Deputy Health Officer Allegany and Garrett Counties Utilizing the CDC Guideline and Checklist if and when prescribing opioids for chronic pain A guideline for primary providers Jennifer Corder, MD Deputy Health Officer Allegany and Garrett Counties

Objectives Review the evidence base behind the 12 CDC recommendations Examine ways to incorporate the recommendations into your primary care practice Understand the importance of promoting other integrative modalities/therapies in the management of chronic pain

Disclosures None

CDC Guideline for Prescribing Opioids for Chronic Pain- United States, 2016 Primary audience: PCPs (Physicians, NPs, PAs) treating 18+ with chronic pain >3 mo Secondary audience: Integrated pain management team members Behavioral Health, pharmacists and pain management specialists This guideline is the first to speaks to PCPs. Previous guidelines from differing bodies were inconsistent, and did not address the PCP environment where most of the burden of treatment occurs.

CDC Guideline inclusions and exclusions Including cancer survivors with chronic pain, in remission or under surveillance Excluding those undergoing active cancer treatment, palliative and end-of-life care Excluding opioid prescribing as part of Opioid Use Disorder Excluding <18 population Also refer to and promote integrated pain management alternative modalities for management of function and pain

CDC Guideline scope of advice When to initiate or continue Selection, dosage, duration, follow-up and discontinuation Assessing risk and addressing harms Promotes management of chronic pain by the use of integrative modalities Also refer to and promote integrated pain management modalities for management of function and pain

Guideline intentions: Improve communication Between clinician and patient about risks and benefits of opioid therapy for chronic pain Improve safety and effectiveness Reduce risks associated with long term opioid therapy Opioid Use Disorder, Overdose and Death Provider-patient relationship is at the center of the equation for success, never has it been more important.

Guideline development: Clinical evidence GRADE method review of published literature answering to 5 Key Clinical Questions Expert Opinion Federal Partner Engagement Stakeholder Comment Constituent Engagement Peer Review Public Comment Federal Advisory Committee Review and Recommendation GRADE framework: Grading of recommendations assessment, development and evaluation Recommendations based on systematic review of scientific evidence Systematic review found research with long-term outcomes lacking

Guideline development: Contextual evidence Complementary information that assists in translating clinical research findings into recommendations -Non-pharmacologic modalities -Non-opioid pharmacologic options -Clinician values -Patient values -Cost

GRADE approach to evaluating evidence Rating of evidence Randomized controlled trials Observational Clinical experience Type 1 ***** Type 2 *** **** Type 3 ** Type 4 * Insufficient - ….for opioids in the treatment of chronic pain….clinical and contextual evidence was rated Limitations of studies increases as you travel from Type1 to Type 4

Recommendation categories Category A Category B Applies to all persons; most patients should receive the recommended course of action Individual decision making needed; different choices will be appropriate for different patients. Clinicians help patient arrive at a decision consistent with patient values and preferences and specific clinical situations

Key Question #1 What is the effectiveness of long-term opioid therapy versus placebo, no opioid therapy, or non-opioid therapy for long term (> 1 year) outcomes related to pain, function and quality of life? Rating of evidence = Insufficient In order to write the recommendations, published research answering 5 key questions were reviewed There are no studies on the long term use of opioids for chronic pain. Plenty has been written about the misleading and false sense of security promised by the industry

Key Question #2 What are the risks of opioids versus placebo or no opioids on abuse, addiction, overdose and other harms? Rating of evidence = Type 3 Summary of clinical evidence for KQ2

Key Question #3 What is the comparative effectiveness of different opioid dosing strategies? Rating of evidence = Type 4 ER/LA…Immediate release + ER/LA, scheduled dosing versus as needed dosing…dose escalation versus maintenance…acute on chronic…tapering strategies

Key Question #4 -opioid management plans Rating of evidence = Type 3 What is the accuracy of instruments for predicting risk of opioid OD, addiction, abuse or misuse? What is the effectiveness of risk mitigation strategies including but not limited to: -opioid management plans -patient education -urine drug testing -PDMP data -pill counts Rating of evidence = Type 3

Key Question #5 What are the effects of prescribing opioid therapy versus not prescribing opioid therapy for acute pain on long-term use? Rating of evidence = Type 3 Summary of clinical evidence for KQ5

Contextual evidence summary Effectiveness of non-pharmacologic Effectiveness of non-opioid pharmacologic treatments Benefits and harms of opioid therapy Clinician and patient values and preferences Costs of therapy and risk mitigation The next 4 slides review these contextual elements considered when writing the recommendations Evidence (not clinical trials) nonetheless answered in some way to an aspect of opioids and chronic pain

Effectiveness of non-pharmacologic and non-opioid pharmacologic treatments Cognitive behavioral therapy (CBT) Exercise therapy Multimodal approaches NSAIDS Acetaminophen COX-2 inhibitors Selected anticonvulsants Selected antidepressants Interventional approaches Durations 2 wk to 6 months Multimodal approaches

Benefits and harms of prescribing opioid therapy Risk factors for harm Modifiable Un-modifiable LA/ER Sleep disordered breathing Time-scheduled Renal or hepatic insufficiency Methadone Elderly High dose Pregnant Co-prescribing with benzodiazepines Depression/mental illness Multiple prescribers/pharmacies Substance use disorder Methadone use has disproportionate risk of OD death relative to the frequency it is prescribed

Clinician and patient values and preferences Clinicians have reported lack of confidence in: Ability to prescribe opioids safely Predicting and detecting opioid prescription abuse Discussing abuse with their patients Clinicians underutilize: PDMP data Urine drug testing Opioid treatment agreements Patients: Are often unaware what an opioid is Experience side effects commonly Side effects (rather than pain relief) explain most variations in patient preferences Research shows that… Building on the doc-pat relationship, incorporating the SBIRT screening tool into routine practice will help identify those at higher risk

Costs of opioid therapy and risk mitigation Non-medical use: 53.4 billion Abuse, dependence and misuse: 55.7 billion OD related costs: 20.4 billion Outpatient Rx opioids: 9 billion (2012) Lower cost therapies Acetaminophen, NSAIDS & TCAs Massage therapy, yoga, physical therapy, cognitive behavioral therapy (CBT), acupuncture Urine drug testing including confirmatory testing: $211-363 per test It is not hard to see that a substantial amount of money can be saved if we stop prescribing opioids as often as we have done

Recommendations: When to initiate or continue opioids for chronic pain Non-pharmacologic and non-opioid pharmacologic therapies preferred for chronic pain. (A,3) Establish pain-related and function-related treatment goals before using opioids for chronic pain. (A,4) Discuss known risks and realistic benefits of chronic opioid therapy before starting and periodically during treatment. (A,3) The first set of 3 recommendations center around initiation or continuation. 1. Use opioids only if expected benefits from pain and function exceed risks…..If opioids are used, they should be part of a larger menu 2. Discuss how therapy will be discontinued if benefits do not outweigh risks;

Recommendations: Opioid selection, dosage, duration, follow-up and discontinuation 4. When starting opioids for chronic pain, avoid ER/LA formulations. (A,4) 5. Prescribe the lowest effective dosage. >50 MME/day triggers reassessment of benefits and risks. Avoid or carefully justify >90 MME/day. (A,3) 6. Treat acute pain with lowest effective dose of short acting opioid. <3 days often enough. >7 days rarely needed. (A,4) 7. Evaluate benefits and harms within 1-4 weeks of starting opioid therapy for chronic pain and on dose escalation; evaluate <Q3 months when on continued therapy. Benefits must outweigh harms. (A,4) You must follow a systematic approach for each patient. These are the modifiable factors you can control. What to choose, how much for how long; all include measuring OUTCOMES (benefits and harms) when choosing to use (repeat PEG)

Recommendations: Assessing risk and addressing harms of opioid use 8. Evaluate risk factors for opioid related harms (before starting and periodically during). Consider naloxone. (A,4) 9. Review PDMP data before starting and periodically during. (A,4) 10. Use urine drug testing before starting and at least annually during opioid use for chronic pain. (B,4) 11. Avoid prescribing opioids and benzodiazepines concurrently. (A,3) 12. Offer MAT and behavioral therapies to anyone with Opioid Use Disorder. (A,2) 8. Hx of OD or SUD, >50mme/day, concurrent benzodiazepines; SBIRT to include screening for other substances

Clinical Tool This checklist incorporates the 12 recommendations into a practical 1-page handout that can be used in the office when you find yourself considering initiation of opioid treatment for a patient with chronic pain, and also when you’re in the position to renew a prescription without a patient visit , and also includes items to check when re-assessing at follow-up visits.

The PEG score, like most other screening instruments, is most useful in tracking changes over time. The PEG score should decrease over time after therapy has begun. Krebs, E. E., Lorenz, K. A., Bair, M. J., Damush, T. M., Wu, J., Sutherland, J. M., Asch S, Kroenke, K. (2009). Development and Initial Validation of the PEG, a Three-item Scale Assessing Pain Intensity and Interference. Journal of General Internal Medicine, 24(6), 733–738. http://doi.org/10.1007/s11606-009-0981-1

The LAST thing on this list is the prescribing…along the lines of start low and go slow, before that there are a number of things that should be incorporated into your practice As we check off each item, you can think about which of these you are already doing, and which of them you can begin incorporating to your practice Have they started yoga for the chronic back pain?

FOR CONTINUING THERAPY: Do not let more than 3 months go by before you see the patient in person, sooner than 3 months is better…. PEG repeat…and risk/benefit analysis

DECISION : Continue, adjust, taper, stop

Modality Low back pain Migraine Osteoarthritis Fibromyalgia Rheumatoid arthritis Neck pain Acupuncture Physical therapy Biofeedback Exercise Yoga/Tai chi Mindfulness-based Massage Weight loss

barbituate

New treatment episode prescribing opioid or benzodiazepine Prescribers: Effective July 1, 2018: New treatment episode prescribing opioid or benzodiazepine At least Q90 days thereafter for duration of treatment Exceptions < 3 day supply Cancer tx or cancer-related pain Patient in inpatient hospital or hospice Patient residing in nursing or other assisted living facility To treat or prevent acute pain for <14 days following surgery with general anesthesia, fracture, significant trauma or childbirth If specific med listed by Secretary in low abuse potential list Electrical or technological issues You will not need to refer to PDMP when prescribing for the exceptions

Heavy burden of expectations Treating pain has implication of eliminating pain

MANAGE use PEG score repeatedly to measure success, Results of PEG can be used to reinforce the benefits of integrative approach Address whole patient: depression, anxiety, obesity, nutrition, exercise, accupuncture, yoga, biofeedback, CBT, etc. If you don’t know enough about the evidence for these integrative modalities, it is time to learn, because the recommendation must be a sincere one, and reinforced by the valuable provider-patient relationship. Believing that something will help is paramount. Lackluster suggestions expressing your personal reservations do your patients no favors and may lead to nocebo effect.

Personal PDMP data when used routinely, allows you to open up discussions and have more honest exchanges, strengthening the doctor-patient relationship in most cases

REFRAME Chronic pain cannot be eliminated quickly. A menu of options is helpful to reach function and pain goals.

Opioids for chronic pain Non-opioid choices for chronic pain Better evidence and safety profile Non-opioid pharmacologic Non-pharmacologic Poor evidence and safety profile The balance of evidence. Although neither side has robust evidence for long term efficacy of it’s modalities, when we weigh in on the side of risk, minimizing the use of opioids for chronic pain is prudent.

Criticisms of the CDC Guideline: Low quality evidence base excluding studies measuring outcomes from 3mo-1year May lead to under-treatment, stigmatization, and marginalization of patients using opioids appropriately Insurance limitations for non-pharmacologic treatments Rebuttal from the CDC: “Whereas the benefits of opioids for chronic pain remain uncertain, the risks of addiction and overdose are clear.”  If there are 8-10 interested providers, a customized weekend course can be arranged Studying the mind-body connection is a common skill utilized in several complementary and integrative modalities such as yoga, biofeedback, exercise and mindfulness meditation

Core take home CDC messages: Non-opioid therapy is preferred for chronic pain outside the context of active cancer, palliative, or end-of-life care. When opioids are used, the lowest possible effective dose should be prescribed to reduce the risks of opioid use disorder and overdose. Clinicians should exercise caution when prescribing opioids and should monitor all patients closely. If there are 8-10 interested providers, a customized weekend course can be arranged Studying the mind-body connection is a common skill utilized in several complementary and integrative modalities such as yoga, biofeedback, exercise and mindfulness meditation

Need more knowledge about complementary and integrative modalities? Allegany College of Maryland Integrative Health Curriculum and special programs Community college affiliate of the Center for Mind-Body Medicine If there are 8-10 interested providers, a customized weekend course can be arranged Studying the mind-body connection is a common skill utilized in several complementary and integrative modalities such as yoga, biofeedback, exercise and mindfulness meditation

References Major source providing non-opioid pain modalities: NIH Chronic Pain In Depth https://nccih.nih.gov/health/pain/chronic.htm#hed3 CDC Guideline Resources: Non-opioid treatments https://www.cdc.gov/drugoverdose/prescribing/clinical-tools.html Other Sources: 1. Mayo Clinics: Evidence-Based Evaluation of Complementary Health Approaches for Pain Management in the United States http://www.mayoclinicproceedings.org/article/S0025-6196(16)30317-2/pdf 2. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016 https://www.cdc.gov/mmwr/volumes/65/rr/pdfs/rr6501e1.pdf 3. Harvard Medical School Special Report: Pain Relief, Natural and alternative remedies without drugs or surgery 4. ACPA Resource Guide to Chronic Pain Management https://theacpa.org/uploads/documents/ACPA_Resource_Guide_2017.pdf

Jennifer Corder, MD Jennifer.corder@maryland.gov If there are 8-10 interested providers, a customized weekend course can be arranged Studying the mind-body connection is a common skill utilized in several complementary and integrative modalities such as yoga, biofeedback, exercise and mindfulness meditation