STOPPING OPIOIDS. William Morrone, DO MS, FACOFP DABAM DAAPM Deputy Chief Medical Examiner & AOAAM June 24, 2015 Noon ET

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1 STOPPING OPIOIDS William Morrone, DO MS, FACOFP DABAM DAAPM Deputy Chief Medical Examiner & AOAAM June 24, 2015 Noon ET 1

2 William Morrone DO, Disclosures William Morrone, DO has presented numerous programs on Pain Management, Forensic and Addiction Medicine. Opinions of Dr Morrone are not the opinions of the Covenant Hospital, AOAAM, Queen of Angels Detox, Bay County Medical Examiner s Office & Recovery Pathways. Dr Morrone has no conflicts to report. Dr Morrone does not endorse any product or organization. Dr Morrone is a associate clinical professor at Michigan State University and faculty at the Thumb Pain Education Center. 2

3 Target Audience The goal of PCSS-O is to offer evidence-based trainings on the safe and effective management of opioid medications in the treatment of pain and/or opioid use disorder (addiction or dependence). Our focus is to reach providers and/or providers-in-training from diverse healthcare professions including physicians, nurses, dentists, physician assistants, pharmacists, and program administrators. 3

4 Educational conclusion of this activity participants should be able to: Differentiate Naloxone Opportunities Interview - identify lack of benefit to patient Recognize 5 reasons to Stop Opioids Recognize 4 options to Stop Opioids Recognize 3 phases of Weaning Temple Opioid - SSRN-id Temple University Beasley School of Law 4

5 Stop death = Stop OPIOIDS on bad risk ratios/treatment goals not met Understand when to appropriately refer high-risk patients to pain management and/or addiction specialists 55

6 FBI Annual deaths: US 6

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10 Why are people still dying? People die because provider education is slower or less effective than advocacy, FDA regulation & federal legislation 10

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16 How do we stop people dying? Naloxone Co-prescription to high risk groups Stop prescriptions of opioids to people with inappropriate risk benefit ratios 2015 PCSS-O 16

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19 NIH Conclusions Sept Aberrant drug-related behaviors ranged from 5.7 percent to 37.1 %. Long-term opioid therapy was associated with increased risk of: abuse (one cohort study), overdose (one cohort study), fracture (two observational studies), myocardial infarction (two observationals) sexual dysfunction (one cross-sectional study) several studies showing a dose-dependent association PCSS-O 19

20 NIH Conclusions Sept Evidence on long-term opioid therapy for chronic pain is very limited but suggests an increased risk of serious harms that appears to be dosedependent. More research is needed to understand long-term benefits, risk of abuse and related outcomes, and effectiveness of different opioid prescribing methods and risk mitigation strategies PCSS-O 20

21 Discontinuing Opioids Educate the patient about the need to stop when goals are not met. Discuss the process involved Explain alternative therapies PCSS-O 21

22 Painful Truth # 1. NO STUDIES exist with Opioid versus nonopioid for chronic pain outcomes 1 year or more 2015 PCSS-O 22

23 Painful Truth # years of treatment based on opioid use versus placebo in chronic pain studies that lasted < 6 weeks 2015 PCSS-O 23

24 VA definition Definition of Chronic Pain: CHRONIC PAIN (noncancer pain) generally refers to intractable pain that exists for three or more months & does not resolve in response to treatment PCSS-O 24

25 3 requirements to stop Initial patient assessment Trial of Opioid Therapy & Functional Goals Adequate Monitoring 2015 PCSS-O 25

26 Patient Reassessment = EXIT STATEGY Initial Patient Assessment Trial of Opioid Therapy Functional Goals Adequate Monitoring Continue or Adjust or Rotate or D/C Opioids Consultation/Referral Patient Reassessment; Adapt the Tx Plan; Intervene as Needed Exit Strategy Adapted from Katz NP. Patient Level Opioid Risk Management. PainEDU.org Manual

27 Neither Safe nor Effective Whereas it was previously thought that unlimited dose escalation was safe, evidence now suggests that prolonged, high-dose opioid therapy may be neither safe nor effective. (review) Ballantyne & Mao NEJM 349; PCSS-O 27

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29 OPIOID vs COX-2 Coronary heart disease outcomes: chronic opioid & COX-2 users compared to a general population cohort Wendy Carman et al Pharmacoepidemiology & Drug Safety Volume 20, Issue 7 pp July 2011 N = (145,657 opioid & 122,810 COX-2) 268, PCSS-O 29

30 Opioid vs Cox-2 Incident Rate Ratio chronic OP cox-2 high dose low dose Series Series PCSS-O 30

31 Murphy et al (2013) Clin J Pain Opioid analgesic use at admission had no discernible impact on treatment outcome in this large VA sample with moderate to severe chronic pain syndrome. Bold clinical implications of these findings for long-term chronic pain treatment, in light of the risks associated with opioids PCSS-O 31

32 Conditions Outside Discontinuation where treatment goals are not linked Post surgical Acute trauma Cancer Pain End of Life pain Pathoanatomic pain 2015 PCSS-O 32

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34 NIH-Opioids Poor Outcomes 3 cases where evidence suggests poor outcomes from opioids: 1. Low back pain w/no pathoanatomic basis 2. Fibromyalgia 3. Headache 2015 PCSS-O 34

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39 Ask the patient to demonstrate progress Bring in family members to witness Show a gym membership card & visits Describe a regular exercise program Show that they re obtaining needed support (group counseling therapist) New employment 2015 PCSS-O 39

40 Guidelines Physicians are in a better position now to control opioid use so that it helps, rather than harms, patients. Current guidelines recommend: # 1.) a cautious approach to dose escalation and # 2.) the discontinuation of opioids if treatment goals are not met PCSS-O 40

41 Why to not prescribe for chronic lower back pain?? Alternate treatments (psycho & physical) have a stronger evidence base OPIOIDS are deactivating not activating Reduced prescribing for nonspecific back pain would reduce overall prescribing and benefit public health Hill et al, Lancet 2011,

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46 Myofascial Release 46

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48 ADJUVANTS Adjuvants allow opioids to be analgesic or give greater analgesia at current/lower dose. Gabapentin or Namenda or Amantadine Valproic Acid or Phenytoin or Pregabalin Amitriptyline or Ketamine or Benadryl Promethazine or Dextromethorphan Baclofen or Ranitidine or Clonidine Carbamazepine mg per day PCSS-O 48

49 GUIDELINES need EXIT Physicians are in a better position now to control opioid use so that it helps, rather than harms, patients. Current guidelines recommend: # 1.) a cautious approach to dose escalation and # 2.) the discontinuation of opioids if treatment goals are not met

50 GUIDELINES need EXIT Physicians are in a better position now to control opioid use so that it helps, rather than harms, patients. Corrected guidelines recommend: # 1.) the discontinuation of opioids if treatment goals are not met. # 2.) a cautious approach to dose escalation 50 50

51 FOUR (4) OPTIONS Refer - methadone clinic 100 % buprenorphine conversion (stone cold) 3 to 10 month taper Go find another provider 2015 PCSS-O 51

52 5 Reasons: Discontinuing Opioids No progress toward therapeutic goals Nonadherence or unsafe behavior Intolerable & Unmanageable AEs Pain level decreases in stable patients Aberrant behaviors suggest addiction &/or diversion 1 or 2 episodes of increasing dose without prescriber knowledge Sharing medications Unapproved opioid use to treat another symptom (e.g., insomnia) Use of illicit drugs or unprescribed opioids Repeatedly obtaining opioids from multiple outside sources Prescription forgery Multiple episodes of prescription loss Chou R, et al. J Pain. 2009;10: Department of Veterans Affairs, Department of Defense. VA/DoD Clinical Practice Guideline for Management of Opioid Therapy for Chronic Pain

53 5 REASONS lead to 4 OPTIONS Explain why lack of progress or breach of treatment agreements raise your concerns of addiction. Benefits of opioids no longer outweigh risks. I cannot responsibly and morally continue prescribing opioids, as I feel it would cause you more harm than good. Always offer a referral for addiction treatment PCSS-O 53

54 THREE (3) phases of weaning #1. Establish a baseline #2. Reduce the dose #3. Treat protracted / postacute withdrawal 2015 PCSS-O 54

55 MEDICAL TAPER 1. Note in chart: legitimate pain diagnosis, reason for discontinuation of opioids, nonemergency situation, outline of taper, end date for prescribing 2. Have the patient read and initial the note. 3. Prescribe 10% fewer opioid analgesics per week 2015 PCSS-O 55

56 MEDICAL TAPER 4. Reassess at week #8: If going well, continue If not going well, plan for detoxification 5. On week #10: Stop prescribing, educate patient about withdrawal symptoms, urge patient to go to the ER if withdrawal appears, and admit for detoxification 2015 PCSS-O 56

57 More Rapid Opioid Taper: 20% /4 days Mg/d 1, DAY 57 57

58 EMERGENCY no taper 1. Altering a prescription = FELONY 2. Selling Rx or drugs = DRUG DEALING 3. Accidental/intentional overdose = DEATH? 4. Threatening staff = EXTORTION 5. Too many stories = OUT OF CONTROL 2015 PCSS-O 58

59 SUMMARY Naloxone has a very important place Chronic OPIOIDs not safe or effective - Ballantyne Years of opioids based on studies that lasted < 6 wks (chronic pain is >12 wks) OPIOID MI risk higher than COX-2 After FISHMAN s book ROP the deaths increased; Provider Ed isn t enough VA study opiate vs. nonopiate = no difference 2015 PCSS-O 59

60 SUMMARY Poor outcomes LBP, fibromyalgia & headache 5 reasons to discontinue 3 phases of weaning 4 options at high dose 10 WEEK TAPER EMERGENCY no taper REMS may not be bold enough to impact The Problem Knowing Discontinuation is more important than cautious dose increase when goals are not met PCSS-O 60

61 THE END 2015 PCSS-O 61

62 References NIH 9/28-29/2014 Pathways to Prevention: Opioids Ballantyne et al 2003 NEJM Chou et al 2009 Pain Katz et al 2007 PainEDU.org Hill et al 2011 Lancet Carman et al 2011 Pharmacoepidem & Drug Safety Osterwell 2013 Medscape.com/viewarticle/814200#vp_1 Holm et al 2012 AP analysis of DEA data Walley et al 2013 BMJ CO*RE-REMS 62

63 PCSS-O Colleague Support Program PCSS-O Colleague Support Program is designed to offer general information to health professionals seeking guidance in their clinical practice in prescribing opioid medications. PCSS-O Mentors comprise a national network of trained providers with expertise in addiction medicine/psychiatry and pain management. Our mentoring approach allows every mentor/mentee relationship to be unique and catered to the specific needs of both parties. The mentoring program is available at no cost to providers. For more information on requesting or becoming a mentor visit: Listserv: A resource that provides an Expert of the Month who will answer questions about educational content that has been presented through PCSS-O project. To join pcss-o@aaap.org. 63

64 PCSS-O is a collaborative effort led by American Academy of Addiction Psychiatry (AAAP) in partnership with: Addiction Technology Transfer Center (ATTC), American Academy of Neurology (AAN), American Academy of Pain Medicine (AAPM), American Academy of Pediatrics (AAP), American College of Physicians (ACP), American Dental Association (ADA), American Medical Association (AMA), American Osteopathic Academy of Addiction Medicine (AOAAM), American Psychiatric Association (APA), American Society for Pain Management Nursing (ASPMN), International Nurses Society on Addictions (IntNSA), and Southeast Consortium for Substance Abuse Training (SECSAT). For more information visit: For questions pcss-o@aaap.org Funding for this initiative was made possible (in part) by Providers Clinical Support System for Opioid Therapies (grant no. 1H79TI025595) from SAMHSA. The views expressed in written conference materials or publications and by speakers 64and moderators do not necessarily reflect the official policies of the Department of Health and Human Services; nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. Government.