New Prescription Drug Information Format to Improve Patient Safety
Jan 20, 2006 - 3:09:37 PM
The U.S. Food and Drug Administration (FDA) 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. 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. 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. * 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.
* 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," said Andrew von Eschenbach, M.D., FDA Acting Commissioner of Food and Drugs. 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. 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. The addition of a new Patient Counseling Information section places greater emphasis on the importance of communication between professionals and patients. 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. All drugs approved within the past five years are included, and they will gradually be converted to the new prescribing information format.
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