1. TRAUMA AND OPIOIDS SUMMIT OUTPATIENT OPIOID THERAPY: MITIGATING RISKS Perry G. Fine, MD Professor of Anesthesiology Department of Anesthesiology School of Medicine University of Utah

2. Objectives 1. Be informed of content, intent and limitation of current Clinical Guidelines 2. Implement a structured approach toward opioid prescribing and teaching/mentoring safe prescribing practices for opioids 3. Define current limitations in pain care in the domains of education, public policy, neuroscience, and clinical care.

3. Basic Precepts: The CDC Guideline DETERMINING WHEN TO INITIATE OR CONTINUE OPIOIDS FOR CHRONIC PAIN Nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain. Clinicians should consider opioid therapy only if expected benefits for both pain and function are anticipated to outweigh risks to the patient. If opioids are used, they should be combined with nonpharmacologic therapy and nonopioid pharmacologic therapy, as appropriate. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. MMWR Recomm Rep 2016;65:1–49. DOI: http://dx.doi.org/10.15585/mmwr.rr6501e1 http://dx.doi.org/10.15585/mmwr.rr6501e1

4. Basic Precepts: The CDC Guideline DETERMINING WHEN TO INITIATE OR CONTINUE OPIOIDS FOR CHRONIC PAIN Before starting opioid therapy for chronic pain, clinicians should establish treatment goals with all patients, including realistic goals for pain and function, and should consider how opioid therapy will be discontinued if benefits do not outweigh risks. Clinicians should continue opioid therapy only if there is clinically meaningful improvement in pain and function that outweighs risks to patient safety. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. MMWR Recomm Rep 2016;65:1–49. DOI: http://dx.doi.org/10.15585/mmwr.rr6501e1 http://dx.doi.org/10.15585/mmwr.rr6501e1

5. Basic Precepts: The CDC Guideline DETERMINING WHEN TO INITIATE OR CONTINUE OPIOIDS FOR CHRONIC PAIN Before starting and periodically during opioid therapy, clinicians should discuss with patients known risks and realistic benefits of opioid therapy and patient and clinician responsibilities for managing therapy. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. MMWR Recomm Rep 2016;65:1–49. DOI: http://dx.doi.org/10.15585/mmwr.rr6501e1 http://dx.doi.org/10.15585/mmwr.rr6501e1

6. Basic Precepts: The CDC Guideline OPIOID SELECTION, DOSAGE, DURATION, FOLLOW- UP, AND DISCONTINUATION When starting opioid therapy for chronic pain, clinicians should prescribe immediate-release opioids instead of extended-release/long-acting (ER/LA) opioids. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. MMWR Recomm Rep 2016;65:1–49. DOI: http://dx.doi.org/10.15585/mmwr.rr6501e1 http://dx.doi.org/10.15585/mmwr.rr6501e1

7. Basic Precepts: The CDC Guideline OPIOID SELECTION, DOSAGE, DURATION, FOLLOW- UP, AND DISCONTINUATION When opioids are started, clinicians should prescribe the lowest effective dosage. Clinicians should use caution when prescribing opioids at any dosage, should carefully reassess evidence of individual benefits and risks when considering increasing dosage to ≥50 morphine milligram equivalents (MME)/day, and should avoid increasing dosage to ≥90 MME/day or carefully justify a decision to titrate dosage to ≥90 MME/day. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. MMWR Recomm Rep 2016;65:1–49. DOI: http://dx.doi.org/10.15585/mmwr.rr6501e1 http://dx.doi.org/10.15585/mmwr.rr6501e1

8. Basic Precepts: The CDC Guideline OPIOID SELECTION, DOSAGE, DURATION, FOLLOW- UP, AND DISCONTINUATION Long-term opioid use often begins with treatment of acute pain. When opioids are used for acute pain, clinicians should prescribe the lowest effective dose of immediate- release opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three days or less will often be sufficient; more than seven days will rarely be needed. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. MMWR Recomm Rep 2016;65:1–49. DOI: http://dx.doi.org/10.15585/mmwr.rr6501e1 http://dx.doi.org/10.15585/mmwr.rr6501e1

9. Basic Precepts: The CDC Guideline OPIOID SELECTION, DOSAGE, DURATION, FOLLOW- UP, AND DISCONTINUATION Clinicians should evaluate benefits and harms with patients within 1 to 4 weeks of starting opioid therapy for chronic pain or of dose escalation. Clinicians should evaluate benefits and harms of continued therapy with patients every 3 months or more frequently. If benefits do not outweigh harms of continued opioid therapy, clinicians should optimize other therapies and work with patients to taper opioids to lower dosages or to taper and discontinue opioids. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. MMWR Recomm Rep 2016;65:1–49. DOI: http://dx.doi.org/10.15585/mmwr.rr6501e1 http://dx.doi.org/10.15585/mmwr.rr6501e1

10. Basic Precepts: The CDC Guideline ASSESSING RISK AND ADDRESSING HARMS OF OPIOID USE Before starting and periodically during continuation of opioid therapy, clinicians should evaluate risk factors for opioid-related harms. Clinicians should incorporate into the management plan strategies to mitigate risk, including considering offering naloxone when factors that increase risk for opioid overdose, such as history of overdose, history of substance use disorder, higher opioid dosages (≥50 MME/day), or concurrent benzodiazepine use, are present. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. MMWR Recomm Rep 2016;65:1–49. DOI: http://dx.doi.org/10.15585/mmwr.rr6501e1 http://dx.doi.org/10.15585/mmwr.rr6501e1

11. Basic Precepts: The CDC Guideline ASSESSING RISK AND ADDRESSING HARMS OF OPIOID USE Clinicians should review the patient’s history of controlled substance prescriptions using state prescription drug monitoring program (PDMP) data to determine whether the patient is receiving opioid dosages or dangerous combinations that put him or her at high risk for overdose. Clinicians should review PDMP data when starting opioid therapy for chronic pain and periodically during opioid therapy for chronic pain, ranging from every prescription to every 3 months. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. MMWR Recomm Rep 2016;65:1–49. DOI: http://dx.doi.org/10.15585/mmwr.rr6501e1 http://dx.doi.org/10.15585/mmwr.rr6501e1

12. Basic Precepts: The CDC Guideline ASSESSING RISK AND ADDRESSING HARMS OF OPIOID USE When prescribing opioids for chronic pain, clinicians should use urine drug testing before starting opioid therapy and consider urine drug testing at least annually to assess for prescribed medications as well as other controlled prescription drugs and illicit drugs. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. MMWR Recomm Rep 2016;65:1–49. DOI: http://dx.doi.org/10.15585/mmwr.rr6501e1 http://dx.doi.org/10.15585/mmwr.rr6501e1

13. Basic Precepts: The CDC Guideline ASSESSING RISK AND ADDRESSING HARMS OF OPIOID USE Clinicians should avoid prescribing opioid pain medication and benzodiazepines concurrently whenever possible. Clinicians should offer or arrange evidence-based treatment (usually medication-assisted treatment with buprenorphine or methadone in combination with behavioral therapies) for patients with opioid use disorder. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. MMWR Recomm Rep 2016;65:1–49. DOI: http://dx.doi.org/10.15585/mmwr.rr6501e1 http://dx.doi.org/10.15585/mmwr.rr6501e1

14. Basic Precepts: The CDC Guideline PRESCRIPTION DRUG MONITORING PROGRAMS (PDMPs) WHAT SHOULD I DO IF I FIND INFORMATION ABOUT A PATIENT IN THE PDMP THAT CONCERNS ME? Confirm that the information in the PDMP is correct. Check for potential data entry errors, use of a nickname or maiden name, or possible identity theft to obtain prescriptions. Assess for possible misuse or abuse. Offer or arrange evidence-based treatment (usually medication-assisted treatment with buprenorphine or methadone in combination with behavioral therapies) for patients who meet criteria for opioid use disorder. If you suspect diversion, urine drug testing can assist in determining whether opioids can be discontinued without causing withdrawal. Discuss any areas of concern with your patient and emphasize your interest in their safety. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. MMWR Recomm Rep 2016;65:1–49. DOI: http://dx.doi.org/10.15585/mmwr.rr6501e1http://dx.doi.org/10.15585/mmwr.rr6501e1

15. Basic Precepts: The CDC Guideline REGISTER AND USE THE PDMP IN YOUR STATE Processes for registering and using PDMPs vary from state to state. For information on your state’s requirements, check The National Alliance for Model State Drug Laws online: www.namsdl.org/prescription-monitoring- programs.cfm Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. MMWR Recomm Rep 2016;65:1–49. DOI: http://dx.doi.org/10.15585/mmwr.rr6501e1 http://dx.doi.org/10.15585/mmwr.rr6501e1

16. Algorithm for Opioid Treatment of Chronic Pain Patient Selection Initial Patient Assessment Trial of Opioid Therapy Alternatives to Opioid Therapy Patient Reassessment Implement Exit Strategy Continue Opioid Therapy Comprehensive Pain Management Plan

17. Patient Selection for Opioid Trial Persistent pain despite reasonable trials of disease modifying therapies, nonopioid analgesics, other analgesic adjuvants, or targeted therapies or Severe pain requiring rapid relief or Patient characteristics contraindicate use of other analgesics or more targeted treatment modalities

18. Algorithm for Opioid Treatment of Chronic Pain Patient Selection Initial Patient Assessment Trial of Opioid Therapy Alternatives to Opioid Therapy Patient Reassessment Implement Exit Strategy Continue Opioid Therapy Comprehensive Pain Management Plan

19. Initial Patient Assessment Define the pain syndrome as precisely as possible (etiology, pathophysiology, mechanism, other attributes) Previous treatments and results Psychosocial history; chemical dependency; other mental health conditions; social/caregiver/family circumstances Patient (specific) perspectives on opioid therapy

20. Risk Assessment: : Suspected Substance Use Disorder Medical history findings associated with substance abuse: hepatitis C, HIV, TB, cellulitis, sexually transmitted diseases, elevated liver function tests, etc Social history: motor vehicle accidents, DUIs, domestic violence, legal history, loss of property in fire Psychiatric history: personal history of psychiatric diagnosis, outpatient and/or inpatient treatment, current psychiatric medications

21. Pain Assessment: The Bottom Line Patient assessment for opioid therapy should include Rationale for opioid therapy Previous treatments Risk(s) of opioid therapy to patient Potential benefit(s) of opioid therapy Specific outcomes that will determine ongoing course of therapy

22. Algorithm for Opioid Treatment of Chronic Pain Patient Selection Initial Patient Assessment Trial of Opioid Therapy Alternatives to Opioid Therapy Patient Reassessment Implement Exit Strategy Continue Opioid Therapy Comprehensive Pain Management Plan 33

23. Comprehensive Pain Management Plan Components Biomedical Approaches pharmacologic and/or nonpharmacologic and/or interventional therapies Psychological Intervention CBT/other modalities (e.g. mindfulness meditation) to improve mood disturbances and coping skills sleep hygiene Social/Rehabilitative Issues family/social relations work issues physical rehabilitation and functional restoration physical/ occupational therapy home exercise program

24. Algorithm for Opioid Treatment of Chronic Pain Patient Selection Initial Patient Assessment Trial of Opioid Therapy Alternatives to Opioid Therapy Patient Reassessment Implement Exit Strategy Continue Opioid Therapy Comprehensive Pain Management Plan

25. Alternatives to Opioid Therapy Alternative pain management strategies adjuvant analgesics nonpharmacologic modalities complementary medicine interventional therapies Refer complex or high-risk patients for SUD, mental health services, interventional pain management

26. Algorithm for Opioid Treatment of Chronic Pain Patient Selection Initial Patient Assessment Trial of Opioid Therapy Alternatives to Opioid Therapy Patient Reassessment Implement Exit Strategy Continue Opioid Therapy Comprehensive Pain Management Plan

27. Patient Care Agreement/ Informed Consent Components Collaborative Process to Optimize Adherence Reminder: opioids are one modality in multifaceted approach to achieving goals of therapy Detailed outline of procedures and expectations between patient and doctor Prohibited behaviors and grounds for tapering or discontinuation Limitations on prescriptions Emergency issues Refill and dose-adjustment procedures Exit strategy

28. Algorithm for Opioid Treatment of Chronic Pain Patient Selection Initial Patient Assessment Trial of Opioid Therapy Alternatives to Opioid Therapy Patient Reassessment Implement Exit Strategy Continue Opioid Therapy Comprehensive Pain Management Plan

29. Risk Assessment and When to Refer? Prior or ongoing excessive use behaviors (caffeine, alcohol, tobacco, other) Chaotic life Conviction of a drug-related crime Prior substance abuse or current use of illicit drugs Regular contact with drug high-risk groups

30. Ongoing dilemmas Inadequate pain and substance abuse education Insufficient resources for primary care clinicians Comprehensive pain care programs Behavioral therapists with pain expertise Functional restoration (rehab) therapists with chronic pain expertise Insufficient funding for comprehensive pain care Limited alternatives to opioids (potency, versatility) Lack of predictable “assay” for opioid effectiveness Highly charged political climate Self-medication has become a societal “norm” Expectations for “no pain” outweigh biomedical science Limitations of neuroscience to “explain” pain chronification

31. Cum Scientia Caritas  All medication management must be tailored to the individual patient’s needs and circumstances. Ongoing critical thinking, sound judgment, and clinical experience can never be replaced by formulae.