Food and Drug Administration

Center for Drug Evaluation and Research

Drug Safety and Risk Management Advisory Committee (DSaRM)

December 4, 2003

Holiday Inn, the Ballroom

Two Montgomery Village Ave., Gaithersburg, MD

DRAFT AGENDA

8:00 Call to Order and Opening Remarks Peter Gross, M.D.

Chair, DSaRM

Introduction of Committee

Conflict of Interest Statement Shalini Jain, PA-C, M.B.A. DSaRM, Executive Secretary

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Issue: Current screening methods to assess sound alike and look alike proprietary

drug names, in order to reduce the incidence of medication error resulting

from look alike and sound alike names.

8:15 Welcome Paul S. Seligman, M.D., M.P.H.

Director, Office of Pharmaco-

epidemiology & Statistical Science

Acting Director,

Office of Drug Safety

ODS, FDA

8:20 Proprietary Name Evaluation at FDA Jerry Phillips, R.Ph.

Associate Director,

Medication Error Prevention, ODS, FDA

8:40 PhRMA: Views on Trademark Evaluation Robert E. Lee, Jr., J.D.

Assistant General Patent Counsel

Eli Lilly and Company

Representing Pharmaceutical

and Research Manufacturer’s

Association (PhRMA)

9:00 Advancing the Science of Drug Trade Name Paul Seligman, M.D., M.P.H.

Review

9:20 Automatic String Matching for Reduction of Bonnie Dorr, Ph.D.

Drug Name Confusion Assistant Professor

Dept. of Computer Science

University of Maryland

Drug Safety and Risk Management Advisory Committee

December 4, 2003

Holiday Inn, the Ballroom

Two Montgomery Village Avenue, Gaithersburg, MD

DRAFT AGENDA (cont.)

9:50 Evaluating Drug Name Confusion Using R.F. Shangraw, Jr., Ph.D.

Using Expert Panels CEO

Project Performance Corporation

10:20 Focus Group Methodology Miriam Bar-Din Kimel, Ph.D.

Senior Project Manager MEDTAP International

10:50 Break

11: 05 Use of Laboratory and Other Simulations in Kraig Schell, Ph.D.

Assessing Drug Name Confusion Assistant Professor

Dept. of Psychology

Angelo State University

11:35 Quantitative Evaluation of Drug Name Safety Sean Hennessy, PharmD, Ph.D.

Using Mock Pharmacy Practice Assistant Professor

Dept. of Epidemiology & Pharmacology

Center for Clinical Epidemiology &

Biostatistics

University of Pennsylvania

School of Medicine

12:00 Lunch

1:00 Open Public Hearing

2:00 Introduction of the Issues for Discussion Paul Seligman, M.D., M.P.H.

2:15 Committee Discussion of Issues/Questions

3:00 Break

3:15 Continuation of Committee Discussion

5:00 Adjourn