Updated April 24, 2015.

Something we stress on this site is educating ourselves. One of our Tips for Safe Medications Use includes keeping the package inserts from medications for future reference. Anyone who has read any of those package inserts knows that reading and understanding them has not been exactly easy.

This month, for the first time in more than 25 years, the FDA has made a major revision to the format for prescription drug information, the package insert.


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.

Health and Human Services Secretary Mike Leavitt stated:

• "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. 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."
  

U.S. Surgeon General Richard H.

Carmona, M.D., M.P.H., FACS, also issued a statement:

• "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... 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 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:

• 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.

Possibly the most important changes for patients are the addition of a summary outlining the most important information about a product, prominently displayed at the top of the page and a new Patient Counseling Information section places greater emphasis on the importance of communication between professionals and patients.

As prescription information is updated in this new format it will be used to provide medication information forDailyMed -- 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.

Approximately 300,000 preventable adverse events occur in U.S. hospitals annually, 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 is designed to provide information 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 patients.

As you fill prescriptions, watch for this new format on the package inserts. Hopefully, it will make this part of educating ourselves simpler and more effective.

 

___________________
Resources:

Food and Drug Administration. Press release, "FDA Announces New Prescription Drug Information Format to Improve Patient Safety." January 16, 2006.

U.S. National Library of Medicine, National Institutes of Health, Department of Health and Human Services. DailyMed. January, 2006.

 
The goal: More understandable information and fewer adverse events.
Something we stress on this site is educating ourselves. One of our Tips for Safe Medications Use includes keeping the package inserts from medications for future reference. Anyone who has read any of those package inserts knows that reading and understanding them has not been exactly easy.

This month, for the first time in more than 25 years, the FDA has made a major revision to the format for prescription drug information, the package insert. 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.

Health and Human Services Secretary Mike Leavitt stated:

• "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. 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."
  

U.S. Surgeon General Richard H. Carmona, M.D., M.P.H., FACS, also issued a statement:

• "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... 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 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:

• 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.

Possibly the most important changes for patients are the addition of a summary outlining the most important information about a product, prominently displayed at the top of the page and a new Patient Counseling Information section places greater emphasis on the importance of communication between professionals and patients.

As prescription information is updated in this new format it will be used to provide medication information forDailyMed -- 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.

Approximately 300,000 preventable adverse events occur in U.S. hospitals annually, 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 is designed to provide information 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 patients.

As you fill prescriptions, watch for this new format on the package inserts. Hopefully, it will make this part of educating ourselves simpler and more effective.

 

___________________
Resources:

Food and Drug Administration. Press release, "FDA Announces New Prescription Drug Information Format to Improve Patient Safety." January 16, 2006.

U.S. National Library of Medicine, National Institutes of Health, Department of Health and Human Services. DailyMed. January, 2006.