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STOPPING OPIOIDS

William Morrone, DO MS, FACOFP DABAM DAAPM Deputy Chief Medical Examiner & AOAAM

June 24, 2015Noon ET

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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.

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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.

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Educational Objectives

• @ 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-id1437163 – Temple University Beasley School of Law

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Stop death = Stop OPIOIDS on bad risk ratios/treatment goals not met

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Understand when to appropriately refer high-risk patients to pain management and/or addiction specialists

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FBI Annual deaths: US

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Why are people still dying?

People die because provider education is slower or less effective than advocacy, FDA regulation & federal legislation

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How do we stop people dying?

• Naloxone Co-prescription to high risk groups

• Stop prescriptions of opioids to people with inappropriate risk benefit ratios

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NIH Conclusions Sept 28-29 2014

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.

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NIH Conclusions Sept 28-29 2014

• Evidence on long-term opioid therapy for chronic pain is very limited but suggests an increased risk of serious harms that appears to be dose-dependent.

• 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.

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Discontinuing Opioids

•Educate the patient about the need to stop when goals are not met.

• Discuss the process involved• Explain alternative therapies.

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Painful Truth

• # 1.• NO STUDIES exist with Opioid versus nonOpioid for chronic pain outcomes 1 year or more

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Painful Truth

• # 2.• 20-25 years of treatment based on opioid use versus placebo in chronic pain studies that lasted < 6 weeks

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VA definitionDefinition of Chronic Pain:

CHRONIC PAIN (non-cancer pain) generally refers to intractable pain that exists for three or more months & does not resolve in response to treatment.

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3 requirements to stop

• Initial patient assessment

• Trial of Opioid Therapy& Functional Goals

• Adequate Monitoring

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Patient Reassessment = EXIT STATEGY

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Adapted from Katz NP. Patient Level Opioid Risk Management. PainEDU.org Manual. 2007

Initial Patient Assessment

Trial of Opioid TherapyFunctional Goals

Patient Reassessment;Adapt the Tx Plan;

Intervene as Needed

Continue or Adjust or Rotate or D/C Opioids

Exit Strategy

Adequate Monitoring Consultation/Referral

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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;20 2003

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OPIOID vs COX-2Coronary 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 754-762 July 2011N = (145,657 opioid & 122,810 COX-2) 268,467

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Opioid vs Cox-2 Incident Rate Ratio

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0 0.5 1 1.5 2 2.5 3

low dose

high dose

cox-2

chronic OP

Series…Series…

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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.

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Conditions Outside Discontinuationwhere treatment goals are not linked

• Post surgical• Acute trauma• Cancer Pain• End of Life pain• Pathoanatomic pain

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NIH-Opioids Poor Outcomes

3 cases where evidence suggests poor outcomes from opioids:

1. Low back pain w/no pathoanatomic basis

2. Fibromyalgia3. Headache

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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

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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.

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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, 378

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Myofascial Release

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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 200-1600mg per day.

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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.

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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

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FOUR (4) OPTIONS

• Refer - methadone clinic• 100 % buprenorphine

conversion (stone cold)• 3 to 10 month taper• Go find another provider

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5 Reasons: Discontinuing Opioids

Chou R, et al. J Pain. 2009;10:113-30. Department of Veterans Affairs, Department of Defense. VA/DoD Clinical Practice Guideline for Management of Opioid Therapy for Chronic Pain. 2010.

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No progress toward therapeutic goals

Intolerable & Unmanageable AEs

• 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 unprescribedopioids

• Repeatedly obtaining opioids from multiple outside sources

• Prescription forgery• Multiple episodes of prescription

loss

Nonadherence or unsafe behavior

Aberrant behaviors suggest addiction &/or diversion

Pain level decreases in

stable patients

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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.

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THREE (3) phases of weaning

• #1. Establish a baseline• #2. Reduce the dose• #3. Treat protracted / post-acute withdrawal

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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

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MEDICAL TAPER4. Reassess at week #8:

– If going well, continue– If not going well, plan for

detoxification5. On week #10:

• Stop prescribing, • educate patient about withdrawal

symptoms, • urge patient to go to the ER if withdrawal

appears, and admit for detoxification

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More Rapid Opioid Taper: 20% /4 days

0100200300400500600700800900

1,000

1 9 17 25 33 41 49 57 65 73 81

57DAY

Mg/

d

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EMERGENCY no taper

1. Altering a prescription = FELONY2. Selling Rx or drugs = DRUG DEALING3. Accidental/intentional overdose = DEATH?4. Threatening staff = EXTORTION5. Too many stories = OUT OF CONTROL

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SUMMARY• Naloxone has a very important place• Chronic OPIOIDs not safe or effective -

Ballantyne• 18-20 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

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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.

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THE END

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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• http://wonder.cdc.gov• http://www.dea.gov• Holm et al 2012 AP analysis of DEA data• Walley et al 2013 BMJ• CO*RE-REMS

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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.

• 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 email: pcss-o@aaap.org.

For more information on requesting or becoming a mentor visit:www.pcss-o.org/colleague-support

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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: www.pcss-o.orgFor questions email: pcss-o@aaap.org

Twitter: @PCSSProjects

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 and

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.