Opioids for Chronic Pain: COPYRIGHT. An Approach to Decision Making, Risk Management, & Monitoring

Transcription

1 Opioids for Chronic Pain: An Approach to Decision Making, Risk Management, & Monitoring Marc Cohen MD Julia Lindenberg, MD Update in Internal Medicine 2016

2 Case n 51 y/o female with h/o bipolar disorder, seizure disorder, chronic back pain secondary to severe spinal stenosis, fibromyalgia presents for routine office visit n She complains of worsening low back pain n Pain is currently 10/10 n She is in a fetal position on the table n On exam, she has no neurologic deficits

3 Objectives n Acquire an approach to assessing patientspecific risk/benefit of opioids for chronic pain n Consider differences among opioids and the risks of particular opioids n Appreciate standards for treatment agreements, risk assessment, and monitoring -- including documentation & standardized tools

4 So.. Why are we here?

5 Increasing Opioid Use Sources: International Narcotics Control Board; World Health Organization population data; By: Pain & Policy Studies Group, University of Wisconsin/WHO Collaborating Center, 2014; pdf

6 First Illicit Drug Used 2013 National Survey on Drug Use and Health,

7 The National Opioid Epidemic Opioid deaths per 100,000 New York Times, Jan 19, 2016

8 Unintentional Opioid Related Overdoses vs. Motor Vehicle Related Injuries

9 Case n 51 y/o female with h/o bipolar disorder, seizure disorder, chronic back pain secondary to severe spinal stenosis, fibromyalgia presents for routine office visit n She complains of worsening low back pain n Pain is currently 10/10 n She is in a fetal position on the table n On exam, she has no neurologic deficits

10 Questions n What are the next steps as her primary care provider? n How do we decide whether to prescribe opioids for chronic pain? n What are the risks involved?

11 Narrow diagnosis Alternative medications and therapies Risk assessment Choosing your opioid Set expectations Agreements A Step-Wise Approach for Safe Prescribing Follow-up and monitoring Evaluate efficacy

12 Narrow the Diagnosis n What is the etiology of the pain? n Is the pain focal or generalized? n Does the pain have an identifiable cause or fit a known pain syndrome? n Would further testing and/or imaging help establish a diagnosis?

13 Common Causes of Chronic Non-Cancer Pain n Chronic Back Pain n Osteoarthritis n Chronic / Recurrent Headache n Neuropathy n Chronic Pancreatitis n Abdominal Pain

14 Other Pain Syndromes n Fibromyalgia n No evidence for efficacy of opioids n Despite this, 10-60% of patients with FM are prescribed opioids n FDA approved non-opioid treatments exist n Somatoform or other poorly defined pains n Predictive of poor response to opioids Goldenberg DL, et al. Mayo Clinic Proc. May (5):

15 Nonopioid Options for Pain Management n OTCs Acetaminophen, NSAIDs, n Prescription NSAIDs n Cyclobenzaprine, Tizanidine, Baclofen n Tricyclic Antidepressants, SNRIs n Gabapentin, Topiramate, Pregabalin n Topicals (lidocaine, capsaicin, menthol) n Physical Therapy n Complementary / Integrative Modalities n Lifestyle Change / Healthy Living (Exercise, Weight Loss, Sleep Hygiene)

16 The Role of the Pain Clinic n Interventional procedures n Pain specific diagnoses n Complex regional pain syndrome n Consideration of alternative treatments n Spinal stimulator n Infusions (i.e. lidocaine) n Pain psychology n Guidance on complex pain regimens or dose adjustments

17 Case, cont. n MRI lumbar spine showed central canal stenosis and left foraminal stenosis at L4-5 n Patient saw Pain Clinic; they tried injections without relief, referred her for surgical evaluation n Orthopedic surgeon did not feel surgery was indicated, referred back to PCP n Patient reports allergies to morphine, gabapentin, and NSAIDS n Patient reports uncontrolled pain

18 Narrow diagnosis Alternative medications and therapies Risk assessment Choosing your opioid Set expectations Agreements A Step-Wise Approach for Safe Prescribing Follow-up and monitoring Evaluate efficacy

19 Misuse is Prevalent n UNC Chapel Hill, 196 patients, academic general medicine practice n 32% with opioid misuse n Kentucky Pain Center, 500 patients n opioid abuse in 9%, illicit drugs 16% n BWH 2007 study: n 45% abnormal urine screens Ives et al BMC health svcs, 6:46; Machikanti L et al. 2006, Pain Physician 9: Michna et al2007, Clin J Pain, 23(2):

20 Source of Pain Relievers Used for Non-Medical Use 2013 National Survey on Drug Use and Health,

21 Source of Pain Relievers Used for Non-Medical Use 2013 National Survey on Drug Use and Health,

22 Changing Views Opioid Use Disorder Opioid Use Disorder Old Model New Model Chronic Pain Chronic Pain

23 Risk Factors n History of substance abuse n Family history of substance abuse n Heavy smokers n Young age (under 45) n Legal problems n Psychiatric illness n H/o sexual abuse n Distance traveled Chabal et al, Clin J Pain 1997; Ives TJ BMS Hlth Svcs 2006; Manchikanti, Pain Physician 2006; Saitz & Liebschutz, J Pain 2010, Webster LR Pain Medicine 2005

24 Risk Assessment Tools n SOAPP: Screener and Opioid Assessment for Patients with Pain n DIRE: Diagnosis, Intractability, Risk, Efficacy n ORT: Opioid Risk Tool Chou R, et al. Journal of Pain 10(2), 2009 Passik SD et al. Pain Clinical Updates 26(7) Dec Passik SD et al. Pain Medicine 9(2). 200

25 DIRE

26 Opioid Risk Tool Webster LR Pain Medicine 2005

27 Case n She has no history of substance abuse n She has bipolar disorder but is on a stable medication regimen and sees psychiatry regularly n DIRE score = 16 (good candidate for opioids) n ORT score = 2 (low risk)

28 Narrow diagnosis Alternative medications and therapies Risk assessment Choosing your opioid Set expectations Agreements A Step-Wise Approach for Safe Prescribing Follow-up and monitoring Evaluate efficacy

29 Choosing an Opioid: Short-acting n Begin with trial of weaker, short-acting opioids n Caution with acetaminophen containing opioids WEAKER STRONGER Codeine Hydrocodone Morphine Oxycodone Hydromorphone Chou et al. The Journal of Pain, Vol 10, No 2 (February), 2009: pp Trescot et al. Pain Physician 2008: Opioids Special Issue: 11:S5-S62

30 Tramadol n Equivalent in strength to codeine n Schedule IV n Dependence/withdrawal and addiction can occur n Has been shown to be effective in treating osteoarthritis, possibly fibromyalgia n Use caution with SSRIs, SNRIs, TCAs, as can increase risk of seratonin syndrome Manchikanti et al, Pain Phys Journal 2011

31 Choosing an Opioid: Long-acting n Weak evidence supports use of sustained-release morphine and fentanyl patches for chronic pain n All trials directly comparing opioids have been rated poor quality n Compared to anticonvulsant/tricyclic antidepressant, increased risk of all-cause mortality over first 180 days Chou et al., Journal of Pain and Symptom Management Vol. 26 No. 5 Nov 2003 Berland et al, American Family Physician 2012 Ray WA et al., JAMA, Vol 315 No 22 June 2016

32 Case n Initially tried on hydrocodone-acetaminophen n Dose was increased to 5-6 tabs per day n Patient continued to report pain despite this treatment n She was allergic to morphine and due to her Medicaid formulary, was unable to receive fentanyl nor oxycodone SR without trying methadone, so methadone initiated

33 Methadone n Must write For pain on the prescription n Used in chronic pain management n Not recommended for breakthrough pain n Pharmacokinetics n Onset: minutes n Duration of analgesia: 4-12 hours n Elimination half-life: 8-59 hours n Accumulation with repeated dosing The Journal of Pain. 2009;10(2): Department of Veterans Affairs. Management of Opioid Therapy for Chronic Pain. Updated 5/10. Dolophine Product Information. Roxane Laboratories, Inc. Updated October 2006.

34 CDC Report July

35 CDC Report July

36 Methadone: Dosing n Start low and titrate slowly n Initial dose: mg Q8-12h n Titrate by 2.5mg every 5-7 days n Use extra caution in geriatric population n Little cross-tolerance with other opioids n % of morphine equivalent dose n Starting dose of methadone should not exceed 30-40mg The Journal of Pain. 2009;10(2): Department of Veterans Affairs. Management of Opioid Therapy for Chronic Pain. Updated 5/10. Dolophine Product Information. Roxane Laboratories, Inc. Updated October 2006.

37 Methadone: QT Prolongation n ECG monitoring recommendations: n Prior to initiation, at 30 days, annually n More frequently in patients with: n Dose > 100mg/day n Unexplained syncope, seizure n QT interval >450 ms during treatment n Concurrent use of other QT prolonging drugs n Discontinue or reduce dose if QT interval >500 ms n Consider physiologic factors, drug interactions Ann Intern Med. 2009;150:

38 Fentanyl Patch

39 Fentanyl Patch: Risks n Reports of toxicity and death after sublingual/buccal use of patches n A 25 mcg fentanyl patch is equivalent to: n AT LEAST Morphine 60 mg/day n AT LEAST Oxycodone 30 mg/day n Lowest dose available: 12 mcg n Counseling: application and disposal Duragesic Product Information. Ortho-McNeil-Janssen Pharmaceuticals, Inc. Revised 7/09.

40 Dose Limits? n Demonstrated increased risk with doses higher than 50 mg of morphine or equivalent n 30 mg oxycodone n mcg fentanyl patch n 15 mg methadone JOEM; Dec 2014; 56:12

41 Caution with High Doses - Per new CDC guidelines, >90 mg morphine = high risk ; Caution > 50 mg Morphine Morphine Milligram Equivalents (MMEs) 100 mg Oxycodone Hydromorphone (Dilaudid) Hydrocodone (Vicodin) 66 mg 30 mg 100 mg n Fentanyl patch Methadone mcg 12 mg (variable)

42 Narrow diagnosis Alternative medications and therapies Risk assessment Choosing your opioid Set expectations Agreements A Step-Wise Approach for Safe Prescribing Follow-up and monitoring Evaluate efficacy

43 Setting Expectations Doctor, Take My Pain Away n Set functional goals n Discuss control of pain vs pain-free n Discuss in context of risk/benefit n Shared responsibility rather than providerfocused Krebs et al; JGIM (6): 733-8

44 Evidence for Treatment Agreements n Mixed results on studies of impact n Annals 2010 Review: 4/11 studies showed reduction; 7/11 showed mixed results n Although evidence weak, many guidelines recommend agreements n APS/AAPM Clinical Guideline: n Consider using a written management plan to n document pain AND patient/clinician responsibilities Ann Intern Med Jun 1;152(11): Journal of Pain 2009 Feb 1-(2):

45 What should be in an opioid treatment agreement? n The goals of treatment, in terms of pain management, restoration of function, and safety. n The patient s responsibility for safe medication use (e.g.,using as directed, not combining with alcohol or other substances, safe storage, & disposal etc) n The patient s responsibility to obtain his or her prescribed opioids from only one physician or practice. n The patient s agreement to periodic drug testing (as of blood, urine, hair, or saliva).

46 What should be in an opioid treatment agreement? n The physician s responsibility to be available or to have a covering physician n How opioids will be prescribed and taken n One prescriber, one pharmacy, 28 day rx n Expectations for concomitant therapies n Specialty care, PT, mental health treatment n Expectations for follow-up/monitoring n Indications for discontinuing therapy

47 What should be in an informed consent? n The potential risks and anticipated benefits n Potential side effects n The likelihood that tolerance to and physical dependence will develop. n The risk of drug interactions and sedation. n The risk of impaired motor skills n The risk of opioid misuse, dependence, addiction, and overdose. n The limited evidence as to the benefit of long-term opioid therapy. FSMB Model Policy of Use of Opioids 2013

48 An Opportunity for Education & Prevention

49 Naloxone

50 Case n Begun on methadone after reviewing risks/benefit n Patient not opioid naïve; started 5 mg TID n Discussed expectations and patient s goals n Be able to get out of house to visit family n Be able to enjoy dinner with friends n Be able to swim twice / week

51 Narrow diagnosis Alternative medications and therapies Risk assessment Choosing your opioid Set expectations Agreements A Step-Wise Approach for Safe Prescribing Follow-up and monitoring Evaluate efficacy

52 Universal Precautions n Standard of care in patients on chronic opioid therapy n Informed consent n Monitoring for adherence n Monitoring for harm n Monitoring for benefit/improvement Gourlay et al; 2000 Pain Med 6:2

53 CDC Guidelines March 2016 Opioids are not first-line or routine therapy for chronic pain Follow-up and re-evaluate risk of harm; reduce dose or taper and discontinue if needed Establish and measure goals for pain and function Discuss benefits and risks and availability of non-opioid therapies with patient Use immediate-release opioids when starting Start low and go slow; Use caution > 50 MME (morphine mg equivalents) & avoid increasing above 90 MMEs. Evalute risk factors for opioid-related harms Check Prescription Drug Monitoring Program for high dosages and prescriptions from other providers Use urine drug testing to identify prescribed substances and undisclosed use Avoid concurrent benzodiazapene and opioid prescribing When opioids are needed for acute pain, prescribe no more than needed Arrange treatment for opioid use disorder if needed JAMA. 2016; and 315(15): doi: /jama MMWR: CDC Guideline for Prescribing Opioids for Chronic Pain United States, 2016

54 Periodic Review & Monitoring: n Affect n Adjuncts n Analgesia n Activities n Adverse Effects n Aberrant Behavior The 6 A s Evaluate mood Nonpharmacologic/Nonopioid Assess pain relief ADLs, Function, Quality of Life Chou R, et al. APS/AAPM Clinical Guideline, Journal of Pain. 10(2). Feb 2009; Jackman RP and BS Mallett, American Family Physician, Nov (10): 1155

55 Periodic Review & Monitoring: How frequent? n Insufficient evidence for precise recommendations n Risk stratification is useful for guiding the approach to monitoring (APS/AAPM) n Low risk: every 3 months n High risk: weekly monthly Chou R, et al. Journal of Pain. 10(2): Feb 2009; Trescot AM, et al Pain Physician 11: 2008; S5-S62 Mass Board of Reg in Medicine Guidelines

56 Periodic Review & Monitoring: n Affect n Adjuncts n Analgesia n Activities n Adverse Effects n Aberrant Behavior The 6 A s Evaluate mood Nonpharmacologic/Nonopioid Assess pain relief ADLs, Function, Quality of Life Chou R, et al. APS/AAPM Clinical Guideline, Journal of Pain. 10(2). Feb 2009; Jackman RP and BS Mallett, American Family Physician, Nov (10): 1155

57 The PEG A Chronic Pain Vital Sign n Validated 3 question questionnaire for interval follow-up visits to assess pain/ progress with chronic narcotic therapy n Pain on average n Enjoyment n General activity Krebs et al; JGIM (6): 733-8

58 The PEG

59 Periodic Review & Monitoring: n Affect n Adjuncts n Analgesia n Activities n Adverse Effects n Aberrant Behavior The 6 A s Evaluate mood Nonpharmacologic/Nonopioid Assess pain relief ADLs, Function, Quality of Life Chou R, et al. APS/AAPM Clinical Guideline, Journal of Pain. 10(2). Feb 2009; Jackman RP and BS Mallett, American Family Physician, Nov (10): 1155

60 Adverse Effects from Opioids

61 Adverse Effects n Somnolence, nausea, sedation usually improve within 10 days n Constipation usually does not decrease n Other considerations: n Hypogonadism n Hyperalgesia Baldini A, et al. Prim Care Companion CNS Disord. 2012; 14(3)

62 Driving on Opioids? n 48 studies reviewed n No impairment in psychomotor abiltiies including immediately after opioids dosed n No increase in motor vehicle violations/ accidents n No impairment on driving simulators n Equivocal on cognitive impairment Fishbain et al., J Pain Sympt Management, 2003;25, 6

63 Driving on Opioids: Suggested Guidelines n Wait 4-5 days before driving when initiating opioids or escalating dose n Report sedation n Avoid alcohol, illicit drugs, antihistamines in combination n Assess only what you can assess in the office; do not extrapolate to full driving assessment Fishbain et al., J Pain Sympt Management, 2003;25, 6

64 Periodic Review & Monitoring: n Affect n Adjuncts n Analgesia n Activities n Adverse Effects n Aberrant Behavior The 6 A s Evaluate mood Nonpharmacologic/Nonopioid Assess pain relief ADLs, Function, Quality of Life Chou R, et al. APS/AAPM Clinical Guideline, Journal of Pain. 10(2). Feb 2009; Jackman RP and BS Mallett, American Family Physician, Nov (10): 1155

65 Case n Patient calls stating she has run out of her methadone early n On inquiry, patient reports confusion about the recommended dosing and was taking more than prescribed

66 Aberrant Behaviors n Abnormal drug screens n Lost or stolen narcotic prescriptions n Early refills n Deterioration in functioning at work or socially n Illegal activities- selling, forging, buying from non-medical source n Resistance to change therapy despite adverse effects n Refusal to comply with drug screens, visits n Use of multiple physicians and pharmacies Chabal et al, Ciln J Pain 1997; Ives TJ BMS Hlth Svcs 2006; Manchikanti, Pain Physician 2006; Saitz & Liebschutz, J Pain 2010, Webster LR Pain Medicine 2005

67 Other Aberrant Behaviors n Complaints about need for more medication n Requesting specific pain medications n Openly acquiring similar medications from other providers n Occasional unsanctioned dose escalation n Non-adherence to other recommendations for pain therapy

68 Other Monitoring Tools n Urine toxicology screens n Prescription Drug Monitoring Programs (PDMPs) n Pill Counts

69 Urine Toxicology Screening n Should we do these? n What is their role? n Once I do one, NOW WHAT?

70 Urine Toxicology n 2007 Study at Brigham & Women s n 45% of patients were found to have abnormal urine screens Michna, et al. Clin J Pain. Feb (2):

71 Urine Toxicology n Small studies have shown significant identification of substance abuse or nonadherence n Small study suggesting 50% reduction in opioid abuse/use of illicit drugs n Guidelines generally recommend, particularly in high risk patients Bhamb B, et al. Curr Med Res Opin. Sept 2006 Chou R, et al. Journal of Pain. Feb 2009 Jackman RP & Mallett BS. Amer Fam Phys Nov 2008 Manchikanti L, Pain Physician 2006 Christo P, et al. Pain Physician Mar/Apr 2011

72 Before You Send Your Patient Ask the patient: off to the Lab n If I check your urine now, will I find anything in it? n When was your last dose of?

73 Windows of Detection n Can be influenced by: n Dose n Route of administration n Metabolism n Urine concentration and ph n General rule is most drugs stay within urine 1-3 days (marijuana often longer) Clin J Pain 2002; 18: S76-S82

74 Types of Urine Testing n Screening immunoassays n Confirmatory testing: n *GC/MS (gas chromatography/mass spectrometry) n LC/MS (liquid chromatography/mass spectrometry) n HPLC (high performance liquid chromatography)

75 Help! What does this mean?!?! n Screening immunoassay: n GC/MS:

76 Urine Toxicology n Every lab is different n Understand which tests your labs run n Have a relationship with your lab director

77 False Positives Peppin et al. Pain Medicine 2012; published online only

78 Interpreting Tox Screens Non-Prescribed Drug Detected - Outside provider/rx - Lab Error - Metabolite - Addiction - Deliberate use/abuse Illicit Drug Detected - Trading Rx drug for illicit - Supplemental pain relief - Addiction - Lab Error Prescribed Drug Not Detected -Taking prn -Drug-drug interaction -Timing of last dose -Rapid metabolism -Not taking -Lab Error -Hoarding/Binging -Diversion Peppin et al. Pain Medicine 2012; published online only

79 Urine Toxicology: A Decision Support n Sometimes used in punitive manner to catch the patient and dismiss from care n Intent should be one of universal precautions n If patterns develop, consider discontinuation of narcotics and/or referral for treatment n Use caution when making a decision based only on one tox screen result

80 Prescription Drug Monitoring Programs Physicians not skilled at detecting deception Data suggest Lower rates of opioid-related overdose Lower rates opioid treatment admissions States with more sophisticated/accessible PMPs appear to have better outcomes Proactive use of PMPs appears key All states, except Missouri, now have PDMPs Katz N, et al. Pharmacoepidemiology Drug Safe (2010): ; Reifler LM, et al. Pain Medicine (2012): ; Twillman R, Journal of Pain (abstract 4/06); Worley J. Issues Ment Health Nursing (2012): Jung, B et al Pain Medicine (2007):

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82 Pill Counts? n Can be considered in patients as part adjunctive monitoring, particularly in high risk patients n Ideally, these are done randomly but can also be done at a scheduled visit n Prescribe 28-day prescriptions (rather than 30 days) to minimize weekend run-out

83 Discontinuing Opioids n Immediate discontinuation n Rapid tapering n Reduce dose by 25% every 3-7 days n Gradual tapering n Reduce dose by 10% per week n When 20% of original dose is reached, reduce by 5% each week n For patients with addiction, may require referrals for treatment n Buprenorphine, methadone maintenance Berland et al, American Family Physician

84 Case, conclusion n Patient currently takes: n Methadone 15 mg QID n Hydrocodone-acetaminophen up to 5 tabs per day n Has adhered to treatment recommendations, tox screens have been consistent with what is prescribed n Reports improved function, better ability to get out of the house and do things

85 Summary n Prior to initiating opioids, try to establish a firm diagnosis and try alternative therapies n Assess risk of misuse and weigh risk and benefits prior to initiating opioids n Treatment agreements should be considered, particularly for high risk patients n Once initiating opioid therapy, monitoring the 6 A s is part of ongoing care n Urine toxicology, pill counts, and the PMP are useful adjuncts to aid in monitoring patients

86 Thank you!