Prescription Drug Information Labels

by Food and Drug Administration (FDA)

In January 2006, the Food and Drug Administration unveiled a major revision to the format of prescription drug information, commonly called the package insert. To manage the risks of medication use and to reduce medical errors, the newly designed package insert will provide the most up-to-date information in an easy-to-read format that draws physician and patient attention to the most important pieces of drug information before a product is prescribed. The new format also will make prescription information more accessible for use with electronic prescribing tools and other electronic information resources.

"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," says Health and Human Services Secretary Mike Leavitt. "By improving the package insert to make it more useful for healthcare 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."

Each year, about 300,000 preventable adverse events occur in hospitals in this country, many as a result of confusing medical information. Research shows that prioritizing the warning information has a greater impact on reducing such events. Therefore, the new prescription label provides the most important information about a prescription product in a format that is better-understood, more easily accessible, and more memorable for physicians. By making these changes, the FDA is seeking to simplify the information on prescription drug labels, making the labels more useful for physicians and their patients.

"Americans are overwhelmed with the complexity of health information. We have hit a point of information overload and the public health message is being diluted," says Surgeon General Richard H. Carmona, M.D. "This is of great concern when it comes to making sure a patient knows how to use prescription drugs safely and effectively. This problem is compounded by prescription medication information that reads more like legal disclaimers than useful or actionable health information."

Revised for the first time in more than 25 years, the new format requires that the prescription information for new and recently approved products meet specific graphical requirements and includes the reorganization of critical information so physicians can find it quickly. Some of the most significant changes include:

• a new section called Highlights to provide immediate access to the most important prescribing information about benefits and risks
• a Table of Contents for easy reference to detailed safety and efficacy information
• the date of initial product approval, making it easier to determine how long a product has been on the market
• a toll-free number and Internet reporting information for suspected adverse events, to encourage more widespread reporting of suspected side effects.

"The new label design makes it easier for doctors to get access to important information about drug safety and benefits, and this in turn will help them have more meaningful discussions with their patients," says Acting Commissioner of Food and Drugs Andrew von Eschenbach, M.D. "This redesigned label is a big step in our commitment to giving health professionals the tools and information they need to optimize their clinical practice and choose among a growing number of effective treatments to make more personalized prescribing decisions for their patients."

The most notable change is the addition of a summary outlining the most important information about a product, prominently displayed at the top of the page. Designed to help health care professionals find the information they need quickly, Highlights will typically be half a page in length and will provide a concise summary of information about specific areas including: Boxed Warning, Indications and Usage, and Dosage and Administration. This section also will refer the health care professional to the appropriate part of the Full Prescribing Information. In addition, drug makers will be required to include a list of all substantive recent changes made within the year, to ensure that health care professionals have immediate access to the most up-to-date information about the product before prescribing it.

Over the past 10 years, the prescribing information for newly approved products has become more complex, and specific information is often difficult to locate. Physicians will now be able to find critical information more quickly, through a new Table of Contents that refers readers to detailed information located in the label. The Full Prescribing Information is reorganized to give greater prominence to the most important and most commonly referenced information. As a result of feedback from two national physician surveys, the Indications and Usage and the Dosage and Administration sections are moved to the beginning of the Full Prescribing Information.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.