- THE WAR ON DRUGS MEETS THE WAR ON PAIN: NURSING HOME PATIENTS CAUGHT IN THE CROSSFIRE

[Senate Hearing 111-611]
[From the U.S. Government Publishing Office]

S. Hrg. 111-611

THE WAR ON DRUGS
MEETS THE WAR ON PAIN: NURSING HOME PATIENTS CAUGHT IN THE CROSSFIRE

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LISTENING SESSION

before the

SPECIAL COMMITTEE ON AGING
UNITED STATES SENATE

ONE HUNDRED ELEVENTH CONGRESS

SECOND SESSION

__________

WASHINGTON, DC

__________

MARCH 24, 2010

__________

Serial No. 111-16

Printed for the use of the Special Committee on Aging

Available via the World Wide Web: http://www.gpoaccess.gov/congress/
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SPECIAL COMMITTEE ON AGING

HERB KOHL, Wisconsin, Chairman
RON WYDEN, Oregon BOB CORKER, Tennessee
BLANCHE L. LINCOLN, Arkansas RICHARD SHELBY, Alabama
EVAN BAYH, Indiana SUSAN COLLINS, Maine
BILL NELSON, Florida GEORGE LeMIEUX, FLORIDA
ROBERT P. CASEY, Jr., Pennsylvania ORRIN HATCH, Utah
CLAIRE McCASKILL, Missouri SAM BROWNBACK, Kansas
SHELDON WHITEHOUSE, Rhode Island LINDSEY GRAHAM, South Carolina
MARK UDALL, Colorado SAXBY CHAMBLISS, Georgia
KIRSTEN GILLIBRAND, New York
MICHAEL BENNET, Colorado
ARLEN SPECTER, Pennsylvania
AL FRANKEN, Minnesota
Debra Whitman, Majority Staff Director
Michael Bassett, Ranking Member Staff Director

(ii)

C O N T E N T S

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Page
Opening Statement of Senator Herb Kohl........................... 1

Panel I

Statement of Michael Schanke, Administrator, Oakridge Gardens
Nursing Center, Menasha, WI; on behalf of American Health Care
Association and National Center for Assisted Living............ 3
Statement of Robert Warnock, D.PH., Vice President of Pharmacy
Services, Golden Living, Fort Smith, AZ........................ 15
Statement of Cheryl Phillips, M.D., President American Geriatrics
Society, New York, NY.......................................... 26
Statement of Ross Brickley, RPH, President, Continuing Care RX,
INC., Raleigh, NC; on behalf of American Society of Consultant
Pharmacists and the Quality Care Coalition For Patients in Pain 35

Panel II

Statement of Joseph Rannazzisi, Deputy Assistant Administrator,
Office of Diversion Control, Drug Enforcement Administration,
U.S. Department of Justice, Washington, DC..................... 64
Statement of Carmen Catizone, DPH, Executive Director, National
Association of Boards of Pharmacy, Mount Prospect, IL.......... 74

APPENDIX

Mr. Schanke's Responses to Senator Brownback's Questions......... 83
Mr. Warnock's Responses to Senator Brownback's Questions......... 83
Ms. Phillip's Responses to Senator Brownback's Questions......... 84
Mr. Brickley's Responses to Senator Brownback's Questions........ 84
Mr. Rannazzisi Responses to Senator Brownback's Questions........ 85
Mr. Catizone's Responses to Senator Brownback's Questions........ 87
Statement submitted from Fran Savard of AOPHA, Columbus, OH...... 88
Statement submitted by Ron Fisher, MD............................ 89
Statement submitted on behalf of the American Medical Directors
Association (amda)............................................. 90
Statement submitted by the American Association of Homes and
Services for the Aging (aahsa)................................. 104
Letters and information from the Members of Seniors Aid NH,
Concord, NH.................................................... 118
Statement of the National Community Pharmacists Association...... 121
Statement submitted by Denise Barter, RPh, MBA, FASCP............ 125
Testimony from the Pharmacy Society of Wisconsin................. 127
Letter from Kristie Roller-Bauknecht, Director of Pharmacy
Services, Sauk City, WI........................................ 131

(iii)

THE WAR ON DRUGS MEETS THE WAR ON PAIN: NURSING HOME PATIENTS CAUGHT IN
THE CROSSFIRE

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WEDNESDAY, MARCH 24, 2010

U.S. Senate,
Special Committee on Aging,
Washington, DC.
The Committee met, pursuant to notice, at 2:05 p.m. in room
SD-106, Dirksen Senate Office Building, Hon. Herb Kohl
(chairman of the committee) presiding.
Present: Senator Kohl.

OPENING STATEMENT OF SENATOR HERB KOHL, CHAIRMAN

The Chairman. Thank you so much for being here today.
This afternoon, we'll examine the dispensing of pain
medication in nursing homes across our country, a very serious
issue that impacts the daily well-being and comfort of millions
of elderly Americans.
It's safe to say that most laws are created to prevent
suffering. In the case of the U.S. Drug Enforcement
Administration's recent crackdown of nursing homes, it appears
that the law exacerbates it. The hours it may take for a
nursing home to fully comply with DEA regulations can feel like
an eternity to an elderly nursing home resident who's waiting
for relief from excruciating pain. Our hope for today's session
is that we can find a better strategy that allows the DEA to do
its job and enables infirmed nursing home residents to receive
their medication in an expedient way.
According to several of our panelists and other industry
sources, nursing homes and long-term care facilities have found
themselves either heightened--under heightened scrutiny from
the DEA, a Federal agency with the vital job of regulating the
use and sales of controlled substances.
The DEA's initiatives often save lives and do make a
positive impact. The problem is that, while the DEA claims that
they are working to keep prescription drugs out of the wrong
hands, in reality they are causing widespread confusion, with
the result of interruption and delays in timely access to pain
medication for vulnerable seniors.
We've heard from many providers in my home State of
Wisconsin who say that they are faced with the impossible
choice of following the letter of the law and caring for sick
residents in the best way they know how.
While I support the DEA's national drug diversion strategy,
which prevents prescribed medications from reaching those who
would abuse them, it seems that their efforts are misplaced
here, with sick seniors paying the price.
Today, we'll hear about pain management for the elderly,
the role of nurses in ordering and administering medication,
and proposals for possible changes to the regulatory scheme
that governs long-term care facilities and pharmacies. We'll
hear from the DEA, in order to gain a better understanding of
what their intentions are.
I understand that unanimous consent was not given this
morning for committees to hold regularly scheduled hearings and
meetings today. We appreciate that some of you have come a long
way at your own expense to have your voices heard on this
important issue. For that reason, although our committee will
not be holding a formal hearing this afternoon, this will be
regarded as a listening session, so that we can get and
understand your positions on this issue.
We'll now turn to our first panel. Our first witness this
afternoon will be Michael Schanke. Mr. Schanke is the Owner of
Oakridge Gardens Nursing Home Center, and President of
Gardenview and the Gardens of Fountain Way Assisted Living in
Menasha, WI. Mr. Schanke is responsible for all aspects of
daily operations at the Oakridge Gardens Nursing Home and these
two assisted living facilities.
He will be followed by Robert Warnock. He is Vice President
of pharmacy services for Golden Living, a skilled nursing
facility chain based in Fort Smith, AR. He's a certified
geriatric pharmacist. Golden Living cares for more than 60,000
nursing home and assisted living facility residents every day
across our country in 37 States.
Our next witness will be Dr. Cheryl Phillips, who's
President of the American Geriatrics Society. She's also a
Geriatrician and Chief Medical Officer of On Look Medical
Senior Services. As President of the American Geriatrics
Society, she represents 6400 geriatric healthcare professionals
committed to improving the health and well-being of older
Americans.
Finally, we'll be hearing from Ross Brickley. Mr. Brickley
is a certified Geriatric Pharmacist and President of CCRX of
North Carolina, Inc. He's a past President of the American
Society of Consultant Pharmacists and currently serves as a
member of ASCP's Board of Trustees and as the Treasurer of that
society.
We're so pleased that you all took the time to be with us
today.
We'll commence testimony with you, Mr. Schanke.

STATEMENT OF MICHAEL SCHANKE, ADMINISTRATOR, OAKRIDGE GARDENS
NURSING CENTER, MENASHA, WI; ON BEHALF OF AMERICAN HEALTH CARE
ASSOCIATION AND NATIONAL CENTER FOR ASSISTED LIVING

Mr. Schanke. Thank you, Chairman Kohl and members of the
committee.
My name is Michael Schanke. My father and I are proud of
the three long-term care facilities that we own and operate in
Wisconsin's Fox Valley. We have 180 full- and part-time staff,
who care for more than 140 seniors.
I appreciate the opportunity to be here today on behalf of
so many of my fellow long-term care providers to share our
collective concerns about this issue.
Most importantly, I'm pleased to be here on behalf of my
patients and others in facilities nationwide who are facing
unacceptable delays in getting much needed pain medication.
I witness firsthand the frustration, fear, and confusion of
patients and family members forced to watch their loved ones
suffer while my staffs struggle with their hands tied because
of these DEA regulations. Usually, the medication they need to
relieve a resident's pain sits within our reach inside of our
contingency kit.
Imagine what it's like to look into the eyes of a resident
or that resident's family as the resident is in clear and
sometimes intense pain, and having to tell those people that we
can't give medication they've been taking all along, not
because we don't have it, but because of a regulation.
Or imagine telling a nursing staff made up of highly
educated and trained medical professionals who are with
patients around the clock, assessing their conditions in real
time, that they are no longer allowed to do the job for which
they have been trained.
We've taken numerous steps to comply with the DEA's
increased enforcement of the Controlled Substances Act, at
times to the detriment of the quality of the life of the
patients we serve.
I would like to share with you one specific example of how
the DEA rules have interfered with our ability to treat
residents in pain. In mid-February, on a Thursday, we had an
admission of an 88-year-old lady to our facility from the
hospital, following a surgical repair of her L2 vertebrae. As
with many of our newly admitted patients, one of our first
goals was to manage her intense pain, so that she could begin
her rehabilitation program, which would include both physical
and occupational therapy.
To treat her pain, the discharging physician ordered two
things: a Fentanyl patch along with Percocet every 4 hours, as
needed, for breakthrough pain. By Saturday, my nurses noted
that she would probably run out of her initial order of
Percocet by late Sunday afternoon. We immediately put a call
out to her attending physician to inform him of the situation
and to begin the process for securing more Percocet to treat
her pain. Throughout the weekend, we followed up, on multiple
occasions, with both the doctor and the pharmacy to inquire
about the status of the Percocet prescription and to ensure
that the written prescription had been received by our
pharmacy. Because we were unable to receive this confirmation,
by Sunday night we had run out of the initial Percocet
prescription. In order to provide her with some relief from her
intense pain, we used contingency medication that we had in our
facility.
By Monday morning, the patient's pain level had reached a 9
or 10 on a 10-0 scale. Her family arrived, witnessed that their
loved one was in such intense pain. They began to question why
we were not treating her, as they knew we had the orders. We
explained to her family that, due to changes in our process
resulting from the need to follow DEA requirements, we would be
unable to medicate her with her Percocet.
By this time, the patient's pain had become so intense and
unmanageable that her family decided to have her transported
back to the hospital emergency room, just before noon on
Monday. The patient was readmitted to the hospital and treated
with morphine and an epidural for pain control. She returned to
our facilities 3 days later, after that second hospitalization.
The example illustrates that the ordering process for
Schedule 2 medications has become too focused on the paperwork,
at the expense of patient care and comfort.
Long-term care facilities work hard daily to meet stringent
State and Federal regulations, which include adequate pain
management for our patients. However, these rules pit
providers' compliance with those rules against compliance with
other regulations. The DEA rules also ignore practical
realities.
We are fortunate to be in a medium-size community where we
have doctors, clinicians, hospital systems, and a family owned
pharmacy 5 minutes away. Not everyone has this ideal situation.
The DEA rules imply that physicians are available at beck and
call, which is not always the case. Healthcare is practiced in
a dynamic setting, and the DEA rules are frustratingly static.
In short, the DEA rules concerning Schedule 2 drugs need to
be updated to account for the realities of medical practice,
nursing-home care, and the three-way system of communication
that occurs in the real world across care settings.
Thank you very much for your time and continued attention
to this important issue.
[The prepared statement of Mr. Schanke follows:]

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The Chairman. Thank you very much, Mr. Schanke.
Now, we turn to Mr. Warnock.

STATEMENT OF ROBERT WARNOCK, D.PH., VICE PRESIDENT OF PHARMACY
SERVICES, GOLDEN LIVING, FORT SMITH, AZ

Mr. Warnock. Chairman Kohl, thank you for inviting me here
today.
My name is Robert Warnock. I speak on behalf of Golden
Living, a leading healthcare services company that operates
more than 300 skilled nursing facilities in 21 States. I am the
company's Vice President of pharmacy services. In addition, I
am a certified Geriatric Pharmacist and licensed Doctor of
Pharmacy.
I'd like to discuss how some Drug Enforcement Agency
regulations are imposing barriers to the timely and medically
appropriate dispensing of controlled medications in skilled
nursing facilities. This is essentially a collision of good
intentions.
The DEA works to protect the public against the diversion
of harmful drugs, but the Agency's regulations concerning the
dispensing of Schedule 2 drugs can cause needless suffering for
patients with legitimate medical needs for those medications.
Additionally, some of these regulations are potentially
placing skilled nursing facilities at risk of being
noncompliant with CMS regulations governing the patient-care
responsibilities of skilled nursing facilities.
That said, Golden Living fully supports and commends the
DEA for its role in protecting the public from drug diversion
and illegal practices regarding the use of controlled
substances. We wish to work cooperatively with the committee
and the DEA, as well as Federal and State healthcare
regulators, to improve the effectiveness of the regulatory
system. However, existing DEA regulations are difficult to
comply with in our skilled nursing facility environment,
particularly in light of CMS regulations under which we already
operate. CMS regulations cover the safe and effective handling
of medications.
Conflicting DEA and CMS regulations place skilled nursing
facilities in a difficult position. On one hand, DEA
regulations increase delays in the provision of needed
medication. On the other hand, CMS regulations require that
skilled nursing facilities provide immediate care of the
patient's needs. Compliance with both sets of regulations is
challenging and, at times, impossible.
Current DEA regulations require long-term care pharmacies
to comply with very specific processes to allow the ordering
and dispensing of Schedule 2 controlled drugs, including the
requirement of hardcopy prescriptions signed by a physician.
Skilled nursing facilities do not have onsite 24-hour physician
staffs. Each patient has an attending physician who is
responsible for his or her medical orders. But, most of these
physicians maintain their primary practice outside of the
skilled nursing facility and conduct many of their activities
offsite and electronically.
Manual processes for ordering and approving Schedule 2
prescriptions may be acceptable during regular office hours,
when physicians, nurses, and long-term care pharmacists are
present in their regular practice setting. After hours,
however, pharmacies may be closed, and physicians may not have
access to fax machines, if they are reachable at all. During
these times, the required process frequently results in lengthy
delays.
DEA requirements for skilled nursing facilities differ from
those under which hospitals operate. DEA provisions help
hospitals and hospital pharmacies meet the immediate needs of
their acute care patients for Schedule 2 medications. In
hospitals, a physician's order on a patient's chart serves as a
legal order and prescription for the pharmacy to fill the
controlled substance. Also, nurses in hospitals are allowed to
serve as physicians' agents and can order the pharmacy to fill
a prescription for the controlled substance.
Similar provisions for skilled nursing facilities would
enable us to better meet the needs of patients who become
acutely ill in our facilities or who are in pain at the time of
admission. In many cases, we would be able to help patients in
severe discomfort faster than we can under current regulations.
We would also ask that DEA follow more of an administrative
approach to their work with skilled nursing facilities. In
2009, Golden Living experienced an unannounced inspection of
five of our skilled nursing facilities by DEA agents. To our
knowledge, these inspections were unusual and unprecedented.
The aggressive law enforcement approach used by the DEA agents
during these visits, including the use of armed escorts, had a
chilling impact on facility operations. It disrupted the staff
and their important caregiving responsibilities, and it
frightened our patients and our employees.
In cases where there is not an immediate concern or issue,
we would suggest that such disruptions may be mitigated if
skilled nursing facilities were given advance notice of future
DEA visits of this nature.
Thank you for your time today.
[The prepared statement of Mr. Warnock follows:]

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The Chairman. Thank you Mr. Warnock.
Dr. Phillips.

STATEMENT OF CHERYL PHILLIPS, M.D., PRESIDENT, AMERICAN
GERIATRICS SOCIETY, NEW YORK, NY

Dr. Phillips. Thank you, Chairman Kohl and thank you for
taking on this really important issue.
I will speak as a geriatrician and an advocate, as we all
are, for the patients and individuals that we're concerned
about throughout this.
In addition to being President of the American Geriatrics
Society--and very happy to represent that organization--I'm
also the past President of the American Medical Director's
Association, which is the organization for physicians in long-
term care practice. My entire clinical practice, scanning some
20 years, has been in the long-term care arena.
This is a very real, palpable issue; it's not just a
theoretical problem. It actually has been, in a variety of
States, going on for many years, escalating, most recently,
with some of the enforcement activities.
So, I'll start--we've had issues with stories. I, too, will
tell the story of Mrs. M, who's demented and 87 and is admitted
back to the emergency room on a Friday night, after 4 days in
the nursing home. She goes back to the same hospital she came
from, because after her hip surgery, her orthopaedic surgeon
felt like she needed to have less confusing pain meds and
reduced her narcotics.
Every day in the nursing home, her pain was slightly
increasing until the day of transfer, when the nurse doing an
assessment, working with the physician, communicating with the
family, realized that we were not able to manage, in a timely
manner; and the family, in frustration, as was mentioned in an
earlier example, said, ``Enough, already,'' and sent her back
to the hospital.
I was part of a CMS panel that looked at
rehospitalizations. One in four Medicare patients who go to the
hospital and go to a nursing home are readmitted within 30
days. A big part of this is, in fact, pain management. This
represents $4.3 billion a year, at about $10,000 per admission.
Not only is it unnecessary cost, it's unconscionable that Mrs.
M needs to go back to the emergency room to have what can be
provided in a licensed facility with nurses, therapists,
physicians, and pharmacists ready to take care of her.
So, what can a physician do if we can't get the narcotic?
Well, we can use a non-narcotic option; that's not great. The
pharmacy and the nurse can go outside of DEA regulations, give
the medicine anyway, face significant sanctions and fine. Or
what often happens is, a patient goes without. They're the ones
paying the price and suffering.
It is not insignificant, untreated pain in the elderly. We
have a lot of myths about pain management in the elderly. When
we don't address pain, seniors tend to not eat, they tend to
not move, they are less mobile, they're more likely to get
pneumonia, they're more likely to fall because of the muscle
weakness related to the immobility. They are certainly more
likely to have pressure ulcers. It often starts that spiral of
decline and death. Pain management in the elderly is a critical
and important medical and social and moral issue.
So, why is it that we have such a problem? As was mentioned
earlier, in the hospital I can get called by a nurse who gives
me an informed, professional assessment. I can have an
interaction in a care plan decision, give an order, and it is
executed in the hospital. That same nurse can go across the
street to the nursing home, use her same assessment skills, can
have the same dialog with me about a patient that I may have
seen in the hospital a day earlier, but now I can't give her
that order for narcotic management or other medicines that
follow under the schedule purview. Instead, I must call a
pharmacy. Often it's a 1-800 number for a regional pharmacist,
sometimes States away. I will tell, from personal experience,
that very often, after hours, that meant I wait for the
pharmacist to call me back. I then have to find a fax after
hours; I'm not one that carries one in my car. So, after hours
or weekends, I need to fax, then, an original signature. Now, I
call back the nursing home nurse, who then calls the pharmacist
to verify the order. Each one of these steps takes time. Each
one of these steps creates the opportunity for significant
error. Each one of these means that Mrs. M is sitting in pain.
That's if things work well. That's when the stars are aligned.
More often than not, they aren't. Most physicians do not
have faxes at home or in their cars. So, after hours, even
though we do have 24-7 availability, we don't have the access
to make this electronic communication with the pharmacies.
Forty percent of physicians now who practice in nursing home
settings don't have typical office practices. So, we are not
talking about the same dynamic of a physician sitting in a room
with a complete support staff.
So, we do recognize that this is a team relationship. This
is not delegating work away from the physician to the nurse or
the nursing home. This is a collaboration, both of us working
in the scope of our licenses, with the most important goal of
serving the individual.
We recognize the importance of the DEA's oversight, but I
would offer that Mrs. M's pain is not a law enforcement issue.
This really is an issue of allowing the nurse to serve as the
agent of the physician in this setting of care. We know that
diversions occur. They occur everywhere. They are no more
likely to be in nursing homes than elsewhere. There are checks
and balances in place that others can speak of.
I commend the effort of this. I wholeheartedly appreciate
this work. We look forward to working with the DEA. We would
like to find a regulatory solution to this. If not, I urge that
we move toward a legislative solution to allow the nurse to be
the managing agent.
Thank you very much.
[The prepared statement of Dr. Phillips follows:]

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The Chairman. Thank you very much, Dr. Phillips.
Now we speak--we turn to Mr. Brickley.

STATEMENT OF ROSS BRICKLEY, RPH, PRESIDENT, CONTINUING CARE RX,
INC., RALEIGH, NC; ON BEHALF OF AMERICAN SOCIETY OF CONSULTANT
PHARMACISTS AND THE QUALITY CARE COALITION FOR PATIENTS IN PAIN

Mr. Brickley. Thank you, Chairman Kohl.
My name is Ross Brickley. I'm a certified Geriatric
Pharmacist in practice in North Carolina.
I'm here on behalf of the American Society of Consultant
Pharmacists and The Quality Care Coalition for Patients in
Pain, a multistakeholder coalition of physicians, nurses, and
pharmacists.
Today, we have filed extensive written comments that
describe in detail the issues and the background that brings us
to this hearing.
In the short time I have to present my testimony, I want to
focus on the following:
First, today across the country, long-term care patients
are not receiving their controlled medications in a timely
basis. Nearly 900 clinicians responded to a survey that the
QCCPP sent out last fall, that we are releasing later today.
Two-thirds of the respondents said that the DEA rules were
impeding patients' access to controlled medications. This
number jumped to 86 percent in Ohio, where DEA enforcement
activity is the highest.
Second, in addition to delays in treatment, the survey
showed the difficulty in accessing controlled medications is
changing prescribing practices. Just as Dr. Phillips mentioned,
physicians are now writing for noncontrolled medications that
are less effective and may create other problems for our frail
elderly.
Third, some nursing facility patients are being sent back
to the hospital, just as our other panelists have indicated,
because they could not get prompt medication treatment in the
nursing home.
One example that I had on Monday of this week--and I have
all the latest technology in my nursing facilities that I
serve--but, a patient was admitted late in the evening, around
6 p.m. He was an end-stage HIV patient on routine narcotic
medication; high dose every 6 hours. So, he was admitted with
chart orders from the hospital. Those were electronically
submitted into my health record. I, electronically, had
everything I needed. Unfortunately, I could not legally
dispense that medication, because it did not have a quantity or
a physician signature on that electronic document.
Subsequently, we worked with the prescribers and such, and
eventually, over an 18-hour period later, we finally got the
signed prescription so we could legally dispense them and
submit them out. I had an automated dispensing device there,
one of the most highly technologically advanced devices
possible. I could not release that medication, available in the
nursing home, until I had that signed prescription in my
pharmacy, available to administer.
Those kind of DEA limitations, with the compliance and the
paperwork, just as our other panelists have indicated, create
challenges and barriers to patient care.
Simply stated, the DEA rules were written nearly 40 years
ago for outpatient treatment where a physician at a local,
office would see a patient. If a controlled-substance
medication was indicated, the physician would write that
prescription, hand it to the patient. The patient would fill it
at a local pharmacy. This is a very different setting than what
we have in the nursing home environment today.
Chairman Kohl, these issues being discussed today are not
new. For decades, the DEA and ASCP have met to discuss these
issues, and the DEA has been fully aware of these systems. As
early as 1974, the DEA's chief compliance officer, Kenneth
Duran, in a letter to ASCP, wrote, ``I've long felt that the
existing regulations do not adequately speak to the nursing
home situation, and members of my staff are presently reviewing
applicable regulations to see if we can arrive at a practical
solution which does not sacrifice necessary control.''
More than two decades later, in March 1996, DEA's Thomas
Gitchel wrote, ``We realize that there's still some
longstanding issues of concern, and it's clear that the
drafters of the Controlled Substance Act did not envision the
evolution of the practice of pharmacy and medical care to what
it has become today.''
ASCP and I, personally, have continued to meet with the DEA
for the past 10 years. We have no explanation for--after all
these years--the DEA has decided to aggressively enforce these
outpatient rules. In response to this, long-term care
pharmacies have been forced to take drastic action. These are
huge patient-care challenges.
The rules that the DEA ask us to follow are simply
incompatible and must be changed. In the interim, we need
immediate relief, and ask for the following:
First, the DEA must update its rules and policies for
prescribing and dispensing controlled medications to reflect
the practice realities of nursing home and hospice patients in
long-term care facilities. We welcome the opportunity to work
with the DEA to help them develop these rules.
Second, to alleviate patient suffering, the DEA has the
authority now, under the regulation, to clarify that a long-
term care facility nurse is the agent of the prescriber, and
may communicate orders to the pharmacy.
Third, if the DEA does not act, we'll call upon Congress to
enact legislation that would require the DEA to recognize the
long-term care facility nurse as an agent of the prescriber and
recognize chart orders as legal prescription orders for
controlled substances.
Thank you, Chairman Kohl.
[The prepared statement of Mr. Brickley follows:]

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The Chairman. Thank you very much, Mr. Brickley.
You've all been fairly clear and consistent in your
expressions of the problem, as you see it.
Hospital nurses may accept verbal orders from physicians
for administration of controlled substances, but nursing home
nurses may not, according to the DEA. Do you believe the DEA is
making a reasonable distinction between these care settings? If
you don't believe so, explain, maybe again, why not.
Would you like to try, Mr. Schanke, and then we'll move on?
Mr. Schanke. In terms of the distinction, I don't see one.
We have RNs with the same education and background and, many
times, the same experience, whether in a hospital or in a
nursing home. In the nursing home, my RNs are able to accept
verbal orders for execution of treatment on any number of
items. Why we're segregating, now, this scheduled medication
specifically, it doesn't make sense to me, from a purely
process standpoint.
The Chairman. Yes. Now, some of you may know precisely how
this thing is working out across the country. This has not
always been the case. This is, what, a new DEA activity, is
that right, Dr. Phillips?
Dr. Phillips. Actually, I would offer--this has been an
intermittent activity. Back--I remember having 2-o'clock-in-
the-morning struggles with dispensing pharmacies, back 2001,
2002, in Northern California. It was typically pharmacies who
either had had pushback from the DEA or who were particularly
focused on this interpretation. So, prior to, I would say, in
the last year or two, it has been spotty enforcement and spotty
action, and you might have one pharmacy in one county not
paying attention to this DEA interpretation, where another
county and different pharmacy would, which also made it very
chaotic for physicians and other practitioners in the long-term
care environment.
So, it's been a very real issue. It's not just a brand new
issue. It has certainly escalated in the past year or two.
The Chairman. OK.
Mr. Warnock, would you make some comments?
Mr. Warnock. Thank you, Senator.
Agree with what my colleagues have said. The increased
enforcement clearly has taken place recently. That is when we
started having this extra attention paid. That's when we
started having issues really come to the forefront in patient
care.
The other piece that I would make the argument is when
these regulations were written, we never imagined--and I've
been in long-term care for 30 years--we never imagined having
the kinds of residents and patients that we now accept into a
skilled nursing facility. These literally are an arm of the
hospital. So, these rules clearly were designed to take care of
custodial-care patients who didn't have immediate, emergent
needs, and that's not the kind of residents we have any more.
The Chairman. In trying to understand why they are moving
so clearly in the direction in which they are moving, can any
of you offer their justification for it? We'll be hearing from
the DEA on the next panel, but, you know, you always try and
look at it from the other person's point of view and understand
what they're doing and why they're doing it.
Mr. Brickley, you have some thoughts on that?
Mr. Brickley. Yes. Putting the shoe on the other foot,
Senator, you know, the Controlled Substance Act of 1970 is what
it is. It was written then. It was written for a different
patient-care population. As I noted in my reference, even in
1973 and 1974, the DEA recognized that there were components of
the Controlled Substance Act that did not apply, did not fit
with our setting. So, I can't contest of the DEA following the
letter of the law.
The Chairman. Dr. Phillips?
Dr. Phillips. Yes, if I may. I believe there's also some
myths and misunderstandings of how clinical practice occurs in
nursing home settings. It is not, as been mentioned, but may be
seen by the DEA as, an outpatient kind of setting with absent
doctors and nurses sort of running the show. That, in fact, is
not the reality. Physicians are responsible for patients, 24/7.
We work in a collaborative team-based environment with nurses,
therapists, pharmacists, the entire spectrum of the license
panel. So, decisions are still made in orders by physicians who
are overseeing the care through the agent, in other contexts of
care of the nurse in the nursing home.
So, I think part of the challenge is getting the
understanding, this is an environment of team-based integrated
care for very frail, vulnerable individuals with considerable
oversights at every step of the way, in both prescribing,
dispensing, and administering and counting for all of the
narcotics and other medications present.
The Chairman. Now, is it fair to say that all of you would
like to have the same method of prescribing pain medication in
nursing home facilities as we have in the hospitals? Is that
right? Is that what you're advocating?
Mr. Schanke. Yes.
The Chairman. Mr. Schanke?
Mr. Schanke. Absolutely.
The Chairman. That's what you're advocating.
Mr. Warnock?
Mr. Warnock. Yes, sir.
The Chairman. Dr. Phillips?
Dr. Phillips. Yes, sir.
The Chairman. Mr. Brickley?
Mr. Brickley. Yes, Chairman.
The Chairman. Any of you see any cautionary reasons why
that shouldn't be done? Do you have any imagined problems that
might occur if we were using the same procedure?
Mr. Schanke. Well, I'll jump in. We've been doing it for a
while, and we've got established procedures, in terms of
tracking scheduled meds, in particular, from shift to shift,
new orders, expired orders. We take managing the scheduled
medications extremely seriously, just for many of the reasons
the DEA wants us to, and we should be. We're concerned about
making sure we don't have diversion issues and that the meds
are used properly for our patients. So, extending the nurse as
agent of physician to us is not going to change any of the sort
of foundational things we already do to make sure we handle
them safely, securely, and they're administered properly.
The Chairman. What are your legal liabilities here? I
mean--any of you--what happens if, in fact, in your facility,
if we were doing it as hospitals do it, and somebody badly
overprescribes? Are you--is there a legal--Dr. Phillips is
there a legal liability here?
Dr. Phillips. Well, there are both licensure and law
enforcement oversight and oversight of the DEA. So, if I am a
negligent practitioner-prescriber, I'm accountable, whether
it's in the community, the nursing home, or the hospital. That
doesn't change by the setting; I still am obligated under my
license and my oversight in my practice.
So, I think that that piece is not a good argument, that
this one setting of care--I applaud the DEA's desire to address
diversion and all issues of diversion which occur in the
hospital, the office, the community and nursing home--need to
be dealt with. But, it is not singularly the nursing home where
the risk lies. Yet, we are creating the burden of this on the
backs and the broken legs of our patients. That's the real
tragedy, and I think it's the unintended consequence.
The Chairman. Yes.
Any comments from this panel on anything, whatever? Mr.
Warnock or Mr. Brickley?
You've been really good and complete in describing the
problem, and I think we all appreciate that very much.
Mr. Warnock. Thank you, Senator. The only thing I would
like to express, and I think it's been expressed very well here
today, but I don't want to leave without saying. It is very
important that we solve this problem. These people deserve
better than what we're giving them today, and we need to
provide better for them.
The Chairman. Well, that's very good.
We're going to have the representative from the DEA here on
the next panel. If--probably redundant, but if you--if you
wanted me to ask him a--just in the interest of trying to get
to a resolution--one question, what would you suggest, Dr.
Phillips?
Dr. Phillips. I guess I would ask, Why the nursing home?
What is it about this setting that makes it, in particular, a
focus for the DEA's interpretation, when licensed nurses are
practicing under the same scope of practice, the nurses are--
the physicians are interacting under their same scope of
practice, under the same State and Federal regulations, why
this setting of care is being identified and targeted?
The Chairman. Why is this any different from a hospital
setting?
Dr. Phillips. Exactly.
The Chairman. Is that right?
Mr. Schanke. Yes.
The Chairman. Would that be your question?
Mr. Schanke. Yes.
The Chairman. I am your faithful servant.
Dr. Phillips. Very good.
The Chairman. Thanks a lot, folks, you've been good.
Dr. Phillips. Thank you.
Mr. Schanke. Thank you.
The Chairman. So, we come to our next panel here today. We
welcome our two witnesses.
Our first witness on this panel will be Joseph Rannazzisi.
Mr. Rannazzisi is the Deputy Assistant Administrator in the
Office of Diversion Control at the Drug Enforcement
Administration, located in the U.S. Department of Justice. As
Deputy Assistant Administrator, he is responsible for
overseeing and coordinating major pharmaceutical and synthetic
drug investigations, drafting and enforcing regulations, as
well as establishing drug production quotas.
We welcome you here today.
Next, we'll be hearing from Carmen Catizone. Mr. Catizone
is the Executive Director of the National Association of Boards
of Pharmacy, and the Secretary of the Association's executive
committee. The National Association of Boards of Pharmacy is
the international association that assists members in
developing and implementing standards for public health.
We welcome you both here.
Mr. Rannazzisi, we'll start with you.

STATEMENT OF JOSEPH RANNAZZISI, DEPUTY ASSISTANT ADMINISTRATOR,
OFFICE OF DIVERSION CONTROL, DRUG ENFORCEMENT ADMINISTRATION,
U.S. DEPARTMENT OF JUSTICE, WASHINGTON, DC

Mr. Rannazzisi. Good afternoon, Chairman Kohl.
On behalf of Acting Administrator Michele Leonhart and the
men and women of the Drug Enforcement Administration, thank you
for holding this hearing on this important issue regarding the
issue of prescribing controlled substances to patients in long-
term care facilities.
DEA is charged with enforcing the Controlled Substances Act
and its implementing regulations, which were designed, first
and foremost, to protect the public health and safety.
DEA accomplishes this mission, in part, through
administrative and regulatory oversight of more than 1.3
million individuals and businesses registered to handle
controlled substances. The registrant population consists of
manufacturers, importers, wholesalers, distributors,
pharmacies, and practitioners.
With very few exceptions, however, DEA does not regulate
long-term care facilities. This is due, in part, to the fact
that these facilities typically do not have State controlled-
substance registrations or hold DEA registrations.
Controlled substances are powerful and potentially
dangerous drugs when used improperly and without the proper
practitioner oversight. That said, the CSA has, in its very
core, the unique ability to provide a protective umbrella
throughout the controlled-substance distribution chain. By
design, the CSA provides built-in checks and balances to ensure
that controlled substances are dispensed for legitimate need,
while protecting the public health and safety from diversion.
The CSA, in implementing regulations, therefore established
specific limitations on who is authorized to prescribe, and
under what conditions. The regulations set forth very precise
elements that must be included in a prescription to reduce
errors and solidify the authenticity of the prescription.
For example, a practitioner--a term clearly defined in the
Controlled Substances Act--is the only person who can prescribe
a controlled substance. Furthermore, the practitioner must be
licensed by the State in which he or she practices and must be
registered by the Drug Enforcement Administration. Once these
conditions have been met, a practitioner can only prescribe a
controlled substance after a determination has been made that
the drug is needed for legitimate medical purpose and is
prescribed in the usual course of professional practice.
Though the responsibility for proper prescribing and
dispensing of a controlled substance rests with the
practitioner, it's the pharmacist who's the final gatekeeper.
Under the Controlled Substances Act, a corresponding liability
rests with the pharmacist to ensure that every prescription
they fill is valid. They are the last line of defense before a
controlled substance leaves the closed system of distribution.
DEA understands that the laws and regulations may need to
adapt whenever possible, to keep pace with advancements in
technology, science, or medicine. DEA regularly works with, and
solicits input from, the medical and scientific community. We
also seek input from the general public through the notice and
comment portion of the regulatory process. Over the years, DEA
has promulgated several regulations to address the unique and
specific needs of patients in long-term care facilities.
For example, a pharmacist can typically only dispense a
Schedule 2 controlled substance upon receipt of an original
written prescription signed by a practitioner. However, if a
patient is a resident of a long-term care facility, the
practitioner can fax the written prescription to the pharmacy.
As far back as 30 years ago, DEA recognized the need to
address emergency situations in long-term care facilities by
authorizing placement of emergency kits in those locations.
These kits, however, are the responsibility and property of the
DEA-registered pharmacy and not the facility.
In 2005, DEA implemented regulations to allow retail
pharmacies to install and operate automatic dispensing machines
within long-term care facilities. These systems provide a means
for patients to receive their medications in a more expedient
manner.
In 2007, DEA implemented a regulation which permits a
practitioner to issue multiple prescriptions for Schedule 2
controlled substances. This option can provide patients with up
to a 90-day supply of medicine. In the event of an emergency,
DEA has authorized pharmacists to dispense Schedule 2
controlled substances upon receipt of a valid oral order from a
prescribing practitioner.
Finally, DEA has drafted an interim final rule that will
allow for the electronic prescribing of controlled substances,
and that rule should be posted today at the Office of the
Federal Register and should be published within the next week
or so.
The current statutory and regulatory regime provides
practitioners and pharmacists with a wide variety of mechanisms
to deliver medications both safely and timely to patients in
long-term care facilities. The Drug Enforcement Administration
recognizes the importance of providing safe and effective
medications to patients in need. As technologies evolve, or
other circumstances dictate, DEA has and will continue to
implement regulations whenever possible, to allow for proper
prescribing and dispensing of controlled substances.
Chairman Kohl, thank you again for your interest on this
important matter and ensuring that patients who reside in these
facilities receive appropriate standard of care that they
deserve. The Department of Justice and the Drug Enforcement
Administration are committed to working with Congress on this
and other matters.
Thank you for this opportunity to appear today, and I look
forward to answering any questions you may have.
[The prepared statement of Mr. Rannazzisi follows:]

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The Chairman. Thank you very much.
Mr. Catizone.

STATEMENT OF CARMEN CATIZONE, DPH, EXECUTIVE DIRECTOR, NATIONAL
ASSOCIATION OF BOARDS OF PHARMACY, MOUNT PROSPECT, IL

Mr. Catizone. Thank you, Chairman Kohl.
With me today is--also, is William Winsley, Executive
Director of the Ohio Board of Pharmacy and President-Elect of
NABP. Mr. Winsely is uniquely qualified to speak on the issues
today, because of his extensive background in pharmacy practice
and regulation. His was the first State to be challenged by
these issues.
NABP appears before you today as an objective third party,
with our only interest being the patient and the integrity of
the medication distribution and dispensing systems. As an
association of State regulatory agencies, we are not involved
in the economics of the profession of pharmacy, and therefore,
are removed from any direct concern with the economic impact on
long-term care and long-term care practitioners that compliance
with Federal and State laws and regulations may have, unless
patient care suffers as a result of burdensome regulation.
Mr. Chairman, it's important to temper today's hearing with
the realization that emotions are running high and some of the
dire consequences predicted to occur will not occur and, in all
likelihood, if they do occur, will not be to the extent that
they have been predicted. Furthermore, the accusations which
characterize this struggle have clouded the issue and have
obstructed necessary avenues of communication. Some of the
statements today also falsely accuse the DEA and law
enforcement authorities of actions that are simply not true.
We concur that patient care is affected, but we also
acknowledge that diversion is a serious issue. To what extent
each of these unfortunate outcomes is occurring, and the
reasons for their occurrence, are at the heart of this hearing.
As NABP approached this issue, we sought to ignore the
inflammatory comments and tried, instead, to determine what the
facts are and what possible solutions exist. In this regard, we
posed two questions to those with whom we spoke.
To the practitioners in the long-term care industry, we
asked whether compliance with the statutes and regulations of
the DEA, which are considered intractable, could occur, but has
not occurred because of the cost and inconvenience to the
industry.
To the DEA and regulatory authorities, we asked whether the
basis for declaring that industry standards were illegal was
statutory and regulatory, or interpretation of statutes and
regulations.
To be perfectly honest, Mr. Chairman, NABP believes that
the inflexible positions advanced are not entirely accurate or
absolute. Furthermore, addressing the issues under
consideration today in an isolated way, even if approached with
the wisdom of Solomon, might prevent the child from being
split, but ultimately would result in further complications and
conflicts, because the issues encompass significant areas and
interpretations of the Controlled Substances Act.
To this end, the member States of NABP have called for us
to invite the DEA and all stakeholders, those in long-term care
and other practice settings, to work with us to review and pose
revisions to the Controlled Substances Act. Those revisions
would address the issues under consideration today, as well as
other issues that need to be addressed because of significant
changes in practice in patient care, technology, and
regulation.
To the immediate question under review by this committee
and affecting patient care in long-term practices, NABP
recommends the following course of action: that DEA establish a
new registration category for long-term care facilities, as
defined by the States, with similar privileges and
responsibilities as now exist for hospitals. If this could be
enacted, the dilemma surrounding chart orders and agent of the
prescriber could move toward a resolution.
Presently the NABP Model Act, and a report developed in
collaboration with the American Society for Consultant
Pharmacists, define long-term care facilities within the
definitions of an institutional facility. That definition
includes hospitals, and would place upon long-term care
facilities the same legal and regulatory standing.
It should be noted, however, that diversion, unacceptable
standards of care for our elderly, and outdated regulations
would not be resolved by this immediate action. For those
broader and more encompassing issues, we again recommend a more
comprehensive analysis and review of the Controlled Substances
Act.
NABP is hopeful that this committee will support our effort
and, through whatever authority available to it, bring the
parties to the table to engage in this much-needed and valuable
effort on behalf of the patient and integrity of the medication
distribution and dispensing systems.
Thank you for the opportunity to comment today.
Mr. Winsley and I would be glad to answer any questions you
may have, Mr. Chairman.
[The prepared statement of Mr. Catizone follows:]

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The Chairman. Thank you very much, Mr. Catizone.
Mr. Rannazzisi, you've heard Mr. Catizone testify that DEA
might well, and should, allow--should create a new registration
category for nursing homes that will allow them to operate more
like hospitals do, with respect to ordering controlled
substances. Do you have a sense that your agency is prepared to
work with the pharmacy boards, other regulators, as well as the
provider community on such a solution?
Mr. Rannazzisi. Yes, sir.
Let me explain our registration process a little. If a
State decides to register, or give controlled substance
authority to, a nursing home, depending on the extent of that
controlled-substance authority, we would be obligated to
register them. So, yes, we would register them. We'd work with
them, and we have no problem registering them. However, our
registration is based on the State-controlled substance
authority that's granted to the prospective registrant. So, it
would be up to the States to make that first step, to give them
controlled-substance authority, and then we would create a new
class of registrant to encompass the nursing homes.
The Chairman. What kind of an impediment does that present,
Mr. Catizone?
Mr. Catizone. Mr. Chairman, if the providers support this
initiative and work with their State board of pharmacy, we see
no impediment on behalf of the boards of pharmacy. The
impediment would come from the provider community that might
oppose this. But, if the panelists today were honest and
sincere in trying to treat the patient, then we would see it
moving forward quite quickly.
The Chairman. So, you see this as being quite doable.
Mr. Catizone. Yes, sir.
The Chairman. Do you, Mr. Rannazzisi?
Mr. Rannazzisi. Absolutely. As long as the State
controlled-substance authority is in place, yes, sir. It would
just take us time to--not a lot of time, but time to create
that new registrant category, but we'd be very expeditious in
the creation of that.
The Chairman. So, how do you imagine that we--if you have a
set of--how do you imagine that we might move toward a
resolution here that long-term care facilities find
satisfactory, as well as yourself? What's the next step?
Mr. Rannazzisi. If we're talking about the registration of
the long-term care facilities, the next step would be the
States to make the decision whether they're going to provide
long-term care facilities with controlled--State controlled-
substance registration. Once that is done, and they've been
provided with that authority, we'll do the rest.
The Chairman. That's a good answer.
You heard the providers on the first panel discuss the
practical dilemmas they face, trying to relieve pain and
suffering among their residents. What efforts are you making to
reach out to long-term care providers in order to help them do
what is expected of them?
Mr. Rannazzisi. As I said in the testimony, the long-term
care providers are not our registrants. We don't have any
regulatory control over them. We don't inspect them. Our
registrants in this community would be either the practitioners
that are prescribing or the pharmacy services corporations that
are actually servicing the long-term care providers.
Now, we do a number of different presentations. I think in
2009, we did over 25 presentations to all different groups in
the medical community--the boards, American Medical
Association, Mayo Clinic, National Community Pharmacists
Association, the National Conference--we bring in medical and
pharmacy board representatives, the American Society of
International Interventional Pain Physicians, the list goes on
and on--about 25 different presentations, and we talk about all
aspects of the Controlled Substances Act, and we answer
questions related to the Controlled Substances Act.
In this situation, there are two registrants that relate
directly to the long-term care facilities that are not
registrants: the practitioners and the pharmacists, the
pharmacists being the gatekeeper for the prescriptions, to
determine whether they're valid or not. I think that the
pharmacists have a very good background, with 40 years of the
Controlled Substances Act, about determining what is a valid
prescription. Inherent in the Act is a determination that a
prescription is valid, on both the practitioner's side and the
pharmacist's side. A prescription, to be valid, is issued for
legitimate medical purpose in the usual course of professional
practice; that's the standard that the doctors are held to. The
pharmacists have a corresponding responsibility to ensure that
that prescription is valid, and they're held to that same
standard. The nurse is just a facilitator to make sure the
medication is received and given to the patient. If the
pharmacist and the practitioners understand the valid
prescription requirement, there shouldn't be a problem with the
nursing homes.
The Chairman. Do you see it that way, Mr. Catizone?
Mr. Catizone. Yes, Chairman Kohl.
The Chairman. Well, I get the sense that we may be moving
in the right direction here. Before we, perhaps, begin to wind
up this hearing, I would to take the somewhat unusual step of
asking the Doctor to come back and sit down for a minute. Tell
us, Dr. Phillips, if you feel that we've made a lot of
progress, some progress, no progress. What do you think?
Dr. Phillips. I am delighted to hear--I am--I guess I'm a
little bit taken back by the sense that somehow we have been
inflammatory or exaggerative, because, in fact, these pain
events were happening last year, they were happening yesterday,
they're happening today, and there will be hundreds of them
happening tomorrow, so it is a very real issue.
I'll speak from personal experience, and maybe a little bit
of ignorance. I had started this issue in California and tried
to look at a State solution, back 5 years ago, and our State
Board of Pharmacy said it was a DEA issue, and they had to go
to defer to the DEA. Now, I'm hearing from the DEA that, in
fact, it's a States issue. So, I guess a little bit of caution
on my part is, Are we going to do one of these, ``It's my turn,
no, it's my turn,'' before it actually gets resolved? Where the
authority lies, I'm unclear. But, I am concerned that we'll do
a little bit of push-pulling back and forth between the States
and the DEA.
The Chairman. Go ahead, if you can.
Mr. Rannazzisi. Again, inherent in the registration process
is a requirement that a controlled--the controlled-substance
authority be granted by the State before DEA can issue a
registration. Once that State decides how they're going to
grant that controlled-substance authority and the exact
authority that they'll be granted, we will proceed with the
registration process. It depends on the State.
The Chairman. Mr. Catizone.
Mr. Catizone. Chairman Kohl, we will issue that explanation
to the States, as well as our recommendation that they
recognize this. Clearly, a letter from this committee or from
you, sir, would help that process--that we could send to all
the States, and work with the Congressmen and Senators in their
States, as well, saying that this is an important initiative,
we need to move quickly. That would move the issue very
quickly.
The Chairman. All right, well, I'll be happy to do it.
Dr. Phillips, you've got a nice smile on your face.
Dr. Phillips. Well, I think that's a wonderful next step,
and I'm delighted and appreciate both the efforts of the DEA,
the pharmacy, and also our panel of providers. With your input,
this will actually start to move.
Thank you.
The Chairman. I think that's great. I'm moved to speculate
and think that if we could have had you all working on
healthcare, we would have done it in a month. It wouldn't have
taken----
Dr. Phillips. You should have asked us, huh? [Laughter.]
The Chairman. Without all the animosity.
You've all done a great job. We thank you all for being
here. I think that this has been a very, very good session that
we've had this afternoon.
Dr. Phillips. Thank you.
The Chairman. Thank you so much.
[Whereupon, at 3 p.m., the hearing was adjourned.]

A P P E N D I X

----------

Mr. Schanke's Responses to Senator Brownback's Questions

Question. It is acceptable for nurses in long-term care to
take phone and ``chart orders'' for all other medications and
treatments--antibiotics, anti-coagulants, insulin, etc. Some of
these medications have life threatening implications if the
order is incorrect and/or administered inappropriately. Given
the dispensing controls that are in place for narcotics, can't
we accomplish the same physician involvement by having them
sign the ``chart order'' with the required information during
their next visit without requiring the extra step of a retail
prescription form?
Answer. The current procedures for continuation of orders
and implementation of new orders for existing patients and
newly admitted patients are effective for all medications and
treatments. There is no reason to believe that the same would
be not be true should we have the ability to include narcotics
and other ``schedule'' medications in those procedures. The
information required for a narcotic order will still be
obtained concurrently with the immediate implementation of the
physicians order for the pain medication. If we had the ability
to use the ``chart order'' or a phone order there would be much
less potential for a delay in the administration of the pain
medication. Delays continue to occur while we wait for DEA
required paperwork/verbal communication to find its way from
physician, direct to pharmacist, back to nursing staff before
we can give the needed pain medications.
Question. Do you think it is time to change the CSA act to
reflect the practice of Long Term Care, similar to what occurs
in hospitals? The hospital nurse is employed by the hospital,
yet can take orders for narcotics over the phone without the
need for a written or verbal prescription to the pharmacist.
Answer. I do think it is time for the CSA act to reflect
the practice of Long Term Care. Nursing staff in Long Term Care
facilities must communicate with the physician and receive that
physician's instructions for any and all treatments and
medications, whether new or existing. There is no practical
difference in starting/continuing an order for insulin or
starting/continuing an order for a pain medication. Insulin can
be ordered by a physician over the phone to my nursing staff
and followed up with a signature. A simple pain medication
cannot be ordered over the phone, but must have specific paper
work completed before we can consider giving it.
The DEA's enforcement of outdated rules does not prevent
diversion. We do not have a diversion problem in the Fox Valley
according to my local police force and our area wide drug
enforcement unit. In fact, there has been only one instance of
diversion of a controlled medication investigated by either
agency in the last three years and that was an Assisted Living
Facility not a Skilled Nursing Facility. As was stated at the
hearing, diversion is no more likely to occur in a nursing home
than it is in any other setting. I would submit that our
internal controls and procedures make it very difficult to
commit diversion and more difficult to continue diversion as
evidenced by the virtual absence of policy activity in this
area. We take the management of controlled medications
seriously; our hope is that the DEA will take our patient's
pain needs just as seriously.
------

Mr. Warnock's Responses to Senator Brownback's Questions

Ms. Phillips Responses to Senator Brownback's Questions

Mr. Brickley's Responses to Senator Brownback's Question

Mr. Rannazzisi's Responses to Senator Brownback's Questions

Question. It is acceptable for nurses in long-term care to
take phone and ``chart orders'' for all other medications and
treatments-antibiotics, anti-coagulants, insulin, etc. Some of
these medications have life threatening implications if the
order is incorrect and/or administered inappropriately. Given
the dispensing controls that are in place for narcotics, can't
we accomplish the same physician involvement by having them
sign the ``chart order'' with the required information during
their next visit without requiring the extra step of a retail
prescription form?
Answer. A proper response to this question requires two
important distinctions be made: (1) the statutory and
regulatory scheme applicable to controlled substances includes
stringent controls not applicable to-- non-controlled
substances; and (2) the characteristics of a physician's order
for a substance to be dispensed to a patient, and the
circumstances surrounding that order, determine whether the
order is deemed a ``chart order'' or a ``prescription,'' which
in turn determines whether dispensing a controlled substance is
authorized under the Controlled Substances Act (CSA).
Even after meeting all applicable requirements under the
Federal Food, Drug, and Cosmetic Act controlled substance
medications can only be dispensed to patients pursuant to the
stringent controls imposed by the CSA, because controlled
substances (as opposed to non-controlled substances) have the
potential for abuse, and are frequently diverted into the
illicit market.
Next, an appreciation for the differences between a ``chart
order'' and a ``prescription'' is necessary. A Drug Enforcement
Administration (DEA)-registered hospital is a ``practitioner''
within the meaning of the CSA; therefore it is permissible for
such a hospital to dispense controlled substances directly to
patients without a prescription. Because of this, in a hospital
setting, a hospital may dispense a controlled substance for
immediate administration to a patient pursuant to an order for
medication made by a physician who is an agent or employee of
the DEA-registered hospital. This may occur, for example,
through the issuance of a ``chart order.'' In this context, the
term ``chart order'' should be distinguished from the term
``prescription.'' A prescription, unlike a chart order, must
contain all of the information specified in 21 C.F.R.
1306.05, including, among other things, the signature of the
physician on the day that the order is authorized.
Unlike hospitals, Long Term Care Facilities (LTCFs) are not
DEA registrants. Therefore, if a ``chart order'' at a LTCF
contains all of the required elements of a prescription,
including the signature of a physician on the day that the
order is signed, then the chart order itself could serve as a
valid prescription. The required elements, which are set forth
in 21 C.F.R. 1306.05, are as follows:

Signature of issuing practitioner
Date of issuance (which must be the same day that
the prescription is signed)
Full name and address of patient
Drug name
Strength
Dosage form
Quantity prescribed
Directions for use
Name, address, and DEA registration number of
issuing practitioner

Depending on the schedule of the drug, there may also be
time limitations on how long a prescription is valid as well as
the number of refills. For example, under 21 CFR 1306.22(a),
``No prescription for a controlled substance listed in Schedule
III or IV shall be filled or refilled more than six months
after the date on which such prescription was issued and no
such prescription authorized to be refilled may be refilled
more than five times.'' Additionally, the determination that
use of a controlled substance is medically necessary in any
particular case must be made by a practitioner acting in the
usual course of professional practice. See United States v.
Moore, 423 U.S. 122 (1975); 21 CFR 1306.04(a). Such
determinations cannot be delegated to LTCF staff.
Practically speaking, though, chart orders at non-DEA
registered LTCFs typically do not contain all of these required
elements of a prescription. In particular, chart orders at
LTCFs often lack the signature of the issuing practitioner,
which is critical to substantiate that he/she did in fact
authorize controlled substance medication(s) for a specific
legitimate medical need.
Prescriptions must contain all of the elements listed above
primarily because controlled substances, in contrast to non-
controlled substances such as antibiotics, anti-coagulants, and
insulin, have potential for abuse and are frequently diverted
into the illicit market. Therefore, the dispensing of
controlled substances is generally subject to tighter controls
and more regulatory oversight than non-controlled substances.
Question. Do you think it is time to change the CSA act to
reflect the practice of Long Term Care, similar to what occurs
in hospitals? The hospital nurse is employed by the hospital,
yet can take orders for narcotics over the phone without the
need for a written or verbal prescription to the pharmacist.
Answer. The CSA already allows for such a result if the
relevant state has granted controlled substance authority to
LTCFs in the same way it does for hospitals. Hospitals have
state controlled substance authority, and are registered with
the DEA--commensurate with that authority--to handle controlled
substances. Individual states make the determination whether to
issue licenses to qualified persons or facilities to handle
controlled substances and under what limitations, and DEA
registered practitioners may only engage in those activities
that are authorized under state law for the jurisdiction in
which they are located. If an LTCF were to satisfy a state's
requirements for licensure as a hospital, such an LTCF could
apply for DEA registration similar to that of a hospital. If
so, registration of the LTCF by DEA would permit independent
controlled substance authority, allow the facility to maintain
a common stock of controlled substances on the premises, and
the LTCF may be able to utilize chart orders like a hospital if
allowed under state law and commensurate with federal
regulations. Registration by DEA would also subject the
facility to DEA oversight, recordkeeping requirements, and
security requirements. In order for this option to be fully
realized, however, states would first need to enact laws or
regulations to permit this type of activity by LTCFs.
Nonetheless, even in the absence of state authorization in
this area, the current statutory and regulatory regime provides
practitioners and pharmacists with a wide variety of means to
deliver controlled substances both safely and timely to
residents of LTCFs. Over the years DEA has implemented
regulations, consistent with the CSA, that were specifically
tailored to assist practitioners and pharmacists by making it
easier to prescribe and dispense controlled substances to
residents of LTCFs. Currently, several options exist for a
practitioner to prescribe controlled substances to their
patient in a LTCF setting. The following is a summary of
existing regulatory exceptions made to ensure that residents'
medical needs at LTCFs are met:

For a controlled substance in schedules II-V a
practitioner can manually write a prescription for his or her
patient. The prescription must be dated as of the date signed,
and is required to contain specific information including: name
and address of the patient; drug name and strength; dosage
form; quantity prescribed; directions for use; and name,
address, and DEA number of issuing practitioner. 21 C.F.R.
1306.05(a).
The CSA provides that a controlled substance in
schedule II--the most stringent schedule for substances having
a medicinal purpose and high abuse potential--may only be
dispensed pursuant to a written prescription of a practitioner.
21 U.S.C. 829(a). However, should an emergency situation
arise, this statutory provision contains an exception that
allows practitioners to issue emergency oral prescriptions with
the regulatory requirement that the oral prescription be
immediately reduced to writing by the pharmacist and contain
all the information required for a written prescription, except
for the signature of the prescribing individual practitioner,
and must be followed up within seven days by a written
prescription from the practitioner to the dispensing pharmacy.
To facilitate the receipt of controlled substances under these
circumstances, DEA has allowed pharmacies to establish
``emergency kits'' in the LTCF that are routinely stocked with
commonly dispensed controlled substances. These kits are
extensions of the pharmacy and are controlled under the
pharmacy's DEA registration.
Another means by which residents can receive
medications more efficiently is a federal regulation that
contains a provision specifically designed to accommodate
LTCFs. The regulation provides for the dispensing of controlled
substances on the premises of a LTCF through the use of an
automated dispensing machine. Such dispensing must still be
accomplished via a legitimate prescription, but places the
supply of controlled substances on location for convenient
dispensing to a patient. 21 C.F.R. 1301.27.
Though practitioners cannot issue refills for
schedule II controlled substance prescriptions, DEA has
implemented a regulation that allows practitioners to issue
multiple prescriptions authorizing a patient to receive up to a
90-day supply for these substances. 21 CFR 1306.12.
An exception for delivery of a schedule II
prescription to a pharmacy for LTCFs also exists at 21 CFR
1306.11(f). Under this regulation a written prescription
containing all the information required by 21 C.F.R. 1306.05,
including the signature of the practitioner, may be transmitted
via fax by the practitioner or practitioner's agent. Partial
filling of schedule II prescriptions is also allowed for LTCF
residents or an individual with a terminal illness as long as
the amount dispensed does not exceed the total amount
prescribed and occurs within 60 days (21 CFR 1306.l3(b).
Schedule III-V prescriptions may also be written
but may be refilled up to five times in a six-month period as
directed by the prescriber. A fax of a written schedule III-V
prescription may also be transmitted to a pharmacy by the
practitioner or the practitioner's agent. Prescriptions for
schedule III-V substances may also be orally transmitted by the
practitioner to a pharmacy. Partial filling is also permissible
for schedule III-V prescriptions not to exceed six months from
date of issuance.

DEA has also published an Interim Final Rule allowing for
the electronic prescribing of controlled substances. The
effective date of this rule was June 1, 2010. This rule
provides yet another tool for practitioners to use when
prescribing a controlled substance for their patient, including
those who reside in an LTCF. This rule allows practitioners to
use a computer, laptop or PDA device to send a prescription to
a pharmacy from a remote location instantaneously.

Mr. Catizone's Responses to Senator Brownback's Questions

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