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**Statement of the**

**Healthcare Leadership Council**

**before the**

**U.S. Food and Drug Administration**

**Public Meeting on**

**Bar Code Label Requirements for Human Drug Products**

**\[Docket No. 02N-204\]**

**July 26, 2002**

***[BACKGROUND]{.underline}***

The Healthcare Leadership Council (HLC) is a coalition of chief
executives representing all disciplines within the healthcare system
that jointly develops policies, plans and programs to achieve our vision
of an effective 21st century healthcare system. The safety of the
nation's health care system is a top priority for HLC. We appreciate the
opportunity to submit the following comments in regard to the Food and
Drug Administration's impending regulation on bar code labeling for
human drug products.

The Healthcare Leadership Council is unique in that it represents all
sectors of the health care industry that would be affected by the FDA's
bar coding regulation, including hospitals and hospital systems,
pharmacies, pharmaceutical companies, pharmaceutical and
medical-surgical distributors, and medical device manufacturers.

In 2000, the Healthcare Leadership Council created a Chief Executive
Task Force on Patient Safety so that these various sectors of the
healthcare industry could work together to help elevate public
confidence in the safety of the nation's healthcare system. The
objective of this task force is to collaborate on specific,
evidence-based, pragmatic solutions and innovations that have the
potential to substantially improve quality and reduce patient errors. We
believe that by focusing on measurable and achievable solutions as our
core priority, the public will be assured of a system dedicated to
safety and continual improvement. Based on a survey of potential patient
safety initiatives that were consistent with this objective, HLC's Task
Force on Patient Safety determined that electronic verification of drugs
at the point of administration ("bedside bar coding") should be a high
priority initiative. We believe that automated drug identification has
the potential to greatly limit the incidence of medication errors.

***[ISSUE]{.underline}***

The delivery of medications is a complex process that requires the
coordination of numerous disciplines and involves a variety of delivery
and administration procedures. When these procedures rely on manual
systems and memory, they create an environment that can promote errors.
A 2000 study by the U.S. Pharmacopeia indicated that, while medication
errors occur at all stages of the medication use process, they most
frequently occur at the administration stage. This is critical since the
administration stage is the final link in the medication process chain,
with little opportunity left to halt an error before harming the
patient. Medical researchers agree that most medication errors can be
prevented and technology -- specifically automated identification of
unit of use packages at the patient bedside -- has great potential for
reducing the frequency of these errors.

A Veterans Affairs medical center implemented a bedside verification
system for medication administration and found that zero errors occurred
when the system was used as designed. The VA medical center found that
bar coding significantly reduced medication errors. The system prevented
378,000 errors, or 5.6 percent of all doses.

The Institute of Medicine (IOM) announced in its 1999 report, *To Err Is
Human: Building a Safer Health System*, that as many as 98,000 Americans
die each year as a result of medical errors. This report specifically
recommended more use of bar-coding for medications at the patient
bedside.

***[RECOMMENDATIONS]{.underline}***

HLC members have long been active in seeking to improve safety, and
their efforts include a broad range of ongoing programs. Several of our
hospital and pharmaceutical members, as well as our medical device and
technology manufacturers, have extensive experience with automated
identification of medical products using bar codes.

In preparation for this hearing, HLC assembled a panel of experts from
our member organizations to evaluate auto-identification options and to
develop recommendations for the FDA. This diverse group identified
numerous issues and developed a consensus position and recommendations.
Our recommendations consist of a set of broad guidelines and a set of
specific recommendations.

***A. Broad Guidelines***

The impact on patient safety of any FDA regulatory standards for
auto-identification will be strongly dependent upon the "usability" and
acceptance of the standards. The prevention of medication errors
requires the cooperation of numerous parties along the drug supply
chain, from the creators of the bar code printing equipment to the nurse
administering the dose at the patient bedside. HLC recommends the
following guidelines to ensure a harmonious system that will be highly
effective in the reduction of errors.

**1. Be pragmatic:** Auto-identification standards for pharmaceuticals
should support the highest level of patient safety possible through the
most feasible and cost efficient approach that can be implemented in the
shortest period of time.

**2. Build upon, but do not disrupt, current market forces:**
Auto-identification, using bar codes in most cases, is growing in use.
Many pharmaceutical companies are printing bar codes, when possible, on
their unit of use packages, and hospitals are increasingly adding
auto-identification to their information systems. This process has been
self-initiated or facilitated through market demands. Any FDA standards
should be careful not to disrupt this process or to discourage unit of
use drug packaging by putting in place requirements that are overly
expensive or highly difficult to implement.

**3. Consider the labor impact:** An FDA bar code labeling regulation
should serve to reduce, rather than increase, the work force needs of
health care organizations over current practices.

**4. Promote emerging technologies:** The FDA should allow for flexible
regulations that can accommodate new, more effective technologies as
they become available. While "barcoding" may be the auto-identification
technology of choice at this time, radio-frequency, dot matrix, or other
similar technologies may prove to be more effective and less costly in
the future.

***B. Recommendations* *Specific to Bar Code Labeling***

Notwithstanding our above recommended guideline to accommodate evolving
technologies, HLC is forwarding the following recommendations
specifically related to the use of bar coding in response to the FDA's
published notice of its intent to develop a bar code labeling
regulation.

**1. Products to be bar coded:** If the FDA determines it is necessary
to *require* bar coding, the requirement should be limited initially to
unit of use drug and biologic packages used in the institutional
environment only, including both prescription and over-the-counter
medications.

**2. Data elements to be included in bar code:** Initially, bar code
data element requirements should be limited to the national drug code
(NDC) number. The NDC contains the necessary information to ensure that
the patient is being administered the right drug in the right dosage.
The addition of lot number and expiration date should be considered when
the technology for printing more dense bar codes is more widely
available, and research is conducted showing that patient safety is
enhanced with this additional information proportional to the cost of
implementation. The FDA currently requires lot number and expiration
date to be included in human readable form on the drug package, which
should be sufficient for recall purposes and for determining if a drug
is still within the effective date.

**3. Bar code symbology:** In the near term, the FDA should not require
the application of bar codes beyond the widely used linear, one
dimensional bar code symbology that conforms to HIBCC or UCC/EAN
standards. Requiring the immediate use of reduced space symbology (RSS)
or two-dimensional bar codes (as would be necessary if bar codes are
required to include lot number and expiration date) would result in
substantially increased pharmaceutical manufacturing and packaging
costs. Using existing bar code printing equipment, RSS and
two-dimensional bar codes could reduce package printing and verification
productivity by 25 to 40 percent. In addition, existing hospital bar
code scanning equipment must be reprogrammed to read the newer bar code
symbologies. As mentioned previously, however, we strongly believe in
supporting emerging technologies and we do not advocate *prohibiting*
the use of two-dimensional, RSS, or other types of more advanced bar
codes. We suggest that the FDA consider conducting research to determine
an appropriate time line for introducing specific standards for RSS,
two-dimensional, and other developing auto-identification symbologies.

**4. Bar code location:** The FDA should not limit flexibility by
specifically mandating the location or position of the bar code on the
package. In developing this regulation, the FDA should not include
extraneous requirements that are only peripherally related to patient
safety.

**5. Containers to be bar coded:** Bar code requirements should apply to
containers that are the most critical to medication safety; this
includes the immediate containers of unit of use-packaged drugs. Less
than 30 percent of drugs are now bar coded at the unit of use level,
whereas over 95 percent are bar coded at the outer carton level as a
result of purchaser demand for inventory control and other reasons.

> An additional consideration for FDA is that unit of use containers
> come in various shapes and sizes -- and some are more easily barcoded
> than others. Examples of such various unit of use forms include oral
> solids, oral liquids, topical creams, pre-packaged unit-dose syringes,
> vials, and ampules. Because of their very small size or irregular
> shape, some of these unit of use drug containers are more difficult to
> print with bar codes than others -- especially in an automated
> printing system. Consideration should be given as to the difficulty of
> printing and scanning bar codes on very small, oddly shaped containers
> such as certain vials and ampules.

**6. Label approval requirements:** The FDA should re-evaluate its
annual label review process with respect to label changes that may be
necessary to accommodate bar codes. They may also need to consider
eliminating some label information which is currently required.

**7. Phase-in schedule:** Any regulation should take into consideration
the time and expense required to re-tool packaging operations, including
purchasing new printing and verification equipment, redesigning package
artwork, and re-filing for label reapprovals. A feasible phase-in
schedule will help to ensure that the FDA's regulation does not
discourage unit of use drug packaging.

> It is important to note that printing bar codes on drug labels will
> not be effective unless medical facilities implement the equipment and
> systems necessary to use the bar codes for safety purposes. Less than
> five percent of hospitals in the U.S. have in place the hardware,
> software, and training programs to conduct patient bedside bar coding.
> Hospitals need to be assured that sustainable bar coding equipment and
> software compatible with their existing information technology is
> available. This should be taken into consideration when determining
> the effective date for this regulation. Additionally, we recommend
> that the FDA continue to revisit and update any standards developed in
> this area to ensure they are current in this environment of fast-paced
> technology development.

**8. Complementary funding initiative:** To maximize effectiveness of
bar coding regulations, the FDA or other agencies within the Department
of Health and Human Services should consider including a grant program
to assist hospitals in acquiring technology necessary to implement
auto-identification of drugs at the patient bedside.

***[CONCLUSION]{.underline}***

The Healthcare Leadership Council believes that the combination of
executive-led, holistic systems of safety, and automated information
technology to corroborate human safety systems, will reduce the
incidence of medication errors. Automated drug identification is an
important element in the effort to achieve a zero-error health care
environment and to instill even greater public confidence in our health
care system. We are encouraged that the U.S. Food and Drug
Administration is exploring ways to help make implementing
auto-identification increasingly effective and we stand ready to assist
the agency at your request.