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




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



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



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.




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






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 &


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