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[Senate Hearing 107-79]
[From the U.S. Government Publishing Office]

                                                         S. Hrg. 107-79

                TECHNOLOGY AND PRESCRIPTION DRUG SAFETY

=======================================================================

                                HEARING

                               before the

                       SPECIAL COMMITTEE ON AGING
                          UNITED STATES SENATE

                      ONE HUNDRED SEVENTH CONGRESS

                             FIRST SESSION

                               __________

                             WASHINGTON, DC

                               __________

                              MAY 3, 2001

                               __________

                            Serial No. 107-4

         Printed for the use of the Special Committee on Aging

                    U.S. GOVERNMENT PRINTING OFFICE
73-598 PS                   WASHINGTON : 2001
_______________________________________________________________________
            For sale by the U.S. Government Printing Office
 Superintendent of Documents, Congressional Sales Office, Washington, 
                               DC. 20402

                       SPECIAL COMMITTEE ON AGING

                      LARRY CRAIG, Idaho, Chairman
JAMES M. JEFFORDS, Vermont           JOHN B. BREAUX, Louisiana
CONRAD BURNS, Montana                HARRY REID, Nevada
RICHARD SHELBY, Alabama              HERB KOHL, Wisconsin
RICK SANTORUM, Pennsylvania          RUSSELL D. FEINGOLD, Wisconsin
SUSAN COLLINS, Maine                 RON WYDEN, Oregon
MIKE ENZI, Wyoming                   EVAN BAYH, Indiana
TIM HUTCHINSON, Arkansas             BLANCHE L. LINCOLN, Arkansas
PETER G. FITZGERALD, Illinois        THOMAS R. CARPER, Delaware
JOHN ENSIGN, Nevada                  DEBBIE STABENOW, Michigan
                                     JEAN CARNAHAN, Missouri
                      Lupe Wissel, Staff Director
                Michelle Easton, Minority Staff Director

                                  (ii)

  

                            C O N T E N T S

                              ----------                              
                                                                   Page
Opening statement of Senator Larry Craig.........................     1
Statement of Senator Debbie Stabenow.............................    27
Statement of Senator Ron Wyden...................................    33
Statement of Senator John Breaux.................................    49

                                Panel I

Janet Corrigan, Ph.D., Director of the Board of Health Care 
  Services, Institute of Medicine, The National Academies........     2
Harold Allen, M.D., practicing orthopedic surgeon in Loudon 
  County, VA, and President, Picos, Inc..........................     9
Peter Klein, R.Ph., Pharmacist and Vice President of Business 
  Development, En-Vision America.................................    16
Neil Reed, Pharmacist and Director of Pharmacy, Eastern Idaho 
  Regional Medical Center........................................    34
David W. Bates, M.D., Chief, Division of General Internal 
  Medicine, Brigham & Women's Hospital; Medical Director of 
  Clinical and Quality Analysis, Partners HealthCare System; and 
  Associate Professor, Harvard Medical School; on behalf of the 
  American Informatics Association...............................    52
Marty R. McKay, R.Ph., Partner/Manager, Pearson Drugs; President 
  of Louisiana Pharmacist Association; and Chief Pharmacist of 
  Pearson Medical Technology, LaCompte, LA.......................    58

                                 (iii)

  

 
                TECHNOLOGY AND PRESCRIPTION DRUG SAFETY

                              ----------                              

                         THURSDAY, MAY 3, 2001

                                       U.S. Senate,
                                Special Committee on Aging,
                                                    Washington, DC.
    The committee met, pursuant to notice, at 2:30 p.m., in 
room SD-608, Dirksen Senate Office Building, Hon. Larry E. 
Craig, (chairman of the committee) presiding.
    Present: Senators Craig, Breaux, Wyden, and Stabenow.

     OPENING STATEMENT OF SENATOR LARRY E. CRAIG, CHAIRMAN

    The Chairman. The committee will be in order.
    Good afternoon, everyone, and thank you for joining us here 
today at the Special Committee on Aging, as we examine the 
critical issue of technology and prescription drug safety.
    It is alarming to find that every year between 44,000 and 
98,000 people are injured or die due to medical errors. In 
fact, just last month, the American Pharmaceutical Association 
estimated that medication misuse cost the economy over $177 
billion per year.
    As Chairman of the Special Committee on Aging, this issue 
is of particular concern to me. Senior citizens often must rely 
on multiple medications to control the many conditions 
associated with aging, conditions like high blood pressure, 
diabetes and arthritis. Each time a patient takes medication, 
they risk an adverse drug event. Since seniors take several 
different kinds of medications each day, they face the 
additional risk of experiencing a drug-to-drug interaction. 
Therefore, it is imperative for us to identify and develop new 
strategies to reduce medication errors.
    The private sector has been working hard to resolve the 
dangerous problems associated with prescribing and dispensing 
errors, and I commend them for their innovative ideas. As 
Congress considers legislation to add a prescription drug 
benefit to the Medicare program, it is important to examine the 
medical technology available to reduce medication errors.
    The witnesses today include Dr. Janet Corrigan, the 
Director of the Board on Health Care Services at the Institute 
of Medicine; Dr. Harold H. Allen, Jr., M.D., an orthopedic 
surgeon and founder of Picos; Peter Klein, the Vice President 
of En-Vision America; Neil Reed, the director of pharmacy at 
the Eastern Idaho Regional Medical Center in Idaho Falls, ID.; 
Dr. David Bates, Division of General Internal Medicine at 
Brigham Women's Hospital, America; and Marty McKay, President 
of the Louisiana Pharmacists Association.
    Because of the table configuration, we have broken these 
into two panels today, and we will proceed accordingly. I want 
to thank all of you for agreeing to testify before the Aging 
Committee this afternoon. We certainly do appreciate your 
participation and look forward to your testimony.
    Now let me ask Dr. Corrigan to proceed. Thank you for being 
with us.

STATEMENT OF JANET M. CORRIGAN, PH.D. DIRECTOR, BOARD ON HEALTH 
  CARE SERVICES, INSTITUTE OF MEDICINE, THE NATIONAL ACADEMIES

    Ms. Corrigan. Thank you.
    Good afternoon, Mr. Chairman. I am the director of the 
Institute of Medicine's Board on Health Care Services, which is 
responsible for IOM's work in the area of health care delivery, 
coverage, access and quality. For the last 3 years, I have also 
directed the IOM's Quality of Health Care in America Project, 
and I am here today representing the IOM Committee which in 
late 1999 released the report, ``To Err is Human.'' It most 
recently released a second report, called ``Crossing the 
Quality Chasm: A New Health System for the 21st Century.''
    In its first report, the IOM committee concluded that as 
many as 44,000 to 98,000 people die in a given year as a result 
of medical errors, more than the number who die from motor 
vehicle accidents, breast cancer, or AIDS. These numbers 
reflect only patients who died in hospitals, and only deaths 
for which there was adequate documentation in the medical 
record for two reviewers to concur that the death was 
attributable to error.
    Medication errors are one of the most common types of 
errors. The Harvard Medical Practice Study, which looked at 
more than 30,000 discharges from 51 hospitals in New York 
State, found that adverse events, manifest by prolonged 
hospitalization or disability, occurred in almost 4 percent of 
hospitalizations, and about one-half of these adverse events 
were judged to have been preventable. Drug complications were 
the most common type of adverse event, about 19 percent, one in 
five, followed by wound infections and technical complications.
    Medication errors occur frequently in hospitals. For 
example, an analysis of near 300,000 medication orders written 
during a 1-year period estimated the overall error rate to be a 
little over three errors for each 1,000 orders written. The 
rate of significant errors, those that result in adverse 
clinical consequences, was almost two per 1,000 orders. These 
estimates of the incidence of medication errors are undoubtedly 
low because many errors go undocumented and unreported, and 
some errors go undetected in the absence of computerized 
surveillance systems.
    An estimated 770,000 people are injured or die each year in 
hospitals from adverse drug events. Not all, but many, if not 
most, of these adverse drug events are preventable.
    In hospital environments, most medication errors can be 
classified into one of five categories: a dose error, a known 
allergy, wrong drug/wrong patient, route error, or error in 
frequency. Over 50 percent of errors occur at the time of 
physician ordering or nurse administration. Two studies 
attribute a sizable proportion of adverse drug events, about 
half, to excessive drug dosage for the patient's age, weight, 
underlying condition, and renal function. The potential for 
medication related error increases as the average number of 
drugs administered increases.
    Most studies of medication error have focused on 
hospitalized patients. We know very little about errors that 
occur outside the hospital. In 1998, nearly 2.5 billion 
prescriptions were dispensed in U.S. pharmacies. Errors 
undoubtedly occur in the prescribing of drugs in physician 
office practices, the dispensing of drugs by pharmacists, and 
the administration of drugs by patients and their families.
    I want to emphasize that errors are seldom due to 
carelessness or lack of trying hard enough on the part of 
health care professionals. More commonly, errors are caused by 
faulty systems, processes and conditions that lead people to 
make mistakes, or fail to prevent them. Errors can be prevented 
by designing systems that make it hard for people to do 
something wrong and easy to do it right.
    Other industries, safe industries, such as aviation, 
chemical manufacturing and nuclear power, they learned this 
lesson long ago. While insisting on training and high standards 
of performance, they recognize these are insufficient to ensure 
safety. They also pay attention to factors that affect 
performance, such as work hours, work conditions, information 
technology, team relationships. Health care must do likewise.
    The good news is that much of the knowledge and technology 
needed to prevent most errors already exists. The key to 
reducing many types of medication errors is the wise use of 
computerized systems. Several evaluations conducted by the 
Agency for Health Care Research and Quality, have shown that 
various types of computer monitoring systems are very 
promising. Anywhere from 28 to 95 percent of adverse drug 
events can be prevented.
    As important as medication errors are, they are only the 
tip of the iceberg. In its most recent report, ``Crossing the 
Quality Chasm'', the IOM committee concluded that safety 
reflects only a small part of the unfolding story of quality in 
American health care.
    Other defects are even more widespread. As medical 
knowledge, science and technology have advanced at an 
extraordinary pace in recent years, the health care delivery 
system has floundered. We fall far short in our ability to 
translate knowledge into practice and to apply new technology 
safely and appropriately.
    The challenges of applying information technology to health 
care should not be underestimated. This is a very complex 
sector of the economy. With huge numbers of transactions, 
sizable capital investments are required, and large numbers of 
providers whose behavior has to be influenced.
    In the absence of a national commitment and financial 
support to build a national health information infrastructure, 
progress on quality and safety improvement will be painfully 
slow. The topic today is a critical one, and a first step in 
the right direction.
    Thank you for this opportunity to testify, and I would be 
happy to answer any questions you have.
    [The prepared statement of Ms. Corrigan follows:]
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    The Chairman. Doctor, thank you very much.
    Now let us turn to Dr. Harold Allen, a practicing physician 
from Loudoun County, right here next door in Virginia, I 
understand.
    Dr. Allen. Not too far out.

   STATEMENT OF HAROLD H. ALLEN, M.D., PRACTICING ORTHOPEDIC 
   SURGEON, LOUDOUN COUNTY, VA, AND PRESIDENT OF PICOS, INC.

    Dr. Allen. Good afternoon, Mr. Chairman, Mr. Ranking 
Member, and distinguished members of the committee and 
assembled guests.
    My name is Dr. Harold Allen, and I have practiced 
orthopedic medicine for about 12 years. I currently am 
practicing in Loudoun County, VA and serve as an orthopedic 
surgeon at Loudoun Hospital Center, which is located in Loudoun 
County, VA. I am also the President of Picos, Inc., a software 
firm also based in Loudoun County.
    I want to thank Chairman Craig, Senator Breaux, and members 
of the Senate Special Committee on Aging for allowing me to 
testify on how technology can be used to ensure the safe and 
efficient distribution of prescription drugs.
    As the latest U.S. Census figures show, America is a 
growing nation. As the latest figures also show, America is 
becoming an older nation as well. More and more Americans than 
ever before will need health care in the coming decade. We owe 
it to them, as physicians, and as leaders, working together, to 
see that these patients get effective health care in as safe 
and as efficient a manner as possible, regardless of whether 
these patients live in a big city like Philadelphia or New 
Orleans, or in a smaller community like Shoup, ID, Evansville, 
IN, or Cape Girardeua, MO.
    Simply put, it is essential that efforts are made to 
modernize the way doctors, hospitals and health care providers 
keep accurate patient medical histories and medical records. It 
is now more important than ever that this system be modernized. 
With the proliferation of new treatments and medicines 
available, and with Congress perhaps on the verge of approving 
a prescription drug benefit that will make helpful drugs become 
even more readily available, the risk of mistakes being made in 
the dissemination of medicines to patients will also increase. 
It is a simple math problem. More people having more access to 
drugs means yes, more benefits, but also more risks if those 
drugs aren't being properly prescribed and distributed.
    These risks include, but are not limited to, giving the 
wrong drug to the wrong person, prescribing one drug that 
causes adverse and possibly fatal effects when combined with 
another, or perhaps distributing to a patient the wrong amount 
of a drug, which would also, of course, cause problems.
    Medicines save lives and also improve our quality of life, 
so, naturally, we want as many people as possible to have 
access to the medicines they need. But the mismanagement of 
medicines can do more than just hurt people. It can kill. So 
the question is, how do we prevent these mistakes from 
happening?
    Well, no doubt some mistakes are caused by human error, bad 
judgment calls, inexperience and oversight. That can be best 
prevented by ensuring that all medical personnel are properly 
trained, certified, and supervised. But another major concern, 
as far as I'm concerned, is the system of medical recordkeeping 
in America's hospitals and private practices.
    I can speak to this from personal experience as a 
physician. I can tell you, I have sometimes read prescription 
forms and patient medical records that I couldn't really read. 
I could barely read them or tell what the dosages were on any 
part of the medical record at all. Furthermore, I have 
encountered situations where a patient's medical records were 
incomplete. Vital information was missing. As a physician, let 
me reaffirm your common sense when I assure you, this is not a 
good thing.
    If a patient has had an allergic reaction to a certain 
medicine in the past, as a doctor, I need to know that before I 
prescribe medication. Information like that absolutely has to 
be documented, and it has to be easily available to me as a 
doctor. We cannot always rely on patients to remember this 
information, especially elderly patients who may be forgetful. 
I also need to know if a drug has worked for a patient in the 
past. Not only does this save a patient time, it can also save 
a patient some money, as well as a whole lot of discomfort and 
pain, if I can quickly give that patient something we both know 
works best of them, from their own experience, as opposed to 
playing a game of trial and error with their treatment.
    Now, keep in mind, I have practiced medicine largely in 
metropolitan areas for hospitals that tend to be relatively 
sophisticated. I shutter to think what the situation is in 
rural hospitals and medical offices, and in hospitals and 
offices located in low-income areas. Certainly, medical 
practices located in these areas tend to have a poorer medical 
infrastructure.
    So, as an orthopedic surgeon, I asked myself the question, 
how can I better keep track of my patients' records, and then 
integrate all of this information into an easy-to-use, easy-to-
find and affordable system. So I founded Picos, Inc. to develop 
what we call the Total Practice Manager, or TPM, software. 
Using this TPM software, I can access and update my patients' 
medical information as necessary, allowing the medicinal 
treatments I prescribe to be as accurate and as safe as 
possible. The Picos TPM software has an automated prescription 
feature that reduces written and transcribed errors with 
pharmacies by providing a typewritten prescription, such as the 
examples you see on the stand there.
    Picos TPM software is HIPAA sensitive and it is secure, as 
you would expect medical records to be. Obviously, we want to 
protect a patient's privacy and ensure that their information 
is kept confidential. TPM allows doctors the access they need 
to a patient's information to keep them safe, but TPM also 
keeps that information as secure as possible. All of the 
information that a physician enters into his or her handheld 
computer remains within the physician's practice computer 
system.
    Best of all, TPM software is affordable, which means 
hospitals and medical practices in rural and low-income areas 
that might not have the financial resources of larger hospitals 
in urban areas can have access to it and make use of it.
    I would urge the members of this committee and Congress to 
seriously consider how technology such as TPM software can be 
used to improve the accuracy of medical recordkeeping. 
America's senior citizens and, indeed, all Americans, rely on 
doctors and health care professionals to provide them with 
effective and safe treatment, regardless of where they live. 
Safe dissemination of prescription drugs is an issue that 
affects every American in every State who rely on their doctors 
to follow that simple creed of the Hippocratic oath: ``First, 
do no harm.'' I thank the committee for its time.
    [The prepared statement of Dr. Allen follows:]
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    The Chairman. Before I go to the next witness, Doctor, 
could you explain the two different displays we have in front 
of us here?
    Dr. Allen. I select prescription, select the drug, and it 
brings up that form there that I can edit if necessary----
    The Chairman. That's the one that says ``my prescription 
pad.''
    Dr. Allen. Yes that allows the information you have entered 
in the computer under a list will pop up, so that if you 
entered it right, and the people who put it in the computer 
have entered it right--which we can check all the time--it will 
pop up automatically dosage correct. Then, when you print it, 
after you have looked at it and see if it's the number you want 
to prescribe, and the dosage also, then when you print it, it 
prints out on a small printer, thermal printer, like this. 
That's the prescription that the patient takes with them.
    The Chairman. OK, and the patient leaves your clinic or 
office with the blue copy to go to the pharmacy?
    Dr. Allen. Yes, sir.
    The Chairman. OK. Thank you.
    Let's now turn to Peter Klein, pharmacist and Vice 
President of Business Development for En-Vision America.

    STATEMENT OF PETER A. KLEIN, R.PH., PHARMACIST AND VICE 
    PRESIDENT OF BUSINESS DEVELOPMENT FOR EN-VISION AMERICA

    Mr. Klein. Thank you. Good afternoon.
    Thank you for the opportunity to speak with you this 
afternoon regarding technology and prescription drug safety. I 
am Peter Klein. I'm a pharmacist and Vice President of Business 
Development for En-Vision America.
    En-Vision America is a privately held company that was 
founded in 1996 to develop and market technologies aimed at 
assisting the visually impaired to live a more independent 
lifestyle. Our most recent invention has been developed into a 
commercially available product known as the ScripTalk talking 
prescription label system. The ScripTalk system is a cost 
effective method that promises to enhance the safety of 
millions of senior citizens as well as a staggering number of 
Americans afflicted by other conditions or situations that 
prevent them from reading or understanding the directions that 
appear on their prescription labels.
    Currently, there are over 120 million Americans who have 
difficulty reading or understanding the instructions of their 
prescription medications. In many cases, even identifying the 
contents of the prescription package is impossible. The small 
print and look-alike packaging of medicine vials can lead to 
confusion, noncompliance, and ingestion errors. The 
repercussions of such adverse events are immense and increase 
health care costs through additional hospitalizations, doctor 
office visits, and changes to or additions of drug therapies.
    En-Vision America set out to develop a technology that 
would allow the visually impaired to safely manage their own 
medication regimen. The result is the ScripTalk, which combines 
radio frequency identification technology with advanced voice 
synthesizer capability to deliver a cost-effective solution for 
those unable to read or understand their prescription 
instructions.
    Medication errors have been in the forefront of the news 
lately. The seriousness of this issue has been articulated 
today by Dr. Corrigan, and also through Institute of Medicine 
reports, that state up to two million people are hospitalized 
from side effects or reactions to prescription drugs. The IOM 
survey, however, does not consider statistics related to poor 
therapeutic outcomes as a result of noncompliance. A 
noncompliant patient does not achieve the expected benefit of 
their drug therapies and their conditions may not improve, or 
even worsen, because they did not take enough medication, or 
they did not take it at the proper interval, or, worse yet, 
they have over-medicated themselves.
    Compliance cannot occur for up to 42 percent of United 
States citizens due to their inability to read, translate, or 
comprehend the instructions and warnings that appear on their 
prescription containers. The ScripTalk prescription label 
system eliminates this barrier to compliance by actually 
reading the text of a prescription label aloud to the user.
    The United States Census Bureau reports that at least 18 
percent of Americans over the age of 65 have a functional 
limitation seeing words and letters, or are unable to see words 
or letters. There are currently more than 35 million Americans 
over the age of 65, and approximately 6.3 million may not be 
able to safely read the directions that appear on their 
prescription labels.
    I refer to Exhibit 1, which not only depicts the year 2000 
statistics, but overlays it and projects through the year 2030.
    According to several prescription utilization reporting 
agencies, seniors over the age of 65 consume, on average, 36 
filled prescriptions annually. Therefore, in the year 2000, 
seniors experiencing a visual impairment consumed over 227 
million prescriptions, which is depicted in Exhibit 2. This 
means that 7 percent of the prescriptions dispensed in the 
United States were for only 2 percent of the population, who 
may not have been able to read the instructions or warnings on 
the label. This alarming statistic illustrates the need for 
technology that enables this population to self-medicate.
    If I could refer to Exhibit 3. Seniors with visual 
impairment are not the only group who could benefit from the 
use of the ScripTalk system. Exhibit 3 illustrates other 
segments of the population who could also benefit from this 
technology. You can see that the seniors with severe visual 
impairments represent the smallest group that could benefit 
from this technology.
    Studies sponsored by the AMA have concluded that 90 million 
people in the United States have difficulty comprehending 
medical information, which limits their ability to care for 
their own medical problems. Of this group, 40-44 million people 
are functionally illiterate, which is reading at or below a 
fifth grade level, while an additional 50 million adults are 
only marginally literate and have difficulty with reading 
comprehension and/or computational skills.
    These Americans are unable to read and/or understand 
prescription medication labels and auxiliary warning labels. 
Low health literacy skills cost the U.S. health care system 
approximately $73 billion annually in unnecessary doctor 
visits, hospitalizations, and longer hospital stays. Low health 
literacy is particularly common among the older population and 
low-income people. Some studies indicate that 66 percent of 
U.S. citizens over the age of 60 have either inadequate or 
marginal literacy skills, and about 45 percent of all 
functionally illiterate adults live in poverty.
    There are roughly 8.8 million people in the United States, 
and 80 million people worldwide, that have visual disabilities 
and are categorized as ``legally blind.'' Only a small 
percentage of this population can actually read Braille, which 
renders Braille prescription labeling useless for the majority 
of that population.
    It is estimated that approximately 11 million are severely 
affected by dyslexia, and 10 percent of the population may show 
some sign of dyslexia.
    When a patient using a ScripTalk prescription read submits 
a prescription, the pharmacy software prints and programs a 
talking label using a dedicated, small-footprint printer. The 
label stores textual prescription information in an electronic 
format on a micro-chip embedded in the label. I am holding in 
my hand an insert, which is actually the micro-chip.
    The pharmacist or technician then places the talking label 
on the prescription container. In the home, the patient uses a 
handheld ScripTalk reader that decodes the label information 
using speech synthesis technology. The patient then hears all 
of the information that is printed on the label. If I may 
demonstrate this technology.
    [Voice Synthesizer: ``Patient, Max Lieber. Drug name, 
Lanoxin, 500 milligram capsules. Instructions. Take one capsule 
three times daily for 2 weeks. Prescription date, March 5, 
2001. Refills remaining: zero. Warning. Important. Finish all 
this medication unless otherwise directed by prescriber.'']
    So all the pertinent information that appears on the label 
is translated into audible speech for the patient to hear.
    The Chairman. What did the handheld read, a bar graph?
    Mr. Klein. No, Senator. There is actually a micro-chip 
that's embedded in the label.
    The Chairman. Oh, all right.
    Mr. Klein. And the handheld reader translates the 
information that was stored on that label through radio 
frequency technology.
    A clinical trial of the ScripTalk system was conducted at 
the Veterans Administration hospital in Hines, IL. The study 
began in September of 2000, and concluded March 15, 2001.
    Based on information provided to En-Vision America during a 
meeting in early April, we anticipate that a favorable report 
outlining the benefits of ScripTalk will be presented to the 
appropriate Veterans Administration officials. It is our 
understanding that the VA will then determine how the product 
may be made available to visually impaired veterans. The Hines 
VA pharmacy chief who was involved in the study has indicated 
his interest in planning another study to determine the 
usefulness of the product for marginally literate veterans.
    We at En-Vision America are confident that this technology 
will be of great benefit to the elderly, visually impaired, and 
functionally illiterate users. We are working diligently to 
create opportunities to make this technology available to as 
many Americans as possible. We appreciate the support of the 
Veterans Administration who recognized the need for such a 
technology within that health system. Their support has been 
vital in helping us develop and refine the ScripTalk 
functionality.
    Thank you so much for providing the opportunity to present 
information on our technology to the Special Committee.
    [The prepared statement of Mr. Klein follows:]
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    The Chairman. Mr. Klein, thank you very much.
    Before we go to Mr. Reed, we have been joined by two of our 
colleagues who are members of this committee. Let me turn to 
them to see if they have any opening comments before we 
proceed.
    Senator Stabenow.

              STATEMENT OF SENATOR DEBBIE STABENOW

    Senator Stabenow. Thank you very much, Mr. Chairman.
    I very much appreciate your holding this hearing on a very 
important and interesting topic that directly affects people's 
lives every day.
    I would like to say that I know many of the errors in 
hospitals and other institutions involve prescription drugs, 
and that the inaccurate dosages and unknown drug allergies are 
just two of what I'm sure are many types of preventable 
mistakes that are occurring in the hospitals that the report 
from the Institute of Medicine outlined. I appreciate all of 
you being here today to talk about ways that we can address 
that with new technologies.
    It is very exciting to see innovative new technologies that 
are being used and that need to be expanded on in order to be 
able to address medical errors.
    I did want to share a couple of things happening in 
Michigan with you, that I discussed as we called around on this 
topic, that I think indicate the direction that many of our 
hospitals are going in. I also wanted, though, to state that, 
whenever I get the opportunity when we're talking about 
prescription drugs, to say that one of the ways, in addition to 
what's being talked about today, that people are making errors 
themselves relates to self-regulating of their medications 
because seniors are unable to afford their prescriptions. I 
hear from doctors all the time about seniors cutting their 
pills in half or taking them every other day or every other 
week because of the inability to afford a full prescription. So 
I think as we're talking about this topic today, it is very 
important to also address the fact that we have seniors who are 
self-medicating because Medicare doesn't cover prescription 
drugs and that that's a critical issue facing all of us.
    Just for a moment, let me just say that the University of 
Michigan health system has initiated a number of programs to 
alleviate prescription error. These programs are system-wide. 
They involve many hospital divisions. The hospital pharmacy was 
one of the first in the Nation to use a robot system based on 
bar codes to prepare prescription refills. Because of the bar 
codes, there is less chance of dispensing the wrong 
prescription, as you know.
    In addition, the hospital uses automated medical dispensers 
and they will soon connect those dispensers to the pharmacy 
patients' data base, which will allow them to prevent even more 
errors.
    Recently, the system was using easier to read and more 
informative labels for intravenous drugs, and it also 
implemented a new policy requiring doctors to double check dose 
calculations for chemotherapy and install the standardized 
medical administration record that helps nurses and doctors 
track medication doses more efficiently.
    I would submit for the record, Mr. Chairman, a more 
extensive description of those things.
    The Chairman. Certainly.
    [The information referred to follows:]

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    Senator Stabenow. I would just say also the Detroit Medical 
Center has been investing in new technologies, as has the Henry 
Ford health systems, which is working on incorporating new 
technologies as well. Those are just three of the systems in 
Michigan, that I found, as a result of your calling this 
hearing. I appreciated the opportunity to speak with some of 
the health care systems in Michigan and ask them what they were 
doing, and I'm anxious to take back the information that we are 
uncovering today to be able to share with them about more that 
they can be doing.
    I thank you.
    The Chairman. Well, thank you very much. In fact, in just a 
few moments, we're going to hear from Neil Reed, who I think 
will talk about his robot and how it applies.
    Now, it's interesting--and, Senator Wyden, you will also 
appreciate this, and for those of you in the audience, eat your 
heart out. This is a packet full of----
    Mr. Reed. Unit doses.
    The Chairman [continuing.] Unit doses that we'll be hearing 
about in a moment. It just so happens that our unit doses are 
candy. Somebody is trying to steal our heart, or our taste 
buds. Anyway, let me turn to Senator Wyden of Oregon for any 
comment he would like to make.

                 STATEMENT OF SENATOR RON WYDEN

    Senator Wyden. Thank you, Mr. Chairman. I very much commend 
you for holding this important hearing. I'm glad to see the 
Northwest controlling the Aging Committee at this point, and 
also----
    Senator Stabenow. I object. [Laughter.]
    Senator Wyden. That was fast.
    The Chairman. Objection not recorded. [Laughter.]
    Senator Wyden. I was just going to register how pleased I 
was that the Senator from Michigan was on the committee, 
because she has already made it clear that seniors and their 
needs are going to be a special priority for her. So we are 
very glad she's here.
    I will be very brief, Mr. Chairman. As I said, I'm glad 
you're holding this hearing. It's very clear, in my judgment, 
that government health programs, in particular Medicare and 
Medicaid, are simply behind the technological revolution. If 
you look at those programs, in many respects they really aren't 
any different than they were 15 or 20 years ago. So it is 
critical that, as we look at the next round of health care, 
particularly for prescription drugs, uninsured and the like, 
that we have this extraordinary opportunity for technology to 
both help in the delivery of quality health care and also to 
save time and money.
    What I'm struck with is the number of doctors who tell us 
that if they had nothing else but access to up-to-date handheld 
devices, a dramatic difference could be made. For example, with 
a handheld device, a Palm or a similar kind of device, by 
making a couple of clicks, it would be possible to find out 
about drug interactions, it would be possible to get up-to-date 
information, and about therapeutic equivalents. This would 
eliminate the problem of physicians scribbling out 
prescriptions and then various people, be their own staff or 
pharmacies, not being able to read it. So, in my view, there is 
the opportunity here to do a world of good by incorporating 
technology like this.
    Again and again, this committee has shown that we can work 
on a bipartisan basis to really ensure that we are keeping up 
with the times as it relates to gerontology issues. So it's an 
exciting development and I look forward to working with you and 
our friend from Michigan.
    The Chairman. Senator Wyden, thank you.
    Oh, by the way. Happy birthday.
    Thank you. I'm moving into my ``golden'' years. [Laughter.]
    Now we will get back to our panelists. Let me introduce to 
the committee Neil Reed, pharmacist, Director of Pharmacy at 
the Eastern Idaho Regional Medical Center in Idaho Falls. Neil, 
welcome before the committee, and thank you for the candy. 
These individually wrapped items certainly provide a great 
visual demonstration of the manner that pills are packaged and 
labeled by your hospitals Robot Rx.

  STATEMENT OF NEIL REED, PHARMACIST, DIRECTOR OF PHARMACY AT 
     EASTERN IDAHO REGIONAL MEDICAL CENTER, IDAHO FALLS, ID

    Mr. Reed. Thank you, Mr. Chairman. My name is Neil Reed, 
and it is my pleasure to testify before you today about the 
potential of pharmacy technology and how to make patients even 
safer with regard to their medications.
    The hospital I work at, Eastern Idaho Regional Medical 
Center, is a 350-bed community tertiary hospital, and it's part 
of HCA, the health care company which is based in Nashville, 
TN. We provide primary, trauma and long-term care for 2,500 
square miles, serving the residents of Eastern Idaho, Wyoming, 
and Yellowstone National Park.
    Our pharmacy department handles anywhere between 80,000 to 
90,000 drug items each month, which translates to 14 to 16 
items per day per patient.
    I want to point out that hospital pharmacies, even those 
without robots, are impressively accurate. National statistics 
show that 99.9 percent of all medications are administered 
correctly. Yet, within health care, safety and well-being of 
our patients are at stake, and we consider even one mistake an 
unacceptable number.
    In 1999, our hospital embarked on a comprehensive 
exploration of the benefits of automating part of our 
medication process. We were able to make this technology leap 
toward automation because we enjoy the support of our parent 
company, HCA. And automation is only part of HCA's extensive 
program to improve medication best practices. Other corporate 
initiatives which are included for every facility include 
adoption of a medication plan, establishing a medication safety 
team which monitors all medication throughout the facility, 
developing a list of high-risk medications for dispensing and 
administration, and education of the staff and physicians to 
heighten awareness of the cause and prevention of medication 
errors.
    Common features of an automated system include bar code 
technology. In our instance, we have to package all medications 
onsite because there is currently no manufacturers' 
standardization of bar codes being put on products.
    Automation also includes robotic, and then, finally, the 
point-of-care which ties together the automation of bar coding, 
the risk span on the patient, which is bar code, the person 
administering the drug, all these three things come together 
for the proper administration of the drug.
    At our facility we have Robot-Rx, which is located in the 
main pharmacy, and then computerized cabinets located 
throughout each nursing area which store and dispense drugs 
based on the patient's electronic medication profile. This is 
all hooked to and driven by the pharmacy information system.
    We believe that automated technologies improve the 
medication delivery process in the following ways: it reduces 
errors, it reduces missed doses, and it frees pharmacists for 
more direct involvement with the patient and doctors.
    For both our patients and health care providers, the 
benefits of automation have been real, measurable, and 
significant.
    All medication picked by Robot-Rx has been 100 percent 
accurate. What that means is that the robot has not made one 
mistake since the implementation of the program. Before 
Acudose-Rx and Robot-Rx were implemented, the pharmacy 
department, on a daily basis, spent 8 hours, and now that task 
translates to an hour-and-a-half. With the extra time, we are 
able to spend more time with the patient and with physicians. 
We are doing more clinical pharmacy and less pill counting, and 
I believe this leads to better patient care.
    In addition, and harder to measure, are the undeniably 
significant economic benefits. Also included is reduced 
liabilities which result from greater accuracy. Only 4\1/2\ 
percent of all hospitals and systems nationwide can be 
designated as fully automated. Particularly, this is due to the 
initial expense of automation which creates barriers for many, 
even those who see and appreciate the technology's potential.
    I would like to recommend four things to improve the 
delivery and administration process of medications.
    No. 1, standardization of bar code technology. Currently, 
there is no standard or requirement for manufacturers to place 
bar coding on unit dose packaged medications. Leaders in 
pharmacy and drug manufacturing must agree on standardization, 
which should include the national drug code, the product 
expiration, and even lot number. With standardization in place, 
even smaller facilities could reap the benefits of the 
technology safety net at the bedside, with the patient match 
technology, even if they lack a robot, again bringing together 
the patient, the person administering the drug, and the drug 
itself.
    Second, I would like to recommend computerized physician 
order entry of the drug orders. And then financial incentives 
for institutions demonstrating improved medication safety, and 
then, last, incentives to increase the number of allied health 
professionals. Currently, there is an extensive shortage of all 
health professionals and all disciplines affected by the 
shortage, from nursing, pharmacy, lab and beyond. The promise 
of automation will not be fully realized without trained, 
qualified personnel to provide clinical decisionmaking and 
ultimately deliver the product.
    Mr. Chairman, I know that our focus today is about our 
aging population and their medication profile. The medication 
profile of this population typically remains constant 
throughout their length of treatment. This would afford a great 
application of automation by removing the human component of 
drug dispensing via bar code technology, followed by 
verification at the patient bedside, which would greatly 
decrease medication errors.
    I appreciate the opportunity to testify before you today, 
and would be happy to answer any questions.
    I would like again to bring attention to the packets that 
have examples of how the medication is packaged in our facility 
and distributed to the patient bedside.
    Thank you.
    [The prepared statement of Mr. Reed follows:]
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    The Chairman. Thank you very much. I appreciate all of your 
testimony. Let me ask you a couple of questions, and I'm sure 
Senator Stabenow will have some, also.
    Dr. Corrigan, in your opinion, why is the health care 
delivery system falling behind other leading service industries 
in the use of innovative technologies?
    Ms. Corrigan. You have asked, Senator, probably the most 
difficult question to answer. Our committee has grappled with 
that for about 3 years. It's complex, and let me just identify 
a few factors that we think contribute to the state of affairs.
    We are convinced that health care is way behind the curve, 
in terms of its adoption of useful information technology. I 
think one of the first reasons I would like to cite is just 
that there has been a lack of awareness of how serious the 
quality of care and safety problems are.
    We have had a steady flow of literature for over 10 years 
now on this issue. We have over 80 publications just in the 
last decade in leading journals on quality of care problems. 
They all point in the same direction. We know we have a very 
sizable quality gap. We do not deliver care safely and 
effectively. We're not using our knowledge base in technology, 
but the American public hasn't known that until very recently. 
Our leaders in the policy world, like yourselves, have not 
known that, either, I don't think. It has tended to be in 
research journals.
    Another reason is that health care is a highly 
decentralized, almost cottage industry. The majority of 
providers still practice in small group settings. As to the 
investment in technology, they may lack access to the necessary 
capital, as well as the skilled personnel that are needed to be 
able to make the investment in an information technology 
infrastructure.
    Third, we are not sure that we know how to infuse capital 
into the industry effectively. Many not-for-profit 
organizations lack the same degree of access to capital as 
perhaps some of the for-profit organizations. So capital 
probably is an issue, and it's probably a particular issue at 
the level of physician groups, small practices. That's the 
primary mode of organizations still.
    Fourth, we lack standards, clinical standards, data 
collection standards, data transmission standards, data 
exchange standards. Until very recently, we lacked standards 
for confidentiality and protection of personally identifiable 
information. We are behind the curve on creating a national 
health information infrastructure. There is a very real need 
for a national policy in these areas, to facilitate what we 
want to have happen at the delivery system level.
    Fifth, we lack a business case in many instances. If one 
hospital invests significant amounts in improving safety, 
improving outcomes, better quality, it's not clear that they 
really benefit because it isn't recognized in the marketplace. 
It may not be recognized by oversight or regulatory agencies. 
We don't measure it. It isn't immediately apparent to everyone.
    I think last, but not least, there are some major cultural 
issues. Our physicians are typically trained to rely on their 
own memory and ability to deliver care, almost in an isolated 
fashion. We have grossly underestimated how complex and 
complicated it is to provide quality health care in this day 
and age. It requires interdisciplinary teams, it requires 
information support systems, and a much different environment 
than the one we're currently training them in.
    The Chairman. Thank you very much for that.
    Dr. Allen, obviously you have sensed the need and you have 
become directly involved in developing systems and software 
that respond to your concerns and the concerns that this 
committee is focusing on.
    What measures does your system take to safeguard a 
patient's most sensitive medical information from computer 
``hackers'', those that might gain access to that information 
pool?
    Dr. Allen. Well, the biggest sort of way we use secure 
measures is that it's all inner-office. They really don't have 
the ability to ``hack'' in from outside. We are not on line as 
yet, and that prevents that from happening.
    As far as people ``hacking'' from inside, it is password 
protected, and also each individual employee has a password and 
has certain areas they can access. The medical side can access 
the chart and some of the others that need to use it for 
billing information can access the chart. It's all integrated.
    So each person doesn't necessarily have the ability to get 
into the part that shows sensitive information, except the ones 
that need to know.
    The Chairman. But it's an in-house system?
    Dr. Allen. Yes, an in-house system.
    The Chairman. You're not on line yet, nor do these patients 
patch to a national system with their medical records?
    Dr. Allen. That's correct.
    The Chairman. My time is up. Let me turn to Senator 
Stabenow.
    Senator Stabenow. Thank you, Mr. Chairman.
    Just to follow up for a moment on the question Senator 
Craig asked, I think it's important to look at the issues of 
privacy. We are talking about very patient-specific information 
that is being placed into these systems.
    I'm wondering if there are issues that we need to be 
addressing or that you see need to be addressed as it relates 
to the gathering of specific information, patient-specific 
information, and how that can be used, because certainly people 
are very concerned right now about their privacy, their health 
privacy, and we always have a challenge as we're developing 
these new technologies to make sure that, in fact, the 
information is used appropriately, that patients are aware of 
sharing of information and that there are systems in place for 
making sure it's not shared inappropriately.
    Dr. Allen. For me?
    Senator Stabenow. Yes. I would be happy to have anyone 
respond to that.
    Dr. Allen. One of the issues it comes down to--I mean, 
charts are accessible by lots of people, more so than some of 
the higher tech ways of charting. Just as we can break into a 
computer, they can break into an office and steal charts maybe 
even easier.
    We want to be absolutely private, but people can get access 
to it through a lot of different ways now without trying too 
hard, through people selling prescription lists, for people 
selling claims lists from insurance companies, people's names 
and other things. So when we're in an electronic record, we can 
protect it pretty well via the password accessibility, and if 
we went on line, encryption would help a whole lot and hacking 
that is pretty difficult.
    I think the protection of that information through 
technology is happening as we go along, but we have had those 
issues in the past anyway, so I think we can address it with 
technological breakthroughs and we can have protected charts 
and protected information just as easy now with higher tech 
ways of charting than we had with the charts.
    Senator Stabenow. Would anyone else like to respond? Yes.
    Mr. Reed. If I could comment. HCA, as far as the house 
system, provides to each of its facilities what I consider to 
be a very sophisticated system, where the pharmacy and every 
department is connected together. We have a very strict zero 
tolerance, of course, on the inappropriate use of accessing 
medical information, to the extent that, for myself, I looked 
up my own medication record and I was called in and given a 
warning, which seems silly. But that's how important it is. I 
do know we have those safeguards in place right now.
    The Chairman. When you called up your own record, Neil, 
what triggered the event of you calling it up?
    Mr. Reed. On a daily basis, our information systems 
monitor--probably what happened for me was my access was access 
to a similar name, so that was a trigger, and then the trigger 
goes off when it compares my name against maybe other people 
with the last name ``Reed''. I can't even access my own wife's 
record without her signoff. So there is a lot of privacy that 
goes on. It's very secure, very secure.
    The Chairman. Excuse me for interrupting.
    Senator Stabenow. Yes, go ahead.
    Ms. Corrigan. I think you ask a very important question, 
Senator. We really are going to struggle over the next few 
years to move toward a balanced policy for protecting the 
confidentiality of information. We know it's critical, from 
studies we've seen again and again, and surveys of consumers, 
we know that if a patient is concerned that their information 
will not be protected and kept private, they don't share it. 
You just can't deliver good health care. So we have to find a 
way to make sure that people are confident and comfortable that 
their information will be handled very carefully. At the same 
time, I think my colleagues are correct, that many different 
types of technology currently exist to put in place some very 
strong safeguards.
    What we have to do over the coming years, as we especially 
move into implementing the most recent regulations that have 
been promulgated in this area, is to monitor whether we've got 
the right balance, because the tighter we make it in terms of 
restrictions on access and sign-offs, the more expensive it is 
to implement these systems, and the more barriers we put up to 
using the information technology. So the American public needs 
to know that they pay a price if the protections are too 
stringent or too costly, because, in turn, the information 
doesn't get automated and these tools aren't used, which really 
are critical to providing good quality and safe care.
    Senator Stabenow. Thank you.
    The Chairman. Mr. Klein, the device you showed us, how much 
does that device cost? How expensive are these computerized 
labels and will the costs of these products add to the overall 
price of medication?
    Mr. Klein. Well, first of all, Senator, as with any 
electronic device, with mass adoption and mass distribution, 
price obviously decreases. Right now, the label technology, 
which basically consists of this circuitry which is embedded in 
the label, will cost somewhere around one dollar. The reader 
itself, right now, costs around $200 to manufacture, but again, 
we anticipate that that cost would drop significantly through 
mass adoption.
    When you ask the question of who will pay for it, or how 
will it be paid for, one thing I would ask you to consider is 
that this is a new technology and there has never been a 
technology delivered to assist people with their compliance in 
this manner. So we have had a very positive response from 
prescription outlets, major chains, major mail order 
pharmacies. The AMA gave us a very positive response, the 
National Federation of the Blind, blind organizations. So we're 
convinced there is a need and a demand and somehow, in getting 
grassroots support, we will be able to figure who will pay for 
the device as time passes on.
    The Chairman. With the experience you have had with it, how 
durable is your device?
    Mr. Klein. Well, it's been engineered to withstand a three 
foot drop on its corner, on to a hard surface. That was one of 
the criteria. So it is very durable and its useful life extends 
well beyond 5 years. So there is really no durability issue 
with it.
    From a user perspective, these are tactile push buttons and 
self-help descriptions are on board. Basically, anybody can 
pick one up and start using it.
    The Chairman. It's fascinating technology. I have seen a 
variety of labels that have chips built into them which can be 
read, and that's a fascinating approach.
    Before I turn to you, Mr. Reed, we have just been joined by 
the ranking member of the committee, Senator Breaux. Do you 
wish to make any comments before we proceed? Senator Breaux.

                STATEMENT OF SENATOR JOHN BREAUX

    Senator Breaux. Thank you, Mr. Chairman. Just very briefly. 
We've been in some other Commerce Committee hearings, and it is 
kind of a busy time, as you well know. Right now we're trying 
to put the budget to bed and trying to do it by the weekend, so 
it has been very difficult.
    This is a very important hearing, to have people who are 
experts, to have their suggestions before the Congress about 
how we can reduce medical errors through modern technology. It 
is very important that we in the Congress, through the work 
that we do with Medicare and Medicaid and government-run health 
programs, to try and encourage and create a climate that allows 
for the greatest use of technology for the greatest number of 
benefits.
    I am fascinated by the technological aspects about what we 
can do to eliminate errors of humans. You're holding up your 
device, and I was showing the Chairman that I got my new 
``smart telephone'', which is a telephone that you just flip 
open and it's a Palm Pilot. It's a combination. These are 
things that are happening so fast.
    The point I would make is that if someone like me can 
understand this, it's amazing what others, I'm sure, will be 
able to do with it. I didn't invent this, as we've heard some 
Democrats say before---- [Laughter.]
    The technology is something that we should not be fearful 
of, not be scared of. We should embrace it, understand it, and 
utilize it. These people have taken the lead in this area and 
I'm delighted they have taken the time to be with us.
    [The prepared statement of Senator Breaux follows:]

               Prepared Statement of Senator John Breaux

    I thank the Chairman for calling this timely and 
interesting hearing on ``Technology and Prescription Drug 
Safety'' and I thank our witnesses for being here today.
    Almost two years ago the Institute of Medicine released 
their report, To Err is Human, which caught the nation off-
guard when it stated that up to 98,000 deaths occur each year 
due to medical errors. I was further alarmed to learn that 
close to 20,000 of these deaths are caused by preventable 
medication errors. During the course of today's hearing we will 
learn about the innovative ways that physicians, pharmacists 
and consumers are working to improve the efficiency of 
prescription drug delivery while reducing needless errors that 
cost both dollars and human lives.
    Health care in the United States continues to make 
impressive progress even though Congress has thus far been 
unable to modernize the Medicare program. As we continue to 
consider reforming our national health insurance program we 
must work to develop a health care system that is flexible 
enough to incorporate cutting-edge technologies without over-
burdening it with reams of regulations and micro-management.
    I look forward to hearing from our witnesses today because 
our country's health care delivery system continues to be 
plagued by medical errors. Every year 770,000 people are 
injured or die in hospitals due to an adverse drug event--and 
that figure is for hospitals alone. As we will hear from Mr. 
Marty McKay, the president of the Louisiana Pharmacy 
Association, long-term care facilities are also rife with 
prescription errors and the number of adverse drug events that 
occur in the outpatient setting remains unknown, but is 
presumed significant.
    Today we will hear that these problems have not gone 
unanswered. I look forward to hearing from our physician, 
pharmacist and consumer-oriented witnesses about the new 
technology that has begun to address this serious problem of 
prescribing errors. Thank you.

    The Chairman. Thank you very much, John.
    Neil, talk to us a bit about the robot and it's 100 percent 
accuracy. That is obviously a marvelous and important 
statement. But what is the risk of cross-contamination if drugs 
are dispensed through a single chamber, or how are they 
dispensed and ultimately arrive in this form?
    Mr. Reed. The very initial step is packaging. First let me 
lead you through the process of what takes place during the 
initial step of packaging the medication. We have two machines 
the overwrap machine and the bulk packager, medications that 
aren't bar coded from the drug manufacturer, we have to either 
place these in this type of envelope, called the overwrap, and 
they're easily opened by nursing. You just open them and then 
you have access to the medication.
    Cross-contamination is very unlikely. During the packaging 
process the technician pulls up the drug on a data base that 
has the NDC number for every drug, matches that, packages it, 
and at that point quality standards per McKesson Automated 
Healthcare. I might pull up a hundred tablets of Lanoxin, 
package those, and the tray that it sits on is cleaned, then I 
package the next item. There is very little possibility of 
cross-contamination.
    After those are packaged with the bar code, they are placed 
into the robot. Currently the robot we have stores about 4,500 
medications, about the top 350 items we use in the pharmacy. 
The process begins driven by the pharmacist putting the 
medication order in. That electronically is fed over to the 
robot.
    The robot we have is eight-sided. It has a stationary 
mechanical arm with a bar code reader. Of course, in the data 
base, it has memorized the position of every item inside the 
octagon cell. Then it goes to each rod where these are stored. 
You can see the little hole there. These hang on a rod. The 
mechanical bar code reader comes out, reads the bar code three 
times, or scans it three times.
    So what the robot actually does, pick the bar code. It 
doesn't pick the med. Again, the error could take place if we, 
as the humans on either the setup side or the side to the 
patient, are incorrect. But the robot has not picked anything 
wrong. Every day we do a 5-percent quality check, just to 
ensure that.
    The Chairman. You mentioned in your testimony the need for 
standardization of bar code technology. Would current software 
programs be capable or compatible for this use? Or are you 
talking about national pharmaceutical companies not bar coding?
    Mr. Reed. All of us know you can bar code a small package, 
but many medications that are unit dosed, are not bar coded. 
Having bar coding placed on medications would allow facilities 
that don't necessarily have a robot to pick the med by bar code 
to still utilize the bar code technology this would allow a 
safety check right before it's administered to the patient.
    Right before I came out, I looked at our refrigerator and 
the medications are stored in there. About every other 
medication had a bar code on it. A lot of them don't have any. 
There just needs to be an effort put forward to drug 
manufacturers and pharmaceutical representatives, such as 
myself, to somehow come up with standardization on a unit dose 
package for bar coding.
    Senator Breaux. Are you talking about bar coding it on the 
medication itself, on the package of medication?
    Mr. Reed. Typically in pharmacies, everything is unit dose. 
So one medication is in its own package. Right now, a lot of 
those don't have bar codes on it. Everything we use, we have to 
package onsite and bar code it ourselves.
    The Chairman. So that the robot, for purposes of----
    Mr. Reed. Can read that.
    The Chairman. It's for the robot's access in reading that?
    Mr. Reed. That's correct.
    The Chairman. Thank you all very much for your testimony 
this afternoon. We appreciate your presence and your 
willingness to come and provide us with your expertise.
    Mr. Reed. Thank you.
    The Chairman. Thank you all.
    Let me call up our second panel. Dr. Bates, we understand 
your presence here is time-sensitive?
    Dr. Bates. That's correct.
    The Chairman. All right.
    Dr. Bates. But we're doing fine.
    The Chairman. Let me introduce to the committee Dr. David 
Bates, Chief of the Division of General Internal Medicine at 
Brigham & Women's Hospital; Medical Director of Clinical and 
Quality Analysis, Partners HealthCare System; and Associate 
Professor of Medicine, Harvard Medical School.
    Dr. Bates, welcome to the committee.

STATEMENT OF DAVID W. BATES, M.D., CHIEF, DIVISION OF GENERAL  
   INTERNAL  MEDICINE, BRIGHAM & WOMEN'S HOSPITAL; MEDICAL  
     DIRECTOR  OF CLINICAL  AND QUALITY ANALYSIS, PARTNERS 
HEALTHCARE SYSTEM; AND ASSOCIATE PROFESSOR OF MEDICINE, HARVARD 
MEDICAL SCHOOL; APPEARING ON BEHALF OF THE AMERICAN INFORMATICS 
                          ASSOCIATION

    Dr. Bates. Thank you very much for the invitation to speak 
with you today, and thanks in particular to Chairman Craig and 
Senator Breaux and members of the committee.
    I have been asked to discuss the role of handheld devices 
in improving the safety of prescription drug prescribing. I am 
speaking on behalf of the American Medical Informatics 
Association. I am an elected member of the American College of 
Medical Informatics.
    I have spent much of the last 7 years doing research on the 
magnitude of the problem of prescribing errors and on the 
impact of computerization of prescribing to prevent those 
errors and the associated injuries. Much of this research has 
been sponsored by the Agency for Healthcare Research and 
Quality, or AHRQ. I am also a member of the board of the 
Institute for Safe Medication Practices, which has prepared a 
white paper on this topic, and I have brought that with me 
today. I have left copies outside.
    Errors in prescribing are a major health care problem and 
can often result in injuries and even death. This is a 
particularly important problem in older patients, who take more 
drugs, have more illnesses, and are thus more likely to 
experience problems with their medications than younger 
patients. In an AHRQ-sponsored study we did in hospitalized 
patients, there were 6.5 adverse drug events for every 100 
admissions, among which 28 percent were preventable. 
Prescribing errors caused most preventable ADEs.
    Computerization of prescribing has major benefits. In one 
study, we found that computerizing prescribing on desktop 
computers with even simple decision support reduced the serious 
medication error rate by 55 percent. In another study, we found 
that computerization of prescribing on desktops with more 
advanced technology reduced the overall medication error rate 
by more than 80 percent.
    As several people have pointed out, compared to data about 
inpatients, we have much less information about the frequency 
of medication errors and adverse drug events outside hospitals, 
where handheld devices are likely to see their greatest use, at 
least at first. However, the available data suggest that such 
problems are frequent in this setting as well.
    Computerization of outpatient prescribing can occur via 
handhelds or desktop technology. The desktop approach is now 
more prevalent, although this may change, and many companies 
now are building applications that will allow electronic 
prescribing via multiple platforms.
    Handheld devices represent an exciting development in 
information technology and health care. Because of their small 
size, they can be taken anywhere, and providers are using them 
enthusiastically. I have mine with me today. One way that they 
can be used is to hold information--for example, information 
about drugs. However, stand-alone applications are limited. To 
have a major impact on errors, it is essential to computerize 
the entire prescribing system, and handhelds can make this 
possible. A number of companies have developed applications 
that allow physicians to write prescriptions electronically 
using handheld devices.
    This approach eliminates the problem of handwriting, which 
has accounted for about 10 percent of errors in inpatient 
studies. The devices can display ranges of doses and require 
that all prescriptions include a dose, route and frequency. No 
published studies to date that I'm aware of address the impact 
of prescribing using a handheld on medication errors or adverse 
drug events.
    However, based on inpatient experiences, such devices will 
have a much greater impact on prescribing errors if patient-
specific information, such as the patient's age, allergies, 
other medications, insurer and medical conditions, are 
available to the device. Handheld devices can use wireless, 
infrared or direct electronic links to communicate with the 
health care organization's applications. Electronic 
prescriptions can also be transmitted to pharmacies.
    This is technically possible today, though it must clearly 
be done in ways that protect consumers' privacy and 
confidentiality. If patient-specific information is available, 
the device can improve safety by doing things such as 
suggesting a dose appropriate for the patient's age and kidney 
function, and checking for allergies. Drug costs can also be 
substantially reduced because the prescriptions can be compared 
to the formulary of the patient's insurer. Most of the 
applications available today provide some but not all of these 
features. It is challenging to do all the computing that's 
required on a handheld device.
    In the long run, I think handheld devices will represent an 
extremely valuable adjunct to information systems, but their 
potential will depend on having effective links to key data. In 
the short run, handheld devices represent one option for 
computerizing prescribing and are especially attractive for 
physicians who are using only paper prescriptions, which are 
the vast majority of physicians in America.
    My guess, based on the inpatient experience with 
computerization of prescribing, is that devices that have 
minimal patient information will reduce medication error rates 
by up to 50 percent, but they will have only a small impact on 
the adverse drug event or injury rate. To affect the injury 
rate, wireless or other types of links which bring patient 
information to the point of care are essential.
    To summarize, computerization of prescribing is a very 
important goal. However, computerization is going to be most 
beneficial only if sophisticated decision support is provided. 
This will happen faster if health care organizations have 
financial incentives to adopt these technologies, like those 
proposed in legislation announced today by Senators Graham and 
Snowe.
    More research on the actual impact of these devices is 
needed. If computerization of prescribing can be accomplished, 
patients will be safer, and our health care costs will be 
substantially reduced.
    Once again, thank you very much for having me here today, 
and I would be happy to take questions.
    [The prepared statement of Dr. Bates follows:]
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    The Chairman. Thank you very much.
    Now let me turn to my colleague, Senator Breaux, for the 
introduction of our next panelist.
    Senator Breaux. Thank you very much.
    Just very briefly, I am delighted to have Marty McKay as 
our next witness, from LeCompte, LA. I think Marty wanted me to 
introduce him because the chairman wasn't sure how to pronounce 
LeCompte. [Laughter.]
    The Chairman. I was struggling with it, yes. I ran it 
through a couple of times, John.
    Senator Breaux. But we are delighted he is here. He is a 
registered pharmacist who has been practicing in both retail 
and long-term areas of medical practice. He's been doing that 
for 27 years. He has worked in this area of pharmacy automation 
and we're delighted that he's going to present some things that 
I have been exposed to, about trying to simplify the way these 
prescriptions are handled and how medicine is distributed.
    He serves also as Chief Pharmacist for Pearson Medical 
Technologies, which is a company in Louisiana that I have been 
fascinated about in what they have been able to do, which sort 
of coincides with everything else that's happening out there. 
Marty, we're glad to have you.

STATEMENT OF MARTY R. McKAY, PARTNER/MANAGER OF PEARSON DRUGS; 
 PRESIDENT OF THE LOUISIANA PHARMACIST ASSOCIATION; AND CHIEF 
      PHARMACIST, PEARSON MEDICAL TECHNOLOGY, LeCOMPTE, LA

    Mr. McKay. Thank you very much for this opportunity to 
speak with you today.
    I would like to discuss the tremendous opportunities we 
have today for using technology to prevent medication errors 
and save lives, how the pharmacist should play a critical role 
in implementing that technology, and how Federal legislation 
and regulation should enable the use and the development of 
that technology and not restrict it.
    In addition to being a member of the Louisiana State Board 
of Pharmacy and the current president of the Louisiana 
Pharmacists Association, I have been a practicing pharmacists 
for over 26 years, and I also have been involved over the last 
15 years in research on using technology to prevent medication 
errors and enhance patient safety.
    As you know, the IOM report released in November 1999 
concluded that up to 98,000 people die each year in hospitals 
due to medical errors. This study estimates that the increased 
hospital cost alone of preventable adverse drug events in 
hospitals is over $2 billion per year. I believe that this 
study may only be the tip of the iceberg. A recent study 
estimates that drug misuse costs the economy more than $177 
billion each year, and the estimated number of patient deaths 
due to drug misuse, both inside and outside hospitals, has 
increased from 198,000 in 1995 to 218,000 in the year 2000.
    Senator Breaux. If I may interrupt you, that's legal drug 
use, right, or is that total for illegal as well?
    Mr. McKay. That may also be illegal drug use in that 
report. That's quite a substantial number when you look at it.
    Senator Breaux. Thank you.
    Mr. McKay. In considering long-term care, there are about 
1.6 million patients in more than 17,000 nursing homes and 
other long-term care facilities in the United States. A recent 
study concluded that about 350,000 adverse drug events occur in 
nursing homes annually, of which about 20,000 are fatal or 
life-threatening.
    The major reason for these errors is that many hospitals 
and most nursing homes and other health care facilities use 
manual medication, prescribing and medical charting systems. 
Most medications are delivered without any automated 
verification technology, such as bar code readers. Once a 
prescription drug leaves a pharmacy, there is more 
sophisticated technology used to determine if you are charged 
the right price for a gallon of milk at a super-market than is 
typically used to make sure that a patient is getting the right 
dose of a potentially fatal drug.
    Please look at Exhibit A, which is the one there nearest 
the front. You will see a typical patient medication 
administration record called an MAR. It is used by most nursing 
homes in the United States. The MAR shows the medications 
prescribed for the patient. Typically, on a routine med pass, 
the nurse must manually find these medications on a medication 
card holding the medications for 25 or more patients. The nurse 
must then pick out the right medication, administer these to a 
patient, manually chart this administration, and then move on 
to the next patient, all within a one to two hour window.
    Changes to the MAR are typically handwritten by the nurse 
pursuant to the doctor's instructions and are communicated to 
the pharmacy by the nurse. Any discontinued medications are 
often then just destroyed. A 1994 study estimated that 6.7 
percent of all medications dispensed in long-term care is 
destroyed.
    I believe that one important way to help prevent adverse 
drug events is to create medication delivery systems and 
procedures that allow the pharmacist to do more than just count 
pills. A 1999 study reported that including the pharmacist on 
medical rounds with the physician reduced the errors related to 
medication ordering by 66 percent. The pharmacist should serve 
as the gatekeeper of a patient's entire drug regimen and, 
through technology and appropriate reimbursement mechanisms, be 
allowed to more actively participate in prescribing and 
monitoring a patient's drug therapy.
    Now look at Exhibit B, which is the second one. This is an 
illustration of a computerized MAR which shows the same 
information as the handwritten MAR, but it is also available to 
the pharmacist electronically. This smart MAR shows the 
medication to be administered to the patient, which medications 
are due for a patient on any given med pass, and charts the 
administration. This information is kept in real time and can 
be electronically linked to an automated medication delivery 
device that uses bar coding or similar technology to verify 
that the right drug is given to the right patient, at the right 
time, and the right dose.
    Comparing the two different medication delivery systems 
described in Exhibits A and B, think about which system you 
would want the nurse administering medication to your mother to 
use.
    I strongly encourage you to enact legislation which would 
help prevent regulatory road blocks to implementing today's 
life-saving technology, and establish new and innovative 
reimbursement mechanisms that will promote investment in 
information technology and automated delivery systems. Federal 
regulations like HIPAA should not prevent or discourage the 
pharmacist's use of the new automated technology. An example of 
a progressive step is the Drug Enforcement Agency, which just 
released for comment its recommendation to allow controlled 
drugs to be stored and delivered from automated dispensing 
devices, located in long-term care facilities, but controlled 
by pharmacists.
    Reimbursement policies and mechanisms should encourage 
investment in sophisticated automation and information 
technology. The States and Federal Government have the most to 
gain financially from decreasing medication errors in our 
medical institutions across the Nation. Reimbursement 
mechanisms should reflect these savings and help pay the up-
front cost of implementing these systems to help save patients' 
lives and save the billions of dollars in unnecessary cost.
    Thank you for this opportunity to testify, and I would be 
happy to answer any questions you might have.
    [The prepared statement of Mr. McKay follows:]
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    The Chairman. Thank you, Mr. McKay. I appreciate your 
testimony.
    Dr. Bates, what do you mean by sophisticated support for 
computerization, and by whom?
    Dr. Bates. What I mean is decisions support that is smart, 
that, for example, calculates the patient's kidney function. To 
do that involves knowing the patient's age, their gender, their 
last serum creatinine level, which tells you how good their 
kidney function is. If you do that, you can adjust the dose of 
a medication so that it's appropriate for patients. So that's 
an example of the sort of thing that I mean.
    The computer can do all of that in the background, and then 
suggest to the clinician an appropriate dose. If that happens, 
we have shown that it is substantially more likely that the 
doctor will choose the right dose for that patient.
    The Chairman. Are there software programs available today 
that do that kind of interfacing, with constant input of the 
patient's condition and, therefore, a reaction to the 
medication that is currently being delivered?
    Dr. Bates. Yes, there are.
    The Chairman. Do you know what percentage of physicians 
currently use a form of computerized prescribing?
    Dr. Bates. Roughly 15 percent of hospitals have 
computerized prescribing applications in place. However, in 
most of those institutions, a minority of physicians actually 
use the applications. So it is hard to say exactly what the 
number is.
    There are a relatively small number of institutions in 
which computerized prescribing is the rule. Our institution 
happens to be one of those.
    On the outpatient side, it's been much harder to come up 
with good numbers. The best guesses are somewhere around the 
range of 5 percent.
    The Chairman. Would you judge that, based on the current 
state of the technology, to be low?
    Dr. Bates. Yes.
    The Chairman. Mr. McKay, in your testimony you propose that 
new technology will free pharmacists to accompany physicians on 
medical rounds. In this time when the cost of health care 
continues to steadily rise, it is hard to financially justify 
paying pharmacists to accompany physicians on medical rounds.
    What service can a pharmacist provide on medical rounds 
that some of the new technologies, such as the handheld device 
we heard talked about today, cannot? That would be one 
question. And does it justify the cost to the patient when 
using these new technologies to ensure safety would be far less 
expensive and, therefore, more accurate?
    Mr. McKay. Well, I think what I wanted to point out with 
that 66 percent figure was the fact that having a pharmacist do 
that prevented these medication errors. Now, technology can 
also do that. But you have to remember that the only place that 
that technology has been used so far has been in the hospitals. 
Many of your prescriptions now come into a pharmacy, a retail 
pharmacy, where there may be multiple doctors seeing a patient, 
so one doctor may not know what the other is prescribing.
    My point that I want to make is that if we have the 
technology available in the retail or in the long-term care, 
where we can see everything that is happening to that patient 
from their drug information, and have other tools and 
information from that patient's chart in there, we can make an 
informed decision. So that if something occurred that maybe 
this physician didn't know, in relation to the other physician, 
then we can be a gatekeeper of that and prevent those medical 
errors.
    Dr. Bates. May I also just comment briefly?
    The Chairman. Yes.
    Dr. Bates. That was a study that we did. The cost of the 
pharmacist per year is around $50,000, and we have shown that 
the pharmacist saved between $450-500,000 in terms of 
suggestions that they made and the interventions that were 
implemented.
    That is something that can be done today. That was in an 
intensive care unit, so it is one specific setting. I don't 
think we could do that in all other settings. But within the 
intensive care unit, I think that can be justified by health 
care institutions around the country.
    The Chairman. Gentlemen, thank you.
    Let me turn to my colleague, Senator Breaux.
    Senator Breaux. Thank you, Mr. Chairman, and I thank the 
panel members.
    This is fascinating information. I was looking at this Time 
article of April 23, about the problems out there with medical 
errors. They talked about a report out last week--and maybe 
this has already been mentioned--by the Federal Agency for 
HealthCare Research and Quality, that electronic prescriptions 
and monitoring could help eliminate many of the medication 
errors and other adverse drug events that kill or injury 
770,000 people in hospitals each year. Mr. McKay, you were 
talking about the number of deaths.
    Also, the article pointed out something that I find really 
fascinating. Each year, pharmacies make 150 million calls to 
doctors, to clarify confusing prescriptions, and they only 
write about 1 percent of their prescriptions electronically 
today.
    A hundred and fifty million phone calls to find out what 
your handwriting was supposed to instruct me to do is 
incredible.
    Mr. McKay. It's even greater than that, when you look at 
how many times we call a physician back daily, and many times 
the problem is it puts the patient at harm, also, because it 
may be 6 or 7 hours before he can even get his prescription 
because the doctor may be at the hospital or we may be unable 
to locate him. But there are many reasons we call back other 
than just not being able to read the prescription. So 
electronic prescribing is going to be great for pharmacies and 
it will take a lot of the risk out of health care.
    Senator Breaux. I'm looking at the two charts that you have 
here. The chart on the left, as I understand it, is a typical 
nursing home chart that's used, where the nurse makes the 
rounds delivering medicine to patients?
    Mr. McKay. Correct.
    Senator Breaux. And all of that is entered by hand, I take 
it, and changes are made by hand?
    Mr. McKay. All the changes are made by hand. Typically, at 
the first of the month it is printed out as accurate as 
possible. They go through and make any changes. But as the 
month unfolds, every time the doctor writes a new order or 
there's a change in the condition of the patient, then it is 
recorded on that chart and she must go through this over and 
over each time.
    If you look at this particular chart up here, one of the 
things you notice is that they had several changes on one drug. 
Sometimes there's as many as two and three on one page. It's 
confusing for the nurse because, when she goes through here, 
she can easily make a mistake by using the wrong line to record 
the drug on and have the wrong dose.
    Senator Breaux. It looks like a very bad eye chart.
    Mr. McKay. It's much worse than that, I can assure you.
    Senator Breaux. I remember talking to Mr. Pearson about 
being able to save medicine that is currently discarded when 
the prescription is changed.
    Mr. McKay. That's correct.
    Senator Breaux. Tell me a little bit more about how that 
would work.
    Mr. McKay. Well, one of the pieces of technology that we've 
been working on is a medicated delivery system that uses an MAR 
like this, and also has a mobile cart that goes up and down the 
hallway with the nurse as she administers the medication. What 
this does, no drug is actually dispensed to that patient until 
the time of use. So you don't have drugs that are being sent to 
the nursing home and then the order is changed and that drug is 
destroyed.
    If you look at----
    Senator Breaux. On that point, if a person in a nursing 
home is on a particular prescription and used maybe only 25 of 
it, if the doctor then changes that prescription, is the other 
75 percent sometimes just discarded?
    Mr. McKay. In most cases, that's what happens. That drug is 
destroyed.
    Senator Breaux. That's a huge cost.
    Mr. McKay. It's a huge amount of money.
    Senator Breaux. Would this type of delivery system be able 
to help reduce that?
    Mr. McKay. With this type of delivery system, you wouldn't 
have any of that type of destruction. The only reason is if the 
drug was dispensed to that patient one dose and the patient 
refused it, or for some reason that patient didn't get that 
dose, you wouldn't have these large amounts of drugs given out 
to the patient and then destroyed because the doctor changed 
the order.
    Senator Breaux. Because the change order would be plugged 
into the delivery device instantaneously?
    Mr. McKay. Immediately. In real time, it would be plugged 
in.
    Senator Breaux. That's a huge savings.
    Is there anything that prevents this technology from being 
used? I mean, we're listening to this as Members of Congress. 
Do we have to pass a law that says use modern technology? Why 
aren't we doing this already? That stuff on the left, that's 
hieroglyphics.
    The Chairman. And Dr. Bates was said there is only 15 
percent application of the use of the technology.
    Dr. Bates. I think the biggest barrier is that hospitals 
are in such bad financial positions right now. Two-thirds of 
the hospitals lost money last year. If you have to invest in a 
new computerized MAR, you might be charged half-a-million 
dollars. Hospitals are finding it hard to justify doing that 
right now.
    Senator Breaux. It would seem that the ultimate outcome of 
this is some real serious financial savings, actually, in 
eliminating errors, which are very costly. I mean, if you give 
the wrong medicine to a person who is a senior citizen on 
Medicare in a hospital, the cost of that one mistake would pay 
for a dozen of these machines.
    Mr. McKay. Absolutely. I think you're correct in that 
analysis.
    But one of the problems we have run into, especially in 
pharmacy, with the reduced reimbursements by third parties, 
including Medicaid, it is very difficult for a pharmacist to go 
out and purchase this type of technology and use it. It may 
save money, and it will save money in the long run. There's no 
doubt about it. But it's going to be difficult to get it used 
unless you find some method of reimbursement that will allow 
him to go out and purchase the technology.
    Senator Breaux. We need to take a look at that, because I 
think in the long term we would end up saving money by helping 
to reimburse for modern technology, whether it's yours or 
somebody else's. I think it would make a lot of sense.
    It has been fascinating. I thank you very much.
    Mr. McKay. Thank you.
    The Chairman. Gentlemen, thank you very much. We appreciate 
your input and your involvement. This is extremely valuable 
information.
    As I mentioned in my opening statement, as we move towards 
a prescription drug program for this country, and certainly for 
the Medicare recipients of this country, it is going to be 
important that we investigate this more thoroughly as it 
relates to the application and the cost and cost savings that 
can come by effective unit doses and their application.
    Thank you very much. The committee will stand adjourned.
    [Whereupon, at 4 p.m., the committee was adjourned.]

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