From: RAY VRABEL /6461 [RVRABEL@OmniCell.com]
Sent: Friday, July 12, 2002 5:43 PM
To: fdadockets@oc.fda.gov
Subject: [Docket No. 02N-0204] Bar Code Label Requirements for Human
Drug Products

Dockets Management Branch {HFA-305}
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
 
Dear Sir/Madam,
 
I wish to submit the following comments for consideration for the public meeting being held on the subject of "Bar Code Label Requirements for Human Drug Products" on July 26th, 2002.
 
I'm writing to you from the perspective of a hospital pharmacist who has been in practice since 1970. As a pharmacy resident in the US Public Health Service Hospital in San Francisco back in 1970-71, I conducted a research project evaluating the concept of "Unit Dose in the Hospital Setting". I have since worked at over seven medical centers, one large volume mail order pharmacy company, and two different pharmacy automation companies. I also had the benefit of working in the retail supermarket industry for three years prior to pursing my pharmacy career. Who would have thought that the solution which solved all of the problems that I created as a tired, underpaid stock clerk would be corrected with a technology solution (bar code scanning of products for purposes of pricing and inventory control) and it would be implemented nationally before a similar system to prevent the occurrence of significant medication errors in patients. What is wrong with our priorities?
 
The reason that the use of bar codes works at the retail level is that it is a simple solution. While there would be as much or more benefit to have information about expiration dating and lot numbers on food products than some of the drug products, the approach that has been taken is to "keep it simple" (i.e., have the bar code only contain a specific product item identifier). That allows a very available type of bar code scanning hardware be used in a variety of different settings. It also allows the vendors to incorporate the bar code as part of their standard label format, one that does not change with every production run of the product.
 
While it would be desirable in the "perfect" world to have more than the drug product identification information (e.g., the NDC) on the unit-of-use/unit-dose packaging, 99%-PLUS of the medication safety issues will be "caught" at the time of verification if a product-identifying bar code on the product can be scanned. Requiring manufacturing vendors to place bar codes containing product identification, lot number, and expiration date on the smallest unit-of-use/unit-dose packaging that they make will effectively either drive up the cost to the consumer significantly or drive the vendor out of the business of producing bar coded unit-of-use/unit-dose packaging. 
 
For bar coded products to be effective, the bar coding must be on the smallest unit-of-use/unit-dose packaging that will be used at the point of administration. Standard inventory control procedures (available with existing automated medication cabinets) can effectively be used to prevent outdated medications from being available at the point of use. Also, the practical fact is that a product's "true expiration date" (i.e., the point at which it may be subpotent and/or otherwise harmful to a patient) is long after the expiration date on the product. Likewise, the tracking of lot numbers is only important for a small handful of drugs (e.g., mostly biologicals) and this information can easily be prompted for the nurse/pharmacist to enter into an automated system at the automated cabinet level and/or with the bedside verification/documentation device. On the otherhand, placing this same lot number/expiration date information on the shipping containers of pharmaceuticals would not be represent a significant manufacturing/packaging barrier and it would product this information in an "automation friendly format" (i.e., the bar code) as part of the inventory process where it would be of most benefit.
 
If a specific bar code format is used, make sure that it is either a one dimentional (1-D) format containing the product identity (NDC), or a stacked, two dimentional (2-D) format where the product identification component of the bar code can still be "read" by a standard one dimentional bar code scanning device. Don't force consumers (hospitals) to purchase more expensive, more difficult to use two dimentional bar code scanners when it is really not necessary.
 
Please keep the requirement simple so that vendors can provide low cost solutions, while a the same time maximizing the ability to use bar codes to prevent significant medication errors.
 
I would be happy to clarify my my position if necessary. Thank you for the opportunity to submit my comments...
 
Ray Vrabel
 

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Ray Vrabel, PharmD 
Director, Medication Safety Systems 
Marketing Department 
Omnicell, Inc. 
1101 E. Meadow Dr. 
Palo Alto, California 94303 

Office: (650) 251-6461 
Cell: (619) 417-8564 
Email: rvrabel@omnicell.com 
Instant Messaging: rbvrabel@vtext.com