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**Statement of the\
National Alliance of Health Information Technology\
in Response to the\
Food and Drug Administration of the\
Department of Health and Human Services\
on\
Bar Code Label Requirements for Human Drug Products**

**Docket No. 02N-0204**

**July 26, 2002**

*The following statement is provided by Tim Zoph., chief information
officer for The Northwestern Memorial Hospital, Chicago Illinois.*

Ladies and Gentleman, I am Tim Zoph., chief information officer for The
Northwestern Memorial Hospital, Chicago Illinois. I am here today on
behalf of the National Alliance of Health Information Technology
(NAHIT), a group of approximately fifty organizations representing
providers, purchasers, manufacturers and standard setting organizations
that is committed to "mobilize the field to address the fragmentation
and lack of coordination in healthcare...improving quality and
performance through standards-based information systems." We are pleased
to have the opportunity to testify on an issue of critical importance
for the healthcare industry and the people they serve: the bar coding of
drug labels for unit-of-use pharmaceuticals.

Northwestern Memorial Hospital is a founding member of the NAHIT and is
committed to the first initiative of the Alliance - promoting the use of
bar coding technology to create safer more efficient and effective
patient care. I am here today to present the consensus recommendations
of NAHIT to the FDA for their consideration as they develop a rule for
the bar code labeling of human drug products.

**BACKGROUND**\
Health care has trailed virtually every other industry in reaping the
benefits of information technology advances due at least in part to (1)
a lack of consistent and uniform standards and protocols and (2) its
dependence on multiple scientific disciplines and medical specialties
each with its attendant technical requirements and demands. As a result,
the health care environment is extremely fragmented, with isolated
systems and databases. To improve the situation, the industry must begin
to approach this more strategically. The recent Institute of Medicine
Report *"Crossing the Quality Chasm"* calls for "a national consensus on
comprehensive standards for the definition, collection, coding and
exchange of clinical data." In comparison to other industries, health
care has been slow to achieve this consensus and, therefore, has failed
to leverage even their limited investment in information technology to
improve patient outcomes and operational efficiency.

The lack of use of bar coding technology in bedside care is one such
example of the failure of healthcare to leverage a technology widely
used by other industries. There are multiple causes for this failure but
one important cause is the absence of a standardized bar code on the
label of the unit-of-use pharmaceutical packaging. Only approximately
35% of all drugs administered at the bedside contain a bar code which
when used in conjunction with r decision support tools could
dramatically reduce the incidence of medication errors.

NAHIT recognizes that implementation of bar codes on the unit-of-use
medication packaging is only the first vital step in realizing the
promise of bar code technology in making our healthcare systems safer.
In pursuing its ultimate goal to achieve standards-based information
systems for the U.S. health care system, NAHIT has developed consensus
recommendations for the implementation of bar codes on the labels of
unit-of-use pharmaceuticals. Accomplishing this objective will help
create the environment that can foster progress in developing
interoperability of our fragmented information systems to achieve the
maximum benefit for patient safety of a bar coded medication delivery
process.

A set of recommendations from the National Coordinating Council for
Medical Error Reporting and Prevention already exists and is a good
starting point for a discussion of bar coded labeling standards. NAHIT
has reviewed these standards and building upon them offers the following
recommendations in response to the FDA's questions.

**THE FDA'S PROPOSED RULE FOR BAR CODE LABEL REQUIREMENTS**\
NAHIT supports the FDA's effort to propose a rule to require a bar code
on the label of human drug products down to the unit-of-use packaging.
Our recommendations, based on the considerable expertise of our member
organizations, can help the FDA to further define the details of a bar
code implementation process for human drug products. Additionally, we
desire to work with the FDA on the further implementation of bar coding
in healthcare to promote patient safety and to protect patients from
human and system errors. It is our desire that today's public meeting
will aid the healthcare field and the FDA in achieving consensus on the
prompt establishment of regulations for the bar code labeling of human
drug products down to the unit-of-use level.

**DRUGS AND BIOLOGICALS**\
NAHIT supports the implementation of requirements for bar coding for
**all** commercially available prescription and non-prescription
medications. The bar code should be included on the labels of all
unit-of-use pharmaceutical packaging. All dosage forms including oral
solids, oral liquids, injectables, inhalers, nasal sprays, topicals, and
other forms of specialized drug product packaging should include a bar
code on their label. In addition to unit-of-use packages, intermediate
containers and cartons and Shelf Keeping Units (SKUs) should also be
labeled with a bar code. Eventually, vaccines, blood and blood products
should have an FDA requirement for labeling with a standardized bar
code. Currently only blood has a bar code and even it is not mandatory.
Bar codes for vaccines are currently under investigation by the CDC. The
absence of bar codes on blood products could raise safety issues
especially for the tracking of contaminated products.

The National Drug Code (NDC), as established by the FDA, should be the
initial data element included in the bar code. This should be
implemented as quickly as possible. Inclusion of the expiration date and
lot number, especially to track recalled and out-of-date products,
should be added to the bar code as soon as it is technically feasible.
These components can be phased in over a longer period of time. Working
out the technical problems related to the lot number and expiration date
should not delay the implementation of a bar coded label that at minimum
identifies the drug, its strength and manufacturer. If the FDA proceeds
with the rule including only the NDC number, NAHIT has the technical
expertise and is willing to work with the FDA to identify solutions and
timeframes for implementation.

The choice of the symbology for the bar code is a critical element of
the proposed rule and should be governed by specific principles. The
NAHIT recommends that only existing symbologies utilized in healthcare
with the capacity to include the NDC, lot number and expiration date be
used for the bar coded label. Additionally, symbologies appropriate to
the pharmaceutical packaging size and capable of being scanned by
existing and readily available commercial scanning technology should be
selected. These principles would allow flexibility to pharmaceutical
manufacturers while providing for a level of standardization for the
users of the scanning devices without significantly increasing their
costs.

The placement of the bar code on the packaging for human drug products
should be in a position where the typical user of the scanning device
can reliably and consistently scan it. The printing quality of the bar
code should be at the C or better ANSII standard. There should only be
one unique bar code for each unit-of-use package.

Blood and blood products, laboratory specimens and reagents, x-rays and
scans, and some unit-of-use pharmaceuticals are currently bar coded.
Additionally, pharmaceuticals at the SKU, case and intermediate
packaging size have bar coded labels. Most bar coding in healthcare
organizations is used for inventory control, tracking of radiology
records and in the dispensing of pharmaceuticals. Hospitals have
employed bar coding in their medication administration system or in
automated dispensing cabinets but only after extensive repackaging of
their pharmaceuticals have been undertaken since only approximately 35%
of medications at the unit-of-use level have a bar code. This lack of
the preprinted bar code creates the attendant risk of introduction of
new error through repackaging and relabeling into the medication
process. Currently, the major users of the bar codes in healthcare
institutions are materials management personnel, pharmacists and
pharmacy techs, laboratory and radiology techs. Nurses and physicians
have had limited experience with bar code technology in the clinical
setting.

**MEDICAL DEVICES**

NAHIT, with its strong interest in patient safety, supports the eventual
inclusion of certain medical devices in a bar code labeling
recommendation. Because of the complexity of this issue, in selecting
the devices to be covered and the information to be included, NAHIT
feels strongly that progress in labeling human drug products with bar
codes should not be impeded by the issue related to medical devices.
NAHIT recommends that the FDA complete its proposed rule on human drug
products and biologics and then explore the feasibility of creating a
bar code rule for selected medical devices.

Not all medical devices would need a bar code. Priority should be given
to those devices that have the potential to or the history of adversely
effecting patient safety.

Since the reprocessing of devices can lead to safety concerns, bar
coding may be helpful in tracking reprocessed device failure or
infection. Bar codes should be similar in content and format to those
the FDA may require from the original manufacturer; however; they may
also need to contain additional information such as reprocessing date
and identification of the reprocessor to enable efficient tracking of
the device.

Bar codes on medical devices could enhance patient safety at the bedside
by tracking device failures, device related infections and unexpected
outcomes related to both the proper and improper use of the devices.
Having a bar code on the device and the information captured in an
integrated database would allow the easy identification of patients who
may be potentially harmed by device failure. This type of data would
also facilitate the review of device performance and allow for the
development of an early warning system when problems occur in the use of
medical devices.

**OBSTACLES AND BENEFITS**

NAHIT recognizes that while the costs to the manufacturer to place the
bar code on the unit-of-use label is not insignificant, much larger
expenditures will have to be made by healthcare organizations to take
full advantage of a bar coded medication delivery that can draw
information from other existing systems for dosage limits, drug-drug,
drug-food interactions, laboratory values, allergies and decision
support. The incompatibility of current legacy information systems is a
significant obstacle to use of a bar coding system; however, this
consideration and the costs to achieve interoperability should not
discourage the widespread promulgation of bar code labeled products.
Health care has always had early adopters who, when given the basic
tools, have led the field to new levels of quality and service. We
expect the same to happen once bar codes are widely available on human
drug product labels.

Implementing a medication delivery system with the support of an
enhanced information technology infrastructure is a complex undertaking.
Issues related to training, process design, and work-arounds will still
need specific attention prior to successful implementation of bar coded
medication delivery systems. NAHIT is committed to work collaboratively
with the FDA and other stakeholders to address these issues and provide
its expertise in the education and consensus building necessary to get
the full benefit for patient safety as a result of the proposed rule.

**TIMEFRAMES**

Today's hearing will raise many concerns related to issuing a final rule
requiring bar coding for human drug products. However, realizing the NDC
is the data element most easily incorporated into the bar code, we
encourage the FDA to move as soon as possible in establishing the
requirement for bar coded labeling with at least the NDC. NAHIT offers
its assistance to work with the FDA in identifying a specific date for
this requirement and in developing a phase-in schedule for the inclusion
of other data elements such as the lot and expiration date in the bar
code. We will also work with the FDA to identify the timeframes for the
labeling of certain medical devices and biologicals with bar codes.

**CONCLUSION**

NAHIT would like to thank the FDA for this opportunity to address the
issues raised in proposing a rule on bar code labeling for human drug
products and biologicals. We stand ready to work with the FDA, drawing
on the expertise of our diverse member organizations, to resolve the
outstanding issues related to the bar coding of drugs, biologicals and
devices. We are committed to a consensus approach that places the
patients and their safety above all other interests. Only through such a
broad-based and committed partnership will we achieve the promise of
high quality patient care.

**\
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