[Federal Register Volume 71, Number 228 (Tuesday, November 28, 2006)]
[Notices]
[Pages 68819-68820]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-20035]


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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://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://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://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: 
[email protected].

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://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