1. 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

2. 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

3. Disclosures
None

4. 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.

5. 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

6. 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

7. 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.

8. 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

9. 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

10. 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

11. 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

12. 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

13. 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

14. 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

15. 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

16. 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

17. 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

18. 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

19. 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

20. 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

21. 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: $ 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

22. 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;

23. 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)

24. 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

25. 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.

26. 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.

28. 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?

29. 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

30. DECISION :
Continue, adjust, taper, stop

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

34. barbituate

36. 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

37. Heavy burden of expectations
Treating pain has implication of eliminating pain

38. 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.

39. 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

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

41. 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.

42. 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

43. 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

44. 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

45. References Major source providing non-opioid pain modalities:
NIH Chronic Pain In Depth
CDC Guideline Resources: Non-opioid treatments
Other Sources:
1. Mayo Clinics: Evidence-Based Evaluation of Complementary Health Approaches for Pain Management in the United States
2. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016
3. Harvard Medical School Special Report: Pain Relief, Natural and alternative remedies without drugs or surgery
4. ACPA Resource Guide to Chronic Pain Management

46. 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