From: Michael E. Coughlin, President and CEO, ScriptPro

Date: July 12, 2002

Re: Food and Drug Administration, HHS, Public Meeting

> Bar Code Label Requirements for Human Drug Products
>
> July 26, 2002, from 9 a.m. to 5 p.m.
>
> Natcher Auditorium, Building 45,
>
> National Institutes of Health, Bethesda, MD.

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**[RECOMMENDATIONS FOR THE DEVELOPMENT OF A REGULATION ON BAR CODE
LABELING FOR HUMAN DRUG PRODUCTS, INCLUDING BIOLOGIC
PRODUCTS.]{.underline}**

**[I. Background]{.underline}**

ScriptPro develops and provides dispensing automation and robotics for
pharmacies. We are dedicated to helping pharmacies lower operating
costs, reduce dispensing errors and increase customer service.

We have focused on those pharmacy dispensing settings where the majority
of prescriptions are filled: community and ambulatory pharmacies. These
settings involve people working to execute health-critical tasks
accurately, at a fast pace and typically in small spaces close in
proximity to the general public.

Our systems are operated to a large extent by bar code scanning. This
provides a level of efficiency, accuracy and speed that would otherwise
not be possible. These systems are user-tested and being used by
thousands of pharmacists and pharmacy technicians every day in every
type of community and ambulatory pharmacy setting.

Bar code labels for drug products are critical to pharmacy dispensing
systems. I will develop here a short list of recommendations which will
be summarized at the end.

**[II. Dispensing Errors - Cause and Prevention]{.underline}**

We have analyzed dispensing errors in community and ambulatory
pharmacies to determine how systems can be applied to prevent them. We
have been engaged for some time in funding independent research to find
out how to absolutely minimize dispensing errors. Some of these studies
are soon to be published.

The most basic dispensing errors are:

-   Prescription filled with wrong drug.

-   Prescription filled with wrong strength.

-   Wrong prescription label or auxiliary labels omitted.

An insurance company has reported that more than 80% of claims against
pharmacists in the community and ambulatory practice settings arise from
these basic mistakes. (Source: Baker, Kenneth R., Pharmacists Mutual
Claims Study 1989-1997, Speech, National Association of Chain Drug
Stores.)

Our systems use bar codes to prevent the basic dispensing errors in both
robotic and manual prescription dispensing processes.

> 1\. Robotic dispensing.
>
> a\. Drug products are loaded into a robot. Bar codes on the products
> are scanned so that the robot can positively identify each product in
> order to handle it accurately.
>
> b\. Prescriptions are transmitted to the robot for filling.
>
> c\. Robot picks the correct product. Bar codes are again verified by
> robot during picking.
>
> d\. Robot prints and applies correct prescription label (with bar
> code).
>
> e\. Final verification by operator using visual aids (person checks
> robot by comparing product picked with prescription order and
> on-screen picture of drug).
>
> 2\. Manual dispensing.
>
> a\. Prescriptions are queued up on screen at prescription filling
> station.
>
> b\. Person picks drug product and scans bar code at station.
>
> c\. Station matches product to prescription.
>
> c\. Station prints prescription label (with bar code) and presents it
> to person for labeling of product.
>
> d\. Final verification by operator using visual aids (person checks
> station by comparing product picked with prescription order and
> on-screen picture of drug).

There are other error that can occur:

-   Wrong prescription in bag provided to patient.

-   Prescription omitted from bag.

-   Wrong bag provided to patient.

-   Failure to provide all prescriptions.

-   Failure to provide counseling to patient.

Again, bar codes are used to prevent errors:

> 1\. Filling bag.
>
> a\. Station prints bar code label for bag.
>
> b\. Bar codes on prescription labels are matched to bag label when
> filling bag.
>
> 2\. Providing bag to patient.
>
> a\. Patient presents card (or other documents) with identifying bar
> code.
>
> b\. Scan of patient card prompts display of bag(s) to be provided.
>
> c\. Bag bar codes are scanned for match to patient.
>
> d\. Patient prompted to obtain counseling and sign for receipt of
> prescription via electronic signature device.

These systems track every step in the dispensing process, recording
every action, drug product and person involved. Bar codes form the
electronic chain that holds the system together. The chain runs from the
electronic signature, to the patient bar code, to the bag bar code, to
the prescription label bar code, to the drug product bar code. Attached
to every link in the chain is the bar code of the person responsible for
that step.

The first link in the chain is the drug product bar code. Without that
link, there is no chain.

**[III. Bar Code Driven Systems]{.underline}**

The systems described above are driven by the bar codes. In other words,
the routine actions of the personnel and equipment are to a large extent
determined by what the bar code scanners read. This design makes the
systems easy to use, efficient and foolproof. It also frees up the
people involved so they can focus on the critically important
non-routine items, like patient care, counseling and medical analysis.

The good news is that some of the most serious problems facing community
and ambulatory pharmacies can be addressed simultaneously using the
efficiency and accuracy of bar code driven systems:

-   Personnel shortages, especially shortage of pharmacists.

-   Dispensing errors.

-   Patient wait time.

-   Failure to provide adequate patient counseling.

**[IV. Bar Codes on Drug Products - Shortcomings]{.underline}**

Unfortunately, there are shortcomings in the bar codes on drug products
and related medical supplies that are prescribed along with them. These
shortcomings undermine pharmacy dispensing and open up opportunities for
errors to occur.

-   Some drug products do not have identifying bar codes.

-   Lot number and expiration date information is not available in bar
    code format.

-   Bar codes in use do not always allow positive identification of drug
    products.

-   There are flaws in the systems that assign identifying numbers and
    bar codes to drug products. This results in multiple drug products
    having the same bar codes.

> 1\. No identifying bar codes.
>
> a\. Some drug products (and prescribed medical supplies) do not have
> identifying bar codes on them. These products must be identified and
> verified manually during the dispensing process.
>
> b\. We recommend that all pharmaceutical products and prescribed
> medical supplies have identifying bar codes.
>
> 2\. No lot number and expiration date bar code.
>
> a\. Drug products typically do not have bar codes indicating lot
> number and expiration date. This data is critical to insure that drugs
> are not used beyond their date limits and also in dealing with recalls
> and other problems. Lot number and expiration date information must be
> entered manually. This is time consuming and subject to omission and
> human error.
>
> b\. A simple calculation shows that the time wasted by pharmacists and
> technicians manually entering and tracking lot numbers and expiration
> dates can be staggering. There are approximately 3 billion
> prescriptions filled annually in community and ambulatory pharmacies.
> Assuming a conservative time figure of 15 seconds to enter lot number
> and expiration date information for each prescription, 12,500,000
> hours per year are spent on this task alone. This accounts for over
> 6,000 FTE\'s (full time employees).
>
> c\. These number are expected to increase by 40% over the next 3-5
> years. In other words, approximately 2,400 additional FTE\'s will be
> wasted over the next 3-5 years entering lot numbers and expiration
> dates.
>
> d\. The shortage of pharmacists has reached a critical level and all
> projections show that the crisis is in a very early stage with no
> relief in sight. We are now hearing reports of pharmacy technician
> shortages.
>
> e\. A comparison with pharmacy school projections shows that continued
> manual entry of lot numbers and expiration dates has the potential to
> waste 25% or more of the supply of new pharmacists being turned out
> each year.
>
> f\. We recommend that all drug products and prescribed medical
> supplies include, within the identifying bar code, the lot number and
> expiration date so that a single scan of the product can obtain the
> identify the product, its lot number and its expiration date.
>
> 3\. Bar codes in use do not allow positive identification.
>
> a\. Manufacturers sometimes make changes in their manufacturing
> processes that modify the physical appearance of a drug. This is
> sometimes done without assigning a different identifying number. For
> example, in the initial release the drug might have been green. One
> day the drug is changed to red. However, the manufacturer does not
> change in the NDC (National Drug Code) number since it is considered
> to be \"the same drug.\"
>
> b\. Drugs are sometimes repackaged without assigning a new identifying
> number.
>
> c\. Some drugs come in an outer packages with multiple interior
> packages. The outer package can be opened and the interior packages
> dispensed separately. Sometimes the same identifying number is shown
> on both outer and interior packages.
>
> d\. These problems undermine the ability of pharmacy systems to
> provide visual inspection aids to support dispensing accuracy.
>
> e\. We recommend that a new product identifying number (and new bar
> code) be assigned when the appearance of the drug or drug package
> changes and that all packages that can be dispensed contain unique
> identifying numbers.
>
> 4\. There is confusion, duplication and errors in the identification
> numbers and bar codes displayed on drug products.
>
> a\. \"Labelers\" of drug products (i.e. manufacturers, and those that
> repackage or relabel products) typically display both the NDC number
> (i.e. the National Drug Code, a 10-digit number administered by the
> FDA) and the UPC number (i.e. the Uniform Product Code, a 12-digit
> number administered by the Uniform Code Council) on their product
> labels.
>
> b\. The UPC is typically displayed in bar code format as well. The bar
> code is typically displayed just above the UPC.
>
> c\. The middle ten digits of the UPC number is typically identical to
> the NDC number, with the first digit set to \"3\" and the last digit
> set as a check digit. However, this is not always the case. Sometimes
> there is no numerical resemblance between these numbers.
>
> d\. We recommend that the identifying bar code contain the NDC number
> in a standard position so that the NDC number can be positively and
> directly identified via bar code scan.
>
> 5\. There are duplicate NDC numbers.
>
> a\. The NDC number is designed to be a concatenation of three numbers
> into a single 10-digit number:
>
> The FDA assigned Labeler Code, which may be either 4 or 5 digits.
>
> \+
>
> The Manufacturer (or Labeler) assigned Product ID, which may be either
> 3 or 4 digits.
>
> \+
>
> The Labeler assigned Pack Size (package identifier), which may be
> either 1 or 2 digits.
>
> b\. In other words, the NDC number is a concatenation of three
> numbers, each of which can come in either a \"large\" or \"small\"
> size. The source of this \"large/small\" confusion was apparently lack
> of coordination when the NDC numbering system was established many
> years ago.
>
> c\. In order for the concatenated number to add up to 10 digits, one
> of the component numbers is of the \"small\" size and the other two
> are of the \"large\" size.
>
> d\. Unfortunately, such a concatenation does always product unique NDC
> numbers. For example, the concatenation of 0001+1000+01 yields the 10
> digit number 0001100001. Likewise, the concatenation of 00011+000+01
> yields the same 10 digit number 0001100001. This is not a theoretical
> problem. There are cases where the 10-digit concatenated NDC number is
> the same for different drug products. This has resulted in cases where
> the identifying bar code in the same for different drug products.
>
> d\. We recommend that duplicate NDC numbers be eliminated and
> prevented from recurring.

**[V. Recommendations]{.underline}**

A. Drug products and prescribed medical supplies should have a single
bar code that identifies the product (NDC number) and also includes the
lot number and expiration date.

B. A new NDC number (and bar code) should be assigned when the physical
appearance of the drug or the package it is dispensed in changes.

C. A separate NDC number (and bar code) should be assigned to each drug
package that can be dispensed.

D. The NDC number should reside in a standard position in the drug
product bar code so that it can be identified via bar code scan.

E. Duplicate NDC numbers (and duplicate bar codes) in use for drug
products should be eliminated and prevented from recurring.