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The U.S. Food and Drug Administration (FDA) today unveiled a major revision to the format of prescription drug information, commonly called the package insert, to give healthcare professionals clear and concise prescribing information. In an effort to manage the risks of medication use and 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 will also 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," said HHS 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, approximately 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 format 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, 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. We have hit a point of information overload and the public health message is being diluted," said Richard H. Carmona, M.D., M.P.H., FACS, U.S. Surgeon General. "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 the information they need quickly. Some of the most significant changes include:
"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," said Andrew von Eschenbach, M.D., FDA Acting Commissioner of Food and Drugs. "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 healthcare 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; and will refer the healthcare professional to the appropriate section 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 healthcare professionals have immediate access to the most up-to-date information about the product before prescribing it.
Over the past ten 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 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.
The addition of a new Patient Counseling Information section places greater emphasis on the importance of communication between professionals and patients. This new section is designed to help doctors advise their patients about important uses and limitations of medications. It will also serve as a guide for discussions about the potential risks involved in taking a specific treatment and steps for managing those risks. If FDA has approved patient information for a prescription drug, it will be printed at the end of the label immediately following the Patient Counseling Information section or will accompany the label so it can be easily shared.
"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 healthcare professionals with critical information at the point of care," said von Eschenbach. "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 healthcare professionals and consumers obtain information about prescription drugs."
The new prescription information format will be integrated into FDA's other e-Health initiatives and standards-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, healthcare professionals and healthcare information providers. The DailyMed is now making up-to-date information about FDA-regulated products widely available on the Internet free of charge. This information can be accessed through the National Library of Medicine at http://dailymed.nlm.nih.gov. In the future, this new information will also be provided through a website called facts@fda, a comprehensive Internet resource designed to give one-stop access for information about all FDA-regulated products.
In December 2000, before issuing the proposed rule the agency evaluated extensive information it received on the usefulness of the present prescription drug labeling for healthcare professionals to determine how content and format could be improved. The agency used feedback from focus groups, national physician surveys, a public meeting and written comments to design the new prescription information format. FDA determined the most common practices for using prescription drug labeling, as well as information considered to be most important, and then developed the new format based on this information. The new drug labeling requirements will be phased in gradually and initially will apply to newly and recently approved prescription drugs and drugs that receive approval for new uses. The agency is encouraging drug makers to consider complying with the new labeling requirements earlier on a voluntary basis. All drugs approved within the past five years are included, and they will gradually be converted to the new prescribing information format.
For additional information, please visit CDER's website: http://www.fda.gov/cder/regulatory/physLabel/default.htm
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Final Guidances for Industry: Content and Format of Labeling for Human Prescription
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Federal Register [PDF,
520KB]
Guidance: Clinical Studies [PDF,
127KB]
Guidance: Adverse Reactions [PDF,
52KB]
Draft Guidances for Industry: Content and Format of Labeling for Human
Prescription Drug and Biological Products
Federal Register [PDF, 483KB]
Draft Guidance: Implementing
the New Content and Format Requirements [PDF, 214KB]
Draft Guidance: Warnings
and Precautions, Contraindications, and Boxed Warning [PDF, 58KB]
Final Rule: Requirements on Content and Format of Labeling for Human Prescription
Drug and Biological Products
Final Rule: Part 1 [PDF,
9.7MB]
Final Rule: Part 2 [PDF,
9.9MB]
Final Rule: Part 3 [PDF,
6.7MB]
Better Prescription Drug Information (Slides from Jan. 18 Press Conference)
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