Chapter 4715-6 Review of Ohio automated Rx reporting system

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

(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,k 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 4729-37-02 of the Administrative Code that are required to be reported to the drug database established and maintained pursuant to section 4729.75 of the Revised Code, including controlled substances in schedules II, III, IV, and V.

(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.

Replaces: 4715-6-01

Cite as Ohio Admin. Code 4715-6-01

Effective: 9/12/2016
Five Year Review (FYR) Dates: 08/01/2021
Promulgated Under: 119.03
Statutory Authority: 4715.302
Rule Amplifies: 4715.30 , 4715.302
Prior Effective Dates: 1/10/12

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

(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 30 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 (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 4729-5-13 and 4729-5-30 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 4729-17-01 of the Administrative Code.

Cite as Ohio Admin. Code 4715-6-02

Effective: 8/31/2017
Five Year Review (FYR) Dates: 06/01/2022
Promulgated Under: 119.03
Statutory Authority: R.C. 4715.03, R.C. 3719.062
Rule Amplifies: R.C. 4715.03, R.C. 3719.062