4 th Annual Thoughtful - PowerPoint Presentation

1. 4th Annual Thoughtful Approach to Chronic Pain“New Horizons, What Clearly Works” Managing Chronic Pain in the Primary Care Setting: Advancing Practice in the Post-Opioid Era 1David J. Tauben, MD, FACPChief, UW Division of Pain MedicineHughes M & Katherine G Blake Endowed ProfessorClinical Associate ProfessorDepts of Medicine and Anesthesia & Pain MedicineUniversity of Washington, Seattle WA

2. DISCLOSURESCME grant support from: ER/LA Opioid Analgesics REMS Program CompaniesNIH Pain Consortium Center of Excellence in Pain EducationOff-label use of many drugs is recommended in the management of pain and so will be discussed2

3. objectivesEvaluate the risks and benefits of drug and non-drug treatments used for pain.Discuss new standards for use of opioids in chronic non-cancer pain.Discuss the emerging models of primary care based pain assessment and treatment tracking Make more informed pain drug treatment decisions in the outpatient setting 3

4. Understanding pain“In order to treat something, we must first learn to recognize it.” -William OslerChronic pain, a complex condition, when understood, assessed, and then treated following a structured approach, improves outcomesThorough assessment of the common biopsychosocial domains of pain adds important diagnoses also requiring treatment

5. Pain is NOT nociception, even if it feels that way…“Unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage” (IASP 1979)Nociceptors selectively respond to noxious stimulationWhat we observe during exam of our patientsResponse to the experience of diminishment of one’s capacityThe “Loeser Onion”

6. Predictors of Abnormal Pain ResponseHistory and examination:Demonstration of “non-anatomic” territory of painDepression or other preexisting mood disorderDistressed socioeconomic statusOverall poor life coping status and satisfactionPreexisting pain processing disorders:Like fibromyalgiaPrior persistent pain problems Active emotional distressParticularly anxiety and fear (of the consequences or significance of an injury.)Prior surgical complications or failure to resolve pain after previous surgery Van Susante J, Acta Orthop Belg. 1998.Von Korff M, Pain. 2005 Carroll LJ, Pain 2004Carragee EJ, Spine J 2005

7. History shapes beliefs, behaviors, & outcomes: Adverse Childhood Events (ACE) Recurrent physical/emotional abuseContact sexual abuseAn alcohol and/or drug abuser in the householdAn incarcerated household memberSomeone who is chronically depressed, mentally ill, institutionalized, or suicidalMother is treated violentlyEmotional or physical neglectSignificant Events:Robust Correlation: Depressed affect, suicide attemptsMultiple sexual partners, sexually transmitted diseasesSmoking & alcoholismSocial, emotional, cognitive impairment Disease, disability & social problems Chronic PainAnda R., www.acestudy.org

8. Centralized Pain SyndromesIrritable bowelTension headacheTemporo-mandibular disorderMyofascial pain syndromePelvic painInterstitial cystitisYunus 2007

9. Pain and the Primary Care Provider30% of adult PCP visits/week involve chronic pain; but,Scant pain education and training“Haven’t got time for the pain”Limited or no access to multidisciplinary pain care Long-term opioids has become the “de facto” pain treatment9Daubresse 2010; Dosa & Teno 2010; Giordano 2009; Mezei & Murinson 2011; Schatman 2006; Von Korff 2008

10. Pain care sites of delivery20-52% of chronic pain presents and is managed in the primary care setting30% of adult PCP visits/week involve chronic pain40% receive care by chiropractors7% by acupuncturists20% care delivered in the EDOnly 2% by Pain Physicians10Breuer 2010; Daubresse 2010; Giordano 2009; Krueger & Stone 2008; Marcus 2009; Von Korff 2008

11. “The Under treatment of Pain” American Medical Association"In the past several years, there has been growing recognition on the part of health care providers, government regulators, and the public that the under treatment of pain is a major societal problem.”“Physicians' fears of using opioid therapy, and the fears of other health professionals, contribute to the barriers to effective pain management.”11AMA 2004

12. The Allure of OpioidsThey make patients happy, …at least initially.They are very available in even the most remote sites.Insurance covers them better than any other pain treatment.The signed prescription closes the visit.12

13. TOTAL OUTPATIENT PRESCRIPTIONS OF ER OPIOIDS1991-2008SDI, Vector One: Nationale. Extracted 12/2009

14. Opioid Rx ChoicesShort-ActingCodeineFentanyl lozenge/buccalHydrocodoneHydromorphoneMorphineOxycodoneOxymorphoneER/LAExtended release (“ER”)MorphineOxycodoneOxymorphoneTransdermal fentanylTransdermal buprenorphine*Long Acting (“LA”)MethadoneLevorphanolwww.cope-rems.org“REMS”: Risk Evaluation and Mitigation Strategies

15. Long or Short Acting Opioid?Conventional wisdom:Long-acting for Long-term useStable and scheduled dosingFewer pillsTrend toward worse outcomes: More deaths and misuseShort-acting taken regularlyActivity/function dependent dosingLower levels while asleepCurrent Approach:Best patient functionLeast non-complianceLowest “Morphine Equivalent Dose”Risk/harm reduction

16. 16Sipress D. New Yorker 4/6/2015HOW WE MEASURE PAIN

17. HOW PAIN should be MEASUREDPain intensity*Interference with Enjoyment/Quality of Life*Interference with Function*Impact on Mood*Anxiety, Depression, PTSDInterference with SleepTreatment Risks Medical: ie. Sleep ApneaBehavioral & Addictions*From Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials. J of Pain 2008:9:105-121

18. 3-item “PEG” Tool18Krebs et al. 2009

19. Identifying co-occurring MOOD diagnosesAnxiety GAD-7 (or PHQ-4)Depression PHQ-9 (or PHQ-4)PTSD PC-PTSD ScreenIn your life, have you ever had any experience that was so frightening, horrible, or upsetting, that in the past month you:Have had nightmares or thought about it when you did not want to?Tried hard not to think about it or went out of your way to avoid situations that reminded you of it?Were constantly on guard, watchful, or easily startled?Felt numb or detached from others, activities, or your surroundings?PHQ-4

20. “When your brain is on fire I can’t help your pain…”

21. Non-Drug Multimodal AnalgesiaCognitive: Identify distressing negative cognitions and beliefsBehavioral approaches: Mindfulness, relaxation, biofeedbackPhysical: Activity coaching, graded exercise land & aquatic with PT, class, trainer, and/or soloSpiritual: Identify and seek meaningfulness and purpose of one’s lifeEducation (patient and family): Promote patient efforts aimed at increased functional capabilities 21Argoff CE, et al. Pain Medicine 2009;10(S2):53–S66.

22. Health professionals involved in Pain ManagementMedical specialtiesNursingPharmacyPhysical therapyOccupational therapyBehavioral healthSocial workChaplainAddiction22

23. PAIN MEASUREMENT BASED STEPPED CARE Tauben, IASP Clinical Update, 12/2012Measure and Track:FunctionMoodSleepRisksTreatment adherenceOpioid MEDGet inter-professional help when need identified! Pain intensity alone is inadequate and in chronic pain a very poor indicator of successful treatment

24. Chronic Pain Treatment “Comparing” EffectivenessOpioids: ≤ 30% Tricyclics/SNRIs: 30%Anticonvulsants: 30%Acupuncture: ≥ 10+%Cannabis: 10-30% CBT/Mindfulness: ≥ 30-50%Graded Exercise Therapy: variable Sleep restoration: ≥ 40%Hypnosis, Manipulations, Yoga: “+ effect” Extrapolated averages of reduction in Pain IntensityTurk, D. et al. Lancet 2011; Davies KA, et al. Rheum. 2008; Kroenke K. et al. Gen Hosp Psych. 2009; Morley S Pain 2011; Moore R, et al. Cochrane 2012; Elkins G, et al. Int J Clin Exp Hypnosis 2007.

25. Yet In spite of Overwhelming evidence…Efficacy of Behavioral Management/ CBT: Astin, et al (2002); Keefe & Caldwell (1997); Bradley (2003); Brox et al. (2003); Burns, et al (2003); Chen et al (2004); Cutler et al. (1994); McCracken & Turk (2002); McGrath & Holahan (2003); Morley et al (1999); Okifuji et al (2007); Pincus et al (2002); Roberts et al (1980);Spinhoven et al. (2004); Turner et al (2006); Vlaeyen & Morley (2005); Weydert, et al. (2003) Efficacy of Multidisciplinary Chronic Pain ProgramsAronoff 1983; Becker et al (2000); Deschner & Polatin (2000); Feuerstein & Zostowny (1996); Flor et al (1992); Gatchel &Turk (1999); Gatchel et al (2007); Guzman et al (2001); Lande & Kulich (); Lang et al (2003); Linton et al (2005); Loeser 1991; McAllister et al (2005); Okifuji (2003); Okifuji et al (1999); Robbins et al (2003); Sanders et al (2005); Skouen et al (2002); Turk (2002) Wright & Gatchel (2002). 25“This review clearly demonstrates that CPPs offer the most efficacious and cost effective, evidence-based treatment for persons with chronic pain.” “Unfortunately, such programs arenot being taken advantage of because of short-sighted cost-containment policies of third-party payers.” Gatchel & Okifuji (2006)

26. Opioid sales, Ods, and addictions

27. Opioid Overdose Risk 1.79%0.68%0.26%0.16%0.04%9-fold increasein risk relativeto low-dosepatientsDunn et al., Annal Intern Med 2010****** Significant increment in risk p<0.05Relative Riskby Average Daily Dose of Prescribed Opioids (Morphine Equivalent Dose)

28. BENZOdiazepinesLack of evidence for sustained benefitsRebound insomniaRisk of over-sedation especially when combined with opioidsComplicating development of tolerance, dependency, and addiction. Use of benzodiazepines for sleep & anxiety are not recommended in chronic pain 28

29. 29

30. “Bending the curve”WA State First in NATION with decline in opioid related adverse events30Source: Jennifer Sabel PhD Epidemiologist, WA State Department of Health, April 18, 2014

31. METHADONE ods >> other opioids31Source: SAMHSA Drug Abuse Warning Network Medical Examiner Component, 2009.

32. MethadoneFor Pain TreatmentEffective analgesicChronic Opioid TherapyLong acting InexpensiveFor Addiction TreatmentRequires special DEA licensing and treatment supportOnce daily liquid dosing eases administrationReduces mortality among heroin usersSignificant accumulation with repeat dosingInitial T½ 13-47 hrs up to 48-72 hrs100% hepatic clearedCYPs: 1A2, 2D6, 3A4Inhibits its own CYP metabolism

33. Drug overdosesWashington State 1999-201333Source: C. Banta-Green WA State Department of Health

34. OpioidsThe Clinical conundrum

35. OpioidsThe Clinical Challenge• Not all patients with pain are suitable candidates for chronic opioid therapy (COT).• Short-term opioid therapy has different goals and purposes and should not progress to COT without reconsideration of goals and purposes.• Opioid dependence develops in all patients receiving COT, may have a strong psychological component, and is not always easily reversible.• COT should be goal oriented and discontinued if goals are not met.• There are significant safety issues that need consideration during COT.From Ballantyne J, Rehab Clin NA. in press 2015

36. Opioids are part of plan, not The plan“Avoid … primary reliance on opioid prescribing, which, when applied alone or in a non-coordinated fashion, may be inadequate to effectively address persistent pain as a disease process and, when employed as the “sole” treatment, is associated with significant societal expense and treatment failure.” ABPM Pain Medicine Position Paper, Pain Medicine 2009:987-988.

37. Anti-Spasm drugsAntispasm drugs have limited evidence for effectiveness, are predominantly sedative, and add polypharmacy to chronic pain management with little benefit.Carisoprodol should never be used because of no benefit and high risk.When true spasticity is present, as in spinal cord injury and multiple sclerosis, baclofen and tizanidine may be useful.Avoid abrupt withdrawal off baclofen because of the potential for severe rhabdomyolysis and fever.37van Tulder MW et al. Cochrane Library 2008

38. antidepressant analgesiaPrincipal neurotransmitters in “descending inhibitory systems”Multimodal benefits:PAIN, SLEEP, & MOODDESCENDING INHIBITORY NOXIOUS CONTROL SYSTEMS“Gate Theory”Ascending pain pathwaysDescending pain pathways

39. Proposed Mechanisms of Antidepressant analgesic effect39Verdu B. Drugs 2008

40. CLINICAL KEY Points Antidepressant AnalgesiaAntidepressants that elevate synaptic norepinephrine (TCAs > SNRIs) are effective analgesicsSedating antidepressants are useful agents to improve both sleep initiation and maintenance Anticholinergic side-effects are most common with TCAsNausea is common with SNRIsDose related QTc prolongation occurs with TCAs >SNRIsWarn patient and family about risks of suicidality when any antidepressant is prescribedMania may be precipitated by any category of antidepressant40

41. Tricyclic Antidepressant Effectiveness:Post Herpetic NeuralgiaNNT* 2.1-2.7Diabetic Peripheral NeuropathyNNT 1.2-1.5Atypical Facial PainNNT 2.8-3.4Fibromyalgia/Central PainNNT 1.7Saarto T, Wiffen PJ. Cochrane Database of Systematic Reviews 2007*NNT = Number needed to treat

42. “Gabapentinoids” for PainPrototypic Ca++ current inhibitorsGabapentinPregabalinWell studiedFewer side effects than other anticonvulsantsLimited drug-drug side effects100% excreted in the urineGabapentin absorption via active transport; not so pregabalin42Side-effects:Weight GainEdemaCognitive slowingDizziness/AtaxiaTwitchingSuicidalityPharmacodynamics (“mechanism”):Selective inhibitory effect on voltage-gated calcium channels containing the α2δ-1 subunit. Larsen MS, et al. Res. Pharm Res. 2014

43. Gabapentinoids efficacy: diabetic Pn and fibromyalgia Pregabalin600 mg: NNT 4300 mg: NNT 6Diabetic Peripheral NeuropathyFibromyalgiaGabapentin 1200-2400mg Pregabalin 300-600mgNNT>30% improvement: 5-9>50% improvement: 8-12NNH: 6-14Freeman R. et al Diabetes Care 2008 Hauser 2009

44. Benefit/risks of Na+ channel AnticonvulsantsRisks of ACDsSIADHIncreased LFTsSedation/Weight gainSuicidalityNeutropenia1Hyperammonemia2Rash/Stevens Johnson Syndrome3Metabolic acidosis4Glaucoma4Kidney stones4Carbemazepine1 & OxcarbazepineValproic Acid2Lamotrigine3Topiramate4LacosamideVariable effectiveness in different disease statesCarbamazepine: Trigeminal neuropathy (TN)Oxcarbazepine: TN, Multiple SclerosisLamotrigine: TN, HIV PN, ± Diabetic PNTopiramate: MigraineCummins TR et al. Pharmacology of Pain. IASP Press; 2010

45. Other “off-label” use of anticonvulsants in pain*Headache disorders:Migraine, Chronic Daily Headaches, Tension-type Visceral “hyperalgesia” syndromes: (gabapentinoids)Chronic Pelvic Pain Chronic Abdominal Pain Peri-operative hyperalgesia prevention: (gabapentinoids)Thoracotomy, abdominal and pelvic surgeries45*Variable levels of quality of evidence to support use

46. Key Points Anticonvulsant Drugs for PainAnticonvulsant drugs with both sodium and calcium channel modulating effects are effective in a variety of neuropathic pain disorders, fibromyalgia, and headache.Sodium channel ACDs have a wide range of potential serious adverse drug effects, including electrolyte disorders, pancytopenias, and skin rashes, and so require routine laboratory monitoring. Gabapentinoids side effects are usually clinically evident: cognitive slowing, weight gain, and edema.  46Tauben D. Phys Med Rehab Clinic NA, in press 7/2015

47. From Finnerup et al., 2007 and adapted from Sindrup SH, Jensen TS.1999.Drug ClassMAJOR EFFECT ON PAINNNT1NNH2Tricyclic antidepressantsInhibition NE>5-HT reuptake, blockade sodium & calcium channels and NMDA receptors1.5-3.710-255-HT/NA Reuptake inhibitors Inhibition 5-HT/NE reuptake3.4-14LidocaineBlockade voltage-dependent sodium channelsCarbemazepine/OxcarbazepineBlockade voltage-dependent sodium channels1.6-2.513-79LamotrigineBlockade voltage-dependent sodium channels/inhibits glutamate release3.5- 8.1Gabapentin/PregabalinBlockade voltage gated calcium channel4.0- 5.64-30Tramadol/TapentadolOpioid agonist, inhibits 5-HT/NE reuptake2.7- 6.72.7- 6.7OpioidsMu-receptor agonists, partial agonists, and antagonists2.0- 3.210-6631NNT (# needed to treat)2NNH (# needed to harm)3Dose related

48. Key Points: Cannabis Use for PainEvidence supports use in neuropathic pain conditions>30 published RCTs, positively supporting moderate efficacy: BUT most low qualityMost clinical trials use combinations of mixed varieties of cannabinoids 50% pain reduction in multiple sclerosis patients in a good quality open label long-term one-year follow-up study Demonstrated risks of reduced lifetime achievement, motor vehicle accidents and addictionMay reduce opioid requirements and lower accidental opioid overdose deathsComplex regulatory and legal environment48Koppel BS, et al. Neurology 2014Aggarwal SK. Clin J Pain 2013Volkow ND, et al. N Engl J Med. 2014

49. OTHer Pain RxCapsaicinTransient receptor potential vanilloid (TRPV1) agonist Transdermal analgesic and is available in several low-dose products (creams, gels, and lotions).Menthol (in combination with methyl salicylate)Mechanism of effect is not fully establishedMagnesium NMDA antagonist, calcium channel blocker, and inhibits catechol release from peripheral nerve endings.49Anand P et al. Br J Anesth. 2011Topp R et al. Int J Sports Phys Ther. 2011Koinig H et al. Anesth Analg. 1998

50. Pain Practice 12(7) 2012…And All Pain Providers!!!INCREASE ACCESS TO PAIN EXPERTISE“Telemedicine”: Patient/Provider interaction “Telementoring”: Provider/Provider support

51. Improving Access To Pain SpecialistsUW TelepainContact Information: Cara Towle RN MSN ctowle@u.washington.eduhttp://depts.washington.edu/anesth/care/pain/telepain/index.shtmlor search: uw telepainSessions: (Pacific time)Wednesdays noon-1:30Thursdays7:00-8:00 am

52. University of Washington PAIN PROVIDER TOOLKIThttp://depts.washington.edu/anesth/care/pain/index.shtml

53. SummaryChronic pain care is NOT:… just a 5th vital sign… to be conflated with opioids … focused on misuse and addictionChronic pain care is: … a chronic multisystem disease… disabling to patients, practices, and communities… complex, so requires a structured assessment… is challenging to treat, but when managed well is enormously satisfying to patient, provider, community and health care system

54. 54