Chapter 4715-6 | Review of Ohio automated Rx reporting system

Rule 4715-6-01 | Standards and procedures for review of "Ohio Automated Rx Reporting System" (OARRS).

• Effective: August 28, 2023
• Promulgated Under: 119.03

(A) Definitions: for the purposes of this rule:

(1) "Delegate" means an authorized representative who is registered with the Ohio board of pharmacy to obtain an OARRS report on behalf of a dentist;

(2) "OARRS" means the "Ohio Automated Rx Reporting System" drug database established and maintained pursuant to section 4729.75 of the Revised Code.

(3) "OARRS report" means a report of information related to a specified patient generated by the drug database established and maintained pursuant to section 4729.75 of the Revised Code.

(4) "Personally furnish" means the distribution of drugs by a prescriber to the prescriber's patients for use outside the prescriber's practice setting. Personally furnish does not include the administration of a drug, as set forth in paragraph (B)(1) of rule 4715-3-01 of the Administrative Code.

(5) "Reported drugs" means all the drugs listed in rule 4729:8-2-01 of the Administrative Code that are required to be reported to the drug database established and maintained pursuant to sections 4729.77, 4729.78 and 4729.79 of the Revised Code, including;

(a) All schedule II controlled substances;

(b) All schedule III controlled substances;

(c) All schedule IV controlled substances;

(d) All schedule V controlled substances.

(B) Standards of care: the accepted and prevailing minimal standards of care require that when prescribing or personally furnishing a reported drug, a dentist shall take into account all of the following:

(1) The potential for abuse of the reported drug;

(2) The possibility that use f the reported drug may lead to dependence;

(3) The possibility the patient will obtain the reported drug for a nontherapuetic use or distribute it to other persons; and

(4) The potential existence of an illicit market for the reported drug.

(5) In considering whether a prescription for or the personally furnishing of a reported drug is appropriate for the patient, the dentist shall use sound clinical judgment and obtain and review an OARRS report consistent with the provisions of this rule.

(C) OARRS Review: a dentist shall obtain and review an OARRS report to help determine if it is appropriate to prescribe or personally furnish an opioid analgesic, benzodiazepine, or reported drug to a patient as provided in this paragraph and paragraph (F) of this rule:

(1) A dentist shall obtain and review an OARRS report before prescribing or personally furnishing an opiate analgesic or benzodiazepine to a patient, unless an exception listed in paragraph (G) of this rule is applicable.

(2) A dentist shall obtain and review an OARRS report when a patient's course of treatment with a reported drug other than an opioid analgesic or benzodiazepine has lasted more than ninety days, unless an exception listed in paragraph (G) of this rule is applicable.

(3) A dentist shall obtain and review an OARRS report when any of the following red flags pertain to the patient:

(a) Selling prescription drugs;

(b) Forging or altering a prescription;

(c) Stealing or borrowing reported drugs;

(d) Increasing the dosage of reported drugs in amounts that exceed the prescribed amount;

(e) Suffering an overdose, intentional or unintentional;

(f) Having a drug screed result that is inconsistent with the treatment plan or

(g) Having been arrested, convicted, or received diversion or intervention in lieu of conviction for a drug related offense while under the dentist's care;

(h) Receiving reported drugs from multiple prescribers, without clinical basis;

(i) Traveling with a group of other patients to the dentist's office where all or most of the patients request controlled substance prescriptions;

(j) Traveling an extended distance or from out of state to the dentist's office;

(k) Having a family member, friend, law enforcement officer, or health care professional express concern related to the patient's use of illegal or reported drugs;

(l) A known history of chemical abuse or dependency;

(m) Appearing impaired or overly sedated during an office visit or exam;

(n) Requesting reported drugs by street name, color, or identifying marks;

(o) Frequently requesting early refills of reported drugs;

(p) Frequently losing prescriptions for reported drugs;

(q) A history of illegal drug use;

(r) Sharing reported drugs with another person; or

(s) Recurring visits to non-coordinated sites of care, such as emergency departments, urgent care facilities, or walk-in clinics to obtain reported drugs.

(D) Patient care documentation: a dentist who decides to utilize an opioid analgesic, benzodiazepine, or other reported drug in any of the circumstances within paragraphs (C)(2) and (C)(3) of this rule, shall take the following steps prior to issuing a prescription for or personally furnishing the opioid analgesic, benzodiazepine, or other reported drug:

(1) Review and document in the patient record the reasons why the dentist believes or has reason to believe that the patient may be abusing or diverting drugs;

(2) Review and document in the patient's record the patient's progress toward treatment objectives over the course of treatment;

(3) Review and document in the patient record the functional status of the patient, including activities for daily living, adverse effects, analgesia, and aberrant behavior over the course of treatment;

(4) Consider using a patient treatment agreement including more frequent and periodic reviews of OARRS reports and that may also include more frequent office visits, different treatment options, drug screens, use of one pharmacy, use of one provider for the prescription or personally furnishing of reported drugs, and consequences for non-compliance with the terms of the agreement. The patient treatment agreement shall be maintained as part of the patient record; and

(5) Consider consulting with or referring the patient to a substance abuse specialist.

(E) Follow-up OARRS reports; frequency:

(1) For a patient whose treatment with an opioid analgesic or benzodiazepine lasts more than ninety days, a dentist shall obtain and review an OARRS report for the patient at least every ninety days during the course of treatment, unless an exception listed in paragraph (G) of this rule is applicable.

(2) For a patient who is treated with a reported drug other than an opioid analgesic or benzodiazepine for a period lasting more than ninety days, the dentist shall obtain and review an OARRS report for the patient at least annually following the initial OARRS report obtained and reviewed pursuant to paragraph (C)(2) of this rule until the course of treatment utilizing the reported drug has ended, unless an exception in paragraph (G) of this rule is applicable.

(F) OARRS reports; time periods; adjoining states: for the purposes of paragraphs (C), (D), and (E) of this rule, when a dentist or their delegate requests an OARRS report in compliance with this rule, a dentist shall review and document receipt of the OARRS report in the patient record, as follows:

(1) Initial reports requested shall cover at least the twelve months immediately preceding the date of the request;

(2) Subsequent reports requested shall, at a minimum, cover the period from the date of the last report to present;

(3) If the dentist practices primarily in a county of this state that adjoins another state, the dentist or their delegate shall also request a report of any information available in the drug database that pertains to prescriptions issued or drugs furnished to the patient in the state adjoining that county; and

(4) If an OARRS report regarding the patient is not available, the dentist shall document in the patient's record the reason that the report is not available and any efforts made in follow-up to obtain the requested information.

(G) Exceptions: a dentist shall not be required to review and assess an OARRS report when prescribing or personally furnishing an opioid analgesic, benzodiazepine, or other reported drug under the following circumstances:

(1) The reported drug is prescribed or personally furnished to a hospice patient in a hospice care program as those terms are defined in section 3712.01 of the Revised Code, or any other patient diagnosed as terminally ill;

(2) The reported drug is prescribed for administration in a hospital, nursing home, or residential care facility;

(3) The reported drug is prescribed or personally furnished in an amount indicated for a period not to exceed seven days;

(4) The reported drug is prescribed or personally furnished for the treatment of cancer or another condition associated with cancer; and

(5) The reported drug is prescribed or personally furnished to treat acute pain resulting from a surgical or other invasive procedure or a delivery.

Last updated August 28, 2023 at 8:27 AM

Supplemental Information

Authorized By: 4715.302
Amplifies: 4715.30, 4715.302
Five Year Review Date: 8/17/2028

Rule 4715-6-02 | Prescribing opioid analgesics for acute pain.

• Effective: August 28, 2023
• Promulgated Under: 119.03

(A) For the treatment of acute pain, the dentist shall comply with the following:

(1) Extended-release or long-acting opioid analgesics shall not be prescribed for treatment of acute pain;

(2) Before prescribing an opioid analgesic, the dentist shall first consider non-opioid treatment options. If opioid analgesics are required as determined by a patient history and clinical examination, the dentist shall prescribe for the minimum quantity and potency needed to treat the expected duration of pain, with a presumption that a three-day supply or less is frequently sufficient and that limiting the duration of opioid use to the necessary period will decrease the likelihood of subsequent chronic use or dependence.

(3) In all circumstances where opioid anangesics are prescribed for acute pain:

(a) Except as provided in paragraph (B) of this rule, the first opioid analgesic prescription for the treatment of an episode of acute pain shall be:

(i) For adults, not more than a seven-day supply with no refills;

(ii) For minors, not more than a five-day supply with no refills. A dentist shall comply with section 3719.061 of the Revised Code, including but not limited to obtaining the parent or guardian's written consent prior to prescribing an opioid analgesic to a minor;

(iii) The seven-day limit for adults and five-day limit for minors may be exceeded for pain that is expected to persist for longer than seven days based on the pathology causing the pain. In this circumstance, the reason that the limits are being exceeded and the reason that a non-opioid medication was not appropriate to treat the patient's conditions shall be documented in the patient's record; the number of days of the prescription shall not exceed the amount required to treat the expected duration of the pain as noted in paragraph (A)(2) of this rule; and

(iv) If a patient is allergic to or otherwise unable to tolerate the initial prescribed opioid medication, a prescription for a different, appropriate opioid may be issued at any time during the initial seven or five-day dosing period and shall be subject to all other provisions of this rule. The allergy and/or intolerance shall be documented in the patient's record. The patient or the minor patients, parent, guardian or other responsible adult must be provided education of the safe disposal of the unused medication.

(b) The patient, or a minor's parent or guardian, shall be advised of the benefits and risks of the opioid analgesic, including the potential for addiction, and the advice shall be documented in the patient's record; and

(c) The total morphine equivalent dose (MED) of a prescription for opioid analgesics for treatment of acute pain shall not exceed an average of thirty MED per day, except when all of the following apply:

(i) The patient has significant and prolonged acute pain related to one of the following conditions:

(a) Traumatic oro-facial tissue injury with major mandibular/maxillary surgical procedures;

(b) Severe cellulitis of facial planes; or

(c) Severely impacted teeth with facial space infection necessitating surgical management.

(ii) The dentist determines that, for the seventy-two hour period following the procedure, it is absolutely necessary to exceed the thirty MED daily limit based on the patient's needs but may not exceed ninety MED per day.

(iii) The dentist has documented the reason for exceeding the thirty MED average in the patient record and why it is the lowest dose consistent with the patient's medical condition.

(iv) In circumstances when the thirty MED average is exceeded, the dose shall not exceed the dose required to treat the severity for the pain as noted in paragraph (A)(2) of this rule and furthermore, the dose will not exceed ninety MED per day within the initial seventy-two hour period as noted in paragraph (A)(3)(c)(ii) of this rule.

(d) Prescriptions which exceed the five or seven day supply or thirty MED average daily dose are subject to additional review by the board.

(e) All prescriptions for opioid analgesics for the treatment of acute pain shall comply with rules 4729:5-5-05 and 4729:5-5-15 of the Administrative Code and all other federal and state controlled substance laws, rules and regulations.

(B) The requirements of paragraph (A) of this rule apply to treatment of acute pain, and do not apply when an opioid analgesic is prescribed:

(1) To an individual who is a hospice patient or in a hospice care program;

(2) To an individual receiving palliative care;

(3) To an individual who has been diagnosed with a terminal condition;

(4) To an individual who has cancer or another condition associated with the individual's cancer or history of cancer; or

(5) To an individual undergoing medication-assisted treatment for a substance use disorder.

(C) This rule does not apply to prescriptions for opioid analgesics for the treatment of opioid addiction utilizing a schedule III, IV or V controlled substance narcotic that is approved by the federal drug administration for opioid detoxification or maintenance treatment.

(D) This rule does not apply to inpatient prescriptions as defined in rule 4729:5-9-02.1 of the Administrative Code.

Last updated August 28, 2023 at 8:27 AM

Supplemental Information

Authorized By: 4715.03, 3719.062
Amplifies: 4715.03, 3719.062
Five Year Review Date: 8/17/2028

Rule 4715-6-03 | Prescribing for subacute and chronic pain.

• Effective: December 21, 2018
• Promulgated Under: 119.03

(A) Definitions

(1) "Acute pain" means pain that normally fades with healing, is related to tissue damage, significantly alters a patient's typical function and is expected to be time limited and not more than six weeks in duration. Acute pain shall be treated in accordance with rule 4715-6-02 of the Administrative Code.

(2) "Medication therapy management" has the same meaning as in rule 4729:5-12-01 of the Administrative Code.

(3) "Subacute pain" means pain that has persisted after reasonable medical efforts have been made to relieve it and continues either episodically or continuously for at least six weeks but less than twelve weeks following initial onset of pain. It may be the result of underlying medical disease or condition, injury, medical or surgical treatment, inflammation, or unknown cause.

(4) "Chronic pain" means pain that has persisted after reasonable medical efforts have been made to relieve it and continues either episodically or continuously for twelve or more weeks following initial onset of pain. It may be the result of an underlying medical disease or condition, injury, medical treatment, inflammation, or unknown cause.

(5) Conditions that may require the dentist to treat subacute or chronic pain include:

(a) Chronic neuropathic or neuralgic pain;

(b) Chronic musculoskeletal pain;

(c) Oro-facial pain disorders, including oro-facial pain dysfunction syndrome and atypical oro-facial pain;

(d) Temporomandibular joint dysfunction; or

(e) Myo-facial pain dysfunction or syndrome.

(6) The treatment of subacute or chronic pain requires adequate training and education in appropriate treatment and understanding of the conditions that may cause subacute or chronic pain. Only dentists who are qualified to practice in one of the following areas may prescribe opioid analgesics for the treatment of subacute or chronic pain:

(a) Oral and maxillofacial surgery;

(b) Oral medicine;

(c) Oro-facial pain;

(d) Endodontics;

(e) Periodontics; or

(f) Anesthesia.

(B) Prior to treating, or continuing to treat subacute or chronic pain with an opioid analgesic, the dentist 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 dentist 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 dentist shall comply with the requirements of rule 4715-6-01 of the Administrative Code.

(C) Before prescribing an opioid analgesic for subacute or chronic pain, the dentist 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 the 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 and/or diagnostic testing or documented review of any available relevant laboratory/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 4715-6-01 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 for safe storage and disposal of the medication;

(7) The dentist 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.

(D) Prior to increasing the opioid dosage to a daily average of fifty MED or greater the dentist shall complete and document the following in the patient's record:

(1) The dentist shall review and update the assessment completed in paragraph (C) of this rule, if needed. The dentist may rely on an appropriate assessment completed within a reasonable time if the dentist 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 dentist shall update or formulate a new treatment plan, if needed;

(3) The dentist 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; and

(b) The patient's responsibility during the treatment to safely store the medication 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 dentist 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.

(E) Prior to increasing the opioid dosage to a daily average of eighty MED or greater the dentist shall complete all of the following:

(1) Enter into written pain treatment agreement with the patient that outlines that dentist'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 dentist 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 (C) 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 by a pharmacist; 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.

(F) The dentist shall not prescribe a dosage that exceeds an average of one hundred MED per day. This prohibition shall not apply in the following circumstances:

(1) The dentist has received a written recommendation for a dosage exceeding an average of one hundred MED per day from a board certified pain medicine physician who based the recommendation on a face-to-face visit and examination of the patient. The prescribing dentist shall maintain the written recommendation in the patient's record; or

(2) The patient was receiving an average daily dose of one hundred MED or more prior to the effective date of this rule. The dentist shall follow the steps in paragraph (F)(1) of this rule prior to escalating the patient's dose.

(G) During the course of treatment with an opioid analgesic at doses below the average of fifty MED per day, the dentist 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.

(H) During the course of treatment with an opioid analgesic at doses at or above the average of fifty MED per day, the dentist 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 4715-6-01 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 dentist with frequency based upon presence or absence of aberrant behaviors or other indications of addiction or drug abuse; and

(7) Evaluation of other forms of treatment and the tapering of opioid medication if continued benefit cannot be established.

(I) The dentist shall not prescribe an opioid analgesic to a patient to treat pain for more than twenty-four continuous weeks. This prohibition shall not apply in the following circumstances:

(1) Written recommendation from a physician pain management specialist to have dentist continue prescribing opioid analgesics for more than twenty-four weeks. The physician pain management specialist will base recommendation on face-to-face visit and examination of the patient. The prescribing dentist shall maintain the written recommendation in the patient's record:

(a) The dentist shall not exceed any aspect of the written recommendation; and

(b) If the written recommendation does not specify otherwise, the dentist shall refer the patient to obtain an updated written recommendation within eight weeks from the date of the most recent written recommendation.

(2) The patient was prescribed an opioid analgesic to treat pain for more than twenty-four continuous weeks prior to the effective date of this rule. The dentist shall follow all other requirements of this rule.

(J) This rule does not apply to inpatient prescriptions as defined in Chapter 4729. of the Revised Code.

Last updated December 6, 2023 at 1:07 PM

Supplemental Information

Authorized By: 4715.03
Amplifies: 4715.03
Five Year Review Date: 9/30/2028