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efta-efta01114703DOJ Data Set 9OtherJnging the Face of Pain Management
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Jnging the Face of Pain Management
12 Complementary and Alternative Medicine
19 Practical Aspects in Pelvic Pain Treatrr
t You Eat: Managing Chronic Pain
14 Treating Post-deployment Chronic Pain
20 Talk on Analgesia Explores New
ossification and Treatments: Master Class
in Challenging Populations
18 Chronic Pain Problems Among the
Medically Underserved
22
Appraoches to Pain Management
Taking a Better Look at Drug Interad
Ig the Concept of the Integrated
linic Means Demonstrating Verifiable
Icy
rry approach to pain management produces the best outcomes for patients. Clinicians who
this approach must avoid repeating the mistakes of the past and concentrate on providing
service.
Discrepant Goals in Pain
int: Strategies for Balancing
rsician, and Other
r Needs" (SIS-19)
ice' E. Schatman, PhD, CPE, DASPE
y, September 8
1- 12:10pm
al 4, Mont-Royal Ballroom
rdisciplinary pain dinics are an endangered
patient numbers keep dwindling, and their
Ming, all because financial considerations of-
elfare.
ernment would compel hospitals to main-
rce insurers to cover treatment, says Mi-
1, PhD, CPE, DASPE, Executive Director of
r Ethics in Pain Care. Until such mandates
Schatrnan. "This strategy works because interdisciplinary pain
management really does help nearly all stakeholders. The trick is
learning to demonstrate that:
To ilustrate the challenges pain specialists face, Schatrnan will
start by tracing the sad decline of interdisciplinary pain manage-
ment and explaining why a nation that had more than 1,000
integrated drics in 1998 has fewer than 100 today.
Integrated pain management clinics initially opened, both
inside hospitals and independently, because researchers consis-
tently found that coordinated teams of complementary pain spe-
cialists—usually a physician, a psychologist, a physical therapist, a
nurse practitioner, and possibly several others—provide the best
care for serious chronic pain.
Indeed, the research looked so good that insurers became (by
their standards) positively enthusiastic about pain clinics, many
of which responded to the easy money by adding services and
padding bills. Worse, the flow of insurance money inspired under-
qualified (and occasionally dodgy) practitioners to open their
own clinics to make a quick buck.
Costs rose. Outcomes worsened. Insurers began slashing
reimbursement rates and dropping coverage altogether. Clin-
rs to see things from the other
rspective and show how he benefits
or desired course of action. This
works because interdisciplinary
nagement really does help nearly
holders. The trick is learning to
rate that.
RECAP
Research into the Intl
of Music and Neuroi
tion May Unlock Nel
Treatments
New data is demonstrating the heali
of music and suggesting new applica
management
everal presentations during PAINWeek
S
tny
the ways in which the brain interacts 1
, pail. On Tuesday, Michael B. Elko.
Daniel F. Cleary presented on the ways ii Ali
can help to aleviate pero. On Wednesday, Reb
spoke about how our brains can be positively
pail differently. The trend contrwed Friday n
tin by Maio J. Trans, MD, PhD, Director Insi
Brain Science; Department of Neurology, Dc
of Medicine at UCLA. Fis presentation, 'The
Nesomodulation of Pain Responses," provided
how the human brain processes sound.VVhileT
adze in the management of pain, he has pa
studies that have examined the correlation b
that way it inpads our bodies.
Tramo began by telling the audience tha:
sic as a healing power dates bock thousand!
mythology, Apollo was associated with both
Asclepius, a Greek god of healing, was belie.
help rid sick patients of their disease. While tl
cal figures, the fact is that there have been
anecdotal reports over the centuries about tio
ameliorate pain and suffering across a wide
eases, and clinical settings. Yes, it is important
when dealing with any kind of anecdotal dc
some of these recounted experiences have I-
study of the correlation of music and healing
There is also a growing body of evidence
ized-controlled trials demonstrating music's of
agement, said Tramo. He went on to discus
ing the pathways by which the brain proces
that, basically, our brains have an auditory N
(con
over, Schatman has some advice for cli-
to revive the integrated pain program,
ore today at PAINWeek 2012 during his
ics began losing money. Then many of them shut their doors.
Needlessly, according to Schatman.
"Patients suffered because everyone got greedy," Schatman
Experience the expanded Living Bey
a "multimedia showcase that presen
EFTA01114703
r rain management in America
)ents touch on all aspects of the delivery of quality pain care—from the research laboratory to
ambers across the nation.
the exam room, from the courtroom
ents in Law and Public
ications for Pain Care
3" (SIS-20)
mei C. Barnes, JD
y, September 8
20pm
≥I 4, Mont-Royal Ballroom
nth isn't the only thing that will change how
ciafists treat patients in the upcoming year.
•ange of recent legal, financial, and cultural
an more to affect standards of care.
nes, JD, managing partner of DCBA Law
Igton, will outline the most relevant recent
n what they could mean for pain clinicians
in his presentation this evening, "Current
d Public Policy: Implications for Pain Care
legislators, regulators, and journalists have
terested in pain management recently, and
iuch in the past year to exercise their power
is and their patients.
are starting to worry about prescription drug abuse. He says
that "Pain specialists may think they can't possibly hear any
more about the dangers of opioid abuse, but they haven't
heard anything yet. The issue has finally reached a tipping
point in terms of mainstream media coverage, which means
coverage will perpetuate itself, probably until the problem is
'solved" in the public mind. Barnes notes that in the past year or
two, "nearly every major newspaper in America has published
articles highlighting the fact that prescription opioid overdoses
kill more people each year than car crashes in some states,"
along with other now-familiar factoids about the effects of pre-
scription opioid abuse and misuse. In the wake of these news
reports, celebrity overdoses continuing to make headlines, and
sensational media accounts of "addicted babies: Barnes says
that "we've already seen an uptick in opioid-related legislation,
regulation, litigation, and prosecution. And more is coming.
Probably a lot more:
Another important trend is that pain advocacy groups are
losing funding and power. Barnes says that concerns about
the opioid abuse problem were already deterring donors, even
before this year's public relations nightmare in which investiga-
tions shined a spotlight on the close ties between some phar-
maceutical companies and advocacy groups. Oddly, these in-
vestigations come just as drug makers—worried that efforts to
curtail opioid abuse will slash overall sales and profits—are cut-
ting expenditures on pain advocacy. Pain advocacy groups are
thus losing money from all sides at the very moment when their
Pain specialists may think they can't
possibly hear any more about the dangers
of opioid abuse, but they haven't heard
anything yet. The issue has finally reached
a tipping point in terms of mainstream
media coverage.
potentially influential events is huge: hun-
•ds each year, certainly: says Barnes. "The
sense of them is to look for trends, and I've
nes that people who treat pain really should
inderstand:
iccording to Barnes, is that more Americans
message about the importance of treating pain is falling out
of favor. As a consequence, Barnes warns that pain specialists
and advocates could see their ability to influence legislatures,
insurers, and the public decline.
Addiction treatment may become a major component of
pain care. Because their expertise would, in theory, allow them
to spot opioid abuse (or even potential abu
patients overcome any problems that develc
selors strike many as a natural fit for pain ilia
few insurers cover addiction treatment, whi
a non-starter, until the Affordable Care Ac
law mandates coverage for addiction treatn
financially feasible opportunities for pain p
to serve patients better (and, potentially, r
ity), either by hiring their own counselors or I
third-party treatment programs.
"Most of the people in the audience prob
to like hearing most of what I have to say," Bc
is different. This is a real opportunity for care
The greater legal risks faced by dinicians
oids "too freely" is another trend that should
attendees, says Barnes. Criminal prosecutions
mills and "careless" practitioners are on the
California stood trial for second-degree murd
patients overdosed. The local DA argued that
ment that there was nothing she could do tc
from taking a month's worth of pills in one da
ful omission, and thus justified the murder chc
Civil suits are dso on the rise, both against dc
companies. In one case, a family landed survh
workers compensation policy after their relative
opioids for an on-the-job story overdosed. Insu
ginreig to increase restrictions on coverage of c
According to Barnes, tamper-resistant op
make-or-break moment. This is an issue becc
studies suggest that new formulations do inc
often quite dramatically—financial considerati
from the market unless the government mand
become tamper resistant. Today's tamper re
are more expensive, branded products. Man
pay for them, and most generic drug maker
licensing fees to make their products tamper t
Finally, Barnes says that clinicians who pn
soon need extra training courses. A couple
ready mandated new educational prograrr
prescribes controlled substances. Many oche
ering it, as is the US Congress.
"The first trend — growing public concern
drug abuse — underlies all the others," Barnes
bly drive more changes to the industry than a
ued from cover)
4 respond to or get excited by sound. Based
terprets these sounds, our body gives a natural
had the experience of going to the dentist and
g 11 our teeth. How many of us have grabbed
clenched our hands to try and decrease the
rt we are having in our mouths? Any of us who
evoking the gate theory for pain. We are alo-
observe the effects in a controlled environment. Although it was a
small-scale study (seven control babies, seven test babies), Tramo
said it prodcued some interesting results. The music "created a lot
of stabiTrty and lowered the blood pressure of those infants that it
was played for: Although only two of the four babies who had
not heard the music stopped crying following the heel stidc, all four
infants who hod been able to hear the music stopped crying.
Tramo told the audience to keep an eye on a relatively new journal
EFTA01114704
UPIWeek:
e to the fourth and final day of the conference.
hedule today features the four sessions of this
Complementary and Alternative Medicine
presentation that focus on pain medicine nurs-
resented by pain management experts from the
*ion, the second half of the pharmacotherapy
lule also includes a trio of sessions on regional
cluing pelvic pain, arm and hand pain, and
("phantom tooth pain"). The Special Interest
cover topics in pharmacy-based pain services,
ferences in pain management, new develop-
Kiblic policy, and the influence of various pain
',alders on the physician-patient relationship.
it 7:00am with Hal S. Blatman, MD, present-
thition aid pain that will explain the ways in
s in our patients' diets actually stop their bod-
nd get in the way of rehabilitation? Blatman
ecific nutrients that will augment healing and/
luce pain? Debra J. Drew, MS, ACNS-BC,
ie the challenges associated with pain assess-
care setting, especially in special populations.
sr, Phenyl!), BCPS, will give a talk on phar-
pharmacokinetic
pain and paVia-
M. Fitzgerald,
e epidemiology
le chronic pelvic
s in pathophysi-
diagnosis, and
s and treatment
irome.
ert A. Bonak-
iew the preva-
nd most con-
'pies as well as
ne patient con-
complementary
spies in pain management. Helen N. Turner,
4S-BC, on the use of multimodal analgesia in
She will also cover various nonpharmaceuticol
to be effective additions to multimodal pain
McPherson, Phenyl!), BCPS, will elucidate
cokinetic and phormacodynamic properties of
mysterious methadone," covering a range of
propriate titration strategies as well as how to
inverted from another drug to methadone?
first of three satellite programs scheduled for
'atients and Your Practice: The Role of Drug
pin and Risk Management," sponsored by Alere
hire Jennifer E. Bolen, JD, and Jeffery A.
issing practical approaches to incorporating
comprehensive chronic pain and risk manage-
theft A. Bonakdar, MD, continues the
id Alternative Medicine track with "Overview
Dietary Supplements," during which he will
ace of supplement use in specific pain condi-
medication facts." Roger B. Fillingim, PhD, will discuss sex and
gender differences in pain management and explore possible
answers to the question "Do we need pink and blue pills?"
Cam-Ann Gibson, MD, and Ilene R. Robeck, MD, will exam-
ine key topics and challenges in evaluating and treating chronic
pain in veterans following deployment.
Following the morning break, at 11:10am, Lora McGuire,
MS, RN, will explore topics in the management of postoperative
pain, induding preemptive analgesia, special methods of delivery
of pain control, and nonopioid, opioid, and adjuvant analgesics.
Srinivas Nalamachu, MD, will discuss the clinical characteris-
tics, assessment diagnosis, and treatment of arm aid hand pain.
Michael E. Schatrrtan, PhD, will talk about the evolving
influence of non-patient and non-physician stakeholders in pain
management (insurance, hospital, pharmaceutical, implantable
device, and urine drug testing industries, etc) and explain why
these various actors must coalesce into a "mutually cooperative
system' if the suffering of pain patients is to be ameliorated.
At 12:30pm, the schedule features the final two satellite events
of PAINWeek 2012. The faculty of "Persistent and Breakthrough
Pain: Responsible Opioid Prescribing for Multidimensional
Disorders" will consolidate clinically relevant scientific studies and
evidence-based
guidelines
into practical approaches to
persistent pain and break-
through pain assessment,
responsible opioid prescrib-
ing, and repeated re-eval-
uation of patient outcomes.
"Mission: Pain Management
- The Efficient First Visit (An
IDEAL® Clinical Encounter)"
v/il discuss nociceptive, neu-
ropathic, and centrally-me-
diated chronic pain; the risks
and benefits of nonpharma-
cologic and pharmacologic
treatments for chronic pain; barriers to the optimal use of opioid
analgesics in chronic pain; and methods for screening and risk miti-
gation in the initial and follow-up care of patients with chronic pain.
At 2:10pm, Hal S. Blatman, MD, will present "a wide range of
options for treatment, recovery, and body maintenance fa a healthy
aid pain-free life" for women at midge. Bill Paquin, CEO of Vertical
Health, will explore "the pivotal role that Web aid mobile applications
wi ploy to both increase the efficiency of physician practices and
improve patient outcomes" in pain management. Edward S. Lee,
MD, and Tu A. Ngo, PhD, MPH, will offer a plenary session focus-
ing on managing psychiatric comorbidties in chronic pain. Gary W.
Jay, MD, will present a master class on the differential diagnosis and
management of migrare and tension-type headache.
Following the afternoon break, Carol P. Curtiss, MSN,
RN-BC, will discuss key principles involved in balancing effective
pain management and saeening for risk of substance misuse and
addiction in persons with pain. Peter A. Foreman, DDS, will
examine the difficult diagnostic and treatment challenges
associated with orofacial neuropathies. Mary Lynn McPherson,
PharmD, and Kathryn A. Walker, PharmD, will duke it out as
Today's Schedule of
Recommended Cou
for First-time PAINVI
Attendees
7:OOam-8:OOam
Nutrition and Pain: Simple R
for Pain-Free Health
Hal S. Blatman, MD
7:OOam-8:OOam
Pelvic Pain
Colleen M. Fitzgerald, MD
8:10am-9:10am
Analgesia: What are the Op
Helen N. Turner, DNP, RN-BC, PCN
9:20am-10:20am
Speed Dating with Pharmaci
50 Top Medication Tips at Er
Mary Lynn McPherson, PharmD, BC
Kathryn A. Walker, PharmD, BCPS
11:10am-12:10pm
Pre- and Postop Pain Manag
Lora McGuire, MS, RN
2:10pm-3:10pm
Women on the Verge: Sleep,
and Pain at Midlife
Hal S. Blatman, MD
5:20pm-6:20pm
VA Health Care: This is Not
Your Father's VA
Lucile Burgo-Black, MD, and Stephi
MD, MPH
EFTA01114705
rTeCT In leOTIenTS IGKIng Up10105 nor
is Pain
'WV
wescribe opioids should be aware of the symptoms of opioid-induced constipation
of the pharmacologic options for managing this condition
goid-kiduced Constipation: Considerations to
'propriate Early Targeted Therapy for Better Pa-
ernes," a CME-accredited session yesterday at
at focused on opioid-induced constipation, its
and the pharmacologic options that are co-
rrect this condition, presenters Bil McCarberg,
O; and Michelle Rhiner, RN-BC, MSN, provided
motion that clinicians can apply to daily practice.
e session by talking about the scope of the
induced constipation (OIC). Because prescrip-
most commonly used medications in the pain
alGative care settings, and because OIC is one
ients with chronic
experience OIC to
gree. In fact, OIC
ed in up to 90%
its with cancer
I 80% of patients
mic nonmalignant
:cause chronic pain
of the most common adverse side effects associated with chronic
opioid therapy,' Rhiner said that most patients with chronic pain
will experience OIC to some degree. In fact, OIC is reported in
up to 90% of patients with cancer pain and 80% of patients with
chronic nonmalignant pain. She noted that because chronic pain
patients rarely develop a tolerance to OIC, most of them will re-
quire some form of pharmacologic therapy for constipation (up
to 94% of patients with advanced illness who take opioids need
laxatives, the most commonly used therapy for OIC).
Untreated or undertreated OIC can compromise pain manage-
ment in patients with cancer. Rhiner said that surveys have shown
that O1C can cause patients to switch to switch to a different opioid,
reduce their opioid dose (either in conjunction with their health care
provider, or on their own without telling their provider), or even stop
taking opioids altogether. Patients with OIC also use more health
coy resources (they have more hospital admissions and doctor visits,
use more home health services, etc). Rhiner said that OK also has
a negative impact on quality of life and functionality in patients with
chronic noncancer pain, leading to missed work, reduced productiv-
ity, and compromised mental and physical health.
Rhiner concluded her portion of the session by briefly review-
ing normal colorectal functional processes. She said that bowel
function is "governed by the enteric brain, an organ comprised of
billions of neurons," and that any disruption in the neurotransmit-
ter and mechanisms that regulate bowel function (such as those
produce by opioids) can lead to constipation and bowel dysfunc-
tion. She said that OK results when opioids bind with periphery
sensors in the gut and in the enteric system.This affects not only the
colon, but other components of the boweVgastrointestinal system,
producing a spectrum of opioid-induced bowel dysfunction. This
can indude cramping, bloating, decreased appetite, nausea and
other symptoms in addition to constipation. She said that many of
these symptoms are often missed by patients and providers and
not attributed to the patient's opioid therapy.
Assessing patients for OIC and selecting an appropriate
management option
During his portion of the presentation, McCarberg discussed the
assessment and management of OK. He said that "there we no
good diagnostic criteria for OIC." Although many patients and cli-
nicians focus on stool frequency when discussing O1C, McCarberg
said that this might not provide a complete picture because "there
is wide variabMty in stool frequency" from patient to patient. Thus,
when assessing patients for O1C, clinicians should also focus on
other factors, such as those outlined in the Rome III criteria for
functional constipation. McCarberg reminded the audience that
these are not necessarily for O1C, just for functional constipation.
There are no OIC-specific criteria:
When assessing patients for O1C, taking a history is important
to find out the patient's normal boweVdefecation routine in order
to establish a baseline. "You have to ask the right questions" about
the patient's previous and current bowel pattern and activity level,
their amount of daly fiber and fluid intake, and laxative use prior
PAINWeek Administ
Redza Ibrahim
Advertising, Sponsorships, Satellite Events
Darryl Fossa
Art Oiled on and Graphic Design
Steve Porada
Corporate Relations
Debra Weiner
Course Development
Holly Caster
Editorial Services
Michael Shaffer
Exhibit Sales', Management
Wanda Tarnoff
Finance
Keith Dempster
Mock Relations
Benjamin R. Metzger, MD
Meckal Direction
Jeffrey Tamoff
Operations and Technology
Charles Brown
Program Management
Patrick Kelly
Web and Print Production
Pain Management
Jack Lapping
vke President, Sales
Steve Porcelli
Director of Sales
Cowie Payson
Notional Accounts Manager
Megan O'Connell
Soles & Marketing Coordinator
Todd Kunkler
Editor
Silas Inman
Web Editor
Stephanie Ogozaly
Assistant Web Ecitor
John Salesi
Art Director
John Burke
Group Director. Ciro,'otion & Production
MJH & Associates
Mike Hennessy
Choir man /Chief Executive Officer/President
Tighe Blazier
Chief Operating Officer
Neil Glasser, CPA/CFE
EFTA01114706
I
itoring gives you the
IGHTof Rx Guardian CDs"
you to compare your patient to a database
nts clinically assessed for adherence.
2 5
The Rx Guardian
(normalized drug
with other clinica
indicate that if yo
pain patient falls:
• Within -2.0 to
higher likeliho
• Outside -2.0 to
a possibility of
Your patient's sta
are tracked over t
identify patterns.
ivardianC,D" with the new Rx Guardian INSIGHT Rel
)vative tool to help assess adherence in your chronic pain patients.
RECEDENTED SCIENCE
'X GUARDIAN CD'"
•
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lizes a proprietary, dynamic database of
)re than one thousand chronic pain patients
lically assessed for adherence
advanced proprietary algorithm creates
formalized value based on your patient's
ysiological variables
ur patient's normalized results are compared
this proprietary database to help you assess
ur patient's adherence
■ Standard scores are tracked over time
to help:
—Detect patterns of results that could
indicate misuse, abuse, or diversion
—Identify possible drug metabolism is!
Identify illicit drug use
Identify the absence of medications
prescribed by you, as well as the presenc
of medications you did not prescribe
cally advanced urine drug monitoring system is brought to you by Ameritox, the leade
ledication Monitoring". Together with your expertise, Rx Guardian CDS with the Rx GI
Report can help you make clinical decisions to enhance the care of your chronic pain
Booth #114, to learn more about Rx Guardii
EFTA01114707
Kiln-fighting diet that calls for eliminating trans fats, artificial sweeteners, nutritionally deficient foods, digestive tract disruptors, and oth
dients, patients may be able to effectively reduce the severity of their pain without the use of prescription medications.
and Pain: Simple Rules for
lealth" (CAM-Ol)
S. Blatman, MD, DAAPM, ABIHM
y, September 8
)0am
'13, Castellano 1
e owes much of its success to a quality that's
I among foodstuffs: an utter inability to sup-
)st forms of life.
) eat it. Mold takes no root inside it. Even
e it a miss. Industrial food makers, who have
a mirade ingredient that can cut costs and
)ave made it one of the most common ingre-
humans
,ond all
pds" that
says Hal
DAAPM,
argarine
yedients
make us
will ex-
hINWeek
wesenta-
nd Pain:
'ain-Free
actively
Others
I stop our
what they are designed to do: heal them-
prevent medications from working properly:
) runs the Blatman Pain Clinic in Cincinnati.
rods and your patients will hurt less. They'll
er to opioid medications—and develop less
:an prescribe lower doses and stop worrying
sing down your door."
:nt the past couple of decades testing ingre-
fighting diet he will outline during his talk. He
very credible book and study he can find on
le conducts tiny experiments, first on himself,
I friends, and finally on patients.
of testing have left him with a reasonably
elines that seem to provide at least some
every patient who sticks to them for any
tman says that he cannot scientifically prove
mess because he recommends it to every
in maintaining control groups, but he be-
hypothesize from what I've read about the mechanisms by
which particular compounds increase pain. But case after case
demonstrates a major impact. It's common for my patients with
fibromyalgia to report that pain goes down by as much as half
when they eliminate all artificial sweeteners," Blatman says.
The insufficiently nutritious category includes many of the
usual suspects: sugar, potatoes, fruit juices, and many other
foods with high glycemic indexes.
As for the digestive tract disruptors, the list there includes
excessive red meat and all wheat products. "The gut plays an
incredibly important role in good health," Blatman says. "The
good flora that are inside of it break down your food so you
can absorb nutrients properly. They also keep your immune sys-
tem working right which is why patients with autoimmune dis-
eases get particular relief when they start eating a gut-healthy
diet."
Blatman's dietary recommendations are simple. Sticking to
them, however, can be tricky. Many diets advise patients to cut
back on certain foods and ingredients. Blatman tells patients to
avoid them completely, a maxim that requires not only iron self-
discipline but also frequent detective work. Many of the forbid-
den ingredients are found in a wide variety of foods, and often
turn up in unexpected places. Blatman remembers one patient
who "gave up" wheat but saw no health benefits--because she
had no idea about the wheat in her favorite soy sauce.
Patients must also be willing to wait long p
start to see any benefits. Blatman cautions
foods take weeks to work their way entirely
Others take as long as four months, and a
bite of the wrong thing can set the clock bac
can see significant benefits just by cutting be
ingredients I advise against, but in most case
only come from total abstinence: Blatman sr
Many patients, obviously, will sabotage th.
ing here and there. Many end up simply at
altogether.
"Patients obviously have the right to cho
but I make it clear to them that they are doir
ing to be in pain. I also make it clear to the
changes come before any unusually large
Blatman says.
"If they follow the diet religiously and the
try what I can to fix that. But if the pain isn't e
a patient to eat better, then it certainly isn't k
to risk his or her health by increasing the op
and again," Blatman says. "This diet isn't an e
anything, but it produces very impressive res
and it can do the same for yours."
"Eliminate problem foods and ingredients and youi
patients will hurt less. They'll also respond better tc
medications—and develop less tolerance—so you cal
prescribe lower doses and stop worrying about the
kicking down your door."
EFTA01114708
fective 24-hour pain control'
nce-daily oral dosing with
e evening meal'
)w incidence of dizziness
id somnolence'
:ration to an 1800 mg dose
2 weeks'
was a reported incidence of dizziness
) vs 2.2% placebo) and somnolence
vs 2.7% placebo) at 1800 mg once daily?
nore information,
3e visit Booth 316.
ition and Usage
ISE' is indicated for the management of
Drpetic neuralgia (PHN). GRALISE is not
)angeable with other gabapentin products
Ise of differing pharmacokinetic profiles
fect the frequency of administration.
-tant Safety Information
ISE is contraindicated in patients who have
nstrated hypersensitivity to the drug or its ingredients.
ileptic drugs (AEDs) including gabapentin, the active ingredient in GRALISE, increase
suicidal thoughts or behavior in patients taking these drugs for any indication. Patient:
with any AED for any indication should be monitored for the emergence or worsenir
)ression, suicidal thoughts or behavior, and/or any unusual changes in mood or beha%
lost common adverse reaction to GRALISE (5% and twice placebo) is dizziness.
3 all GRALISE clinical trials the other most common adverse reactions (2%) are
Dlence, headache, peripheral edema, diarrhea, dry mouth, and nasopharyngitis.
'pes and incidence of adverse events were similar across age groups except for
leral edema, which tended to increase in incidence with age.
;ee next page for Brief Summary of Prescribing Information,
V.
14311-Hil+)+0
- • ,
Watch how GRALI:
r rin technology works
z Scan the barcode to view
the video at
/0-1
•
EFTA01114709
antuntunata tiacnue natas t tat um %ea...maw at um picouniscin.
Dose should be adjusted in patents with reduced renal function. GRALISE should not be
h Gra less than 30 or in patents on hernodialysis.
emetic neuralgia. GRALISE therapy should be initiated and nitrated as follows:
ommended Titration Schedule
Day 2
Days 3-6
Days 7-10
Days 11-14
Day 15
600 mg
900 mg
1200 mg
1500 mg
1800 mg
S
ated in patients with demonstrated hypersensitivity to the drug or its ingredients.
age Based on Renal Function
Once-daily dosing
GRALISE dose (once daly with evening meal)
1800 mg
600 mg to 1800 mg
GRALISE should not be administered
3digysis
GRALISE should not be administered
CAUTIONS
engeable with other gabapentin products because of differing pharmacokinetic profiles that
administration. The safety and effectiveness of GRALISE in patients with epilepsy has not been
(prior and Ideation Antiepileptic drugs (AEDs). including gabapentn. the active Ogredient in
risk of sticidal thoughts or behavior in patients taking these drugs for any indication. Patients
ir any ideation should be monitored for the emergence or worsening of depression, suicidal
nd/or any unusual changes in mood or behavior.
ation for Antiepileptic Drugs (including gabapentin, the active ingredient
Jed Analysis
vents per 1000 patients
its per 1000 patients
of events in
3in placebo patients
nal drug patients
atients
Epilepsy
Psychiatric
Other
Total
1.0
5.7
1.0
2.4
3.4
8.5
1.8
4.3
3.5
1.5
1.9
1.8
2.4
2.9
0.9
1.9
*dal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials
=dittos, but the absolute risk dif ferences were similar for the epilepsy and psychiatric
isiderng prescribing GRALISE must balance the risk of suicidal thoughts or behavior with
less. Epilepsy and many other illnesses for wtich products containng active components
gabapenfin. the active component n GRALISE) are prescribed are themselves associated
tarry and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and
I treatment. the prescriber needs to consider whether the emergence of these symptoms
y be related to the illness being treated. Patients, their caregivers. and families should be
contains gabapentin %Mich is also used to treat epilepsy and that AEDs increase the risk of
ehavior and should be advised of the need to be alert for the emergence or worsening of the
depression. any unusual changes in mood or behavior, or the emergence of suicidal thoughts.
bout self-harm. Behaviors of concern should be reported immediately( to healthcare providers.
actin Gabapentin should be withdrawn gradualy. If GRALISE is discontinued. this should
a minimum of 1 week or longer (at the discretion of the prescriber). Tumorigenic Potential
vivo lif etime carcinogenicity studies, an unexpectedly high incidence of pancreatic acinar
identified in male. but not female. rats. The cinical significance of this finding is triknoym.
pentin therapy in epilepsy comprising 2,085 patient-years of exposure in patients over
imam were reported in 10 patients, and preexisting tumors worsened in 11 patients, during
fiscontinung the drug. However, no similar patient population untreated with gabapentin was
:kground tumor incidence and recurrence nformaton for comparison. Therefore. the effect
in the incidence of new tumors in humans or on the worsenng or recurrence of previously
Morn. Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)!
°silkily Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known
nsitivity. has been reported in patients taking antiepileptic drugs, including GRALISE. Some
een fatal or life-threatening. DRESS typically, although not exclusively. presents with fever,
!nopathy in association with other organ system involvement. such as hepatitis. nephritis,
elites. myocardits, or myositis. sometimes resembling an acute viral infection. Eosinophilia
ise this disorder is variable in its expression, other organ systems not noted here may be
t to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy,
lough rash is not evident. If such signs or symptoms are present, the patient should be
. GRALISE should be discontinued it an alternative etiology for the signs or symptoms
Laboratory Tests Clinical trial data do not indicate that routine monitoring of clinical
s necessary fa the sate use of GRALISE. The value of monitoring gabapentin blood
been established.
S
ence Because clinical trials are conducted under widely varying conditions, adverse reaction
itical trials of a drug cannot be directly compared to rates in the cinical trials of another
:t the rates observed in practice. A total of 359 patients with neuropathic pain associated
ilgia have received GRALISE at doses up to 1800 mg daily during placebo-controlled cfrical
. in patients with postherpetic neuralgia, 9.7% of the 359 patients treated with GRALISE
its treated with placebo discontinued prematurely due to adverse reactians. In the GRALISE
ost common reason for discontinuation due to adverse reactions was dizziness. Of GRALISE-
:perienced adverse reactions in clinical studies, the majority of those adverse reactions were
ate'. Table 4 lists all adverse reactions, regardless of causally, occurring n at least 1% of
It pain associated with postherpetic netralgia in the GRALISE group for which the incidence
placet:0 group
nergent Adverse Reaction Incidence in Controlled Trials in Neuropathic Pain
therpetic Neuralgia (Events in at Least 1% of all GRALISE-Treated Patients and
in the Placehn Gronnl
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 followng adverse reactionswith
relationship to GRALISE were reported during the clinical development for the treatment of posthr
Events in we than 1% of patients but equally or more frequently in the GRALISE-treated patient
the placebo group included blood pressure increase, confusional state, gastroenteritis viral. herp
hypertension, joint swelling, memory impairment. nausea, pneumonia, pyrexia, rash, seasonal all
respiratory infection. Postmarlceting and Other Experience with other Formulations of Ga
addition to the adverse experiences reported during clinical testing of gabapentin, the following ad
have been reported n patients receiving other formulator's of marketed gabapentin. These adverse
not been fisted above and data are insufficient to support an estimate of their incidence or to establ
fistng is alphabetized: angioedema, blood glucose fluctuation, breast hypertrophy, erythema multi(
liver function tests, fever. hyponatrernia. jaundice. movement disorder, Stevens-Jdrison syndrome.
followng the abrupt discontinuation of gabapentin immediate release have also been reported. The
reported events were anxiety, insomnia, nausea, pain and sweating.
DRUG INTERACTIONS
An increase in gabapentin AUC values has been reported when admiristmed with hydrocodone
with morphine. An antacid containing aluminum hydroxide and magnesium hydroxide reduced lt
of gabapentin immediate release by about approximately 20%, but by only 5% when gabapentir
2 hours after antacids. It is recommended that GRALISE be taken at least 2 hours following antaci
There are no pharmacokinetic interactions between gabapentin and the folowing antiepileptic drui
carbamazepine. valproic add, phenobarbital. and naproxen. Cimefidne decreased the apparent or
gabapentin by 14% and creatinine clearance by 10%. The effect of gabapentin immediate release
was not evaluated. This decrease is not expected to be clinically significant. Gabapentb immediate
three times daily ) had no effect on the pharmacokinetics of nmethindrone (2.5 mg) or ethiwl esti
administered as a single tablet, except that the Cin, of norethindrone was increased by 13%. This
considered to be clinically significant. Gabapentil immediate release pharmacokinetic parameters
with and without probenecid, indicating that gabapentin does not undergo renal tubular secretion t
that is blocked by probenecid.
USE IN SPECIFIC POPULATIONS
Pregnancy Pregnancy Category C: Gabapentin has been shown to be fetotoxic in rodents, causi
ossification of several bales in the skull, vertebrae, forelimbs. and hindlimbs. There are no adequati
controlled studies in pregnant women. This drug should be used dung pregnancy only if the potent
justifies the potential risk to the fetus. To provide information regarding the effects of in Om expos'
physicians are advised to recommend that pregnant patients taking GRALISE ergot in the North i
Antiepileptic Drug (NAAED) Pregnancy Registry. This can be done by calling the toll free number 1-I
and must be done by patients themselves. Information on the registry can also be found at the webs
aedpregnancyregistry.org/. Nursing Mothers Gabapentin is secreted into human milk folowiig
A nursed infant could be exposed to a maximum dose of approximately 1 mg/kg/day of gabapentin.
effect an the nursing infant is unknown. GRALISE should be used in women who are nursing only it
clearly outweigh the risks. Pediatric Use The safety and effectiveness of GRALISE in the manag
postherpetic neuralgia in patients less than 18 years of age has not been studied. Geriatric Use
of patients treated with GRALISE n controlled clinical trials n patients with postherpetic neuralgia
which 63% were 65 years of age or older. The types and incidence of adverse events were simile
groups except for peripheral edema, which tended to increase in incidence with age. GRALISE is
substantially excreted by the kidney. Reductions in GRALISE dose should be made in patients wit
compromised renal function. (see Dosage and Administration]. Hepatic Impairment Because g
metabolized, studies have not been conducted in patients with hepatic impairment. Renal Impai
is known to be substantially excreted by the kidney. Dosage adjustment is necessary in patients will
function. GRALISE should not be administered in patients with CrCL between 15 and 30 or in patier
hemodmtysis [see Dosage and Admitistrafion].
DRUG ABUSE AND DEPENDENCE
The abuse and dependence potential of GRALISE has not been evaluated n human studies.
OVERDOSAGE
A lethal dose of gabapentin was not identified in mice and rats receivng single oral doses as high as •
Signs of acute toxicity in animals included ataxia. labored breathing. Mosis, sedation, hypoactivity, c
Acute oral overdoses of gabapentin immediate release in humans up to 49 grams have been reports
cases, double vision, slurred speech, drowsiness, lethargy and diarrhea were observed. Al patients
supportive care. Gabapentin can be removed by hemocfmtysis. Although hemodialysis has not been
the few overdose cases reported, it may be ndicated by the patient's cinical state or in patients wit
renal inpairment.
CLINICAL PHARMACOLOGY
Pharmacokinetics AbsomPtion and Sioavalability Gabapentin is absorbed from the proximal small
saturable L-amino transport system. Gabapentin bioavaiabifity is not dose proportional: as the dose
bioavailability decreases. When GRALISE (1800 mg once daily) and gabapentin immediate release
times a day) were administered with high fat meals (50% of calories from fat), GRALISE has a bight
AUC at steady state compared to gabapentii immediate release. Toe to reach maximum plasma a
for GRALISE is 8 hcsirs.whth is about 4.6 hours longer compared to gabapentin immediate Meas.
NONCLINICAL TOXICOLOGY
Ca rcinogenesis, Mutagenesis, Impairment of Fertility Gabapentin was given in the diet to rr
600. and 2000 mg/kg/day and to rats at 250. 1000. and 2000 mg/kg/day for 2 years. A statistic
increase in the incidence of pancreatic acinar cell adenoma and carcinomas was found in male rat
high dose; the no-effect dose for the occurrence of carcinomas was 1000 mg/kg/day. Peak plasm
of gabapentn in rats receiving the high dose of 2000 mg/kg/day were more than 10 times higher
concentrations in humans receiving 1800 mg per day and in rats receiving 1000 mg/kg/day peal
concentrations were more than 6.5 times higher than n humans receiving 1800 mg/day. The pant
carcinomas did not affect survival, did not metastasize and were not locally invasive. The relevana
to carcinogenic risk in humans is unclear. Studies designed to investigate the mechanism of gabag
pancreatic carcinogenesis in rats indicate that gabapentin stimulates DNA synthesis n rat pancrea
in vitro and, thus. may be acting as a tumor promoter by enhancing mitogenic activity. It is not knot
gabapentin has the ability to increase cell proliferation in other cell types or in other species, ncbc
Gabapentn did not demonstrate mutagenic or genotoxic potential in 3 in vitro and 4 in vivo assays.
hunch/ rr .nn,, cenn wan nhenniarl in rate al .here urn In ,nnn ennArn lennmvirnehal
EFTA01114710
'the uassitications and treatments
sis and treatment requires an understanding of the signs, symptoms, and clinical presentation of the multiple forms of tension-type headache
rand Tension-Type
Differential Diagnosis and
ant" (MAS-06)
y W. Jay, MD, FAAPM, DAAPM
y, September 8
10pm
≥l 4, Nolita 3
;sfully address
' needs and to
lining treatment-
idverse outcomes,
Is need to be able
nine the type of
e their patient is
T
ee way headache specialists think about the relationship
between tension-type and migraine headaches has shift-
d considerably over the last several decades. At one
point, not that far back, people thought of headaches as a
spectrum; a straight line with tension-type headaches (BHA)
at one end and migraines at the other end. Everything in be-
tween were gradations," says Gary W. Jay, MD, FAAPM. He
says that the question nowadays is whether they are essentially
one headache with two different clinical pictures.
To bring attendees of PAINWeek 2012 up to speed on the
latest trends in headache medicine, Jay will present a two-hour
master class, "Migraine and Tension-Type Headache: NOT Two
Ends of a Spectrum!: on Saturday afternoon. During this com-
prehensive session, he will review the pathophysiologies and
varieties of migraine headaches and TTHAs, as well appropri-
ate treatment options.
According to Jay, a major challenge faced by health care
providers who treat patients with headache is recognizing the
multiple forms of TTHAs and migraines. "I will review what we
know about what happens in the brain, particularly different
forms of migraine headaches: says Jay.
When many people think about migraines, they still think
of the classical migraine headache—typically, a woman with a
one-sided throbbing headache who has pain that is triggered
by sound or light. Jay says that there are "multiple types of mi-
graine and they can occur with or without aura." He also notes
that the nature of aura varies widely, Aura is visual in 80 to 85
percent of patients; patients can have neurological aura that
may elicit speech difficulty or even hemiplegia."
To successfully address patients' needs and to avoid induc-
ing treatment-related adverse outcomes, physicians need to be
able to determine the type of headache their patient is experi-
encing. As an example, triptans and ergot alkaloids are typical
abortive treatments for migraines. "Both of these are vasocon-
strictors and you never want to offer them to a patient that may
have significant aura secondary to vasoconstriction," says Jay.
"This can cause further vasoconstriction and neurological deficit
and very possibly lead to long-term or permanent damage. It
can induce infarction:
The ability to differentiate between symptoms and possible
causes can have a profound impact on outcomes and quality
of life. if a patient calls you in the middle of night and tells
you something is happening, you need to be able to make
a decision on whether to meet them at the emergency room
as soon as possible: Jay says. In some visual auras, patients
may develop transient monocular vision loss. This presents simi-
larly to amaurosis fugax, a transient ischemic attack involving a
retinal artery. During his session, Jay will discuss strategies for
confidently and accurately assessing these types of episodes
and others.
Earlier this year, the American Academy of Neurology and
the American Headache Society jointly published updated
evidence-based guidelines on preventive pharmacologic treat-
ment for episodic migraine headaches. The guideline authors
used stringent evaluation criteria to review existing evidence.
ops," he says. "So what starts as possibly
becomes centralized."
In addition to reviewing TTHA pathophys
ments, Jay will talk about diagnostic criteria
mon TTHAs. Certain types of headaches a
reproducible patterns of pericranial muscle tc
ger point activation. "Pericranial muscle ten
multiple etiologies, but arises most commont
myofascial pain syndrome: says Jay. Myofa
along the masseter muscle refer pain to the
Trigger points may also elicit autonomic dysf,
in the sternodeidomastoid muscle where tri<.
sociated with lacrimation and redness, in ad
"An example of what often happens i≤
comes in with temporomandibular joint (TMJ
multiple surgeries for it, and the real problen
the TMJ is being referred by a muscle: says
In cases like this, "It is the job of the physi
what the patient needs: Physicians need to
origin of the pain. Jay hopes to convey the m
the right questions is an important part of tre
headaches. "Patients don't know what to tell
them what you need to know: he says.
Gary W. Jay is a neurological consultai
in pain and disorders of the central nery
president-elect of the Eastern Pain Associati.
tion of the American Pain Society. He is a f
the American Academy of Pain Manageme
Academy of Pain Medicine. He was one of I
the American Academy of Pain Medicine in
EFTA01114711
pain assessment means going beyond matching a patient's pain to a number on a scale; it requires dinicians to consider
ors and approaches.
anent in Acute Care" (NRS-01)
Ira Drew, MS, ACNS-BC, RN-BC
y, September 8
OOam
≥l 3, Gracia 7
,ent is gaining traction as an important faun-
:ment of pain management. In August 2012,
ommission issued a Sentinel Event Alert re-
m of opioids in the hospital setting. This pub-
he need to assess and monitor pain as part
management program.
specialists on this topic, Debra Drew, MS,
will present "Pain Assessment in Acute Care"
ek 2012. The presentation will provide an
ossessment, including tools and approaches
cial populations relevant to acute care set-
eed to understand the complexities of the
KI all its facets before they can design a plan
omfortable," says Drew.
nize the importance of viewing pain assess-
that involves much more than administering
iestionnaire to assign a score to the patient's
ion of good pain management begins with
assessment," says Drew. "Is the 0-10 pain in-
J think of when you think of pain assessment?
lot is 'yes,' you may be missing the boat:
entation, Drew will review the latest findings
pain assessment and discuss some of the
ted with pain assessment in special popula-
children and the elderly), as well as patients
>us, ventilated, or developmentally delayed.
)atients who can't verbalize their pain, who
Is what they are feeling or can't speak," says
cuss how to optimally assess pain when you
lenging population:
pain of patients in the intensive care unit
ologic measures like blood pressure or pulse
are often used to measure patient pain—represents one exam-
ple of a challenging pain assessment scenario. Because blood
pressure and pulse are not reliable pain indicators, providers
are often left feeling helpless when trying to manage pain
in this setting. "There are some observational tools that can
be introduced in the ICU that provide a better way to assess
whether or not a patient has pain, rather than relying on unreli-
able variables," she says. "Pain assessment and management
become complex when a patient cannot tell you what they are
feeling. The fad that pain is a totally subjective and complex
experience amplifies the difficulties:
For some challenging populations, nurses and physicians
may believe that pain assessment is not possible. But, Drew
asserts that there is no such thing as a patient who cannot be
assessed. "I would like to debunk that notion: she says. "There
ting. During her presentation, Drew will provi
for using the DIRE scale. "Primary care phys
very helpful because they are trying to make
guess on how to help their patients after thi
of the hospital," she says.
Drew cautions that comprehensive pain a
time to do properly. "But a good pain asses
time in the end because it will get a patient
without adverse events in the beginning," sF
try to take shortcuts because we are busy c
assessment up front it can lead to a lot of
redundancy later on and a lot of adverse at.
tient: She compares assessment with obtair
cal history and conducting a thorough ph)
"These take time, too; yet if you miss some
I think as a pain community we are realizing how li
those simple, unimodal pain measures are, especic
patients with chronic pain. I think there is going to
evolution where we will be focusing more and mor
pain and functional status.
is always something you can consider for each patient; some
patients are more complex than others, but they can all be
assessed: Drew will recommend approaches to consider for a
variety of special populations.
Drew's presentation will also offer attendees a summary of
assessment tools with which many providers are not comfortable
or familiar. Along with general background information on these
tools, she will provide a framework for how and when to use
them in practice. She will also offer clinical examples throughout
the presentation to supplement the information provided.
She will also relate assessment to patient selection for chron-
ic opioid analgesia. The Diagnosis, Intractability, Risk, Efficacy
(DIRE) scale is an example of a tool that can be used to help
practitioners decide whether their patient is a good candidate
for long-term opioid therapy. It takes into account factors like
substance abuse history and characteristics of the home set-
badly for the patient:
Drew also plans on talking about the emi
of functional status as it relates to pain. In
ment focused on pain intensity. "I think as a r
are realizing how limited those simple, unimc
are, especially for patients with chronic pain,'
there is going to be an evolution where
more and more on pain and functional sta
some of these earlier tools: The focus will st
patients with activities of their daily lives.
Debra Drew, MS, ACNS-BC, RN-BC is a
cialist for pain management at the Univei
Medical Center, Fairview. In addition to he
bilities, she is involved in patient and staff e.
and institutional committees on pain and pa
tinued from cover)
I serve the patients who very much need us,
the stakeholders what's changed and what
an care can do for them:
very starts with verifiable efficiency.
will never roll again, so Schatman notes that
to provide integrated pain care must learn to
hey confine their efforts to clinically-validated
ted at reasonable costs.
clinicians can responsibly offer payers far bet-
ers compensation policy, and the insurer's primary goal will
be returning the patient to productive employment. In such
cases, pain clinicians should bombard the insurer with studies
that show how interdisciplinary pain treatment restores patient
function better than any alternative.
If, on the other hand, a patient is injured at home, the medi-
cal bills will fall to a regular health insurer that will focus pri-
marily on minimizing long-term costs. In such cases, caregiv-
ers should bombard the insurer with studies that show cost
costs a fortune because he keeps seeking new
for years on end:
Hospitals, likewise, have their own spec
cerns, which caregivers need to consider bef
open (or, in many cases, reopen) pain clini
no plausible way to argue that hospital p<
become directly profitable again, but he d
pain clinics could generate indirect profits
able hospital employees from their existing
EFTA01114712
ation in this area of pharmacology is necessary for improving outcomes and maximizing treatment options.
T
he conference room where Thomas 8. Gregory, PharmD,
BCPS, DASPE, CPE, gave his presentation "opioids A to r
was so jam-packed on Friday morning that Gregory joked
that "You guys are such hardcore pain guys that you bypassed
the breakfast spread just to be in here early this morning." (Luckily
there were still leftover urns of coffee and trays of croissants for
those who waited for the session to end to grab breakfast.)
If there is one thing that serves as a common denominator for
all PAINWeek 2012 attendees—which includes physicians, phar-
macists, nurse practitioners, physician assistants, and even social
workers—it is a unified interest in the dosing strategies, side effects,
and patient and medication variables associated with opioids.
That is exactly what Gregory spoke about during his engaging
presentation.
Beginning with the patient and medication variables, Gregory
started by discussing the importance of knowing the distinction
between opioids that are pure agonists, which have no ceiling ef-
fect and are not problematic in terms of increasing dosage (until
side effects become intolerable) and those that are partial ago-
nists, which can have a ceiling effect (ie, once a plateau dose is
achieved, there will be no further analgesic activity).
Gregory also touched on many different aspects of patient vari-
ables in opioid therapy. He said that clinicians who are prescribing
or administering opioids must consider a patient's age, particu-
tive formulation technology
ing intended drug action
its of INTAC°
outstanding crush resistance
urdles against prescription drug abuse
riendly formulation requires no aversive additives
ade release properties to match reference
or clinical needs
ed at commercial manufacturing scale
in FDA-approved products
lady because metabolic enzymes in our bodies
Muscle mass must also be considered due to
patterns. Comorbidities must be taken into co
renal dysfunction, for instance, can cause seric
patients on chronic opioid therapy. The cost of
be a factor, and not just in terms of the pat
about whether the medication allows the patir
mal daily routine," said Gregory.
As far as medication pharmocokinetics is r
sorption rate of opioids must be considered
istered transdermally via a patch, Gregory s
will vary depending on age. During this part
one of the audience members asked Gregor
to be the best method for disposing of opioic
said that although there is no one correct a
rules and regulations governing disposal vary
he thinks that patches should be absorbed
and that the diffused drug should then be
drain. He added that attendees should mak•
out what their states' rules and regulations
they were abiding by the law.
The discussion segued into various opioid cic
(contin,
EFTA01114713
)nge in patient condition, or even health care
iregory reminded the audience that when they
nge a patient's dosage formulation or route of
necessary to review opioid equianalgesic dos-
: said should "serve as a guide and not a gos-
s cross tolerance is not universal in nature. He
of specific scenarios, such as what health care
)e aware of when switching patients from one
dtiondly bioequivalence between routes of administration must be
considered before beginning the 5-step opioid conversion process:
1. Gbbally assess pain complaint.
2. Determine total daily dose of current °plaid.
3. Decide which opioid analgesic will be used for the new agent
and consult established conversion tables to determine new
dose.
Gregory conveyed a significant amount of
Lion about opioids during his session, and le•
number of excellent instructions, resources, an
motion on dosing, conversion charts, and man
ementary and Alternative Medicine: Putting Evidence It
nplementary and alternative medicine (CAM) use among chronic pain patients range from 30 to
ing to try CAM approaches, including for pain management.
entary and Alternative
3verview and Effective
n Pain" (CAM-02)
ert Bonakdar, MD
ry, September 8
10am
al 3, Castellana 1
:ult to define because it consists of diverse
ns and it is constantly changing. Many
oaches have gained attention as safe and
les or adjuncts to pharmacologic interven-
agement of chronic pain. With increasing
of CAM and integrative medicine is men-
sed in evidence-based guidelines. Despite
ations, many practitioners remain hesitant
into their own practice or to discuss CAM
; MD, will present "Complementary and Alter-
eerview and Effective Therapies in Pain"on Sat-
Meek 2012. His presentation will review exist-
imendations for CAM use and offer guidance
nt these recommendations in practice. "The key
engage patients and discuss CAM approaches
most out of them in conjunction with everything
lending: says Bonakdar.
ration of CAM as part of mainstream treat-
,v+ paradigm for many physicians. in many
are learning these approaches on the fly,
flts we may not have learned about in
sidency, or fellowship: says Bonakdar. This
ncies and fellowships are starting to incor-
iodologies into their training programs. In
ts Bonakdar, "Physicians need to get more
:AM, especially if the evidence is saying we
In fact, Bonakdar says that discussions about CAM happen
so infrequently that the National Institutes of Health has de-
veloped a packet to guide doctors and patients on how to
approach the topic of CAM. He will review this and other re-
sources to guide CAM usage during his talk.
He plans to address many of the factors that contribute to
providers lack of motivation to use CAM. The presentation will
include useful information about a variety of CAM interven-
tions that are backed by strong evidence. "I will go into a host of
treatments and help providers know what to consider, and more
importantly, how to coordinate care," says Bonakdar. He will pro-
vide guidance on accessing and obtaining products and services,
dosing, side effects, and potentially dangerous interactions.
The inclusion of CAM in practice guidelines represents ad-
vancement in the fields of CAM and pain management.At the
same time, this development has actually posed some barri-
ers to implementation because not all of the guidelines are in
agreement. "Part of my talk will be about how to arrive at a
bottom line you are comfortable suggesting to your patient:
says Bonakdar. "Along with practical advice for how to use the
guidelines, I will talk about who is a good candidate for CAM:
Providers also need to be updated and aware of impor-
tant safety issues related to CAM usage. When using CAM
approaches that are backed by trial evidence, for example,
Bonakdar recommends using the standardized version used in
the trial. He will review this and other safety considerations that
must be kept in mind during patient selection and follow up.
Financial considerations may play a role in whether patients and
providers pursue CAM therapies. if you ask most physicians who
have not considered bing through their office whether any of
these interventions would be covered, they would think no," says
Bonakdar. "My clink tries to put everything through insurance and
we have found reasonable reimbursement." He wil discuss reim-
bursement and other financial factors that may be posing a barrier
to integrating CAM recommendations into finical practice.
In terms of cost-effectiveness of CAM, not many analyses
have been performed. Bonakdar says, "There can be cost sav-
ings, but the care needs to be coordinated: Cost savings will
not be achieved if a patient goes to a CAM provider three
times a week indefinitely. "If a patient is self-choosing a CAM
therapy, it may not be cost-effective because there is no over-
In many cases, physi
are learning about C
approaches on the fl
especially treatment
may not have learns
about in medical sch
residency, or fellows
Physicians need to gi
comfortable with CA
EFTA01114714
Cir EVENTS
nts and Your Practice: The Role of
Chronic Pain and Risk Management
eptember 8, 8:25-9:55an
era Ballroom
I: NO
3 (breakfast)
squired: NO
re Toxicology
otion, Jennifer E. Bolen, JD, and Jeffery A.
Gudin, MD, will discuss practical
approaches to incorporating drug
screening into comprehensive chronic
pain and risk management plans.
They will also address key topics in
legal and regulatory considerations
for drug testing frequency, docu-
mentation, and the interpretation of
results.
and BTP, and multidisciplinary approaches tha
range of biopsychosocial causes and sympton
persistent pain and BTP.
Mission: Pain Management —The
First Visit (An IDEAL® Clinical En
Time: Saturday, September 8, 12:30-2:00p
Room: Level 4, Gracia 1-4
CE/CME certified: YES
Meal served: YES (lunch)
Preregistration required: N/A
Supported by educational grants provided by
and Mallinckrodt, the pharmaceuticals bui
The faculty will discuss the underlying pothopl
transmission mechanisms associated with noci
pothic, and centrally-mediated chronic pain; c
five risks and benefits of nonphormocologic ai
treatment options for chronic pain; explain hog
barriers to the optimal use of opioid analgesic
chronic pain; and assess methods for screenin
lion in the initial and follow-up care of patient
Persistent and Breakthrough Pain: Responsible
Opioid Prescribing for Multidimensional Disorders
Time: Saturday, September 8, 12:30-2:00pm
Room: Level 4, Gracia I
CE/CME certified: YES
Meal served: YES (lunch)
Preregistration required: N/A
Supported by an educational grant from Teva Pharmaceutical
Industries Ltd.
This activity was designed to "consolidate clinically relevant
scientific studies and evidence-based guidelines into practical
approaches to persisten pain and BTP assessment, responsible
opioid prescribing, and repeated
re-evaluation of patient outcomes.°The
faculty of Michael J. Brennan, MD; Jeffrey
A. Gudin, MD; Douglas C. Schottenstein,
MD; and David M. Simpson, MD, MAN,
will discuss the diagnostic criteria for
BTP pain and clinical characteristics of
its subtypes, strategies for indMdual-
izing opioid therapy for persistent pain
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EFTA01114715
c rain and comorbidities
istration hospitals have a unique and extensive expertise when it comes to treating post-deployment chronic pain and its associated a
≥nary session, PAINWeek attendees will learn more about what the VA has to offer and how clinicians in the private sector can improv
its by liaising with the VA.
lyment Chronic Pain
ies" (VHA-02A)
Ti-Ann Gibson, MD, and Ilene R.
y September 8
:20am
4, Nolita 1
s in Iraq and Afghanistan have had a tre-
s impact on US troops and their loved ones.
:terans are returning home with physical in-
motional difficulties, such as post-traumatic
;D).
!012, two specialists in caring for returning
M. Gibson, MD, DAAPM, Chief of Spe-
ion, Mental Health and Behavioral Sciences
mes A. Haley Veterans' Hospital in Tampa,
beck MD, Co-Chair of the National Primary
rce in St. Petersburg, FL will be presenting
Chronic Pain Comorbidities" in a Plenary
n will review the prevalence of PTSD and
heoretical models that explain the mainte-
xlitions, and the challenges faced by pro-
s who care for these patients. In addition,
k will present Department of Veterans Affairs
(VA)/Department of Defense (DOD) VA/DOD Clinical Practice
Guideline for Management of Post-Traumatic Stress, with spe-
cial attention to chronic pain.
limited scientific evidence supports specific care and treat-
ment of PTSD and chronic pain, and this challenges providers to
investigate and research potential treatment options. This pre-
sentation will focus on the techniques and strategies to address
not only PTSD and chronic pain, but other conditions, induding
substance dependence and depression," Gibson says.
All veterans who have
honorably served our
country have earned
and truly deserve the
most comprehensive,
individualized, and holistic
treatment approaches that
can be made available to
address their physical and
emotional conditions.
"We have many patients coming back fr
Iraq and Afghanistan with chronic pain probl
"Many people assume that all of these patier
by the VA; however only 50% of returning
foot into a VA. The rest are cared for by outsi
many of the patients who do get seen by VA
seek care by outside providers, so outside
understand the dynamics of what happens •
and their comorbidities, even if they are beinc
way by the VA."
Importantly, 100% of the family member
erans are seen by outside providers, and al
the VA. Unfortunately, many of the problems
veterans also impact their families, Robeck n,
important for non-VA providers to understc
what is involved in terms of chronic pain in
and their families:
It can be challenging to treat post-deplo)
with comorbidities, and this makes it imperati
viders to learn what the VA has learned at
returning veterans, Robeck says.
"The important thing to keep in mind is t
patients are young and resilient and when
ately, they respond to treatment. This fad fu
importance of learning about their problen
what the VA has learned about treating t
what resources are available for co-manage
she says.
Outside providers should know that it i!
patients to get care at both the VA and thei
dinics. They should also know that if they we
tients established at the VA, this does not me
will get all of their care at the VA. What it do
is that the non-VA provider can then work wi
the VA and be able to access the VA service
access, Robeck says.
"The VA welcomes the partnership or tf
outside provider. We understand that some
remain with their own family doctor and tF
but their own family doctor may end up feel
equipped to do everything, so I think there
she says.
"That family doctor knows the family or
that patient for years. We don't want to los.
But we also want to make sure that the full
available to these patients is understood, an,
misconceptions about how to access care a
to make sure that our desire to be able to a
with the outside provider is well understood,
All veterans who have honorably served
earned and truly deserve the most compreher
and holistic treatment approaches that can be
address their physicd and emotional condition
EFTA01114716
An early-bird registration fee of $249
is being offered until September 30, 2012.
Register NOW at www.painweek.org
using code 2013.
PAINWEE <
EFTA01114717
ms do to manage OK? McCarberg slid that
nith OK requires a "professional and sensitive
ize any potential embarrassment for patients:
patients, especialy older patients, ore uncom-
>ut defecation. Many will attempt to self-treat
and other medications.
ms ore "the current stcn-
revernon and trwhnent
>erg. Although there are
guideines for the use of
IcCarberg said that the
is to initiate Inzuliteent
of stool softeners and
recommended that &II-
4 bulk-forming agents in
fails to produce a satis-
cians can treat with PEG
approach doesn't work,
try an opioid receptor
nettiyhaltrexone. Doses
r all forms of treatment.
OK, but you have to
loses of bowel stimulants
rberg said.
>f laxative use ridude pain, flatulence, nausea,
perianal soreness. Mother important consider-
mediations is onset of action. McCarberg said
>refer laxative agents that have a shorter onset
owel predictability is very important for patients,
the faster acting litutilient: Saline laxatives
ours to take effect, bowel stimulants take 6-12
Jute and osmotic laxatives can take 1-3 days.
ie and other agents for opioid-induced
ed issues in the management of OIC during
ssion, offering information about the clinical
side effects of oral nalxone, methylnaltrexone,
iprostone, and other agents.
produce symptoms of opioid withdrawaft. Several short-term trials us-
ing a range of doses and frequency of administration of oral naloxone
in patients with OIC have produced mixed results, wih some producng
signifiord increases n stool frequency and improvement in symptoms.
Some reversal and analgesia and/or opioid withdrawal symptoms
were observed in most of the trials.
Methybotirexcne is approved for the
annulment of OIC n patients with advanced
ilness who are receiving paktive care and
have demonstrated nsufficient response to
laxative therapy. It is currently available for
subcutaneous administration. Peppin said
that iuetliylnaltrexone "does not stinulate
the bowel, it just returns it to normal," which
is why it is important to take the patient's
history to know what the patient's normal
bowel process and routines are.
In one study, nearly half of patients
with OC treated with inelnInaltiexone
plus laxative therapy achieved rescue-free
Icaation after three doses (0.15 mg/kg) ad-
ministered over five days. In another study,
patients with advanced Less (riducting
patients with cancer, ordovascular dis-
ease, COPD, and Alzheimer's disease or dementia) who were receiving
opioid therapy and who also had OIC were treated with repeated dos-
ing of either placebo plus laxatives or inutliyInaltiexone plus laxatives.
Nearly half (48%) of patients treated with methybotirexcne demon-
strated taxation response within four hours of receiving their first dose.
More than half (52%) of patients treated with nr thylnaltrexone dem-
onstrated bxation response within four hours after two or more of their
first four doses of the medication Peppin noted that the data indcates
that "you may have to by up to four doses before seeing a response:
In another trial invoking patients with chronic noncancer pain 6n-
clucing back pain, cervicaVneck pain, fbromyalgia, hip pain, and
osteoarthrilis) who were receiving opioid therapy and who also
had OK were treated with either placebo or methylnaltrexone (12
mg QD or QOD). More than one-third (34%) of patients achieved
rescue-free bowel movement within four hours after receiving the:-
The most common adverse effects associi
altrexone use reported by patients in contr
abdominal pain (28.5% of patients), flatulent
sea (11%). Other adverse effects reported
diarrhea, and hyperhidrosis.
Another option for OIC, alvimopan, does n
brain barrier and demonstrates higher bindinc.
ceptors than methylnaltrexone. It is approved I
time to upper and lower GI recovery followi
surgery: Peppin said that alvimopan is "a hos
states (e, only surguuns can write for it).
The chloride-channel activator lubiprostor
proved for use in chronic idiopathic constip<
women. In one 12-week trial of lubiprostone in
k noncancer pain and OIC, 26% of patients
bowel function. The most common adverse eff
nausea, and abdominal pain.
According to Peppin, there are currently sets
therapies in trials for OIC, induding prucalopr
which is an oral PEGylated naloxol conjuga
promising results in a short-term trial of park
ducing increased frequency of spontaneous b
patients during the first week of therapy.
Peppin concluded the presentation by reminding
• OIC is a significant and ncreasingly commi
bents with chronic pain
• OIC can compromise a patient's quality of
effectiveness of pain management
• Laxatives we the main therapy for preventioi
of OIC, but their usefulness may be limited b
adverse effects
• There is not much data on treatment for OK
• Peripheral mu-opioid receptor antagonists in
reversing analgesia, producing "rapid laxat
advanced illness without inducing opioid with
central analgesic effects"
• There are a number of phcrmacologic agent
strafed benefit for the treatment of OIC
'sing, Assessing and Treating Diabetic Gastroparesis
f diabetes is increasing worldwide, according to the International Diabetes Federation. In 2007 alone, the United States spent $218 bill
?s, with more than 500/0 of spending related to hospitalization for diabetes-related complications.
>ugh, when it comes to diabetes and GI symptoms, "we tend to think of them as
4 symptoms: Michael Bottros, MD, said during his PAINWeek 2012 presentation,
and GI Pain." Hs tak focused on the prevalence of GI symptoms associated with
sed treatment options as well as possible future research areas to prevent or treat
with diabetes.
the session was of particular use and interest because of the effect this particular
s having in health care as they have repeated hospital admissions. "These patients
hospital and they describe upper GI pain," Bottros said. "They have nausea, they
so we tend to think that most of the problems... occur n the upper GI tract. That's
I the neuronal degeneration and changes that affect the gastrointestinal tract
ptiros said that, in this patient population, the prevalence of upper and lower GI
; and there is a considerable amount of turnover in symptoms. Over time, as a
pain. So, when you talk about GI pain in relation to diabetes, you're essentially tal
gastroperesis:
Bottros stressed the importance of performing a thorough differential diagno
It will enable the physician to be sure that they have not missed any major prob
with these patients, as it will be a diagnosis of exclusion. To make a diagnosis, phy
a physical examination and imaging studies to rule out other causes. Scintigrar
objectively measure gastric emptying.
Although advances have been made in understanding the cellular changes t
condition, there are few treatments for diabetic gastroparesis. Pharmacologic tn
the condition include antiemetic agents, tricyclic antidepressants, and anticonvuk
that opioids should be used sparingly with these patients. "Management of dic
needs to focus on assessing the severity of the disorder, correcting nutritional dysft
ing symptoms," he said.
EFTA01114718
analgesic development can be arduous. Clinicians need to be aware of the necessary guidelines and regulations to tollow so that the c
Drehensive, ethical, and offer societal benefit.
k 2012 presentation, "Analgesic Development: From Bench to Bedside and Back:
:e, MD, highlighted the process of clinical trial design. During the session, Wallace
A trial phases, discussed the purpose and role of institutional review boards, and
Its of informed patient consent.
I clinical trials related to the development of analgesics, Wallace said physicians
pf institutional review board guideines and federal regulations as well as ethical
arch with human subjects. "One of the biggest hurdles with trial design is the issue
Wallace said.
hat the history behind institutional review board regulations dates back to Nazi
development of the Nuremberg Code. "Individuals should be treated as autono-
is a group," Wallace told attendees. "So we do these clinical trials, and we tend
ngs in the population, and you forget the individual. You have to look at each
'kat trial:
ated that some patient populations are entitled to certain protections that
sic clinical trial design and development more difficult. Children, people
titles, and prisoners require special consideration.. seeing more and more
the pediatric population: Wallace said. -There is actually a movement of
should be. We need better analgesics for children. We shouldn't be excluding
urdle for clinicians designing clinical trials in pain management is folding partici-
part to doing finical trials is patient recruiting,"Wallace told the audience. it's just
Physicians should remember that any procedure done solely to determine eligi
a part of the research and requires patient consent before the procedure.
Wallace also highlighted the guiding principles of the Belmont Report on the e
for the protection of participants in clinical trials, which include:
• Beneficence: Clinical trials should do no harm, maximize possible benefits anc
should be applied at an individual level for participating patients as well as at
• Justice: Clinical trials should have fair distribution of the benefits and burdens
the participant selection should involve groups that will benefit from the resea
nient' populations.
Wallace emphasized to attendees that if the risks outweigh the benefits, the trial
be approved by the institutional review board. He also stressed the importance c
The general accepted principle is that, if it is practicable to get consent, consen
and documented.
Some of the elements of informed consent indude on explanation of the purpc
a description of the procedures, the risks and benefits, the expected duration of j
reminder that pcnicipation is voluntary.
Wallace's presentation examined the difficulties of designing clinical trials while
tance of maintaining participant autonomy and maximizing societal benefit.
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CME/CE Credit Instructions for PAINWeek
To obtain your CME/CE certificates, you will be required to complete evaluations for each cour≤
as well as an overall PAINWeek evaluation. These evaluations must be completed online (eg, or
smartphone, or in the Cyber Café).
When entering a session, please scan the square bar code on your name badge, which will reci
attendance for ease of completing evaluations. Each evening of the conference (starting with W
you will receive an e-mail notification indicating you have evaluations to complete.
Please click the link in the e-mail, and you will be taken to a listing of evaluations for courses in y,
have participated. In the event courses are missing or additional courses have been recorded, y
the ability to edit the courses you wish to evaluate.
To ensure accuracy and streamline issuing of credit for the various disciplines at PAW
certificates will be issued electronically after the evaluation system closes.
The evaluation system will be available until OCTOBER 31, 2012. You will only be el
receive credit for sessions if the respective evaluations are completed by this date.
Regrettably we will be unable to grant any extensions or make any exceptions to th
SPECIAL NOTE TO PHARMACISTS:
Please note: pharmacy learners will not be eligible to receive partial credit. Individual courses in
attended in their entirety in order to be eligible to receive credit for those 1.0 or 2.0 credit hour s
If you still need to create an NABP e-Profile and obtain an ID number, please visit http://www.n
https://store.nabp.net/OA HTML/xxnabpibeGblLogin.jsp.
EFTA01114719
ipecialist and I do not want to be. I am a fam-
try to care for my patients in as comprehen-
35 possible. While I certainly value and make
believe that in many cases a patient's medical
fectively satisfied within the boundaries of a
dical home. Furthermore, my patients are un-
nsured. I am fortunate to have the support of
ilitates my patients access to medical supplies
its access is limited. Finally, by education and
lining, I am as much a humanist as a scientist.
pg on specific diseases or injuries, my job is to
ny patients medical reality within the context
.omote their well-being.
iers recently observed that I have a particu-
management. It is true that I have made an
?. myself with orthopedic and rheumatologic
that I perform a fair number of injections—
nd some of my partners' patients—and that I
-e comfortable and willing to prescribe pain
her narcotic, non-narcotic, disease-modify-
Ian some other physicians. My interest in the
stems from my belief that I am obligated to
t of my ability those processes that threaten
eing. To deny these obligations would be no
ring their heart disease or diabetes.
nomic and demographic factors lead to an
.e of endocrine and cardiovascular disease
s, these same patients suffer from a high in-
Prthermore, my patients have a great deal of
c, and addictive comorbidity. Even when my
ss to an orthopedist, rheumatologist or pain
>nsultants are limited in what interventions
d are sometimes hesitant to do so for eco-
ico-legal and logistical reasons. My practice
eat I treat medical disease to a level at which
patients elsewhere would have been referred to specialists.
While I believe that my partners and I usually rise to the occa-
sion and meet this demand, I fear that this is not often enough
the case when it comes to chronic pain. This is detrimental to
our patients health and well-being.
I, like most of my peers, learned little about the manage-
ment of chronic pain in medical school or residency training.
I have been actively trying to increase my knowledge in this
area through face to face, online, and print resources, as well
as interacting with specialists, but I have much yet to learn. I
have also recently had the opportunity to join a regional col-
laborative focusing on the safe treatment of chronic pain in a
primary care setting, but this program focuses on systems and
learning how to collaborate with specialists t.
goals. I am also working on ways to make
these patients in the primary care setting
primary care practitioners.
Rudolph Virchow—a pioneer in social mi
pathology—observed that 'medicine is poli
medicine on a grand scale:This is nowhere ≤
tersection of socio-economic need, medical
pain. I am neither a pain specialist nor a pair
family doctor and a patient advocate. I have
in the treatment of chronic pain because i
patients need and will not get elsewhere. \A,
my patients had pain, it is a fact of their—ar
"I, like most of my peers, learned little about the
management of chronic pain in medical school or r
training. I have been actively trying to increase my
knowledge in this area through face to face, online
print resources, as well as interacting with specialis
I have much yet to learn."
processes more than therapeutic strategies. I hope that through
resources like PainEDU and attending PAINWeek I can increase
my skills, knowledge base, and strategies. I am especially in-
terested in increasing my comfort with treating pain in patients
with medical, psychiatric, and addictive comorbidities, and in
lives, and managing it is not only an ethical
many of the social and existential issues that
to primary care medicine. I do the best I ca
and I am trying to improve my skills in this
the help I can get.
Congratulations to the 2012 PainEDU.org
PAINWeek Scholarship Recipients
Visit the PainEDU.org website (www.PainEDU.orq) to learn more about the scholarship and read several of the prize-winning essays.
Moshe Usadi, MD (grand prize winner)
Charlotte Medical Center - Biddle Point
Charlotte, NC
Kelly Brewer, LCSW
Center for Wellness & Pain Management
Kalispell, MT
Maria Foglio, RN
Ashtabula County Medical Center
Ashtabula, OH
Maria Maldonado, /V
Stamford Hospital
Stamford, CT
e Dahring, MSN, RN, CP
Toni L. Glover, MSN, FNP-BC
Rebecca A. Maxson, Pharm
EFTA01114720
-y four women of reproductive age suffers from chronic pelvic pain. Pain Clinicians who want to provide comprehensive care to this po
id the general diagnosis of chronic pelvic pain and learn more about the subtypes and etiologies of this complex condition.
i" (REG-01)
:en M. Fitzgerald, MD
y September 8
)0am
14, Nolita 3
ions of pelvic pain are wide ranging. The
yatively affects quality-of-life, jobs, relation-
xtion. Additionally, it puts women at greater
p invasive procedures such as laparoscopy
'sic Pain" symposium on Saturday morning
2, Colleen Fitzgerald, MD, will provide an
related to clinical management of the condi-
tion will be broad in scope," says Fitzgerald.
ubtypes and etiologies; risk factors; patient
symptoms; differential diagnosis—including
ons, imaging, and other workups; treatment;
Jerald will also talk about pregnancy-related
medical help for pelvic pain are labeled
Gagnoses that can be gynecologic, urologic,
usculoskeletal, or psychological in nature.
epends on the type of specialist seen. The
-ien evaluating a woman who presents with
tzgerald, is not to assign a general diagnosis
Fain. "It should be broken down into a real
or, in some cases, more than one diagnosis,"
uld like to help the audience think beyond
gnosis and be more specific in terms of sub-
w, because it makes a difference in terms
gnosis of pelvic pain can be confusing. For
may present as a musculoskeletal response
woblem with an internal organ such as the
eview treatment options, including medico-
-ijections, surgical interventions, and comple-
mentary alternative medicine possibilities. She plans on spend-
ing a significant amount of time talking about rehabilitation
and reasonable therapeutic goals.
"Anyone who treats women with chronic pelvic pain knows
that these are some of our toughest cases," says Fitzgerald. She
attributes this to lack of training and guidelines and to the com-
plexity of the problem. "Any time pain persists for more than six
months, there is a large psychological overlay," she says. 1 am
hopeful that many will attend the session just because pelvic
pain is such an unknown; the field is really in its infancy in terms
of understanding of causes:
"The field is so new in research; we have some guidelines, but
we don't have guidelines based on subtype yet," says Fitzger-
ald. "Minimal guidelines exist for musculoskeletal causes." Pelvic
girdle pain guidelines, such as the "2008 European Guidelines
on Pelvic Girdle Pain," may not be applicable for every patient;
it really depends on their diagnosis. In 2011, the American Uro-
logical Association published guidelines for interstitial cystitis/
bladder pain syndrome. The group suggests general relaxation
and stress management as first-line treatment, followed by
second-line physical therapy and oral medication (eg, amitrip-
tyline, cimetidine, hydroxyzine, or pentosan polysulfate).
Fitzgerald contrasts those recommendations with standards-
of-care for women with pelvic floor or myofascial pain. For
those diagnoses, immediate first-line physical therapy is recom-
mended. Since the evidence shows that physical therapy works,
practitioners should try to avoid complex medications and po-
tential drug-related side effects.
To help attendees truly understand how to apply the infor-
mation in practice, Fitzgerald will walk through the physical
exam, differential diagnosis, and treatment selection using spe-
cific patient examples.
Fitzgerald will also offer some insight into the future of the
field and talk about some recent progress made in understand-
ing chronic pelvic pain. She says that "One of the things we
are working on in research is to look at not just the organ as
the problem—for example, the uterus, bladder, or muscle—but
really looking at the whole patient as one who has gone into
chronicity as a neurologic pain processing problem."
Fitzgerald is part of a team that is using neuroimaging to
evaluate the neurobiology of chronic pelvic pain. Their research
has showed that women with
chronic pelvic pcin actually
have a different way of pro-
cessing pain compared with
the brains of normal healthy
control women. "We found
changes in the central ner-
vous system that suggest the
way to address this may be
along the neuroaxis," says
Fitzgerald. "Maybe the insult
was initially to an organ or
muscle, but over time, as pain
signals get transmitted and
perpetuated, the body's abil-
how the central nervous system changes as
pelvic pain.
Colleen Fitzgerald, MD, is an associate p
rics and gynecology and female pelvic medi,
versity of Chicago and associate professor
and rehabilitation at Northwestern Universii
of Medicine. She specializes in treating and
nancy-related musculoskeletal disease, won
pain, and pelvic floor disorders.
The important thing
evaluating a woman
presents with pelvic I
is not to assign a ger
diagnosis of chronic
pain. It should be bri
down into a real prir
diagnosis or, in SOME
more than one diagr
EFTA01114721
acnes to rain management
xist to treat pain and awareness is growing that non-pharmacologic approaches can be just as effective, if not more so, than pharmac
this talk, clinicians will learn about some of the newer non-pharmacologic options for treating pain, and will also learn how combining
a sensible medication plan can result in optimal pain relief.
:What are the Options?"
to N. Turner, DNP, RN-BC,
AN
y, September 8
loam
4 3, Gracia 7
orner, DNP, RN-BC, PCNS-BC, FAAN, Clinical
ecialist, Pediatric Pail Management Oregon
l Science University in Podicad, OR, will be pre-
What are the Optionsr today at PAINM/eek
talking about newer, non-analgesic approaches
aid how they can best be combined with tra-
I approaches to provide good pain relief.
topic and days could be spent on analgesic
es. There are two general categories of pain
rmacologic and non—pharmacologic—and
strong effort recently to get clinicians to use
?,s together.
Ire has been a very heavy use of the pharma-
d we know that some of the non-pharmaco-
an in fad stand on their own. We also know
er, you can often use much less medication,
less dangerous for the patient," she says.
n-pharrnacologic analgesia include physical
I, massage, transcutaneous electronic nerve
relaxation methods, biofeedback, hypnosis,
uided imagery, and virtual reality. "We use a
dual reality with kids," Turner says. "You can
her mindset."
*Ives having the child wear what looks like a
.Imet that has a saeen inside. "You put the hel-
n watch something. One of the more common
on a mountcin, skiing, cod it comes with al of
I. Their minds are able to actually go there on
be present in that virtual space, and those kids
he Publishers of
ICAN JOURNAI. Of'
QED CARE
can block out almost everything going on around them. One of
the children's hospitals in Ohio actually uses virtual reality when
they are doing bum care, with phenomenal results. Their use of
medication in doing that has dedined significantly," Turner says.
Turner adds that people are just beginiing to understand the
connection between body and mind. "There are tons of knowledge
out there around opioids and the traditional pain medicines, and
there's getting to be more understanding about some of the ad-
juvants, like antidepressants and anticonvulsants. But knowledge
about non-pharmacologic methods is still a little behind," she says.
"Even something like acupuncture is still considered to be
voodoo by some people; however, there is a lot of science now
to support that acupuncture is not voodoo. But it's taking time
to catch on,"Turner says.
In her presentation, Turner says a main goal will be to show her
audience how the non-drug and drug modes of analgesia can
work well together. She says, "We shouldn't just reach for the med-
ications; we need to incorporate those other modalities, as wel."
Turner is a pediatric pain specialist. She says that it is harder
for adults to adapt to non-pharmacological methods of pain
control "because we have forgotten how to play. We dampen
our imagination, and we can be very skeptical. Some of these
non-drug modalities can be harder to believe in for older peo-
ple, whether you are the provider or the patient, and that can
be challenging to deal with. I've got it really easy with kids; they
are open to anything. Plus, a lot of the non-pharmacological
approaches are technologically based, which kids love."
Different types of pain respond to different types of analgesia,
and this can often be due to the person's past experience of
pain, she says. "Pain is a very subjective experience and is based
on the individual's life experience with pain and pain treatment,
and all of that plays into how they deal with pain and how their
body and mind have been programmed. If pain is very fear-
based, it will be completely different than pain in someone who
doesn't mind getting hurt because they were doing rock climbing
or something they really want to do," says Turner.
Being able to identify what the patients' stressors are, and
helping them manage those stressors, are important aspects of
pain management. "It's incredibly complex.. hardly scratch-
ing the surface with this talk, because there is so much you can
go into. My intent is more to increase awareness and to think
uirey
lllll meat and
Coat In rp., (1111.11111b
el Pettunintsb
To examine the treatment benefits, cost
concerns, and potential insurance coverage
strategies for pertuzumab, AJMCs Co-Editor-
in-Chief, Michael E. Chernew, PhD, moderated
this audio cane) discussion with Lee N.
about adding these other modalities of trea
to reach for the medications," she says.
Nevertheless, Turner will be discussing me
adjuvant medications that, when added to trc
as the opioids and anti-inflammatories, can he
effectively. She will also discuss the role of ow
gesics. "Many consumers think that the types
you can buy in the drug store without a dock
weaker. That is not necessarily the case. Indei
"Pain is a very subje,
experience and is be
the individual's life e
with pain and pain ti
and all of that plays
they deal with pain c
their body and mind
been programmed."
especially if you have inflammation, a non-sti
to get that inflammation down: she says.
Her talk promises to give lots of food forth
"I won't have time for a lot of detail, but
awareness about all of the options. Right n4
common buzz word in the pain world, and
analgesia. Ifs using multiple methods to get
and it encompasses a wide variety of aspect,
psycho, social, and spiritual aspects of the p.
View the latest issue, which includes original
research on the dinical and economic outcomes
MANAGED CARE®
7.7
411
EFTA01114722
Rheumatoid
Arthritis
and Opioids
PAI
LIV
provides frontline pain professionals with resources and infc
ns to improve patient care. It's your connection to articles, live cor
coverage, resources, and video interviews with key opinion leaders
Site Features Include:
Social media options available on each page
Fresh content added daily
A news updates, clinical trials, twitter, interactive polls all available in one easy loca
EFTA01114723
na rainative care
>otential drug-drug interactions in the pain and palliative care settings requires a proactive approach that relies on the proper tools or
le patient's medications and pain care needs.
kinetic and
ynamic Drug Interactions in
dilative Care" (PHM-06)
tryn A. Walker, PharmD, BCPS, CPE
y, September 8
OOam
≥I 3, Castellano 2
erapy for patients with chronic pain or re-
liative care is typically complex and prone
: for drug-drug interactions (DDIs). In 2011,
icted a retrospective chart review (N =
631 potential drug interactions among
its in a palliative care setting. Patients in
.n have advanced disease and are receiv-
:ations. In the 2011 study, a median of 14
prescribed per patient during the hospital
ker, PharmD, BCPS, CPE, will present "Nor-
'harmacodynamic Drug Interactions in Pain
e this morning at PAINWeek 2012. During
le will review the basic pharmacology of fre-
int drug interactions relevant to these popu-
y, she will offer guidance on how to monitor
interactions.
rtant when seeing a pain or palliative care
'ing an issue to rule out whether it is some-
e is causing or something that needs to be
cer. "Whether to order additional medication
iedication is not a straightforward decision."
wstanding drug interactions plays a big part
,blems, "I will review the kinds of drug inter-
Jers should worry about in these settings."
a on DDIs among pain and palliative care
substantive imparts a particular challenge to
w these patients.
at some providers assume that pharmacists
)I before prescriptions are filled and admin-
"I don't see a lot of providers routinely con-
in practice," she says. But, pharmacists may
er is aware of the interaction and, practically
mot call the doctor for every potential drug
to convince people that it is better to think
ant DDIs for these populations before pre-
ns and to keep in mind the red flag drugs
thlems: says Walker. Automated DDI check-
it providers are often overwhelmed by the
al DDIs flagged by these systems; deciding
nically relevant is difficult.
.w.e how to check for DDIs using recommend-
Walker says that if the potential for DDI exists, "it does not
mean that you cannot use the drug, you just have to use it with
a plan."This means that if a provider decides to use a medicine
with a potential for interaction, he or she needs to know what
to monitor and consider dosing and administration schemes
that may prevent or minimize interactions. "For example, some
interactions are based on timing," she points out. "If you give
the drugs at different times, you may avoid an interaction."
For many drugs, providers only pay attention to a sub-
set of potential interactions or complications related to that
drug. One example of this is methadone. "It is a compli-
cated drug to use, in general: says Walker. "People worry
family's whole plan for end-of-life care."
"Palliative care patients are so complex; a
to prevent additional burden to these pati
says Walker. Drug effects can make a big dif
of-life experience. "Our duty is still to do n.
days a patient has left, a time that may be t
in their life," she says.
Kathryn A. Walker, PharmD, BCPS, CPE
fessor at the University of Maryland Schoo
a palliative care clinical specialist at MedSt<
Hospital. She serves on the palliative med
and oversees the hospital's pain consult tec
"I am hoping to convince people
that it is better to think about thi
important drug-drug interaction
these populations before prescri
medications and to keep in minc
flag drugs that may cause probli
about dosing, administration, and monitoring because they
are all complicated." But, Walker cautions that methadone
is prone to many drug interactions that are not widely rec-
ognized. "Many drug interactions for methadone often go
overlooked," she says.
Bleeding risk for patients on warfarin is another common
concern. "Sometimes providers focus on whether or not to
keep a patient on warfarin, but they neglect to consider oth-
er things that may impact bleeding," she says. Bleeding risk is
one of the most recognized DDIs. Yet, oversedation, confusion,
and delirium are common results of DDIs that can be quite
scary to families and patients. "Even if a patient is not aware,
these symptoms can alarm families, making them worry about
whether they can care for the patient at home; it can change a
io
EFTA01114724
Fly and modem Las Vegas French brasserie with an emphasis on quality ingredients'
d traditional fare that is accessible yet provocative, deticious yet chic" Doily spe-
dude beef wellington, housemade sausage, a selection of offal, and dayboat
torte flambee, steak tartore, roasted beets, and French onion soup. Lunch entrees
lame, oxtail benedict, steamed nvicw1c, and roasted lamb sandwich. Diners con
-course "Quick Lunch° Dinnerstandouts include the roasted bone marrow and ox-
commended9, brick roasted chicken, slow-cooked veal, a classic bouillabaisse, and
r. Comme Ca also offers a multi-flighttistronomystasting menu. Diners will also find
ers in Las Vegas, handmade pastas, delectable charcuterie and cheese plates, and
lice menu. The tipplers among our readers will not want to miss Comme Ca's menu
afted classic cocktails shaken with Chef David Myers) modem sensibility"
rtion:
00pm (Monday-Thursday)
)0pm (Friday-Sunday)
OOpm (Friday-Sunday)
urger concept" that was "tailor-made for The Cosmopolitan of Las Vegas with
:sh, natural and organic ingredients," Holsteins serves custom-crafted specialty
Je sausage, and "riffs on traditional American snacks and appetizers, as well as
lakes and sides.' Start things off with a high-octane "bam-boozled shake"(one of
Bowl,' combines
Crunch cereal with Absolut Vanilla) and a selection from
wises indude southern fried chicken fingers-n-waffles, buffalo wings, onion rings,
fhe "Tiny Buns menu features sliders, crispy pork belly, lobster rolls, and meat-
Jaleo
Looking to take a break from steaks, pastas, and heavierfaret Then an evening of
at Joleo may be just what you're looking for. Choose from a selection of small
(sausages and cured meats, including the famous lemon Iberico ham made frc
quesos (including several varieties of sheep's and goat's milk cheeses), Eocadillos I
es), &auras (chicken, ham, dates—just about everything tastes better fried), and •
dishes), and other dossic ta pas. And, as the menu says, Chef Jose Andres lcnows
plates, too," induding some of the best paella you will ever hove (in fact, Jale
changes throughout the day).
Hours of Operation:
Sunday-Thursday: 5:00pm-11:00pm
Friday-Saturday: 5:00pm-12:OOam
Scarpetta
Described os a modem Italian restaurant with an earthy-yet-sophisticated
cuisine,Scarpetta featuresso satisfying and soulful menu of seasonally-inspired 'tali
offerings indude braised short ribs, creamy potent] with mushrooms, and other c
course selections include duck & foie gins ravioli, black tonarelli with king crab ar
and short rib agnolotti. For the main course (pelt), diners at Scarpetta can chc
of northern Italian-inspired dishes, including several fish entrees, Colorado lam
duck breast. Scarpetta also offers a delectable °signature tasting menu," as well
EFTA01114725
F
i sIARRWST
PERIOD OF
TI E
healthy
wom n
PAIN SEX:HAY
American Chronic Pain Association
•
EDUCATE before,./te
fOU MEDICATE?
Cadtembnignii
lationel Council on Patient Information. and Education
Tioe MINE
www.talkaboutrsoro
National Kidney
Foundation
rican Academy of
SICIAN ASSISTANTS
LOMA PAL narnformIng Cate
Americal7Aeademy
Nurse P scririoners
IHEvv iv
ALTH
CONCERN
The management of pain and inflammation—whether acute or
chronic—requires proper consideration and attention to individu
patients' therapeutic needs and the issues that may affect apprc
and effective treatment. Nonsteroidal anti-inflammatory drugs (N
whether over the counter (OTC) or by prescription, are some of
most commonly used and effective drugs for pain relief, but, like
medication, only appropriate use can maximize their therapeu.
benefit while minimizing risk 1 2
Unfortunately, prescription and OTC NSAID use often falls out
of explicit but simple guidance. The US Food and Drug Admir
European Medicines Agency, and numerous medical societies
recommend their use at the lowest effective dose for the shor
period of time required to provide therapeutic effect.3
Data demonstrate an unequivocal relationship between dose
duration of NSAID use and the increased risk of gastrointestin
renal, and cardiovascular adverse events.' Only by following g
for use, taking patients' clinical needs and risk factors into acc
fully understanding what medications patients may be taking,
educating them about what NSAIDs are, and facilitating an or
dialogue can we maximize the therapeutic benefits of NSAIDE
minimize the likelihood of adverse events, and prevent patient:
from living in pain due to fear of pain medications.
The Alliance for Rational Use of NSAIDs—a public health coati
aims to bridge the gap between guidance and clinical practice
educating health care professionals and the public at-large to
ensure appropriate and safe use of NSAIDs.
Please join us in our efforts to ensure appropriate and
relief for people with pain. To download educational m;
and learn more about the Alliance for Rational Use of
visit
Alliance for Rational
Use of NSAIDs
Bill McCarberg, MD
Chairman. Alliance for Rational Use of NSAIDs
EFTA01114726
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View in Artifacts BrowserEmail addresses, URLs, phone numbers, and other technical indicators extracted from this document.
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aedpregnancyregistry.orgDomain
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www.painweek.orgURL
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Kristen M. Simkins From: Sent: To: Cc: Subject: Irons, Janet < Tuesday, July 12, 2016 10:47 AM Richard C. Smith Hello Warden Smith, mother is anxious to hear the results of your inquiry into her daughter's health. I'd be grateful if you could email or call me at your earliest convenience. I'm free today after 2 p.m. Alternatively, we could meet after the Prison Board of Inspectors Meeting this coming Thursday. Best wishes, Janet Irons 1 Kristen M. Simkins From: Sent:
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