1. Opioid Therapy of Chronic Pain: Evolving Trends Nociception Other physical symptoms Physical impairments NeuropathicPsychological Social isolation mechanismsprocessesFamily distress Role disruption Other co-morbidities Pain Disability/ Suffering

2. Approaches to the Patient with Chronic Pain –Pharmacological –Rehabilitative –Psychological –Anesthesiologic Primary Rx for pain etiology Symptomatic therapies: –Surgical –Neurostimulatory –CAM –Lifestyle change

3. Treatment of the Patient with Chronic Pain Pharmacotherapy –Opioid analgesics –Nonopioid analgesics –Adjuvant analgesics –Syndrome-specific drugs (e.g., headache)

4. Positioning Opioid Therapy: Trends over 20 years Early Consensus (Sustained) First-Line Therapy for: –Severe acute pain –Moderate-severe chronic cancer pain

5. Positioning Opioid Therapy: Trends over 20 years Evolving Recognition of Undertreatment Research findings in acute pain, cancer and AIDS pain, and pain at EOL: –Opioid use contrary to published guidelines –Worse than expected patient outcomes –Clinicians with limited knowledge about opioids and negative attitudes

6. Positioning Opioid Therapy: Trends over 20 years Evolving Recognition of Barriers Patient-related factors –stoicism, fear of addiction System factors –fragmented care, lack of reimbursement Clinician-related factors –Poor knowledge of pain management, opioid pharmacology, and chemical dependency –Fear of regulatory oversight

7. Positioning Opioid Therapy: Trends over 20 years Efforts to Redress Undertreatment –Guidelines and consensus statements from professional societies –New standards (JCAHCO) –Educational initiatives supported by academic programs, professional societies and organizations, and industry

8. Positioning Opioid Therapy: Trends over 20 years Chronic Non-Cancer Pain Changing perspectives –Evolving consensus among pain specialists –Gradual diffusion to primary care

9. Positioning Opioid Therapy: Trends over 20 years Pain Specialists Early negative view influenced by experience of chronic pain programs: Opioids associated with poor function Opioids associated with substance use disorders and other psychiatric disorders Opioids associated with poor outcome

10. Positioning Opioid Therapy: Trends over 20 years Pain Specialists Increasing use of long-term opioid therapy –Slowly growing evidence base –More sophisticated pharmacologic understanding –Reassurance from regulators and law enforcement –Influence of broad movement to improve acute pain and cancer pain treatment –Pressure from the media –Influence of industry

11. Positioning Opioid Therapy: Trends over 20 years Pain Specialists Current view embodied in consensus statements from: APS and AAPM ASAM CPS Others

12. Positioning Opioid Therapy: Trends over 20 years Pain specialists believe that opioids are significantly underused for chronic non-cancer pain Recognition of barriers as illegitimate Recognition of biases in published reports from multidisciplinary pain programs Positive reports in the literature and personal experiences with patients

13. Positioning Opioid Therapy: Trends over 20 years Pain specialists support the use of opioid therapy by primary care MDs Recognition of barriers as illegitimate Belief that treatment principles are simple Knowledge of pain epidemiology Feeling overwhelmed Influence of advocates, media, and industry

14. Positioning Opioid Therapy: Trends over 20 years Pain Specialists Recent acknowledgement of concerns: Many specialists have inadequate knowledge of addiction medicine principles, which are essential to safe and effective treatment Generalists are adopting the therapy without adequate knowledge of pain management principles, opioid pharmacology, and addiction medicine principles

15. Positioning Opioid Therapy: Trends over 20 years Pain Specialists Recent acknowledgement of concerns: Tacit reluctance on the part of supporters-- specialists, media, patient advocates, and industry--to discuss legitimate risks associated with opioid toxicity and abuse/addiction liability

16. Positioning Opioid Therapy: Trends over 20 years Evolving Consensus Still considered first-line for patients with severe acute pain, and moderate to severe pain related to cancer or AIDS, or other life-threatening illness

17. Positioning Opioid Therapy: Trends over 20 years Evolving Consensus Consider for all patients with moderate to severe non-cancer pain, but weigh the influences: What is conventional practice? Are opioids likely to work well? Are there reasonable alternatives? Will the risk of side effects be relatively high? Are drug-related behaviors likely to be responsible?

18. Positioning Opioid Therapy: Trends over 20 years Evolving Consensus Safe and effective therapy requires: Knowledge and skills sufficient to assess pain and relevant co-morbidities Knowledge of conventional pain treatments sufficient to appropriately position opioid therapy among others Knowledge of opioid pharmacotherapy

19. Positioning Opioid Therapy: Trends over 20 years Evolving Consensus : Safe and effective therapy requires: Knowledge and skills in addiction medicine sufficient to judge risks, monitor treatment, and handle problems Commitment to documentation and infrastructure

20. Positioning Opioid Therapy: Trends over 20 years Evolving Consensus Safe and effective therapy requires: Pain specialists as consultants educated in both pain management and principles of addiction medicine

21. Opioid Treatment of Chronic Pain Critical Issues for Ongoing Review –Perceived risk of sanctions –Establishing effectiveness –Understanding safety considerations

22. Opioid Treatment of Chronic Pain Critical Issues –Perceived risk of sanctions Survey of >1300 NYS physicians (1998) showed that >50% moderately to very concerned about regulatory scrutiny and 25-50% admit changing practice because of concern

23. Opioid Treatment of Chronic Pain Critical Issues –Effectiveness l Opioid responsiveness l Durability of response (tolerance?) l Achieving optimal therapy

24. Opioid Treatment of Chronic Pain Opioid Responsiveness –Many thousands of patients reported in surveys of cancer pain--70-90% efficacy –Numerous surveys of patients with non- cancer pain--25-70% efficacy –Small number of relevant RCT’s

25. Opioid Treatment of Chronic Pain Opioid Responsiveness –Conclusion: – Opioid therapy probably can be effective for any type of pain syndrome But data are limited Responsiveness varies across individuals and subpopulations Responsiveness cannot be assessed unless therapy is optimized by individualization of the dose

26. Opioid Treatment of Chronic Pain Durability of Response –Conclusions: – Tolerance is complex – Most patients stabilize at a dose for a prolonged period – Fear of tolerance is greater problem than its effect on therapy

27. Opioid Treatment of Chronic Pain Achieving Optimal Therapy –Drug selection –Individualization of the dose –Treating side effects –Managing the poorly responsive patient

28. Opioid Treatment of Chronic Pain Critical outcomes –Pain relief –Side effects –Function--physical and psychosocial –Drug-related behaviors

29. Opioid Treatment of Chronic Pain Critical Issues –Safety – Major organ toxicity and risk of side effects – Addiction liability

30. Opioid Treatment of Chronic Pain Toxicity and Side Effects –Conclusions –No major organ toxicity –Persistent side effects in some, but most achieve a favorable balance between analgesia and side effects –Studies suggest that most normalize cognitive function and driving usually not impaired

31. Opioid Treatment of Chronic Pain Addiction Liability Relevant definitions evolving (APS/AAPM/ASAM) Relevance of studies limited Acute Pain: Very unlikely Cancer Pain: Very unlikely Chronic Non-Cancer Pain: Mixed results

32. Opioid Treatment of Chronic Pain Addiction –Disease with pharmacologic, genetic, and psychosocial elements –Distinguished from tolerance, physical dependence, and pseudoaddiction

33. Opioid Treatment of Chronic Pain Addiction –Fundamental features Loss of control Compulsive use Use despite harm –Diagnosed by observation of aberrant drug-related behavior

34. Opioid Treatment of Chronic Pain Aberrant Drug-Related Behavior –Differential Dx Addiction Pseudoaddiction Other psychiatric disorders Encephalopathy Family disturbances Criminal intent

35. Opioid Treatment of Chronic Pain Aberrant Drug-Related Behavior Monitor Diagnose the disorder Manage the behavior Treat the disorder

36. Opioid Therapy: Conclusions An approach with extraordinary promise and substantial risks An approach with clear obligations on prescribers –Assessment and reassessment –Skillful drug administration –Knowledge of addiction medicine principles –Documentation and communication