[Federal Register Volume 75, Number 69 (Monday, April 12, 2010)]
[Notices]
[Pages 18514-18516]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-8233]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0168]
Developing Guidance on Naming, Labeling, and Packaging Practices
to Reduce Medication Errors; Public Workshop; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Developing Guidance on Naming, Labeling, and
Packaging Practices to Reduce Medication Errors.'' The purpose of the
public workshop is to initiate constructive dialogue and information
sharing among regulators, researchers, the pharmaceutical industry,
health care organizations, health care professionals, and others from
the general public about the design of drug and therapeutic biologic
container labels, carton labeling, and product packaging, and practices
to develop proprietary names to reduce medication errors. The input
from this workshop will be used to develop draft guidance for industry
on practices for naming, labeling, and packaging of drugs and biologics
to reduce the potential for medication errors. FDA is also opening a
public docket to receive comments on this topic to assist in the
development of draft guidance.
DATES AND TIME: The public workshop will be held on Thursday and
Friday, June 24 and 25, 2010, from 8:30 a.m. to 5 p.m. each day.
Register to make a presentation at the workshop by May 25, 2010. See
section IV of this document for information on how to attend or present
at the meeting. Submit written or electronic comments to the docket by
July 23, 2010, to receive consideration.
ADDRESSES: The public workshop will be held at the Marriott Residence
Inn at 7335 Wisconsin Ave., Bethesda, MD 20814. Submit electronic
requests to register and make a presentation to
GNLP.meeting@fda.hhs.gov. Submit written requests to register and make
a presentation to Colleen O'Malley (see FOR FURTHER INFORMATION
CONTACT).
Submit written comments to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Colleen O'Malley, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, rm. 4305, Silver Spring, MD 20993, 301-796-
1786, FAX: 301-796-9832, email: colleen.omalley@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In title I of the Food and Drug Administration Amendments Act of
2007 (FDAAA) (Public Law 110-85), Congress reauthorized and expanded
the Prescription Drug User Fee Act program for fiscal years (FYs) 2008
through 2012 (PDUFA IV). As part of the performance goals and
procedures set forth in an enclosure to the letter from the Secretary
of the Health and Human Services referred to in section 101(c) of
FDAAA, FDA committed to certain performance goals and procedures. (See
http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm119243.htm). In that letter, FDA stated that it would use fees
collected under PDUFA to implement various measures to reduce
medication errors related to look-alike and sound-alike proprietary
names, unclear label abbreviations, acronyms, dose designations, and
error-prone label and packaging designs. Among these measures, FDA
agreed that by the end of FY 2010, after public consultation with
academia, industry, and others from the general public, the agency
would publish a draft guidance describing practices for naming,
labeling, and packaging drugs and biologics to reduce medication
errors.
II. Workshop Objectives and Issues for Discussion
This workshop represents the first step in meeting the PDUFA goal
described previously and is intended to provide valuable information to
assist the agency in developing draft guidance for industry on
practices to reduce medication errors. The workshop will not discuss
the ongoing FDA pilot program to evaluate proposed proprietary name
submissions. Persons seeking more information on the pilot program
should refer to the FDA concept paper entitled ``PDUFA Pilot Project
Proprietary Name Review'' at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidance/ucm072229.pdf and the
Federal Register notice entitled ``Pilot Program to Evaluate Proposed
Proprietary Name Submissions; Procedures to Register for Participation
and Submit Data'' (74 FR 50806, October 1, 2009) announcing procedures
for participation in the voluntary pilot program.
The workshop objectives are as follows: (1) Initiate constructive
dialogue and information sharing among regulators, researchers, the
pharmaceutical industry, health care organizations, health care
professionals, and others from the general public about the design of
drug and therapeutic biologic container labels, carton labeling, and
product packaging, and practices in developing proprietary
[[Page 18515]]
names to reduce medication errors; (2) share current FDA experience
regarding the evaluation of labels, packaging, and proprietary names;
and (3) obtain input on developing consistent review criteria for FDA
to use in evaluating container labels, carton labeling, and product
packaging submitted to the agency. FDA will use information from the
workshop to help develop a draft guidance for manufacturers and
distributors for creating product names and designing product labels
and packaging to reduce medication errors.
Four panel discussions will focus on areas in which the agency
requests input.
Panel 1 will focus on characteristics of container label and carton
labeling design as they relate to reducing the risk of medication
errors. Topics with respect to container label and carton labeling
design include content, format, type of label, layout, use of color,
use of graphics, and costs associated with designing labels.
Panel 1 will address the following questions:
1. What does FDA need to consider to ensure that the container
labels and carton labeling designs are safe and reduce the risk of
medication errors?
2. What are the challenges in designing container label and carton
labeling to reduce the risk of medication errors?
3. What are some strategies for addressing these design challenges
without compromising safety?
Panel 2 will focus on characteristics related to study design,
conduct and interpretation of human factors analysis, Failure Mode and
Effects Analysis (FMEA), usability studies, and other studies
specifically focused on evaluating the safety of container label and
carton labeling designs to reduce the risk of medication errors. Topics
include methodology, selection of participants and subjects, collection
of data, analysis of data, costs and time to conduct such studies, and
interpretation of study findings.
Panel 2 will address the following questions:
1. What are the strengths and limitations of performing such
studies?
2. Are there other types of studies and analyses that provide
useful information about the medication error risks associated with the
container label or carton labeling design?
3. How can FDA ensure that the study design accurately captures and
assesses potential medication error risks that should be considered in
our evaluation of the container labels and carton labeling?
Panel 3 will focus on characteristics of the manufacturers'
packaging used for medications as they relate to the safe use of the
medicine from a medication errors perspective. Topics include
medication error considerations when designing a container-closure
system for a medication, drug-device combination packaging, studies and
analyses to evaluate the safety of product packaging design, and costs
associated with designing product packaging.
Panel 3 will address the following questions:
1. What information does FDA need to consider to ensure that the
manufacturers' packaging design is safe and reduces the risk for
medication errors?
2. What are the challenges in designing manufacturers' packaging to
reduce the risk of medication errors?
3. What are some strategies for addressing these challenges without
compromising safety?
4. How can FDA ensure that the study design accurately captures and
assesses potential medication error risks that should be considered in
our evaluation of a proposed manufacturers' packaging design for a
particular medication?
5. Are there other types of studies and analyses that provide
useful information about the medication error risks associated with the
manufacturers' packaging design?
Panel 4 will focus on recommended practices in developing
proprietary names as they relate to reducing medication errors. Topics
include choosing a nomenclature strategy for new products containing
the same active ingredient as marketed products; selection and
application of modifiers to proprietary names; and medication error
potential from use of the same proprietary name as a component of the
proprietary names for multiple products containing different active
ingredients; U.S. Adopted Names (USAN) Council Stems; medical
abbreviations; encoding dosage forms or dosing intervals; and including
the established name or ingredients within the proprietary name.
Panel 4 will address the following questions:
1. What are the challenges in developing a proprietary name from a
safety perspective to prevent medication errors?
2. What are some strategies for addressing these challenges without
compromising safety?
3. When products are developed containing the same ingredient as a
marketed product, how can risks associated with a given nomenclature
strategy for the proposed product be evaluated, minimized, and
mitigated (e.g., use of a modifier ``Proprietary XL'' versus the use of
an alternate proprietary name)?
III. Comments
Regardless of attendance at the public workshop, interested persons
may submit written or electronic comments to the Division of Dockets
Management (see ADDRESSES). Submit a single copy of electronic comments
or two paper copies of any mailed comments, 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. Received
comments may be seen in the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
IV. Attendance and Registration
There is no fee to attend the workshop, and attendees who do not
wish to make a formal presentation do not need to register. Seating
will be on a first-come, first-served basis.
If you would like to make an oral presentation to the panelists
during the meeting, you must register by mail or email (see ADDRESSES)
and provide an abstract of your presentation by 5 p.m. on May 25, 2010.
You must also provide your name, title, business affiliation (if
applicable), address, telephone and fax numbers, and e-mail address.
Identify the panel number and question number(s) you will address in
your presentation.
FDA will do its best to accommodate requests to speak. Individuals
and organizations with common interests are urged to consolidate or
coordinate their presentations and request time for a joint
presentation. FDA will determine the amount of time allotted to each
presenter and the approximate time that each oral presentation is
scheduled to begin. Persons registered to make a formal presentation
should check in before the workshop. Ample time will be allowed during
the scheduled agenda for attendees who have not registered to ask
questions of the panelists. In addition, we strongly encourage written
comments to the docket.
If you need special accommodations because of disability, please
contact Colleen O'Malley (see FOR FURTHER INFORMATION CONTACT) at least
7 days before the workshop.
V. Transcripts
Please be advised that as soon as a transcript of the workshop is
available, it will accessible at http://www.regulations.gov. It may be
viewed at the Division of Dockets Management
[[Page 18516]]
(see ADDRESSES). A transcript will also be made available in either
hard copy or on a CD-ROM upon submission of a Freedom of Information
request. Written requests are to be sent to Freedom of Information
(HFI-35), Food and Drug Administration, 5600 Fishers Lane, rm. 6-30,
Rockville, MD 20857.
Dated: March 31, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-8233 Filed 4-9-10; 8:45 am]
BILLING CODE 4160-01-S