FDA announces revisions to prescription drug package inserts

February 2006

The FDA unveiled a major revision to the format of prescription drug information, commonly called the package insert, to give health care professionals clear and concise prescribing information.

The new format will also make prescription information more accessible for use with electronic prescribing tools and other electronic information resources.

“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,” Andrew von Eschenbach, MD, acting commissioner of the FDA, said in a statement. “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.”

Changes to reduce complexity

Revised for the first time in more than 25 years, the new format requires prescription information for new and recently approved products to meet specific graphical requirements and include the reorganization of critical information, so physicians can find the information they need 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; and
• A toll-free number and Internet site for reporting information about suspected adverse events to encourage more widespread reporting of these events.

“Providing health care 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 health care,” Michael Leavitt, secretary of the U.S. Department of Health and Human Services, said in the release. “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.”

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, which will help health care professionals find the information they need quickly. This section, called “Highlights,” will typically be half a page in length; will provide a concise summary of information about specific areas, including Boxed Warning, Indications and Usage and Dosage and Administration; and will refer the health care professional to the appropriate area of the Full Prescribing Information section.

In addition, drugmakers will be required to include a list of all substantive recent changes made within the year, which will help 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 increasingly 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 FDA reorganized the Full Prescribing Information section to give greater prominence to the most important and most commonly referenced information.

As a result of feedback from two national physician surveys, the FDA moved the Indications and Usage and the Dosage and Administration sections to the beginning of the Full Prescribing Information section.

The addition of a new “Patient and Counseling Information” section places greater emphasis on the importance of communication between professionals and patients and helps physicians advise patients about uses and limitations of medications. It also serves as a guide for discussions about the potential risks involved in taking a specific treatment and steps for managing those risks.

Any patient information for a prescription drug will be printed at the end of the label, immediately following the “Patient Counseling Information” section, or it will accompany the label.

What prompted the change?

Each year, approximately 300,000 preventable adverse events occur in hospitals in the United States, many as a result of confusing drug information. Research shows that prioritizing the warning information has a greater effect on reducing such events. Therefore, the new prescription label format provides the most important information about a prescription product in ways that are better understood, more easily accessible and more memorable for physicians.

By making these changes, the FDA is seeking to reduce the complexity of information on prescription drug labels, making them more useful for physicians and their patients.

“Americans are overwhelmed with the complexity of health information,” Richard H. Carmona, MD, MPH, FACS, the U.S. surgeon general, said in a statement. “We have hit a point of information overload and the public health message is being diluted. 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.”

The new prescription information format will be integrated into the FDA’s other e-Health initiatives and standard-setting efforts through a variety of ongoing initiatives at the agency. As prescription information is updated in this new format, it will be used to provide medication information for DailyMed, a new interagency, online, health information clearinghouse that will provide the most up-to-date medication information free to consumers, health care professionals and health care information providers.

The DailyMed is now making up-to-date information about the FDA-regulated products widely available on the Internet free of charge. People can access this information through the National Library of Medicine at dailymed.nlm.nih.gov.

In the future, this new information will also be provided through a Web site called “facts@fda,” a comprehensive Internet resource designed to give one-stop access for information about all FDA-regulated products.

“In the last month, we have announced important steps toward creating an electronic environment for drug safety and effectiveness information that can provide patients and health care professionals with critical information at the point of care,” von Eschenbach said. “This revised prescription information format, in combination with new requirements for electronic labels announced earlier this month and requirements for barcodes on drugs, will dramatically improve the way health care professionals and consumers obtain information about prescription drugs.”

The new drug labeling requirements will be phased in gradually; they initially will apply to newly and recently approved prescription drugs – ie, drugs approved within the past five years – and drugs that receive approval for new uses.

The agency encouraged drug makers to comply with the new labeling requirements earlier and on a voluntary basis.

For additional information, visit the Center for Drug Evaluation and Research’s Web site at www.fda.gov/cder/regulatory/physLabel/default.htm.