From: Michael E. Coughlin, President and CEO, ScriptPro
Date: July 26, 2002
Re: Food and Drug Administration (FDA), HHS, Public Meeting
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Barcode 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
RECOMMENDATIONS
FOR THE DEVELOPMENT OF A REGULATION ON BARCODE LABELING FOR HUMAN
DRUG PRODUCTS, INCLUDING BIOLOGIC PRODUCTS
I. Background
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 largest number 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 barcode scanning. Barcode scanning 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.
In maintaining the
databases for our systems, we work extensively with drug products
and their barcodes. ScriptPro's research laboratory has samples
of most of the drugs and related medical supplies that are dispensed
in community and ambulatory pharmacies across the
United States.
Barcode labels for
drug products are required for efficient and accurate pharmacy
dispensing systems. We certainly support initiatives that will
provide more and better barcode information for drugs. However,
there are serious shortcomings and errors inherent in the drug
product barcodes that we have on drug products today. We should
develop and execute a plan for fixing these problems in conjunction
with expansion of the use of barcodes. If we do not, we will
create an even bigger problem for someone else to solve later.
I will explain this
in more detail below, and I will develop a short list of recommendations
that will be summarized at the end.
SP 200
