U.S. GOVERNMENT PRINTING OFFICE

73–598 PS WASHINGTON : 2001

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

(

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

CONRAD BURNS, Montana

RICHARD SHELBY, Alabama

RICK SANTORUM, Pennsylvania

SUSAN COLLINS, Maine

MIKE ENZI, Wyoming

TIM HUTCHINSON, Arkansas

PETER G. FITZGERALD, Illinois

JOHN ENSIGN, Nevada

JOHN B. BREAUX, Louisiana

HARRY REID, Nevada

HERB KOHL, Wisconsin

RUSSELL D. FEINGOLD, Wisconsin

RON WYDEN, Oregon

EVAN BAYH, Indiana

BLANCHE L. LINCOLN, Arkansas

THOMAS R. CARPER, Delaware

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)

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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-todrug 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.

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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

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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 preVerDate 11-MAY-2000 14:35 Aug 16, 2001 Jkt 000000 PO 00000 Frm 00013 Fmt 6633 Sfmt 6633 C:\DOCS\73598.TXT saging1 PsN: saging1
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vented 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

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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 lookalike 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.

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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 eiVerDate 11-MAY-2000 14:35 Aug 16, 2001 Jkt 000000 PO 00000 Frm 00021 Fmt 6633 Sfmt 6633 C:\DOCS\73598.TXT saging1 PsN: saging1
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ther 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 microchip 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.

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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.

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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

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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

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because there is currently no manufacturers’ standardization of bar

codes being put on products.

Automation also includes robotic, and then, finally, the point-ofcare 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-anda-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 41⁄2 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

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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 proVerDate 11-MAY-2000 14:35 Aug 16, 2001 Jkt 000000 PO 00000 Frm 00050 Fmt 6633 Sfmt 6633 C:\DOCS\73598.TXT saging1 PsN: saging1
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vide 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

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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.

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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 selfhelp 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 teleVerDate 11-MAY-2000 14:35 Aug 16, 2001 Jkt 000000 PO 00000 Frm 00053 Fmt 6633 Sfmt 6633 C:\DOCS\73598.TXT saging1 PsN: saging1
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phone’’, 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 cuttingedge technologies without over-burdening it with reams of regulations and micromanagement.

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

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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.

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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

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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

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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 longterm 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?

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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.

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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.

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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?

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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.

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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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