Presented by Dr.Perry Fine at Pain Management for the Elderly Course, 2010. Scribe medical events egypt. www.scribeofegypt.org

1. Chronic Opioid
Therapy: Indications,
Risk Stratification
and Management
Perry G. Fine, MD
Professor of Anesthesiology
Pain Research Center
School of Medicine
University of Utah
Salt Lake City, Utah

2. Considerations I
• What is conventional practice for this type of pain or pain
patient?
• Is there an alternative therapy that is likely to have an
equivalent or better therapeutic index for pain control,
functional restoration, and improvement in quality of life?
• Does the patient have medical problems that may
increase the risk of opioid-related adverse effects?
• Is the patient likely to manage the opioid therapy
responsibly?
Fine PG, Portenoy RK. Clinical guide to opioid analgesia. Vendome Group,
New York, 2007

3. Considerations II
• Who can I treat without help?
• Who would I be able to treat with the assistance of a
specialist?
• Who should I not treat, but rather refer, if opioid therapy is a
consideration
Fine PG, Portenoy RK. Clinical guide to opioid analgesia. Vendome Group,
New York, 2007

4. Opioid Therapy in Older Patients with
Persistent Pain
• Ferrell B, Fine PG, Herr K, et al, for the AGS Panel on
Persistent Pain in Older Persons: 2009. Clinical guideline for
the pharmacological management of persistent pain in older
persons. J Am Geriatr Soc; 57:1331-1346

5. Recommendations
• All patients with moderate-severe pain, pain related functional
impairment or diminished quality of life due to pain should be
considered for opioid therapy. (low evidence, strong rec)

6. Recommendations
• Patients with frequent or continuous pain on a daily basis
should be treated with around-the-clock (ATC) opioid therapy.
(low evidence, weak rec)

7. Recommendations
• Clinicians should anticipate, assess for, and identify potential
opioid associated adverse effects.
(moderate evidence, strong rec)

8. Recommendations
• Maximal safe doses of acetaminophen or NSAIDS should not
be exceeded when using fixed dose combination agents as
part of an analgesic regimen.
(moderate evidence, strong rec)

9. Recommendations
• Breakthrough pain should be assessed prevented and/or
treated.
(moderate evidence, strong rec)

10. Recommendations
• Methadone should be initiated and titrated cautiously only by
clinicians well versed in its use and risks.
(moderate evidence, strong rec)

11. Recommendations
• Patients taking opioid analgesics should be reassessed for
ongoing attainment of therapeutic goals, adverse effects, and
safe and responsible medication use. (moderate evidence,
strong rec)

12. On-line Resources
SOCIETY LINK
American Academy of Pain Medicine http://www.painmed.org/clinical_
info/guidelines.html
American Pain Society http://www.ampainsoc.org/pub/cp_
guidelines.htm
http://www.ampainsoc.org/links/
clinician1.htm
Federation of State Medical Boards http://www.fsmb.org/RE/PAIN/
resource.html
American Academy of Pain Management http://www.aapainmanage.org/
literature/Publications.php
Assessment and Risk Management Tools http://www.painedu.org/soap.asp
http://www.painknowledge.org

13. APS-AAPM
Clinical Guidelines for the Use of Chronic
Opioid Therapy for Chronic Noncancer Pain
Director, APS Clinical Guidelines Project
• Roger Chou, MD
Oregon Evidence-based Practice Center, Oregon health & Sciences
University
Co-chairs
• Gilbert Fanciullo, MD, MS
Dartmouth-Hitchcock Medical Center
• Perry G. Fine, MD
University of Utah, Pain Research Center
■Chou R, Ballantyne JC, Fanciullo GJ, Fine PG, Miaskowski C: 2009. Research gaps on use of opioids for
chronic noncancer pain: findings from a review of the evidence for an American Pain Society and
American Academy of Pain Medicine clinical practice guideline. J Pain;10(2):147-59.
■ Chou R, Fanciullo GJ, Fine PG, et al: 2009 Clinical guidelines for the use of chronic opioid therapy in
chronic noncancer pain. J Pain;10(2):113-30.
■ Chou R, Fanciullo GJ, Fine PG, Miaskowski C, Passik SD, Portenoy RK: 2009. Opioids for chronic
noncancer pain: prediction and identification of aberrant drug-related behaviors: a review of the evidence
for an American Pain Society and American Academy of Pain Medicine clinical practice guideline. J
Pain;10(2):131-46.

14. Process
• 22 panel members (100+ nominations) from 15 disciplines
• Scope defined; key questions formulated; systematic review of
literature
• Data abstraction
• Quality rating (Jadad and Cochrane Back Review)
• Data synthesis (GRADE System)
• Draft evidence review
• Final evidence review
• Formulation and grading of recommendations
• Peer review; publication; dissemination

15. Grade of
recommendation/de
scription
Benefit vs.
Risk and
burdens
Methodological Quality
of Supporting Evidence Implications
Strong
recommendation,
high-quality
evidence
Benefits
clearly
outweigh risk
and burdens,
or vice versa
RCTs w/o important
limitations or
overwhelming evidence
from observational
studies
Can apply to most
patients in most
circumstances
without reservation
Strong
recommendation,
moderate quality
evidence
Benefits
clearly
outweigh risk
and burdens,
or vice versa
RCTs with important
limitations or
exceptionally strong
evidence from
observational studies
Can apply to most
patients in most
circumstances
without reservation
Strong
recommendation,
low-quality
evidence
Benefits
clearly
outweigh risk
and burdens,
or vice versa
Observational studies or
case series
May change when
higher quality
evidence becomes
available
Interpretation: “Strong”
recommendations
May 10, 200850

16. Grade of
recommendation/de
scription
Benefit vs. Risk
and burdens
Methodological Quality
of Supporting Evidence Implications
Weak
recommendation,
high-quality
evidence
Benefits closely
balanced with
risks and
burdens
RCTs w/o important
limitations or
overwhelming evidence
from observational
studies
Best action may
differ depending on
circumstances or
patient/societal
values
Weak
recommendation,
moderate quality
evidence
Benefits closely
balanced with
risks and
burdens
RCTs with important
limitations or
exceptionally strong
evidence from
observational studies
Best action may
differ depending on
circumstances or
patient/societal
values
Weak
recommendation,
low-quality
evidence
Uncertainty in
estimates of
benefits, risks,
and burdens
Observational studies or
case series
Other alternatives
may be reasonable
Interpretation: “Weak”
recommendations
May 10, 200851

17. 1. Patient Selection and Risk Stratification
• 1.1 Prior to initiating COT, clinicians should
conduct a history, physical examination and
appropriate testing, including an assessment of
risk of substance abuse, misuse, or addiction
(strong recommendation, low-quality evidence).
• 1.2 Clinicians may consider a trial of COT as
an option if CNCP is moderate or severe, pain is
having an adverse impact on function or quality
of life, and potential therapeutic benefits
outweigh or are likely to outweigh potential
harms (strong recommendation, low-quality
evidence).

18. 1. Patient Selection and Risk Stratification,
cont.
• 1.3 A benefit-to-harm evaluation including a history,
physical examination, and appropriate diagnostic testing
should be performed and documented prior to and on an
ongoing basis during COT (strong recommendation, low-
quality evidence).

19. 2. Informed consent and opioid management
plans
• 2.1 When starting COT, informed consent should be
obtained. A continuing discussion with the patient
regarding COT should include goals, expectations,
potential risks, and alternatives to COT (strong
recommendation, low-quality evidence).
• 2.2 Clinicians may consider using a written COT
management plan to document patient and clinician
responsibilities and expectations and assist in patient
education (weak recommendation, low-quality evidence).

20. 3. Initiation and titration of COT
• 3.1 Clinicians and patients should regard initial
treatment with opioids as a therapeutic trial to
determine whether COT is appropriate (strong
recommendation, low-quality evidence).

21. 3. Initiation and titration of COT
• 3.2 Opioid selection, initial dosing, and titration should
be individualized according to the patient’s health status,
previous exposure to opioids, attainment of therapeutic
goals, and predicted or observed harms (strong
recommendation, low-quality evidence).
– There is insufficient evidence to recommend short-
acting versus long-acting opioids, or as-needed versus
round-the-clock dosing of opioids.

22. 4. Methadone
• 4.1 Methadone is characterized by complicated and variable
pharmacokinetics and pharmacodynamics and should be
initiated and titrated cautiously, by clinicians familiar with its
use and risks (strong recommendation, moderate-quality
evidence).

23. 5. Monitoring
• 5.1 Clinicians should reassess patients on COT
periodically and as warranted by changing
circumstances. Monitoring should include
documentation of pain intensity and level of
functioning, assessments of progress towards
achieving therapeutic goals, presence of
adverse events, and adherence to prescribed
therapies (strong recommendation, low-quality
evidence).
• 5.2 In patients on COT who are at high risk or
who have engaged in aberrant drug-related
behaviors, clinicians should periodically obtain
urine drug screens or other information to
confirm adherence to the COT plan of care
(strong recommendation, low-quality evidence).

24. 5. Monitoring, cont.
• 5.3 In patients on COT not at high risk and not
known to have engaged in aberrant drug-related
behaviors, clinicians should consider periodically
obtaining urine drug screens or other information to
confirm adherence to the COT plan of care (weak
recommendation, low-quality evidence).

25. 6. High-risk patients
• 6.1 Clinicians may consider COT for patients
with CNCP and history of drug abuse,
psychiatric issues, or serious aberrant drug-
related behaviors only if they are able to
implement more frequent and stringent
monitoring parameters. In such situations,
clinicians should strongly consider consultation
with a mental health or addiction specialist
(strong recommendation, low-quality evidence).
• 6.2 Clinicians should evaluate patients
engaging in aberrant drug-related behaviors for
appropriateness of COT or need for restructuring
of therapy, referral for assistance in
management, or discontinuation of COT (strong
recommendation, low-quality evidence).

26. 7. Dose escalations, high-dose opioid therapy,
opioid rotation, and indications for discontinuation
of therapy
• 7.1 When repeated dose escalations occur in
patients on COT, clinicians should evaluate
potential causes and re-assess benefits relative
to harms (strong recommendation, low-quality
evidence).
• 7.2 In patients who require relatively high
doses of COT, clinicians should evaluate for
unique opioid-related toxicities, changes in
health status, and adherence to the COT
treatment plan on an ongoing basis, and
consider more frequent follow-up visits (strong
recommendation, low-quality evidence).

27. 7. Dose escalations, high-dose opioid therapy,
opioid rotation, and indications for discontinuation
of therapy, cont.
• 7.3 Clinicians should consider opioid rotation when
patients on COT experience intolerable adverse effects or
inadequate benefit despite dose increases (weak
recommendation, low-quality evidence).
• 7.4 Clinicians should taper or wean patients off of COT
who engage in intractable aberrant drug-related
behaviors or drug abuse/diversion, experience no
progress towards meeting therapeutic goals, or
experience intolerable adverse effects (strong
recommendation, low-quality evidence).

28. 8. Opioid-related adverse effects
• 8.1 Clinicians should anticipate, identify and treat
common opioid-associated adverse effects (strong
recommendation, moderate-quality evidence).

29. 9. Use of non-opioid therapies
• 9.1 As CNCP is a complex biopsychosocial
condition, clinicians who prescribe COT should
routinely integrate psychotherapeutic
interventions, functional restoration,
interdisciplinary therapy, and other adjunctive
non-opioid therapies (strong recommendation,
moderate-quality evidence).

30. 10. Driving and work safety
• 10.1 Clinicians should counsel patients
on COT about transient or lasting
cognitive impairment that may affect
driving and work safety. Patients should
be counseled not to drive or engage in
potentially dangerous activities when
impaired of if they describe or show signs
of impairment (strong recommendation,
low-quality evidence).

31. 11. Identifying a medical home and when to
obtain consultation
• 11.1 Patients on COT should identify a clinician
who accepts primary responsibility for their
overall medical care. This clinician may or may
not prescribe COT, but should coordinate
consultation and communication among all
clinicians involved in the patient’s care (strong
recommendation, low-quality evidence).
• 11.2 Clinicians should pursue consultation,
including interdisciplinary pain management,
when patients with CNCP may benefit from
additional skills or resources that they cannot
provide (strong recommendation, moderate-
quality evidence).

32. 12. Breakthrough pain
• 12.1 In patients on around-the-clock COT with
breakthrough pain, clinicians may consider as-needed
opioids based upon an initial and ongoing analysis of
therapeutic benefit versus risk (weak recommendation,
low-quality evidence).

33. 13.Opioids in pregnancy
(not exactly a geriatric issue…)
• 13.1 Clinicians should counsel women of childbearing
potential about risks and benefits of COT during
pregnancy and after delivery. Clinicians should
encourage minimal or no use of COT during pregnancy,
unless potential benefits outweigh risks. If COT is used
during pregnancy, clinicians should be prepared to
anticipate and manage risks to the patient and newborn
(strong recommendation, low-quality evidence).

34. 14. Opioid policies:
Discussion point: What is regulatory status of
opioid use in CNCP in Egypt?
• 14.1 Clinicians should be aware of current federal and
state laws, regulatory guidelines, and policy statements
that govern the medical use of COT for CNCP (strong
recommendation, low-quality evidence).

35. Domains for Pain Management Outcome:
The 4 A’s
• Analgesia
• Activities of Daily Living
• Adverse Events
• Aberrant Drug-Taking Behaviors
Passik SD, Weinreb HJ. Adv Ther. 2000;17:70-83.
Passik SD, et al. Clin Ther. 2004;26:552-561.

36. Webster LR, Webster RM. Pain Med. 2005;6(6):432-442.
Prevalence of Misuse, Abuse,
and Addiction
Misuse 40%
Abuse: 20%
Total Pain
PopulationAddiction: 2% to 5%

37. Katz NP, et al. Clin J Pain. 2007;23:103-118; Manchikanti L, et al. J Opioid Manag. 2007;3:89-100.
Webster LR, Webster RM. Pain Med. 2005;6:432-442.
• Age ≤ 45 years
• Gender
• Family history of
prescription drug
or alcohol abuse
• Cigarette
smoking
• Substance use
disorder
• Preadolescent
sexual abuse
(in women)
• Major psychiatric
disorder
(eg, personality
disorder, anxiety
or depressive
disorder, bipolar
disorder)
• Prior legal
problems
• History of motor
vehicle accidents
• Poor family
support
• Involvement in a
problematic
subculture
Biological Psychiatric Social
Risk Factors for
Aberrant Behaviors/Harm

38. • No past/current
history of
substance abuse
• Noncontributory
family history of
substance abuse
• No major or
untreated
psychological
disorder
• History of treated
substance abuse
• Significant family
history of
substance abuse
• Past/comorbid
psychological
disorder
• Active substance
abuse
• Active addiction
• Major untreated
psychological
disorder
• Significant risk
to self and
practitioner
Low Risk Moderate Risk High Risk
Stratify Risk
Webster LR, Webster RM. Pain Med. 2005;6:432-442.

39. 10 Principles of Universal Precautions
1. Diagnosis with appropriate differential
2. Psychological assessment including risk of addictive disorders
3. Informed consent (verbal or written/signed)
4. Treatment agreement (verbal or written/signed)
5. Pre-/post-intervention assessment of pain level and function
6. Appropriate trial of opioid therapy adjunctive medication
7. Reassessment of pain score and level of function
8. Regularly assess the “Four As” of pain medicine: Analgesia,
Activity, Adverse Reactions, and Aberrant Behavior
9. Periodically review pain and comorbidity diagnoses, including
addictive disorders
10.Documentation
Gourlay DL, Heit HA. Pain Med. 2009;10 Suppl 2:S115-123.
Gourlay DL, et al. Pain Med. 2005;6(2):107-112.

40. Principles of Responsible Opioid Prescribing
Treatment Plan
• I have resolved key points before initiating opioid therapy
– Diagnosis established and opioid treatment plan developed
– Established level of risk
– I can treat this patient alone/I need to enlist other consultants to co-
manage this patient (pain or addiction specialists)
• I have considered nonopioid modalities
– Pain rehabilitation program
– Behavioral strategies
– Non-invasive and interventional techniques

41. Principles of Responsible Opioid Prescribing
Treatment Plan (cont)
• Drug selection, route of administration, dosing/dose titration
• Managing adverse effects of opioid therapy
• Assessing outcomes
• Written agreements in place outlining patient
expectations/responsibilities
• Consultation as needed
• Periodic review of treatment efficacy, side effects,
aberrant drug-taking behaviors

42. Summary
• The dichotomy of “pro-opioid” and “anti-opioid” is
a false one, and serves neither the practitioner,
the patient or society well. The ethical clinician is
“pro-health”, and makes treatment decisions with
her/his patient within that context.
• Until such time that there is a p’col class of
drugs as efficacious and versatile as the opioids,
clinicians need to learn how to select patients for
opioid therapy, when indicated, and manage
them as safely and effectively as possible.