PUBLIC HEARING

BAR CODING - A REGULATORY INITIATIVE

July 26, 2002

9:00 a.m.

William H. Natcher Conference Center

Building 45

National Institutes of Health

45 Center Drive

Bethesda, Maryland

P A N E L I S T S

FDA Panel (a.m.)

Margaret M. Dotzel, Esq., Moderator

Lester Crawford, D.V.M.

Theresa Mullin, Ph.D., Associate Commissioner,

Planning and Evaluation, FDA

Steven Galson, M.D., M.P.H., Deputy Director,

Center for Drug Evaluation and Research, FDA

Diane Maloney, Associate Director for Policy,

Center for Biologics, FDA

David Feigal, J.D., Director, Center for

Devices and Radiological Health, FDA

Erica L. Keys, Esq., Office of Chief Counsel,

HHS

FDA Panel (p.m.)

Margaret M. Dotzel, Esq., Moderator

Steven Galson, M.D., M.P.H.

Diane Maloney, Associate Director for Policy, Center

forBiologics Evaluation and Research, FDA

David Feigal, M.D.

Peter C. Beckerman, Esq., Office of Chief

Counsel, HHS

Nancy C. Gieser, Ph.D., Office of Planning

and Evaluation, FDA

A G E N D A

PAGE

Introductions - Margaret M. Dotzel, Esq.,

Associate Commissioner for Policy, FDA 5

Welcome/Overview - Lester Crawford, D.V.M.,

Deputy Commissioner, FDA 6

Logistics - Margaret M. Dotzel, Esq. 11

VA Promotes Patient Safety through Barcoding,

Kay Willis, Chief of Pharmacy, SPD VA

Medical Center, North Chicago 13

9:45 - Panel 1 (Health Professional)

Kasey Thompson, Pharm.D., American Society

of Health Systems Pharmacists 18

Joseph Cranston, Ph.D., American Medical

Association 27

Tim Zoph, National Alliance of Health

Information Technology 33

Pamela Cipriano, Ph.D., R.N., FAAN, American

Nurses Association 43

John Combes, M.D., American Hospital

Association 52

Questions from FDA Panel 63

Questions from Audience 95

12:15 - Panel 2

Richard Johnson, Ph.D., PhRMA 124

Steven Bende, Ph.D., Generic Pharmaceutical

Association 128

William Soller, Ph.D., Consumers Healthcare

Products Association 131

Kay Gregory, American Association of Blood

Banks and America\'s Blood Centers 139

Mary Grealey, Healthcare Leadership Coalition 146

Tess Cammack, AdvaMed 155

Questions from FDA Panel 163

Questions from Audience

Open Public Hearing

Allen Dunehew, AmeriNet 198

John J. Roberts, UCC 203

John Terwilliger, UCC 209

Bert Patterson, R.Ph., Premier 214

Terry O\'Brien, Meds Alert 220

Mike Sim, ADVIAS 225

Bruce Weniger, M.D., CDC 230

Robert Krawisz, NPSF 235

Diane Cousins, USP 239

Mike Cohen, ISMP 242

Jane Englebright, HCA 248

Skip Robinson, Pharm.D., Consorta Catholic

Resource Partners 252

Mark Neuenschwander, Hospital Rx 255

Bruce Wray, Computype 259

Bruce Ritchie, J.D., Canadian Hemophilia

Society 263

Edwin Steane, Ph.D., ICCBBA 266

Peter Mayberry, HCPC 269

Steven Polinsky, GenuOne 272

Robert Schwartz, HDMA 275

David Collins, Data Capture Institute 279

Daniel Ashby, Johns Hopkins Hospital 283

Ronald Barenburg, Barcode Technology, Inc. 287

Billy Snipes, Returns Online 292

Ed Hancock, American Health Packaging 296

Michael Coughlin, ScriptPro 301

Karen Longe, AIM 305

Joyce Sensmeier, HIMSS 310

Edith Rosado, NACDS 314

Robert Rack, Rack Design Group 320

Stuart Creque, findtheDOT 325

Laurence Edzenga, VISI 329

John Riddick, Novation 332

Vaughan Hennum, Portex 336

Max Peoples, RxScan 340

Wrap-Up - Margaret M. Dotzel, Esq. 345

P R O C E E D I N G S

MS. DOTZEL: My name is Peggy Dotzel, and I\'m the Associate Commissioner
for Policy at the FDA. And I will be your moderator today. On behalf of
the FDA, I\'d like to welcome everyone here. And to get started, what
I\'d like to do is introduce you to the FDA panel.

Actually, first what I\'d like to do ‑‑ I apologize ‑‑ is to thank Chuck
Daniels ‑‑ he\'s the director of pharmacy services at the Nih Pharmacy
Department ‑‑ for cosponsoring this meeting today.

And now I\'d like to acquaint you with the FDA panel.

First we have our deputy commissioner, Dr. Lester Crawford. From our
Center for Drugs, we have Dr. Steven Galson, who\'s the deputy director.
From our Center for Devices, we have the center director, Dr. David
Feigal.

Joining me from the Commissioner\'s office, we have Dr. Theresa Mullin,
who is our associate commissioner for planning. From the Center for
Biologics, we have Diane Maloney, who is the associate director for
policy. And from our Office of Chief Counsel, we have Erica Keys.

And now I\'d like to turn the floor over to Dr. Crawford.

DR. CRAWFORD: Thank you very much, Peggy. It\'s a pleasure to be here,
and it\'s a great thrill to see so many people come out on a stormy
morning. And I hope that the storms are now over, both outside and
inside.

It\'s my pleasure to talk about this morning how best to develop a
regulation on barcode labeling for human drugs and biological products,
and what should be the scope of such a rule. We will also begin to
explore the feasibility of barcoding medical devices.

The issue before us goes to the heart of FDA\'s responsibility to the
American people as the agency charged with the promotion and protection
of public health. One of FDA\'s most exacting and critical duties is to
make sure that drugs and medical devices that are used to treat patients
are as safe as well as effective, and that their benefits outweigh their
risks.

To meet this requirement, the pharmaceutical and device industries spend
millions of dollars on conducting carefully designed and demanding
clinical trials. And our agency uses still more resources, including
state-of-the-art scientific expertise, to submit the results of these
trials to a rigorous review.

The mutual goal is to make sure that each drug and device that reaches
our market is as safe as it is humanly possible to make it. And we are
confident that the products we approve meet that high standard.

Healthcare products that receive FDA\'s approval can be relied upon to
develop important medical benefits. But they must be properly used.
Unfortunately, that is not always the case.

Medication errors are a serious public health hazard, whether they are
caused by a wrong diagnosis, misread prescription, mistaken dosage,
incorrect device use, or poorly followed medication regimen. These
errors can invalidate all of the expense, effort, and scientific
erudition that had been invested into making these products safe and
effective, with tragic consequences for the patient.

Research cited by the National Academy of Sciences three years ago
estimated that up to 100,000 patients die from preventable medical
errors in hospitals alone. Medical errors are the eighth leading cause
of death in the United States, or, as Secretary Thompson has put it, the
equivalent of two passenger planes crashing every three days.

We believe that 30 to 50 percent of these deaths are associated with
errors involving the use of FDA-regulated medical products, drugs,
vaccines, blood and blood products, and medical devices.

In addition to the human cost, the economic cost of these errors is
staggering. According to some studies, preventable morbidity and
mortality related to drugs alone increases the nation\'s healthcare bill
by more than \$177 billion per year. Reducing this enormous toll, which
exceeds the annual traffic fatalities on our highways, has been a high
FDA priority for more than 20 years.

Over the years, our agency has addressed the hazard of medication errors
by initiating many consumer and health professional-oriented measures.
These include: medication guides; drug- and disease-specific education
programs; improved prescription and over-the-counter label formats; risk
management initiatives; and a review of proposed product names to
prevent their mixup with drugs already on the market.

Today we will discuss the pros and cons of yet another innovative
measure that will help reduce preventable drug-related injuries and
deaths, and that is the application of barcoding to human pharmaceutical
products, biological products, and medical devices.

This is an important initiative that could bring great benefits to the
public health because we know that barcoding can help ensure that the
right patient gets the right drug and the right dose of it at the right
time.

The use of barcoding in several hospitals has shown that the system can
significantly diminish medication errors. For example, we have invited a
representative of the Veterans Administration Hospital in Chicago,
Illinois to tell us about their experience with the barcoding system
that is estimated to have prevented about 380,000 medication errors in a
five‑year period. And we all look very much forward to hearing that
presentation.

One hospital in New Hampshire registered an 80 percent reduction in
medication errors, and a medical center in Colorado reduced its
medication rate \[sic\] by more than 70 percent. In both cases, as a
result of their use of barcoding, these accomplishments were achieved. A
70 percent reduction in medication error rate is probably about as good
as it can get.

The healthcare industry has projected that the use of barcoding across
the medical supply chain could result in substantial annual savings. So
we are very interested in your views, all of you here, on how a
barcoding regulation should work, what it may cost to implement, and how
it would affect patient safety.

Peggy Dotzel, FDA\'s associate commissioner for policy to my right, will
be the moderator of today\'s discussions. In addition, we have other
senior managers from our office and from FDA\'s Centers for Drugs,
Biological Products, and Medical Devices. And we are all eager to hear
your thoughts and suggestions on this matter.

Once again, I want to thank you for attending this important meeting,
and I hope you will find today\'s discussions useful and stimulating.
And now I\'ll turn the proceedings back over to Ms. Dotzel. Thank you
very much.

MS. DOTZEL: Thank you, Dr. Crawford.

Before we continue on with the agenda, I\'d like to go over a few
housekeeping details. First of all, we have noticed that a number of you
have luggage with you, and if you\'d like, they can store that luggage
for you out at the registration desk so you don\'t have to keep it at
your seats here.

Also, submissions to the docket can be made out at the registration
desk. And the closing date for submissions to the docket is August 9th.

And then lastly, a transcript of today\'s meeting will be available,
hopefully in about two weeks. And it will be available on our website.

You hopefully have also received out at the registration desk a copy of
our agenda for today. As you can see from the agenda, we have a very
full day. We have some ‑‑ we have two panels scheduled to present, and
then we have over 35 additional people who have registered to speak.

Because we have so many interested parties and because we have so much
to accomplish, I am really going to ask the speakers to stick to the
allotted time. We have a timer set up here so that you will see what ‑‑
you know, how your time is going. A yellow light will come on when there
is a minute left. And then a red light will flash when your time is up.

And I apologize in advance if I have to start cutting people off, but
like I said, we really have a lot to get through and I\'d like to give
everyone who has registered an opportunity to say their piece, and also
I\'d like for everyone to be able to go home for the weekend. So again,
I really urge people to keep their eye on the clock so that we can keep
things moving.

With that, I\'d like to move on to our first agenda item. As Dr.
Crawford noted, the VA hospital already has had experience with using a
barcoding system. We have with us here today Kay Willis, who is the
chief of pharmacy at the VA Medical Center in Chicago, and she is going
to present a video that provides an overview of the system that they are
using in their hospital.

We are having some technical difficulties with the video and the sound
is not very high, so I am really going to ask people to try to keep the
background noise down while this video is being presented.

And with that, Kay?

MS. WILLIS: Okay. This is a tape from the Pinnacle Awards from the
American Pharmaceutical Association. And it has been edited due to time
constraints. So you can roll the tape.

(A videotape was played.)

MS. WILLIS: The medical literature clearly shows that medication errors
have the potential to compromise patient safety and dramatically
increase healthcare costs. The sources of medication errors are
multi-disciplinary and often system-related. Within the Department of
Veterans Affairs, a barcode medication administration system, or BCMA,
has been developed and implemented that addresses these issues.

The Department of Veterans Affairs is committed to improving patient
safety through the use of barcodes and technology. VA pioneered the use
of barcodes to improve the medication administration process at the VA
Medical Center in Topeka, Kansas beginning in the early 1990s.

Data collected on reported medication errors from 1993, the last year
before the barcode system was implemented in Topeka, compared to
post-implementation data reported for 2001, show that Topeka VA was able
to reduce its reported medication errors by an astounding 86.2 percent
compared to the base year.

The medication error improvements by type of event include: 75.5 percent
improvement in errors caused by the wrong medication being administered
to a patient; 93.5 percent improvement in errors caused by the incorrect
dose being administered to a patient; 87.4 percent improvement in wrong
patient errors; and 70.3 percent improvement in errors caused when
medications scheduled for administration were not given.

The Veterans Health Administration mandated the use of BCMA in June 2000
at all 173 medical centers in its network. Expansion of the BCMA
software to include validation of IV medications has been added in
Version 2. VHA has mandated that Version 2 be implemented by November
30, 2002.

One of the things VA is currently struggling with is a lack of barcodes
on IV solution packaging. The national IV contract is coming to an end
soon, and VHA will likely make barcoding a contract requirement for the
next solicitation.

The National Center for Patient Safety was created as the patient safety
arm of VHA. This office has worked to further improve the BCMA program
within VA and facilitate the implementation of Version 2.

VHA pharmacy leadership is committed to patient safety and has made
great strides in its endeavors. In addition to BCMA, VA\'s consolidated
mail outpatient pharmacies, or CMOPs, have a lower error rate than other
comparable facilities because of the use of barcodes and technology.

The drug is checked by a pharmacist via screens that print an image of
the drug that can easily be matched to the medication in the bottle.
Drugs loaded into the automated equipment are barcoded for accuracy
before they are loaded. Barcodes are also used in inventory management
for ordering, receipt, and stocking within CMOPs.

VA\'s standardization of the appearance of multi-source generic products
across the system by using committed use, multi-year contracts also
promotes patient safety by alleviating patient confusion over
differently appearing products.

VA recommends the implementation of uniform barcode standards down to
the immediate unit of use package for legend drugs, over-the-counter
drugs, vaccines, blood derivatives, and IV solutions.

Currently, VA pharmacies are required to repackage or relabel most unit
of use products for inpatient use. Nationally, 14 percent of all
preventable intercepted and non-intercepted adverse drug events result
from dispensing errors alone. The incidence of dispensing errors
increases with each product that requires repackaging.

Manufacturers\' barcodes on unit of use products would eliminate the
need for repackaging prior to dispensing, thereby reducing or
eliminating the potential for error associated with repackaging.

Uniform barcode standards should include the national drug code, lot
number, and expiration date. VA invites our industry partners to help in
reducing medication errors and improving patient safety by embracing
barcodes on all immediate unit of use packaging.

Once standards are reached, the national acquisition center can put some
teeth into barcoding requirements in its solicitations. It is time for
the pharmaceutical industry to continue its contribution to improving
healthcare in the U.S. by voluntarily adopting uniform barcode standards
and implementing the technology into all commercially-available products
as soon as practical.

A medical student called me last week to discuss a possible medication
error at another hospital. Two sound-alike medications were involved in
the error. The student asked, \"Mom, this wouldn\'t have happened if we
had BCMA.\"

Thank you.

MS. DOTZEL: Thank you very much, Kay.

And now we\'re going to have our first panel come up. The first panel
this morning is a panel of representatives from various health
professional organizations, and I\'m going to ask them to come up to the
stage now.

Okay. The way we\'re going to do this this morning is we\'re going to
ask the different panel members to come up to the podium and give your
presentations, and then after that we will have an opportunity for the
FDA panel to ask you some questions. And if time permits, we will then
also turn to the audience, and if the audience has any questions, we
have mikes in each of the two aisles and you can come up and ask your
questions.

First, from the American Hospital Association, we have John ‑‑ is John
not here? All right.

Well, we will move on to Kasey Thompson, who is here from the American
Society of Health System Pharmacists.

MR. THOMPSON: Good morning. My name is Kasey Thompson, and I am the
director of the Center on Patient Safety of the American Society of
Health System Pharmacists.

ASHP is the 30,000-member professional association that represents
pharmacists who practice in hospitals, health maintenance organizations,
long-term care facilities, home care agencies, and other components of
healthcare systems. I am pleased to provide you with ASHP\'s views on
the proposal to require that pharmaceutical manufacturers include
barcoding on all drug products.

Before I address the question that the FDA asked in its announcement of
this meeting, I would like to draw the FDA\'s attention to one point.
Barcoding technology is entrenched throughout America in all types of
venues ‑‑ grocery stores, department stores, libraries. It is something
that everyone expects, and it is found everywhere except where it can do
the greatest good, saving lives.

This is a high urgency public health and safety issue, and the time for
action is now. ASHP has long supported the use of barcoding technology
to help prevent patient harm resulting from medication errors. ASHP
adopted a policy in 2001 to urge the Food and Drug Administration to
mandate that standardized machine-readable coding be placed on all
manufacturers\' single‑unit drug packaging to, one, ensure the accuracy
of medication administration; two, improve efficiencies within the
medication use process; and three, improve overall public health and
patient safety.

This is not a new concept. We know that the FDA has heard this
recommendation numerous times. Finally, last December, the FDA announced
in its semi‑annual agenda that it would publish a proposed a rule
requiring barcoding on drug and biological products. ASHP welcomed the
FDA\'s announcement, and supports its stated purpose of reducing
medication errors.

But again, time is slipping by. The most recent agency guess is that the
proposed rule would be issued in November. ASHP has criticized the FDA
in the past for dragging its feet on necessary changes in drug product
packaging to ensure patient safety. The need for this step is great, and
the time for it is long overdue.

ASHP has the following specific comments related to the questions the
FDA asked in the Federal Register notice announcing this July 26th
public hearing.

Number one, which medical products should carry a barcode? What about
blood products and vaccines?

Barcodes should be required on all pharmaceutical product packages down
to the unit dose, single unit level. For barcoding to be effective in
hospitals and health systems, products in unit dose packages must be
made available by pharmaceutical manufacturers.

While we have received reports that some major manufacturers are about
to make a public commitment to add barcodes to all packaging, including
unit dose, some of our members report a disturbing trend whereby fewer
and fewer manufacturers are producing drug products in unit dose
packages, leaving repackaging up to individual hospitals.

This is a major concern. Not only does repackaging introduce new
opportunities for mistakes to be made, it adds an additional cost which
most average- to small-sized hospitals cannot afford. Repackaging also
takes pharmacists away from their most important duty in hospitals, that
is, managing patients\' drug therapy.

There is evidence from over 40 years of research that proves that unit
dose drug distribution systems improve patient safety by reducing
medication errors, improving efficiency, and reducing costs.

The second question: What information should be contained in the barcode
that is critical to reducing medical product errors?

Barcodes on drug products must contain the product\'s NDC number. This
is the primary element that will be effective in meeting the expectation
that health professionals will be able to verify that the patient is
receiving the right drug at the right dose and at the right time.

Other elements that should be mandated include the product\'s lot
number, which can identify products for the purposes of drug recall; a
database can link a specific lot to a drug given to a specific patient.
Inclusion of the lot number would also be useful during public health
crises where mass vaccinations or drug treatments need to be given.

The third data element, product\'s expiration date. Drugs are kept in
numerous places throughout hospitals, and even with the diligent efforts
of pharmacists and technicians to check for out-of-date drug products,
it is impossible to verify and find all of them. Placing the expiration
date on the barcode would tell the nurse at the patient\'s bedside if a
drug is out of date before the patient gets the drug.

Third question: Should the proposed regulation adopt a specific barcode
symbology?

Numerous symbologies exist for machine-readable coding of products, but
some are receiving more attention than others because of their ability
to fit on small package sizes and readability by most
commercially-available scanners.

Common information systems standards need to be developed, either by FDA
mandate in the proposed regulations or through collaboration between
industry, healthcare professionals, and technology experts, and
consistently applied, for barcode systems to effectively interface with
other hospital computer systems such as pharmacy, laboratory, blood
bank, and billing systems, just to name a few.

Fourth question: Where on the package of drug products should the
barcodes be placed?

The barcodes should appear on both the inner and outer wrap below the
human-readable information. Barcodes on outer wraps are useful for
inventory and distribution control. Barcodes on inner packaging are
imperative at the time of drug administration.

Fifth question: What products already contain barcodes? Who uses the
barcodes and how?

Reliable data does not exist on how many current products packaged in
unit dose form contain barcodes, but it is well recognized that that
number is few, especially for unit dose packages containing a standard
barcode and the necessary data elements of lot, NDC, and expiration
date.

The Department of Veterans Affairs, as we have heard, is a national
leader in using barcoding systems for scanning patient, nurse, and drugs
at the bedside. A 1999 ASHP survey revealed that only 1.1 percent of
U.S. hospitals used barcoding to scan patient, nurse, and drug at the
bedside.

We are all aware, however, of mounting public pressures to improve
patient safety. Once drug product packaging has barcodes, the pressure
to improve patient safety by applying barcoding technology in
institutional settings will escalate.

Institutions need incentives to use this important patient
safety-enhancing technology. This can be achieved through an FDA
requirement and commitment by manufacturers to do what is right for
patients. Include barcodes on all product packages and make all product
packages available in unit dose.

Sixth question: What is the expected rate of acceptance of
machine-readable technologies in healthcare sectors? What are the
benefits of using this technology in delivering healthcare services and
other potential uses?

Practitioner demand for barcodes on prescribing ‑‑ on prescription drug
products and the capability of implementing such technology exists. More
hospitals and health systems are in various stages of adopting
machine-readable coding systems. What is needed is the product packaging
that would allow its use.

The benefits of using machine-readable coding in healthcare sectors are
twofold. First and foremost, a barcode system will improve patient
safety by ensuring that the right patient gets the right dose of the
right drug by the right route at the right time.

Second, a properly designed and implemented barcode system will enhance
the efficiency and work flow of pharmacists, nurses, and other health
professionals using the technology. A barcode system will be useful in
bedside scanning, inventory control, billing, and laboratory systems.

Seventh question: When should a final rule requiring barcoding on drug
products become effective?

We hope that there will be no more delays in an FDA requirement and
commitment by manufacturers to do what\'s right for patients. Clearly,
an early effective date is necessary.

We\'re afraid, however, that from the continual hesitation to take
action on this issue, we will not see anything from the FDA soon. If a
proposed rule is not issued until this fall, even with a short public
comment period it will probably be at least a year from now until we see
the Agency\'s final rule.

How much time, then, will be given to manufacturers to make the
necessary changes? A year or two? Market demand by end users ‑‑
hospitals, healthcare practitioners, wholesalers, and patients ‑‑ can
help drive the speed at which drug manufacturers implement the new
regulation.

ASHP appreciates the opportunity to comment to the FDA on this
significant issue. We are ready to assist the agency in any way in
developing its proposed and final regulations requiring barcoding on
drug and biological products. Thank you.

MS. DOTZEL: Thank you, Kasey.

I\'d next like to invite Dr. Joseph Cranston, who is here representing
the American Medical Association.

DR. CRANSTON: Good morning. My name is Joseph Cranston. I\'m a
pharmacologist by training. And I currently serve as the director of
science, research, and technology at the American Medical Association.

The AMA is the largest national professional association representing
physicians and physicians in training, and I am speaking on behalf of
the AMA at this meeting.

The AMA has had a longstanding commitment both to improve the quality of
medical care delivered to patients by their physicians and to promote
efforts that will improve patient safety. For example, the AMA
established the National Patient Safety Foundation in 1997, and has
participated in a number of initiatives on clinical quality improvement.
The AMA also has been a partner and strong supporter of MedWatch, the
FDA\'s adverse incident reporting program.

In 1999, the Institute of Medicine published its seminal report, \"To
Err Is Human,\" which raised public awareness to the important issue of
patient safety. As discussed in that report, there is considerable
documentation in the medical literature that medication errors result in
numerous patient injuries and deaths. This situation is unacceptable,
and efforts must be made to minimize medication errors.

Evidence suggests there are numerous causes of medication errors, and
therefore a variety of approaches will be needed to address this
problem. The implementation of new information technologies is an area
that offers enormous opportunities to improve patient safety. And the
use of machine-readable coding, that is, barcoding, is one such
technology.

The incorporation of scannable barcodes in a standardized format on all
medication packages and containers should help ensure that the right
drug and dose are administered to the correct patient. Thus, the AMA
supports and encourages efforts to create and expeditiously implement a
national barcoding system for prescription and over-the-counter medicine
packaging in an effort to improve patient safety.

The extension of barcoding to other FDA-regulated products, such as
blood products, vaccines, and certain medical devices, also appears to
be a reasonable and attainable goal.

The AMA has no official position on the specific elements that should be
included in a proposed rule on barcoding. As a general comment, the AMA
encourages the FDA to balance the need to put uniform barcode standards
into place as soon as possible to reduce medication errors with the need
not to stifle further innovation in barcode technology.

As a start, the AMA believes the June 2001 recommendations of the
National Coordinating Council for Medication Error Reporting and
Prevention, otherwise known as NCCMERP, entitled, \"Preventing and
Standardizing Barcoding on Medication Packaging, Reducing Errors, and
Improving Care,\" should be given strong consideration by the FDA.

The NCCMERP recommendations were developed by a coalition of
stakeholders, including representatives from medicine, pharmacy,
nursing, consumers, risk managers, hospitals, accrediting bodies, the
pharmaceutical industry, and government agencies, including the FDA.

In developing its recommendations, the council conducted a thorough
literature review and held a conference of invited experts in August
2000 to discuss needs assessment, current standards, equipment
manufacturers, and cost implications. While the NCCMERP recommendations
on barcodes focus on institutional settings such as hospitals, the
recommendations may be applicable to other settings.

Now, the FDA is undoubtedly very familiar with the NCCMERP
recommendations. However, the AMA would like to just briefly mention
some of the key points for the record.

First, the FDA, the United States Pharmacopeia, the pharmaceutical
industry, and other appropriate stakeholders should establish and
implement uniform barcode standards, down to the immediate unit of use
packaging, as defined in the U.S. PNF.

Two, the barcode should contain three data elements. A Uniform National
Drug Code or NDC number should be the primary unique product identifier.
Second, either the lot, control, or batch number should be one secondary
identifier, and the expiration date as another secondary identifier.

Point number three, the three data elements ‑‑ the NDC, the lot number,
and the expiration date ‑‑ should be uniformly ordered on the barcode
using existing symbologies.

Fourth, there should only be one barcode on the label and it should have
a standardized location.

And finally, the barcode should be included on the immediate container,
labels of all commercially available prescription and OTC medications in
any dosage form, on intermediate containers or cartons, and on
shelf-keeping units.

As emphasized by NCCMERP, its recommendations are \"a first step to the
ultimate use of barcodes in the medication use process.\" Before
hospitals, physicians, pharmacists, nurses, and especially patients can
benefit optimally from this technology, barcodes must be uniformly
present in a standardized format on unit of use packaging of all
commercially available prescription and over-the-counter drug products.

In conclusion, the implementation of a national system for barcoding of
commercially available drug products and possibly other FDA-regulated
products should help physicians and other health professionals to
decrease the number of medication errors and the harm to patients that
is associated with these errors. The AMA urges the FDA to quickly move
forward with a proposed rule to require barcodes on drug product
packaging. Thank you.

MS. DOTZEL: Thank you, Dr. Cranston.

Next, from the National Alliance of Health Information Technology, we
have Tim Zoph.

MR. ZOPH: Thank you. Good morning. I am Tim Zoph. I\'m vice president
and chief information officer for Northwestern Memorial Hospital in
Chicago, Illinois.

I\'m here today on behalf of the new National Alliance for Health
Information Technology, or known as the Alliance, a group of
approximately 50 organizations representing providers, purchasers,
manufacturers, and standard-setting organizations committed to
\"mobilize the field to address the fragmentation and lack of
coordination in healthcare, improving quality and performance through
standards-based information systems.\"

We are pleased to have the opportunity to testify on an issue of
critical importance for the healthcare industry and the people they
serve, the barcoding of drug labels for unit of use pharmaceuticals.

Northwestern Memorial Hospital is a founding member of the Alliance and
is committed to the first initiative of the Alliance, promoting the use
of barcoding technology to create a safer, more efficient and effective
patient care. I am here today to present the consensus recommendations
of the Alliance to the FDA for their consideration as they develop a
rule for the barcode labeling of human drug products.

By way of background, healthcare has trailed virtually every other
industry in reaping the benefits of information technology advances, at
least in part due to, one, a lack of consistent and uniform standards
and protocols; two, its dependence on multiple scientific disciplines
and medical specialities, each with its attendant technical requirements
and demands.

As a result, the healthcare environment is extremely fragmented, with
isolated systems and databases. To improve the situation, the industry
must begin to approach this more strategically.

The Institute of Medicine report, \"Crossing the Quality Chasm,\" calls
for \"a national consensus on comprehensive standards for the
definition, collection, coding, and exchange of clinical data.\" In
comparison to other industries, healthcare has been slow to achieve this
consensus. As a result, there has been an apparent failure to leverage
even their limited investment in information technology aimed at
improving patient outcomes and operational efficiency.

There are multiple causes for this failure, but one important cause is
the absence of a standardized barcode on the label of unit of use
pharmaceutical packaging. Only approximately 35 percent of all drugs
administered at the bedside contain a barcode, which when used in
conjunction with decision support tools, could dramatically reduce the
incidence of medication errors.

The Alliance recognizes that the implementation of barcodes on unit of
use medication packaging is only the first vital step in realizing the
promise of barcode technology in making our healthcare system safer. A
set of recommendations for the National Coordinating Council for Medical
Error Reporting and Prevention already exists and is a good starting
point for discussion of barcoded labeling standards.

The Alliance reviewed these standards, and building upon them offers the
following recommendations in response to the FDA\'s questions.

Firstly, for the proposed rule, the barcode label requirement, the
Alliance supports the FDA\'s effort to propose a rule to require a
barcode on the label of human drug products down to the unit of use
packaging.

Our recommendations, based on the considerable expertise of our member
organizations, can help the FDA to further define the details of a
barcode implementation process for human drug products. Additionally, we
desire to work with the FDA on further implementation of barcoding in
healthcare to promote patient safety and protect patients from human and
system errors.

It is our desire today, in today\'s public hearing, it will aid the
healthcare field and the FDA in achieving consensus on the prompt
establishment of regulations for barcode labeling on human drug products
down to the unit of use level.

Drugs and biologicals: The Alliance supports the implementation of a
requirement for barcoding for all commercially available prescription
and nonprescription medications. The code must be included on the labels
of all unit of use pharmaceutical packaging.

All dosage forms, including oral solids, oral liquids, injectables,
inhalers, nasal sprays, topicals, and other forms of specialized drug
product packaging should include a barcode on their label. In addition
to unit of use packaging, intermediate containers and cartons and
shelf-keeping units should also be labeled with a barcode.

Eventually, vaccines, blood, and blood products should have an FDA
requirement for labeling with a standardized barcode. Currently, only
blood has a barcode, and even it is not mandatory. Barcodes for vaccines
are currently under investigation by the CDC. The absence of barcodes in
blood products and vaccines could raise safety issues, especially for
the tracking of contaminated products.

The National Drug Code, as established by the FDA, should be the initial
data element included in the barcode. This should be implemented as
quickly as possible. Inclusion of the expiration date and lot number,
especially to track recalled and out-of-date products, should be added
to the barcode as soon as technically feasible.

These components can be phased in over a longer period of time. Working
out the technical products related to the lot number and expiration date
should not delay the implementation of a barcoded label that, at
minimum, identifies the drug, its strength, and manufacturer.

If the FDA proceeds with a rule including only the NDC number, the
Alliance has the technical expertise and is willing to work with the FDA
to identify solutions and time frames for implementation.

The choice of symbology for the barcode is a critical element of the
proposed rule and should be governed by specific principles. The
Alliance recommends that only existing symbologies utilized in
healthcare with the capacity to include the NDC, lot number, and
expiration date be used for the barcoded label.

Additionally, symbologies appropriate to pharmaceutical packaging size
and capable of being scanned by existing and readily available
commercial scanning technology should be selected. These principles
would allow flexibility to pharmaceutical manufacturers, while providing
for a level of standardization for the users of scanning devices,
without significantly increasing their costs.

The placement of the barcode on packaging for human drug products should
be in a position where the typical user of a scanning device can
reliably and consistently scan it. The printing quality of the barcode
should be at a C or better ANSI standard. There should only be one
unique barcode for a unit of use package.

Hospitals have employed barcoding in their administration system or
automated dispensing cabinets, but only after extensive repackaging of
their pharmaceuticals has been undertaken. This lack of a preprinted
barcode creates the attendant risk of introduction of new error through
repackaging and relabeling into the medication process.

Medical devices: The Alliance, with its strong interest in patient
safety, supports the eventual inclusion of certain medical devices in
the barcode labeling recommendation. Because of the complexity of this
issue, in selecting the devices to be covered and the information to be
included, the Alliance feels strongly that the progress in labeling
human drug products with barcodes should not be impeded by the issue
related to medical devices.

The Alliance recommends that the FDA complete its proposed rule on human
drug products and biologics, and then explore the feasibility of
creating a barcode rule for selected medical devices.

Benefits and obstacles: The healthcare system will become safer with
barcoding. Barcoding will decrease medication errors. Barcoding will
foster progress in developing interoperability of fragmented information
systems. Barcoding will serve as a tracking tool for medication and
device distribution.

The Alliance recognizes that while the cost to the manufacturer to place
the barcode on a unit of use label is not insignificant, much larger
expenditures will have to be made by the healthcare organizations to
take full advantage of barcoded medication delivery.

However, healthcare has always had early adopters who, given the basic
tools, have led the field to new levels of quality and service. We
expect the same to happen once barcodes are widely available on human
drug products.

Time frames: Today\'s hearings will raise many questions related to
issuing a final rule requiring barcoding for human drug products.
Realizing the NDC is the data element most easily incorporated in the
barcode, we encourage the FDA to move quickly in establishing the
requirement for barcoded labeling with at least the NDC. The Alliance
offers its assistance to work with the FDA in identifying a specific
date for this requirement.

In conclusion, the Alliance would like to thank the FDA for this
opportunity to address issues raised in proposing a rule on barcode
labeling for human drug products and biologicals. We stand ready to work
with the FDA, drawing on the expertise of our diverse member
organizations, to resolve the outstanding issues related to the
barcoding of drugs, biologicals, and devices.

We are committed to a consensus approach that places the patients and
their safety above all interests. Only through such a broad-based and
committed partnership will we achieve the promise of high quality
patient care.

From a personal perspective, from a CIO who has the responsibility for
the automation of the healthcare information processes at an institution
that has patient safety at the core of its mission, we are now
positioning our environment to take full advantage of barcoding
technologies.

If this rule is adopted, we will support it. We will be technically and
culturally ready to implement barcoding to its fullest. We will benefit
from its measurable results in safer care and operating efficiencies.

We see this barcoding rule as the capstone and last step in achieving a
fully automated medication administration process that has our
patients\' interest and safety at its core. We firmly believe that safer
care will be the ultimate result for our patients. Thank you.

MS. DOTZEL: Thank you, Tim.

Next we have Pamela Cipriano, who is here on behalf of the American
Nurses Association.

MS. CIPRIANO: Thank you. I am Pam Cipriano, chief clinical officer at
the University of Virginia Health System, and am representing the
American Academy of Nursing and the American Organization of Nurse
Executives, subsidiaries of the American Nurses Association and the
American Hospital Association, respectively.

As front line healthcare workers, the nation\'s work force of 2.7
million registered nurses have made and continue to make substantial
contributions to reduce healthcare errors. The American Academy of
Nursing and the American Organization of Nurse Executives embrace the
development of point-of-care technologies that reduce medical errors and
increase productivity, and appreciate the opportunity to discuss our
view on the particular issue of barcode labeling for human drug
products, biologicals, and devices.

A few weeks ago, the American Academy of Nursing, in conjunction with
over 20 organizations, convened an interdisciplinary conference focused
on using innovative technology to enhance patient care delivery. Nurses,
pharmacists, physicians, hospital trustees, administrators,
manufacturers, health policy analysts, architects, software engineers,
and others gathered in Washington to begin harnessing the strength of
technology in redesigning our practice environment and care delivery
system in order to improve nurse retention and healthcare quality.

Conference participants supported the establishment of a system that,
one, uses technology to improve productivity and safety through
automation; two, improves medication administration processes; and
three, provides interactive, automatically recorded data at the point of
care.

The opportunity for error reduction with barcode labeling for human drug
products promises to be significant. Barcodes and other machine-readable
codes are most effective when they are in a standard format, not yet
consistently found in healthcare applications.

Barcoding is currently available to assist in the identification of
patients, caregivers, specimens, medications, and equipment. It further
facilitates automated documentation, record-keeping, billing, inventory
tracking, and the study of near-misses and errors.

Ensuring appropriate medication administration is a complex process
involving a series of interrelated decisions and actions among a variety
of professionals. Errors can occur at any point in the process.
Automated information and decision support systems have proven effective
in reducing many types of medical errors. More specifically, barcode
technology can minimize the variation in the medication cycle and
decrease medication errors.

Use of barcoding automates the distribution, management, and control of
medications. Such technology not only allows professional registered
nurses to more accurately and efficiently administrator medications, but
it also streamlines nursing\'s workload, thus allowing more time to be
devoted to direct patient care activities.

Studies indicate that barcode labeling of drugs in acute care settings
can prevent over 7,000 deaths a year and save nearly \$5,000 per
admission.

Further development and wide scale deployment of barcoding require the
healthcare industry to address issues of standardization of code
technology, compatibility, reliability, and affordability. Keys to the
successful application of such technology include, one, ensuring end
users are involved in the process from the beginning; two, creating
integrated systems that do not require reentry or rekeying of data; and
three, reducing the workload burden.

While the literature indicates that the mandated use of barcode labeling
for human drug administration can provide substantial benefits to the
quality and safety of patient care, there are certain aspects in the
implementation of this technology that require further consideration.
And these are patient populations, standardization, compatibility,
reliability, and financial considerations.

Children are a population at risk for errors. The IOM noted that a
four-year prospective study found 350 medication errors resulting in
injury among over 2,000 neonatal and intensive care admissions. Many
pediatric doses are nonstandard and are prepared internally by the
pharmacy. A mechanism for adding a barcode to institution-specific
medications increases the cost of dose preparation and adds time.

Infant identification also presents challenges to barcoding for
identification, given the tiny size of the limbs and the ID bands.
Systems that link mother to baby may have barcode labeling for the
mother but only manual identification for the infant. So the full
benefit of the technology is not realized.

A second area for further consideration is the standardization of
barcode terminology. While we are pleased with forward movement toward
developed appropriate standards for information exchange, the data and
technology must be acceptable across various settings.

Nursing joins other organizations in support of the recommendations of
the National Coordinating Council for Medication Error Reporting and
Prevention that you have heard previously, which asks for the National
Drug Code, NDC, lot, control, batch number, and expiration date at the
unit of use package.

Barcoding of drugs should also be possible for nonstandard items at
minimal cost to the dispensing pharmacy. This would include such
preparations as ointments, lipids, TPN, manually prepackaged items,
crash cart supplies, et cetera. Labeling of blood products should
contain the donor, blood type, blood product, and attended patient, at a
minimum.

Administration of a drug or therapy would also be guided or assisted
with barcoding of the patient\'s identification data. Wristbands with
barcoding can prevent any error by alerting the caregiver to a mismatch
between the patient and the intended drug or treatment.

Implementation of barcodes for medication control often succeed in
decreasing errors related to wrong dose, wrote time, omitted dose, and
transcription or order entry. One Colorado hospital saw a drop of over
50 percent in different types of medication errors after implementation
of their point-of-care information system for medication management.

Bedside medication verification products have been on the market as a
complete system for two years. However, some of these systems are still
very cumbersome. Nurses need a reliable, accurate, and rapid system that
reduces workload and is more efficient or faster than a manual one.

One hospital discovered it had an eight-second delay in medication
recognition and reconciliation with the patients\' database. Until
discovered through investigation of a medication error, this
unacceptable delay was determined to be causing the nurses to circumvent
the system. Nurses can be masterful at finding ways around systems when
they don\'t work to their benefit. I must emphasize the importance of
involving end users in the development and implementation phase of this
technology.

It is also desirable that manufacturers and suppliers of drugs and
biological products provide 100 percent of products with barcoding. This
will ease the workload of not only nurses but also pharmacists, also in
short supply in the current and future workforce.

Implementing standards for barcoding will introduce some challenges for
existing equipment. Systems need maximum flexibility to support both
existing handheld scanner technology as well as other machine-readable
formats.

Right now many organizations are challenged with having incompatible
identification technologies. For example, a blood gas analyzer that is
equipped to read the magnetic identification strip on the caregiver
testing the specimen cannot read the patient identification system if it
is in barcode format and if the machine has not been adapted for this
scanning technology. Therefore, again, we don\'t have complete data
capture.

The location of barcode labels on drugs needs to be adaptable to current
technology, such a robots, that pick medications and fill medication
parts, again, dealing with the rewrap and overwrap issue. Transition to
future two-dimensional codes will also require a bridge from existing to
new technology. These codes are very promising, with high data density,
redundant data, low contrast reading, and easy writing on conventional
printers.

Further, the reliability of scanners to read the barcode is critical to
the success of such technology. It has been found that some bar scanners
cannot read curved surfaces. Since almost all identification bracelets
are on a wrist, valuable time can be spent flattening out the
identification band to allow the scanner to recognize it, often
requiring as much time as would be spent administering a medication
without benefit of technology.

Finally, we must raise the issue of affordability and financing of such
technology. Clearly, the cost of implementation in practice settings
will vary based on each institution and the structural changes required
to manage the point-of-care systems.

Manufacturers and suppliers must share in the production of materials
that respond to the mandate for safety and address workload burden.
Collectively, we had a duty to reduce error and prevent avoidable
adverse events.

Barcode labeling has proven beneficial for other advantages such as
charge capture, billing, record-keeping, inventory tracking and control,
and automated documentation for patient records and quality improvement
review.

In conclusion, we applaud the FDA\'s efforts to improve patient safety
and reduce the number of adverse drug events due to medication errors.
Barcode labeling for human drug and biologic products is one means of
applying simple technology to a broad spectrum of high-risk processes
and realizing a significant safety impact. Thank you.

MS. DOTZEL: Thank you, Pamela. And then last, from the American Hospital
Association, we have Dr. John Combes.

DR. COMBES: Good morning. My name is John Combes. I\'m the senior
medical advisor to the American Hospital Association and the Hospital
and Health System Association of Pennsylvania. I\'m here today on behalf
of AHA\'s 5,000 member hospitals, health systems, networks, and other
healthcare providers.

We are very pleased to testify today on an issue that promises to
improve patient safety, the barcoding of drugs, devices, and
biologicals. I also represent AHA on and currently serve as chair of the
National Coordinating Council on Medication Error Reduction and
Prevention.

NCCMERP, as it is fondly known as, recently offered a series of
recommendations on the implementation of uniform barcode standards, down
to the unit of use level, for all pharmaceutical product packaging. The
AHA, as a founding member of the council, supports those recommendations
and desires to work with the Food and Drug Administration and other
interested parties in the successful implementation in America\'s
hospitals.

NCCMERP\'s recommendations for barcoding of the unit of use medication
offers a good starting point for the development of regulations for
labeling standards. The recommendations identify the minimum data to be
included in the barcode, labeling and format parameters, and suggest
which packaging should be barcoded.

The council recommends the expeditious implementation of barcode
labeling standards by the FDA in collaboration with the U.S.
Pharmacopeia and the pharmaceutical industry. However, the council also
recognized that the use of barcoding technology as a mechanism to
improve medication safety should be implemented incrementally, with
careful planning and giving thoughtful deliberation for cost, cultural,
and implementation issues.

The AHA supports the FDA\'s efforts to require a barcode on the label of
human drug products down to the unit of use packaging. Stakeholders
still need to identify what products should be labeled with a barcode,
what data should be included in the barcode, and what symbologies should
be employed.

However, the general principle of including the barcode as an integral
part of the label is supported by hospitals and health systems. We
should not wait until all the details are worked out for barcoding
drugs, devices, and biologicals before instituting change.

Today\'s public meeting should help identify what can be done rapidly
and what steps will require additional time. The FDA\'s regulation
should codify what is doable now, and the FDA and healthcare industry
together should develop a plan that will lead to the timely phase-in of
barcodes on devices and other medical products for which we cannot
implement barcoding immediately. The AHA stands ready to assist the FDA
in these efforts.

Now I\'ll turn my attention to some of the questions raised by the FDA
in their announcement of this meeting in the Federal Register.

The AHA supports the timely phased-in implementation of a requirement
for barcode labeling beginning first with human drug products, both
prescription and over-the-counter drugs. This approach allows for the
development of bedside scanning capabilities in hospitals, which will
enhance patient safety in the administration and dispensing of
medications.

Additionally, for those hospitals and health systems that already use
bedside scanning, it will reduce the need for repackaging of
medications, eliminating another potential source for medical error.
Following the labeling of human drug products, the FDA should also
mandate the barcode labeling of vaccine and blood products.

Adamant among the barcode should include the National Drug Code, the NDC
number, as established by the FDA. Including the expiration date and lot
number would also be beneficial and desirable, especially to track
recalled products.

But there may be technical and cost issues that make this less feasible
immediately. Resolving the technical problems related to the inclusion
of the lot number and the expiration date, however, should not delay the
implement of barcode label that, at a minimum, identifies the drug, its
strength, and the manufacturer.

If the FDA proceeds with this rule, including only the NDC number, it
should explore with the field other ways for the lot number and
expiration date to be available at the bedside.

It is important to recognize that hospitals have already made a
significant investment in scanning technologies for clinical care and
inventory control. Any symbology adopted by the FDA for barcodes should
be compatible with current scanning devices used by healthcare
organizations. Symbologies requiring optical scanning should not be
mandated since this would require the wholesale replacement of current
information systems at a significantly increased cost.

Barcodes are currently being used in hospitals for laboratory specimen
identification, blood and blood products, inventory control, and
automated dispensing cabinets. Some hospitals use barcodes in their
medication administration systems, but only after extensive repackaging
of their pharmaceuticals, which increases the possibility of medical
error.

The major obstacle to the more widespread use of barcoding to improve
patient safety is this lack of the preprinted barcode on the unit of use
dose. Barcodes should be required on all packaging and containers down
to the level of use just prior to the administration of the product to a
patient.

One of the most significant factors in reducing medication errors is the
ability to identify the right drug and the right dose administered to
the right patient. By including the barcode on the packaging used for
the administration of the drug at the bedside, the right drug and the
right dose can be easily identified.

The next step in a phased-in implementation of barcoding standards would
be applying the technology to medical devices. The AHA supports the
labeling of certain medical devices with machine-readable codes. This
can improve patient safety by allowing the tracking of device failures,
device-related infections, and unexpected outcomes related to the proper
and improper uses of the device.

But not all medical devices need to be tracked in this way. Certain
simple devices, such as bandages, tongue depressors, and crutches, may
not require this type of labeling. Prior to the FDA proposing a rule for
the labeling of devices with machine-readable codes, studies should be
undertaken to determine which devices labeled with barcodes would have
the most impact on improving patient safety.

We should really look at our devices and stratify them according to the
risk to the patient, and only those that pose the highest risk should be
the ones that are barcoded. However, these studies should not delay the
FDA from implementing a rule for the labeling of human drug products
with barcodes.

A label for devices should include a unique identifier, which contains
information on the specific manufacturer of the product and possibly the
lot number. The FDA should establish a separate process, and perhaps a
separate public meeting, to address the issues around the labeling of
devices. Additionally, any labeling format should be consistent with
what is established by the FDA\'s rule for the labeling of human drug
products and biologicals.

The AHA encourages the FDA to have a planned process for the
implementation of barcoding, beginning with drugs and blood products. At
the same time, the FDA should start the process for identifying what
devices should be barcoded and what information should be contained in
those particular barcodes.

Medication errors are a critical concern for everyone involved in
healthcare. We must build systems that make sure the right patient is
getting the right medication at the right dose at the right time.
Barcoding technology can greatly enhance patient safety by ensuring
there is a realtime verification of the correct patient, medication,
dose, and time.

And hospitals are committed to using the best available technology
within their resource capacity to improve patient care and reduce
medical errors. We must recognize that placing a barcode on the label of
human drug products is only the first step in creating a safer
medication delivery system. Hospitals must have information systems in
place, complementary technology, and trained personnel to create a safer
system.

To maximize patient safety and to take full advantage of the information
available from using barcodes, such a patient alerts about dosage
limits, drug/drug interactions, drug/food interactions, and allergies,
hospitals and health systems must make significant investments.

The incompatibility of current information systems is an obstacle and a
disincentive in hospitals that would need to make significant
investments to put such systems in place. Can compatible systems be
created in hospitals? Is technology stable enough to endure over time?
Are hospitals investing in technology that will be quickly obsolete?
These incompatibilities and questions are a major source of the costs
associated with the use of the unit of use barcode.

In addition, hospitals face other costs, such as staff training in the
use of barcodes and scanning and bedside scanning, and repackaging and
labeling of extemporaneous preparations.

Finally, to improve medication safety through point-of-care barcode
scanning, hospitals will need to establish a radio frequency backbone
inside the hospital so that wireless devices may be used, without which
many of the efficiencies of barcoding are lost.

Recently the AHA convened multiple stakeholders interested in
standardizing healthcare information technology. And you heard earlier
from Tim Zoph from the National Alliance of Health Information
Technology. I have the latest numbers. We are now over 60 organizations,
representing providers, purchasers, manufacturers, and standard-setting
entities.

The Alliance mission is to mobilize the field to address the
fragmentation and lack of coordination in healthcare, improving quality
and performance through standards-based information systems. The
Alliance\'s first initiative is to promote the use of barcoding in
creating a more efficient and effective system of healthcare.

The AHA has demonstrated its commitment of working with all stakeholders
on this very important issue by being involved with the Alliance and
helping to create the Alliance. It is our desire to move forward with
the FDA and other interested stakeholders, including pharmaceutical
manufacturers, device manufacturers, group purchasing organizations, to
implement quickly this requirement for barcode labeling of human drug
products, and then to move as expeditiously as possible to the labeling
of certain medical devices, blood, and other biologics.

I want to thank you for the opportunity for the AHA to speak before you.
We are committed to improving patient safety. And with all your help, we
can advance the science of patient safety and assure better outcomes for
all our patients. Thank you very much.

MS. DOTZEL: Thank you, John.

Now I\'d like to ask members of the FDA panel if they have any questions
they\'d like to ask our health professional panel.

Dr. Crawford?

DR. CRAWFORD: Yes. A clarification from Kasey Thompson. I believe you
said approximately 1 percent of hospitals use barcoding. Is that
correct?

MR. THOMPSON: Yes. An ASHP national survey conducted in 1999 ‑‑

VOICE: We can\'t hear you.

MR. THOMPSON: The microphone doesn\'t appear to be on. An ASHP national
survey conducted in 1999 of about 5- to 7,000 hospitals determined that
only about 1.1 percent of those institutions currently use
machine-readable coding technology to verify drug administration by the
provider at the bedside.

DR. CRAWFORD: And is it your understanding that that is increasing, or
remaining the same, or do you know?

MR. THOMPSON: My guess, and we\'ll have up-to-date data in the next few
months, is that it\'s probably not increasing significantly because the
product\'s not available. The fact that there\'s very few products
available in unit dose packages with a barcode on it at this point in
time doesn\'t provide a lot of incentive to hospitals at this point to
purchase the technology.

I think once we get the technology available and the tools are there,
meaning the unit dose packages with the barcode, you\'ll see the number
of hospitals using the technology increase dramatically.

DR. CRAWFORD: And secondly, I\'d like to ask a question of the entire
panel. And that is is that what we are proposing is a regulation to
cover the issue of barcoding. And what we are about here is trying to
figure out what should be included within that.

I take it you are all in favor of the regulatory approach?

MR. THOMPSON: Yes.

DR. CRAWFORD: Anyone not in favor?

(No response.)

DR. CRAWFORD: This is a first in my many years of ‑‑ I am going to
retire at this point.

(Laughter)

DR. CRAWFORD: Dr. Combes, you did say that it should be phased in, and
over about how long a period. One of the problems with phasing in is
that, you know, we run the risk of losing momentum, and we believe this
is very important from a public health point of view.

So I\'d like for you to elaborate on that, if you wouldn\'t mind.

DR. COMBES: I think that after consultation with some of the
pharmaceutical manufacturers, we should be able to get the barcode onto
the label of unit of use packaging with at least the NDC number almost
immediately. I mean, I think there really shouldn\'t be much delay in
doing that. In fact, we had an announcement from one of the major
pharmaceutical companies the other day that they would be doing that in
the future. And so I think we can get there.

There are some issues that we need to work on, technical issues about
getting the lot and the expiration date. But I don\'t think those should
take longer than a year to 18 months. I think the biggest problem is
going to be with devices because we really do need to stratify the
devices. Not all devices will need a universal product number or a
barcode.

But there are certain devices which it would be very helpful to track
when we have device failure, and particularly infections. I mean, we all
are very familiar with the cases of the bronchoscopes up at Hopkins, and
things of that nature, where you can go back and really hone down into
what might be the problem. And that also gets into when we look at the
sterilization of devices and the use of devices ‑‑ multiple uses of a
single device.

DR. CRAWFORD: Thank you.

FDA PANELIST: I\'d like to ask the panel a question that you probably
could each talk about for ten minutes. But just very, very briefly, what
would you identify as the single biggest problem or impediment or
concern about an FDA regulation in this area? The single biggest
problem?

DR. COMBES: I\'ll take a shot at it. I guess if the regulation was
overarching and didn\'t hear the concerns of the industry in terms of
what was included in the regulation. But I think if we took a phased-in
approach, there are things I think we can, as I just said, do right
away, and are considerate of what technologies already exist in
healthcare organizations.

I think that will work well. And I think if you work cooperatively with
providers and manufacturers, we can get there. What we would hate to see
is somebody say, we need to have data matrix codes or other kinds of
codes on the label that we would have to change all our scanning devices
and do a whole lot of retraining.

MR. THOMPSON: Well, I think you heard great agreement at this table that
an FDA mandate is an absolute requirement at this point. It\'s been
clear for years and years that this wasn\'t going to be something that
the industry was going to do on a voluntary basis.

So it really ‑‑ at this point in time, I think that the, you know,
negative effects of an FDA mandate are very minimal. I mean, this needs
to be done. There probably isn\'t a person in this room who hasn\'t
experienced a medication error themselves or had a family member who
has.

I mean, we\'re not talking about new technology here. We\'re not
developing flying cars or alternative fuel sources. This is technology
that\'s currently available now, and it\'s achievable. There\'s
manufacturers testing it. They\'ve said they can do it and include all
three data elements. So it\'s there.

MS. CIPRIANO: I think one of the biggest concerns, however, is the
implementation of a complete system. And probably the biggest fear is
cost, particularly as we look at how broadly across our healthcare
delivery system would these requirements be required ‑‑ in other words,
nursing homes, the home care environment, outpatient environment where
typically we may have the same conditions existing in someone\'s own
home that exist in some of these other low-intensity, low-risk
environments.

So I think the biggest fear would be how sweeping would this requirement
be; how quickly would the costs need to be incurred to have a system
that not only provided identification of the drug in the dispensing end
of the system, but also the match to the patient identification; and
recording and looking for any kind of alerts in the system.

DR. CRANSTON: Yes. I think, from the AMA\'s perspective ‑‑ and we\'re
going to be very flexible on this issue because we certainly are not the
experts ‑‑ but I think that the benefits of a proposed rule or a final
rule clearly outweigh the risks, I think.

But I think the problem side is that sometimes when FDA issues a rule,
you know, kind of everything stops. And so, you know, the future
innovation, ways to improve the system, you know, might be impeded.

So I think that you have to take that into consideration as you\'re
putting together this rule so that we can get something out there
quickly that\'s useful that cause the hospitals to really want to take
advantage of it, but at the same time, you know, there\'ll be means to
improve the system in the future.

MR. ZOPH: Yes. I would just make the point, and you can tell from my
testimony that the biggest challenge may be setting forth a rule and
still having some unanswered questions related to medical devices and
other evolving standards.

So I think that may be a challenge in terms of knowing that a rule may
come forward and there is more work to be done. However, I believe that
is absolutely the right thing to do.

FDA PANELIST: Much of the emphasis has been on the importance of these
systems in hospitals. But an issue that\'s come up from time to time
with recalls has been the changing practice of pharmacy. At one time in
some states, it was required for pharmacists to write lot numbers on
prescriptions and to track that. But as I understand it, most states
have dropped that.

Would anyone care to update on the role that you see for barcoding in
prescription drug containers given to the patient in an outpatient
setting for medications at the home? Is this something also that is
something that should have benefits, or is this just a nice to have
thing which shouldn\'t be required?

MR. THOMPSON: Well, I think something that\'s very clear in our interest
here, and I think in the interest of patients, is that all
pharmaceutical products contain a barcode. And, you know, we emphasize
that that go all the way down to the single unit unit dose package.

We need to be very careful in some of the nomenclature on this as well.
We\'re using unit of use and unit dose somewhat interchangeably.
They\'re not. I won\'t get into the details of that.

But a single unit unit dose package is a package that contains a single
drug in one individual package. A unit of use package is, for example,
something like a package of oral contraceptives or a Medrol dose pack
that has a specified series of doses. But you can look at the USP on
that one. I won\'t get into a lot of detail.

But the key point here is the manufacturers be required to place
barcodes on all pharmaceutical product packages.

FDA PANELIST: But I guess my question is, would that extend to when the
pharmacist, outpatient pharmacist, prints a label for that little
amber-colored plastic bottle you take home? Does that barcode go on that
for future reference as well? Do the pharmacists now track lot numbers
to patients in the outpatient setting as well, or do you see this
largely as an initiative that is primarily needed in the inpatient?

MS. CIPRIANO: I believe it needs to be extended to outpatient. What we
find is that there are already ‑‑ up to 70 percent of patients never
take their drugs correctly. So the barcodes aren\'t going to help with
that part of the problem.

But I think if we\'re absolutely certain that we\'ve done the correct
identification, and then if a patient comes in and we are trying to
track back any problems with those medications, or if we have recalls
just like we record ‑‑ we do record lot numbers for samples of drugs
that are dispensed in outpatient clinics and things like that. I think
the more information that is available, if there is any untoward effect,
the better our management of those medications.

DR. COMBES: Actually, this issue came up in some discussions we were
having several weeks ago. And we all kind of sat around and said, well,
we didn\'t see how a patient would benefit in their home with a barcode
on their medication label.

And somebody said, given how technology has advanced so rapidly in this
area, particularly with handheld devices, one could imagine that a
patient would maintain their own individual medication administration
record at home, particularly patients who have complex drug regimens,
and could actually, with the use of a PDA, scan their medications to
make sure that they\'re taking the right medication at the right time.

So I think it might be shortsighted of us to dismiss that these would
have any application in the home setting. And I think, you know, this is
America, where there\'s an opportunity if somebody will come up with a
device and make it work. So I think we should consider that as we go
forward.

FDA PANELIST: The other application that occurs to me is that on
refills, the patient brings the product back. The pharmacist could
rescan the label, see if they\'re actually dispensing the same medicine
before ‑‑ make sure you don\'t have a name lookalike-type problem.

MR. THOMPSON: Let me just make one more point to address your question
about the capability and the usefulness in the ambulatory sector. It
would be very useful, and you addressed the point of should be this on
product labels, meaning the actual prescription file you get.

Well, actually, if the lot number and expiration date and NDC were
contained in the barcode, it would scanned in the pharmacy and then
populated into a database there in that pharmacy. So you\'d be able to
identify patient with product dispensed and, you know, know who you gave
a certain lot number to.

So I\'m not advocating for or against putting this on an actual
prescription vial but, you know, you would be able to do that through
technological means that way.

And with vaccines now, it\'s currently a requirement, I think, federally
that we record lot numbers and expiration dates for all vaccines that
are given. So it would be useful there just to be able to scan a barcode
on the product and have that populated database.

FDA PANELIST: I have a question. All the panel members think that all
three elements of the barcode that we\'ve asked about should be in
there, and some have said that a staggered implementation or incremental
approach would be good.

Ms. Cipriano and Mr. Thompson, you advocated all three pieces, but
didn\'t say anything about how it should be done. Do you see value in
getting something like the NDC code on there as soon as possible, as
opposed to delay for all components?

MR. THOMPSON: Well, clearly, the NDC is the most important element that
would identify the drug and the dose and, you know, the specific
product. So clearly, that absolutely positively has to be in the
product.

Now, my concern is that with lot number and expiration date, that we not
just let this fall by the wayside and delay it for five or ten years. If
a tiered approach is needed to do that to get the industry, you know, in
gear to do that, then that is fine.

I do know that there are pharmaceutical companies out there now that are
testing this and have told me in private conversation that it\'s
achievable to include lot number and expiration date and print on a
high-speed production line at this point in time.

Now, if there needs to be some kinks worked out in that, fine. But
let\'s not take too long to actually implement that and require that.

MS. CIPRIANO: I would agree. I think we need to move forward so that we
can begin to implement the use of at least the NDC, as has already been
supported by FDA.

FDA PANELIST: I have a question for Mr. Combes ‑‑ or Dr. Combes. I
apologize. You spoke about a staggered implementation, and suggested
first drugs and then biologic ‑‑ or vaccines, at least, and blood
second.

And my question to you is, given that, for instance, in the blood area,
there already is some barcoding going on, what would be your
justification or rationale for waiting for that, for those products?

DR. COMBES: Again, I think it\'s so we don\'t lose focus on the human
drug products. Because that is something that there really hasn\'t ‑‑
hospitals and other healthcare organizations haven\'t taken advantage of
because they haven\'t had the barcode.

In blood, it\'s my understanding that there are recommended standards,
but no required standards out there around it. And there is some concern
about the technology or the symbologies that were used for blood. And
that may need to be investigated in terms of which symbology to choose
for blood and what are the data elements as you go through a mandate.

I think that\'s going to take you a longer period of time than it would
be to say, let\'s have the NDC number in the barcode on the label by
January 1st. I think there\'s a little bit more investigation that has
to be done. There has to be a lot more work with the blood suppliers on
that issue. And there has to be a resolution of the issues around
symbologies, from my understanding.

FDA PANELIST: And just to pick up on that, and this is, I guess, for the
whole panel, what I\'m hearing people talk about is a lot of support for
use of the NDC. And I think, Dr. Combes, you\'re the only who has sort
of just mentioned the difference between, you know, sort of what\'s
happening with blood products and the others.

I don\'t know if the rest of you have thought about the use of the NDC
for blood products, given what\'s currently happening in blood. I
believe they\'re not using the NDC now, and yet do some barcoding.

And then finally, my last question is for Tim Zoph. You talked about the
data 35 percent, if I understood right, of medicines at the bedside are
barcoded?

MR. ZOPH: Yes. We ‑‑

FDA PANELIST: If you can just tell me. And then, you know, you can add
to that. But who\'s doing that barcoding? Is it the hospital? Is it the
manufacturer?

MR. ZOPH: We have ‑‑ what our experience is, again, the data, our
evaluation of that is approximately 35 percent today of unit of use
medications come in with a barcode. We actually repackage about 1
percent.

One of the points I\'d make on this, too, on the repackaging because I
know that has come up, we looked at what it would take for us to
repackage all those medications that don\'t come in with a unit of use
barcode.

And if you look at the error rate introduction into the process, if we
give 2-1/2 million doses a year, and even if we take a ten-step process,
assuming we can hit, say, a 99.9 percent effectiveness, we\'re going to
introduce 70 new errors a day just from repackaging. So that\'s one
point that I would make.

The other observation I\'d make is that our own experience is that
because unit of use packaging is a small part of the pharmaceutical
business, and you may hear about this from the manufacturers this
afternoon, is that we\'re actually seeing some decrease in the actual
packaging of unit of use into our institutions. So it\'s not only the
label, but it\'s also the packaging that\'s occurring.

FDA PANELIST: But I\'m still not ‑‑ who is putting the barcoding on? The
VA talked about they did the barcoding themselves ‑‑ I don\'t know if
that was correct ‑‑ as opposed to is anyone else doing that?

MR. ZOPH: Yes. We have manufacturers who are putting barcodes.

FDA PANELIST: Manufacturers?

MR. ZOPH: Yes.

FDA PANELIST: And how are you using those barcodes?

MR. ZOPH: Well, that goes to the core of it, is that unless we get to
the point where we have such a high volume of barcode where we can
introduce it in a reliable way into the process, that barcoding doesn\'t
really serve a purpose for us now because we have a smaller number of
products coming in with a barcode. So therefore, we\'ve got to get to a
much higher penetration of those barcodes coming into the institution
before we can introduce it in a reliable and predictable process.

DR. COMBES: There\'s a lot of repackagers out there and distributors
that will barcode medications, particularly when you have automated
dispensing carts. Those are generally repackaged with a barcode on them
so that you can take advantage of those carts. So that would be one
example.

FDA PANELIST: Can I just another question, then? If they are repackaging
and putting a barcode, is there some sort of standardization right now
with regard to what is on those because? The NDC number? The expiration
date? The lot number?

DR. COMBES: I think they all have the NDC number on them. But beyond
that, I\'m not sure that there\'s any standardization, and it would
depend on the repackager and it would depend on the distributor that was
doing it.

Many of them are done by vendors of those automated systems, who supply
the ‑‑ will repackage the drugs for you as part of their contract with
you to have that automated system within the hospital. So they really do
it for the purposes of their own devices rather than have a universal
standard that everybody would follow.

FDA PANELIST: Just following up on that, I\'m assuming, then, these
various readers that the hospitals have can read all of these different
barcodes that might be unstandardized?

DR. COMBES: It\'s a little confusing, to say the least. Clearly, there
are two levels of scanners that you can be concerned about. One is to
move into optical reading devices. Those are very, very expensive
scanners. They read the data matrix codes, which you can get barcodes
in.

Now, there are linear scanners now, particularly the latest generation
of linear scanners, that can be programmed up to read composite code. So
you could read a linear code and the composite that they have the lot
number and the expiration date in it. So a lot of the RSS codes can be
read by these.

Some of the older scanners can\'t do that, and they theoretically could
be upgraded but there may be problems in upgrading them. But the point
is, most of these scanners have maybe a four- to five-year half life or
full life, and they get replaced over time. And the current generation
of scanners can read almost anything other than moving to the optical
scanning level.

So in terms of symbologies, you can really program the scanners to read
almost anything if you tell them what to read, or you tell them that\'s
a potential being out there.

FDA PANELIST: Let\'s assume that the rule goes into effect or that the
NDC code is on all products at the unit dose a year from now. How
quickly would you expect hospitals and the hospital pharmacies and other
healthcare providers to adopt or to purchase the technology, invest in
the technology, to scan it and start actually reaping the benefits? What
would be the time horizon after that that you would expect to see those
kinds of benefits?

MR. ZOPH: I\'d be happy to take this. I think one observation I have for
you now is that hospitals are, as you know, working very aggressively to
implement computerized order entry. And as the studies show, that\'s
obviously a very high point of error in the system.

I do think by getting a standard out there, it will allow the providers
of information technology solutions to understand that there is a
standard and begin to develop those solutions, get them integrated into
their electronic medical records so that the ‑‑ you know, a very quick
add-on phase or subsequent phase of that, then when the barcode is
available, institutions can begin to adopt and implement it. There is a
period of time for which you need to pull together the technology
community behind a common standard.

And I think the other thing it allows us to address as well is that
there\'s a lot of benefit from things other than the medication scanning
at the bedside, things like specimen collection.

And those of us in hospitals that have been really trying to understand
how many different devices and scanning devices do we need at the
bedside, and so on and so forth, it allows us to begin to take a look at
scanning technology as a more universal tool at the bedside, and begin
to work with our vendor community to say, we want one device. It needs
to be able to read these scanning technologies, and begin to work
importantly with the whole cultural point of care setting that says, you
know what? We can deal with medications, laboratory specimens, other
material products, and have more universal solutions.

So we would be working aggressively in the meantime, once a standard is
announced, to make sure that the products begin to get in the
development life cycle within the technology community so when it\'s
available, early adopters in the industry will be able to take advantage
of the technology.

MR. THOMPSON: I think if you combine the FDA mandate that manufacturers
do this and include the necessary data elements, and assuming that
manufacturers continue to produce an enhanced production of products in
unit dose packages, and provide that incentive to hospitals and
healthcare organizations, that you\'ll see them adopt this fairly
quickly.

Now, let\'s move out and look and see the demand for patients and the
marketplace out there. We\'ve seen groups like leapfrog, say, you know,
implement CPOE. They haven\'t said barcoding yet. But there\'ll be
incredible market pressures out there by patients and others and private
sector initiatives to tell hospitals to do this.

I mean, this is important in enhancing patient safety. But we\'ve got to
have the product available, and it has to have a barcode on the product
package.

DR. COMBES: One of the by-products of having the rule, and I think this
is why we\'re most interested in having the rule, is it will bring to
our awareness our inability to get our hospital systems to communicate
to one another.

The barcode will be only of an advantage if we can have patient
information systems, laboratory systems, decision support systems, and
other systems all linked together so that we can leverage the barcode to
really make sure it\'s the right drug to the right person at the right
time with no contraintroductions and no incompatibilities.

And that is only going to happen ‑‑ that is the long-haul process.
That\'s only going to happen when we start to develop more universal
standards about how we use information technology in healthcare in the
first place.

So I think, by the FDA taking this step, you can really push forward the
industry in really seriously looking at how to capitalize off the
advancements in information technology.

We heretofore have not done that, and I think this will help us. Because
as Kasey said, there\'s going to be a tremendous amount of public
pressure when they see the barcode on the label: Why are you not using
it? And we will have to turn around to the people we work with and say,
how come we can\'t use it in an effective way? We need to sit down
together and work on some standards on this.

MS. CIPRIANO: I want to just elaborate on what John just said. The
biggest difficulty is not getting a scanner. It\'s not acquiring the
barcoded drugs. It\'s not putting the barcodes on yourself. It is having
that information then be used at the point of care.

And that\'s really where the cost issues come in, and that\'s where the
time delay is, that if there is a mandate, most organizations ‑‑ and if
we are thinking primarily hospitals and locations where patients are at
higher risk ‑‑ the lead times for those kinds of changes can be no less
than two years.

It\'s not an issue of philosophy, of safety, of things like that. But
the practicalities right now, in terms of planning for technology, where
there\'s either absent any other technology or information technology or
in trying to look at getting systems to communicate, is just extremely
taxing both timewise and financially.

MS. DOTZEL: I have two questions. One\'s a follow up question. I heard
someone way ‑‑ I can\'t remember now if it was Tim or Kasey ‑‑ that
right now manufacturers are not making a lot ‑‑ and I don\'t know
whether the proper term is unit of use or unit dose, the individually
packaged products that you oftentimes see in the hospital setting.

And my question is, to the extent that I think ‑‑ I would assume that
type of packaging is more expensive, and then you add barcoding to that
type of packaging, which makes it even more expensive, is there a
concern on your part that we might be creating even greater disincentive
for manufacturers to package that way?

MR. THOMPSON: That\'s a real concern that we have. One thing I mentioned
when I was speaking was that the unit dose drug distribution system has
very good science behind it that it improves patient safety. And
fundamental to that system is having products in unit dose packages.

Now, you combine a barcode with that, and the ability to add that extra
layer of safety and protection and assurance for that nurse at the
bedside that\'s giving the personal the medication that they\'re giving
the patient the right medication, with all the five rights and
everything, you have very powerful patient safety improvement.

There\'s a real concern out there that you\'ve pointed out that we
don\'t want to see an adverse effect of a rule becoming an industry ‑‑
I\'ll say excuse not to produce products in unit dose packages. There\'s
science behind the unit dose drug distribution system. It\'s effective
at improving patient safety, and hospitals need this.

Now, I don\'t know what the costs associated with doing that are. But my
guess is that they\'re minimal compared to the impact on improving
patient safety.

MR. ZOPH: I guess my follow-up on that would be that, again, we talked
about the repackaging issue. If you look at what\'s the right thing to
do, the time to do this is the time of manufacture that\'s the highest
quality and safest place to do it.

And secondly, there are a lot of costs of adoption, which we\'ve talked
about. So if the manufacturing industry embraces this, the cost of
embracing is then the unit of use at the hospital level employing the
technology, training the people and so on.

So there are costs, but I think there are costs to the complete system.
But again, the right point to do this with the highest quality, I
believe, is at the point of manufacturer.

MS. DOTZEL: And then my second question is that there\'s been a lot of
discussion about three data elements in the barcode, the NDC number, the
expiration date, and the lot number. Are there any other data elements
that we should be considering?

DR. COMBES: No. I don\'t think so. And this is why I have a little
concern about the expiration date and the lot number, that there might
be another way to get at it.

I think if you look at a barcode as really not a very intelligent
item ‑‑ it\'s really a pointing device, a pointing device to a
database ‑‑ you really don\'t have to have too much in the barcode as
long as you have the databases to back it up.

Now, what we\'re asking you to do is make that barcode a little bit more
intelligent for this labeling purpose by having the NDC number in it,
and then beyond that, to get the expiration date and the lot number. But
there are ‑‑ other elements that you may need will come when we again
integrate our systems in able to point that barcode at these other
databases.

So I don\'t think the FDA needs to get that into the barcode to make it
smarter. We should be able to do that by, again, working with industry
to get some standards about how we can point that barcode to all these
different databases we have.

The problem is as you start putting too much information in the barcode,
then the real estate on the label gets taken up by the barcode. Even
with some of the reduced symbologies, you\'re not going to get the
information in there.

So I think where we are, to get the three items in it, would be very,
very good. If we can start with the NDC number, that would at least get
us ‑‑ get the ball rolling.

FDA PANELIST: One question I have that the panel can comment, and
perhaps some of the speakers later in the day that are going to address
device issues. But often, with medical devices, the same labeling is
used in multiple countries.

And part of my question is, first, if you have any comments on what\'s
happening in Europe or other kinds of systems with these kinds of
technologies. But the other pressure that comes up in the device area in
using ‑‑ moving to the increased use of symbols, not just barcodes but
other types of symbols, is to actually decrease the amount of language
on the label and develop standardized meaning for symbols, like symbols
for expiration date and other types of symbols, in part because of the
European Union requirement to have information in all 17 languages of
the European Union on the label. And for small products, that gets to be
quite challenging.

So it\'s kind of a general question. But the question is, do you have
some comments about, you know, where you see the future of getting
standardized elements? And if you have any comments on the international
scene?

MR. THOMPSON: I\'ll just make an indirect comment. We\'ve talked about
staggered implementation of things. I would suggest hat the FDA stay
very focused on writing a workable regulation to provide barcodes on all
pharmaceutical product packages down to the unit dose level.

I think it would be fantastic one day if we had devices barcoded. But I
think the greatest impact, the greatest area of impact, on improving
patient safety is on the pharmaceutical product package.

I can\'t speak with any expertise about any of the issues that are going
on in Europe with devices. I mean, I\'ve worked with device failures in
healthcare. But, you know, by and large, let\'s stay focused on getting
barcodes on pharmaceutical product packaging.

FDA PANELIST: Actually, my question extended to pharmaceuticals as well.
To your knowledge, does Europe use barcoding or other kinds of systems
in their pharmaceutical systems?

DR. COMBES: It\'s my understanding that they do not use the NDC, which
would be a problem. They\'re using universal product number, and that
would be a whole nother issue that I think we would open up.

I think we have ‑‑ the NDC is something that we have. It\'s pretty pure.
And I think, again, it would be very helpful because hospitals use it.
Others use it to recognize drugs. It\'s used for reimbursement purposes.

So I think that\'s the major difference between the European system and
our system.

FDA PANELIST: At the practical level, what it would get down to would
also be things like importation rules, whether drugs could be imported
if they didn\'t have barcodes, NDCs, things like that.

MS. DOTZEL: I think now I\'d like to give people in the audience an
opportunity to ask any questions of our panel members. We have
microphones in each of the aisles. And so if anyone has anything, please
step forward to the microphones.

AUDIENCE MEMBER: Can we make a comment or ask a question? Either?

MS. DOTZEL: Questions for the panel is what we\'re looking for now,
please.

AUDIENCE MEMBER: Okay.

(Laughter)

MS. DOTZEL: And if you could identify yourself as you come to the mike,
that would be great.

MR. BRODO: Hello. A question. I\'d like to just explore with the panel
for a moment the intersection between this proposed regulation and the
Prescription Drug Marketing Act; specifically, comments around the
tracking of promotional drug samples and the use of barcodes on those
packages.

Oh, I am sorry. My name is Robert Brodo. I am sorry. LScan Technologies.

MS. CIPRIANO: Was your question basically, should they be barcoded as
well?

MR. BRODO: Yes. Is it your recommendation, is it part of your proposal,
to make sure that barcoding is extended to all drugs, including not only
in use in the hospital in use to patients, but also promotional drug
samples? And there\'s implication as that perhaps transcends the
Prescription Drug Marketing Act.

MS. CIPRIANO: My simple answer would be yes, for a lot of reasons,
again, because the need to control the use of samples and track who
they\'ve been given to and what happens is probably even more difficult
in an outpatient setting.

And so, again, it enables us to be able to track what patient, you know,
got the medication, and be able to then carefully ‑‑ be able to have the
data, just as if you were dispensing another prescription.

DR. COMBES: My answer would be yes. But I think in some respects, we\'re
making the next leap. What we\'re asking the FDA to do here is to put
the barcode on the label of all drugs, over-the-counter drugs ‑‑ we\'re
asking over-the-counter drugs, prescription drugs. So it wouldn\'t
matter if it was a sample. It wouldn\'t matter ‑‑ every unit dose would
have a barcode on it, or any unit packaging would have a barcode on it.

How that\'s used is going to be a whole different issue. And I don\'t
think we\'re asking the FDA to tell us how to use it. We\'re asking them
to give us the tool so we can use it.

And so we may be looking to some point in the future where physicians
will scan the samples they hand out in their office and keep a record of
it in their hopefully electronic medical record in their office someday.
I mean, that\'s ‑‑ who knows. I won\'t be alive to see that.

But again, that ‑‑ but you can\'t do that unless you have the barcode on
there. So we\'re asking them to take the first step on that.

MR. BRODO: Thank you.

MR. RITTENBURG: I\'m Jim Rittenburg with Biocode. And I wanted to ask
the panel if they\'ve considered using the barcode to also be a tool for
helping to prevent diversion and counterfeiting, or diverted and
counterfeited products from entering into the distribution chain by
individually license plating every item through the barcode that\'s put
onto that item.

MR. THOMPSON: I don\'t know if I can answer your question perfectly. But
I think a lot of that would be taken care of if the pharmaceutical
manufacturer producing the product was also doing all the packaging, and
including the data elements on the barcode.

I can\'t really go much deeper into that than that but to say yes, I
think that would be useful for that purpose.

MR. RITTENBURG: Yes. Because the only additional comment I\'d make is
with the recent cases of counterfeiting that have occurred, in many
cases it\'s been due to labels being copied, and any information on that
would also be copied.

So if a barcode only had an NDC number or lot number, that could be
produced en masse and copied, whereas if it was individually identified
for every item, it would be much more difficult for somebody to just
copy labels off and shove it into the distribution chain.

MR. MAYBERRY: My name is Peter Mayberry. I\'m with the Health Care
Compliance Packaging Council. A follow-up on the European question and
the question about, you know, other countries specific to
pharmaceuticals.

Kasey, you made the dichotomy between unit of use and unit dose. In your
experience, do many other countries ‑‑ are you aware of other countries
which do dispense in unit dose as opposed to bulk distribution, which we
rely on in this country?

MR. THOMPSON: That\'s a good question, and I don\'t have any science to
back this up. But I was on a recent vacation to Vietnam, Singapore, and
Tokyo, and just walked through community pharmacies in those countries,
they primarily dispense product in unit dose and unit of use packaging.
That was just an observational method I used. But it seemed very common
in Asia.

MR. MAYBERRY: That also relates back to the cost. I mean, if they can
afford to do it over there, do you have any speculation on why we can\'t
afford to do it here?

(Laughter)

DR. COMBES: Well, unit dosing for most pharmaceutical companies is not a
big part of their ‑‑ for hospitals, at least, a big part of their
product line. I mean, they\'re not dispensing a whole lot of unit doses.

However, over-the-counters are almost always in unit doses. So
obviously, it makes sense in an over-the-counter product that you\'re
dispensing ‑‑ any time you get a cold preparation, it\'s always in the
unit dose blister pack.

So I\'m not sure why the problem is, except that it hasn\'t been a big
part of what they\'ve been selling to hospitals in the past, and putting
another burden on ‑‑ may have them shut down those lines, which we think
are very, very important for patient safety reasons.

MR. THOMPSON: And that was an excellent point you made, and I would
highly encourage you to ask the pharmaceutical insurance company that
question this afternoon.

MS. SHAW: Hi. My question is for Dr. Cranston. And ‑‑

MS. DOTZEL: Could you provide your name, please?

MS. SHAW: I\'m sorry. It\'s Sherry Shaw, from Aventis Pasteur. And just
specifically somewhat related to the sampling issue, but with vaccines,
almost all of the vaccines are administered within the office setting as
opposed to a hospital setting. And in order for such a system to be
effective, it really would require physicians\' adoption of the
technology at the office level.

What would you foresee uptake at the physician level to be with regard
to that type of technology?

DR. CRANSTON: Frankly, I don\'t have a clue. I really don\'t know. I
think that based on the major discussion we\'re having here today and
the slow uptake by hospitals because of the lack of barcoding of the
products that are available commercially, you know, my suspicion would
be that it would be relatively slow.

But, you know, as we talk about computerized order entry and the
likelihood that that\'s going to become mainstream in the
not-too-distant future, and as the cost of scanning devices, you know,
are very low, you know, I think that that will happen. But at this time,
I don\'t think it\'s been thought about.

MS. SHAW: Thank you.

MR. GALLAGHER: My name is Derek Gallagher. I\'m with Aventis
Pharmaceuticals.

Is there any data that shows either the number or the impact of
medication errors due to dispensing of expired product or recalled lots,
as opposed to wrong product or wrong dose?

MR. THOMPSON: None that I\'m immediately aware of, but that would
certainly be something I would be happy to look up and verify and get
you the information if it\'s available.

MR. GALLAGHER: Thank you.

MS. TABORSKY: My name is Jeanne Taborsky and I work for SciRegs
Consulting. We represent a number of different kind of drug companies. I
have two different comments.

One is that while we\'ve been talking about all these products, one of
the products where there have been some MedWatch reports are nebules.
These are the little plastic devices that have drug, and they\'re used
in nebulizers.

And FDA currently does not allow us to label those directly. And
they\'re currently packaged in pouches, and then the pharmacist will ‑‑
at the hospital scene will take them out of the pouches and sometimes
put them in bins. And there have been some instances where the
pharmacists have actually had problems where they have mixed them up in
bins.

One thing, we\'re going to need agency help in trying to find a way to
label nebules where we can\'t even put a label on them. Because I don\'t
know of any way to barcode something without a label. So that\'s one
thing to consider.

The other is, on OTC products where we have ‑‑ we\'re trying to put a
lot of information on small blisters already. I don\'t see where the
person in their home is going to gain advantage of having a barcode on
that small blister for an OTC product. And a lot of these people are
getting older, and as we\'re getting older our eyes are having more
trouble reading small print. And so it\'s just something else to
consider, as to how we\'re going to put a barcode on each individual
blister of material.

Any comments?

DR. COMBES: The only comment I would make is that we use OTC products
all the time in hospitals. And if we have an integrated system where
we\'re doing bedside scanning, including prescriptive medications as
well as over-the-counters, we would certainly like to have the advantage
of scanning the over-the-counters as well.

And again, I don\'t know that you can predict what the future is. And I
agree the real estate on an OTC blister pack may not be all that large.
But the symbologies are getting smaller, and there are kind of unique
ways.

I was at the recent packaging conference, and everybody had blisters
with lots of information on them and barcodes on them. And I think we
need to look at it because you don\'t know where the technology is
going. And it may be at home people will be using more of these kinds of
devices in the future.

MS. TABORSKY: Thank you.

MR. BILLS: Hi. My name is Ed Bills, from Hill-Rom. And my question is
for Dr. Feigal.

We\'ve been talking about the label and concentrating a lot on the
label. But it looks to me like we\'re introducing a new medical device
here. And what do you see the product clearance process for the
barcoding system to be, and how long will that take to get in place?

DR. FEIGAL: The thought occurred to me as well.

(Laughter)

But there are a number of hospital information systems that we have
chosen not to regulate. Some of them are actually Class I exempt. But we
would look at these and have to see where they fit into the framework.

But in general, if you look at most laboratories\' information systems,
things like that, we historically have not chosen to regulate those.

MR. RACK: Bob Rack, RDG Barcode America. This is particularly directed
to Dr. Combes.

You\'ve indicated that NDC is a first step. Okay? And you can do that
with your existing scanners. It\'s also been indicated here that only
1.1 percent of hospitals are using any scanning technology. You\'ve
indicated that you want to stay with existing scanning technology, even
though you also indicated that over four to five years, these existing
scanners will cycle out.

At the same time, you\'ve indicated that you\'d like to see the expiry
date and lot code put on there, and to accomplish that, you need to go
to either RSS codes or data matrix codes, particularly on your small
packages. At the same time, you\'ve indicated your resistance to data
matrix multiple times. And you\'re trying to do two things that they\'re
exclusive to one another.

And my other point, you\'ve made reference multiple times to the extreme
cost of data matrix reading devices. They can be had for under \$500.

DR. COMBES: What I was saying to you was that we have made ‑‑ maybe only
1 percent of hospitals are using scanning at the bedside. But we\'re
using scanning all throughout the hospital. We\'re using scanning for
inventory control. We\'re using scanning for laboratory specimen
identification. We have scanners available in the institution.

My understanding ‑‑ and I may be wrong on this, and we\'ve spent some
time trying to understand it ‑‑ is that an RSS code can be read by the
current generation of scanners that we have in the hospitals that are
not optical scanners, and that what I was saying is that the older
scanners that are not current generation will be cycled out, will be
replaced, by the current generation, which can read RSS, can read
composite barcodes.

So what I\'m trying to say to you is we don\'t think we should move to
the next order of magnitude of scanners, replacing the scanners we
currently have in the institution. And some of them are current
generation scanners that we\'re using in various different departments
within the hospitals.

We are not scanning at the bedside precisely because we don\'t have the
barcode on the medication, and that\'s what we\'re asking for.

MR. RACK: But when you\'re talking about inventory control, you can do
that with current existing technology. When you\'re going to small
packages, you have to go to the next step. When you talk about
reprogramming existing scanners that you have, okay, that can be done to
read certain subsets of RSS. But they may not be the subsets that can
fit on this information that\'s required.

If we\'re only doing the NDC number, you\'re right. But if we\'re going
to do the expiry date and lot code, it\'s not right.

DR. COMBES: That\'s why I said the expiration date and the lot number
needs to be phased in because there are technical issues there. And
I\'ve heard all sides of this argument, and I don\'t think we\'re going
to be able to resolve it today. It\'s going to take some time in sitting
down with people who know a lot more about this than I do to figure out
how you can do this.

But my understanding, that there\'s a possibility it can be done using
the current generation of scanners that we have in the hospitals. Again,
I think there\'s going to be a lot of technical work that has to be done
around this issue. I certainly don\'t have the expertise to answer it
today, but I do think people do have it, and I think if we take a
measured approach, we\'ll get to that point.

Our concern is just, let\'s get something on the label that we can start
to work with. We don\'t scan at the bedside because there\'s nothing to
scan right now.

MR. RACK: Okay. I guess my point is, if you stay at NDC number, you\'re
okay. Thank you.

MR. GROSS: Hello. My name is Michael Gross, from Aventis Behring.

I\'d like to ask the healthcare provider panel what thoughts they have
about how this is going to impact the use of diluents that are used to
reconstitute dry products for injection. What complications are going to
be derived from this, the labeling of those products?

MR. THOMPSON: Expand a little bit. I\'m not sure I understand your
question. Now, we would support diluents are pharmaceutical products
also being barcoded.

MR. GROSS: I believe that not all of them contain NDC numbers. Some of
them are sort of customized diluents for particular products that really
go with the product. Sometimes, as I understand it, in practice, the
diluent can get separated from the actual drug that it\'s used for, I
think, in practice. You might know more about that than I do, but this
is what I hear.

So I think there\'s some complications around diluents. And I guess I\'m
asking if you\'ve thought this through and how this might work.

MR. THOMPSON: Not in any great detail related to diluents specifically.
However, one thing that we have recognized as hospital/health system
pharmacists is that even if we get manufacturers producing all products
in unit dose packages and making those available to hospitals, we\'re
still going to have to do some repackaging within the pharmacy
department and some barcoding at the pharmacy department level.

We heard about pediatric institutions and children\'s hospitals and the
specialized dosage forms there. So the capability to barcode at the
hospital level is still going to have to be there for some products.

And I don\'t know if I\'m addressing diluents in that or there\'s some
other technical issues or regulatory issues associated with that.
Perhaps the FDA can help answer that one.

MS. CIPRIANO: Let me just comment on your statement that the diluent
gets separated from the medication.

MR. GROSS: That\'s what I understand that happens.

MS. CIPRIANO: Well, I would hope that\'s really not happening, I mean,
because the final preparation, all of those contents should accompany it
through all of the system checks that are done before that medication
would be released.

So that part of the medication cycle would really need to be examined if
in fact it was separated before all of the final checks. I mean, again,
every institution has its system. But I would be surprised if that is
happening to any great extent.

MS. DOTZEL: Before you ask your question, let me just ask that everybody
who\'s standing up to ask a question, we\'ll go through those questions,
and then we\'ll probably break after that.

MS. ALLINSON: Hi. I\'m Jen Allinson from Procter & Gamble
Pharmaceuticals.

I have a question about whether or not the rule would be extended to
repackagers.

FDA PANELIST: We haven\'t made any final decisions about the rule.
We\'re here to get input today. Do you have something you want to say
about that?

MS. ALLINSON: Well, I guess what I want to say is mostly what these
folks are using are items that are coming from repackagers. So if that
rule is not extended to those folks, then there is a great possibility
that you\'re still going to be dealing with the same issues.

DR. COMBES: We would like to see it extended to repackagers. We\'d like
to see a common standard that everybody uses so that there is no
confusion about what scanning device to use or where to use it or what
information is in there, so certainly any time a pharmaceutical comes
into the hospital, either repackaged or packaged originally from the
manufacturer, there\'s a barcode on it that we could read at the
bedside.

MS. ALLINSON: Thank you. Second question: Regarding your comments about
not wanting to see data matrix because of barcode scanners, et cetera,
that could potentially increase the costs to all the manufacturers
because we would potentially have to go to one standard now.

And then if we want to add lot number and expiration date later and have
to go to, you know, data matrix, now we\'re making a whole second change
in terms of all of our labels, all of our, you know, printing
capabilities, et cetera, et cetera. So you may be actually creating a
barrier for the pharmaceutical industry to provide the data that you
need.

DR. COMBES: I recognize that. But there are some manufacturers right now
that will put a barcode on with the NDC and then add the composite
afterwards in the last step of the manufacturing process so they can get
into the lot number and expiration date because you don\'t have that
information until you\'re coming off the line, basically.

And so if the technology is there ‑‑ and this is why I say we think it
needs to be phased in ‑‑ it may be possible to have it linear coded, and
then have a barcode either adjacent to it in the composite form.

MS. ALLINSON: You\'re right. That is a possibility. But it is something
that\'s even less developed and more uncertain for high-speed lines. So
I would just keep that in ‑‑

DR. COMBES: And I understand that. And again, that\'s why ‑‑ but if we
wait till we get it perfect and get the right scanners to get all three
elements on, we might be sitting around for the next several years being
right where we are today.

MR. HANCOCK: Ed Hancock, American Health Packaging.

What we\'re talking here today is an issue that\'s significant enough
for regulation, for federal regulation. And there\'s a lot of discussion
about what is critical and what is nice to have, questions focused
around that.

I think Dr. Crawford set the scene this morning when he spoke of 100,000
deaths annually through ‑‑ and many through medication administration
errors. So it\'s critical that we figure out this, what\'s critical and
what\'s nice to have.

My question to the panel, to each and all of the panel, and I think it
can be answered in a yes or no: Does the content of the NDC, which
defines the medication, manufacturer, and strength, coded on the package
provide sufficient information by itself to address the five rights ‑‑
right patient, right medication, right dose, right time, right route?

MR. THOMPSON: The answer is yes. But that\'s one part of the medication
use process which is an extremely complex process. So also the ability
of having lot number and expiration date for product tracking, recall,
and identifying whether a product is in date or out of date would be
very useful.

I mean, you mentioned the 100,000 deaths associated with medical errors.
A subset of that in the IOM was 7,000 related to medication errors. Do
we have to wait until an expired product caused a patient harm? Do we
have to wait until we have a product recall that we really need to be
able to track who got what and when?

I completely agree, the NDC has the necessary data elements. It is the
primary element within the code that will be the most useful at the
bedside for preventing administration errors. But let\'s not minimize
the complexity of the medication use process and, you know, just put
these things on the back burner and forget about them five years from
now.

MR. HANCOCK: I understand the possibilities are enormous if we expand.

Others?

DR. COMBES: I think our position, from the American Hospital
Association, is pretty clear. I mean, we think we can get a lot out of
having the NDC number on it.

When you say, you know, does it guarantee the five rights, well, if
you\'re giving an expired drug or a recalled drug to somebody, then
you\'re not giving the right drug any more. So again, you know, nice to
have the ability to get that information.

Again, off the top of my head, I wonder if there\'s a way to do that by
using the barcode as a pointing device since the lot number and
expiration date ‑‑ and I may be wrong about this ‑‑ but is generally in
the shelf-keeping unit.

And if there\'s a way to link the dose that you\'re delivering back to
the shelf-keeping unit in your database, you may be able then to pick up
the lot number and expiration date.

There are different ways to look at this, and I think we have to explore
that. But it is very clear that tomorrow, if we had the will, we could
get that NDC number on the unit of use and have it barcoded.

MS. ESTHER: I\'m Sarah Esther. I\'m a pharmacy student from Purdue
University.

And I was wondering if the panel had any comments on the implication of
barcode labeling requirements on pharmacists\' jobs, and if this might
eventually lead to the elimination of pharmacists in some practice
sections and greater responsibilities for technicians who might now have
the final check.

MR. THOMPSON: Well, I\'m the pharmacist on the panel, and I\'m fairly
confident that this will not eliminate the need for pharmacists as the
experts in the medication use process and the use of medications. Very
good question.

But this is another layer of protection for the patient. And, you know,
that\'s the way we need to look at it. You know, I mean, all of us as
healthcare professionals, if we could develop systems that protected
patients and provided total failsafes and we were all out of jobs, we
all become obsolete and out of a job, then we\'ve done our job.

So we\'re not going to get to that point. Systems are complex, and I
think you have a long career ahead of you.

(Laughter)

DR. COMBES: Also, a little reassurance from the hospitals\' perspective.
One of the things that\'s very clear in the patient safety movement, and
does ensure safety of the medication system, is use of the clinical
pharmacist as part of the care team.

The more we can free the pharmacist up from this routine of checking and
counter-checking and counting and doing everything else, and getting
them involved in the care team, the better off our patients are.

The amount and complexity of pharmaceuticals we use in healthcare is
amazing, and no physician, no nurse, can do that on their own. And the
more we employ clinical pharmacists to round with us, to help us tailor
drug regimens, and to work as part of the team, the better off everybody
will be. So I wouldn\'t worry about it, either.

MR. MURRAY: Good morning. My name is John Murray. I\'m in the Office of
Compliance for the Center for Devices.

My question is for the industry panel. Do you envision that this barcode
regulation will address the validation, the design control, and the
overall quality of systems? And if it\'s not going to be in this
regulation, what is your recommendation about how we approach that
problem to ensure that these systems actually work to protect public
health?

(No response.)

I have a part B question for the lawyers.

(Laughter)

My part B question is, how do you envision that this barcode rule will
impact on legal liability? Currently now I guess it\'s, you know, a
practice of medicine, that whole legal liability history. Will now we
shift the big error blame to the IT system, take the human out of the
loop?

And then who gets ‑‑ who is liable? Is it the hospital? The barcode
maker? The label maker? I mean, I\'m just wondering how this could shift
the scale of justice.

MR. THOMPSON: Now, I\'m not an attorney, but we\'re not talking about
taking the human out of the loop here. We\'re talking about providing
humans with another layer of protection for patients as part of the
process.

So, you know, this isn\'t a way to take the human out of the loop. So
we\'ll let an attorney answer the question related to legal liability,
but ‑‑

MS. CIPRIANO: Let me just add one other issue, though, that hospitals
are facing. The more we move to technology, and I\'ll just use robotics
as an example, we are seeing limits on liability from the manufacturers.

And so whether it\'s the repackagers or whether it\'s the dispensing
manufacturers, I think there\'s growing tug and pull in terms of how
contracts are written and where the liability is placed.

And so I think it is an issue that we have to pay some serious
consideration to because, you know, institutions are willing to buy into
technology, and even if we believe that the systems are 98 to 99 percent
accurate, there is certainly that concern about risk when you are buying
a system in order to reduce your liability to begin with for errors.

So I think it\'s an unanswered question and an important one that you
raise.

DR. COMBES: I think the other challenge for hospitals is that having the
barcode on a label will probably create some liability, and probably in
a good sense that there\'ll be an expectation that it\'s used. And when
it\'s not used and patients suffer from a medication error, it will be
pointed out to us quite clearly. You have this capability to do
something. Why don\'t you do it?

And I think that\'s really going to be the pressure to make the industry
move forward in using information technology much more judiciously than
we have in the past, and for better patient outcomes.

MS. DOTZEL: Well, that concludes our morning session. I\'d like to thank
the panel for getting us off to a good start today. I think the
discussion this morning has been very productive, and I think it\'s
gotten everybody thinking about the issues we want to continue to talk
about this afternoon.

There is a cafeteria upstairs on the main floor. You may have seen it as
you came into the building this morning. They\'re expecting us, so
we\'ll break now. We are going to reconvene at 12:15.

(Whereupon, at 11:20 a.m., a luncheon recess was taken.)

A F T E R N O O N S E S S I O N

12:18 p.m.

MS. DOTZEL: We\'re going to start in a minute. Why don\'t the members of
our next panel come on up and take your seats while everybody else is
getting seated.

Okay. Why don\'t we get started. Before I introduce our next panel, I\'m
going to walk through the government panel again. We\'ve had a few
changes for this afternoon\'s session, and I just want to make sure that
everybody is acquainted with who\'s up here.

Starting with Dr. Steven Galson. He\'s the deputy center director in our
Center for Drugs. Seated next to Dr. Galson is Dr. David Feigal, who is
the center director in our Center for Devices. Seated next to Dr.
Feigal, we have Nancy Gieser, who is the acting director on our
economics staff in the Office of the Commissioner.

And then Diane Maloney, who is the associate director for policy in the
Center for Biologics. And sitting next to Diane, we have Peter Beckerman
from our Office of Chief Counsel.

And our panel this afternoon is the industry panel. We have
representatives from the different trade groups, and I will call you up
individually. I\'ll walk through the panel so that everybody knows
who\'s up here, and also so I can make sure I know everybody who\'s up
here.

We have Richard Johnson here representing PhRMA. Steve Bende from the
Generic Pharmaceutical Association. We have Bill Soller from the
Consumer Healthcare Products Association. Kay Gregory is here on behalf
of the American Association of Blood Banks, the American Blood Centers,
and the American Red Cross. We have Mary Grealey, here from the
Healthcare Leadership Coalition. And Tess Cammack ‑‑ am I saying that
correctly? ‑‑ representing AdvaMed.

And with that, we\'ll get started. We\'ll start with Dr. Johnson from
PhRMA.

DR. JOHNSON: Thank you for the opportunity. Can everybody hear me? Okay?
Hopefully everybody had a good lunch and has come back energized to hear
more about barcodes this afternoon. I\'m very pleased to be able to
offer the PhRMA statement regarding barcode label requirements for human
drug and biologic products.

PhRMA continues to be supportive of efforts to utilize standardized
barcodes down to the unit of use level on drug and biologic products as
part of an initiative to reduce medication errors. Current printing and
scanning technology allows for the application and reading of a barcode
on the label for all but the smallest primary containers. Here are some
examples.

PhRMA encourages the use of a standard barcode and data structure for
encoding the NDC number in these applications. The NDC number is a
unique identifier for the manufacturer or distributor, the drug
formulation, and package size and type.

In addition to the currently used UPC code and Code 128 symbologies,
which you can see here, PhRMA also endorses the reduced space symbology
and the 2D code data matrix. And for those of you that may not be so
familiar, maybe it\'s helpful to see what they look like. This is
another example. This is a Code 128 on a different type of package.

Based upon the current state-of-the-art technology available for
incorporating barcodes on small container labels, it may be necessary to
amend current FDA text requirements so that certain human-readable
information now required to be on all primary drug and biologic
container labels be exempted.

This would provide sufficient space to print a high-quality
machine-readable barcode and more prominent human-readable text to help
reduce medication errors. And I thought this was a good illustration of
how small some of these container labels that we\'re dealing with can
be.

If there were agreement on the above conditions, it would be possible
for pharmaceutical manufacturers to extend the use of machine-readable
barcodes on container labels where there\'s available space, and have
those barcodes on such container labels within two to three years.

For container labels where the necessary space is not readily available,
the feasibility of incorporating the NDC number into a machine-readable
barcode and the timing for its implementation would require further
discussion with the FDA regarding requirements for handling exemptions
and supplements for label changes.

The present technology is limited in its ability to support the
application of machine-readable barcodes incorporating additional
information beyond that contained in the NDC number, such as product lot
number and expiration date. These are variable information that would
have to be applied lot to lot. And you can see some of the wide variety
of pharmaceutical packages that we deal with.

The material benefit of a barcoded lot number and expiration date to
achieve a reduction in medication errors warrants further discussion
among stakeholders.

As a recent paper from NCCMERP cites, further research is needed to
quantify the safety and cost-effectiveness of barcoding in the
medication use process, and should be undertaken before their universal
incorporation into these processes. The use of barcoding technology as a
mechanism to improve medication safety should be implemented
incrementally with careful planning, and given thoughtful deliberation
for cost, cultural, and implementation issues.

PhRMA is prepared to convene a group of interested stakeholders to do
this kind of needs assessment, and looks forward to the opportunity to
work with the agency and other stakeholders in efforts to improve
patient safety. Thank you.

MS. DOTZEL: Thank you, Dr. Johnson.

Next we have Dr. Steven Bende, who is here on behalf of the Generic
Pharmaceutical Association.

DR. BENDE: Good afternoon. On behalf of the Generic Pharmaceutical
Association, I\'d like to thank Secretary Thompson and the FDA for their
efforts to reduce medication errors, and for providing an opportunity
for industry comment on barcode labeling of human drugs and biologics.

GPHA represents 98 percent of the generic drug manufacturers whose drugs
are dispensed for 45 percent of all prescriptions written in the United
States, and representing less than 10 percent of total drug
expenditures.

GPHA is now the united voice of the generic drug industry. We are
completely committed to patient health and safety, and strongly support
any measure in all areas that improve these. Indeed, the foundation of
our industry relies on the safety and effectiveness of affordable
pharmaceuticals to provide increased access to therapeutically
equivalent prescription medications for all patients.

Consistent with this commitment to quality and safety, GPHA firmly
supports the comprehensive use of standardized barcode labeling on human
drugs and biologics. We also support the use of associated standardized
data formats to aid in the reduction of medication errors.

Now, clearly there are some hurdles to overcome, and we\'ve heard about
a lot of those this morning, including space limitations of smaller drug
packages, current regulations on label text specifications, and the
state of technology to actually apply barcoding to packaging online in
high enough quality and high enough speed to insure readability.

Other issues include what information we\'ve been hearing a lot about,
lots and expiration date numbers, and which of the various technologies
we should standardize on.

At this time, we will not be making a recommendation for technologies to
support or what information should be on there ‑‑ should be contained in
any code. However, we do support ‑‑ from hearing from our health system
colleagues this morning, we do support NDC number, lot number, and
expiration date. And how many of those and which of those are included
immediately needs to be debated.

To that end, we recommend formation of a task force to swiftly
investigate solutions to these issues to aid the agency in developing
new barcode regulations that might result in decreased medication
errors. Some of the participants of this task force should include end
users of the technology, pharmacists, drug manufacturers, FDA, and
especially the technology companies who make the technologies behind
barcode labeling and the scanners.

We stand ready to participate in such a task force, and we extend an
offer to assist in its formation and operation. And thanks for the
chance to make these comments.

MS. DOTZEL: Thank you, Dr. Bende.

Up next we have Dr. William Soller, who is here representing the
Consumer Healthcare Products Association.

DR. SOLLER: Good afternoon. I\'m Dr. Bill Soller. I\'m senior vice
president and director of science and technology for the Consumer
Healthcare Products Association, CHPA. We represent manufacturers and
distributors of nonprescription medicines and dietary supplements.

CHPA supports efforts to reduce medication errors, including those that
encompass errors in information acquisition by consumers, who are the
principal end users of self-care products, as well as by those in the
professional setting that also might be using OTCs.

Potential market-based solutions and the ability to leverage existing
systems are critical to our industry, and I have three general areas of
comment. First, in the consumer self-care setting, drug facts labeling
is a means designed to address medication errors. Barcoding to prevent
medication errors would not be of value in the self-care setting.

OTC manufacturers and FDA have been mutually concerned about optimizing
safe and effective use of OTCs through even better labeling, including
ways to minimize medication errors in the self-care setting. Working
with other groups, including CHPA, FDA developed the Drug Facts Final
Rule for improving the content and format of all OTC labels for outer
packaging to make essential information on use and selection easy to
access and comprehend.

This regulation dictates the format, order, print size, content of
wording which the lay consumer will receive when they obtain an OTC
drug, and requires the active ingredients section to appear first on all
information in a special box entitled \"Drug Facts,\" which also
contains directions of use, warnings, storage information, and lot
number and expiration date are required by separate regulation.

The new drug facts labeling is an important step to reduce potential
medication errors in the self-care setting. And in the development of
the drug facts box, consideration was given to how consumers use
nonprescription drug products in the OTC setting, which is quite
different than OTC utilization in the professional setting.

In the self-care setting, this encompasses self-selection by consumers
and represents the vast majority of self-use of nonprescription
medicines. Access and veterans are key drivers to purchase decisions,
and reliance on the consumer reading the OTC label is the principal
stratagem for self-care with OTCs. We want and we encourage consumers to
read the label, to understand their medication, and to dialogue when
necessary with health professionals.

It\'s unlikely that the use of barcodes by consumers in the
non-institutional self-care setting is reasonably feasible or preferred
over the human-readable printed label to prevent medication errors.
Scanners are needed to read barcodes.

Consumers do not have handheld scanners linked to their personnel
medication records. Further, they most likely don\'t have the need nor
the desire for such access, given their state of health, current
medications, and cost and upkeep of what might be envisioned as a
futuristic personal scanning system for all consumers.

My second general point is that the universal product code, the UPC on
OTCs, is an efficient and effective means to track retail distribution
and sales. Currently, all OTC products intended for retail sale bear a
barcode, the UPC on the outer container.

The UPC is a unidimensional barcode that can be read at high speeds at
the checkout counter. It is the symbolic representation of a number,
like a license plate, which is assigned by the manufacturer for tracking
each SKU or shelf-keeping unit through its distribution and sales
network.

Since the UPC is a number, it is simply a link to a different
electronic-based archival system within distribution centers and retail
stores. The vast majority of the 750,000 OTC retail locations use the
UPC to track some 150,000 individual shelf-keeping units for literally
billions of OTC packages.

The vast majority of OTC products have more than one SKU. While each SKU
has its own NDC number, National Drug Code number, it may have a number
of different UPCs, between one and twelve, in order to track different
modes of distribution and sales for the SKU of the product. And a UPC
has a retail life of about six months to many years.

Companies need to track SKUs individually by their UPC in order to
assess sales by account, promotion success by package size, inventory
management, and package tracking in case of product tampering or for a
recall. This system is essential for a robust business environment. It
is very efficient and it is very effective.

My third general set of points focus on the scope and extent of a
possible rule in this area. On scope, given that the major use of OTCs
is by the consumer versus in institutions, should a barcode rule apply
where it would not be used, the self-care consumer retail setting, but
where it would be potentially very disruptive to distribution? We think
not.

On extent, do you mandate the NDC as the barcode on all OTCs, as the UPC
or as a separate barcode in addition to the UPC? Well, if the NDC were
mandated as the UPC, this would mean that we would not be able to track
all our channels of distribution and sales models, and this would have a
major small business and larger business impact, unless ‑‑ unless we
were to frequently change the NDC, which would increase manyfold the NDC
listing and delisting activities by FDA, industry, and institutions. And
there would be another source of medication errors.

Could you use two unidimensional barcodes, the NDC and the UPC? Well,
this wasn\'t recommended by the panel this morning to have more than one
barcode. It\'s not recommended by the council that administers the
barcode. And we have heard of instances of confusion in the retail area
in terms of inventory and pricing and other matters.

Could you go to different or combined symbologies, reduced size
symbology or composite symbology? These are very attractive to us
because they record the size of that barcode, potentially giving us more
label space for consumer information.

But it\'s fair to say that this is a fast-evolving area. Suppliers are
supportive of this, and will be coming out with new adaptable scanners
in the near term. Other industries, the fruit industry for individual
UPC labeling, want to go to reduced size symbologies, as does the CD
industry.

But this is in the future, I think the near term future, because at the
same time, we have a retail environment that is highly invested in
flatbed scanners that don\'t read RSS easily or at all. And this could
lead to pushback from retailers due to consumer dissatisfaction and
refusal to stock products.

Longer term, and maybe not so far in the longer term, RSS, CS, and maybe
other technologies offer a longer term solution, and no regulation
should interfere with this kind of technological advance.

Again a comment on extent. Do you barcode to the individual OTC dose? We
don\'t think this would be useful to the consumer in the self-care
setting, as I outlined earlier. And this raises the general scope of the
rule. And it would likely require that if this were done, that we would
have to delete the needed opening instructions on the back of the
blister pack.

Do you require a lot number and expiration date? Well, they are already
on the OTC label. And as a practical matter, if you look at a
unidimensional barcode, as is currently used, you cannot put the lot
number and expiration date into that. You would require some sort of
composite symbology, which is not available today in terms of a
widespread production form.

We simply don\'t have the validated systems or processes for online
application of lot number and expiration date through barcoding
technology. This would likely require major retooling, and again, the
question of scope vis-a-vis OTCs comes in mind.

So as you consider scope and extent, and phased-in implementation, does
the immediate answer for the fewer number of OTCs used in the hospital
setting reside with the repackager? And/or do you consider a national
information database linked to the UPC to be the least disruptive to the
overall distribution channels, thereby allowing technology to advance
and be implemented at the retail level for even better solutions in the
future?

As a way of marshaling industry expertise and thinking on how to
overcome the significant barriers surrounding this issue, we have formed
an industry coalition on barcoding that includes PhRMA, GPHA, CHPA, and
HDMA in order to address the stakeholder input from this meeting and
provide future suggestions on how we might move forward in a feasible,
practical, and cost-efficient way. Thank you.

MS. DOTZEL: Thank you, Dr. Soller.

Next we have Kay Gregory, who is here on behalf of the American
Association of Blood Banks, America\'s Blood Centers, and the American
Red Cross.

MS. GREGORY: Good afternoon. I\'m pleased to be here today representing
the blood banking community. Just by way of explanation, when we
originally submitted our statement for the panel, we did not yet have
approval from the American Red Cross. We\'re pleased to say that they
have now joined in our statement. So I can truly say I\'m here
representing the entire blood banking community.

The American Association of Blood Banks is the professional society for
over 8,000 individuals and 2,000 institutional members involved in blood
banking and transfusion medicine throughout the world. Our members are
responsible for virtually all of the blood collected and more than 80
percent of the blood that is transfused in the United States.

America\'s Blood Centers is an international network of community-based
blood centers that collects nearly half of the U.S. blood supply and
about 25 percent of the Canadian blood supply.

The American Red Cross, through its 36 blood services regions, supplies
approximately half of the nation\'s blood for transfusion needs.

We welcome the opportunity to work with the Food and Drug Administration
and other interested parties in developing regulations on barcode
labeling for human drug products, including biologics. Remember that
blood is classified both as a drug and as a biologic.

The primary problem in transfusion medicine indicates a need to reduce
the human error, not the problem you may all think would be most
prevalent, which is transmission of infectious diseases through blood
transfusion. That\'s really relatively minor and has been pretty well
conquered. Now we\'re looking for other areas for improvement.

The introduction of new technologies such as barcoding aimed at reducing
the risk of human error can save patient lives. We suggest that FDA
adopt a broad systems approach to the issue of minimizing the need for
human interface. Mandating the use of barcodes without also considering
how the barcode can be read and how it will be utilized in various
hospital systems will not automatically reduce human error.

And while barcodes may offer one approach to reducing transfusion
errors, the FDA must not codify policy that would limit the use of other
equally effective technologies in development, such as radio frequency
tagging.

The important issue is not to mandate the particular symbology to be
used. Rather, FDA and providers should focus on requiring electronic
data interchange, and the definition and use of standard data
structures.

In answer to the questions that were posed in the Federal Register
notice, you should be aware that blood and blood components are already
barcoded. Codabar has been in use since the 1980s. However, a newer
barcode, ISBT-128, has been successfully introduced in other countries,
and is currently under consideration in the United States.

The FDA endorsed ‑‑ note the word \"endorsed,\" not \"mandated\" ‑‑
ISBT-128 in a guidance document published in June of 2000, \"Guidance
for Industry: Recognition and Use of a Standard for the Uniform Labeling
of Blood and Blood Components.\"

It is also expected that future editions of the AABB standards for blood
banks and transfusion services will require ISBT Code 128 if a facility
is to remain accredited by the AABB.

Since many of the considerations in the design of ISBT-128 are also
under consideration at this public meeting, our written statement
provides a detailed description of considerations that led to adoption
of ISBT-128. I want to quickly highlight just a few of them.

First, internationally agreed-upon placement of labeling information.
And note the word \"international.\" Internationally unique numbering
system. Internationally standardized product codes. Encoding of date and
time of collection, production, and expiration.

Encoding of special testing results. Encoding of manufacturer, catalog
number, and lot numbers of blood. And finally, most importantly, a
mechanism for continued maintenance and growth of the standard.

This slide shows an example of a labeled unit of blood with all the
various pieces of information encoded in the barcode. Starting at the
upper left is the identification number, or what for many of you would
be considered the lot number. The ABO and Rh type, which is extremely
important.

The product number or the product code, as we call it. The expiration
date and time. Any special testing results. And finally, although it\'s
not identified here, the barcode at the bottom left is the product name.
In this instance, it\'s red blood cells with adenine saline added.

Now let me move to the other side of the people that we represent, and
that is the transfusion medicine side, and talk about additional
technologies needed to prevent mistransfusion of the wrong unit of
blood.

Transfusion of incompatible blood, or mistransfusion of blood, is the
most common cause of morbidity and mortality related to transfusion.
Serious errors are made at the time of sample collection within the
laboratory, at the moment of blood issue from the laboratory, and at the
bedside when transfusion occurs.

ADO-incompatible transfusions due to misidentification of recipients at
the time of transformation are the reported cause for as many as two
dozen patient deaths a year in the United States, and such instances we
know are under-reported.

The blood banking community encourages research, development, and
widespread application of new technologies aimed at ensuring that the
right patient gets the right unit of blood. Some such technologies,
including methods of computerized barcoding and patient wristbands, are
already being introduced in some individual hospitals. Unfortunately,
there has been only limited application of existing technology to reduce
mistransfusion.

Here are our recommendations, in conclusion. The entire transfusion
medicine community, both the government and private agencies, must move
forward to encourage the use of promising technologies designed to avoid
patient harm. In this light, these are our recommendations.

First of all, FDA should require the blood bank community to adopt
ISBT-128 or a comparable system for labeling of blood or blood
components. One of the reasons for saying comparable is that we wanted
to hear what the outcome of this particular meeting would be, although
our preference right now would certainly be for ISBT-128.

However, FDA should also recognize that this cannot be done overnight.
If it were mandated today, it would require three to four years for
implementation. It will require significant resources on the part of
both industry and the agency. Because blood bank systems are classified
as medical devices, they undergo 510(k) review. The agency must be
prepared to do such reviews in a timely manner.

Finally, we encourage the development and use of patient and product
identification systems for blood products that will be compatible with
whatever is developed for drugs, pharmacy use, et cetera. Thank you.

MS. DOTZEL: Thank you, Kay.

Next I\'d like to invite Mary Grealey, who is here on behalf of the
Healthcare Leadership Coalition.

MS. GREALEY: Good afternoon, and thank you for the opportunity to be
here today and to share the Healthcare Leadership Council\'s views on
this vitally important subject. Before I discuss our specific
recommendations, let me say a word about the Healthcare Leadership
Council and our approach to this issue of barcoding.

The HLC is unique in that it represents all sectors of the healthcare
industry that would be affected by the FDA\'s barcoding regulation. We
are a coalition of chief executives of hospitals and health systems,
pharmacies, pharmaceutical companies, pharmaceutical and
medical/surgical companies and distributors, and medical device
manufacturers. We also represent pharmaceutical benefit managers as well
as health plans. As you can see, a pretty diverse group, but all would
be affected by this regulation.

Two years ago, the HLC members created a CEO-level task force on patient
safety, a task force that has focused on measurable, evidence-based, and
achievable solutions to the patient safety challenges our nations face.

This task force has determined that electronic verification of drugs at
the point of administration should be a high priority initiative. We
believe strongly that automated drug identification has the potential to
greatly limit medication errors.

The remainder of my statement will be divided into two sections. First,
I will offer our broad guidelines on automated identification of medical
products that have been developed by our HLC members, and then I\'ll
share with you some of our specific recommendations.

I cannot stress strongly enough a critical element in the
recommendations I\'m about to offer for your consideration. They reflect
a consensus of our membership. In other words, we have reached common
understanding between the healthcare providers, product distributors,
and manufacturers, who will each play a critical role in the success of
using barcoding to auto-identify medical products.

And it goes without saying that the success of an FDA regulatory
standard hinges strongly upon the cooperation of numerous parties along
the drug supply chain, from the creators of the barcode printing
equipment to the nurse that administers that dose at the bedside. We
believe the following suggestions and suggested guidelines will lead to
a harmonious and effective system.

First, we must be pragmatic. Auto-identification standards should
support the highest attainable level of safety through the most feasible
and cost-efficient approach that can be implemented in the shortest
period of time.

Second, the regulatory standards should build upon and not disrupt
current market forces. Many pharmaceutical companies have already
initiated the printing of barcodes wherever possible on their unit of
use packages. An increasing number of hospitals are adding
auto-identification systems to their hospitals. We should not discourage
this progress, and we certainly should not discourage unit of dose
packaging by pursuing requirements that are overly expensive and highly
difficult to implement.

Third, an FDA barcode labeling regulation should, over the long term,
result in reducing or at least not increasing the workforce needs of the
healthcare system. Many healthcare providers, as many of us know, are
already trying to deal with workforce shortages, and their personnel are
stretched very thinly at this point. A new regulation should not
exacerbate this problem.

And finally, the FDA should construct a regulation flexible enough to
accommodate new and more effective technologies as they become
available. Barcoding may be the auto-identification choice of technology
today, but radio frequency, data matrix, or other technologies may prove
to be more effective and less costly in the future. We must not preclude
technological advances.

These four guidelines, we believe, should comprise the foundation of any
FDA barcoding regulation that can expect wide acceptance and successful
implementation throughout the healthcare system.

Now, having laid that foundation, let me move on to eight specific
recommendations the HLC offers in response to the FDA\'s notice.

Number one, if the FDA requires barcoding, then this requirement should
be limited to unit of dose drug and biologic packaging used only in the
institutional environment. This should include both prescription and
over-the-counter medications.

Number two, initially barcode data element requirements should be
limited to the National Drug Code number, the NDC that we\'ve heard so
much about today. The NDC contains all of the necessary information to
ensure that the patient is given the right drug in the right dosage.

Lot number and expiration date should only be considered when the
technology for printing dense barcodes is more widely available, and
when we have research showing that patient safety is enhanced to a
degree that warrants the difficulty and cost of implementing this
additional information. The FDA already requires lot number and
expiration date to be in human-readable form on the drug package, and at
this time this should be sufficient.

Number three, in the near term the FDA should not require the
application of barcodes beyond the currently widely used linear,
one-dimensional barcode symbology. Requiring the immediate use of
reduced-space symbology or two-dimensional barcodes would substantially
increase manufacturing and packaging cost and could also reduce printing
and verification productivity by up to 40 percent, according to our
technical experts. Also, existing hospital barcode scanning equipment
would have to be reprogrammed to read newly configured codes.

Let me be clear: We do not advocate prohibiting the use of more advanced
technologies or symbologies. However, we do believe that the FDA should
conduct research and convene the appropriate stakeholders to determine
an appropriate timeline for introducing specific standards for the newer
developing auto-identification technologies.

Number four, we ask that the FDA not limit flexibility by mandating the
specific location of the barcode on a package. This kind of specificity
is not needed to protect patient safety and could perhaps unduly
increase costs.

Number five, barcode requirements should apply to containers that are
the most critical to medication safety. This includes unit of dose
containers. An additional consideration for the FDA is that unit of use
containers come in various shapes and sizes, from oral solids and
topical creams to prepackaged syringes and vials and ampules.

Unit of use containers that are small or irregularly shaped are more
difficult to print with barcodes, especially using automated printing
systems. Consideration should be given to this particular but very
important difficulty.

Number six, we believe that the FDA should reevaluate the annual label
review process with respect to label changes that may be necessary to
accommodate barcodes. Creating a fast track process and eliminating
certain element size and data requirements would help accommodate the
placement of the barcodes.

Number seven, careful thought must be given to the phase-in schedule of
any regulation. Consideration must be given to the time and expense
involved, and retooling packaging operations, purchasing new printing
and verification equipment, redesigning packaging artwork, and refiling
for label approvals. The last thing we want to do is to discourage unit
of use drug packaging with an unfeasible phase-in schedule.

Let\'s also keep in mind that less than 5 percent of the hospitals in
this country have the hardware, software, and training programs in place
to conduct bedside barcoding at this time. In determining the effective
date of this regulation, we need to assure hospitals that sustainable
barcoding equipment and software compatible with their existing
information technology will be available.

And finally, number eight, the FDA or other agencies within Health and
Human Services should consider including a grant program to assist
hospitals in acquiring the technology necessary to implement bedside
auto-identification of medications.

Let me close by saying that I can\'t emphasize strongly enough the
commitment on the part of all sectors of the healthcare industry to take
the steps necessary to enhance safety and to reduce the possibility of
medical errors.

Significant progress is taking place. Earlier this week, for example,
one of our HLC members, Abbott Laboratories, announced that it will have
barcodes on all of its hospital-dispensed drugs by early next year. This
is but one example of the advancement in the marketplace that is
occurring across the spectrum of American healthcare, and it is
essential that any regulation facilitate and not inhibit this progress.

The FDA needs to take great care that regulations aren\'t so costly or
so difficult to implement that they result in unintended consequences,
such as hindering the production of unit dose packaging. And if we are
to realize the broad nationwide gains in patient safety through
barcoding, then we need to ensure that hospitals have access to the
technologies essential to make it happen at the patient\'s bedside.

On behalf of the members of the Healthcare Leadership Council, I\'d like
to thank you for the opportunity to address this issue, and we stand
ready to assist you in any way possible for the safety of all patients.
Thank you.

MS. DOTZEL: Thank you, Mary.

The last speaker on our panel this afternoon is Tess Cammack, who\'s
here on behalf of AdvaMed.

MS. CAMMACK: Good afternoon. Thank you for this opportunity to present
AdvaMed\'s views on this important issue. I am Tess Cammack, associate
vice president of technology and regulatory affairs for the Advanced
Medical Technology Association, or AdvaMed.

AdvaMed is the largest medical technology association in the world,
representing more than 1100 manufacturers of medical devices, diagnostic
products, and health information systems, a diverse range of hundreds of
thousands of distinct products.

AdvaMed and its members are committed to the voluntary use of
industry-approved automatic identification for medical devices where it
is economically and technically feasible, and where it is clinically
practical.

My use of the term \"automatic identification\" is carefully chosen. We
all recognize traditional barcodes used on retail packages, but there
are other configurations, including radio frequency technology, that
uses an embedded chip.

All these technologies can use various data structures under the
universal product numbering system, and most modern scanning technology
can read them all. Because these technologies will continue to evolve,
we refer to automatic identification rather than barcoding, which could
inappropriately lock industry into one standard, one coding language, or
one technology.

AdvaMed is concerned that the request for FDA to require barcoding on
all medical devices falls short of the needs of a heterogeneous
industry. Devices come in all sizes. They are packaged individually or
by the hundreds. They are made from a wide range of materials requiring
various sterilization and storage needs. They may be designed for single
use or multiple use. Their clinical applications vary greatly.

I am here today to challenge us all to see the unique design
characteristics and usages of devices as significantly different from
drugs and biologics, particularly in light of the agency\'s interest in
exploring whether UPNs on devices can improve patient safety.

For this reason, AdvaMed recommends that FDA not include devices in its
forthcoming rule on barcoding for drugs and biologics, and that any
consideration of auto-identification for devices be addressed
separately.

Industry surveys indicate that from 1995 to 1997, there was
approximately 30 percent more UPNs on devices at the unit of use level,
and nearly 17 percent more on the shelf-pack level. Unfortunately, this
older data are soft and there is a need for updated, unbiased surveys
that look at not only the number of UPNs on devices, but also the extent
to which healthcare professionals utilize the products that are coded
and why they do so. Even so, the data we do have confirm that
manufacturers, without regulation, increasingly are auto-identifying
medical devices.

Decisions are best made when manufacturers work with healthcare
professionals to clearly identify the goals and practical limitations of
auto-identification. They may ask how a device is used, how often it\'s
used, how it\'s packaged. The manufacturer will consider lot size,
device and packaging size, and surface material.

They should consider how hospital protocols might be changed by the use
of UPNs, which format might be appropriate, and at what level of
packaging UPNs should be used. All this is a process to determine
whether the expected benefits warrant the additional burden to the
healthcare system.

Manufacturers use UPNs on devices for various reasons. Most temporary
and permanent orthopedic implants, for example, are auto-ID\'d to
provide traceability. Other products are auto-ID\'d to assist in
inventory control. And while some devices may be auto-ID\'d to reduce
medical errors, there is a notable lack of statistically significant
data to indicate that UPNs on all medical devices would reduce medical
errors.

There are, unfortunately, significant obstacles to auto-identifying
medical devices. The packaging material may inhibit the use of printable
codes. Small devices with limited packaging may need to rely on
two-dimensional symbols or RF technology instead of a linear barcode, or
they may require larger, costlier packages.

Because a UPN may be applied at different levels of packaging, the UPN
may not be present at the point of use, especially for multiple use
devices that have been sterilized in-house.

Most device companies are small firms for whom, in particular, auto-ID
reflects significant investments. The costs to hire technology experts
and purchase printers, scanners, and software must be weighed against
the expected benefits of auto-ID. Identifying each and every throat swab
at the unit of use level, for example, would not be practical or
beneficial.

On the other end of the spectrum is capital equipment, for which
auto-identification at the unit of use may not be appropriate. What
would the patient safety benefit be in requiring UPNs on these products?

These examples tell us several things about industry working with its
customers to voluntarily apply UPNs to certain devices. There is no
one-size-fits-all approach because medical devices come in too many
shapes and sizes.

They are packaged differently and in different quantities. They may be
used singly or multiple times. They are manufactured in lot sizes that
vary from firm to firm. Requiring auto-identification on all devices
could unnecessarily increase healthcare costs without improving patient
safety.

This brings us to the heart of my discussion, whether FDA should require
auto-identification on devices to reduce medical errors. A 1999
Institutes of Medicine Report suggests that medication errors,
transcription errors, user errors, staffing shortages, and lack of
training are the prevailing root causes of medical errors.

Those attributed to medical technology are notably absent from this
list. You could argue, therefore, that a mandate to auto-ID all devices
would have only proportional success and would impose a significant cost
burden on the healthcare system.

Secondly, it\'s unclear how healthcare professionals are expected to use
auto-IDs on devices to improve patient safety. For drugs, the
application is certainly clearer. A patient\'s list of drugs, dosages,
administration times, can be benchmarked against actual usage to
minimize the risk of errors.

But a similar expectation to benchmark device usage is far more vague. A
UPN is but one piece of a system that requires a commitment to scan
products, identify patients, update code information, and analyze data
if benefits are to be realized. Increased patient safety may be
attainable for only a subset of medical devices, depending on the nature
of the device and its use in a clinical setting.

A UPN identifies a product. It provides traceability, not patient
safety. For instances where FDA has determined that traceability is
necessary, device tracking has already been ordered. Effective systems
to track devices have been in place for years, and applying a UPN to a
device will not necessarily improve this process.

Clearly, auto-identification is not a silver bullet to resolve medical
device-related errors. Firms have already auto-ID\'d thousands of
devices, and they will continue to work with customers to decide which
other products should be auto-ID\'d. It is a dynamic process that moves
forward, albeit deliberately, in a way that is responsive to customer
needs and is cost-effective, employing UPNs selectively where benefits
can be realized.

To summarize, AdvaMed encourages greater communications between
healthcare stakeholders to ensure that automatic identification is
voluntarily applied to devices where it is economically and technically
feasible and where it is clinically practical.

AdvaMed strongly encourages providers and purchasers to fully utilize
UPNs when they appear on medical devices. Using auto-ID to prevent
medical errors requires not only that manufacturers apply a UPN, but
also that users commit to its appropriate employment.

AdvaMed supports the voluntary use of UPNs on medical devices, which
allows for the use of industry-approved UCC/EAN or HBIC standards, a
decision that reflects the clinical use of devices, the interests of
healthcare professionals, and the challenges faced by manufacturers in
auto-identifying medical technology.

For all these reasons, AdvaMed strongly encourages FDA to recognize that
the unique diversity of medical devices is so significant that they
should be excluded from the agency\'s forthcoming rule on barcoding for
drugs and biologics, and addressed separately.

We look forward to working with the agency and stakeholders on this, and
we appreciate your attention and interest today. Thank you.

MS. DOTZEL: Thank you, Tess. Now I\'d like to give the FDA panel members
an opportunity to ask questions of our second panel.

DR. GALSON: I\'ve got a question for Dr. Soller.

If we require barcodes on prescription drugs but not over-the-counter
drugs, how do you anticipate dealing with the issue of all the
over-the-counter drugs used in hospital settings, particularly ones that
are used a lot, like analgesics, where the doses may be very important
and we really want to make sure to avoid errors?

DR. SOLLER: Let me comment on that. That\'s a good question, and I tried
to address our view in my comments. I think in looking at a proposed
rule, it\'s important to consider scope, and as I mentioned, to think
about whether requiring a barcode or a new type of barcode or a revision
of the current barcode across an entire category where the intent of the
rule would not have necessarily a direct benefit, but where that rule
might have a benefit in a subset. That scope should be looked at very
carefully.

And then also, as I put through some of the comments that our group has
been concerned with in terms of what might be a change to the UPC, to
think about ways where, you know, on the other hand ‑‑ just stepping
back for a moment, on the other hand you might think about a perfect
solution that\'s totally systems perform and then plunked into
operation.

And that clearly can\'t happen, particularly when the machinery is
simply not there. And so you can imagine the industry view, being
required to do something when you wonder whether it\'s even going to be
used by the end user. And that is balanced by a perspective that it\'s
important to try and find a way to address medication errors, and
there\'s a commitment by the industry to do that.

So how do you balance it? And do you go to the perfect solution, or do
you look for some sort of phased-in approach? And what I was trying to
suggest from our group, a willingness to dialogue on this, but to think
about the repackager as a vehicle here where very specific coding
symbology could be worked out with institutions interested in moving
forward, and I suspect that will be an incremental march among the
institutions and not somebody that will occur quickly.

And also to think, in that regard, there\'s ‑‑  currently ongoing for
NDA products, looking at establishing an informational database on
labeling. Can that be taken to a next step that might allow linkage of
current UPC which is being used and electronic updating, and then access
by various institutions that will slowly move forward to do this.

So I think the public health solution is not always a perfect one, but
is one that may recognize all the different facets and look for the kind
of approach, near, mid, and longer term, that would be appropriate. And
our group certainly endorses the kind of regulation that would not put a
damper on technological advances, whether it\'s radio frequency or RSS
or CS. All of these are very attractive options for the industry to want
to explore.

DR. GALSON: Just a quick follow-up. Just as a point of information,
really, are your products in general packaged separately for
institutional users, or is it ‑‑ do they get the same ‑‑

DR. SOLLER: No. We actually have very little control of that. The
institutions will go to distributors. We would sell to distributors. And
then that stream of distribution is essentially out of our control.

And the institution would then go to the distributor or the repackager.
You know, the VA goes to a repackager ‑‑ or may do it itself; I don\'t
know that system ‑‑ and then work out whatever supply they would need.

So we don\'t ‑‑ we\'ve looked into that. We do not have a segmented
hospital-directed market that represents any kind of significant size of
our industry.

MS. GREALEY: I\'d just like to comment on that. I think Dr. Soller has
raised some very important points there, and really has defined well
rather than ‑‑ and this may be too harsh of a word ‑‑ overreaching by
trying to capture every over-the-counter medication, where what we\'re
really trying to get at is what\'s used at the patient bedside, that
yes, going through distributors, repackagers, may be a way to approach
that that would get at what you\'re trying to get.

DR. GALSON: Thanks.

Dr. FEIGAL: I had a comment on a device area. I mean, I appreciate the
suggestion to change the terminology to auto-identification and not lock
us into a specific technology because there are some pretty exciting
technology changes in auto-identification, some of which are very small
and may be cheaper than even printing, just as now magnetic storage is
cheaper than paper, and who would have thought we would be at that
point.

There are some unique challenges in the device area for hospitals and
healthcare facilities. And one of them is tracking products which have
been recalled. And this may be a safety issue that is different for
devices than it is for drugs, where the issue, the safety issue, may be
more focused on getting the right drug to the right patient.

Every year there\'s between 1,000 and 1400 medical device recalls, and
actually that number has been growing. And that\'s just the number of
recalls. The actual number of products recalled every year is in the
millions. In fact, I think one year we topped out at four billion units
of products recalled.

Just to highlight one example this year, there was a company whose
products were recalled who were shipping 10,000 surgical instruments a
month which were not sterilized. And one of the difficulties in
hospitals finding these is all of the paths of consignees and middlemen
and so forth.

But it would seem that there would be an interest on the hospital side
of being able to rapidly respond and identify inventories and to be able
to work with these types of products. Typically, in the recalls, it\'s
not unusual to not even get 5 percent of the products back or have the
hospitals even to be able to identify 5 percent of the products which
are defective and have been recalled.

And it\'s a little hard to explain why the performance is so difficult
in this area. But it seems like this is one of the potential areas.
It\'s more on the inventory control side of things, but a few years back
when a manufacturer was shipping iodine that was grossly contaminated
with pseudomonas ‑‑ in fact, the blood industry picked that up as they
cultured the product looking for another product ‑‑ there wasn\'t any
way to trace where any of that product had gone. It affected over 140
different device manufacturers. But in terms of patient safety, there
was no way to really tell or track where any of that had gone or to
identify was it a significant risk or, you know, wasn\'t it.

I realize these things create certain liability concerns. But I\'d be
interested in your comments on whether or not there are tools that are
needed that would help industry meet its responsibilities a little
better than it\'s currently doing in the recall area, where its
performance is fairly inadequate.

MS. CAMMACK: You raise a very good issue. And I think the diversity of
the industry underscores why this needs to be looked at more carefully
and why are recalls ‑‑ you said that it\'s difficult to know why they
may or may not be working efficiently.

Barcoding may or may not be the answer to that. This is one of the
reasons why we\'d like to be working more closely with the stakeholders
to determine if things aren\'t going correctly as they should, or the
information isn\'t coming from manufacturers as rapidly or as
efficiently as it should. Why is that occurring? Can barcoding resolve
that? Maybe it can assist it. Maybe other things are needed as well.

But to have a blanket approach for such a wide, diverse industry and
say, let\'s put barcoding on everything so we can improve recalls, are
you really going to get your expected benefit at the expense of putting
that burden on industry?

I think many of the questions that we ask about coding devices, we have
to go through that balance and see if we\'re achieving it. And it comes
back ‑‑ maybe where we need to start is being clear on the starting data
on this.

I think it\'s been suggested a couple of times today we need to do a
better job of understanding where products are being coded, how those
products are being used in the clinical setting, and how has it been
effective in improving patient safety, before we know where are the
applications it would be appropriate.

MS. GIESER: We\'ve heard some discussion this morning, and again this
afternoon, about potential implementation periods, anywhere from
possibly as soon as one year, two to three years, and maybe four years,
I believe I heard.

I wonder if the panel would speak to ‑‑ elaborate more on how you would
benefit from longer implementation periods. Is it reduced costs? Are
there some products that are more problematic to you so that you need
more time? Can you elaborate?

DR. JOHNSON: If I can start, anyway, I think a key issue ‑‑ the first
issue that it would affect cost and implementation is what data elements
are going to be required. Speaking for pharmaceuticals, if it\'s NDC
number only, then the implementation time is more of a package design
question.

And then how long does it take to get the barcode or some
auto-identification code placed on the artwork; where necessary, to get
that approved; to get it to the printers; to get it phased in; and to
get it out into the marketplace.

And that is what we believe we can do two to three years. Again, you\'ve
got to consider the wide variety of packages. Some of them already have
barcodes. I work for a company that has been working very diligently and
made commitments to implement barcodes on injectables, but I can tell
you there have been literally probably tens of thousands of manhours of
work just to put the NDC number on that subset of our total group of
pharmaceutical products.

So if you say we have to do other data elements, frankly, we\'re not
exactly sure how to even do that. So to give an estimate on how long it
would take becomes very problematic.

So I think that deciding what data elements are required, and then
considering the wide variety of packages, some will be able to be
implemented much more quickly than others.

MS. GIESER: If we just spoke to the NDC code only, just for ballpark
discussions?

DR. JOHNSON: Again, in talking with the other member PhRMA companies, we
felt like we could achieve that for most of the products within two to
three years. And given that there are some products that are very tiny,
there would have to be some discussion on whether or not we would have
to remove so much text or shrink the text down that that would be
defeating the purpose.

Because we have to remember, for a long time to come, we have to
maintain both human-readable and machine-readable. And if we have
unreadable human-readable text, is that going to contribute to
medication error reduction or actually make that worse?

So there are some that we just don\'t know of a solution, even with just
the NDC number.

DR. SOLLER: Just a comment. Again, I would agree. It depends upon scope
and extent. And at least as it would relate to OTCs, I don\'t think
it\'s just a package design question. I think there\'s a clear
distinction between the PhRMA-related products and the CHPA OTC
drug-related products in this regard.

I think there are issues relating to listing and delisting. We would see
a manyfold increase in that activity. And the impact of that on the
system and how that is updated and the validation of that system, I
think, would be very important if we\'re truly interested in going that
route and thinking that therefore the many different NDC numbers would
now represent how we would track our channels of trade.

I don\'t think personally that ‑‑ nor does my group think that that\'s
the best approach. And if you\'re looking at mandating it down to unit
dose or lot number or expiration date, I can tell you that that will
require major packaging changes on the former and major retooling, if
it\'s going to be online lot number and expiration printing through
barcoding. And that is a very long and length process.

With the question noted earlier, to what extent does that really add to
patient safety? And so I would think there should be an evidence-based
approach there particularly.

Last comment, just to reiterate what I said to Dr. Galson earlier:
Looking at a repackaging and/or an informational database solution on
the OTC side is a much nearer-term type of solution.

DR. BENDE: Yes. I mean, just to echo some of the things that have been
said, I think implementation time comes after planning and agreement of
standards time. And I think we\'re just beginning the debate about ‑‑
and the discussion about that, I hope, now and such that we\'re hearing
all these different technologies aside from barcoding, such as, you
know, radio transmitters and what have you.

Hopefully, there will be a standardized data format that they all read
into, or there\'ll be some goal that we can all agree upon that is
best ‑‑ you know, that our end user friends can tell us is going to be
the best for them to use, actually, and to actually give a benefit.

So in terms of giving it a timetable, I think the first order of
business is to agree upon some standards that all of the different
technologies would read into. So again, I think we\'re ‑‑ we need
probably some good time for planning.

You know, I\'ve heard from one or more of our member companies that we
would hope that this wouldn\'t turn into a situation as difficult as
Part 11 has been. So with that in mind, I think the planning and
agreement upon standards throughout the industry ‑‑ the PhRMA companies,
GPHA, CHPA, et cetera ‑‑ and I think you heard from us that at least
some of us have already agreed to talk together, to work together, to
move toward that. So I think we\'re really at that stage rather than the
implementation stage.

MS. GREALEY: I just wanted to reinforce the importance of the data
elements that everyone has touched on here. And we discussed it at
length with technical experts, again representing all the different
sectors of the healthcare industry, that if we can keep it to the NDC,
then we can move ahead and we can move ahead a lot more quickly than if
we do try to do something that includes lot and expiration number
immediately; that right now, that that would so reduce the productivity
of the manufacturers because there doesn\'t really exist equipment that
would allow them to verify and to package at a high rate at their
current rate of speed if you were to require that additional
information.

So it\'s going to be a constant balancing act. How quickly do you want
to move ahead? How costly do you want it to be? How easy do we want it
to be implemented? And how much can we achieve in terms of improving
patient safety by limiting the data elements that would be required?

And I don\'t think we should lose sight of what is already occurring in
the marketplace. The marketplace is driving a lot of this as well. I
think you can help it along, but manufacturers and others are stepping
up because their customers are demanding that they do it.

MS. GREGORY: I think from the blood banking industry, we\'re a little
ahead of everybody else. We\'ve clearly already identified all of the
information that we need to capture. We\'ve even been capturing some of
it under Codabar. The problem is that that\'s an outdated symbology and
we need to move on to something else.

I think for us, the real problem is cost, as everybody has alluded to,
but also competing priorities, because what we will need to do is to
convert all of our software systems that we\'re currently using so that
we can utilize all these elements most effectively.

And the issue is, okay, do we do that? Do we do nucleic acid testing? Do
we computerize donor screening? Exactly which of the safety initiatives
that we\'re working on ‑‑ where does it fall in line? And I think
that\'s really our big issue.

And one of the things is because FDA hasn\'t mandated it, it kind of
falls way down here in comparison to those things that FDA maybe has
already mandated.

MS. CAMMACK: I\'d like to echo a number of the comments that were made
on the panel, but add to that as well on the device side, for many of
our companies ‑‑ I think it\'s 75 percent of the industry are
representative of small companies. And they\'re not going to have the
resources that some of the larger companies have. Maybe they haven\'t
even, you know, entered this arena yet.

So they\'re going to have significant startup costs. So what one company
is doing versus a larger company, per se, they may be able to move on a
faster track. And it\'s hard to come up with one target date for how
implementation would happen.

Or even at a large company level, they may have manufacturing production
lines in different countries. Technology used in one country may not be
the same as used in another to put the code on something. And if
they\'re having to update those or change those, you know, they\'re
going to be doubly challenged to meet the requirements that would be set
forth.

So I think the voluntary process that we have is moving forward, and it
results in some of the best decisions because it allows manufacturers to
add coding when it\'s responsive to customer needs. And often, it can be
done at a time when other labeling changes were done as well, since you
have to consider how this is all going to fit on a label.

MS. MAHONEY: I have a question, Kay, for you. The blood industry, as you
said, has been using barcoding for a while. And I wanted to know whether
you have a sense of how that had resulted in reduced errors, and what
you see if you think ISBT will result in more reduction in errors, and
why.

MS. GREGORY: I think that ISBT will result in reduction of errors on
what we call the manufacturing side or the blood collection side. I\'m
not sure how it will result in reduction of errors on the transfusion
side unless it is tied in to patient identification systems.

We clearly want to go that direction, so that you identify the patient.
You identify the caregiver. You identify the unit. And you notice, there
are a number of elements of information that need to be tracked for a
unit of blood that are somewhat different from what you\'re talking
about on your drugs. For instance, I don\'t think the NDC code would do
anything for us because we can\'t get all of that information in there.

I think one of the big issues may have to do with something else that
Dr. Feigal has talked about, and that is tracking. Because one of the
advantages of ISBT-128 is that there is a unique identifier.

The way things work right now, I might have a blood center, and I use
identification code 12345 as identification of a particular donor.
Someone else may have a collection center, and they\'re also using
12345.

So if I\'m a hospital, I get 12345, and now I have to make sure that I
can track, well, exactly which place sent me this. Well, this is all
built into the ISBT code, so that it can all be barcoded. And I think
the tracking will be much simpler for that reason.

MS. MAHONEY: And then just a question for PhRMA and the generics
industry. I think I heard support for the concept of some sort of
coding. And I don\'t think I heard either of you distinguish between the
prescription drugs versus the OTC.

Do you have a difference of opinion with regard to those products?

DR. JOHNSON: I think PhRMA\'s focus has been on prescription medications
and vaccines. There are some questions about clinical supplies that may
present some special concerns. And we hadn\'t come to a conclusion about
samples, although we heard some comments earlier today. So we did not
focus on OTC products.

MR. BENDE: Yes. We didn\'t really focus on that, either. I mean, we\'re
talking more specifically about prescription drugs. And I would just
like to point out that Bill and I have spoken about this issue, and some
of our members are member companies that we actually share member
companies, a couple of them, you know.

So it\'s an issue that ‑‑ but primarily, GPHA is really more ‑‑ we\'re
more focused on the prescription drugs. But, you know, we haven\'t
really weighed in specifically on the OTC problem. But clearly it\'s of
interest to some of our members.

DR. SOLLER: We were unanimous in our view.

MR. BECKERMAN: I\'ve got a question for AdvaMed. Recognizing the
diversity of medical device manufacturers and knowing that you represent
a very broad range of them, does AdvaMed have a position on combination
devices, things that incorporate both drugs and devices?

MS. CAMMACK: Well, I think we\'d have to follow how those are regulated
by the Agency.

MR. BECKERMAN: And I guess, sort of to follow up, a related question.
There was some discussion this morning about stratifying medical devices
dealing with different classes of devices in different ways. I wanted to
see if you would address that, whether you view that as a workable
solution.

MS. CAMMACK: I think that\'s an excellent place to start when we talk
more with stakeholders. And probably the best way to begin stratifying
that is to go back to where are most medical errors occurring and what
role do medical devices play in those errors then and is there a way
then that barcoding could ‑‑ or auto-identification could reduce those
opportunities.

MS. DOTZEL: I just have one last question. This morning we heard a lot,
I think, from the health professional panel ‑‑ a lot of, hurry up, FDA.
We\'re waiting for you to do this. You should have done this. You know,
get moving. Let\'s get this out there. And this afternoon, I think
we\'re hearing a little bit more of, whoa, slow down. Create a task
force. Study this a little bit more.

Obviously, in a perfect world, we would be able to, you know, bring in
every piece of information that\'s out there before we made any
regulatory decision. Obviously, if we waited for all that, we\'d never
make a regulatory decision.

And so just your comments on how we kind of balance the need for getting
as much information as we possibly can before making a decision on where
to go on this rule, with the need to actually do something to address
the problems that we\'re trying to address.

MS. GREALEY: I was struck by reading the statements and listening this
morning: I think there is much more consensus here than perhaps was
apparent to you. They weren\'t saying, try to do everything all at once.

I think they recognized a lot of what you heard here this afternoon:
NDC. Linear symbology. It\'s something that is much more widespread. We
could do it now. Let\'s try and accomplish that.

And then, yes, you do need to bring in the stakeholders for some of
these other issues that I think everyone on both panels sort of
admitted: You know, we\'re not quite sure how we could do it on smaller
vials, ampules, those sorts of things. How do we work in lot and
expiration number?

I think everyone has had more time since the initial notice had been
produced to really look into this, bring their technical experts in. But
I think there is a lot of consensus around there are some things that we
could do in the near time. And then, yes, let\'s be firm about
establishing a timeline for accomplishing the others, not let it go by
the wayside.

DR. BENDE: I think I would tend to agree with that. But I think it
doesn\'t benefit anyone to move forward too quickly when we hear our
friends from the hospital association say, for example, that ‑‑ you
know, I don\'t think they want to have to juggle six different kinds of
scanners because there are six different kinds of technologies that
people could use to code product.

So we really have to start there and say, can we standardize in some
way? Can we make this as streamlined as possible to benefit the
manufacturers as well, so that there\'s one ‑‑ you know, there\'s one
standard data readout, and give the hospitals and the end users ballpark
what they have to ‑‑ you know, ballpark a little bit better so they can
predict what their users are going to need and they\'ll have to purchase
for them.

So I would even say that just the NDC number probably isn\'t just
something we could do, you know, in a couple of months or something like
that because there is no standard. I mean, what kind of data ‑‑ we heard
ideas from Dr. Combes, I believe, about how this could read into a ‑‑
this is part of a data issue.

So what database, what formats is this going to be going into? Can the
hospitals and all the providers agree on a format that it reads into, so
that we can get this settled at the beginning, and then we don\'t have
manufacturers having to make changes, you know, in six months for NDC
numbers and then in two years for everything else, and they wind up
having to implement multiple systems.

So I think to do this right for patients, even, it needs to be thought
out beforehand, before we even say, well, let\'s do NDC numbers and
worry about everything else. I think we need to start from the beginning
and really map this out.

MS. CAMMACK: I think for the device industry, we see ourselves as being
a very distinct position from drugs and biologics, so much so that I
think, when you look at how coding can help improve patient safety, it
seems to be a lot more obvious on the drugs and biologics side than it
is on the device side.

And we feel that there could be some inadvertent or unintended
consequences if medical devices were at this time hurried up or rushed
into a bill that is really more appropriately addressing drugs and
biologics.

I think the kind of discussion that\'s happened today, we could have a
full day ‑‑ a week-long meeting alone just on devices. I think there are
some unique issues there that have to be teased out on a
product-by-product category basis.

And to suggest that this is ‑‑ the time is right to include devices in
this forthcoming rule with drugs and biologics, we just think that
that\'s a premature decision. And we may not reap the intended benefits
if we progress at that pace.

DR. SOLLER: From CHPA\'s standpoint, I think the meeting has been very
helpful in terms of enhancing awareness, and certainly in terms of a
coalition of expertise within the industry and beginning that process. I
think that is a positive outcome of scheduling this meeting, and
clearly, the definition of the issues and where the various stakeholders
are in terms of their staked-out positions, in a sense.

My view is that there is ‑‑ you know, in the discussions to date here,
that there is a pretty good consensus of what the end game here is. And
I like the terminology that Tess brought in here of automated
identification because it implies the need for flexibility and it
implies the need to be aware of technological advances.

So therefore, scope and extent become very important issues. I\'m not
telling you anything you don\'t already know. But probably here an
incremental advance is probably best. It allows a measured business
response. It allows the advance of technology. And it most certainly
allows the evolving market forces to push all of that along and push it
on a lot faster.

MS. GREGORY: I would just like to caution about the dangers of
inactivity and not doing anything. I think that that\'s what happened to
the blood bank industry, is that, you know, we\'ve been kind of going
along and we\'ve identified this and we\'ve identified that, you know.

But we haven\'t really laid out a clear road map, and particularly FDA
hasn\'t laid out clear road map, of we really want you to do this. So
consequently, we just sort of keep on, and everybody says to me, well,
maybe there will be something better down the road that we should adopt,
so let\'s wait a little while. And consequently, we\'re still using a
barcode from the 1980s, and you can imagine ‑‑ you know, if you were
using anything else from the 1980s, you can imagine how things have
advanced since then.

So I think the idea of planning and figuring out what you want to do is
very important. But I think having a road map and some sort of target
dates is equally important.

DR. SOLLER: Could I make one comment here? And this is with sincere, all
due respect to the representative from the blood supply industry. And
I\'ve benefitted from that.

But we heard of a barcode in the 1980s being applied in this comment
just now. And I think that\'s a perspective here. To look on one
industry that has done a great job, worked decades to get a process that
is pretty close to being in place is a lesson relative to other
industries that might be affected by barcoding, and how fast you move,
and whether you move to expect a full system or whether you move
incrementally, as I mentioned earlier, to allow market forces in this
American industry to do some good as well.

DR. JOHNSON: I would certainly repeat many of the things I\'ve heard. I
think we would all urge action as quickly as possible. But I hope that
we\'ve also expressed that there are things that can be done in the
nearer term, and things that there need to be more discussion before a
reasonable timeline could be agreed upon.

So, you know, that\'s probably as clear as we can be. We could say we
would like to have serial number identification on every unit, but
that\'s not very feasible.

MS. GIESER: Have any of your members provided you any information about
ballpark cost estimates, assuming the simpler case of some unique
identifying number being placed on the product?

And I know you\'ve mentioned a couple of conditions where the costs
become quite high, such as verification or high-speed production and
certain package sizes. If you can elaborate in any way on issues of
cost, we\'d appreciate it.

DR. JOHNSON: Are you talking about situations where it would be NDC
number only?

MS. GIESER: Just to start with the simple case.

DR. JOHNSON: I can tell you, because Abbott Laboratories did make a
public announcement about this yesterday, so for injectables, we\'re
actively working on implementing barcodes. And we are absorbing those
costs. So we\'re not changing the cost of any of our products.

So again, that also feeds into timing. If you do it as a phase-in, it\'s
going to have less of a cost impact. If you require changing all of your
labels in a very short period of time, costs can be quite dramatic.

But there are always label changes going on. It\'s how many more are you
trying to do in a certain period of time?

DR. SOLLER: My experience in doing economic estimates with our members
is that it\'s probably always best to wait till the comment period. Then
you know the numbers are there and not provide numbers that may change
over time. So undoubtedly, as you\'re asking this, various groups will
be looking at that particular issue.

But just a comment, and that is that as a company might move forward and
essentially represent the prototype and be willing to absorb costs, I
can tell you from looking at all different size companies that that is
not necessarily how the production world works, and that ultimately it
is transferred out.

We don\'t have specific figures for that, but I think that would be true
as well for an institution that might use a repackager, that the end
user and the end benefit of that repackaging process is the patient in
the institution as it would relate to an OTC, for example.

And if that were passed on in that context for whatever the nominal cost
would be, spread out over a large purchase, again, it\'s targeted
towards the end user, the end benefitter, of that particular
repackaging, as opposed to across the entire gamut of the industry where
a large part of our end user would not benefit necessarily from that.

MS. CAMMACK: And none of our members have provided cost estimates to us
at this time. I do know that there are some members that are preparing
written responses to FDA as a result of the Federal Register questions,
and you should be getting those within the time period.

But I would caution, too, even those that are able to provide cost
estimates, when they do it on a product-category-by-product-category
basis, what one company may experience or anticipate for costs may be
very different from another company putting codes on those very same
products.

It has to do with the way their particular production line is run, their
volume, and where they\'re located. So there is extreme diversity, not
only throughout the industry because of the diversity of the device
products, but also because of the company size. So you\'ll see it from
product to product.

MS. GREALEY: And I think it\'s been made clear that you really need to
draw the distinction between a more simple versus a more complex data
requirement, especially what it could do in terms of reducing the speed
of manufacturing and the production line.

So that definitely would be a much more significant cost. And again,
I\'m not even sure that the technology is available to do it in a
high-speed way if you were willing to make the investment to do that.

MR. BECKERMAN: Just quickly, I was wondering whether any of the industry
groups have data on hand about what percentage of products are currently
packaged in individual unit dose packages. Or, I guess, a related
question: What percentage of products, in a big macro view, are sent to
repackagers?

And if you don\'t have that sort of information readily at hand, I\'d
encourage you to submit it to the docket.

MS. GREALEY: The one statistic we can provide is, I think, right now 35
percent of the pharmaceutical products are at the unit dose level.

MS. DOTZEL: Okay. I\'m afraid we\'re not going to have time to take
questions from the audience for this panel. What I\'d ask the panel
members to do is if you could, you know, take seats up front, and then
at the end of our next session, if we have additional time, we\'ll give
people the opportunity to ask those questions.

We\'re going to take a break now. People who have registered to speak
this afternoon, if you could during the break please see Mary Gross.
Mary, if you would stand up so people who could see who you are. And she
will try to get things organized so that we can move through this
afternoon, the second part of this afternoon, quickly so that everyone
will have sufficient time to speak.

We\'ll reconvene in ten minutes.

(A brief recess was taken.)

MS. DOTZEL: I\'d like to ask everyone to start taking their seats so we
can get started.

Okay. We\'re going to get started. First I\'d like to introduce one new
member to the FDA panel. Dr. Galson had to leave, and we\'re delighted
to have Paul Seligman here. He\'s the director in our Office of
Pharmacoepidemiology and Statistical Science in the Center for Drugs.

This afternoon, for the second part of the afternoon, we are going to
hear from speakers who have registered to present their views. The way
we\'re going to try to work this is we are going to ask ‑‑ we are going
to have people come up to the stage, six at a time. We think it will be
easier for you to hear them if they\'re sitting up here than standing
down at the mikes. And so we\'re going to work it so that we come up to
the stage six at a time.

I\'m going to ask the speakers to use the microphones that are provided
at the table. You\'ll have to switch out there, probably two per
microphone. Clearly state your name so that we have that for the record.
And I\'ll let you go down the line, and then we\'ll bring up the next
panel.

We\'ll hold all questions until the end to see that we have time to do
it. And if time permits, we\'ll provide an opportunity, first, for the
FDA panel to ask some questions of this afternoon\'s speakers, and then
if we have even more time than we anticipate, we\'ll be able to turn to
the audience.

So with that, I\'m going to take a seat, and we\'ll start ‑‑ oh, one
other thing is, for the speakers, I\'ve turned the timer here so ‑‑ the
lights aren\'t on now, but you should be able to see the lights. And it
will give you, again, the yellow ‑‑ it will turn yellow when you have a
minute left so that you can kind of have a warning that time is running
close.

And again, I\'m going to try to keep things moving so that everyone who
is registered to speak will have an opportunity to speak.

MR. DUNEHEW: Thank you. My name is Allen Dunehew. I am the vice
president of pharmacy at AmeriNet GPOs, located in St. Louis. I\'d like
to thank the FDA for the opportunity to come and participate in this
event.

It was an interesting discussion this morning and this afternoon.
Obviously, varying opinions between the morning and the afternoon, but
you can probably understand where those come from based upon the
constituencies that each represents.

In terms of GPOs, we represent providers who provide direct care. So I
think it\'s important we have large numbers of members, essentially in
all practice settings, whether that be physician offices, other
non-acute surgery centers, hospitals, whatever.

At AmeriNet specifically, we\'ve just gone through a competitive bid
process, so I do have some updated information to provide you in terms
of the number of products that are available in a barcode fashion.

And we do have that data by NDC number, actually, either available today
or will be by the end of next year. And I could share that at a later
date. We required manufacturers to respond to our bid with an indication
of whether or not those products are barcoded or not.

To get into some general comments, I think it\'s important to understand
when we start to consider regulation, and actually this afternoon\'s
discussion with the panel probably explains why we\'re here at this
point in terms of regulation, because we don\'t have a uniform system
yet and wide availability of products yet.

There were some discussions about what comes first. It\'s kind of like
the chicken or the egg. If the hospitals are not going to invest money
into expensive systems if the products aren\'t there, and they can\'t
afford to do that themselves, the other side of it is true that there
has to be products ‑‑ there has to be a market for those.

And it\'s interesting that some of our members even indicated that they
would be willing to pay a slight upcharge for that availability because
they recognize the significant savings and the improvement in patient
care that can come as a result of that.

Some of the discussion about device versus medication, NDC versus lot
number and expiration date, meds used at the bedside versus those that
aren\'t used at the bedside, I would just encourage you to take into
consideration we are here primarily because of patient safety.

And so when you think about a long-term implementation of barcoding and
wait until a complete barcode system is together with lot number and
expiration date, I think we have to think about the patient impact of
that, and those patients that are going to die in the meantime who could
possibly have preventable medication errors just simply by recognition
of an NDC number.

So when we think about timelines and we start to get out to two years
and three years and five years, I think it\'s pretty obvious and
there\'s very good data about the number of medication errors. Many of
those are wrong drug, wrong dose. We know about some that have been
highly publicized. Many of those could be prevented with the system. So
I\'d like to have you take that into consideration.

Also, it\'s true that the availability of barcoding is rapidly changing.
So as well as the utilization of systems within hospitals that can
recognize that information, the \'99 study by ASHP ‑‑ and I think they
said that they\'re going to have some new information in a couple
months ‑‑ I suspect that that will be very different.

But when you think about those who can scan at the bedside, you have to
think about the availability of the medications to scan. One of our
members in North Dakota is well along this way, but they put a lot of
investment to repackage everything that doesn\'t come in. Many hospitals
can\'t do that or don\'t want to do that, so they wait for it to be
available.

In terms of priority for products, I think it\'s important, and I
personally don\'t see any distinction between NDC ‑‑ or between
over-the-counter, rather, and prescription items. I think both of those
are important.

I think it\'s important to understand, from a safety process standpoint,
the nurse at the bedside needs to work with one system, not a manual
system for OTC meds and another system for prescription meds, because
you introduce more potential for med errors and it could be worse than
what we started with.

But when we focus on ‑‑ and this primarily also goes to the
manufacturers ‑‑ think about the types of medications that are used at
the bedside. When you look at products to barcode, it\'s not those with
the highest sales dollars nor those that cost the most. It\'s those that
are administered at the bedside where there could be a benefit from
barcoding and recognition at the bedside.

Unit dose medications, ampules, vials, those kinds of things, certainly
not bulk vials that stay in the pharmacy. There may be some barcoding
application, but again, if you think about the greatest return on
investment, that\'s going to come from the bedside aspect of that.
Topical tubes, medications that are dispensed in eyedroppers, and
whatnot.

And it\'s interesting to note, with the RSS technology today, that the
barcode scanner ‑‑ the barcode symbol is now capable of being put an
ampule as small as 2 mls and not compromise the label. So the technology
is there. Abbott is one of the leaders, and I\'ve got some other
companies that are far along in that stage. But Abbott has put some
effort into that as well.

MR. ROBERTS: Good afternoon. I\'m John Roberts. I\'m the director of
healthcare for the Uniform Code Council. We\'re the largest standards
body in the world. I\'d like to thank the Food and Drug Administration
for this opportunity to talk about patient safety.

The proposed rule to mandate barcoding at the unit dose level is
essential to improving the quality of patient care. Medication errors
are deadly and costly, and can have a devastating impact on the
healthcare industry.

Rather than ask the FDA to select a single symbology, such as
reduced-space symbology or composite symbology, I instead ask you to
endorse the EAN/UCC system for the barcoding of all healthcare products
in the United States, and let the marketplace decide what symbol goes on
what package, and uses our data structure. Our data structure already
encodes NDC, lot number, expiration date, serial number, and a hundred
other different data structures.

Barcoding of all healthcare products down to the unit dose has been a
goal of the EAN/UCC system. The Uniform Code Council and EAN
International developed the reduced space symbology and composite
symbology specifically to address this need.

Manufacturers, healthcare providers, and leading industry groups have
been working with us for the past five years to develop a solution that
brings greater automation accuracy and information detail to small
healthcare products.

What is important to note is the reduced space symbology and composite
symbology are just the latest tools of this system. The EAN system is
used by nearly a million companies conducting business in 140 countries
around the world. These standards for product identification and
electronic communication allow companies to bring greater accuracy and
efficiency to products and the corresponding flow of information.

The EAN/UCC system is used by 23 major industries worldwide and provides
a global language for companies to identify products, assets, shipping
containers, and locations throughout the supply chain. This system has a
strong presence in the healthcare industry.

Nearly 10 percent of the Uniform Code Council\'s membership comes from
healthcare. That\'s 18,000 of our 260,000 members in North America
alone, including manufacturers, retailers, distributors, and healthcare
providers.

The overwhelming majority of all products purchased by hospitals utilize
the EAN/UCC system, whether it is linens, cleaning supplies,
medical/surgical products, food, pharmaceutical products, beds, or even
flowers, everything a hospital purchases is encoded with our system of
barcodes and standard structures.

Wherever the healthcare industry has a presence in the hospital and
drugstores or grocery stores or any retail store selling
over-the-counter products, the EAN system is at work. For nearly
30 years, the Uniform Council has provided barcode innovations and has
benefitted consumers and industry alike.

By selecting RSS and CS, the healthcare industry will be able to utilize
their existing investment in the EAN/UCC system because it uses the same
data structure as the other symbols. This will cause the least
disruption to the healthcare supply chain. It will also allow the
industry to implement the FDA mandate faster. Radical system upgrades
will not be an issue, so the industry can quickly respond and address
the need to reduce medical errors.

As a part of the EAN/UCC system, RSS and composite symbology are
globally recognized standards. There was a question before about
question before about what the Europeans are doing for medication
errors. They are very concerned about them because I have e‑mails with
them back and forth. The Japanese right now, their parliament is looking
into this right now and they\'re in session right now.

For medical/surgical items, there is a standard out there. In 1999, the
Japanese healthcare industry mandated barcoding on medical/surgical
products, to include G-10, lot number, expiration date, and quantity. It
took place in 2001. So the Japanese have done this already.

Universal guidelines of our system have been established for the
placement of symbols, density, and texture, and ANSI grade of the symbol
for commercial use. These guidelines could be modified by industry
consensus, and have been.

RSS and composite can be printed, scanned, and verified by readily
available commercial equipment. Two of the leading scanner
manufacturers, Symbol and HHP, tell us that there are an estimated two
million scanners in the commercial marketplace today that can read RSS
or composite.

The UCC knows of at least two major pharmaceutical firms that are now
labeling or about to label their products with RSS and composite
symbology for commercial distribution.

It is also important to note that UCC is a neutral, not-for-profit
standards organization. The Council does not sell barcodes, software,
scanners, or a proprietary solution. There is no vested interest in
promoting RSS and composite to the FDA today.

Our system is open and voluntary. The patents for RSS and composite,
like all our standards, have been placed in the public domain, freely
available to any company that wishes to use them. The reason the EAN/UCC
system is globally successful is that any company in any industry
anywhere in the world can use our barcode and electronic standards and
dramatically improve the accuracy, speed, and efficiency of their
business.

Accuracy is essential to reducing medication errors, and one of the
important benefits of RSS and composite is that the healthcare industry
will be able to utilize their existing supply chain infrastructures for
the use of the system.

In closing, we believe the FDA should pick a system that improves
patient safety, not just a particular barcode. I am confident the UCC
and the EAN/UCC system can provide tools and global strength to help the
FDA improve the quality and safety of patient care in the United States.
Thank you.

MS. DOTZEL: Thank you. Again, I\'m going to just urge the speakers to
please pay attention to the timer over here.

MR. TERWILLIGER: My name is John Terwilliger, also with the Uniform Code
Council. I am responsible for directing our various activities across
those 23 sectors.

I would like to thank the Food and Drug Administration for the
opportunity to speak this afternoon about patient safety and medication
errors. This is an issue that the Uniform Code Council takes very
seriously, and we have been working with members of the healthcare
industry ‑‑ pharmaceutical manufacturers, drugstore retailers,
medical/surgical product companies, and healthcare providers ‑‑ to
important a solution to address this problem. The Uniform Code Council
has been at this for about eight years in this whole area of improving
patient safety.

As John just mentioned, patient safety cannot be fully solved by simply
selecting a barcode. The Uniform Code Council strongly believes that the
best way to solve the problem of medication errors is to select not a
symbology but a system. And the system that provides best performance,
global acceptance, and greatest visibility is the EAN/UCC system.

This system provides the strength the FDA needs to enable quick response
to reducing patient medication errors. For almost 30 years, our barcodes
and electronic commerce standards have been used in healthcare for both
retail and non-retail applications. Our system of standards is widely
established in healthcare and adjacent industries, which will allow your
mandate to be quickly and effectively implemented.

The system is global and will allow pharmaceutical companies to use a
single barcode system to uniquely identify their products anywhere in
the world, whether they be retail or non-retail. And a strong consumer
focus has always been at the heart of our system. It\'s always about the
end user, when you get down to it.

A PriceWaterhouse Coopers study that we had done stated that the UPC
alone in the U.S. grocery industry has saved American consumers
approximately \$17 billion annually, which has enabled greater accuracy,
lower food prices, and consumer convenience. This is something that has
all happened, and we don\'t even think much about it. But there\'s been
a lot of money saved.

It is because of this track record of performance that the FDA can
select the EAN/UCC system with confidence. Reduced space symbology and
composite symbology have been specifically developed by the Uniform Code
Council and the members of the healthcare industry to improve patient
safety by improving identification accuracy at the unit dose level and
all other levels of packaging.

The EAN/UCC system has had the NDC embedded into it, into the global
trade item number, for more than 25 years. The very genesis of this
system was to make sure that the NDC number could be incorporated
directly.

I\'d like to make a few points regarding the FDA\'s proposed rulemaking
and how the EAN/UCC system meets the proposed requirements and provides
the greatest performance.

First, this system is the de facto standard in the over-the-counter
retail market, both domestically and in 140 countries around the world.
While NDC identification is important, this requirement would be
unnecessary in the over-the-counter segment because healthcare
manufacturers and drug retailers are already using barcode standards,
the global trade item number, or UPC, more simply, to accurately,
uniquely, and globally identify OTC products. Mandating the NDC for OTC
products would add costs to healthcare and provide no benefit. These
products are already uniquely identified per standard. There is no
reason to pick another one.

Second, the EAN/UCC system\'s strength and flexibility eliminates the
need for a new NDC at every level of packaging. This has been a concern
some have mentioned. It\'s important to know that per the standard, a
manufacturer can change the indicator digit which will reflect the
particular packaging level, whether it\'s the unit dose, an intermediate
carton, a case, or maybe a whole pallet of product, without changing the
NDC number. This will eliminate costly and unnecessary processes that
add no value to the quality of patient care.

And the third point is that the EAN/UCC system already accommodates
secondary information such as lot number and expiration date uniquely.
That\'s very important. We have a way to uniquely identify those. Plus
we can include other information such as serial number, if you begin to
think about things like devices where the serial number is actually
used. We have a way to uniquely identify serial numbers also.

Reduced space symbology and composite symbology can incorporate this
secondary information to facilitate accurate recalls, enhance inventory
controls, and improve drug traceability. It is important to add that
secondary information can be carried in the composite symbol over the
barcode symbologies of the EAN/UCC system.

The UCC is working not only with the healthcare industry, but leaders of
many industries, to use this system to improve identification and
traceability throughout the global supply chain. In this post-September
11th world, these enhancements will provide immeasurable contributions
to public confidence and the safety of our medicines, food, and everyday
essentials.

With the EAN/UCC system, improved medication accuracy can be achieved.
Most importantly, the healthcare industry would be better positioned to
deliver an even higher quality of patient care. Thank you.

MR. PATTERSON: I am Bert Patterson. I\'m a pharmacist, and I\'m also the
vice president of contracting for Premier.

On behalf of the more than 1600 leading not-for-profit hospitals and
health systems allied with Premier, I thank the Food and Drug
Administration for holding this important meeting on health industry
adoption of barcode.

For health providers, purchasers, and suppliers nationwide, tapping the
potential of new and emergent technology is an integral component of
strategic thinking, planning, and execution. Health industry observers
herald the potential of technology to promote quality of care
improvement and great cost efficiency through a merger of private sector
initiatives and public policy.

Premier strongly supports the adoption via FDA regulation of an
electronically readable uniform health industry data standard
incorporating the universal product number, UPN, displayed at every
level of drug, device, and biological packaging for the transmission via
barcode technology into hospital and vendor information systems. We
applaud the FDA\'s efforts to solicit industry insight and input into
the components necessary for successful regulation.

UPN implementation and the use of electronically readable identification
has vast potential for improving healthcare safety and quality,
facilitating clinical product and service, innovation, and enhancing
cost efficiency at the supply chain level.

The requisite barcode technology exists today. It is widely used, and
with documented success in countless other industries, the retail sector
perhaps being the most familiar. Premier as a company will require the
inclusion of barcodes on all prescription products that are put under
contract at Premier as of July 1, \'03.

Implementation within healthcare has been far less extensive of this
technology, particularly at the unit of use level. I must underscore
that the failure of our health systems to enhance the technology and the
UPN does not imply reticence on the part of our hospitals. Hospitals, in
fact, are eager to develop and deploy this kind of technology to improve
the quality of care they provide and to achieve economic efficiencies
throughout the supply chain.

In this regard, I wish to focus on three important areas in which the
UPN and electronically readable identification as an essential e-health
initiative can achieve sustainable improvements in patient health and
safety.

The UPN and barcoding have vast potential to facilitate sustained
quality improvement and medical error reduction, generate industry-wide
cost savings and efficiencies, and enhance knowledge transfer and
engender quality improvement through the use of comparative data.

While the causes of medical errors and other adverse events are complex,
system-based, and deeply rooted, the most immediate and far-reaching
remedies lie in the implementation of technology.

As numerous interdisciplinary studies have documented, patient safety
will be improved, sustained, and reinforced beginning at the supply
chain through industry adoption of a standardized system of
machine-readable coding on all medication packages and medical devices.

Technology advances over the last few decades permit data of
ever-increasing complexity to be embedded within barcodes, making
possible the coding of increasingly smaller and varied drug and device
packaging. The technology is out there. It can be done.

In addition to this potential for improving patient safety, UPN
implementation can generate significant cost savings and efficiencies
across the supply chain. Unlike pharmaceuticals, to which unique
National Drug Code numbers are assigned, medical and surgical supplies
and devices have no such standardized identification. Clearly, this
renders web-enabled linkage of information systems, even for the
purposes of comparison, anything but seamless.

Federal regulation and support of a standardized system for
identification for medical and surgical supplies would greatly
facilitate industry compliance and broad-based implementation of these
technologies.

The 1996 EHCR report predicted that UPN implementation would yield an
annual savings of 11.6 billion in healthcare supply chain costs. These
projected savings are based on the automation of transactions and the
integration of a frictionless data stream from point of manufacturer to
point of use. EHCR projects that upon standardization adoption of the
UPN across the healthcare supply chain, investments in automated
transactions would likely bring the highest returns.

Finally, UPN implementation holds great promise for knowledge transfer
and quality improvement through the analysis and subsequent application
of comparative data. Prospective Premier signature healthcare
informatics product is the most complete cost-based test-level clinical
and financial data warehouse in the country, permitting peer group
comparison at the level of resource consumption. In a nutshell, this
would enable us to provide an apples-to-apples comparison of hospitals\'
clinical experience on multiple levels.

In conclusion, Premier believes that adoption of an industry standard
and requirement of machine-readable identification is a critical
e-health initiative with the potential to yield significant progress in
patient safety, quality improvement, and cost efficiency.

On behalf of Premier, its hospitals and alternate care facilities\'
patients, I appreciate having this opportunity to attest the potential
of technology to reduce the occurrence of medical misadventures,
including medication errors, and to positively impact development of
e-health and the future of the industry. Thank you.

MS. DOTZEL: Thank you.

MR. O\'BRIEN: Good afternoon, ladies and gentlemen. I\'m Terry O\'Brien,
president and founder of Meds Alert USA, Incorporated.

Why not read barcodes in the home? Isn\'t that where most of the
medication errors occur? Would it surprise you to know that barcodes can
be read in the home today?

As we all know, barcodes are being targeted as a way to reduce
medication errors and increase productivity of the healthcare delivery
system. We\'ve begun work with the University of Tennessee to that end.
We are seeking a strategic partner, and what a better one than the FDA.

Meds Alert systems will save lives and save money, 6- to \$800 million a
year in Medicaid housing costs only if the Meds Alert barcoded system
were used in Illinois. This is according to Governor Ryan of Illinois,
and the Director of Aging, Margo Schreiber. It would keep people out of
nursing homes for mixing up their medications. A recent study has said
that we are spending \$177 billion a year to correct medication errors.

Meds Alert has developed and patented a system to bring the use of
barcoded medicine, caregivers, supplies, and equipment into the
patient\'s home or the patient\'s institutional setting. Meds Alert was
granted patents by the U.S. Patent Office within six months because,
under patent law, if it would help a cancer or an AIDS patient, they
would put it at the top of the list. We received both patents.

We also have international patent rights for most of the industrialized
world. Meds Alert communications links are wire telephone, cable TV,
wireless, and cell phones. Meds Alert raises prosecution compliance by
signaling the patient in any language to take their medication.

We verify by having them read the ‑‑ pass the prescription vial in front
of a barcode reader that they have the correct medication. If they
don\'t, we tell them not to take it. If they insist on that, we sound an
alarm for noncompliance and send over a caregiver or call 911. We also
provide a safe home environment for these people.

Good care is compromised by patient noncompliance. Illiterate or those
with low health literacy have trouble reading prescription labels and
medical forms. Barcodes offer a solution. Noncompliance often leads to
emergency room visits or institutionalization. The average cost for a
nursing home today is approximately \$50,000 a year.

Additionally, the Kaiser Foundation on May 2nd just released a study
where 4,000 women were studied and found that 21 percent did not even
fill their prescription. Meds Alert has a system for that, too. We call
it rescribe.

According to Kiplinger, the newsletter of 6/14, people with chronic
diseases are only 20 percent of those insured but make up 80 percent of
the healthcare cost. Chronic disease management is the one area sure to
reduce healthcare cost.

In a Time Magazine article, Dr. Victor Villagra, president of the
Disease Management Association and an executive of CIGNA, has 600,000
members enrolled in a chronic care program for diabetics. He has seen a
cost savings of 14 percent.

But he said, and I quote, \"This is no longer sufficient. What is,
apparently, is having someone tell you to take your medication or
else.\" And I\'m wondering if Medicare or Medicaid may be headed in this
direction.

Meds Alert reminds someone to take their medication and records the
event. Who are the chronically ill? There are patients who suffer from
heart disease, diabetes, asthma, AIDS, cancer, and as yet uncounted, I
believe, the two million plus organ transplant recipients. And I\'m
wondering if cognitive impairment is counted as that as well.

The coming tidal wave of baby boomers will make up 26 percent of the
population by 2010, and along with them come the chronic diseases and
cognitive impairment. Another serious condition that they bring with
them is depression.

There are shortages in all areas of healthcare. Caregivers: Daughters
primarily provided most home health care, but now most work. Nurses:
It\'s estimated that over 60 percent of them are 40 years old, and we
need replacements. According to Dean Gorley at the University of
Tennessee, there are 10,000 pharmacy jobs with no one to fill them.

Low wages are another problem. The average paid caregiver, according to
a Chicago Tribune article, says that the average caregiver in Illinois
makes \$18,000 a year. That\'s not enough to pay for an apartment or for
food.

The only way to handle the overwhelming problem is automation, barcoded
unit dose packaging. Senator Kennedy is on record, and others, that they
will introduce litigation this year to reduce healthcare costs by
mandating they use automation. Barcodes must be part of that technology
automation.

The national barcode standard: How close is it? After today, I see that
we\'re working on it and still working on it. But I know that the
Uniform Code Council, Health and Human Services, the U.S. Pharmacopeia,
and NCCMERP, as well as U.S. drug manufacturers, should want a standard.

Meds Alert stands ready with its patented technology to address unit
dose packaging. We have a demonstration unit completed, and we welcome
discussion with other entities. Our patents allow for migration and
expansion. And I thank you for your interest.

MS. DOTZEL: Thank you.

MR. SIM: Good afternoon. My name is Mike Sim. I\'m the chief executive
officer of ADVIAS, which is a Virginia-based company specializing in
advanced information assurance solutions. We do biometrics in a barcode.

You will detect from my accent that I\'m not from the U.S. In fact,
I\'ve lived most of my life in the U.K., having only been here since
September. Questions were asked this morning, what\'s happening in
Europe in healthcare? I think I probably know the answer, having spent
25 to 30 years of my life in healthcare in the U.K.: Very little.

Most of the effort, particularly on barcoding, I think was undertaken by
myself. I spent two years canvassing to get barcoding used in drug
prescriptions for general practice. At the end of that two years, the
government was very encouraged, and they said, this has gone almost to
the top of the list. This is the second option now. I asked, what\'s the
first option? And they said, no change. And I think there was a very
response this morning.

Okay. What\'s a Brit doing here in the U.S.? Basically, I\'ve spent the
last six years, having come into the drug industry and a nurse by
profession, looking at ways to secure drug delivery. I\'ve been saddened
today hearing some of the responses here about barcoding and how far the
technology actually goes because I believe it goes a lot further.

We have been very forward-thinking in the U.K., and in fact we have a
number of systems already running, and running quite well. I won\'t go
over all the problems in the system here in the U.S., or anywhere,
really, because those have been covered today, and I think we\'re all
very aware that the wrong patients get the wrong drugs. And even with
the most sophisticated pharmacy systems, the wrong drug can get taken
off the shelf, and once the label is applied, we all know the
consequences.

But I think it\'s also very important to look at ‑‑ there have been a
number of points today about, you know, do we need to really put
additional barcoding on the cover for manufacturer expiry dates. Well, I
think we do because the problem is ‑‑ the question was asked, how many
incidents are there of adverse effects to drugs that have run out of
date or drugs which have manufacturing problems? We don\'t know the
answers because we have no way of tracking the drugs.

The system today is, if a drug manufacturer finds a problem in their
stock, they\'ll send out a letter to their wholesalers, and the
wholesaler will write to the hospitals, and they\'ll write to doctors,
and they\'ll write to nursing homes, and there\'s a cascade of letters
that go out. But there is no way of tracking those drugs.

Nor is there any way of correlating the effects that have occurred with
those drugs. And in fact, it will probably need some real clinical
evidence to actually show that there is an effect when these drugs are
out there.

And the U.K. is exactly the same for that. They haven\'t done anything
better, and I don\'t think the whole of Europe. I hear that the Japanese
are moving forward, and I\'m not at all surprised.

Given that we\'ve got this problem with identifying patients and
supplying medication, we also have to look at what\'s the common link in
the supply chain? Well, the common link is the barcode. It is coming
through. Manufacturers increasingly now are marking their drugs with
barcodes; sadly, not all of them. I think in the U.K. we\'ve got a much
higher proportion than you\'ve got.

But even if the original pack comes in in a barcode format, perhaps to
the barcode format with manufacturer date, expiry date, et cetera, it\'s
then possible, if they have to repackage, to actually copy that through
the process.

My company has been looking primarily at all the barcodes that are
available today, and there are quite a range of barcodes. Now, this
morning I heard talk of should we in fact be having a single barcode
that refers ‑‑ that\'s a reference?

Well, unfortunately, not all care is in hospital. A lot of care may be
in hospital. A lot of care may be in outpatients. But a lot of care may
be at the roadside. I mean, it may be the paramedics delivering drugs.
It may be doctors going out and visiting people in hospitals.

And we need to be able to access that information from those drugs
wherever we treat them. And I believe the only way to do that is to put
a 2D barcode on those drugs so that you can actually use equipment. We
don\'t have the luxury of radio connectivity when we\'re in a patient\'s
home or when we\'re lying on the roadside.

The 2D barcodes that we\'ve primarily worked with is PDF-417, which was
developed by Symbol Technologies. The vast majority of you, if you take
your driving license out, you\'ll find it on the back of your license,
or military, on the back of your ID. It\'s a tried and tested product
that reads ‑‑ sorry.

MS. DOTZEL: Thank you.

MR. WENIGER: My name is Bruce G. Weniger. I\'m the assistant chief for
vaccine development at the Vaccine Safety and Development Branch of the
National Immunization Program at the Centers for Disease Control and
Prevention in Atlanta. I thank the Food and Drug Administration for this
opportunity to comment on the issue of mandating identifying barcodes on
primary pharmaceutical packaging.

For the past several years, I have coordinated the Vaccine
Identification Standards Initiative, known as VISI, or V-I-S-I, which is
a collaborative effort by a variety of public health agencies and
private organizations and groups involved in the practice of
immunization, including medical and nursing associations and the vaccine
industry itself. Full information about VISI and its recommendations are
available at our website, www.cdc.gov/nip/visi.

The purpose of VISI is to establish voluntary uniform guidelines for
packaging and labeling of vaccines and the recording of their
identifying information. The goal is to improve the accuracy and
convenience of transferring vaccine identifying information into medical
records and immunization registries, and thus to enhance the monitoring
of immunization programs and their surveillance for adverse events
following vaccination.

The National Childhood Vaccine Injury Act of 1986 mandates that all
persons who administer recommended childhood vaccines must record the
vaccine identity and lot number in the medical record. However, evidence
from the Vaccine Adverse Events Reporting System, or VAERS, which CDC
runs jointly with the FDA, suggests that from 10 to 20 percent of
medical records lack these lot numbers.

CDC\'s separate vaccine safety datalink project monitors the vaccination
and medical experience of a cohort of 2-1/2 percent of the U.S.
population through a network of HMOs. It finds a similarly high
frequency of nonexistent lot numbers recorded, and ambiguous vaccine
identities, probably as a result of transcription errors and handwriting
ambiguity.

Among the six major recommendations of VISI, the first is for vaccine
vials and prefilled syringes to have RSS, reduce size symbology,
barcoding and duplicate or triplicate peel-off stickers containing the
National Drug Code, expiration date, and lot number. This information
could then be readily captured into the medical records and other forms,
either electronically or by old-fashioned peel-off and pasting.

We have learned in VISI from our consultations with printing experts in
online printing and barcoding experts that the label printing technology
has made many advances in recent years that make this recommendation
feasible today.

This new technology includes labels with multiple layers and peel-off
stickers as well as high-resolution, high-speed printers that can print
barcodes at the time of vial filling, or online printing in industry
parlance. This is important because lot numbers and expiration date are
usually assigned on the day of filling and cannot be preprinted on the
label stock.

In my written statement, which will be in the docket, I understand, are
photos illustrating examples of these multiple peel-off stickers and the
reduced size barcoding on vaccine vials. I have samples with today. I\'m
happy to pass them around to the panel and to the audience. Hopefully
I\'ll get them back at the end of the day.

The remaining five components which VISI recommends include ‑‑ and by
the way, if you don\'t want to wait for the docket, if you\'ll send me
an e-mail at bgw2@cdc.gov, I\'ll be happy to send you the statement with
the photographs.

The remaining five components which VISI recommends include full
barcoding on the outer cardboard or secondary vaccine packaging of the
National Drug Code, the expiration date, and the lot number. Currently,
only the NDC is routinely barcoding now, and that\'s because the
National Wholesale Druggists Association insisted on it years ago.

Third, a uniform vaccine administration record form to receive the
peel-off stickers for non-computerized medical practices.

Fourth, a user-friendly National Drug Code vaccine database on the web
to assist software developers and others to identify vaccines from their
NDC and vice versa, and in the future to convert them to other coding
systems like CPT and HL-7.

Fifth, a vaccine facts information sidebar on outer cardboard packaging
in order to standardize the format and location of key information for
safe administration of vaccines, as the FDA has done so wonderfully with
its mandated and highly appreciated nutrition facts sidebars on food.

And sixth, standardized abbreviations for vaccine types and vaccine
manufacturers to save real estate on small peel-off stickers on these
vaccine vials.

We would particularly urge FDA, in mandating barcodes on unit of use
packaging, to specify the use of numbering systems and reduced-size
two-dimensional barcoding symbologies promulgated by the EAN/UCC, an
international collaboration of nonprofit standards organizations which
already set the guidelines for the existing barcodes we now see on
pharmaceuticals, foods, and most other products of global commerce. This
would avoid the headaches and confusion of a Balkanized system in which
manufacturers might use diverse or ad hoc numbering systems or barcode
technologies.

This could result in much extra work and expense if hospitals and
clinics were thus required to set up customized systems to read them all
rather than use off-the-shelf hardware and software. Better to use an
existing global ID numbering standard already at work in many U.S.
hospital receiving docks, warehouses, and pharmacies.

Finally, we would suggest that both expiration date and lot number are
important data fields for both future bedside monitoring and accurate
assurance systems, as well as for existing national drug and vaccine
safety surveillance systems. Thank you.

MR. KRAWISZ: My name is Bob Krawisz. I\'m executive director of the
National Patient Safety Foundation. Prior to joining the National
Patient Safety Foundation, I was director of business development for
the American Society for Quality and vice president of the National
Safety Council.

I\'m here today to speak in favor of barcoding regulation. The Institute
of Medicine reports that more than 7,000 inpatient deaths per year
nationwide are attributable to medication error. Research shows that
medication errors occur when flaws in the medication administration
process lead to human error.

As we have heard today, a promising strategy to help avoid these errors
is using barcoding to automate aspects of the process. And I think the
time is now to take that action.

Barcoding has been used effectively for decades by supermarkets and
other businesses, including healthcare, to reduce errors, improve
quality, and lower costs. Documented improvements in accuracy have
approached the level of sic sigma, and improvements in productivity
range from 30 to 50 percent.

If anyone really cares to look at a variety of case studies, the
Association for Automatic Identification and Data Capture Technologies
on their website have more than a hundred case histories of using
barcodes, and the improvement in accuracy that was obtained, and also
the improvement in productivity.

Barcoding can easily be adapted to medication administration. By
printing scanning codes on medication labels and on patient ID bands,
machines can readily discriminate one item number from another and
identify mismatches.

Integrating this technology with a prescriber order entry system and
unit dose barcode medication labeling creates an efficient and accurate
electronic medication administration system.

Kay Willis this morning pointed out that the VHA has taken a leadership
role in developing systems with outstanding results in error reduction.

I think she pointed out actual improvements of around 84 or 85 percent
in error reduction.

Given a compliance achieved by the Department of Defense and the
commitment being made by other major suppliers to support barcoding, now
is the time for healthcare organizations to make barcoding part of their
overall quality and safety strategy.

Kasey Thompson indicated that the American Society of Health System
Pharmacists supports marking each container with a standard, compact,
multi‑dimensional barcode that would contain a reliable drug identifier,
lot number, and expiration date that any software program could scan,
decode, and report.

A single scan could be used to inform users whether they have the right
drug and whether the drug had expired. That scan would support lot
number and expiration date tracking, which is impractical in many of
today\'s systems because of overhead costs and data capture.

The barcode printing and scanning technologies necessary to support this
ideal exist today. Lacking such an ideal system, the use of a
HBT-compliant barcode containing the NDC code on every container would
provide a significant advance.

It is recognized that labeling changes create significant regulatory
burdens for drug manufacturers, and smaller containers pose label
formatting problems that must be overcome. However, some manufacturers
have already found solutions to these problems. FDA and/or purchaser
mandates are required to move all drug producers to the next level of
patient safety. Thank you.

MS. COUSINS: Good afternoon. My name is Diane Cousins, and I\'m here
representing the United States Pharmacopeia.

USP sets legally enforceable standards for drug products in the United
States that include packaging and labeling as well as quality, strength,
and purity. We have been operating a medication error reporting program
since 1991, and we spearheaded the formation of the National
Coordinating Council for Medication Error Reporting and Prevention.

In June of 2001, the National Coordinating Council issued a set of seven
recommendations which include a call to action that USP and FDA
collaborate with pharmaceutical manufacturers and other appropriate
stakeholders to establish and implement uniform barcode standards down
to the immediate unit of use package.

The Council also urged the expeditious implementation of its
recommendations so that healthcare practitioners and organizations could
benefit from machine-readable codes present in a standard format on unit
of use medication packaging. USP fully supports the Council\'s
recommendations.

Insofar as USP is concerned, USP could provide standards for barcoding
requirements that would be enforceable under the FD&C Act for official
articles. USP awaits the definition of FDA\'s regulatory authority in
order for USP to determine how best to support and compliment these
requirements.

Because many states recognize our labeling requirements, USP\'s
barcoding requirements could be extended to practice situations such as
computerized prescribing and pharmacy dispensing labels.

Label readability and product identification have been ongoing issues
important in tracking and controlling product quality and information as
the pharmaceutical product moves from the manufacturer to the patient.

Based on medication errors reported through the USP reporting programs,
confusion over the similarity of drug names accounts for approximately
15 percent of reports submitted, and as many as 33 percent of reports
cite labeling and packaging concerns that contribute to medication
errors. Barcoded products can help reduce such errors, and have broad
impact that spans the multiple phases and settings of healthcare
delivery.

USP views the barcode requirement as a part of a larger medication error
prevention approach, which includes useful and clear names for
compendial articles, imprint codes, label simplification, and even
standardized prescription ordering.

USP is developing new general information chapters on unit of use
packaging that may include a discussion of barcodes. USP is considering
the advisability of developing other general information chapters that
would include guidelines regarding imprint codes and label readability.

Therefore, USP supports the December 3 Federal Register proposal, but
believes that exemptions should be issued at this time for certain
containers, specifically ampules of 5 milliliter size or less, based on
the limitations of current technology to accurately and consistently
convey information for such package sizes.

USP also supports the December 3 Federal Register proposal regarding
human drug labeling. USP encourages FDA\'s expeditious implementation of
such a regulation.

In closing, USP recommends that a barcode contain, at a minimum, the
product NDC number, lot number, and expiration date. This recommendation
is contingent on FDA\'s revision of the current NDC system to provide
greater accuracy and consistency to those codes.

Barcodes should be standardized in format and information, and should be
present on packaging at the point of care, but should not replace
human-readable labeling. Thank you.

MR. COHEN: I\'d like to thank FDA for giving me the opportunity to
speak, and also to all of you, thanks for showing up today and
supporting barcoding.

My name is Michael Cohen. I\'m a pharmacist, and I\'m president of the
Institute for Safe Medication Practices. It\'s a nonprofit organization
located in Huntington Valley, PA. And we work pretty closely with
practitioners, healthcare organizations, regulatory authorities, and
standards organizations in initiatives to prevent medication errors.

Yesterday, for the third time in my career ‑‑ I guess it\'s a
coincidence that it happened yesterday ‑‑ I was called to an
organization that had a fatal medication error with potassium chloride
concentrate injected directly into a patient instead of another drug.

And I had to face one of the individuals who was directly involved in
this case, and she was entirely devastated by this incident. Remorseful
as she was, there were no words that could describe what an event this
was yesterday. And obviously, the family of the patient was devastated,
too.

And I was asked, you know, for advice on how to prevent errors like
this. And there are many ways to do that, of course, notwithstanding the
withdrawal of potassium chloride from nursing units. One that struck me,
because I was going to be here today, was obviously barcoding of the
pharmaceuticals. It was a switch, a swap. She used the wrong ampule. And
it could have been prevented, it along with the thousands of others that
you\'ve heard about today.

Rather than repeat a lot of what you\'ve heard already, because we fully
believe in the idea of barcoding unit dose packaging, I\'d like to talk
about another aspect of this. But I do want to clarify the unit dose
package and what we mean by that.

I\'m talking about a single unit dose, a single dose. This is in
contrast to the terminology unit of use, which might be a 30-day supply
package in a single package. They\'re quite different. And what I
describe is about unit dose, but all pharmaceutical packaging, including
unit of use. But we would like to see the unit dose package with a
barcode on it.

I wish to focus my attention on the need for barcodes on the unit dose
package of medication, and most importantly, the barcoded 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 \'60s by many organizations. And
although this is a proven safe way to provide medications in the acute
care setting, especially with the recent use of barcode scanning to
match patients\' specific doses with the patient and the record, we\'re
experiencing a decrease in the availability of the unit dose package by
many manufacturers.

And our fear is that many more manufacturers will cease to provide unit
dose medications if a barcoding regulation is put in place. We certainly
hope that that does not occur. We believe that a regulation is needed,
and I don\'t know how this could even be accomplished. There might even
need to be some type of an incentive. But we\'ve got to get the
manufacturers to cooperate with the unit dose package itself being
barcoded.

There are too many hospitals in rural communities that will not be able
to afford robotics to do packaging from bulk. And I don\'t know how else
to accomplish this, without the cooperation of the pharmaceutical
industry.

And let me tell you, the readership of our newsletter is extremely
concerned about the lack of availability. We did a survey this past
year, and I\'d just like to review that very briefly. We have about
6,000 hospitals that get our newsletter. And we asked them to respond to
a survey. So over 500,000 people read this.

Three-quarters of the respondents reported problems with the 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 six to ten brand products that have not been
available in unit dose packaging in the past year. And another quarter
reported problems with 11 to 20 brand products. Over 6 percent reported
problems with more than 40 different brand products. Even more
experienced problems with generic oral solid products.

Most respondents who repackage medications now estimate a 1 to 10
percent error rate when they do it on their own. So we really need you,
manufacturers, to cooperate. It is critical to make this work.

It was clear from our survey that despite some initial worry about
costs, many hospitals are ready to do their part and move barcode
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 they\'d be more likely to select a
therapeutically equivalent product if it is available in unit dose
packaging.

More to the point, 84 percent felt that a slight increase in cost would
not deter them from purchasing a specific vendor\'s product. Only
11 percent felt a slight cost increase would be a deterrent.

On behalf of its members, you\'ve heard group purchasing organizations
like Premier say, let\'s get this rolling. I hope that it doesn\'t take
what some of the regulations take to formulate and publish in the
Federal Register. I too would like to see this, as Premier said, by July
next year.

ISMP strongly recommends that FDA require barcodes on all medications,
to include the NDC number as the standard identifier for prescription
medications, the medication\'s lot number, and the expiration date.

However, if necessary, we support a phased-in approach, with the
barcoded NDC required as soon as possible and the lot and expiration
date required within a time certain. Thank you very much.

MS. DOTZEL: Thank you.

MS. ENGLEBRIGHT: Good afternoon. My name is Jane Englebright. I\'m the
vice president for quality at HCA, Incorporated. And I\'m speaking to
you today as a nurse who has given medications using a barcoded
administration system, and who has seen the difference they make in
medication errors. And currently, I\'m working to roll out barcoding
administration to all of the HCA hospitals.

I\'m testifying today on behalf of both HCA and the Federation of
American Hospitals. HCA owns and operates about 200 hospitals and other
healthcare facilities in 24 states, England, and Switzerland. And the
Federation is a national trade association representing the nation\'s
privately owned and managed community hospitals and health systems from
the acute and post-acute spectrum.

In February of 2000, HCA made a decision to do its first corporate-wide
quality initiative, and the first component of that was improving
medication practices. And what we set about doing was trying to improve
medication safety, reduce errors, and prevent harm and injury to our
patients.

We\'ve done that in a comprehensive manner, looking at both operational
improvements and the development and employment of two technologies, one
of those an electronic physician ordering system, and the second an
electronic barcode-assisted medication administration system that\'s
used by nurses and respiratory therapists throughout our hospitals.

This is the technology that would greatly benefit from federal
standardization of barcoding related to medications. We have 186
hospitals that will have this technology in place by the end of 2005. We
have two of them currently doing it, and we\'ll have two per month
coming on board through the rest of this year. We feel a strong sense of
urgency. We firmly believe that this technology prevents injury and
prevents death.

What we have found, to answer a few of the questions from earlier, is
that even by moving our inventory in our pharmacies to preferentially
buy from manufacturers who provide barcoding at the unit of dose, we
still have to repackage about half of what\'s in our pharmacy. We have
learned, with a fairly inexpensive scanning system, how to read UPC, how
to read 128, and how to read RSS symbologies.

But we are buying packaging equipment and repackaging our medications
ourselves for about 50 percent of the inventory in each one of the
hospitals where we\'re doing that. We do that understanding that we
introduce a potential for a labeling error in the process of doing that,
and understanding we\'re incurring a cost of anywhere from 12 to 15
cents per dose, sometimes more for the packaging than it actually is for
the pharmaceutical that\'s contained in there.

We believe the process that we\'ve put in place where we have a patient
that has their medication profile, their orders from the doctor
available electronically, where each dose of medication is then
identified with machine-readable code, and where the patient\'s armband
has not only human-readable but barcoded patient identifier on it, are
the elements of a safe medication administration system.

So the nurse goes to the bedside with a computerized profile of the
medication administration, scans each dose of medication to verify that
that is what the doctor has ordered for this medication, and the five
rights of medication administration have been observed, and then
verifies the patient identification by scanning the armband.

At the time they file that interaction, then, we have for the first time
in our hospitals a comprehensive record of all the chemicals that are in
the patient\'s body, regardless of where in the hospital and who in the
hospital has administered that medication, that\'s available to the
physician for clinical decision-making and, maybe even more
phenomenally, we have an accurate bill.

(Laughter)

With that, we would like to encourage the FDA to require the
pharmaceutical industry to have standardized machine-readable barcoded
information that includes the NDC, the lot number, and the expiration
date. We too would welcome a phased-in approach if that is necessary. We
believe that the most significant medication errors, the ones that
really cause damage to patients, are wrong medication and wrong dose,
both of which could be prevented with the NDC number in the barcode.
Thank you.

MR. ROBINSON: Good afternoon. I am Dr. Skip Robinson, and I have the
honor of directing the clinical program for Consorta Catholic Resource
Partners. We are the leading healthcare resource management company and
group purchasing organization whose shareholders are Catholic-sponsored,
faith-based, and nonprofit.

I am pleased to have the opportunity to testify to the importance
healthcare industry and the people they serve the barcoding of drugs and
biologicals. Consorta promotes the use of barcoding technology to create
a safer, more efficient, and more effective patient care system.

I am here today representing the consensus recommendation of our over
500 acute care hospitals representing 70,000 beds, and more than 1800
non-acute care sites.

As we are all aware, the relationship between technology advancement in
human health, patient care, and patient safety has greatly improved the
health and mortality of most Americans. However, in some respects, the
healthcare industry trails far behind many industries in reaping the
benefits of new technologies.

We practitioners are aware that we must find better ways to verify and
review medications before they are administered to patients. Barcoding
of unit of use medication serves to close the gap in distribution.
Without it, front-end technologies such as robotic cart fills and drug
interaction checks will never reach full potential. The lack of use of
barcode technology without all those changes will greatly hinder patient
care.

Consorta recognizes that the implementation of barcodes on the unit of
use medication packaging is only the first vital step in recognizing the
promise of barcode technology and making our healthcare system safer.

Consorta supports the implementation of requirements of barcoding on all
commercially available prescription and nonprescription medications,
that barcodes should be included on the labels of all unit of use
pharmaceutical products.

The NDC code, which is established by the FDA, should be the initial
data element included on the barcodes. This should be implemented as
quickly as possible. Inclusion of the expiration date and lot number,
especially to track recalls and out-of-date products, should be added to
the barcode as soon as technically feasible.

Consorta supports the eventual inclusion of medical devices for the
label recommendation.

To conclude, Consorta recognizes that there are some costs associated
with this. And we have looked and talked to our hospitals, and they are
all willing and ready to aid more money to do this.

However, much larger expenditures will be taken out of the system
because our institutions will have to adopt these new technologies as
they go forward because what we have to do is be able to, at the
bedside, check drug/drug, drug/food interactions, laboratory values,
allergies, and decisions. They must be done at bedside. Thank you.

MR. NEUENSCHWANDER: My name is Mark Neuenschwander. I have been a
patient and I am a consultant in the field of pharmacy automation.

It was 27 years ago that Wrigley\'s opened the door by putting a barcode
on a pack of chewing gum. It was really a statement of faith because
grocery stores and drugstores didn\'t have scanners. But their faith was
not in vain. Within a decade, virtually every item on the shelves of
those drugstores and supermarkets had a barcode, and the vast majority
of checkout stands were equipped with scanners to read them.

Within five years, 1990, virtually every retail item had a barcode, not
just Q-Tips at Walgreens and Cheerios at Safeway, but also duct tape at
Home Depot and dresses at Nordstrom\'s. Barcodes on everything, scanners
everywhere ‑‑ almost.

In 1991, the first unit dose medication was barcoded by a manufacturer.
The door was opened. And ten years later, still two thirds of the
medications that make their way from the manufacturer to the hospital
bed are without barcodes, and about 3 percent ‑‑ it\'s not 1 ‑‑ about 3
percent of our hospitals have scanners at the point of medication
administration.

The reason? For years, drug manufacturers have argued, why should we
apply barcodes if hospitals don\'t have scanners? And hospitals have
argued back, why should we buy scanners when drugs don\'t have barcodes?

And the whole thing reminds me of a slapstick comedy. A couple of
Keystone Cop cars come to a narrow bridge, not being able to cross,
because the drivers are shouting back and forth, \"After you.\" \"No,
after you.\" And it\'s been this way for the last ten years.

And I am asking you as a concerned citizen and someone who traffics in
this world of healthcare, FDA, please help us get this thing across the
bridge. There\'s a wonderful world of safety on the other side.

Now, what we all want is labels with medications that contain
machine-readable codes ‑‑ I\'ll use the term barcodes ‑‑ that can be
read at the point of administration. And we\'ve heard all the values
about point of administration scanning.

I want to reemphasize one other value, and that is documentation at the
point of administration, as critical to safety, in my opinion, as
verification for when a doctor comes in to evaluate a patient, he or she
obvious the patient, looks at the patient administration record, and
right now our patient administration records are MARs.

Too often we treat them as if M stands for memory. A nurse comes to the
end of a shift, all too often, and treats the MAR the way I\'m going to
treat my expense account when I get at the end of this trip, trying to
remember what taxi did I take, was that this day, was the hotel this
date. And we end up with an approximate MAR. I want my doctor to have an
accurate MAR. Scanning at bedside helps us.

Now, which symbologies do we want on these labels? I\'ll just put it
this way: today\'s symbologies that today\'s barcode readers can read.
And if the Dick Tracy micro-mini radio chips come in our lifetime, we
can put them on top. But I\'m tired of waiting. I think we all ought to
be tired of waiting. Jeez, we\'ve been waiting for Dick Tracy watches
since 1931.

Now, what exactly is it that we want barcoded? Units of use? Unit dose?
And all this nomenclature has confused us for years. And as an outsider,
I sit and go, what is this? What\'s that? And I asked some medication
safety expert, \"What\'s the difference?\" And he says, \"Well, my
colleague and I disagree, but here\'s how we define it.\"

An old preacher told a young understudy, he says, \"If there\'s a mist
in the pulpit, there\'s a fog in the pew.\" Doggone it, there is a fog
in the pew when it comes to barcode scanning. There is not a mist in the
pulpit, though, if you go back and read the FDA definitions. We\'re
talking about immediate containers. That\'s the terminology when you
talk about labeling.

So we\'re asking you to barcode all immediate containers. What should it
include? Obviously, lot number, drug ‑‑ I mean, excuse me, drug,
strength, manufacturer, lot number, and expiration date.

Let me just say this in conclusion, that hospitals have already started
across this road. They are going pell-mell into bedside scanning. And
they are ‑‑ I have been in hospitals where volunteers are slapping
barcodes on syringes.

There are a reason why we have GMPs. And when we go ahead into barcode
scanning, let\'s not leave those GMPs behind by having hospitals who
don\'t have to comply with those GMPs become packaging houses just so
they can scan. Let\'s help the manufacturers catch up to all these
hospitals that are going across the bridge into the future. There\'s
room for two on the bridge.

Other than that, I have no opinion.

(Laughter)

MR. WRAY: Good afternoon. I\'m Bruce Wray, the director of marketing at
Computype. We\'re a supplier of barcode labels, label printing systems,
scanners, and software. We\'ve served the blood and plasma and general
laboratory markets since the mid-1970s.

It was my privilege back in October of 1989, at a meeting in the
Netherlands, to recommend to the international blood bank community that
they switch the standard blood bank symbology from Codabar to Code 128.
They adopted that suggestion, and the result was ISBT‑128, a formal
specification for the identification of human blood and blood products
now being adopted throughout Europe but largely being ignored here in
the U.S.

What did we learn as we developed this new specification? I think we
learned several things. First, the statement, \"If you build it, they
will come,\" sounds great in the movies, but it isn\'t true in real
life. It would be more accurate to say, \"If the law requires it, they
will come,\" or, \"If they can\'t compete without it, they will come.\"

Simply having a well-written and thorough specification, which we did in
blood banking, and having that specification available, does not
guarantee that it\'s going to be adopted.

Second, we learned that technology is advancing today faster than most
formal groups can make decisions about its use.

Third, we confirmed what everybody already knows: Barcodes reduce
errors. They\'re fast, they\'re accurate, and they\'re easy to use. The
case for the use of barcodes or other means of auto-ID is a compelling
one.

Fourth, and most importantly in my view, we learned the importance of
formally agreed-upon data structures as opposed to symbology standards.
I think the approach that we used in the development of ISBT‑128 was an
effective one.

It involved the cooperation of all the stakeholders ‑‑ blood banks,
transfusion services, hospitals, software providers, instrument
suppliers, the barcode community, and the FDA. The only thing we lacked
was the regulatory impetus for the change to be made.

Based on that experience with ISBT-128, we would make the following
recommendations to the industry and to the FDA.

First, the FDA should require the use of machine-readable symbols on all
human drug and biologic products. Eye-readable representation of
significant information should always accompany the machine-readable
symbols.

Two, rather than require a specific barcode symbology or barcode
language, the FDA should mandate that an agreed-upon data structure be
encoded for machine reading. Were existing standards are available, such
as ISBT-128, their use should be required.

Third, guidelines should be provided by the FDA to each stakeholder
industry group which outline the minimum information content of the
symbols and the timeline for implementation.

Finally, an auto-ID coordinating council, perhaps made up of some of the
wonderful industry and regulatory groups that have been mentioned this
afternoon and this morning. That auto-ID coordinating council should be
appointed to help resolve implementation issues.

It would be made up of volunteers from the disciplines involved in the
new requirements, barcode suppliers, and the FDA. It would be charged
with ensuring that minimum information requirements are met. It would be
charged with maintenance of databases and the assignment of code
structures; charged with making sure that the best technology available
is used, and that costs to the individual institutions are minimized.
Thank you.

MR. RITCHIE: My name is Bruce Ritchie. I\'m a hematologist, a hemophilia
treater, and I represent the Canadian Hemophilia Society and the
Association of Hemophilia Clinic Directors in Canada. We also discussed
the issue of barcoding in depth with Health Canada, and also with the
National Hemophilia Foundation here in the U.S.

What I\'d like to start out with is to say that machine-readable
labeling of pharmaceuticals is clearly something whose time has come.
And I think we have heard that today from many, many different people.
And I applaud the FDA for moving this process forward with this public
meeting. I think it\'s very important.

The FDA must be aware, however, that other regulators are interested in
a global standard and are watching to see what the FDA does. I know the
Europeans have been waiting to see what the outcome o this and other
meetings are before proceeding with standardization there in Europe.

Given the success of harmonization in the application for licensure of
drugs, I think the FDA should consider harmonization of standardized
machine-readable labeling, in particular standardization of the drug
identifier, such as the NDC or the GTIN. I know the NDC information can
be included in the GTIN standard that\'s been set by the UCC council.

As everyone else has said, I believe labeling of medicines is a safety
issue. Everyone involved in the production, distribution, prescription,
and use of medicines is responsible, either legally or otherwise, for
tracking pharmaceuticals, for monitoring adverse events, and for recall
of drugs.

So all the players must be able to tell exactly what\'s in the medicine
package and record this information quickly and accurately, and that\'s
where machine-readable labels or barcodes comes in.

Machine-readable labels such as barcodes offer dramatically improved
speed and accuracy of data input, and will therefore foster the use of
database tools which are useful to track drugs, to record and report
adverse events as they occur, and to aid in recalls.

In Canada, we\'ve developed a national database program called CHARMS,
which we use for tracking all blood coagulation products. And when
recalls happen, and they happen all too frequently, we in the hemophilia
clinics know exactly where the products are. These products are stored
in patients\' homes in large inventories, which is always a surprise to
the governments who are funding these drugs in Canada.

So by setting standards of machine-readable labels, the FDA will allow
everyone to track these products. And they will encourage drug
prescribers, pharmacies, clinics, and users to use this data, and
everyone will use this data. I know of three pharmaceutical companies
who are setting up global Palm Pilot-based systems for patients to use
in maintaining their inventory at home and recording their use of
coagulation blood products.

Therefore, the simple philosophy that should guide this process is,
apply the machine-readable label, such as a barcode, at the source
because that\'s the easiest, cheapest, and most accurate way to do it.
And use a barcode that everyone can use. This means setting a standard
for data format now.

And secondly, establishing a harmonized process to set standards for
machine-readable systems now and in the future. As everyone has alluded
to, the technology is changing, so we should have a process in place to
set standards not only for the present, for today, for barcodes today,
but for radio frequency chips for tomorrow.

In summary, I think the FDA should think separately about the data
format and the way data is transmitted. The FDA should standardize the
data format quickly, and allow manufacturers to add new technologies,
meaning new standards for each new technology, to promote a widespread
usefulness of this system.

The FDA should think carefully about setting a harmonized standard for
data format and machine-readable technologies, a widely usable barcode
for today, and standardized emerging technologies in the future. Thank
you.

MR. STEANE: My name is Edwin Steane, and I\'m with ICCBBA. ICCBBA is the
group that was alluded to earlier by Kay Gregory as those that maintain
and extend the ISBT-128 standard.

Bruce has already told you that the initial proposal for the ISBT-128
standard was in 1989. I would point out that it took five years to write
that specification. None of this happens as quickly as you think it
might, not if you\'re going to do what we did, which is to adopt three
rules: Do it once. Do it right. Do it internationally.

We also had another rule that we displayed prominently: Never forget the
law of intended consequences. You can do this as quickly as you want,
but if you don\'t put the appropriate thought into it, it\'s going to
fail.

As Bruce said, and as Kay said, if you build it, they will not come. The
mandate that is needed fro the FDA is the use of machine-readable
symbols in therapeutic settings wherever possible. Putting them on
products and not requiring that they be used is a waste of time. What\'s
needed is absolute insistence that they be used. The goal should be the
elimination of data entry by humans, whether it be through a keyboard or
in written notes.

I would like to emphasize once again that the FDA should concentrate on
data structures. They should not mandate technology. And the Dick Tracy
radio frequency tag, by the way, is already available as part of a
linear barcode on a blood group label. No one uses it, but it\'s already
available.  It\'s too expensive, of course.

So the emphasis should be placed on the data structure, not the means of
capturing the data. The industry will look after that very well if you
leave it to them.

So what should be in the data structures? I would suggest that the FDA
can apply a very simple rule. If they require you to capture and record
that information, then there should be a standard format in which that
information is to be captured. And then putting those into
machine-readable symbols becomes relatively simple.

Barcoding by itself, although a lot of people in this room don\'t want
to hear me say this because they want to tell you how difficult it is
and how complex it is, is trivial. It\'s the consensus that\'s needed in
order to be able to make the system work that is difficult.

Also, the information which is encoded and which appears on a label that
an end user is to use should be the information that is of importance to
the end user. And you should get everything else off that label because
all it does is interfere with what the end user should be concentrating
upon.

I would suggest to the hospitals, and I\'ve listened to them with care,
that if they really want to do something to make this system move, they
all need to sit down and talk about a standardized way to identify the
patient. And once you do that and the products are barcoded, the errors
will go away. Thank you.

MR. MAYBERRY: Yes, hi. My name is Peter Mayberry, and I am the executive
director for the Healthcare Compliance Packaging Council, which is a
not-for-profit trade association founded in 1990 to promote the many
benefits of unit dose blister and strip packaging.

The HCPC is submitting formal responses to all the questions raised by
FDA in the Federal Register notice announcing this meeting, but my
purpose today is to underscore one primary point in our responses, and
that is that the Institute of Medicine report on which a large part of
this effort is based called for recommendations not only for barcoding
but for unit dose packaging.

And I know you\'ve heard quite a bit of difference between unit of use
versus unit dose, but I think Dr. Cohen summed it up very, very well by
saying a unit of use can be a container with 30, 60, 90 tablets ‑‑ it\'s
basically an entire course of regimen ‑‑ whereas a unit dose is a single
dosage unit.

Specifically, on pages 166 through 167 of the 1999 report, \"To Err Is
Human,\" IOM notes that, \"If medications are not packaged in single
dosages by the manufacturer, they should be prepared in unit doses by
the central pharmacy.\" The report justifies this recommendation by
noting that, \"Unit dosing reduces handling as well as the chance of
calculation and mixing errors.\"

But the IOM also sounded an ominous alert in this section of the report
by pointing out that, \"Unit dosing was a major systems change that
significantly reduced dosing errors when it was introduced more than 20
years ago. Unfortunately, some hospitals have recently returned to bulk
dosing as a cost-cutting measure, which means that an increase in dosing
errors is bound to occur.\"

Indeed, in the time since the IOM report was first released, the HCPC
has heard a growing number of anecdotal reports that pharmaceutical
manufacturers are dropping the number of products offered in hospital
unit dose or HUD formats. And as recently as May 15th this year, one
pharmaceutical manufacturer noted during our national symposium on
patient compliance that his company had deleted HUD formats for some 80
percent of their entire drug stock over the past two years.

Why are they doing this? According to the pharmaceutical manufacturers,
because the hospitals are not purchasing HUDs because they\'re cheaper
to buy them in bulk, just as IOM said.

So as FDA considers the user of barcodes as a mandatory requirement, the
HCPC recommends that you consider a requirement that the barcode be
placed at the unit level. In other words, every single dose of medicine
has a barcode on it. The technology is there, and the requirement would
be there such that the manufacturer would then have the obligation of
providing medications which are intended for dispensing at inpatient
settings. Each individual dosage would have a barcode on it.

And that would be about the only way that the IOM and the other
organizations that have weighed in on this, as well as the practices of
many other countries around the world, you would be able to achieve the
degree of safety to which you\'re seeking. That\'s my primary point for
the afternoon.

MR. POLINSKY: I\'m Steven Polinsky. I am with GenuOne Corporation, and
we provide pharmaceutical manufacturers and biological product
manufacturers with enhancements that are technology-based against
counterfeiting and parallel trade. So we do a lot with barcoding and
other marketing.

Our solutions include unique machine-readable authentication that can be
integrated directly into existing barcodes and other packaging mediums.
Also, we enable pharmaceutical manufacturers to print barcodes that are
invisible to the human eye. The reason that this is necessary is in the
parallel trade and gray market business, gray marketers tend to deface
product packaging. So we have to stay one step ahead of these folks with
our manufacturers.

And it came up today, but it was asked, what other data elements should
be considered when putting together some type of barcode standard. And
it\'s very clear to me it should be machine-readable authentication, and
the reason being that \$12 billion annually of counterfeit medications
find their way into hospitals, and especially biological products over
the past 18 months have been very hard hit because these drugs are
high-priced and have high margins.

And the result obviously can be illness and even death. And the bottom
line is, even if a counterfeit drug is administered properly, the result
can be adverse and be the same. So it\'s up to the FDA to provide a cost
of scale to manufacturers when they build the solution to address both
of these issues together.

Although the authentication technology is much more sophisticated than
barcoding ‑‑ barcoding is actually rather simple ‑‑ implementation and
integration of an authentication mark that\'s a unique signature that\'s
machine-readable is actually fairly simple. It can be directly put into
the ink. It can be into the dye that\'s actually printed when they print
the barcode, the manufacturers, onto a particular box. So it\'s inherent
in what they\'re doing already.

We actually have a lot of clients that are doing this, so they\'re
already providing not only barcoding, but it might be invisible so they
can\'t be human-readable. It can be scanned and it can provide a unique
authentication to stay one step and raise the bar on counterfeiters that
are out there as well.

Scanners can also be retrofitted or calibrated to be able to read these
unique marks as they are reading barcoding informatics as well. And this
addition to your standard will help mitigate what I believe, and a lot
of other people feel, is a major patient safety issue, probably the
other big one. That\'s consumption of counterfeit drugs. Thank you.

MR. SCHWARTZ: My name is Robert Schwartz and I\'m chairman of the board
of the Healthcare Distribution Management Association.

HDMA is a national trade association representing pharmaceutical and
related healthcare product distribution in the United States. HDMA\'s
distributor members operate over 260 distribution centers nationwide and
provide products and services to approximately 120,000 pharmacy
settings, including independent, chain, hospital, mail order, mass
merchandisers, food stores, long-term care, home health facilities,
clinics, and HMOs. HCMA also represents over 220 pharmaceutical
manufacturer companies who distribute prescription products from
hundreds of facilities.

HDMA\'s mission is to secure the safe and effective distribution of
healthcare products across the supply chain from point of manufacture to
point of administration.

HDMA is supportive of efforts to utilize barcodes at the unit of use
level of all drug and biologic products as part of an initiative to
reduce medication errors. We appreciate the caution that FDA has
exhibited in this process, and welcome the opportunity to work with the
agency and other stakeholders to ensure that our efforts enhance patient
safety without an undue economic impact to the industry and risk of
disruption of the supply of drugs through the healthcare system.

HDMA supports barcode labeling for all prescription drugs and vaccines
supplied for administration to patients in hospital or institutional
settings. We believe this would address the vast majority of critical
medication error issues.

However, there is no current evidence that this would be so in retail or
other treatment settings. To require barcodes on all products in all
settings during the initial phase of any forthcoming FDA mandate would
greatly add to the costs of barcode labeling implementation and
substantially slow the process, causing possible delays in reducing
medication errors that are readily avoidable in the near term with
current standards and technology.

HDMA supports the use of the National Drug Code in any barcode
application. The NDC is a standard identifier with a unique, all-numeric
system identifying the pharmaceutical manufacturer or distributor, drug
product, and package size.

It is widely used by manufacturers and distributors throughout the
industry, and is already required by FDA regulation. Product and dose
information which is included in the NDC number is critical for
preventing administration of the wrong medication of strength.

HDMA is not aware of any current data demonstrating that the inclusion
of secondary information such as lot number and expiration date in a
barcode will reduce medical errors. We do not believe that including
such information in a barcode at this time will have a noticeable effect
on FDA and the industry\'s goal of medication error reduction.

It is our opinion that this information is not critical bedside scanning
in order to screen for medication error. Screening for out-of-date or
recalled medications should not be performed at the bedside and
therefore is not needed in the unit of use barcode.

Consequently, HDMA discourages FDA from adding auxiliary information
such as lot number and expiration date to the first requirements for
barcode usage. Under FDA\'s current charge to reduce medication errors,
especially at the unit of use bedside level, such information is not
essential at this time, and inclusion would only add to the costs and
complexity of implementation.

HDMA does not believe the agency should specify a single barcode
symbology and require its use at this time. If FDA limits the healthcare
community to a single symbology, it will significantly reduce our
ability to comply quickly since more work will need to be done for the
industry to adapt.

In addition, HDMA finds that two-dimensional symbology is not currently
required to meet the goals of error reduction. A linear barcode for the
NDC number, supplying product and dosage information, will address the
vast majority of medication errors without the need to render entire
systems obsolete.

The requirement of 2D symbology will add considerable expense and time
delays to the supply chain while the industry invests in this
still-developing technology. The mandatory use of barcodes will have a
significant economic impact on the industry, especially manufacturers
and distributors that will be required to invest in packaging
technology, equipment components, computer systems for integration, and
implementation costs across the supply chain.

FDA should not mandate a particular location for the barcode on all
products. Variations in size, shape, and packaging will make consistency
next to impossible, particularly when viewed in light of the regulated
information and presentation already required for medical product
labeling.

Instead, HDMA recommends that guidelines be offered requiring barcode
placement in a way that is fully scannable, especially on small or
rounded products. It is far more important to ensure that the barcode is
placed in a location where it may be scanned instead of being in a
particular location. Thank you.

MR. COLLINS: My name is David Collins. I am the president of Data
Capture Institute. And our activity centers around the expert
development of architectural systems where barcode or auto-ID is a
driving influence to the information technology in large enterprises.

I\'m here to make a recommendation, and the recommendation goes to the
heart of controlling the complex, long-life assets used in providing or
delivering healthcare. I don\'t think the position taken earlier today
by a panelist saying, forget the medical devices category because you
can\'t justify labeling on a tongue depressor, makes any sense at all.

There are complex delivery systems used in healthcare. Healthcare is an
asset-intensive industry. And they are going without supervision,
largely, and primarily because those manufacturers who are delivering
these systems don\'t have a standard format for expressing who the
manufacturer is and what that serial number related to the manufacturer
is in a format that can be recognized universally, even though one
format exists and serves that purpose.

The format we recommend is the EAN/UCC global individual asset
identifier. It\'s been available since 1995, and it has three principal
fields of information. The first field is a message indicator that says,
I am an asset and I should be monitored. The second field of information
gives the manufacturer identification. The third field of information
expresses the serial number assigned by that manufacturer in whatever
format the manufacturer desires. It\'s that simple.

Since it\'s an EAN/UCC standard, it\'s available for creation of
information and support anywhere in the world. And as far as the cost to
the label is concerned, this on my fingertip, instead of a 30-foot-long
label in a slide, represents such a label. And the cost would be,
nominally, five cents.

With that label in play, if you will, in the healthcare community, you
will find many software providers coming forward with software
applications that will allow you to very easily drive a system to
monitor assets. That gives you product ownership and stewardship from
creation to current use. It gives you in-service history. It gives you
repair history, warranty information, reclaimability for recall, and
many other features I don\'t have the time to cover.

But it has a precedent being mandated in the federal government today.
The FAA adopted this marking systems for suppliers of air traffic
control systems in 1998, and to date over \$2 billion of equipment has
been placed on order, and about half of that equipment already
delivered, bearing this unique identification which allows the
traceability. You might say they\'re in the healthcare industry as well.

With the proper use of this on medical devices, medical devices will
always be assigned to the appropriate patient. After patient use, the
reusable medical devices will be properly cleaned. Medical devices
requiring recalibration will have an audit trail to ensure that this has
been done.

These assets will be visible through a database screen or a browser, and
they will be shown in all their assigned locations. And linking the
medication provided to these devices through the methodologies described
in most of this conference can be easily accomplished to give one more
level of security in healthcare delivery. Thank you.

MR. ASHBY: My name is Daniel Ashby. I\'m director of pharmacy at Johns
Hopkins Hospital, and also associate professor at the School of Pharmacy
for the University of Maryland. I\'m pleased to be here today to offer
comments concerning the needs and value of barcodes, maybe from the
perspective of a hospital and a department of pharmacy.

I wanted to share two stories with our panel. I\'m now part of an
organization that finds itself on the front page of the Baltimore Sun
and other publications on a pretty regular basis.

Sometimes that\'s a source of pride. Those articles often reflect
accomplishments. Sometimes they\'re accomplishments that reflect what\'s
happening in hospitals all across the country and the efforts healthcare
providers everywhere make on behalf of patients in America.

Sometimes it\'s a source of frustration. When we learn that we didn\'t
receive a notice for a recall for a bronchoscope, when we realize that
we didn\'t get the job done, when we realize that patient harm resulted
because of that, it creates some real concerns.

That event drove us to look at the recall procedure for everything we
did in the hospital. From a pharmacy standpoint, I was surprised. There
are hundreds of recalls every month. Sometimes it\'s a capital S versus
a small S. That turns into thousands of line items sometimes. It turns
into 200 areas that we have to check.

Our conclusion was, we did a pretty good job. We thought we usually got
the notice. We thought we usually checked all the areas. Well, we
usually checked most of the areas. We usually documented that check.

Usually isn\'t good enough. Barcode technology would help. Did we order
it? Did we receive it? And where did we ship it to? I don\'t disagree,
we wouldn\'t do this at the bedside. We would, however, do it at a
single unit of use package level.

When you distribute the drug to the hospital, you put a hundred doses in
a bin. To check them, you have to check them one at a time visually.
There is no job more boring in a hospital than checking for expired
drugs on the unit. Barcode technology clearly could improve the process
and improve the safety of medication use system.

A second story I\'d share with you: The Department of Pharmacy at
Hopkins dispenses 15,000 doses or more every day. We\'ve been working
hard to decrease the number and percentage of missing doses that occur.

We\'ve made progress. We\'ve decreased that percentage from 1.7 to 1.3
percent over the last several months, a 25 percent improvement. That\'s
the good news. However, the bad news is we still have 195 missing doses
every day. It causes delays, interruptions, and the potential for error.

I found it interesting, thinking back last week, that I can send a
package to my Peace Corps volunteer son in Honduras, and I can check
online to see where that package is. On the other hand, when we get a
call from a nurse asking where a dose of a critically needed medication
is, we don\'t know. We\'ll be happy to send you another one. Do we ever
stop to wonder what happened to the other dose and where it went?
Clearly, barcode technology can help with this also.

To our colleagues in the pharmaceutical industry, we realize this isn\'t
as simple, maybe, as everyone makes it seem. We use the example that we
can buy a loaf of bread in the grocery store. If we can do it there, why
can\'t we do it in healthcare? The challenge is more difficult. We want
you to wrap each slice individually, and we want you to barcode that
slice.

The reality, too, though is this isn\'t new technology. The concept of
unit dose is almost as old as mountains. Barcode technology, on the
other hand, has been around a long time, too. Group purchasing
organizations, ASHP, and associations for years have said, this is the
standard. This is the direction we ought to be going to. What you\'re
hearing today shouldn\'t be a revelation.

Two to three years is not acceptable. I\'d offer the following four
recommendations.

In terms of which products should carry barcodes, drug manufacturers
should provide all prescription and over-the-counter drugs in barcode
packages down to a single unit of dose level.

In terms of the information to be provided, clearly the drug identifier,
name, strength, and unit needs to be there. But we also need the lot
number for recall purposes and the expiration date to prevent the
utilization of expired medications.

In terms of where the barcode needs to be placed on the package that\'s
going to be used by the patient, if you market a drug in America, you
must provide a unit dose or unit of use package.

In terms of when, as soon as humanly possible. Two to three years is not
acceptable. We haven\'t been successful with a voluntary effort. We
haven\'t been successful with market forces. Winston Churchill is
attributed to have said, \"We can always count on Americans to do the
right thing, but only after they\'ve exhausted all the other options.\"

(Laughter)

A mandate from the FDA is clearly needed at this time. Thank you.

MR. BARENBURG: Good afternoon. My name is Ron Barenburg, senior vice
president of Barcode Technology, Incorporated, or BTI. Some of you may
know us as International Barcode, which is our prior name.

BTI specializes in providing barcode software and hardware solutions.
Through our subsidiary S&X, we have provided and serviced Barcode Pro
software to over 120,000 clients worldwide over the past 13 years. Our
offices are located in New York City and Coral Gables, Florida.

Thank you for giving BTI an opportunity to address the FDA and the
healthcare community on the need for expert information concerning
reduced space symbology barcodes. This family of barcodes can encode the
NDC, or NDC, lot, and expiration date, on various packaging levels of
prescribed an/or over-the-counter medications.

Ladies and gentlemen, over the past one and a half years, I have
traveled well over 100,000 miles to visit many of the pharmaceutical
companies here today. Many of you are BTI\'s clients, and you are the
true visionaries.

You\'ve not only seen the value of reduced space symbology as an asset
in improving patient safety, but as a significant tool for product
control and traceability.

In August of 2001, under the guidance of the Uniform Code Council, BTI
software provided the RSS barcode graphics Abbott Laboratories used to
print labels on small vials and ampules. These RSS NDC labels were then
scanned at bedside at St. Alexis Hospital in Bismarck, North Dakota.
This was one of the first successful pilots of RSS on small unit dose.

Since that time, we\'ve come a long way. Two days ago, on July 24th,
Abbott Laboratories announced that they pledge to affix unit of use
barcodes to all of its hospital injectable pharmaceuticals and IV
solutions product lines by early 2003.

RSS is currently in use by other companies in the healthcare industry.
Its small size, powerful encoding capabilities, and human-readable
formats make it ideal to print machine-readable information on unit
dose, over-the-counter, and prescribed medications. And it is part of
the global UCC/EAN family of barcodes, ensuring worldwide acceptance and
use.

As its full potential is realized, RSS will also be a solution for
encoding information to aid in record tracking and to provide portable
databases on medical, surgical, and blood products. RSS barcode can
replace the human-readables currently preprinted on labels with a
minimum of effort and cost, encoding the NDC number with accompanying
human-readables.

As for the critical step of placing lot number and expiration dates on
products in realtime on the manufacturing line, BTI and its strategic
alliance partners, Domino Amjet and Zebra Technologies, have already
demonstrated the capability of inkjet and thermal inline printing at
line speeds, with laser printing in the near future.

Verification prior to webscan: Another BTI strategic alliance partner
has off-the-shelf and readily available verifiers to provide ANSI-grade
reports on RSS-generated barcodes.

Symbol and handheld scanners have both announced substantial sales of
RSS-enabled scanners, which can also read all the current symbologies in
use by healthcare today. Just as important is the RSS upgrade methods
available for existing scanners.

This should provide a comfort level that when pharmaceutical companies
encode information in RSS to reduce medical errors, end users can have
scanners that are available to read that information.

We look to the FDA for the following:

First, to establish a barcode symbology standard like RSS that has
software that is readily available and in use by healthcare today, a
barcode that is easily scanned by off-the-shelf, readily available
scanners.

Second, to provide for an aggressive but realistic time frame for
adoption of this barcoding requirement.

And third, to establish minimum machine-readable information
requirements with implementation of NDC, lot, and expiration date as the
fastest timetable.

But let us not forget the larger purpose of our work here today.
Machine-readable barcoding information and global standardization will
save lives. Thank you.

MR. SNIPES: I\'m Billy Snipes, executive vice president of Returns
Online, Incorporated. Our company provides comprehensive recall
management services to manufacturers, distributors, and retail entities
of pharmaceutical and medical device products.

I\'m also a pharmacist, and for the last 15 years have been involved in
the pharmaceutical returns industry and recall industry. We\'ve handled
hundreds of thousands of returned pharmaceutical products, and hundreds
of thousands of recalled pharmaceutical products. Therefore, I\'d like
to direct my statement this afternoon regarding the recall end of the
spectrum and how I think the safety of the patient could be enhanced
there.

Returns Online commends and supports the development of a regulation on
barcode labeling for human drug products and medical devices for the
following reasons:

Any human drug product or medical device that will be administered or
dispensed to the public should contain a barcode that identifies the
drug product through the NDC, the lot number of the batch, and the
expiration date of the product. To enforce this stance, let\'s consider
how accuracy and patient safety could be improved in the distribution of
the product, the dispensing of the product, and if necessary, the recall
of the product.

The manufacturer and/or distributor would have the ability to scan the
barcode to immediately indicate the lot number and expiration date that
it is shipping to an entity, either a retailer or another distributor,
and begin the building of a database that would track that drug from
either the manufacturer or the distributor to the next step. This
database has been mentioned several times today on trackability. How can
we track that product all the way?

The pharmacist, on the other hand, would be able to scan that bottle or
that container and capture that lot number, along with the
identification of the product, and further enhance that database. It\'s
now gone from the manufacturer to the distributor to the dispenser.

When he dispenses the medication to the public, he would also scan that.
It was mentioned earlier that several states had mandated the lot number
be put on the label of prescription drugs, and a lot of that, I think,
went away because lot numbers are hard to capture manually.

They are up to ten characters long, either alpha or numeric. Some of
them are stamped on the top of the boxes and are really hard to read. o
the barcoding of a lot number onto a container would make it much easier
to continue that tracking process.

Both the distribution and pharmacy software should have the able to
carry a database of previously recalled products. If you had previously
recalled lot numbers listed under NDC numbers in a database upon
dispensing or distributing, and you scanned that barcode on the
container that you\'re utilizing, if it had been recalled in the past,
that would be an automatic flag that that doesn\'t need to go out. I
think the gentleman before me talked about that happening.

And a recall is a one-time event for lot number, and specifically. And
if it\'s missed on the shelf, either in the pharmacy or in the
distribution center ‑‑ because about the only way we\'ve got now is just
to go manually look for it. Some of them are missed and some of them are
utilized later.

It\'s understood that some of these things could be done by manually
entering these lot numbers rather than utilizing the scanner and the
barcode technology. However, as I mentioned before, those lot numbers
are hard to read.

In conclusion, there are a number of far-reaching benefits to expanding
current barcode labeling requirements for pharmaceutical and medical
devices as it pertains to safety recall management specifically, the
accuracy and time efficiencies to monitor and assess the effectiveness
of a recall event, and come up with the recall effectiveness.

Additionally, automation in the distribution and dispensing level can
improve the identification and segregation of recalled product to
prevent further distribution, and safeguarding the public against the
dangers of receiving outdated and recalled product.

Dr. Feigal, I think, mentioned several times the trackability. One of
those was that out of a thousand to 1400 medical device recalls last
year, sometimes only 5 percent of the recalled product was in hand or
gotten back.

If we had the ability to track that through the lot number and the
databases that we could build in distribution, I think we\'d be a lot
better off. Thank you.

MR. HANCOCK: My name is Ed Hancock. I\'m president of American Health
Packaging. American Health Packaging is a packaging subsidiary of
Amerisource Bergen Corporation, the largest pharmaceutical distributor
in the United States.

We are a full-service packaging provider, offering pharmaceuticals
repackaged under the American Health Packaging label, as well as
packaged under contract to manufacturers under their label. We\'re
organized to provide packaging needs to the end users and retail
institutional markets, as well as to the manufacturers themselves.

Types of packaging that we utilize include bottles, unit dose blisters,
and pouches, utilizing the same processes as do the manufacturers
themselves. And we also offer pharmaceuticals also packaged in other
unit dose formats such as vials, prefilled syringes, et cetera, applying
barcodes to those packages.

For the sake of time, I\'ll confine my brief comments to making two
points out of the full comments I made to the docket. One is about
barcode content, the other about barcoded package availability.

Regarding barcode content, product and dose information is critical for
preventing administration of the wrong medication or strength. Other
information may be useful and may present opportunities for other
medication safety activities, but it\'s not critical to bedside
scanning, effectively screening for medication error.

The NDC number of a medication is specific to the medication and dose
and manufacturer. And since it is available extensively on medication
packages today, it makes the most sense to use rather than add any other
unique code to the package. The NDC is already the most common barcoded
information in pharmaceutical packages, as has been stated.

Other information considered, like package type or lot and expiration
date, are needed in pharmacies for inventory control purposes, but not
add significant benefit to bedside scanning. Screening for out-of-date
or recalled medications, as stated before, should not be left to deal
with at the bedside.

These matters are critically important, but must be dealt with
effectively prior to the medications reaching the patient. To regulate
barcode content for purposes other than bedside scanning risk adding
unnecessary complexity, which can deter implementation.

The recommendation then is to require the NDC only for the smallest
administered dose level. In most cases, that is the unit dose.

As a repackager of pharmaceuticals, we\'ve initiated applying barcoded
information on all types of packaging for all end use markets. Most
major repackagers in the United States have made similar decisions, and
apply barcodes to the dose level for unit dose package on
pharmaceuticals packaged under their label. A few have demonstrated the
capability to apply various symbologies. That creates a source of
barcoded packages for every setting where pharmaceuticals are dispensed
to patients.

The predominant use for barcoded information today is for the inventory
control in all settings, institution and retail. But a growing number of
hospitals are launching bedside scanning initiatives, as we\'ve heard,
and are beginning to use the barcoded information applied to the unit
dose packaging for that purpose.

In every case where that is happening today, the NDC number, and only
the NDC number, is being used as the key information to prevent
medication dispensing errors. As we understand it, this is the case at
the Veterans Administration facilities reportedly holding the leadership
position in these systems.

There are many potential uses of barcoded information, and many of them
are potentially beneficial to the safety of patients. But all the other
uses are facilitated by activities somewhere other than at the bedside,
where the most critical need is ensuring the patient is getting the
medication prescribed.

There are other systems being developed, developed to address the
potential for the physician to prescribe the wrong medication, or the
prevention of errors in transcribing of prescriptions. All of these
preventable systems must happen somewhere before the medication appears
at the bedside in the hospital setting.

Speaking of availability, even though commercial repackagers today offer
many products in unit dose formats for hospitals, many more could be
made available with a decision to allow interpretation of the recent
U.S. Pharmacopeia and National Formulary guidance as written.

The first supplement to USP 25-NF(20), effective April 1st, Packaging
Practice: Repackaging of Solid Oral Drug Product in the Unit Dose
Container, provides the capability of repackagers to establish a
beyond-use state of up to 12 months for oral solid pharmaceuticals
repackaged in unit dose formats. Under that guidance, many more products
could be made available to the barcode unit dose packages.

It is currently interpreted to be only applied to the in-house
repackaging dispensers, not to commercial repackagers. We encourage the
FDA to consider the extension of that language to commercial
repackagers. It would provide many more barcoded packages in hospitals
today. Thank you.

MR. COUGHLIN: Hello. My name is Mike Coughlin. I\'m the president and
CEO of ScriptPro. ScriptPro develops and provides dispensing automation
and robotics for pharmacies.

And unlike much of the discussion we\'ve heard this afternoon, we work
in the outpatient community/ambulatory pharmacy environment. And that\'s
a very, very important environment. A very large number of
prescriptions, the largest number, are filled there.

I wanted to show you how important barcode systems are in what we do.
And I submitted a report to the docket here that you have. And I wanted
you to be able to see how these systems work, not just tell you how the
systems work.

So you can go through and you can see how, in these kinds of
environments, a drug product is picked up, a manufactured drug product.
It is scanned, recognized by its barcode. It is poured into a robotic
dispensing cell. That has a barcode on it. The robot manages the process
by rechecking the cell. The robot prints a barcode label and puts it on
the product. It puts a picture on the product.

The patient can take the product home, theoretically scan a barcode, see
a picture of the drug they\'re taking, learn about it, see a picture of
the drug on the label. It\'s all tied together. It\'s a complete link.
That\'s sort of the heart of how these systems work. I\'ve given you
several examples in the reference material.

Obviously, these systems are barcode-driven. Barcodes are very
important. Unfortunately, sometimes when the patient or the pharmacist
scans that barcode with the NDC number on it, our famous NDC number
doesn\'t produce the picture that they were expecting. And this is a
serious problem relating to data structure, organization, coordination,
standards, et cetera.

That\'s the second half of the pictures in this report, which are not
all that pleasant, because what what they\'re going to show you is that
we have drugs out there that have the same barcode, but the drug appears
four different ways. Okay?

We have drugs out there that are repackaged and relabeled, but the same
barcode is there. We have drugs that are dispensed in different
packages, and the same barcode may appear on one package and maybe not
on another that\'s an interior pack.

It\'s very easy to find in our drug database systems ‑‑ it\'s very easy
to find a barcode that maps back to multiple drug products. The
numbering system for drugs has been used in different ways by different
manufacturers and repackagers, sadly enough, and this is unfortunate.
It\'s a data structure problem.

How did this happen? The National Drug Code neighbor, or NDC,
administered by the FDA is a ten-digit number that\'s made up of three
segments, the manufacturer number, a number that identifies the product,
a number that identifies the package size. But there is not even
agreement, never has been, on the sizes of these three segments, or
consistent use of these segments. And I\'ve got examples here and
pictures; you can see them.

For example, some manufacturers use the package size segment to indicate
a medical property of the product. Maybe it works for their inventory
control system, but that\'s not the way the NDC was supposed to be used.

There is so much confusion that most computer databases have expanded
the NDC to eleven digits just to get drug numbers that are not
duplicates. They do this by padding the FDA\'s NDC with a zero,
sometimes at the front, sometimes at the middle, sometimes just before
the end.

This has introduced even more confusion. You have before you graphic
proof that in our country\'s drug numbering system, almost everything
that can go wrong has gone wrong. Let\'s expand the use of the barcodes,
but let\'s not do this on the foundation of Murphy\'s law. Let\'s fix
this foundation before we build it to the next level.

Besides dispensing errors, there are other serious problems facing
pharmacy today: Critical shortage of pharmacists. Patient wait times are
too long. Not enough time for patient counseling. The good news is that
barcode-driven systems, properly designed, can help us solve all these
problems at once.

I have a series of recommendations that are in the report: that we fix
the numbering system itself; that we have a clear definition of what
barcodes are on the drugs; and above all, get the lot numbers and
expiration dates in these barcodes; and have a different barcode and a
different drug number for a different drug, even if it only looks
different, because if you can\'t verify it by looking at it, what good
does the number do for you? Thank you very much.

MS. LONGE: My name is Karen Longe. My company is Karen Longe &
Associates. And we specialize in assisting the healthcare industry in
the use of automatic identification and data capture, including barcode.
And I would like to thank the FDA and all of you here for the
opportunity to make comments on this issue that\'s really impacted the
entire industry, right down from the manufacturer to the patients.

However, today I\'m here as chair of the healthcare committee for AIM.
AIM is the association of automatic identification data capture
technologies. AIM is committed to standards development, education, and
market promotion. It has a membership of over 900 companies, global
companies, that provide the equipment and systems that capture, track,
and transfer information about people, places, and things.

I would first of all like to compliment the healthcare industry for
developing and approving standards. There are standards out there for
making products. Those standards include the health industry barcode
supplier labeling standard, the EAN/UCC system, and the ISBT-128 system
we\'ve heard about, as well as the health industry barcode provider
application standard for identifying other things that we\'re probably
not talking about today except for patients, that Ed Steane mentioned.

The most important part of developing the standards was to identify the
nature of the information that should be encoded in a barcode, and how
the various elements of the information should be identified and
presented. The really important part of that work, and perhaps really
the one I noticed, was a realization that before considering a
particular barcode symbology or any other kind of radio ‑‑ excuse me ‑‑
any kind of machine-readable technology, such as RFID or contact memory,
the business problem had to be clearly defined.

This is because all of these technologies that can be used to
automatically identify products and collect information, they\'re only
tools. These technology tools continue to change and, fortunately, in
most cases, improve.

I also would like to insert a word of caution. Some of the things we\'ve
been hearing today about the method to encode the information, to limit
it to barcode only or, I think, even more dangerous is just specify only
one barcode symbology.

Doing something like this would be like a specification back in the
mid-\'60s that said that all information had to be collected on punch
cards; or maybe the music industry said, okay, the only thing we\'re
ever going to do is allow 33-1/3 LPs. Where would we be today? While I
agree that standards are a must, please, don\'t be limited by the
technical advancements. Don\'t limit it so the advancements ‑‑ you
can\'t take advantage of them.

Another point that should be made: The industry is looking at barcoding
as a tool to improve patient safety, but there are many other business
benefits of barcoding that should not be overlooked. Manufacturers,
distributors, healthcare facilities, will benefit from the ability to
identify and track any type of product ‑‑ the drugs, medical devices,
blood ‑‑ from the point of manufacturing through distribution to
receiving, use by healthcare facility, and then of course the reordering
process, and everything starts again.

The technology that works best on a pallet of products is not
necessarily the one that works best at the unit dose or unit issued
level: Again, my concern over legislating a technology rather than
identifying the elements of information and how they are presented.
That\'s why healthcare developed standards that ‑‑ and they developed
the standards that improved the standards that are based on data
structures.

These standards allow for the use of several different AIM-approved and
tested symbologies. Data structures provide a description and the order
of the data to be encoded in a symbology or an RFI tag or a contact
memory button.

Be assured, though, that current technology out there ‑‑ the barcode
printers and scanners we\'ve been talking about today ‑‑ they do produce
and read the full range of publicly available barcode symbologies
identified by the healthcare standards.

Mandating the use of appropriate machine-readable technology, using a
health industry-developed and approved standard, will help to improve
patient safety and improve efficiencies in the healthcare chain; will
allow the industry to take advantage of advancements in technology to
meet their own business needs. However, mandating a particular
technology or a particular barcode symbology will limit the industry\'s
ability to reach its goals.

The members of AIM are ready to assist the FDA and the healthcare
industry as it moves forward to gain the benefits offered by automatic
identification and data capture. Thank you.

MS. SENSMEIER: My name is Joyce Sensmeier. I\'m here on behalf of the
Healthcare Information and Management Systems Society. It is a nonprofit
association focused on advancing the best use of information and
management systems for the betterment of human health.

We are based in Chicago. We have more than 13,000 individual members who
work in healthcare organizations throughout the world. The individual
members include healthcare professionals and hospitals, healthcare
systems, clinical practice groups, healthcare information technology
supply organizations, consulting firms, and government settings, in
professional levels ranging from senior staff to CIOs. HIMSS also serves
over 80 corporate members, which include suppliers and consultants in
the health information and management systems industry.

HIMSS strongly supports industry cooperation in achieving viable point
of care unit of use barcoding to reduce medical errors and improve
productivity. HIMSS members represent all aspects of the supply chain
impacted by unit of use barcode technology.

HIMSS is working to accelerate the adoption of barcoding at the point of
care through several initiatives: publication of a white paper on
barcoding; formation of a supply chain special interest group; formation
of a barcoding task force; development of a flow chart describing the
effect of barcoding technology on the continuum of care, which has been
submitted to the docket as Exhibit A to my statement; joining the
National Alliance for Health Information Technology as a founding
member, and you heard from that group this morning.

We have plans for developing a barcoding handbook to assist providers
with the implementation of this technology. And we have also developed a
HIMSS position statement on point of care unit of use barcoding, which
follows.

With the goal of moving towards a fully electronic health record system,
the Healthcare Information and Management System Society advocates the
comprehensive use of standards-based barcoding technology in the
healthcare environment.

And the Society recognizes that significant benefits of this technology
can be brought forward in multiple areas, including: patient
registration and admission; patient safety; clinical care delivery;
patient tracking; product supply logistics; materiel management
coordination; and patient accounting and billing, which was mentioned
this afternoon, not altogether unimportant to some people.

At our annual conference in January, we polled attendees to see what was
the use of barcoding technology in their organizations. Nearly 77
percent of the 619 respondents of the survey reported that their
organization was using barcoding technology in some way.

The two areas which reported the most prevalent use were laboratory, 45
percent of the respondents, and the supply chain/materiels management at
40 percent. However, only 15 percent of our respondents indicated that
their organization used barcode technology for medication administration
at the point of care.

It is our recommendation that barcoding be applied immediately to the
medication administration process. Use of this technology, along with
embedded decision support, which includes alerts and reminders, will go
far to enhance patient safety at the point of care and provide the nurse
with support in documenting and administering timely, accurate, and
effective medication therapy.

On a personal note, I would like to share a brief experience that I
witnessed back in the 1980s working as an R.N. in a 350-bed community
hospital. I worked with a nurse named Claire who was exactly the kind of
nurse that I would want taking care of me if I was a patient. She was
bright, thorough, efficient. She questioned the physician\'s orders when
they needed to be questioned. And she provided excellent care.

One day Claire made a grievous medication error. Her patient was a
300-pound truck driver who was recovering from arm surgery and various
multiple trauma injuries. He was on a blood thinner to prevent blood
clots.

The dose was ordered for 9:00 a.m. daily, but we had a protocol in place
that you should check the blood level of the drug prior to giving the
medication. On this particular day, in a rush, Claire gave the blood
thinner without checking the blood level. It so happened that the
patient\'s blood level was high, and the patient bled internally into
his surgical incision.

The blood was trapped. He developed compartmental syndrome, and
eventually became disabled from his truck driving job. Needless to say,
Claire was devastated by this situation, but each of us knew that it
could have happened to any of us.

Today\'s environment in healthcare is even more challenging than in the
1980s: fewer resources, a nursing shortage, and patients in the hospital
are sicker. Barcode technology provides a check and balance at the point
of care. With embedded decision support, it could prevent errors like
this. Please take action quickly so that this technology can be used to
help us provide optimal patient care.

MR. ROSADO: Good afternoon. My name is Edith Rosado and I\'m vice
president of pharmacy affairs at the National Association of Chain Drug
Stores.

NACDS is pleased to provide comments on the development of a regulation
on barcode labeling for human drug products. NACDS supports the use of
barcoding for all prescription products, vaccines, and over-the-counter
medicines to help improve the quality of pharmacy care provided to
patients, as well as to create efficiencies in the provision of
prescription services.

NACDS membership includes more than 200 chain pharmacies that operate
33,000 community retail pharmacies. Chain pharmacy is the single largest
segment of pharmacy practice, employing approximately 100,000
pharmacists.

Chain community pharmacy fills about 70 percent of the three billion
prescriptions provided to patients each year. It is predicted that
community pharmacy will fill roughly four billion prescriptions by the
year 2004. And again, 70 percent of these prescriptions will be filled
by chain community pharmacy.

This fact, coupled with the continuing shortage of pharmacists,
including 6500 vacancies alone just in chain community pharmacy, will
require that community pharmacy seek technological solutions to keep up
with the increasing demand of prescriptions in an efficient and a safe
manner.

NACDS supports the use of barcode through that supports not only the NDC
but also the lot number and expiration date of the product down to the
unit of dispensing package. With all three pieces of information
present, the product can then be tracked throughout the supply chain
system from point of distribution from the manufacturer to the end user
patient.

From a patient safety perspective, this is important information to
have, especially during a drug recall. Additionally, having this
information as part of the barcode makes tracking of inventory a much
easier task. This becomes a useful tool when dealing with return goods
and inventory management.

NACDS supports the use of barcodes as a way to compliment the various
programs that community pharmacies already have in place to enhance
patient quality. Many automated dispensing systems that are in use today
accomplish this goal.

A recent chain market survey shows that 45 percent of the chains
surveyed use barcode scanning for data entry and prescription
verification. One in particular allows the pharmacist to scan the
barcode on the label of the completed prescription.

This allows viewing of the image of the correct product. The pharmacist
can then compare and doublecheck the image against what is in the
pharmacy container before it is ultimately dispensed to the patient.

Pilot tests are also being conducted to investigate the use of barcoding
for proper drug selection. The barcode is scanned at the point of data
entry so that the NDC, drug name, and strength automatically populates
the necessary fields on the computer screen.

This eliminates the need to choose one drug from an entire alphabetic
list. When all fields are then populated, other dispensing functions,
such as drug utilization review and billing, may also be conducted since
many of these functions depend on the NDC number and specific product
information.

Enhancing barcoding will substantially improve the current FDA recall
system. In recall of product withdrawal situations, all affected product
must be identified or removed from the marketplace. Especially during
Class 1 recalls, the pharmacist must contact every person who has
received the drug to warn them of possible adverse reactions as well as
to communicate the need for product withdrawal.

If lot numbers were utilized as part of the barcode and recorded as part
of the patient\'s prescription record, identification of the affected
patient population then becomes easy. The pharmacist only needs to
contact those patients that have actually received the affected product,
eliminating unnecessary alarm to other patients since they would have to
contact all patients that received the prescription in question.

Additionally, the pharmacist would also be able to pull all this
unwanted stock expeditiously from their pharmacy shelves, their
warehouse, and distribution center.

Using barcodes could also facilitate other patient quality initiatives.
New technologies exist that allow the physician to send the prescription
electronically to the pharmacy provider of the patient\'s choice.
Electronic prescribing helps to eliminate ambiguous abbreviations and
specifies all elements needed for a complete order ‑‑ the drug name,
dosage, directions, and the route of administration ‑‑ thereby reducing
the chance for medication-related errors.

Barcoding technology also increases efficiency. In fact, barcoding
technology could be considered as an alternative to keyboard data entry.
Barcode scanners are faster than the human eye and much more accurate,
and tests have shown that barcode information has an accuracy rate of
one error in ten million characters, versus keyboard data entry error of
one in 100.

Efficiencies and technology in community retail pharmacy have allowed
the pharmacist to spend less time on the administrative tasks of filling
the prescription and more time interacting and counseling the patients
about their prescriptions. A recent study conducted by Arthur Andersen
found that pharmacists still perform many of the tasks filling
prescriptions that do not really need to be performed by pharmacists.

That is, they\'re spending over two-thirds of their time on tasks such
as computer data entry, counting and packaging medications, resolving
prescription insurance program disputes, and other clerical activities.
These non-clinical tasks consume pharmacists\' valuable time that could
be better devoted to patient care activities.

MS. DOTZEL: Thanks very much. We need to move on.

MR. RACK: I\'m Robert Rack, president of Rack Design Group and
BarcodeAmerica.com.

I have the benefit of 27 years of experience implementing automatic
identification solutions in barcode, and maybe uniquely, six years
experience working for a major pharmaceutical firm, so I understand the
issues from both sides, and providing end user solutions with our
present company.

Let\'s not decide that a 1 percent implementation level dictates the
technology chosen. The issues are safety, compatibility, reliability,
affordability, product security. Commonality of data structures are a
must. The ability to fit the data on the drug or medical device is
paramount. Potential lethality of the drug or device should be
considered in determining whether NDC number encoding alone is
sufficient. Increased danger mandates NDC number, lot number, and expiry
date and coding.

Product cost and potential for counterfeiting may mandate the use of a
supplemental four-character alphanumeric serial number to identify it to
the individual unit level. A four-character number would allow 1.6
million possibilities in a lot.

On some medical devices, this is necessary, too, to have traceability
because you cannot tell by looking at the device if certain operational
steps have been done on it, like heat treating and things of that
nature.

In terms of choosing a symbology, we could use code 128. We could use
RSS. We could use data matrix. All those codes should be acceptable.
NASA did their evaluation of product marketing, and they chose data
matrix codes, as have several other industries.

A point I\'d like to make is that handheld readers capable of reading
all existing codes can be purchased today for less than \$500. By this
time next year, due to the development of CMOS imagers on a chip, cost
of handheld readers will drop to \$200 to \$250 to read every symbology
that exists.

At this time, the capability for printing data matrix codes at the
fastest line speeds exists. RSS can be printed at lower line speeds.
High-speed thermal transfer or inkjet printing that can meet quality
requirements in vision systems that can read and determine anti-print
grades now exists for matrix codes, and can be run at line speeds up to
2,000 labels per minute.

We first installed data matrix systems on pharmaceutical lines in 1994.
It\'s proven technology. Virtually any system installed in the
pharmaceutical industry over the last three years for human-readable
date and lot inspection is also data matrix capable. The pharmaceutical
manufacturer merely has to enable this capability.

High-speed machine vision systems capable of reading RSS will start
becoming available within 60 days. These will initially command a
premium price. Installed costs for such systems will start at about
\$16,000. Costs for installed medium-speed data matrix systems start at
about \$8,000. It is anticipated that at some future date, the same
systems will read all the RSS variants at similar costs.

Data matrix could be installed and made operational sooner by
pharmaceutical companies than RSS codes. It also uses the least label
real estate, allowing it to fit where other symbologies will not.

Some existing online laser systems will be capable of being upgraded to
RSS if the laser manufacturers have the incentive to do so. It\'s not
assured.

What makes sense? Perhaps we should phase in lower lethality drugs first
using only NDC or UCC/EAN standards over the next 18 months. For higher
lethality drugs or drugs with higher counterfeit potential, the NDC, lot
and expiry, and possibly sequential numbers should be phased in over a
36-month period, giving time to acquire the printing systems, the online
printing systems, that are needed and need to be implemented.

This way, the pharmaceutical manufacturers will have time to invest,
install, and validate the online printing and inspection systems. People
have to remember that time is required to do validation and do the
equipment purchase. But the first phase will not require these upgrades
to online printing capability since this data can be printed offline.

Manufacturers could also possibly chose the 50 percent of their products
that will fall into the first phase. My concern otherwise is that
implementation will be stalled and deadlines extended, much as what
happened with component verification during the \'90s.

Lastly, consider that image-based readers are capable of reading all
symbologies and performing image capture.

A point to consider: Perhaps if the physicians\' signatures were
captured, you would be more careful and lower the opportunity for
transcription errors. Thank you.

MR. CREQUE: Good afternoon. I\'m Stewart Creque, vice president of
business development of findtheDOT. Thank you for allowing me to make
this presentation to you today regarding the barcode labeling
regulation. We put specific answers to your questions into our docket
submission. I just want to use this presentation to set the background
for that.

findtheDOT has developed a unique new technology for creating links
between physical objects and digital data that relates to those objects.
This alternative to barcode solves problems that have so far prevented
wider acceptance of machine-readable codes for patient safety.

Automated identification of unit dose packages at the patient bedside is
a key element and the last line of defense in preventing medication
errors in the clinical setting. While bedside verification systems using
traditional barcodes have shown good success when used as designed in
reducing medication errors, these systems have not achieved widespread
acceptance. This is due to three factors.

The cost of packaging unit dose medications to fit barcodes: Traditional
barcodes are large and therefore require large packages, which waste
material and add cost. And they also rely on inline printing at
production speeds for variable data elements.

Cost of bedside verification systems: Barcode scanners are relatively
expensive and are incorporated into very costly systems requiring major
IT investments. If the current barcodes are replaced by RSS, CS, or data
matrix-type codes, acquisition costs of scanning hardware will rise
substantially.

And third, reluctance of bedside staff to utilize unwieldy barcode
scanning hardware and software: Barcode scanners are inconvenient at the
bedside and the software driving them is generally complex, slowing down
the bedside nurse.

findtheDOT\'s MedDot technology improves both sides of this tradeoff by
offering, first, a code physically small enough, just 5 millimeters in
diameter, to fit onto existing packaging and on other small spaces such
as infant wristbands or custom dispensing labels.

Second, low-cost readers within the reach of hospital capital budgets
such that every bedside nurse can have a personal reader at an
affordable total cost to the hospital, including a low-cost, low-power
RF link in each device.

And third, a linking mechanism whereby any MedDot can link to a related
data set that can contain any types and quantity of data, both static
and dynamic. Dr. Combes of the AHA alluded to that in his remarks this
morning.

This removes barriers both to rapid deployment of machine-readable codes
on unit of use packages and rapid implementation of bedside scanning
systems at hospitals. And further, because MedDots support a code space
of ten billion billion unique values, each and every unit dose
medication, biologic product, and medical device can have a unique
serialized identifier link to a specific design, manufacturing, and use
data, including who ordered it, who dispensed it, and who administered
it.

Instead of being forced to print at production line speeds, the
manufacturer can preprint MedDots onto packaging material along with the
nonvariable data, inspect them offline, and then pre-load the database
with product information.

At the time of packaging, the manufacturer updates the MedDot database
with the lot number and expiration date. And when the product is sold,
the data can be transferred to a local system at the purchasing
hospital. Of course, MedDots can also be generated in the hospital
pharmacy for nonstandard or custom preparations.

On the nursing floor, a nurse uses the MedDot reader to identify the
patients assigned to her that shift and each of her patients\'
medication orders, the MAR, are wirelessly transmitted to her MedDot
reader. As she prepares to administer medication, she reads MedDots on
the patient wristband and on the unit dose package and receives positive
confirmation that the five rights of medication safety are satisfied,
and, of course, a negative confirmation if they are not.

MedDots all have the same small size and distinctive appearance for ease
of visual identification. And the MedDot reading device can prompt for
further data such as route of administration, and also can accept
charting notes from a pocket menu card.

The system thus supports automated charting as well as reporting of
near-misses or of errors. It also supports inventory control and other
administrative functions in the hospital.

So this simple technology can be incorporated easily with existing
hospital IT systems. And, moreover, findtheDOT will gladly license the
MedDot reading capability to vendors of barcode-based systems, and we
will also license pharmaceutical manufacturers and barcode equipment
manufacturers at very low cost in order to make MedDots a healthcare
standard. Since bedside scanning is still rare, there is really no
significant installed base of barcode scanners to be displaced in that
application.

The MedDot is an innovative technology that breaks the existing logjam
in acceptance of machine-readable codes for bedside verification, and as
such, it offers an immediate increase in patient safety. Thank you.

MR. EDZENGA: Good afternoon to all that\'s left. I\'m Larry Edzenga. I
represent the vaccines biological products manufacturers\' position on
unit dose barcoding of VISI. Just a reminder:

VISI is the Vaccine Identification Standard Initiative. I\'m
representing the vaccine manufacturer member companies from Aventis
Pasteur, Careon, GlaxoSmithKline, Merck, and Wyeth, working in
conjunction with the Centers for Disease Control and Prevention, Bruce
Weniger.

In our effort to reduce medical errors, the VISI members companies align
with the PhRMA statement that was presented earlier as a co-contributor
to the development of that document.

VISI members are ‑‑ I want to say, though, unlike PhRMA, our challenge
with the vaccine and vaccine labeling is a little different than
PhRMA\'s. It\'s included in PhRMA\'s recommendation. However, we have
some particular issues around size when it comes to prefilled syringes
and vials.

So VISI member companies have researching barcode technologies in the
market, done extensive work in this area, in our effort to meet very
small available space to print on vaccine labels and at high running
speeds in production, and in particular, variable data, and in
particular, for the base label, let alone any detachable labels.

VISI member companies conclude that reduced size symbology is required,
and specifically two-dimensional data matrix is selected code to barcode
vaccine labels, again because of size. VISI member companies feel it has
met the objective for vaccine standard barcode identification for users
from affordable scanning technology now available, and can read multiple
barcode symbologies.

VISI member companies, however, are also concerned the public health
organizations and physician offices will use barcodes provided on labels
by the industry. As we heard earlier, vaccines make up about 1 percent
of hospital dispensing at bedside.

Government agencies will need to educate and poll the medical community
for the appropriate use to meet the objectives barcodes are intended.
VISI member companies want to continue to work with the CDC, the agency,
and healthcare stakeholders of this process in an effort to reduce
medical errors. Thank you.

MR. RIDDICK: I\'m John Riddick, director of quality assurance and
regulatory affairs for Novation. I requested to speak on behalf of
Novation today because of my expertise in the regulatory and quality
arena, especially as it relates to medical labeling and barcode
applications. I also come to you today as a representative of America\'s
leading hospitals.

Novation is the supply company of two large not-for-profit hospital
alliances, VHA and UHC. These alliances represent more than 2,300
community-based medical centers ranging in size from 20-bed rural
facilities to multi-thousand-bed teaching institutions. We estimate that
the two alliances account for about 35 percent of the occupied beds in
the country. In 2001, the purchases of Novation contracts amounted to
almost \$18 billion.

Through our work with Novation, we regularly come into contact with
physicians, nurses, pharmacists, and other clinicians practicing in our
hospitals of all sizes. Continually, they tell us that one of the top
priorities for their hospitals, in keeping with their focus on patient
safety and cost-effectiveness, is barcoding on as many medical products
as possible. Selection of safer products and prevention of label mixups
and medication errors are key goals in Novation institutions.

As part of our member-driven philosophy, Novation has launched a
comprehensive safety initiative, including, among other programs, the
requirement for machine-readable barcodes at unit of use. A daunting
challenge for all of us is the application of barcodes on the very small
product containers, especially pharmaceutical vials, in light of the
FDA\'s current requirements around human readability.

There are certainly smaller barcodes in the newer emerging technologies.
We all want to make sure that the systems in each of our individual
hospitals are capable of reading any applied barcoding.

As requested in the Federal Register, our guidance to FDA is as follows:

Number one, mandate the use of machine-readable barcodes at the unit of
use level on all dosage forms of commercially available pharmaceutical
products, blood products, and vaccines.

Number two, initially demand that all the information contained in the
NDC number is included in that barcode.

Number three, with respect to time frames, urge the suppliers to make
this change as soon as economically feasibly possible. Novation has set
the deadline for our suppliers for 2004.

Number four, consider the inclusion of lot numbers and expiration dating
in the barcode when the technology is more widely available and when the
end users are more universally prepared to read and scan these new
technologies within their institutions. Certainly, inclusion of the lot
number and expiration date will benefit end users when tracking expired
products or recalled products, and Novation supports the inclusion and
asks FDA to address it as soon as technically feasible.

Number five, eventually consider the use of barcodes on medical devices.
As relates to safety issues, prevention of medication errors, et cetera,
many medical devices would not even need a barcode. Priority should be
given to those devices that have potential to adversely affect patient
safety.

As stated by many here today, the critical need to move immediately in
the area of pharmaceuticals should not be diluted by consideration of
barcodes on medical devices at this time.

Number six, evaluate and promote new and emerging technologies that
we\'ve heard about so many times today, such as radio frequency, dot
matrix, 2D, or NSS, as they become more readily available and easily
embraced by end users.

In the near term, however, FDA should not require the application of
barcodes beyond the scope of one-dimensional symbologies currently
available and widely used.

And number seven, consider relaxing the rules surrounding
human-readability requirements, especially in the extremely small
containers. If there were more space available on the small labels, the
supplier and the end user would benefit from the added flexibility.

Although suppliers are in agreement that barcoding would be a positive
step, all the ones that we talked to tell us the same thing we hear from
our customers: Yes, it\'s something they would like to do. We feel that
a standardized, comprehensive FDA directive will further move those
suppliers to accept this important enhancement, as well as lead
consistency to the process.

Most imply, these improvements could only promote patient safety and
help to reduce medication errors while streamlining cost savings and
efficiencies. Thank you.

MR. HENNUM: Hi. I\'d like to thank the FDA for the opportunity to
address the proposed regulation on barcode labeling. My name is Vaughan
Hennum. I\'m CIO for Portex, Inc., which is part of Smiths Medical. And
I am representing an actual mid-sized device manufacturer selling to the
acute care marketplace who might be affected by a barcode regulation.

I\'m going to focus principally on the economic impact questions, and
try to share a few insights about what we think something like that
might cost us. I think our situation might be illustrative for other
suppliers. I think, honestly, just from a casual survey of other device
manufacturers, device manufacturers have a way to go in this arena.

First off, will barcode printing costs cause changes in labeling for the
Smiths medical companies, it absolutely will. We have implemented
barcode item number case label printing, but we are not far along on
unit of use.

There\'s no question that our regulatory function demands validation and
verification of any barcode labels. That\'s a real cost. We do item
numbers on the case label, but lot number and expiry dates, we\'ve got a
ways to go.

We do agree there are equipment solutions out there. But one of the
things that really concerns us the most is the rate of technology
acceptance and the time for this regulation to become effective.

I\'m going to read you a quote. \"HIDA and the industry need
medical/surgical manufacturers to identify with industry standard
product barcodes by\" ‑‑ the target date for very small unit of use was
July 1997. That was published in July 1995.

That hasn\'t happened, and the real question is, why not? And I think it
comes down to, who is the owner or stakeholder of barcodes? If you
examine other industries that have been very successful with barcoding
throughout the supply chain, whether it\'s retail or automotive,
ultimately you had a large end user who said, if you want to sell to me,
you must barcode.

In Japan, which has been alluded to, we are actually seeing now some
large university hospitals saying, even if the price is higher, we will
buy only barcoded products at the unit of use level with lot number and
with expiry date.

So the challenge, it seems to me, in the health industry, which does not
have large consolidated hospitals to drive all elements of the supply
chain to barcode, is how do we get there? The solution that we\'re
talking about is an FDA regulation, which has compliance through the
entire supply chain.

The reality is, for a medical device manufacturer, barcoding at the unit
of use level, item, lot number, expiry, will cost a significant amount
of money and time to implement and to validate, with very little
internal gain, especially considering, as someone pointed out today, the
multiple language labels. And I\'m going to actually go through what
we\'ve estimated our costs to be for our company.

So I guess I would say if we are to move forward with this expenditure
to avoid the failures of past voluntary compliance initiatives, the
regulation must cover the entire supply chain with standard,
well-accepted barcode symbologies to avoid the high cost of new
technology, with existing data structures such as UCC-128.

Just as a for instance, we have about 3,000 SKUs. We\'ve estimated that
to do the entire piece of capital investment as well as labor, IT, et
cetera, would look like about \$650,000. And that doesn\'t include the
ongoing cost of additional labels.

For Smiths Medical, across all of the manufacturing companies, we\'ve
estimated that the cost would be three-quarters of a percent to 1
percent of our revenues to effect this regulation.

So in conclusion, then, my point in making this presentation is, we
think the benefits appear to be clear for barcoding. It seems like it\'s
a very good public policy to improve patient safety. But if the FDA
regulates barcoding, it must drive that compliance throughout the entire
medical device supply chain by regulation for patients to obtain the
benefits of our expenditures.

I am not limited just to suppliers. We think that it would take us about
two years to actually implement this regulation. We could do item number
first. Lot number and expiry date are more challenging.

Thank you very much for the opportunity to make this presentation.

MR. PEOPLES: Okay. MACs people, are we still all awake? I am a
pharmacist. I have both community and hospital experience. I currently
am the president of Rxscan. Rxscan has for several years developed
national drug barcode scanning equipment and processes used to reduce
medication dispensing and administration errors.

Currently, our equipment is used to verify the accurate dispensing of
over 100 million prescriptions per year. Hopefully, this practical
experience means I know something about what I\'m going to talk about
today.

Since we started out today with a video, as a windup, why don\'t we just
do a quick 30-second live case demonstration. Here\'s the patient. This
patient is represented by a barcode. I scan that barcode. The scanner
now knows the information on what drug this patient is supposed to
receive.

I now take my medication container. It could be this enteric coated
aspirin that is barcoded here. I scan this product. It yells and screams
at me and gives me a red light, saying I just about gave the wrong
medication to this patient. That\'s two seconds, and it takes two
seconds of training. This is what we\'ve spent the whole day talking
about. This is what all of this effort is for.

Which medical products should carry a barcode? It is my belief that all
healthcare products should carry a barcode. This includes medical
supplies, prescription medical products, and over-the-counter should
carry a national drug barcode.

It is necessary, obviously, to increase utilization of automation to
decrease medication errors and distribution costs. We include
nonprescription products because OTC medications are also administered
to patients in healthcare facilities and sometimes dispensed by
prescriptions in community pharmacies, OTC medicines, like aspirin,
laxatives.

Everyone in here would like to make sure they receive the right
laxative. Right? Or how about not get a laxative when they\'re not
supposed to? Vitamins are often prescribed. Prescribing them is often
done, so is there a complete medical record of what the patient is
taking and the specific directions for that patient on that patient\'s
container?

Currently many over-the-counter products, such as diabetic supplies and
insulin, have both an NDC number and a UPC, a universal product code
number. And usually it is the universal product code number that is
barcoded. Why did we have two identification numbers for the same
product? Also, for billing purposes in healthcare, the UPC number is not
normally recognized. It\'s only the NDC number.

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, barcoded
on all over-the-counter products will expedite the identification of
these potentially dangerous interactions using software drug interaction
programs.

What information should be contained in the barcode? The minimum
information is the National Drug Code. That is the common ID that we
need to eliminate dispensing or administration errors. Lot number and
expiration date? We\'ve all got lots of great reasons why we need those,
but it is not the most important element to eliminate these errors.

Our statistics show ‑‑ obviously, we can capture data in this scanner.
Our statistics show that over 5 percent of the first medication that is
pulled from a shelf to supply to a patient is not the medication that is
in the patient\'s medical record. Okay?

Should we adopt a specific barcode symbology? Pros and cons:

Pro: Adopting one barcode symbology would speed up the process of
adopting universal medication barcode scanning by, A, allowing the
hardware manufacturers producing everything from barcode readers to
barcode 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
barcoding accomplished as rapidly as possible.

Con: It restricts future adoption of improved barcode symbology
technology.

We believe a compromise is to have just a general requirement that
whatever we come out with has a linear component that will work with
today\'s equipment. That way, today\'s stuff will continue to work for
as long as it needs to work anywhere in the distribution process.

What packages ‑‑ or where should it be on the package? We\'d like to see
it down to the package that gets closest to the patient. So here\'s a
sample. There\'s a barcode on the outer package. It comes in boxes of
three. This is an inner package. This is what the average person is
going to get. It also has a barcode.

But what happens when we get into a situation where what the patient
actually is going to get is the individual dose right here? Okay. That
also is barcoded. That\'s what we mean when we say, get down to the dose
that gets closest to the patient.

What products already contain barcodes?

MS. DOTZEL: I just need to ask you to wrap up.

MR. PEOPLES: Sure. Basically, in community pharmacy, which is where most
of our stuff is used, most community pharmacy products are bulk.
They\'re already packaged. The stuff that we\'re really talking about
today is hospital and nursing home-based. Thank you very much.

MS. DOTZEL: Okay. Well, we heard a lot of great information this
afternoon. I apologize to people for having to cut you short or not give
you sufficient time to probably give us all the information that you
wanted to give us.

Obviously, we, you know, heard a lot of really good things. We think
that everybody out there has a lot of valuable information. And we
encourage you to give us the additional information you have. Submit
your comments to the docket.

As I said earlier today, the docket closes on August 9th. The docket
number is on the notice, the meeting notice you have. And if you don\'t
have a copy of that, you can probably still get a copy out of the
registration desk or from our website.

I think we heard a lot of support today for this initiative. We heard a
lot of people say that ‑‑ you know, express their feeling that we needed
to approach this thoughtfully. We needed to think about, you know, the
scope of this. We needed to think about implementing and how and how far
we would go with our implementation.

And I think another big thing that we heard today was flexibility and
the need to adopt something that does ‑‑ that allows for, you know,
technological innovation as we move forward.

We appreciate everybody\'s input today. And again, I urge people to
continue to give us that information over the course of the next few
weeks while the docket is open. And with that, I will close the meeting.
And thank you very much for your participation today.

(Whereupon, at 4:50 p.m., the public hearing was concluded.)

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