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  5. The FDA Announces New Prescription Drug Information Format
  1. Laws, Acts, and Rules

The FDA Announces New Prescription Drug Information Format

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.

The addition of a new Patient Counseling Information section places greater emphasis on the importance of communication between health care professionals and patients. This new section is designed to help doctors advise their patients about important uses and limitations of medications. It also will serve as a guide for discussions about the potential risks involved in taking a specific treatment and steps for managing those risks. If the FDA has approved patient information for a prescription drug, it will be printed at the end of the label immediately after 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," says von Eschenbach. This revised prescription information format, in combination with new requirements for electronic labels and requirements for bar codes on drugs, will dramatically improve the way health care professionals and consumers obtain information about prescription drugs, he says.

The new prescription information format will be integrated into the 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, health care professionals, and health care 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 Web site called facts@fda, a comprehensive Internet resource designed to give one-stop access to 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 health care 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. The FDA determined the most common practices for using prescription drug labeling, as well as information considered to be the 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 to 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.

Electronic Drug Labels

In November 2005, the FDA began requiring drug manufacturers to submit prescription drug label information to the agency in a new electronic format. This format will allow health care professionals and the public to more easily access the product information found in the FDA-approved package inserts for all approved medicines in the United States.

Under the new regulations, drug manufacturers are required to submit prescribing and product information in a structured product labeling (SPL) format that gives accurate, up-to-date drug information using standardized medical terminology in a readable, accessible format.

With embedded computer tags, information in the SPL format can be electronically managed, allowing a user to search for specific information. These tags can instruct computers to read specific sections of a drug label including product names, indications, dosage and administration, warnings, description of drug product, active and inactive ingredients, and how the drug is supplied.

Having the labels submitted to the FDA in SPL will improve the drug labeling review process, so that the agency can provide immediate access to the most recent information about medications to doctors and patients. Physicians will be able to quickly search and access the specific information they need before prescribing a treatment, resulting in fewer prescribing errors and better-informed decisions.

Products Affected

The new prescribing information requirements apply to:

  • prescription drugs, including those that were approved on or after the effective date of the final rule
  • drugs that had been approved in the five years before the effective date of the final rule
  • older drugs for which there is a major change in the prescribing information, for example, approval of a new use.

For More Information

The FDA's Center for Drug Evaluation and Research:
New Requirements for Prescribing Information

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