The Science of Communicating Medication Information to Consumers
In February 2009, the Risk Communication Advisory Committee recommended that the Food and Drug Administration (FDA) adopt a single standard document for communicating essential information about prescription drugs, which would replace Patient Package Inserts, Consumer Medication Information, and Medication Guides. FDA developed three draft patient medication information (PMI) prototypes and on May 4, 2010, announced the design of an evaluation strategy in the Federal Register. Following review and approval by the Office of Management and Budget, FDA will evaluate the three prototypes using a consumer testing study.
On July 21, the Engelberg Center for Health Care Reform hosted a one-day workshop focused on improving CMI. Experts from academia, the private sector, and FDA discussed several topics, including:
- Overarching principles for effectively communicating prescription information to patients
- Most useful content and format of a single medication information paper document
- Comments on FDA prototypes
- Metrics for evaluating PMI
- Alternatives to paper-based PMI
Agenda
Welcome, Introduction, and Meeting Objectives
Mark B. McClellan
Former Brookings Expert
Director, Margolis Center for Health Policy - Duke University
FDA Opening Remarks
Rachel Behrman
Director, Office of Medical Policy, Center for Drug Evaluation and Research
Using CMI to Effectively Communicate Important Messages to Patients
Angela Fagerlin
University of Michigan
Jann Keenan
The Keenan Group, Inc.
Metrics for Success in Communicating Prescription Information
Dorothy Smith
Consumer Health Information Corporation
Terry Davis
Louisiana State University Health Sciences Center
Lead Respondents
Theo Raynor
Professor of Pharmacy Practice - University of Leeds
Sue Stableford
University of New England
FDA Prototype Leaflets, Study Design, and Next Steps
Janet Norden
Office of Medical Policy, Center for Drug Evaluation and Research, FDA
Amie O’Donoghue
Office of Medical Policy, Center for Drug Evaluation and Research, FDA
Lead Respondents
Ruth Parker
Emory University School of Medicine
Tom Cantu
Global Regulatory Affairs, GlaxoSmithKline
Session 3: Alternatives to Paper-Based CMI
Michael Wolf
Professor of Medicine, Feinberg School of Medicine - Northwestern University
Kala Paul
The Corvallis Group, LLC
Baxter Byerly
Catalina Health Resource
Lead Respondents
Art Levin
Center for Medical Consumers
Recap and Closing Remarks
Mark B. McClellan
Former Brookings Expert
Director, Margolis Center for Health Policy - Duke University
More Information
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