[Senate Hearing 113-680]
[From the U.S. Government Publishing Office]
S. Hrg. 113-680
OVERMEDICATION: PROBLEMS AND SOLUTIONS
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HEARING
BEFORE THE
COMMITTEE ON VETERANS' AFFAIRS
UNITED STATES SENATE
ONE HUNDRED THIRTEENTH CONGRESS
SECOND SESSION
__________
APRIL 30, 2014
__________
Printed for the use of the Committee on Veterans' Affairs
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COMMITTEE ON VETERANS' AFFAIRS
Bernard Sanders, (I) Vermont, Chairman
John D. Rockefeller IV, West Richard Burr, North Carolina,
Virginia Ranking Member
Patty Murray, Washington Johnny Isakson, Georgia
Sherrod Brown, Ohio Mike Johanns, Nebraska
Jon Tester, Montana Jerry Moran, Kansas
Mark Begich, Alaska John Boozman, Arkansas
Richard Blumenthal, Connecticut Dean Heller, Nevada
Mazie Hirono, Hawaii
Steve Robertson, Staff Director
Lupe Wissel, Republican Staff Director
C O N T E N T S
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April 30, 2014
SENATORS
Page
Sanders, Hon. Bernard, Chairman, U.S. Senator from Vermont....... 1
Burr, Hon. Richard, Ranking Member, U.S. Senator from North
Carolina....................................................... 3
Blumenthal, Hon. Richard, U.S. Senator from Connecticut.......... 5
Isakson, Hon. Johnny, U.S. Senator from Georgia.................. 5
Begich, Hon. Mark, U.S. Senator from Alaska...................... 53
WITNESSES
Petzel, Robert, M.D., Under Secretary for Health, Veterans Health
Administration, U.S. Department of Veterans Affairs;
accompanied by Tracy Gaudet, M.D., Director, Office of Patient
Centered Care and Cultural Transformation and Peter Marshall,
M.D., Director of Primary Care Pain Management, Minneapolis VA
medical center:
Impromptu question/answer.................................... 7
Oral statement............................................... 8
Prepared statement........................................... 9
Response to posthearing questions submitted by:
Hon. Bernard Sanders....................................... 19
Hon. Mark Begich........................................... 23
Hon. Richard Blumenthal.................................... 24
Coots, BG Norvell V., USA, Deputy Commanding General (Support),
U.S. Army Medical Command and Assistant Surgeon General for
Force Projection, Office of the Surgeon General, U.S. Army;
accompanied by COL Kevin T. Galloway, Director, Army Pain
Management Program, Rehabilitation and Reintegration Division.. 24
Prepared statement........................................... 26
Response to posthearing questions submitted by:
Hon. Bernard Sanders....................................... 32
Hon. Richard Blumenthal.................................... 34
Hon. Mark Begich........................................... 35
Briggs, Josephine, M.D., Director, National Center for
Complementary and Alternative Medicine, National Institutes of
Health......................................................... 36
Prepared statement........................................... 38
Response to posthearing questions submitted by:
Hon. Bernard Sanders....................................... 40
Hon. Mark Begich........................................... 42
Additional information....................................... 44
Kahn, Janet, Ph.D., Research Assistant Professor, Department of
Psychiatry, University of Vermont and Senior Policy Advisor,
Consortium of Academic Health Centers for Integrative Medicine. 60
Prepared statement........................................... 63
Edlund, Mark, M.D., Ph.D., Senior Research Public Health Analyst,
Behavioral Health Epidemiology Program, RTI International...... 97
Prepared statement........................................... 99
APPENDIX
American Legion, The; prepared statement......................... 109
Ilem, Joy J., Deputy National Legislative Director, Disabled
American Veterans (DAV); prepared statement.................... 112
Maffucci, Jacqueline A., Ph.D., Research Director, Iraq &
Afghanistan Veterans of America (IAVA); prepared statement..... 115
Citizens Commission on Human Rights International (CCHR); report. 117
OVERMEDICATION: PROBLEMS AND SOLUTIONS
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WEDNESDAY, APRIL 30, 2014
U.S. Senate,
Committee on Veterans' Affairs,
Washington, DC.
The Committee met, pursuant to notice, at 10:05 a.m., in
room 418, Russell Senate Office Building, Hon. Bernard Sanders,
Chairman of the Committee, presiding.
Senators present: Senators Sanders, Rockefeller, Begich,
Blumenthal, Burr and Isakson.
OPENING STATEMENT OF HON. BERNARD SANDERS,
CHAIRMAN, U.S. SENATOR FROM VERMONT
Chairman Sanders. Let us get to work. Let me thank our
panelists for being with us for a really important discussion
about a significant issue.
Within the veterans' community--and in fact, throughout our
Nation both in the public sector and the private sector--we
face a very serious problem of overmedication.
The result of that overmedication is significant numbers of
people treated in the Department of Defense facilities, VA
facilities, and in the private sector become dependent upon
those medications intended to help them and ease their pain.
Pain is a huge problem in the country and how we treat that
pain in the most effective way is really what we are discussing
today.
Some people who are treated with a whole lot of medication
become addicted, and I think we all know what happens when
people become addicted, in the worst cases some may end up
losing their lives due to overdoses. In my State and throughout
this country, this is a huge problem.
This is a major issue that has been discussed on this
Committee during the last year, and we are so glad we have such
a distinguished panel with us today to help us examine this
problem.
But, before we get to this issue at hand, I did want to say
a very brief word about another issue that has attracted a lot
of attention in this country, and that is the developing
situation at the VA medical center in Phoenix.
As I think everyone in this room knows, some very, very
serious allegations have been made regarding delays in health
care access and, as a result, the possible deaths of veterans.
I just want to make it very very clear that I take and this
Committee takes these allegations extremely seriously; and we
are going to do everything we can to get to the bottom of this
story and get to the truth.
Yesterday I spoke to the VA's acting inspector general,
Richard Griffin. There is a thorough investigation being
conducted by the VA IG in Phoenix and I have been assured by
Mr. Griffin that he has the resources he needs to thoroughly
investigate that situation.
I expect that the inspector general's office will conduct
its investigation thoroughly and provide this Committee with an
objective analysis of these very serious allegations. And as I
indicated the other day, it is my intention to hold a hearing
on this issue once the inspector general's inquiry is complete.
I want to make two brief points on this issue. First, we
will get to the bottom of what has happened in Phoenix. We will
reach conclusions based on an objective investigation of the
facts, not TV reports but an objective investigation of the
facts.
Second, we should not let these allegations impugn the
excellent work done throughout this country by hundreds of
thousands of VA doctors, nurses, administrators, and staff at
all levels, many of whom are veterans themselves or are closely
related to veterans.
I have been all over this country. I just came back from
the VA facility in Minneapolis, MN, and my assessment is that
we have some great people there doing great work.
Additionally, a recent survey by the American Consumer
Satisfaction Index, an independent consumer service survey,
pointed out patient satisfaction is incredibly high within VA--
higher, perhaps, than the private sector. And I can tell you in
Vermont--and I think this story is true all over this country--
that when veterans walk into the VA, they feel very good about
the quality of care they get.
And I do not want anything that is happening or may have
happened in Phoenix to impugn the very good work done by people
throughout this country.
Getting back to the issue at hand, as a Nation, we must
remember that for many veterans, chronic pain is a part of
their daily life. According to VA data, the most common
diagnosis among post-
9/11 veterans is musculoskeletal ailments, including joint,
neck, and back disorders. Chronic pain is a common symptom of
this cluster of conditions.
VA research demonstrates greater than 50 percent of male
veterans using VA primary care report instances of chronic pain
and the prevalence of chronic pain may be even higher among
women veterans.
Therefore, options for managing chronic pain among our
veteran population are paramount to improving quality-of-life
and reintegration.
Additionally, PTSD, along with other mental health
diagnoses, such as depression and anxiety, are frequently
diagnosed among our veterans. According to the most recent data
from VA, more than 55 percent of our post-9/11 veterans have
been diagnosed with some type of mental health disorder.
Just as with chronic pain, it is critical these veterans
receive the treatment they need and deserve. Oftentimes,
opioids are used to treat both chronic pain and certain mental
health disorders. While opioids can be quite effective in
treating these conditions, they also come with significant risk
which is what we are going to be discussing today.
Therefore, it is critical that these medications are
prescribed to the right patients, with careful monitoring and a
clear understanding of proper usage.
I would point out that Senator John Boozman of Arkansas has
been one of those Senators here who has raised this issue and I
think, as we all know, John has been in the hospital with a
heart issue. I think I speak for the whole Committee in wishing
him the very best of luck and returning to us as soon as
possible.
Senator Burr.
STATEMENT OF HON. RICHARD BURR, RANKING MEMBER,
U.S. SENATOR FROM NORTH CAROLINA
Senator Burr. Well, thank you, Mr. Chairman, and let me
report for my colleagues that Senator Boozman is home. He did
not have a heart attack. He had a problem with his aorta. It
was not an aneurism. It was a genetic flap that had he not
caught it and had they not been able to do a surgical graft on
his aorta, he would not have survived like many Americans.
But the report is good. He is home. He will be back with us
hopefully soon with a few synthetic parts but I think that by
all accounts those synthetic parts work every bit as good as
the original.
Mr. Chairman, thank you for this hearing and, as important,
thank you to our witnesses for being here.
Since the Chairman has talked about Phoenix, let me just
say this. This is not the first issue on quality of care that
faces the department, and one veteran death related to delays
in care is one too many.
I strongly believe that this Committee needs to hold
aggressive oversight hearings into these issues that the
department continues to struggle with, including long wait
times for specialty care appointments, the misuse of wait
lists, and the issues documented in the health care inspections
conducted by the inspector general which, by my count, is now
over 50 since January 2013.
Even with all of these issues being publicly reported or
included in the reports by the IG, this Committee has yet to
hold a single oversight hearing on the quality of care veterans
are receiving at the VA facilities.
Mr. Chairman, I would fully support and urge you to hold
those hearings.
I say as it relates to Phoenix, I think the Chairman is
right. Let us get as many of the facts as we can and not rely
on what is publicly printed.
But again, I point to the IG investigations from the past
and suggest that it is the responsibility of this Committee to
respond to some of the problems and to work with the VA, Dr.
Petzel, as a partner. And I have never seen the agency shy away
from trying to solve those quality of care issues.
Now, turning to today's subject matter, the United States
is facing an epidemic of prescription drug abuse. That is why
it is important that we are here today to conduct oversight
over the care of veterans who have chronic pain. It is critical
that we ensure that VA is taking the necessary steps to address
the overuse of certain medications and the potential risk of
misuse and dual prescriptions.
It has been estimated that as many as 50 percent of male
veterans and as high as 75 percent of female veterans--OEF and
OIF veterans--struggle with pain.
The prevalence of chronic pain will likely increase as more
servicemembers transition into the VA system. These numbers
demonstrate the need for VA to provide quality pain management
services to ensure veterans with chronic pain are able to live
productive and healthy lives.
According to the Centers for Investigative Reporting,
between 2001 and 2012 the number of VA prescriptions within
four opiate categories--including hydrocodone, oxycodone,
methadone, and morphine--surged 270 percent. Additionally,
during 2012, VA providers wrote more than 6.5 million
prescriptions within those opiate categories.
I found these numbers alarming, in combination with recent
media reports that describe veterans with known and documented
drug addictions who were still being prescribed these types of
medications.
I would just like to highlight a couple of stories. A
veteran with PTSD who self-medicated using oxycodone and heroin
who later struggled to become clean and sober, who is still
struggling with PTSD and his addiction, now faces a new battle
with the VA system which continues to prescribe him opiates
even though his electronic health record documents his
addiction and the subsequent detox provided by VA.
Another veteran, while still on active duty, says he was
injecting himself with an anti-inflammatory drug prescribed by
military doctors. When he was treated by VA, they only
responded to his pain by, ``loading him up on narcotics.'' This
veteran goes on to make the following statement, ``There were
better options to treat my pain, and those were not presented
to me. The priority was treating me the fastest, seemingly
least expensive way, and it was the most detrimental.''
Now, I am not sure that this is the patient-centered or
veteran-centric care that we constantly hear VA describing.
Even in today's testimony from the Department we will hear,
``care is increasingly personalized, proactive and patient
driven.''
If these stories reflect what VA believes is personalized,
proactive, and patient driven, we have more problems to address
than just the quality of care and long wait times.
When it comes to the care we are providing to those who
have sacrificed so much for our Nation, we cannot afford to get
it wrong. This Committee needs to hold VA accountable to ensure
they are providing world-class care.
Right now, with the media reports and even VA's own
research, I am not sure we are. Today VA will describe their
policies, directives, and initiatives to ensure opiate
therapies are prescribed to veterans in a safe manner. It is
our obligation to hold VA accountable and to ensure that they
are providing the highest standard of care to those who are
already in the system.
Mr. Chairman, I thank you for calling this hearing. I look
forward to the witnesses' testimony which will enlighten us and
the opportunity to follow up with questions.
Chairman Sanders. Senator Burr, thank you very much.
Senator Blumenthal.
STATEMENT OF HON. RICHARD BLUMENTHAL,
U.S. SENATOR FROM CONNECTICUT
Senator Blumental. Thank you, Mr. Chairman.
I want to thank our witnesses for being here and for your
dedicated and hard work to the service of our veterans and our
Nation; and thank you, Mr. Chairman and Ranking Member Burr for
your comments.
I want to join in expressing my very strong alarm about the
reports from Arizona. If true, these reports indicate not only
a betrayal of trust but also, very bluntly, violation of our
criminal laws in shredding documents and obfuscating evidence
that is important to protect the public trust.
So, I hope that the inspector general will complete his
report as quickly as possible to restore that trust and
confidence in the integrity of our system.
I want place in the record, Mr. Chairman, if I may, a
request that we be informed as to what the time table is for
completing that investigation because I very much share the
Chairman's concern that this Committee has a obligation
separately and independently of the inspector general, which
has been articulated by the ranking member as well, that we
uncover whatever the facts are here and make sure that we
fulfill our responsibility. And I believe that if the inspector
general's investigation lags that we should proceed
independently.
I agree that we should make use of the inspector general's
investigation if it proceeds promptly but I think that we
should require some kind of preliminary report to us as to what
the claims are and what the preliminary findings are because
the reports about a secret waiting list, and about neglect of
care, and about disregard of the responsibility to provide that
care are beyond alarming. They are truly angering.
I want to also express my interest and concern about the
subject matter of this investigation. I have seen in
Connecticut, as we have around the country, an epidemic of
overuse and abuse of these powerful pain killers and other
prescription drugs. They are not only deeply concerning
themselves, but they are potentially a gateway to other abuse
such as heroin.
We have seen in Connecticut and Vermont as well, Mr.
Chairman, how these prescription drugs can be a gateway to
heroin use and other drug abuses; and so, particularly when it
comes to our veterans, we need to make sure that we do whatever
possible to prevent this kind of overuse and abuse. I know that
alternate care, which we will discuss today, is integral to
that effort.
Thank you very much, Mr. Chairman.
Chairman Sanders. Thank you, Senator Blumenthal.
Senator Isakson.
STATEMENT OF HON. JOHNNY ISAKSON,
U.S. SENATOR FROM GEORGIA
Senator Isakson. Well, Chairman Sanders, thank you for
calling this hearing. I want to echo the words of Ranking
Member Burr, yourself, and Senator Blumenthal that the Arizona
situation is troubling for all of us.
I am glad we are going to get to the bottom of it. I hope
we will do so as expeditiously as possible, and then I hope we
can take action to help support VA in finding out where there
is a problem, if there is one, and then correcting it.
Dr. Petzel and I have become close friends over the last 8
to 9 months because of incidences that neither one of us wish
would have happened. His quick response in Atlanta has been
greatly appreciated. His response at the VA hospital in Augusta
has been greatly appreciated, and the fact that he is going to
be visiting in the next week, I think this weekend, again is
very much appreciated and his attention to those matters.
The VA situation we had in Augusta 2 or 3 years ago: the
concern about, sterilization of colonoscopy and endoscopy
equipment, the difficulty that we had in Atlanta with the
suicide situation and the postponement or untimely following of
mental health patients; and now what has happened in Arizona
should be a warning call for all of us.
I believe we have 340,000 great employees at VA. They do a
tremendous job; and as the Chairman and Ranking Member said, I
am very proud of what they do. But if there is a growing
culture that believes it does not matter or it is not as
important or our care is not as important as we think it should
be, we need to nip that in the bud and see to it VA is to every
veteran and to this country what it was promised to and what it
must be.
I think it is important and incumbent upon this Committee
to get to the bottom, wherever the facts lead us, and to get
the leadership of VA to go with us so that hand-in-hand we can
correct the inequities that are going on.
My last point is this. Pharmaceutical therapy is a godsend
in terms of pain, in terms of management of disease and other
chronic ailments. But it also can interact inappropriately with
other drugs for other ailments. It can also be overprescribed.
It also can mask a greater problem, particularly with regard to
mental health.
This is a terribly important hearing today. I am not a
person of medicine nor a person of science but I am familiar
enough with what goes on in terms of drug abuse and one drug
leading to another, that we cannot allow ourselves to take the
easy way out in terms of pain management or therapy for our
veterans.
We need to always be looking for the long-term benefit of
that veteran, not just the short-term easing of pain when we
are prescribing the power opiates that we are talking about
today.
Thank you for calling this hearing, Mr. Chairman.
Chairman Sanders. Senator Isakson, thank you very much for
your very apt and important remarks. I agree with virtually
everything you said.
What I want to do now, if it is alright with the Committee,
is to introduce our panelists, but I did want to give Dr.
Petzel a minute or two to address concerns about Arizona. I
want the main focus of this hearing to stay on overmedication
while there is interest about what is happening in Arizona.
Dr. Petzel, could you briefly give us your understanding of
the situation there?
Dr. Petzel. Thank you very much, Chairman Sanders.
First of all, it is important to state that we do care very
deeply about the care of every single veteran that we are
privileged to serve. They have earned and they deserve the
absolute highest quality care that we can provide.
We take these allegations, as all of you do, very
seriously. That is why we have asked the independent office of
VA's IG to go there and do an objective, independent, complete
review as to exactly what has occurred.
We also sent, from VHA, a team to Phoenix early to review
the appointment and scheduling processes, and I need to say
that to-date we found no evidence of a secret list and we have
found no patients who have died because they have been on a
wait list.
We think it is very important that the inspector general be
allowed to finish their investigation before we rush to
judgment as to what has actually happened in Phoenix.
The other important point is that when an incident like
this occurs, as with colonoscopies and mental health consults
that were mentioned earlier, we conduct a thorough systemwide
look which we are in the process of doing now with scheduling
and wait lists, seeing if the alleged practices are not
occurring at any one of our other 150 medical centers.
If the allegations are true, they are absolutely
unacceptable and we--if the inspector general does confirm and
substantiate these claims--we are going to take swift and very
appropriate action.
The last point is that the veterans deserve to have full
faith in their VA health care system. VA facilities are
committed to transparency. We undergo multiple external and
independent reviews and every year we are committed to ensuring
our veteran community and the public that VA hospitals are safe
and that the quality of care there is high.
Finally, as has been mentioned by several of you, we do
appreciate the hard work and the dedication of all of our
employees. These people are committed to the person to
providing, again, the best care possible to these veterans who
have earned and who deserve that care.
Thank you.
Chairman Sanders. OK. Thank you very much, Dr. Petzel.
I thought it was important we deal with that issue briefly.
Now, let us focus on the issue at hand which is overmedication
problems and solutions. In order to address that issue, we have
two excellent panels.
Our first panel will include Dr. Petzel, who is the Under
Secretary for Health, Veterans Health Administration,
Department of Veterans' Affairs; accompanied by Dr. Tracy
Gaudet, who is the Director, Office of Patient Centered Care
and Cultural Transformation. Dr. Peter Marshall, Director of
Primary Care Pain Management at the Minneapolis VA medical
center.
Brigadier General Norvell V. Coots, Deputy Commanding
General, U.S. Army Medical Command and Assistant Surgeon
General for Force Projection, Office of the Surgeon General;
and he is accompanied by Colonel Kevin T. Galloway, Program
Director, Army Pain Management Program.
We also have Dr. Josephine Briggs, Director of the National
Center for Complementary and Alternative Medicine, National
Institutes of Health.
So, thank you all very much for being with us; and Dr.
Petzel, you may begin.
STATEMENT OF ROBERT PETZEL, M.D., UNDER SECRETARY FOR HEALTH,
VETERANS HEALTH ADMINISTRATION, U.S. DEPARTMENT OF VETERANS
AFFAIRS; ACCOMPANIED BY TRACY GAUDET, M.D., DIRECTOR, OFFICE OF
PATIENT CENTERED CARE AND CULTURAL TRANSFORMATION AND PETER
MARSHALL, M.D., DIRECTOR OF PRIMARY CARE PAIN MANAGEMENT,
MINNEAPOLIS VA MEDICAL CENTER
Dr. Petzel. Good morning, Chairman Sanders, Ranking Member
Burr, and the Members of the Committee.
I want to thank you for the opportunity to participate in
this hearing to discuss the Department of Veterans Affairs'
pain management and opioid safety programs, our use of
complementary and alternative medicine, and psychotropic drug
safety. I am accompanied today by Dr. Gaudet as was mentioned
earlier and by Dr. Peter Marshall.
Before I begin, I want to express my joy at hearing that
Senator Boozman is recuperating well. We wish him a speedy
recovery and look forward to him participating again in the
affairs of this Committee.
Let me begin today by acknowledging all of our Nation's
veterans who suffer from chronic and acute pain. The burden of
pain on veterans is considerable. Studies say that more that 50
percent of all veterans receiving care at the VA are affected
by some type of chronic pain, much of it being musculoskeletal.
Six elements of effective pain control include the safe and
effective use of pain care to enhance the quality of life and
the satisfaction of veterans that are living with chronic pain.
VA's concept of safe and effective pain care follow these
six essential elements. Education of veterans and family
members about good pain care. Education of the treatment teams
about good pain care. Developing non-pharmacological and self-
management approaches. Safe and evidence-based use of all
interventions and medications including opioids. Developing
effective modalities for bringing pain care, especially
expertise, to the veteran when needed. And finally, monitoring
pain care efficacy at both the individual veteran level and at
the system level.
VA recently developed and implemented an innovative opioid
safety program. This program uniquely combines feedback to
providers at facilities on their prescribing practices with
education and training to ensure opioid pain medications are
used safely, effectively, and judiciously across our entire
system.
The purpose of the initiative is to help ensure that pain
management is addressed thoughtfully, compassionately, and
safely. This initiative holds considerable promise for
mitigating the risks of harm among veterans receiving long-term
opioid therapy, for promoting provider competence and safe
prescribing of opioids, and in promoting veteran-centered,
evidence-based, coordinated, disciplined, multi-disciplinary
pain care for chronic pain.
For cases where veterans have developed problems with
opioid abuse and addiction, VA offers effective evidence-based
treatments for opioid use disorder. Intensive treatments
consisting of options for evidence-based psychotherapy and
effective pharmacological therapy for opioid use disorder is
available at all of our VA medical centers to help facilitate
veterans' recovery.
Recognizing that psycho-pharmacological treatments for
mental health conditions require on-going efforts in quality
improvement, VA is implementing a psychosocial drug safety
initiative.
It addresses pharmacological treatments across the range of
mental health conditions including PTSD, depression,
schizophrenia, bipolar disorder, substance abuse disorder, and
many other mental health conditions.
This psychotropic drug initiative is designed to identify
overuse, underuse, and inappropriate use of these drugs by
reviewing provider prescribing habits, patient use, and
providing feedback to providers about their use of these
medications and education about the appropriate use when we do
find that the use is inappropriate.
Key leadership has identified as its number 1 strategic
goal to provide veteran patients with personalized, proactive,
patient-driven health care. This approach to health prioritizes
the veteran and their values and partners with them to
personalize the strategies to optimize their health, healing,
and sense of well-being.
Many of the strategies that may be of benefit extend beyond
what we conventionally address or provide by the health care
system. Integrative medicine, which includes complementary and
alternative medicine, provides a framework that aligns with
this goal of personalized, proactive, patient-drive care.
There is a growing evidence for the effectiveness of non-
pharmacological approaches as part of a comprehensive plan for
chronic pain. These include acupuncture, massage, chiropractic
care, mindfulness meditation, exercise therapy, relaxation
therapies, and yoga. These are all being increasingly made
available to our veteran patients.
Mr. Chairman, we know our work to improve veteran care
through accessible, safe, and effective pain management service
is an ongoing task and is not yet finished.
However, we are confident that we are developing and
implementing programs that are responsive to veteran needs. We
appreciate your support in identifying and resolving these
challenges as we find new ways to care for America's veterans.
Mr. Chairman, this concludes my testimony. My colleagues
and I are prepared to answer your questions.
[The prepared statement of Dr. Petzel follows:]
Prepared Statement of Dr. Robert Petzel, Under Secretary for Health,
Veterans Health Administration (VHA), U.S. Department of Veterans
Affairs
Good morning, Chairman Sanders, Ranking Member Burr, and Members of
the Committee. Thank you for the opportunity to participate in this
hearing and to discuss the Department of Veterans Affairs' (VA) pain
management programs and the use of complementary and alternative
medicine. I am accompanied today by Dr. Tracy Gaudet, Director of
Office of Patient Centered Care & Cultural Transformation, and Dr.
Peter Marshall, Director of Primary Care Pain Management.
The challenges related to living with chronic pain and providing
safe and effective pain care are by no means unique to Veterans and the
VA health care system. As described in the 2011 Institute of Medicine
(IOM) report, ``Relieving Pain in America: A Blueprint for Transforming
Prevention, Care, Education, and Research,'' \1\ pain is a public
health challenge that affects millions of Americans and is increasing
in prevalence. Pain contributes to morbidity, mortality, and disability
across our Nation and the costs of pain can be measured both in terms
of human suffering as well as economic impact. The IOM estimated that
chronic pain alone affects 100 million United States citizens and that
the cost of pain in the United States is at least $560-$635 billion
each year, which is the combined cost of lost productivity and the
incremental cost of health care.
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\1\ Institute of Medicine. 2011. Relieving Pain in America: A
Blueprint for Transforming Pain Prevention, Care, Education and
Research. Washington, DC: The National Academies Press.
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chronic pain in veterans
The burden of pain on the Veteran population is considerable. We
know that Veterans have much higher rates of chronic pain than the
general population, with more than 50 percent of all Veterans enrolled
and receiving care at VA affected by chronic pain.\2\ Chronic pain is
the most common medical problem in Veterans returning from the last
decade of conflict (almost 60 percent).\3\ Many of these Veterans have
survived serious and at times catastrophic injuries frequently a result
of road-side bombs and other blast injuries. These events can result in
multiple physical traumas including amputations and spinal cord
injuries as well as concomitant psychological trauma which can compound
chronic pain concerns. Often these Veterans require a combination of
strategies for the effective management of pain, which may include
treatment with opioid analgesics. That makes pain management a very
important clinical issue for VA. Further, the treatment of pain is
highly complex, and in the recent past, health care providers have
often been accused of undertreating the pain that patients suffer.
Getting the balance right is a challenge that we continue to work
toward.
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\2\ Gironda, R.J., Clark, M.E., Massengale, J.P., & Walker, R.L.
(2006).. Pain among Veterans of Operations Enduring Freedom and Iraqi
Freedom. Pain Medicine, 7, 339-343.
\3\ Veterans Health Administration (2013). Analysis of VA health
care utilization among Operation Enduring Freedom (OEF), Operation
Iraqi Freedom (OIF), and Operation New Dawn (OND) Veterans. Washington,
DC: Department of Veterans Affairs.
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In 2010, VA and the Department of Defense (DOD) published evidence-
based Clinical Practice Guidelines for the use of chronic opioid
therapy in chronic pain. The guidelines reserve the use of chronic
opioids for patients with moderate to severe pain who have not
responded to, or responded only partially to, clinically indicated,
evidence-based pain management strategies of lower risk, and who also
may benefit from a trial of opioids to improve pain control in the
service of improving function and quality of life.
We also know that the long-term use of opioids is associated with
significant risks, and can complicate health care for Veterans with
Posttraumatic Stress Disorder (PTSD), depression, Traumatic Brain
Injury (TBI) and family stress--all common in Veterans returning from
the battlefield, and in Veterans with substance use disorders. Chronic
pain in Veterans is often accompanied by co-morbid mental health
conditions (up to 50 percent in some cohorts) caused by the
psychological trauma of war, as well as neurological disorders, such as
TBI caused by blast and concussion injuries. In fact, one study
documented that more that 40 percent of Veterans admitted to a
polytrauma unit in VHA suffered all three conditions together--chronic
pain, PTSD, and post-concussive syndrome.\4\
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\4\ Lew, H.L., Otis, J.D., Tun, C., Kerns, R.D., Clark, M.E., &
Cifu, D.X. (2009). Prevalence of chronic pain, Post Traumatic Stress
Disorder, and post-concussive syndrome in OEF/OIF veterans: The
polytrauma clinical triad. Journal of Rehabilitation Research and
Development, 46, 697-702.
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In addition to these newly injured Veterans suffering from chronic
pain conditions and neuropsychological conditions, VA cares for
millions of Veterans from prior conflicts, who along with chronic pain
and psychological conditions resulting from their earlier combat
experiences, are now developing health concerns related to aging, such
as cancer, neuropathies, spinal disease, and arthritis, all of which
may be accompanied by chronic and at times debilitating pain. All of
these Veterans deserve safe and effective pain care that may include
the use of opioid analgesics when clinically appropriate.
Thus, VA cares for a population that suffers much higher rates of
chronic pain than the civilian population, and also experiences much
higher rates of co-morbidities (PTSD, depression, TBI) and
socioeconomic dynamics (family stress, disability, joblessness) that
contribute to the complexity and challenges of pain management with
opioids.\5\ So even as more Veterans have the kind of severe and
disabling pain conditions that require stronger treatments such as
opioids, so do more of them have increased risk for overdose
complicated by depression, PTSD and substance use disorders.
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\5\ See citations 3 and 4.
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In recognition of the seriousness of the impact of chronic pain on
our Veterans' health and quality of life, VHA was among one of the
first health systems in the country to establish a robust policy on
chronic pain management and to implement a system-wide approach to
addressing the risks of opioid analgesia.
I would like to at this time outline our approach to this pain care
transformation. I will highlight VA's current pain management
strategies as well as actions being taken to improve the management of
chronic pain, including the safe use of opioid analgesics, the
prevalence and use of opioid therapy to manage chronic pain in high
risk Veterans, the challenges of prescription drug diversion \6\ and
substance use disorders among Veterans, and efforts being made to
broaden non-pharmacological approaches to pain care. I will also
describe some of the best pain care practices across the VA health care
system.
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\6\ Diversion is the use of prescription drugs for recreational
purposes.
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va's pain care mission
VA's mission relative to pain care is simple: safe and effective
pain care to enhance the quality of life and satisfaction of all
Veterans living with chronic pain.
VA's concept of safe and effective pain care includes the following
six essential elements:
1. Education of Veterans and family members about good pain care;
2. Education of the treatment teams about good pain care;
3. Developing non-pharmacological and self-management approaches;
4. Safe and evidence-based use of all interventions and
medications, including opioids;
5. Developing effective modalities for bringing pain care specialty
expertise to the Veteran; and
6. Monitoring pain care efficacy at the individual and system
level.
As a blueprint for implementing these principles throughout the
system,\7\ VHA Pain Management Directive 2009-053 \8\ was published in
October 2009 to provide uniform guidelines and procedures for providing
pain management care. These include standards for pain assessment and
treatment, including use of opioid therapy when clinically appropriate,
for evaluation of outcomes and quality of pain management, and for
clinician competence and expertise in pain management. Since
publication of the Pain Management Directive, a dissemination and
implementation plan has been enacted that supports the following:
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\7\ The overall objective of the national strategy is to develop a
comprehensive, multicultural, integrated, system-wide approach pain
management that reduces pain and suffering and improves quality of life
for Veterans experiencing acute and chronic pain associated with a wide
range of injuries and illnesses, including terminal illness.
\8\ www.va.gov/vhapublications/viewpublication.asp?pub_id=2781
Comprehensive staffing and training plans for providers
and staff;
Comprehensive patient/family education plans to empower
Veterans in pain management;
Development of new tools and resources to support the pain
management strategy; and
Enhanced efforts to strengthen communication between VA's
Central Office (VACO) and leadership from facilities \9\ and Veterans
Integrated Service Networks (VISN).
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\9\ The term ``facilities'' or ``facility'' refers to VA's 151
medical centers, hospitals, or health care systems.
Following the guidance of the VHA National Pain Management
Strategy, and in compliance with generally accepted pain management
standards of care, the Directive provides policy and procedures for the
improvement of pain management through implementation of the Stepped
Care Model for Pain Management (SCM-PM), the single standard of pain
care for VHA, central to ensuring Veterans receive appropriate pain
management services. The Directive also requires tracking opioid use
and implementing strong practices in risk management to improve
Veterans' safety.
To establish the six essential elements of good pain care listed
above, numerous modalities have been recently implemented or are in the
process of implementation throughout the VHA, including: pain schools,
tele-pain schools, apps and web based modules for patient and family
education; case based audio conferences, Rural Health Initiative and
VeHU trainings, Nation-wide community of practice calls and numerous
other training initiatives to educate and train teams; developing
Cognitive Behavioral Therapy (CBT) in primary care, tele-CBT, self-
management strategies and complementary and integrative medicine
modalities; a number of initiatives to address opioid prescribing which
I will discuss shortly; e-consultation, Specialty Care Access Network-
Extension for Community Healthcare Outcomes (SCAN-ECHO), and
telemedicine to bring pain care expertise to all settings; and pain
dashboards to monitor care at the individual and populations levels.
VA facilities are now increasingly leveraging their video
conferencing capabilities to reach Veterans in the community based
outpatient clinics (CBOC) both rural and highly rural to provide group
and individual visits for pain schools, evidence based CBT, smoking
cessation, and weight loss through the MOVE program all important for
the self-care and self-management skills needed as part of a chronic
pain care plan.
A particularly exciting initiative is the development of a pain
management application for smart phones that will be used by Veterans
and their care partners to develop pain self-management skills. This
tool, called VA Pain Coach, will eventually interface with VHA's
Electronic Health Record (EHR), with appropriate privacy protections,
allowing Veteran-reported information about pain, functioning, and
other key elements in a secure mobile application environment to be
securely stored and accessible to clinicians. VA Pain Coach, which is
part of a suite of VA applications called ``Clinic in Hand,'' has just
finished a one-year pilot test phase with 1150 Operation Enduring
Freedom/Operation Iraqi Freedom/Operation New Dawn Veterans and their
caregivers and is now being converted to HTML 5 and will be available
for smart phones, tablets and as a web based application. In the
future, a complementary initiative will build a clinician-facing
application that will enhance the capacity of clinicians and Veterans
to share in monitoring, decisionmaking, treatment planning, and
reassessment of pain management interventions.
the patient aligned care team (pact): the core of the stepped care
model
The VA approach to pain care mirrors its approaches to all health
care concerns: care is increasingly personalized, proactive and patient
driven. Chronic pain, as is the case with all chronic health
conditions, is most safely and effectively addressed using a
biopsychosocial model in which all aspect of the Veterans health and
well-being are included in both the assessment and management of the
condition: physical health, psychological health and social health. The
basic platform for providing such care is the Veteran's PACT, or
patient aligned care team, supported by pain and other specialists.
PACT is a partnership between the Veteran and the health care team,
which emphasizes prevention, health promotion, and self-management.
Veterans are the center of the care team and the PACT teamlet, which
includes at its core a primary care provider, nurse care manager,
clinical associate, and clerical associate. Core pain teams in PACT
often add a behavioral health clinician and pharmacist to help address
the complexity of pain management.
the pain medicine specialty team: specialty care access supporting pact
PACT access to consultation and collaborative care with
interdisciplinary pain specialty teams is critical. VHA's Pain Medicine
Specialty Team Workgroup, chartered on January 26, 2012, provides
standards for pain specialty care services and support of PACT pain
management in the Stepped Care Model. Key areas of focus include the
development of collaborative care models and participation in provider
and team education through telehealth, e-consults, and SCAN-ECHO. VA
SCAN-ECHO pain experts provide didactics and case-based learning to
PACT members using videoconferencing technologies to strengthen the
competencies of providers in pain management. More than 95 percent of
VHA facilities have specialty pain clinics with documented yearly
increases in use and capacity.
vha pain management centers: developing and promulgating
strong practices
The complexity of managing chronic pain may require a more
intensive and structured approach to care than can be provided in the
primary care or specialty pain medicine clinics. To address the need
for tertiary care pain services, on December 15, 2010, the VHA charted
the Interdisciplinary Pain Management Workgroup to assist Veterans
Integrated Service Network (VISN) Directors in determining the need for
tertiary pain care and pain rehabilitation services. As of
January 2014, VA has ten sites in seven VISNs with Commission on
Accreditation of Rehabilitation Facilities (CARF)-accredited tertiary
care pain rehabilitation programs, an increase from only 2 programs in
2009, with 11 more sites in active preparation or actually applying for
CARF status. These Centers have the capacity for providing advanced
pain medicine diagnostics, surgical and interventional procedures, and
in addition provide intensive, integrated chronic pain rehabilitation
for Veterans with complex, co-morbid, or treatment refractory
conditions.
VHA is in process of greatly expanding access to such Chronic Pain
Rehabilitation Centers. Pursuant to the expectation that every VISN
shall have at least one CARF-accredited tertiary, interdisciplinary
pain care program no later than September 30, 2014, the long-standing
CARF Center at the James Haley Veterans Hospital in Tampa, one of only
two multidisciplinary pain management centers that has been twice
recognized by the American Pain Society as a Clinical Center of
Excellence (the other being a program at Stanford University), has
provided direct training to VISN teams from across VHA who wish to
start CARF programs. Some VISNs may eventually have 2 or more such
programs. In addition, there is an ongoing system-wide education
effort, using the expertise at these Centers and in other facilities,
to educate physicians in Primary Care PACT and other providers taking
care of Veterans with chronic pain conditions about Chronic Pain
Rehabilitation approaches.
implementing the stepped care model in vha
To help manage the implementation of the Stepped Care Model, VHA's
National Pain Management Program Office (NPMPO) works closely with
other VHA national offices such as pharmacy, mental health, and primary
care. Other collaborations include NPMPO's partnership with Women's
Health Services to develop a strategic plan to strengthen the capacity
for women Veteran pain management services. NPMPO also relies on
consultation with the interdisciplinary National Pain Management
Strategy Coordinating Committee, consisting of members of all relevant
clinical offices/programs in VHA, and meets regularly with all VISN
Pain Points of Contact (POC). VISN POCs in turn meet regularly with
Facility POCs in their VISN.
The role of the Pain POCs, at the VISN and at the facility level,
is primarily to coordinate efforts in regard to pain management from an
administrative side. The Pain POCs are expected to work closely with
the Pain specialists at each facility within the facility Pain
Management Committee. This structure creates a two-way communication of
successful `best practices' in the field, which are then communicated
nationally, as well as advice and support on policy implementation. The
Pain POCs are not the point of contact for clinical issues regarding
individual patients. With regards to evaluation and treatment, a
Veteran's clinical point of contact for their individual pain needs is
their primary care provider within the PACT. As necessary, the pain
medicine specialty team at the facility would work in collaboration.
stepped care model for pain management
As mentioned earlier, SCM-PM is the single standard of pain care
for VHA to ensure Veterans receive appropriate pain management
services. Specifically, SCM-PM provides for assessment and management
of pain conditions in the primary care setting. This is supported by
timely access to secondary consultation from pain medicine, behavioral
health, physical medicine and rehabilitation, specialty consultation,
and care by coordination with palliative care, tertiary care, advanced
diagnostic and medical management, and rehabilitation services for
complex cases involving co-morbidities such as mental health disorders
and TBI.
In FY 2012, VHA made several important investments in implementing
the SCM-PM. Major transformational initiatives support the objectives
of building capacity for enhanced pain management in the primary care
setting, including education of Veterans and caregivers in self-
management, as well as promoting equitable and timely access to
specialty pain care services.
There are other important efforts contributing to the
implementation of SCM-PM in VHA facilities. Current initiatives focus
on empowering Veterans in their pain management, and expanding capacity
for Veterans to receive evidence-based psychological services as a
component of a comprehensive and integrated plan for pain management.
For example, during FY 2012, the VHA National Telemental Health Center
expanded its capacity to deliver face-to-face, psychological services
to Veterans remotely via high-speed videoconferencing links. This
initiative not only emphasizes the delivery of cognitive behavior
therapy for Veterans with chronic pain, but also promotes pain self-
management, leading to reductions in pain and improvements in physical
functioning and emotional well-being.
Additionally, a Primary Care and Pain Management Task Force is
developing a comprehensive strategic and tactical plan for promoting
full implementation of the SCM-PM in the Primary Care setting, and it
continues to work on several products in support of this effort. For
instance, the Task Force is continuing to expand its network of
facility- level Primary Care Pain Management points of contact (Pain
Champions) who meet monthly, via teleconference, to identity and share
strong practices that have led to improved pain care in primary care
settings.
VA's pain management initiatives are designed to optimize timely
sharing of new policies and guidance related to pain management
standards of care. Of particular importance are VHA's continuing
efforts to promote safe and effective use of opioid therapy for pain
management, particularly those initiatives designed to mitigate risk
for prescription pain medication misuse, abuse, addiction, and
diversion.
opioid prescribing
While opioid medications, due to their high risk to benefit ratio
in chronic pain, will be playing a less prominent role in chronic pain
management in the future, they are a primary focus currently due to the
attendant risk of their use, particularly in individuals with some of
the co-morbid conditions mentioned above.
To monitor the use of opioids by patients in the VA health care
system, VA tracks multi-drug therapy for pain in patients receiving
chronic or long-acting opioid therapy for safety and effectiveness.
This includes tracking of use of guideline recommended medications for
chronic pain (i.e., certain anticonvulsants, tricyclic antidepressants
(TCA), and serotonin and norepinephrine reuptake inhibitors (SNRI)
which have been shown to be effective for treatment of some chronic
pain conditions), and tracking of concurrent prescribing of opioids and
certain sedative medications (e.g., benzodiazepines and barbiturates)
which can contribute to over sedation and overdose risk when taken with
opioids and the other medications for pain listed above.
The prevalence of Veterans using opioids has been measured for
Veterans using VHA health care services. For FY 2012, of the 5,779,668
patients seen in VA, 433,136 (7.5 percent) received prescriptions for
more than 90 days supply of short-acting opioid medications and 92,297
(1.6 percent) received at least one prescription for a long-acting
opioid medication in the year. Thus, since more than 50 percent of
Veterans enrolled in VHA suffer from chronic pain, the most common
condition in all Veterans, a relatively small percentage of those
Veterans are receiving chronic opioid therapy, consistent with the DOD/
VA Clinical Practice Guidelines which limit their use to patients with
moderate to severe persistent pain that has not responded to other
safer alternatives that are clinically appropriate. Of these 525,433
patients that received chronic or long-acting opioid therapy, 79,025
(15 percent) were also prescribed a TCA, 90,066 (17 percent) were also
prescribed an SNRI, and 178,361 (34 percent) were also prescribed an
anticonvulsant some time in FY 2012.
The co-prescription of either TCAs and SNRIs with opioids is first
line therapy for the more severe cases of pain related to nerve damage
from disease (e.g., diabetes, cancer) or from injuries (e.g.,
battlefield blast and projectile injuries with or without limb
amputation and spinal cord injury). The numbers above suggest that
clinical teams are using medically indicated combinations of
medications that are specifically needed for these more severe
conditions, which themselves are often co-morbid with musculoskeletal
pain such as injuries to joints, spine and muscles. Of note, these
prescriptions may or may not have overlapped with the opioid
prescription during the year.
Notably, 272,719 (52 percent) of patients on chronic or long-acting
opioid therapy received non-medication-based rehabilitative treatments
as part of their treatment plan (e.g., physical therapy (32 percent),
chiropractic care (1 percent), programs to encourage physical activity
(9 percent) or occupational therapy (17 percent), and 241,465 (46
percent) also received behavioral or psychosocial treatment for chronic
pain or co-morbid mental health conditions.
These data, showing the use of non-medication treatments, suggest
that Veterans are benefiting from VHA's efforts to create access to
additional pain treatment modalities besides medication. This is
consistent with VA's commitment to transform pain care to a
biopsychosocial model \10\ that addresses all the factors that by
research are demonstrated to affect Veterans' success in chronic pain
treatment. Pursuant to this aim, a multimodality, team-based, stepped
care model, per VHA Directive 2009-053, is being implemented widely
throughout VHA, and in coordination with DOD.
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\10\ The Biopsychosocial Model takes the position that the causes
and outcomes of many illnesses often involve the interaction of
physical and pathophysiologic factors, psychological traits and states,
and social-environmental factors. Effective treatment planning accounts
for the salience of these factors in the precipitation and perpetuation
of illness and illness-related disability.
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Opioid analgesics may help many patients manage their severe pain
when other medications and modalities are ineffective or are only
partially effective. However, there may be risks to both individual
patients as well as to the surrounding community when these agents are
not prescribed or used appropriately. VA has embarked on a two-pronged
approach to addressing the challenge of prescription drug diversion and
substance use disorders among Veteran patients. One approach is to
improve the education and training in pain management and safe opioid
prescribing for clinicians and the interdisciplinary teams that provide
pain management care for Veterans. A complementary approach involves
improving risk management through two systems initiatives.
opioid safety initiative
VA recently developed and implemented an Opioid Safety Initiative
(OSI) program to ensure opioid pain medications are used safely,
effectively and judiciously. The Opioid Safety Initiative Requirements
were issued to the VISN's on April 2, 2014. The purpose of the
initiative is to ensure pain management is addressed thoughtfully,
compassionately and safely. The nine goals are summarized below:
Goal One: Educate prescribers of opioid medication
regarding effective use of urine drug screening
Goal Two: Increase the use of urine drug screening
Goal Three: Facilitate use of state prescription databases
Goal Four: Establish safe and effective tapering programs
for the combination of benzodiazepines and opioids
Goal Five: Develop tools to identify higher risk patients
Goal Six: Improve prescribing practices around long-acting
opioid formulations
Goal Seven: Review treatment plans for patients on high
doses of opioids
Goal Eight: Offer Complementary and Alternative Medicine
(CAM) modalities for chronic pain at all facilities
Goal Nine: Develop new models of mental health and primary
care collaboration to manage opioid and benzodiazepine prescribing in
patients with chronic pain
To do this, the initiative leverages the VHA's Electronic Health
Record, making visible the totality of opioid use at all levels,
patient, provider and facility, in order to identify high-risk
situations. The OSI includes key clinical indicators such as the number
of unique pharmacy patients dispensed an opioid, unique patients on
long-term opioids who receive a urine drug screen, the number of
patients receiving an opioid and a benzodiazepine (which puts them at a
higher risk of adverse events) and the average dosage per day of
opioids such as hydromorphone, methadone, morphine, oxycodone, and
oxymorphone. Patients at risk for adverse events from use of opioids
are identified through the use of administrative and clinical databases
using pre-determined parameters based on published evidence and expert
opinion. Providers whose prescribing practices are not aligned with
medical evidence/strong practices are provided with counseling,
education and support for to improve their care of Veterans with pain.
Several aspects to measure the implementation of the Opioid Safety
Initiative upon opioid use were underway at the time of the October 10,
2013 hearing and suggested positive impacts:
Despite an increase in the number of Veterans who were
dispensed any medication from a VA pharmacy, (i.e., all pharmacy users)
in October 2012 compared to November 2013, 39,088 fewer Veterans
received an opioid prescription from VA during that time period.
Performing urine drug screens is a useful tool to assist
in the clinical management of patients receiving long-term opioid
therapy. As of November 2013, urine drug screens were performed on
80,294 more patients than in October 2012.
Whenever clinically feasible, the concomitant use of
opioid and benzodiazepine medications should be avoided. In
November 2013, 9,609 fewer patients were receiving these drugs at the
same time than in October 2012.
Last, the average dose of selected opioids has begun to
decline slightly in VA, demonstrating that prescribing and consumption
behaviors are changing.
While these changes may appear to be modest given the size of the
VA patient population, they signal an important trend in VA's use of
opioids. VA expects this trend to continue as it renews its efforts to
promote safe and effective pharmacologic and non-pharmacologic pain
management therapies. Very effective programs yielding significant
results have been identified (e.g. Minneapolis, Tampa, Columbus), and
are being studied as strong practice leaders.
The second system-wide risk management approach to support the
Veterans' and public's safety is promulgation of new regulations that
enable VHA to participate in state Prescription Drug Monitoring
Programs (PDMPs). VA providers can now access the state PDMP for
information on prescribing and dispensing of controlled substances to
Veterans outside the VA health care system. Participation in PDMPs will
enable providers to identify patients who have received non-VA
prescriptions for controlled substances, which in turn offers greater
opportunity to discuss the effectiveness of these non-VA prescriptions
in treating their pain or symptoms. More importantly, information that
can be gathered through these programs will help both VA and non-VA
providers to prevent harm to patients that could occur if the provider
was unaware that a controlled substance medication had been prescribed
elsewhere already.
leveraging strong practices to change opioid prescribing:
the minneapolis va medical center (vamc)
In summary, there is growing evidence of the successful
implementation of a Stepped Care Model for Pain Management in VHA.
Importantly, Veterans receiving long term opioid therapy for management
of chronic pain are increasingly likely to be receiving this therapy in
the context of multidisciplinary and multimodal care that often
incorporates physical and occupational therapy and mental health
services. All VISNs provide specialty pain clinic services, and the
number of Veterans who receive these services has grown steadily for
the past five years. Ten facilities now provide CARF accredited pain
rehabilitation services, a rapid increase in the availability of these
higher specialized pain rehabilitation services for our most complex
Veterans with debilitating chronic pain and comorbid mental health
disorders.
VA learns from VISNs and VAMCs that are early adopters of
implementing evidence-based guidelines and best practices. The
Minneapolis VAMC has had great success with decreasing over utilization
of opioid pain medications and developing a full range of pain
management services. These efforts began with the Minneapolis VA Opioid
Safety Initiative in 2011. Strong medical center leadership support led
to the development of systems to identify patients on high risk opioids
and provide team-based support from pharmacy, primary care, and mental
health to develop individualized care plans to decrease high risk
opioid use and improve patient safety. Implementing this best practices
approach, Minneapolis has seen a nearly 70 percent decrease in high-
dose opioid prescribing for chronic non-cancer pain patients. This
early success lead to a coordinated effort between Minneapolis VAMC and
VISN 23 to expand support for PACT team-based pain management, Step 2
pain consultation services, and rehabilitation focused
multidisciplinary pain specialty services. The Minneapolis pain
specialty services are now developing state-of-the-art, evidence-based
interdisciplinary pain management programs and services, and also
providing leadership, guidance, and support for primary care pain
management throughout VISN 23 and VHA.
VA is working aggressively to promote the safe and effective use of
long-term opioid therapy for Veterans with chronic pain for whom this
important therapy is indicated. VA's Opioid Safety Initiative holds
considerable promise for mitigating risk for harms among Veterans
receiving this therapy, for promoting provider competence in safe
prescribing of opioids, and in promoting Veteran-centered, evidence-
based, and coordinated multidisciplinary pain care for Veterans with
chronic pain. VA's Opioid Safety Initiative Tool provides monthly
reports to all VISNs and facilities as to overall opioid prescribing an
average dose per day of opioid therapy, which informs facilities of
Veterans who are at risk for adverse outcomes and enables remedial
steps to reduce those risks as described earlier by the Minneapolis
VAMC. Interventions include VISN level, facility level and committees
that provide support and education to improve the appropriate opioid
risk mitigation for individual providers and facilities. Early evidence
of success in reducing overall opioid prescribing and average dose per
day of opioid therapy is encouraging.
complementary and integrative medicine
VHA leadership has identified as its number one strategic goal ``to
provide Veterans personalized, proactive, patient-driven health care.''
Integrative Health (IH), which includes CAM approaches, provides a
framework that aligns with personalized, proactive, patient-driven
care. There is growing evidence for effectiveness of non-
pharmacological approaches as part of a comprehensive care plan for
chronic pain which includes acupuncture, massage, yoga and spinal
manipulation. These are all being increasingly made available to
Veterans.
In 2011, VA's Healthcare Analysis and Information Group published a
report on Complementary and Alternative Medicine in VA. At that time,
89 percent of VHA facilities offered some form of CAM/IH; however,
there was extensive variability regarding the degree, level, and
spectrum of services being offered in VHA. The top reasons for offering
CAM/IH included the following:
Promotion of wellness;
Patient preferences; and
Adjunct to chronic disease management.
The most commonly offered CAM/IH modalities in VHA facilities were:
Meditation, Stress Management/Relaxation Therapy, Progressive Muscle
Relaxation, Biofeedback, and Guided Imagery. The conditions most
commonly treated with CAM/IH include: Stress management, Anxiety
Disorders, PTSD, Depression, and Back Pain.
In VA, chiropractic care is part of the standard medical benefits
and is administratively aligned under Rehabilitation and Prosthetic
Services. The number of Veterans receiving chiropractic services in VA
has expanded form under 4,000 in FY 2004, to over 26,000 in FY 2013. In
addition to clinical services, Rehabilitation and Prosthetic Services
is working to develop innovative approaches to foster chiropractic
inter-professional education strategies and research projects.
VA recognizes the importance and benefits of recreational therapy
in the rehabilitation of Veterans with disabilities. Currently, over 30
VA medical centers across the country participate in therapeutic riding
programs. These programs use equine assisted therapeutic activities to
promote healing and rehabilitation of Veterans with a variety of
disabilities and medical conditions (e.g. Traumatic Brain Injury,
polytrauma). VA facilities participating in such programs utilize their
locally appropriated funds to support their participation. Facilities
can also request supplemental support through the VA Secretary's
General Post Fund, a trust fund administered by the Department to
support a variety of recreational and religious projects and national
rehabilitation special events.
A monthly Integrative Health (IH) community of practice conference
call provides VHA facilities national updates, strong practices, and
new developments in the field and research findings related to IH.
A key development is a Joint Incentive Fund DOD/VA project to
improve Veterans' and Servicemembers' access to CAM, the ``Tiered
Acupuncture Training Across Clinical Settings'' (ATACS) project. ATACS
represents VHA's initiative to make evidence-based complementary and
alternative medicine therapies widely available to our Veterans
throughout VHA. A VHA and DOD network of medical acupuncturists are
being identified and trained in Battlefield (auricular) Acupuncture by
regional training conferences organized jointly by VHA and DOD. The
goal of the project is for them to return to their facilities and VISNs
with the skills to train local providers in Battlefield Acupuncture,
which has been used successfully in DOD front-line clinics around the
world. This initiative ultimately aims to provide all Veterans with
access to this intervention, and a wider array of pain management
choices generally, when they present with chronic pain.
integrative health--the way forward
In late 2012, the Under Secretary for Health appointed a Team to
review the organizational structure to support implementation of
integrative health strategies in VHA. The Team recommended the
expansion of the VHA Office of Patient Centered Care and Cultural
Transformation's (OPCC&CT) capacity to develop and implement
integrative health strategies in clinical activities, education, and
research. OPCC&CT is now serving as the lead office in this work,
expanding on existing efforts and with active partnerships across the
organization. An Acting Director of VHA's Integrative Health
Coordinating Center (IHCC) has been named and recruitment for core
staff is in process. Additional staffing is being vetted now and that
will continue until the program is fully developed.
OPCC&CT has deployed a number of clinical, research, and education
strategies to begin developing a more coordinated approach. This
includes clinical pilots, work within the existing Centers of
Innovations, and close alignment with the Office of Research and
Development, as well as creating curricula and expanding education in
these areas. VA's Evidence Synthesis program, in conjunction with
OPCC&CT and Patient Care Services, is examining the scientific
literature on various CAM modalities and presenting the findings in the
form of an evidence map. At the present time, reviews are being done on
Yoga, Tai Chi, and mindfulness meditation and a review was recently
completed on acupuncture. The evidence map on acupuncture showed a
positive effect of acupuncture on headaches, migraines, and chronic
pain as well as a potential positive effect in multiple domains
including depression and insomnia. The information from these reviews
will help guide decision on how to best use CAM modalities within VA.
The Whole Health Clinical Education Program, which includes an
integrative health focus, launched last year, has received outstanding
evaluation feedback from the clinicians and leadership who have taken
the course. An online curriculum is under development and will have
greater than 40 modules. These have been co-created with VA and the
University of Wisconsin, leaders in the field of Integrative Medicine.
Finally, the DOD/VA Health Executive Council (HEC) Pain Management
Work Group (PMWG) was chartered to develop a model system of
integrated, timely, continuous, and expert pain management for
Servicemembers and Veterans. The Work Group participates in VA/DOD
Joint Strategic Planning (JSP) process to develop and implement the
strategies and performance measures, as outlined in the JSP guidance,
and shares responsibility in fostering increased communication
regarding functional area between Departments. The Group also
identifies and assesses further opportunities for the coordination and
sharing of health related services and resource between the
Departments. A key development is the HEC PMWG's sponsoring of two
Joint Incentive Fund projects to improve Veterans' and Servicemembers'
access to competent pain care in the SCM-PM: the Joint Pain and
Education Project (JPEP), and the ``Tiered Acupuncture Training Across
Clinical Settings'' (ATACS) projects.
oversight and accountability
Several key responsibilities are articulated in the Pain Management
Directive. The Directive establishes a National Pain Management Program
Office (NPMPO) in VACO that has the responsibility for policy
development, coordination, oversight, and monitoring of VHA's National
Pain Strategy. The Directive further authorizes the establishment of a
multidisciplinary VHA National Pain Management Strategy Coordinating
Committee that supports the Program Office in achieving its strategic
goals and objectives. The Committee is comprised of 15 members to
include: anesthesiology, employee education, geriatrics and extended
care, mental health, neurology, nursing, pain management, patient
education, pharmacy benefits management, primary care/internal
medicine, quality performance, rehabilitation medicine, research, and
women Veterans' health.
The Directive requires VISN Directors to ensure that all facilities
establish and implement current pain management policies consistent
with this Directive. The NPMPO maintains records of VISN and facility
compliance, along with other key organizational requirements contained
in the Directive. All VISNs and facilities have appointed National Pain
Office pain management points of contact, established multidisciplinary
committees, and implemented pain management policies as required by the
Directive. Health Care Provider Education and Training
First, as recognized by the IOM in its extensive 2011 review,
``Pain in America'' and the American Medical Association in its 2010
Report on Pain Medicine \11\, and as articulated in VHA's Pain
Management Directive in 2009-053, a formal commitment to pain
management education and training for all appropriate clinical staff is
required.
---------------------------------------------------------------------------
\11\ Lippe P.M., Brock C., David J.J., Crossno R., Gitlow S. The
First National Pain Medicine Summit--Final Summary Report. Pain Med
2010;11(10):1447-68.
---------------------------------------------------------------------------
The Joint Pain and Education Project, JPEP, mentioned earlier, has
proposed training faculty in all VA training sites to pursue the
implementation of such a curriculum; new generations of providers and
other clinicians will themselves ultimately become the practitioners
and teachers of good pain care. JPEP will target all levels of learner:
the Veteran and his/her family and caregiver; the public; clinicians
from all disciplines; specific providers and clinicians in practicing
at each level of the SCM-PM: primary care, pain medicine specialty
care, and other specialty care. VA is providing national leadership in
developing interdisciplinary and discipline-specific competencies for
pain management, in developing a system-wide approach to trainings, and
in providing leadership roles in national projects to improve pain
education and training.
conclusion
Mr. Chairman, I would be the last person to say that we are now
right where we want to be with our pain care in VA, but I will be the
first person to say that we are well along in the process of getting
there. I am confident that we will be setting standards for pain care
nationally in the coming years. We are confident that we are building
more accessible, safe and effective pain care that will be responsive
to the needs of our Veterans and will better serve to enhance the
quality of their lives. VA is committed to providing the high quality
of care that our Veterans have earned and deserve, and we appreciate
the opportunity to appear before you today. My colleagues and I are
prepared to respond to any questions you may have.
______
Response to Posthearing Questions Submitted by Hon. Bernard Sanders to
Robert A. Petzel, MD, Under Secretary for Health, Veterans Health
Administration (VHA), U.S. Department of Veterans Affairs
opioid safety initiative
Question 1. How does VA plan to implement the Opioid Safety
Initiative system-wide?
Response. The Veterans Health Administration (VHA) has been
vigorously pursuing implementation the Opioid Safety Initiative (OSI)
to ensure optimal pain management and to safeguard Veterans from harm
inherent in high-risk medications such as opioids and benzodiazepines.
The objective of OSI is to make the totality of opioid use visible at
all levels in the organization with a particular emphasis on
identifying and remediating prescribing practices that place Veterans
at increased risk for adverse outcomes. To this end, VHA has embarked
on a system-wide program of education and training in pain management,
opioid safety, access to alternative medical and non-medical treatments
for pain, and patient education in self-management. These programs are
manifestations of the core principles and policies outlined in the 2009
Directive and are emphasized in the new draft Directive which is in
development. In the meantime, Directive 2009-053 remains as VHA policy
until replaced with the new Directive. To assist Veterans, providers
and clinical teams in achieving OSI goals for safer opioid prescribing
practices, an interdisciplinary VHA Task Force assembled a 15 module,
peer-reviewed OSI Toolkit that is continually updated as new
information becomes available, including new evidence-based practices.
The OSI Toolkit is accessible to all VHA clinicians and disseminated
widely and repeatedly through multiple communication channels and
educational formats to facilitate safe opioid prescribing practices.
a. What is the timeline for full implementation?
Response. While The Opioid Safety Initiative (OSI) was launched in
October 2013, it is an on-going endeavor, comprised of multiple inter-
disciplinary approaches, which will be constantly evaluated, modified
and/or introduced to effective pain management and decrease the risks
for complications due to both over- and under-treatment with opioids
and other therapies. As an example, VHA OSI Task Force assembled a 15
module, peer-reviewed OSI Toolkit that is continually updated as new
information becomes available, including new evidence-based practices.
Question 2. What are the implications of the Opioid Safety
Initiative beyond pain care, such as reducing the reliance of
medications to treat mental health conditions?
Response. VHA original response: The Opioid Safety Initiative
addresses the risks of opioid analgesia comprehensively through a
system-wide program with the following aims that include management of
Veterans with co-morbid pain and mental health conditions:
To reduce risks, such as high opioid doses, co-prescribing
of benzodiazepines, close monitoring of Veterans with urine drug
screens and Veterans with risks such as substance use disorders
(addiction) and PTSD.
To encourage the use of psychological, physical and
complementary and alternative medicine (CAM) therapies such as
acupuncture and yoga in pain management.
To provide feedback and educational support for our
clinical teams caring for patients with co-morbid pain and mental
health disorders.
Question 3. How does VA plan to publicize this initiative--
particularly to veterans who may have avoided seeking treatment in the
past because of concerns regarding medication?
Response. VHA has embarked on a system-wide program of education
and training in pain management, opioid safety, access to alternative
medical and non-medical treatments for pain, and patient education in
self-management. These programs are manifestations of the core
principles and policies outlined in the 2009 Directive and are
emphasized in the new draft Directive which is currently in
concurrence. In the meantime, Directive 2009-053 remains VHA policy
until replaced with the new Directive.
Question 4. One of the goals of the Opioid Safety Initiative is to
facilitate use of state prescription databases. In which state
prescription databases is VA able to participate? Is VA currently
participating in all of the databases where it is able?
Response. As of the date of this response, Prescription Drug
Monitoring Program (PDMP) deployment is completed in 29 states, and is
scheduled for completion in 6 more states by the end of August 2015.
Please note that in 2 of these 6 states--Florida and Oregon--PDMP
deployment is very near completion. In Florida, 4 of 6 sites are
transmitting and in Oregon, 2 of 3 sites are transmitting. Deployment
will occur in 13 other states by December 2016. The longer
implementation period for these 13 states is due to their individually
customized PDMP requirements that VA is working to satisfy. One state--
New Mexico--has advised the Department that it needs to purchase and
install new software to support a PDMP, and that its timeline to
accomplish this purchase is not yet determined. This issue affects all
dispensing pharmacies within New Mexico. VA stands ready to activate
the transmission of prescription drug data to New Mexico's PDMP system
as soon as the state is ready. Missouri is the only state that has not
enacted a PDMP law. The District of Columbia is currently developing
its recently enacted PDMP. A complementary effort to PDMP deployment is
the issuance of the VHA Directive, Querying State Prescription Drug
Monitoring Programs, which we are planning to publish in the coming
months. This Directive would establish policy requiring VHA health care
provider participation in state PDMPs, consistent with applicable state
laws. The Directive would assign responsibility to each facility
Director to ensure that local policy and processes are established to
support the Directive. Specifically, the Directive would outline when a
query is needed, the frequency of a query, and any exclusions.
Specifically, the draft would exclude any controlled substance
prescription that is a 5 day supply or less without refills and any
patient who is enrolled in Hospice care, unless required by state law.
complementary and alternative medicine (cam)
Question 5. VA offers a number of CAM therapies, but they are not
necessarily evenly distributed across the system and veterans are not
always aware of what's available to them. What is VA doing to more
evenly distribute access across the system? What is VA doing to inform
veterans their options for CAM therapies? What is VA doing to encourage
providers to offer these therapies and how is this being tracked?
Response. VA is committed to offering Veterans more personalized,
proactive and patient driven care. This entails better understanding of
the needs and desires of Veterans and addressing their health care
goals in a more holistic fashion. VHA has established an Integrative
Health Coordinating Center whose mission is to help evaluate and where
appropriate help integrate Complementary and Integrative Health (CIH)
services into VA. In addition, the Office of Patient Centered Care and
Cultural Transformation (OPCC&CT) has developed education on Whole
Health, which is being disseminated throughout VA. These courses
educate providers on how to approach healthcare in a more holistic
fashion and educates them on CIH practices and how these may be able to
play a part in Veterans healthcare. This education on CIH practices
will expand the resources available to providers when they engage their
patients in identifying their healthcare goals and the strategies they
wish to embark on to attain these goals. As VA offers personalized,
proactive, patient-driven care it is through educating providers that
we work to ensure that Veterans have a discussion with their provider
and discuss the best treatment option including all appropriate
therapies including indicated CAM/CIH which is unique to the Veteran
and their circumstance. VHA's educational programs for clinical staff
are being disseminated in the field. These clinical courses educate
providers on how to approach health care in a more holistic way and
educates them on CAM therapies available. Other efforts are underway to
provide information to Veterans. One example is that OPCC&CT developed
an internet site as the focal point for messaging, resource delivery,
and community engagement for the patient centered care body of work and
the Veteran-facing products developed to educate and communicate with
Veterans. Through the Health for Life site, we are providing products
that enable Veterans to achieve their greatest health and well-being.
OPCC&CT has also trained field implementation teams that are being
deployed around the country to work with local leadership to create a
culture that supports a whole health, patient-centered model inclusive
of CIH services. They have developed an education campaign that
includes both internal and external customer facing modules describing
the new models of care and services that focus on putting the patient
at the center of their care to create a personalized, proactive,
patient-driven model.
Question 6. What factors limit VA from further broadening CAM
therapies across the VA Health Care System?
Response. The medical benefits package states that VA may offer
those services that are in accord with generally accepted standards of
medical practice. There are a vast number of Complementary and
Integrative Health (CIH) practices, but the evidence base for many of
them is limited. Questions remain about the efficacy of many of these
practices, who responds to them, how they should be used, and for how
long. Although no CIH practice is the gold standard for care, several
practices show promise as adjuncts to care. In addition, many CIH
practices lack standardized education, training, certification and
licensure standards. These factors, combined with a lack of
occupational classes for CIH practitioners within VA, pose significant
barriers to the hiring of such providers within VA.
dod/va collaboration
Question 7. What benefits has VA seen from the standardization of
the prescription medication between VA and DOD available to both
servicemembers and veterans? Are servicemembers able to continue their
existing course of treatment as they transition to VA health care?
Response. Yes, Servicemembers are able to continue their existing
course of treatment as they transition to VA health care, unless a
change would be warranted based on a VA provider's clinical assessment
(i.e., drug is no longer effective, patient's changing medical
condition warrants a change, drug is no longer safe given clinical
circumstances, etc.). There have been widespread anecdotal reports of
Servicemembers' mental health and pain medications being switched due
to differences between the VA and DOD drug formularies. However, these
anecdotes were not substantiated in a medication continuity pilot
evaluation of over 2,000 Servicemembers recently conducted by VA. In
this pilot evaluation, VA found that 99% of patients receiving a mental
health or pain medication were able to continue those medications
despite differences between the VA and DOD formularies. The data from
VA's pilot evaluation validates VA's long standing practice of
continuing medication therapy started by Department of Defense
prescribers. See (http://www.pbm.va.gov/PBM/
vacenterformedicationsafety/othervasafetyprojects/DOD--VA--Medication--
Continuation--Report.pdf).
Question 8. What other efforts have DOD and VA taken to
collaborate and standardize treatment options for servicemembers and
veterans for the treatment of chronic pain and mental health
conditions?
Response. The DOD/VA Health Executive Council's Pain Management
Work Group ( HEC PMWG), which meets monthly, was chartered in 2010 to
``actively collaborate in supporting the development of a model system
of integrated, timely, continuous, and expert pain management for
Servicemembers and Veterans.'' The HEC PMWG has articulated 6
objectives for its present work:
Objective 1--Standardize Pain Measurement. The PMWG has sponsored
the development of the Defense and Veterans Pain Rating Scale to
improve the measurement of pain. The tool has been validated and
published, is in use in multiple military facilities and in civilian
hospitals. Additional validation studies continue in DOD and VHA.
Objective 2--Develop a clinical pain support tool and pain data
registry. The PASTOR tool, incorporating the NIH ``PROMIS'' patient
report outcome measures and computer adaptive testing, is under
development and is being piloted in a collaboration between Madigan
Army Hospital, NIH, and the University of Washington.
Objective 3--Standardize Suboxone (buprenorphine and naloxone)
Prescribing Practices. A common guidance document is developed and VHA
and DOD working implementation in each organization.
Objective 4--Develop Medical Drug Testing guidance. The PMWG
developed DOD/VHA core guidance and have developed and share clinical
education and training in JPEP modules and in the Opioid Safety
Initiative Toolkit.
Objective 5--Develop Acupuncture Credentialing guidance. The PMWG
developed shared DOD/VHA core guidance for VHA and DOD clinicians and
is working implementation of core guidance within their respective
organizations
Objective 6--Develop Informed Consent for Long-term Opioid Therapy.
The VHA developed and approved a patient education document, ``Taking
Opioids Responsibly,'' to assist in the informed consent process, and
the DOD is evaluating the VHA document for implementation in DOD.
Currently there are two Joint Investment Fund (JIF) supported
projects to improve the competencies of our workforce across both
systems:
The Joint Pain Education and Training Project (JPEP).
- Has developed 35 optional evidence-based training modules in
pain management for use in its multiple pain education programs
to help standardize pain management education and training
across the two health systems and to support and educate
clinicians and Veterans about safe and effective stepped pain
management, including use of opioids.
- JPEP modules are being used for primary care residency
training and for practicing clinicians and clinical teams being
trained by the Pain Mini-residency, Pain SCAN ECHO,
asynchronous web-based courses, and Community of Practice
conferences.
- All these programs reach across the VHA to train primary
care providers in all settings in the assessment and treatment
of pain and in the use of patient education in self-management,
the use of multiple modalities such as behavioral, integrative
medicine, and physical therapies and the use of consultant
specialists in pain, mental health, and CAM.
- On the topic of opioids safety, for example, these programs
have presentations on universal precautions and risk
management, including clinical evaluation, written informed
consent, screening such as urine drug monitoring, use of state
prescription monitoring programs, and safe tapering.
The Tiered Acupuncture Training Across Clinical Settings
(ATACS)
- Has trained more than 1290 front-line providers in the VA
and DOD in Battlefield Acupuncture as well as dozens of
physicians in medical acupuncture.
- Represents VHA's initiative to make evidence-based
complementary and alternative medical therapies widely
available to our Veterans throughout VHA.
- Provides Veterans with a wider array of pain management
choices when they present with chronic pain.
acupuncture training
Question 9. How would the Joint Incentive Fund Project to
implement a standardized acupuncture training and sustainment model
across DOD and VA medical facilities improve acupuncture services VA
provides veterans? When can we expect system-wide implementation of
this joint model?
Response. By providing standardized training in the short course
for Battlefield (auricular) Acupuncture (BFA) to hundreds of providers
across the system, and by credentialing trainees to add BA to their
pain management toolbox, these providers will be able to use this
treatment as one of many they have to offer Veterans with pain. The
physicians being trained in Medical Acupuncture will also be trained as
BFA Faculty, so they can train their local facility providers in BFA to
sustain the program's development system-wide.
Question 10. How many providers are trained in acupuncture already
working in the VA Health Care System? How many of these providers are
exclusively providing acupuncture? What is the average number of hours
each provider trained in acupuncture offers this therapy each week?
Response. We do not have information on the number of providers
based at facilities who provide acupuncture or how many hours a week
therapy is provided. However, from the 2015 Healthcare analysis and
information group survey on VA Complementary and Integrative Health
practices, we do know that 79 facilities offer acupuncture services
primarily performed by physician-trained acupuncturists as a part of
their duties at least a half day per week up to several times a week.
Question 11. What efforts are being made to ensure an adequate
number are available to treat veterans once the joint model is
implemented?
Response. At the current time, physicians and chiropractors are the
only VHA occupations with scopes of practice that include acupuncture.
As a result, the availability of trained acupuncture providers within
VA is limited. VA continues to support the training of physicians in
acupuncture, but is also pursuing the development of a licensed
acupuncturist occupational class within VHA. The addition of licensed
acupuncturists to VHA occupations will expand VHA's ability to hire
trained acupuncture providers.
pain management directive
Question 12. On October 28, 2009, VA issued the Pain Management
Directive to improve VHA's processes for treating and managing chronic
pain. How has system-wide implementation of the National Pain
Management Strategy--as required by the Pain Management Directive--
improved VA's approach to pain management?
Response. The implementation of Stepped Care has increased
resources for primary care pain management, such as behavioral health
clinicians, access to CAM, access to multidisciplinary pain specialty
clinics, and access to tertiary care Commission on Accreditation of
Rehabilitation Facilities (CARF) rehabilitation programs.
Question 13. Does VA plan to extend the Pain Management Directive?
If not, please explain why not. If so, please explain whether it will
be extended in its current form or if changes will be made.
Response. Yes, a new Directive has been drafted and is undergoing
VHA Concurrence. Until which time the new Directive is approved, the
current Pain Management Directive will remain in effect.
______
Response to Posthearing Questions Submitted by Hon. Mark Begich to
Robert A. Petzel, MD, Under Secretary for Health, Veterans Health
Administration (VHA), U.S. Department of Veterans Affairs
Question 14. My office has received casework from veterans who
have severe PTSD issues that affect their day to day life, and say I
quote ``I'm pretty much done with medications.'' They have asked for
Hero Dogs, who raise and train service dogs and places them free of
charge with our Nation's Veterans to improve quality of life and
restore independence. Veterans with disabilities have given enough.
Tell me what the VA is doing with expanding service/therapy dogs; I
think this would be a cheaper option and a safer option rather than
treating with opioids and other drugs.
Response. Veteran preference is an important consideration when
choosing a therapeutic approach to treat PTSD. Effective cognitive
behavioral therapies are made available to every Veteran who seeks VA
care for PTSD. VA is currently attempting to find ways to increase
Veteran engagement with these treatment modalities and increase the
likelihood that Veterans remain in treatment until remission or
significant clinical improvement is accomplished. While dogs and other
animals can provide great comfort and companionship, and we do not
disagree with Veterans' subjective accounts that service dogs have
improved the quality of their lives. At this time, there is not
sufficient evidence that animals are effective in the treatment of
mental health conditions, including Post Traumatic Stress Disorder
(PTSD). Consequently, VA does not provide service dog benefits for
mental health service dogs. VA is currently evaluating the efficacy of
mental health service dogs pursuant to a congressionally mandated study
to learn whether service dogs and/or emotional support dogs can be
effective in treating or rehabilitating persons with PTSD. The study,
expected to take several years to complete, is currently ongoing at
three sites (Atlanta, GA; Iowa City, IA; and Portland, OR) and has
begun pairing enrolled Veterans with dogs.
Question 15. The following is from a veteran in Kenai: ``I'm on
ten different types of medications that deal with sleep, back pain,
depression, anxiety, blood pressure, and inflammation * * *. I've
really lost count of what I'm taking. I'm sick of it. I don't want to
take any more medications. I would like to see if we can make a push
for the VA to fund holistic style medical treatments. I believe in
these, and I believe that they are cheaper rather than pushing big
pharma on us. I for one am sick of it and would rather live in a state
of depression and anxiety as opposed to taking 10+ pills a day. I'm
also battling with the VA for an increase in VET benefits. They have
turned down request for shoulder pain connected disability; they've
turned down requests for increase in ringing in my ears but will give
me pills!''
I am glad the VA and the Committee is addressing this, it is very
real, and how would you respond to this veteran?
Response. Thank you for raising this important point. The problems
you mention affect our entire nation and this is an issue we are
challenged to manage effectively for our Veterans as well. The VA is
actively addressing these problems in multiple ways, as well as
contributing to the national effort, outlined in the National Pain
Strategy, to improve the education and training of all health
professionals, including those who eventually will care for our
Veterans and military. The potential for side effects and toxicity
increases when medications that affect the central nervous system (the
brain and spinal cord) are prescribed together for symptoms of
different, but sometimes related, conditions such as sleep disorders,
chronic pain conditions, anxiety and depression disorders, Traumatic
Brain Injury (TBI) and PTSD. To help combat this problem the VA can
take advantage of its unique combination of assets, such as its
electronic medical record and its Veterans Health Administration (VHA)-
wide communication and education systems which reach all facilities and
providers.
VHA has developed a new tool, the Opioid Therapy Risk Report
(OTTR), which is available now to all VHA Primary Care clinicians when
treating a Veteran with opioid therapy for chronic pain. This report
provides information about the dosages of opioid analgesics and other
centrally active medications such as benzodiazepines, significant
medical and psychiatric problems that could contribute to an adverse
drug reaction, and monitoring data to aid in the review and management
of complex patients. OTTR is right on the dashboard of the electronic
medical record, which enables VA providers to review this pertinent
clinical data related to pain treatment all in one place while actually
talking to patients about their symptoms and medications. As a result,
Veterans are afforded a comprehensive Veteran-centered and more
efficient level of pain management not previously available to Primary
Care providers. VHA is actively deploying training aids to providers
and facilities to familiarize them with how to utilize this tool in
their daily practice.
VHA has formalized several education and academic detailing
projects that provide all VA prescribers and facilities guidance and
education on safe symptom management. One program is the OSI, which
monitors reductions in potential risks such as prescribing opioids and
benzodiazepines together or high doses of opioids, monitors how
facilities are increasing the use of evidence-based alternative
treatments such as cognitive behavioral therapies and integrative
medicine (CAM) (which are now required to be available in all
facilities as alternatives to medication), and also provides feedback
and support for providers whose prescribing profiles do not meet
acceptable clinical standards. An OSI Toolkit with detailed education
and guidance for both providers and patients is available on the VA's
Pain Management Intranet and Internet sites and has been widely
presented throughout the VHA in multiple educational formats and
communications. For example, the Toolkit has detailed instructions
about guiding safe medication tapers when clinically indicated.
Programs such as the ATACS are presently training physicians in
medical acupuncture and providers in ``battlefield (auricular)
acupuncture'' across both systems. Already 1,293 Providers have been
trained in battlefield acupuncture in military treatment facilities VA
hospitals across the country.
______
Response to Posthearing Questions Submitted by Hon. Richard Blumenthal
to Robert A. Petzel, MD, Under Secretary for Health, Veterans Health
Administration (VHA), U.S. Department of Veterans Affairs
Question 16. I have heard from one of my constituents that it is
difficult for some veterans to obtain their VA Identification Card,
which is required to obtain VA health benefits. Can you please provide
information about the process a veteran needs to follow and what are
the criteria to obtain these benefits?
Response. The Veterans Health Identification Card (VHIC) is for
identification and check-in at VA appointments. It cannot be used as a
credit card or an insurance card, and it does not authorize or pay for
care at non-VA facilities. To receive a VHIC, a Veteran must be
enrolled. If the Veteran is not enrolled, the Veteran may apply for
enrollment online at www.va.gov/healthbenefits/enroll, by calling 1-
877-222-VETS (8387), or apply for enrollment in person at his or her
local VA medical facility.
In February 2014, VA began issuing the VHIC to newly enrolled
Veterans and enrolled Veterans who were not previously issued the old
VIC but requested an identification card. Enrolled Veterans who were
not issued the old VIC may contact their local VA medical center
Enrollment Coordinator to arrange to have their picture taken for the
new VHIC, or they may request a new VHIC at their next VA health care
appointment.
Veterans who are already enrolled should ensure the address VA has
on file is correct so you can receive your VHIC in a timely manner. For
more information, please visit http://www.va.gov/HEALTHBENEFITS/vhic/
index.asp.
Chairman Sanders. Dr. Petzel, thank you very much.
General Coots.
STATEMENT OF BRIGADIER GENERAL NORVELL V. COOTS, USA, DEPUTY
COMMANDING GENERAL (SUPPORT), U.S. ARMY MEDICAL COMMAND AND
ASSISTANT SURGEON GENERAL FOR FORCE PROJECTION, OFFICE OF THE
SURGEON GENERAL, U.S. ARMY; ACCOMPANIED BY COLONEL KEVIN T.
GALLOWAY, USA, DIRECTOR, ARMY PAIN MANAGEMENT PROGRAM,
REHABILITATION AND REINTEGRATION DIVISION
General Coots. Chairman Sanders, Ranking Member Burr, and
distinguished Members of this Committee, thank you for the
opportunity to appear before you to discuss some of the Army
Medicine's initiatives to address health and pain management
needs of our servicemembers. I am accompanied by Colonel
Galloway, who is the director for Army Medicine's Pain
Management Program.
On behalf of the over 150,000 dedicated soldiers and
civilians that make up Army medicine, I want to extend our
appreciation to Congress for the support given to military
medicine which provides the resources we need to deliver
leading-edge health services to our warriors, families, and
retirees.
The Army has been engaged over the last 13 years in combat
operations and related activities that have challenged the
bodies and spirits of our soldiers and their families. Army
medicine has worked with our sister services and the Veterans'
Health Administration to meet the emerging medical needs of our
servicemembers and veterans.
Our initiatives which are detailed further in my written
testimony are aimed at improving outcomes, increasing safety,
and enhancing the transition of care to the VA.
Treating pain is one of medicines oldest and more
fundamental responsibilities. Yet modern medicine continues to
struggle in its efforts to understand pain mechanisms and to
relieve pain and suffering of our patients. These complex
issues impact patients, providers, leaders, and organizations
across the military, the VA, and in the civilian sector.
Effective solutions must involve innovative strategies,
comprehensive solutions, and collaborative efforts.
While the complicated nature of pain management and
overmedication is not unique to the military or military
medicine, we do face some unique challenges. We provide medical
care on the battlefield and across an 8,000-mile medical
evacuation chain that moves injured servicemembers from remote
locations to U.S. hospitals with lightening efficiency.
I have been there receiving our wounded warriors during my
time in Afghanistan as well as at Walter Reed when I was the
hospital commander. I know that for military medical providers,
we begin pain management on the battlefield at the point of
injury and continue throughout evacuation, treatment, and
recovery.
Army medicine initiative aimed at non-opioid medications
and regional nerve blocks to provide local relief are important
to expanding opioid sparing strategies at the earliest moments
of care.
In 2010, the Army-led pain management task force was
chartered to develop a comprehensive, holistic, and multi-
disciplinary pain management strategy for the DOD. The Army has
been working to implement the task force recommendations
through the Army pain management campaign and while continuing
to build collaborations both inside and outside of the
Department of Defense.
Current Army initiatives are aimed at improving pain
management, patient care and safety, and reducing adverse
outcomes related to prescription drugs. These are all a part of
comprehensive strategy that includes establishing a network of
standardized pain management capabilities, developing the DOD
pain assessment screening tool, and outcomes registry by
leveraging previous NIH investment in research, comprehensive
medication reviews, and pharmacy screening tools within the
medical home which is our primary care model to identify active
duty servicemembers at increased risk, expanding the role of
clinical pharmacists by embedding them in the medical home as a
member of the comprehensive care team, improving pain
management specialty support to primary care providers through-
out pain ECHO tele-mentoring initiative, expanding our
understanding and utilization of effective integrative medicine
modalities such as acupuncture, yoga, medical massage, and
biofeedback through our collaborative partnerships and
collaboration with the National Center for Complementary and
Alternative Medicine and the Defense and Veterans' Center for
Integrative Pain Management on research studies of non-
medication complements or alternatives to standard pain
management therapies.
There efforts have been associated with fewer adverse drug-
related events, reduced hospital admissions, improved patient
outcomes, and overall cost avoidance.
Finally, I would like to mention ongoing work with the VA
to endure the smooth transition of care as servicemembers enter
the VA system. The overarching pain management task force
objective is to provide a standardized DOD and VA approach to
optimize the care for warriors and their families.
Our providers and patients benefit from a standardized
approach to pain management while they are in uniform and as
they transition to the VA health care system.
I want to thank my partners in the DOD, the VA, and our
colleagues testifying here today for the efforts made and our
shared goals.
I also want to thank Congress and the Committee for your
continued support and I look forward to your questions. Army
medicine is serving to heal and honored to serve.
[The prepared statement of General Coots follows:]
Prepared Statement of Brigadier General Norvell V. Coots, Deputy
Commanding General (Support), U.S. Army Medical Command and Assistant
Surgeon General for Force Projection, Office of the Surgeon General,
United States Army and Colonel Kevin T. Galloway, Army Pain Management
Program Director, Rehabilitation and Reintegration Division, Office of
the Surgeon General, United States Army
Chairman Sanders, Ranking Member Burr, and Distinguished Members of
this Committee--thank you for the opportunity to appear before you to
discuss some of the Army Medicine's initiatives to address healthcare
needs of our Soldiers, specifically as they relate to the challenges
the entire Nation is facing with pain management and the use of
opioids. On behalf of the over 150,000 dedicated Soldiers and civilians
that make up Army Medicine, I want to extend our appreciation to
Congress for the support given to military medicine, which provides the
resources we need to deliver leading edge health services to our
Warriors, Families and Retirees. I'm accompanied today by Colonel Kevin
Galloway, Director for Army Medicine's Pain Management Program.
The Army has been engaged over the last 13 years in combat
operations and related activities that have challenged the bodies and
spirits of our Soldiers and their families. Throughout this intensive
period of military operations, Army Medicine, along with our Sister
Services and the Veterans Health Administration (VHA), have been
evolving and adapting to meet the emerging medical needs of our
wounded, ill, and injured Servicemembers and Veterans. While some of
the medical challenges facing Servicemembers and Veterans are unique to
the military and military medicine, the challenges related to pain
management and the potential overuse, abuse, and diversion of pain
medications are shared by the Nation at large. These complex issues
impact patients, providers, leaders and organizations across the
military health system, the VHA, and civilian medicine. Consequently,
effective solutions and strategies will involve patients, providers,
leaders and organizations across military, VHA and civilian medicine. I
would like to share some of our innovative strategies, comprehensive
solutions, and collaborative efforts with you today as well as
emphasize our commitment to continuous improvement and research
efforts.
pain management
First, I'd like to place the challenges of pain management in some
context. Treating pain is one of medicine's oldest and most fundamental
responsibilities, yet modern medicine continues to struggle in its
efforts to understand pain mechanisms and to relieve pain and suffering
for our patients. Pain is an enigmatic issue for medicine that places
significant burdens on patients, families, medical providers, and
employers. Pain is the most frequent reason patients seek medical care
in the United States. A 2011 Institute of Medicine (IOM) Report noted
that more than 116 million Americans suffer from chronic pain. The
annual cost of chronic pain in the U.S. is estimated at $560 billion,
including health care expenses, lost income, and lost productivity. The
Centers for Disease Control identified prescription medication abuse as
an ``epidemic'' in the United States. The military is not immune to
these challenges.
In 2010, the Army-led Pain Management Task Force was chartered to
develop a comprehensive, holistic, multidisciplinary, and multimodal
strategy utilizing state-of-the-art/science practices in the field.
Comprised of representatives from the Uniformed Services and VHA, the
Pain Management Task Force examined staff education, clinical practice,
and the structure of pain management in military medicine, the VHA, and
in civilian medicine. I would like to emphasize that the Task Force
benefited immensely during this analysis from the VHA's previous and
ongoing initiatives to develop and implement pain management
strategies.
The 2010 Pain Management Task Force Report has been widely
circulated and recognized across U.S. Medicine and abroad. The American
Academy of Pain Medicine recognized the Pain Management Task Force with
its Presidential Commendation. One year after the release of the
report, the IOM released its own report entitled, ``Relieving Pain in
America,'' which acknowledged and referenced the work of the Pain
Management Task Force. More importantly, the IOM report's findings and
recommendations largely paralleled those contained in the Pain
Management Task Force Report. When the IOM report was released in
June 2011, the Army was already operationalizing the Pain Management
Task Force's recommendations through the Comprehensive Pain Management
Campaign Plan. Since the release of the IOM report, the Army has been
representing the Department of Defense on the National Institutes of
Health (NIH) Interagency Pain Research Coordinating Committee, the
Federal advisory committee created by the Department of Health and
Human Services to enhance pain research efforts and promote
collaboration across the government.
The Comprehensive Pain Management Campaign Plan provides a roadmap
for this holistic, multimodal, multidisciplinary pain management
strategy. Army Medicine's pain strategy includes several lines of
effort: first, to implement a culture of pain awareness, education, and
proactive intervention; second, to provide tools and infrastructure
that support and encourage practice and research advancements in pain
management; and last, to build a full spectrum of best practices for
the continuum of acute and chronic pain, based on a foundation of the
best available medical evidence.
The foundation of the MEDCOM pain management program is developing
a tiered or ``Stepped Care'' strategy that provides the appropriate
level of pain management capability, provider education and access to
consultative/referral support at each level of care (i.e. from Primary
Care to Specialty Care). Interdisciplinary Pain Management Centers
(IPMC) are being established at each of the Army's eight medical
centers. IPMCs provide the highest tier of pain management delivered by
a multidisciplinary team of providers working together to provide
consultation, care, and expertise for interventional pain medicine. Our
goals are rehabilitation and functional restoration through these
integrative medicine modalities.
The Army Pain Management Extension for Community Healthcare
Outcomes (ECHO) tele-mentoring initiative leverages the model developed
by the University of New Mexico (UNM) Project ECHO initiative. The Army
is completing a two-year collaboration with UNM to adapt this best
practice for use in the Army's pain program. ECHO's objective is to
complement the capacity, competence and confidence of remote primary
care providers. Utilizing weekly video teleconferencing to create
regional communities of practice, ECHO links the IPMC specialty teams
(i.e. hubs) with their designated Patient Centered Medical Homes (i.e.
spokes). This improves provider knowledge, increases care coordination,
and decreases the need for continued specialty referrals to the direct
and purchased care systems.
complementary integrative medicine modalities
As recommended by the Pain Management Task Force, the integrative
medicine modalities in our IPMCs include acupuncture, movement therapy/
yoga, medical massage, and bio-feedback. The use of these modalities in
our IPMCs provides our patients with non-medication pain management
options. The Army has been collaborating with several organizations
with a common interest in expanding the utilization of complementary
integrative medicine modalities. The National Center for Complementary
and Alternative Medicine at NIH, the Bravewell Collaborative, and the
Samueli Institute have all been extremely helpful in this effort.
Army clinicians are participating with the Air Force, Navy, and VHA
in a $5.4 million Joint Incentive Fund Project to field a standardized
basic acupuncture training and sustainment model across DOD and VHA
medical facilities. Training teams have already started traveling to
Army, Navy, Air Force, and VHA medical facilities to deliver this
training. The response from providers and patients has been
overwhelmingly positive.
Army Medicine, along with the Navy and Air Force, is collaborating
through the Defense and Vet Center for Integrative Pain Management on
research studies related to the use of acupuncture and yoga as non-
medication complements/alternatives to standard pain management
therapies. Initial evidence indicates these can be effective
complements and sometimes an alternative to medications.
pain outcomes measurement
In response to the 2010 National Defense Authorization Act and the
recommendations in the Pain Management Task Force Report, the DOD began
development of the Pain Assessment Screening Tool and Outcomes Registry
(PASTOR). PASTOR was designed as a tool to reduce the burden of
questionnaires during clinical contact through modern information
technology, make use of well-established pain assessment tools already
available, and provide a framework for development of new assessment
tools. Furthermore, PASTOR is envisioned as a critical first step in
realizing the vision of outcomes driven pain care across the DOD and
VHA health care systems.
The PASTOR prototype results in a clinician report, displaying
alerts for concerning responses to questions covering PTSD, depression,
anxiety, and alcohol use. These alerts are intended to prompt further
individualized evaluation by the clinician. Areas of greatest pain are
mapped on an image of a body, and self-reported pain values are tracked
over time. When these scores are analyzed in concert with validated
measures of emotional (anxiety, depression, anger) and physical (sleep,
physical function) health domains, trends are easily identified.
Additionally, each patient has an opportunity to list and rate ability
on activities that are important to that individual. This functional
data provides practical indicators of pain management success. A new
set of opioid use measures are also under development and will be field
tested in both civilian and military setting later this year.
A significant advantage in the PASTOR development program is its
collaborative partnership and development strategy with the NIH Patient
Reported Outcomes Measurement Information Systems, or PROMIS. PROMIS
represents an existing Federal investment of approximately $100
million, over 8 years of research and development, and the product of
150 scientists at 15 primary research sites. PROMIS created more than
80 royalty free instruments which can be used to capture numerous
components of health related quality of life including physical health,
mental health and social health. Computerized adaptive testing (CAT)--
enables computer-based delivery of measures which can obtain clinical
accuracy in five items or less. Scientists at Northwestern University
have teamed with the military to integrate brief PROMIS measures with
the needs of military personnel and their families who require pain
management. This reduction in patient burden, without loss of clinical
reliability, enables PASTOR to frequently assess multiple facets of
pain and opioid use.
Thus far, a working prototype has been constructed, pain threshold
values for appropriate initiation of PASTOR have been identified, and a
pilot test of the system has begun in two military treatment
facilities, with more to follow in the coming months.
Army Medicine is adopting the Defense and Veterans Pain Rating
Scale (DVPRS). Something as simple as changing how we ask our patients
about their pain can impact the prevalence of medication use. The scale
was developed by the Pain Management Task Force and validated through
DOD/VHA research studies. It recalibrates the pain discussion along the
lines of: ``How is pain affecting your function and quality of life?''
The scale includes supplemental questions on pain's effect on sleep,
mood, stress and activity. The Army is integrating DVPRS into the
Patient Centered Medical Home workflows.
pain management transition to vha
Another area I'd like to highlight with regard to pain management
is our ongoing collaboration with the VHA to ensure the smooth
transition of care for Soldiers who will be receiving care in the VHA
health system. Prominently positioned on the Pain Management Task Force
Report cover is the overarching Task Force objective: ``Providing a
standardized DOD and VHA vision and approach to pain management to
optimize the care for Warriors and their Families.'' Army Medicine has
continued to engage with the Air Force, Navy and VHA to move our
organizations in that direction. The Army Pain Management Program's
incorporation of the VHA's Stepped Care approach synchronizes provider
education with the expectations of our patients. Not only do our
military providers and patients benefit from a standardized approach to
pain management while they are in uniform, but this also makes the
transition to VHA care far less disruptive.
DOD and VHA collaboration has also resulted in standardized
prescription medication formularies to ensure Soldiers with chronic
pain are able to continue effective care plans after their transition
to the VHA. Last, military and VHA providers are engaged in a project
to develop and implement a common pain management education curriculum
for both providers and patients. The curriculum will be fully developed
within the next twelve months, and will be implemented across VHA and
DOD within the next eighteen months. These initiatives will take us
closer to the standardized DOD and VHA vision and approach to pain
management referenced by the Pain Task Force.
In addition to the Pain Management Campaign, Army Medicine is
addressing the potential overuse, abuse and diversion of opioids
through a comprehensive strategy that integrates several other
initiatives including Polypharmacy, Substance Abuse, Behavioral Health,
and Warrior Transition Care.
polypharmacy
Soldiers with complex injuries often require the use of multiple
medications (i.e. polypharmacy) which can place them at greater risk
for medication-related adverse events. The Army seeks to reduce risk,
enhance safety and optimize care by including the Soldier, Family
members, healthcare providers, pharmacists and commanders as part of
the healthcare team. Army policies also establish procedures to
identify polypharmacy trends that could lead to misuse by Soldiers and
Wounded Warriors.
Army Medicine uses best practices that are comparable to, or
exceed, civilian programs, such as prescription drug monitoring to
identify polypharmacy cases. Positive interventions include
comprehensive medication reviews, sole provider programs, limiting the
dispensed supply of medication, restricting high-risk patients to the
utilization of one pharmacy, informed consent, use of non-drug
treatment options, clinical pharmacist referrals, and patient and
provider education.
The Army trains its providers on the risks of prescription opioid
overuse and ways to prevent medication misuse. The US Army Public
Health Command and the Uniformed Services University of the Health
Sciences developed an interactive storyline-based training aimed at
increasing the knowledge and skills health professionals need to better
interact with Soldiers in a clinic setting. Army Medicine has
implemented systems and procedures our clinicians regularly use to
prevent and detect issues of opioid overuse. These tools include the
ability for our clinicians to review all prescriptions paid for by the
Defense Health Agency (DHA) pharmacy benefit regardless of the point of
service (Military, Home Delivery or Retail Pharmacy). The DHA
Pharmacoeconomic Branch Web site allows clinicians to identify
concerning use of opioids dispensed under the TRICARE Pharmacy Benefit
through the use of prescription screening tools such as the Medication
Analysis and Reporting Tools.
Army Medicine is expanding the role of clinical pharmacists to
address national concerns with polypharmacy and adverse drug events
that lead to hospital admissions. The Army Surgeon General supports
evidence-based enhancements drawing on the expertise and contributions
of pharmacists embedded in Patient-Centered Medical Homes. The addition
of clinical pharmacists to the patient care team translates into
decreased overall costs, fewer adverse drug-related events, reduced
hospital admissions, and improved medication-related patient outcomes
and appropriate adherence to medications. Clinical pharmacists improve
readiness of the force through policy and practice, systematically
identifying Soldiers with polypharmacy risk and communicating these
concerns to health care providers. The Army uses an automated
polypharmacy screening tool to screen all Active Duty Servicemembers
monthly to identify Soldiers prescribed different combinations of high
risk medications. These reports are provided to the medical team for
review and follow-up. Clinical pharmacists embedded in Army medical
homes optimize patient adherence to appropriate drug therapy by
conducting medication reviews, resolving medication problems and
recommending cost effective treatment alternatives.
Current Army initiatives aimed at reducing adverse outcomes and
harm due to prescription drug abuses include informed consent for
polypharmacy, sole provider program, limiting authorized use of
prescriptions to six months following the prescription fill date,
adjusting the panel of drugs in random urine drug testing to include
prescription drugs and polypharmacy education for healthcare providers
and patients.
Healthcare providers must review identified risks and potential
interactions with the Soldier, provide education on detection and
management of interactions, and must document informed consent in the
medical record. Informed consent includes a brief description of
discussed risks and whether or not the indication for which the
medication is being used is a Food and Drug Administration (FDA)
approved indication or the medication is used off-label.
The Army policy instructs healthcare providers to have a low
threshold for referring patients to Behavioral Health resources and the
Sole Prescriber Program. Healthcare providers enroll Soldiers at
increased risk of adverse effects, drug interactions, or inappropriate
medication use in the Sole Prescriber Program to optimize care. Once
enrolled, only a Soldier's designated provider or alternate provider is
authorized to prescribe controlled substances for the Soldier. If
necessary, the Soldier may be restricted to a specific pharmacy or
pharmacies by activating the Prescription Lock-out Program.
In addition to Soldiers who are identified as having intentional or
unintentional risk for medication overdose, healthcare providers will
refer Soldiers who present with polypharmacy-related concerns to a
clinical pharmacist. The pharmacist will identify medication-related
problems, develop a medication action plan, and provide medication
education to the patient. Clinical pharmacists document patient
encounters and consultations for medication therapy management in an
electronic medical record template to improve communication with
providers.
Army policy limits authorized use of prescriptions to six months
following the prescription fill date. In addition, Army medical
providers may prescribe only the minimum quantity of controlled
substances necessary to treat an acute illness or injury, and
quantities of controlled substances used to treat acute conditions are
dispensed as a 30-day supply. Prescribers and pharmacists inform
Soldiers that, per Army policy, controlled substance prescriptions have
an expiration date of six months from the dispensed date, and that a
positive urinalysis test for the drug after six months from dispensing
may result in a ``no legitimate use'' finding.
Polypharmacy education and training is available to healthcare
providers and beneficiaries to improve appropriate prescribing and use
of medications, respectively. Patient-specific training is available to
Warrior Transition Units (WTU) to improve awareness of safe medication
use, proper medication disposal, and promotion for the bi-annual drug
take back events.
Army Medicine has participated in all Drug Enforcement Agency (DEA)
National Prescription Drug Take Back Day events since their inception
in 2010. Thirty-six Army Military Treatment Facilities participated in
the Take Back Day on 25 and 26 October 2013, with over 2,000 patients
participating and 7,491 pounds of unused medications collected. The
Army will continue to participate in bi-annual Take Back events in an
effort to maintain attention on the importance of appropriate disposal
of medications that are no longer needed. Army Medicine provides
support through coordinated public affairs communications and education
directed at medical staff, patients, Families and military leadership,
to include on-site presence at every designated event.
substance abuse programs
The Army continues to synchronize clinical care and processes
provided through the Army Substance Abuse Program and Army Medical
Command's primary care providers, pain specialists, and behavioral
health specialists. The Army uses the DOD's drug testing program to
test not only for illegal drugs, but also for prescribed medications
taken inappropriately (that is without an active prescription).
Identified Soldiers are referred to the Army Substance Abuse Program
where they are assessed and enrolled for treatment. Commanders and
clinicians support this treatment process regardless of the Soldier's
disposition, because we recognize that we have an obligation to ensure
our Soldiers remain effective on active duty or make their transition
from active service with drug use properly managed.
behavioral health program
Army Medicine's Behavioral Health Service Line is an interconnected
group of standardized programs delivering a wide variety of Behavioral
Health services to Soldiers and beneficiaries. For the treatment of
substance abuse disorders, the Army has five Addiction Medicine
Intensive Outpatient Programs. There are currently 187 beds designated
for long-term Substance Use Disorder treatment in the Military Health
System, 22 of which are in the Army. These Military Health System
facilities have consistently had 85% or higher utilization rates for
the past 18 months. Purchased care inpatient substance use disorder
treatment accounts for approximately 70 Soldiers per month. Demand for
network inpatient substance use disorder treatment has decreased
sharply with the implementation of the NDAA 2010, Section 596, but
continues to remain high enough to justify increases in capacity in the
coming years to recapture inpatient substance use disorder care going
to the network.
Army Medical Command conducted an analysis of all health care and
pharmacy records involving Army Active Duty Servicemembers, reflecting
an annual average population of 657,000 Soldiers from 2007 to 2012.
This analysis showed a 65% increase in the number of Soldiers seeking
behavioral health services (151,620 in 2007 to 250,410 in 2012), and a
corresponding 44% increase in the number of Soldiers prescribed any
medication within the broad psychiatric category (101,914 in 2007 to
147,197 in 2012). In other words, there has not been any
disproportionate increase in medication use. There are multiple
safeguards in place to ensure that psychiatric medications, including
antipsychotic medications, are prescribed safely and judiciously
according to accepted clinical practice guidelines and nationally
recognized standards of care.
medical home and warrior transition clinics
Optimizing the use of medications through pharmacist interaction as
part of a Patient Centered Care Team is best exemplified by their work
within the Wounded Warrior Clinics. Of the 22 Warrior Clinics in
support of Army Medicine Warrior Transition Units, 21 Clinics are
currently supported by approximately 25 clinical pharmacists and 5
pharmacy technicians. These Warrior Clinics are consistent with the
Medical Home model, where pharmacists manage complex medication
regimens and mitigate risks for Wounded Warriors.
The Risk Assessment Management within the Warrior Care and
Transition Program enables WTUs to monitor the safety of Soldiers. WTU
Commanders, in coordination with the Soldiers' interdisciplinary team,
conduct risk assessments for every Soldier. The initial risk assessment
occurs within 24 hours of the Soldier's arrival at the WTU, ongoing
assessments are regularly made throughout the Soldier's stay, and
additional assessments occur during key events such as during quarterly
scrimmages as directed by the Soldier's personalized Comprehensive
Training Plan. Risk assessments focus on therapy adherence, behavioral
health history, substance abuse history, and access to care patterns.
The intent is to assess whether Soldiers on these medications need
additional monitoring and assistance with medication management. If a
Soldier is identified as needing additional monitoring and assistance,
the interdisciplinary team determines what risk mitigation strategies
are needed to maintain the Soldier's safety. If needed, the Soldier is
entered into the Army Medical Department's Sole Provider Program.
Soldiers enrolled in the Sole Provider Program may only receive
medications from their assigned provider, and receive no more than a 7-
day supply of narcotics or psychotropic medications. Clinical
Pharmacists also provide oversight as they review the medication
profiles of all Soldiers in a WTU, who are determined to be at high
risk. These reviews occur at least weekly.
Army Medicine has engaged in a comprehensive campaign to address
the pain management needs of Soldiers and their Families. Our strategy
involves developing and implementing solutions with our DOD, VHA, and
Civilian Medicine partners. Thank you again for the opportunity to
testify before the Committee and for your support to our Soldiers and
Veterans.
______
Response to Posthearing Questions Submitted by Hon. Bernard Sanders to
BG Norvell V. Coots, USA, Deputy Commanding General (Support), U.S.
Army Medical Command and Assistant Surgeon General for Force
Projection, Office of the Surgeon General, U.S. Army
complementary and alternative medicine (cam)
Question 1. How can the Army improve access to CAM therapies among
servicemembers? How can it help improve what information is available
to servicemembers and their providers about CAM services?
Response. In Army Medicine, perhaps the single greatest application
of Complementary and Alternative Medicine (CAM) has been seen in pain
management. Initially, Servicemembers were often the ones who
identified integrative medicine treatments to their medical providers
as uniquely effective in restoring and maintaining their health with
minimal side effects. In response to this call to action and as a
result of increasing medical evidence, Army Medicine has deliberately
expanded its experience and utilization with integrative medicine as
part of the Army's Comprehensive Pain Management Program.
The Army Pain Program has been moving toward a more multi-
disciplinary, multi-modal pain management strategy that leverages
selected CAM modalities alongside more conventional pain management
treatments such as medications and interventional procedures such as
injections, nerve blocks, and surgeries. In addition to chiropractic
care, the Army's Interdisciplinary Pain Management Centers are
employing modalities such as acupuncture, massage therapy, movement
therapies to include yoga, and biofeedback. These are all proving to be
effective complements and sometimes alternatives to medications.
Army Medicine will continue to expand the utilization and
collection of evidence regarding the efficacy of integrative medicine
modalities alongside more conventional therapies.
Question 2. What factors currently limit DOD from further
broadening CAM therapies across the Army and other branches?
Response. Of the many treatment strategies addressed in the Army's
Comprehensive Pain Management Campaign Plan, the use of CAM therapies
has been one of the most challenging. As noted in the Army's 2010 Pain
Task Force Report, there are an increasing number of reports in medical
literature regarding the safety and efficacy of these treatment
modalities, and their use is becoming more widespread across medicine.
It is believed that the use of the various CAM modalities can lead to
an improved sense of being, health status or functional outcome through
pain reduction, lower medication usage or increased quality of life.
However, there is still a paucity of evidence-based scientific
literature on the precise role for these modalities in the overall
management of acute and chronic pain.
Per the Code of Federal Regulations, Section 199.4(g)(15), TRICARE
is unable to pay for healthcare in the purchased care sector that has
not been proven to be both safe and effective in the treatment of the
underlying condition. While there have been an increasing number of
articles published on the use of CAM for the treatment of acute and
chronic pain, there have been no evidence-based clinical practice
guidelines published or other evidence based protocols developed that
incorporate the general use of CAM, or specific types of CAM.
However, within the DOD, Military Treatment Facilities (MTFs) are
allowed, under very specific conditions and specifications, to offer
certain types of services that would otherwise not be covered benefits
under TRICARE. That is the case with certain CAM therapies. Under these
circumstances, the MTF Commander is responsible for ensuring that all
existing community standards of care are met, to include any
credentialing requirements of practitioners if they are not otherwise
considered to be TRICARE authorized providers. Army Medicine is working
with the Navy and Air Force to develop credentialing guidelines and
oversight provisions to provide appropriate, standardized credentialing
of practitioners who will employ CAM at our MTFs.
One notable exception can be seen in the military's expanded use of
chiropractic care. Unlike the other CAM modalities, chiropractic care
was originally offered in 1995 as a demonstration program and later
expanded as directed under Section 702 of the National Defense
Authorization Act (NDAA) for Fiscal Year 2001. Three subsequent NDAA's
allowed for expansion of the program, resulting in chiropractic
services now being offered at 62 MTFs but still limited to Active Duty
Servicemembers.
acupuncture training
Question 3. How would the Joint Incentive Fund Project to implement
a standardized acupuncture training and sustainment model across DOD
and VA medical facilities improve acupuncture services the Army
provides servicemembers? When can we expect system-wide implementation
of this joint model?
Response. The variances in acupuncture integration, utilization,
reimbursement, and practice in health systems are not limited to
Federal/military medicine. The absence of universally accepted
protocols, credentialing, and clinical practice guidelines have
inhibited more aggressive implementation across the DOD and VHA health
systems. The $5.4 million, Joint Incentive Fund (JIF) acupuncture
project will develop, pilot, evaluate and implement a uniform tiered
acupuncture education and training program for Military Health System
(MHS) and Veterans Health Administration (VHA) providers in order to
provide initial and expanded access to this modality across MHS and VHA
treatment facilities.
The acupuncture JIF provides a pathway to uniform implementation
and integration of this modality across military and VA healthcare
systems through a proven practical program of training and
certification for providers. It drives adoption and further development
of acupuncture best practices across the MHS and VHA. The two-year
acupuncture JIF project is scheduled to be completed by 2016. In
progress reviews are provided to the Health Executive Council on a
quarterly basis.
Question 4. How many providers trained in acupuncture already
working in the Army? How many of these providers exclusively offer
acupuncture services? On average, how many hours per week do these
offer acupuncture to servicemembers?
Response. U.S. Army Medical Command (MEDCOM) providers, including
physicians, physician assistants, nurse practitioners and dentists who
wish to use acupuncture in their practice are required to document
their acupuncture training and competency in their facility
credentialing file. As of April 2014, 46 MEDCOM providers have added
acupuncture to their credentialing files. None of these providers are
exclusively offering acupuncture services but use acupuncture as a
complementary modality in their practice.
The number of hours per week where acupuncture is offered is not
possible to calculate. However, the Army does capture the number of
acupuncture procedure performance. In FY 2012, over 23,000 acupuncture
procedures were performed in Army medical treatment facilities. The FY
2013 numbers for acupuncture utilization is currently unavailable but
should trend upwards.
The Army pain management program has been working to integrate
licensed acupuncturists in the eight Army interdisciplinary pain
management clinics. These individuals are being hired with a primary
responsibility to provide acupuncture. At this time, the Army Pain
Program, along with the Air Force, Navy, and VHA are working to
standardize coding, treatment protocols, and credentialing for licensed
acupuncturists.
Question 5. Is the current amount of acupuncture offered within the
Army sufficient to meet the demand for this therapy? If not, what
efforts are being made to ensure an adequate number are available to
treat veterans once the joint model is implemented?
Response. The current capacity within the Army direct healthcare
system is insufficient to support the perceived demand for acupuncture.
While the Joint Incentive Fund acupuncture project to field a
standardized basic acupuncture training and sustainment model across
DOD and VHA will greatly improve access to basic acupuncture
techniques, there will likely be a need for additional organized
efforts to increase the enterprise wide training, availability, and
utilization of acupuncture and other complementary integrative
modalities.
dod/va collaboration
Question 6. What benefits has DOD seen from the standardization of
the prescription medication between VA and DOD available to both
servicemembers and veterans? Are servicemembers able to continue their
existing course of treatment as they transition to VA health care?
Response. Ongoing efforts to harmonize formularies are aimed at
improving continuity of care for DOD beneficiaries transitioning to the
VA. The VA has established policy that supports the continuation of DOD
prescribed medications upon transfer whether or not the drug is listed
on the formulary or if its use is consistent with VA prescribing
guidelines. The VA provider is permitted to change previously
prescribed medications to allow consistency with prescribing guidelines
after careful consideration and implementation to prevent avoidable
problems.
Question 7. What other efforts have DOD and VA taken to collaborate
and standardize treatment options available to servicemembers and
veterans for chronic pain?
Response. Phased implementation of the Comprehensive Pain
Management Campaign Plan is ongoing across Army Medicine and Tri-
Service/VA implementation of Task Force recommendations continues as
part of Health Executive Council Pain Management Work Group. In FY
2013, Army, Air Force, Navy, and the VA demonstrated increased interest
and activity in synchronized implementation of Pain Task Force
Recommendations. Uniformed Services and the VA will focus on executing
several joint pain management projects as listed below. These projects
will provide information to Defense Health Agency and Uniformed
Services in order to facilitate re-evaluation and possible revisions of
policies.
a. Pain Management Outcome Tool
b. Tiered Acupuncture Course for Primary Care Providers
c. Development/Implementation of DOD/VHA education curriculum
d. Synchronized DOD/VA transition policies for medications
One specific project that highlights DOD/VA collaboration is the
basic acupuncture training course. Army clinicians are participating
with the Air Force, Navy, and VHA in a $5.4M Joint Incentive Fund
Project to field a standardized basic acupuncture training and
sustainment model across DOD and VHA medical facilities. Training teams
have already started traveling to Army, Navy, Air Force, and VHA
medical facilities to deliver this training. The response from
providers and patients has been overwhelmingly positive.
______
Response to Posthearing Questions Submitted by Hon. Richard Blumenthal
to BG Norvell V. Coots, USA, Deputy Commanding General (Support), U.S.
Army Medical Command and Assistant Surgeon General for Force
Projection, Office of the Surgeon General, U.S. Army
Question 8. Do you have any further breakdown as to the usage for
each of the branches of the Armed Forces?
Response. Yes. Information is available on the usage of opiates for
all branches of the Armed Forces. Question #9 and #10 responses provide
information for Army Servicemembers.
Question 9. How much of the opioid use is for acute conditions and
for chronic conditions?
Response. For acute conditions, the proportion of Active Duty Army
Servicemembers prescribed an opiate medication at least once in a year
for the last 10 years is as follows:
2004--21%
2005--22%
2006--25%
2007--26%
2008--26%
2009--26%
2010--27%
2011--29%
2012--29%
2013--27%
Chronic opioid use is defined as cumulative use of 90 or greater
days of use in a six-month period. Information on chronic use is
provided in the response to question #10.
Question 10. How much opioid use is for >90 days in duration?
Response. Chronic opioid use is defined as cumulative use of 90 or
greater days of use in a six-month period. The proportion of Active
Duty Army Servicemembers with any chronic opiate use in a year is as
follows:
2004--1.27%
2005--1.54%
2006--1.76%
2007--1.96%
2008--1.95%
2009--1.97%
2010--2.09%
2011--2.36%
2012--2.57%
2013--2.34%
______
Response to Posthearing Questions Submitted by Hon. Mark Begich to BG
Norvell V. Coots, USA, Deputy Commanding General (Support), U.S. Army
Medical Command and Assistant Surgeon General for Force Projection,
Office of the Surgeon General, U.S. Army
Question 11. PTSD, depression, TBI, family stress, disability, and
joblessness plague our veterans' community and increase the risk of our
veterans overmedicating to soothe chronic pain. How are you addressing
growing mental health issues in conjunction with pain management? How
does this initiative take into account rural and remote locations that
may not have Behavioral Health professionals or telehealth?
Response. In the past several years, the Army has vastly expanded
and completely overhauled its system of behavioral healthcare and pain
management program to address complex co-morbidities and co-occurring
conditions.. The Army's Behavioral Health Service Line is comprised of
11 interconnected standardized programs that provide consistent and
ready access to behavioral health services covering all behavioral
health conditions across our supported beneficiary population.
The 2010 Army-led Pain Management Task Force was chartered to
develop a strategy that is comprehensive, holistic, multidisciplinary,
and multimodal, utilizing state-of-the-art/science practices in the
field resulting in the Comprehensive Pain Management Campaign Plan.
Army Medicine's pain strategy includes three primary lines of effort:
1) implement a culture of pain awareness, education, and proactive
intervention, 2) provide tools and infrastructure that support and
encourage practice and research advancements in pain management, and 3)
build a full spectrum of best practices for the continuum of acute and
chronic pain, based on a foundation of the best available medical
evidence. This includes incorporating behavioral health care as part of
pain management solutions and ensuring pain management for Soldiers and
pain management training for providers outside of the main area of
care.
Soldiers with complex injuries often require polypharmacy, or the
use of multiple medications, which place them at greater risk for
medication-related adverse events. The Army seeks to reduce risk,
enhance safety and optimize care by including the Soldier, Family
members, healthcare providers, pharmacists and commanders as part of
the healthcare team. Army policies establish procedures to identify
polypharmacy trends that could lead to misuse by Soldiers and Wounded
Warriors.
Army Medicine also uses best practices that are comparable to, or
exceed, civilian programs, such as prescription drug monitoring to
identify polypharmacy cases. Positive interventions include
comprehensive medication reviews, sole provider programs, limiting the
dispensed supply of medication, restricting high-risk patients to the
utilization of one pharmacy, informed consent, use of non-drug
treatment options, clinical pharmacist referrals, and patient and
provider education.
The Army trains its providers on the risks of prescription opioid
overuse and ways to prevent medication misuse. Army Medicine has
implemented systems and procedures our clinicians regularly use to
prevent and detect issues of opioid overuse. These tools include the
ability for our clinicians to review all prescriptions paid for by the
Defense Health Agency (DHA) pharmacy benefit regardless of the point of
service (Military, Home Delivery or Retail Pharmacy).
The Army policy instructs healthcare providers to have a low
threshold for referring patients to Behavioral Health resources and the
Sole Prescriber Program. Healthcare providers enroll Soldiers at
increased risk of adverse effects, drug interactions, or inappropriate
medication use in the Sole Prescriber Program to optimize care. Once
enrolled, only a Soldier's designated provider or alternate provider is
authorized to prescribe controlled substances for the Soldier. If
necessary, the Soldier may be restricted to a specific pharmacy or
pharmacies by activating the Prescription Lock-out Program.
In addition to Soldiers who are identified as having intentional or
unintentional risk for medication overdose, healthcare providers will
refer Soldiers who present with polypharmacy-related concerns to a
clinical pharmacist.
Army Medicine is expanding the role of clinical pharmacists to
address national concerns with polypharmacy and adverse drug events
that lead to hospital admissions. The Army Surgeon General supports
evidence-based enhancements drawing on the expertise and contributions
of pharmacists embedded in Patient-Centered Medical Homes.
Army Medicine has participated in all Drug Enforcement Agency (DEA)
National Prescription Drug Take Back Day events since their inception
in 2010. Thirty-six Army Military Treatment Facilities participated in
the Take Back Day on 25 and 26 October 2013, with over 2,000 patients
participating and 7,491 pounds of unused medications collected. The
Army will continue to participate in bi-annual Take Back events in an
effort to maintain attention on the importance of appropriate disposal
of medications that are no longer needed. Army Medicine provides
support through coordinated public affairs communications and education
directed at medical staff, patients, Families and military leadership,
to include on-site presence at every designated event.
Specific to Telehealth, the Army has developed and vastly expanded
a comprehensive Telehealth system over the past several years that now
enables the Army to cross-level clinical care capacity across the
globe. In fiscal year 2013, Army clinicians offered care across 18 time
zones and in over 30 countries and territories, to include remote
locations where Soldiers serve. In fiscal year 2013, Army clinicians
provided over 34,000 patient encounters and provider-to-provider tele-
consultations in garrison; approximately 85 percent of these encounters
were related to outreach via Tele-Behavioral Health.
The Army's Pain Management Task Force recommended the Army ``Expand
telemedicine capabilities to incorporate pain management initiatives''
(Pain Management Task Force, 2010). The Army Pain Management Extension
for Community Healthcare Outcomes (ECHO) tele-mentoring initiative
leverages the model developed by the University of New Mexico (UNM)
Project ECHO initiative. The Army is completing a two-year
collaboration with UNM to adapt this best practice for use in the
Army's pain program. ECHO's objective is to complement the capacity,
competence and confidence of remote primary care providers. Utilizing
weekly video tele-conferencing to create regional communities of
practice, ECHO links the IPMC specialty teams (i.e. hubs) with their
designated Patient Centered Medical Homes (i.e. spokes). This improves
provider knowledge, increases care coordination, and decreases the need
for continued specialty referrals to the direct and purchased care
systems. Army Pain ECHO will be available to Providers supporting
Community Based Warrior Transition Units (CBWTU). Additionally, the
Army is collaborating with the Air Force, Navy, and Veterans Health
Administration on development and utilization of a common DOD/VHA Pain
ECHO education curriculum.
Chairman Sanders. General Coots, thank you very much.
Dr. Briggs.
STATEMENT OF JOSEPHINE BRIGGS, M.D., DIRECTOR, NATIONAL CENTER
FOR COMPLEMENTARY AND ALTERNATIVE MEDICINE, NATIONAL INSTITUTES
OF HEALTH
Dr. Briggs. Good morning, Chairman Sanders, Ranking Member
Burr, and Members of the Committee. I want to add my well
wishes to Senator Boozman.
Thank you very much for inviting me. I am the Director of
the National Center for Complementary and Alternative Medicine
at the National Institutes of Health. NCCAM is the leading
Federal agency responsible for research on the usefulness and
safety of complementary and integrative health practices.
The most common reason Americans turn to these health
approaches is for treatment of pain. Pain is a major health
problem affecting over 100 million Americans. It is one of the
main drivers of our horrific national epidemic of prescription
drug abuse.
As a physician, I am well aware that drugs, including
opioids, are absolutely essential for the management of pain
but also of their serious side effects including overmedication
dependency and even death.
As a Nation, we need to find the appropriate balance
between the substantial benefits of these medications and the
risks. Deaths from opioids exceed those attributed to cocaine
and heroin combined. Every day over 100 Americans die of drug
overdoses, mostly from prescription painkillers.
Opioids are particularly deadly when combined with Post
Traumatic Stress Disorder; and as this Committee knows well,
pain and PTSD is a common and tough combination faced by many
veterans, also a very common problem in civilian populations.
So, finding better alternatives for pain management is an
absolutely critical national need.
Concern about research on better strategies for pain
management is shared by leadership across the NIH. I serve as
one of the co-directors of the Trans-NIH Pain Consortium and a
member of the Federal Interagency Pain Research Coordinating
Committee. Together with other Federal leaders, we are
partnering to develop a cooperative research strategy to meet
these important needs.
Some of the very active areas of NIH research include the
development of better pain measures including some of the
measures that have been incorporated by the DOD, the PASTOR
PROMIS measures, for example, understanding why acute pain
sometimes turns into chronic pain, and the development of pain
medications with less abuse potential.
NCCAM's particular focus is strengthening non-
pharmacological treatment and self-management of pain. The
evidence that some complementary approaches are of value in
pain management is reflected in evidence-based guidelines from
the American College of Physicians and the American Pain
Society.
Select practices including meditation, acupuncture, spinal
manipulation, massage, and hypnosis are increasingly part of
the kind of integrative care being offered in some of our
health care settings, including hospitals, nursing homes,
hospices, and most notably, health facilities in the Veterans'
Administration and Department of Defense.
Integrative practitioners place particular emphasis on a
patient-centered approach that identifies patient goals and,
when appropriate, minimizes the use of drugs.
Research on the mechanism and efficacy and safety of these
approaches is the highest priority for NCCAM. We hope to learn
how they work, who they help, and how they can be strengthened
to better help people with chronic pain.
As part of this effort, we have established a new
intramural program that will study the biologic underpinnings
of pain using state-of-the-art neuroscience methods to study
the brain.
We are particularly delighted to be embarking on an
important partnership with the DOD and VA to support the value
of these approaches to address the needs of military personnel
and veterans for improvement non-pharmacological management of
pain together with conditions such as PTSD, depression, and
anxiety.
We are funding new studies in partnership with the DOD, VA,
National Institute on Drug Abuse, and the National Institute on
Alcohol Abuse and Alcoholism on these important problems.
We have created a working group of members of NCCAM's
advisory council to advise us on this research agenda. The
working group includes distinguished DOD and VA officials such
as former Army Surgeon General Eric Schoomaker and the VA's Dr.
Tracy Gaudet. It is chaired by Dr. Lloyd Michener, Director of
Family Medicine at Duke University.
In summary, Mr. Chairman, NIH and NCCAM are committed to
partnerships with the VA and the DOD to strengthen research to
understand pain, to improve pain management, and reduce
overmedication and opioid dependency.
Thank you. I am very happy to be here and happy to answer
any questions.
[The prepared statement of Dr. Briggs follows:]
Prepared Statement of Josephine Briggs, M.D., Director, National Center
for Complementary and Alternative Medicine, National Institutes of
Health, U.S. Department of Health and Human Services
Chairman Sanders, Ranking Member Burr, and Members of the
Committee, thank you for inviting me to be here today to discuss the
need to improve pain management strategies to reduce overmedication and
opioid dependency. My name is Josephine Briggs, M.D., and I am the
Director of the National Center for Complementary and Alternative
Medicine (NCCAM) at the National Institutes of Health (NIH), the
Federal Government's lead agency for supporting scientific research on
complementary practices and integrative health interventions. Our
mission at NCCAM is to define the usefulness and safety of
complementary and integrative health practices and their role in
improving health through rigorous scientific investigation. Our
research priorities are driven by scientific promise and public health
need. We support the study of complementary interventions, approaches,
and disciplines across the continuum of basic, translational, efficacy,
and effectiveness research.
Complementary, alternative, and integrative health practices are
defined as having origins outside of mainstream conventional medicine.
They include both self-care practices like meditation, yoga, and
dietary supplements, and health care provider administered care such as
acupuncture, and chiropractic, osteopathic, and naturopathic medicine.
As these modalities are increasingly integrated into mainstream health
care, NCCAM is committed to developing the evidence needed by the
public, health care professionals, and policymakers to make informed
decisions about their use and integration into medical practice. In
addition to supporting the research, we disseminate the latest
evidence-based information on these approaches to scientists, health
care providers, and the general public through an information-rich Web
site (www.nccam.nih.gov) and other media.
According to the Centers for Disease Control and Prevention,
approximately 30 percent to 40 percent of Americans use complementary
and integrative health practices, spending some $34 billion in 2007.\1\
This represents 1.5 percent of total health expenditures and 11 percent
of out-of-pocket costs. These practices are increasingly being offered
in hospitals and hospice settings. The most common reason cited for use
of complementary and integrative health practices is for the
alleviation of pain.
---------------------------------------------------------------------------
\1\ Nahin RL, Barnes PM, Stussman BA, et al. Costs of complementary
and alternative medicine (CAM) and frequency of visits to CAM
practitioners: United States, 2007. CDC National Health Statistics
Report #18. 2009.
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Pain is a public health problem of substantial impact. It affects
more than 100 million Americans each year--more than the total affected
by heart disease, cancer, and diabetes combined--and is estimated to
cost the Nation $560-$635 billion each year in medical costs and lost
productivity.\2\ While an important part of pain management,
pharmaceutical approaches may provide incomplete relief and can carry
serious side effects, including overmedication and opioid dependency
and, in some cases, addiction. Commonly prescribed opioid pain
relievers can be dangerous as even a single large dose can cause severe
respiratory depression and death. Deaths from opioid pain relievers
exceed those attributed to cocaine and heroin combined. Finding
alternatives for pain management is needed.\3\
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\2\ IOM (Institute of Medicine). 2011. Relieving Pain in America: A
Blueprint for Transforming Prevention, Care, Education, and Research.
Washington, DC: The National Academies Press.
\3\ Drug Facts: Prescription and Over-the-Counter Medications,
National Institute on Drug Abuse, National Institutes of Health,
May 2013. http://www.drugabuse.gov/publications/drugfacts/prescription-
over-counter-medications, accessed April 28, 2014.
---------------------------------------------------------------------------
In 2011, after examining pain as a national public health problem,
the Institute of Medicine (IOM) released a Consensus Report in 2011,
entitled ``Relieving Pain in America: A Blueprint for Transforming
Prevention, Care, Education, and Research.'' The IOM report encourages
Federal and state agencies and private organizations to accelerate the
collection of data on pain incidence, prevalence, and treatments, and
to take steps to develop integrative pain management strategies. The
report notes that ideally, most patients with severe persistent pain
would obtain care from an interdisciplinary team using an integrated
approach that would target multiple dimensions of chronic pain--
including disease management, reduction in pain severity, improved
functioning, and emotional well-being and health-related quality of
life.
In addition, the Federal Government created an Interagency Pain
Research Coordinating Committee (IPRCC) to enhance pain research
efforts and promote collaboration across the government, to advance our
fundamental understanding of pain, and to improve pain-related
treatment strategies. Members include representatives of the
Departments of Health and Human Services, Veterans Affairs (VA), and
Defense (DOD), the scientific and medical communities, the public, and
stakeholder groups. I serve as one of the NIH representatives. The
IPRCC is developing a comprehensive population health level strategy
for pain prevention, treatment, management, and research. One of the
first efforts of the IPRCC was a thorough analysis of pain research
across Federal agencies, resulting in the recently released ``2011
IPRCC Federal Pain Research Portfolio Analysis Report'' \4\ which
revealed many areas of shared research interests between and across
Federal entities, but no notable redundancies.
---------------------------------------------------------------------------
\4\ National Institutes of Health, National Institute of
Neurological Disorders and Stroke, Office of Pain Policy. 2011 IPRCC
Federal Pain Research Portfolio. Analysis Report. Available at
iprcc.nih.gov/news/CC_Pain_Portfolio_Analysis_Report.pdf. Accessed
April 28, 2014.
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NCCAM participates in the NIH Pain Consortium to enhance and
increase the coordination of pain research across NIH. The Consortium's
efforts include targeted initiatives such as the development of the
first clinically-based data registry to help identify pain management
interventions that are most effective for specific patient-types with
chronic pain, led by the National Institute on Drug Abuse (NIDA), and
the creation of standard research measures to assess chronic low back
pain, which was spearheaded by NCCAM.
To improve pain education in health professional schools, the Pain
Consortium established 12 Centers of Excellence in Pain Education to
advance teaching and provide comprehensive curricula about the
pathophysiology of pain, its assessment, diagnosis, management, and
treatment. The curricula include the latest research results in
complementary and integrative pain management, factors that contribute
to both under- and over-prescribing of pain medications, and how pain
manifests itself differently by gender, by age, and in diverse
populations. In addition, NIDA, Medscape Education, and the White House
Office of National Drug Control Policy developed two continuing medical
education courses on practical guidance for physicians and other
clinicians in screening pain patients for substance use disorder risk
factors before prescribing, and in identifying when patients are
abusing their medications. The courses use videos that model effective
communication about sensitive issues, without losing sight of
addressing the pain. To date, more than 80,000 health care
professionals have completed these courses.
At NCCAM, an increasing proportion of our research budget is
dedicated to studies examining promising non-pharmacological approaches
for pain management, including mindfulness meditation, spinal
manipulation, massage, acupuncture, and exercise forms, such as yoga
and Tai chi. Some of these approaches are already being recommended by
the American College of Physicians and the American Pain Society in
their guidelines for the diagnosis and treatment of low back pain.
NCCAM is interested in better understanding how these interventions
work, for what type of pain conditions, and the optimal methods of
practice and delivery. We also support Centers of Excellence for
Research on Complementary and Alternative Medicine that bring a
multifaceted interdisciplinary approach to research on pain. In
addition, NCCAM recently established a new intramural research program
that focuses entirely on pain using state-of-the-art neuroimaging and
other advanced technologies to study the mechanisms of pain including
the role of emotions and attention on the modulation of pain.
Last year, NCCAM joined NIDA, the National Institute on Alcohol
Abuse and Alcoholism, and DOD in a joint initiative to conduct research
on prevention and health promotion interventions to prevent alcohol and
other drug abuse and associated physical and psychological health
problems in Veterans and military personnel. NCCAM also issued a
solicitation, along with NIDA and the VA, specifically focused on
complementary and integrative approaches to managing pain and other
symptoms such as posttraumatic stress, Traumatic Brain Injury,
substance use disorders, anxiety, and sleep disturbances often
experienced by Veterans and military personnel. The initiative
requested research approaches to study (a) mind-body interventions such
as mindfulness- or meditation-based stress reduction approaches, (b)
yoga, (c) acupuncture, (d) art therapy, (e) massage, and (f) cognitive-
behavioral interventions. Grant applications are currently under
review, and we look forward to funding multiple studies later this
year. Research findings from these initiatives are expected to lead to
enhanced patient care and improved pain and symptom management through
better integration of evidence-based complementary approaches.
At my direction, a special Working Group of the National Advisory
Council on Complementary and Alternative Medicine was recently formed
to explore ways to foster rigorous research that will inform the use
and incorporation of complementary approaches in military and veteran
populations and promote collaboration among the VA, DOD, and NCCAM. The
Working Group, chaired by Lloyd Michener, M.D., of Duke University,
includes current and former VA and DOD officials. The group is charged
with defining a research agenda for mind/body interventions for pain
and symptom management, including identifying the most promising
therapies and the next steps for development of large clinical trials.
Experts will present perspectives of patients, Veterans, military
personnel, and clinicians to help shape the Working Group's
recommendations.
In summary, NIH and NCCAM are committed to improving understanding
and treatment of pain and related conditions for all Americans
including military personnel and Veterans. We expect research results
to provide information to the public and health care providers and
policymakers. I appreciate the opportunity to appear before this
Committee, and I look forward to answering any questions. Thank you.
______
Response to Posthearing Questions Submitted by Hon. Bernard Sanders to
Josephine Briggs, M.D., Director, National Center for Complementary and
Alternative Medicine, National Institutes of Health
complementary and alternative medicine (cam)
Question 1. What can be done to increase long-term programmatic
research to help better understand CAM therapies and their impact on
servicemembers and veterans?
Response. As the Federal Government's lead agency for scientific
research on complementary practices and integrative health
interventions, the National Center for Complementary and Alternative
Medicine (NCCAM) is committed to greater understanding of the
usefulness and safety of complementary and integrative health practices
and their role in improving health and health care. Since 2010, NCCAM
has been working with the Departments of Defense (DOD) and Veterans
Affairs (VA) to explore opportunities for partnerships and
collaborations.
After participating in workshops on complementary interventions for
pain management with DOD and Post Traumatic Stress Disorder with VA,
NCCAM issued a Funding Opportunity Announcement (FOA) in 2012, to
encourage collaborations with DOD and VA researchers and clinicians to
study integrative approaches to pain and symptom management in military
and Veteran populations. Under this initiative, seven collaborations
were funded to study modalities such as massage, acupuncture and
chiropractic for musculoskeletal pain and post-traumatic headache, as
well as Tai Chi and mindfulness for treating stress disorders, anxiety,
and depression. In 2013, NCCAM participated in a FOA with the National
Institute on Drug Abuse (NIDA) and DOD, to promote research on
interventions to prevent alcohol and other drug abuse and associated
physical and psychological health problems in military personnel and
Veterans. NCCAM funded two research projects under this FOA, both
involving the study of innovative interventions for pain management and
to reduce substance abuse.
Last year, NCCAM issued three FOAs, along with NIDA and VA, to
encourage research on the non-pharmacological management of pain and
co-morbid conditions in military personnel and Veterans. NCCAM has
committed two million dollars in Fiscal Year 2014, and hopes to fund
studies exploring a variety of complementary interventions for pain
management, including combined interventions for treating pain and
substance abuse, bright light treatment, mindfulness training, and the
use of mobile neurofeedback applications for pain management.
To guide future collaborative efforts with DOD and VA, NCCAM
recently established a special Working Group of the National Advisory
Council on Complementary and Alternative Medicine. The Working Group is
charged with advising NCCAM on potential collaborations, opportunities
and strategies for integrative health research within DOD and VA health
care settings. Invited experts will present perspectives of patients,
military personnel and Veterans, clinicians, researchers, and
policymakers to inform the Working Group in shaping its final
recommendations. The Working Group is expected to submit a report to
the National Advisory Council for Complementary and Alternative
Medicine in early 2015.
NCCAM looks forward to building on current collaborations and
continuing to partner with other NIH Institutes and Centers, DOD, and
VA to further investigate the usefulness and safety of complementary
and integrative health interventions for servicemembers and Veterans.
Question 2. A challenge of medical research is the length of time
it takes for research to move from bench to bedside. What is the
National Center for Complementary and Alternative Medicine doing
specifically--and NIH more generally--to expedite this process?
Response. NCCAM is committed to improving the translation of
research findings into improved public health. At NCCAM's core is a
vision in which rigorous scientific evidence about complementary health
practices informs both the decisions Americans make regarding the use
of these health practices and their potential integration into health
care. As such, NCCAM funds research across the continuum of basic,
translational, efficacy, and effectiveness research. As part of our
translational portfolio, NCCAM supports research required to design and
implement definitive clinical research and ``real-world'' outcomes and
effectiveness research that capitalizes on the reality that many
complementary health interventions are in widespread public use. This
research includes identifying and validating biomarkers or other
signatures of biological effect; developing and validating measures of
outcome; validating treatment algorithms and measures of quality
control; and developing preliminary clinical evidence.
Additionally, NCCAM is leading the Health Care Systems Research
Collaboratory, an NIH Common Fund initiative. This program is engaging
health care delivery organizations as research partners, with the goal
of strengthening the national capacity to conduct rigorous large-scale
clinical trials in ``real-world'' settings. Through the Collaboratory,
NIH is pioneering the development of approaches to conduct large-scale,
cost-effective clinical research studies in the setting where patients
already receive their care. Ultimately, this program could help
increase the number and types of health care systems engaged in
clinical research and enhance the relevance of research results to
health care practice.
At the bedside-end of the continuum, NCCAM ensures that research
results are widely disseminated to help the public make informed
decisions about the use of complementary health practices and to enable
health care providers to better manage patient care. NCCAM provides
reliable, objective, and evidence-based information through a variety
of approaches including emerging technology and platforms (i.e., video,
social media, and mobile applications). Specifically for health care
professionals, NCCAM's web site features a portal with links to
scientific literature on complementary health practices, including
reviews from the Cochrane Collaboration; clinical practice guidelines
issued by third-party organizations; and online continuing education
modules. In addition, NCCAM's monthly e-newsletter, NCCAM Clinical
Digest, summarizes the state of the science on complementary health
practices for specific health topics.
Across the NIH, many NIH Institutes and Centers and trans-NIH
initiatives are also focused on expediting the process of turning
observations in the laboratory and clinic into effective interventions
that improve the health of the individual and the public--from
diagnostics and therapeutics to medical procedures and behavioral
changes. For example, the newest Center at NIH, the National Center for
Advancing Translational Sciences (NCATS) was established to transform
this process by catalyzing the generation of innovative methods and
technologies that will enhance the development, testing, and
implementation of diagnostics and therapeutics across a wide range of
human diseases and conditions. Advances from NCATS are aimed at
enabling researchers throughout the public and private sectors to more
efficiently develop treatments for diseases, demonstrate effectiveness
in improving health, and accelerate the pace at which new treatments
are delivered to patients.
opioid usage
Question 3. How can collaborative efforts, such as the Interagency
Pain Research Coordinating Committee, be leveraged to reduce the
American health care system's dependency on high-dose medications to
reduce chronic pain and mental health conditions?
Response. Collaborative efforts across the National Institutes of
Health (NIH) and the Federal Government to increase the understanding
of pain are helping to enable the development of novel therapies,
including non-pharmacological approaches to treat those who suffer from
pain conditions. Better strategies for the management of chronic pain
may also reduce symptoms associated with some mental health conditions,
such as depression and anxiety that are often comorbid with pain.
The Interagency Pain Research Coordinating Committee (IPRCC) was
created to enhance pain research efforts and promote collaboration
across the Federal Government, with the ultimate goal of advancing
fundamental understanding of pain and improving pain-related treatment
strategies.\1\ The Committee comprises seven Federal members and 12
non-Federal members, six drawn from the scientific and medical
communities and six from public and stakeholder groups. Six Federal
Agencies are involved in this effort.\2\ NCCAM is one of the NIH
representatives.
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\1\ http://www.iprcc.nih.gov
\2\ DOD, VA, and within HHS, NIH, the Agency for Healthcare
Research and Quality, the Centers for Disease Control and Prevention,
and the Food and Drug Administration.
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The IPRCC conducted a thorough analysis of the Fiscal Year 2011
Federal pain research portfolio and released a report that identified
areas for potential collaboration among the IPRCC- represented
agencies. The analysis and accompanying report provide important tools
to assist in sharing resources across the pain research community and
for enhancing pain research efforts. For example, the Office of Pain
Policy at NIH's National Institute on Neurological Disorders and
Stroke, under the auspices of the IPRCC, launched the Federal
Government's pain research database on May 27, 2014. This resource
provides the public and the research community with an important tool
to learn more about the breadth and details of pain research supported
across the Federal Government.
The IPRCC is also charged with developing the National Pain
Strategy, a comprehensive population health level strategy for pain
prevention, treatment, management, and research. One objective of the
strategy is to describe how efforts across Government agencies,
including public-private partnerships, can be established, coordinated,
and integrated to encourage population-focused research, education,
communication, and community-wide approaches that can help reduce pain
and its consequences. The development of the National Pain Strategy
will involve coordination between the IPRCC and the NIH's Pain
Consortium, as well as private-sector participants.
Within the NIH, the NIH Pain Consortium helps coordinate and
support a number of pain research initiatives and activities across the
NIH. Importantly, the Pain Consortium is cosponsoring a workshop with
the NIH Office of Disease Prevention to address several issues related
to pain management, including the long-term effectiveness of opioids
for treating chronic pain and the use and effectiveness of opioid
management strategies in minimizing opioid addiction, abuse, and
misuse, maximizing pain relief, and improving patients' quality of
life. Based on the evidence presented, an independent panel of experts
will release a comprehensive report in early 2015 on the state of the
evidence, identifying research gaps and proposing research priorities.
The efforts of the Pain Consortium have already made an impact. On
May 21, 2014, NIH announced that the NIH Pain Consortium's first pain
care curriculum--part of the 12 ``Centers of Excellence in Pain
Education''--showed significant improvements in medical student
clinical skills.\3\ The educational materials are designed to advance
the assessment, diagnosis, and safe treatment of pain, while minimizing
risks of abuse and addiction. The curricula include the latest research
results in complementary and integrative pain management, factors that
contribute to both under- and over-prescribing of pain medications, and
how pain manifests itself differently by gender, by age, and in diverse
populations. In addition, NIDA, Medscape Education, and the White House
Office of National Drug Control Policy developed two continuing medical
education courses on practical guidance for physicians and other
clinicians in screening pain patients for substance use disorder risk
factors before prescribing, and in identifying when patients are
abusing their medications. The courses use videos that model effective
communication about sensitive issues, without losing sight of
addressing the pain. To date, more than 80,000 health care
professionals have completed these courses. These efforts will help
current and future health care professionals build clinical skills to
better support, manage and treat patients with pain.
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\3\ http://www.nih.gov/news/health/may2014/nida-21.htm
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______
Response to Posthearing Questions Submitted by Hon. Mark Begich to
Josephine Briggs, M.D., Director, National Center for Complementary and
Alternative Medicine, National Institutes of Health
Question 4. I know I hear from Veteran's in my state that ask for
more alternative methods for pain, PTSD and with our large native
population, many native veterans rely on native healers, in the Native
Health Care system, they are called doctors. Have you researched the
use of Native healing and if not will you be looking at this effective
method of healing?
Response. NCCAM is committed to studying the usefulness, safety and
efficacy of complementary and integrative health approaches, many of
which have origins in traditional healing practices. Although a wide
variety of these practices are used by the American public, better
information is needed on how or whether they work.
According to the Centers for Disease Control and Prevention, over
50 percent of American Indian/Alaska Native (AI/AN) adults use
complementary therapies--greater than any other ethnic group.\4\ Given
the prevalence of complementary therapies among this population,
research on native healing practices is important, and NCCAM takes a
number of approaches to encourage such research. For example, NCCAM is
interested in research projects utilizing systems of healing and health
practices outside the conventional medical care and those studying the
extent and use of self-care and integrative health practices,
conventional medical care, or a combination of the two. Examples of
NCCAM funded research projects include:
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\4\ Barnes PM, Bloom B, Nahin R. CDC National Health Statistics
Report #12. Complementary and Alternative Medicine Use Among Adults and
Children: United States, 2007. December 2008.
``Drum-Assisted Recovery Therapy for Native Americans,''
Daniel Lee Dickerson, D.O., MPH, University of California, Los Angeles.
Dr. Dickerson' grant focused on developing and pilot testing a
treatment approach that included Drum Circles and the 12-steps of
Alcoholics Anonymous within the conceptual framework of the Native
American Medicine Wheel.
``Chemopreventative Properties of Medicinal and Food
Plants of the Lumbee Tribe,'' Tracie Locklear, Ph.D., University of
Illinois, Chicago. Dr. Locklear's grant supported her research on the
development and testing of natural agents isolated from medicinal and
food plants of the Lumbee Tribe. The long term goal of the project was
to develop new and novel natural agents for the chemoprevention of
breast cancer.
In addition, NCCAM participates in the Native American Research
Centers for Health (NARCH),\5\ which is a partnership between the
Indian Health Service and NIH. The goal of the NARCH program is to
provide opportunities for tribes and tribal organizations to conduct
research, research training, and faculty development that meet the
needs of AI/AN communities.
---------------------------------------------------------------------------
\5\ http://www.nigms.nih.gov/Training/NARCH/Pages/default.aspx
---------------------------------------------------------------------------
______
Additional Information from Josephine P. Briggs, M.D., Director,
National Center for Complementary and Alternative Medicine, Public
Health Service, National Institutes of Health
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Chairman Sanders. Dr. Briggs, thank you very much.
Let me begin with Dr. Petzel. Dr. Briggs, I think
appropriately, talked about this issue as an epidemic. We have
a horrific problem in Vermont but I think it is shared in
States throughout this country. People overdosing, getting
addicted, turning to crime, self-destruction. It is an awful
issue.
As we know, as bad as this problem is for the civilian
population, it is likely even worse among our military and
veteran population, largely because of the nature of the
injuries and conditions they experience.
Dr. Petzel, first, how serious is the problem you are
addressing and second--Dr. Gaudet and maybe Dr. Marshall might
want to join in--tell me the role that you think complementary
and alternative medicine can play in addressing those problems.
Dr. Petzel. Thank you, Mr. Chairman.
First of all, in terms of the magnitude of the problem,
several have mentioned it. We estimate that 50 percent of
veterans that are coming to us seeking care have some sort of
pain. Much of it is musculoskeletal, back injuries, et cetera,
associated with the work that a soldier, sailor, airman, and
Marine may be doing.
We are prescribing opioids for somewhere around 650,000
veterans at the present time which is a large number of people,
and we recognize the fact that this is an issue that has to be
addressed very directly.
I would like to just take a minute before I turn to the
other panel members to describe the opioid safety program that
we are involved in to try and get a grip on and reduce the use
of opiates which, by the way, has reduced the number of
patients receiving opioids in the last 18 months by 50,000.
Still, there are a lot of people getting it but----
Chairman Sanders. So, 50,000 fewer veterans are now
receiving opioids?
Dr. Petzel. That is correct.
The five things that are the central part of the pain
management program are: one, every medical center has to have a
pain management clinic; two, every medical center has a pain
consultation service. VA requires the use of integrative CAM
approaches.
The details of this--we require the use of the step care
model which was developed in the VA and I think has been
adopted by the Department of Defense now which begins with, in
the primary care clinic, self-management and management in
primary care of pain. If needed, it moves to the secondary pain
clinic; and then finally, there are tertiary pain services
available.
The centerpiece of this, though, is the opioid dashboard,
monthly report to the facilities, to the providers in the
facility, and to the pain management point of contact about
people that are prescribing outside of the standard and
patients that are taking medication outside of the standard.
That is followed by education and discussion and
consultation with the providers to bring their use of opioids
into the standard.
Chairman Sanders. OK. If I can interrupt you, we will take
a little bit more time for everybody, because we only have four
of us here. But I wonder--if it is OK with you, Dr. Petzel, I
wanted to shift over to Dr. Gaudet and Dr. Marshall.
What are you doing with complementary and alternative
medicine and is it, in fact, working?
Dr. Gaudet. Thank you, Chairman Sanders.
I think you are aware that the vision for health care, as
Ranking Member Burr referenced, is personalized proactive
patient-driven; central to that are strategies that are
inclusive of complementary approaches that empower the veteran
to take into their own hands whether they have pain issues. Of
course, this expands far beyond pain to the many, many
conditions facing veterans and the public, complex conditions
where a simple fix does not exist.
So, I think that these areas, particularly pain, are
phenomenal places where the VA is committed to bringing more
holistic approaches to veterans. The veterans are finding them
very empowering, very much an asset to the complement of what
they can do to address their issues of pain as well as other
issues. Yes sir.
Chairman Sanders. In English.
Dr. Gaudet. Yes, sorry.
Chairman Sanders. What are you offering the patient? So,
somebody walks in. They have chronic pain. They are concerned
about overmedication. You are concerned. What therapies are you
offering and are they, in fact, working?
These are fairly radical ideas in a certain sense, yes? Or
not?
Dr. Gaudet. I do not know how radical they are, but I think
that the therapies that are most promising and most often
utilized right now in the VA are very parallel to the DOD and
the public.
So, they tend to be mind-body approaches such as
meditation, acupuncture, movement therapies such as, yoga, tai
chi, spinal manipulation. These are the general approaches that
seem to have the greatest promise--relatively noninvasive and
at low risk.
Chairman Sanders. Now, I have been impressed. I have been
to VA facilities all over the country and I have been to a
couple of DOD facilities and I am amazed. You know, 20 or 30
years ago I think it is fair to say that if we were talking
about this list of therapies, people would have thought there
were a few folks in California or certain other places
utilizing them, not the U.S. Department of Defense or VA.
So, in terms of treatments like acupuncture, are they
working? What can you tell us about your success rates? Does it
work?
Dr. Gaudet. I think the most evidence actually exists for
acupuncture as it relates to pain. Our research office of
evidence-based synthesis just finished a comprehensive look at
all the evidence related to acupuncture. It is a very useful
document because it basically says where is there evidence for
the use of acupuncture, do we know, and is it of benefit or do
we know it is not of benefit or there is a category where we
just do not know yet, we do not have research.
The areas where there is the best and strongest evidence
for acupuncture are pain, chronic pain, headaches, and
migraines. So, it is a rational place to start.
Chairman Sanders. All right. Dr. Marshall, if I walk into
your beautiful facility in Minneapolis, and I was just there a
few days ago, and I am in pain, what are my options other than
drugs?
Dr. Marshall. Mr. Chairman, thank you for that question.
I would say at Minneapolis we view pain management as a
full-spectrum opportunity to engage with a patient and move
them toward a healthier and more functional life.
So, we have deployed various complementary and alternative
modalities at different levels of our facility. For instance,
nurses, we trained 900 nurses in January of this year; a 4-hour
training in complementary and alternative medicine with
integrative nursing.
Modalities that we trained specifically to those nurses
included acupuncture, relaxation breathing, meditation, and
essential oils or aroma therapy.
Chairman Sanders. When you tell your patients these
therapies are available, do they say, hey, I would like to try
that? What do they say?
Dr. Marshall. There is a lot of variability. Some patients,
you know, express a strong desire for opioid pain medications.
Many patients, though, are very open once they learn that these
alternatives are a standard part of our medical treatment
armamentarium at Minneapolis VA. I think many patients are
gravitating toward these kind of services.
Chairman Sanders. Can you tell us some success stories? Are
there people who have lived with pain, who were heavily
medicated but because of complementary and alternative medicine
have been able to get rid of medication? Dr. Marshall, do you
have stories?
Dr. Marshall. Yes, I would like to talk briefly about a
program that we have just started. This is part of the VA's
efforts to have Council for Accreditation of Rehabilitation
Facilities, CARF, pain rehab center at each VISN. So, we
started one in January of this year.
We recruited the Director of the Mayo Clinic Pain Rehab
Program who is now leading our efforts. So that program which
is just starting at Minneapolis VA had seven veterans, four of
them were on opioids, three of them were tapered off, and one
was tapered down.
And a cornerstone of that program is a 3-week intensive
residential program and a cornerstone of that program is
activating patients' innate healing abilities through use of
primarily complementary and alternative modalities, including
cognitive behavioral therapy, meditation, relaxation breathing,
tai chi, yoga, and other active forms.
Chairman Sanders. So, you have some specific indications
that these therapies are working?
Dr. Marshall. Yes.
Chairman Sanders. OK. I have exceeded my time.
Senator Burr.
Senator Burr. Thank you, Mr. Chairman.
Dr. Petzel, just one follow-up to this hope that we get a
pathway on Phoenix to some facts. When we had one death at the
Columbia VA medical center that was related to delays, when the
medical center and the VISN leadership became aware of that
problem there were four outside reviews, specifically the task
force, the Office of Medical Inspector, and the IG.
Are you confident that we have the sufficient focus on
Phoenix for this Committee and for the VA to understand what,
if anything, went wrong?
Dr. Petzel. Senator, I am. I think that the IG's presence,
the inspector general, with their independent look, and they
have a huge collection of manpower that they are focusing.
Senator Burr. What would trigger so many components for
Columbia on one death versus just the IG on this?
Dr. Petzel. I really cannot answer that. I do not know. We
sent our team in. I think the IG actually went in twice. I
really cannot speak specifically to what they did. But I am
confident that the IG has the resources and has them present in
Phoenix to get to the bottom of what has occurred there.
Senator Burr. OK. Dr. Gaudet, let me ask you. Is it easier
to write a prescription or to try a CAM approach?
Dr. Gaudet. It is easier to write a prescription.
Senator Burr. Yes. Can you envision, any of you from the
VA, that it would be appropriate to prescribe an opiate to
somebody who, in their medical records, has an opiate
addiction?
Dr. Gaudet. I am probably not the best person to answer
that, not being a pain doctor.
Senator Burr. Dr. Marshall?
Dr. Marshall. I think the indications would be extremely
rare. It would be very unusual to do that, but it might be done
in certain situations, especially situations around acute pain
from trauma after an operation.
Senator Burr. So, for a veteran with an opiate addiction
being treated by VA and sent home for the weekend with 19
prescriptions, including 12 tablets of oxycodone, and 3 hours
later he dies of a drug overdose; that would be an unusual
circumstance?
Dr. Marshall. I would concur with your previous statement
that one death too many. It should not happen.
Senator Burr. Dr. Petzel, VA issued a pain management
directive in 2009 and in a House Veterans' Affairs Committee
hearing last fall on the issue, Dr. Jesse said that all VISNs
and VA facilities have implemented a pain management directive.
Yet data obtained by the Center for Investigative Reporting
shows, ``VA doctors are prescribing more opiates than ever and
the data suggests adoption of the directive varies widely.''
This is not the only time we have heard problems about
regulations and programs being executed inconsistently across
the VA. What oversight does the VA central office perform to
make sure that the new programs and directives issued are
implemented as intended?
Dr. Petzel. Thank you, Senator Burr.
One, the opioids safety initiative is intended to
standardize the way we approach. Two, we have demonstrated that
opioid prescribing in the VA has actually decreased, as I
mentioned earlier, by 50,000 in the last approximately 18
months; and we expect to see that plummet. Number 3----
Senator Burr. We put this management plan into effect in
2009 and we had an upward spike. You will agree to that?
Dr. Petzel. Yes.
If I could digress for a minute. In this country in
general, not just the VA, there was 10-15 years ago a feeling
that pain was not being adequately managed, and an effort was
made to educate doctors about using opioids and other things to
adequately manage pain, and I think in this country there was
an overreaction to that phenomenon. And that is part of why we
are involved in this effort to try and get a grip on opioid
prescribing and to aggressively pursue other approaches to
managing pain. While I was not here at the time, my suspicion
is that that was part of what was going on within the VA.
Senator Burr. Well, I think Dr. Gaudet reinforced, I think,
our belief, and I think it is the fact that it is easier to
write a prescription than it is to go through a CAM process;
and I think Dr. Briggs would probably agree with me.
There are some medical conditions that we probably will not
be able to use an alternative for. The pain is real. It is
consistent. It can only be addressed with some type of opiate
medication or alternative to an opiate. For those people, they
usually fall into a category of a specific illness that they
have. Certainly, we do have some servicemembers that fall into
that category.
Here is my concern, Dr. Petzel, and my question is this,
when people do not follow the guidelines set by VA--be it a
doctor, nurse, whoever--what tools do you have to hold them
accountable?
I mean, we have seen difficulty with sterilization of
medical devices. You and I have seen where insulin injection
pens--multi-use injection pens--that we have now made a
determination that we are not going to use them at the VA
anymore because we----
Dr. Petzel. No, they are not used in-patient. They are
very, very deeply used as outpatients. They are great.
Senator Burr. Why do we not use them in-patient?
Dr. Petzel. Because of the possibility that there might be
confusion, as we talked about.
Senator Burr. Because we cannot with certainty believe that
it is being executed by those guidelines, which means you
cannot stick a different person with the same pen.
So, if something that simple is tough to do, what gives us
confidence that we can carry out a pain management directive
successfully or any other directive within the health care
system?
Dr. Petzel. Senator Burr, I would point out that the opioid
dashboard is our tool for monitoring the prescriber's use of
opioids. And the first step when somebody is not using these
appropriately is to educate them about the way that it ought to
be done properly.
So, do we have the tools to correct behavior that we think
needs to be modified? Absolutely yes.
Senator Burr. OK, Mr. Chairman. Thank you.
Chairman Sanders. Thank you.
Senator Begich.
STATEMENT OF HON. MARK BEGICH,
U.S. SENATOR FROM ALASKA
Senator Begich. Mr. Chairman, thank you very much. I know
earlier you talked about the issue in Arizona so I just want to
know that--assuming that as soon as the IG report comes, and I
know, Mr. Chairman, you noted that we will have some sort of
process here. Obviously, we will look forward to that.
The question that I am going to be very interested in, and
it can be answered now or later, and that is the issue of the
information that the Arizona VA was sending to the national,
whatever the information was on appointment status; in other
words, how long it took people to come through their
appointments--that information. Was that correct or were there
issues with it. That is going to be my question.
There are a lot of details of deaths and so forth. What I
want to know is did the information that came from the VA in
Arizona to the national--who keeps track of successes at the
different VAs and the amount of backlog and appointment
scheduling--on those metrics, will that report or other reports
confirm accuracy in the delivery of that information. That is
going to be my fundamental question.
Dr. Petzel. Senator Begich, as I mentioned earlier, we had
a team down there looking in a preliminary fashion at the
circumstances in Phoenix, and to date we have not found that
there is any discrepancy between the information that we were
aware of and were getting and the information as it actually
existed in Phoenix.
We have found no evidence for a secret list and we have not
found any evidence to-date that anybody died while sitting on
the waiting list.
Senator Begich. Understood. And the IG is looking at all
those questions I am assuming?
Dr. Petzel. Yes, they are; as near as I know, yes.
Senator Begich. OK. And I apologize. I know this part was
answered. What is their timetable? Do you know?
Dr. Petzel. They have not shared that with us, so I do not
know.
Senator Begich. OK. We will probably hear details as time
moves on.
Dr. Petzel. I hope.
Senator Begich. OK. Thank you. I missed one meeting--I
cannot remember if I was here or at the Appropriations
Committee--but I wanted again to commend you all for working on
and reviewing the NUKA model in Alaska.
We think this is--as we talk about overmedication and many
other things--I think they have really capitalized on a very
unique model that is looking at the whole body and all people
engaged in health care. One of the things that I want to ask
is, I am assuming in this issue today that we are talking
about, overmedication, as you look at the NUKA model you will
be also looking at this piece of the equation.
For example, I know they use not only alternative medicines
but they also use through the native health care, native
healing methods. Is that also something as you look at the NUKA
model you can be examining because I want to make sure that is
part of the equation.
Dr. Petzel. My understanding, Senator Begich, is the
central feature of the NUKA model is listening to the patient's
story and then crafting the therapy around that individual
patient's story and their circumstance. Since it is an Alaskan
native program, those medicines, et cetera, are woven
intimately into the way they deliver care.
In the Native community here in the States where the VA is
dealing, we also employ native healers, et cetera, and those
concepts in dealing with that particular patient population.
But I think Dr. Gaudet can maybe comment briefly on the fact
that that is a tone that goes through our program.
Dr. Gaudet. Yes, thank you, Senator. I would certainly just
underscore the importance of this holistic approach which I
appreciate your question actually brings to the surface.
I think the challenge before us really--truly not just in
VA health care but nationally in the model of health care that
is dominant in this country--it is so much easier to write a
prescription, as Ranking Member Burr said.
The system is designed to do that. We as physicians are
trained to find it-fix it. I can operate and I can write you a
prescription and anything outside of that--and this is a slight
exaggeration--but I am not actually trained to think about or
understand.
So, this transformation is a huge system change, and it
does as you have described and as Dr. Petzel has described,
begin with understanding the person. If we are in a situation
such as Senator Boozman, thank goodness we have the high-tech
approach. Perfect. They can go in. We can sew you up. We can
fix the problem.
Senator Begich. Right.
Dr. Gaudet. But in the myriad of things like pain, like
obesity, like PTSD, those find it-fix it cures do not exist.
So, this holistic approach starting with the individual,
understanding their cultural beliefs and creating a
personalized approach for and with them is absolutely
essential.
Senator Begich. Very good. Let me proceed, if I can,
because I have limited time here. General, I know the Army and
TRICARE have recently required mental health counselors to our
veterans be credited through the Council for Accreditation of
Counseling Related Educational Programs.
Here is the challenge in Alaska. We do not have the
capacity to meet those standards because of the uniqueness of
Alaska. It is not offered in Alaska, so it makes it difficult;
and with huge gaps in mental health professional numbers, how
can we go with this when in reality we have vacancies that we
should fill which can easily be filled with qualified
counselors. But how are we going to meet this in Alaska?
I mean, I know everyone likes a one-size-fits-all solution.
Those do not work in Alaska. I will tell you there is no better
health care as what the VA is looking--Indian Health Services--
no better health care delivery system in the country. So, we
figured out how to do it and it does not come from a national
model. It does not come from the standards that people sit
around and make up.
I mean, we deal with reality. That is why we have a great
dental program in the Indian Health Services. You know, the
dental community does not necessarily like it totally,
nationally, but it works in Alaska because we have remote areas
and we have huge tooth decay and other things that we have been
able to accomplish through dental therapists.
So, how are we going to handle this?
Chairman Sanders. In 24 seconds.
General Coots. Yes, sir. Alaska is known for its use of
tele-medicine initiatives, and I think that for the military
utilizing tele-behavioral health is probably one of the biggest
initiatives that we have in serving areas that are remote or
where we do not have those health care providers.
We are looking at some different ways of attracting
additional behavioral health providers. We are also looking at
training some of our own. As we draw down the military, we have
a large core of physicians assistants that we are looking at
retrainings some of them as behavioral health physicians'
assistants.
Senator Begich. Very good. Let me say, Mr. Chairman, I have
a couple of cases which I am going to send to Dr. Petzel and
maybe some very specific questions on how we would respond to
these kind of individuals that deal with medication.
Thank you very much.
Chairman Sanders. Thank you, Senator Begich.
Senator Isakson.
Senator Isakson. General Coots, first of all, thank you for
your service particularly at Walter Reed. You all performed
miracles on a daily basis in rehab for our servicemen. We
appreciate it very much.
I know Colonel Galloway's responsibilities are
rehabilitation and reintegration of DOD active duty troops back
into society I take it or back into the military?
General Coots. Both.
Senator Isakson. Which tells me that opiate
overprescription is probably as big a problem in DOD as it is
in veterans' health care. Is that correct?
General Coots. Sir, I would say we have statistics that
show that up until about 2011, about 26 percent of all active
duty were on some level of opioid medications, either one
single opioid or multiple opioids.
The Army is traditionally a little bit higher, 2 or 3
percentage points higher, I think, by the nature of what we do
and the pain that our servicemembers have from repeated combat
tours in remote areas.
But all the statistics are showing now that with a big push
for cultural change, with integration of these alternative
medical modalities, that we are seeing a downturn in opioid use
across the military, particularly across the Army, and then a
large upswing from 10 percent up to 28 percent now, utilizing
alternative medicine.
Senator Isakson. Which is my point because, you know, we
use DOD for all kinds of medical research: breast cancer,
prostate cancer, things like that because you have a controlled
environment. You have people who are not necessarily
voluntarily participating but they are participating because it
is their job. We get a lot of medical data.
I guess we have learned from addiction and opioid overuse
that the ``settled science'' is there in terms of what
constitutes an addiction or an overuse. What we are trying to
do is find out how we deal with it, and once it happens, to
prevent it from happening again. Is that right?
General Coots. Yes, Senator, that is correct.
Senator Isakson. Then that brings me to my question.
Seamless transition from DOD health care to veterans health
care, which by the way General Schoomaker did a remarkable job
of improving in his service at Walter Reed and in the military.
What is DOD doing as these active duty military personnel
go into veteran status? What is the transition like
particularly with regard to opiates and then opiates having
been prescribed, of them having been addicted? Is there a
program or do they go into a black hole and the VA just has to
discover the problem all for themselves?
General Coots. Senator, that is a good question. I will
answer it in two parts.
First, we have a shared formulary where we have lined up
the formulary so that any medications that a military member
might be on, as they transition into the veterans health care
system, that same medication or modality is available to them
in the transition.
We also are working on improving our warm handoff such that
our military servicemembers have a lead coordinator. There is a
corresponding lead coordinator on the VA side so that their
information is transmitted directly in a handoff from that
military lead coordinator to the VA system so that all of the
associated and ancillary modalities that have treated them for
whatever their problems are, be it opiate, be it anything else,
all of those will transfer over so there is a knowledge
transfer.
So, there is no falling off in the cracks or going into a
black hole.
Senator Isakson. Good. Good.
Dr. Marshall, the opioid safety initiative started in
Minneapolis, is that right?
Dr. Marshall. That is correct, Senator.
Senator Isakson. If you uncover a provider who is not
following the proper safety administration of opioid
prescriptions, what training or what follow-up do you require
to make sure that they do not do it again, or is there a
prescription for doing that?
Dr. Marshall. Well, first of all, Senator, thank you for
that question because I think it is an integral part of what is
happening at Minneapolis. So, we are building a standard of
care and a cultural change in how we prescribe opioids.
Part of it is building the prescribing of opioids into a
team setting so we are using the providers who are doing the
prescribing, the pharmacists who bring their unique skill set
to the primary care team to help monitor for adverse effects
or, you know, dosage problems, and also mental health. So, a
lot of the control happens at that point working with the
patient and the primary care team.
Another phase of the accountability process is that we have
transparent data--the dashboard that Dr. Petzel mentioned. So,
we are using that to understand who are the outlying
prescribers who need more help with changing their prescribing
patterns.
And the final stage of accountability rests with the chief
of staff who, at our facility, has been very involved in
providing specific direction to providers who are outside of
the standard of care.
So, it is a supportive system but there are levels of
accountability.
Senator Isakson. Dr. Petzel, you are familiar with our
question with regard to suicide in the Atlanta VA, and I
appreciate very much your attention to the ongoing initiative
there.
But it occurred to me that in the Atlanta VA situation
where there were four instances now taking place over the last
year, two of those were non-drug addicted Vietnam-era,
noncombat veterans, meaning that they were veterans who served
during the Vietnam era--my age group, in their late 60s or
early 70s. They were not in combat. They did not transition
from DOD to VA health care recently. They did it over a long
period of time.
I worry sometimes that prescribing opiates to mental health
patients who come in for their first encounters at VA
prescribing opiates might mask a greater problem or might
accelerate a problem that exists.
Is there any disciplinary requirements within the VA as far
as mental health encounters are concerned in terms of
prescribing opiates?
Dr. Petzel. Senator Isakson, that is an excellent question.
There are certain antecedents that are frequently found in
patients who have either attempted suicide or actually
committed suicide. Depression, PTSD, sleep disorders, and pain.
Pain is often an antecedent to suicide, particularly chronic
pain.
So, the mental health provider is attuned to the fact that
when they see somebody who is new to them that they need to be
evaluated for those antecedents to be sure that they are taken
into account when they begin to write prescriptions.
So, anybody who has mental health problems who then also
presents with a pain problem requires and gets very special
attention.
Senator Isakson. Thank you.
Thank you, Mr. Chairman.
Chairman Sanders. Thank you, Senator Isakson.
Senator Blumenthal.
Senator Blumenthal. General Coots, you mentioned a
statistic before which I missed as to the percentage of use of
opioids. I think that was the percentage in the Army or the
military. Could you repeat that?
General Coots. Yes, Senator. Up to 2011, the number was
about 26 percent of all active duty had been prescribed at
least one opioid medication.
Senator Blumenthal. And that could be in the course of the
individual soldier's entire service? Or over what period of
time?
General Coots. We are actually tracking that on a year by
year basis, watching it; and over time, say, from 2007 to 2011,
you saw a steady increase up to that 26 percent point. After
about 2011 over the last 2 years, going on almost 3 years, we
have seen a steady drop off, either stabilization or decline in
the numbers that are using it.
Senator Blumenthal. So, let us take 2013. Over 2013, what
percentage of active duty Army soldiers were prescribe some
form of opioid?
General Coots. Senator, I do not have that exact number.
Senator Blumenthal. What is the last year for which you
have a number?
General Coots. Sir, actually I do. It looks like about 24
percent or so, about 24 percent in 2013. So, down from 26
percent in 2011.
Senator Blumenthal. 26 percent in 2011 to 2013, 24 percent?
General Coots. Yes, Senator.
Senator Blumenthal. So, it is a pretty small difference.
General Coots. It is a small difference but I think it
still represents a big cultural change and a move ahead because
over the war years you saw a steady increase in it and the war
is not yet over. We are still getting casualties although
fewer; but over those last few years, we have been able to use
these alternative modalities to include battlefield
acupuncture. We use intranasal ketamine on the battlefield now
which decreases the amount of morphine that you have to use.
So, I think all of that is contributing as well in those
complex casualties, and then translate that to our primary care
clinics and our interdisciplinary pain management centers where
we are implementing these alternative medications. I think all
of that has been contributing to it.
So, we are right at the beginning of this cultural shift
and this cultural change.
Senator Blumenthal. Let me just make sure that I understand
that number. That is total active duty soldiers.
General Coots. That is total active duty.
Senator Blumenthal. 26 percent were prescribed some form of
opioid in 2011 and 24 percent in 2013. That is not injured
soldiers. It is all soldiers.
General Coots. That is all soldiers. This is all soldiers
sailors, airmen, and Marines. That is all DOD.
Senator Blumenthal. OK. Let me ask you. You mentioned the
warm handoff from active duty service to separation and VA
treatment. As you probably know, many of us on this Committee
have been concerned about the lack of interoperability of the
Army medical records with the VA records in terms of the
electronic medical record systems that each has.
Do you see an effect of the lack of complete compatibility?
I do not know what exactly the technical term would be, but I
know that everybody is talking about trying to make it work
better but still do not have an interoperable system.
Do you see an effect of that?
General Coots. Actually, no, Senator. We are very
compatible and very interoperable when it goes to that. There
may be narrow pipelines between the two electronic health
records but it still allows us to transition and transfer that
critical information on complex patients and patients on----
Senator Blumenthal. Is there an automatic re-evaluation
when a soldier or an airman or Marine, or sailor goes from
active duty to veteran status; re-evaluation of the
prescription opioids?
In other words, does somebody say, well, you have been
getting this medication or that, let us have a look here. Maybe
we need to do something different.
General Coots. To my understanding, there is an intake.
Anytime you do a handoff or handover of a servicemember's care
into the veterans' system, there is going to be an intake
process.
We transition all of that information from that one lead
coordinator to the next. But certainly when they get in and
they have a new provider, a new team who is taking over, there
is a re-evaluation of everything that has happened in that
servicemember's medical history now than they have become a
veteran.
That does not necessarily mean there is a change in
therapeutic approach or a change in modalities but it certainly
could mean that.
Senator Blumenthal. It could mean it for an individual
case.
Let me ask Secretary Petzel whether he has any
observations.
Dr. Petzel. Thank you, Senator Blumenthal.
A comment on a couple of things. First of all, we have
ready access to everything that is electronic in the DOD
records. The interoperability part, we are working toward being
sure that things mean the same in each kind of record. So, that
is improving. It is definitely improving.
Also the transition is improving with TAP, the Transition
Assistance Program. We present to each one of the exiting
servicemembers about what is available in DOD. People are often
identified now in that program that need to have a warm
handoff. We are seeing much more of the at-risk patients being
handed off to VA in a warm fashion.
Senator Blumenthal. Just so I understand, I use the term
but what does that mean?
Dr. Petzel. That means there is a specific call to a VA
medical center, this patient, John Jones, is transiting into
the VA health care system. This is who he is. Here is what it
means. We need an appointment for him. That is a warm handoff.
What happens when they come to the VA--not all of them do,
by the way. We need to understand that unfortunately we do not
see as many people as we would like to see. They are evaluated.
Our perspective as an organization is that we want to use the
least risky, effective way of managing a patient's pain.
So that my hope would be and the expectation would be that
their pain is evaluated. The medications that they are
evaluated on, a plan is developed with that patient for the
management of their pain that would again lead to the least
risky, most effective way of managing their pain.
Chairman Sanders. I want to thank all of our panelists.
This Committee considers the issue of overmedication to be a
serious national problem, a problem within the VA and a problem
within the DOD. We appreciate your focusing on it and the good
work you are doing. So, thank you all very much.
At this time I want to introduce our second panel. First, I
am pleased to welcome Dr. Janet Kahn, who is a member of the
Department of Psychiatry at the University of Vermont and
Senior Policy Adviser for the Consortium of Academic Health
Centers for Integrative Medicine. That is a mouthful.
Then we have Dr. Mark Edlund, who is the Senior Research
Public Health Analyst in the Behavioral Health Epidemiology
Program at RTI International.
Thank you both very much for being with us.
Dr. Kahn, let us begin with you.
STATEMENT OF JANET KAHN, Ph.D., RESEARCH ASSISTANT PROFESSOR,
DEPARTMENT OF PSYCHIATRY, UNIVERSITY OF VERMONT AND SENIOR
POLICY ADVISOR, CONSORTIUM OF ACADEMIC HEALTH CENTERS FOR
INTEGRATIVE MEDICINE
Ms. Kahn. Chairman Sanders, Ranking Member Burr, Members of
the Committee, I want to thank you for the honor of testifying
before this distinguished body on what we all agree is a really
critical issue, the issue of overmedication, particularly
overuse of opioids for pain management.
I have been asked to share my understanding of what
integrative health care approaches could offer to people in
pain and people treating them.
So, by way of background, I am a medical sociologist and
for the past 30 years my work has focused on issues of
integrative health care. I am also a clinician. I am a massage
therapist and instructor of meditation and somatic awareness
training. So, in that capacity in the treatment room what I
have spent the last 30 years doing is trying to understand how
people can move from illness to wellness, from pain and ease,
and how a nervous system that has gotten stuck in a flight or
fight or freeze state can reset itself for optimal functioning.
For the past 5 years, almost all of my work has been with
veterans of OEF, OIF, and OND and their partners. I have seen
them in my private practice; and with my research partner,
William Collinge, we utilize a program called Mission
Reconnect.
This is a self-directed, home-use Web- and app-based
program that offers instructions to help veterans and their
partners learn various mind-body techniques that we know to
support mental, physical, and relationship health.
Preliminary research that was conducted with veterans of
the Vermont and Oregon National Guard units showed 8 weeks of
this program to be effective in decreasing pain, decreasing
anxiety levels, and decreasing people scores on PTSD checklist
measurements.
We are now conducting a randomized clinical trial of
Mission Reconnect in San Diego, Dallas, Fayetteville, North
Carolina, and New York to understand the regional differences
and to cover all branches of the military.
The term ``integrative medicine'' has been used with
various meanings, so, I want to be clear that when I speak of
integrative health care, I use the term to refer to team-based,
coordinated use of the most appropriate evidence-based
interventions from across the full conventional, complementary,
and alternative medicine spectrum, including preventive efforts
and a particular focus on interventions that educate and engage
the patient and his or her family members in their own care
and, therefore, hopefully leaving them with skills for a
lifetime.
I think we all know the relevant reports from the Army Pain
Management Task Force and the IOM, and I would like to echo
those reports in calling for a comprehensive change not only in
how we treat pain but literally how we think about pain so that
it can guide the treatment beginning with understanding that we
do not actually treat pain, we treat people in all their
complexity, and pain is part of what they bring to the picture.
So many of the men and women returning from these wars have
multiple wounds. They have injuries to their bodies, to their
brains, to their hearts, to their minds, to their spirits, to
their relationships; and we need to find a way to deal with
that complexity as we treat them because they need more than
just having their symptoms quieted. They actually need help
learning to heal and to lead fulfilling lives in the many
decades, being young, that they have ahead of them.
Our current approach to pain management can too easily lead
to prescribing a drug for each identified problem and that in
turn, as we know, can lead to a poly pharmacy problem that we
may not have the capacity to actually manage.
These veterans have already been asked to carry and
maneuver with more weight in their packs than their bodies were
designed for. They have been exposed to more stress than their
nervous systems can manage as we see absolutely every day. So,
over medicating them is no solution and no gift.
There are evidence-based, non-pharmaceutical ways to
address pain. In this kind of complexity, I suggest that we
reorient toward a positive vision of health and wellness for
our veterans; try to come up under them.
We know that lack of sleep, emotional stress, inability to
take a deep breath, these things exacerbate pain. They
literally make pain hurt more. They change the experience of
it.
So, addressing the building blocks of wellness can reduce
the need for pain medication, and research clearly indicates
that massage, acupuncture, yoga, and other mind-body therapies
can significantly enhance sleep quality as well as duration,
can help the nervous system rest down and thus reduce the
experience of physical and emotional pain and alter the
treatment needs for it.
Educational interventions that include family members or
groups of veterans can impart needed skills at the same time
that they build community; and loss of community is an
important element of a veteran's pain.
So, on top of all that they have already offered this
country, veterans are offering us, I believe, the opportunity
to embrace a wellness approach to the care of people who have
incurred complex trauma, to kick our pharmaceuticals-only
habit, come up with something more complex and interactive, and
learn to collaborate across disciplines on their behalf. We
should recognize this as one more gift they are giving us and
move toward it quickly.
[The prepared statement of Ms. Kahn follows:]
Testimony of Janet Kahn, Ph.D., Research Assistant Professor,
Department of Psychiatry, University of Vermont and Senior Policy
Advisor, Consortium of Academic Health Centers for Integrative Medicine
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Chairman Sanders. Thank you very much, Dr. Kahn.
Dr. Edlund.
STATEMENT OF MARK EDLUND, M.D., Ph.D., SENIOR RESEARCH PUBLIC
HEALTH ANALYST, BEHAVIORAL HEALTH EPIDEMIOLOGY PROGRAM, RTI
INTERNATIONAL
Dr. Edlund. Good morning. Thank you for inviting me. My
name is Mark Edlund, and I am a health services researcher at
RTI International and a practicing psychiatrist.
For the past 10 years my colleagues and I have researched
patterns of opioid painkiller prescribing in Blue Cross/Blue
Shield, Arkansas Medicaid, and more recently the VA.
Our research involves analyzing administrative data and
pharmacy records. Most recently, our research has focused on
national patterns of opioid prescribing in the VA, supported by
a grant from the National Institute of Drug Abuse.
The VA data come from the years 2009 to 2011. My testimony
today will provide initial findings from our NIDA-funded work.
This work examined three aspects of opioid prescribing in the
VA.
One, rates of opioid prescribing in VA patients with
chronic non-cancer pain. Two, factors associated with
discontinuation of chronic opioid therapy. And, three, factors
associated with heavy utilization of opioids among VA patients
with chronic pain.
Rates of opioid prescribing in VA patients with chronic
pain. Many VA patients have chronic pain, most commonly back
pain and arthritis. Our results suggest that, among VA patients
with chronic non-cancer pain who are using VA services at least
twice per year, a little over half receive at least one
outpatient opioid prescription in that year.
Although comparing rates of opioid use between health care
systems can be imprecise, this rate is approximately the same
rate as found in other health care systems and in other health
care plans.
VA patients with chronic pain who receive opioids have a
median of about 120 days of use in a year, that is, they used
opioids about one 1 of 3 days--the median individual. This is
generally higher than in other health care systems.
In this same VA cohort, the median daily opioid dose is
modest, about 21 milligram morphine equivalents. So, morphine
equivalents are the way we standardize all these different
opioids, and 21 milligrams is fairly low. High would be thought
of as, say, 120 to 200. So, the median dose is generally lower
in the VA than in other health care systems.
Of the VA chronic pain patients prescribed opioids, the
percentage who receive high doses of opioids is relatively
small, about 5 percent. This is also lower than in other health
care systems. This is important because high dose is an
important predictor of adverse outcomes.
The opioid use of OEF/OIF VA patients has been the subject
of scrutiny. We found that, among VA patients with chronic
pain, OEF/OIF patients were less likely to be prescribed
opioids as compared to other VA patients; and among VA patients
with chronic pain who were prescribed opioids, OEF/OIF veterans
were less likely to be heavy utilizers of opioids.
Rates of opioid discontinuation. Among VA patients who
received at least 90 days of VA opioids within a 180-day period
in 2009, we looked at rates of discontinuation where
discontinuation was defined as 6 months with no opioid
prescription.
We found that among these VA patients nearly 80 percent
will receive years of opioid therapy. This is consistent with
what we have found in analyses of other health care plans.
While high daily doses is not common among VA patients, both
high daily doses and use of long-acting opioids were strong
predictors of opioid discontinuation, or excuse me,
continuation.
Individuals with substance abuse disorders and mental
health disorders were more likely to discontinue opioids in the
VA. This is important because these patients are those who are
at increased risk for opioid abuse.
Factors associated with heavy opioid utilization among VA
patients. In analyses of data from other health systems show
individuals with substance abuse disorders are at a high risk
for heavy utilization of opioids.
However, in an analysis of VA patients with chronic pain
known to be using the VA at least twice in a fiscal year,
individuals with substance abuse were less likely to be heavy
utilizers of opiates.
In summary, while comparing health care systems can be
imprecise, we found, one, among chronic pain patients rates of
any opioid use is approximately the same in the VA and non-VA
systems.
However, among chronic pain patients in VA who receive
opiates, the number of days for which they received opioids in
a given year is generally higher than in non-VA systems.
However, median daily dose in the VA is lower than in other
health care systems.
Finally, it appears that the VA does a better job of
screening out individuals with substance abuse and mental
health disorders from heavy utilization of opioids which is
also very important because those are the people who are most
likely to go on to abuse.
[The prepared statement of Dr. Edlund follows:]
Prepared Statement of Mark J. Edlund, M.D., Ph.D., Senior Research
Public Health Analyst, Behavioral Health Epidemiology Program, RTI
International
Good morning, thank you for inviting me. My name is Mark Edlund. I
am a health services researcher at RTI International, and a practicing
psychiatrist. For the past 10 years my colleagues and I have researched
patterns of opioid painkiller prescribing in different health care
systems. Our research involves analyzing administrative data and
pharmacy records. Most recently, our research has focused on national
patterns of opioid prescribing in the VHA, supported by a grant from
the National Institute of Drug Abuse (NIDA).
My testimony today will provide initial findings from our NIDA-
funded work. This work examined three aspects of opioid prescribing in
the VHA: rates of opioid prescribing in VHA patients with chronic
noncancer pain; factors associated with discontinuation of chronic
opioid therapy; and, factors associated with chronic opioid use among
VHA patients.
Our research used VHA administrative and pharmacy data from years
2009 to 2011. We have thus far conducted three different analyses of
this data. The results from those analyses were reported at the
Addiction Health Services meetings held October, 2013 in Portland,
Oregon and the American Academy of Pain Medicine meetings held March,
2014 in Phoenix, Arizona.
While some of the research methods were the same for all three
studies, some methods varied in each study, as did the VHA patient
sample.
methods for all analyses
Data Source
We used data from three VHA Sources
Pharmacy Benefits Management Service (PBM)
VHA Corporate Data Warehouse
OEF/OIF roster
Opioid Use Variables. Data included all opioid prescriptions
(including date, daily dose, and type of opioid), other than injectable
opioids and opioid suppositories (due to lack of conversion factors).
We recorded the total number of opioid prescription fills for each
patient within the fiscal year and calculated the number of days
supplied for each patient in the year, as recorded by the dispensing
pharmacist. The mean dose in morphine equivalents per day supplied for
each patient was calculated by summing the morphine equivalents for
each prescription filled during the year, and dividing by the number of
days supplied.
Other Variables. We used International Classification of Diseases-
9th Revision (ICD-9) codes from VHA Corporate Data Warehouse to
construct variables for mental health diagnoses and substance use
disorders. Chronic non-cancer pain conditions were also identified
through ICD-9 codes and grouped into five broad categories encompassing
the most common chronic noncancer pain conditions. These groupings
included neck pain, back pain, arthritis/joint pain, headache/migraine
and neuropathic pain, which are common to VHA patients. Demographic
information such as age, race, gender and marital status were also
extracted from the VHA Corporate Data Warehouse.
IRB Approval. All analyses were approved by the Institutional
Review Boards of The Central Arkansas Veterans Healthcare System and
the University of Arkansas for Medical Sciences. A data use agreement
was executed with each data repository.
analysis 1--patterns of opioid use for chronic noncancer pain
Study Sample
The study sample consisted of VHA patients in years 2009 to 2011
who met the following criteria. Inclusion Criteria: 1) chronic
noncancer pain diagnosis, as defined by two clinical encounters for the
same chronic noncancer pain condition (neck pain, back pain, arthritis,
headache/migraine, or neuropathic pain) at least 30 days apart, but no
more than 365 days apart, 2) Received at least one opioid prescription
during the year of chronic noncancer pain diagnosis, 3) Age 18 or
older. Exclusion Criteria: 1) Cancer diagnosis at any time in 2008-12
other than non-melanoma skin cancer, 2) resident of VHA nursing home or
living in VHA domiciliary, 3) enrolled in VHA hospice benefits, 4)
incomplete opioid prescription data, or 5) a prescription for a
parenteral, suppository, or trans mucosal opioid. These criteria allow
us to focus on VHA patients likely receiving opioids for the treatment
of chronic noncancer pain.
key results from first analyses
Many VHA patients have chronic pain, with the most common sources
being back pain and arthritis. Our results suggest that, among VHA
patients with chronic noncancer pain who are using the VA at least
twice per year, a little over half receive at least one outpatient
opioid prescription in that year. VA patients with chronic pain who
receive opioids have a median of 120 days of use in a year, or about
one out of three days. In this same VHA cohort the median daily opioid
dose is modest, about 21 milligram morphine equivalents. 21 milligram
morphine equivalents is fairly low, equivalent to about 2 Vicodin
tablets. In our analyses the percentage of VHA patients who received
high doses of opioids was relatively small--about five percent. Among
VHA patients with chronic noncancer pain, 44% of all opioids were used
by just 5% of patients; 1% of patients accounted for 17% of all opioids
utilized.
The opioid use of OEF/OIF VHA patients has been the subject of
scrutiny. We found that, among VHA patients with chronic noncancer
pain, OEF/OIF patients were less likely to be prescribed opioids
compared to non OEF/OIF VHA patients, and less likely to be heavy
utilizers of opioids.
Conclusions: About half of all VHA patients with chronic noncancer
pain receive opioids, and among those who receive opioids, the median
days of use is 120 days. The median daily dose is modest. Total opioid
use is heavily concentrated among a relatively small proportion of the
VHA population with chronic noncancer pain.
Second Analysis:
Our second set of analyses focused on discontinuation from chronic
opioid therapy.
analysis 2--discontinuation from chronic opioid therapy
Study Sample
The study sample consisted of all adult VHA patients receiving 90
days or greater supply of non-parenteral opioids with less than a 30-
day gap in supply within a 180-day period between January 1, 2009 and
December 31, 2011. We refer to individuals who met these inclusion
criteria as receiving chronic opioid therapy. The index date was
defined as the first day of this 90-day period. A minimum of two prior
encounters in the year preceding the index date were required to
document routine use of VHA care. The year preceding the index period
was used to identify additional exclusionary criteria and relevant co-
variables. Veterans with an ICD-9 cancer diagnosis (with the exception
of non-melanoma skin cancers) and administrative codes for VHA nursing
home use, hospice or palliative care services in the 360 days before
and after the index date were excluded. Additionally, veterans with
incomplete opioid prescription data (unknown dosages or types) or
enrollment in a methadone maintenance program or receiving
buprenorphine at any time were excluded.
Given high rates of interrupted or episodic use among chronic
opioid users and to maintain consistency in definitions,
discontinuation was defined as the first run-out day of a minimum 180-
day period with no opioid prescriptions. In order to distinguish
clearly between disenrollment from VHA and opioid discontinuation,
participants without any VHA services use in the 90 days after
discontinuation were excluded.
If any two prescriptions overlapped by greater than 20% or greater
than ten days, the overlapping portions of the prescription were
assumed to be taken concurrently and the overlapping days were only
included once in the opioid days calculation. If the overlap was > 20%
and > 10 days the second prescription was shifted and the overlapping
days from both the first and second prescription were included in the
opioid days calculation. A dichotomous variable for the presence of
multiple opioids defined as two or more types of opioids that
overlapped by more than 30 days in any 40-day period was created as a
surrogate for potential opioid misuse.
VHA service utilization during the period of chronic opioid therapy
was calculated as the total number of mental health encounters,
substance use encounters and all other VHA encounters abstracted from
Current Procedural Terminology (CPT) codes in the 90 days post-index.
key results from analysis 2--discontinuation from chronic opioid
therapy
We identified 814,311 VHA patients who met our criteria for chronic
opioid therapy. After exclusions were applied, 550,548 (67.6% of
chronic opioid users) were eligible for analysis and 542,843 were
entered into the statistical models. (We excluded 7,705 (1.4%) of the
sample due to missing data, primarily the absence of reliable rural/
urban coding). The sample was primarily male (93%), white (74%) and
urban-dwelling (68%), with a mean age of 57.8 years and 52% were
married. At one year after their index prescription date, only 7.5% of
the sample had discontinued chronic opioid therapy.
The majority of the sample suffered from at least one chronic
noncancer pain condition (82.3%); just over a quarter of the sample had
two chronic noncancer pain conditions (26.7%). Similarly, 62.3% of the
sample had a mental health diagnosis, the most common being depressive
disorder (29.7%). Only 14.5% of the sample had a substance use
disorder, while 25.6% of the total sample used tobacco. The mean number
of total clinical encounters in 90-days post-index was almost 9 (mean
8.92, SD 11.01).
The mean daily morphine equivalent dose was 40.7 mg (SD 61.67 mg)
among the VHA patients in this analysis though the median was 26 mg and
only 7% received greater than 100 mg daily morphine equivalent. Nearly
all received short-acting opioids (97.1%). Only 12.3% received multiple
concurrent opioid prescriptions, usually a long-acting plus a short-
acting opioid, and over half (57%) had received greater than 90 days
total opioid supply in the year preceding their index date.
We conducted analyses to examine factors associated with
discontinuation from long-term opioid therapy. The maximum time
available for follow-up was 1,279 days (3.5 years), and of those who
discontinued (20%, N=110,460), the mean time to discontinuation was 530
days (SD 298.15, median: 465). The majority of the sample continued use
through the end of the follow-up period. Demographic characteristics
associated with higher rates of discontinuation of long-term opioid
therapy included being younger or older than VHA patients aged 50-65
(0-30 years HR=1.52, 95% CI 1.47 to 1.57 and > 65 years HR=1.34, 95% CI
1.32 to 1.36), non-married status (HR 1.06, 95% CI 1.05 to 1.08) and
African American race (HR 1.04, 95% CI 1.02 to 1.06). Compared with VHA
patients living in an isolated rural setting, those in an urban setting
were significantly more likely to discontinue long-term opioid therapy
(HR 1.08, 95% CI 1.05 to 1.10).
VHA patients who were receiving higher average daily doses of
opioids were less likely to discontinue chronic opioid therapy. Those
taking long-acting opioid formulations had roughly 6% lower rates
discontinuation of chronic opioid therapy compared with those taking
short-acting opioid medications. (HR 0.94, 95% CI 0.90 to 0.98 VHA
patients). Those receiving multiple opioid prescriptions concurrently
had about a 20% lower rate of discontinuation compared with VHA
patients receiving only one opioid medication (HR 0.80, 95% CI 0.78 to
0.82). Finally, VHA patients with significant use of opioids in the
year prior to the index date had almost a 30% lower rate of opioid
discontinuations (HR 0.69, 95% CI 0.68 to 0.70). VHA patients who had
multiple types of pain or who had greater level of medical comorbidity
were more likely to continue chronic opioid therapy.
For the cohort of VHA patients in this analysis, mental health
diagnoses were associated with greater likelihood of discontinuation of
chronic opioid therapy, with schizophrenia and bipolar diagnoses
associated with nearly 20% greater hazard of discontinuation (HR 1.20,
95% CI 1.16 to 1.25 for schizophrenia and HR 1.20, 95% CI 1.16 to 1.23
for bipolar). Alcohol use disorder (HR 1.10, 95% CI 1.07 to 1.12),
opioid use disorder (HR 1.09, 95% CI 1.06 to 1.13) and non-opioid use
disorders (HR 1.22, 95% CI 1.19 to 1.25) were all significantly
associated with higher rates of discontinuation. In contrast to other
mental health and substance use predictors, tobacco use disorders were
associated with higher rates of continued long-term opioid therapy
(HR 0.96, 95% CI 0.94 to 0.97).
Conclusions: Among VHA patients who had received at least 90 days
of opioids within a 180 day period in 2009, nearly 80% went on to
receive years of opioid therapy. This is similar in other health care
plans. However, in other health care plans we studied, individuals who
were at high risk for opioid abuse, namely those with substance use
disorders and mental health disorders, were more likely to receive high
dose opioids and less likely to discontinue opioids. We generally did
not find this in the VHA. As noted above, VHA patients with mental
health diagnoses, diagnosed disorders related to alcohol use as well as
opioid and non-opioid substance use disorders were more likely to be
discontinued from long-term opioid therapy. Thus, it appears that VHA
does better than other health care systems previously studied in terms
of discontinuing patients from chronic opioid therapy.
Third Analysis:
Our third analysis examined factors associated with chronic opioid
use among VHA patients who regularly used VHA care in FY 2011.
analysis 3--chronic opioid use among all vha patients with or without
chronic non cancer pain
Study Sample
To be included in the cohort for the third analysis we identified
all Veterans who had at least one outpatient opioid prescription in FY
2011 using data from the VHA Pharmacy Benefits Management Service.
Similar to our 2nd analysis we used secure mechanisms to link the data
from the Pharmacy Benefits Management Service to that of the Corporate
Data Warehouse to identify VHA patients who used VHA care at least
twice in FY 2011. VHA patients with an ICD-9 cancer diagnosis (with the
exception of non-melanoma skin cancers) and administrative codes for
VHA nursing home use, hospice or palliative care services, had codes
for methadone maintenance or were receiving buprenorphine were also
excluded from the sample. In addition, VHA patients receiving
outpatient opioid prescriptions for injectable opioids, opioid
suppositories or trans mucosal opioid preparations were also excluded
from the analysis. VHA patients were not required to have a chronic
pain diagnosis to be included in this sample. Based on these inclusion
and exclusion criteria, we identified a total of 1,127,955 VHA patients
who were using opioid medications in FY 2011. Almost 52% (584,765) of
VHA patients in this analysis were using opioids for 91 or more days
during that fiscal year.
key results from analysis 3--chronic opioid use among all vha patients
with or without chronic noncancer pain
In unadjusted results, chronic opioid users were slightly older
than non-chronic users (59 years vs 57 years), were more likely to be
white (72.9% vs 65.9%), and were less likely to be OEF/OIF/OND Veterans
(5.9% vs 11.1%).
We used a logistic regression model to identify factors associated
with chronic opioid use in this cohort in FY 2011 (adjusted results).
In this cohort, opioid use was most common in VHA patients ages 56 to
65 years; patients in other age groups were less likely to have chronic
opioid use. The difference was most noticeable in the youngest age
group. VHA patients ages 18-25 were almost 62% less likely than VHA
patients ages 56-65 years to receive chronic opioid therapy (OR=0.38,
95% CI=.36-.39). Non-white VHA patients were approximately 28% less
likely than white VHA patients to receive opioid medications
chronically (OR=.72, 95% CI=.71-.73). VHA patients in whom race was
unknown were also less likely to receive chronic opioid medications
although the difference was less pronounced with these patients being
8% less likely to receive chronic opioid therapy compared with white
patients (OR=.92, 95% CI=.90-.93). In this cohort women patients were
22% less likely to receive chronic opioid therapy compared with male
patients (OR=.78, 95% CI=.77-.79). VHA patients who were identified as
OEF/OIF Veterans were 34% less likely to receiving chronic opioid
therapy compared with non-OEF/OIF Veterans (OR=.66, 95% CI=.65-.67).
In this cohort having PTSD or a depressive disorder was associated
with receiving chronic opioid therapy. VHA patients in this cohort with
a PTSD diagnosis were 16% more likely to receiving chronic opioid
therapy compared with VHA patients without PTSD (OR=1.16, 95% CI=1.15-
1.18). VHA patients in this cohort with a diagnosis of a depressive
disorder were 25% more likely to receive chronic opioid medications
(OR=1.25, 95% CI=1.24-1.26).
In this model, likelihood of chronic opioid use was most strongly
associated with opioid dose, use of long-acting opioid medications and
receiving multiple opioid medications concurrently. VHA patients in
this cohort who were receiving 100MG morphine equivalent dose or more
each day were 68% more likely to receive opioids chronically (OR=1.68,
95% CI=1.60-1.76. VHA patients who were receiving long-acting opioid
medications were almost four times as likely to receive opioids
chronically compared to those receiving short-acting medications
(OR=3.77, 95% CI=3.6-3.8) while those receiving multiple opioid
medications concurrently were more than 30 times more likely to receive
opioids chronically (OR=30.8, 95% CI=29.4-32.3).
Conclusions: Of VHA patients who use opioids, about half use them
chronically (at least 89 days per year). VHA patients who were non-
whites, OEF/OIF, or female were less likely to receive chronic opioid
therapy. Individuals with mental health disorders were more likely to
receive opioids chronically, but the magnitude of this effect was
small. Higher opioid dose, use of multiple opioids concurrently and use
of long-acting opioid medications were strongly associated with chronic
opioid use.
caveats
Our results should be interpreted with 4 factors in mind. First, we
had access only to VHA records, and do not know about opioids VHA
patients may be receiving outside the VHA system. Second, the
definition of chronic pain is inherently subjective. In our first
analysis we used a definition that is relatively strict. With less
strict definitions, the percentage of VA chronic pain patients
receiving opioids would likely be lower, as would the number of days of
opioids used in a year. Third, the definition of high dose opioids is
also subjective. We used a measure of high dose opioids that is on the
low side. If we had used a measure that was higher, then our estimate
of the percentage of VA patients with chronic pain who received high
dose opioid therapy would have been lower. Fourth, although we reviewed
records of all VHA patients in various years we included only specific
patients in our analyses because we wanted to identify Veterans that
were known to be using VHA care regularly.
Thank you.
Chairman Sanders. Dr. Edlund, thank you very much for your
testimony.
Let me start with Dr. Kahn and just ask you a pretty simple
question. Let's say there is a veteran who is coming back from
Iraq and Afghanistan dealing with pain issues, back pain or
whatever it may be, he or she has difficulty sleeping, maybe
the marriage is in trouble, they have difficulty holding on to
a job.
You said the issue here is not to deal with pain but to
deal with the person. In the real world, somebody walks into
your door with the issues I have described, the easy path is to
medicate. Historically, we have done a lot of that. You have
got pain; here are some drugs.
You are proposing a different way. In English and maybe
some concrete examples, what does that mean? What do you do
with that individual who walked in your door?
Ms. Kahn. So, I hope I made it clear that I am not
suggesting an either/or approach.
Chairman Sanders. No. We understand absolutely.
Ms. Kahn. OK. And I want to state clearly that I am not a
physician.
Chairman Sanders. Right.
Ms. Kahn. OK. So, that said, yes. I assume a physician
would address issues of pain directly but at the same time
because people's experience of pain and their capacity to
handle and to cope with pain and manage whatever level of pain
they are experiencing, is influenced by these other things like
their general state of anxiety or whether or not they are sleep
deprived and, therefore, on edge in a different way, we want to
come up under them in terms of those elements of life at the
same time as addressing the pain directly. That is what I am
suggesting.
Chairman Sanders. Give me some examples, if you can, of the
effectiveness of the approach you are utilizing. Does it work?
Do you have some examples of people who have walked in the door
who have been able to get effective treatment, see real
improvements in their lives with minimal use of heavy drugs?
Ms. Kahn. I think I am actually not in a position to answer
that yet because in my own practice of offering Mission
Reconnect to people the first trial with that program was not
done in a VA context or in a medical context, thus I did not
have access to medical records to be able to assess changes in
medication prescription or use.
We have been approached by psychologists at the Tampa VA,
and they are in the process of preparing a proposal to look at
exactly that, to apply Mission Reconnect with other care for
people who are both high PTSD and high pain.
Chairman Sanders. OK. Dr. Edlund, do you have some thoughts
on that?
Dr. Edlund. I think that these strategies are
underutilized. I think that they hold promise. I think that
they are particularly attractive in that they are noninvasive
and they do not involve medication.
I think that ultimately they are going to be an important
part of the puzzle and there is no one piece of the puzzle that
is dominant. So, I agree that all of these elements need to be
brought to the fore.
Chairman Sanders. In your opinion, Dr. Edlund, has VA been
aggressive in exploring these new approaches?
Dr. Edlund. I would say that the VA has been more
aggressive than the rest of the American health care system and
that the level of aggressiveness has markedly increased in the
last 2 or 3 years.
Chairman Sanders. So, if you walked into a VA facility you
would be more likely to have the option of looking at these
approaches than in a private-sector hospital. Is that what you
are saying?
Dr. Edlund. Yes, almost certainly.
Chairman Sanders. OK. Dr. Kahn, do you have anything to add
to that?
Ms. Kahn. Well, only that because in the non-governmental
world, in the world of private insurance, most complementary
and alternative medicine forms have not been and continue not
to really be fully reimbursed. Then the patient is faced with a
tougher choice if they are going to have to pay for it
themselves in a private hospital than in the VA. So, I would
imagine there would be greater use in the VA.
Chairman Sanders. Well, that is an interesting observation.
So, because insurance companies do not cover many of these
complementary or alternative approaches, the private hospital
is constrained about what kind of therapies it can offer.
Ms. Kahn. Not necessarily what ones they offer but how they
offer them. An increasing percentage of private hospitals do
offer them, sometimes paid for philanthropically. Sometimes the
hospital itself will pay and often it will be a fee that the
patients themselves have to absorb.
Chairman Sanders. OK. Thank you very much.
Senator Burr.
Senator Burr. Mr. Chairman, thank you.
The one thing that I hope I will not fall prey to is trying
to practice medicine from this side of the dias.
Chairman Sanders. Give it a try.
[Laughter.]
Senator Burr. The truth is that the VA is a medical home
and not everybody that prescribes in the private sector is
necessarily that patient's medical home. They are referred to
that pain specialist by their medical home and I think a
medical home is more apt to look at all the conditions that
surround an individual before they make a determination as to
which course to follow, and I think that is why maybe in the
private sector there are options.
I think the Chairman's intent was to say that they are not
all paid for by their insurance company where we have expanded
it greatly in the VA.
Dr. Kahn, I am fascinated to look at the studies once you
have completed them in these multi-geographical areas with a
variation of our active duty forces to see if we find
variations between the Army and others. I look forward to that.
But you testified that the VA needs to change from a
problem-fixing mentality to a more rounded approach toward
health care, and I think you alluded to the fact that this is a
big organization. There are a lot of people, and that makes it
challenging.
What do you see as those challenges?
Ms. Kahn. Well, first of all, any big boat takes a while to
turn. So, size is simply one problem. I do not know exactly
what the level of acceptance right now is among providers
across the VA so that would have to be assessed.
In general, I would say in the field of health care across
all health care professions--complementary, alternative,
conventional, I would say many of us are fairly arrogant about
our own approach and not necessarily even well informed about
other approaches.
Senator Burr. What do you see as the biggest impediment for
VA making this transition?
Ms. Kahn. I do not see anything insurmountable. I think if
the will is there it can absolutely be done. I think in general
we have not seen large-scale use of integrative health care. It
has been sort of an almost boutique form, but I think the
single largest civilian health system that is integrating
across the whole system is Allina Health, which is in Minnesota
and Wisconsin. It is not the 150 medical centers and 1,500
clinics that the VA has. It is 12 hospitals and 150 clinics.
But it begins to show the scalability, and I think the VA could
do it.
Senator Burr. Dr. Edlund, tremendous research comes out of
RTI, and we are grateful for that, and thank you for your work
on this. Your testimony discusses several research studies you
conducted regarding the patterns of opiate prescribing in VA
facilities.
Let me ask you, does RTI plan to conduct further research
in that area?
Dr. Edlund. I am hoping to submit another grant, yes; and
we have submitted grants in the past that have not been funded.
So, yes, it is an active area of research.
Senator Burr. Can you describe for us what you see that
next research project structured like, that you would submit
that grant for?
Dr. Edlund. Yes. The most recent grant that I have is
actually not a VA grant. It is outside of the VA. Well, we will
also be using VA physicians.
We are looking at what goes into or how do physicians
arrive at the decision to prescribe an opiate. Opiates are a
two-edged sword, and the question is always how do you balance
the risks and benefits.
I am interested in understanding how they do that and what
makes them decide along with the patient, OK, we are going to
prescribe an opiate in this case or we are not going to
prescribe an opiate in this case or we are going to escalate
the opiate.
So, these kind of fundamental decision-making processes
that the physicians have to make along with the patient, we
really do not understand at all and our next grant is to go in
and try to better understand that.
Senator Burr. Well, maybe, I can persuade Dr. Briggs for
the Committee to answer that question that I believe she has
probably looked at and it is a fascinating thing because I
think we are making a big assumption that there is a tremendous
amount of thought put into that determination.
My observation would be opiates are prescribed a lot of
times because that is what the patient came in and asked for,
and doctors feel compelled to send them out with what, in fact,
they requested. That may be part of our problem.
I thank the Chair.
Chairman Sanders. Thank you, Senator Burr.
Senator Blumenthal.
Senator Blumenthal. Thank you, Mr. Chairman.
Dr. Edlund, this number may have been in your testimony but
I have trouble seeing it highlighted there. Is there an average
for the amount of time or the amount of drugs, opioids that are
taken when they are prescribed?
Dr. Edlund. I am sorry. I am not understanding. Is there
what?
Senator Blumenthal. Is there an average either period of
time or amount of drugs over a period of time? In other words,
someone who is prescribed an opioid takes it on average for 6
months, 2 weeks, a year.
Is there any data on how long the average prescription
lasts?
Dr. Edlund. Yes. Well, what we know is that--we
differentiate between acute opiate use and chronic opiate use.
So acute use would be you hurt your ankle and that is not what
we are talking about.
But with chronic use, what we know is that once an
individual has been on chronic opioids for about 90 days, then
most of those individuals will go on to use opioids for years.
Really, you know, we cannot figure out and an average because
at the end of 5 years, 75 percent of them will still be on
opiates.
Senator Blumenthal. Is there any data on whether the
prescription for chronic users increases over time? In other
words, does the amount of opioids prescribed have to increase
to, in effect, take care of the same level of pain or for some
other reason?
Dr. Edlund. No. That is a very good question and that is
poorly understood, meaning whether or not in what percentage of
cases the opioid dose can be stable.
Definitely in some cases you have to increase the dose over
time because the patient develops a tolerance and that is the
whole problem with opiate use is that, you know, it is a spiral
that is always going upward. But we do not know how many people
are in a spiral going upward and how many people are relatively
stable.
Senator Blumenthal. Is that not an important question?
Dr. Edlund. Yes. There are a lot of fundamental important
questions in opioids that have not been answered.
Senator Blumenthal. I apologize for interrupting you but my
time is limited; to follow up on Senator Burr's excellent
question, it may well be that the patient comes in and says I
need more, Doc.
Dr. Edlund. It may very well be and I agree that a lot of
times probably not a lot of thought is put into these
decisions.
Senator Blumenthal. And is there a way, for example, to
have trip wires, for a lack of a better word? In other words,
after 6 months there has to be a complete review by some
independent medical professional or panel or some kind of
authority to say, you know, there is a pattern here, increasing
use over 6 months or, in other words, some kind of independent
review.
Dr. Edlund. Yes. Obviously that could be done easily, but
to my knowledge it is fairly rarely done.
Senator Blumenthal. And in your experience, to talk about
Post Traumatic Stress--and I would ask this question of Dr.
Kahn as well--Post Traumatic Stress, is that condition
addressed therapeutically by opioid use or does opioid use
address other conditions that, as Secretary Petzel said, may be
found accompanied with Post Traumatic Stress, pain along with
Post Traumatic Stress; is there an affect on the Post Traumatic
Stress of using opioids either good or bad?
Dr. Edlund. I am not familiar with that research. I do know
that a lot of people with PTSD receive opioids, but I cannot
speak to the finding.
Senator Blumenthal. There is no research so far as you are
aware----
Dr. Edlund. Not that I am aware of.
Senator Blumenthal [continuing]. Showing the effects on
Post Traumatic Stress, minus of opioid use?
Dr. Edlund. No, not that I am familiar with.
Senator Blumenthal. Dr. Kahn, are you aware of any such
research?
Ms. Kahn. No, I am not.
Senator Blumenthal. I would welcome--since I cannot ask the
past panel whether they are aware of such research, if they
are, please make me and perhaps the Committee aware of it.
I thank you, Mr. Chairman. Just one footnote here which I
have said before. I refer to Post Traumatic Stress as Post
Traumatic Stress rather than Post Traumatic Stress Disorder,
and I had said it to others who have testified here including
Secretary Shinseki.
You may agree or disagree but I think it is important to
remove the stigma of Post Traumatic Stress by not referring to
it as a disorder. I may be clinically and medically out in left
field but so be it. Thank you.
Thank you Mr. Chairman.
Chairman Sanders. Senator Blumenthal, thank you very much
and, Dr. Kahn, Dr. Edlund, thank you very much for helping us
out on this very important issue.
Ms. Kahn. Thank you.
Chairman Sanders. And with that, the hearing is now
adjourned.
[Whereupon, at 11:53 a.m., the Committee was adjourned.]
A P P E N D I X
----------
Prepared Statement of The American Legion
By the time Justin Minyard discovered the video of himself
stoned, drooling and unable to help his daughter unwrap her
Christmas presents, he was taking enough OxyContin, oxycodone
and Valium every day to deaden the pain of several terminally
ill cancer patients.
``Heroin addicts call it the nod,'' the former Special Forces
soldier says of his demeanor in that video. ``My head went
back. My eyes rolled back in my head. I started drooling on
myself. My daughter was asking why I wasn't helping her, why I
wasn't listening to her.''
Seeing that video jolted Minyard out of a two-year opiate
stupor. He asked a Fort Bragg pain specialist to help him get
off the painkillers his primary care physician had prescribed.
``I was extremely disappointed in myself,'' he says. ``I knew I
couldn't do that to my family again.''\1\
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\1\ Excerpt ``On the Edge'' The American Legion Magazine story by
Ken Olsen, April 1, 2014.
The preceding story is just one of many recent anecdotal accounts
of veterans struggling with over-prescription of medications. In the
best cases, the veteran in question has been able to pull themselves
back from the brink, regroup, and work toward a different mode of care
that doesn't have the same devastating effect on the veteran and their
families. In the worst cases, veterans have died from accidental
overdose, or attempted suicide in a medication-induced haze.
In September 2013, CBS news reported the tragic tale of 35 year old
Army SPC Scott McDonald, who tragically perished from the accidental
overdose brought about by the cumulative effects of the lengthy list of
medications he had been prescribed.\2\ The American Legion believes
these risks increase the importance of exploring Complementary and
Alternative Medicine (CAM) therapies \3\ that can reduce the
overreliance on prescription drugs and help bring these veterans back
from the brink of the abyss.
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\2\ http://www.cbsnews.com/news/veterans-dying-from-overmedication/
\3\ Resolution #108: Request Congress Provide the Department of
Veterans Affairs Adequate Funding for Medical and Prosthetic Research
---------------------------------------------------------------------------
The American Legion has continued to be concerned with the
unprecedented numbers of veterans returning from the wars in Iraq and
Afghanistan suffering from TBI and PTSD, categorized as the ``signature
wounds'' of these conflicts. The American Legion believes that all
possibilities should be explored and considered in an attempt to
finding treatments, therapies, and cures for TBI and PTSD to include
alternative treatments and therapies, and they need to make them
accessible to all veterans. If these alternative treatments and
therapies are deemed effective they should be made available and
integrated into the veterans' current health care model of care.
As a result The American Legion established the TBI and PTSD
Committee in 2010 comprised of American Legion Past National
Commanders, Commission Chairmen, respected academic figures, and
national American Legion staff. The Committee is focused on
investigating existing science and procedures as well as alternative
methods for treating TBI and PTSD that are not being employed by the
Department of Defense (DOD) and VA for the purpose of determining if
such alternative treatments are practical and efficacious.
During a three year study the Committee met with leading
authorities in the DOD, VA, academia, veterans, private sector mental
health experts, and caregivers about treatments and therapies veterans
have received or are currently receiving for their TBI and PTSD
symptoms. Last year the Committee released their findings and
recommendations in a report titled ``The War Within.'' ``The War
Within'' report highlights these treatments and therapies and also
identifies findings and recommendations to the DOD and VA.
key highlights and findings of the report:
Some of the critical findings of The War Within included:
Most of the existing research for the last several years
has only validated the current treatments that already exist--VA and
DOD research is not pushing the boundaries of what can be done with new
therapies, merely staying within an environment of self-confirmation
bias.
There seems to be a lack of fast track mechanisms within
DOD and VA to employ innovative or novel therapies--a standardized
approach to these therapies could help servicemembers and veterans gain
access to care that could help them.
While some VA medical centers (VAMCs) do offer
complementary alternative medicine (CAM) therapies, they are not
offered in a consistent or uniform manner across all 152 VAMCs
nationwide--VA struggles with consistency and needs better guidance.
In addition to those findings, the TBI and PTSD Committee made some
recommendations for the way forward:
Congress needs to provide oversight and funding to DOD and
the VA for innovative TBI and PTSD research that is being used
successfully in the private sector healthcare systems such as
hyperbaric oxygen therapy, virtual reality exposure therapy, and non-
pharmacological treatments and therapies.\4\
---------------------------------------------------------------------------
\4\ Resolution #108: Request Congress Provide the Department of
Veterans Affairs Adequate Funding for Medical and Prosthetic Research
---------------------------------------------------------------------------
Congress needs to increase DOD and the VA research and
treatment budgets in order to improve the research, screening,
diagnosis, and treatments for TBI and PTSD.
DOD and VA need to accelerate their research efforts in
order to effectively and efficiently diagnose and develop evidence-
based TBI and PTSD treatments.
continued efforts:
The American Legion's efforts to assess the care and treatments
available for veterans suffering from TBI and PTSD are not limited to
the efforts of the TBI and PTSD Committee. In 2003, The American Legion
established the System Worth Saving Task Force to conduct ongoing, on-
site evaluations of the Veterans Health Administration (VHA) medical
system. Annually, System Worth Saving visits provide Legionnaires,
Congress and the public with an in-depth, boots on the ground view of
how veterans are receiving their healthcare across the country.
Over the last several years, the System Worth Saving reports have
examined the full spectrum of VHA care, but specifically have noted
several things about how VHA delivers on complementary and alternative
medicine (CAM) in their facilities.
VA medical centers throughout the VA healthcare system are
committed, dedicated, and compassionate about treating veterans with
TBI. Many medical centers throughout the country have found successful
complementary and alternative methods for the treatment of TBI and PTSD
such as hiking, canoeing, nature trips, equine, and music therapy.\5\
While some systems like the El Paso VA Healthcare System offer several
CAM solutions, such as yoga, guitar lesions, sleep hygiene and other
practices, other locations such as the Pittsburgh VA and Roseburg VA
Healthcare System are more limited, offering only acupuncture in
Pittsburgh, and acupuncture for pain management through the fee basis
program in Roseburg.\6\
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\5\ 2011 SWS--``Transition of Care from DOD to VA''
\6\ 2014 SWS--``Past, Present and Future of VA Health Care''
---------------------------------------------------------------------------
In addition to the ongoing System Worth Saving Task Force visits,
The American Legion is taking the lead for veterans by aggressively
pursuing the best possible treatment options for veterans on multiple
fronts.
hearing from veterans about their treatment:
On February 3, 2014, The American Legion launched a TBI and PTSD
survey online in order to evaluate the efficacy of the veterans' TBI
and PTSD care, treatments, and therapies and to find out if they are
receiving and benefiting from CAM treatment offered by the DOD and VA.
The survey, conducted in coordination with the Data Recognition
Corporation (DRC), Dr. Jeff Greenberg, Ph.D., and the Institute for the
Advancement of Military and Veteran Healthcare, was to assist The
American Legion to better understand the experiences of veterans who
receive care throughout the VA healthcare system.
William Detweiler, Past National Commander and Chairman of the TBI
and PTSD Committee has stated about the survey, ``The American Legion
is very concerned by the unprecedented number of veterans who suffer
from these two conditions * * * We firmly believe that both VA and DOD
need to act aggressively in adopting all effective treatments and
cures, including alternatives being used in the private sector, and
make them available to our veterans nationwide * * *. By completing
this survey, veterans across America will have the opportunity to tell
the true story of the types of care and treatments that they are
actually receiving for PTSD and TBI. The survey will greatly help The
American Legion in its efforts to advise the Administration, Congress,
DOD, VA on the best possible care and treatments for these injuries.''
The full survey results will be released and discussed in detail at
the upcoming American Legion TBI and PTSD Symposium, June 2014, however
two key data points emerged which bear special significance to this
testimony.
Medication appears to be the front line treatment reported
by respondents.
A sizable proportion of respondents reported prescriptions
of up to 10 medications for PTSD/TBI across their treatment experience.
Both of these data points should raise concerns about whether
veterans are getting the right treatment for these signature wounds of
the past decade's wars.
symposium:
On June 24, 2014 in Washington, DC, The American Legion is hosting
a TBI and PTSD Symposium entitled ``Advancing Care and Treatment for
Veterans with TBI and PTSD.'' The symposium aims to discuss the
findings and recommendations from the TBI and PTSD veteran's survey,
and will hear directly from servicemembers, veterans, and caregivers on
their TBI and PTSD experiences, treatments and care. The symposium will
also help us determine how the Administration, Congress, DOD and VA are
integrating complementary and alternative treatments and therapies into
current models of veterans' health care.
conclusion:
After a decade of war, America is still grappling with an evolving
understanding of the nature of the wounds of warfare. Veterans must be
reassured that the care they receive, whether serving on active duty in
the military, or through the VA Healthcare system in their home town,
is the best treatment available in the world. To combat the physical
and psychological wounds of war, sometimes the old treatments are not
going to be the most efficacious.
Just as new understanding about the nature of these wounds emerges,
so too must the new understanding about the best way to treat these
wounds continue to adapt and evolve. Veterans are fortunate to have
access to a healthcare system designed to treat their wounds, but that
system must recognize that different treatments will have differing
levels of effectiveness depending on the individual needs of the
wounded veteran. There is no silver bullet. There is no single
treatment guaranteed to cure all ailments. With a national policy that
respects and encourages alternative therapies and cutting edge
medicine, veterans have the best possible shot to get the treatment
they need to continue being the productive backbone of society their
discipline and training prepares them to be.
Consider the following condensed version of one of the many veteran
stories in The American Legion's The War Within:
Tim Hecker joined the Army at 18 and soon decided to make a
career of it. He served 22 years in all, in and out of combat,
rising to the rank of master sergeant. In the summer of 1990,
he married his high school sweetheart, Tina, and the couple had
three children.
Then Tim couldn't remember having married Tina. He couldn't
tell his sons apart. Their names escaped him. Injuries suffered
in two separate roadside-bomb explosions in a span of two
months in Iraq in early 2008 left him with a Traumatic Brain
Injury and severe post-traumatic stress. He was no longer the
man Tina had married.
Frustrated with her husband's descent and the lack of
progress with traditional care, Tina went online and found
information about hyperbaric medicine. Following a phone call
and an initial interview, Tim was selected to be part of a
pilot study on the use of hyperbaric oxygen therapy (HBOT) for
Traumatic Brain Injury (TBI) and Posttraumatic Stress Disorder
(PTSD). He claims the treatments have given him back most of
his pre-injury life.
``By the fourth treatment, I started feeling like a new
person,'' he says at his home in West Edmeston, N.Y. ``I was
more aware. I could see things. The deeper I got into the
treatments, my cognition started to come back--my motor skills
and my balance. My vision started to improve. The biggest
benefit was my emotional control.''
``We're talking a 180-degree turn around,'' Tina says.
``There are days when he's almost back to normal with his
personality.''\7\
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\7\ http://www.legion.org/publications/217301/war-within-treatment-
traumatic-brain-injury-and-post-traumatic-stress-disorder
Ultimately, that is why it's so important to ensure VA solves the
over medication puzzle. The veterans have already returned home from
war. This is about helping the veterans to finally return home to their
families.
The American Legion looks forward to working with the Committee, as
well as VA, to find solutions that work for America's veterans. For
additional information regarding this testimony, please contact Mr. Ian
de Planque at The American Legion's Legislative Division, (202) 861-
2700 or [email protected].
______
Prepared Statement of Joy J. Ilem, Deputy National Legislative
Director, Disabled American Veterans
Chairman Sanders, Ranking Member Burr and Members of the Committee:
DAV (Disabled American Veterans), an organization of 1.2 million
wartime veterans who were wounded, injured or made ill due to their
military service, appreciates this opportunity to offer testimony for
the record of your hearing to examine overmedication and its problems
and solutions in the Department of Veterans Affairs (VA).
Less than a month ago, VA formally directed its 21 Veterans
Integrated Service Networks (VISN) to launch a new and intensive opioid
safety initiative. The stated goals are to reduce harm to veterans from
unsafe medications and dosages, but to adequately control veterans'
pain. While DAV offers no opposition to this initiative, our experience
in recent years in several local instances with VA physicians who
decided to abruptly discontinue prescribed opioids for our members
without offering them alternatives does not lend confidence that this
initiative will be carried out with sensitivity to the needs of
veterans to tolerably manage their pain in absence of such drugs. Some
of our members who contacted DAV had been prescribed these drugs for
decades, and were tolerating their pain well, but were offered little
to no alternatives when VA physicians decided to abruptly end such
prescribing. In situations such as these, we are concerned that these
veterans will turn to alcohol or illicit drugs in search of pain
relief, or will be left to needlessly suffer.
As we understand it, VA's opioid safety initiative contains nine
goals. The initial goals (to be accomplished within six months,
according to the directive) would establish systems to educate VA
prescribers about safely and effectively prescribing opioids; increase
the usage of urinalysis to detect presence of opioids in veterans'
urine; provide VA prescribers potential access to state prescription
databases to identify veterans who are in receipt of opioids from
private prescribers; and establish ``tapering programs'' for certain
veterans using opioids along with other drugs.
The second set of VA goals, to be achieved over the next nine
months, includes central development of a ``risk stratification
toolkit'' to be deployed locally in VA facilities to enable physicians
to assess veterans using opioids who should not be treated with them,
or identify those who can be given reduced doses at a safer level.
Another goal calls for each VISN to implement a uniform tapering
program for certain ``high-risk'' opioids, with an overall objective of
VA's achieving a 75 percent reduction in the use of certain opioids by
not later than December 15, 2014.
The third set of VA goals, to be achieved over a year or possibly
longer, requires all VA facilities to identify veterans who are
prescribed opioids above a stated dosage ceiling (200 milligrams of
morphine equivalents per day). VA Central Office will collate this data
and provide it to VISNs and facilities, which will be required to
conduct appropriateness reviews with prescribers who are identified as
providing veterans dosages higher than the dosage ceiling. Another goal
is for all VA facilities to provide at least two unspecified
complementary and alternative medicine (CAM) modalities in the
treatment of chronic pain. These modalities are to be put in place by
March 15, 2015.
The last goal is to establish a mental health component within the
Patient Aligned Care Team approach to delivering VA care to veterans
with a history of prescribed opioid use, focusing on establishing a
three-facility trial of deploying ``interdisciplinary medication risk
management teams,'' to identify ``strong practices that can be
operationalized across the VHA Healthcare System,'' to achieve further
reductions in the use of prescribed opioids.
The above description of VA's initiative is oversimplified and
summarized for the Committee's use, but constitutes our understanding
of its purpose based on our review of the directive and information we
have received from VA practitioners who remain concerned about this new
program's effectiveness and its impact on veterans in pain. To our
knowledge neither DAV nor the remainder of the veterans service
organization community have had a comprehensive briefing by VA on this
new program, its purpose and justification, and how it will be
implemented and monitored. It is also our understanding that, although
already issued to VISNs and facilities, the directive is being
reconsidered based on numerous concerns that have arisen since, and may
be amended.
While we have not received a national resolution from our
membership on the topic of opioid reduction in VA health care, as
indicated above, many of our members who were wounded, injured or made
ill due to military service during wartime suffer from chronic pain
from numerous causes other than malignancy (the only stated exception
to this initiative), and presumably will be targeted by this new
policy. The directive suggests that the use of CAM combined with
integration of a specialized, and as yet untested, new mental health
treatment model can substitute for existing prescribing practices by VA
physicians who are dealing over time in primary and specialty care with
veterans suffering from chronic pain and chronic pain syndrome.
In a confounding countertrend, the Veterans Benefits Administration
recently announced in the Federal Register that it has determined
justification is sufficient to award service-connected ratings to
veterans suffering from chronic pain and chronic pain syndrome, as
discrete disabilities. DAV fully supports this broader authority to
recognize that chronic pain is real, damaging and even debilitating.
Also, this decision on rating veterans with chronic pain would suggest
that chronic pain is a significant disabling condition from the vantage
point of the VA division that awards disability compensation, whereas
based on this new opioid reduction directive, another division of VA
may see it quite differently.
DAV is also concerned about VA's potential participation in state
drug monitoring programs. Many of these activities were stimulated by
law enforcement, not public health authorities, in a search for illicit
prescribing practices by private physicians, and trafficking in
controlled substances by people who defraud physicians. While we
appreciate VA's legitimate interest in protecting against abuse and
overuse of opioids, we are concerned about potential unintended
consequences of VA's approach to these state monitoring programs and
recommend close oversight by the Committee to ensure its purposes are
limited to the health and safety of veterans and of their health care.
DAV would never advocate for broad use of narcotics as a first
line, or only line, of treatment for wounded, injured and ill veterans
with chronic pain or chronic pain syndrome; however, the intent of VA's
new initiative seems dedicated first to a drastic reduction in the use
of painkiller drugs over other purposes, and may not keep uppermost the
needs of veterans who suffer from chronic pain as a clinically
legitimate treatment population.
DAV strongly supports bringing significant CAM treatments into VA
health care, particularly for younger veterans who do not want
traditional health care, prescription medications or typical mental
health treatments; however, if VA intends to use CAM as a substitute
for, or replacement of, legally prescribed opioid medications in a
known and older population, we urge VA to ensure the effects of
shifting veterans away from these medications is closely followed in
clinical care, lest these veterans resort to the abuse of alcohol or
other drugs to compensate for the loss of painkillers that actually
work for them. Additionally, VA facilities' selection of CAM models may
not have the desired effect intended by this directive. For example, a
study in the Journal of the American Medical Association (``Acupuncture
for the Treatment of Cocaine Addiction: A Randomized Controlled
Trial,'' January 27, 2010) that followed treatment of a large group of
cocaine users diverted to acupuncture therapy as a substitute did not
demonstrate effectiveness in reducing the use of cocaine in that
population. In fact, the study ``does not support the use of
acupuncture as a stand-alone treatment for cocaine addiction or in
contexts in which patients receive only minimal concurrent psychosocial
treatment.'' Numerous other published studies replicate this finding on
acupuncture, and are reported on VA's Health Services Research and
Development web page, http://www.hsrd.research.va.gov/publications/esp/
acupuncture.cfm. In our view, VA health care officials should carefully
study the efficacy of CAM modalities as exchanges for prescribed
opioids for pain to ensure they can accomplish the results intended,
and that CAM modalities selected by facilities are efficacious for
these purposes, are evidence-based, and are accompanied by appropriate
other treatment resources.
Mr. Chairman, perhaps most important to the purposes of this
hearing, DAV is concerned that the required rapid implementation of
this new directive will not be standardized and uniform across the vast
VA system. In fact, the directive itself allows for local deviations
and modifications, by ``providing opportunity for customization to meet
local needs.'' The alternative approaches that are offered in the
directive are vague, and may lead to wide variations, or only limited
local implementation. In DAV's view, the directive should mandate
interdisciplinary pain management teams be established at each
facility, and ensure these teams are functional, before launching such
an aggressive tapering program. The structure and function of such
teams should be specified and mandatory. Without more specificity, a
``pain management team'' may simply become a single provider designated
in a facility whose primary (or imposed) clinical role would be to
reduce the prescribing of opiates to veterans, without providing viable
alternatives to address their pain.
We believe any alternative treatments accompanying this plan should
be specified and required in the directive. This availability should
include psychological pain management treatments and other alternative
treatments, including but not limited to specialized counseling,
chiropractic care, and CAM approaches that are evidence-based. Even
when some of these services are made ``available,'' a veteran with
chronic pain may only be given a limited course of treatment, or be
made to choose one or the other but not both to meet pain care needs.
This would be an unfortunate and unsafe way to deal with opioid
reduction due to its impact on the health of individual veterans. As an
advocate for these veterans, especially those who were wounded, injured
and ill due to military service, such an outcome would be unacceptable.
During VA's initiative to implement a national formulary 15 years
ago, many prescribers complained that they were disallowed from
prescribing preferred, standard medications they had used for years in
their practices because they were not a part of the then-new national
formulary. In order for VA physicians to procure off-formulary drugs
under the policy, VA established a national procedure in which the
prescriber had to submit an explicit justification for use of a
particular drug in an individual veteran's case, before a local or VISN
VA pharmacy prescribing board, to gain approval of the deviation. This
process at the time was seen as time consuming, a dampening influence,
an interference of professional practice, and a difficult bureaucratic
barrier. The formulary change accomplished the VA's goal of producing
cost savings, but it came at the expense of many veterans who needed to
adjust to new medications without warning and in some cases against the
interests of their prescribing physicians. We hope and trust this new
initiative will not carry similar consequences for the veterans it is
going to affect.
Finally, also about 15 years ago, it is helpful to recall that VA
took the national and even international lead on establishing pain as
the ``fifth vital sign.'' Hospitals and physician practices all over
the world now use this concept in evaluating patients' pain level and
developing interventions for pain as an important treatment goal on its
own merit. Pain is the number one reason people, including wounded,
injured and ill veterans, seek health care. DAV hopes VA will be able
to carry out this new initiative to reduce opioid prescribing recalling
its stewardship of pain management in western medicine, without rushing
to judgment that veterans under VA care are atypically overprescribed
narcotic medications. We understand from practitioners in VA facilities
that, already, the pressure on, and monitoring of, providers to
decrease their prescribing of opioids in pain management is leading to
significant reductions in such prescribing, with no good alternatives
available for affected veterans who are suffering from chronic pain.
This is a troubling development, and we hope the Committee will
thoroughly review this situation, not only during this hearing but on a
recurring basis, to ensure that veterans experiencing pain remain VA's
primary focus.
Mr. Chairman and Members, this concludes DAV's statement. Again,
DAV appreciates the indulgence of the Committee in permitting the
submission of this testimony.
______
Prepared Statement of Jacqueline A. Maffucci, Ph.D.,\1\ Research
Director, Iraq & Afghanistan Veterans of America
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\1\ Dr. Jackie Maffucci, IAVA's Research Director, holds a Ph.D. in
neuroscience from the University of Texas at Austin. She previously
worked with the Provost Marshall General and other senior leaders at
the Armed Forces Services Corporation to develop, implement, and
monitor research programs and opportunities to address the health and
wellness needs of servicemembers.
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Chairman Sanders, Ranking Member Burr, and Distinguished Members of
the Committee: On behalf of Iraq and Afghanistan Veterans of America
(IAVA), I would like to extend our gratitude for being given the
opportunity to share with you our views and recommendations regarding
overmedication, an important issue that affects the lives of thousands
of servicemembers and veterans.
As the Nation's first and largest nonprofit, nonpartisan
organization for veterans of the wars in Iraq and Afghanistan, IAVA's
mission is critically important but simple--to improve the lives of
Iraq and Afghanistan veterans and their families. With a steadily
growing base of nearly 270,000 members and supporters, we aim to help
create a society that honors and supports veterans of all generations.
In partnership with other military and veteran service
organizations, IAVA has worked tirelessly to see that veterans' and
servicemembers' health concerns are comprehensively addressed by the
Department of Veterans Affairs (VA) and by the Department of Defense
(DOD). IAVA understands the necessity of integrated, effective, world-
class healthcare for servicemembers and veterans, and we will continue
to advocate for the development of increased awareness, recognition and
treatment of service-connected health concerns.
A recent report from the Center for Investigative Reporting found
that over the last 12 years, there has been a 270 percent increase in
Veterans Health Administration (VHA) prescriptions for four powerful
opiates.\2\ There has also been an increase in psychiatric medication
prescriptions as well.\3\
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\2\ Glantz, A. (2013, September 28). VA's opiate overload feeds
veterans' addictions, overdose death. Center for Investigative
Reporting. Retrieved from http://cironline.org/node/5261
\3\ Government Accountability Office. (2012, November 14). DOD and
VA Healthcare: Medication Needs during Transitions May Not Be Managed
for All Servicemembers. Retrieved from http://www.gao.gov/products/GAO-
13-26
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Given the last 12 years of conflict and the very physical and
psychological demands on our troops, it is no surprise that veterans
are seeking care at the VA for a multitude of needs. The use of
medication to treat certain physical and mental conditions is a valid
treatment option, but the VA must continue to develop a comprehensive
and multidisciplinary approach to treatment.
The need for comprehensive treatment is particularly prevalent in
polytrauma cases, which are among the most complex medical cases to
address. Pain often presents in consort with other conditions, such as
depression, anxiety, PTSD, or TBI. Providers can be challenged to treat
such polytrauma cases because of the challenge of managing multiple
conditions. Some of these conditions may limit the drugs available to
the patient, making treatment options limited.
These issues constitute major challenges for providers. Certainly
part of a treatment program for chronic pain or mental health issues
may include strong medication, including opioids and psychiatric
medications; but a schedule of treatment should not be limited to
pharmaceutical treatment and should integrate a host of other proven
therapies. This is why a stepped case management system can be very
helpful. In this type of system, a primary care physician has the
support of an integrated, multi-disciplinary team of providers to
design and implement a comprehensive treatment plan for the patient.
With approximately 22 veterans dying by suicide every day, and more
attempting suicide,\4\ reducing instances of overmedication and
limiting access to powerful prescription medications that can be used
to intentionally overdose must be included in a comprehensive approach
to addressing the issue. Particularly considering that overdosing is a
common mechanism for suicide attempts, with over half of all non-fatal
suicide events among veterans resulting from overdose or intentional
poisoning.\5\
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\4\ Kemp, J. and Bossarte, R. (2012). Suicide Data Report 2012.
Department of Veterans Affairs. Retrieved from http://www.va.gov/opa/
docs/suicide-data-report-2012-final.pdf
\5\ Ibid.
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The VA's 2012 Suicide Data Report also showed that between 74-80
percent of servicemembers and veterans sought care from a provider
within four weeks of attempting suicide.\6\ This evidence shows the
critical need for providers to not only provide access to timely mental
health services, but also to ensure that the risk of overdose and
overmedication are minimized through the use of state prescription
monitoring programs and the creation of formulary take-back programs.
---------------------------------------------------------------------------
\6\ Ibid.
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Given the challenging nature of understanding the medical and
mental health needs of veterans, the VA and the DOD have made laudable
initiatives to meet these needs. But the challenge remains to uniformly
and effectively translate all of these efforts to practice. Too often
we hear the stories of veterans who are prescribed what seems like an
assortment of psychiatric medications and/or opioids with very little
oversight or follow-up. On the flip side, there are also stories of
veterans with enormous pain and doctors who won't consider their
requests for stronger medication to manage the pain.
One IAVA family member has expressed frustration and concern in
regards to the VA's current opioid drug usage. Her husband, who was
prescribed nine different medications to address a range of health
issues related to pain, anxiety, and depression, tragically passed away
from what was labeled an accidental overdose by the corner. Since then,
his widow has been fighting for overmedication by the VA to be included
on his death certificate.
In a similar case highlighted by CBS, a veteran with 5 tours of
duty in Iraq and Afghanistan received a treatment plan from the VA with
a total of eight prescriptions. When he was prescribed a ninth drug by
the VA he took the medicine as instructed. The next morning he was
found by his wife. His death was classified as an accidental death due
to overmedication. His widow plans to sue the VA for his death.
It is not our job to second-guess the judgment of the doctors
treating these patients, but it is our job to question the system that
is providing overall care to our veterans and tracking this care. The
VA has established practices and policies aimed at providing quality
care to veterans, but it won't do our veterans any good if VHA cannot
efficiently and effectively integrate these findings into their
management practices and have a plan in place to continually improve
upon accepted practice with evidence-based findings. While the VA has
made great strides to recognize the need for comprehensive and
multidisciplinary support, clearly there is still a lot of room for
improvement in implementing these procedures.
In part, some of the challenges may be in the inherent differences
between the VA and DOD systems of care, whether it be in their
available formularies, uniformity of record keeping and medical
terminology used, or the interoperability, or lack thereof, of the
medical record systems, care for our military and veteran population
should be one integrated approach. A comprehensive treatment plan
requires the VA and DOD have an integration of medical records such
that receiving doctors are clear on the history of the patients that
they intake. But beyond that, once the veteran is received into the VHA
system, it's not just about putting out policies, clinical practice
guidelines, and funding research. At the end of the day, the success
will be seen in how those products are implemented into practice and
how they are continually assessed for effectiveness. The key will be in
education, integration, and assessment.
Again, we appreciate the opportunity to offer our views on this
important topic, and we look forward to continuing to work with each of
you, your staff, and this Committee to improve the lives of veterans
and their families.
Thank you for your time and attention.
______
A Report by Citizens Commission on Human Rights International
April 2014
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