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Evaluating
Drug Names for Similarities:
Methods and Approaches
Public Meeting
(Meeting formerly called
Minimizing Medication Errors -
Evaluating the Drug Naming Process)
Meeting Date: June 26,
2003
The Renaissance
Washington DC Hotel
At this meeting, we will explore current methods being used
to evaluate proprietary drug names to reduce medication errors due
to similarity in drug names. The purpose of this meeting is to have an
open discussion with industry, health professionals, consumers and
academia on how to best minimize the potential for medication errors due
to similarities in proprietary drug names and will include a discussion on
current methods and approaches. We will also be soliciting feedback on a
recommendation by the Department of Health and Human Services that drug
manufacturers perform proprietary name testing prior to submitting new
drug applications and abbreviated new drug applications to FDA.
Meeting Date: June 26, 2003
Meeting Name: Evaluating Drug Names for
Similarities: Methods and Approaches
Co-sponsored by:
- Food and Drug Administration
- Institute for Safe Medication Practices
- Pharmaceutical Research and Manufacturers Association
Location: The Renaissance Washington DC
Hotel, 999 9th Street, NW, Washington,
D.C. 20001. (202) 962-4470.
Time: 8 a.m. - 5:30 p.m.
Agenda
Meeting Transcript [WORD]
[PDF] 
(Posted 7/8/2003)
Meeting Presentations
(Posted 7/15/2003)
Morning Speakers
- Five
Questions, Paul Seligman, CDER
- Proprietary
Names and the Drug Approval Process, John K.
Jenkins, CDER
- Look-Alike
and Sound-Alike Medications Practitioner Perspectives, Timothy
Lesar, Albany Medical Center
- Trademark
Evaluation Process: An Industry Perspective, Sharon Olmstead,
Pfizer
- Proprietary Name
Testing Using "Prescription Analysis Studies", Thomas Hassall,
Merck Research Laboratories
- Current
Practices for Data Collection and Decision Analysis, Robert E.
Lee, Jr., PhRMA Trademark Subcommittee
- Evaluating
Drug Names for Similarities: Techniques and Methods Used to Collect
Data and Make Decisions, James Dettore, Brand
Institute, Inc.
- Responses to the Panel Moderator, Clement J. Galuccio,
Interbrand Wood Healthcare
- The
Med-E.R.R.S. Trademark Process, Susan Proulx, Med-E.R.R.S.
- DMETS Evaluation
of Proprietary Names, Thomas (Jerry) Phillips, CDER
Open Public Hearing -- 10:45 - 11:45
Afternoon Speakers
- Sampling,
Brian Strom, University of Pennsylvania, School of Medicine
- Screening Proprietary Drug Names for Similarities:
Research Design and
Questionnaire Structure, Shari Diamond,
Northwestern University
- Evaluating Drug
Names Similarities applying Handwriting Recognition Technologies, Kaz
Jaszczak, Parascript, LLC
- Expert
Committees , Rick Shangraw, Project Performance
Corporation. (Presentation References: [WORD])
- Computational
Linguistic Techniques Applied to Drugname Matching, Bonnie Dorr,
University of Maryland
- Computer
Assisted Decision Analysis in Drug Naming, Bruce Lambert,
University of Illinois at Chicago
- Screening
for Drug Similarities with Human Factors Engineering & Failure
Mode and Effects Analysis, John Gosbee, VA
National Center for Patient Safety
- Evaluating
Drug Names for Similarities: Methods and Approaches, Bill Campbell,
UNC School of Pharmacy
Questions: Screening Drug Names for
Similarities – Methods and Approaches
- Are methods currently employed by sponsors and FDA appropriate for
evaluating look-alike and sound-alike names? Examples of methods
currently being used include handwriting and voice recognition
studies, computer tools, expert committee analyses, and
questionnaire/surveys.
- In studies designed to evaluate potential prescription errors: (a)
What is an appropriate study design? (b) What is the appropriate size
for an expert committee or for a prescription drug (written and voice
recognition) study? (c) What should be the composition of a group of
evaluators (e.g., what proportion of physicians, pharmacists, nurses,
consumers)? (d) What are appropriate outcome measures?
- What kind of information (e.g., drug name, strength, quantity,
directions) should be included in verbal or handwritten prescription
drug studies?
- Sometimes similar drug names are approved contingent on a
pre-marketing agreement for a risk management program. Describe
examples of effective risk management programs (e.g., an educational
campaign) that could be used to minimize look-alike, sound-alike
confusion. How should the effectiveness of a risk management program
be evaluated?
- Should there be different trade-name evaluation procedures for
different classes of drugs (prescription vs. over-the-counter)?
Minimizing Medication
Errors--Methods for Evaluating Proprietary Names for Their Confusion
Potential; Public Meeting. Federal
Register notice [TXT]
[PDF]
Speaker Contact: Mary Gross, telephone: (301)
827-7849, fax: (301) 443-9664 grossm@cder.fda.gov
Deadline for those wishing to speak: June 13, 2003
To register to attend, please contact Elizabeth
Scheiman, elizabeth.scheiman@phrma.org.
Please include: name, title, company or organization, address and
phone number in order to register.
Deadline for those wishing to attend: June 20,
2003
Useful Resources
USP
Quality Review.  March, 2001
list of similar drug names reported to the
USP Medication Errors Reporting Program.
Medication Errors web page.
From CDER's Office of Drug Safety.
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Last Updated: July 15, 2003
Originator: OTCOM/DLIS
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