Public Health
Reducing childhood sugar-sweetened beverage consumption
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
RBRachel Behrman Director, Office of Medical Policy, Center for Drug Evaluation and Research -
Using CMI to Effectively Communicate Important Messages to Patients
AFAngela Fagerlin University of MichiganJKJann Keenan The Keenan Group, Inc. -
Metrics for Success in Communicating Prescription Information
DSDorothy Smith Consumer Health Information CorporationTDTerry Davis Louisiana State University Health Sciences Center -
Lead Respondents
TRTheo Raynor Professor of Pharmacy Practice - University of LeedsSSSue Stableford University of New England -
FDA Prototype Leaflets, Study Design, and Next Steps
JNJanet Norden Office of Medical Policy, Center for Drug Evaluation and Research, FDAAOAmie O’Donoghue Office of Medical Policy, Center for Drug Evaluation and Research, FDA -
Lead Respondents
RPRuth Parker Emory University School of Medicine -
Session 3: Alternatives to Paper-Based CMI
MWMichael Wolf Professor of Medicine, Feinberg School of Medicine - Northwestern UniversityBBBaxter Byerly Catalina Health Resource -
Lead Respondents
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Recap and Closing Remarks
Mark B. McClellan Former Brookings Expert, Director, Margolis Center for Health Policy - Duke University
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