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

Agenda

Welcome, Introduction, and Meeting Objectives

FDA Opening Remarks

D

Rachel Behrman

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

Using CMI to Effectively Communicate Important Messages to Patients

Metrics for Success in Communicating Prescription Information

L

Terry Davis

Louisiana State University Health Sciences Center

Lead Respondents

P

Theo Raynor

Professor of Pharmacy Practice - University of Leeds

FDA Prototype Leaflets, Study Design, and Next Steps

O

Janet Norden

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

O

Amie O’Donoghue

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

Lead Respondents

G

Tom Cantu

Global Regulatory Affairs, GlaxoSmithKline

Session 3: Alternatives to Paper-Based CMI

P

Michael Wolf

Professor of Medicine, Feinberg School of Medicine - Northwestern University

Lead Respondents

Recap and Closing Remarks

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