Rule 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 an overdose reversal drug 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, carisprodol, tramadol, or gabapentin; or
(c) The patient has a concurrent substance use disorder.
(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 who is neither a specialist in the area of the body affected by the pain nor a pain management specialist 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 an overdose reversal drug 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 an overdose reversal drug 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, the physician who is neither a specialist in the area of the body affected by the pain nor a pain management specialist shall 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.
(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, board certification in hospice and palliative care, board certification in hematology, or board certification in oncology;
(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 rule 4731-11-01 of the Administrative Code.
(I) This rule does not apply to inpatient prescriptions as defined in rule 4729-17-01 of the Administrative Code.
Last updated July 31, 2023 at 8:24 AM
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