In an effort to reduce medication errors, the FDA has announced a major overhaul of prescription drug package inserts. Drug regulators said that the change would make Rx package inserts more readable by physicians and pharmacists.
Many of the 300,000 preventable adverse events that occur in US hospitals each year are the result of confusing medical information. Federal health officials hope that the reorganized prescription information will help to reduce the number of these events.
"By improving the package insert to make it more useful for health care providers in their day-to-day clinical practice, we are making it easier for them to explain the benefits and risks of medications for their patients," said Health and Human Services Secretary Michael O. Leavitt.
The revised package inserts will include a new section called Highlights to provide immediate access to the most important prescribing information about benefits and risks. Other new features will include a table of contents for easy reference to detailed safety and efficacy information, information on the date of the initial product approval, and a toll-free number and Internet reporting information for suspected adverse events.
One study linked multiple pregnancies to an increased risk of developing atrial fibrillation later in life, and another investigated the association between premature delivery and cardiovascular disease.
Clinical features with downloadable PDFs