Prescription Drug Information (Package Insert) Format Changes – Are we There Yet?

As many of you know, earlier this year the Food and Drug Administration (FDA) rolled out a major revision to the format of prescription drug prescribing information (the package insert). One of the major reasons for the change was to help reduce the risks of medication use and medical errors by having a package insert in an easier to read format that draws physician and patient attention to the most important pieces of the drug information (FDA Consumer Magazine). The Patient Medication Guide will be included either at the end of the new package insert or accompany the labeling as a separate document.

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."

In addition to providing a better organizational style for finding information in the insert, the new approach importantly will require that the information be placed in a structured electronic format. The information will then be uploaded and integrated into a new National Library of Medicine online health information clearinghouse called the DailyMed.

This has all been a long time coming…no more fine print on a sideways poorly scanned pdf to read! Although still not the perfect solution to the information overload and medication use problems, I think this is a big step forward and expect further refinements to come. It will also take a while for a substantial number of package inserts on the DailyMed site to reflect the new format. Meanwhile, I’ll be curious to see how patients, physicians, and pharmacists are reacting to these changes. . .and what future suggestions they might have.