Patient Labeling and Risk Communication
(includes Medication Guides)

FDA-Approved Patient Labeling

• Patient Package Inserts.  For some prescription medicines, FDA approves special patient materials to instruct patients about the safe use of the product. These materials may be given to patients by their health care provider or pharmacist, and are considered part of FDA-regulated product labeling.
  
  
• Medication Guides.  FDA-approved patient information for selected prescription drugs that pose a serious and significant public health concern.

Useful Private Sector Written Prescription Drug Information for Patients

• Public Meeting on Consumer Medication Information, July 31, 2003 (Posted 7/29/2003, Updated 8/4/2003)
  

• Evaluation of Written Prescription Information Provided in Community Pharmacies, 2001  This report describes the methods and findings of a national study to assess the quality of written prescription information provided voluntarily to persons receiving new prescription medicines in community pharmacies.

  • FDA Talk Paper: Success of Private Sector Patient Information with Prescription Medicines Assessed.
    

• Public Workshop held February 29-March 1, 2000.  

  • Agenda and background reports for the meeting

  • Summary of the meeting

  • Meeting transcripts Part 1

  • Meeting transcripts Part 2

National Telephone Surveys of Prescription Medicine Information Received by Consumers

Since 1982, FDA has conducted eight national telephone surveys to determine the percentage of consumers who receive oral and written information about their prescription medicine from their doctor’s office or pharmacy.

• Program description and tables of survey results (12/1/2006)