Rational Approach to the Use of Opioids in the Treatment of Chronic Non-Malignant Pain

1. Rational Approach to the Use of Opioids in the Treatment of Chronic Non-Malignant Pain David A. Ryan, M.D. Medical Director Southwest General Hospital Regional Spine and Pain Management Center

2. Or How to Slay Dragons

3. Objectives • Be able to identify misconceptions regarding opioid prescriptions relationship to opioid crisis • Be able to describe the role of the role of comprehensive pain management in managing chronic opiate therapy. • Be able to describe and list opiate sparing strategies • Be able to summarize opiate prescribing guidelines from CDC,APS/AAPM, Federation of State Medical Boards • Review Ohio Prescribing Rules

4. Misconceptions regarding opioid prescriptions relationship to opioid crisis • Treatment of Chronic Pain is a Lifestyle issue • Chronic Pain is the second medical cause of suicide after bipolar disorder • Suicide rates have been increasing as access to opiates have decreased • The negative impact of chronic pain on quality of life is more severe than CHF, RF and major depression and on par with dying of cancer

5. Misconceptions regarding opioid prescriptions relationship to opioid crisis • Opiate analgesic deaths soared in 2014 and continue to increase. • Fact: Fatal prescription opiate OD have steadily declined since 2011. • 2014 increase was not due to prescription opiates, according to the CDC in 2016 - illicit fentanyl was the causative agent for the 2014 increase.

6. Misconceptions regarding opioid prescriptions relationship to opioid crisis • Misconception: CDC Guidelines and State Law Prevent PCP and Surgeons form Prescribing Opiates • CDC Guidelines are specifically for PCPs • Ohio State Law requires Non Hospital Based Physicians to register if more than 50% of Patients are prescribed opioids • Estimates are there are 25,000 Chronic Pain Patients for every Pain Specialist • Abruptly stopping COT based on this rationale could be considered a form of abandonment.

7. Misconceptions regarding opioid prescriptions relationship to opioid crisis • There is no evidence that long term opiates are safe and effective • Few if any analgesic drugs used in chronic pain have evidence of long term safety and efficacy • NSAID are the second most deadly medication prescribed, but not addictive • VA study showed opioids not superior to non-opioids after 1 year. • Results were similar in both groups • Tramadol was used in non-opioid group • All patients were opiates naive and did not necessarily have sever pain diagnosis such as Post-laminectomy syndrome, CRPS, Trigeminal Neuralgia, sever peripheral neuropathy • Argues opioids are appropriate if NSAID are contraindicated

8. Misconceptions regarding opioid prescriptions relationship to opioid crisis • Prescription opioid abuse frequently lead to heroin use • Data on 609,000 persons at risk for Nonmedical Pain Reliever use or heroin initiation, between 2002 and 2011, indicated 3.6% NMPR users initiated heroin within 5 years • Most heroin users start with prescription opiates, but progression of NMPR abuse rarely leads to heroin use.

9. The Role of a Comprehensive Pain Management Clinic in Managing Chronic Opiate Therapy. • Ideally collaborate to manage chronic opiates and pain • Treating Acute radiculopathy on an urgent basis • Minimizing chronic opiates with interventions and comprehensive approach • Spine Institute model to minimize post-laminectomy syndrome

10. The Role of Comprehensive Pain Management Clinic in Managing Chronic Opiate Therapy. • Majority of Chronic Pain is Spine related • A high percentage is related to post-laminectomy syndrome • United States Performs more spine surgery than other industrialized nations • Some estimates are 2.5 times as many • Spine Institute Model has been shown to reduce number of Surgeries

11. Clinical effects of opiates • Analgesia • Addiction • Hyperalgesia/Tolerance • Side Effects • Nausea and Vomiting • Sedation • Constipation • Itching • Endocrine dysfunction • Edema and sweating Confusion

12. Opioid Use in Pain Management PharmacologyReceptors • Three Opiod receptor Classes • Mu: β-endorphin; morphine • Kappa: butorphanol • Delta: enkephalin • Mu receptor

13. Development of Tolerance Trial of Opioid Therapy Cellular Mechanisms Pharmacological Tolerance Opioid-Induced Pain Sensitivity Worsening Pain State Apparent Tolerance Opioid Dose Escalation 23

14. Opiate Sparing Strategies • Focus on minimizing central sensitization • Medication can be helpful • Includes multidisciplinary approach • Cognitive behavioral therapy • Biofeedback • PT, Chiropractic, Acupuncture, Message, • Interventions can be helpful

15. Central Sensitization Can manifest in three ways • enlargement of the area in the periphery where a stimulus will activate neurons • increased response to a suprathreshold input • previously subthreshold inputs reach threshold and initiate action potential discharge

16. Central SensitizationWindupPhysiology of the dorsal horn of the spinal cord Neuropathic pain aetiology, symptoms, mechanisms, and management. Woolf, C.Lancet 1999; 353: 1959-64

17. Central SensitizationDisinhibitionin the dorsal horn following nerve injury Neuropathic pain aetiology, symptoms, mechanisms, and management. Woolf, C.Lancet 1999; 353: 1959-64

18. Central SensitizationA-fiber phenotypic switching • C fibers and Aδ fibers afferents express nociceptors substance P and calcitonin-gene-related peptide • Facilitate sensory transmission between nociceptors & CNS • Significant role in generation of central sensitization • Down regulated after peripheral nervy injury, • Large myelinated Aβ fibers begin to express these neuropeptides— • This is a phenotypic switch. • Result : low threshold stimuli → Aβ fibers activation → substance P in the dorsal horn → central hyperexcitability

19. Opiate sparing StrategiesPharmacology • Gaba and serotonin are inhibitory plays so gaba and serotonin based medication can be helpful • Gabapentine -- Tramadol • Lyrica • NMDA plays a role so NMDA antagonist can help minimize central sensitization • Tramadol --Ketamine • Methadone (very problematic medication) • CBDs • Supplement, mechanism unknown but effective in neuropathic and central windup conditions primarily in the opiate naive

20. Opiate sparing StrategiesTherapies • Physical Therapy • Chiropractic Treatment • Cognitive Behavioral Therapy • Bio Feedback • Acupuncture • Dry Needling • TENS unit

21. Opiate sparing StrategiesInterventions • Medial nerve branch block eliminates nociceptive input breaking the central sensitization cycle • Spinal Cord Stimulator • Increasingly effective Technology • Neuromodulator has affect at the level of the spinal cord and some technologies have been shown to affect the brain • Considered and end stage treatment

22. Spinal Cord Stimulator

23. Percutaneous Lead Placement:Confirm Lead Position

24. Benefits of Neurostimulation • An effective method of pain control for many patients • Reduces or eliminates pain medications • Non-destructive and less invasive than surgical alternatives • Reversible – can be discontinued or surgically removed • Systems reprogrammable without surgery • Trial helps assess patient response • Patient control within physician-set limits Kumar K, Nath RK, Toth C. Deep Brain Stimulation for Intractable Pain: A 15-year experience. Neurosurgery. 1997

25. Government Regulations The federal government recognizes the validity of chronic opioid therapy. Currently….. Chronic opioid therapy forpain vs. addiction are two very different circumstances that require different licensure. There are no laws or regulations that consider the use of opioids for intractable pain to be an illegitimate practice.

26. CDC Guidelines • March 18th, 2016 • Based on limited evidence • type 3 (observational studies, or randomized clinical trials with notable limitations), • or type 4 (clinical experience and observations, observational studies with important limitations, or randomized clinical trials with several major limitations). • When no studies were present, evidence was considered to be insufficient.

27. CDC Guidelines • Targeted PCP • Noted the largest increase in opiate prescribing was in this group • Made specific recommendations for limiting Morphine Equivalents • Made recommendations for considering Naloxone in high risk situations

28. CDCDetermining 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. • 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 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. • 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.

29. CDCOpioid 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. • 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 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. • 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. • 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.

30. CDCAssessing 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. • 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. • 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. • 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. • * All recommendations are category A (apply to all patients outside of active cancer treatment, palliative care, and end-of-life care) except recommendation 10 [drug testing] (designated category B, with individual decision making required); see full guideline for evidence ratings.

31. Federation of State Medical BoardsGuidelines for the Chronic use of Opioid Analgesics • Published April 2017 • Based on CDC FDA Guidelines and recommendations • Specifically noted that the guidelines do not create a standard of care • Specifically did not address acute pain, perioperative pain management, cancer pain, palliative care or end of life care. • advocate the position that the goal of pain management should be an acceptable level of pain control vs complete elimination of pain.

32. FSMB GuidelinesKey components • Screening for depression and mental health disorders as part of the patient assessment and evaluation process • Incorporation of written informed consent and treatment agreements between patient and prescriber • Strong recommendation that state PDMPs be consulted before, and during the course of, chronic opioid therapy • Warnings on the risks associated with concurrent use of opioids and benzodiazepines • Encouragement of co-prescribing of naloxone for all patients placed on opioid therapy

33. FSMB GuidelinesDevelopment of a Treatment Plan and Goals • goals of pain treatment include reasonably attainable improvement in pain to decrease suffering and to increase function • improvement in pain-associated symptoms • such as sleep disturbance • depression and anxiety • screening for side effects of treatment • avoidance of unnecessary or excessive use of medications

34. FSMB GuidelinesDevelopment of a Treatment Plan and Goals • Include medications other than opioids: • anti-inflammatories • acetaminophen • selected antidepressants • anticonvulsants) interventional • Interventional Treatment • non-pharmacologic therapies • cognitive behavioral therapy • massage, • Exercise • multimodal pain treatment • osteopathic manipulative treatment.

35. FSMB GuidelinesInformed Consent and Treatment Agreement •   Potential risks and benefits of opioid therapy •   Potential side effects (both short and long term), such as cognitive impairment and • constipation •   The likelihood that tolerance to and physical dependence on the medication will • develop •   Risk of drug interactions and over-sedation •   Risk of impaired motor skills (affecting driving and other tasks) •   Risk of substance use disorder, overdose and death •   The clinician’s prescribing policies and expectations, including the number and • frequency of prescription refills, early refills and replacement of lost or stolen • medications •   Reasons for which drug therapy may be changed or discontinued (including violation of • the treatment agreement) or that treatment may be discontinued without agreement • by the patient. •   Education of the patient that the complete elimination of pain is not to be expected. •  Limited evidence as to the benefit of opioids or other pharmaceutical therapies in the management of chronic pain (except for cancer)

36. FSMB GuidelinesInformed Consent and Treatment Agreement High Risk for Substance Abuse Disorder • Treatment goals in terms of pain management, restoration of function and safety • Patient’s responsibility for safe medication use (not taking more than prescribed; dangers of using in combination with alcohol, cannabis, or other substances like benzodiazepines unless closely monitored by the prescriber, etc.) • Secure storage and safe disposal • Patient’s responsibility to obtain prescribed opioids from only one clinician or practice • Patient’s responsibility of getting the prescriptions filled at only one pharmacy • Patient’s agreement to periodic drug testing •  Clinician’s responsibility to be available or to have a covering clinician available to care for unforeseen problems and to prescribe scheduled refills.

37. FSMB GuidelinesInitiating an Opioid Trial • Lowest effective short acting dose • Avoid combination with benzodiazepines • Caution with Methadone • Consider Pain consult when reaching CDC thresholds • Consider naloxone

38. FSMB GuidelinesOngoing Monitoring and Adapting the Treatment Plan • Continuation, modification or termination of opioid therapy for pain is contingent on the clinician’s evaluation of • (1) evidence of the patient’s progress toward treatment objectives • (2) the absence of substantial risks or adverse events, such as signs of substance use disorder and/or diversion • A satisfactory response to treatment would be indicated by: • a reduced level of pain • increased level of function • improved quality of life

39. FSMB GuidelinesPeriodic and Unannounced Drug Testing • Does not recommend an interval • Ohio regulations are every 3 to 6 months • Recommends urine and states there are flaws with POC testing • Does not specify mandatory dismissal for inappropriate screens but recommends a conversation with the patient

40. FSMB GuidelinesAdapting Treatment • Evaluate PDMP to verify no multiple providers as well as other medication such as benzodiazepine • Consider referral for substance abuse disorder • Illicit drug on tox screen • recurrent early requests for refills • multiple reports of lost or stolen prescriptions • obtaining controlled medications from multiple sources without the clinician’s knowledge • intoxication or impairment (either observed or reported), • pressuring or threatening behaviors

41. FSMB GuidelinesConsultation and Referral • consider referral to an interdisciplinary pain management program • interventional pain management • physical and occupational therapy • acupuncture, or other non-pharmacologic therapies to avoid unnecessary reliance on opioids as the sole therapy for chronic or complex pain issues. • Clinicians should be aware of treatment options for opioid use disorder and addiction so as to make appropriate referrals when needed • (including those available in licensed opioid treatment programs [OTPs]) • office-based opioid treatment [OBOT]) • Suboxone

42. FSMB GuidelinesDiscontinuing Opioid Therapy • Reasons for discontinuing opioid therapy include • resolution of the underlying painful condition • emergence of intolerable side effects • inadequate analgesic effect • failure to improve the patient’s quality of life despite reasonable titration • failure to achieve expected pain relief or functional improvement • failure to comply with the treatment agreement, or significant aberrant medication use, including signs of addiction. • Clinicians should not continue opioid treatment unless the patient has received a benefit, including demonstrated functional improvement. • Clinicians have an obligation to provide transition therapy in order to minimize adverse outcomes.

43. FSMB GuidelinesCONCLUSION • Adequate attention to initial assessment to determine if opioids are clinically indicated and to determine risks associated with their use in a particular individual with pain. • Adequate monitoring during the use of potentially abusable medications: • Adequate attention to patient education and informed consent • Justified dose escalation with adequate attention to risks or alternative treatments • Avoid excessive reliance on opioids, particularly high dose opioids for chronic pain management • Utilization of available tools for risk mitigations

44. The American Pain Society (APS) and the American Academy of Pain Medicine (AAPM) Opioids Guidelines • The American Pain Society (APS) and the American Academy of Pain Medicine (AAPM) Opioids Guidelines Panel developed Clinical Guidelines for the Use of Chronic Opioid Therapy (COT) in Chronic Noncancer Pain (2009). • These guidelines consist of 25 recommendations • each recommendation is rated by the strength of the recommendation (Strong/Weak) and the quality of the evidence (high/moderate/poor). • There are 19 strong recommendations, 4 of which are supported by moderate-quality evidence. • None of the recommendations are rated as having high-quality evidence to support it.

45. APS/AAPM GuidelinesFor the Use of COT in CNCPStrong recommendations with Moderate Quality Evidence • 4. Methadone • 4.1. Methadone is characterized by complicated and variable pharmacokinetics and pharmacodynamics and should be initiated and titrated cautiously, by clinicians familiar with its use and risks. • 8. Opioid-Related Adverse Effects • 8.1. Clinicians should anticipate, identify, and treat common opioid-associated adverse effects. • 9. Use of Integrated Psychotherapeutic and Other Cointerventions • 9.1. As CNCP is often a complex biopsychosocial condition, clinicians who prescribe COT should routinely integrate psychotherapeutic interventions, functional restoration, interdisciplinary therapy, and other adjunctive nonopioid therapies. • 11. Identifying a Medical Home and When to Obtain Consultation • 11.2. Clinicians should pursue consultation, including interdisciplinary pain management,when patients with CNCP may benefit from additional skills or resources that they cannot provide.

46. APS/AAPM GuidelinesFor the Use of COT in CNCPStrong recommendations with Weak Quality Evidence • Most are similar to other guidelines • 10. Driving and Work Safety • 10.1. Clinicians should counsel patients on COT about transient or lasting cognitive impairment that may affect driving and work safety. Patients should be counseled not to drive or engage in potentially dangerous activities when impaired or if they describe or demonstrate signs of impairment. • 11. Identifying a Medical Home and When to Obtain Consultation • 11.1. Patients on COT should identify a clinician who accepts primary responsibility for their overall medical care. This clinician may or may not prescribe COT, but should coordinate consultation and communication among all clinicians involved in the patient’s care

47. APS/AAPM GuidelinesFor the Use of COT in CNCPStrong recommendations with Weak Quality Evidence • 13. Opioids in Pregnancy • 13.1. Clinicians should counsel women of childbearing potential about the risks and benefits of COT during pregnancy and after delivery. Clinicians should encourage minimal or no use of COT during pregnancy, unless potential benefits outweigh risks. If COT is used during pregnancy, clinicians should be prepared to anticipate and manage risks to the patient and newborn.

48. Ohio Board of Nursing Rule 4723-9-10Ohio Administrative Code 4731-11-14 Prescribing for subacute and chronic pain • 4731-11-14 Prescribing for subacute and chronic pain. • (A) Prior to treating, or continuing to treat subacute or chronic pain with an opioid analgesic, the physician shall first consider and document non-medication and non-opioid treatment options. • (1) If opioid analgesic medications are required as determined by a history and physical examination, the physician shall prescribe for the minimum quantity and potency needed to treat the expected duration of pain and improve the patient's ability to function. • (2) The physician shall comply with the requirements of rule 4731-11-02 of the Administrative Code. • (B) Before prescribing an opioid analgesic for subacute or chronic pain, the physician shall complete or update and document in the patient record assessment activities to assure the appropriateness and safety of the medication including: • (1) History and physical examination including review of previous treatment and response to treatment, patient's adherence to medication and non-medication treatment, and screening for substance misuse or substance use disorder; • (2) Laboratory or diagnostic testing or documented review of any available relevant laboratory or diagnostic test results. If evidence of substance misuse or substance use disorder exists, diagnostic testing shall include urine drug screening; • (3) Review the results of an OARRS check in compliance with rule 4731-11-11 of the Administrative Code; • (4) A functional pain assessment which includes the patient's ability to engage in work or other purposeful activities, the pain intensity and its interference with activities of daily living, quality of family life and social activities, and the physical activity of the patient; • (5) A treatment plan based upon the clinical information obtained, to include all of the following components: • (a) Diagnosis; • (b) Objective goals for treatment; • (c) Rationale for the medication choice and dosage; and • (d) Planned duration of treatment and steps for further assessment and follow-up. • (6) Discussion with the patient or guardian regarding: • (a) Benefits and risks of the medication, including potential for addiction and risk of overdose; and • (b) The patient's responsibility to safely store and appropriately dispose of the medication. • (7) The physician shall offer a prescription for naloxone to the patient receiving an opioid analgesic prescription under any of the following circumstances: • (a) The patient has a history of prior opioid overdose; • (b) The dosage prescribed exceeds a daily average of eighty MED or at lower doses if the patient is co-prescribed a benzodiazepine, sedative hypnotic drug, carisprodal, tramadol, or gabapentin; or • (c) The patient has a concurrent substance use disorder.

49. Ohio Board of Nursing Rule 4723-9-10Ohio Administrative Code 4731-11-14 Prescribing for subacute and chronic pain • (C) Prior to increasing the opioid dosage to a daily average of fifty MED or greater the physician shall complete and document the following in the patient's medical record: • (1) The physician shall review and update the assessment completed in paragraph (B) of this rule, if needed. The physician may rely on an appropriate assessment completed within a reasonable time if the physician is satisfied that he or she may rely on that information for purposes of meeting the further requirements of this chapter of the Administrative Code; • (2) The physician shall update or formulate a new treatment plan, if needed; • (3) The physician shall obtain from the patient or the patient's guardian written informed consent which includes discussion of all of the following: • (a) Benefits and risks of the medication, including potential for addiction and risk of overdose. • (b) The patient's responsibility to safely store and appropriately dispose of the medication. • (4) Except when the patient was prescribed an average daily dosage that exceeded fifty MED before the effective date of this rule, the physician shall document consideration of the following: • (a) Consultation with a specialist in the area of the body affected by the pain; • (b) Consultation with a pain management specialist; • (c) Obtaining a medication therapy management review by a pharmacist; and • (d) Consultation with a specialist in addiction medicine or addiction psychiatry, if aberrant behaviors indicating medication misuse or substance use disorder are noted. • (5) The physician shall consider offering a prescription for naloxone to mitigate risk of overdose. • (D) Prior to increasing the opioid dosage to a daily average of eighty MED or greater, the physician shall complete all of the following: • (1) Enter into a written pain treatment agreement with the patient that outlines the physician's and patient's responsibilities during treatment and requires the patient or patient guardian's agreement to all of the following provisions: • (a) Permission for drug screening and release to speak with other practitioners concerning the patient's condition or treatment; • (b) Cooperation with pill counts or other checks designed to assure compliance with the treatment plan and to minimize the risk of misuse or diversion; • (c) The understanding that the patient shall only receive opioid medications from the physician treating the chronic pain unless there is written agreement among all of the prescribers of opioids outlining the responsibilities and boundaries of prescribing for the patient; and • (d) The understanding that the dosage may be tapered if not effective or if the patient does not abide by the treatment agreement. • (2) Offer a prescription for naloxone to the patient as described in paragraph (B) of this rule. • (3) Except when the patient was prescribed an average daily dosage that exceeded eighty MED before the effective date of this rule, obtain at least one of the following based upon the patient's clinical presentation: • (a) Consultation with a specialist in the area of the body affected by the pain; • (b) Consultation with a pain management specialist; • (c) Obtain a medication therapy management review; or • (d) Consultation with a specialist in addiction medicine or addiction psychiatry if aberrant behavior indicating medication misuse or substance use disorder may be present.

50. Ohio Board of Nursing Rule 4723-9-10Ohio Administrative Code 4731-11-14 Prescribing for subacute and chronic pain • (E) The physician shall not prescribe a dosage that exceeds an average of one hundred twenty MED per day. This prohibition shall not apply in the following circumstances: • (1) The physician holds board certification in pain medicine or board certification in hospice and palliative care; • (2) The physician has received a written recommendation for a dosage exceeding an average of one hundred twenty MED per day from a board certified pain medicine physician or board certified hospice and palliative care physician who based the recommendation on a face-to-face visit and examination of the patient. The prescribing physician shall maintain the written recommendation in the patient's record; or • (3) The patient was receiving an average daily dose of one hundred twenty MED or more prior to the effective date of this rule. The physician shall follow the steps in paragraph (E)(2) of this rule prior to escalating the patient's dose. • (F) During the course of treatment with an opioid analgesic at doses below the average of fifty MED per day, the physician shall provide periodic follow-up assessment and documentation of the patient's functional status, the patient's progress toward treatment objectives, indicators of possible addiction, drug abuse or drug diversion and the notation of any adverse drug effects. • (G) During the course of treatment with an opioid analgesic at doses at or above the average of fifty MED per day, the physician shall complete and document in the patient record the following no less than every three months: • (1) Review of the course of treatment and the patient's response and adherence to treatment. • (2) The assessment shall include a review of any complications or exacerbation of the underlying condition causing the pain through appropriate interval history, physical examination, any appropriate diagnostic tests, and specific treatments to address the findings. • (3) The assessment of the patient's adherence to treatment including any prescribed non-pharmacological and non-opioid treatment modalities; • (4) Rationale for continuing opioid treatment and nature of continued benefit, if present. • (5) The results of an OARRS check in compliance with rule 4731-11-11 of the Administrative Code. • (6) Screening for medication misuse or substance use disorder. Urine drug screen should be obtained based on clinical assessment of the physician with frequency based upon presence or absence of aberrant behaviors or other indications of addiction or drug abuse. • (7) Evaluation of other forms of treatment and the tapering of opioid medication if continued benefit cannot be established. • (H) This rule does not apply to the physician who prescribes an opioid in any of the following situations: • (1) The medication is for a patient in hospice care. • (2) The patient has terminal cancer or another terminal condition, as that term is defined in section 2133.01 of the Revised Code. • (I) This rule does not apply to inpatient prescriptions as defined in Chapter 4729. of the Revised Code. • Replaces: 4731-21-02, 4731-21-06 • Effective: 12/23/2018