[Federal Register: November 28, 2006 (Volume 71, Number 228)]
[Notices]
[Page 68819-68820]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28no06-56]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0465]
Improving Patient Safety by Enhancing the Container Labeling for
Parenteral Infusion Drug Products; 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) is announcing a public
meeting on improving patient safety by enhancing the container labeling
for parenteral infusion drug products. This will be a 1-day workshop
involving FDA staff and representatives of the United States
Pharmacopeia (USP) and the Institute for Safe Medication Practices
(ISMP). The purpose of the meeting is to explore how labels on
intravenous (IV) drug products could be designed to minimize medication
errors. Design issues include placement, style and type of information,
the need for standard expression of strength, quantity of information,
and use of color on the label.
DATES: The public meeting will be held on January 11, 2007, from 8 a.m.
to 4 p.m. Submit written or electronic requests to speak by December
28, 2006. Written or electronic comments to the docket will be accepted
until April 12, 2007.
ADDRESSES: The public meeting will be held at the Lister Hill Center
Auditorium (the center), National Institutes of Health (NIH) campus,
9000 Rockville Pike, bldg. 38A, Bethesda, MD 20815, 301-496-4441. The
center can be reached by Metro using the Medical Center Station on the
red line. Parking is limited at NIH, so Metro use is recommended. For
directions and visitor information, see http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.nih.gov/about/visitor/index.htm.
(FDA has verified the Web site address, but FDA is
not responsible for any subsequent changes to the Web site after this
document publishes in the Federal Register).
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
Submit written or electronic requests to speak at
the meeting to the information contact. Transcripts of the hearing will
be available for review at the Division of Dockets Management and on
the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/meeting/parenteral_labeling.htm
.
FOR FURTHER INFORMATION CONTACT: Jean Chung, Center for Drug Evaluation
and Research (HFD-400), Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301-796-2380, e-mail:
jean.chung@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Premixed large volume parenterals (LVPs) and small volume
parenterals (SVPs) in ready to infuse final dosage forms are designed
to deliver premixed drugs (e.g., antibiotics, electrolyte solutions,
pain management infusions). Premixed LVPs and SVPs improve standardized
drug delivery and can reduce the potential for medication errors by
reducing the steps required in IV preparation and the additional
quality control checks needed by the pharmacy prior to dispensing and
administering the product. Premixed LVPs and SVPs: (1) Provide an end
product that is labeled with the ingredients including a product
identification code (e.g., bar code), (2) promote a sterile
environment, and (3) maintain accurate concentration within a closed
system. According to the USP, ``the designation large-volume
intravenous solution applies to a single-dose injection that is
intended for intravenous use and is packaged in containers labeled as
containing more than 100 mL. The designation small-volume injection
applies to an injection that is packaged in containers labeled as
containing 100 mL or less.''
Although premixed LVPs and SVPs can reduce the potential for mixing
errors, the labels and labeling of these products, as well as base
solutions of LVPs and SVPs without drug, have been documented as
contributing to medication errors in both acute care and ambulatory
settings, as well as in home care settings. The types of errors
reported involve the inability to distinguish different drug products,
as well as different strengths of drug products, because the containers
look similar and use similar colors for label text. In addition to
these visual similarities, manufacturers may label the same drug
product with varying units of measure (e.g., micrograms versus
milligrams), which has also contributed to error. There is also a large
amount of information that is placed on the container label that can
not only crowd the label but can distract from the most important
information, that is, the proprietary and established names and product
strength.Thus, we would like to explore how current IV labels should be
designed to minimize medication errors.
II. Scope of the Public Meeting
The public meeting is intended to explore how IV labels could be
designed to minimize medication errors. Design issues include
placement, style and type of information, the need for standard
expression of strength, quantity of information, and use of color on
the label.
This 1-day workshop will assemble drug safety experts, patient
advocates, government experts, and pharmaceutical and device
manufacturers to discuss outstanding regulatory, technological, and
resource issues. Other interested constituencies (e.g., patient
advocacy and education groups, pharmaceutical sponsors, general public)
will have an opportunity to provide input during the question and
comment periods. FDA is interested in obtaining public comment and
encourages all interested parties to submit requests to speak at the
meeting or to submit written or electronic comments to the docket. (See
sections III. and IV. of this document.)
The meeting will include an overview of FDA and USP requirements,
presentations from the clinical perspective (nurse and pharmacist) and
industry perspective, and a series of panel discussions. The following
topics will be discussed: Look-alike containers, confusing labels on
sterile water containers, container label requirements, and the lack of
standardized expression of medication concentration on labels.
Questions that will be considered during this public meeting include,
but are not limited to, the following:
1. What are the best solutions to differentiate look-alike
container labels
[[Page 68820]]
of premixed LVPs and SVPs containing different medications (among
different product lines from the same manufacturer and across different
manufacturer product lines)?
2. Would the use of color differentiation on labels prevent
medication errors? Can different colors be used on intravenous bags? If
not, what are the barriers and possible ways to address them?
3. What information currently required to appear on intravenous
container labels can be eliminated or placed elsewhere in order to make
room for more important information such as barcodes, larger font size
for drug names, new standard ways to express drug concentration, and
product warnings? How can industry make the best use of the limited
space on labels? What type of standards for layout and type size would
need to be applied to correct for the confusion among the products?
4. How does the lack of standardization in the expression of
medication concentrations on labels contribute to error? How can we
standardize the expression of drug concentrations on IV drug container
labels?
5. How do the similar labels for Sterile Water for Injection,
Sterile Water for Irrigation, and Sterile Water for Inhalation lead to
medication errors (i.e., deaths in some instances have been reported)?
How can the label for sterile water be improved to minimize the risk of
confusing the different routes of administration?
6. What strategies are there to prevent inadvertent administration
of solutions not intended for parenteral IV use?
7. What are the regulatory, technological, and resource (cost)
barriers that would need to be eliminated to correct the challenges
identified today, if any? What are the practical resolutions to address
these challenges?
III. Registration, Requests to Speak, Agenda, and Presentations
No registration is required to attend the meeting. Seating will be
on a first-come, first-served basis. If you need special accommodations
due to a disability, please inform the contact person (see FOR FURTHER
INFORMATION CONTACT).
Interested persons may request to speak at the meeting (see FOR
FURTHER INFORMATION CONTACT). Statements from the public will be
scheduled between 2:45 p.m. and 3:45 p.m., and the time allotted for
each speaker will be limited. Requests to speak at the meeting should
include: (1) The specific topic or issue to be addressed, (2) a brief
summary of remarks, and (3) the participant's name, address, telephone
number, and e-mail.
The agenda for the public meeting will be available on FDA's Center
for Drug Evaluation and Research (CDER) Web site at: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/meeting/parenteral_labeling.htm.
After the meeting,
the agenda, presentations, and transcript will be placed on file in the
Division of Dockets Management under the docket number found in the
heading of this document and on CDER's Web site identified in the
previous sentence.
IV. Request for Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments on the topics discussed
in this document (see DATES). Submit 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.
V. Transcripts
Copies of the transcript may be requested in writing from the
Freedom of Information Office (HFI-35), Food and Drug Administration,
5600 Fishers Lane, rm. 6-30, Rockville, MD 20857, approximately 20
working days after the meeting at a cost of 10 cents per page or on
compact disc at a cost of $14.25 each. You may also examine the
transcript at the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday.
Dated: November 20, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-20035 Filed 11-27-06; 8:45 am]
BILLING CODE 4160-01-S