Food and Drug
Risk Communication Advisory Committee
February 26-27, 2009
Meeting Topic Both Days: Improving the communication of information about prescription drugs to patients, including different types of prescription drug information currently available to patients in the form of Medication Guides, Patient Package Inserts (PPIs), and Consumer Medication Information (CMI).
February 26, 2009
Deborah Henderson, Director, Office of Executive Programs, CDER
Background and Overview of the CMI, PPI, Medication Guides Programs
Nancy Ostrove, Ph.D., Director for Risk Communication,
Office of Policy and Planning, FDA
Jodi Duckhorn, M.A., Team Leader, Division of Risk Management
Office of Surveillance and Epidemiology, CDER
Expert and Consumer Evaluation of Consumer Medication Information –
2008 Final Report
Carole L. Kimberlin, Ph.D.
Professor, Pharmaceutical Outcomes and Policys
Almut Winterstein, Ph.D.
Associate Professor, Pharmaceutical Outcomes and Policy, College of Pharmacy, and
Epidemiology and Biostatistics, College of Public Health and Health Professions
University of Florida
Open Public Hearing, February 26, 2009
National Community Pharmacists Association
Gerald K. McEvoy, Pharm. D.
Assistant Vice President, Drug Information, and
Editor in Chief, AHFS Drug Information and Consumer Medication Information American Society of Health-System Pharmacists
Saul Shiffman, Ph.D.
Senior Scientific Advisor
Pinney Associates (Bethesda, MD)
Jeffrey E. Fetterman
President & CEO
February 27, 2009
The effectiveness of the drug facts box in communicating the benefits and side
effects of prescription drugs
Lisa Schwartz, M.D., M.S. and Steven Woloshin, M.D., M.S.
Outcomes Group, VA Medical Center, White River Junction, VT
Consumer Medicines Information in Europe;
learnings from research, policy and practice
Dr DK Theo Raynor
Professor of Pharmacy Practice, University of Leeds, UK
Communicating with patients about prescription drugs and health care:
The role of diminished status and
other systemic factors in addressing risk and vulnerability
David P. Moxley, M.S.W., Ph.D., D.P.A.
Oklahoma Healthcare Authority Medicaid Endowed Professor of Health
and Public Health, and Professor of Social Work
University of Oklahoma
Open Public Hearing, February 27, 2009
Michael J. Miller, RPh, DrPH
Department of Pharmacy: Clinical and Administrative Sciences
College of Pharmacy
The University of Oklahoma
Cassie Plummer, PharmD MPH
Drug Information Pharmacist
Ellen Hoenig Carlson
Baruch Fischhoff, with Committee Discussion
Draft Possible Recommendations
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