Educating Practitioners about Pain - PAINWeek

friday
2011
The Cosmopolitan of Las Vegas
Las Vegas, NV
news
4 Barriers to Effective Chronic Pain Management
14 Functional Neuroimaging in Pain
21 Buying in to Biofeedback
6 Are You Confident Your Practice Could Withstand an Audit
12 Talking with Patients about Opioid Risks
13 Diagnosing the Cause of Joint Inflammation
15 Addictive Illness Should Not Rule out the Use of Opioids
16 The Key to Effectively Diagnosing “Back Pain”
17 Treating Myofascial Pain
25 Pill Mill Legislation
26 Managing Risk in Pain Management
28 The Human Toll of Prescription Drug Abuse
PREVIEW
Educating Practitioners about Pain:
It’s More than Just Synapses
Clinicians who wish to learn more about the ethical, moral, and social ramifications of pain, and who
also want to enhance their ability to treat people with pain, should attend the “Pain Education in the Real
World” series of lectures put on by Tufts University’s Program in Pain Research, Education & Policy (PREP), on
Saturday, September 10.
Recent developments in pain research make it clear
that pain education requires more than simply a
description of the machinery of nociception—the
biologic process of some receptor being activated by
heat, crush, or other nerve impulse being sent along a
nerve, according to Daniel Carr, MD, MD, FABPM, Professor
of Public Health and Community Medicine at Tufts University
School of Medicine, Boston, MA, and Director of
Tufts’ Program in Pain Research, Education & Policy (PREP).
Carr says that “pain is not the same topic in terms of pure
intellectual knowledge of a physiologic process such as glucose
regulation or acid balance.” He says that the essence of pain is
that “it is an interpersonal experience. I understand what your
pain is because you use words or behavior to relate your subjective
experience to the observer, and I as the observer look at
you and intuit or construct what is the nature of your experience
based on my past experience. I understand your pain by reconstructing
how it would feel to me subjectively. This is totally different
than measuring your blood pH or sodium concentration.”
Several faculty members from PREP, Tufts’ decade-old innovative
program that was developed to help clinicians and others
with an interest in the field relate to and manage people
with pain, will be presenting four talks on pain education on
Saturday, September 10.
Talks will include “From Compassion to Public Health Initiative:
Shaping the Graduate Pain Curriculum”, by Libby Bradshaw,
DO, MS; “Innovations in Learning: Building a Program
through Alliances and Collaborations,” by Richard Glickman-
Simon, MD; and “Enhancing Pain Education’s Real-World
Impact: Organizational, Sociocultural, and Ethical Considerations”,
by Carol Curtiss, MSN, RN-BC. Carr will lead off the
session with his presentation, “More Than Synapses: Why Pain
Education is Different”.
He says that pain education encompasses everything associated
with the phenomenon of the sensation of pain, and that
makes it a complex topic in its own right. To illustrate this complexity,
Carr describes a pattern of concentric circles. “If nociception
occurs, and you are conscious, and if your experience
is aversive, then you have pain. Next, if in concert with that
perceived or impending injury, illness, or operation, you sense
that your capacities are diminished or feel a sense of loss, you
can be deemed to be suffering. The final circle around those
three factors denotes pain behavior,” he says. An example of
pain behavior is the grimace. According to Carr, “the purpose
of a grimace, from an evolutionary point of view, is for someone
to see it and help.”
Research to understand the causes and treatments of pain,
education to help people apply the research, and efforts to
ensure that improvements will be embodied through health
policy are the crucial components of the PREP program’s mission
to educate patients and clinicians. “That is why we made our
logo—to emphasize that in our program we are taking more of
a public health and social view of pain, but we do not exclude
the biologic view. Indeed, we teach the biologic view in some
of our courses, but our framework is much broader,” Carr says.
Carr also emphasizes that there is a large moral and ethical
component to treating pain. “Because pain is linked to suffering,
you are harming someone by ignoring their suffering
when you could actually treat it,” Carr says.
The ethical dimension of pain care was further extended at
the 13th World Congress on Pain, held in 2010 in Montreal,
Canada, when a group of delegates got together and created
“The Declaration of Montreal,” which spoke of pain relief and
pain control as being fundamental human rights. “The argument
is that pain is like torture. If you know someone is in pain,
you have an obligation to alleviate it. If you could alleviate
something that is directly linked to suffering and that is avoidable,
don’t you have an ethical duty to do that” says Carr.
Carr says that PAINWeek attendees who come to the PREP
talks will learn to become more effective clinicians. “We want to
guide attendees to be able to better communicate about pain
and think about their patients’ pain. For example, listening to the
patient’s story, trying to determine the meaning of pain for that
patient, is a very important skill,” Carr says. “Almost always, the
meaning of pain ties in with some ability to function or perform
what is expected of that patient in a family or social context.”
His presentation will enhance attendees’ ability to communicate
with patients who have pain. “It will make them more
open to aspects of the clinician-patient interaction that they
may have brushed aside or marginalized because they’re not
as quantitative as things like blood pressure or blood sugar.
My colleague, Melanie Thernstrom, will talk about those other
aspects of the pain experience that are less easily conveyed.
She uses the word ineffableso our purpose is to try to enrich
attendees’ ability to be a multidimensional clinician and increase
their effectiveness in communicating with and treating
their own patients with pain,” he says.
Pain education has enormous and intrinsic qualitative and
subjective aspects, which, according to Carr, many traditionally
trained doctors, nurses, and pharmacists do not like to deal
with. “Clinicians may feel uncomfortable dealing with these
aspects because they sound vague and ‘squishy,’ but they’re
actually really important,” he says.
—By Fran Lowry
RECAP
Drug Abuse:
We Can’t Afford It
Crime and criminal activity associated with the
abuse, misuse, and diversion of prescription opioids
are an increasingly significant problem that will
require a multifaceted approach that includes
law enforcement, education, and the health care
commuity
Drug abuse and its consequences are not just a concern
of the law enforcement community, Lisa McElhaney,
vice president of the National Association
of Drug Diversion Investigators, told the audience yesterday
during “A Law Enforcement Perspective to Drug Abuse.” Drug
abuse affects us all, and its costs are disastrous, she said.
“You cannot say, ‘It’s not my problem,’” McElhaney said.
“Each one of us needs to step up to the plate.” McElhaney
shared several statistics and indicators to illustrate the grim
physical and financial toll exacted by drug abuse in the US:
• It is a multibillion dollar industry.
• In 2001, the estimated total cost for opioid misuse/abuse
was $8.6 billion; direct care necessary to treat overdoses
(continued on page 4)
Important Course Changes
Michael Ellner and Dan Cleary will host two
Hypnosis Workshops today. They will be held from
11:05 am-12:00 pm and from 2:00-2:55 pm in
Praga 3/Level 3.
Brought to you by the publisher of
PAIN
MANAGEMENT

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friDAY
September 9, 2011
Pain Education in the Real World
Interdisciplinary, Collaborative, Compassionate Models of
Education in Pain Management
Clinicians and researchers from a unique education program share insights into how they are working to transform pain education in the real world
This special program at PAINWeek 2011 will showcase the ideas and principles behind the Tufts University School of Medicine Program in Pain Research, Education & Policy (PREP), a unique
interdisciplinary educational program that is designed to address “the multidimensional public health burden of pain by preparing diverse learners to contribute with expertise and compassion
to pain research, education and policy.”
More Than Synapses: Why Pain
Education is Different
Presenters: Daniel B. Carr, MD, FABpm, and
Melanie Thernstrom
Time: 10:00am – 10:55am
Location: Level 3/Gracia 1
Because “recent developments in pain research
make it clear that pain education
requires more than simply a description of
the machinery of nociception,” this course
will examine curricula that “deepens our
understanding of the intersubjective and
biopsychosocial qualities of pain,” while
emphasizing the importance of “qualitative
and narrative approaches to studying and
educating others about the topic of pain.”
Carr and Thernstrom will also discuss the efforts
of Tufts’ PREP program “to inform its approach
to interdisciplinary pain education
through the incorporation of these recent
insights.”
Innovations in Learning: Building
a Program through Alliances and
Collaborations
Presenter: Richard Glickman-Simon, MD
Time: 11:05am – 12:00pm
Location: Level 3/Gracia 1
Glickman-Simon will discuss the evolving approach
to pain education that relies on “interprofessional
partnerships across educational
programs and institutions that have overlapping
missions.” He will review the benefits
and risks associated with these collaborative
initiatives, using as an example the alliance
between Tufts University School of Medicine
and the New England School of Acupuncture.
He will also examine the ways in which
“emerging educational methodologies and
innovations can broaden alliances across disciplines
and geographical locations.”
To learn more, watch for the session preview
and interview with Glickman-Simon in the
Saturday daily.
From Compassion to Public Health
Initiative: Shaping the Graduate Pain
Curriculum
Presenter: Ylisabyth Bradshaw, DO, MS
Time: 2:00pm – 2:55pm
Location: Level 3/Gracia 1
Continuing the theme of interdisciplinary and
inter-institution collaboration and cooperation
in the delivery of innovative pain education,
this session will focus on “how to construct
pain-related curricula that both convey objective
knowledge and also create communities of engaged
learners who support each other through
a shared sense of collegiality rather than professional
rivalry.” Bradshaw will explain that the key
to success in this model is to ensure that the curriculum
and the context within which it is provided
“deliberately sustains and fosters” health care
professionals’ compassion for patients.
To learn more, watch for the session preview
and interview with Bradshaw in the Saturday
daily.
Enhancing Pain Education’s Real-
World Impact: Organizational, Sociocultural
and Ethical Considerations
Presenter: Carol P. Curtiss, MSN, RN-BC
Time: 3:05pm – 4:00pm
Location: Level 3/Gracia 1
The final session of this unique PAINWeek
program track will explore the ways in which
“sociocultural, ethical, and organizational values
and beliefs produce different expectations
about pain and pain relief among individuals
and organizations,” and the challenges (and
opportunities) this presents when educators integrate
“biopsychosocial, cultural, and ethical
aspects of pain and pain management into
education and everyday practice.” Curtiss will
also discuss strategies to promote organizational
change to improve pain care.
To learn more, watch for the session preview
and interview with Curtiss in the Saturday
daily.
EDITORIAL
FDA Must Strive for Progress, Not Perfection
When it comes to research on promising new classes of pain therapies, the agency must weigh its understandable caution regarding safety concerns against the
unmet needs of millions of patients suffering with pain
By Michael C. Barnes
An estimated 116 million adults in the United States
experience chronic pain, according to a report
released in June by the Institute of Medicine of
the National Academies (http://hcp.lv/qtGpQ0). At the
same time, the Centers for Disease Control and Prevention
(CDC) has officially labeled prescription drug abuse a national
epidemic (http://hcp.lv/naT889). These dual public
health concerns—both of which cause inestimable human
suffering in the United States—are multifaceted and complex,
and require serious, immediate attention.
The Food and Drug Administration (FDA) recently required
the manufacturers of long-acting and extended-release opioid
pain relievers to address the abuse, addiction, and overdose
risks of their products by implementing coordinated Risk
Evaluation and Mitigation Strategies (REMS). Communities
can expect to begin seeing the results of these new requirements
in the second quarter of 2012. The FDA action came
after the agency undertook extensive yet time-consuming
public consultations, and it reflected responsiveness to stakeholder
input. Care and consideration are crucial to our nation’s
success in reducing undertreated pain and prescription
drug abuse, but so is speed. In that area, the FDA must
improve.
Industry researchers are hopeful that a new class of pain
therapies may be the most important development in pain
treatment since aspirin came into general use at the end
of the nineteenth century. The new treatments are injectable
antibodies that block a protein called nerve growth factor
(NGF), which is associated with pain and is often present
in inflamed tissues, such as arthritic joints (http://hcp.lv/
oQgB29). Accordingly, the class is known as NGF-targeting
antibodies, or anti-NGF drugs.
Pharmaceutical companies are conducting trials of NGFtargeting
antibodies in treating cancer pain and chronic
pancreatitis, though research suffered a setback in December
2010. The FDA placed a hold on clinical trials for other
conditions, such as osteoarthritis, chronic low back pain, and
diabetic nerve pain, after some patients in the trials needed
joint replacements. Industry representatives speculate that
the pain relief the therapies provided was so significant that
patients increased their physical activity and accelerated
damage to their joints (http://hcp.lv/oQgB29).
In July, the FDA announced that it would meet with outside
experts on its Arthritis Advisory Committee to seek their guidance
on whether the reports of joint destruction represent
a safety signal related to the anti-NGF class, and whether
the FDA should permit industry to continue developing
these drugs for use as analgesics. A month later, the agency
postponed the meeting, citing a need for additional time
to review new information. The FDA fulfills a crucial role in
the United States by ensuring that the benefits of drugs outweigh
their risks, but the agency’s sluggishness and risk aversion
with respect to anti-NGF drugs are excessive in light
of the urgent public health crises of undertreated pain and
prescription drug abuse.
No one knows now what the experts on the Arthritis Advisory
Committee will recommend to the FDA, but the public
will also be permitted to comment at the upcoming meeting.
The perspectives of two vital stakeholder groups are already
clear.
People in recovery, overdose survivors, and aggrieved
families of victims of overdoses will eagerly tell the FDA
that products showing promise toward treating pain without
exposing patients and their communities to the risks of
opioid diversion, abuse, addiction, and overdose must be
researched with a sense of urgency. Similarly, people living
with pain will urge the FDA to authorize and expedite
research on therapies that could provide health care professionals
another tool with which to help patients regain
the ability to bathe and dress themselves, prepare their own
meals, earn a living, enjoy their time with their families, and
engage in other activities of daily living. Both of these communities
stand to benefit when new FDA-approved medications
whose risks are known and reported become available
to prescribers and patients.
Individuals recovering from substance-related disorders
are often counseled to strive for “progress, not perfection”
in addressing the complex and multi-faceted issues that
contribute to their disease. The FDA should heed that simple
guidance as it seeks to address our nation’s dual maladies
of undertreated pain and prescription drug abuse. Time is of
the essence.
Michael C. Barnes is an attorney and policy advisor with
DCBA Law & Policy, and serves as interim executive director of
the not-for-profit Center for Lawful Access and Abuse Deterrence
(http://claad.org).

The Cosmopolitan of Las Vegas
news 3
What’s on the Schedule Today at PAINWeek
Welcome to the third day of the conference. The
schedule today offers tracks with programs that
address topics in pain and chemical dependency,
rheumatology and pain management, and pain and palliative
care. Attendees will also find Master Class sessions on overcoming
communication challenges in the clinical pain care setting
and on evaluating orofacial pain. Today’s Special Interest Sessions
focus on medical ethics in the pain clinic, the challenges of
treating post-amputation pain, breakthroughs in neuroimaging
of pain, the positive and negative aspects of using opioids for
treating chronic pain, and clinical trial regulations and design.
Early-morning sessions today include a panel discussion on
ethical dilemmas in the pain clinic, particularly the tension between
the need for patients to comply fully with all treatment
instructions and the desire to promote and encourage patient
autonomy and empowerment. Michael E. Schatman,
PhD, CPE, John F. Peppin, DO, FACP, and Ana Smith
Iltis, PhD, will discuss these issues and recommend potential
solutions. Jennifer Bolen JD, and Eric Vinsant, JD,
will conduct “Establishing Your Drug Testing Platform,” a workshop
designed to help practices fully evaluate their drug testing
policies, documentation, and
lab choices. During “Assessment
of Pain in Advanced Illness,” the
first session of the day in the Pain
and Palliative Care track, Mary
Lynn McPherson, PharmD,
BCPS, CPE, will discuss the
pathogenesis and clinical presentation
of pain in a variety of advanced
illnesses, including cancer.
Kathryn L. Hahn, PharmD,
DAAPM, CPE, will present a
program that reviews the current
selection of opioids available
for treating a range of painful
syndromes. Hahn will discuss criteria for patient
selection, the merits and clinical characteristics
of short-acting and long-acting opioids, dosing
opioids for treating breakthrough pain, and more.
This course is recommended for all clinicians who
are attending PAINWeek for the first time.
The Pain and Palliative Care track today features
three additional sessions that address key
topics in pain management at the end of life. At
10:00am, Mary Lynn McPherson, PharmD,
BCPS, CPE, will present “Pharmacologic
Management of CV, GU, GI, and Respiratory
Symptoms in Patients with Advanced Illness,” which covers the
assessment and management of the cardiorespiratory, genitourinary,
and gastrointestinal symptoms that may be present
in patients with advanced illness. At 3:05pm, Robert D.
Sproul, PharmD, will discuss the pharmacologic management
of neuropsychiatric symptoms at the end of life, stressing a
holistic approach with the necessary psychosocial and spiritual
support systems in place. McPherson returns at 4:30pm to present
“Pharmacologic Management of Pain in Advanced Illness,”
the final session in this track. She will review the management
of pain associated with both cancer and noncancer advanced
illness, with a focus on polypharmacy.
Howard A. Heit, MD, FACP, FASAM, and Douglas
L. Gourlay, MD, MSc, FRCPC, FASAM, will present
the two-session Pain and Chemical Dependency track today
at PAINWeek 2011. The first session, “The Patient-centered
Approach to Urine Drug Testing in the Chronic Pain Patient,”
is scheduled for 10:00am. It will explore the shortcomings associated
with urine drug testing in the pain population, and
offer insights into the identification, treatment, and monitoring
of patients being treated with opioids for chronic pain. The second
session, “When Pharmacology Fails: Exit Strategies from
the Agonist Class of Medications,” will clarify several myths and
facts associated with concepts such as addiction, physical dependency,
withdrawal, and tolerance, and offer “a rational look
at tapering, substitution, and ultimate discontinuation of several
common, dependency-producing agents.”
The two-session Rheumatology track at PAINWeek 2011 is
also scheduled for today, with Ronald J. Rapoport, MD,
FACR, sharing insights into the differential diagnosis of a patient
with monoarticular, oligoarticular, or polyarticular presentation.
He will outline a framework and approach for diagnosis
based on his clinical experience and current examples from the
literature. Rapoport will conclude this track with the second session,
beginning at 4:30pm. During “Polymyalgia Rheumatica
and Giant-cell Arteritis,” he will explore the assessment, diagnosis,
and treatment of the patient with polymyalgia rheumatica
and giant-cell arteritis. To read more about these sessions, read
the interview with Rapoport on page 13.
Clinicians interested in learning more about various complementary
and alternative approaches to pain management can
choose from among several offerings on today’s schedule,
including “Carpal Tunnel Syndrome: New Understanding
and New Treatment Ideas,” presented by Hal
Blatman, MD, DAAPM, ABIHM. He will review
several diagnostic modalities, including thermal imaging
and musculoskeletal ultrasound, and the ways in which
the evolution of our medical understanding of the anatomy
of fascia has given rise to new ideas of pathophysiology
and treatment. At 11:05am, Robert A. Bonakdar,
MD, FAAFP, will discuss the techniques involved
in acupuncture and auricular therapy and review the
evidence regarding these methods. Bonakdar returns at
2:00pm with “The Impact of Stress and
Anxiety on Chronic Pain Management,”
a discussion about the behavioral, cardiometabolic,
and cognitive impact that
stress can have on patients suffering with
chronic pain. At 4:30pm today, Blatman
will close out the Complementary and
Alternative Medicine track at PAINWeek
2011 with “Myofascial Pain: New Understanding
and New Treatment Ideas.”
trigger point injections, prolotherapy,
platelet-rich plasma, regenerative therapy
injections, myofascial release, and
other body work disciplines.
There are several non-CE/CME accredited
“Product Theater” sessions on today’s schedule, including
“A Unique Approach to the Delivery of Rapid Onset Opioids,”
which will be presented by Srinivas Nalamachu,
MD, and James Rho, MD, at 8:30am. They will discuss
the use of transmucosal fentanyl treating breakthrough cancer
pain in opioid-tolerant patients. Also at 8:30am, Mary
Lynn McPherson, PharmD, BCPS, CPE, will present
“Acetaminophen: When to Use It, When to Say When.” She will
review the prevalence of acetaminophen use in the US and
examine the data showing the situations when acetaminophen
is a viable option (whether as monotherapy or in combination
with other medciations) for pain management, and when it is
not. At noon today, Michael R. Clark, MD, MPH, will
present “Pathophysiology of Pain: Mechanisms and Manifestations,”
during which he will discuss acute and chronic pain
transmission and review pain pathways in the peripheral and
central nervous system and the mechanisms leading to the development
of chronic pain.
The Master Class sessions on the schedule for today will
include a two-part program on the evaluation of orofacial
pain presented by Peter Foreman, DDS, DAAPM. The
first session will explore the challenges associated with the accurate
diagnosis of orofacial and other head and neck pain,
the strength of evidence supporting various interventions and
treatment approaches, and the ways in which advances in our
understanding of pain mechanisms are changing the approach
to these painful conditions. Part two, scheduled for 2:00pm, will
review specific treatment modalities, including demonstrations
of trigger point injection techniques and other interventional approaches.
Additional Special Interest Sessions on the schedule today
include “Postamputation Pain: Mechanisms and Model,” presented
by R. Norman Harden, MD. Harden will discuss
the pathophysiology of postamputation pain and review several
therapeutic targets. Sean Mackey, MD, PhD, CPE,
will talk about the neuroimaging of pain at 11:05am. He will
discuss functional magnetic resonance imaging, magnetic resonance
spectroscopy, and other imaging technologies that have
provided insights into the anatomic, chemical, and connectivity
changes in the brain of people with chronic pain. At 2:00pm,
Mackey will return with “Opioids: The Good, the Bad, and
the Ugly,” a discussion of current literature on opioid-induced
hyperalgesia, opioid-induced androgen deficiency, and the
effects of opioids on the immune system. Finally, at 2:00pm,
Joseph V. Pergolizzi, MD, Chairman of the PAINWeek
Scientific Poster and Abstracts Committee, will be joined by
Joseph W. Stauffer, DO; Robert Raffa, PhD; Rami
Ben-Joseph, PhD; Edmundo Muniz, MD, PhD; Sri
Nalamachu, MD; and Errol Gould, PhD, for a two-hour
plenary session on pain clinical trials.
Also, please note that from 7:30am – 8:25am today, Joseph
V. Pergolizzi, MD, will moderate a session featuring
oral presentations of eight noteworthy posters selected by the
PAINWeek Scientific Poster and Abstracts Committee. For a brief
preview of these posters, please see page 18 in this issue.
Today’s Schedule of Recommended
Courses for First-time PAINWeek
Attendees
7:30am – 8:25am
Short-Acting and Long-Acting Opioids in the Treatment of
Chronic, Episodic, and Breakthrough Pain
Kathryn L. Hahn, PharmD, DAAPM, CPE
10:00am – 10:55am
Postamputation Pain: Mechanism and Model
R. Norman Harden, MD
11:05am – 12:00pm
A “Topical” Review of Pain Treatment
Christopher M. Herndon, PharmD, BCPS, CPE
2:00pm – 2:55pm
Opioids: the Good, the Bad, and the Ugly
Sean Mackey, MD, PhD, CPE
3:05pm – 4:00pm
Inflammatory Arthritis
Ronald J. Rapoport, MD, FACR
4:30pm – 5:25pm
Pharmacologic Management of Pain in Advanced Illness
Mary Lynn McPherson, PharmD, BCPS, CPE

4
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friDAY
September 9, 2011
PREVIEW
Examination of Barriers to Effective Chronic Pain Management
with Opioids
Chronic pain affects more adults in the United States than heart disease, cancer, and diabetes, combined
Opioids have become a staple in the armamentarium
of providers who treat patients with
chronic pain. Due to widespread media coverage
and legal scrutiny, many of the drawbacks associated
with opioid use are common knowledge. As a result
of these issues, combined with side effects and psychosocial
challenges associated with opiate use, many patients
and prescribers are reluctant to rely on these medications
for the treatment of chronic pain.
To address some of the barriers to the appropriate use of
opioids for the treatment of chronic pain, Thomas Gregory,
PharmD, BCPS, will present, “Opioid Adverse Events: Beyond
Constipation,” one of three talks during the Pharmacology session
on Saturday. Gregory is clinical lead pharmacist for general
and trauma surgery and co-chair of the corporate pain
committee at Truman Medical Centers, Kansas City, Missouri.
He also has faculty assignments with the school of pharmacy at
University of Missouri, Kansas City and is an American Society
of Pain Educators certified pain educator.
Gregory’s talk will cover physiologic processes that are negatively
affected by opiates, the psychosocial effects of opiate
use, and recent changes in health care policy and law regarding
opiate use. Gregory says that his talk will cover “not only
the physiological effects but also data regarding overall side
effects from the social stigma of users of opioids and prescribers’
fear of reprisal from law enforcement officials.”
A number of organ systems can be adversely impacted by
opioids. Side effects that will be discussed include neurologic
disorders (ie, sedation, psychomotor, cognitive, hyperalgesia);
arrhythmia; respiratory depression; gastrointestinal complications
(ie, nausea, vomiting, sphincter of oddi); hormonal imbalance;
immune suppression; urinary retention; and pruritis. For
each side effect, Gregory will explain its underlying physiological
mechanism and offer tips for its management.
In providing an overview of the psychosocial effects of opioid
use, Gregory will differentiate physical and psychological
dependence, explain mechanisms of analgesic tolerance, and
review common social misconceptions and factors that lead to
clinician apprehension about prescribing opioids.
A review of this information is needed because, according to
Gregory, side effects or negative social pressure may prompt
patients to stop taking their medication, resulting in resumption
of pain and decreased quality of life. Untreated pain can lead
to changes in the neural network that evoke persistent pain. A
full understanding, by both patients and providers, of the benefits
and harms of opiate use is critical to achieving effective
and safe pain management with opioid medication.
Prescribers may not realize how important it is to sit down
with patients who are under consideration for opioid therapy
and to fully explain to them what might or might not happen
when they take these medications. These discussions should explore
whether a patient has preconceived notions about taking
A full understanding,
by both patients and
providers, of the benefits and
harms of opiate use is critical
to achieving effective and
safe pain management with
opioid medication.
opioid medications and should provide instructions on proper
use. Gregory suggests that patients should walk away with an
understanding that allows them to make an informed decision
about whether or not to take opioids. He also stresses the importance
of following up with patients taking opioids, not only
for the obvious reasons of abuse, addiction, and side effects,
but also because some patients may stop taking their medication
when they begin to feel better and others may stop taking
it due to fear or social issues.
In April, 2011, the US federal government announced a multiagency
initiative aimed at reducing the abuse of prescription
drugs in this country. Part of this program is the US Food and
Drug Administration’s (FDA) Risk Evaluation and Mitigation Strategy
(REMS) for certain types of opioids and other medications.
According to the FDA website, “a REMS is a risk management
plan that FDA can require a drug company to develop and
implement to manage serious risks associated with a drug.”
The plan entails a number of key elements: education, monitoring,
proper disposal, and enforcement. For the benefit of
those practitioners who are not familiar with the newest regulations
and REMS that are going to be taking effect, Gregory will
review recent changes in opioid prescribing policies and other
legal nuances of interest to prescribers of opioids.
Doctor training, patient counseling, and other risk reduction
measures affiliated with the REMS are expected to become effective
by early 2012. “One of the big problems for practitioners
is then you have to have documentation of this training and
so without documentation of this training a lot of doctors don’t
want to mess with it,” says Gregory. This may lead to providers
opting not to prescribe these medications. His talk will, hopefully,
“prevent them from becoming gun-shy and not being willing
to work with the patients that are in pain, because there are
a lot of them.”
—By Kim Farina-Graham, PhD
(continued from cover)
accounted for $2.6 billion, and lost productivity totaled
$4.6 billion.
• Since 2002, more than 25,000 individuals have died in Florida
with one or more prescription medications in their system.
• By 2007, more teenagers were using opioid analgesics recreationally
than used marijuana.
• In 2008, there were an estimated 100,340 emergency department
(ED) visits involving accidental ingestion of drugs,
primarily pharmaceuticals; of these, 69,121 (68.9%) were
made by patients aged 5 or younger.
McElhaney began her talk by providing a definition of drug
diversion, calling it, “Any criminal act involving a prescription
drug.” She said that the problem has reached epidemic proportions,
and impacts everyone. “Everyone knows someone who
has been affected by this problem,” she said. “You may think
that you are not affected by it, and the next thing you know, you
get slammed into by someone under the influence or you have
your house robbed by an addict.”
It is hard to pinpoint when the problem started to reach such
epic proportions, but prescription diversion has been occurring
for decades. McElhaney said that many medical clinics have
basically become drug trafficking organizations. In the last decade
alone, the culprits have included weight loss clinics, lifestyle
rejuvenation clinics, pain management clinics, and medical
marijuana clinics.
And the problem is not geographically confined or demographically
discriminatory. McElhaney found illegal pain clinics
while visiting in Guam. “If they can’t get it in the US, they go to
Mexico or Canada or whatever it takes,” she said. McElhaney
has arrested grandmothers (ages 87 and 92) who were dealing
drugs, and has met three generations of the same family
who were involved in peddling illegal drugs during her 21 years
as sworn law enforcement officer. McElhaney has also worked
as a sergeant for the Broward County sheriff’s office, and has
18 years with the National Association of Drug Diversion Investigators
as national vice-president and educator. She has
worked for 17 years with the Broward County Commission on
Substance Abuse, serving as a chairperson for the Prescription
Drug Task Force and on the Board of Governors. She works with
the Broward County Commission as a chairperson for its Pain
Management Clinic Task Force.
McElhaney’s law enforcement experience has helped her to
more clearly see the “big picture” and link drug abuse to its subsequent
deleterious effects. She said that the effects of this can
be seen in obvious outcomes like the increase in drug-related
crime—for example, pharmacy robberies have increased significantly
in the last five years—but also in other, less visible areas.
For example, workers’ compensation claims related to drugseeking
behavior have adversely affected the financial health
of many businesses. When insurance rates go up because of
this, “It’s coming out of your pocket,” she said. McElhaney said
drug-related crime produces a complex web of consequences
in the families affected by it; “Children go into foster care, and
domestic violence increases.” Other ways that it can affect us
as individuals include increases in health, automobile, and
property insurance costs. The problem requires the expenditure
of more resources on law enforcement, emergency, and state
support services, and it also effects the banking industry when
banks need to forfeit illegal monies to the government.
McElhaney said that government and law enforcement
have changed tactics to adapt to the new reality. For example,
she noted that now, in the ongoing campaign to eliminate
“pill mills” (pain management clinics that are improperly or illegally
selling prescription drugs), law enforcement officials are
not only targeting the physicians who run the operations and
write the shady prescriptions, but are also going after employees
and associated family members. Now law enforcement
will eradicate the entire business. “If you are part of that structure,
you are going to be considered part of the investigation,”
she said.
McElhaney suggested that along with greater focus on law
enforcement measures, we also need to focus more time and
resources on creating and implementing awareness, education,
and prevention initiatives that focus on bad choices and
the harmful consequences involved. McElhaney believes that
truly lasting results will only be accomplished through education
and awareness, a low acceptance/tolerance of bad
behaviors, complete societal involvement in the problem, and
a multifaceted approach that starts at birth and runs throughout
an individual’s life.
—By Sandra Kear

The Cosmopolitan of Las Vegas
news 5
September 7-10, 2011
Cosmopolitan - Chelsea 1-3 & 5-8
Las Vegas, NV
1020
1016
1017
1024
1117
1216
1320
1219
1318
1000 1316
1323 1324
1319 1418
1317 1416
1419
1417
1415
113 114 115 116 117 118 119
105 106 107 108 109 110 111 112
97 98 99 100 101 102 103 104
89 90 91 92 93 94 95 96
81 82 83 84 85 86 87 88
73 74 75 76 77 78 79 80
65 66 67 68 69 70 71 72
57 58 59 60 61 62 63 64
49 50 51 52 53 54 55 56
Posters
41 42 43 44 45 46 47 48
1012
1011
1111
1213
1211
1310
1313
1311
1412
1410
1413
1411
33 34 35 36 37 38 39 40
25 26 27 28 29 30 31 32
17 18 19 20 21 22 23 24
9 10 11 12 13 14 15 16
1209 1309
1 2 3 4 5 6 7 8
1006
1004
1002
1003
Cyber Cafe
1204
1202
1306
1205
1304
1307 1406 1409
1405
1507 1606 1707
1705
1303 1402
1503
1403
1602 1703
1706
1000
1001
Exhibitor List
1313 Aegis Sciences Corporation
1319 Alere/Capital Toxicology
1703 Alliance Toxicology
1005 AIT Laboratories
1405 American Chronic Pain Association
1111 Ameritox
1204 American Society of Pain Educators
1004 Aspen Medical Products
1001 The Biomat Store
1213 Boston Scientific Neuromodulation
1205 C.A.R.E.S Alliance
1016 Calloway Labs
1024 Cephalon, Inc.
1507 Challenger Corp
1211 Chronic Pain Impact Network (CPAIN)
1310 Chronic Pain Perspectives
1209 Covidien
1003 DJO Global
1000 Dominion Diagnostics
1219 eLab Solutions
1020 Emerging Solutions in Pain
1303 Endo Pharmaceuticals, Inc.
1308 EPIC
1606 Express Diagnostics Int’l (EDI)
1306 Forest Pharmaceuticals, Inc.
1202 HRA Research
1419 International Medical and Dental
Hypnotherapy Association (IMDHA)
1416 INSYS Therapeutics, Inc.
1002 Janssen Pharmaceuticals, Inc.
1410 LabCorp
1017 Lilly USA, LLC
1323 Lippincott, Williams, & Wilkins
1706 Living Beyond Pain
1316 Pain Managment Magazine/Intellisphere, LLC
1402 Millennium Laboratories
1403 ML International
1413 Mother Earth Pillows
1320 National Association of
Drug Diversion Investigators (NADDI)
1415 National Fibromyalgia &
Chronic Pain Association
1217 NECC (New England
Compounding Center)
1406 NeurogesX, Inc.
1707 Opioid Analgesia Tool Kit
1006 PainEDU.org
1307 Pentec Health
1304 PharmaTech
1318 Pharmacy Times
1409 Power of Pain Foundation
1417 Power-Pak C.E. ®
1411 PPM Communications, Inc./
Spine Universe/Vertical Health
1216 ProStrakan
1011 Purdue Pharma L.P.
1418 Pure Biomed, LLC
1602 QuantiaMD
1503 Somaxon Pharmaceuticals
1117 Salix Pharmaceuticals, Inc.
1317 StreamlineMD
1012 Take Courage Coaching
1311 Tufts University School of Medicine
1412 U.S. Pain Foundation

6
news
friDAY
September 9, 2011
PREVIEW
How Confident Are You that Your
Practice’s Urine Drug Testing Policies
Could Withstand an Audit
The changing legal environment and increased scrutiny on testing practices make this one of the
must-see presentations at PAINWeek 2011
The temptations are huge. Doctors can make more money
testing their patients for drugs than treating them for
pain. But doctors would be wise to avoid these temptations
and implement defensible urine testing policies, says
Jennifer Bolen, JD, who will discuss the complexities of setting
such policies and the explain the reasons for making the effort
during her presentation “Documenting Medical Necessity
for Drug Testing,” Friday at PAINWeek 2011.
“You don’t see doctors going to jail for this‐‐yet. But I can’t
begin to count the number of state agencies and federal
agencies and insurance companies that are looking at doctor
testing patterns and demanding that doctors defend their
actions or return hundreds of thousands of dollars,” she says.
Pain specialists have long questioned how they should
monitor patients with ongoing opioid prescriptions. Should
you only test patients who fit the “high-risk” profile Should
you only test patients who act suspiciously Should you test
every patient, every month, just to be safe Should you implement
a random testing policy, to prevent patients from
gaming the system And what should you test for, just the
substances you prescribe or other drugs that could cause
interactions and signal problems
No studies have answered these questions definitively, so
doctors are left to wing it. Using whatever research they can
find and their own notions of common sense, some rarely test
any of their patients who are being treated with prescription
opioids, while others test nearly all of their pain patients.
The incredible variety of strategies, combined with the near
impossibility of calling any given strategy right or wrong, has
created profitable opportunities for those testing companies
that can convince doctors to test frequently.
In some cases, salesmen have succeeded by scaring doctors
with tales of untested patients whose overdose deaths
led to malpractice suits. In other cases, they have offered
direct incentives that ranged from cash to loner employees
who would handle drug testing in the doctor’s offices, free of
charge. These practices went unchallenged for so long that
many doctors‐‐Bolen won’t speculate on percentages‐‐have
come to regard blatant profiteering from testing as a legitimate
perk. Bolen says that her presentation will explain why
such behavior must change now, for reasons of safety if not
reasons of conscience.
Direct cash kickbacks have always been illegal, but government
has more authority now to look at financial crimes
and takes steps to restrict other tricks that help doctors inappropriately
profit from testing, inducements like giving doctors
ownership stakes in testing services or loaning employees
so doctors can save on overhead and maximize profits.
Even in places where such arrangements are not yet illegal,
doctors would be wise to avoid them, Bolen says,
because they violate medical ethics codes and may well
violate participation contracts for commercial insurance,
not to mention state business and insurance laws. “Conflicts
of interest call all your decisions into question. If someone
who has paid you hundreds of thousands of dollars finds
undisclosed business arrangements involving inducements
and kickbacks, you won’t have much of a defense when the
payer demands money back,” she says.
Bolen also warns that doctors must also be careful to select
urine testing services that charge reasonable prices. She
says that “codes of conduct state that doctors must choose
services first on the basis of quality and then, when there are
many quality laboratory services, on the basis of price. But
many doctors test urine samples with companies that charge
10 times what competitors charge. Even in cases where the
doctor has no financial incentive for this and has just been
careless with customer money, he is setting himself up for
problems.”
Indeed, Bolen says there are far more cases where doctors
get into trouble through carelessness than malice. They
simply haven’t thought through their policies on drug testing
and found the most effective way to implement them. But that
carelessness is costing patients and insurers millions of dollars
and putting even well-meaning doctors at risk.
“The most important concept is documenting medical necessity
for testing. Right now, there are no definitive clinical
guidelines on the proper nature and frequency of testing.
Doctors still have a lot of discretion, but they need to leave
paper trails that illustrate why they make the choices they
make. If you order monthly urine tests but never show any
sign of even looking at them, let alone using them in your
treatment of the patient, you’ve got problems. If your record
shows why you’re doing what you’re doing, then you’re on
pretty solid ground,” she says.
Doctors wishing to avoid problems should also keep up
with new research on the value of drug testing, said Bolen,
who will tell doctors who come to her presentation where to
find the most reliable information.
“We’re finally starting to get some good research on
when it makes sense to test and when it doesn’t. That research
should eventually answer a lot of questions for doctors
and it should provide the ultimate defense for those who
use it to formulate their drug testing policies.”
—By Andrew Smith
PAINWeek Administration
Redza Ibrahim
Advertising, Sponsorships, Satellite Events
Darryl Fossa
Art Direction
Stephen Porada
Corporate Relations
Debra Weiner
Course Development
Holly Caster
Editorial Services
Donna Kelley
Exhibits, Logistics, Hotel Management
Wanda Anderegg
Finance
Keith Dempster
Media Relations
Benjamin R. Metzger, MD
Medical Direction
Jeffrey Tarnoff
Operations and Technology
Anna Carson
Production
Paris Fossa
Program Coordination
Patrick Kelly
Program Management
Michael Shaffer
Program Management
PAIN MANAGEMENT
Peter Ciszewski
President
Todd Kunkler
Editor
Christina Puglisi
National Accounts Manager
Sandra Kear
Projects Editor
Teisia Park
Sales & Marketing Coordinator
Silas Inman
Web Editor
Marissa Murtaugh
Assistant Editor
John Salesi
Art Director
Dan Coffey
Director of New Media
Keli Rising
Manager of Digital Media
John Burke
Director of Circulation
MJH & Associates
Mike Hennessy
Chairman/Chief Executive Officer/President
Jack Lepping
Vice President Sales
Neil Glasser
Chief Financial Officer
Brian Haug
Chief Sales Officer
Judy V. Lum, MPA
Executive Director of Education
Jeff Brown
Group Creative Director

The Cosmopolitan of Las Vegas
news 7
CHRONIC PAIN DIAGNOSIS
NUMEROUS CONCERNS

8
news
Opana ® ER Indications and Important Safety Information
Indication
• Opana ® ER is indicated for the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of
time.
Limitations of Usage
• Opana ® ER is not intended for use as an as needed analgesic.
• Opana ® ER is not indicated for pain in the immediate post-operative period or if the pain is mild or not expected to persist for an extended period of time.
• Opana ® ER is only indicated for post-operative use if the patient is already receiving the drug prior to surgery or if the post-operative pain is expected to be
moderate or severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as
appropriate (see American Pain Society guidelines).
friDAY
September 9, 2011
Opana ® ER has a boxed warning as follows:
WARNING: POTENTIAL FOR ABUSE, IMPORTANCE OF PROPER PATIENT SELECTION AND LIMITATIONS OF USE.
See full Prescribing Information for complete boxed warning.
• Opana ® ER contains oxymorphone which is an opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid analgesics.
• Oxymorphone can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing Opana ® ER in
situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse, or diversion.
• Opana ® ER is NOT intended for use as an as needed analgesic.
• Opana ® ER tablets are to be swallowed whole and are not to be broken, chewed, dissolved, or crushed as this leads to rapid release and absorption of a
potentially fatal dose of oxymorphone.
• Patients must not consume alcoholic beverages, prescription or non-prescription medications containing alcohol. Co-ingestion of alcohol with Opana ® ER may
result in a potentially fatal overdose of oxymorphone.
• Opana ER is contraindicated in patients with a known hypersensitivity to oxymorphone hydrochloride, morphine analogs such as codeine, or any of the other
ingredients of Opana ER; in patients with moderate or severe hepatic impairment or in any situation where opioids are contraindicated such as: patients with
respiratory depression (in the absence of resuscitative equipment or in unmonitored settings), acute or severe bronchial asthma, hypercarbia, and in any patient
who has or is suspected of having paralytic ileus.
• Opana ER is not indicated for pain in the immediate post-operative period or if the pain is mild, or not expected to persist for an extended period of time.
Opana ER is only indicated for post-operative use if the patient is already receiving the drug prior to surgery or if the post-operative pain is expected to be
moderate or severe and persist for an extended period of time. Physicians should individualize treatment, moving from parenteral to oral analgesics as
appropriate (see American Pain Society guidelines). Opana ER is not indicated for pre-emptive analgesia (administration pre-operatively for the management
of post-operative pain).
• Respiratory depression is the chief hazard of Opana ER, particularly in elderly or debilitated patients. Opana ER should be administered with extreme caution to
patients with conditions accompanied by hypoxia, hypercapnia, or decreased respiratory reserve.
• Patients receiving other opioid analgesics, general anesthetics, phenothiazines or other tranquilizers, sedatives, hypnotics, or other CNS depressants (including
alcohol) may experience additive effects resulting in respiratory depression, hypotension, profound sedation, coma or death.
• In the presence of head injury, the respiratory depressant effects of Opana ER and the potential to elevate cerebrospinal fluid pressure may be markedly
exaggerated.
• Opana ER may cause severe hypotension in patients with compromised ability to maintain blood pressure. Administer with caution to patients in circulatory
shock.
• Prolonged gastric obstruction may occur in patients with gastrointestinal obstruction, especially paralytic ileus.
• Use with caution in patients with biliary tract disease, as it may cause spasm of the sphincter of oddi.
• Opioid analgesics impair the mental and physical abilities needed to perform potentially hazardous activities such as driving a car or operating machinery.
• Opana ER is not recommended during labor and delivery, pregnancy, or nursing.
• Opana ER should be used with caution in elderly and debilitated patients and in patients who are known to be sensitive to CNS depressants, such as those with
cardiovascular, pulmonary, renal, or hepatic disease. Opana ER should be used with caution in patients with mild hepatic impairment and in patients with
moderate to severe renal impairment. These patients should be started cautiously with lower doses of Opana ER while carefully monitoring for side effects.
• Adverse reactions reported at (≥2%) in placebo-controlled trials were: nausea, constipation, dizziness, somnolence, vomiting, pruritus, headache, sweating
increased, dry mouth, sedation, diarrhea, insomnia, fatigue, appetite decreased, and abdominal pain. In clinical trials there were several adverse events that were
more frequently observed in subjects 65 and over compared to younger subjects. These adverse events included dizziness, somnolence, confusion, and nausea.
• Drug Interactions—CNS depressants: Increased risk of respiratory depression, hypotension, profound sedation, coma or death. When combined therapy with CNS
depressant is contemplated, the dose of one or both agents should be reduced. Mixed agonist/antagonist opioids (i.e., pentazocine, nalbuphine, and
butorphanol): May reduce analgesic effect and/or precipitate withdrawal symptoms. Cimetidine: Combination use may precipitate confusion, disorientation,
respiratory depression, apnea, seizures. Anticholinergics: May result in urinary retention and/or severe constipation, which may lead to paralytic ileus. Monoamine
oxidase inhibitors (MAOIs): Potentiate the action of opioids. Opana ER should not be used in patients taking MAOIs or within 14 days of stopping such treatment.
• Patients and their families should be instructed to flush any Opana ER tablets that are no longer needed.
Please see Brief Summary of Prescribing Information on back of adjacent page.

The Cosmopolitan of Las Vegas
news 9
Complex challenges.
One solution.
Opana ® ER is the only long-acting opioid that pairs the
efficacy of oxymorphone with TIMERx ® -N technology.
No known CYP450 PK drug-drug
interactions at clinically relevant doses 1
Opana ® ER should be started at 1/3 to 1/2 of the usual
dose in patients who are concurrently receiving other
CNS depressants.
True 12-hour dosing 1
Symmetrical, every 12h dosing is appropriate for
the majority of patients.
Flexible dosing and individualized therapy 1
Opana ® ER should be administered on an empty
stomach, at least 1 hour prior to or 2 hours after eating.
Widely available on managed care
plans (including Medicare Part D) for 8
out of 10 covered patients 2
Visit www.opana.com for complete information.
Rx Only
DEA Order Form Required.
Opana ® is a registered trademark of Endo Pharmaceuticals.
TIMERx ® –N is a registered trademark of Penwest Pharmaceuticals Co.
References: 1. Opana ® ER [Prescribing Information]. Endo Pharmaceuticals, Inc.
Chadds Ford, PA; 2010. 2. SDI data. Accessed February 2008.
CHADDS FORD, PENNSYLVANIA 19317 © 2011 Endo Pharmaceuticals. All Rights Reserved. OP-00982b/August 2011 www.opana.com 1-800-462-ENDO (3636)

10
news
Brief Summary (For full Prescribing Information including Dosage and
Administration, and Patient Information, refer to package insert.)
WARNING: POTENTIAL FOR ABUSE, IMPORTANCE OF PROPER PATIENT
SELECTION AND LIMITATIONS OF USE
Potential for Abuse
Opana ER contains oxymorphone, which is a morphine-like opioid
agonist and a Schedule II controlled substance, with an abuse liability
similar to other opioid analgesics.
Oxymorphone can be abused in a manner similar to other opioid
agonists, legal or illicit. This should be considered when prescribing or
dispensing Opana ER in situations where the physician or pharmacist is
concerned about an increased risk of misuse, abuse, or diversion.
Proper Patient Selection
Opana ER is an extended-release oral formulation of oxymorphone
indicated for the management of moderate to severe pain when
a continuous, around-the-clock opioid analgesic is needed for an
extended period of time.
Limitations of Use
Opana ER is NOT intended for use as an as needed analgesic.
Opana ER Tablets are to be swallowed whole and are not to be broken,
chewed, dissolved, or crushed. Taking broken, chewed, dissolved, or
crushed Opana ER Tablets leads to rapid release and absorption of a
potentially fatal dose of oxymorphone.
Patients must not consume alcoholic beverages, or prescription or
non-prescription medications containing alcohol, while on Opana ER
therapy. The co-ingestion of alcohol with Opana ER may result
in increased plasma levels and a potentially fatal overdose of
oxymorphone.
INDICATIONS AND USAGE
Opana ER is indicated for the relief of moderate to severe pain in patients requiring
continuous, around-the-clock opioid treatment for an extended period of time.
Limitations of Usage
Opana ER is not intended for use as an as needed analgesic.
Opana ER is not indicated for pain in the immediate post-operative period if the pain
is mild, or not expected to persist for an extended period of time.
Opana ER is only indicated for post-operative use if the patient is already receiving
the drug prior to surgery or if the post-operative pain is expected to be moderate or
severe and persist for an extended period of time. Physicians should individualize
treatment, moving from parenteral to oral analgesics as appropriate. (See American
Pain Society guidelines).
CONTRAINDICATIONS
Opana ER is contraindicated in patients who have:
• significant respiratory depression
• or are suspected of having paralytic ileus
• acute or severe bronchial asthma or hypercarbia
• moderate and severe hepatic impairment [see Warnings and Precautions].
• known hypersensitivity to any of its components or the active ingredient,
oxymorphone or with known hypersensitivity to morphine analogs such as codeine.
WARNINGS AND PRECAUTIONS
Information Essential for Safe Administration
Opana ER tablets are to be swallowed whole, and are not to be broken,
chewed, crushed or dissolved. Taking broken, chewed, crushed or
dissolved Opana ER tablets could lead to the rapid release and absorption
of a potentially fatal dose of oxymorphone [see Boxed Warning].
Patients must not consume alcoholic beverages, or prescription or nonprescription
medications containing alcohol, while on Opana ER therapy.
The co-ingestion of alcohol with Opana ER may result in increased plasma
levels and a potentially fatal overdose of oxymorphone.
Instruct patients against use by individuals other than the patient for
whom Opana ER was prescribed, as such inappropriate use may have
severe medical consequences, including death.
Respiratory Depression
Respiratory depression is the chief hazard of Opana ER. Respiratory depression is
a potential problem in elderly or debilitated patients as well as in those suffering
from conditions accompanied by hypoxia or hypercapnia when even moderate
therapeutic doses may dangerously decrease pulmonary ventilation.
Administer Opana ER with extreme caution to patients with conditions
accompanied by hypoxia, hypercapnia, or decreased respiratory reserve such as:
asthma, chronic obstructive pulmonary disease or cor pulmonale, severe obesity,
sleep apnea syndrome, myxedema, kyphoscoliosis, CNS depression or coma. In
these patients, even usual therapeutic doses of oxymorphone may decrease
respiratory drive while simultaneously increasing airway resistance to the point of
apnea. Consider alternative non-opioid analgesics and use Opana ER only under
careful medical supervision at the lowest effective dose in such patients.
Misuse, Abuse and Diversion of Opioids
Opana ER contains oxymorphone, a mu opioid agonist and a Schedule II controlled
substance with an abuse liability similar to morphine. Opioid agonists are sought by
drug abusers and people with addiction disorders and are subject to criminal diversion.
Oxymorphone can be abused in a manner similar to other opioid agonists, legal or
illicit. This issue should be considered when prescribing or dispensing oxymorphone
in situations where the physician or pharmacist is concerned about an increased risk
of misuse, abuse, or diversion.
Opana ER tablets may be abused by crushing, chewing, snorting or injecting the
product. These practices will result in the uncontrolled delivery of the opioid and
pose a significant risk to the abuser that could result in overdose and death [see Drug
Abuse and Dependence].
Opana ER may be targeted for theft and diversion. Healthcare professionals should
contact their State Medical Board, State Board of Pharmacy, or State Control Board
for information on how to detect or prevent diversion of this product, and security
requirements for storing and handling of Opana ER.
Healthcare professionals should advise patients to store Opana ER in a secure place,
preferably locked and out of the reach of children and other non-caregivers.
Concerns about abuse, misuse, diversion and addiction should not prevent the
proper management of pain.
Interactions with Alcohol and other CNS Depressants
Patients receiving other opioid analgesics, general anesthetics, phenothiazines
or other tranquilizers, sedatives, hypnotics, or other CNS depressants (including
alcohol) concomitantly with oxymorphone may experience respiratory depression,
hypotension, profound sedation, coma and death [see Drug Interactions). Avoid
concurrent use of alcohol and Opana ER.
Use in Patients with Head Injury and Increased Intracranial Pressure
In the presence of head injury, intracranial lesions or a preexisting increase
in intracranial pressure, the possible respiratory depressant effects of opioid
analgesics and their potential to elevate cerebrospinal fluid pressure (resulting from
vasodilation following CO 2 retention) may be markedly exaggerated. Furthermore,
opioid analgesics can produce effects on papillary response and consciousness,
which may obscure neurologic signs of further increases in intracranial pressure in
patients with head injuries.
Administer Opana ER with extreme caution to patients who may be particularly
susceptible to the intracranial effects of CO 2 retention, such as those with evidence
of increased intracranial pressure or impaired consciousness. Opioids may obscure
the clinical course of a patient with a head injury and should be used only if
clinically warranted.
Hypotensive Effect
Opana ER may cause severe hypotension in a patient whose ability to maintain
blood pressure has been compromised by a depleted blood volume, or after
concurrent administration with drugs such as phenothiazines or other agents
that compromise vasomotor tone. Administer Opana ER with caution to patients
in circulatory shock, since vasodilation produced by the drug may further reduce
cardiac output and blood pressure.
Hepatic Impairment
A study of Opana ER in patients with hepatic disease indicated greater plasma
concentrations than those with normal hepatic function. Use Opana ER with
caution in patients with mild impairment, starting with the lowest dose
and titrating slowly while carefully monitoring for side effects. Opana ER is
contraindicated in patients with moderate or severe hepatic impairment.
Special Risk Groups
Use Opana ER with caution in the following conditions: adrenocortical insufficiency
(e.g., Addison’s disease), prostatic hypertrophy or urethral stricture, severe
impairment of pulmonary or renal function, and toxic psychosis.
Opioids may aggravate convulsions in patients with convulsive disorders, and may
induce or aggravate seizures in some clinical settings.
Gastrointestinal Effects
Opana ER decreases bowel motility. Opioids diminish propulsive peristaltic waves
in the gastrointestinal tract. Monitor for decreased bowel motility in post-operative
patients receiving opioids. The administration of Opana ER may obscure the
diagnosis or clinical course in patients with acute abdominal conditions. Opana ER is
contraindicated in patients with paralytic ileus.
Ambulatory Surgery and Post-Operative Use
Opana ER is not indicated for pre-emptive analgesia (administration pre-operatively
for the management of post-operative pain).
Opana ER is only indicated for postoperative use in the patient if the patient is
already receiving the drug prior to surgery or if the postoperative pain is expected to
be moderate to severe and persist for an extended period of time. Physicians should
individualize treatment, moving from parenteral to oral analgesics as appropriate
(see American Pain Society guidelines).
Patients who are already receiving Opana ER as part of ongoing analgesic therapy
may be safely continued on the drug if appropriate dosage adjustments are made
considering the procedure, other drugs given, and the temporary changes in
physiology caused by the surgical intervention.
Use in Pancreatic/Biliary Tract Disease
Opana ER, like other opioids, may cause spasm of the sphincter of Oddi and should be
used with caution in patients with biliary tract disease, including acute pancreatitis.
Driving and Operating Machinery
Opioid analgesics impair the mental and physical abilities needed to perform
potentially hazardous activities such as driving a car or operating machinery.
friDAY
September 9, 2011
ADVERSE REACTIONS
The following serious adverse reactions are discussed elsewhere in the labeling:
• Respiratory depression [see Warnings and Precautions]
• Misuse and abuse [see Warning and Precautions and Drug Abuse and Dependence]
• CNS depressant effects [see Warnings and Precautions]
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse
reaction rates observed in the clinical trials of a drug cannot be directly compared
to rates in the clinical trials of another drug and may not reflect the rates observed
in clinical practice.
The safety of Opana ER was evaluated in a total of 2011 patients in controlled clinical
trials. The clinical trials consisted of patients with moderate to severe chronic nonmalignant
pain, cancer pain, and post surgical pain.
The following table lists adverse reactions that were reported in at least 2% of
patients in placebo-controlled trials (N=5).
Adverse Reactions Reported in Placebo-Controlled Clinical Trials
with Incidence ≥2% in Patients Receiving Opana ER.
MedDRA Preferred
Term
Opana ER
(N=1259)
Placebo
N=461)
Nausea 33% 13%
Constipation 28% 13%
Dizziness (Excl Vertigo) 18% 8%
Somnolence 17% 2%
Vomiting 16% 4%
Pruritus 15% 8%
Headache 12% 6%
Sweating increased 9% 9%
Dry mouth 6%

The Cosmopolitan of Las Vegas
Cimetidine
CNS side effects have been reported (e.g., confusion, disorientation, respiratory
depression, apnea, seizures) following coadministration of cimetidine with opioid
analgesics; a causal relationship has not been established.
Anticholinergics
Anticholinergics or other medications with anticholinergic activity when used
concurrently with opioid analgesics may result in increased risk of urinary retention
and/or severe constipation, which may lead to paralytic ileus.
MAO Inhibitors
Opana ER is not recommended for use in patients who have received MAO inhibitors
within 14 days, because severe and unpredictable potentiation by MAO inhibitors
has been reported with opioid analgesics. No specific interaction between
oxymorphone and MAO inhibitors has been observed, but caution in the use of any
opioid in patients taking this class of drugs is appropriate.
USE IN SPECIFIC POPULATIONS
Pregnancy
The safety of using oxymorphone in pregnancy has not been established with
regard to possible adverse effects on fetal development. The use of Opana ER in
pregnancy, in nursing mothers, or in women of child-bearing potential requires that
the possible benefits of the drug be weighed against the possible hazards to the
mother and the child.
Prolonged use of opioid analgesics during pregnancy may cause fetal-neonatal
physical dependence.
Teratogenic Effects
Pregnancy Category C
There are no adequate and well-controlled studies of oxymorphone in pregnant
women. Opana ER should be used during pregnancy only if the potential benefit
justifies the potential risk to the fetus [see Use in Specific Populations].
Oxymorphone hydrochloride administration did not cause malformations at any
doses evaluated during developmental toxicity studies in rats (≤25 mg/kg/day) or
rabbits (≤50 mg/kg/day). These doses are ~3-fold and ~12-fold the human dose
of 40 mg every 12 hours, based on body surface area. There were no developmental
effects in rats treated with 5 mg/kg/day or rabbits treated with 25 mg/kg/day. Fetal
weights were reduced in rats and rabbits given doses of ≥10 mg/kg/day and 50
mg/kg/day, respectively. These doses are ~1.2-fold and ~12-fold the human dose
of 40 mg every 12 hours based on body surface area, respectively. There were no
effects of oxymorphone hydrochloride on intrauterine survival in rats at doses ≤25
mg/kg/day, or rabbits at ≤50 mg/kg/day in these studies (see Non-teratogenic
Effects, below). In a study that was conducted prior to the establishment of
Good Laboratory Practices (GLP) and not according to current recommended
methodology, a single subcutaneous injection of oxymorphone hydrochloride on
gestation day 8 was reported to produce malformations in offspring of hamsters
that received 15.5-fold the human dose of 40 mg every 12 hours based on body
surface area. This dose also produced 20% maternal lethality.
Non-teratogenic Effects
Oxymorphone hydrochloride administration to female rats during gestation in a
pre- and postnatal developmental toxicity study reduced mean litter size (18%) at
a dose of 25 mg/kg/day, attributed to an increased incidence of stillborn pups. An
increase in neonatal death occurred at ≥5 mg/kg/day. Post-natal survival of the
pups was reduced throughout weaning following treatment of the dams with 25
mg/kg/day. Low pup birth weight and decreased postnatal weight gain occurred
in pups born to oxymorphone-treated pregnant rats given a dose of 25 mg/kg/day.
This dose is ~3-fold higher than the human dose of 40 mg every 12 hours on a body
surface area basis.
Labor and Delivery
Opioids cross the placenta and may produce respiratory depression in neonates.
Opana ER is not recommended for use in women during and immediately prior
to labor, when use of shorter acting analgesics or other analgesic techniques are
more appropriate. Occasionally, opioid analgesics may prolong labor through
actions which temporarily reduce the strength, duration and frequency of uterine
contractions. However this effect is not consistent and may be offset by an increased
rate of cervical dilatation, which tends to shorten labor.
Neonates whose mothers received opioid analgesics during labor should be
observed closely for signs of respiratory depression. A specific opioid antagonist,
such as naloxone or nalmefene, should be available for reversal of opioid-induced
respiratory depression in the neonate.
Upon delivery from a mother who received opioids for a long period of time,
neonatal withdrawal may occur. Symptoms usually appear during the first days of
life and may include convulsions, irritability, excessive crying, tremors, hyperactive
reflexes, fever, vomiting, diarrhea, sneezing, yawning, and increased respiratory rate.
Nursing Mothers
It is not known whether oxymorphone is excreted in human milk. Because many
drugs, including some opioids, are excreted in human milk, caution should be
exercised when Opana ER is administered to a nursing woman. Infants exposed
to Opana ER through breast milk should be monitored for excess sedation and
respiratory depression. Withdrawal symptoms can occur in breast-fed infants when
maternal administration of an opioid analgesic is stopped, or when breast-feeding
is stopped.
Pediatric Use
Safety and effectiveness of Opana ER in pediatric patients below the age of 18 years
have not been established.
Geriatric Use
Opana ER should be used with caution in elderly patients.
Of the total number of subjects in clinical studies of Opana ER, 27% were 65 and over,
while 9% were 75 and over. No overall differences in effectiveness were observed
between these subjects and younger subjects. There were several adverse events that
were more frequently observed in subjects 65 and over compared to younger subjects.
These adverse events included dizziness, somnolence, confusion, and nausea.
Hepatic Impairment
In a PK study of Opana ER, patients with mild hepatic impairment were shown to
have an increase in bioavailability of 1.6 fold. Use Opana ER with caution in patients
with mild impairment. Start these patients on the lowest dose and titrate slowly
while carefully monitoring for side effects. Opana ER is contraindicated for patients
with moderate and severe hepatic impairment [see Contraindications and Warnings
and Precautions].
Renal Impairment
In a PK study of Opana ER, patients with moderate to severe renal impairment were
shown to have an increase in bioavailability ranging from 57-65%. Start these
patients with the lowest dose of Opana ER and titrate slowly while monitored for
side effects.
DRUG ABUSE AND DEPENDENCE
Controlled Substance
Opana ER contains oxymorphone, a mu opioid agonist and a Schedule II
controlled substance with an abuse liability similar to morphine and other
opioids. Oxymorphone can be abused and is subject to criminal diversion [see
Warning and Precautions].
Abuse
All patients treated with opioids require careful monitoring for signs of abuse and
addiction, since use of opioid analgesic products carries the risk of addiction even
under appropriate medical use. Addiction is a primary, chronic, neurobiologic
disease, with genetic, psychosocial, and environmental factors influencing its
development and manifestations. Addiction is characterized by one or more of the
following: impaired control over drug use, compulsive use, use for non-medical
purposes, and continued use despite harm. Drug addiction is a treatable disease,
utilizing a multidisciplinary approach, but relapse is common.
“Drug seeking” behavior is very common to addicts and drug abusers. Drug-seeking
tactics include emergency calls or visits near the end of office hours, refusal to
undergo appropriate examination, testing or referral, repeated claims of loss of
prescriptions, tampering with prescriptions and reluctance to provide prior medical
records or contact information for other treating physician(s). “Doctor shopping”
(visiting multiple prescribers) to obtain additional prescriptions is common among
drug abusers and people suffering from untreated addiction. Preoccupation with
achieving adequate pain relief can be appropriate behavior in a patient with poor
pain control.
Abuse and addiction are separate and distinct from physical dependence and
tolerance. Physicians should be aware that addiction may not be accompanied
by concurrent tolerance and symptoms of physical dependence in all addicts.
In addition, abuse of opioids can occur in the absence of true addiction and is
characterized by misuse for non-medical purposes, often in combination with other
psychoactive substances. Opana ER, like other opioids, may be diverted for nonmedical
use. Careful record-keeping of prescribing information, including quantity,
frequency, and renewal requests is strongly advised.
Opana ER is intended for oral use only. Abuse of Opana ER poses a risk of overdose
and death. This risk is increased with concurrent abuse of Opana ER with alcohol
and other substances. Parenteral drug abuse is commonly associated with
transmission of infectious disease such as hepatitis and HIV.
Proper assessment of the patient, proper prescribing practices, periodic reevaluation
of therapy, and proper dispensing and storage are appropriate measures
that help to limit abuse of opioid drugs.
Dependence
Opioid analgesics may cause physical dependence. Physical dependence
results in withdrawal symptoms after abrupt discontinuation of a drug or upon
administration of an opioid antagonist or mixed opioid agonist/antagonist agent.
Withdrawal also may be precipitated through the administration of drugs with
opioid antagonist activity, e.g., naloxone, nalmefene, or mixed agonist/antagonist
analgesics (pentazocine, butorphanol, buprenorphine, nalbuphine). Physical
dependence may not occur to a clinically significant degree until after several days
to weeks of continued opioid usage.
Tolerance is the need for increasing doses of opioids to maintain a defined effect
such as analgesia (in the absence of disease progression or other external factors).
The development of physical dependence and tolerance is not unusual during
chronic opioid therapy.
Opana ER should not be abruptly discontinued. If Opana ER is abruptly discontinued
in a physically-dependent patient, an abstinence syndrome may occur. Some
or all of the following can characterize this syndrome: restlessness, lacrimation,
rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other symptoms
also may develop, including: irritability, anxiety, backache, joint pain, weakness,
abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased
blood pressure, respiratory rate, or heart rate.
Infants born to mothers physically dependent on opioids will also be physically
dependent and may exhibit respiratory difficulties and withdrawal symptoms
[see Use in Specific Populations].
OVERDOSAGE
Symptoms
Acute overdosage with Opana ER is characterized by respiratory depression (a
decrease in respiratory rate and/or tidal volume, Cheyne-Stokes respiration, cyanosis),
extreme somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold
and clammy skin, constricted pupils and sometimes bradycardia and hypotension. In
some cases, apnea, circulatory collapse, cardiac arrest and death may occur.
news 11
Opana ER may cause miosis, even in total darkness. Pinpoint pupils are a sign of
opioid overdose but are not pathognomonic (e.g., pontine lesions of hemorrhagic or
ischemic origin may produce similar findings). Marked mydriasis rather than miosis
may be seen with hypoxia in overdose situations.
Treatment
In the treatment of Opana ER overdosage, primary attention should be given to
the re-establishment of a patent airway and institution of assisted or controlled
ventilation. Supportive measures (including oxygen and vasopressors) should
be employed in the management of circulatory shock and pulmonary edema
accompanying overdose as indicated. Cardiac arrest or arrhythmias may require
cardiac massage or defibrillation.
The opioid antagonist naloxone hydrochloride is a specific antidote against
respiratory depression that may result from overdosage or unusual sensitivity to
opioids including Opana ER. Nalmefene is an alternative pure opioid antagonist,
which may be administered as a specific antidote to respiratory depression resulting
from opioid overdose. Since the duration of action of Opana ER may exceed that
of the antagonist, keep the patient under continued surveillance and administer
repeated doses of the antagonist according to the antagonist labeling as needed to
maintain adequate respiration.
In patients receiving Opana ER, opioid antagonists should not be administered in
the absence of clinically significant respiratory or circulatory depression. Administer
opioid antagonists cautiously to persons who are known, or suspected to be,
physically dependent on any opioid agonist including Opana ER. In such cases, an
abrupt or complete reversal of opioid effects may precipitate an acute abstinence
syndrome. In an individual physically dependent on opioids, administration of
the usual dose of the antagonist will precipitate an acute withdrawal syndrome.
The severity of the withdrawal syndrome produced will depend on the degree of
physical dependence and the dose of the antagonist administered. If respiratory
depression is associated with muscular rigidity, administration of a neuromuscular
blocking agent may be necessary to facilitate assisted or controlled ventilation.
Muscular rigidity may also respond to opioid antagonist therapy.
NONCLINICAL TOXICOLOGY
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis
No evidence of carcinogenic potential was observed in rats. No evidence of
carcinogenic potential was observed in mice.
Mutagenesis
Oxymorphone hydrochloride was not mutagenic when tested in the in vitro
bacterial reverse mutation assay (Ames test) at concentrations of ≤5270 µg/plate,
or in an in vitro mammalian cell chromosome aberration assay performed with
human peripheral blood lymphocytes at concentrations ≤5000 µg/ml with or
without metabolic activation. Oxymorphone hydrochloride tested positive in both
the rat and mouse in vivo micronucleus assays.
Impairment of fertility
The dose of oxymorphone that produced no adverse effects on reproductive
findings in female rats is 0.6-fold the human dose of 40 mg every 12 hours on a
body surface area basis.
STORAGE AND HANDLING
Opana ER contains oxymorphone, which is a controlled substance. Oxymorphone
is controlled under Schedule II of the Controlled Substances Act. Oxymorphone,
like all opioids, is liable to diversion and misuse and should be handled accordingly.
Patients and their families should be instructed to flush any Opana ER tablets that
are no longer needed.
Opana ER may be targeted for theft and diversion. Healthcare professionals should
contact their State Medical Board, State Board of Pharmacy or State Control Board
for information on how to detect or prevent diversion of this product.
Healthcare professionals should advise patients to store Opana ER in a secure place,
preferably locked and out of the reach of children and other non-caregivers.
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP
Controlled Room Temperature].
Dispense in tight container as defined in the USP, with a child-resistant closure
(as required).
Advise patients to dispose of any unused tablets from a prescription by flushing
them down the toilet as soon as they are no longer needed [see Patient Counseling
Information].
PATIENT COUNSELING INFORMATION
See FDA-Approved Medication Guide
(See full prescribing information for details on information for patients).
CAUTION: Federal law prohibits dispensing without prescription.
Manufactured for:
Endo Pharmaceuticals Inc.
Chadds Ford, Pennsylvania 19317
Manufactured by:
Novartis Consumer Health Inc.
Lincoln, NE 68517
TIMERx®-N is a registered trademark of Penwest Pharmaceuticals Co., Danbury,
Connecticut and is used herein pursuant to a license agreement between Penwest
and Endo Pharmaceuticals.
© 2010 Endo Pharmaceuticals Rev. September 2010
OP-00983 / February 2011 2005648
L404505_OPANA ER BriefSum.indd 2
2/17/11 12:51 PM

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September 9, 2011
PREVIEW
Talking with Patients about Opioid Risks and Safety
Geralyn Datz, PhD, will present “Preparing Patients
for Opioid Therapy” Saturday at PAINWeek 2011.
Datz, a psychologist and pain specialist who directs
the Pain Management Program at Forrest General
Hospital in Hattiesburg, MS, will review practical strategies
for using effective spoken and written communication to
help patients prepare for chronic opioid therapy.
Why is it important that clinicians take the time to talk to their
patients about the risks and benefits of opioid therapy
The most compelling reason is that opioids are one of the most
abused prescription substances. Increased rates of opioid prescribing
has occurred concurrent with greater misuse, abuse,
and diversion of opioids. The number of pain medication-related
admissions and poisonings related to opioids is at an alltime
high. The number of people who are dying from prescription
medication overdoses has now exceeded the number of
motor vehicle-related deaths. There is a national crisis, and it
must be recognized.
What information do prospective patients need to know about
these medications
It begins with open communication between the provider and
patient. This should include education about risks and benefits,
awareness of adverse effects and how to report them, and an
elementary understanding of addiction and how it develops.
Patients also require instruction about risks of sharing or taking
another person’s medicines while using opioids, potential interactions,
and knowledge of how to properly stop opioid therapy,
if desired. It is also important to educate patients about proper
storage and disposal of opioids, as these are avenues by which
opioids can be diverted. It is possible to achieve these goals fairly
quickly and succinctly with patients.
During your presentation, what spoken communications strategies
will you discuss
Shared decision making is one strategy that is useful with patients.
This requires a dialogue with the patient about his or her
preferences or concerns, and allows the patient to ask questions,
while the prescriber also communicates recommendations.
Research with pain patients has suggested these pain
patients want their pain legitimized, and that the strength of
the patient–provider relationship predicts adherence. These are
important pearls of wisdom for prescribers. For example, if you
have a patient that feels you are being dismissive of his or her
pain and experience, he or she will be less likely to follow your
instructions. In the best case, this could result in nonadherence.
In the worst case, this could result in accidental overdose or
even death. Neither outcome is desirable. This presentation will
focus on strategies that enable your patients to feel empowered
and understood, and on improving compliance.
How important is it for clinicians to supplement these discussions
with printed patient education materials
It is vital to include both spoken and written materials when educating
patients. Most patients do not remember everything that is
said during an office visit, no matter how important the information
may be. Written materials should reinforce every vital point
that a prescriber wants his or her patients to know. Patients need
time to reflect on what they’ve been told and read about opioid
medications, discuss options and concerns with family or trusted
friends, and be invited to return with questions. Patient education
materials should be written in a simple and straightforward style,
at an 8th-grade reading level, and with as little jargon as possible.
This allows the patients to comprehend the information being
conveyed, and not feel confused about their care and what
is expected of them.
Most health care
professionals do not receive
nearly enough education
and training to adequately
address issues of opioid
addiction, misuse, and
diversion. However, attending
conferences like PAINWeek
is an important and positive
step in the right direction.
How can prescription opioid addiction, misuse, and diversion be
curtailed
That question is the focus of much debate. Some would say
these are system-based problems, which require a multifaceted
prevention approach that includes prescribers, manufacturers,
prescription monitoring programs, insurance companies,
and law enforcement. Education alone will not do it. Education
needs to be paired with action, consequences, monitoring, and
consistency. That said, there are heuristics and patient care
processes that prescribers can employ to assist in reducing aberrant
behavior and addiction risk in their patients. One is the
“Universal Precautions” approach created by Douglas Gourlay
and colleagues. This is a simple yet thorough guideline that
basically walks the provider through 10 steps for evaluating,
monitoring, and reassessing how effective opioid therapy is.
Most health care professionals do not receive nearly enough
education and training to adequately address issues of opioid
addiction, misuse, and diversion. However, attending conferences
like PAINWeek is an important and positive step in the
right direction.
What is the best source of (or tool for) information regarding how
to manage side effects
Side effects of opioid therapy are common and can range from
mild to extremely unpleasant. Some side effects may not be tolerated
at all, and lead to discontinuation of therapy or trial of
another opioid. First and foremost, side effects should be reported
and discussed with the prescribing provider. It can be dangerous
to abruptly stop opioid therapy. Secondly, patients need to
be aware that many side effects can be effectively managed,
and give the provider a chance to do so. I also encourage patients
to be active in their pain care and seek out information on
their own. This may include talking to their pharmacists and using
self-management resources. Pharmacists are an underutilized
resource and have a wealth of information to share. Patients can
also go online to look up information about opioid medications
via the manufacturer’s website or credible online resources such
as PainSafe.org (www.painsafe.org).
Why is proper opioid storage such an important topic to discuss
with patients
Diversion is one of the most important reasons. Opioids are the
most commonly abused prescription drugs. Alarmingly, research
from the Substance Abuse and Mental Health Services Administration
(SAMHSA) indicates that friends and family members
are the most common source for prescription pain relievers obtained
for free for nonmedical use. This means that pain medications
were freely given (or taken) from people legitimately
prescribed pain medications, and then abused, misused, or
sold by someone else. Not only is this dangerous, but it is illegal.
The two age groups most likely to overdose are ages 18 to 25,
and 12 to 17. In a nutshell this means that at-risk teenagers and
young adults are getting their drugs of choice from mom and
dads, grandma and grandpa’s medicine cabinets, and then dying.
On another level, storage is also important to prevent accidental
overdose, in age groups under 5, for example. When
someone is prescribed an opioid, they have the responsibility to
store the prescription properly.
What are your thoughts on treatment agreements and their effect
on the patient-provider relationship
A treatment agreement is one possible tool for enhancing
patient-provider communication. Agreements put in writing
what the expectations of the professional relationship are that
surround chronic opioid therapy. Ideally, they cement what is
already known and communicated verbally. There are good
agreements, and there are poor agreements. A well-written
agreement should include safety instructions and troubleshooting
advice, which may prevent misunderstandings and/or accidental
or intentional breaches of the relationship later on. For
example, treatment agreements can describe what patients
should do in case of a pain emergency, how to handle it if another
provider gives them a pain prescription, and what to do if
their medicine is lost or stolen. When patients know what to do,
they may act less impulsively. This is safer and also less frustrating
for both patients and providers. When used well, treatment
agreements enhance the patient-provider relationship. If used
improperly, however, they can definitely harm this relationship.
It is important to know the difference.
How will your presentation at PAINWeek assist physicians with
REMS
One of the cornerstones of REMS is the idea that health care
providers need more education regarding controlled substances
and especially opioid analgesics. Once educated, the goal
is for providers to translate the risks and benefits of opioid therapy
more transparently to patients. This presentation will cover
several key topic areas that were suggested as important by
the REMS panel: careful patient selection and monitoring; safety
measures; and ways to improve patient awareness about
how to use these drugs safely.
—By Sandra Kear

The Cosmopolitan of Las Vegas
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PREVIEW
Diagnosing the Cause of Joint Inflammation Right from the Start
What happens when a patient comes into your office with one or more inflamed joints How do you make a diagnosis and where do you go from there
Inflamed joints may be the result of a number of conditions,
including crystal-induced arthritis and rheumatoid
arthritis. Ronald Rapoport, MD, FACR, a practicing
rheumatologist at the Truesdale Clinic in Fall River,
MA, will discuss these and other topics during back-toback
presentations, “Inflammatory Arthritis” and “Polymyalgia
Rheumatica and Giant Cell Arteritis” on Friday,
September 9, 2011, during the Rheumatology session of
PAINWeek 2011.
Both presentations will provide general practitioners with
useful information to help accurately diagnose the underlying
cause of early onset joint pain and inflammation. The discussion
of polymyalgia rheumatica and giant cell arteritis is new
to PAINWeek this year. Rapoport says that these conditions are
often difficult to diagnose when assessing the cause of joint
pain, and that for all of the diseases he will cover in these sessions,
early diagnosis and appropriate management are critical
to forestalling loss of functional capacity and preserving
quality of life for the patient.
Inflammatory arthritis describes a number of diseases including
rheumatoid arthritis, psoriatic arthritis, gout, pseudogout,
and certain spondyloarthropathies. “Inflammatory
arthritis can follow different patterns; for instance, a patient
may present with monarticular arthritis, oligoarticular arthritis,
or polyarticular arthritis,” explains Rapoport. Many patients
who present with early stage disease are initially seen
in the primary care setting, so it is important that primary
care physicians are able to accurately diagnose each of
the inflammatory arthritides. For primary care physicians,
“Securing a diagnosis is by far the most important thing,”
says Rapoport.
Securing a diagnosis for established disease may be
straightforward since unique patterns of joint involvement,
characteristic of the different types of inflammatory arthritis,
may be evident in these cases. In the early stages, however,
different types of inflammatory arthritis may display very similar
presentations. These overlaps in presentation can confound
diagnosis and may delay appropriate treatment and referral.
According to Rapoport, even practicing rheumatologists who
see these conditions all the time find it challenging to differentiate
these diseases in the early stages of onset. “Usually when
the disease is established and the pattern of joint involvement
is more evident the diagnosis can be more readily secured. But,
in the beginning, the patterns of involvement may overlap so
one disease may actually look like another. So you have to ask
the history in more detail; laboratory tests and X-rays can be
helpful,” he says.
Among the elderly population, in whom these diseases
are fairly common, prolonged pain reduces quality of life
and activity level. This may lead to deterioration and additional
sequelae from inactivity and depression. To facilitate
timely relief from symptoms and disease progression, diagnosis
needs to be made as early as possible. In many cases,
a patient will be referred to a specialist, but specialty care
may not be immediately available, meaning that treatment
must be initiated in the primary care setting. Rapoport says
that “The reason you want to make a decision about what
type of arthritis it is, is because they may be treated differently.
So, for somebody who has rheumatoid arthritis versus
psoriatic arthritis, you may choose a different path of treatment.
But you can also imagine somebody with gout who
may present with joints that are inflamed. There is another
illness called pseudogout that may have a similar presentation
to gout but it is caused by a different crystal. Gout is
caused by monosodium urate crystal. So same look, but different
cause, and you may end up with different treatments.”
Rapoport will present a number of case studies during his
interactive presentations that illustrate the use of medical history,
physical examination, imaging, and laboratory testing to
differentiate the underlying causes of inflamed joints. Basically,
he says that the talks will discuss, “What happens when a patient
comes into your office with an inflamed joint or multiple
inflamed joints How do you make diagnosis and where do
you go from there”
For example, patients with rheumatoid arthritis and those with
psoriatic arthritis both, “tend to have multiple joints involved, significant
stiffness when awakening in the morning, and fatigue…
people who have rheumatoid arthritis tend to have tests that
point toward rheumatoid arthritis such as positive rheumatoid
arthritis factor and another test called the anti-CCP antibody.
People with psoriatic arthritis tend to have a different pattern of
joint involvement than rheumatoid. Rheumatoid arthritis tends to
be bilateral and symmetrical while psoriatic arthritis tends to be
more asymmetrical and there is the presence of psoriasis. There
are no laboratory tests for psoriatic arthritis that are specific for
that illness,” Rapoport says.
A variety of well-established imaging techniques and diagnostic
laboratory tests such as erythrocyte sedimentation rates
(ESR) will be covered. Rapoport will also discuss some newer
tests that may not be familiar to all general practitioners, for example,
the anti-cyclic citrullinated peptide (anti-CCP) antibody
test and the complex antinuclear antibody (ANA) test and its
subtests. Assessment of synovial fluid aspiration to differentiate
infection, inflammatory arthritis, noninflammatory arthritis, gout,
and pseudogout will be specifically addressed during the presentation.
Each presentation will offer a detailed overview of a
variety of clinical assessment techniques and tests recommended
for the diagnosis of each disease. Rapoport
will review basic elements of the physical examination of
inflamed joints and provide practical tips on its execution.
He will also rely upon images to help participants
see the differences between the types of inflammatory
arthritis. This is important information because, in many
cases, physical assessment itself can provide important
information. Swelling itself differs depending on the type
of inflammatory arthritis the patient has. “If someone has
gout, the intensity of swelling usually is far greater than
that of somebody with rheumatoid arthritis. There can be
overlap, but it is usually different. In addition, the amount
of heat coming from the joint can be different. The presentation
and the distribution of the joints involved can
be different. It is the way the joints feel, the way the joints
look, which joints are involved,” he says.
Rapoport will also talk about significant comorbidities to
consider, especially those associated with rheumatoid arthritis,
for example Sjögren’s syndrome. Rapoport encourages participants
to use the discussion period at the end of the presentations
to raise questions about specific applications and treatments.
During “Polymyalgia Rheumatica and Giant Cell Arteritis,”
Rapoport will present a case that goes over the differential in
polymyalgia rheumatica and giant cell arteritis. Polymyalgia
rheumatica is an important condition to discuss because it is not
an uncommon presentation of pain in older patients (60 years
of age and older), affecting approximately 1 out of 200 adults
Many patients who present
with early stage disease
are initially seen in the
primary care setting, so it
is important that primary
care physicians are able to
accurately diagnose each of
the inflammatory arthritides
in the United States. While it is not classic inflammatory arthritis,
the similarities in presentation that it bears to inflammatory
arthritis can confound diagnosis. For example, Rapoport says
that “Mild rheumatoid arthritis, in the beginning, it can look just
like polymyalgia rheumatica, at least in the beginning. So you
really have to keep your ears open.” Polymyalgia rheumatica
usually strikes the shoulder and hip girdles and can be quite
disabling. Some of these patients may have puffy swelling on
their hands making its presentation appear similar to that of
rheumatoid arthritis.
Approximately 15% of patients with polymyalgia rheumatica
have giant cell arteritis, a condition characterized by inflammation
of the arteries. Practitioners should evaluate patients with
polymyalgia rheumatica for this condition. Patients with giant
cell arteritis often present with palpable temporal arteries, new
onset of unilateral headache, oral cortication, new onset of
cough, visual blurring, loss of vision, or double vision. Effective
management of this disease is critical because, among other
things, it can lead to irreversible visual loss when arteries leading
to the eyes are involved.
—By Kim Farina-Graham, Phd

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friDAY
September 9, 2011
PREVIEW
Understanding Pain: A Picture is Worth a Thousand Words
Functional neuroimaging holds great promise in allowing clinicians to develop a better understanding of the intensely subjective nature of patients’ experience of pain
Pain is a personal and subjective experience influenced
by cognitive, emotional, and environmental
factors. There are no objective measurements for
pain, unlike for diseases such as diabetes or hypertension.
When assessing pain, clinicians must attempt to correlate
existing objective data (eg, physical exam findings, imaging
results, and lab test results) with a patient’s subjective
report. Effective pain management is complicated by the
wide variability in how patients respond to pain and to
treatment. Much of the variability is thought to be mediated
by central brain mechanisms.
Friday at PAINWeek 2011, in a presentation titled “Neuroimaging
of Pain,” Sean Mackey, MD, will cover several perspectives
on pain and use data from relevant studies to provide an
overview of functional neuroimaging as a way to better understand
pain, its complexities, and factors that influence it. Mackey
is chief of the division of pain management and associate
professor in the department of anesthesia at Stanford University
School of Medicine, Palo Alto, CA. He also serves as the director
of the Stanford Systems and Pain Lab.
Neuroimaging is a method of observing brain activation and
structure. Functional neuroimaging has provided useful information
regarding: 1) brain regions involved in pain; 2) neural plasticity
associated with neuropathic pain and other chronic pain
disorders; and 3) the effects of therapeutic agents on central neural
systems. According to Mackey, “Functional neuroimaging is
transforming our understanding of the neurobiology of pain and
will be instrumental in helping us design more rational treatments
ultimately aimed at reducing its impact on our patients.”
During his presentation, Mackey will talk about individual differences
in the experience of pain. Specifically he will explore
the questions, “Why is there such a wide variability in perception
of pain to a given stimulus and such a large variability
in response to analgesic agents” and “What is 10-out-of-10”
pain” He will present neuroimaging study data that offer some
insights into individual variability in pain experiences.
It is well appreciated that thoughts and feelings (eg, attention,
fear, anxiety, love, and depression) can modulate an individual’s
pain experience and impact the way that pain is perceived.
Mackey will review data showing how emotional centers of the
brain influence pain perception and brain activity, explore the
underlying neurophysiological mechanisms of these associations,
and present the neurological similarities and differences
of other emotions (eg, empathy and love) in relation to pain
perception. Evidence suggests that the brain areas involved in
drug abuse and addiction are also involved in pain processing
and perception. Mackey will discuss this during the portion of
his talk dedicated to the neurophysiology of addiction.
While data is just emerging, neuroimaging has begun to
provide insight into the phenomenon of chronic pain. Mackey
says, “There is a growing awareness that chronic pain should
be thought of as a disease in its own right—a disease that fundamentally
alters the central nervous system. As a central nervous
system disease, pain can be maintained and amplified
even after the original injury that caused the pain has healed.
My talk will update the audience on the central nervous system
changes that occur in chronic pain and help the audience better
understand why many patients continue to have persistent
and complex pain problems for many years.”
At the forefront of pain research is the idea that people can
learn to control specific, localized processes that occur within
their brains. Mackey will talk about the healthy adult brain’s capacity
to undergo plastic changes and the ability of voluntary
brain mechanisms to control pain.
Neuroimaging is a relatively new field with many obstacles.
Mackey will discuss the future of functional neuroimaging studies
of pain in humans and will describe its current limitations,
along with emerging technologies expected to help overcome
some of the existing barriers. The real goal of the field of neuroimaging
is to translate its discoveries into novel therapies.
There is no question that pain is a significant public health
burden. It affects over 116 million individuals and costs an
estimated $635 billion each year in medical care and loss
of work. It also causes suffering and reduced quality of life.
While there is still much to learn about all of the neural players
involved in pain modulation, Mackey says that the brain
is the key to understanding the pain experience. Functional
neuroimaging is being used to reveal the sensory and emotional
components of pain. These technologies have led to
the understanding that pain is a highly plastic condition that
involves multiple central neural systems, not a static disease
with peripherally localized pathology. Mackey says that
functional neuroimaging promises to reveal even more about
the neural mechanisms underlying pain and to link existing
data from decades of research in animal models to clinical
practice.
—By Kim Farina-Graham, PhD
RECAP
What Will Opioid REMS Mean for Patients and Pain Practitioners
The current opioid REMS will rely on education to achieve its goals, but may also produce unintended consequences for patients
During “Clinical Implications of the Opioid REMS,”
presented Thursday morning at PAINWeek 2011,
Kevin Zacharoff, MD, compared the risk management
approach taken by physicians when putting a patient
on warfarin with that taken by physicians who prescribe
opioids for pain patients. In contrast with the uneven approach
to informing patients about the risks and side effects
associated with opioids, Zacharoff said that “When
putting a patient on warfarin, there’s no thought about the
discussion of risks and no problem starting the process of
treatment.” He said that nobody would prescribe warfarin
without clearly and thoroughly explaining to the patient
the potentially serious side effects associated with the
drug; it’s easy to have a straightforward and informative
conversation that leaves the patient with a clear understanding
of the issues. Yet, when it comes to opioids, too
many physicians don’t have that conversation with the patient,
and too many patients remain unaware of the risks.
Zacharoff isn’t buying it, though. “If you can have that talk
with warfarin, you can do that with opioids. All of the tools,
all of the thinking, all of the processes, all of the paradigms
with opioids need to mirror what goes on with patients on
anticoagulant therapy,” he said.
The lack of education and awareness of the risks associated
with prescription opioid medications has, along with
other factors (including an increase in the number of opioid
prescriptions, an increase in the population of people suffering
from chronic pain, and greater emphasis on treating pain)
contributed to a severe increase in opioid abuse, misuse, and
diversion over the last 20 years, leading to a concomitant increase
in the number of unintended deaths associated with
this class of medication.
Zacharoff said that the statistics on non-medical use
of opioids are particularly eye-opening. He said that the
2009 National Survey on Drug Use and Human Health
found that, for children age 12 and older, the 2009 estimate
of 5.3 million current nonmedical users was up 20%
from the 2002 estimate of 4.4 million. In children age 12-17,
the survey found that the rate of nonmedical use increased
17%. The survey also revealed that in 2009 there were 2.6
million new users of prescription pain medications, 2.2 million
of whom were non-medical users. The 2009 National
Survey on Drug Use and Health found that, in 2008, more
than 13% of all Americans age 12 and older had used a
prescription pain medication non-medically at least once
in their lifetime.
Where are all of these opioids coming from Zacharoff
said that in 2009, 28% of opioids were prescribed by family
practitioners and 14% were written by internal medicine
physicians. Dentists also wrote a substantial number of prescriptions.
According to CDC data, in 2009 more than threequarters
(76%) of opioids used for non-medical purposes
were prescribed to someone other than the user; 20% of
opioids used non-medically were prescribed to the user.
Clearly, opioids continue to have a far-reaching public
health impact in the United States. And because consumers,
drug makers, and the health care community have not been
successful in ensuring the safe and appropriate use of these
medications, the federal government has shown an increasing
willingness to step in and mandate that all stakeholders
take specific actions to rectify the situation. Most meaningfully,
the Food and Drug Administration Amendments Act of
2007 authorized the FDA to require certain drug manufacturers
to submit a proposed Risk Evaluation and Mitigation
Strategy (REMS) if the FDA determined that a REMS is necessary
to ensure that the benefits of the drug continue to outweigh
the risks. Zacharoff said that although REMS enforcement
means that drug manufacturers face substantial fines
if the plans are not followed, “it all eventually ends up on
the doorstep of health care providers and patients.” He said
that the goal of REMS is to help providers and patients think
about how to use opioids safely and effectively, and the FDA
believes that opioid REMS will reduce the risks associated
with the drugs while ensuring continued access to them for
patients with legitimate medical needs.
What will opioid REMS mean for pain practitioners and
their patients Zacharoff said that there are many unknowns
and unanswered questions at this stage: Is a class-wide
opioid REMS truly class-wide Will the fact that the current
REMS plan applies only to long-acting and extended-release
opioids merely mean that providers will write fewer prescriptions
for those drugs, and shift prescribing to short-acting
opioids And if so, will that worsen the current problems of
misuse and diversion Will this approach lead to decreased
access to pain medications for patient with legitimate medical
needs What other unintended consequences will result
from this approach to REMS

The Cosmopolitan of Las Vegas
news 15
EDITORIAL
Addictive Illness in a Patient Suffering with Pain
Does Not Rule Out the Use of Opioids
Determining such a patient’s risk for developing opioid dependence requires a skillful and observant clinician
By Stuart Gitlow, MD, MPH, MBA
All individuals can
be divided into
two groups with
respect to addictive illness:
those who have
the illness and those
who do not. This seems
intuitive, but the discussion
becomes interesting
as we consider that patients
with a substance
use disorder can be further divided between those who
have tried the substance and those who have not.
It is possible to have a patient with an unexpressed substance
use disorder who has never been exposed to narcotics
in any form, and who may likely go the rest of his life without
opioid dependence if never so exposed. But wait, you say;
that’s not how opioid dependence is diagnosed. Opioid dependence
is diagnosed based upon certain behavioral patterns
with respect to opioid use. It isn’t possible to diagnose
or detect prior to the patient ever having used the substance
in the first place!
We cannot rule in diabetes without examining the patient’s
blood sugar, but we can certainly have suspicion by
simply exploring symptomatic detail, family history, or other
aspects of the patient’s presentation. And the diabetes is
there, in fact, from the time the autoimmune activity starts to
result in a decrease in islet cells, even if blood sugar remains
normal. So in opioid dependence, although the actual opioid
use may not be present, there are many other details
that can be assessed to determine risk. It is purely an issue of
diagnostic semantics as to whether the disorder exists prior
to the patient using the drug in the first place. Given that the
disorder is genetic, we must assume that it is in fact present
in the first place and that the use of an addictive drug will
trigger the rest of the illness.
That being said, let’s now return to the standard definitions
wherein opioid dependence does not exist until after opioids
have been used in a manner despite the patient’s best interest.
In the treatment of pain when narcotic use is being considered,
there are actually four possibilities:
• The patient who has never had narcotic exposure and who
is at high risk of having opioid dependence should narcotics
be initiated.
• The patient who has never had narcotic exposure and who is
at low risk of having opioid dependence.
• The patient who has received narcotics in the past with no
sign of substance use disorder.
• The patient who has received narcotics in the past and who
has a known substance use disorder.
Tricks of the trade include differentiating between (a) and (b),
and between (c) and (d), as well as knowing how to cope with
(d) in cases where the use of narcotic pain relievers is critical.
Step 1 therefore involves a determination as to whether addictive
disease exists in a given patient. Appropriate history taking
is critical, focusing on all addictive drugs, including tobacco.
Patients who smoke, or who have smoked, have a greater likelihood
of having other addictive disease than those without such
a history. Patients who have a history of alcoholism and who
have a well-established and long-lasting recovery are at greater
risk of narcotic dependence than those with no past issues
relating to alcohol use. The duration of recovery does not reflect
risk of relapse; that is to say that patients who have active substance
use disorders may have no greater risk with exposure to
narcotics than those who have had long recovery periods from
their drugs of choice.
Step 2, which follows if Step 1 shows no history of addiction,
involves determining whether a substance use disorder is likely
to be present even though the patient has never been exposed
to the planned pharmacotherapy. This is a more complex question
that requires you to seek out clues, family history being perhaps
the most prominent. The manner in which the patient relates
to other people in his or her life is also important; this may
be difficult to establish during an intake interview, however. It is
here that an addiction consult may be helpful. In all likelihood,
two of every 10 patients being considered for pain treatment
have addictive illness. Establishing the risk for each new patient
is therefore an essential step in reducing the risk of a “new onset”
addictive disease.
Step 3 takes place only if narcotic use is instituted. Follow
the patient closely. Observe for signs of dependence: failure to
improve, frequent requests for increased dosage, requests for
specific medication, and sad stories of lost, stolen, or misplaced
medication. Patients with addictive illness can be treated with
narcotics where necessary, but close following and attention to
detail is critical.
Stuart Gitlow, MD, MPH, MBA, is Acting President of the American
Society of Addiction Medicine (www.asam.org).
PREVIEW
A Timely Talk on Topicals for Pain Relief
The judicious use of topical formulations of pain-relieving drugs can effectively relieve many types of pain while freeing the patient from unnecessary adverse
systemic effects.
Nowadays, there are a variety of patches, solutions,
and creams that deliver pain medications
where they are actually needed. These topical
formulations provide clinicians with an opportunity to target
their patients’ pain more efficiently, without incurring
the systemic side effects that are associated with some
medications.
Chris Herndon, PharmD, BCPS, CPE, Assistant Professor in the
Department of Pharmacy Practice at Southern Illinois University,
Edwardsville, IL, will present a session Friday at PAINWeek 2011
that will teach attendees about the physiologic properties of
skin and the factors that are necessary for the transdermal absorption
of drugs. His presentation, titled “A ‘Topical’ Review of
Pain Treatment,” is recommended for first-time attendees.
“We’ve learned that putting the drug where it hurts will help
stop the pain but won’t give all the same side effects as if the
drug were streaming through your blood system. A good example
of this is the Lidoderm patch. It has lidocaine in it and you
can put it right where it hurts. It’s especially good for people who
have shingles pain or pain from other types of nerve damage,
and it is a prime example of a medicine that we do not want to
get into the circulation where it may cause problems. If we can
get it right around the painful area, it’s great,” says Herndon.
Topical analgesics work locally. Transdermal analgesics, although
applied to the skin, work everywhere in the body. Good
examples are fentanyl and the buprenorphine patch Butrans.
“It doesn’t matter where you put the patch, you are going to
get large blood levels of drug that will help the pain,” notes
Herndon.
Administering pain medications through the skin can be especially
helpful in older individuals. Herndon cites the example
of an elderly person confined to bed who develops bedsores.
“Wounds that develop from being in bed too long, like bedsores,
are very painful,” he says. Instead of giving an older
person oral morphine, which “makes them super sleepy and
confused, and constipates them and has all of those nasty side
effects, even stops them from breathing, I can take that same
drug and I can mix it in a special gel and put it right into the
wound. This makes the pain go away without that person getting
lots of morphine in the system.” Herndon says that severe
burns are another example of a painful condition that responds
to this kind of treatment.
Herndon says that he could make these compounds himself
but he prefers to have the pharmacists in his pain management
clinic do it. “They really know how to do that very well, they
have the expertise, so I tell them what concentrations of what
drug we want and then they make it up,” he says.
In his presentation, Herndon will also discuss the literature
that documents the successful use of non-commercially available
compounded topical analgesics. He says that this is a
good source of information from which he sometimes gets his
inspiration for creating such compounds. “For my own purposes,
I want to practice at the edge of the envelope, but I also do not
want to be a cowboy, where I do things that don’t make any
sense whatsoever. Being able to show that there have been
others who have documented their experiences with creating
topical compounds that successfully relieve pain is very important,”
Herndon says.
For example, amitriptyline, an antidepressant, also helps to
quiet neuropathic pain. “If you had foot reconstruction surgery
and as a result had a damaged nerve with lots of burning, tingling,
and numbness in your foot, we might put you on amitriptyline
because it helps slow that signal down. But if I give it as
a tablet, it will make your mouth dry, make it difficult to urinate,
and do all kinds of nasty things. But if I put it in a gel, and you
can rub it on your feet, and it helps your pain, why not do it”
At a recent World Congress on Pain meeting, Herndon found
a poster by Norwegian researchers showing how they did just
that. “I will be presenting this and other data because I believe
it is important to show evidence that we can apply these compounds
and get analgesic levels that are effective for relief of
pain, and not hurt anyone,” Herndon says.
His talk will also touch on over-the-counter topical analgesics
that are available for arthritis and muscle pain, and examine
the data supporting epidermal transport enhancers such as dimethyl
sulfoxide (DMSO) and other penetration enhancers for
transdermal drug delivery systems.
—By Fran Lowry

16
news
friDAY
September 9, 2011
PREVIEW
What’s the Secret to Accurately Diagnosing a Patient
Who Complains of Back Pain
David Glick says patients would be better served if their clinicians ditched the imaging tests in favor of a more hands-on approach
David Glick, DC, CPE, may be the only speaker in the
history of PAINWeek who gets upset when he hears
medical professionals speak the name of his presentation‐‐“Back
Pain”‐‐as part of a diagnosis.
“No physician who examines an ailing knee would ever diagnose
‘knee pain.’ The physician would diagnose a torn meniscus
or sprained ligament or some other specific ailment that would
lead to a specific course of treatment. Yet somehow we expect
less when physicians examine the back. We think it’s acceptable
to say ‘back pain’ and confine treatment to generalized medication.
This is just one step removed from diagnosing everyone with
‘pain’ and sending them home with aspirin,” he says.
Some of those practitioners might counter that many back
problems defy specific diagnosis, but Glick believes he can
teach those skeptics to spot the most common problems in just
a couple of hours, which is why he hopes that anyone who
speaks of generalized “back pain” will attend his two-hour presentation
at PAINWeek 2011.
What’s the secret A detailed, hands-on examination that follows
specific steps to find the specific problem. Glick says that
hands-on examinations yield far better results than x-rays or
any other kind of scan. Such technology, which seems to have
replaced manual examination in many practices, not only fails
to detect most actual problems, Glick says, but often misleads
physicians by finding anatomical pathologies that are not hurting
patients.
MRIs, for example, commonly show herniated or bulging discs
when they are used to examine people with back pain, leading
physicians to assume those problems are causing the pain and
often leading them to recommend surgical fixes. But Glick says
that herniated and bulging discs turn up just as frequently when
you image people with no back pain, which
means that finding such things in people with
back pain doesn’t mean they’re causing the
pain.
“When they first studied this and saw all
these disc problems in people with no back
pain, they hypothesized that these people
would be far more likely than subjects with
normal discs to develop back pain. It made
sense, but when they went back and re-surveyed
a number of study participants a few
years later, the people with the normal backs
were just as likely to have developed pain as the people with
the bulging discs,” he says.
Glick acknowledges that the results are wildly counterintuitive,
and that it is so hard for physicians to believe this that “they generally
just ignore the results and go on thinking that disc problems
invariably cause pain.” But, he says that “the more you think about
the studies, the more mysteries they explain, like why so many
people still have back pain after you correct their bulging discs.”
Using treatment in this manner, to test uncertain diagnoses, is
obviously expensive and painful for the patient. In other cases,
however, using treatments to test ideas actually creates misleading
results. Glick says that if a condition has multiple pain generators
and the experimental treatment only addresses one, its
failure does not falsify the original hypothesis and demonstrate
that the patient has a different condition. Unfortunately, many
physicians fail to realize that they’ve undertaken an incomplete
treatment and get thrown off the trail.
“It’s insane to try a repair before you know what the problem
is. If your auto mechanic did it and expected you to keep paying
for each of his failures, you’d find another
mechanic. Back specialists have gotten away
with it so far by blaming the ‘mysterious’ back,
but all the guesswork has led back treatments
to have a miserable failure rate. Now, insurance
companies are beginning to deny payment
for a lot of back procedures on grounds
that the treatments are ineffective. This has
already started to adversely affect patients
by having necessary procedures denied and
lowering reimbursements for many that are
not. If back specialists can’t increase success
rates, as an industry, they’re going to find very few insurers will
pay for back treatment,” he says.
By adding to the clinical examination before making a diagnosis,
any practitioner can improve clinical outcomes dramatically.
During his presentation, Glick will run through a series
of maneuvers that, collectively, can help clinicians with time to
spend diagnose a wide range of ailments. However, Glick also
points out that even practitioners with limited time can add significantly
to their clinical examination in just minutes.
For example, Glick says that several problems in the middle
back present with pain in the low back and are almost always
misdiagnosed as low back problems. It’s one of the most common
errors in back pain and Glick will demonstrate how to
avoid it. Another quick move Glick will discuss is a reflex check,
administered to the hamstring, that tests the L5 nerve root that is
frequently affected by specific lower back problems.
“I have dozens of clinical gems like those that will change
how everyone in the audience treats back pain,” he says.
—By Andrew Smith
Satellite Events at PAINWeek 2011 Non-certified Activities (there is no CE/CME credit attached to these activities)
FRIDAY
A Unique Approach to the Delivery of Rapid
Onset Opioids
Time: 8:30am – 9:30am
Room: Mont-Royal Ballroom (Level 4)
Sponsored by ProStrakan, Inc.
Srinivas Nalamachu, MD, and James Rho, MD, will present information
on “a unique transmucosal fentanyl that has been shown
to be effective for treating breakthrough cancer pain in opioidtolerant
patients.” The speakers will supplement this information
with case studies that highlight the safety and tolerability of sublingual
fentanyl. Nalamachu and Rho will also share their insights
on how sublingual fentanyl can be used effectively and appropriately
to manage breakthrough pain in patients with cancer.
Space is limited. Learn more about this activity and register
to attend at www.breakthroughpainpdm.com. Breakfast
will be served at this event.
Pathophysiology of Pain: Mechanisms
and Manifestations
Time: 12:00pm – 2:00pm
Room: Mont-Royal Ballroom (Level 4)
Sponsored by Lilly USA, LLC
Michael R. Clark, MD, MPH, director of the Adolf
Meyer Chronic Pain Treatment Programs and
Associate Professor in the Department of Psychiatry
and Behavioral Medicine at The Johns Hopkins University
School of Medicine, will discuss acute and chronic pain
transmission and review pain pathways in the peripheral and
central nervous system and the mechanisms leading to the development
of chronic pain. This activity will explain how pain
transmission and processing occurs in the periphery, spinal
cord, and brain; review the role of ascending and descending
pain pathways; and discuss the ways in which neural plasticity
within the nervous system may alter pain processing as well
as contribute to changes in pain perception and the development
of persistent pain.
No pre-registration is required to attend this event; attendees
are invited to sign up starting at 11:50am. Lunch will be
provided.
SATURDAY
Responsible Opioid Prescribing in
the Era of REMS
Time: 8:00am – 10:15am
Room: Mont-Royal Ballroom (Level 4)
Sponsored by the American Pain Foundation
and supported through an educational grant
from Endo Pharmaceuticals
Based on the principles of the NIPC Critical Thinking Model
for Chronic Opioid Therapy, this activity will provide attendees
with critical thinking strategies to optimize analgesia and facilitate
safe use of opioid therapy in clinical practice. Lynn R. Webster,
MD, FACPM, FASAM, Medical Director of Lifetree Clinical
Research, will also review sound principles of opioid prescribing
and documentation and explain how clinicians can integrate
these into daily practice to foster compliance with state medical
boards, governmental agencies, and REMS. Finally, this activity
will teach attendees how to communicate effectively with
patients to promote safe and appropriate use of opioid analgesics
and minimize potential adverse events.
Program attendees will receive a participant guide that
includes the entire slide curriculum presented at the live program,
a “physician tool” that delineates key components for
each patient interaction when prescribing opioid analgesics
for moderate to severe pain, and a “patient tool” that will
help people with pain stay on top of their pain treatment
plan and understand prescribing guidelines.
Register to attend this activity at http:hcp.lv/qAjY3. Breakfast
will be served at this session.
Acetaminophen: When to Use it and When to Say When
Time: 12:00pm – 1:30pm
Room: Mont-Royal Ballroom
Sponsored by Zogenix, Inc.
Mary Lynn McPherson, PharmD, BCPS, CPE, will present an encore
of this presentation that will examine the risks and benefits associated
with the use of acetaminophen for pain relief. McPherson will
review the prevalence of acetaminophen use, present data on the
efficacy of acetaminophen when used as monotherapy and in
combination with other analgesics, discuss circumstances in which
acetaminophen does not contribute additional pain relief, and
identify common toxicities associated with acetaminophen.
Attendees are not required to pre-register for this event.
Lunch will be provided.

The Cosmopolitan of Las Vegas
news 17
PREVIEW
When it Comes to Chronic Pain, Stress Matters
Evaluating patients for stress and anxiety and teaching them some simple-yet-effective stress management techniques can help
reduce patients’ pain and improve their quality of life
Stress is a common experience among Americans; in
a 2010 survey, three out of four healthy Americans
reported that they were experiencing moderate or
high levels of stress. The negative consequences of stress for
mental and physical health have been well-documented.
Today, at PAINWeek 2011, Robert Bonakdar, MD, will present
“Impact of Stress and Anxiety on Chronic Pain Management,”
during which he will explore the connections
between stress and chronic pain.
Bonakdar believes that there is not enough attention paid to
stress and anxiety. Consideration of stress and anxiety level is
particularly relevant for patients with chronic pain—the simple
fact that they are in pain adds to the likelihood that they are
in stress. In his own practice, Bonakdar estimates that approximately
90% of chronic pain patients experience significant levels
of stress. During his presentation, he plans to clearly demonstrate
how effectively stress management can improve the well-being of
chronic pain patients. He will also share his perspectives on how
to incorporate stress evaluation and management into practice.
According to Bonakdar, successful stress management requires
awareness, response modification, and training by the patient. As
a practical resource for clinicians who would like to address their
patients’ stress management needs, Bonakdar will review simple
techniques for evaluating stress and pain. “Simply asking about
current pain and stress levels is the first step; it is a simple technique.
Ask patients, ‘Do you have stress What are your coping
strategies Are you interested in simple techniques to alleviate
your stress’ Then, ask the patient what he or she is doing about
it. Depending on what their answer is, there are simple resources.
It doesn’t have to take more than one minute,” says Bonakdar.
He will also review more structured stress- and pain-assessment
questionnaires, inventories, and scaling instruments.
The presentation will cover a variety of stress management
devices and approaches, including practiced breathing, mindfulness
meditation, and biofeedback therapy. When used with
chronic pain patients, the goal of these interventions is to help
distract patients from their stress, to resolve underlying physiological
conditions contributing to chronic pain, to decrease
stress and anxiety amplification of the pain response, and to reduce
pain-related distress. Bonakdar will review free resources
that busy clinicians can suggest to their patients who need help
with stress management, including handouts, simple stress reduction
methods, and smartphone applications.
Bonakdar says that he will also ask audience members to
participate in simple breathing techniques so they can experience
for themselves the impact that these exercises have on
their own feelings of stress and anxiety. He will present evidence
demonstrating the effectiveness of a variety of stress management
interventions in reducing physiologic indicators of stress.
Bonakdar will also discuss several clinician training programs
that are available to participants who would like to continue to
hone their stress management skills.
In addition to sharing practical tips and techniques, Bonakdar’s
presentation will detail the basic principles, physiology,
prevalence, and impact of stress and stress-related symptoms.
Stress and pain actually activate similar pathways of the sympathetic
nervous system. Resulting signaling mechanisms lead
to the release of certain neurochemicals that increase heart
rate, cardiac output, blood pressure, blood sugar release, insulin
level, and brainwave activity. Long-term negative outcomes
associated with stress include increased risk for metabolic syndrome,
cardiac disease, bone disease, decreased cognitive
ability, and accelerated telomere shortening (possibly leading
to advanced aging or onset of age-related disease).
It has been proven that stress heightens pain. Furthermore,
there is physiological evidence that demonstrates both the positive
outcomes achieved with stress management techniques
and the negative impacts of stress and pain on the brain. Bonakdar
will present data from neuroimaging studies that shed
light on the effects that stress and stress management have on
human brain structure.
Bonakdar first became interested in the connections between
stress and pain during a Richter Fellowship in Southeast Asia,
where he studied acupuncture, tai chi, and mind-body practices.
There, he noticed a reliance on daily practices intended to keep
the body in balance. He also noticed the contrast between this
approach and the Western mindset. “It doesn’t involve a lot of
preventative medicine—we probably do more for our car than
for ourselves—it is more of an illness-based mentality,” he says.
This realization led him to a career focused on integrative pain
management; in other words, exploring the mind-body connection
and its impact on chronic pain.
Robert Alan Bonakdar, MD, FAAFP, is the director of pain
management at the Scripps Center for Integrative Medicine
and a member of the Scripps Green Hospital Pain Management
Committee. He also serves as Assistant Clinical Professor
(Voluntary) at the University of California, San Diego, School of
Medicine. He is currently on the board of directors of the American
Academy of Pain Management. His current clinical and research
interests include novel approaches to pain management
such as dietary supplementation and biostimulation, including
microcurrent, laser, auricular and acupuncture therapy.
—Kim Farina-Graham, PhD
PREVIEW
Chronic Pain: Heal It, Don’t Manage It
A better understanding of myofascial pain can help clinicians provide better treatment for all types of pain
Pain is one of the most common reasons that people
visit their health care professional, yet many clinicians
receive minimal instruction on pain management
during their training. During “Myofascial Pain: New
Understanding and New Treatment Ideas,” scheduled for
Friday afternoon at PAINWeek 2011, Hal Blatman, MD, will
examine myofascial pain as a way to understand most of
the pain in the body. The overall message that Blatman
would like attendees of his presentation to come away with
is, “Pain practice isn’t about giving people drugs and making
them numb; pain practice is about restoring the body.”
Blatman will begin the presentation with a discussion of what
health care providers are traditionally taught about pain. “The
reality is, these theories don’t have lot of basis in science…
and there are answers to pain other than what we have been
taught,” he says. According to Blatman, most pain in the body is
generated by the muscle and fascia. Furthermore, the nervous
system’s integration with muscle and fascia is a key to understanding
how pain patterns are generated. He would like to
offer attendees a skill set and understanding that allows them
to more confidently take their patients down the road to healing
instead of masking pain with medication.
In his discussion, Blatman will explain how knots in muscle
and fascia can generate pain that occurs not only in situ, but
that is referred to other locations. The brain can interpret the
pain as numbness, tingling, burning, aching, or cramping. In essence,
there is no pain sensation a patient can describe that
can’t be coming from the muscle and fascia. This concept is important
for clinicians to appreciate because it means that there
is no good clue in a patient’s description of pain that points
solidly to its cause.
To better illustrate how pain can travel from one place to
another via the fascia, Blatman will use video footage from a
dissection of a human body. The video will show the fascia lines
through the body and demonstrate how the head is connected
to the foot. Blatman will also review various treatments for these
pain patterns, including compounding pharmacy, topical and
manual therapies, and herbal therapies. He also plans to cover
trigger point injections and prolotherapy, topics that may be
relatively unfamiliar to many attendees. He will talk about the
similarities between these procedures, what they do, and how
they can stimulate healing and regeneration.
Blatman explains trigger point injections this way: “If you injure
a tendon, your body has mechanisms to help heal that tendon.
Your body runs the mechanism (provided you didn’t take any
ibuprofen) and most of healing is completed within two or three
weeks, maybe four weeks. There is some more healing that happens
over the next several months, but most of it is done within
the first couple of weeks. When this is all said and done, if that
tendon is still tender or that tendon is still loose and never really
tightened back up, your body has no way to really know that or
to improve the repair it just went through. When I take a needle
and poke that tendon that was injured, I create an injury. That
injury isn’t significant enough to cause harm, but it is significant
enough to draw your biologic response to injury and repair your
tendon.” Blatman will also review prolotherapy, an approach that
injects dextrose, saline, or growth factor slurry into the affected
area to further stimulate repair.
Although there may be some controversy associated with
prolotherapy, Blatman explains that this is really just due to
a lack of understanding about the technique. He adds, “The
concern is limited to the injection of irritants to trigger healing
response. When you are limiting injected reagents to dextrose,
saline, and platelet rich plasma, it is not controversial at all.”
Blatman plans on reviewing the interactions between the
sympathetic nervous system and pain to bridge the connection
between stress and increased pain. He will also share his opinions
on the future of pain medicine, including the use of plateletrich
plasma for tissue regeneration. Blatman’s group has been
using platelet-rich plasma, with great success, for more than five
years. “As more people get trained and as it becomes more
popular and available, it will be used increasingly more in the
future, so this is a good time to learn how to do it,” says Blatman.
Hal Blatman, MD, is the founder and director of the Blatman
Pain Clinic, Cincinnati, Ohio. He is a nationally recognized
specialist in treating myofascial pain, board certified in both
Integrative Holistic Medicine and Occupational and Environmental
Medicine, and credentialed in Pain Medicine. He served
as the president of the American Holistic Medical Association
from 2007-2009.
—By Kim Farina-Graham, PhD

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September 9, 2011
PREVIEW
Course on Female Chronic Pelvic Pain to Highlight Current Research
Nearly one in four women of reproductive age experience chronic pelvic pain, yet researchers have just begun to explore its different causes.
It is estimated that some 25% of reproductive age women
have chronic pelvic pain of some kind, yet many
physicians, even gynecologists, don’t have a clue
about how to treat them, says Colleen M. Fitzgerald, MD,
Medical Director of Women’s Health Rehabilitation at the
Rehabilitation Institute of Chicago, in Chicago, IL.
Female chronic pelvic pain is a huge problem, but training
on how to manage it is scant. “Traditionally, many of us do not
get a lot of training in how to manage pain at all, and if we do,
it’s usually related to pain in the lower back, or pain related to
some type of rheumatologic problem. But the pelvis is such an
unknown for physicians. Even gynecologists don’t know; in fact,
most of my referrals come from gynecologists,” she says.
During her presentation, titled “Understanding Female Chronic
Pelvic Pain”, Fitzgerald will review the epidemiology and pathophysiology
of female chronic pelvic pain, discuss the differential
diagnosis and assessment of this condition, explain the impact
female chronic pelvic pain has on patients’ quality of life, and
outline various approaches to treatment and rehab. She will also
review the latest scientific research currently being conducted to
expand our understanding of this often baffling condition.
Science has just begun to explore both the central and peripheral
factors underlying various subgroups of chronic pelvic
pain. Traditionally, diagnosis and treatment has centered on the
visceral and abdominal causes. Fitzgerald will expand her talk to
include a discussion of musculoskeletal and neurologic causes.
In her experience, the main causes of chronic pelvic pain in
women are bladder pain, endometriosis, interstitial cystitis, and
vulvodynia, a superficial pelvic pain problem of the vulva. “Experts
are debating about the causes of bladder pain syndrome.
Some believe it is a problem with the bladder itself, but more
current thinking is that it is likely a neurologic problem, due to
peripheral sensitization of the bladder,” Fitzgerald says.
This leads to central sensitization. She says that “the brain
begins to perceive the bladder as a painful region and keeps
sending signals downbasically thinking that there is an injury
there when there is not. So, even though the pain manifests in
the bladder, the problem is with the central nervous system.”
Endometriosis (a condition in which endometrial tissue grows
outside of the uterus), is also commonly seen in patients with
chronic pelvic pain. However, the amount of endometrial tissue
that is located outside of the uterus does not always correspond
to the level of pain patients have. “Some could have very little
endometrial tissue as discovered when they go in for surgery, and
yet they can have very high levels of pain,” Fitzgerald notes.
Research is beginning to show that both chronic bladder
pain and endometriosis are associated with problems of the
pelvic floor or Kegel muscles. “Whether those muscles are responding
to the bladder or endometrial pain, or if they are
where the problem is originating, is unknown now but under
investigation,” she says. Vulvodynia, once thought to be caused
by a skin infection, is also now believed to have a neurological
etiology, as is interstitial cystitis.
Fitzgerald also plans to discuss pregnant and postpartum
women who get classic sciatica-type pain which then becomes
persistent. “These women are told they have sciatica, but in fact
they do not. In this population, it is probably pelvic joint, ligamentous
and muscular pain because of giving birth. It probably
begins in pregnancy, with all the changes that occur to the musculoskeletal
system at that time,” she says.
According to Fitzgerald, clinicians do not need to be confused
about how to handle these patients. “I really want to
emphasize this. Traditionally we have focused on visceral or
abdominal causes but new evidence is beginning to emerge
suggesting a complex interplay of somatic or muscular structures,
so we have more to offer these women, who for the most
part have pain despite seeing a lot of physicians,” she says.
Fitzgerald cautions that there are no good surgical options
for this population, but plans to “touch on some of these” during
her presentation. She will also discuss which medications are
helpful, and also talk about the role of diet in managing female
chronic pelvic pain.
“A multidisciplinary approach to chronic pelvic pain is very
important,” she says. Present modalities include “manual therapy,
motor control training, the judicious use of neuromodulatory
pain drugs and joint/triggerpoint/sympathetic botulinum toxin
injections, as well as psychological interventions to reduce anxiety
and “catastrophizing”. The course will also include a discussion
of the controversial role of opioids.
“Clinicians often approach female chronic pelvic pain with
a sort of fear because they usually know so little about its underlying
courses, but this course is expected to help learners
enhance their ability to manage these patients,” Fitzgerald says.
—By Fran Lowry
PAINWeek 2011 Oral Poster Presentations
Join your colleagues to hear the latest research news and listen to the poster authors review their findings
From 7:30am – 8:25am today, Joseph V. Pergolizzi, MD, Chairman of the PAINWeek Scientific Poster
and Abstracts Committee, will moderate a session featuring oral presentations of eight noteworthy posters
selected by the PAINWeek Scientific Poster and Abstracts Committee.
Dose-proportionality, Relative Bioavailability,
and Effects of Food on Bioavailability of an
Immediate-release Oxycodone Hcl Tablet
Designed to Discourage Tampering
Almasa Bass and colleagues conducted an open-label, singledose,
randomized, five-way crossover study comparing an
abuse-deterrent formulation of an immediate-release oxycodone
HCl product (IRO-A) with an immediate-release, commercially
available oxycodone HCl tablet (IRO). They compared doseproportionality,
food effect on pharmacokinetics of oxycodone
from IRO-A, and relative bioavailability for the two formulations.
Subjects received oral doses of 1x5 mg, 2x5 mg, and 2x7.5 mg
IRO-A after an overnight fast, and 2x7.5 mg IRO-A and 1x15 mg
IRO following a high-calorie/high-fat breakfast. Subjects also
received naltrexone 12 hours and one hour prior to dosing. Although
the subjects who received IRO-A with food experienced
decreased peak plasma oxycodone concentration, but took
longer to achieve that peak, and had the drug in their bloodstream
longer, the authors reported that these changes were
not clinically significant.
Daily Average Consumption of Oxycodone CR and
Oxymorphone ER Before and After the Introduction
of Reformulated Oxycodone CR
R. Amy Puenpatom and colleagues performed a retrospective
database analysis of health insurance claims data to compare
daily average consumption of oxymorphone ER and traditional
oxycodone CR before the release of reformulated oxycodone
CR and daily average consumption of oxymorphone ER, traditional
oxycodone CR, and reformulated oxycodone CR after
the release of reformulated oxycodone CR. Consumption was
calculated by dividing the total number of tablets dispensed by
days supplied. The share of reformulated oxycodone CR of all
oxycodone CR dispensed increased rapidly following its availability.
Average daily consumption of both types of oxycodone
CR was higher than oxymorphone ER over the course of the
study, with the authors concluding that oxycodone CR is frequently
prescribed 3 times daily, whereas oxymorphone ER is
more often prescribed twice daily.
A 3-Year, Open-label, Flexible-dosing Study of
Milnacipran for the Treatment of Fibromyalgia
Lesley Arnold and colleagues conducted an open-label study
to evaluate the safety and efficacy of milnacipran in the management
of fibromyalgia. This study consisted of a 2-week
washout period, a 2-week dose-escalation period (to milnacipran
100 mg/day), an 8-week stable-dose period (at milnacipran
100 mg/day), and a flexible-dose period (milnacipran 50
mg/day to 200 mg/day) for the remainder of the study (up to
three years). Subjects were evaluated for 24-hour and weekly
recall visual analog scale pain, and with the Patient Global Impression
of Change, Patient Global Disease Status, SF-36 Physical
Component Summary, and the Brief Pain Inventory (BPI). The
authors reported improvements in 24-hour and weekly recall
visual analog scale pain scores, as well as in BPI scores, global
status, and physical function.
Pain Paradox: Clinician Judgment for Assessment
and Management of Risks in Chronic Opioid
Therapy
James Miller and colleagues evaluated data collected during
the Pain Paradox continuing medical education program
to assess clinicians’ judgment regarding best clinical practices
for management of chronic opioid therapy. Data included clinicians’
answers to multiple-choice questions posed during simulated
longitudinal clinical sessions using actors as patients, with
assessment focusing on risk factors associated with addiction,
urine drug testing (UDT), treatment agreements, legal requirements
for prescribing controlled substances, and differential diagnoses
related to aberrant behaviors. The authors reported
that nearly one-quarter of clinicians were unsure of applicable
state and federal laws for controlled substances; more than half
misinterpreted UDT results as definitive evidence of diversion.
Many clinicians also struggled to differentiate between pseudoaddiction,
medication tolerance, and physical dependence.
The authors concluded that “Clinical judgment regarding urine
drug testing, dose escalation, and aberrant behaviors was suboptimal
even after a one-hour educational activity,” underscoring
the need for clinician education in these areas.
Functional Assessment of Chronic Pain Patients in a
Multidisciplinary Pain Clinic
John F. Peppin and colleagues reviewed the charts and 6-minutes
walk test scores of 45 chronic pain patients treated in a multidisciplinary
pain clinic. Scores at initiation of treatment, three
months, and six months were compared to assess response to
treatment (patients received a “full range of possible therapeutic
modalities”). Scores improved from an average 272.87 yards
at baseline to 339.04 yards at follow up. Although this was a
significant improvement, subjects were unable to reach the 400-
yard threshold for normal, healthy adults. These results show
that the 6-minutes walk test may be a suitable addition in assessing
chronic pain patients and their treatment regimens.

The Cosmopolitan of Las Vegas
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Consistency of Symptom Improvement in Elderly Adults with Chronic Insomnia
Treated with Doxepin 1 mg, 3 mg, and 6 mg
Robert Taylor and colleagues conducted two randomized, double-blind, placebo-controlled trials
of doxepin 1 mg, 3 mg, and 6 mg in elderly adults with a DSM-IV-TR definition of primary
insomnia. In one trial, subjects received doxepin 1 mg, 3 mg, or placebo for three months; in the
other, subjects received doxepin 6 mg or placebo for four weeks. Researchers used the Clinical
Global Impression scale, 5-item Patient Global Impression scale, and the Insomnia Severity Index
to measure symptom improvement. They reported that doxepin produced significant and clinically
meaningful improvements in clinicianrated assessments of illness severity and therapeutic
effect and in patient-rated assessments of therapeutic effect.
Chorionic Gonadotropin Initial Doses for Intractable Pain
Forest Tennant studied 22 adult intractable pain patients maintained on daily opioids who were
refractory to interventions and treatments directed at peripheral pain sites. Subjects were given
thrice-weekly human chorionic gonadotropin (125 units per milliliter) and told to adjust the dosage
over a three-month period until they required lower opioid doses and reported experiencing less
pain. Nearly three-quarters of the subjects reported a decrease in opioid dosage, lesser pain, and
more energy at the end of the study period. Minimum time to achieve these endpoints was three
weeks. Minimum effective dose was 1500 units per week (subcutaneously) and 1750 units per week
(sublingual). Maximum dosage was up to 3500 units per week.
Pharmacokinetic Interaction between the Opioid-Analgesic Fentanyl and the
CYP3A Inhibitor Ketoconazole
Victoria Ziesenitz and colleagues conducted a prospective, open-label, randomized, crossover
study to investigate the influence of CYP3A inhibition by ketoconazole on the pharmacokinetics
of fentanyl in 16 healthy volunteers. Subjects received bodyweight-adjusted doses of
IV fentanyl, along with naloxone. Subjects also received oral ketoconazole and midazolam.
Researchers calculated 24-hour concentration-time curves and clearances of fentanyl and its
metabolites, along with partial metabolic clearance of midazolam as a measure of CYP3A
activity. They reported that fentanyl metabolism “was significantly altered by coadministration
of the CYP3A inhibitor ketoconazole leading to an increased exposure to fentanyl and
reduced clearance. Ketoconazole decreased the formation of the metabolites norfentanyl and
hydroxynorfentanyl significantly.
RECAP
Just Say No: The Physician’s Role
in Reducing Drug Diversion
With prescription pain medications becoming a hot commodity on the street, the
onus is on physicians to identify drug seekers and help prevent diversion.
Perhaps the scariest thing about drug diversion is the fact that many of those involved—
from physicians who unknowingly prescribe opioids to patients who are addicted to pain
killers, to parents who store unused drugs in the medicine cabinet—have no idea they’re
doing it.
John J. Burke, Commander, Warren County Drug Task Force in Lebanon, OH, addressed this
issue in a talk, titled “Rx Abuse and Pain Patients,” Thursday morning at PAINWeek 2011. Burke,
who is also president of the National Association of Drug Diversion Investigators, described the
most commonly abused prescription drugs and discussed how to identify a prescription drug
seeker and prevent him or her from obtaining drugs.
Every time someone commits diversion—which Burke described as “any criminal act involving
a prescription drug”—it hurts legitimate pain patients, making it all the more difficult for them to
obtain the medications they need. Unfortunately, it also hurts many more people. Each day, four
people in the state of Ohio and seven people in Florida die as a result of an unintentional overdose,
according to Burke.
One factor behind these sobering statistics is the fact that more controlled substances are being
doled out than ever before. Among adolescents, the rate of opioid prescribed nearly doubled
from 1994 to 2007. An increase in the number of prescriptions written, however, is one just driver
behind drug diversion. Others include forged and altered prescriptions, patients who “shop doctors”,
theft among health facility workers, drug theft by those who work for shipping and packaging
companies, pharmacy robbery, and Internet pharmacies.
The latter is one of the biggest culprits. In a 2006 report from the Office of National Drug
Control Policy, 34 rogue Internet pharmacies were identified. Of these pharmacies, which had
dispensed more than 98 million dosages of hydrocodone, just 3.4% were found to be “potentially
legitimate,” with most not requiring a prescription.
(continued on next page)
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20
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September 9, 2011
(continued from page 19)
Another key source in drug diversion is the failure to properly dispose
of unused medications. Burke related an interesting experience
he had after undergoing gallbladder surgery a few years ago. He was
prescribed 40 pills of oxycodone to help manage the postoperative
pain, only three of which he used. Although he knew from experience
that it was necessary to keep the remaining drugs in a secure location,
most people, when given such an excess of pain medications, would
simply store them in a medicine cabinet, where “they’re available to
a whole host of people,” he said. “If you’re not using medications, put
them in a safe place where you can find them but others can’t. It’s a
good way to actively be involved in reducing diversion.”
The controlled substances most often abused, according to Burke,
are hydrocodone (marketed as Vicodin, Lortab, and Lorcet), oxycodone
(marketed as Percocet, Percodan, and Tylox), and Alprazolam
(Xanax). Whereas hydrocodone is mostly taken intact orally, oxycodone
can be taken orally, injected or smoked. Alprazolam, which goes
for about half the price of the other two drugs ($3 per pill), takes effect
faster, making it more appealing to some users. Other prescription
drugs that are abused include methodone, oxymorphone (Opana),
methylphenidate (Ritalin), and hydromorphone (Dilaudid), Burke said.
In addition to being less expensive (in most cases) than drugs like
heroin or cocaine, pain medications are easier to obtain and there is
less perceived risk of detection from law enforcement, which, for many
patients, adds to their appeal. According to the US Department of
Health and Human Services, prescription medications are one of the
most commonly abused types of drug, second only to marijuana.
In light of these trends, it is imperative that healthcare providers are
able to spot the signs of patients who hope to obtain prescription
pain medications for the purposes of either trafficking or abuse. Some
signs to look for include paying a high amount of compliments to endear
himself or herself to the physician, purposely mispronouncing the
name of a drug, becoming angry when denied the drug of choice,
threatening legal action, or leaving quickly when a scam doesn’t work.
To help prevent diversion, Burke offered the following tips for physicians:
• Use Rx pads for prescribing only and keep close track of them
• Record the medication, amount, and number of refills in the patient’s
chart
• Do not leave the refill space blank or fail to circle appropriate
number
• Document everything
He also suggested that providers make use of prescription monitoring
programs, encourage the office staff to come forward about anything
suspicious they see or hear from patients, and always trust their gut
feelings about a patient. Above all, physicians should prescribe medications
based on their training and experience—not based on fear of
regulators or law enforcement.
PREVIEW
Examining the Pros and Cons of
Opioid Therapy for Chronic Pain
A thorough understanding of the benefits, risks, and side effects associated with prescription
opioid use is essential for patients and clinicians when making treatment decisions
Sean Mackey, MD, will present “Opioids: The
Good, the Bad, and the Ugly,” Friday during a
special session at PAINWeek 2011. Mackey is
chief of the division of pain management and associate
professor in the department of anesthesia at Stanford
University School of Medicine, Palo Alto, CA. He also
serves as the director of the Stanford Systems and Pain
Lab. He will provide an overview of not only the benefits
of using opioids to treat chronic noncancer pain but
also the obvious (and the not so obvious) downsides.
Mackey says that his presentation is not intended to be
a review of the use of opioids to manage chronic pain,
but to build upon existing recommendations with more
detailed information about the real-world complications
that physicians may encounter when prescribing these
medications.
It is important for clinicians to appreciate not only the
tremendous benefits that can be achieved with these
drugs, but also the potential risks that they carry. Mackey
will discuss some of the latest research on the risks
and benefits of opioids as a class. He will also examine
the misunderstandings in the community about the
use of these medications and discuss the repercussions
of the inadequate training on the appropriate use of
opioids received by many physicians during medical
school and residency. This issue becomes all the more
important when one considers that opioids are the most
prescribed class of medication in the United States. The
number of new users of pain relievers has steadily increased
over the past two decades, according to the
National Household Survey on Drug Abuse. Vicodin is
the single most prescribed medication in this country
with 128 million prescriptions per year, far surpassing the
second most prescribed medication, simvastatin (80 million
prescriptions per year). With a better understanding
of the downsides, doctors can make better informed
decisions, on a patient-by-patient basis, about how and
when to use these medications.
In addition to providing an overview of the current
use of opioids in clinical practice, Mackey will talk about
their mechanisms of action and some of the physiological
changes that can occur in response to opioids. He
will also review the “good” aspects of opioid use and
discuss optimal drug selection for chronic pain, presenting
data showing that opioids have been effective
and helpful with chronic nonmalignant pain and have
helped to reduce pain and suffering. “Most people will
not be surprised that opioids can improve patient pain,
but there are gaps in understanding how these agents
[positively] impact other aspects of quality of life and
physical functioning,” says Mackey.
To help physicians balance the potential risks and
benefits associated with opioid use for each patient,
Mackey will also review the “bad” aspects of opioid
therapy. These include the more commonly recognized
side effects such as constipation, somnolence, mental
clouding, nausea, myoclonus, itchiness, urinary retention,
sweating, and headache. Mackey will also discuss
less commonly appreciated side effects such as opioidinduced
hyperalgesia, hypogonadism, and immune dysfunction.
It has been documented that opioids can modulate
certain components of the endocrine system. Endocrinebased
adverse events occur with some degree of frequency.
The testosterone effects, for example, have been
seen in fairly large number of people who have been on
chronic opioids, while hypogonadism and reduced testosterone
have been observed in patients receiving larger
doses of opioids. There is also evidence to suggest
that the chronic opioid use can suppress the immune
system, although data on the incidence and relevance
of these effects are just emerging.
Opioid-induced hyperalgesia is a controversial topic,
but it is also critically important for providers to understand
that opioids can actually sensitize the central nervous
system and cause people to feel more pain, not less
pain. This phenomenon can confuse the clinical picture
and complicate pain management. Mackey will review
the hallmark signs of opioid-induced hyperalgesia and
offer some tips for overcoming it.
—By Kim Farina-Graham, PhD
Position Available
Nurse Practitioner
Summa Western Reserve Hospital
Cuyahoga Falls, Ohio
Nurse Practitioner will cover the inpatient pain consults at
Akron City Hospital. Employee will evaluate pain consults
and make recommendations to the covering/rounding
pain physician, assist with pain procedures as needed,
and serve as a liaison between Akron City physicians
and nurses and SWRH Center for Pain Medicine physicians.
Previous clinical experience preferred, but new
graduates are welcomed. Great benefits!
Visit www.westernreservehospital.org to apply online.
Or contact Lisa Keeley at keeleyl@summahealth.org or
(330) 971-7308 for more information or to submit a resume.

The Cosmopolitan of Las Vegas
news 21
RECAP
Buying into Biofeedback: The Role of Physiological Changes in
Improving Overall Health
Biofeedback, a treatment most patients don’t turn to until later in the game, can offer significant benefits for patients with chronic pain, and help put them back in the
driver’s seat
Biofeedback, a process that enables an individual to
learn how to change physiological activity for the purpose
of improving health, is often seen as a last resort
for patients with chronic pain. That’s something Anthony A.
Whitney, MS, a behavioral therapist and biofeedback specialist
at St. Luke’s Rehabilitation Institute in Spokane, WA, would
like to see change.
In a session titled “Biofeedback in Managing Chronic
Pain,” delivered Thursday morning at PAINWeek 2011, Whitney
examined the unusual demands that biofeedback places
on patients, and explained how it can benefit patients
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with chronic pain, when it is appropriate to refer patients
for biofeedback/psychological treatment, and the warning
signs that can signal the presence or development of a pain
disorder.
He began the discussion by introducing the analogy of
health care as a three-legged stool, with pharmaceuticals,
surgery, and lifestyle management being the three legs.
What happens too often, Whitney noted, is that patients
and providers immediately turn to the first two legs to alleviate
pain, waiting only until those methods don’t produce
the desired result before attempting to manage the condition
through diet, exercise, stress management, psychology,
and biofeedback. The latter method doesn’t offer a quick fix;
rather, it provides patients with an opportunity to take more
control of their condition—and their health. By listening to
the signals they receive from their body, patients are able to
gain the tools they need to improve their lives, according to
Whitney.
Before going into the specifics of biofeedback and behavioral
therapy, however, it is important to appreciate the
burden that chronic pain places on patients. Whitney pointed
out that in addition to the negative impacts of pain that
many people experience—including increased stress, metabolic
rate, and blood clotting, impaired immune system and
gastrointestinal functioning, and problems with appetite
and sleep—many patients with chronic pain also cope with
psychological issues, such as feelings of low self-esteem,
elevated anxiety, and depression.
For the physicians who treat these patients, it can become
extremely frustrating when there is no response to
surgery or drug treatment. Providers might begin to question
whether the patient is indeed experiencing the level of
pain that they claim to suffer from, and they may not know
how to proceed when a surgery is deemed successful, but
symptoms persist. In these cases, physicians often refer patients
to programs like Structured Intensive Multidisciplinary
Pain Program at St. Luke’s. Individuals who participate in
this program often have undergone procedures such as
artificial disc replacements, spinal cord stimulators, discectomies,
electroconvulsive shock therapy, and even amputation—and
yet still feel pain, and so they are willing to try
biofeedback.
It is critical that patients who enter this type of program understand
the underlying philosophy of biofeedback and behavioral
therapy and are invested in the concept. “They need
to decide this is something they want to do. If they don’t buy
into it, it will not work,” said Whitney. “With chronic pain patients,
you can’t just treat the brain, and you can’t just treat the
body. You have to do both, and biofeedback offers a way to
do that.”
For patients, understanding the mind-body connection in
pain management is critical. This is where behavioral therapy
comes into play, according to Whitney, who noted that in
many patients, the root of physical pain may exist in a past
event such as sexual abuse suffered as a child. Behavioral
therapy focuses on identifying the thinking that causes unwanted
feelings and behaviors and learning how to replace
that thinking with thoughts that facilitate a more desirable response.
Patients with chronic pain often express hate and anger
when discussing their pain, particularly if it resulted from an
injury that wasn’t their fault. In these cases, psychological services
can help them to more effectively manage those feelings.
These services, however, are focused on achieving functional
goals in the short-term, and are not designed to become a
crutch for patients, Whitney said.
Patients with chronic pain also struggle with the unknown;
for example, wondering when the condition will return, how
long it will take for the pain to subside, and whether medications
will work. For this reason, biofeedback can offer a significant
benefit by helping them to use information from their own
body to gauge the progress they are making.
According to Whitney, biofeedback can be as simple as
stepping on a scale, taking a temperature, or getting a blood

22
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friDAY
September 9, 2011
test. Patients can use this input to take the next step, whether
that means losing weight or seeking medical care for hypertension.“
In this way, it puts the patient in the driver’s seat,” said
Whitney, noting that health care professionals can look at patients’
measurements and tailor a plan to meet their needs and
help them get back to a state of homeostasis.
In order to get the most benefit from biofeedback and behavioral
treatment, the patient needs to do the following:
• Examine their lives to learn what they may be doing to
contribute to their disease
• Recognize that they have ability to make positive changes
• Commit to the idea of doing biofeedback/relaxation exercises
every day
• Change bad habits
• Accept the changes and limitations (including the pain itself),
and take responsibility for maintaining their own health
“You have to help patients understand that until they accept
the problem, they can’t fix it,” said Whitney. “It’s a hard concept
to sell,” particularly when many problem would rather undergo
surgery or take medications—methods that they believe would
solve the problem more quickly.
When it comes to accepting the condition and taking responsibility,
therapists can play a significant role by acting as a
guide or even a cheerleader, he noted.
Whitney also discussed relaxation, a technique that has
“With chronic pain
patients, you can’t just
treat the brain, and you
can’t just treat the body.
You have to do both, and
biofeedback offers a way
to do that.”
B:23
T:2
S:2
For the management of fi bromyalgia
Savella relieves symptoms
of fibromyalgia
Delivers simultaneous improvements on 3 measures
of fi bromyalgia 1
— Pain reduction
— Improvement in patient global
fi bromyalgia assessment
— Improvement in physical function
Decrease in pain as early as week 1 of treatment with a stable
dose in some patients who reported global improvement 1
— Primary endpoint was assessed at week 15
Low potential for pharmacokinetic drug-drug interactions 1
— Clinically important interactions may occur with MAOIs,
serotonergic drugs (including other SSRIs, SNRIs, lithium,
tryptophan, antipsychotics, and dopamine antagonists), triptans,
catecholamines (epinephrine and norepinephrine), CNS-active
drugs (including clomipramine), and select cardiovascular
agents (digoxin and clonidine)
A dual reuptake inhibitor that blocks the uptake of norepinephrine
over serotonin with approximately 3 times greater potency in vitro 1
— The clinical signifi cance of in vitro data is unknown
Widely available on managed care formularies 2
IMPORTANT SAFETY INFORMATION
Savella is a selective serotonin and norepinephrine reuptake inhibitor (SNRI), similar to some drugs used for the treatment of depression and
other psychiatric disorders. Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children,
adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering
the use of such drugs in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show
an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with
antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated
with increases in the risk of suicide. Patients of all ages who are started on Savella should be monitored appropriately and observed closely
for clinical worsening, suicidality, or unusual changes in behavior, especially during the initial few months of drug therapy or at times of dose
changes, either increases or decreases. Families and caregivers should be advised of the need for close observation and communication with
the prescriber. Savella is not approved for use in the treatment of major depressive disorder. Savella is not approved for use in pediatric patients.
References: 1. Savella (milnacipran HCl) prescribing information. Forest Pharmaceuticals, Inc. St Louis, MO. 2. MediMedia Database as of April 2011 for Savella.

The Cosmopolitan of Las Vegas
news 23
.25”
become more mainstream recently, yet is still largely misunderstood.
The physiological definition of relaxation is the lengthening
of an inactive muscle or muscle fiber, or a return to equilibrium
following a disruption.
True relaxation can be difficult to attain, since many patients
lose their diaphragmatic breathing ability long before an injury
occurs. Therefore, it is critical that patients on reeducated on how
to properly breath and relax. True relaxation, said Whitney, requires
mental, emotional, and physical aspects, with the physical
aspect of getting the breath right to improve circulation being the
most difficult. “Once you learn you learn the physical part, the
emotional part can fall into place,” he noted. “When you bring all
three pieces together, that’s when the magic happens.”
The final point covered by Whitney is perhaps the most important:
the warning signs of a potential pain disorder.
Some of the key red flags are as follows:
• Consistently high pain complaints
• Pain complaints that become worse over time
• Discontinuing physical therapy because it causes too
much pain
• High level of narcotic use
• Family stress such as divorce or separation
• Substance abuse
• Limited activity level
• High levels of anger
• Frequent pain behaviors
• Overly solicitous or protective family members
• Strong focus on finding out what’s wrong or on being fixed
• Doctor shopping
• History or trauma or abuse in the past
• Job dissatisfaction
• Family members disabled or get social security or other benefits
• Legal involvement
• Lack of social support
The bottom line, according to Whitney, is the methods like biofeedback
and behavioral therapy can be extremely beneficial,
but are most effective when utilized early in the game. “The earlier
you can send someone to biofeedback, the better,” he said.
3”
2”
Contraindications
Savella is contraindicated in patients taking monoamine oxidase inhibitors
(MAOIs) concomitantly or within 14 days of discontinuing treatment with
an MAOI. There have been reports of serious, sometimes fatal, reactions in
patients started on an MAOI who were receiving or had recently discontinued
a serotonin reuptake inhibitor. At least 5 days should be allowed after
stopping Savella before starting an MAOI.
Savella is contraindicated in patients with uncontrolled narrow-angle glaucoma
and should be used with caution in patients with controlled narrow-angle
glaucoma. In clinical trials, Savella was associated with an increased risk
of mydriasis.
Warnings and Precautions
Prescriptions for Savella should be written for the smallest quantity of
tablets, consistent with good patient management, in order to reduce the risk
of overdose.
Development of a potentially life-threatening serotonin syndrome or
neuroleptic malignant syndrome (NMS)-like reactions have been reported
with SSRIs and SNRIs alone, including Savella, but particularly with
concomitant use of serotonergic drugs (including triptans), drugs that
impair metabolism of serotonin (including MAOIs), or antipsychotics or
other dopamine antagonists. The management of these reactions should
include immediate discontinuation of Savella and the concomitant agent
and supportive symptomatic treatment. The concomitant use of Savella with
serotonin precursors is not recommended.
SNRIs, including Savella, have been associated with cardiovascular effects,
including cases of elevated blood pressure, requiring immediate treatment.
In clinical trials, sustained increases in systolic and diastolic blood pressure
occurred more frequently in Savella-treated patients compared to placebo.
Among patients who were non-hypertensive at baseline, approximately twice
as many patients receiving Savella, vs placebo, became hypertensive at the
end of the study. Clinically signifi cant increases in pulse (≥20 bpm) occurred
more frequently in Savella-treated than placebo-treated patients. Blood
pressure and heart rate should be monitored prior to initiating treatment with
Savella and periodically throughout treatment. Pre-existing hypertension,
tachyarrhythmias, and other cardiac diseases should be treated before starting
therapy with Savella. Savella should be used with caution in patients with
signifi cant hypertension or cardiac disease. Concomitant use of Savella with
drugs that increase blood pressure and pulse has not been evaluated, and
such combinations should be used with caution. For patients who experience
a sustained increase in blood pressure or heart rate while receiving Savella,
either dose reduction or discontinuation should be considered.
Savella should be prescribed with caution in patients with a history of seizure
disorder or mania.
Savella has been associated with mild elevations of ALT and AST (1 to 3 times
the upper limit of normal). Rarely, reports of serious liver injury, including
fulminant hepatitis, have been reported in patients treated with milnacipran.
Savella should be discontinued in patients who develop jaundice or other
evidence of liver dysfunction and should not be resumed unless another
cause can be established.
As with other SNRIs and SSRIs, withdrawal symptoms have been observed
following discontinuation of milnacipran. A gradual dose reduction
is recommended.
Hyponatremia may occur as a result of treatment with SSRIs and SNRIs,
including Savella. Elderly patients may be at greater risk. Discontinuation
should be considered for patients with symptomatic hyponatremia.
SSRIs and SNRIs, including Savella, may increase the risk of bleeding events.
Patients should be cautioned regarding the risk of bleeding associated with
concomitant use of Savella and NSAIDs, aspirin, warfarin, or other drugs that
affect coagulation.
Savella can affect urethral resistance and micturition. Caution is advised
in the use of Savella in patients with a history of dysuria, notably in male
patients with a history of obstructive uropathies as these patients may
experience higher rates of genitourinary adverse events.
Savella should ordinarily not be prescribed to patients with substantial
alcohol use or evidence of chronic liver disease.
Use in Specific Populations
There are no adequate and well-controlled studies in pregnant women.
Savella should be used during pregnancy only if the potential benefi t justifi es
the potential risk to the fetus.
Adverse Reactions
In clinical trials, the most frequently occurring adverse reaction was nausea
(37% vs 20% for placebo). The most commonly occurring adverse reactions
(≥5% and greater than placebo) were headache (18% vs 14%), constipation
(16% vs 4%), dizziness (10% vs 6%), insomnia (12% vs 10%), hot fl ush
(12% vs 2%), hyperhidrosis (9% vs 2%), vomiting (7% vs 2%), palpitations
(7% vs 2%), heart rate increased (6% vs 1%), dry mouth (5% vs 2%), and
hypertension (5% vs 2%).
Please see brief summary of Prescribing Information on the following pages.
Please also see Full Prescribing Information at www.Savella.com.
Licensed from Pierre Fabre and Cypress Bioscience, Inc.
© 2011 Forest Laboratories, Inc. 43-1021076T 06/11

news
24
friDAY
September 9, 2011
Savella ® (milnacipran HCl) Tablets
Rx Only
Brief Summary of Full Prescribing Information
Initial U.S. Approval: 2009
WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS Savella is a selective serotonin and norepinephrine reuptake inhibitor (SNRI), similar to some
drugs used for the treatment of depression and other psychiatric disorders. Antidepressants increased the risk compared to placebo of suicidal thinking
and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric
disorders. Anyone considering the use of such drugs in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term
studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk
with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with
increases in the risk of suicide. Patients of all ages who are started on Savella should be monitored appropriately and observed closely for clinical
worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication
with the prescriber. Savella is not approved for use in the treatment of major depressive disorder. Savella is not approved for use in pediatric patients
[see Warnings and Precautions, Use in Specific Populations].
INDICATIONS AND USAGE: Savella is indicated for the management of fibromyalgia. Savella is not approved for use in pediatric patients [see Use in Specific
Populations].
CONTRAINDICATIONS: Monoamine Oxidase Inhibitors-Concomitant use of Savella in patients taking monoamine oxidase inhibitors (MAOIs) is contraindicated. In
patients receiving a serotonin reuptake inhibitor in combination with a monoamine oxidase inhibitor (MAOI), there have been reports of serious, sometimes fatal,
reactions including hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include
extreme agitation progressing to delirium and coma. These reactions have also been reported in patients who have recently discontinued serotonin
reuptake inhibitors and have been started on an MAOI. Some cases presented with features resembling neuroleptic malignant syndrome. The effects of combined
use of Savella and MAOIs have not been evaluated in humans. Therefore, it is recommended that Savella should not be used in combination with an MAOI, or within
14 days of discontinuing treatment with an MAOI. Similarly, at least 5 days should be allowed after stopping Savella before starting an MAOI [see Dosage and
Administration, Warnings and Precautions]. Uncontrolled Narrow-Angle Glaucoma-In clinical trials, Savella was associated with an increased risk of
mydriasis. Mydriasis has been reported with other dual reuptake inhibitors of norepinephrine and serotonin; therefore, do not use Savella in patients with
uncontrolled narrow-angle glaucoma.
WARNINGS AND PRECAUTIONS: Suicide Risk-Savella is a selective serotonin and norepinephrine reuptake inhibitor (SNRI), similar to some drugs used for the
treatment of depression and other psychiatric disorders. Patients, both adult and pediatric, with depression or other psychiatric disorders may experience worsening
of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking these medications,
and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders
themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants, including drugs that inhibit the reuptake
of norepinephrine and/or serotonin, may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases
of treatment. In the placebo-controlled clinical trials of adults with fibromyalgia, among the patients who had a history of depression at treatment initiation, the
incidence of suicidal ideation was 0.5% in patients treated with placebo, 0% in patients treated with Savella 100 mg/day, and 1.3% in patients treated with Savella
200 mg/day. No suicides occurred in the short-term or longer-term (up to 1 year) fibromyalgia trials. Pooled analyses of short-term placebo-controlled trials of drugs
used to treat depression (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents,
and young adults (ages 18-24) with major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of
suicidality with these drugs compared to placebo in adults beyond age 24; there was a reduction in suicidality risk with antidepressants compared to placebo in adults
age 65 and older. The pooled analyses of placebo-controlled trials in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other
psychiatric disorders included a total of 24 short-term trials of 9 drugs used to treat depression in over 4400 patients. The pooled analyses of placebo-controlled
trials in adults with MDD or other psychiatric disorders included a total of 295 short-term trials (median duration of 2 months) of 11 antidepressant drugs in over
77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs
studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk of differences (drug
versus placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of
suicidality per 1000 patients treated) are provided in Table 1 of the full prescribing information. There were 14 additional cases reported in patients under the age of
18, while 5 additional cases were reported in patients between 18 and 24 years of age. Patients between 25 and 64 years of age reported 1 fewer case of suicidality,
while patients 65 years of age and over reported 6 fewer cases. No suicides occurred in any of the pediatric trials. There were suicides in the adult trials, but the
number was not sufficient to reach any conclusion about drug effect on suicide. It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond
several months. However, there is substantial evidence from placebo-controlled maintenance trials in adults with depression that the use of antidepressants can delay
the recurrence of depression. All patients being treated with drugs inhibiting the reuptake of norepinephrine and/or serotonin for any indication should be monitored
appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a
course of drug therapy, or at times of dose changes, either increases or decreases. The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability,
hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, have been reported in adult and pediatric patients being treated with
drugs inhibiting the reuptake of norepinephrine and/or serotonin for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric.
Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been
established, there is concern that such symptoms may represent precursors to emerging suicidality. Consideration should be given to changing the therapeutic regimen,
including possibly discontinuing the medication, in patients who may experience worsening depressive symptoms, or who are experiencing emergent suicidality
or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe or abrupt in onset, or were not part of
the patient’s presenting symptoms. If the decision has been made to discontinue treatment due to worsening depressive symptoms or emergent suicidality,
medication should be tapered, as rapidly as is feasible, but with recognition that abrupt discontinuation can produce withdrawal symptoms [see Dosage and
Administration—Recommended Dosing, Dosage—Discontinuing Savella, and Warnings and Precautions—Discontinuation of Treatment with Savella]. Families
and caregivers of patients being treated with drugs inhibiting the reuptake of norepinephrine and/or serotonin for major depressive disorder or other indications,
both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes
in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care
providers. Such monitoring should include daily observation by families and caregivers. Prescriptions for Savella should be written for the smallest quantity
of tablets consistent with good patient management, in order to reduce the risk of overdose. Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-
Like Reactions-The development of a potentially life-threatening serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)-like reactions have been reported
with SNRIs and SSRIs alone, including Savella, but particularly with concomitant use of serotonergic drugs (including triptans), with drugs which impair metabolism
of serotonin (including MAOIs) or with antipsychotics or other dopamine antagonists. Serotonin syndrome symptoms may include mental status changes
(e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia,
incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea) [see Drug Interactions]. Serotonin syndrome, in its most severe form, can
resemble neuroleptic malignant syndrome, which includes hyperthermia, muscle rigidity, autonomic instability with possible rapid fluctuation of vital signs, and
mental status changes. Patients should be monitored for the emergence of serotonin syndrome or NMS-like signs and symptoms. The concomitant use of Savella
with MAOIs is contraindicated [see Contraindications]. If concomitant treatment of Savella with a 5-hydroxytryptamine receptor agonist (triptan) is clinically
warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases [see Drug Interactions]. The concomitant use of
Savella with serotonin precursors (such as tryptophan) is not recommended [see Drug Interactions]. Treatment with Savella and any concomitant serotonergic or
antidopaminergic agents, including antipsychotics, should be discontinued immediately if the above events occur and supportive symptomatic treatment should be
initiated. Effects on Blood Pressure-Inhibition of the reuptake of norepinephrine (NE) and serotonin (5-HT) can lead to cardiovascular effects. SNRIs, including
Savella, have been associated with reports of increase in blood pressure. In a double-blind, placebo-controlled clinical pharmacology study in healthy subjects
designed to evaluate the effects of milnacipran on various parameters, including blood pressure at supratherapeutic doses, there was evidence of mean increases
in supine blood pressure at doses up to 300 mg twice daily (600 mg/day). At the highest 300 mg twice daily dose, the mean increase in systolic blood pressure was
up to 8.1 mm Hg for the placebo group and up to 10.0 mm Hg for the Savella treated group over the 12 hour steady state dosing interval. The corresponding mean
increase in diastolic blood pressure over this interval was up to 4.6 mm Hg for placebo and up to 11.5 mm Hg for the Savella treated group. In the 3-month placebocontrolled
fibromyalgia clinical trials, Savella treatment was associated with mean increases of up to 3.1 mm Hg in systolic blood pressure (SBP) and diastolic blood
pressure (DBP) [see Adverse Reactions]. In the placebo-controlled trials, among fibromyalgia patients who were non-hypertensive at baseline, approximately twice
as many patients in the Savella treatment arms became hypertensive at the end of the study (SBP ≥ 140 mmHg or DBP ≥ 90 mmHg) compared with the placebo
patients: 7.2% of patients in the placebo arm versus 19.5% of patients treated with Savella 100 mg/day and 16.6% of patients treated with Savella 200 mg/day. Among
patients who met systolic criteria for pre-hypertension at baseline (SBP 120-139 mmHg), more patients became hypertensive at the end of the study in the Savella
treatment arms than placebo: 9% of patients in the placebo arm versus 14% in both the Savella 100 mg/day and the Savella 200 mg/day treatment arms. Among
fibromyalgia patients who were hypertensive at baseline, more patients in the Savella treatment arms had a >15 mmHg increase in SBP than placebo at the end of
the study: 1% of patients in the placebo arm versus 7% in the Savella 100 mg/day and 2% in the Savella 200 mg/day treatment arms. Similarly, more patients who
were hypertensive at baseline and were treated with Savella had DBP increases > 10 mmHg than placebo at the end of study: 3% of patients in the placebo arm
versus 8% in the Savella 100 mg/day and 6% in the Savella 200 mg/day treatment arms. Sustained increases in SBP (increase of ≥ 15 mmHg on three consecutive
post-baseline visits) occurred in 2% of placebo patients versus 9% of patients receiving Savella 100 mg/day and 6% of patients receiving Savella 200 mg/day.
Sustained increases in DBP (increase of ≥ 10 mmHg on 3 consecutive post-baseline visits) occurred in 4% of patients receiving placebo versus 13% of patients
receiving Savella 100 mg/day and 10% of patients receiving Savella 200 mg/day. Sustained increases in blood pressure could have adverse consequences. Cases
of elevated blood pressure requiring immediate treatment have been reported. Concomitant use of Savella with drugs that increase blood pressure and pulse has
not been evaluated and such combinations should be used with caution [see Drug Interactions]. Effects of Savella on blood pressure in patients with significant
hypertension or cardiac disease have not been systematically evaluated. Savella should be used with caution in these patients. Blood pressure should be measured
prior to initiating treatment and periodically measured throughout Savella treatment. Pre-existing hypertension and other cardiovascular disease should be treated
before starting therapy with Savella. For patients who experience a sustained increase in blood pressure while receiving Savella, either dose reduction or discontinuation
should be considered. Effects on Heart Rate-SNRIs have been associated with reports of increase in heart rate. In clinical trials, relative to placebo, Savella
treatment was associated with mean increases in pulse rate of approximately 7 to 8 beats per minute [see Adverse Reactions]. Increases in pulse ≥ 20 bpm occurred
more frequently in Savella-treated patients when compared to placebo: 0.3% in the placebo arm versus 8% in the Savella 100 mg/day and 8% in the 200 mg/day
treatment arms. The effect of Savella on heart rate did not appear to increase with increasing dose. Savella has not been systematically evaluated in patients with a
cardiac rhythm disorder. Heart rate should be measured prior to initiating treatment and periodically measured throughout Savella treatment. Pre-existing
tachyarrhythmias and other cardiac disease should be treated before starting therapy with Savella. For patients who experience a sustained increase in heart rate
while receiving Savella, either dose reduction or discontinuation should be considered. Seizures-Savella has not been systematically evaluated in patients with a seizure
disorder. In clinical trials evaluating Savella in patients with fibromyalgia, seizures/convulsions have not been reported. However, seizures have been reported infrequently
in patients treated with Savella for disorders other than fibromyalgia. Savella should be prescribed with care in patients with a history of a seizure disorder.
Hepatotoxicity-In the placebo-controlled fibromyalgia trials, increases in the number of patients treated with Savella with mild elevations of ALT or AST (1-3 times
the upper limit of normal, ULN) were observed. Increases in ALT were more frequently observed in the patients treated with Savella 100 mg/day (6%) and Savella
200 mg/day (7%), compared to the patients treated with placebo (3%). One patient receiving Savella 100 mg/day (0.2%) had an increase in ALT greater than 5 times
the upper limit of normal but did not exceed 10 times the upper limit of normal. Increases in AST were more frequently observed in the patients treated with Savella
100 mg/day (3%) and Savella 200 mg/day (5%) compared to the patients treated with placebo (2%). The increases of bilirubin observed in the fibromyalgia clinical
trials were not clinically significant. No case met the criteria of elevated ALT > 3x ULN and associated with an increase in bilirubin ≥ 2x ULN. There have been
cases of increased liver enzymes and reports of severe liver injury, including fulminant hepatitis with milnacipran from foreign postmarketing experience. In the cases
of severe liver injury, there were significant underlying clinical conditions and/or the use of multiple concomitant medications. Because of underreporting, it is impossible
to provide an accurate estimate of the true incidence of these reactions. Savella should be discontinued in patients who develop jaundice or other evidence
of liver dysfunction. Treatment with Savella should not be resumed unless another cause can be established. Savella should ordinarily not be prescribed to patients
with substantial alcohol use or evidence of chronic liver disease. Discontinuation of Treatment with Savella-Withdrawal symptoms have been observed in clinical
trials following discontinuation of milnacipran, as with other SNRIs and SSRIs. During marketing of milnacipran, and other SNRIs and SSRIs, there have been
spontaneous reports of adverse events indicative of withdrawal and physical dependence occurring upon discontinuation of these drugs, particularly when
discontinuation is abrupt. The adverse events include the following: dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesias such
as electric shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures. Although these events are
generally self-limiting, some have been reported to be severe. Patients should be monitored for these symptoms when discontinuing treatment with Savella. Savella
should be tapered and not abruptly discontinued after extended use. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment,
then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate
[see Dosage and Administration]. Hyponatremia-Hyponatremia may occur as a result of treatment with SSRIs and SNRIs, including Savella. In many cases, this
hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH). Cases with serum sodium lower than 110 mmol/L
have been reported. Elderly patients may be at greater risk of developing hyponatremia with SNRIs, SSRIs, or Savella. Also, patients taking diuretics or who are
otherwise volume-depleted may be at greater risk [see Geriatric Use]. Discontinuation of Savella should be considered in patients with symptomatic hyponatremia.
Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which may lead to
falls. Signs and symptoms associated with more severe and/or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death.
Abnormal Bleeding-SSRIs and SNRIs, including Savella, may increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory
drugs, warfarin, and other anti-coagulants may add to this risk. Case reports and epidemiological studies (case-control and cohort design) have demonstrated an
association between use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding. Bleeding events related to SSRIs and SNRIs
use have ranged from ecchymoses, hematomas, epistaxis, and petechiae to life-threatening hemorrhages. Patients should be cautioned about the risk of bleeding
associated with the concomitant use of Savella and NSAIDs, aspirin, or other drugs that affect coagulation. Activation of Mania-No activation of mania or hypomania
was reported in the clinical trials evaluating effects of Savella in patients with fibromyalgia. However those clinical trials excluded patients with current major depressive
episode. Activation of mania and hypomania have been reported in patients with mood disorders who were treated with other similar drugs for major depressive
disorder. As with these other agents, Savella should be used cautiously in patients with a history of mania. Patients with a History of Dysuria-Because of their
noradrenergic effect, SNRIs including Savella, can affect urethral resistance and micturition. In the controlled fibromyalgia trials, dysuria occurred more frequently
in patients treated with Savella (1%) than in placebo-treated patients (0.5%). Caution is advised in use of Savella in patients with a history of dysuria, notably in male
patients with prostatic hypertrophy, prostatitis, and other lower urinary tract obstructive disorders. Male patients are more prone to genitourinary adverse effects,
such as dysuria or urinary retention, and may experience testicular pain or ejaculation disorders. Controlled Narrow-Angle Glaucoma-Mydriasis has been reported
in association with SNRIs and Savella; therefore, Savella should be used cautiously in patients with controlled narrow-angle glaucoma. Do not use Savella in
patients with Uncontrolled Narrow-Angle Glaucoma [see Contraindications]. Concomitant Use with Alcohol-In clinical trials, more patients treated with Savella
developed elevated transaminases than did placebo-treated patients [see Warnings and Precautions]. Because it is possible that milnacipran may aggravate preexisting
liver disease, Savella should not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease.
ADVERSE REACTIONS: Clinical Trial Data Sources-Savella was evaluated in three double-blind placebo-controlled trials involving 2209 fibromyalgia
patients (1557 patients treated with Savella and 652 patients treated with placebo) for a treatment period up to 29 weeks. The stated frequencies of adverse
reactions represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse reaction of the type listed. A reaction was
considered treatment emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation. Because clinical trials are
conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical
trials of another drug and may not reflect the rates observed in practice. Adverse Reactions Leading to Discontinuation-In placebo-controlled trials in patients with
fibromyalgia, 23% of patients treated with Savella 100 mg/day, 26% of patients treated with Savella 200 mg/day discontinued prematurely due to adverse reactions,
compared to 12% of patients treated with placebo. The adverse reactions that led to withdrawal in ≥ 1% of patients in the Savella treatment group and with an
incidence rate greater than that in the placebo treatment group were nausea (milnacipran 6%, placebo 1%), palpitations (milnacipran 3%, placebo 1%), headache
(milnacipran 2%, placebo 0%), constipation (milnacipran 1%, placebo 0%), heart rate increased (milnacipran 1%, placebo 0%), hyperhidrosis (milnacipran 1%,
placebo 0%), vomiting (milnacipran 1%, placebo 0%), and dizziness (milnacipran 1% and placebo 0.5%). Discontinuation due to adverse reactions was generally
more common among patients treated with Savella 200 mg/day compared to Savella 100 mg/day. Most Common Adverse Reactions-In the placebo-controlled
fibromyalgia patient trials, the most frequently occurring adverse reaction in clinical trials was nausea. The most common adverse reactions (incidence ≥ 5% and
twice placebo) in patients treated with Savella were constipation, hot flush, hyperhidrosis, vomiting, palpitations, heart rate increased, dry mouth, and hypertension.
Table 2 lists all adverse reactions that occurred in at least 2% of patients treated with Savella at either 100 or 200 mg/day and at an incidence greater than that
of placebo. Table 2 in the full PI shows the incidence of common adverse reactions that occurred in at least 2% of patients treated with Savella at either 100 or
200 mg/day and at an incidence greater than that of placebo. Savella 100 mg/day (n=632); Savella 200 mg/day (n=934); All Savella (n=1557); Placebo (n=652):
Cardiac Disorders: Palpitations (8%; 7%; 7%; 2%); Tachycardia (3%; 2%; 2%; 1%); Eye Disorders: Vision blurred (1%; 2%; 2%; 1%); Gastrointestinal Disorders:
Nausea (35%; 39%; 37%; 20%); Constipation (16%; 15%; 16%; 4%); Vomiting (6%; 7%; 7%; 2%); Dry mouth (5%; 5%; 5%; 2%); Abdominal pain (3%; 3%; 3%;
2%); General Disorders: Chest pain (3%; 2%; 2%; 2%); Chills (1%; 2%; 2%; 0%); Chest discomfort (2%; 1%; 1%; 1%); Infections: Upper respiratory tract
infection (7%; 6%; 6%; 6%); Investigations: Heart rate increased (5%; 6%; 6%; 1%); Blood pressure increased (3%; 3%; 3%; 1%); Metabolism and Nutrition
Disorders: Decreased appetite (1%; 2%; 2%; 0%); Nervous System Disorders: Headache (19%; 17%; 18%; 14%); Dizziness (11%; 10%; 10%; 6%); Migraine (6%;
4%; 5%; 3%); Paresthesia (2%; 3%; 2%; 2%); Tremor (2%; 2%; 2%; 1%); Hypoesthesia (1%; 2%; 1%; 1%); Tension headache (2%; 1%; 1%; 1%); Psychiatric
Disorders: Insomnia (12%; 12%; 12%; 10%); Anxiety (5%; 3%; 4%; 4%); Respiratory Disorders: Dyspnea (2%; 2%; 2%; 1%); Skin Disorders: Hyperhidrosis (8%;
9%; 9%; 2%); Rash (3%; 4%; 3%; 2%); Pruritus (3%; 2%; 2%; 2%); Vascular Disorders: Hot flush (11%; 12%; 12%; 2%); Hypertension (7%; 4%; 5%; 2%);
Flushing (2%; 3%; 3%; 1%). Weight Changes-In placebo-controlled fibromyalgia clinical trials, patients treated with Savella for up to 3 months experienced a mean
weight loss of approximately 0.8 kg in both the Savella 100 mg/day and the Savella 200 mg/day treatment groups, compared with a mean weight loss of approximately
0.2 kg in placebo-treated patients. Genitourinary Adverse Reactions in Males-In the placebo-controlled fibromyalgia studies, the following treatmentemergent
adverse reactions related to the genitourinary system were observed in at least 2% of male patients treated with Savella, and occurred at a rate greater
than in placebo-treated male patients: dysuria, ejaculation disorder, erectile dysfunction, ejaculation failure, libido decreased, prostatitis, scrotal pain, testicular pain,
testicular swelling, urinary hesitation, urinary retention, urethral pain, and urine flow decreased. Other Adverse Reactions Observed During Clinical Trials of Savella
in Fibromyalgia-Following is a list of frequent (those occurring on one or more occasions in at least 1/100 patients) treatment-emergent adverse reactions reported
from 1824 fibromyalgia patients treated with Savella for periods up to 68 weeks. The listing does not include those events already listed in Table 2, those events for
which a drug cause was remote, those events which were so general as to be uninformative, and those events reported only once which did not have a substantial
probability of being acutely life threatening. Adverse reactions are categorized by body system and listed in order of decreasing frequency. Adverse reactions of major
clinical importance are described in the Warnings and Precautions section. Gastrointestinal Disorders – diarrhea, dyspepsia, gastroesophageal reflux disease,
flatulence, abdominal distension; General Disorders – fatigue, peripheral edema, irritability, pyrexia; Infections – urinary tract infection, cystitis; Injury, Poisoning,
and Procedural Complications – contusion, fall; Investigations – weight decreased or increased; Metabolism and Nutrition Disorders – hypercholesterolemia;
Nervous System Disorders – somnolence, dysgeusia; Psychiatric Disorders – depression, stress; Skin Disorders – night sweats. Post-marketing Spontaneous
Reports-The following additional adverse reactions have been identified from spontaneous reports of Savella received worldwide. These adverse reactions have been
chosen for inclusion because of a combination of seriousness, frequency of reporting, or potential causal connection to Savella. However, because these adverse
reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship
to drug exposure. These events include: Blood and Lymphatic System Disorders – leukopenia, neutropenia, thrombocytopenia; Cardiac Disorders – supraventricular
tachycardia; Eye Disorders – accommodation disorder; Endocrine Disorders – hyperprolactinemia; Hepatobiliary Disorders – hepatitis; Metabolism and Nutrition Disorders
– anorexia, hyponatremia; Musculoskeletal and Connective Tissue Disorders – rhabdomyolysis; Nervous System Disorders – convulsions (including grand
mal), loss of consciousness, Parkinsonism; Psychiatric Disorders – delirium, hallucination; Renal and Urinary Disorders – acute renal failure; Reproductive System
and Breast Disorders – galactorrhea; Skin Disorders – erythema multiforme, Stevens Johnson syndrome; Vascular Disorders – hypertensive crisis.
DRUG INTERACTIONS: Milnacipran undergoes minimal CYP450-related metabolism, with the majority of the dose excreted unchanged in urine (55%), and has
a low binding to plasma proteins (13%). In vitro and in vivo studies showed that Savella is unlikely to be involved in clinically significant pharmacokinetic drug
interactions [see Pharmacokinetics in Special Populations]. Monoamine Oxidase Inhibitors - [See Contraindications] Serotonergic Drugs - Due to the mechanism
of action of SNRIs and SSRIs, including Savella, and the potential for serotonin syndrome or Neuroleptic Malignant Syndrome (NMS)–like reactions, caution is advised
when Savella is co-administered with other drugs that may affect the serotonergic neurotransmitter systems. This includes drugs such as triptans, lithium,
tryptophan, antipsychotics and dopamine antagonists. Co-administration of Savella with other inhibitors of serotonin re-uptake may result in hypertension and coronary
artery vasoconstriction, through additive serotonergic effects. Concomitant use of Savella with other SSRIs, SNRIs, or tryptophan is not recommended [see
Warnings and Precautions]. Triptans - There have been rare postmarketing reports of serotonin syndrome with use of an SSRI and a triptan. If concomitant treatment
of Savella with a triptan is clinically warranted, careful observation of the patient is advised, particularly during treatment initiation and dose increases [see Warnings
and Precautions]. Catecholamines - Savella inhibits the reuptake of norepinephrine. Therefore concomitant use of Savella with epinephrine and norepinephrine
may be associated with paroxysmal hypertension and possible arrhythmia [see Warnings and Precautions – Effects on Blood Pressure and Effects on Heart Rate].
CNS-active drugs - Given the primary CNS effects of Savella, caution should be used when it is taken in combination with other centrally acting drugs, including
those with a similar mechanism of action. Clomipramine: In a drug-drug interaction study, an increase in euphoria and postural hypotension was observed in patients
who switched from clomipramine to Savella. Clinically Important Interactions with Select Cardiovascular Agents - Digoxin: Use of Savella concomitantly
with digoxin may be associated with potentiation of adverse hemodynamic effects. Postural hypotension and tachycardia have been reported in combination
therapy with intravenously administered digoxin (1 mg). Co-administration of Savella and intravenous digoxin should be avoided [see Warnings and Precautions].
Clonidine: Because Savella inhibits norepinephrine reuptake, co-administration with clonidine may inhibit clonidine’s anti-hypertensive effect.
USE IN SPECIFIC POPULATIONS: Pregnancy-Pregnancy Category C. Milnacipran increased the incidence of dead fetuses in utero in rats at doses of
5 mg/kg/day (0.25 times the MRHD on a mg/m 2 basis). Administration of milnacipran to mice and rabbits during the period of organogenesis did not
result in embryotoxicity or teratogenicity at doses up to 125 mg/kg/day in mice (3 times the maximum recommended human dose [MRHD] of 200 mg/day on a
mg/m 2 basis) and up to 60 mg/kg/day in rabbits (6 times the MRHD of 200 mg/day on a mg/m 2 basis). In rabbits, the incidence of the skeletal variation, extra
single rib, was increased following administration of milnacipran at 15 mg/kg/day during the period of organogenesis. There are no adequate and well-controlled
studies in pregnant women. Savella should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. To provide information
regarding the exposure to Savella during pregnancy, physicians are advised to recommend that pregnant patients taking Savella enroll in the Savella Pregnancy
Registry. Enrollment is voluntary and may be initiated by pregnant patients or their healthcare providers by contacting the registry at 1-877-643-3010 or by email
at registries@kendle.com. Data forms may also be downloaded from the registry website at www.savellapregnancyregistry.com. Nonteratogenic Effects; Neonates
exposed to dual reuptake inhibitors of serotonin and norepinephrine, or selective serotonin reuptake inhibitors late in the third trimester have developed complications
requiring prolonged hospitalization, respiratory support, and tube feeding. Such complications can arise immediately upon delivery. Reported clinical findings
have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia,
tremor, jitteriness, irritability, and constant crying. These features are consistent with either a direct toxic effect of these classes of drugs or, possibly, a drug discontinuation
syndrome. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome [see Warnings and Precautions]. In rats,
a decrease in pup body weight and viability on postpartum day 4 were observed when milnacipran, at a dose of 5 mg/kg/day (approximately 0.2 times the MRHD
on a mg/m 2 basis), was administered orally to rats during late gestation. The no-effect dose for maternal and offspring toxicity was 2.5 mg/kg/day (approximately
0.1 times the MRHD on a mg/m 2 basis). Labor and Delivery-The effect of milnacipran on labor and delivery is unknown. The use of Savella during labor and delivery
is not recommended. Nursing Mothers-There are no adequate and well-controlled studies in nursing mothers. It is not known if milnacipran is excreted in human
milk. Studies in animals have shown that milnacipran or its metabolites are excreted in breast milk. Because many drugs are excreted in human milk and because
of the potential for serious adverse reactions in nursing infants from milnacipran, a decision should be made whether to discontinue the drug, taking into account
the importance of the drug to the mother. Because the safety of Savella in infants is not known, nursing while on Savella is not recommended. Pediatric Use-Safety
and effectiveness of Savella in a fibromyalgia pediatric population below the age of 17 have not been established [see Box Warning and Warnings and Precautions].
The use of Savella is not recommended in pediatric patients. Geriatric Use-In controlled clinical studies of Savella, 402 patients were 60 years or older, and no overall
differences in safety and efficacy were observed between these patients and younger patients. In view of the predominant excretion of unchanged milnacipran
via kidneys and the expected decrease in renal function with age, renal function should be considered prior to use of Savella in the elderly [see Dosage and
Administration]. SNRIs, SSRIs, and Savella, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for
this adverse event [see Warnings and Precautions].
DRUG ABUSE AND DEPENDENCE: Controlled Substance-Milnacipran is not a controlled substance. Abuse-Milnacipran did not produce behavioral signs indicative
of abuse potential in animal or human studies. Dependence-Milnacipran produces physical dependence, as evidenced by the emergence of withdrawal symptoms
following drug discontinuation, similar to other SNRIs and SSRIs. These withdrawal symptoms can be severe. Thus, Savella should be tapered and not abruptly
discontinued after extended use [see Discontinuation of Treatment with Savella].
OVERDOSAGE: There is limited clinical experience with Savella overdose in humans. In clinical trials, cases of acute ingestions up to 1000 mg, alone or in
combination with other drugs, were reported with none being fatal. In postmarketing experience, fatal outcomes have been reported for acute overdoses primarily
involving multiple drugs but also with Savella only. The most common signs and symptoms included increased blood pressure, cardio-respiratory arrest, changes
in the level of consciousness (ranging from somnolence to coma), confusional state, dizziness, and increased hepatic enzymes. Management of Overdose-There
is no specific antidote to Savella, but if serotonin syndrome ensues, specific treatment (such as with cyproheptadine and/or temperature control) may be considered.
In case of acute overdose, treatment should consist of those general measures employed in the management of overdose with any drug. An adequate airway,
oxygenation, and ventilation should be assured and cardiac rhythm and vital signs should be monitored. Induction of emesis is not recommended. Gastric lavage
with a large-bore orogastric tube with appropriate airway protection, if needed, may be indicated if performed soon after ingestion or in symptomatic patients.
Because there is no specific antidote for Savella, symptomatic care and treatment with gastric lavage and activated charcoal should be considered as soon as
possible for patients who experience a Savella overdose. Due to the large volume of distribution of this drug, forced diuresis, dialysis, hemoperfusion, and exchange
transfusion are unlikely to be beneficial. In managing overdose, the possibility of multiple drug involvement should be considered. The physician should consider
contacting a poison control center for additional information on the treatment of any overdose. Telephone numbers for certified poison control centers are listed in
the Physicians’ Desk Reference (PDR).
Manufactured for:
Manufactured by:
Forest Pharmaceuticals, Inc.
Forest Laboratories, Inc.
Licensed from Pierre Fabre Medicament and Cypress Bioscience, Inc.
Revised: May 2010
© 2009 Forest Laboratories, Inc.
Live:11.5”

The Cosmopolitan of Las Vegas
news 25
EDITORIAL
Pill Mill Legislation: Is it the Answer
Pill mills are a problem nationwide, but new legislation against these questionable practices may not always provide the best solutions.
By John J. Burke
There has certainly been a huge outcry by many, including
law enforcement, to do something about the “pill mills”
in the United States, especially those located in great
numbers in Florida, most noticeably Broward County. Florida
certainly seems to have the most, but other states also are experiencing
these issues— my home state, Ohio, is one of them.
One of the first considerations is defining what the term pill
mill really means, especially in the eyes of the law. I don’t know
any particular official definitions, but most of us probably think
of a physician’s office where the prescriber(s) are either recklessly
writing or dispensing very large amounts of controlled
substances, usually pain medication, to patients who have
questionable symptoms.
These often seem to be located in strip malls, with some sort
of security to handle the vehicular and pedestrian traffic, keep
an eye out for signs of investigative reporters and undercover
cops, and, of course, keep the peace while “patients” stand in
long lines waiting to see the doctor. During training, I often ask
law enforcement officials, after describing the scenario above, if
this is what they experience at their doctor’s office. They quickly
get the point.
Dispensing large amounts of controlled substances out of a
physician’s office has long been a red flag for law enforcement
and regulatory agents. It is difficult in my mind to understand
why a prescriber would want to do this, except for the fact that
they do not want retail pharmacists to review their prescribing
habits, plus it can put some additional money in their pockets.
Ohio’s new law will put a strict limit on how many dosage units
can be dispensed and over what period of time.
Sometimes when people get frustrated with a problem, however,
and especially when it is not easily contained, they overreact
and cause more problems than they solve. Politicians are
great at this, and sometimes they are spurred on by local or
federal law enforcement. They have good intentions, but tend
to forget that most states, including Ohio, have good laws already
on the books that allow for aggressive investigation and
prosecution of these rogue prescribers and their staff.
Please don’t misunderstand me; I am very much in favor of
pursuing prosecution against any and all illegal prescriber operations,
wherever they may be found. These mills contribute to
the heavy body count associated in most states with pharmaceuticals.
They perpetuate enormous addiction and trafficking
levels in and around the community in which they are located—
or way beyond, as has been true with the Florida-Ohio connection
and many other Midwestern states.
I frankly get concerned when I hear of some of the proposals
that have come up in various states’ proposed legislation
to curb the problem of pill mills. Some, I believe, are putting
restrictions on physicians and their practices that will surely be
challenged in court, putting more burden on the appeals courts
and possibly ending in a win for the prescriber, whether they
were legitimate or not.
Some of them are making it so that only a physician can
have any ownership in the practice, or that the doctor must
have privileges at 1 or more of the local hospitals in order to
have a pain management practice, or that if 51% or more of
their practice involves treating pain, the prescriber falls under
strict rules. It is only a guess, but I wouldn’t be surprised if
many family practices meet or exceed that percentage. I am
certainly not a lawyer, but some of these issues seem to be
problematic. The last thing that I think we want to see is a
flurry of new laws governing pain clinics that either hurt legitimate
practices or become overzealous, with the result being
lengthy court battles.
I am still a firm believer that most states have sufficient laws
on their books that cover criminal activity, such as trafficking
in drugs, health care fraud, money laundering, tax evasion,
conspiracy, and organized crime, to help pursue illegal
prescribers and bring them to justice. This is primarily a law
enforcement problem, and we need to work even harder to
identify the criminal prescribers while safeguarding the vast
majority of physicians who provide compassionate care to
their patients.
John Burke is a 40-year veteran of law enforcement and the
current president of the National Association of Drug Diversion
Investigators (www.naddi.org). This column originally appeared in
the July issue of Pharmacy Times (www.pharmacytimes.com).
Congratulations to the 2011 PainEDU.org PAINWeek
scholarship recipients!
This year, PainEDU awarded scholarships to cover the cost of registration at PAINWeek to 10 health
care professionals who submitted essays that discussed the health care setting in which the writer
practices, the patient population under his or her care, barriers to pain management education and
training that the writer has experienced, and the value of the scholarship and education.
You can visit the PainEDU.org website to access the complete collection of
essays at http://hcp.lv/nFlaDB.
Congratulations!
The American Society of Pain Educators
would like you to join us in congratulating
our 2011 ASPE Fellows and our 2011 ASPE
Distinguished Members. We thank them for
their contributions to our commitment to pain
education.
Karel Schram, PA-C: Hackley
Community Care Center, Muskegon, MI
(grand prize winner)
James Adam Dailey, MD, Intern: Pitt
Country Memorial Hospital, Greenville, NC
Cathy Haberle, RN, BS, CHPN: Grand
View Hospital, Sellersville, PA
Reginald Hall, MD: Federal Medical
Center, Butner, NC
Kelly Lynn Kluesner, RN: Greenwood
Ambulatory Surgery Center, Greenwood
Village, CO
Noel S. Lee, 3rd-year medical student:
UCSD Medical Center and VA San Diego
Healthcare System, San Diego, CA
Karen Marlowe, Pharm D, BCPS, CPE:
Auburn University Harrison School of
Pharmacy, Mobile, AL
Vineeta Risbood, Pharm D, BCPS: Kaiser
Permanente of Ohio, Cleveland, OH
Pamela Ronning, MPA, BSN, RN: Hackley
Community Care Center, Muskegon, MI
Julie Rossow, RN: Madrid Home
Communities, Madrid, IA
2011 ASPE Fellows
B. Eliot Cole, MD, MPA, FASPE, CPE
David M. Glick, DC, DAAPM, FASPE, CPE
Mary Lynn McPherson, PharmD, BCPS,
FASPE, CPE
2011 Distinguished Members
Charles E. Argoff, MD, DASPE, CPE
Barbara L. Kornblau, JD, OTR/L, DASPE, CPE
Michael E. Schatman, PhD, DASPE, CPE

26
news
friDAY
September 9, 2011
RECAP
Managing Risk as Part of a Tailored Approach to
Pain Management
Treating medium- and high-risk patients for pain requires rigorous testing, an individualized approach, and realistic expectations
“This is not
Burger King.
You do not get
to have it ‘your
way’ when it
comes to pain
meds. They are
called ‘controlled
substances’ for a
reason.”
Thursday morning at PAINWeek 2011, Ted W. Jones, PhD, a clinical
psychologist at the Behavioral Medicine Institute in Knoxville, TN,
and Darren McCoy, NP, MSN, an adjunct faculty member and
clinical preceptor at the University of Tennessee College of Nursing in
Knoxville, TN, offered a detailed account of how their practice, Pain
Consultants of East Tennessee (PCET), assesses medium- and high-risk
pain patients and treats them using prescription opioid medications.
McCoy stressed that providers who are planning to treat patients
with opioids “have to do some kind of risk assessment” to gauge that
patient’s potential to abuse and/or misuse their medications, and noted
that “there are many tools available to do so,” including the ORT,
SOAPP, SOAPP-R, MPQ, DIRE, and others. However, he cautioned that
“it’s not enough to just assess risk; it’s what you do with that data in
treating patients the makes the difference.”
In McCoy’s community, there is no nearby academic or tertiary pain
center to which patients can be referred. This, combined with what he
said was “frequent overprescribing of opioids by other providers in the
community,” has meant that PCET has had to develop its own detailed
policies and procedures for providing safe and effective care to a
wide range of patients.
Jones said that 33%-70% of patients at PCET are categorized as
medium- to high-risk depending on the measure used to assess them
(he said the SOAPP-R rates higher than ORT, in their experience). The
question for most non-pain specialists when dealing with this population
is whether to treat the patients themselves, consult with a specialist,
or refer the patients to another specialist provider. For practices
that do not have access to these resources, Jones said that there are
several general principles to keep in mind when treating high-risk patients.
Providers should increase the frequency and number of monitoring
methods they use, including the use of urine drug testing and
pill counts. He also recommended that providers refer to their state’s
prescription drug monitoring program (PDMP) if their state has one.
Jones said that increased office visits are important, and suggested
that providers limit the use of rapid-onset and short-acting opioids in
this patient population.
If patients object to these measures (especially the limits on the type
and amount of medications the practice will prescribe), McCoy said
that “We remind them that this is not Burger King. You do not get to
have it ‘your way’ when it comes to pain meds. They are called ‘controlled
substances’ for a reason.”
At PCET, the standard practice during the first office visit for a pain
patient is to assess them for risk of misuse and abuse. This includes a
thorough review of their past medical records, checking the Tennessee
PDMP database, and administering a urine drug test. McCoy said
that his practice will try all non-opioid treatments before starting a
patient on opioids, at which point all patients are also required to sign
a medication agreement. McCoy also noted that, although it seems
a simple detail, providers should make sure to document a diagnosis
that supports the use of opioids and that is supported by the clinical
presentation and data. All patients must also go through a “medication
class” that explores addiction vs. dependence, safe storage of
medications, and other important safety and risk management topics.
Other risk management and monitoring strategies recommended by
Jones and McCoy for all patients being treated with opioids include
follow-up urine drug screening at least annually (with more frequent
testing for higher risk patients), conducting pill counts during every
office visit, following daily dosing limits, avoiding the use of easily manipulated
time-release medications with new patients, and perhaps
forgoing the use of potent immediate-release opioids.
McCoy reminded the audience that they should “treat pain at least
adequately, if not aggressively.” Otherwise, he said “it is a setup for
the patient to fail,” which can restrict treatment options even further.
When selecting opioid medications and doses, McCoy recommended
prescribing fewer than 100 doses per month of short-acting opioids
(3-4 doses daily) for all patients. If that does not adequately control
the patient’s pain, then “you should consider shifting to a long-acting
opioid” at a smaller number of doses, he said. He cautioned that shortacting
opioids should be prescribed for “incident or activity-related
pain” and should not be given to supplement time-release opioids.
For patients determined to be “medium risk,” McCoy suggested
starting them on long-acting opioids (especially as they may already
be opioid tolerant). If short-acting medications are used, he recommended
tighter limits on the number of doses prescribed (maybe 30-40
per month). He also recommended more frequent use of urine drug
testing in these patients (at least quarterly). High-risk patients should
not be prescribed short-acting opioids at all, and should have their
urine tested frequently (at PCET, this is done at each visit for these patients).
Random pill counts and random urine drug testing may also be
warranted (pill counts can also be performed by a pharmacist if the
patient cannot make it to the office).
Jones said that PCET runs an “intensive treatment program” for highrisk
patients that requires them to make weekly visits for 12 weeks, followed
by biweekly visits for 24 weeks. Patients are subject to all of
the monitoring measures previously discussed (medication checks, pill
counts, urine drug testing, etc) and must also attend the medication
class. Jones said that this “is really helpful; if nothing else it highlights
the medication agreement.” It also offers the opportunity to talk with
the patients about why the medication agreement is important, the
risks associated with prescription opioids, the reasons why patients
should not share medications, safe storage and disposal practices,
and other topics.
He shared data from the program based on follow-up with 50 patients.
He said that 80% of the patients were started in the program
based on the initial risk assessment, and 20% started after showing
significant aberrant medication behavior. About one-third (32%) of the
patients completed both stages of the program, another third (36%)
were discharged, and 22% left on their own. He said that he was
surprised to find that nearly half (46%) of the patients in the program
demonstrated aberrant behavior. Half of the aberrant patients either
took too many of their medications, had a pill count come up short, or
had a negative urine drug test. He said that about half of the patients
obtained opioids from sources other than their prescriber. Less than
10% of patients used illicit drugs or alcohol.
The evidence shows that this approach appears to be working at
PCET. Jones said that only about 2% of their pain patients get a negative
urine drug screen, only 4% or so test positive for illicit substances.
He said they have about a 15% aberrancy rate overall.
Key takeaway points:
• The more you can do on the front end of treatment to help people,
the better it is for patients, and the longer they will stay in treatment.
• The importance of documentation cannot be overstated. Explain
what you’re doing and why you’re doing it.
• Be realistic about what you can do during treatment, and help the
patient be realistic, too.
• Individualize care and stratify risk.
• Understand that not all patients will be helped by opioids.
• Know the limits of UDTs. Don’t react inappropriately and know
the cut-off limits. Get to know the people at the lab you use and
consult with their toxicologists. Be fair to your patients.
• When discharging a patient from your practice, check the local
laws and regulations regarding what you’re supposed to do.
• Consider allowing patients to appeal a discharge in certain cir-

The Cosmopolitan of Las Vegas
news 27
www.painweek.org

28
news
friDAY
September 9, 2011
EDITORIAL
I Once Had a Son Named Joey
The story of how one family’s tragic loss led to the creation of an organization dedicated to raising awareness of the risks associated with prescription drug abuse
By April Rovero
On December 18, 2009, my husband and I received
the devastating and inconceivable news
that our youngest son, Joseph John Rovero, III
(Joey), had been found dead by friends in his apartment
off campus near Arizona State University (ASU), where he
was attending college. Over the next few days, as we
worked to get his body returned home to California and
plan his funeral, a stunning story began to unfold.
We learned that Joey and two other ASU students had
traveled six hours from Arizona to southern California
on December 9, to visit an osteopathic doctor who was
known for routinely prescribing narcotics to her patients
with just a cursory exam. All three boys walked into her
office together and left a short time later with prescriptions
in hand.
Joey’s prescriptions included ninety 30 mg tablets of
Roxicodone, ninety 350 mg tablets of Soma, and thirty 2
mg tablets of Xanax. He and his “friends” were instructed
to go to a specific pharmacy about 35 miles away, which
filled their prescriptions with no questions asked. We’ve
since learned that both the doctor and pharmacy had
been under investigation by the DEA for their prescribing
and prescription-filling practices for at least two years
before Joey died.
Joey had never been previously treated for any of the
conditions that were cited in his medical record as the
basis for what was prescribed for him that day. There was
no indication that the doctor or pharmacy counseled him
about how dangerous these medications can be when
abused, misused, or mixed with alcohol. Joey died just
nine days after his fateful trip to California. He went to
sleep after a typical college party and never woke up.
The coroner’s report indicated that Joey died from low
levels of Xanax and moderate levels of Roxicodone, combined
with a blood alcohol level of 0.13. It stated that
while none of the individual levels of these substances
should have been lethal, in combination they shut down
his central nervous system and he stopped breathing. The
manner of his death was classified as an “accident.”
There are no words
Joey had been due home for winter break the day after
he died, and the Christmas we expected to share with him
never happened. Instead, we struggled to get through
the most awful week of our lives. Stunned, shocked, and
grieving, we picked out a gravesite, coffin, and clothes
for Joey to be buried in the day after Christmas. It was
almost unbearable for me to have to write an obituary
for my son, who had not had time to develop the lifetime
achievements I should have been able to cite. Through it
all we struggled to understand how this could have happened
to Joey
There are really no words that can adequately describe
how severely my entire family has been impacted
by Joey’s death. He was my husband’s only biological
child, and his brother’s only sibling. As his mother, I feel
as though a piece of me has been ripped away. Our lives
were irrevocably changed the night that we lost Joey. I’m
sure none of us will ever fully recover from this tragedy
that was so senseless and completely avoidable.
Losing a child is the worst nightmare a parent can experience.
Not only is it terribly painful to recount all the
wonderful years you had with your child, you lament the
“what ifs” and “should have beens” you’ll miss out on.
What career would they have developed after college
graduation Who would they have married What about
those precious unborn grandchildren—what would they
have looked like and what mark would they have made
in this world Who will be there as an advocate for you
as you grow old and your health fails You can’t help but
reflect on how you raised your child and obsess on what
you could have done differently or better. You wonder
how you will ever live normally again with a piece of your
own life’s puzzle missing.
A big part of the problem is
a lack of awareness about
how dangerous prescription
drugs can be. Many people
assume that they are safer
than illicit drugs because a
doctor prescribes them.
The story doesn’t end there
Unbelievably, tragedy struck again nine months to the day
of Joey’s death when one of his college roommates shot
and killed himself in front of his girlfriend after a night of
heavy drinking and prescription drug abuse. This young
man had struggled immensely with Joey’s death and his
own addiction to prescription drugs. Unfortunately, Joey
and his roommate are just two of eight ASU students who
have died from prescription drug-related causes over
the past 18 months. All were bright young men with very
promising lives ahead of them who are now gone forever.
Every week, I learn about more deaths from prescription
drug abuse, and each one is another dagger to my heart.
In Florida alone, we lose an average of seven people
a day from overdoses. More than 32,000 people in the
US die each year from adverse reactions to medications.
A big part of the problem is a lack of awareness about
how dangerous prescription drugs can be. Many people
assume that they are safer than illicit drugs because a
doctor prescribes them, but it is imperative that we spread
the word that they simply aren’t.
Realizing that education could help reduce the death
and addiction toll from prescription drugs, my family
founded the National Coalition Against Prescription Drug
Abuse (NCAPDA) in March, 2010. NCAPDA’s primary focus
is to increase public awareness and to stimulate and
support legislative action that can reduce deaths and addiction
due to prescription drugs. To learn more about our
work, visit our website (www.ncapda.org) and join us on
Facebook (NCAPDA).
No parent should ever have to live this new life my husband
and I are now forced to endure, without the beautiful
son we created together. We’re doing all we can to
help others avoid what we’ve experienced by sharing
Joey’s story with students, parents, and others throughout
the country. However, prescription drug abuse is a
multi-faceted epidemic that is going to take all of us to
tackle. We’ve got to take action NOW to stem the tide of
death, crime, and addiction that is affecting every American
community.
Please don’t think this can’t happen to you. It can and
does happen to the best of families. Unfortunately, I know
that from personal experience, as I once had a son named
Joey who died from a prescription drug overdose.
—April Rovero is the founder and president of the National
Coalition Against Prescription Drug Abuse (www.ncapda.org).
Please do your part to raise
awareness
Strong, highly addictive opiate analgesics such as oxycodone
and hydrocodone are currently being prescribed
routinely for moderate to severe pain. This prescribing
range is far too wide and is resulting in unnecessary addiction
and deaths. Be careful never to over-prescribe and to
recommend treatment options other than drugs whenever
possible. Also, don’t just prescribe medication to simply
manage the symptoms, but treat the underlying medical
problem your patients present.
It is crucial that more affordable drug treatment and care
options be established throughout the country to deal
with the escalating prescription drug addiction epidemic.
The impact on our communities is enormous in terms of increased
crime levels and human suffering. Crime increases
as addicts become criminals to support their drug habits.
Families become emotionally and financially bankrupt as
they deal with their loved one’s long struggle.
America’s colleges and universities are not adequately
educating their students about the dangers of prescription
drug abuse. Given the college party scene, which often
includes excessive drinking and illicit or prescription drug
abuse, it’s critical that students understand the dangers
of misusing, abusing, and mixing these substances. Help
educate college students about prescription drug abuse
dangers, and be very careful when prescribing stimulants,
painkillers, and sedatives, which are the most commonly
abused medications on college campuses.
Over time, those who are addicted to prescription drugs
typically begin to “doctor shop” in order to obtain the
quantity of drugs they need to avoid withdrawal. Learn
what tactics prescription drug addicts use to obtain the
drugs they need and be on the alert for them in patients
you interface with. Don’t ignore the signs of drug abuse
and rather than feed their habit with refilled prescriptions
or additional drugs, refer them to the specialists who can
help them address and manage their addiction.

The Cosmopolitan of Las Vegas
news 29
RECAP
From Bruno Mars and the Beatles to Brahms:
Music Therapy for Chronic Pain
Music therapy can be an important part of a multifaceted approach to pain management
Today I don’t feel like doing anything ...
I just wanna’ lay in my bed ...
Don’t feel like picking up my phone ...
Established 1995
Clinical
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Relationship Between Short-Acting b 2 -Adrenergic
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Silver, Blanchette, Kamble, Petersen, Letter, Meddis,
and Gutierrez
Healthcare Costs and Nonadherence
Among Chronic Opioid Users
Leider, Dhaliwal, Davis, Kulakodlu, and Buikema
Relationship Between Patient Satisfaction
With Inpatient Care and Hospital Readmission
Within 30 Days
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A System-Based Intervention to Improve
Colorectal Cancer Screening Uptake
Hoffman, Steel, Yee, Massie, Schrader, Moffett,
and Murata
Hypertension Treatment and Control Within
an Independent Nurse Practitioner Setting
Wright, Romboli, DiTulio, Wogen, and Belletti
Policy
Health Plan Resource Use—Bringing Us
Closer to Value-Based Decisions
Turbyville, Rosenthal, Pawlson, and Scholle
Managerial
Effects of Health Savings Account–Eligible Plans
on Utilization and Expenditures
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Web Exclusive Abstracts
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So leave a message at the tone ...
Cus’ today I swear I’m not doing anything ...
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AJMC_11jan_Cvr.indd 1 1/25/11 10:54 AM
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F r o m t h e e d i t o r
A Word of Welcome
Jan e. Berger, md, mJ
t h e P h a r m a c y & t h e r a P e u t i c s s o c i e t y
A New Alliance: Message From the PTS President
edmund J. Pezalla, md, mPh
m e d i c a r e P a r t d
Examining Part D Beneficiaries’ Medication Use in the Doughnut Hole
shawn X. sun, Phd; Kwan y. Lee, Phd; and meghana aruru, Phd
c o m P a r a t i v e e F F e c t i v e n e s s r e s e a r c h
Quantitative Analysis of 2 Treatment Options for
Osteoarthritis in Adults
elena Pavlova-mccalla, md; Frederick L. newman, Phd; and Gulcin Gumus, Phd
B e n e F i t d e s i G n
The Value-Based Model: Health Management Worth Exploring
Kent c. hunter, Pharmd
P ay e r P e r s P e c t i v e
Driving the Value of Health Interventions
cyndy nayer, ma
d r u G t r e n d s
Factors Affecting Pharmacy Trends in 2008
anna a. theodorou, rPh, mBa; and Julie slezak, ms
Together...the most
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in the market.
Issue 1, Vol. 1 • Spring 2009
Translating Evidence-Based Research into Value-Based Decisions
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APEUTICS
RTHE PHARMACY & THE
The popular song by Bruno Mars makes a good ice
breaker for music therapy sessions with chronic pain sufferers,
according to Joanne Loewy, DA, LCAT, MT-BC, adjunct
faculty at the Albert Einstein College of
Medicine, who presented yesterday’s
session on Music in the Treatment of
Chronic Pain Management.
“It acknowledges the need, when
you are in pain, to not do anything,”
Loewy said. She also said that the
upbeat reggae sound doesn’t hurt either.
Loewy is often referred to as the
“Pain Queen in Music Therapy” at the
Louis Armstrong Center for Music and
Medicine, Beth Israel Medical Center
in New York, where she practices.
But music therapy, contrary to some
misconceptions, does not merely involve
putting on a popular CD, said
Loewy, although that can be therapeutic,
especially when sitting in traffic.
In order to reap the therapeutic
benefits of music therapy, the therapist
first works as part of a multidisciplinary
team to devise a comprehensive
pain assessment that involves not
only a detailed patient pain history,
but also ongoing functional and psychosocial
assessments.
The functional assessment looks
at physical impairments, activities of
daily living, “up time” (ie, walking, lifting),
sleep, appetite and weight, and
other physical symptoms. The psychosocial
assessment looks at psychological
symptoms and disorders, the
patient’s mood, his or her coping ability,
personality, and cognition. The assessment
also considers the patient’s
role, such as his or her ability to work,
engage in hobbies, and do housekeeping
or parenting tasks. The social
portion of the assessment delves into
subjects such as family disturbances,
social support, and intimacy. Other
considerations include medication
use or abuse, family history of chronic
pain, the financial impacts of the patient’s
condition, cultural influences,
and spiritual beliefs.
These clinical interventions are
based on a growing body of evidence
that supports a long list of benefits
from music therapy. According to
Loewy, music therapy enhances respiratory
function, regulates heart rate
and blood pressure, improves homeostasis
in the nervous system, addresses
pain, builds resiliency, facilitates
social engagement, provides ego
support, and enhances the patient’s
overall quality of life. The evidence for
these benefits is growing, said Loewy,

30
news
friDAY
September 9, 2011
Music therapy, contrary to
some misconceptions, does
not merely involve putting
on a popular CD, said
Loewy, although that can be
therapeutic
who provided a slide that listed research articles on the effectiveness
of music therapy in pain management.
Loewy did more than just present data showing that music
therapy can be an effective part of a pain management
treatment, she shared video case studies in her presentation
that showed some of the live music therapy sessions she performs
with her clients. In one video, a patient with cancer,
who is terrified of needles, played the chimes, which is a
cultural instrument for her with positive associations to church
bells. While the patient played the chimes, a guitarist played
the Beatles’ “Blackbird” in the background, while the patient
flapped her arms up and down as part of the necessary chemotherapy
procedure. Later, the music shifted to a Brahms
lullaby, while the patient tried to relax during her infusion.
According to Loewy, there are pros and cons to this type
of live music therapy. First, it allows for a shift in musical composition
that fits the mood and preference of the patient. It
also allows for a change in tempo according the patient’s
heart rate and respiratory rate. Volume can be controlled, as
well as dynamic shifts in subject matter or mood. It enhances
a feeling of reciprocity that is otherwise unavailable; patients
will sometimes respond to a music therapist even when
they are unresponsive to other treatment team members. The
therapist also provides observations and clinical recommendations,
along with ongoing updates, to the medical team.
The cons involve the expense of hiring a program-certified
music therapist, and the fact that it is difficult to quantify the
individual’s results. But, Loewy believes that “the best evidence
is the patient,” based on her personal observations.
“Music is very important to our bodies. Music can turn off the
cycle of pain,” she said.
—By Sandra Kear
PREVIEW
It’s All in the Wrist
A Q&A with Hal S. Blatman, MD
Hal S. Blatman, MD, Medical Director at the Blatman
Pain Clinic, Cincinnati, OH, will present “Carpal Tunnel
Syndrome: New Understanding and New Treatment
Ideas” Friday at PAINWeek 2011. Blatman will review
new technologies and advances in our understanding of the
mechanisms of this condition, and discuss new approaches to
treatment that are less invasive than older techniques.
What causes carpal tunnel syndrome
There are a few theories that have been proposed over the
years. It has been generally assumed that if you use your
fingers and wrists in a repetitive matter, there develops an
inflammatory condition of the tendons that share space in
the carpal canal with the median nerve. As the inflammation
happens and the tendons swell, the nerve gets compressed
and you end up with symptoms of carpal tunnel syndrome.
It’s been shown that this needs to be seriously questioned because
when you biopsy the cover of those tendons and send
them to the lab at the time of surgery, the evidence is there
are no inflammatory cells and there is none of the supposed
or theorized inflammation. Yet, that’s still the explanation that
most people understand for the cause of carpal tunnel syndrome.
There’s a traumatic cause where people use their wrist as
a hammer and repeated trauma to the nerve causes injury.
There are tumors in the wrist that can cause it. It often happens
in pregnancy because the tissue of the forearm and
hand starts to swell, and that swelling will cause compression
of the nerve.
There are two other more recently proposed mechanisms for
cause that make much more sense to me. One is that, when it
comes to using your fingers and wrists for repetitive motion, in
order for your brain to know where your fingers are so they can
type quickly or whatever you’re doing, it requires a sustained
contraction of the biceps muscle in the arm. Although the biceps
muscle may physically end on the forearm just below the elbow,
the fascia that goes through that muscle continues on into the
forearm, which also tightens and continues into the wrist. What
ends up happening is the fascia, the ligament that goes across
the wrist, actually shrinks and the carpal canal tightens. The
canal itself shrinks because the fascia of the arm and forearm
tightens because of the physical activity and sustained posture
that the person is asking their body to do.
The tendons in the forearms that go into the fingers slide in
this canal as you open and close your hand. Not only are the
tendons supposed to glide through the canal, the nerve is supposed
to glide in the canal as you open and close your fingers.
The nerve endings, just like the tendons, go out to the end of the
fingers. If there are adhesions in any way between the nerve
and the transverse carpal ligament, then the nerve is stuck in
the canal and doesn’t move as well. Then when you open and
close your hand, the nerve gets tugged on and that tugging
on the nerve creates injury and the symptoms of carpal tunnel
syndrome.
What tests are used to diagnose carpal tunnel syndrome
With the onset of musculoskeletal ultrasound, we have new
tools to examine the carpal tunnel to help with the diagnosis in
ways we have not had available previously. Standard measure
of carpal tunnel syndrome is a mixture of physical examination,
and the most accurate physical examination finding is called
Phalen’s Test, in which you hold the wrist flexed. Its maximum
range of motion is typically somewhere around 80 or 90 degrees,
and in that position, the carpal canal is compressed.
If there is a compromise of the space that the median nerve
passes through, this will accentuate that compromise, which
brings on symptoms usually within 30 to 60 seconds. That test
has been a reliable physical exam finding and probably one of
the standard physical exam findings for many years.
Other gold standard tests are the EMG test and nerve
conduction tests, in which you put needles into the forearm
and into the hand or place electrodes on the forearm and
hand, then an electrical shock travels down toward the fingers
and you make an assessment as to the quality of the
transmission of nerve impulses after the nerve passes through
the carpal tunnel. Usually, if the nerve is compressed long
enough, that test is abnormal. Unfortunately, that test is not
100% accurate because there are people who have the
problem but who test normal, and there are also people
who have false negatives.
Then there are the patient symptoms, which weigh heavily.
Sometimes an orthopedic surgeon will operate on somebody
who has negative tests and negative exams and positive symptoms.
So there really is no absolutely accurate test that can determined
whether you should operate on this person.
More recently, with the advent and technology of musculoskeletal
ultrasound, we can actually visualize the diameter of
the nerve within the canal, and it is often evident in people that
have carpal tunnel syndrome that the nerve has an increased
diameter in the end of the forearm and decreased diameter as
the nerve is compressed through the carpal tunnel itself. That’s
a newer data point that not many people know about, but
people are becoming more aware of it.
What criteria need to be considered when choosing
the right treatment for patients with this condition
There are a lot of things that go into the decision: the jobs the
person has, how long they’ve had the problem, how severe the
problem is, what kind of funding is available to help with whatever
treatment decisions are made, and personal preference
and choice of the patient are all integrated into that decision.
What treatments are available
Other than stretches, there is a surgical correction in which an
incision is made in the skin and you cut through the transverse
carpal ligament, sew up the skin, and send the patient home in
a splint. As the ligament heals, it may grow back together or not.
But, as it grows back together, you may form scar tissue again. If
you go back to the same job that caused the condition in the first
place, the odds are you’ll get the condition again. A more recent
treatment that we’re going to talk about at PAINWeek involves
visualizing the nerve with ultrasound. You can put a needle in at
the crease of the wrist, direct it toward the fingertips, and, by injecting
fluid through the needle, you can dissect the nerve away
from the transverse carpal ligament, open up the space and allow
that nerve to guide freely and relieve the symptoms. In many
cases it offers relief overnight, and it’s long-lasting without any
knife. Then you can maintain that with the stretches. That’s a real
modern treatment that is just being taught to doctors who have
ultrasound and the technology in their office.
What advice do you give your patients who are at
risk for this condition because of their occupation
We teach our patients to do stretching exercises that will help reduce
the symptoms or even make them go away. We recommend
wrist splints at nighttime because while you’re sleeping, you bend
your wrists in the same position that you do during the Phalen’s Test.
You wake up with numb arms, numb forearms, and numb hands.
All you have to do to prevent that is keep the wrist from flopping
down into that position while you sleep. And that’s what the braces
at nighttime are for. I’m not convinced that braces in the daytime
are that helpful; many people will fight the brace because they still
want to do the same activity that they were doing before. So they
still try to use their hands. Although I’m not sure how helpful the
braces are universally, there are circumstances where the braces
are real helpful during the daytime. Certainly, they’re universally
helpful at night. For people who have a severe problem, we encourage
them to undergo the carpal tunnel release and avoid the
open surgery with incision. Also, although this is controversial, the
general feeling is if you give people Vitamin B6, especially in the
form of pyridoxal-5-phosphate once or twice a day, that provides
some extra nutrients to the nervous system and many people think
helps treat the condition.

The Cosmopolitan of Las Vegas
news 31
The Cosmopolitan of Las Vegas Restaurant Guide
Holsteins
An “exciting new burger concept” that was “tailor-made
for The Cosmopolitan of Las Vegas
with an emphasis on fresh, natural and organic
ingredients,” Holsteins serves custom-crafted
specialty burgers, house-made sausage, and
“riffs on traditional American snacks and appetizers,
as well as a wide variety of shakes
and sides.” Start things off with a high-octane
“bam-boozled shake” (one of which, the “Cereal
Bowl,” combines Cap’n Crunch and Fruity
Pebbles cereals with Absolut Vanilla) and a selection
from the “Snacks” menu (choices include
pizza “Twinkies,” fried green tomatoes, and truffle
lobster mac ’n cheese). The “Tiny Buns” menu
features a variety of sliders, sausages, and
other sandwiches; the “Big Buns” menu features
more of the same on a grander, more elaborate
scale. The dessert menu continues the
themes of whimsy and decadence. Because
nothing goes better with a burger than beer,
Holsteins also features an impressive selection
of canned, bottled, and draft beers.
Hours of Operation:
Open every day for lunch (11:00am-4:00pm)
and dinner (4:00pm-12:00am)
Late-night menu: Friday-Monday (12:00am-
2:00am
Scarpetta
Described as a modern Italian restaurant with
an earthy-yet-sophisticated approach to the
cuisine, Scarpetta features “a satisfying and
soulful menu of seasonally-inspired Italian fare.”
First-course offerings include braised short ribs,
creamy polenta with mushrooms, and other
delicious fare. Pasta course selections include
duck & foie gras ravioli, black farfalle with lobster,
and raviolini made with sheep’s milk ricotta.
For the main course (piatti), diners at Scarpetta
can choose from a variety of northern Italianinspired
dishes, including several fish entrees,
pancetta-wrapped veal loin, and roasted capretto.
Don’t skip the cheese course here, and
definitely do not skip dessert. Relax after dinner
with a glass of port, grappa, single malt, or
other digestif.
Hours of Operation:
Open 7 days a week: 5:30pm-11:00pm
STK
This is not your stuffy, run-of-the-mill steakhouse;
STK prides itself on being “a celebrity hotspot
that breaks with tradition, offering a flirty, feminine
take on the classic American steakhouse.”
What does this mean For starters, it means
that this steakhouse has a DJ. It also means that
in addition to classic steakhouse fare such as
creamed spinach and iceberg wedge salad,
you’ll also find shrimp rice krispies and foie
gras French toast. But really, you go to a place
like this for the steak. The menu at STK helpfully
lists the steak offerings according to size (small,
medium, and large), and also features several
non-beef selections, including lamb chops,
duck breast, and dover sole. Assorted toppings,
sides, and sauces are also available.
Hours of Operation:
Sunday-Thursday: 6:00pm-11:00pm
Friday-Saturday: 5:00pm-12:00am
The STK lounge is open Sunday-Thursday
5:30pm-1:00am, Friday-Saturday 5:30pm-
2:00am
The Henry
Come to The Henry for revamped, reinterpreted
versions of classic Las Vegas dishes. Start your
day (or end your night) with a hearty breakfast
of steak&eggs, huevos rancheros, or The
Henry’s signature short rib Benedict. If you’re
still hungry when lunchtime rolls around, you
will find a variety of soups, salads, burgers, and
sandwiches. The dinner menu is loaded with
heartier fare, including pot pie, pot roast, prime
rib, and other grilled and roasted entrees. The
late-night menu offers burgers, sandwiches,
breakfast items, and assorted appetizers. Desserts
here are big and bold (including oversized
banana splits, enormous slices of banana
cream pie, and something called a “Hershey
Hand Grenade”), as are the specialty cocktails
(cf. a “Midtown Manhattan,” made with
bacon-infused Makers Mark, cinnamon-andfig-infused
sweet vermouth, angostura, and
chocolate bitters).
Hours of Operation:
Breakfast — Monday-Friday: 6:00am-11:00am
Lunch — Monday-Friday: 11:00am-4:00pm
Brunch — Saturday-Sunday: 6:00am-4:00pm
Dinner — Sunday-Saturday: 4:00pm-11:00pm
Late Night — Sunday-Saturday: 11:00am-
6:00am
NEWS
American Pain Foundation Launches “If I Lived in a World with
Less Pain, I Could…” Social Media Campaign in Observance of
Pain Awareness Month
Advocacy organization leads the Institute of Medicine’s charge for relieving pain in America
The American Pain Foundation (APF) is leading the
charge made by the Institute of Medicine (IOM) calling
for a cultural transformation on how pain is prevented,
assessed, treated and understood. Today, APF, the
nation’s largest advocacy group for people with pain, announced
the launch of the “If I Lived in a World with Less
Pain, I Could…” campaign.
This social media campaign will highlight the scope of
the problem with pain and the need for effective and timely
pain care for all. APF encourages everyone who is affected
by pain to virtually attend the online event and submit a
video, photo or written response to what they could do if
they lived in a world with less pain on APF’s Facebook event
page (http://hcp.lv/rauq25).
“Pain is a horrible state of existence that we have a moral
obligation to address,” said Will Rowe, chief executive officer
of APF. “‘If I Lived in a World with Less Pain, I Could…’ is just
one way APF stands committed to embracing the IOM’s blueprint
for action in relieving pain in America and taking an active
role in ensuring that a cultural transformation on pain becomes
a reality. The campaign not only unites people affected
by pain, but provides a platform for our voices to be heard.”
APF will share selected campaign submissions with President
Barack Obama to help secure a first-ever presidential
proclamation recognizing each September as National Pain
Awareness Month.
To learn more about the “If I Lived in a World with Less
Pain, I Could…” campaign, visit www.painfoundation.org.
About Pain in America
According to the IOM’s report, Relieving Pain in America: A
Blueprint for Transforming Prevention, Care, Education and Research:
• Acute and chronic pain affects large numbers of Americans
with at least 116 million, or one-third, of U.S. adults
burdened by chronic pain alone.
• More adults in the US are affected by pain than heart
disease, diabetes and cancer combined
•Pain is one of the most frequent reasons for visiting a
health care provider.
•Pain affects physical and mental functioning, quality of
life and productivity.
•The economic cost of chronic pain in adults, including
health care expenses and lost productivity, is estimated
to be $635 billion annually. This amount equals approximately
$2,000 for everyone living in the United States.
About the American Pain Foundation
Founded in 1997, the American Pain Foundation (APF) is an
independent nonprofit 501(c)3 organization that serves
people affected by pain. APF speaks out for people living
with pain, caregivers, health care providers and allied
organizations, working together to dismantle the barriers
that impede access to quality pain care for all. The mission
of APF is to educate, support and advocate for people affected
by pain. For more information, visit www.painfoundation.org.

Announcing the
Launch of
PainLive.com
PainLive.com is the website for the pain specialist with
the goal of providing pain professionals with the resources
and information they need to provide the best patient care.
It’s your connection to articles, live conference coverage,
resources, and video interviews with key opinion leaders.
www.PainLive.com
Site Features Include:
· Social media options available on each page
· Fresh content added daily
· FDA news updates, clinical trials, twitter, interactive
polls all available in one easy location.
From the publisher of Pain Management.