U.S. Food and Drug Administration
Drug Safety and Risk Management Advisory Committee
- Overview of patient information history at FDA
- "Evaluation of Written Prescription Information Provided in Community Pharmacies, 2001: Final Report to the U.S. Department of Health and Human Services and the Food and Drug Administration"
FDA is seeking scientific discussion of and advice on the following questions:
- What are the priority areas for improvement of useful consumer medication information?
- Where in the process of development and distribution of written patient medication information might interventions improve the quality of information patients receive?
- What kinds of intervention strategies could be helpful?
- What are meaningful times to reevaluate consumer medication information before 2006?
- What outcomes research can be implemented to assess how well the usefulness criteria serve to inform and guide the actions of patients?
- How can outcomes research be used to establish priorities, if necessary, among criteria?