1. Slide 1 of xx Emerging Pharmacy Issues in the Texas Workers’ Compensation System Presented by Suzanne Novak, MD, PhD CEO, Austin Outcomes Research, Inc. June 9, 2009 A ustin O utcomes R esearch

2. Slide 2 of xxSlide 2 A ustin O utcomes R esearch Any reproduction of this material is prohibited without the author’s express written permission Copyright 2008, Austin Outcomes Research Presentation Outline Slide 2 DO WE HAVE A PROBLEM? - Current data - Adverse effects -Opioids and workers’ compensation - What is in the guidelines -Special issues

3. Slide 3 of xxSlide 3 A ustin O utcomes R esearch Current Data A ustin O utcomes R esearch Slide 3

4. Slide 4 of xxSlide 4 A ustin O utcomes R esearch What is the Current Data? Americans consume 80% of the global supply of opioids This includes 99% of the world’s hydrocodone and 2/3s of the world’s illegal drugs They constitute 4% of the world’s population Number of new opioid users 1990: 573,0002000: 2.5 million Manchikanti L. National drug control policy and prescription drug abuse: facts and fallacies. Pain Physician. 2007;10:399-424. Opioid Abuse: Current Data

5. Slide 5 of xxSlide 5 A ustin O utcomes R esearch Current data on Prescription Drug Abuse The reported range of patient’s exhibiting problematic opioid use ranges from 2.8% to 62.2% - Seeking prescriptions from multiple providers - Forging prescriptions - Preoccupation with obtaining more opioids despite evidence of pain relief - Unsanctioned dose escalations Abuse rose 71% between 1997 and 2002 Opioid misuse reports range from 20% to 40% Turk DC, et al. Clinical Journal of Pain 2008;24:497-508. Opioid Abuse: Current Data

6. Slide 6 of xxSlide 6 A ustin O utcomes R esearch Overdose Deaths: West Virginia - 2006 Death Rate from unintentional overdose 16.2/100,000 population (295) - US average: 5.6/100,000 - Rate of opioid prescribing from 2000 to 2005 increased at a higher rate in WV - Pharmaceutical diversion: 63.1% - Doctor shopping: 21.4% - Only 44.4% had been prescribed these drugs Opioid Abuse: Current Data Hall AJ et al. JAMA 2008

7. Slide 7 of xxSlide 7 A ustin O utcomes R esearch Why am I telling you this?  Only 19% of surveyed physicians received any medical school training in identifying prescription drug diversion  Only 40% received any training in identifying prescription drug abuse and addiction  43% do not ask about prescription drug abuse and diversion  1/3 do not obtain old records before prescribing controlled drugs Manchikanti L. National drug control policy and prescription drug abuse: facts and fallacies. Pain Physician. 2007;10:399-424.

8. Slide 8 of xxSlide 8 A ustin O utcomes R esearch Adverse Effects A ustin O utcomes R esearch Slide 8

9. Slide 9 of xxSlide 9 A ustin O utcomes R esearch 1. Sedation 2. Cognitive impairment 3. Respiratory depression 4. Nausea 5. Constipation 6. Edema 7. Hypogonadism 8. Hormonal changes 9. Immunosuppression 10. Hyperalgesia Opioid Abuse: Side Effects

10. Slide 10 of xxSlide 10 A ustin O utcomes R esearch 1. Higher disability 2. Higher rates of healthcare utilization 3. Higher rates of tobacco and other substance abuse 4. Higher levels of depression Opioid Abuse: Side Effects (psychosocial) Dersch J et al. Spine 2008: 2219-27

11. Slide 11 of xxSlide 11 A ustin O utcomes R esearch Opioids and Worker’s Compensation A ustin O utcomes R esearch Slide 11

12. Slide 12 of xxSlide 12 A ustin O utcomes R esearch Opioids and Workers’ Compensation Webster et al study Controlling for age, gender, job tenure, and LBP severity, the receipt of higher amounts of morphine equivalent medications in early treatment was associated with: Prolonged disability Higher medical costs Higher costs of surgery Late use of opioids Webster BS, et al. Relationship between early opioid prescribing for acute occupational low back pain and disability duration, medical costs, subsequent surgery and late opioid use. Spine. 2007 Sep 1;32(19):2127-32. Opioids and Workers’ Compensation

13. Slide 13 of xxSlide 13 A ustin O utcomes R esearch Opioids and Workers’ Compensation These findings suggest that the intensive use of opioids for the management of acute LBP may not be effective for: Long-term pain reduction Improving function May be counterproductive to recovery Opioids and Workers’ Compensation

14. Slide 14 of xxSlide 14 A ustin O utcomes R esearch Risk Factors A ustin O utcomes R esearch Slide 14

15. Slide 15 of xxSlide 15 A ustin O utcomes R esearch Psychosocial factors may be better predictors of pain and disability than physical or diagnostic factors Chronic pain patients have an increased prevalence of: - Depression- Anxiety - Substance abuse/dependence - Somatization and personality disorders Opioids and Workers’ Compensation Dersch J, et al. Spine 2007;1917-25

16. Slide 16 of xxSlide 16 A ustin O utcomes R esearch Substance abusers have a higher rate of: - Psychiatric comorbidity: Depression; Anxiety; Personality disorders - History of physical and sexual abuse - Use of other substances known for dependence - Tobacco dependence - Family history of substance abuse Opioids and Workers’ Compensation Dersch J, et al. Spine 2007;1917-25

17. Slide 17 of xxSlide 17 A ustin O utcomes R esearch Evidence for use of Opioids for Neuropathic Pain A ustin O utcomes R esearch Slide 17

18. Slide 18 of xxSlide 18 A ustin O utcomes R esearch Opioids for Neuropathic Pain Eisenberg et al. Cochrane 2006  The use of opioids for neuropathic pain remains controversial  Opioids have high side effect profiles  Studies are small and have yielded equivocal results  There is no established long-term risk- benefit ratio

19. Slide 19 of xxSlide 19 A ustin O utcomes R esearch Opioids for Neuropathic Pain  Short-term studies only provided equivocal evidence regarding efficacy  Intermediate-term studies demonstrated significant efficacy of opioids over placebo  Further randomized controlled trials are need to establish long-term efficacy, safety (including addiction potential) and effects on quality of life.

20. Slide 20 of xxSlide 20 A ustin O utcomes R esearch When to use Opioids When moderate to severe pain is having an adverse impact on function or quality of life Benefits outweigh risk

21. Slide 21 of xxSlide 21 A ustin O utcomes R esearch What is in the Guidelines? A ustin O utcomes R esearch Slide 21

22. Slide 22 of xxSlide 22 A ustin O utcomes R esearch APS/AAPM Guidelines  Prior to initiating treatment:  Conduct a H&P including assessment of risk of substance  abuse, misuse, or addiction  Obtain Informed Consent: includes goals, expectations,  potential risks, and alternatives to treatment  Consider a written management plan to document patient  and clinician responsibilities  The initial treatment should be considered a trial.

23. Slide 23 of xxSlide 23 A ustin O utcomes R esearch ODG: Indicators of Poor Outcomes Little or no relief with acute or subacute treatment There is evidence of psychiatric pathology such as conversion disorder, somatization disorder, pain associated with psych factors (depression, anxiety, or history of previous substance abuse) Patient requests opioids and there are inconsistencies in the history, presentation, and physical findings.

24. Slide 24 of xxSlide 24 A ustin O utcomes R esearch ODG: Steps Before the Trial  Obtain at least one physical and psychosocial assessment “When subjective complaints do not correlate with imaging studies and/or physical findings and/or psychosocial concerns exist, a second opinion with a pain specialist and psychological assessment should be obtained.” Sullivan 2006, Sullivan 2005, Wilsey 2008, Savage 2008, Ballyantyne 2007

25. Slide 25 of xxSlide 25 A ustin O utcomes R esearch ODG: On-Going Management  Prescriptions from a single practitioner  Lowest possible dose to improve pain and function  Maintain ongoing review of outcomes Four A’s: analgesia; activities of daily living; adverse effects; aberrent drug-taking behavior.  Urine drug screening for abuse, addiction or poor pain control (Webster, 2008)

26. Slide 26 of xxSlide 26 A ustin O utcomes R esearch ODG: On-Going Management  Document misuse  Consult: multidisciplinary pain clinic - Doses of opioids are required beyond that usually required for the condition - Pain does not improve in 3 months  Consider a psych consult if there is evidence of depression or anxiety.  Consider an addiction consult if there is evidence of substance abuse

27. Slide 27 of xxSlide 27 A ustin O utcomes R esearch ODG: When to Discontinue  No overall improvement in function  Continued pain with evidence of intolerable adverse effects and lack of significant benefit (lack of improved function at high doses with persistent pain, i.e. > 120 mg MED)  Evidence of serious non-adherence

28. Slide 28 of xxSlide 28 A ustin O utcomes R esearch ODG: When to Continue  The patient has returned to work  The patient has improved function and pain

29. Slide 29 of xxSlide 29 A ustin O utcomes R esearch Special Issues A ustin O utcomes R esearch Slide 29

30. Slide 30 of xxSlide 30 A ustin O utcomes R esearch What about Patients at High Risk?  Closer monitoring  Random urine drug screens  Involvement of family/partner  Consider a consultation with a mental Health or addiction specialist Urine drug screens are also recommended periodically for all patients to confirm adherence.

31. Slide 31 of xxSlide 31 A ustin O utcomes R esearch What about those frequent escalations? WHY?  Is there evidence of disease progression?  Is there evidence of another pain generator?  Is there evidence of issues such as secondary gain, exacerbation of underlying depression or anxiety?  Is there evidence of development of addiction?

32. Slide 32 of xxSlide 32 A ustin O utcomes R esearch What about those frequent escalations? HISTORY OF RESPONSE TO OPIOIDS  Has the patient responded to opioids in the past? IF SO:  IS THIS TOLERANCE?  IS THIS OPIOID HYPERALGESIA?

33. Slide 33 of xxSlide 33 A ustin O utcomes R esearch Opioid Hyperalgesia Patients who receive opiate therapy sometimes develop unexpected changes in their response to opioids.  Development of abnormal pain (hyperalgesia)  Change in pain pattern  Persistence in pain at higher levels than expected. Opioids in this case actually increase rather than decrease sensitivity to noxious stimuli.

34. Slide 34 of xxSlide 34 A ustin O utcomes R esearch Diagnosis of Opioid Hyperalgesia Opioid trial (assumes there has been previous improvement) IMPROVEMENT  Tolerance NO IMPROVEMENT  Possible opioid hyperalgesia  A pain condition that is non-opioid responsive

35. Slide 35 of xxSlide 35 A ustin O utcomes R esearch Treatment of Opioid Hyperalgesia  Wean the dose  Rotate opioids  Use of adjuvant pain medications  Further evaluation by a specialist with additional expertise in psychiatry, pain medicine, or addiction medicine

36. Slide 36 of xxSlide 36 A ustin O utcomes R esearch What if the diagnosis is addictive disease? YOU ARE GOING TO DO THE EXACT SAME THING

37. Slide 37 of xxSlide 37 A ustin O utcomes R esearch How do we stop opioids? A ustin O utcomes R esearch Slide 37

38. Slide 38 of xxSlide 38 A ustin O utcomes R esearch Thank You contact Info: snovak@austinor.com A ustin O utcomes R esearch Slide 38

39. Slide 39 of xxSlide 39 A ustin O utcomes R esearch