Prescription Drug Information Changes: Why Now?
The print is extremely small.
Information is long and confusing.
It's important to read and understand it.
But, it's over your head.
It's difficult, and some may say nearly impossible, to determine which are the most important facts you should glean from prescription drug information. Frustrated? Understandably so. But it's going to get better.
For the first time in over 25 years, the U.S. Food and Drug Administration (FDA) is redesigning the prescription drug information, also known as the package insert, which is available for all prescription drugs. The redesigned prescription drug information will help to:
The public is overwhelmed by the complexity of prescription drug information, according to the FDA. The new format for prescription drug information will be more clear and concise. The most useful prescription drug information for patients and physicians will be moved to the top.
Adverse Events
About 300,000 adverse events occur each year in hospitals which are considered preventable. By making prescription drug information less complex and by prioritizing warning information, the FDA is trying to reduce the number of preventable adverse events.
Prescription Drug Information: What Will The New Design Look Like?
Healthcare providers need up-to-date information for the medications they prescribe. The new format will require that drugmakers provide a list of changes made within the year. Other prescription drug information format changes include:
When Will We See The New Format On Prescription Drug Information?
All new drugs approved after June 30 must include the new label for prescription drug information. Use of the new format will be phased in for drugs approved within the last 5 years, and drugs currently under FDA review.
Where Can You Get Prescription Drug Information?
Prescription drug information comes with the medication. The patient does not always see the prescription drug information on the package insert unless given an unopened bottle of medication. The prescription drug information can easily be found on the Internet or perhaps your pharmacist could provide a copy. It will also be used by DailyMed. DailyMed provides high quality information about marketed drugs. This information includes FDA approved labels (package inserts). This Web site provides health information providers and the public with a standard, comprehensive, up-to-date, look-up and download resource of medication content and labeling as found in medication package inserts
Related Prescription Drug Information
Source: FDA Announces New Prescription Drug Information Format To Improve Patient Safety, FDA, 1/18/06
