Summary of Bar Code Label Requirements for Human Drug Products
Presentation

Good Afternoon, thank you for inviting me to speak today.

My Name is Max Peoples. I am a pharmacist, and President of *Uptown
Pharmacy, LLC*, a community pharmacy in Westerville, Ohio and *RxScan*,
*LLC.*

*RxScan* has for several years developed National Drug Code bar code
scanning equipment and processes used to reducing medication dispensing
and administering errors. Currently our equipment is used to verify the
accurate dispensing of over 100 million prescriptions per year.

I am responding to the general questions related to Drugs and Biologics.

A.  General Questions

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1)  **Which medical products should carry a bar code?\...**

> It is my belief that all health care products, including medical
> supplies, prescription medical products and over the counter
> medications (OTC) should carry a National Drug Code bar code

a)  It is necessary to increased the utilization of automation to
    decrease:

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1)  Medication dispensing and administration errors and their associated
    human and economic costs

2)  distribution costs

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b)  We include non-prescription drug products because OTC medications
    are also administered to patients in health care facilities and
    sometimes dispensed by prescription in community pharmacies. OTC
    medications like aspirin, laxatives, vitamins are often prescribed.
    Prescribing them is often done so there is a complete medical record
    of what the patient is taking and the specific directions for the
    patient are on the container.

> Currently many OTC products such as diabetic supplies and insulin have
> both a NDC number and a UPC ( universal Product Code number .Usually
> it is the Universal Product Code that is bar coded. ). Why have two
> identification numbers for the same product. Also, for billing
> purposes the UPC number is not normally recognized by insurance
> providers only the NDC number is.
>
> Almost weekly we hear of serious drug interactions occurring when
> mixing certain vitamins, herbals and other OTC products with
> prescription medications. Having one ID number, the NDC number, bar
> coded on all OTC products will expedite the identification of these
> potentially dangerous interactions using software drug interaction
> programs

2)  **What information should be contained in the bar code?** \...

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a)  The minimum information needed in the bar code is the products
    National Drug Code.

> The National Drug Code is the common ID needed to eliminate the
> dispensing or administering of the incorrect medication to a patient.

b)  The lot number and expiration date.

> These have their purposes, however, they are not involved in stopping
> administration or dispensing errors such as providing the wrong
> medication, strength or dosage form of a medication to a patient.
>
> They have value in simplifying medication recalls, and avoiding
> dispensing or administrating an out of date to a patient. I am not
> aware of any research showing that this is currently a major problem,
> however, including the lot number and expiration date will improve the
> efficiency of tracking them.

c)  ***[We recommend that the product description be
    included]{.underline}***.

> As manufacturers change their product appearance this identification
> change can be instantly updated in the bar code and with bar code
> reading as the medication is dispensed the pharmacy or medical system
> databases can be updated. This is accomplished without the need for
> each health care provider to purchase a product description database.
>
> In community pharmacy this product identification can be printed on
> the patient label or patient education materials. Doing so allows the
> patient to check and determine that they have received the medication
> that there bottle is labeled to contain.
>
> In institutional settings this can be provided at the point of care
> for use by the nurse etc.

d\) We recommend examining the potential for including patient and
professional information on\
the outer bulk packaging

> Attached is data on the percentage of prescription errors eliminated
> by using our handheld National Drug Code bar code scanning
> prescription verifiers.
>
> These statistics were taken from 129 of our *RxScan Plus Prescription
> Verifiers.* These were used to catch errors in the dispensing of over
> 7 million community pharmacy prescriptions.
>
> *[What the study shows is that over 5% of the medications first
> selected to fill a patient's]{.underline}*
>
> *[prescription are incorrect, meaning they didn't match what was in
> the patients medical record.]{.underline}*

3\) \... **should the rule adopt a specific bar code symbology**\....

Pro's and Con's

Pro - Adopting ONE bar code symbology would speed up the process of
adopting universal medication bar coding by allowing:

a\) The hardware manufactures producing everything from bar code readers
to bar code printers to focus on making the best equipment at the best
prices possible for a single symbology not many different symbologies.

b\) The medication manufacturers and packagers to focus on getting bar
coding accomplished not spending time deciding on which symbology to
use.

c\) Everyone gets used to looking for one symbology when determining
what to scan

Con - Mandating one bar symbology restricts future adoption of improved
bar code symbol technology.

We believe that a compromise is to have general requirements that the
bar codes used must meet.

*The most important minimum requirement being that the bar code
symbology a manufacturer or packager chooses should have a linear (1
dimensional) component compatible with today's linear bar code readers.*

*Including a compatible component will allow current bar code scanning
procedures that do not require anything but the NDC number to continue
without having to invest in new bar code scanning equipment.*

**We do not want to make all of the bar code scanning equipment
currently in use obsolete**.

That might be good for those of us in the solution provider business but
it is not good use of our limited national health care resources.

I am sure the UUC (Uniform Council Code) and others can or have provided
plenty of symbologies that would meet this **one basic requirement**.

> 4)\... **where on packages should the bar codes be placed?\....**
>
> National Drug Code bar codes need to be placed on an easily accessible
> location on the packaging that will reach closest to the patient, by
> which we mean;

1)  The final package that will be opened to provide medication to the
    patient

2)  The final package that will be handed to the patient.

> Examples

a)  Community pharmacy examples:

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1)  Monthly osteoporosis packs where the individual package is provided
    to the patient. The bar code needs to be on this final package, not
    just the larger carton that several monthly packs come in.

2)  If medication is to be taken out of a bulk container and provided to
    the patient in a separate medication bottle, the bulk container
    needs the National Drug Code bar code.

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b)  For hospital/nursing facilities, vaccine clinics etc. the NDC bar
    code needs to be on the individual patient dose because it is that
    individual dose package that will get closest to the patient.

This will be the individual tablets, capsules, syringes, IV's etc.

Only with a National Drug Code bar code at this stage in the
administration process (i.e. the\
bedside) can the bar coded data be used to verify that this is the:

1)  correct medication

2)  at correct dose

3)  in the correct dosage form

for the patient.

> 5\) **\... What products already contain bar codes?\...**

a)  Most community pharmacy bulk manufacturer packaging has National
    Drug Code bar code packaging. There are a few manufacturers that bar
    code most of their products but not all and a smaller number that
    bar code none.

b)  The majority of unit dose/unit of use products in nursing homes and
    hospitals are **not** bar coded. A director of hospital pharmacy in
    Columbus, Ohio told me Wednesday of this week that in the last few
    years the number of hospital medications available that are bar
    coded has decreased from 4,800 to 2,800.

*Let me demonstrate a two-second NDC bar code scanning process currently
being used in thousands of community pharmacies to eliminate misfilled
prescriptions*.

We believe the simplicity of this process demonstrates the value and
rapid return on investment for requiring that at least a National Drug
Code bar code be placed on all medical products.

*One last point, we need to urgently get on with the passing of these
regulations*.

Pharmacy and medical system software will require time to make the
modifications necessary to use the new data.

It will take time for the manufacturers and processors to initiate bar
code printing on their products.

Every day thousands of people are receiving the wrong medications and
these human dispensing and administration errors could be avoided by the
use of a simple NDC bar code and NDC bar code scanning verification.

Max Peoples R.Ph.

President

RxScan, LLC