Find even more news coverage online @ www.eMPR.com/PAINWeek
THURSDAY
September 10
5 news
KEYNOTE ADDRESS
Top 10 Reasons to Stay in the
Pain Management Game
“P
ain medications are neither
panacea nor pariah, and experienced prescribers understand the need for a nuanced approach
to pain management,” Michael R. Clark,
MD, MPH, MBA, of Johns Hopkins
University School of Medicine and the
American Society of Pain Educators,
said at the keynote session.
He identified several key elements
necessary for the development of a
successful individualized, patientfocused pain management practice:
•Skill in risk assessment, monitoring,
and documentation
•An understanding of psychosocial
factors that contribute to pain
•Familiarity with alternate and adjuvant modalities of treating pain
•Sensitivity to age- and gender-related differences in pain conditions
•The ability to motivate patients to
be invested in the success of their
treatment
“No one said this is easy. Given the
time and resource constraints of our
medical practices, it clearly is a challenge. And the complexity of the task
is only compounded by a changing
legal/regulatory environment in which
states are starting to take matters into
their own hands, crafting their own
responses to the epidemic of opioid and
heroin addiction,” explained Dr. Clark.
Dr. Clark then passed the baton to
Charles Argoff, MD, CPE, professor of neurology and director of the
Comprehensive Pain Center at Albany
Medical College, who outlined his “Top
10 Reasons to Stay in the Pain Game,”
or “Why The Deli Will Have to Wait.”
1. The current state of pain management. Pain is the number one rea-
son people in the United States seek
healthcare, and more than 100 million
adults are affected by pain, according to a recent Institute of Medicine
(IOM) report. A national pain strategy released in April 2015 proposed
a new plan to improve the treatment
of chronic pain both now and in the
future. The strategy includes objectives and plans in key areas of pain
and pain care including professional
education and training, public education, communication, service delivery,
reimbursement for care, preventive
care, and attention to disparities in
population research.
“We’ve truly only just begun in this
young but growing field to really
address pain management in a systemic and coordinated fashion,” Dr.
Continues on page 4
AWARD WINNERS
PAINWeek and the American
Society of Pain Educators are
proud to honor those who have
demonstrated a
commitment
to clinical
pain practice
and pain
education.
➤ PAINWeek Practitioner of the Year
Kelvin B. Burton, MD
➤ Pain & Palliative Care Practitioner
of the Year
Tanya J. Uritsky, PharmD, BCPS
➤ Welcoming a New Year of
Advances in Pain Management
Attendees to PAINWeek ’15 take a break from viewing the scientific poster
presentation to mingle with their colleagues at the welcome reception.
Guidelines Important for Prescribing
Medications for Workers’ Compensation Patients
A
s many as 10% to 20% of patients
who enter the worker’s compensation system due to physical trauma go on to develop chronic
pain due to either progression of the
injury or the initial injury being severe
in nature.
Patients who require long-term
treatment may have started on typical
medications, such as anti-inflammatory drugs and muscle relaxants, but
in the long run these patients often
have higher use of antidepressants,
anticonvulsants, and long-acting opioids, according to Matthew P. Foster,
PharmD, a senior clinical pharmacy
manager with Helios.
“The top medication classes in workers’ compensation are drastically different than group health,” Dr. Foster
noted. For worker’s compensation
cases, opioids, anticonvulsants, nonsteroidal anti-inflammatory drugs
(NSAIDs), antidepressants, and muscle
relaxants top the list of medications
that are prescribed, whereas group
health medications are more likely to
include lipid regulators, antidepressants, beta-blockers, and antidiabetics.1
Currently, opioids are responsible for
30.9% of the total medication spend
in workers’ compensation. Overall,
the top 10 therapeutic classes account
for nearly 86% of the total spend,
Dr. Foster noted.2 These prescribing
trends can be influenced at least in
part with the use of legal changes and
treatment guidelines, he said.
One example of how prescriber
behavior was influenced occurred
when hydrocodone changed from a
Continues on page 3
➤ ASPE Pain Educator of the Year
Paul Gileno
Founder, US Pain Foundation
Brought to you by Haymarket Media, Inc., publishers of MPR and The Clinical Advisor
PAINWEEK news
Thursday, September 10
Workers’ Compensation
Continued from page 1
schedule III to a schedule II controlled
substance.
“ [ Wo r k m e n ’s c o m p e n s a t i o n
patients] did see a drop in the number of prescriptions, but there was an
increase in other medications, like
oxycodone/APAP. Most disturbing
The following is a brief summary only; see full Prescribing
Information for complete product information.
INDICATIONS AND USAGE
Opioid-Induced Constipation in Adult Patients with Chronic
Non-Cancer Pain
RELISTOR is indicated for the treatment of opioid-induced
constipation in adult patients with chronic non-cancer pain.
Opioid-Induced Constipation in Adult Patients with
Advanced Illness
RELISTOR is indicated for the treatment of opioid-induced constipation
in adult patients with advanced illness who are receiving palliative
care, when response to laxative therapy has not been sufficient.
Limitation of use: Use of RELISTOR beyond four months has not
been studied in the advanced illness population.
CONTRAINDICATIONS
RELISTOR is contraindicated in patients with known or suspected
gastrointestinal obstruction and patients at risk of recurrent
obstruction, due to the potential for gastrointestinal perforation.
WARNINGS AND PRECAUTIONS
Gastrointestinal Perforation
Cases of gastrointestinal perforation have been reported in adult
patients with opioid-induced constipation and advanced illness with
conditions that may be associated with localized or diffuse reduction of
structural integrity in the wall of the gastrointestinal tract (e.g., peptic
ulcer disease, Ogilvie’s syndrome, diverticular disease, infiltrative
gastrointestinal tract malignancies or peritoneal metastases). Take into
account the overall risk-benefit profile when using RELISTOR in patients
with these conditions or other conditions which might result in impaired
integrity of the gastrointestinal tract wall (e.g., Crohn’s disease). Monitor
for the development of severe, persistent, or worsening abdominal pain;
discontinue RELISTOR in patients who develop this symptom.
Severe or Persistent Diarrhea
If severe or persistent diarrhea occurs during treatment, advise patients to
discontinue therapy with RELISTOR and consult their healthcare provider.
Opioid Withdrawal
Symptoms consistent with opioid withdrawal, including hyperhidrosis,
chills, diarrhea, abdominal pain, anxiety, and yawning have occurred
in patients treated with RELISTOR. Patients having disruptions to the
blood-brain barrier may be at increased risk for opioid withdrawal
and/or reduced analgesia. Take into account the overall risk-benefit
profile when using RELISTOR in such patients. Monitor for adequacy of
analgesia and symptoms of opioid withdrawal in such patients.
ADVERSE REACTIONS
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.
Opioid-Induced Constipation in Adult Patients with Chronic
Non-Cancer Pain
The safety of RELISTOR was evaluated in a double-blind,
placebo-controlled trial in adult patients with opioid-induced
constipation and chronic non-cancer pain receiving opioid analgesia.
This study (Study 1) included a 4-week, double-blind, placebo
controlled period in which adult patients were randomized to receive
RELISTOR 12 mg once daily (150 patients) or placebo (162 patients).
After 4 weeks of double-blind treatment, patients began an 8-week
open-label treatment period during which RELISTOR 12 mg was
administered less frequently than the recommended dosage
regimen of 12 mg once daily.
Adverse reactions in adult patients with opioid-induced constipation
and chronic non-cancer pain receiving RELISTOR are shown in the
following table. The adverse reactions in the table below may reflect
symptoms of opioid withdrawal.
Adverse Reactions* in 4-Week Double-Blind, PlaceboControlled Period of Clinical Study of RELISTOR in Adult
Patients with Opioid-Induced Constipation and Chronic
Non-Cancer Pain
RELISTOR
Placebo
12 mg once daily
n = 162
n = 150
Abdominal Pain
21%
6%
Nausea
9%
6%
Diarrhea
6%
4%
Hyperhidrosis
6%
1%
Hot Flush
3%
2%
Tremor
1%
< 1%
Chills
1%
0%
* Adverse reactions occurring in ≥ 1 % of patients receiving RELISTOR
12 mg once daily and at an incidence greater than placebo.
During the 4-week double-blind period, in patients with
opioid-induced constipation and chronic non-cancer pain that
received RELISTOR 12 mg every other day, there was a higher
incidence of adverse reactions, including nausea (12%), diarrhea
(12%), vomiting (7%), tremor (3%), feeling of body temperature
Adverse
Reaction
029757_salrep_v2_ad_painwk_fa2.indd 2
was that the quantity per prescription
of hydrocodone products went up by
15% to 20%,” Dr. Foster said.
He noted that this most likely had
to do with the physicians not being
able to see their patients consistently
every 4 weeks, and instead writing
prescriptions for longer periods of
time to hold patients over until their
change (3%), piloerection (3%), and chills (2%) as compared to
daily RELISTOR dosing. Use of RELISTOR 12 mg every other day
is not recommended in patients with OIC and chronic non-cancer
pain. The rates of discontinuation due to adverse reactions during
the double-blind period (Study 1) were higher in the RELISTOR
once daily (7%) than the placebo group (3%). Abdominal pain was
the most common adverse reaction resulting in discontinuation
from the double-blind period in the RELISTOR once daily group (2%).
The safety of RELISTOR was also evaluated in a 48-week,
open-label, uncontrolled trial in 1034 adult patients with
opioid-induced constipation and chronic non-cancer pain (Study 2).
Patients were allowed to administer RELISTOR 12 mg less
frequently than the recommended dosage regimen of 12 mg
once daily, and took a median of 6 doses per week. A total of
624 patients (60%) completed at least 24 weeks of treatment and
477 (46%) completed the 48-week study. The adverse reactions
seen in this study were similar to those observed during the
4-week double-blind period of Study 1. Additionally, in Study 2,
investigators reported 4 myocardial infarctions (1 fatal), 1 stroke
(fatal), 1 fatal cardiac arrest and 1 sudden death. It is not possible
to establish a relationship between these events and RELISTOR.
Opioid-Induced Constipation in Adult Patients with Advanced Illness
The safety of RELISTOR was evaluated in two, double-blind,
placebo-controlled trials in adult patients with opioid-induced
constipation and advanced illness receiving palliative care: Study
3 included a single dose, double blind, placebo-controlled period,
whereas Study 4 included a 14-day multiple dose, double-blind,
placebo-controlled period.
The most common (≥5%) adverse reactions in adult patients
with opioid-induced constipation and advanced illness receiving
RELISTOR are shown in the following table.
Adverse Reactions from all Doses in Double-Blind, PlaceboControlled Clinical Studies of RELISTOR in Adult Patients
with Opioid-Induced Constipation and Advanced Illness*
Adverse
RELISTOR
Placebo
Reaction
n = 165
n = 123
Abdominal Pain
29%
10%
Flatulence
13%
6%
Nausea
12%
5%
Dizziness
7%
2%
Diarrhea
6%
2%
* Adverse reactions occurring in ≥ 5 % of patients receiving all
doses of RELISTOR (0.075, 0.15, and 0.30 mg/kg/dose) and at
an incidence greater than placebo.
The rates of discontinuation due to adverse events during the
double-blind placebo controlled clinical trials (Study 3 and Study 4)
were comparable between RELISTOR (1%) and placebo (2%).
Postmarketing Experience
The following adverse reactions have been identified during
post-approval use of RELISTOR. Because they are 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.
Gastrointestinal
Perforation, cramping, vomiting
General Disorders and Administrative Site Disorders
Diaphoresis, flushing, malaise, pain. Cases of opioid withdrawal
have been reported.
DRUG INTERACTIONS
Other Opioid Antagonists
Avoid concomitant use of RELISTOR with other opioid antagonists
because of the potential for additive effects of opioid receptor
antagonism and increased risk of opioid withdrawal.
Drugs Metabolized by Cytochrome P450 Isozymes
In healthy subjects, a subcutaneous dose of 0.30 mg/kg
of methylnaltrexone did not significantly affect the metabolism
of dextromethorphan, a CYP2D6 substrate.
USE IN SPECIFIC POPULATIONS
Pregnancy
Pregnancy Category C
There are no adequate and well-controlled studies with RELISTOR
in pregnant women. The use of RELISTOR during pregnancy may
precipitate opioid withdrawal in a fetus due to the immature fetal
blood brain barrier. In animal reproduction studies, no effects on
embryo-fetal development were observed with the administration
of intravenous methylnaltrexone during organogenesis in rats and
rabbits at doses up to 20 times and 26 times, respectively, the
maximum recommended human dose (MRHD) of 0.2 mg/kg/day.
RELISTOR should be used during pregnancy only if the potential
benefit justifies the potential risk to the fetus.
Nursing Mothers
It is not known whether RELISTOR is present in human milk.
However, methylnaltrexone bromide is present in rat milk. Because
of the potential for serious adverse reactions, including opioid
withdrawal, in nursing infants, a decision should be made to
discontinue nursing or discontinue the drug, taking into account
the importance of the drug to the mother.
Pediatric Use
Safety and effectiveness of RELISTOR have not been established
in pediatric patients.
In juvenile rats administered intravenous methylnaltrexone
bromide for 13 weeks, adverse clinical signs such as convulsions,
next visit. “This is one of the more
troubling trends we’re monitoring […]
that there are more of these products
being used based on the presumption
that there will be a longer period of
time in between refills.”
The purpose of treatment guidelines
is to establish evidence-based information that provides clarity for clinicians
tremors and labored breathing were observed, and the juvenile
rats were found to be more sensitive to the adverse effects of
methylnaltrexone bromide when compared to adult animals.
Juvenile dogs administered intravenous methylnaltrexone bromide
for 13 weeks had a toxicity profile similar to adult dogs.
Geriatric Use
In the double-blind studies, a total of 118 (14%) patients aged
65-74 years (79 methylnaltrexone bromide, 39 placebo) and a total
of 108 (13%) patients aged 75 years or older (64 methylnaltrexone
bromide, 44 placebo) were enrolled. No overall differences in safety
or effectiveness were observed between these patients and younger
patients, and other reported clinical experience has not identified
differences in responses between the elderly and younger patients,
but greater sensitivity of some older individuals cannot be ruled out.
Based on pharmacokinetic data, and safety and efficacy data
from controlled clinical trials, no dose adjustment based on age
is recommended.
Renal Impairment
No dose adjustment is required in patients with mild or moderate
renal impairment. Dose reduction by one-half is recommended in
patients with severe renal impairment (creatinine clearance less
than 30 mL/min as estimated by Cockcroft-Gault).
Hepatic Impairment
No dose adjustment is required for patients with mild or moderate
hepatic impairment.
OVERDOSAGE
A study of healthy volunteers noted orthostatic hypotension
associated with a dose of 0.64 mg/kg administered as an
intravenous bolus. Monitor for signs or symptoms of orthostatic
hypotension and initiate treatment as appropriate.
If a patient on opioid therapy receives an overdose of RELISTOR,
the patient should be monitored closely for potential evidence
of opioid withdrawal symptoms such as chills, rhinorrhea,
diaphoresis or reversal of central analgesic effect. Base treatment
on the degree of opioid withdrawal symptoms, including changes
in blood pressure and heart rate, and on the need for analgesia.
PATIENT COUNSELING INFORMATION
Advise patients to read the FDA-approved patient labeling
(Medication Guide and Instructions for Use).
Administration
Advise all patients to:
• Inject RELISTOR subcutaneously in the upper arm, abdomen
or thigh. Do not inject at the same spot each time (rotate
injection sites).
• Safely dispose of needles by following the sharps disposal
recommendations described in the RELISTOR Instructions for Use.
• Be within close proximity to toilet facilities once RELISTOR
is administered.
• Discontinue RELISTOR if treatment with the opioid pain
medication is also discontinued.
Advise chronic non-cancer pain patients receiving RELISTOR for
opioid-induced constipation to:
• Discontinue all maintenance laxative therapy prior to initiation
of RELISTOR. Laxative(s) can be used as needed if there is a
suboptimal response to RELISTOR after three days.
• Inject one dose every day.
• Inform their healthcare provider if their opioid regimen is
changed, to avoid adverse reactions, such as diarrhea.
Advise patients with advanced illness receiving RELISTOR for
opioid-induced constipation to:
• Inject one dose every other day, as needed, but no more
frequently than one dose in a 24-hour period.
Gastrointestinal Perforation
Advise patients to discontinue RELISTOR and to promptly seek
medical attention if they develop unusually severe, persistent, or
worsening abdominal pain.
Severe or Persistent Diarrhea
Advise patients to discontinue RELISTOR if they experience severe or
persistent diarrhea.
Opioid Withdrawal
Advise patients that symptoms consistent with opioid withdrawal
may occur while taking RELISTOR, including sweating, chills,
diarrhea, abdominal pain, anxiety, and yawning.
Pregnancy
Advise females of reproductive potential, who become pregnant or
are planning to become pregnant that the use of RELISTOR during
pregnancy may precipitate opioid withdrawal in a fetus due to the
undeveloped blood brain barrier.
Nursing
Advise females who are nursing against breastfeeding during
treatment with RELISTOR due to the potential for opioid withdrawal
in nursing infants.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch
or call 1-800-FDA-1088.
To report adverse events, a product complaint, or for additional
information, call: 1-800-508-0024.
Manufactured for:
Under License from:
Salix Pharmaceuticals, Inc.
Raleigh, NC 27615
Progenics Pharmaceuticals, Inc.
Tarrytown, NY 10591
REL-RALAB56-102014
8/11/15 9:27 AM
3
and patients, and to assist patients with
functional improvement, returning to
work, and keeping them informed, Dr.
Foster explained.
Currently, 3 main guidelines govern Workman’s Compensation:
Official Disability Guidelines (ODG),
American College of Occupational and
Environmental Medicine Guidelines
(ACOEM), and individual state
guidelines.
Dr. Foster explained that the ODG
guidelines detail specific work flows
for clinicians, including detailing what
pain complaint the patient has, the
initial therapy prescribed, and other
aspects of the individual patient.
Some states have adopted legislation
that adopt one or a hybrid of these
guidelines, Dr. Foster said, adding
that “more and more states are picking
up this process of having their own
guidelines.”
At the state level, Dr. Foster noted
that the use of treatment guidelines
for pain management has been shown
to be very effective, with Texas showing a 76% decrease in nonformulary
medication use, which includes a 65%
decrease in opioid prescriptions.3
Discussing recently adopted ACOEM
changes, Dr. Foster explained those
specifically pertaining to morphine
equivalency dosing (MED). After a
review of several studies last year, the
ACOEM recommended that “in most
cases MED should be limited to 50
mg, particularly in the acute setting,
although subacute and chronic pain
patients may require higher doses.”
Dr. Foster said the effect of this
change is mainly on chronically
injured workers. “This targets claimants for an earlier intervention to
address ongoing pain management
before doses continue to escalate.”
However, even with treatment
guidelines, there is still room for
improvement. Dr. Foster noted that
even though most treatment guidelines recommend urine drug testing
at least once a year, compliance is still
only approximately 30% to 40%.
Disclosure: Dr. Foster reports he serves
on the Workers’ Compensation Advisory
Board for Iroko Pharmaceuticals.
REFERENCE
1. IMS Institute for Healthcare Informatics. National Prescription Audit. https://www.imshealth.com/ims/Global/
Content/Insights/IMS%20Institute%20for%20Healthcare%20Informatics/IHII_Medicines_in_U.S_Report_2011.
pdf. December 2010. Accessed September 9, 2015
2. Helios. 2015 Workers’ Compensation Drug Trend
Report. http://www.helioscomp.com/insights/2015drug-trends-report. Accessed September 9, 2015.
3. Texas Department of Insurance. Worker’s Compensation
Research and Evaluation Group. https://www.tdi.state.
tx.us/wc/regulation/roc/. Accessed September 9, 2015.
4
PAINWEEK news
Thursday, September 10
Top 10 Reasons
Continued from page 1
Argoff said. “There are new scientific
discoveries reported nearly daily and
new treatments—both medical and
nonmedical—that are newly available
or currently in development. Now is
not the time to leave the field.”
2. The public’s perception of pain.
Despite the huge number of patients
with chronic pain in need of care, there
is still a lifetime of work to be done
to educate the public and especially
the media, healthcare providers, and
payors that chronic pain is real and
needs to be taken seriously.
“The media has had a tragic field
day, focusing nearly solely on negative
aspects of pain management without
reporting sufficiently on the very positive and exciting progress being made
in our field,” Dr. Argoff said. “Pain is
often ignored or misconstrued, and
steps must be taken to educate and
engage the public.”
3. Not enough qualified pain
management providers. Addressing
the gap in the United States between
the number of patients who are in
pain and who are in need of evaluation and treatment, the number of
pain specialists, and the number of
primary care providers (PCPs) who are
also involved in the care of persons in
pain is a top priority. The IOM report
estimates that 100 million adults in
the United States experience chronic
pain, yet there are only approximately
4000 pain specialists. At the same time,
there are more than 400,000 PCPs,
including internists, family practice
Michael Clark, MD, welcomes the audience to PAINWeek ‘15 during the keynote address.
regarding regulatory oversight.
Also of interest, many survey respondents reported that they did not feel
comfortable in their ability to manage musculoskeletal and neuropathic
pain, but at the same time were also
not likely to favor mandatory pain
management education.
“Our system needs to be designed so
that the need of patients with chronic
pain are matched to and addressed
by the appropriate practitioner,” Dr.
Argoff said. “We would not expect a
single provider to be able to provide
every type of cardiac care to a person
with a cardiovascular disorder. Why
would we expect anything different
from pain management providers?”
4. Optimal pain management
requires a multidisciplinary effort.
People in pain benefit most when
their pain is assessed and addressed in
an integrated fashion. This approach
must be embraced by those creating
undergraduate and graduate-level
“We’ve truly only just begun in this young but
growing field to address pain management in
a systemic and coordinated fashion”
providers, pediatricians, obstetricians/
gynecologists, and geriatricians.
Data from a recent survey involving
3000 primary care providers, pain specialists, chiropractors, and acupuncturists indicated that 52% of patients with
chronic pain are primarily treated by
a PCP, 2% by a pain specialist, 40%
by chiropractor, and 7% by an acupuncturist. Other survey findings indicated that certain medical therapies for
pain reduction—such as long-acting
opioids, anticonvulsives, and antidepressants—are prescribed much more
frequently by pain specialists compared
with PCPs, and that both PCPs and
pain specialists reported prescribing
opioids less often now due to concerns
healthcare provider education, those
paying for health care, those reporting
about health care, and those receiving
care. “Chronic pain does not exist in a
vacuum, and the broader medical community needs to become engaged,”
Dr. Argoff said.
5. Lifelong pain management
education. Fewer than 50% of 170
accredited US medical or osteopathic
schools currently require students to
complete a pain management course
as part of undergraduate medical
training. Dr. Argoff asked, “How can
we possibly be prepared to optimally
evaluate our patients who are experiencing chronic pain, unless we receive
such training?”
Pain management training needs to
be mandatory and uniform at multiple
levels and across all types of healthcare
providers, he argued. Although progress is being made, it is not happening
quickly enough.
“One consequence of this is the
demonization of the person in pain.
With so many healthcare providers ill prepared to appropriately and
comprehensively assess and treat peoples’ chronic pain, the person in pain
becomes the problem,” Dr. Argoff said.
6. Where will you be treated,
if you need pain management?
As non-pain management providers
increasingly refuse to treat pain, and
as pain specialists limit their treatment modalities due to regulatory
concerns, too many patients with pain
will be lost without anyone to care for
them. Dr. Argoff continued, “I often
ask myself what would I do if I couldn’t
find someone to treat my pain?”
7. Changes to patient satisfaction
measures. The Center for Medicare
& Medicaid Services (CMS) is now
using new measures of patient satisfaction that may significantly affect pain
management. Historically there have
been many approaches to measuring patient satisfaction. Now patients
are asked to rate their satisfaction on
a scale from 1 to 10. The number
reported by CMS is the percentage
of respondents who answer 9 or 10,
which must be 80% or above for an
institution or a provider to pass.
“Patients don’t know this when
they’re given these surveys, and
providers are not allowed to coach
patients about this scoring system or
provide them with a practice questionnaire. This scheme may have profound
implications because reimbursement
is tied to these scores,” Dr. Argoff said.
8. The need to teach evidencebased medicine (EBM) as it was
defined. In 1996, David Sackett, the
father of EBM, and his international
colleagues wrote an editorial outlining
what EBM is:
“It’s about integrating individual
clinical expertise and the best external evidence. The conscientious, judicious, and explicit use of current best
evidence in making decisions about the
care of individual patients. The practice
of EBM means integrating individual
clinical expertise with the best available
evidence from systemic research. By
individual clinical expertise, we mean the
proficiency and judgment of individual
clinicians as they acquire such through
clinical experience and practice.”
Dr. Argoff argued that this is not
the way EBM guidelines are currently derived, stating that many clinical
guidelines do not include clinical experiences in any way, but are generated
solely from literature review.
“Such reviews and therefore the
guidance provided leave out most of
the patients for whom we care. The
patients we treat often have comorbidities that would exclude them from
inclusion in many studies and disqualify them from many of the particular
studies that so-called evidence-based
guidelines are based on,” he said.
9. The need to address inherent
conflicts of interest. Ensuring that
the virtues of corporations are on a
level playing field with what is best
for the patient is of utmost importance. “We’ve received notice from
the largest US healthcare insurers that
use of Botox for chronic migraine is
considered experimental, even though
it’s been approved for this use since
October of 2010,” said Dr. Argoff.
Under current insurance guidelines,
patients with chronic migraine need to
demonstrate treatment failure on as
many as 3 oral treatments for 60 days
each before the patient is considered an
appropriate candidate for Botox, even
though none of these oral treatments
are approved by the US Food and Drug
Administration for chronic migraine.
Many of the largest health insurers
are publicly traded companies that are
responsible to corporate stakeholders.“It
is time for us to look at the elephant
in the room and take a stand against
corporations delegating how we should
treat our patients,” Dr. Argoff said.
10. Remember why you became
a healthcare provider. “I hope you
all continue to be great healthcare
providers,” Dr. Argoff concluded. “We
are all here to listen to and learn from
our colleagues, and to speak and interact with each other, all in the name
of improving the care of the people
with chronic pain who depend on us.”
PAINWEEK news
Thursday, September 10
PREVIEWS IN BRIEF
Friday’s PAINWeek sessions not to be missed.
Comprehensive Migraine Education Program
THE EXPLOSION IN NEW TREATMENT OPTIONS, different modalities for
delivering headache medication (including patches, inhalers, and nasal sprays),
and possible ways to prevent the onset of headache represent unique opportunities for clinicians to treat patients with headache. Discussing these options
with patients also opens the door for communicating about how their current
treatments are working and what may be on the horizon for them in the future,
as there are newer molecular entities in development that offer various advantages to existing treatments. In a two-part presentation, Dr. Richard Lipton
and a panel of experts will provide an overview of the exciting progress that
has taken place in the headache field during the past 10 years, with extensive
discussions focusing on new ways to deliver older medications and research
into monoclonal antibodies as a way to prevent headache onset. The session
will include both lectures and cases, with ample time for questions and audience participation.
Management of Pain and Maintaining Function
in Older Adults
THE PREVALENCE OF MANY PAIN TYPES increases with age, and pain is often
more widespread and disabling among older adults. In light of the aging of
society, healthcare practitioners are increasingly tasked with managing pain in
their older patients. It is imperative that clinicians are aware of the prevalence
of pain in older patients and how pain responses may change as patients age.
In addition, data suggest that chronic pain may be associated with accelerated
aging, including potential effects on biological and psychosocial processes.
Pain processing also appears to change with age, in that older adults shift
toward a more pain-promoting rather than a pain-reducing balance in their
pain modulation systems. This may help explain the increased prevalence of
pain as we age. Dr. Roger Fillingim will discuss the multiple biological and
psychosocial processes that contribute to age-related changes in the experience
of pain. The audience will hear discussions on the importance of careful pain
assessment, which can provide information related to the mechanisms driving
their pain, helping to guide more effective pain treatment.
5
THURSDAY SCHEDULE OF EVENTS
7:00 am–7:55 am
● Pain-Free Insights of Public Equity Investing*
● Current Evidence-Based Guidelines for the Use of Ultrasound in Pain
● Understanding DEA Requirements for Electronic Prescribing of Controlled
Substances
● Controversies in Pain Medicine: Fudin vs Gudin: The Gloves Come Off!
8:00 am–8:55 am
● Opioid-Induced Constipation: The Science, the Struggle, and an Orally
Administered Treatment Option*
● Prioritizing the Patient in the Opioid Debate: A Roundtable Discussion*
9:00 am–9:55 am
● Rx Abuse and Diversion: The Scope of the Problem in 2015
● Diagnosis and Treatment of Superimposed Chronic Lower Extremity Nerve
Entrapment in Patients with Metabolic Disease
● The Imperfect Solution
9:00 am–10:55 am
● Shaken—Not Stirred: Minor Traumatic Brain Injury and Concussion
10:00 am–10:20 am BREAK/EXHIBITS
10:20 am–11:10 am
● Scammers, Shammers, and Thieves
● Controversies in Pain Medicine: X = The Unknown: Widespread Pain
10:20 am–12:10 pm
● Focus on Changes in Billing/Coding Clinical Laboratory: Roll With the
Changes and Learn How to Keep Payors Out of Your Bank Account
● Talking (and Perhaps Listening to) Patients With Pain: A Primer
11:15 am–12:10 pm
● Morton’s Neuritis
● Regional Pain Syndromes: When Sex Hurts
● Facet Joint Pain: Advances in Diagnosis and Treatment
12:15 pm–1:30 pm
● Understanding Abuse-Deterrent Opioid Technologies*
● Opioid-Induced Constipation*
1:35 pm–2:30 pm
● Opioid Overdose Strategies: Are They Working?
● Risk Assessment: What It Is and How to Use It
● Hurts So Good: Examining the Crossroads of Pain and Pleasure
1:35 pm–3:30 pm
● Integrative Pain Management
2:35 pm–3:30 pm
● Adult Learning: Not for the Faint of Heart
● “Underneath the Radar” Lower Extremity Pain Generators—Diagnosis
and Treatment
● Suspicion: What Should I Do if I Think My Patient Is Diverting, Abusing, or Both?
3:35 pm–4:30 pm BREAK/EXHIBITS
Peripheral Neuropathies
NEW RESEARCH IS HELPING HEALTHCARE PROVIDERS better understand
the brain and nervous system and is leading to improved treatments and therapies for painful peripheral neuropathies. The options for treatment include
medications, noninvasive devices, injections, invasive devices, therapy, and/or
complementary or integrative treatments. Surgical interventions may even be
considered for some types of neuropathies. Dr. Natalie Strand will provide a
comprehensive overview on peripheral neuropathies, including a discussion of
the pathophysiology of peripheral neuropathy, and nervous system physiology.
Causes of peripheral neuropathy, clinical presentation, diagnosis, and diagnostic
testing will be reviewed. Dr. Strand will also explain how advances in treatment
strategies can enable clinicians to maximize the use of a multimodal approach
tailored to each patient to slow the progression of the condition, relieve pain,
and ultimately improve quality of life.
3:35 pm–4:30 pm
● Overview of Emerging Technologies: Opioids With Labeled AbuseDeterrent Properties and Claims (OADP)*
● Salix Pharmaceuticals Product Theatre*
4:35 pm–5:25 pm
● Addiction and Drug Histories: A Cop’s Eye View from the Street to the
Clinician’s Office
● Creating a Treatment Plan for Higher Risk Patients: A Case-Based Approach
● Regional Pain Syndromes: Simplifying the Gender Specific Complexities
of Female Chronic Pelvic Pain
7:00 pm–9:00 pm
● Scientific Poster Session and Reception*
*Not certified for credit
PAINWEEK news
6
Thursday, September 10
EXHIBIT HALL September 9-12, 2015 | Cosmopolitan | Las Vegas, NV
238 Medorizon
XenoPort
401
PainEDU
405
Purdue
Medical
Information Millennium
407
AstraZeneca
EN EpicGenetics
cal
T15
T13
102
Pernix
Therapeutics
mSPEC
432
428
Aegis Sciences Corp. TechNeal
Lab Corp-Medtox
Confirmatrix
Dominion
Diagnostics
Infinite
Therapeutics
323
327
331
333
Ethos Laboratories
438
440
442
444
ApolloLIMS
Acetaminophen
Awareness
Coalition
C-MED
Solutions
Genotox
Laboratories
Radeas
Labs LLC
Endo
HRMD
myoscience
Ameritox Pharmaceuticals
120
118
106
224
Quest Diagnostics
Collegium
226
Freedom
Parkway Clinical
Laboratories (PCL)
Gensco
Laboratories
125
124
Aeon
Clinical
Laboratories
Mylan
Inc.
343
345
347
230
232
Drug Testing
Program
Management
eLab
Solutions
Purdue OADP
129
128
130
Continuum American
Laboratory Screening
Solutions
Corp
338
Thermo
340
342
344
346
AllMeds
Specialty
Practice
Services
Thermo
Fisher
MedComp
Scientific Scientific Sciences
Noble RADARS
Pharmaco
Quantum PharmBlue
Aspen Alternative Technologies
Analytics
Medical Biomedical
Solutions
231
222
123
446
451
349 Mercedes Medical
T33 Metabolic Medical Institute
448
450
Proove
Biosciences
Hawaiian
Moon
MTL
GenTech PainBrain Mercedes Chemware
Medical
Solutions Scientific
339
337
HealthOS
225
117
111
449
436
Iroko
T10 Memorial Hermann
Expo
Enterprise RxProLogic
445
349
351
348
350
237
239
241
243
245
247
249
251
236
238
240
242
244
246
248
250
PCCA
MEDISCA
SI-BONE
133
137
Acadian
Diagnostic
Pain
Medicine
News
Benzer
Medorizon Laboratories SurgiLogix Pharmacy
Feel
Good,
Inc.
139
Innovative
Healthcare
Solutions
Schuyler
House
141
143
Healthcare
Chaplaincy RxAssurance
Network
Corp
Integrity
Health
ProCare
Counseling
145
147
AML
Diagnostics
149
Calloway
Labs
151
426 mSPEC
446 Mylan Inc.
AdvaLetco
Net
Medical
Xpress
GLOBO- Laboratories
SA
Alere
Toxicology
409 Millennium Health
343 MTL Solutions
BELMONT EXHIBIT HALL
Egalet
217
Salix
101
kaléo
426
336
Teva
Patrumin
Investors
Linden
Care
Depomed
INSYS
Therapeutics
T14
424
InSource
Diagnostics
439
BELMONT EXHIBIT HALL
211
T12
edical
cts
Logan
nc. Laboratories
6
317
Hamilton
Robotics
NeuroMetrix Orchard Software Sciex
425
429
433
422
Takeda
Pharmaceuticals
T5
fic
Genova
ogy Diagnostics,
ories
Inc.
Waters
Corp
423
222 Myoscience
T31 NADDI
T7
National Headache Foundation
T2
Nema Research
425 NeuroMetrix
342 Noble Medical
Purdue
429 Orchard Software
Medical
XenoPort
PainEDU Information Millennium
T5
Otto Trading,
Inc. 409
405 407
401
T11 Pacific Toxicology Laboratories
132
Gulfstream
Diagnostics
Autogenomics,
Inc.
415
347 PainBrain
GRACIA COMMONS EXHIBIT ANNEX (Level 3)
BELMONT COMMONS EXHIBIT ANNEX (Level 4)
405 PainEDU
Purdue
Pharma
AstraZeneca
T32
PainPathways Magazine
L.P.
125 Parkway Clinical Laboratories (PCL)
T13
Patrumin Investors
301
309
246 Pain Medicine News
T20
T21
U.S. Pain
Foundation
T27
T28
T26
T29
American Cardiometabolic
Society of Health Congress
Addiction
Medicine
Take
Courage
Coaching
T35
T22
T23
American
Academy of
Pain Medicine
Wolters
Kluwer
Health
Power
of Pain
Foundation
Practical
Pain
Management
T25
T24
T30
American
Headache
Society
T31
NADDI
T33
T2
NEMA
Research
National
Postgraduate Headache
Foundation
Medicine
T8
CME
Desk
Metabolic
Medical
PainPathways
Institute, Inc.
Magazine
T34
T1
Bull
Publishing
T7
T3
T4
AVACEN EpicGenetics
Medical
ASPE
Otto
Trading, Inc.
T6
T5
T11
T12
236 PCCA
T19
1
301
Otto
Trading, Inc.
419
REGISTRATION
E
415
Purdue
Pharma
L.P.
309
IBIT ANNEX (Level 4)
T4
CompuGroup
Medical
Autogenomics,
Inc.
409
T32
T9
AllSource
Screening
BV Trading
T18
T10
Memorial
Hermann
Advanced
Pathology
Solutions
T17
102 Pernix Therapeutics
241 Pharmaco Technologies
Pacific
Genova
Toxicology Diagnostics,
Laboratories
Inc.
Electromedical
Products
Logan
Intl, Inc. Laboratories
T16
T15
245 PharmBlue
T14
Patrumin
Investors
T13
T8
Postgraduate Medicine
211
INSYS
Therapeutics
101
448 Proove Biosciences, Inc.
442 Genotox Laboratories
407 Purdue Medical Information
244 Benzer Pharmacy
T12 Genova Diagnostics, Inc.
T1
123 Gensco Laboratories, LLC
129102
Purdue OADP 106
Pernix
HRMD
309Therapeutics
Purdue Pharma L.P.
T18 BV Trading
345 GenTech Scientific
243 Quantum Analytics
151 Calloway Labs
249 GLOBO-SA
120 Quest Diagnostics
T29 Cardio Metabolic Health Congress
132 Gulfstream Diagnostics
344 RADARS
351 Chemware
439 Hamilton Robotics
440 C-MED Solutions
450 Hawaiian Moon
118 Collegium
248 Healthcare Chaplaincy Network
419 CompuGroup Medical
231 HealthOS
327 Confirmatrix
106 HRMD
128 Continuum Laboratory Solutions
333 Infinite Therapeutics
217 Depomed
141 Innovative Healthcare Solutions
331 Dominion Diagnostics
445 InSource Diagnostics
230 Drug Testing Program Management
211 INSYS Therapeutics
T30 American Headache Society
225 Egalet
147 Integrity Health
T6
232 eLab Solutions
337 Iroko Pharmaceuticals, Inc.
224 Ameritox
T16 Electromedical Products Intl, Inc.
422 kaléo, Inc.
149 AML Diagnostics
339 Endo Pharmaceuticals
323 LabCorp-Medtox
436 ApolloLIMS
T4
350 Letco Medical
T20 US Pain Foundation
T28 ASAM
111 Ethos Laboratories
424 Linden Care
423 Waters Corp
237 Aspen Medical
449 Expo Enterprise
T15 Logan Laboratories
T23 Wolters Kluwer Health
301 AstraZeneca
139 Feel Good Inc.
340 MedComp Sciences
401 XenoPort
415 Autogenomics
226 Freedom Pharmaceuticals
133 MEDISCA
251 Xpress Laboratories
EXHIBITOR LIST
240 Acadian Diagnostic Laboratories
438 Acetaminophen Awareness Coalition
T17 Advanced Pathology Solutions
348 Adva-Net
428 Aegis Sciences Corp
124 Aeon Clinical Laboratories
247 Alere Toxicology
346 AllMeds Specialty Practice Services
T9
AllSource Screening
239 Alternative Biomedical Solutions
T22 American Academy of Pain Medicine
American Society of Pain Educators
Bull Publishing
EpicGenetics
D
21
Teva
145 ProCare Counseling
Avacen Medical
31
T25 Power of Pain Foundation
T24 Practical Pain Management
T3
Pha
444 Radeas Labs LLC
250 RxAssurance Corp
451 RxProLogic
117 Salix
143 Schuyler House
433 Sciex
137 SI-BONE
242 SurgiLogix
T35 Take Courage Coaching
317 Takeda Pharmaceuticals
432 TechNeal
101 Teva Pharmaceuticals
338 Thermo Fisher Scientific
336 ThermoScientific
S
Ethos Laboratories
111
11
1
Co
8
PAINWEEK news
Thursday, September 10
SATELLITE EVENTS
Opioid-Induced Constipation:
The Science, the Struggle,
and an Orally Administered
Treatment Option
Speaker: Gerald M. Sacks, MD
Time: 8:00 am–8:55 am
Location: Level 3/Brera Ballroom
CE/CME: No
Meal served: Yes (breakfast)
Sponsored by: AstraZeneca
Prioritizing the Patient
in the Opioid Debate:
A Roundtable Discussion
Speaker: TBD
Time: 8:00 am–8:55 am
Location: Level 3/
Opioid-Induced Constipation
Castellana Ballroom
CE/CME: No
Meal served: Yes (breakfast)
Sponsored by: Pernix
Therapeutics
Ballroom
Understanding
Abuse-Deterrent Opioid
Technologies
Pharmaceuticals
Speakers: Jeffrey Gudin, MD;
Srinivas Nalamachu, MD
Time: 12:15 pm–1:30 pm
Location: Level 3/Brera Ballroom
CE/CME: No
Meal served: Yes (lunch)
Sponsored by: Teva
Pharmaceuticals
Speaker: Steven Simon, MD
Time: 12:15 pm–1:30 pm
Location: Level 3/Castellana
CE/CME: No
Meal served: Yes (lunch)
Sponsored by: Salix
Overview of Emerging
Technologies: Opioids
with Labeled
Abuse-Deterrent Properties
and Claims (OADP)
Speaker: TBD
Time: 3:35 pm–4:30 pm
How to Assess and Manage Acute and
Chronic Low Back Pain
One common misconception about back pain is that acute back pain will turn into chronic back pain.
U
sing a multimodal approach
could be a better method for
managing acute or chronic back
pain than prescribing opioids for a
patient, especially if that patient will
require lifelong treatment.
Unlike acute low back pain, chronic
low back pain will typically last for
more than 3 months. As for affecting
the workforce, chronic low back pain
is the most common cause of disability
in people younger than 45 years, said
Russell Bell, MD.1 It is also one of
the top reasons why individuals visit
a primary care physician.1
Back pain is the most expensive
benign medical condition in the
United States, reports Dr. Bell. 1
Nearly 19% of all workers’ compensation claims are related to back pain,
and 2% of all US workers sustain back
injuries each year.1
Individuals at risk for back pain have
not been clearly identified in the past.
Gender, race or ethnicity, and genetics are not considered factors that
contribute to back pain. However,
some studies have shown that extreme
height, extreme weight, and cigarette
smoking may contribute to back pain.
Typical low back pain generators
include muscle (often relieved by trigger point injections), bone (lumbar
facet joint and sacroiliac joint) and
articulations, nerve, ligament, and disc.
One common misconception about
back pain is that acute back pain will
turn into chronic back pain, but that
is not always the case.
“On average, acute low back pain
will resolve with time, typically
within a 6-week period,” said Peter
Pryzbylkowski, MD. “It is important
for front-line providers to classify
acute low back pain into low axial vs
radicular as the treatment paradigm
is distinct for each.”
Another misconception with chronic
low back pain is that opioid treatment
is an effective method for the management of the disease process.
“In fact, even patients with chron-
ic back pain can gain benefit from
interventional procedures, appropriate physical therapy modalities, and
appropriate medication selection.
The treatment goal for patients with
Location: Level 4/
Mont-Royal Ballroom
CE/CME: No
Meal served: No
Sponsored by: Purdue
Pharma L.P.
Salix Pharmaceuticals
Product Theatre
Speaker: Steven Simon, MD
Time: 3:35 pm–4:30 pm
Location: Level 3/Castellana
Ballroom
CE/CME: No
Meal served: No
Sponsored by: Salix
Pharmaceuticals
tory depression, nausea, mental status
changes—as well as risk of addiction
or misuse.”
“There is minimal evidence that longterm opioid use for chronic back pain
improves overall pain or function,” he
said. “Opioids should be prescribed
with caution and used for short-term,
finite periods of time.”
Alternative medications used for
both acute and chronic low back pain
fall into several categories: muscle
relaxants, neuropathic agents, and
anti-inflammatory agents. Other
The treatment goal for patients with
chronic low back pain is not curative but
rather to restore functionality.”
chronic low back pain is not curative
but rather to restore functionality.”
Opioid treatment does have its place,
however. That being said, there are
still a variety of precautions clinicians
should take before prescribing painkillers to patients, Dr. Pryzbylkowski said.
“While opioid medications can help
with back pain, especially an acute
episode of back pain, these medications play a lesser role in chronic back
pain,” he said. “Physicians should be
aware of the potential for adverse reactions from opioids—sedation, respira-
treatments include physical therapy, appropriate interventional pain
procedures, acupuncture, yoga, and
cognitive behavior modalities, Dr.
Pryzbylkowski noted.
“It is important to treat chronic low
back as a chronic medical condition that
will require lifelong treatment,” he said.
REFERENCE
1. National Institute of Health. Low back pain fact sheet:
National Institute of Neurological Disorders and
Stroke (NINDS). http://www.ninds.nih.gov/disorders/
backpain/detail_backpain.htm. Updated August 3,
2015. Accessed September 2, 2015.
PAINWEEK news
Thursday, September 10
9
Approaching Pain Management From a New Perspective
Moving from a ‘taking the car to a mechanic’ paradigm to a biopsychosocial paradigm of the actively engaged patient.
T
o move forward in medicine, perhaps the best approach would be to
take a step back and rethink what
the medical community considers to
be standard care. Applying this process
to pain management encourages medical specialists to meet their patients’
myriad clinical and emotional needs.
Becky Curtis, PCC, believes painmanagement paradigms need to be
reexamined to effectively manage and
treat pain in patients. As a survivor of a
serious rollover motor vehicle accident,
she recognized the need to advocate
for those suffering with chronic pain.
The pain management coach points out
that there are several ways a physician
can build an environment where both
the clinician and patient become an
integral part of the pain-management
process: developing new language
tools to empower patients; acquiring
methods to reduce stress in working
with patients; and learning to establish
restorative partnerships with patients.
“I know many physicians who are
building restorative relationships with
patients. But those who do take fewer
patients, and take more time with them,”
she said. “Those who aren’t may have
time constraints that make it difficult to
work this closely with a patient.”
low self-esteem, and low levels of confidence. Negative-thinking patterns
and fear-avoidance behavior can also
contribute to pain syndromes.
These aspects of a life in pain can
impede an individual’s ability to see
beyond his or her personal situation.
In addition, the stigma associated with
“The new paradigm takes patients out
of the mechanic’s waiting room and puts
them in the driver’s seat.”
Understanding what a patient with
chronic pain is experiencing can build
upon those foundational elements.
Individuals with chronic pain often
report a sense of feeling defeated.
They may lack a support system and
often don’t have appropriate coping
skills for managing the effects of their
pain. They may experience depression,
chronic pain negatively affects the way
patients with chronic pain see themselves. Ms. Curtis advises healthcare
practitioners to encourage their patients
to engage in exercise and to increase
their activity so that they can stay functional by learning to cope with their
conditions. It takes an actively engaged
patient to manage his or her own pain.
A Multimodal Approach to Pain Management
Pain management goals vary depending on whether the pain is acute or chronic.
“P
ain is the leading reason
people seek medical attention, costing the nation $625
billion annually — more than heart
disease, cancer, and diabetes combined,” said Theresa Mallick-Searle,
MS, RN-BC, ANP-BC, a nurse practitioner at the Stanford University Pain
Management Center in Redwood City,
California.
Using a series of interactive case
studies, Ms. Mallick-Searle guided
audience members through a hands-on
discussion exploring the pathophysiology of pain and multimodal pain
management approaches, touching
on concepts including pain pathways,
neuroplasticity, central sensitization,
and pain modulation.
“In addition to current therapies,
new methods of managing pain are on
the horizon that may help personalize
pain management,” Ms. Mallick-Searle
said. “Opioids are being reformulated
to have less potential for addiction.
Additionally, scientists are using the
human genome to determine how individual patients will react to specific
medications, which has positive implications for patient-centered treatment.”
For acute pain relief, opioid analgesics are the current “gold standard,”
offering numerous routes of administration, immediate and extendedrelease formulations, and options for
targeting opioid receptors to modify
pain signals and diminish pain perception. However, chronic use can lead
to adverse effects including tolerance,
dependence, and addiction.
Opioid withdrawal can lead to
adverse effects such as psychomotor arousal in the form of irritability,
restlessness, pacing, and sleeplessness;
and autonomic arousal as indicated by
mydriasis, yawning, sweating, diarrhea,
lacrimation, rhinorrhea, mild tachycardia, and hypertension. Individuals
undergoing opioid withdrawal may
also experience muscle aching, joint
pain, and stomach cramping.
For peripheral/central pain, anticon-
vulsants work by slowing down “overly
excited” nerve impulses via sodium and
calcium channel modulators.
Tricyclic and serotonin-norepinephrine reuptake inhibitor antidepressants
modify the combination of serotonin
and norepinephrine to decrease the
amount of pain a patient perceives.
Typically used nonopioid analgesic
options are acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs),
and tramadol, as well as sedatives, sleep
aids, and muscle relaxants.
The basis of interventional pain
management is to block the production and/or transmission of pain signals to the brain through methods
including neurologic procedures,
nerve blocks, spinal cord stimulation, drug-delivery system implants,
or injection of an anesthetic.
Goals of these interventional techniques include pain reduction, improving and maintaining mobility, and
minimizing medication use. The
administration strategies enable pain
Empowering patients can help them
alleviate pain on their own. During
her presentation, Ms. Curtis made
note of several chronic pain treatments and stopped short of endorsing
them as methods to relieve patients
of their symptoms. She suggests a
“focused-attention” approach that can
be used to “positively reprogram brain
pathways.”
Educating patients on chronic pain
can help them cope with their conditions, she said. Managing pain is a
team effort between physician and
patient. Once a patient accepts responsibility for managing pain symptoms,
the healing process can begin.
“The new paradigm takes patients
out of the mechanic’s waiting room and
puts them in the driver’s seat,” she said.
“It’s a paradigm that is more organic
than mechanic. What is needed is a new
tool in the provider’s tool box: referral
to a pain management coach.”
management specialists to selectively
target injured and painful body regions
while minimizing complications such
as infection, bleeding, further injury,
and sympathetic crisis.
Emerging behavioral and psychological approaches for addressing pain
focus on the mind-body relationship
and consist of techniques including
relaxation and stress reduction training, cognitive behavioral therapy
(CBT), communication skills, and
flare management.
Complementary therapies include
passive modalities such as acupuncture/accupressure, hypnosis, occupational and physical therapy, massage,
and transcutaneous electrical nerve
stimulation; and active modalities
such as relaxation, biofeedback, deep
breathing, guided imagery, distraction,
and visualization.
“New research continues to shed light
on the treatment and understanding
of pain; but even with these strides,
involving patients in care is the key to
determining the best course of treatment,” Ms. Mallick-Searle concluded.
Disclosure: Theresa Mallick-Searle is a
member of speakers’ bureaus for Allergan
and Depomed.
PAINWEEK news
Thursday, September 10
13
SPECIAL PROGRAMS
NATIONAL ASSOCIATION OF DRUG DIVERSION INVESTIGATORS
Rx Abuse: The Scope of the
Problem in 2015
Presenter: Lisa M. McElhaney, BS
Time: 9:00 am–9:55 am
Location: Level 4/Mont-Royal
Ballroom
In 2013, there were more than 2.8
million new illicit drug users in the
United States, or approximately 7800
new users per day. Although drug
abuse is not a new concept, attitudes
have shifted and recreational use has
become more commonly accepted
in society. A change in the types of
drugs in demand has accompanied
this cultural shift, with prescription
drug abuse reaching “epidemic
proportions.”
In this session, Lisa M. McElhaney,
president of the National Association
of Drug Diversion Investigators
(NADDI), will discuss both historic
and current data on pharmaceutical
drug abuse and diversion, trends in
drug abuse, and the role of healthcare practitioners in this epidemic.
She will review what happens when
legal medications are distributed illegally, who the different players are,
drugs of choice, and patterns of abuse,
as well as market availability and
accessibility of certain drugs before
describing tactics for prevention.
Scammers, Shammers, and Thieves
Presenter: Marc S. Gonzalez,
PharmD
Time: 10:20 am–11:10 am
Location: Level 4/Mont-Royal
Ballroom
Have you ever wondered how to
handle discharging patients who
doctor shop or illegally distribute
or abuse drugs? If so, then you do
not want to miss this session where
former counterdrug consultant for
the US Department of Defense
and supervising investigator for the
state of California Marc S. Gonzalez,
PharmD, will describe the best ways
healthcare providers can document
these occurrences and outline what
clinicians can do in the event they
ever experience such an unfortunate
scenario.
Now the owner of Pharmaceutical
Diversion Consultants LLC, Dr.
Gonzalez—a NADDI training and
education coordinator—brings to
the stage at PAINWeek 2015 more
than 20 years of experience observing the ways people have scammed
healthcare practitioners and pharmacists and duped the system to
obtain prescription painkillers illegally. He will describe the various
routes legal medications take to
make it to the black market, detailed
accounts of crimes perpetrated
against medication prescribers and
dispensers, and how to best communicate criminal activity to law
enforcement.
“Healthcare practitioners need
to realize that they’re only human.
They’ll be shocked to learn behaviors that they recognize in their own
patients,” he said. “You cannot have
an absolutely flawless practice. You
are going to be scammed at some
point, and you will have to lick your
wounds and move on.”
Opioid Overdose Strategies:
Are They Working?
Presenter: Lisa M. McElhaney, BS
Time: 1:35 pm–2:30 pm
Location: Level 4/Mont-Royal
Ballroom
Deaths from drug overdose have
been increasing incrementally during the past two decades and now
represent the leading cause of accidental death in the United States.
An estimated 60% of drug overdoses
are related to pharmaceutical drugs,
and approximately 15,000 people die
each year from prescription painkiller overdoses.
As the epidemic has expanded, so
too have efforts to prevent opioid
overdoses, with more education and
resources available on the topic than
ever before. But are these efforts
working?
NADDI president Lisa M.
McElhaney will highlight national
statistics on illegal opioid use and
describe interventions to reduce
the numbers of overdose, death,
and dependence related to these
drugs.
Addiction and Drug Histories:
A Cop’s Eye View From the Street
to the Clinician’s Office
Presenter: Marc S. Gonzalez,
PharmD
Time: 4:35 pm–5:25 pm
Location: Level 3/ Gracia 3
This presentation will review the
aspects and mechanisms of addiction as
it relates to the background and experiences of a law-enforcement officer.
During this session, Marc S.
Gonzalez, PharmD, will review current methods of manipulating illicit
prescription medication, as well as
the various classes of illicit drugs.
Information on drug cocktails and
combinations will be provided in
an effort to assist medical practitioners in better understanding the
long-term effects of all drugs when
obtaining histories from new and
current patients.
Actual case studies will further
reinforce the information presented
for a better understanding of the
impact on healthcare practitioners’
treatment plans, the need for further consultation, and being able to
determine the degree of necessary
patient monitoring.
From this presentation, healthcare
practitioners will be better able to
determine whether a patient may
have more serious physical and psychological issues beyond their scope
of practice that necessitate referral
to another practitioner.
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14
PAINWEEK news
Thursday, September 10
Adolescent Patients With Chronic Pain
Different From Adults, Children
How adolescents approach their chronic pain condition at their current age has an effect on
how they will experience their condition in adulthood.
A
dolescence is defined as the period between ages 10 and 19,1 and
many individuals in this age group
are reported to have chronic pain.2
Despite the prevalence of chronic
pain in adolescence, many healthcare professionals do not differentiate adolescents experiencing chronic
pain from other age groups when it
comes to treatment, and this does not
serve the adolescent population well,
according to Melissa E. A. Geraghty,
PsyD, a health therapist in private
practice from Naperville, Illinois.
It is Dr. Geraghty’s opinion that such
limitations often diminish the difficulties and capabilities of the adolescent
in chronic pain, “making medical and
psychotherapeutic interventions that
are empirically sound more difficult
to find and consequently implement.”
It is also important to note that many
adults with chronic pain first experience unceasing pain as an adolescent
or child.3
Although there is only limited
evidence to support the claim, selfmanagement behaviors related to
chronic illness are likely established
in adolescence, making psychoeducation and proper medical interventions
imperative at the time of presentation,
according to Dr. Geraghty.4 How adolescents approach their chronic pain
condition at their current age has an
effect on how they will experience
their condition in adulthood.
Research on chronic pain often
focuses on pediatric or adult populations and does not provide insight
on how to implement evidencebased treatment for adolescents with
chronic pain. This lack of research
creates a treatment challenge, she said,
because adolescence itself is a diverse
age group due to differences in biology, psychological functioning, social
interactions, and spirituality.
During her discussion, Dr. Geraghty
explored the effects of chronic pain on
an adolescent’s life, including adverse
effects on neural and cognitive processes, puberty, gender, sleep, and fatigue.
She said treating adolescent patients
must encompass several components,
including psychological and social.
Psychological components include the
grief cycle, cognitive processes, comorbid diagnoses, fear avoidance, physical
trauma, body image, and substance use
and abuse. Social components include
peer groups, familial support, absenteeism, and cultural factors.
Spirituality is another important
component to consider in the management of the adolescent with pain.
Awareness of this aspect of an individual’s personality can assist the healthcare provider in guiding the patient to
find meaning in his or her suffering.
REFERENCES
1. World Health Organization. Adolescent health and
development. Available at: http://www.who.int/
maternal_child_adolescent/topics/adolescence/dev/
en/. Accessed August 14, 2015.
2. King S, Chambers CT, Huquet A, et al. The epidemiology of chronic pain in children and adolescent revisited:
a systematic review. Pain. 2011;152(12):2729-2738.
3. Eccleston C, Jordan AL, Crombez G. The impact of
chronic pain on adolescents: A review of previously
used measures. J Pediatr Psychol. 2006;31(7):684-697.
4. Santrock JW. Child Development. 11th ed. New York,
NY: McGraw-Hill; 2007.
Remove Mental Health Barriers to Fully Treat Patients With Chronic Pain
Depression, substance abuse are commonly reported in patients who have chronic pain.
P
ainful chronic conditions often
are accompanied by equally
debilitating comorbidities such
as depression, substance use disorders,
and suicidal ideation. Unfortunately,
there are significant barriers to accessing mental health services that need to
be addressed to adequately treat these
complex patients.
That was the advice from Martin
Cheatle, PhD, who is director of
the Pain and Chemical Dependency
Program at the Center for Studies
of Addiction at the University of
Pennsylvania in Philadelphia.
“There is a preponderance of evidence that depression and suicidal
ideation are very common in patients
with chronic pain and patients with
substance use disorders, and those
patients who suffer from both pain and
substance use disorders are particularly vulnerable to developing a major
depressive disorder and experiencing
suicidal ideation and behavior,” Dr.
Cheatle told PAINWeek News.
He further explained that this evidence points to a need to routinely
screen for depression and suicide in
patients with pain.
While there has been considerable
focus on the misuse and abuse of prescription opioids and the rising rate of
opioid-related overdoses, both depression and suicidal ideation in patients
Diagnostic and Statistical Manual of
Mental Disorders, 4th Edition (DSMIV) classification system to document
typical vegetative signs of depression including anhedonia, depressed
mood, trouble sleeping, feeling tired,
change in appetite, feelings of guilt or
“The clinician should always attempt to
gather corroborating information from
family members and from medical records
to obtain an accurate assessment of
the potential for a substance use disorder.”
with pain, as well as substance use
disorders in this patient population,
have become “silent epidemics,” Dr.
Cheatle said.
In discussing ways to identify
patients who may be at risk for
depression, Dr. Cheatle discussed
use of the PHQ-9 (9-item patient
health questionnaire), which is a selfadministered survey derived from the
worthlessness, trouble concentrating,
and feeling slowed down or restless.
A number of risk assessment tools
have also been developed and validated
to assess the risk of misusing or abusing
prescription opiates, Dr. Cheatle said.
These include the ORT (Opioid Risk
Tool), SOAPP® (Screener and Opioid
Assessment for Patients with Pain®),
COMM® (Current Opioid Misuse
Measure®), and PDUQ (Prescription
Drug Use Questionnaire).
Additionally, a number of instruments
are available to assess for substance use
disorders that are not specific to the
pain patient population. Examples of
these include the AUDIT-C (Alcohol
Use Disorders Identification Test
Consumption), CAGE-AID (Cut down,
Annoyed, Guilty, Eye-opener Tool
Adjusted to Include Drugs), and the
DAST (Drug Abuse Screening Test).
But many of these tools depend
upon patient self-assessment, which
is always susceptible to response bias
and the influence of social desirability,
Dr. Cheatle warned.
He offered this pearl: “The clinician
should always attempt to gather corroborating information from family
members and from medical records to
obtain an accurate assessment of the
potential for a substance use disorder.”
He said that clinics that manage these
complex patients should have a plan of
action if a patient’s screening is suggestive of possible substance use disorder,
severe depression, and/or suicide.
PAINWEEK news
Thursday, September 10
15
Pain Management and the Groundhog Day Phenomenon
Thorough documentation can reduce medicolegal exposure and risk of regulatory sanction.
A
lthough policies, procedures,
and practices related to treating
chronic pain are being discussed
at national and international levels,
there are often challenges to implementing widespread change.
Kevin Zacharoff, MD, of PainEDU.
org, discussed some of these hurdles,
and ways to get over them, during
his session, “The Groundhog Day
Phenomenon.” Named after the popular film in which the main character
relives the same day over and over, Dr.
Zacharoff said that the inspiration for
his session’s title came about because
he believes the medical community
seems to be unable to make progress in
pain policy and procedure; in essence,
reliving the same day.
“From healthcare system to healthcare
system and practice to practice I have
spoken with, it seems that everyone
who thinks that the time has come for
a ‘pain policy and procedure set’ feels as
if they’ve discovered this on their own,
when in actuality it has been promoted
in many different ways and forms at least
over the past 15 to 20 years or more,”
said Dr. Zacharoff. “This ‘reinventing the wheel’ phenomenon, despite a
plethora of writings, guidelines, national
meetings, and debates, certainly seems
like a ‘Groundhog Day’ phenomenon
to me and doesn’t seem to be changing.”
Fortunately, Dr. Zacharoff noted that
there is a growing body of evidence
that has helped to clarify “the misunderstanding of addiction, physical
dependence, and analgesic tolerance;
the misconception that chronic opioid
therapy inevitably causes personality
changes … and the lack of information
on the correct use of opioid analgesics
with regard to titration and management of related side effects.”1
Dr. Zacharoff offered some of his
own clinical perspectives on this growing body of evidence. He said in addition to arriving at a diagnosis for the
cause of a patient’s pain, it is important
to “address any comorbid conditions,
including probable substance use disorders and other psychiatric illness.”
Discussing psychiatric illness, Dr.
Zacharoff explained that a complete
psychological assessment, including personal and family history of
substance use, is integral to treating
patients with chronic pain. He urged
said. “Without prior assessment of
pain level and function, it would be
impossible to measure progress.”
He said it is important to consider
that opioids “may or may not be the
first treatment of choice, and will most
likely be used with other adjunctive
medications.”
Discussing alternatives to opioids, Dr.
Zacharoff cited data that concluded:
“A sensitive and respectful assessment of
risk should be done with available tools and
should not be seen in any way as diminishing
a patient’s complaint of pain or reliability.”
clinicians to discuss patient-centered
urine drug testing with all patients. A
psychological assessment should also
include risk, he explained.
“A sensitive and respectful assessment of risk should be done with available tools and should not be seen in
any way as diminishing a patient’s
complaint of pain or reliability,” Dr.
Zacharoff said.
Obtaining informed consent is also
important, Dr. Zacharoff noted, adding that it is imperative that clinicians “educate the patient about the
proposed treatment plan with opioids
including: anticipated benefits, foreseeable risks, and concerns at a level
appropriate to the individual patient.”
Dr. Zacharoff explained that a treatment agreement is also key. Such
agreements should incorporate the
expectations and obligations of both the
patient and the treating practitioner.
Also integral to treating the patient
with chronic pain is a pre- and postintervention assessment.
“Initiation of opioid therapy for
patients in this setting should be considered a ‘trial’ of therapy by both the
clinician and patient,” Dr. Zacharoff
“Methadone is characterized by complicated and variable pharmacokinetics
and pharmacodynamics and should be
initiated and titrated cautiously by clinicians familiar with its use and risks.”2
REASSESSMENT OF PAIN AND
FUNCTION
In addition to preassessment of pain
and making a judicious decision regarding the use of opioids, Dr. Zacharoff
explained that it is important to regularly assess the patient for either continuing or discontinuing therapy. He
called this assessment the “Four As”
of pain medicine: analgesia, activity,
adverse effects, and aberrant behavior.
“Clinicians should reassess patients
on chronic opioid therapy periodically and as warranted by changing
circumstances,” Dr. Zacharoff said. He
added that monitoring should include
documentation of the pain intensity,
the patient’s level of function, assessment of progress, adverse events, and
adherence.
“Refills should only be provided with
conclusion that the therapeutic index
is moving in the right direction,” he
cautioned.
Discussing high-risk patients, Dr.
Zacharoff explained, “Clinicians may
consider chronic opioid therapy for
patients with chronic noncancer pain
and a history of drug abuse, psychiatric issues, or serious aberrant drugrelated behaviors only if they are able
to implement more frequent and stringent monitoring parameters.” He also
urged consultation with mental health,
addiction, and/or pain specialists.
ADDITIONAL STEPS
In all patients, Dr. Zacharoff explained
that thorough risk/benefit analysis is
vital to treatment success, as are rotating opioid agents and discontinuation
of treatment when appropriate. He
encouraged clinicians in attendance to
consider adjunctive medications and
therapies, and to monitor breakthrough
pain treatment medications as well.
IMPORTANCE OF
DOCUMENTATION
Documenting is in the best interest
of both patients and clinicians, Dr.
Zacharoff said, noting that “thorough
documentation can reduce medicolegal exposure and risk of regulatory
sanction.”
The rule of thumb to remember,
Dr. Zacharoff said, is “if you do not
document it, it did not happen.”
“Reproducible and clinically relevant
and implementable information that
resonates with clinicians providing
treatment for people with chronic
pain needs to happen so people can
share this information with each other
and become vectors for knowledge,”
concluded Dr. Zacharoff.
REFERENCES
1. Pappagallo M, Heinberg LJ. Ethical issues in the management of chronic nonmalignant pain. Semin Neurol.
1997;17(3):203-211.
2. Chou R. 2009 Clinical Guidelines from the American
Pain Society and the American Academy of Pain Medicine on the use of chronic opioid therapy in chronic
noncancer pain: what are the key messages for clinical
practice? Pol Arch Med Wewn. 2009;119(7-8):469-477.
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16
PAINWEEK news
Thursday, September 10
Pharmacogenetic Testing:
A Good Tool for Treating
Patients With Pain
Pharmacogenetic testing yields information that informs how
an individual will metabolize medications.
P
harmacogenetic testing can serve
as a tool that provides information in terms of how genetic variability affects individual responses to
medications, specifically by helping
clinicians determine how medications
may be metabolized.
Jeffrey Fudin, PharmD, clinical
pharmacy specialist and director of
the PGY-2 Pharmacy Pain Residency
Program at the Stratton VA Medical
Center in Albany, New York, discussed pharmacogenetic testing as
part of a presentation on dosage
thresholds during a session here.
Traditionally 4 common phenotypes designate how an individual will
metabolize medications: normal or
extensive metabolizers, poor metabolizers, intermediate metabolizers, and
ultrarapid metabolizers. Clinicians
need to understand the effect of genetic polymorphisms in metabolizing
enzymes, Dr. Fudin said, which can
vary depending on the phenotype and
the specific medication.
In discussing poor metabolizers, Dr.
Fudin said, “for a medication that has an
active parent compound, the potential
clinical consequences in general include
increased efficacy and the potential
for lower doses to provide efficacy, or
increased toxicity as a result of buildup
of the active parent compound.”
For a medication for which the parent drug has little or no activity, he
said, the clinical consequences may
include decreased toxicity, little or
no efficacy, and the potential need for
higher doses of the drug.
Pharmacogenetic testing may also
be helpful, Dr. Fudin explained, to
identify the potential benefits and
risks of certain medications, such as
methadone, prior to prescribing or
continuing treatment.
“Methadone has unique pharmacokinetic characteristics and for this reason
has been associated with distinctive
and serious toxicity compared with
other opioids,” he cautioned.
Methadone is a racemic mixture of
the (R) and (S) isomers.
The (R)-enantiomer is primarily
responsible for analgesic effects while
the (S)-enantiomer is associated with
cardiotoxic adverse effects, specifically
prolongation of the heart-rate corrected QT (QTc) interval, Dr. Fudin
explained. Both isomers are metabolized to the inactive metabolite, EDDP,
but through different pathways.
(R)-methadone is metabolized primarily by CYP3A4 (but other CYP
enzymes have a lesser role, including
2C19 and 2D6). (S)-methadone is primarily metabolized by CYP2B6; thus,
he said, a poor metabolizer of CYP2B6
would be at increased risk for buildup
of the cardiotoxic S-enantiomer and
at higher risk for QTc prolongation
and arrhythmia associated with sudden death.
Knowing this information through
testing, prior to prescribing, may
be helpful to minimize the risk of a
potentially serious or fatal toxicity,
according to Dr. Fudin.
Disclosure: Jeffrey Fudin is a member
of the speakers’ bureau for Millennium
Health, LLC, and a consultant for
AstraZeneca, Millennium Health LLC,
Kaléo Pharma, Zogenix, and Depomed.
Safe Opioid Prescribing in the Era of Overdose
Drug screening, risk stratification, and pharmacogenetic testing should be used to guide prescribing habits.
T
he number of opioid prescriptions filled in US pharmacies has
tripled since the early 1990s, from
76 million in 1991 to 219 million in
2001.1 During this time period, emergency department (ED) visits for opioid misuse or abuse and opioid-related
drug overdose deaths also rose sharply.
Continuing the upward trajectory, ED visits attributable to opioids
increased from 600,000 to more than
1.2 million from 2004 to 2010, and
overdose deaths have quadrupled from
4000 to more than 12,000 annually
from 1999 to 2010, according to data
from the Substance Abuse and Mental
Health Services Administration.2
“As a result many states are enacting
legislation to ensure appropriate, safe
opioid prescribing,” said Brett Badgley
Snodgrass, MSN, APRN, FNP-C.
“Safe prescribing is of utmost importance, primarily to decrease diversion
and abuse, but also to make it as safe and
appropriate for our patients,” she said.
To ensure safe and effective chronic
pain management, urine drug testing,
risk stratification, and pharmacoge-
netic testing are also paramount.
“Drug screening is one of the elements we use in guiding our prescriptive habits when we’re talking about
opiates or controlled substances. It
absolutely should be used in practice;
how often depends on state mandates,
the individual prescriber, and the
patient,” Ms. Snodgrass said.
Drug testing helps providers determine if patients are taking their medications as prescribed, and also if they are
taking other drugs that may interfere
with their medications. Such screening
methods include urine analysis, blood
immunoassays, and gas chromatography/mass spectrometry (GC/MS).
“Urine drug screening is one of
the easiest and most reliable ways to
obtain information on drug use. It
can be performed quickly, so you can
perform a point-of-care test and have
some working knowledge of what is
in that patient’s urine when he or she
leaves your office,” Ms. Snodgrass said.
When interpreting point-of-care
test results, clinicians should assess the
risk of false positives or negatives and
should not make definitive decisions
based on findings. If a urine drug test
yields an unexpected finding, providers should limit the provision of the
opioid to a 7- to 14-day period.
Clinicians should also be aware that
some medication use or abuse may go
undetected on a point-of-care test.
Prescription drugs such as fentanyl,
oxycodone, and carisoprodol are often
omitted, certain opioid normetabolites
may not react (typically <0.1%), and
high thresholds are typically used in
point-of-care tests.
Confirmation testing with more
accurate methods such as GC/MS
should be performed prior to making
a final care decision, she advised.
Genomic testing to detect genetic
predispositions—such as allelic variation in the CYP2D6 and CYP2C19
genes, which can markedly increase or
decrease drug metabolism—is a new
trend in opioid management that can
improve diagnostic and prescribing
accuracy and speed.
Weaning is another key aspect in
managing patients taking opioids,
either as a natural course of therapy
when pain scores decrease and a patient
has recovered or when a patient is displaying aberrant or divertive behavior.
The clinician’s main goal during
opioid weaning should be preventing
withdrawal symptoms. Most patients
can have their opioid treatment
tapered with a 10% to 20% weekly
decrease.
“Treating pain is not synonymous
with opiate use. We need to consider
all other alternatives.” Ms. Snodgrass
added that healthcare providers should
not be afraid to use an opioid when
it is appropriate. Some patients truly
have no other options, such as elderly
patients for whom other medications are
contraindicated. For these patients, Ms.
Snodgrass advised starting with a low
dosage and titrating upward very slowly.
REFERENCES
1. IMS Institute for Healthcare Informatics. National
Source Prescription Audit, Vector One.
2. Substance Abuse and Mental Health Services Administration (SAMHSA). The DAWN report. July 2, 2012.
Available at: http://www.samhsa.gov/data/sites/
default/files/DAWN096/DAWN096/SR096EDHighlights2010.pdf. Accessed August 14, 2015.
PAINWEEK news
Thursday, September 10
17
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PAINWEEK news
Thursday, September 10
Virtual Reality for Pain Relief: From
Science Fiction to Medical Therapy
As opioid use undergoes more scrutiny, healthcare providers are looking at alternate
ways to manage pain.
T
he concept of virtual reality has
progressed past the realm of the
science fiction genre into medical
reality and is currently under investigation as potential therapy for a wide
range of conditions from addiction to
autism to posttraumatic stress disorder
and now pain management.
“One of the best ways to alleviate
pain is to introduce a distraction,” said
Theresa Mallick-Searle, MS, ANPBC, of the Division of Pain Medicine
at Stanford Health Care. “Because
virtual reality immerses users in a
3-dimensional computer-generated
world, it is uniquely situated to distract
patients from their pain.”
A small but growing body of evidence
suggests that virtual reality distraction
is effective for reducing pain, according
to Ms. Mallick-Searle. In several studies, burn patients undergoing wound
care reported a significant decrease in
pain when they engaged in a virtual
reality program called SnowWorld.1,2
Developed by researchers at the
University of Washington’s Harborview
Burn Center in Seattle, SnowWorld is
an immersive virtual reality experience
in which patients interact with the virtual world by throwing snowballs at a
cast of characters.
The concept is to use the experience
to direct patients’ conscious attention
away from reliving the original burn
experience during wound care.
Initial findings are encouraging
and suggest that the technology goes
beyond simply changing the way
patients interpret incoming pain signals to directly effect neuromodulation.
In a 2011 study by Maani et al,1 12
US soldiers who sustained burns in
combat received half of their severe
burn wound cleaning procedure
(approximately 6 minutes) with standard-of-care pharmacologic therapies and half while in the SnowWorld
virtual reality experience (treatment
order randomized).
During two pauses in the wound care
procedure—once after each 6-minute
wound care period with and without
virtual reality—each patient completed
subjective pain ratings.
Pain reduction during virtual reality
was greatest in patients with the highest pain during wound care without
the technology, the researchers found.
In a study by Hoffman et al,2 participants reported feeling moderate to
severe pain on subjective pain rating
scales when pain stimuli were administered with no virtual reality; they
reported experiencing much less pain
while immersed in SnowWorld.
“Short-duration, acute episodic pain
has really been where this therapy has
proven out thus far. There have been
some good studies looking at chronic
pain, but right now the literature is
looking more at favorable outcomes in
these patients,” Ms. Mallick-Searle said.
She called for more methodologically sound and statistically well-powered
controlled studies to assess the effectiveness of immersive virtual reality
distraction therapies in reducing the
Which Clinical Trial Design Is the Right One?
The FDA approval process requires 3 elements: efficacy, safety, and ability to manufacture
a quality product reproducibly.
U
nderstanding what is required
in a clinical trial for approval by the US Food and Drug
Administration (FDA) when bringing
a particular drug to market can help
researchers avoid challenges later on
in the process.
The FDA approval process requires
the assurance of 3 elements: efficacy
of the product, safety of the product,
and demonstration of the ability to
manufacture a quality product reproducibly. That being said, the current
system is time consuming and costly,
Errol Gould, PhD, director of Medical
Affairs at Pernix Therapeutics, told
the crowd at PAINWeek.
The FDA approval process goes
through several stages: chemistry and
discovery, pharmacology and safety,
clinical trials, and ultimately market.
Dr. Gould stressed that it is important to remember that there is a range
of clinical trial designs available that
demonstrate both the safety and efficacy of medications.
Clinical study designs used for
approval of a new medication are typically based on precedent. There are
more than enough study designs to
choose from: superiority, equivalence,
noninferiority, crossover, dual crossover, enriched enrollment randomized
withdrawal, combination rule, and
adaptive design.
“Study design selection is often
based on historical information
obtained from the prescribing information of medications in the same
drug class and published literature,
or after discussions with the FDA,”
Dr. Gould said.
Researchers are given the ability to
select which study design they’d like
to use for a given report. The decision
usually depends on what they believe
will work best for what they are trying
to accomplish.
“The FDA does not dictate which
study design is required for approval,”
Dr. Gould explained.
discomfort associated with a variety
of invasive medical procedures and
chronic pain conditions.
Ms. Mallick-Searle also noted several
barriers to more widespread study and
clinical implementation, specifically
cost and provider/patient acceptance.
Current virtual reality software packages range from freeware to custom
equipment worth thousands of dollars.
“We know that immersive virtual reality experiences are effective.
The ability to have a clinic that puts
patients in an alternate state with virtual reality goggles and tactile devices
is cost dependent,” she said.
Patients must also be willing to
accept virtual reality as a plausible
therapy after having become used to
traditional therapies like injections,
medications, physical therapy, and
acupuncture.
“If you have a practitioner who isn’t
skilled at delivering virtual reality
therapy, then patients are going to
be skeptical,” Ms. Mallick-Searle said.
Disclosure: Theresa Mallick-Searle is a
member of speakers’ bureaus for Allergan
and Depomed.
REFERENCES
1. Maani CV, Hoffman HG, Morrow M, et al. Virtual
reality pain control during burn wound debridement
of combat-related burn injuries using robot-like arm
mounted VR goggles. J Trauma. 2011;71(10):S125-S130.
2. Hoffman HG, Chambers GT, Meyer WJ III, et al.
Virtual reality as adjunctive non-pharmacologic analgesic for acute burn pain during medical procedures.
Ann Behav Med. 2011;41(2):183-191.
“Clinical trials are designed to meet
the requirements set forth by the FDA
that the medication is both efficacious and generally well tolerated by
the study participants,” he said. “This
typically means that not all patients
receive the study drug; some patients
are treated with a placebo.”
A challenge to investigators when
considering a clinical trial focused on
pain is that the trial design may differ
markedly from actual clinical practice.
In the point-of-care setting, patients
are not typically subjected to the possibility of receiving a placebo as part
of their treatment plan. However, in
pain clinical trials, patients are often
prohibited from having their medication dose changed during the doubleblind treatment period.
“In clinical practice the patient’s dose
or even the medication will be changed
if the patient is having adverse events
or not responding well,” Dr. Gould
explained.
PAINWEEK news
Thursday, September 10
How to Protect Your Practice From a
Drug Diversion Investigation
As government regulation increases to control opioid abuse, legitimate pain management
practitioners and patients alike are at greater risk than ever for being unfairly stigmatized.
H
ealthcare providers got an insider’s look at how law-enforcement officials conduct drug
diversion investigations, learning how
to avoid unintentional mistakes that
may garner unwanted scrutiny from
regulatory bodies and how to better
protect their practices.
Two members of the National
Association of Drug Diversion
Investigators, Marc Gonzalez,
PharmD, and Steven Louie, JD, hosted
an interactive session detailing actual
cases in which “pill mills” were busted,
letting clinicians enact scenarios in
which they assume the role of the drug
diversion investigator.
Dr. Gonzalez and Mr. Louie identified a laundry list of factors from
previously documented legal cases
that could provoke probable cause for
law enforcement to obtain a warrant,
make an arrest, or conduct a personal
or property search in the event that
criminal charges are being considered
for drug diversion (see Table).
The investigators then assigned cli-
TABLE. Red Flags for Probable Cause in Drug Diversion Investigations
Demonstrating lack of “good faith” — defined as honesty of purpose, lack of intent to
defraud, and being faithful to one’s duty or obligation — when conducting a patient
examination, as indicated by spending very little time with the patient
Issuing large numbers of prescriptions
Distributing an inordinate quantity of controlled substances
Directing patients to fill prescriptions at different pharmacies or to travel far distances
to fill prescriptions
Issuing prescriptions to a patient known to be delivering drugs to others
Asking patients what they want and prescribing what they want
Writing prescriptions used at intervals inconsistent with legitimate treatment, or writing
multiple prescriptions during the same visit
Billing patients based on the type of prescription, number of prescriptions written, or
quantity of drug dispensed instead of by the office visit
Treating patients whose conditions never improve or worsen
Prescribing every patient the same amount of medication (eg, 100 hydrocodone; 100 Xanax)
Attracting long lines of patients or crowds
Writing prescriptions using multiple, sometimes fictitious names
nicians to work in teams to develop
a plan for how they would act on
anonymous tips provided for several
case-based scenarios, as well as for
organizing an undercover investigation and obtaining a search warrant.
While working through the cases,
Dr. Gonzalez and Mr. Louie offered
practical advice to attendees in the
event that they become subjects of a
drug diversion investigation.
•Observe the right to remain silent.
Pain Treatment Selection: Which Is Best?
Treating painful conditions typically requires an approach that uses a variety of methods.
F
inding the right therapeutic
approach for a patient does not
have to be a challenging task for
clinicians specializing in the treatment
and management of pain. More often
than not, pain management specialists are required to use more than one
approach for patients with painful conditions. At the end of the day, it is up to
the expert to make the final decision
on the most effective treatments for
his or her own patient.
“It is important to have an understanding of the mechanism of drug
binding in order to apply this to drug
therapeutics,” said Tanya J. Uritsky,
PharmD, BCPS, a clinical pharmacy specialist at the Hospital of the
University of Pennsylvania. “A common misconception is that if a drug in
a particular class does not work, that
an alternative within the same class is
not an option—but this is not true.”
If an agent within a drug class does
not work, an alternative within the
same class may still yield results, Dr.
Uritsky told conference attendees.
She also reminded the audience that
patients typically will not immediately
feel any pain relief.
“Many of these drugs take time to
work. Often painful conditions do not
occur overnight; therefore, careful drug
selection, dose titration, and a variety of
modalities may need to be employed to
successfully achieve an acceptable level
of pain control,” she said. “Additionally,
patients may expect to experience no
pain at all, which is often not achievable
with available medication therapies.”
Selecting the right medication also
depends on how it can complement
nonpharmacologic modalities. Even
within the same class, there are a variety of agents available for a pain management specialist to choose among.
“Agent selection should be based on
patients and drug-related variables that
may provide compelling indications,”
Dr. Uritsky said. “Also, remember that
there are evidence-based guidelines
to help guide practitioners in making
good therapeutic decisions.”
Opioid analgesics can be an appropri-
23
• Do not prescribe controlled substances to new patients without
obtaining a full history and performing a comprehensive workup.
•Follow Federation of State Medical
Boards Model Guidelines.
•Create a “Practice Committee”
within your community.
•Establish a liaison with local law
enforcement.
As government interventions are
ramped up to control opioid prescription abuse, legitimate pain management
healthcare providers and patients alike
are at greater risk than ever for being
unfairly stigmatized, said Dr. Gonzalez.
An increasing number of general practice and family medicine clinicians are
opting out of offering pain management services, and pain management
specialists are overloaded.
It is more important than ever for
pain management providers to protect
themselves from unnecessary litigiousness, while at the same time avoiding
the unintended adverse consequence
of underprescribing pain medications
to patients who need them. “Don’t
become complacent,” cautions Dr.
Gonzalez. “Have a plan in place.”
The best way to do this is to establish
a community standard of what it means
to be an ordinary, reasonable practitioner. “Regulatory will see right away
that you have gone above and beyond
your standard duties,” Dr. Gonzalez
emphasized. “Nothing is completely
bulletproof, but this is pretty close.”
ate modality for patients with painful
conditions; there are several classes
and multiple routes of administration
to consider.
Non-opioid options for pain include
nonsteroidal anti-inflammatory drugs
(NSAIDs) such as celecoxib, diclofenac, ibuprofen, and naproxen. Other
adjuvant treatment options for pain
include antidepressants, anticonvulsants, anesthetics (eg, lidocaine), capsaicin, and muscle relaxants.
Staying up to date on the latest
happenings in the pain management
field is one of the best ways to gain
insight, discuss treatments, and partake in insightful and meaningful
conversations.
“It creates an opportunity to get
updated on the literature and new evidence and modalities, and it provides an
opportunity to interact with colleagues
in the same field or with the same interests,” Dr. Uritsky said.
24
PAINWEEK news
Thursday, September 10
“It Could Be Worse” and Other Things to
Avoid Saying to Your Patients With Chronic Pain
Avoid rushing to speak words of comfort; listen to your patient instead.
O
pening the lines of communication with your patients with
chronic pain and discussing
times when they may have felt that
you, as their clinician, did not understand their pain can be integral to better treating their condition, according
to Melissa E. A. Geraghty, PsyD.
Dr. Geraghty, a health therapist
who works in a private practice in
Naperville, Illinois, explained that so
many people in the life of a person with
chronic pain say things such as, “It’ll get
better” or “It could be worse.” As their
clinician, avoiding the use of invalidating language is crucial to understanding
and managing the pain experience.
“For most people, it is extremely
uncomfortable to acknowledge all
that a person with pain deals with. So
instead of truly listening and allowing
persons with pain to express them-
selves, people often rush to speak words
of comfort or advice,” Dr. Geraghty
said. “This can be very invalidating as
it does not allow the person in pain to
feel that he or she is being heard.”
Dr. Geraghty noted that there are
two highly effective tools available to
help clinicians better communicate
with their patients.
“Clinicians should immerse themselves in the pain community in ways
beyond the standard expectation of
reading pain-specific journal articles
and receiving pain-based education—
although, of course, these are very
important as well,” she said.
Clinicians can further immerse themselves through peer supervision, consulting pain advocacy websites, and
participating in patient forum websites to
learn more about the patient perspective.
The second tool is the patients them-
selves. Dr. Geraghty reports that the
best form of communication is truly
listening to patients and not just waiting for the opportunity to speak.
“Show a genuine interest in learning how conditions affect patients
individually instead of placing them
in a standardized box,” she said.
In discussing pain catastrophizing,
Dr. Geraghty offered this pearl: “If you
suspect a patient is catastrophizing, do
not assume that all of what he or she
is saying is being exaggerated or representative of a psychiatric diagnosis.”
She explained that it is important to
use open-ended questions in a supportive manner, such as: “Tell me more
about what you mean when you said
you felt like you were dying during
that intense pain episode.”
She said it is also important to avoid
stereotyping patients, because “pre-
conceived stereotypes can influence
questions asked by healthcare professionals and thus influence diagnosis
and treatment planning.”
The most important facet of treating
patients with chronic pain is setting up
realistic expectations, she said.
For many people with physical disabilities, their condition will likely
worsen due to age and/or new medical
difficulties, even if the disability itself
is not considered progressive.
She urged clinicians in attendance:
“Do not present statements full of false
hope such as, ‘I’m sure they will find
a cure soon’ or ‘I’m sure it could not
get any worse.’ ” Engaging patients in
their care and setting realistic expectations and attainable goals will help
patients to become more active participants in the management of their
condition.
Puzzle, Puzzle, Toil and Trouble
GETTING A GRIP ON PAIN
PAIN MUMBLE JUMBLE
GETTING A GRIP
ON PAIN
JUMBLED WORD
ACUPUNCTURE
NERVE
ADDICTION
NEURALGIA
ALLODYNIA
NEURITIS
ANALGESIA
NEUROPATHIC
ANESTHESIA
NOCICEPTIVE
ARTHRITIS
NOXIOUS
BREAKTHROUGH
NSAIDS
CHRONIC
OPIATE
CRAMPING
OPIOID
DEPENDENCE
PAIN
DYSESTHESIA
PARESTHESIA
EPIDURAL
PERIPHERAL
FIBROMYALGIA
RADICULAR
HEADACHE
REFRACTORY
TOSNEIORN
HYPERALGESIA
SENSITIZED
DSELTRANRAM
HYPERESTHESIA
SOMATIZATION
INFLAMMATION
STIMULUS
LANCINATING
TOLERANCE
MYOFASCIAL
WITHDRAWAL
VRIDSEOIN
IOLAOUDMNT
DRSNPETSIATEASN
EFKOABICBDE
HICDPAOIIT
TIHCAESNET
IABNNGPAET
FASYMCOILA
SADSIN
Answers will appear in the Saturday
edition of PAINWeek News
NARCOTIC
PAINWEEK news
Thursday, September 10
29
Opioid Monitoring Clinic Improved Compliance
With Clinical Practice Guidelines
Encouraging initial findings support developing specialized clinics to manage complicated and high-risk patients on opioid therapy.
A
nurse practitioner-led opioid
monitoring clinic (OMC) implemented at the VA-Las Vegas
improved primary care provider compliance with Department of Veterans
Affairs (VA)/Department of Defense
(DoD) clinical practice guidelines
for opioid prescribing and participation with the Nevada Prescription
Monitoring Program (PMP).
Richard Talusan, DNP, FNP-BC,
NEA-BC, surveyed all 40 primary
care providers (PCPs) at the VA-Las
Vegas to determine whether they felt
they would benefit from an OMC
to assist in identifying opioid abuse,
misuse, and diversion.
In the initial needs assessment,
slightly more than half of respondents
indicated that they were aware that
VA/DoD clinical practice guidelines
for opioid prescribing existed, and a
similar number indicated that they
adhered to the guidelines.
after participating in the OMC (54%).
“By accessing the PMP to screen
their patients on opioid therapy, PCPs
can help identify and stop abuse and
misuse of opioids as early as possible
with subsequent referral for treatment
as indicated,” said Dr. Talusan.
All PCPs who referred patients
to the OMC (n=11) reported overall satisfaction in having the OMC
co-manage their patients on chronic
opioid therapy.
Overall, 114 patients were seen and
evaluated in the OMC from July 1,
2013 to February 18, 2014, and 61
patients agreed to participate in the
study (average age 53 years; 4 women,
57 men).
To be eligible to participate in the
study, participants needed to have
provider-diagnosed chronic noncancer pain and be prescribed chronic
opioid therapy, have a history of
substance abuse (ie, heroin, cocaine,
“doctor shopping.” Types of misuse
and abuse included:
•Illicit substance abuse but negative
opioid level, despite an active prescription for opioid therapy (n=1; 2%)
•Consistently negative opioid levels in
the urine despite an active prescription for opioid therapy (n=9; 15%)
“By accessing the PMP to screen their
patients on opioid therapy, PCPs can
help identify and stop abuse and misuse
of opioids as early as possible.”
•Illicit substance in the urine (n=12;
20%)
•Having an opioid identified on urine
drug screen that was different from
the one they were prescribed or
having hospital admissions related
to opioid overdose (n=3; 5%).
TABLE. Summary of Study Participants
Average
Age
Participants,
n=61
53
Gender
Major
Source
of Pain
M=57
F=4
Back
37 (62%)
After implementation of the OMC,
the percentage of PCPs who completed the user survey (n=30) and reported
following the VA/DoD clinical practice guidelines increased from 58% at
baseline to 90%. Furthermore, more
than half of survey respondents indicated that they routinely accessed the
PMP to check for doctor shopping
among patients on opioid therapy
Concurrent
Use of a
Controlled
Substance
25 (41%)
Prior Pain
Agreement
Prior
Urine
Drug
Screens
Positive Urine
Drug Screen at
Initial OMC Visit
or Later Visit
54 (89%)
49 (80%)
23 (38%)
alcohol), and/or demonstrate provideridentified and documented aberrant
behaviors (ie, report of medication
loss, request for early refills).
Unexpected urine drug screen results
indicating substance misuse or abuse
were identified among 23 study participants (38%) at the initial or at a
subsequent OMC visit. A total of 12
participants (20%) were found to be
doctor shopping and 9 were referred
to an integrated pain clinic for nonopioid pain management (15%).
Other encouraging findings included
decreases in the average morphine
equivalent dose per day (from 96 mg/d
at baseline to 46 mg/d; 52%; P<.001),
decreases in functional pain assessment
Opioids were discontinued in 22
participants (36%) due to discovery
of active illicit substance abuse, doctor
shopping, opioid abuse, noncompliance with the treatment plan, or selfdecision to discontinue therapy (2%).
Among those whose opioid therapy
was discontinued, 12 were referred
to an alcohol and drug treatment program (20%) for illicit drug abuse or
scores on the Brief Pain Inventory
(6.3 at baseline to 5.8; P=.389), and
an increase in the number of drug
screens ordered at the VA-Las Vegas
(from 1849 in July 2013 to 2293 in
December 2013; 30%)
“This is very encouraging,” Dr.
Talusan said. “Although there are
increased costs associated with ordering more urine drug screens, this is
offset by the potential cost saving by
preventing even one patient from
experiencing an opioid overdose and
from associated opioid pharmacy costsavings from discontinuing opioids
that are being abused and misused.”
The OMC program implemented
at the VA-Las Vegas is a clinic specific
to the needs of the PCPs at that location and may not be representative
of other primary care clinics in the
VA system nationwide, Dr. Talusan
warned. However, he noted that
encouraging initial findings support
developing similar specialized clinics to assist clinicians in managing
complicated and high-risk patients
on opioid therapy.
HAYMARKET MEDIA
PAINWEEK
NEWS
Kathleen Walsh Tulley Editorial Director
Dominic Barone Publisher
C.J. Arlotta, Nicole Blazek, Colleen Hall Editors
John Pal Senior Vice President
Jennifer Dvoretz Group Art Director,
Haymarket Medical
Lee Maniscalco Chief Executive Officer,
Haymarket Media, Inc.
30
PAINWEEK news
Thursday, September 10
Why Improving Common Tests for Pain is Essential to Patient Satisfaction
The reliability or the clinical relevance of any diagnostic procedure is never 100%.
C
linicians involved in the treatment of musculoskeletal pain
pathologies are frequently looking for tools that can change the way
tests are ordered, interpreted, and used
to improve the care of their patients.
Understanding when a test is necessary not only assists with determining a diagnosis, but it also improves
patient satisfaction.
“Not only are many procedures
unnecessary, some are actually harmful
and can lead to mistaken diagnosis or
endless rounds of follow-up testing
when nothing is wrong,” said David
M. Glick, DC, DAAPM, CPE.
He told attendees at PAINWeek
that the medical community can
enhance the use of common studies for pain diagnosis by the “better
understanding of the clinical limitations as well as the significance of the
results of such studies.”
Dr. Glick spoke of Choosing
Wisely, an initiative launched by the
ABIM Foundation that aims to iden-
tify unnecessary medical treatments,
during his presentation. To date, the
initiative has identified hundreds of
potentially unnecessary medical tests
and treatments.
The most important tools for differential diagnosis include history,
reviewed shortcomings of common
studies and identified ways to address
them in a clinical setting. For instance,
research shows that approximately
50% of asymptomatic patients have
pathologies present on magnetic resonance imaging (MRI).1
“Objective clinical examination findings
should not be dismissed based solely upon
negative test results.”
clinical examination, and clinician
experience, he said. There are adverse
factors affecting physical diagnosis:
limitations of time, reliance upon
technology, and lack of clinical
experience.
The reliability or the clinical relevance of any diagnostic procedure
is never 100%, he said. The studies
themselves could be deficient in a
particular clinical situation.
During his presentation, Dr. Glick
“The reverse is also true. So just
because a study is negative for pathology, does not mean that a patient’s pain
should go untreated,” he cautioned.
“On the other hand, that same information when combined with clinical
examination findings can be quite
defining of the underlying pathology,
even when the MRI is negative. Being
able to understand how to use this
information in the clinical decisionmaking process can completely alter
An Overview of Fibromyalgia in 55 Minutes
W
ith treatment approaches for
fibromyalgia evolving over the
course of modern medicine,
many clinicians are reviewing the way
they address potential symptoms of
the common chronic, widespread pain
condition.
“We as clinicians have to be proactive
but also be advocates for patients with
this condition,” said Steven Stanos,
DO, medical director of Swedish
Pain Services at the Swedish Health
Systems, at PAINWeek.
The pathophysiology of fibromyalgia includes central sensitization
(amplification of pain in the spinal
cord via spontaneous nerve activity, expanded receptive fields, and
augmented stimulus responses),
abnormalities of descending inhibitory pain pathways (dysfunction in
brain centers that regularly downregulate pain signaling in the spinal
cord), neurotransmitter abnormalities
(where decreased serotonin in the
central nervous system could lead to
aberrant pain signaling), neurohu-
moral abnormalities (dysfunction in
the hypothalamic-pituitary-adrenal
[HPA] axis), and comorbid psychiatric
conditions (persons with fibromyalgia
have increased rates of psychiatric
comorbid conditions).1
Fibromyalgia shares several features with depression, said Dr. Stanos.
These include a strong genetic predisposition and similar comorbidity;
coaggregation in families; cognitive
disturbances; dysfunction of the HPA
axis; chronic stress-induced cytokine
expression in the brain; and central
monoaminergic neurotransmission.
Dr. Stanos described the stepwise
treatment algorithm for fibromyalgia:
confirm the diagnosis of fibromyalgia;
recommend treatment based on the
individual evaluation; and if the patient
is not responding to medication alone,
consider cognitive behavioral therapy
or group education.2
Patients living with fibromyalgia may
undergo a range of physical, cognitive, social, and activity changes. For
example, a patient could feel fatigued,
experience memory problems, witness disruption in family relationships, and admit to a reduction in
activities of daily living. Patients with
fibromyalgia also report abnormal
sleep characteristics: delayed sleep
onset, more frequent arousals, sleep
disordered breathing, and changes on
electroencephalography.
Dr. Stanos recommended that clinicians use both nonpharmacologic and
pharmacologic therapies to address
increased distress, decreased activity,
isolation, poor sleep, and maladaptive
illness behaviors.
Nonpharmacologic therapies can
alleviate pain in fibromyalgia, but not
all options are as evidence-based as
others. Cognitive behavioral therapy
and aerobic exercise are commonly
recommended for these patients, and
there is strong evidence in support of
their use. Tender point injections and
flexibility exercises, however, are less
common.3,4
Pharmacologic therapies for fibromyalgia include dual-reuptake inhibi-
the potential clinical course, resulting
in improved clinical outcomes.”
It is important to note that there are
various assessment measures tied to
outcomes and patient satisfaction, he
mentioned during his presentation.
“Being able to explain what these
tests are to a patient in simple terms
they can understand goes a long way
to address such measures,” Dr. Glick
explained. “With even more patients
having to deal with larger deductibles
and out-of-pocket expenses, I would
expect there are and will be thousands of discussions occurring daily as
healthcare providers are attempting to
explain the importance of the patients
undergoing these tests.”
“Objective clinical examination findings should not be dismissed based solely
upon negative test results,” he said.
REFERENCE
1. Moosmayer S, Tariq R, Stiris MG, Smith HJ. MRI
of symptomatic and asymptomatic full-thickness
rotator cuff tears. A comparison of findings in 100
subjects. Acta Orthop. 2010;81(3):361-366. doi:
10.3109/17453674.2010.483993.
tors, anticonvulsants, and selective
serotonin reuptake inhibitors (SSRIs).
There is weak evidence supporting the
use of growth hormones or tropisetron, and little evidence to support the
use of nonsteroidal anti-inflammatory
agents or opioids in these patients.3,4
The new American College of
Rheumatology (ACR) diagnostic
criteria for fibromyalgia require that
other potential causes be ruled out
and that a patient has been experiencing symptoms for at least 3 months.
It also includes two new methods of
assessment: the widespread pain index
(WPI) and the symptom severity (SS)
scale score.
Dr. Stanos concluded that fibromyalgia is best understood from a
multidisciplinary perspective because
of its complexity.
REFERENCES
1. Abeles AM, Pillinger MH, Solitar BM, et al. Narrative
review: the pathophysiology of fibromyalgia. Ann
Intern Med. 2007;146:726-734.
2. Arnold LM. Biology and therapy of fibromyalgia. New
therapies in fibromyalgia. Arthritis Res Ther. 2006;8:212.
3. Burckhardt CS, Goldenberg D, Crofford L. Guideline for
the Management of Fibromyalgia Syndrome Pain in Adults
and Children. Glenville, Ill: American Pain Society; 2005.
4. Goldenberg DL, Burckhardt C, Crofford L.
Management of fibromyalgia syndrome. JAMA.
2004;292:2388-2395.
PAINWEEK news
Thursday, September 10
31
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GRALISE® (gabapentin) tablets
BRIEF SUMMARY: For full prescribing information, see package insert.
INDICATIONS AND USAGE
GRALISE is indicated for the management of Postherpetic Neuralgia (PHN). GRALISE is not interchangeable
with other gabapentin products because of differing pharmacokinetic profiles that affect the
frequency of administration.
DOSAGE AND ADMINISTRATION
Postherpetic neuralgia
• GRALISE should be titrated to an 1800 mg dose taken orally once daily with the evening meal. GRALISE tablets
should be swallowed whole. Do not split, crush, or chew the tablets.
• If GRALISE dose is reduced, discontinued, or substituted with an alternative medication, this should be done
gradually over a minimum of one week or longer (at the discretion of the prescriber).
• Renal impairment: Dose should be adjusted in patients with reduced renal function. GRALISE should not be used
in patients with CrCl less than 30 or in patients on hemodialysis.
• In adults with postherpetic neuralgia, GRALISE therapy should be initiated and titrated as follows:
Table 1 GRALISE Recommended Titration Schedule
Day 1
Day 2
Days 3-6
Days 7-10
Days 11-14
Day 15
Daily dose 300 mg 600 mg 900 mg
1200 mg
1500 mg
1800 mg
CONTRAINDICATIONS
GRALISE is contraindicated in patients with demonstrated hypersensitivity to the drug or its ingredients.
Table 2 GRALISE Dosage Based on Renal Function
Once-daily dosing
Creatinine clearance (mL/min)
GRALISE dose (once daily with evening meal)
≥ 60
1800 mg
30-60
600 mg to 1800 mg
< 30
GRALISE should not be administered
Patients receiving hemodialysis
GRALISE should not be administered
WARNINGS AND PRECAUTIONS
GRALISE is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles
that affect the frequency of administration. The safety and effectiveness of GRALISE in patients with epilepsy has
not been studied. Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including gabapentin, the active
ingredient in GRALISE, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any
indication. Patients treated with any AED for any indication should be monitored for the emergence or worsening
of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
Table 3 Risk by Indication for Antiepileptic Drugs (including gabapentin, the active ingredient
in Gralise) in the Pooled Analysis
Indication
Epilepsy
Psychiatric Other
Total
Placebo patients with events per 1000 patients 1.0
5.7
1.0
2.4
Drug patients with events per 1000 patients
3.4
8.5
1.8
4.3
Relative risk: incidence of events in
drug patients/incidence in placebo patients
3.5
1.5
1.9
1.8
Risk difference: additional drug patients
with events per 1000 patients
2.4
2.9
0.9
1.9
The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for
psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric
indications. Anyone considering prescribing GRALISE must balance the risk of suicidal thoughts or behavior with the risk
of untreated illness. Epilepsy and many other illnesses for which products containing active components that are AEDs
(such as gabapentin, the active component in GRALISE) are prescribed are themselves associated with morbidity and
mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during
treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be
related to the illness being treated. Patients, their caregivers, and families should be informed that GRALISE contains
gabapentin which is also used to treat epilepsy and that AEDs increase the risk of suicidal thoughts and behavior and
should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression,
any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about
self-harm. Behaviors of concern should be reported immediately to healthcare providers. Withdrawal of
Gabapentin Gabapentin should be withdrawn gradually. If GRALISE is discontinued, this should be done
gradually over a minimum of 1 week or longer (at the discretion of the prescriber). Tumorigenic Potential In
standard preclinical in vivo lifetime carcinogenicity studies, an unexpectedly high incidence of pancreatic acinar
adenocarcinomas was identified in male, but not female, rats. The clinical significance of this finding is unknown. In
clinical trials of gabapentin therapy in epilepsy comprising 2,085 patient-years of exposure in patients over 12 years
of age, new tumors were reported in 10 patients, and preexisting tumors worsened in 11 patients, during or within 2
years after discontinuing the drug. However, no similar patient population untreated with gabapentin was available to
provide background tumor incidence and recurrence information for comparison. Therefore, the effect of gabapentin
therapy on the incidence of new tumors in humans or on the worsening or recurrence of previously diagnosed
tumors is unknown. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan
Hypersensitivity Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as Multiorgan
Hypersensitivity, has been reported in patients taking antiepileptic drugs, including GRALISE. Some of these events
have been fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, and/or
lymphadenopathy in association with other organ system involvement, such as hepatitis, nephritis, hematological
abnormalities, myocarditis, or myositis, sometimes resembling an acute viral infection. Eosinophilia is often present.
Because this disorder is variable in its expression, other organ systems not noted here may be involved. It is important
to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though
rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately. GRALISE
should be discontinued if an alternative etiology for the signs or symptoms cannot be established. Laboratory Tests
Clinical trial data do not indicate that routine monitoring of clinical laboratory procedures is necessary for the safe use
of GRALISE. The value of monitoring gabapentin blood concentrations has not been established.
ADVERSE REACTIONS
Clinical Trials 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 practice. A total of 359 patients with neuropathic pain associated with
postherpetic neuralgia have received GRALISE at doses up to 1800 mg daily during placebo-controlled clinical
studies. In clinical trials in patients with postherpetic neuralgia, 9.7% of the 359 patients treated with GRALISE
and 6.9% of 364 patients treated with placebo discontinued prematurely due to adverse reactions. In the GRALISE
treatment group, the most common reason for discontinuation due to adverse reactions was dizziness. Of
GRALISE-treated patients who experienced adverse reactions in clinical studies, the majority of those adverse
reactions were either “mild” or “moderate”. Table 4 lists all adverse reactions, regardless of causality, occurring in at
least 1% of patients with neuropathic pain associated with postherpetic neuralgia in the GRALISE group for which
the incidence was greater than in the placebo group.
Table 4 Treatment-Emergent Adverse Reaction Incidence in Controlled Trials in Neuropathic Pain
Associated with Postherpetic Neuralgia (Events in at Least 1% of all GRALISE-Treated Patients and
More Frequent Than in the Placebo Group)
Body system—preferred term GRALISE N = 359, %
Placebo N = 364, %
Ear and Labyrinth Disorders
Vertigo
1.4
0.5
Gastrointestinal Disorders
Diarrhea
3.3
2.7
Dry mouth
2.8
1.4
Constipation
1.4
0.3
Dyspepsia
1.4
0.8
General Disorders
Peripheral edema
3.9
0.3
Pain
1.1
0.5
Infections and Infestations
Nasopharyngitis
2.5
2.2
Urinary tract infection
1.7
0.5
Investigations
Weight increased
1.9
0.5
Musculoskeletal and Connective
Tissue Disorders
Pain in extremity
1.9
0.5
Back pain
1.7
1.1
Nervous System Disorders
Dizziness
10.9
2.2
Somnolence
4.5
2.7
Headache
4.2
4.1
Lethargy
1.1
0.3
In addition to the adverse reactions reported in Table 4 above, the following adverse reactions with an uncertain
relationship to GRALISE were reported during the clinical development for the treatment of postherpetic neuralgia.
Events in more than 1% of patients but equally or more frequently in the GRALISE-treated patients than in the
placebo group included blood pressure increase, confusional state, gastroenteritis viral, herpes zoster, hypertension,
joint swelling, memory impairment, nausea, pneumonia, pyrexia, rash, seasonal allergy, and upper respiratory
infection. Postmarketing and Other Experience with other Formulations of Gabapentin In addition to the
adverse experiences reported during clinical testing of gabapentin, the following adverse experiences have been
reported in patients receiving other formulations of marketed gabapentin. These adverse experiences have not
been listed above and data are insufficient to support an estimate of their incidence or to establish causation. The
listing is alphabetized: angioedema, blood glucose fluctuation, breast hypertrophy, erythema multiforme, elevated
liver function tests, fever, hyponatremia, jaundice, movement disorder, Stevens-Johnson syndrome. Adverse events
following the abrupt discontinuation of gabapentin immediate release have also been reported. The most frequently
reported events were anxiety, insomnia, nausea, pain and sweating.
DRUG INTERACTIONS
Coadministration of gabapentin immediate release (125 mg and 500 mg) and hydrocodone (10 mg) reduced
hydrocodone Cmax by 3% and 21%, respectively, and AUC by 4% and 22%, respectively. The mechanism of this
interaction is unknown. Gabapentin AUC values were increased by 14%; the magnitude of this interaction at other
doses is not known. When a single dose (60 mg) of controlled-release morphine capsule was administered 2 hours
prior to a single dose (600 mg) of gabapentin immediate release in 12 volunteers, mean gabapentin AUC values
increased by 44% compared to gabapentin immediate release administered without morphine. The pharmacokinetics
of morphine were not affected by administration of gabapentin immediate release 2 hours after morphine. The
magnitude of this interaction at other doses is not known. An antacid containing aluminum hydroxide and magnesium
hydroxide reduced the bioavailability of gabapentin immediate release by about approximately 20%, but by only 5%
when gabapentin was taken 2 hours after antacids. It is recommended that GRALISE be taken at least 2 hours following
antacid administration. There are no pharmacokinetic interactions between gabapentin and the following antiepileptic
drugs: phenytoin, carbamazepine, valproic acid, phenobarbital, and naproxen. Cimetidine 300 mg decreased the
apparent oral clearance of gabapentin by 14% and creatinine clearance by 10%. The effect of gabapentin immediate
release on cimetidine was not evaluated. This decrease is not expected to be clinically significant. Gabapentin
immediate release (400 mg three times daily) had no effect on the pharmacokinetics of norethindrone (2.5 mg) or
ethinyl estradiol (50 mcg) administered as a single tablet, except that the Cmax of norethindrone was increased by
13%. This interaction is not considered to be clinically significant. Gabapentin immediate release pharmacokinetic
parameters were comparable with and without probenecid, indicating that gabapentin does not undergo renal
tubular secretion by the pathway that is blocked by probenecid.
USE IN SPECIFIC POPULATIONS
Pregnancy Pregnancy Category C: Gabapentin has been shown to be fetotoxic in rodents, causing delayed
ossification of several bones in the skull, vertebrae, forelimbs, and hindlimbs. There are no adequate and wellcontrolled studies in pregnant women. This drug should be used during pregnancy only if the potential benefit
justifies the potential risk to the fetus. To provide information regarding the effects of in utero exposure to
GRALISE, physicians are advised to recommend that pregnant patients taking GRALISE enroll in the North
American Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll free number
1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at
the website http://www.aedpregnancyregistry.org/. Nursing Mothers Gabapentin is secreted into human milk
following oral administration. A nursed infant could be exposed to a maximum dose of approximately 1 mg/kg/
day of gabapentin. Because the effect on the nursing infant is unknown, GRALISE should be used in women
who are nursing only if the benefits clearly outweigh the risks. Pediatric Use The safety and effectiveness of
GRALISE in the management of postherpetic neuralgia in patients less than 18 years of age has not been studied.
Geriatric Use The total number of patients treated with GRALISE in controlled clinical trials in patients with
postherpetic neuralgia was 359, of which 63% were 65 years of age or older. The types and incidence of adverse
events were similar across age groups except for peripheral edema, which tended to increase in incidence with
age. GRALISE is known to be substantially excreted by the kidney. Reductions in GRALISE dose should be made
in patients with age-related compromised renal function. [see Dosage and Administration]. Hepatic Impairment
Because gabapentin is not metabolized, studies have not been conducted in patients with hepatic impairment.
Renal Impairment GRALISE is known to be substantially excreted by the kidney. Dosage adjustment is necessary
in patients with impaired renal function. GRALISE should not be administered in patients with CrCL between
15 and 30 or in patients undergoing hemodialysis [see Dosage and Administration].
DRUG ABUSE AND DEPENDENCE
The abuse and dependence potential of GRALISE has not been evaluated in human studies.
OVERDOSAGE
A lethal dose of gabapentin was not identified in mice and rats receiving single oral doses as high as 8000 mg/kg.
Signs of acute toxicity in animals included ataxia, labored breathing, ptosis, sedation, hypoactivity, or excitation.
Acute oral overdoses of gabapentin immediate release in humans up to 49 grams have been reported. In these
cases, double vision, slurred speech, drowsiness, lethargy and diarrhea were observed. All patients recovered with
supportive care. Gabapentin can be removed by hemodialysis. Although hemodialysis has not been performed in
the few overdose cases reported, it may be indicated by the patient’s clinical state or in patients with significant
renal impairment.
CLINICAL PHARMACOLOGY
Pharmacokinetics Absorption and Bioavailability Gabapentin is absorbed from the proximal small bowel by a
saturable L-amino transport system. Gabapentin bioavailability is not dose proportional; as the dose is increased,
bioavailability decreases. When GRALISE (1800 mg once daily) and gabapentin immediate release (600 mg three
times a day) were administered with high fat meals (50% of calories from fat), GRALISE has a higher Cmax and lower
AUC at steady state compared to gabapentin immediate release. Time to reach maximum plasma concentration
(Tmax) for GRALISE is 8 hours, which is about 4-6 hours longer compared to gabapentin immediate release.
NONCLINICAL TOXICOLOGY
Carcinogenesis, Mutagenesis, Impairment of Fertility Gabapentin was given in the diet to mice at 200,
600, and 2000 mg/kg/day and to rats at 250, 1000, and 2000 mg/kg/day for 2 years. A statistically significant
increase in the incidence of pancreatic acinar cell adenoma and carcinomas was found in male rats receiving the
high dose; the no-effect dose for the occurrence of carcinomas was 1000 mg/kg/day. Peak plasma concentrations
of gabapentin in rats receiving the high dose of 2000 mg/kg/day were more than 10 times higher than plasma
concentrations in humans receiving 1800 mg per day and in rats receiving 1000 mg/kg/day peak plasma
concentrations were more than 6.5 times higher than in humans receiving 1800 mg/day. The pancreatic acinar cell
carcinomas did not affect survival, did not metastasize and were not locally invasive. The relevance of this finding
to carcinogenic risk in humans is unclear. Studies designed to investigate the mechanism of gabapentin-induced
pancreatic carcinogenesis in rats indicate that gabapentin stimulates DNA synthesis in rat pancreatic acinar cells
in vitro and, thus, may be acting as a tumor promoter by enhancing mitogenic activity. It is not known whether
gabapentin has the ability to increase cell proliferation in other cell types or in other species, including humans.
Gabapentin did not demonstrate mutagenic or genotoxic potential in 3 in vitro and 4 in vivo assays. No adverse
effects on fertility or reproduction were observed in rats at doses up to 2000 mg/kg (approximately 11 times the
maximum recommended human dose on an mg/m2 basis).
© December 2012, Depomed, Inc. All rights reserved. GRA-410-P.1
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