Summary of presentation by Michael R. Cohen, RPh, MS,
ScD at the Food and Drug
Administration's July 26, 2002, public meeting on bar code
labeling for drug products.
Docket No. 02N-0204
Good afternoon. Thank you for the opportunity to speak with
you this afternoon about this important health care safety
regulation. I am Michael R. Cohen, president of the Institute
for Safe Medication Practices (ISMP). ISMP is an independent,
nonprofit organization that works closely with practitioners,
regulatory agencies, health care institutions, professional
organizations and the pharmaceutical industry to provide education
about adverse drug events and their prevention. A board of
trustees representing the health care community at large governs
this interdisciplinary effort by nurses, pharmacists, physicians
and health care consumers. Our primary focus has been on proper
and safe use of medications. We have a long history of learning
about medication errors from health care practitioners and
consumers who voluntarily report medication errors and hazardous
conditions through a national reporting program operated by
the United States Pharmacopeia. All reports are shared directly
with the US Food and Drug Administration, Office of Drug Safety.
Dialog with FDA is ongoing when reports relate to drug nomenclature
issues (proprietary and nonproprietary names), or pharmaceutical
labeling, packaging and medical device design.
Medications are a blessing, but humans must safely prescribe,
prepare, dispense, and administer these drugs. Yet humans
are fallible, and as clearly articulated in the recent reports
by the Institute of Medicine (IOM), errors and other adverse
events occur and cause unbearable human and financial cost.
Medication use has been further complicated by the large number
of new drugs introduced every year, an increasing elderly
population with chronic and acute conditions requiring complex
treatment strategies, and the proliferation of over-the-counter
products. In light of this fact, much can and should be done
to enhance medication safety.
An important advance to help identify medications in the
processes of drug procurement, inventory, storage, preparation,
dispensing, and administration has been the use of bar code
scanning of medications. This technology used in many other
industries has gained rapid acceptance in the health care
industry. Today many community pharmacies, mail order pharmacies,
and hospital pharmacies have adopted bar code scanning of
medications to ensure the correct preparation and dispensing
of medications. In the acute care setting especially, the
use of bar code scanning of the health care provider, the
medication, the patient's medical record, and the patient
themselves helps assure the safety in drug administration.
Rather than repeat many of the reasons why bar coding of medications
by manufacturers is needed, and the symbologies and components
of the bar code, I wish to focus my attention on the necessity
of bar codes on unit dose packages of medications and most
importantly that bar coded unit dose packages of medications
remain readily available from the manufacturers.
The importance of unit dose medication dispensing in the
acute care setting has been advocated since the 1960"s.
The American Society of Health-System Pharmacists, the Joint
Commission on Accreditation of Healthcare Organizations, and
other organizations are leaders in promoting unit dose drug
dispensing. Although this is a proven safe way to provide
medications in the acute care setting, especially with the
recent use of bar code scanning to match patient specific
doses with the patient and their record we are experiencing
a decrease of the availability of unit dose packaging by many
manufacturers. Our fear is that many more manufacturers will
cease to provide unit dose medications if a bar coding regulation
is put in place. We believe that a regulation is needed but
that an important component of the regulation must be that
manufacturers provide unit dose packaging of medications with
a bar code. As I mentioned previously, ISMP receives error
reports from practitioners but we also receive reports of
hazardous conditions and safety concerns from practitioners.
One of their concerns that have been brought to our attention
repeatedly in the last few years is the unavailability of
unit dose packaging by manufacturers. This is not only on
new medications introduced into the marketplace but also the
discontinuance of previously available unit dose packaging
I would like to review a survey ISMP did of the readership
of its ISMP Medication Safety Alert! in the late winter
of this year. The safety alert is distributed to the majority
of hospitals in the United States as well as several foreign
countries and many ambulatory health care settings. Our readership
exceeds 500,000 per issue. We inquired from our readers their
experiences with the availability of unit dose packaging of
The results of the survey showed that:
- Three-quarters of respondents reported problems with unit
dose packaging of both new and well-established brand
oral solid products on the market, including those that
had been previously available in unit dose packages. A third
reported about 6-10 brand products that have not
been available in unit dose packaging in the past year.
Another quarter reported problems with 11-20 brand
products, and over 6% reported problems with more than 40
different brand medications that were no longer available
in unit dose packages last year! Even more experienced problems
with generic oral solid products.
- Most respondents who repackaged medications now estimated
a 1-10% error rate due in some part to the repackaging process.
Many also told us they were worried about the cost of implementing
bar code technology, especially in small, rural hospitals,
and in pediatric hospitals because so many drugs are not available
in unit dose packages.
It was clear from our survey that, despite some initial worry
about costs, many hospitals are ready to do their part to
move bar coding technology forward. About half now consider
the availability of unit dose packaging when making decisions
about new drugs for the formulary, and two-thirds reported
that they would be more likely to select a therapeutically
equivalent product if it is available in unit dose packaging.
More to the point, 84% felt that a slight increase in cost
would not deter them from purchasing a specific vendor's unit
dose medication with a bar code. About 62% felt very strongly
on this issue. Only 11% felt that a slight cost increase would
be a deterrent. On behalf of its members, group-purchasing
organizations have begun to stipulate the need for bar coded
unit dose packaging.
ISMP strongly recommends that the FDA require bar codes on
all medications with bar code data to include the NDC number
as the standard identifier for prescription medications, the
manufacturer's lot number, and the expiration date. If necessary,
we support a phased-in approach with the bar coded NDC required
as soon as possible, and the lot and expiration required within
2 years. This includes proprietary as well as nonproprietary
medications. We also support the specific bar coded requirements
included in the recommendations of the American Society of
Health-System Pharmacists but also encourage the FDA to ensure
that the pharmaceutical industry does its part and make all
products available in unit dose packages with this uniform
Thank you for the opportunity to speak today.