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Accreditation Statement
Informed is accredited by the Accreditation Council for
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Informed designates this enduring material for a maximum of 3
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This activity developed without Commercial Support
Faculty
Sorin J. Brull, MD, FCARCSI (Hon)
Professor of Anesthesiology, Mayo Clinic, College of Medicine
Consultant, Department of Anesthesiology, Mayo Clinic
Lynn R. Webster, MD, FACPM, FASAM
Medical Director and Founder, Lifetree Clinical Research &
Pain Clinic
Director-At-Large for the American Academy of Pain Medicine
Stewart B. Leavitt, MA, PhD
Executive Director, Pain Treatment Topics
Stephen Braun
Medical Writer
Braun Medical Media
Activity Director
Sarina J. Grosswald, EdD
Director of CME, Informed
SJ Grosswald & Associates
Disclosure
Resolution of Conflicts of Interest
In accordance with the ACCME Standards for Commercial
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the planning and implementation of this CME activity, to identify
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Planning Committee/Faculty Disclosure
The following faculty and/or planning committee members have
indicated they have no relationship(s) with industry to disclose
relative to the content of this CME activity:
Sarina J. Grosswald, EdD
Stephen Braun
The following faculty and/or planning committee members have
indicated that they have relationship(s) with industry to disclose:
Lynn R. Webster, MD, FACPM, FASAM has received
honoraria related to formal advisory activities and as a
consultant from American Academy of Pain Management,
American Board of Pain Medicine, Covidien Mallinckrodt,
Iroko Pharmaceuticals, LLC, Medtronic, Inc., Nektar
Therapeutics, Pfizer Inc., and Salix Pharmaceuticals, Inc.
Stewart B. Leavitt, MA, PhD has received unrestricted
Medical Education Grants from Purdue Pharmaceuticals,
Endo Pharmaceuticals, and Millenium Laboratories.
Sorin J. Brull, MD, FCARCSI (Hon) has received
honoraria from Merck, Inc as a member of their Global
Advisory Board.
2013. All rights reserved. These materials, except those in the public domain, may not
be reproduced without permission from InforMed. This publication is designed to
provide general information prepared by professionals in regard to the subject matter
covered. It is provided with the understanding that InforMed, Inc. is not engaged in
rendering legal, medical or other professional services. Although prepared by
professionals, this publication should not be utilized as a substitute for professional
services in specific situations. If legal advice, medical advice or other expert assistance
is required, the service of a professional should be sought.
Location of pain
Character of pain (i.e., shooting or stinging,
continuous or intermittent, worse at night or
in the morning)
Lowest and highest pain on 0 to 10 scale in a
typical day
No Pain
5
Moderate pain
10
Source: Goodwin J, Bajwa ZH. Evaluating the patient with chronic pain. In: Principles and Practice of Pain Medicine 2nd Ed. Warfield CA, and Bajwa
ZH., Eds. 2004. New York, NY, McGraw-Hill Companies, Inc. Page 65, column 1, paragraph 3.
Diagnosis, Intractability,
Risk, Efficacy (DIRE)
Opioid Risk Tool (ORT)
Screener and Opioid
Assessment for Patients with
Pain, Version 1 and Revised
(SOAPP, and SOAPP-R)
Use
Monitor for misuse
by patients
currently on longterm opioid therapy
Screen for risk of
opioid
addiction
Screen for risk of
opioid addiction
Screen for risk of
opioid
addiction
Who
Administers?
Patient self-report
17 items
www.inflexxion.com/COMM/
Clinician
7 items
Clinician or
patient self-report
Patient self-report
5 yes/no
questions
24 items
www.opioidrisk.com/node/887
Length
Access
www.inflexxion.com/SOAPP/
Patient-Provider Agreements
A written agreement between a clinician and
a patient about the specifics of their pain treatment
with opioids can help clarify the plan with the
patient, the patients family, and other clinicians
who may become involved in the patients care.1
Such agreements can also reinforce expectations
about the appropriate and safe use of opioids.1
Caution must be exercised, however, to ensure that
patient/provider agreements are not used in a
coercive way to unethically place patients in the
position of having to agree to its terms or else lose
an important component of their treatment (or even
lose all treatment).22
Although evidence is lacking about the most
effective methods to convey the information
included in most patient-provider agreements, such
agreements have been widely used and are
recommended by regulators and many experts on
treatment guidelines for long-term opioid therapy.1
Recently, the Veterans Administration and U.S.
Daily exercise
Evidence
Letter from physical
therapist
Report by family member
or friend (either in-person
or in writing)*
Letter from group leader
Report by family member
or friend
Pedometer recordings or
written log of activity
Report by family member
or friend
Report by partner
Pay stubs from employer
or letter confirming the
patient is off of disability
leave
Gym attendance records or
report from family
member or friend
Evidence of non-medical or
inappropriate use of the medication(s)
Dose Titration
Patients who are opioid-nave or have
modest previous opioid exposure should be started at
a low dose of a short-acting opioid and titrated
10
11
12
13
Monitoring Adherence
Trust is a necessary part of any
patient/clinician relationship, but studies suggest that
in the context of controlled substances, it is unwise
to rely on a patients word that medications are
being consumed as prescribed.2 Although the use of
more objective ways to monitor adherence to
medication regimens is an imperfect science, such
methods remain an essential component of periodic
review. Multiple objective methods to assess
adherence exist, but there is no single best
approach and all such methods have both advantages
and potential drawbacks.
Drug testing should be approached in a
consensual manner as part of an agreed-upon
treatment plan and with the idea that such testing
benefits both the patient and the provider.2 The
potential benefits of clinical drug testing include:2
14
Respiratory depression
Sedation
Urinary hesitancy or retention
Dry mouth
Nausea/vomiting
Itching
Sweating
Hypogonadism
Myoclonus
15
16
Treatment Termination
Reasons for discontinuation of an opioid
analgesic can include the healing of or recovery
from an injury, medical procedure, or condition;
intolerable side effects; lack of response; or
discovery of misuse of medications. Regardless of
the reason, termination should be accomplished so as
to minimize unpleasant or dangerous withdrawal
symptoms by tapering the opioid medication slowly,
or by carefully changing to a new formulation.
Approaches to weaning range from a slow 10%
reduction per week to a more aggressive 25 to 50%
reduction every few days.1 In general, a slower taper
will produce fewer unpleasant symptoms of
withdrawal.
In general, opioid therapy must be
discontinued or re-evaluated whenever the risk of
therapy is deemed to outweigh the benefits being
provided. A clinician may choose to continue opioid
treatment with intensified monitoring, counseling,
and careful documentation if it is deemed in the best
interest of the patient. This requires, however,
careful consideration and a well-documented risk
management plan that addresses the greater
resources necessary for opioid continuation
following evidence of misuse.
If termination of the provider/patient
relationship is deemed necessary, clinicians must
ensure that the patient is transferred to the care of
another provider and ensure that the patient has
adequate medications to avoid unnecessary risk,
such as from uncontrolled or potentially dangerous
withdrawal.17 Practitioners can be held accountable
for patient abandonment if medical care is
discontinued without justification or adequate
provision for subsequent care.
17
Methadone
Methadone has recently received growing
attention and concern because it is frequently
involved in unintentional overdose deaths.40 These
deaths have escalated as methadone has increasingly
been used as an analgesic drug for chronic pain.41 At
one time, methadone had been used almost
exclusively in opioid maintenance therapy programs
to treat addiction. Its relatively long plasma
elimination half-life compared to its relatively short
analgesic half-life makes it optimal for maintenance,
allowing for once-daily dosing. But methadone only
exerts potent analgesic effects in the early phase of
its elimination half-life, and this, along with the fact
that it is among the least expensive opioids, has led
to a dramatic increase in its use for alleviating
chronic non-cancer pain.1
Methadone has unique pharmacokinetic and
pharmacodynamic characteristics that add
substantial risk to its use. Although its chemical
structure is different from classic opioids such as
morphine, methadone acts on the same set of opioid
receptors, though with different affinities for the
various opioid receptor subtypes.34 In addition,
methadone possess non-opioid receptor effects that
may explain some of its potential special efficacy.
These varied effects across opioid receptors, along
with its non-opioid properties, have garnered
methadone the reputation of being a broad
spectrum opioid.34 For a number of reasons,
however, methadone must be titrated very carefully
in order to avoid overdose. These reasons include:34
18
Safe Storage
Patients need to be reminded that even
children or close relatives can be tempted to use pain
medications they have not been prescribed. Opioids
are often obtained by teens, for example, from unsecured medicine cabinets of family and friends.
If possible, opioid pain medications should
be stored in a locked cabinet or other secure storage
unit. Storage areas should be cool, dry, and out of
direct sunlight. Remind patients not to store
medications in their car, to keep medications in the
original containers, and to avoid storing medications
in the refrigerator or freezer unless specifically
directed to do so by a healthcare provider or
pharmacist.
Proper Disposal
The Office of National Drug Control Policy
currently recommends that unused opioid pain
medications be flushed down a toilet.47 Some states,
however, may have different or more stringent
guidelines. California, for example, instructs
consumers not to flush any medicines down the
toilet or drain. If flushing medicines is not allowed
in your state, instruct patients to follow the
instructions of a pharmacist for disposal or to mix
the medicines with an undesirable substance, such as
used coffee grounds, put the mixture into a
disposable container with a lid or a sealable bag, and
place it in the trash.
Before they are thrown out, personal
information, including the prescription number,
should be removed from empty medication
containers. Patients should also be encouraged to use
any drug take-back programs available in the local
community. [Note: the Drug Enforcement
Administration maintains up-to-date information on
national take-back programs, as well as ways to find
drug collection sites in any given locale.
Information can be accessed at:
www.deadiversion.usdoj.gov/drug_disposal/takebac
k/index.html.]
19
Take-Home Naloxone
In the future it may become more common
to provide patients and their caregivers with the
intranasal preparation of the opioid antagonist
medication naloxone as a way to reverse the
complications associated with accidental overdose.
Although naloxone was FDA-approved in 1971 and
has been used for decades by emergency medical
services personnel, intranasal administration of
naloxone is not currently approved by the FDA for
at-home use as an antidote for opioid overdose so, as
of this writing, this represents an off-label use of this
medication. Numerous studies and community
initiatives have attested to the safety, convenience,
and effectiveness of providing intranasal naloxone to
patients who may be at risk of overmedication or
overdose.48 This includes patients who:
Intoxicated behaviorconfusion,
slurred speech, stumbling;
Feeling dizzy or faint;
Acting very drowsy or groggy;
Unusual snoring, gasping, or snorting
during sleep; and
Difficulty waking up from sleep or
staying awake.
Patients and their caregivers should be
counseled to immediately call 911 or an emergency
service if they observe any of these warning signs. If
naloxone has been provided for the patient, it should
be administered immediately, which will reverse
respiratory depression and should allow the patient
to begin breathing more normally. If a person has
stopped breathing, artificial respiration/cardiopulmonary resuscitation (CPR, including rescue
breathing) should be begun immediately until
emergency help arrives.
Conclusions
This monograph has summarized best
practices for the responsible prescribing of opioid
pain medications for chronic non-cancer pain. More
detailed information on many of these topics is
available from the resources listed to the right. The
treatment of pain is a dynamic and evolving field,
and clinicians should periodically refresh their
knowledge through reading, attending seminars or
other events, or by taking additional CME courses.
Clinicians face the competing demands of
relieving pain while minimizing potential harm to
both patients and society. The steps and procedures
described in this monograph provide a roadmap and
structure by which clinicians can achieve these twin
goals without incurring undue burdens of time or
energy. Pharmacovigilance simply means that
prescribers apply basic principles of prudent
medicine to the needs of patients in pain. And
because the evidence base for current guidelines
remains sub-optimal, clinicians retain a great deal of
latitude in deciding how that vigilance is best
deployed on a day-to-day basis.
20
Table 5: Specific Drug Information for Extended-Release and Long-Acting Opioid Analgesics (ER/LA opioid
analgesics)
Morphine Sulfate ER
Avinza
Capsules, 30 mg, 45 mg, 60 mg, 75 mg, 90 mg, and 120 mg
Dosing Interval
Once a day
Key Instructions
Initial dose in opioid non-tolerant patients is 30 mg.
Titrate using a minimum of 3-day intervals.
Swallow capsule whole (do not chew, crush, or dissolve).
May open capsule and sprinkle pellets on applesauce for patients who can reliably swallow
without chewing; use immediately.
Maximum daily dose: 1600 mg due to risk of serious renal toxicity by excipient, fumaric
acid.
Specific Drug Interactions Alcoholic beverages or medications containing alcohol may result in the rapid release and
absorption of a potentially fatal dose of morphine.
PGP inhibitors (e.g. quinidine) may increase the absorption/exposure of morphine sulfate
by about two-fold.
Use in Opioid-Tolerant
90 mg and 120 mg capsules are for use in opioid-tolerant patients only.
Patients
Product-Specific Safety
None
Concerns
Buprenorphine
Butrans
Transdermal System, 5 mcg/hr, 10 mcg/hr, 20 mcg/hr
Dosing Interval
One transdermal system every 7 days
Key Instructions
Use in Opioid-Tolerant
Patients
Drug-Specific Safety
Concerns
Relative Potency To Oral
Morphine
Initial dose in opioid non-tolerant patients when converting from less than 30 mg morphine
equivalents, and in mild to moderate hepatic impairment - 5 mcg/hr dose.
When converting from 30 mg to 80 mg morphine equivalents - first taper to 30 mg
morphine equivalent, then initiate with 10 mcg/hr dose.
Titrate after a minimum of 72 hours prior to dose adjustment.
Maximum dose: 20 mcg/hr due to risk of QTc prolongation.
Application
o Apply only to sites indicated in the Full Prescribing Information.
o Apply to intact/non-irritated skin.
o Skin may be prepped by clipping hair, washing site with water only
o Rotate site of application a minimum of 3 weeks before reapplying to the
same site.
o Do not cut.
Avoid exposure to heat.
Dispose of used/unused patches by folding the adhesive side together and flushing down
the toilet.
CYP3A4 Inhibitors may increase buprenorphine levels.
CYP3A4 Inducers may decrease buprenorphine levels.
Benzodiazepines may increase respiratory depression.
Class IA and III antiarrythmics, other potentially arrhythmogenic agents, may increase risk
for QTc prolongation and torsade de pointe.
Butrans 10 mcg/hr and 20 mcg/hr transdermal systems are for use in opioid-tolerant patients
only.
QTc prolongation and torsade de pointe.
Hepatotoxicity
21
Table 5 (continued): Specific Drug Information for Extended-Release and Long-Acting Opioid Analgesics (ER/LA
opioid analgesics)
Methadone Hydrochloride
Dolophine
Tablets, 5 mg and 10 mg
Dosing Interval
Every 8 to 12 hours
Key Instructions
Initial dose in opioid non-tolerant patients: 2.5 to 10 mg
Conversion of opioid-tolerant patients using equianalgesic tables can result in overdose and
death. Use low doses according to the table in the full prescribing information.
Use in Opioid-Tolerant
Patients
Product-Specific Safety
Concerns
22
Table 5 (continued): Specific Drug Information for Extended-Release and Long-Acting Opioid Analgesics (ER/LA
opioid analgesics)
Use in Opioid-Tolerant
All doses of Duragesic are indicated for use in opioid-tolerant patients only.
Patients
Product-Specific Safety
Accidental exposure due to secondary exposure to unwashed/unclothed application site.
Concerns
Increased drug exposure with increased core body temperature or fever.
Bradycardia
Application site skin reactions
Relative Potency To Oral
See individual product information for conversion recommendations from prior opioid
Morphine
Morphine Sulfate ER-Naltrexone
Embeda
Capsules, 20 mg/0.8 mg, 30 mg/1.2 mg, 50 mg/2 mg, 60 mg/2.4 mg,
80 mg/3.2 mg, 100 mg/4 mg
Dosing Interval
Once a day or every 12 hours
Key Instructions
Initial dose as first opioid: 20 mg/0.8 mg.
Titrate using a minimum of 3-day intervals.
Swallow capsules whole (do not chew, crush, or dissolve)
Crushing or chewing will release morphine, possibly resulting in fatal overdose, and
naltrexone, possibly resulting in withdrawal symptoms.
May open capsule and sprinkle pellets on applesauce for patients who can reliably swallow
without chewing, use immediately.
Specific Drug Interactions Alcoholic beverages or medications containing alcohol may result in the rapid release and
absorption of a potentially fatal dose of morphine.
PGP inhibitors (e.g. quinidine) may increase the absorption/exposure of morphine sulfate
by about two-fold.
Use in Opioid-Tolerant
Embeda 100 mg/4 mg capsule is for use in opioid-tolerant patients only.
Patients
Product-Specific Safety
None
Concerns
Hydromorphone Hydrochloride
Exalgo
Extended-Release Tablets, 8 mg, 12 mg or 16 mg
Dosing Interval
Once a day
Key Instructions
Use the conversion ratios in the individual product information.
Start patients with moderate hepatic impairment on 25% dose that would be prescribed for
a patient with normal hepatic function.
Start patients with moderate renal impairment on 50%, and patients with severe renal
impairment on 25% of the dose that would be prescribed for a patient with normal renal
function.
Titrate using a minimum of 3 to 4 day intervals.
Swallow tablets whole (do not chew, crush, or dissolve).
Do not use in patients with sulfa allergycontains sodium metabisulfite.
Specific Drug Interactions None
Use in Opioid-Tolerant
All doses of Exalgo are indicated for opioid-tolerant patients only.
Patients
Drug-Specific Adverse
Allergic manifestations to sulfa component.
Reactions
Relative Potency To Oral
Approximately 5:1 oral morphine to hydromorphone oral dose ratio, use conversion
Morphine
recommendations in the individual product information.
23
Table 5 (continued): Specific Drug Information for Extended-Release and Long-Acting Opioid Analgesics (ER/LA
opioid analgesics)
Kadian
Dosing Interval
Once a day or every 12 hours
Key Instructions
Product information recommends not using as first opioid.
Titrate using a minimum of 2-day intervals.
Swallow capsules whole (do not chew, crush, or dissolve).
May open capsule and sprinkle pellets on applesauce for patients who can reliably swallow
without chewing, use immediately.
Specific Drug Interactions Alcoholic beverages or medications containing alcohol may result in the rapid release and
absorption of a potentially fatal dose of morphine.
PGP inhibitors (e.g. quinidine) may increase the absorption/exposure of morphine sulfate
by about two-fold.
Use in Opioid-Tolerant
Kadian 100 mg and 200 mg capsules are for use in opioid-tolerant patients.
Patients
Product-Specific Safety
None
Concerns
Morphine Sulfate
MS Contin
Controlled-release Tablets, 15 mg, 30 mg, 60 mg, 100 mg, and 200 mg
Dosing Interval
Every 8 hours or every 12 hours
Key Instructions
Product information recommends not using as first opioid.
Titrate using a minimum of 2-day intervals.
Swallow tablets whole (do not chew, crush, or dissolve).
Specific Drug Interactions PGP inhibitors (e.g. quinidine) may increase the absorption/exposure of morphine sulfate by
about two-fold.
Use in Opioid-Tolerant
MS Contin 100 mg and 200 mg tablet strengths are for use in opioid-tolerant patients only.
Patients
Product-Specific Safety
None
Concerns
Tapentadol
Nucynta ER
Extended-Release Tablets, 50 mg, 100mg, 150 mg, 200 mg, and 250 mg
Dosing Interval
Every 12 hours
Key Instructions
Use 50 mg every 12 hours as initial dose in opioid nontolerant patients
Titrate by 50 mg increments using a minimum of 3-day intervals.
Maximum total daily dose is 500 mg
Swallow tablets whole (do not chew, crush, or dissolve).
Take one tablet at a time and with enough water to ensure complete swallowing
immediately after placing in the mouth.
Dose once daily in moderate hepatic impairment with 100 mg per day maximum
Avoid use in severe hepatic and renal impairment.
Specific Drug Interactions Alcoholic beverages or medications containing alcohol may result in the rapid release and
absorption of a potentially fatal dose of tapentadol.
Contraindicated in patients taking MAOIs.
Use in Opioid-Tolerant
No product-specific considerations.
Patients
Product-Specific Safety
Risk of serotonin syndrome
Concerns
Angioedema
Relative Potency To Oral
Equipotency to oral morphine has not been established.
Morphine
24
Table 5 (continued): Specific Drug Information for Extended-Release and Long-Acting Opioid Analgesics (ER/LA
opioid analgesics)
Oxymorphone Hydrochloride
Opana ER
ER Tablets, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg, 30 mg, and 40 mg
Dosing Interval
Every 12h dosing, some may benefit from asymmetric (different dose given in AM than in PM)
dosing.
Key Instructions
Use 5 mg every 12 hours as initial dose in opioid non-tolerant patients and patients with
mild hepatic impairment and renal impairment (creatinine clearance < 50 mL/min) and
patients over 65 years of age
Swallow tablets whole (do not chew, crush, or dissolve).
Take one tablet at a time, with enough water to ensure complete swallowing immediately
after placing in the mouth.
Titrate using a minimum of 2-day intervals.
Contraindicated in moderate and severe hepatic impairment.
Specific Drug Interactions Alcoholic beverages or medications containing alcohol may result in the absorption of a
potentially fatal dose of oxymorphone.
Use in Opioid-Tolerant
No product specific considerations.
Patients
Product-Specific Safety
None
Concerns
Relative Potency To Oral
Approximately 3:1 oral morphine to oxymorphone oral dose ratio
Morphine
Oxycodone Hydrochloride
OxyContin
Controlled-release Tablets, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, 60 mg, and 80 mg
Dosing Interval
Every 12 hours
Key Instructions
Opioid-nave patients: initiate treatment with 10 mg every 12 hours.
Titrate using a minimum of 1 to 2 day intervals.
Hepatic impairment: start with one third to one half the usual dosage
Renal impairment (creatinine clearance <60 mL/min): start with one half the usual dosage.
Consider use of other analgesics in patients who have difficulty swallowing or have
underlying GI disorders that may predispose them to obstruction. Swallow tablets whole
(do not chew, crush, or dissolve).
Take one tablet at a time, with enough water to ensure complete swallowing immediately
after placing in the mouth.
Specific Drug Interactions CYP3A4 inhibitors may increase oxycodone exposure.
CYP3A4 inducers may decrease oxycodone exposure.
Use in Opioid-Tolerant
Single dose greater than 40 mg or total daily dose greater than 80 mg are for use in opioidPatients
tolerant patients only.
Product-Specific Safety
Choking, gagging, regurgitation, tablets stuck in the throat, difficulty swallowing the tablet.
Concerns
Contraindicated in patients with gastrointestinal obstruction.
Relative Potency To Oral
Approximately 2:1 oral morphine to oxycodone oral dose ratio.
Morphine
For detailed information, refer to prescribing information available online via DailyMed at www.dailymed.nlm.nih.gov
or Drugs@FDA at www.fda.gov/drugsatfda.
Source: FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics. 7/9/2012.
25
PatientCounselingDocument(PCD)
Patient Counseling Document on Extended-Release / LongActing Opioid Analgesics
Patient
Name:
Patient
Name:
The DOs and DONTs of
Extended-Release / Long-Acting Opioid Analgesics
DO:
If the dose you are taking does not control your pain
Take this card with you every time you see your
healthcare provider and tell him/her:
Resources
American Academy of Pain Medicine
painmed.org
Opioids911-Safety
www.opioids911.org
26
References
1
Chou E, Fanciullo GJ, Fine PG, et al. Clinical Guidelines for the
Use of Chronic Opioid Therapy in Chronic Non-cancer Pain. J Pain.
2009;10(2):113-130.
2
Webster LR, Dove B. Avoiding Opioid Abuse While Managing
Pain. Sunrise River Press, North Branch, MN. 2007.
3
Centers for Disease Control and Prevention. Vital Signs: Risk for
Overdose from Methadone Used for Pain ReliefUnited States, 1999-2010.
Morbidity and Mortality Weekly Report. July 3, 2012, Vol. 61.
4
IMS Health. IMS National Prescription Audit. February 23,
2012.
5
Joint meeting of the anesthetic and life support drugs advisory
committee and the drug safety and risk management advisory committee.
Risk evaluation and mitigation strategies for extended-release and longacting opioid analgesic. July 22 and 23, 2010.
6
Substance Abuse and Mental Health Services Administration.
(2010). Results from the 2009 National Survey on Drug Use and Health:
Volume I. Summary of National Findings (Office of Applied Studies,
NSDUH Series H-38A, HHS Publication No. SMA 10-4586Findings).
Rockville, MD.
7
Substance Abuse and Mental Health Services Administration,
Office of Applied Studies. (June 18, 2010). The DAWN Report: Trends in
Emergency Department Visits Involving Nonmedical Use of Narcotic Pain
Relievers. Rockville, MD. Available at:
http://www.samhsa.gov/data/DAWN.aspx.
8
Substance Abuse and Mental Health Services Administration.
Treatment Episode Data Set. Substance Abuse Treatment Admissions
Involving Abuse of Pain Relievers. SAMHSA; 1998 and 2008. July 15, 2010.
9
Centers for Disease Control and Prevention (CDC). Unintentional
drug poisoning in the United States, July 2010. National Center for Injury
Prevention and Control, CDC. Available at:
http://www.cdc.gov/HomeandRecreatonalSafety/pdf/poison-issue-brief.pdf.
Accessed August 28, 2012.
10
U.S. Food and Drug Administration (FDA) news release. FDA
Introduces new safety measures for extended-release and long-acting opioid
medications. July 9, 2012.
11
Executive Office of the President of the United States. Epidemic:
Responding to Americas Prescription Drug Abuse Crisis. 2011. Available at:
http://www.whitehouse.gov/ondcp/prescription-drug-abuse. Accessed:
August 28, 2012.
12
International Association for the Study of Pain. Classification of
chronic pain: Descriptions of chronic pain syndromes and definitions of pain
terms. Prepared by the International Association for the Study of Pain,
Subcommittee on Taxonomy. Pain Suppl S1S226, 1986.
13
Institute of Medicine. Relieving Pain in America: A blueprint for
transforming prevention, care, education, and research. Report Brief. June
2011.
14
NCHS. Health, United States, 2006 with Chartbook on Trends in
the Health of Americans. Hyattsville, MD: U.S. Department of Health and
Human Services; 2006.
15
American Cancer Society (ACS). Cancer Facts and Figures 2012.
Atlanta: ACS; 2012.
16
Food and Drug Administration, CDER Final Blueprint for
Prescriber Continuing Education Program. July 9, 2012.
17
Fishman SM. Responsible Opioid Prescribing: A Clinicians
Guide, 2nd Ed. Waterford Life Sciences. 2012.
18
Goodwin J, Bajwa ZH. Evaluating the patient with chronic pain.
In: Principles and Practice of Pain Medicine 2nd Ed. Warfield CA, and
Bajwa ZH., Eds. 2004. New York, NY, McGraw-Hill Companies, Inc.
19
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pain. In: Principles and Practice of Pain Medicine 2nd Ed. Warfield CA, and
Bajwa ZH., Eds. 2004. New York, NY, McGraw-Hill Companies, Inc. p.58
20
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prevalence, risk factors, and psychological links. Psychological Medicine
2006; 36:575-586.
21
Gourlay D, Heit H. Universal precautions: a matter of mutual
trust and responsibility. Pain Medicine. 2006; 7(2):210-211.
22
Payne R, Anderson E, Arnold R, et al. A Rose by any other
name: pain contracts/agreements. American Journal of Bioethics.
2010;10(11):5-12.
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Group. VA/DoD clinical practice guideline for management of opioid
therapy for chronic pain. Washington (DC): Department of Veterans Affairs,
DoD; May 2010.
24
Roskos SE, Keenum AJ, Newman LM, Wallace LS. Literacy
demands and formatting characteristics of opioid contracts in chronic
nonmalignant pain management. Journal of Pain. 2007;8(10):753-758.
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preparing patient education handouts. UC Davis Health System. Available at:
http://www.ucdmc.ucdavis.edu/cne/health_education/guide.html. Accessed
July 22, 2011.
26
Fishman SM, Mahajan G, Wilsey BL. Author Response letter to
the editor about article: The trilateral opioid contract: bridging the pain clinic
and the primary care physician through the opioid contract. J Pain Symptom
Manage. 2003;25(5):403.
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Pain Inventory. Annals of the Academy of Medicine, Singapore. 1994;
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Crews KR, Gaedigk A, Dunnenberger HM, et al. Clinical
Pharmacogenetics Implementation Consortium 9CPIC) guidelines for
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Clin Pharmacol Ther. 2012;91(2):321-6.
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Leavitt SB. Intranasal Naloxone for At-Home Opioid Rescue.
Prac Pain Mngmnt. October, 2010:42-46.
27
Self-Assessment
Choose the best possible answer for each question and mark your answers on the Self-Assessment
answer sheet at the end of this book. There is a required score of 70% or better to receive a Certificate
of completion.
1. Long-acting (LA) and extended-release
(ER) formulations of opioids should
typically not be used for which of the
following?
a. Treating cancer pain.
b. Treating acute pain.
c. Treating end-of-life pain.
d. Treating chronic non-cancer pain.
2. If an organic pathology cannot be found
to explain a patients pain, what should a
clinician infer?
a. The pain is real, though unexplained.
b. The pain is psychosomatic.
c. The patient is seeking opioids for illegal
use.
d. The pain is the result of a mental health
condition.
3.
28
29
30
Course:EOL12Credits
OriginalReleaseDate11/2012 LastUpdate09/2013
ExpirationDate:10/31/2015
1.
1.
2.
3.
Accreditation Statement
Informed is accredited by the Accreditation Council for
Continuing Medical Education (ACCME) to provide continuing
medical education for physicians.
Faculty
Paul J. Christo, MD, MBA
Associate Professor, The Johns Hopkins University School of
Medicine
Director, Multidisciplinary Pain Fellowship (2003-2011)
Director, Blaustein Pain Treatment Center (2003-2008)
Division of Pain Medicine. Department of Anesthesiology and
Critical Care Medicine
Stephen Braun
Medical Writer
Braun Medical Media
Activity Director
Sarina J. Grosswald, EdD
Director of CME, Informed
SJ Grosswald & Associates
Disclosure
Resolution of Conflicts of Interest
In accordance with the ACCME Standards for Commercial
Support of CME, the Informed implemented mechanisms, prior to
the planning and implementation of this CME activity, to identify
and resolve conflicts of interest for all individuals in a position to
control content of this CME activity.
Staff and Content Validation Reviewer Disclosure
Informed staff involved with this activity and any content
validation reviewers of this activity have reported no relevant
financial relationships with commercial interests.
Planning Committee/Faculty Disclosure
The following faculty and/or planning committee members have
indicated they have no relationship(s) with industry to disclose
relative to the content of this CME activity:
Sarina J. Grosswald, EdD
Stephen Braun
The following faculty and/or planning committee members have
indicated that they have relationship(s) with industry to disclose:
Paul J. Christo, MD, MBA has served on the Advisory
Boards of Ameritox and Quadrant HealthCom and has acted
as a consultant for Actavis, Perrigo, and Chattern, Inc.
Designation of Credit
Informed designates this enduring material for a maximum of 2
AMA PRA Category 1 Credits. Physicians should claim only
the credit commensurate with the extent of their participation in
the activity.
This activity developed without Commercial Support
2013. All rights reserved. These materials, except those in the public
domain, may not be reproduced without permission from InforMed. This
publication is designed to provide general information prepared by
professionals in regard to the subject matter covered. It is provided with the
understanding that InforMed, Inc. is not engaged in rendering legal, medical
or other professional services. Although prepared by professionals, this
publication should not be utilized as a substitute for professional services in
specific situations. If legal advice, medical advice or other expert assistance
is required, the service of a professional should be sought.
31
Figure1:Percentofsampledadultswhoratedthehypotheticalstate
ofseverepainasworsethandeath.
Source: Patrick DL, Pearlman RA, Starks HE, et al. Validation of preferences for life-sustaining
treatment: implications for advance care planning. Ann Intern Med 1997;127(7):509-17.
InforMed 1-800-237-6999 Fax 1-800-647-1356
32
33
34
35
36
Agent
Antidepressants
Nortriptyline
Route of
Administration
Oral
Desipramine
Oral
Venlafaxine
Oral
Duloxetine
Gabapentin
Pregabalin
Clonazepam
Dexamethasone
Oral
Oral
Oral
Oral
Oral/IV/Sq
Lidocaine
Lidocaine patch
Lidocaine
infusion
Topical
IV/sq
NMDA
antagonists
Ketamine
Oral/iv
Bisphosphonates
Pamidronate
Zoledronic acid
THC (Marinol)
Nabilone
(Cesamet)
THC (Sativex)
IV
IV
Oral
Oral
Anti-epilepsy
drugs
Corticosteroids
Cannabinoids
Oromucosal
spray
Potential adverse
effects
Anticholinergic
effects
Cardiac
arrhythmia
Nausea,
dizziness
Nausea
Dizziness
Dizziness
Sedation
Steroid
psychosis
Erythema (rare)
Perioral
numbness,
cardiac changes
Hallucinations
Pain flare,
osteonecrosis
Dizziness,
nausea,
tachycardia,
euphoria
Indications
Neuropathic pain
Neuropathic pain
Currently available in: United Kingdom, Canada, Spain, Germany, Denmark, and New Zealand
As evidenced in some clinical trials; not an FDA-approved indication
Sources: Paice JA, Ferrell B. CA Cancer J Clin. 2011;61-157-182.; Marinol Full Prescribing Information
Adjuvant Analgesics
Although opioid medications are a mainstay
of pain management at the end-of-life, many
other classes of medications have proven to
be effective and, in some cases, preferable to
opioids. Some exert a direct analgesic effect
mediated by non-opioid receptors centrally
or peripherally. Other adjuvant analgesics
have no direct analgesic qualities but may
provide pain relief indirectly by affecting
organs or body systems involved in painful
sensations (Table 2).
Some antidepressant agents appear to exert
37
38
39
Figure2.PercentageofpatientsreportingusingspecificCAMtherapiesduringstudy
period
Source: Kutner JS, Corbin L. The use of complementary and alternative medicine therapies by patients with
advanced cancer and pain in a hospice setting: a multi-centered, descriptive study. J Palliat Med. 12(1):78. 2009.
InforMed 1-800-237-6999 Fax 1-800-647-1356
40
41
42
43
44
Conclusions
Expert pain management in the terminal
phase of life requires clinicians to employ
the full range of pain assessment, diagnosis,
treatment, and management used for patients
with acute or chronic non-life-threatening
pain. But, in addition, clinicians must be
aware of and knowledgeable about the many
unique physiological, emotional, and
cultural components that come into play at
the end of life. As it is in other phases of life,
pain management at the end of life is highly
dynamic. Ongoing comprehensive pain
assessment is necessary to detect changes in
pain such as the development of painful
bone metastasis, resolution of treatable
causes such as infections, or worsened
neuropathic or visceral pain due to tumor
growth. Careful refinement of pain
management regimens are often required at
the end of life and may include changes in
the route of analgesics if patients can no
longer take oral medications, the need to
rotate opioids, or the addition of agents such
as steroids for a pain crisis (as in
pathological fracture).
45
Resources
American Academy of Hospice and Palliative Medicine - http://www.aahpm.org
American Cancer Society - http://www.cancer.org or
American Pain Society - http://www.ampainsoc.org
American Society for Pain Management Nursing - http://www.aspmn.org
City of Hope Pain & Palliative Care Resource Center - http://prc.coh.org
Hospice and Palliative Nurses Association - http://www.hpna.org
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48
Self-Assessment
Choose the best possible answer for each question and mark your answers on the SelfAssessment answer sheet at the end of this book. There is a required score of 70% or better to
receive a Certificate of completion.
24. A sample of older well adults
considered having which of the
following conditions as worse than
death?
a. Alzheimer Disease
b. Severe pain
c. Heart attack
d. Stroke
25. Which of the following correctly
describes the distinction between
palliative care and hospice care?
a. Hospice care is a broader term than
palliative care as it includes the
family
b. Palliative care focuses only on pain
control
c. Hospice care is reserved only for
patients who are not expected to live
more than 6 months
d. Palliative care is reserved for
patients with life-threatening
diseases
26. Which statement is most true about
pain relief at the end of life?
a. Pain relief is the primary treatment
goal at the end of life
b. The goal of treatment should be zero
pain for the patient
c. Patients typically ask for maximum
pain relief
d. Some patients choose less pain relief
in exchange for mental alertness
49
50
ExpirationDate:10/31/2015
1.
2.
3.
4.
1.
2.
3.
Faculty
Stephen Braun
Medical Writer
Braun Medical Media
Activity Director
Sarina J. Grosswald, EdD
Director of CME, Informed
SJ Grosswald & Associates
Disclosure
Resolution of Conflicts of Interest
In accordance with the ACCME Standards for Commercial
Support of CME, the Informed implemented mechanisms, prior to
the planning and implementation of this CME activity, to identify
and resolve conflicts of interest for all individuals in a position to
control content of this CME activity.
Staff and Content Validation Reviewer Disclosure
Informed staff involved with this activity and any content
validation reviewers of this activity have reported no relevant
financial relationships with commercial interests.
Planning Committee/Faculty Disclosure
The following faculty and/or planning committee members have
indicated they have no relationship(s) with industry to disclose
relative to the content of this CME activity:
Sarina J. Grosswald, EdD
Stephen Braun
Accreditation Statement
Informed is accredited by the Accreditation Council for
Continuing Medical Education (ACCME) to provide continuing
medical education for physicians.
Designation of Credit
Informed designates this enduring material for a maximum of 1
AMA PRA Category 1 Credit. Physicians should claim only the
credit commensurate with the extent of their participation in the
activity.
This activity developed without Commercial Support
2013. All rights reserved. These materials, except those in the public
domain, may not be reproduced without permission from InforMed. This
publication is designed to provide general information prepared by
professionals in regard to the subject matter covered. It is provided with the
understanding that InforMed, Inc. is not engaged in rendering legal, medical
or other professional services. Although prepared by professionals, this
publication should not be utilized as a substitute for professional services in
specific situations. If legal advice, medical advice or other expert assistance
is required, the service of a professional should be sought.
51
Patient care
Medical knowledge
Professionalism
Systems-based practice
These competencies are patient-centered, driven by the
goal of improving the overall care and safety of patients.
The four component categories are:
Part I:
Professional Standing
Part II:
Lifelong Learning and SelfAssessment
Part III:
Cognitive Expertise
Part IV:
Practice Performance Assessment
52
Figure1
54
Figure2
Figure3
55
Figure4
Figure4
and this additional time can also be claimed for AMA PRA
Category 1 Credit. At present, the maximum amount of
time that you can claim is 30 minutes for each individual CME
activity. To claim this credit you simply return to
directus.cme.edu, login and your CME history will be
displayed which contains every individually-directed CME
activity you have claimed for credit. Simply click on the
Activity Title (which in our example was Hypertension and
Alzheimers), to display the activity record with all the
information captured by Directus (see Figure 4). The only
thing that you can change on the activity record is the actual
amount of time claimed for CME credit. You can deduct time
either manually or by making adjustments in the time log.
Likewise you can claim up to 30 minutes for reflection time.
FORECAST
CME is in the midst of transformation with its outcome being
directed by a number of stakeholders, with particular input
from three. First, The American Board of Medical Specialtys
maintenance of certification (MOC) emphasis on life-long,
self-directed learning relevant to a physicians practice. Next,
the Federation of State Medical Boards model for
maintenance of licensure (MOL) concurrency that physicians
satisfying the requirements of MOC have also substantially
56
How?
Lectures 55%
Disease and Condition Information 43%
Demonstrations of Medical Procedures 40%
Health News 37%
References
57
Self-Assessment
Choose the best possible answer for each question and mark your answers on the Self-Assessment answer sheet at the end
of this book. There is a required score of 70% or better to receive a Certificate of completion.
58
SELF-ASSESSMENT ANSWERS
Mark One Answer Per Question
First
Middle
Last
DEA Number
Mailing Address
City
State
Zip Code
E-mail Address
Specialty
REMITTANCE AMOUNT
COURSE FEE
$50.00
[D]
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PAYMENT METHODS
VISA
MasterCard
American Express
Discover
Card #
Card ID*
Exp. Date
Signature
Total Payment
24
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NJ1415
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Evaluation Form
Please read the following questions, in their context, and provide
a response based on the content of this educational activity.
1. Current knowledge is information you already know, weighed,
considered or incorporated prior to starting this activity.
For this overall educational activity, I: (choose only one)
only reaffirmed my current knowledge.
gained new knowledge I will weigh, consider or incorporate
in my practice of medicine.
ER/LA OPIOID REMS EDUCATION
For 2-6, with regard to opioids and controlled substances, (A) did the
content provide any knowledge that you will weigh, consider, or
incorporate in your practice and (B) do you expect this to improve
your patients outcomes?
PART A
PART B
Knowledge
Outcomes
Yes
Yes
2. Assessing patients for treatment.
No
No
Initiating therapy, modifying
Yes
Yes
3. dose, and discontinuing use in
No
No
treating patients.
Yes
Yes
4. Managing ongoing therapy.
No
No
Counseling patients and
caregivers about the safe use of
Yes
Yes
5.
and including proper storage and No
No
disposal of the drug.
Familiarity with general and
Yes
Yes
6. product-specific drug
No
No
information.
7. Identify a specific change, if any, you will make in your practice
related to prescribing opioids or other controlled substances.
8. Describe with one word or short phrase any barrier to making that
change.
SELF-DIRECTED LEARNING
For 14-15, (A) did the content provide any knowledge that you will
weigh, consider, or incorporate in your practice and (B) do you
expect this to improve your patients outcomes?
PART A
PART B
Knowledge
Outcomes
Using the internet for self Yes
Yes
14.
directed learning.
No
No
Increasing CME credit hours
Yes
Yes
15. you claim for self-directed
No
No
learning.
Please read the following questions, in their context, and provide
a response based on the content of this educational activity.
17. If CME participant records are going paperless (electronic
transmission), what is your preference for administrator and privacy?
A. Administrator
Regulatory (e.g., Federal, State, other agencies)
Special Interest (e.g., AMA, AAFP, AOA, ACCME)
Physicians and CME providers
Other
B. Privacy - Disclosure of any data is under the control of:
Administrator
Physician
Physician and Administrator only with authorization by physician
18. Any national CME system will require a Unique Identifier Code
(UIC) for all participants. Which is the most convenient for you and
which would you feel most comfortable using?
convenience
Soc. Sec. #
St. Med Lic. #
DEA#
NPI#
ME#
Other
comfort
No
60
SATISFACTION
MAIL
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PHONE
1-800-237-6999
FAX
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e
Now theres a way to earn CME CREDIT for the time spent
researching topics and areas of interest SPECIFIC TO YOU
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InforMed is accredited by the Accreditation Council for Continuing Medical Education (ACCME)
to provide continuing medical education for physicians.
InforMed has been providing high-quality CME activities to physicians and physician
assistants for over 40 years. InforMed specializes in developing quality educational
activities to ensure that physicians meet mandatory CME requirements.