**Summary of presentation at the Food and Drug**
![](media/image1.jpeg){width="1.9423611111111112in" height="1.79375in"}

# **Administration's July 26, 2002, public meeting** 

**on bar code labeling for drug products.**

Docket No. 02N-0204

Presentation by Kasey Thompson, Pharm.D.

Director, Center on Patient Safety

American Society of Health-System Pharmacists

7272 Wisconsin Ave.

Bethesda, MD 20814

301-657-3000

kthompson@ashp.org

The American Society of Health-System Pharmacists (ASHP) welcomes and
supports the Food and Drug Administration's (FDA) initiative to require
bar code labeling for human drug products. ASHP has long supported the
use of such technology to help prevent patient harm resulting from
medication errors. In a policy adopted in 1999, ASHP supported the
application of machine-readable codes to improve patient safety in
health systems and specified that the Society would "advocate that all
drug product packaging include a machine-readable code in a manner that
identifies the package contents, including NDC, lot numbers, and
expiration dates." In 2001, ASHP adopted a more specific policy to "urge
the Food and Drug Administration to mandate that standardized
machine-readable coding be placed on all manufacturers' single-unit drug
packaging to (1) ensure the accuracy of medication administration, (2)
improve efficiencies within the medication-use process, and (3) improve
overall public health and patient safety."

ASHP welcomed the FDA's announcement in December 2001 that it was going
to issue a proposed rule requiring human drug products and biological
products to be bar coded to help reduce the number of medication errors.
The need for this step is great, and the time for it is long overdue.

ASHP has the following specific comments related to the questions the
FDA asked in the *Federal Register* notice announcing the July 26 public
hearing:

General Questions Related to Drugs and Biologics:

1.  Which medical products should carry a bar code. What about blood
    products and vaccines?

> Bar codes should be required on all pharmaceutical product packages
> down to the unit-dose -- single unit level. This should include
> prescription and over-the-counter medications, as well as vaccines and
> blood products. For bar coding to be effective in hospitals and health
> systems, products in unit-dose packages *must* be made available by
> pharmaceutical manufacturers. A disturbing trend has emerged whereby
> fewer and fewer pharmaceutical manufacturers are producing products in
> unit-dose, leaving repackaging up to individual hospitals. Not only
> does repacking introduce new opportunities for mistakes to be made, it
> adds an additional cost, which most average- to small-size hospitals
> can not afford. Repacking also takes pharmacists away from their most
> important duty in hospitals -- *managing patients' drug therapy*. In
> the interest of patient safety, ASHP advocates for the inclusion of
> bar codes on all pharmaceutical product packages, and for
> pharmaceutical manufacturers to make all products available in
> unit-dose form.

2.  What information should be contained in the bar code that is
    critical to reducing medical product errors.

> Bar codes on drug products *must* contain the product's NDC number.
> This is the primary element that will be effective in meeting the
> FDA's expectation, as noted in the agency's semi-annual agenda on
> December 3, 2001, that "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 patient is receiving the right drug, at the right
> dose, and at the right time."
>
> Other elements that should be included are: (1) a product's lot
> number, which can identify products for the purpose of a drug recall.
> A database can link a specific lot given to a specific patient.
> Inclusion of the lot number would also be useful during public health
> crises where mass vaccinations or drug treatments need to be given.
> (2) a product's expiration date. Drugs are kept in numerous places
> throughout hospitals, and even with the diligent efforts of
> pharmacists and technicians to check for out-of-date products, it is
> impossible to verify (and find) them all. Placing the expiration date
> on the bar code would tell nurses at a patient's bedside if a drug is
> out-of-date -- before the drug is given to the patient.

3.  Should the proposed regulation adopt a specific bar code symbology?

> Numerous symbologies exist for machine-readable coding of products,
> but some are receiving more attention than others because of their
> ability to fit on small package sizes and readability by most
> commercially available scanners. Common information system standards
> need to be developed \--either by FDA mandate in the proposed
> regulation or through collaboration between industry, health-care
> professionals, and technology experts -- and consistently applied for
> bar code systems to effectively interface with other hospital computer
> systems such as pharmacy, laboratory, blood bank, and billing systems.

4.  Where on the package of drug products should the bar codes be
    placed?

> The bar code should appear on both the inner and outer wrap. Experts
> in the pharmaceutical industry are most qualified to decide where on
> the package a bar code can most reliably be scanned to prevent scan
> failures.

5.  What products already contain bar codes, who uses the bar codes, and
    how?

> Scientifically reliable data does not exist on how many current
> products packaged in unit-dose form contain bar codes, but it is
> well-recognized that that number is few, especially for unit-dose
> packages containing a standard bar code and the necessary data
> elements of NDC, lot number, and expiration date. The Department of
> Veterans Affairs is a national leader in using bar coding systems for
> scanning patient, nurse, and drugs at the bedside. A 1999 ASHP survey
> revealed that only 1.1 percent of U.S. hospitals use bar coding to
> scan patient, nurse, and drug at the bedside. Institutions need
> incentives to use this important patient safety enhancing technology.
> This can be achieved through an FDA requirement and a commitment by
> manufacturers to do what's right for patients -- include bar codes on
> all product packages, and make all products available in unit-dose
> form.

General Questions and Economic Impact Questions:

6\. What is the expected rate of acceptance of machine-readable
technologies in health-care sectors: What are the benefits of using this
technology in delivering health car services and other potential uses?

> The benefits of using machine readable coding in health care sectors
> are two-fold:

1.  First and foremost, a bar coding system it will improve patient
    > safety. Scanning medications against an original,
    > pharmacist-verified order before a drug leaves the pharmacy as
    > well as scanning patient and unit-dose medication at a patient's
    > bedside will help ensure that the right patient gets the right
    > dose of the right drug by the right route and at the right time.

2.  Second, a properly designed and implemented bar code system will
    enhance the efficiency and workflow of pharmacists, nurses, and
    other health professionals using the technology. A code system will
    be useful in bedside scanning, inventory control, billing, and
    laboratory systems.

> 7\. When should a final rule requiring bar coding on drug products
> become effective?
>
> Considering the number of years this proposal has been discussed with
> no clear action having been taken, an early effective date is
> necessary. Market demand by end users -- hospitals, healthcare
> practitioners, wholesalers, and patients -- can help drive the speed
> at which drug manufacturers implement the new regulation.