Practical Issues in Chronic Pain: Managing Analgesia in the Primary Care Setting

1. Practical Issues in Chronic Pain: Managing Analgesia in thePrimary Care Setting

2. Identify the negative impact of chronic pain on health and quality of life, current methods to assess pain levels, appropriate use of opioid medications, and documentation required for compliance with regulatory policies Integrate appropriate risk assessment strategies for patient abuse, misuse, and diversion among opioid therapies into an overall management approach for chronic pain Describe the specific elements of new abuse deterrent technologies associated with opioid therapy and assess their implications for clinical practice Educational Learning Objectives

4. Multiple Types of Pain

5. Case Study 1 A 56-year-old healthy male with chronic back pain Spinal stenosis after auto accident (age 45) Negative for OP Conservative therapy ineffective Persistent pain 6/10 and activity related pain 10/10 ORT 5 UDT consistent therapy PMP: no opioids Rx started with hydrocodone 10 mg/APAP q 4 hours Titrated to 50 mg CR morphine/naltrexone BID Slide 64 is an alternative version of this slide. Instead of the last 2 bullet points, the audience is given an open-ended question to encourage participation in the case. Slide 64 is an alternative version of this slide. Instead of the last 2 bullet points, the audience is given an open-ended question to encourage participation in the case.

6. Long-Term Consequences of Acute Pain: Potential for Progression to Chronic Pain

7. Neuroplasticity in Pain Processing

8. Vicious Cycle of Uncontrolled Pain

9. Breaking the Chain of Pain Transmission

10. Multimodal Treatment

11. Components of Chronic Pain Chronic pain Baseline persistent pain Breakthrough pain (BTP)  Each component of chronic pain needs to be independently assessed and managed

12. Monitoring Weekly visits until stable Prescribe only enough medication until next visit Rx Short acting for BTP CR formulation (with less street attractiveness) Six month follow-up Difficulty sleeping No aberrant behaviors PMP showed no aberrant behavior Monthly Urine Drug Test (UDT) consistent with therapy Transferred to dextropropoxyphene/acetaminophen 10 /day

13. Positioning Opioid Therapyfor Persistent Pain Chronic non-cancer pain: evolving perspective Consider for all patients with severe chronic pain, but weigh the influences What is conventional practice? Are there reasonable alternatives? What is the risk of adverse events? Is the patient likely to be a responsible drug-taker?

14. Chronic Opioid Therapy Guidelines

15. Chronic Opioid Therapy Guidelines

16. Opioid Formulations

17. Formulation Points to Consider Dose-limiting issues and toxicity with co-analgesics 4 g/day acetaminophen limit Importance of titration Risk of overdose, challenges of dose conversion during rotation Pharmacokinetics versus temporal patterns of pain Adherence Cost Convenience Caregiving issues

18. Domains for Pain Management Outcome: The 4 A�s Analgesia Activities of Daily Living Adverse Events Aberrant Drug-Taking Behaviors

19. Model Policy for the Use of Controlled Substances for the Treatment of Pain Federation of State Medical Boards House of Delegates, May 2004. http://fsmb.org. Accessed March 2010.

20. FSMB Model PolicyBasic Tenets

21. New Illicit Drug Use United States, 2006

22. Definition of Terms

23. Prevalence of Misuse, Abuse, and Addiction

24. Who Misuses/Abuses Opioids and Why?

25. Rx Opioid Users Are Heterogeneous SUD = Substance Use DisorderSUD = Substance Use Disorder

26. Risk Factors for Aberrant Behaviors/Harm

27. Stratify Risk

28. 10 Principles of Universal Precautions Diagnosis with appropriate differential Psychological assessment including risk of addictive disorders Informed consent (verbal or written/signed) Treatment agreement (verbal or written/signed) Pre-/post-intervention assessment of pain level and function Appropriate trial of opioid therapy adjunctive medication Reassessment of pain score and level of function Regularly assess the �Four A�s� of pain medicine: Analgesia, Activity, Adverse Reactions, and Aberrant Behavior Periodically review pain and comorbidity diagnoses, including addictive disorders Documentation Universal precautions revisited: managing the inherited pain patient. Gourlay DL, Heit HA. Pain Med. 2009 Jul;10 Suppl 2:S115-123. Universal precautions in pain medicine: a rational approach to the treatment of chronic pain. Gourlay DL, Heit HA, Almahrezi A. Pain Med. 2005 Mar-Apr;6(2):107-112.Universal precautions revisited: managing the inherited pain patient. Gourlay DL, Heit HA. Pain Med. 2009 Jul;10 Suppl 2:S115-123. Universal precautions in pain medicine: a rational approach to the treatment of chronic pain. Gourlay DL, Heit HA, Almahrezi A. Pain Med. 2005 Mar-Apr;6(2):107-112.

29. Initial Visits Initial comprehensive evaluation Risk assessment Prescription monitoring assessment Urine drug test Opioid treatment agreement Opioid consent form Patient education

30. Principles of Responsible Opioid Prescribing Patient Evaluation Assessment and history Directed physical exam Personal and family history of substance abuse/psychiatric problems Assessment of comorbidities Accurate record keeping

31. 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

32. 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

33. Medical Records Maintain accurate, complete, and current records Medical Hx & PE Diagnostic, therapeutic, lab results Evaluations/consultations Treatment objectives Discussion of risks/benefits Tx and medications Instructions/agreements Periodic reviews Discussions with and about patients

34. Opioid Treatment Agreement http://www.lni.wa.gov/ClaimsIns/Files/OMD/agreement.pdfhttp://www.lni.wa.gov/ClaimsIns/Files/OMD/agreement.pdf

35. Differential Diagnosis of Aberrant Drug-Taking Attitudes and Behavior Addiction (out-of-control, compulsive drug use) Pseudoaddiction (inadequate analgesia) Other psychiatric diagnosis Organic mental syndrome (confused, stereotyped drug-taking) Personality disorder (impulsive, entitled, chemical-coping behavior) Chemical coping (drug overly central) Depression/anxiety/situational stressors (self-medication) Criminal intent (diversion)

36. Identifying Who Is at Risk for Opioid Abuse and Diversion Predictive tools Aberrant behaviors Urine drug testing Prescription monitoring programs Severity and duration of pain Pharmacist communication Family and friends Patients

37. Signs of Potential Abuse and Diversion Request appointment toward end-of-office hours Arrive without appointment Telephone/arrive after office hours when staff are anxious to leave Reluctant to have thorough physical exam, diagnostic tests, or referrals Fail to keep appointments Unwilling to provide past medical records or names of HCPs Unusual stories

38. ORT Validation

39. Current Opioid Misuse Measure (COMM) Butler SF, Budman SH, Fernandez KC, et al. Development and validation of the Current Opioid Misuse Measure. Pain. 2007;130(1-2):144-156. Clinicians recognize the importance of monitoring aberrant medication-related behaviors of chronic pain patients while being prescribed opioid therapy. The purpose of this study was to develop and validate the Current Opioid Misuse Measure (COMM) for those pain patients already on long-term opioid therapy. An initial pool of 177 items was developed with input from 26 pain management and addiction specialists. Concept mapping identified six primary concepts underlying medication misuse, which were used to develop an initial item pool. Twenty-two pain and addiction specialists rated the items on importance and relevance, resulting in selection of a 40-item alpha COMM. Final item selection was based on empirical evaluation of items with patients taking opioids for chronic, noncancer pain (N=227). One-week test-retest reliability was examined with 55 participants. All participants were administered the alpha version of the COMM, the Prescription Drug Use Questionnaire (PDUQ) interview, and submitted a urine sample for toxicology screening. Physician ratings of patient aberrant behaviors were also obtained. Of the 40 items, 17 items appeared to adequately measure aberrant behavior, demonstrating excellent internal consistency and test-retest reliability. Cutoff scores were examined using ROC curve analysis and reasonable sensitivity and specificity were established. To evaluate the COMM�s ability to capture change in patient status, it was tested on a subset of patients (N = 86) that were followed and reassessed three months later. The COMM was found to have promise as a brief, self-report measure of current aberrant drug-related behavior. Further cross-validation and replication of these preliminary results is pending.Butler SF, Budman SH, Fernandez KC, et al. Development and validation of the Current Opioid Misuse Measure. Pain. 2007;130(1-2):144-156. Clinicians recognize the importance of monitoring aberrant medication-related behaviors of chronic pain patients while being prescribed opioid therapy. The purpose of this study was to develop and validate the Current Opioid Misuse Measure (COMM) for those pain patients already on long-term opioid therapy. An initial pool of 177 items was developed with input from 26 pain management and addiction specialists. Concept mapping identified six primary concepts underlying medication misuse, which were used to develop an initial item pool. Twenty-two pain and addiction specialists rated the items on importance and relevance, resulting in selection of a 40-item alpha COMM. Final item selection was based on empirical evaluation of items with patients taking opioids for chronic, noncancer pain (N=227). One-week test-retest reliability was examined with 55 participants. All participants were administered the alpha version of the COMM, the Prescription Drug Use Questionnaire (PDUQ) interview, and submitted a urine sample for toxicology screening. Physician ratings of patient aberrant behaviors were also obtained. Of the 40 items, 17 items appeared to adequately measure aberrant behavior, demonstrating excellent internal consistency and test-retest reliability. Cutoff scores were examined using ROC curve analysis and reasonable sensitivity and specificity were established. To evaluate the COMM�s ability to capture change in patient status, it was tested on a subset of patients (N = 86) that were followed and reassessed three months later. The COMM was found to have promise as a brief, self-report measure of current aberrant drug-related behavior. Further cross-validation and replication of these preliminary results is pending.

40. Urine Drug Testing (UDT) General drug tests only detect nonsynthetic substances, such as morphine Specific tests for synthetic drugs must be requested

41. Detection of Opioids Opiate immunoassays detect morphine and codeine Do not detect synthetic opioids Methadone Fentanyl Do not reliably detect semisynthetic opioids Oxycodone Hydrocodone Buprenorphine Hydromorphone GC/MS will identify these medications

42. The Role of UDT UDT in clinical practice may Provide objective documentation of compliance with treatment plan by detecting presence of a particular drug or its metabolites Assist in recognition of addiction or drug misuse if results abnormal Results are only as reliable as testing laboratory�s ability to detect substance in question

43. Positive forensic testing Legally prescribed medications Over-the-counter medications Illicit drugs or unprescribed medications Substances that produce the same metabolite as that of a prescribed or illegal substance Errors in laboratory analysis Negative compliance testing Medication bingeing Diversion Insufficient test sensitivity Failure of laboratory to test for desired substances Positive and Negative Urine Toxicology Results

44. Detection Times of Common Drugs of Misuse

45. Risk Evaluation and Mitigation Strategies Position of the FDA The current strategies for intervening with [the problem of prescription opioid addiction, misuse, abuse, overdose and death] are inadequate New authorities granted under FDAAA: [FDA] will now be implementing Risk Evaluation and Mitigation Strategies (REMS) for a number of opioid products [FDA expects] all companies marketing these products to [cooperate] to get this done expeditiously If not, [FDA] cannot guarantee that these products will remain on the market

46. Identifying and Managing Abuse and Diversion Assessing risk and aberrant behaviors Performing scheduled and random UDTs Utilization of PMPs Assessing stress and adequacy of pain control Developing good communication with pharmacists Receiving input from family, friends, and other patients

48. Physical Deterrent: Viscous Gel Base SR oxycodone formulation: Remoxy� Deters dose dumping Accessing entire 12-h dose of CR medication at 1 time Difficult to crush, break, freeze, heat, dissolve The viscous gel-cap base of PTI-821 cannot be injected Resists crushing and dissolution in alcohol or water

49. Aversive Component Capsaicin � Burning sensation Ipecac � Emetic Denatonium � Bitter taste Niacin � Flushing, irritation

50. Pharmacologic Deterrent: Antagonist Oral formulation Sequestered antagonist Antagonist bioavailable only when agent is crushed for extraction SR morphine + naltrexone (Embeda�) FDA approved 2009

51. Remaining Questions How much does the barrier approach deter the determined abuser? How much do agonist/antagonist compounds retain efficacy? How much do agonist/antagonist compounds pose serious adversity?

52. Case Study 2 A recently widowed 72-year-old female with severe osteoarthritis of hips and knees has been having increasing difficulty ambulating due to pain She had been taking over-the-counter NSAIDs for the pain but developed an upper GI bleed She resides with her unmarried son who has a history of substance abuse Quit smoking 40 years ago, drinks occasional glass of wine Has been taking duloxetine for anxiety and depression Upon discharge from the hospital she was given a prescription for acetaminophen/codeine but stopped taking the prescription due to severe constipation

53. Case Study 2 (cont) Rx Multimodal therapy included osteopathic manipulation and physical therapy for gait training, progressive exercise program, and aquatherapy Lidocaine 5% patches were prescribed Two weeks later She appears to be more ambulatory but still rates the pain in her hips and knees as 7/10 per NRS Is she a candidate for opioid therapy? Which opioid, what delivery system?

54. Conclusion

55. Pharmacovigilance Functional outcomes Standard medical practice FSMB policy Open Issues What is meant by pain management? Who needs what treatment? Do universal approaches work? Does it improve outcomes? For patients For regulators

57. Online Resources Melzack R. The McGill Pain Questionnaire. In: Pain Measurement and Assessment. New York:Raven Press, 1983, 41-48. Melzack, R. The short-form McGill Pain Questionnaire. Pain 1987;30:191-7. OTA: see Gourlay? Passik? Melzack R. The McGill Pain Questionnaire. In: Pain Measurement and Assessment. New York:Raven Press, 1983, 41-48. Melzack, R. The short-form McGill Pain Questionnaire. Pain 1987;30:191-7. OTA: see Gourlay? Passik?

58. McGill Short Form Pain Questionnaire The short-form McGill Pain Questionnaire (SF-MPQ). Descriptors 1-11 represent the sensory dimension of pain experience and 12-15 represent the affective dimension. Each descriptor is ranked on an intensity scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The Present Pain Intensity (PPI) of the standard long-form McGill Pain Questionnaire (LF-MPQ) and the visual analogue (VAS) are also included to provide overall intensity scores. The short-form McGill Pain Questionnaire (SF-MPQ). Descriptors 1-11 represent the sensory dimension of pain experience and 12-15 represent the affective dimension. Each descriptor is ranked on an intensity scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The Present Pain Intensity (PPI) of the standard long-form McGill Pain Questionnaire (LF-MPQ) and the visual analogue (VAS) are also included to provide overall intensity scores.

59. Initiation of Therapy for Chronic Pain

60. Current Opioid Misuse Measure (COMM)

61. Monitoring Chronic PainReview of Efficacy of Therapy

62. Alternative to Slide 6:

63. Case Study 1 A 56-year-old healthy male with chronic back pain Spinal stenosis after auto accident (age 45) Negative for OP Conservative therapy ineffective Persistent pain 6/10 and activity related pain 10/10 ORT 5 UDT consistent therapy PMP: no opioids Plans? This patient was treated in the following way: Rx started with hydrocodone 10 mg/APAP q 4 hours Titrated to 50 mg CR morphine/naltrexone BID This patient was treated in the following way: Rx started with hydrocodone 10 mg/APAP q 4 hours Titrated to 50 mg CR morphine/naltrexone BID