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July 12, 2002

Ms. Mary Gross

Office of Drug Safety

Center for Drug Evaluation and Research

Food and Drug Administration

5600 Fishers Lane, Room 15B-32

Rockville, MD 20857

Dear Ms. Gross:

Premier, Inc., a strategic alliance of leading not-for-profit hospitals
and health systems nationwide, is appreciative of this opportunity to
offer our perspective on the Food and Drug Administration\'s
promulgation of a rule to require bar code labels on institutionally
administered drugs, biologicals, and medical devices. We look forward to
discussing our position in person, at the FDA\'s July 26 public meeting
on this subject.

Premier is in a position to offer the FDA a unique perspective on
industry adoption of the bar code. For the not-for-profit hospitals and
health systems allied in Premier, cost-effective quality improvement of
care is not only a priority---it\'s our mission. Bar coding is a
critical component of a larger, broad-based strategy to assist our
hospitals achieve the highest quartile in quality and lowest quartile in
costs.

Research conducted at the Colmery-O\'Neil Veterans\' Administration (VA)
facility in Topeka, KS, is demonstrative of the potential of bar code
implementation to improve safety and quality and reduce costs. The
Colmery-O\'Neil study, conducted between 1993 and 1999, revealed that
bar code labeling of drugs reduced medication error rates by 64 percent
overall. This experience compelled the VA to implement bar code
technology in all of its 172 medical facilities.

Premier believes that patients across the healthcare delivery system are
deserving of a comparable level of medication safety, which the issuance
of a comprehensive regulation would do much to ensure. Attached, please
find a short summary of our position, per the June 18 *Federal Register*
notice, along with the Veterans' Administration study referenced above.
Again, thank you for the opportunity to offer our perspective on this
important quality and cost management issue. We look forward to working
with you to achieve the patient safety improvements in that bar code
implementation would facilitate.

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Sincerely,

Bert Patterson, R. Ph.

Vice President for Contracting and Contract Services

Premier

Attachments

**[ON FDA PROMULGATION OF BAR CODE LABELING REQUIREMENTS]{.underline}**

# 

# A summary of Premier's position, per questions posed in the June 18 *Federal Register* notice.

### General Questions Relating to Drugs and Biologics

1.  Premier believes that all hospital-administered drugs and
    biologicals ought to feature bar code labels---with the Universal
    Product Number (UPN), including the National Drug Code (NDC), as the
    standard industry identifier---at every level of packing, especially
    that of the unit-dose.

2.  Premier agrees with recommendations issued by the National Council
    for Coordinating Medical Error Reporting and Prevention (NCC-MERP)
    with respect to the information bar code labels ought to contain. We
    are cognizant of the concerns of some of our vendor business
    partners, with regard to the feasibility of meeting these
    requirements in the near term. Therefore, we believe the regulation
    issued in November ought to require the NDC code, while stipulating
    a reasonable timeframe in which the applicable labels would contain
    the NCC-MERP-recommended data.

3.  Premier believes that the industry ought to move toward the
    implementation of the more advanced two-dimensional bar codes.
    Current scanning technology is compatible with both the Health
    Industry Business Communications Council's health bar code labeler
    identification code (HIBC-LIC) and the Uniform Code Council /
    European Article Numbering's (UCC/EAN) universal product code (UPC).
    Therefore, we consider either symbology acceptable as the industry
    moves toward two-dimensional bar codes.

> Another feature critical to the success of any bar code labeling
> initiative is the readability of the data so contained. This would
> safeguard against the challenges clinicians and practitioners would
> encounter if problems with the requisite scanning technology were to
> arise.
>
> In addition, regardless of the symbology or symbologies the FDA might
> propose, Premier would respectfully request that they be compatible
> with current scanning technologies. We would urge the FDA
> [not]{.underline} to adopt standards that would require hospitals to
> purchase optic scanning technology. We believe such a burden would
> delay the patient safety improvements that bar coding would foster and
> facilitate.

4.  Premier is primarily interested in ensuring that health
    professionals can easily and successfully scan the bar code at the
    bedside. Once that consideration has been achieved, we would
    comfortably defer to others to make such a determination.

5.  It is our understanding that a small number of hospitals currently
    utilize bar coding in their facilities. It is important to note,
    however, that these bar codes are not of the UPN format. Further,
    most of the items are not coded at the level of patient
    dispensation. Therefore, hospitals currently utilizing bar coding
    must repackage virtually every item for which they desire the
    technology to apply. In addition, a somewhat larger, but still
    relatively limited, number of hospitals are using bar code
    technology for laboratories, blood products, and inventory control.

> Reports about the percentage of healthcare items that currently
> contain bar codes are inconsistent. Consensus exists, however, over
> the fact that the *least* amount of bar coding occurs at the unit-dose
> level of product packaging. Unfortunately, unit-dose products are
> where the greatest promise for patient safety improvement lies.

### Medical Device Questions

1.  Premier believes that all medical devices employed in the hospital
    setting ought to feature bar code labels with the Universal Product
    Number (UPN) as the standard industry identifier. We believe the
    information contained in the bar code ought to meet the HIBC-LIC
    and/or UCC/EAN standards.

2.  Premier believes that the medical devices for which bar code labels
    ought to be required are those with the strongest implications for
    patient safety and efficacy. Therefore, requiring that tongue
    depressors or crutches, for instance, feature bar code labels, is
    not Premier's primary concern. We would note, however, that in most
    cases, items such as bed pans, etc., sold in retail outlets do, in
    fact, feature bar codes. The arguments offered by the medical device
    industry against bar codes in the institutional setting ring
    somewhat hollow when such labeling is relatively prevalent in the
    retail setting.

3.  Premier believes that those medical devices with the greatest
    potential impact on patient safety ought to contain bar code labels.
    Bar code standards pertaining to medical devices ought to be
    consistently applied, whether such devices are "original," or
    reprocessed, repackaged, refurbished, or multiple-use.

4.  The public health and patient safety implications of bar code
    labeling are far-reaching. Should a medical device be recalled,
    either voluntarily or by the FDA, bar code implementation and
    appropriate technology would facilitate identification and protect
    against subsequent use and/or re-use. A bronchoscope recall, issued
    earlier this year by FDA, provides a telling example. Some hospitals
    received notice of the recall, while others, apparently, did not.
    Bar code labeling would provide an extra level of security to help
    ensure that the use of recalled devices is halted.

> The bar coding of syringes and other products in the medication
> delivery arena harbor great promise for patient safety improvement.
> Oftentimes, the syringe utilized plays a critical role in the success
> of medication administration. Bar coding would help ensure that
> clinicians utilize the appropriate syringe in each case of drug
> administration. In addition, bar code technology would enhance the
> ability of clinicians to conduct research on medical devices for
> maximum efficacy, with respect to patient care, thereby facilitating
> quality improvement.

### General Questions and Economic Impact Questions

1.  Premier will institute a bar code labeling requirement on all
    pharmaceutical product contracts signed after July 1, 2003.

2.  Premier has requested that the NDC code be used initially, with
    respect to drugs and biologics, in the context of a gradual
    transition toward inclusion of lot number and expiration date in the
    code. For medical devices, Premier believes HIBC-LIC or UCC/EAN are
    acceptable standards.

3.  Not applicable to Premier.

4.  Not applicable to Premier.

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5.  Not applicable to Premier.

6.  Premier believes that the successful implementation and integration
    of bar code technology is directly related to the embrace of
    standards. We are extremely pleased that FDA subscribes to the goal
    that we and many of our business partners share---that of improving
    patient safety. However, without an agreed upon industry standard,
    investment in the infrastructure necessary to utilize bar coding to
    its full capacity will not yield the desired optimal result.

> Premier also believes that the implementation of bar code technology
> will generate efficiencies in the supply chain. A 1998 study conducted
> by Ernst & Young for the Efficient Healthcare Consumer Response Group
> (American Hospital Association, Health Industry Business
> Communications Council, Health Industry Distributors Association,
> National Wholesale Druggists\' Association, and Uniform Code Council)
> identified the potential for \$11 billion in savings by "redesigning
> the healthcare supply chain" through efficient product movement, order
> management, and information sharing.
>
> Premier is cognizant of the considerable effort that would be required
> of hospitals in preparing to integrate and utilize the requisite bar
> code technology following implementation of the FDA rule. We are
> committed to assisting our hospitals in that effort. Premier has
> actively championed legislation introduced in the 107^th^ Congress
> that would provide grants and other assistance to hospitals for the
> implementation of the bar code and other patient safety technologies.

7.  Premier believes that the effective date for the proposed rule ought
    to allow affected companies ample time to comply. However, we also
    believe that innovative and forward-thinking manufacturers who have
    already addressed and/or engaged in bar code labeling ought not be
    penalized by an implementation date that is, in effect, too
    far-removed. Premier will, in fact, require bar codes on all
    pharmaceutical products for which contracts are signed, effective
    July 1, 2003.