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Dockets Management Branch \[HFA-305\]

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, Maryland 20852

**RE: Bar Code Label Requirement for Human Drug Products**

> **and Blood \[Docket No. 02N-0204\]**

Dear Sir or Madam:

McKesson Corporation commends the FDA on issuing its proposed rule in
the March 14, 2003 Federal Register (Volume 68, Number 50, Docket \#
02N-0204) on the Bar Code Label for Human Drug Products and Blood. We
welcome the opportunity to offer comments on the proposed rule and we
appreciate your continued collaboration with industry in the development
of bar code standards.

McKesson Corporation is the world's largest pharmaceutical supply
management and healthcare information technology company. As the
nation's largest healthcare services corporation, we do business with
over 5,000 hospitals, 35,000 physician practices, 10,000 extended care
facilities, 700 home care agencies, 25,000 retail pharmacies, 600
payors, 450 pharmaceutical manufacturers and 2,000 medical-surgical
manufacturers.

We are also the industry leader and only single-source provider of drug
distribution, automation, scanning and information technologies to help
healthcare organizations reduce medication errors throughout the
continuum of care. Over 10,000 hospitals, outpatient, and retail
pharmacies are utilizing our bar code-based automation for
pharmaceutical products. McKesson pioneered retail pharmacy automation
with the Baker Cell pill counting technology with products in over
10,000 retail and outpatient pharmacies world-wide. We invented the
first robotic dispensing system, which automates the dispensing of
unit-dose bar coded medications, and introduced the product to the
hospital market in 1992. We also manufacture medication dispensing
cabinets for nursing units that support bar code scanning for accurate
drug restocking, and we have incorporated bar code scanning utilizing a
hand-held wireless scanner at the point of medication administration at
the patient's bedside. McKesson was also the first drug distributor to
fully automate our distribution process by implementing radio frequency
and scanning technology throughout our entire warehouse and distribution
network.

McKesson strongly supports the bar coding of pharmaceutical products to
help reduce medication errors and improve efficiencies in the supply
chain. Drawing on our experience and that of our customers, we are
uniquely positioned to provide the FDA with information about
pharmaceutical bar coding and currently available technology and
automation solutions.

As early as 1993, the University of Wisconsin Hospitals and Clinics
(UWHC) embraced McKesson's bar code and automation solutions for
pharmaceutical distribution through our robotic system (ROBOT-Rx) and
our unit-based cabinet (AcuDose-Rx). They are also implementing
point-of-care bar code scanning at the bedside (Admin-Rx). The bar code
format that the University of Wisconsin is utilizing on unit-dose
medications is a linear bar code that includes NDC and expiration date.

Working with McKesson on clinical programs and adverse drug event (ADE)
tracking, they have demonstrated a significant reduction in medication
errors, enhanced efficiency, increased clinician satisfaction, and
improved medication documentation. They are currently using bar code
technology and robotics in their outpatient pharmacy as well. They have
performed a pre- and post-automation study, using the naïve observer
technique, to assess the error reduction associated with their
technology implementation.

The following results from the University of Wisconsin Hospitals and
Clinics demonstrate the medication error reduction that has been
achieved utilizing a linear bar code that includes the NDC number and
expiration date along with dispensing and point of care bedside scanning
technology[^1]:

-   Reduction in dispensing errors from 1.43 percent to 0.13 percent,
    utilizing the ROBOT-Rx and bar-coded medication dispensing

-   Return on investment realized in 2 years

-   Increase from 89 percent to 95 percent in nursing satisfaction with
    switch from manual drug dispensing systems to our robotic and
    cabinet drug dispensing systems

-   79 percent reduction in narcotic discrepancies utilizing the
    AcuDose-Rx dispensing system

#### 85 percent improvement in documentation accuracy in the emergency room and 71 percent reduction in overall discrepancies utilizing the AcuDose-Rx dispensing system

-   89 percent reduction in medication administration errors due to
    point of care bar code scanning at administration, utilizing the
    Admin-Rx medication administration system

#### 

Early adopters of bar codes to promote safety should not be
disadvantaged. Proposed requirements should take into consideration the
considerable investments that many hospitals have made to date in bar
coding technology and give them the flexibility to support and build
upon these investments.

**§VIII. Request for Comments (68FR12529)**

McKesson is a founding member of the National Alliance of Health
Information Technology (NAHIT) and a member of the Healthcare Leadership
Council and HIMSS bar coding task forces. Additionally we have
participated in the Industry Coalition on Patient Safety (ICPS), an
industry-wide group convened to discuss and make recommendations on the
FDA's medication error reduction initiative.

While we support most of the comments offered by these organizations on
the proposed rule, our leadership in automation technology and
information systems enables us to provide unique insight into the
potential impact that certain requirements would have on providers with
bar code systems currently in place. Specifically, we are advocating a
bar code mandate that requires the National Drug Code (NDC) number and
expiration date in a linear bar code. Additionally, we are commenting on
the technical, implementation and workflow issues that the FDA should
consider before issuing a final bar code rule.

**[FDA Question 1:]{.underline}**

**Should the rule require bar codes on prescription drug samples and if
so what are the costs/benefits of their inclusion? (See FDA Proposed
Rule Description, Section II.B.2a, (Proposed §201.25(b)), 68FR12505)**

McKesson supports the proposed rule as presented.

**[FDA Question 2:]{.underline}**

**What are the risks and benefits of including vaccines in the rule?
(See FDA Proposed Rule Description, Section II.B.2.a, 68FR12505)**

McKesson agrees with the inclusion of vaccines in the final rule for bar
code labeling. We recommend that the FDA require the inclusion of
expiration date, as well as the NDC number, on vaccines within the
three-year implementation timeframe of the Proposed Rule. To the extent
that vaccines are administered in hospitals, they are an essential part
of the patient's medical record. Scanning the barcode on a vaccine will
prevent errors and provide improved electronic documentation.

**[FDA Question 3:]{.underline}**

**Are the terms used to describe the Over-the-Counter (OTC) drug product
covered by the rule sufficient? (See FDA Proposed Rule Description,
Section II.B.2.b, 68FR12505)**

We advocate language that describes OTC drug products in the FDA
proposed rule, Section 201.25 (b) as "non-prescription drugs used
therapeutically pursuant to a clinician's order." As was recommended by
NAHIT, we concur that the term "commonly used in hospitals" should be
defined as packaged for [hospital]{.underline} use, labeled for
[hospital]{.underline} use, or marketed, promoted, or sold to
[hospitals]{.underline}.

**[FDA Question 4:]{.underline}**

**Should the Lot Number and Expiration Date be included in the rule and
if so what is the data on the costs and benefits that would justify
their inclusion? (See FDA Proposed Rule Description, Section II.C.2,
68FR12507)**

We recommend that both the NDC number and expiration date be included in
the final rule. McKesson has demonstrated that NDC number and expiration
date can be encoded in a linear bar code on a unit dose medication, and,
combined with bar code scanning, can reduce medication errors.

The minimum amount of data in a bar code on a unit-dose medication that
will prevent medication errors is the NDC number, as issued by the FDA,
and the expiration date. Used alone, bar codes will not prevent
medication errors; technology and decision support systems must be in
place to ensure that patient safety benefits are derived from the use of
bar coding. Scanning drug and dose information, such as the NDC number
and expiration date, and comparing it to the patient profile will ensure
accurate dispensing and administering of the medication. It will also
prevent outdated medications from being administered.

Although the inclusion of lot numbers in bar codes would provide
additional tracking capability, they would also add complexity to the
workflow of these decision support systems and increase costs:

-   Increasing the amount of data in the bar code may require that a
    different bar code type (such as RSS or 2-D) be utilized. This would
    impact all existing scanning technology currently utilized in
    hospitals and require upgrades to scanners capable of reading the
    newer symbology.

-   Tracking additional data, particularly lot numbers, would also
    impact workflow for the pharmacy and nursing staff, adding
    additional steps to their drug-handling process. Each time a new lot
    arrived, they would have to first ensure that the lot number was
    entered into the formulary, and then track the dispensing of
    medication lot numbers at the nursing unit level. This process would
    be simplified if point-of-care bar code scanning were in place;
    without that technology it would be more labor intensive.

-   There is no national standard for lot number formatting. Currently,
    the data included, the format, and the length of lot numbers vary
    among pharmaceutical manufacturers.

We recommend that the FDA require the UCC/EAN or HIBCC standards for any
voluntary encoding of the Lot Number and expiration date.

**[FDA Question 5:]{.underline}**

**Should the rule refer to linear bar codes without mentioning any
particular standard? (See FDA Proposed Rule Description, Section II.D.1,
68FR12508)**

McKesson recommends that linear bar codes be used as the initial
requirement, and supports the inclusion of both the UCC/EAN and HIBCC
standards.

As we have previously noted, proposed requirements should take into
consideration the considerable investments that many hospitals have made
to date in bar coding technology and provide them with the flexibility
to support and build upon these investments. Hospitals that have been
early adopters of bar codes to promote safety should not be
disadvantaged. Thousands of hospitals currently utilize unit-dose
packaging technology, which is only capable of printing single
dimensional barcodes. McKesson's customers alone print more than 220
million linear barcodes on an annual basis. The costs to replace this
legacy barcode equipment would be significant.

**[FDA Question 6:]{.underline}**

**What is the current state of bar code scanners and their ability to
read various symbologies? (See FDA Proposed Rule Description, Section
II.D.1, 68FR12508)**

As of today, the bar code printing and scanning technology deployed in
hospitals will support only linear bar codes. We provide technology to
support bar code scanning throughout the supply chain and medication use
process and have been deploying these systems for more than ten years.
We have confirmed with our hardware suppliers that the technology
*currently installed* in most hospitals

cannot be upgraded to support non-linear bar code technology; therefore,
it will have to be replaced if the mandate requires non-linear bar
codes. The cost implications of this requirement will be significant. We
believe that a mandate that requires non-linear bar codes will penalize
the early adopters that have

implemented bar code systems.

A recent report published in the American Journal of Healthcare
Pharmacists found that 9.5% of hospitals use bar code verification for
dispensing and 7.8% utilize robotics to scan bar codes in the dispensing
process.[^2] The same study indicates that 1.5% of hospitals currently
scan bar codes at the point of care. (Note: *This number is probably
higher than 1.5% because the study did not include the VA system, which
has deployed bar code scanning in all VA hospitals, and additional
systems have been installed in non-VA hospitals since the data was
collected in June 2002.*) All of these hospitals have bar code printing
and scanning technology deployed in the pharmacy today, which will have
to be replaced if the mandate includes new generation bar codes. Our
experience demonstrates that safety can be achieved through linear bar
codes that include only the NDC number and expiration date.

**[FDA Question 7:]{.underline}**

**Should the rule adopt a different format for the machine-readable
code; what should that format be; how widely is it accepted by the
industry; and will hospitals be able to read it with existing equipment
or equipment under development? (See FDA Proposed Rule Description,
Section II.D.1, 68FR12508)**

We urge the FDA to include enough flexibility in the final rule to
encourage the adoption of improved auto identification technology as it
develops. By referencing a class of standards administered through a
designated standards organization, such as UCC/EAN and HIBCC, rather
than a particular technology or format, the FDA can provide for such
flexibility in the rule. As noted in our responses to questions 5 and 6,
we do not believe that hospitals will be able to read new generation bar
codes with the equipment that is currently installed. As new generations
of bar codes or auto-id are developed, equipment will also become
available to read them. In order to utilize the new technology,
hospitals will have to incur the cost of purchasing new equipment.

**[FDA Question 8:]{.underline}**

**Should there be specific product exemptions from the rule and how
should they be defined? (See FDA Proposed Rule Description, Section
II.F, 68FR12511)**

McKesson recommends that the FDA not provide an exemption for particular
products or a class of products, but rather have in place a general
mechanism for waivers which could be applied on a case-by-case basis
through a reasonable and expeditious process.

**[FDA Question 9:]{.underline}**

**Is the implementation timeframe of three years appropriate or can it
be shortened; should there be a different timeframe for new drug
products? (See FDA Proposed Rule Description, Section II.G, 68FR12512)**

McKesson recommends that the FDA final rule requiring a bar code label
encoded with the NDC number and expiration date for all human drug
products become mandatory for:

1.  new drug product applications two (2) months after the effective
    date of the final rule; and

2.  existing drug labels as soon as practical, but not later than
    three (3) years after the effective date of the final rule.

**[FDA Question 10:]{.underline}**

**Should the ISBT-128 standard be adopted for blood or should an UCC/EAN
standard be required? (See FDA Proposed Rule Description, Section II.H,
68FR12512)**

The FDA should require a standard for the bar coding of blood products
that is recognized by the field and that can be read by the same
scanning technology employed in the medication and supply use processes.
We recommend that this standard be the ISBT-128, since it can be
recognized by the technology currently in use for medications and
supplies. The implementation timeline may need to be revised since many
of the frozen blood products available today have a shelf life well
beyond three years.

**[FDA Question 11:]{.underline}**

**How will the rule for blood affect hospitals purchasing decisions for
bar code technology given the requirements in the rest of the rule for
drug products? (See FDA Proposed Rule Description, Section II.H,
68FR12512)**

By adopting the ISBT-128 standard, the FDA will promote the scanning of
blood products with the same bedside scanning technology used for human
drug products. Since current HIBCC and UCC/EAN standards and the
ISBT-128 standard are linear codes, scanners now used in hospitals can
recognize both.

**[FDA Question 12:]{.underline}**

**Are any of the alternatives discussed by the FDA in the economic
impact section of the rule, of issuing no rule or requiring additional
information in the code, viable? (See FDA Proposed Rule Description,
Section VII.O, 68FR12528)**

McKesson agrees with the FDA that most of the alternatives discussed in
the economic impact section are not viable with the exception of
inclusion of the expiration date. We already have demonstrated that it
is possible to encode the NDC number and expiration date in a linear bar
code on a unit dose medication.

### FDA Economic Analysis Concerns

**[FDA Question:]{.underline}**

**Are there concerns about the economic assumptions made by the FDA in
the proposed rule and how might they be addressed?**

While specific assumptions in the economic analysis could be challenged,
we agree with the NAHIT consensus that generally the assumptions are
reasonable and provide a valid justification for the proposed rule.
However, as already discussed in our response to question 6, we caution
that a requirement to implement non-linear bar codes could disadvantage
early adopters of bar code technology by requiring these hospitals to
incur significant costs to replace existing bar code printing and
scanning technology.

**FDA's Intent to Revise NDC**

Though no specific information is provided in the proposed rule for
comment, McKesson is concerned about the statement that the FDA "intends
to revise the drug establishment registration and listing regulations to
redefine the NDC number and to make the NDC number unique and more
useful to informational databases, whether those databases are created
for the purposes of preventing medication errors, obtaining the latest
information about a specific drug, or tracking the use or distribution."
We recognize that there may be value in doing this and do not oppose it.
However, there are far reaching implications for all parts of the supply
chain and therefore any proposed changes must be thoroughly investigated
with all stakeholders.

Conclusion

Bar coding of pharmaceutical products and the use of technology to
leverage the benefits of bar coding are essential to patient safety. In
addition to medication error reduction in the dispensing and
administration phases, bar code technology has many additional benefits.
The use of bar codes in combination with automated dispensing technology
and robotics can free pharmacists from dispensing tasks to perform
clinical duties. With the pharmacy work force shortage, automation will
become critical to ensuring pharmacy services in some hospitals. Bar
codes also provide a means for inventory management and tracking as well
as for automating patient billing. Point of care bar code scanning
allows for critical checking of the "5 Rights" of medication
administration, thereby preventing errors before they occur. It also
allows for real-time documentation of medication administration which
provides immediate on-line data for clinical care, and accomplishes
accurate billing based on what was administered to the patient.

We commend the FDA for its willingness to collaborate with industry and
health care providers to accomplish this critical goal of reducing
medication errors and improving patient safety. We look forward to
working with the FDA on the implementation of the final rule, and hope
to continue to collaborate with the agency should you move forward with
redefining the NDC number.

Respectfully submitted,

![](media/image2.png){width="2.748611111111111in" height="0.8125in"}

Ann Richardson Berkey

Vice President, Public Affairs

[^1]: Rough, Steve, MS, RPh, Thielke, Tom, M.S., FASHP, *Closing the
    Loop; Strategies to Reduce Medication Errors*, presented American
    Society of Health-System Pharmacists December 5, 2001

[^2]: Rough, Steve, MS, RPh, Thielke, Tom, M.S., FASHP, *Closing the
    Loop; Strategies to Reduce Medication Errors*, presented American
    Society of Health-System Pharmacists December 5, 2001