Evaluating Drug Names for Similarities: 
Methods and Approaches
Public Meeting

Agenda

(Meeting formerly called Minimizing Medication Errors - 
Evaluating the Drug Naming Process)

Food and Drug Administration
Institute for Safe Medication Practices
Pharmaceutical Research and Manufacturers of America

Date: 
June 26, 2003

Location: 
Renaissance Washington  D.C. Hotel, 999 9^th Street, N.W., Washington, D.C. 20001

Purpose of the Meeting

The FDA has determined that many of the medication errors reported to the agency result from medical products having proprietary names that look or sound like the names of other medical products. A December 1999 Institute of Medicine report (recommendation 7.3) said that FDA "require pharmaceutical companies to test (using FDA approved methods) proposed drug names to identify and remedy potential sound alike and look alike confusion with existing drug names." Subsequently, the Office of the Secretary published Recommendation #238 (from the November 21, 2002 report from the HHS Advisory Committee on Regulatory Reform). This recommendation calls for FDA to shift from doing drug name safety testing, in most cases, to reviewing data from sponsors who follow protocols designed to evaluate potential for look-alike and sound-alike errors with proprietary names prior to FDA approval. During this meeting, FDA will encourage an open public discussion with representatives from industry, health professional and consumer groups, and academia on how best to minimize the potential for medication errors due to similarities in drug names, including discussion on current methods and approaches.

This public meeting is co-sponsored by FDA, the Institute for Safe Medication Practices, and the Pharmaceutical Research and Manufacturers Association. This meeting discussion will not cover other factors that may also contribute to medication errors, such as poor handwriting, incomplete patient and drug information, the use of dangerous abbreviations and dose expressions, distractions in various health care settings, working conditions, and staffing conditions. The meeting will also not cover the evaluation of proprietary names for their promotional implications.

Meeting Agenda

7:30 a.m. Registrant Check-In

8:00 a.m. Welcome

• Michael R. Cohen, M.S., Sc.D., President, Institute for Safe Medication Practices
• Robert E. Lee, Jr., J.D., Trademark Counsel, Eli Lilly
• Capt. Thomas G. Phillips, Associate Director for Medication Error Prevention, FDA

8:15 a.m. Meeting Overview and Introduction of Questions

• Paul S. Seligman, M.D., Director, Office of Pharmacoepidemiology and Statistical Science

8:30 a.m. Perspectives on the Issue

• FDA - John K. Jenkins, M.D., Director, Office of New Drugs
• Practitioner – Timothy Lesar, Pharm.D., Director of Pharmacy, Albany Medical Center
• Industry – Sharon Olmstead, Executive Director, US Regulatory Liaison, Worldwide Regulatory Affairs, Pfizer
  Thomas Hassall, Director, Regulatory Liaison, Merck

9:10 a.m. Techniques and Methods Used to Collect Data and Make Decisions – Robert E. Lee, Jr. (Moderator)

• Brand Institute – James L. Dettore, President, Brand Institute
• Interbrand Wood – Clement J. Galluccio, Managing Director, RxMark
• Med-ERRS – Susan Proulx, Pharm.D., President, Med-ERRS
• FDA (Prescription and OTC) – Captain Thomas G. Phillips, Associate Director for Medication Errors Prevention, Toni M. Stifano, Center for Biologics Evaluation and Research

10:15 a.m. Questions and Answers

10:30 a.m. Break

10:45 a.m. Open Public Hearing   (Posted 6/23/2003)

• Susan C. Winckler, RPh, JD 10:45 am - 10:52 am 
  Vice President, Policy and Communications and Staff Counsel American Pharmacists Association
• Maury M. Tepper, III 10:52 am - 10:59 am
  Womble Carlyle Sandbridge and Rice
• Bruce L. Lambert, PhD 10:59 am - 11:06 am
  Associate Professor, College of Pharmacy, University of Illinois at Chicago
• Beston Jack Abrams 11:06 am - 11:13 am
  President, ACT, Inc.
• Suzanne Coffman, PharmD 11:13 am - 11:20 am
  Product Manager, NDC Health
• Kasey Thompson, PharmD 11:20 am - 11:27 am
  Director of Patient Safety
  American Society of Health Systems Pharmacists
• David R. Wood 11:27 am - 11:34 am
  CEO,  Interbrand Wood

11:45 a.m. Lunch (on own)

12:45 p.m. Independent Experts Perspective on Data Collection Tools, – Michael R. Cohen (Moderator)

12:50 p.m. Sampling – Brian L. Strom, M.D., M.P.H., University of Pennsylvania School of Medicine

1:15 p.m. Questionnaire Construction – Shari Diamond, JD, Northwestern University School of Law

1:40 p.m. Handwriting/Voice Recognition Models – Kaz Jaszczak, Director, Product Planning and Operations, Parascript, LLC

2:05 p.m. Questions and Answers

2:15 p.m. Break

2:30 p.m. Independent Experts Views on Decision Analysis Tools –  Peter A. Gross, M.D., Chairman, Internal Medicine, Hackensack University Medical Center (Moderator)

2:35 p.m. Expert Committees – R.F. Shangraw, Jr., Ph.D, Chief Executive Officer, Project Performance Corporation

3:00 p.m. Computer Assisted Decision Analysis

• Bonnie Dorr, Ph.D., Associate Professor, Department of Linguistics, University of Maryland
• Bruce Lambert, Ph.D., Associate Professor, College of Pharmacy, University of Illinois at Chicago

3:40 p.m. Premarketing Evaluation and Decision Analysis through Failure Mode and Effects Analysis

• John Gosbee, M.D., P.E. Section Director, Patient Safety, VHA National Center for Patient Safety

4:05 p.m. Premarket Risk Management Programs

• William H. Campbell, Ph.D., University of North Carolina at Chapel Hill

4:30 p.m. Questions and Answers

4:45 p.m. Session Wrap-ups with Moderators

• Robert E. Lee, Jr.
• Michael R. Cohen
• Peter A. Gross

5:20 p.m. Closing Remarks – Captain Thomas G. Phillips, FDA

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Last Updated: June 23, 2003
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