[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

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

                           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/
                               index.html



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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

                              ----------                              --



                       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

    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. Yes, it is acceptable for all non-controlled drugs 
to be ordered verbally and chart orders are the official orders 
for these drugs. I agree that we could treat controlled drugs 
just as we do all other drugs and the risk of diversion would 
not change appreciably.
    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. Yes, I believe this is the most reasonable and 
easily implemented solution to this issue. I only hope we can 
find a path to accomplish this change quickly so we can move 
forward with better care of our patients more quickly.
                                ------                                


        Ms. Phillips 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. Yes, we can give telephone orders for these other 
medications and yes, they often DO have life-threatening 
implications if not administered correctly, And yes, one piece 
of what we are saying is that we (physicians) do have to sign 
the orders within 7 days and thus would also have to sign any 
orders for narcotics ordered as well. There is a check and 
balance process in place. Every verbal order must be signed and 
the pharmacy will not release meds without an order--so even if 
the nurse were diverting, it would be identified when the 
physician was asked to sign the order.
    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. Yes, very much. What we are hoping is that the 
nurse will become the ``agent'' as it is in the hospital.
                                ------                                


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

    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 monthly physician order sheet recaps do 
not contain all of the data required by the DEA (i.e. quantity, 
DEA #, patient address, Physician address etc..) Although we 
could ask 70-80 software companies to re-design the monthly 
physician order re-caps, there is still the patient care 
barriers for new controlled substance orders for existing or 
new admissions to the long term care facilities. Only by 
getting the DEA to recognize a nurse as the agent of the 
prescriber and to recognize a ``chart order'' as a valid 
prescription order will be able to promptly dispense controlled 
substances for these frail, elderly residents.
    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. Yes, it is clearly time to update the Controlled 
Substance Act to reflect the practice standards that are being 
followed in LTC facilities. The chart orders and medical record 
systems are very similar to a hospital setting so it makes 
sense to modify the CSA to treat LTC facilities similar to 
hospitals.

      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

    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 question involves an area of expertise best 
answered by the DEA. Our understanding is that the Controlled 
Substances (CSA) and accompanying regulations specifically 
prohibit the activities noted.
    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. NABP believes that the CSA has been effective in 
protecting patients and combating drug diversion since its 
creation and adoption. However, pharmacy practice in long term 
care and other settings has changed dramatically since the 
inception of the CSA more than 30 years ago. The member State 
Boards of NABP are requesting a review of the CSA and 
amendments to recognize the changes in pharmacy practice across 
all settings, including long term care.

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