New Prescription Medication Information Format Released

By Anonymous

The US Food and Drug Administration (FDA) has announced a major revision to the format of prescription medication information (ie, the package insert), according to a Jan 18, 2006, news release from the FDA. This is the first format revision in more than 25 years.

The revised format is intended to provide clear and concise prescribing information in an easy-toread format that draws physician and patient attention to the most important pieces of medication information before a medication is prescribed. The new format also will make prescription information more accessible for use with electronic prescribing tools and other electronic information resources. The new format will include

* a new “highlights” section that provides immediate access to the most important prescribing information regarding benefits and risks of taking the medication,

* a table of contents for easy reference to detailed safety and efficacy information,

* the date of initial product approval, and

* a toll-free telephone number and online instructions for reporting suspected adverse events to encourage more widespread reporting of suspected side effects.

FDA Announces New Prescription Drug Information Format to Improve Patient Safety (news release, Rockville, Md: US Food and Drug Administration, Jan 18, 2006) http://www .fda.gov/bbs/topics/news/ 2005/NEW01272.html (accessed 2 Feb 2006).

Copyright Association of Operating Room Nurses, Inc. Mar 2006