of the new package insert requirements are one of the most "potentially exciting opportunities" created by the new system, he said, adding that the ...