SERIES: Patient Medication Information | Number 1 of 3 Next »

Jul 21

Past Event

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

Event Agenda

  • Welcome, Introduction, and Meeting Objectives

  • FDA Opening Remarks

    • Rachel Behrman

      Office of Medical Policy, Center for Drug Evaluation and Research, FDA

  • Using CMI to Effectively Communicate Important Messages to Patients

    • Angela Fagerlin

      University of Michigan

      Ann Arbor VA Health Services Research and Development Service

    • Jann Keenan

      The Keenan Group, Inc.

      The Clear Language Group Consortium

  • 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

      University of Leeds

      Luto Research, Ltd.

    • 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 of School of Medicine

    • Tom Cantu

      Global Regulatory Affairs, GlaxoSmithKline

  • Session 3: Alternatives to Paper-Based CMI

    • Michael Wolf

      Feinberg School of Medicine at Northwestern University

    • Kala Paul

      The Corvallis Group, LLC

    • Baxter Byerly

      Catalina Health Resource

  • Lead Respondents

    • Art Levin

      Center for Medical Consumers

    • Ray Bullman

      National Council on Patient Information and Education

  • Recap and Closing Remarks


July 21, 2010

9:00 AM - 3:30 PM EDT

The Brookings Institution

Saul/Zilkha Rooms

1775 Massachusetts Avenue, NW


For More Information

Engelberg Center for Health Care Reform

(202) 797-4391

SERIES: Patient Medication Information | Number 1