[Federal Register Volume 67, Number 117 (Tuesday, June 18, 2002)]
[Proposed Rules]
[Pages 41360-41361]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-15208]
[[Page 41360]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 201, 211, and 601
[Docket No. 02N-0204]
Bar Code Label Requirements for Human Drug Products; Notice of
Public Meeting
Agency: Food and Drug Administration, HHS.
ACTION: Notice of public meeting.
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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting to solicit comments for the development of a regulation on bar
code labeling for human drug products, including biologic products. We
(FDA) will also explore issues surrounding bar codes on medical
devices. We are holding this meeting to support the initiative of the
Secretary of Health and Human Services to reduce medication errors.
DATES: The public meeting will be held on July 26, 2002, from 9 a.m. to
5 p.m. Registration to attend the meeting must be received by July 12,
2002. Submit written or electronic comments for consideration during
the meeting by July 12, 2002.
ADDRESSES: The meeting will be held at the Natcher Auditorium, Building
45, National Institutes of Health (NIH), Bethesda, MD. Parking will be
limited and there may be delays entering the NIH campus due to
increased security. We recommend arriving by Metro if possible. NIH is
accessible from the Metro's red line at the Medical Center/NIH stop.
FOR FURTHER INFORMATION CONTACT:
Registration for Speaking Attendees: If you wish to speak at the
public meeting, please contact Mary C. Gross, Office of Drug Safety,
Center for Drug Evaluation and Research, Food and Drug Administration,
5600 Fishers Lane, rm. 15B-32, Rockville, MD 20857, 301-827-3193, FAX
301-443-9664, e-mail: [email protected]. Speakers must register and
submit a short summary of your presentation by July 12, 2002, to Mary
C. Gross; faxed copies of presentations are permissible. We encourage
consolidation of like-minded presentations to enable a broad range of
views to be presented.
Registration for General Attendees: If you wish to attend the
public meeting, register with Elizabeth French, Office of Policy,
Office of the Commissioner, Food and Drug Administration, 5600 Fishers
Lane, rm. 14-101, Rockville, MD 20857, 301- 827-3360, FAX 301-827-6777,
e-mail: [email protected]. General attendees should register no later
than July 12, 2002. As time permits, we will accept oral comments from
the audience. More information is available on the Internet at http://internet-dev.fda.gov/oc/meetings/barcodemtg.html.
SUPPLEMENTARY INFORMATION:
I. Background
In 1999, the Institute of Medicine (IOM) report entitled ``To Err
is Human: Building a Safer Health System'' cited research stating that
there are an estimated 100,000 deaths in the United States every year
from preventable medical errors in hospitals alone.\1\ The range of
deaths reported, between 44,000 and 98,000 deaths, was based on the
1984 Harvard Medical Practice Study and confirmatory studies done in
Colorado and Utah. These numbers reflect the entire area of medical
errors, including, for example, surgical errors, iatrogenic infections,
medication errors, and incorrect use of medical products. Of the
projected 100,000 deaths, we believe that approximately 30 to 50
percent are associated with errors involving FDA regulated medical
products (e.g., drugs, devices, blood and blood products, or vaccines).
In addition to the human cost of errors involving drugs, there are also
significant economic costs. An article published in 1995 estimated the
direct cost of preventable drug related mortality and morbidity to be
$76.6 billion, with drug related hospital admissions accounting for
much of the cost.\2\ Another article, published in 2001, used updated
cost estimates derived from current medical and pharmaceutical
literature to revise the $76.6 billion estimate to exceed $177.4
billion; of which hospital admissions accounted for $121.5 billion in
costs, and long-term care admissions accounted for another $32.8
billion.\3\
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\1\ Linda T. Kohn, Janet M. Corrigan, and Molla S. Donaldson,
editors; ``To Err Is Human: Building a Safer Health System,''
Committee on Quality of Health Care in America, Institute of
Medicine, November 29, 1999.
\2\ Johnson, J. A. and J. L. Bootman, ``Drug-Related Morbidity
and Mortality: A Cost-of-Illness Model,'' Archives of Internal
Medicine, pp. 1949-1956 (1995).
\3\ Ernst, F. R. and A. J. Grizzle, ``Drug-Related Morbidity and
Mortality: Updating the Cost-of-Illness Model,'' Journal of the
American Pharmaceutical Association, vol. 41, pp. 192-199, March/
April 2001.
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Medication errors are a subset of the wider category of medical
errors. Medication errors are defined by the National Coordinating
Council for Medication Error Reporting and Prevention as:
* * * any preventable event that may cause or lead to
inappropriate medication use or patient harm while the medication is
in the control of the healthcare professional, patient, or consumer.
Such events may be related to professional practice; healthcare
products, procedures, and systems, including prescribing; order
communication; product labeling, packaging, and nomenclature;
compounding; dispensing; distribution; administration; education;
monitoring; and use.\4\
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\4\ National Coordinating Council for Medication Error Reporting
and Prevention, ``What is a Medication Error?'' (Undated).
Medication errors can lead to adverse drug events. It is estimated
that 770,000 adverse drug events leading to injury or death occur
yearly in U.S. hospitals alone, and that between 28 to 95 percent of
these are preventable, i.e., can be defined as errors. Computerized
hospital medication use and monitoring systems could prevent many of
these medication errors.\5\
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\5\ Agency for Health Care Quality and Research, ``Research in
Action: Reducing and Preventing Adverse Drug Events (ADEs) to
Decrease Hospital Costs,'' April 11, 2001. (http://www.ahrq.gov/qual/aderia/aderia.htm)
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In response to the IOM report, the Secretary of Health and Human
Services directed FDA to explore possible regulatory approaches to
reduce these preventable errors. Errors related to dispensing and
administration can be minimized through the use of bar codes. For
example, if a health professional could use a bar code scanner to
compare the bar code on a human drug product to a specific patient's
drug regimen, the health professional would be able to verify that the
right patient is receiving the right drug, at the right dose, and at
the right time. Bar code advocates have recommended that the bar code
contain a unique numerical code that is dose specific to identify the
manufacturer, product, and package size or type, lot number, and
expiration date.
The availability of bar codes for pharmaceuticals would also
facilitate other patient safety initiatives, for example, automated
drug prescribing or ordering, automated monitoring for drug toxicities
in hospitals, and as a component of the automated medical record.
Automation of the drug prescribing and ordering system, if linked to a
bar coding system, has the potential not only to minimize drug mixups,
but also to make sure prescribers have access to crucial information at
the point of prescribing.
We are considering whether to require bar codes on human drug
products, including certain biologic products. The bar code would
contain certain information about the product, such as a dose-specific
individual identifying
[[Page 41361]]
number. We are considering whether to require the bar code to contain
other information, such as the drug product's expiration date and lot
number, to make it easier to identify expired drugs and recalled drugs
that may not be safe and effective for use. We are also exploring
issues surrounding bar codes on medical devices.
II. Scope of Discussion
We will hold a public meeting on June 13, 2002, from 9 a.m. to 5
p.m., to discuss bar code labeling. We will give careful consideration
to technical issues regarding the development and implementation of a
possible bar code label. We anticipate that discussions will include
presentations from invited speakers as well as from members of the
public.
We invite public comment on this issue, and we intend to focus on
the following questions:
A. General Questions Related to Drugs and Biologics:
1. Which medical products should carry a bar code? For example,
should all prescription and over-the-counter (OTC) drugs be bar coded?
Should blood products and vaccines carry a barcode?
2. What information should be contained in the bar code? What do
you consider to be critical bar code information that will reduce
medical product errors? If data exists, please provide it for the
record. What information would be helpful but not necessarily critical,
for reducing medication errors? Provide data.
3. Considering current scanners and their ability to read certain
symbologies, should the rule adopt a specific bar code symbology (e.g.,
reduced space symbology (RSS) and 2-dimensional symbology)? Should we
adopt one symbology over another, or should we allow for ``machine
readable'' formats? What are the pros and cons of each approach?
4. Assuming that we require bar codes on all human drug products,
where on the package should the bar codes be placed? Are there benefits
to placing bar codes on immediate containers, such as the bottles,
tubes, foiled-wrapped tablets, and capsules, found inside prescription
or OTC product cartons? Is there a way to distinguish whether certain
containers with a bar code will have a more significant effect on
preventing errors than others?
5. What products already contain bar codes? Who (i.e., hospitals,
nursing homes, outpatient clinics, retail pharmacies, etc.) uses these
bar codes and how? As with all comments, if data exists, please provide
it for the record.
B. Medical Device Questions
1. Should medical devices carry a bar code? What information should
be included in the bar code? For example, unlike drug products, medical
devices do not have unique identifier numbers.
2. If medical devices are bar coded, should all medical devices, or
only certain devices be bar coded? For example, tongue depressors,
syringes, and crutches are medical devices, but perhaps do not need a
bar code.
3. Should reprocessed, repackaged, refurbished, or multiple-use
medical devices be bar coded? Who should be responsible for generating
and applying the new bar codes and how should these barcodes be
different from the original manufacturers' bar codes?
4. What public health/patient safety benefits can be derived from
bar coding medical devices? If data exists, please provide it for the
record.
C. General Questions and Economic Impact Questions
1. Will bar code printing costs cause you to modify your packaging
choices, such as reconsidering the use of blister packages or
influencing future package choices? If so, how?
2. Have you implemented bar code technology in your product line?
If so, what elements and symbology are included in the bar code?
3. If you manufacture and bar code products, how do verification
requirements for bar codes affect your ability to add bar codes? How
much barcode verification is appropriate as part of the quality system?
4. Can bar codes be produced with a dose specific unique
identifying number, lot number, and expiration date at your highest
production line speeds?
5. What equipment solutions are vendors offering to manufacturers
for bar coding or scanning? How quickly can such systems run? What type
of packaging line is equipment used for?
6. What is the expected rate of technology acceptance in all health
care sectors of machine-readable technologies? What are the major
inhibiting factors to the current use of machine readable technologies?
What would be the expected benefit of using machine readable technology
in the delivery of health care services (including drug products)? What
would be the expected benefit of machine readable technology for other
potential uses (e.g., reports, recordkeeping, inventory control,
formulary setting, etc.)?
7. Assuming a final rule is issued requiring bar coding, when
should it become effective? For example, would some industries or
products require more time than others to comply with a bar coding
requirement? Would a certain compliance time sharply reduce costs of
relabeling?
III. Comments
Interested persons, who wish their comments to be considered during
the meeting, may submit to the Dockets Management Branch (HFA-305),
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville,
MD 20852, written or electronic comments by July 12, 2002. Comments
will be accepted after the meeting until August 9, 2002. Submit
electronic comments to [email protected] or http://www.accessdata.fda.gov/scripts/oc/dockets/comments/commentdocket.cfm.
Two copies of any comments are to be submitted, except that individuals
may submit one copy. Comments are to be identified with the docket
number found in brackets in the heading of this document. A copy of the
document and received comments are available for public examination in
the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through
Friday.
IV. Transcripts
You may request a transcript of the meeting in writing from the
Freedom of Information Office (HFI-35), Food and Drug Administration,
5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857. The transcript of
the public meeting will be available approximately 15 working days
after the meeting, at a cost of 10 cents per page. You may also examine
the transcript of the meeting after June 28, 2002, at the Dockets
Management Branch (see Comments) between 9 a.m. and 4 p.m., Monday
through Friday and on the Internet at http://www.fda.gov.
V. Electronic Access
Persons with access to the Internet may obtain additional
information on the public meeting at http://internet-dev.fda.gov/oc/meetings/barcodemtg.html.
Dated: June 11, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-15208 Filed 6-17-02; 8:45 am]
BILLING CODE 4160-01-S