Pharmacy Times
Volume 0

In an effort to reducemedication errors, theFDA has announced amajor overhaul of prescriptiondrug packageinserts. Drug regulatorssaid that the changewould make Rx package inserts more readableby physicians and pharmacists.

Many of the 300,000 preventable adverseevents that occur in US hospitals each year are theresult of confusing medical information. Federalhealth officials hope that the reorganized prescriptioninformation will help to reduce the number ofthese events.

"By improving the package insert to make itmore useful for health care providers in their day-to-day clinical practice, we are making it easier forthem to explain the benefits and risks of medicationsfor their patients," said Health and HumanServices Secretary Michael O. Leavitt.

The revised package inserts will include a newsection called Highlights to provide immediateaccess to the most important prescribing informationabout benefits and risks. Other new featureswill include a table of contents for easy referenceto detailed safety and efficacy information, informationon the date of the initial product approval,and a toll-free number and Internet reporting informationfor suspected adverse events.

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