FDA revamps rules for drug package inserts
will make medicines safer. The layout of prescription drug package
inserts have been updated for the first time in 25 years, requiring
drug makers to provide doctors with easier access to important
information about drug safety.
Over the past ten years, the prescribing information for newly approved products has become more complex, and specific information is often difficult to locate in the package insert.
In US hospitals, 300,000 preventable adverse drug events occur every year, many as a result of confusing medical information.
Research shows that prioritizing the warning information has a greater impact on reducing these events.
With this in mind, the >FDA, has designed a new package insert that will give the most up-to-date information in an easy-to-read format and draws the doctor's attention to the most important pieces of drug information before a product is prescribed.
"Providing healthcare professionals and patients with clear and concise information about prescriptions will help ensure safe and optimal use of drugs, which translates into better health outcomes for patients and more efficient delivery of healthcare," said US Health and human Services secretary Mike Leavitt.
The new drug labeling requirements will be phased in gradually and will initially apply to newly approved prescription drugs and those approved within the last five years, including drugs that receive approval for new uses.
The FDA is also encouraging drug makers to comply with the new labeling requirements earlier on a voluntary basis.
The most significant format change is a new half-page section called Highlights, which will provide immediate access to the most important prescribing information about benefits and risks and include Boxed Warning, Indications and Usage, and Dosage and Administration sections.
Other new features include a Table of Contents, for easy reference to safety and efficacy information; the date of initial product approval, to indicate how long a product has been on the market; contact information for reporting suspected adverse drug events; and a new Patient Counseling Information section to encourage communication between doctors and patients.
Drug makers will now also be required to update the package insert each year and include a list of all substantive changes made within the year.
In addition to the new labeling rules, the FDA has also been actively taking steps to improve drug safety through implementing new requirements for electronic labels and barcodes on drugs.
