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Chronic Opioid
Therapy: Indications,
Risk Stratification
and Management
Perry G. Fine, MD
Professor of Anesthesiology
Pain...
Considerations I
• What is conventional practice for this type of pain or pain
patient?
• Is there an alternative therapy ...
Considerations II
• Who can I treat without help?
• Who would I be able to treat with the assistance of a
specialist?
• Wh...
Opioid Therapy in Older Patients with
Persistent Pain
• Ferrell B, Fine PG, Herr K, et al, for the AGS Panel on
Persistent...
Recommendations
• All patients with moderate-severe pain, pain related functional
impairment or diminished quality of life...
Recommendations
• Patients with frequent or continuous pain on a daily basis
should be treated with around-the-clock (ATC)...
Recommendations
• Clinicians should anticipate, assess for, and identify potential
opioid associated adverse effects.
(mod...
Recommendations
• Maximal safe doses of acetaminophen or NSAIDS should not
be exceeded when using fixed dose combination a...
Recommendations
• Breakthrough pain should be assessed prevented and/or
treated.
(moderate evidence, strong rec)
Recommendations
• Methadone should be initiated and titrated cautiously only by
clinicians well versed in its use and risk...
Recommendations
• Patients taking opioid analgesics should be reassessed for
ongoing attainment of therapeutic goals, adve...
On-line Resources
SOCIETY LINK
American Academy of Pain Medicine http://www.painmed.org/clinical_
info/guidelines.html
Ame...
APS-AAPM
Clinical Guidelines for the Use of Chronic
Opioid Therapy for Chronic Noncancer Pain
Director, APS Clinical Guide...
Process
• 22 panel members (100+ nominations) from 15 disciplines
• Scope defined; key questions formulated; systematic re...
Grade of
recommendation/de
scription
Benefit vs.
Risk and
burdens
Methodological Quality
of Supporting Evidence Implicatio...
Grade of
recommendation/de
scription
Benefit vs. Risk
and burdens
Methodological Quality
of Supporting Evidence Implicatio...
1. Patient Selection and Risk Stratification
• 1.1 Prior to initiating COT, clinicians should
conduct a history, physical ...
1. Patient Selection and Risk Stratification,
cont.
• 1.3 A benefit-to-harm evaluation including a history,
physical exami...
2. Informed consent and opioid management
plans
• 2.1 When starting COT, informed consent should be
obtained. A continuing...
3. Initiation and titration of COT
• 3.1 Clinicians and patients should regard initial
treatment with opioids as a therape...
3. Initiation and titration of COT
• 3.2 Opioid selection, initial dosing, and titration should
be individualized accordin...
4. Methadone
• 4.1 Methadone is characterized by complicated and variable
pharmacokinetics and pharmacodynamics and should...
5. Monitoring
• 5.1 Clinicians should reassess patients on COT
periodically and as warranted by changing
circumstances. Mo...
5. Monitoring, cont.
• 5.3 In patients on COT not at high risk and not
known to have engaged in aberrant drug-related
beha...
6. High-risk patients
• 6.1 Clinicians may consider COT for patients
with CNCP and history of drug abuse,
psychiatric issu...
7. Dose escalations, high-dose opioid therapy,
opioid rotation, and indications for discontinuation
of therapy
• 7.1 When ...
7. Dose escalations, high-dose opioid therapy,
opioid rotation, and indications for discontinuation
of therapy, cont.
• 7....
8. Opioid-related adverse effects
• 8.1 Clinicians should anticipate, identify and treat
common opioid-associated adverse ...
9. Use of non-opioid therapies
• 9.1 As CNCP is a complex biopsychosocial
condition, clinicians who prescribe COT should
r...
10. Driving and work safety
• 10.1 Clinicians should counsel patients
on COT about transient or lasting
cognitive impairme...
11. Identifying a medical home and when to
obtain consultation
• 11.1 Patients on COT should identify a clinician
who acce...
12. Breakthrough pain
• 12.1 In patients on around-the-clock COT with
breakthrough pain, clinicians may consider as-needed...
13.Opioids in pregnancy
(not exactly a geriatric issue…)
• 13.1 Clinicians should counsel women of childbearing
potential...
14. Opioid policies:
Discussion point: What is regulatory status of
opioid use in CNCP in Egypt?
• 14.1 Clinicians should ...
Domains for Pain Management Outcome:
The 4 A’s
• Analgesia
• Activities of Daily Living
• Adverse Events
• Aberrant Drug-T...
Webster LR, Webster RM. Pain Med. 2005;6(6):432-442.
Prevalence of Misuse, Abuse,
and Addiction
Misuse 40%
Abuse: 20%
Tota...
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....
• No past/current
history of
substance abuse
• Noncontributory
family history of
substance abuse
• No major or
untreated
p...
10 Principles of Universal Precautions
1. Diagnosis with appropriate differential
2. Psychological assessment including ri...
Principles of Responsible Opioid Prescribing
Treatment Plan
• I have resolved key points before initiating opioid therapy
...
Principles of Responsible Opioid Prescribing
Treatment Plan (cont)
• Drug selection, route of administration, dosing/dose ...
Summary
• The dichotomy of “pro-opioid” and “anti-opioid” is
a false one, and serves neither the practitioner,
the patient...
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Chronic Opioid Therapy

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

Published in: Health & Medicine, Education
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Transcript of "Chronic Opioid Therapy"

  1. 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. 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. 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. 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. 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. 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. 7. Recommendations • Clinicians should anticipate, assess for, and identify potential opioid associated adverse effects. (moderate evidence, strong rec)
  8. 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. 9. Recommendations • Breakthrough pain should be assessed prevented and/or treated. (moderate evidence, strong rec)
  10. 10. Recommendations • Methadone should be initiated and titrated cautiously only by clinicians well versed in its use and risks. (moderate evidence, strong rec)
  11. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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.
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