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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 9th 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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Evaluating Drug Names
FDA/Center for Drug Evaluation and Research
Last Updated: June 23, 2003
Originator: OTCOM/DLIS
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