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
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July 21
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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 MichiganJann Keenan The Keenan Group, Inc. -
Metrics for Success in Communicating Prescription Information
Dorothy Smith Consumer Health Information CorporationTerry Davis Louisiana State University Health Sciences Center -
Lead Respondents
Theo Raynor Professor of Pharmacy Practice - University of LeedsSue 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, FDAAmie O’Donoghue Office of Medical Policy, Center for Drug Evaluation and Research, FDA -
Lead Respondents
Ruth Parker Emory University School of MedicineTom Cantu Global Regulatory Affairs, GlaxoSmithKline -
Session 3: Alternatives to Paper-Based CMI
Michael Wolf Professor of Medicine, Feinberg School of Medicine - Northwestern UniversityKala Paul The Corvallis Group, LLCBaxter 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
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