[Federal Register Volume 68, Number 104 (Friday, May 30, 2003)]
[Notices]
[Pages 32529-32530]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-13591]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0201]


Minimizing Medication Errors--Methods for Evaluating Proprietary 
Names for Their Confusion Potential; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA), in cooperation with 
the Pharmaceutical Research and Manufacturers Association (PhRMA) and 
the Institute for Safe Medication Practices (ISMP), is announcing a 
public meeting to explore current methods being used to evaluate 
proprietary drug names to reduce medication errors due to similarity in 
drug names. The goal of the meeting is to solicit views on a 
recommendation by the Department of Health and Human Services (HHS) 
that drug manufacturers perform proprietary name testing prior to 
submitting new

[[Page 32530]]

drug applications (NDAs) and abbreviated new drug applications (ANDAs) 
to FDA. The input received at the workshop and from comments received 
during and after the workshop may be considered in developing a draft 
guidance on this topic.

DATES: The public meeting will be held on June 26, 2003, from 8 a.m. to 
5:30 p.m. Registrants must sign in beginning at 7:30 a.m. on June 26. 
Submit written or electronic requests to speak at the public meeting by 
June 13, 2003. Written or electronic comments on the questions will be 
accepted until July 15, 2003.

ADDRESSES: The public meeting will be held at the Renaissance 
Washington DC Hotel, 999 9th St. NW., Washington, DC 20001, 202-962-
4470. The hotel may be reached by Metro using the Gallery Place/
Chinatown Station on the red line. Seating will be limited to the first 
300 people registered.
    Submit written or electronic requests to speak and comments to Mary 
Gross (see FOR FURTHER INFORMATION CONTACT) by June 13, 2003. A 
transcript of the workshop will be available for review after the 
meeting at the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852 and on 
the Internet at http://www.fda.gov/ohrms/dockets.

FOR FURTHER INFORMATION CONTACT:
Those wishing to speak should contact: Mary Gross, Office of Drug 
Safety (HFD-400), Center for Drug Evaluation and Research (CDER), 5600 
Fishers Lane, Rockville, MD 20857, 301-827-7849, e-mail: 
[email protected].
Those wishing to attend the meeting should contact: Elizabeth Scheiman, 
PhRMA, 1100 15th St. NW., Washington, DC 20005, 202-835-3533, FAX: 202-
572-7797, e-mail: [email protected].
    Those wishing to attend the meeting should preregister by June 20, 
2003. You will be asked to provide your name, affiliation, and e-mail 
address to register.

SUPPLEMENTARY INFORMATION:

I. Background

    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. Reducing the 
potential for medication errors due to proprietary name confusion is 
part of FDA's ongoing medical product risk management effort.
    Recommendation [numsign]7.3 in the December 1999 Institute of 
Medicine report proposed 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 [numsign]238 (from the November 21, 2002, report from 
the HHS Advisory Committee on Regulatory Reform). This recommendation 
calls for FDA to shift, in most cases, from performing drug name safety 
testing to reviewing data submitted by sponsors who have followed 
protocols designed to evaluate their products' names for possible look-
alike and sound-alike errors prior to FDA approval.
    This meeting is intended to encourage an open public discussion 
with representatives from industry, the health care professions, 
consumer groups, academia, or other interested individuals on how best 
to minimize the potential for medication errors due to similarities in 
drug names, including discussion of current methods and approaches 
being used to evaluate the potential for name confusion.
    This public meeting is being cosponsored by FDA, ISMP, and PhRMA. 
The meeting discussion will not address other factors that may 
contribute to medication errors such as poor handwriting, incomplete 
patient and drug information, the use of abbreviations, or working and 
staffing conditions. The meeting will also not cover the evaluation of 
proprietary names for their promotional implications. FDA will be 
developing questions to help facilitate discussion and obtain public 
feedback. Questions will be available on the CDER workshop Web site at 
http://www.fda.gov/cder/workshop.htm (choose Minimizing Medication 
Errors--Evaluating the Drug Naming Process; Public Meeting).

II. Scope of the Meeting

    The meeting will include expert speakers from regulated industry, 
academia, health professional groups, and FDA. Independent experts will 
discuss the use of sampling, questionnaire design, handwriting and 
voice recognition models, expert committees, computer assisted decision 
analysis, and failure modes and effects analysis as a potential tool to 
minimize naming errors resulting from look-alike and sound-alike names. 
Panels will be assembled to stimulate discussion among the experts and 
with the audience. Time will be allowed for persons who wish to provide 
comments on the questions posed in the Federal Register. Speakers who 
wish to participate in the open public hearing must register by June 2, 
2003. Time will also be allowed for questions and answers after each 
panel discussion.

III. Registration and Requests for Oral Presentation

    To speak at the meeting, you must preregister by June 2, 2003. 
Requests must be submitted electronically or in writing. In your 
request to speak, you should state the questions you will be addressing 
and the amount of time you wish to speak. Requests to speak will be 
accepted on a first-come, first-served basis. Individuals who register 
to speak will be notified of the scheduled time before the workshop and 
will have reserved seating. Depending on the number of speakers, FDA 
may need to limit the time allotted for each presentation. Speakers 
must submit two copies of each presentation by the registration date. 
If you need special accommodations due to a disability, please inform 
the registration contact person when you register. Presentations should 
be limited to the questions being made available on the Internet at 
http://www.fda.gov/cder/workshop.htm. Preregistration is necessary to 
attend this meeting, as seating is limited. Attendees should 
preregister by June 20, 2003.

IV. Request for Comments

    Regardless of attendance at the meeting, interested persons may 
submit written or electronic comments on the issue of similarity in 
drug naming or questions posed on http://www.fda.gov/ohrms/dockets to 
the Dockets Management Branch (see ADDRESSES). You should annotate and 
organize your comments to identify the specific question or questions 
you are addressing. Two paper copies of any mailed comments are to be 
submitted, except that individuals may submit one paper copy. Comments 
are to be identified with the docket number found in brackets in the 
heading of this document. Transcripts of the hearing also will be 
available for review at the Dockets Management Branch.

    Dated: May 27, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-13591 Filed 5-28-03; 11:17 am]
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