(A) Definitions; for purposes of this rule:
(1) "APRN" means a clinical nurse specialist, certified nurse-midwife, or certified nurse practitioner who holds a current, valid license as an advanced practice registered nurse issued by the board.
(2) "Delegate" means an authorized representative who is registered to obtain an OARRS report on behalf of an APRN.
(3) "OARRS" means the Ohio automated RX reporting system established and maintained according to section 4729.75 of the Revised Code.
(4) "OARRS report" means a report of information related to a specified patient generated by the drug database established maintained by the state board of pharmacy pursuant to section 4729.75 of the Revised Code.
(5) "Reported drugs" means all drugs listed in rule 4729-37-02 of the Administrative Code that are required to be reported to the drug database established and maintained according to section 4729.75 of the Revised Code, including controlled substance schedules II, III, IV and V.
(B) Standards of care: in addition to the requirements set forth in rule 4723-9-08 and rule 4723-9-10 of the Administrative Code, accepted and prevailing standards of care require that when prescribing or personally furnishing a reported drug, an APRN shall taking into account the potential for abuse of the reported drug, the possibility that the reported drug may lead to dependence, the possibility the patient will obtain the reported drug for a nontherapeutic use or distribute it to other persons, and the potential existence of an illicit market for the reported drug. When considering these circumstances in the course of determining whether to prescribe or personally furnish a reported drug to a patient, the APRN shall use sound clinical judgment and consider obtaining and reviewing an OARRS report, consistent with the requirements of this rule.
(C) Red flags: an APRN shall obtain and review an OARRS report when any of the following red flags pertain to the patient:
(1) Selling prescription drugs;
(2) Forging or altering a prescription;
(3) Stealing or borrowing reported drugs;
(4) Increasing the dosage of reported drugs in amounts that exceed the prescribed amount;
(5) Suffering an overdose, intentional or nonintentional;
(6) Having a drug screen result that is inconsistent with the treatment plan or refusing to participate in a drug screen;
(7) Having been arrested, convicted, or received diversion, or intervention in lieu of conviction for a drug-related offense while under the APRN's care;
(8) Receiving reported drugs from multiple prescribers, without clinical basis;
(9) Traveling with a group of other patients to the APRN's office, where all or most of the patients request controlled substances prescriptions;
(10) Traveling an extended distance or from out of state to the APRN's office;
(11) 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;
(12) A known history of chemical abuse or dependency;
(13) Appearing impaired or overly sedated during an office visit or examination;
(14) Requesting reported drugs by specific name, street name, color, or identifying marks;
(15) Frequently requesting early refills of reported drugs;
(16) Frequently losing prescriptions for reported drugs;
(17) A history of illegal drug use;
(18) Sharing reported drugs with another person; or
(19) Recurring visits to non-coordinated sites of care, such as emergency departments, urgent care facilities, or walk-in clinics to obtain reported drugs.
(D) OARRS review; opioid analgesics and benzodiazepines.
Except as provided in paragraph (G) of this rule, an APRN shall:
(1) Obtain and review an OARRS report before initially prescribing to a patient a reported drug that is an opioid analgesic or benzodiazepine;
(2) Obtain and review an OARRS report when prescribing opioid analgesics for the treatment of sub-acute and chronic pain as set forth in rule 4723-9-10 of the Administrative Code;
(3) If the patient continues to receive opioid analgesics or benzodiazepines for more than ninety days after the initial report is requested, the APRN shall obtain and review OARRS reports for the patient at intervals not exceeding ninety days, determined according to the date the initial request was made, and until the course of treatment has ended; and
(4) In obtaining and reviewing OARRS reports, comply with paragraph (F) of this rule.
(E) OARRS review; reported drugs that are not opioid analgesics or benzodiazepines.
Except as provided in paragraph (G) of this rule, an APRN shall:
(1) Obtain and review an OARRS report following a course of treatment for a period of more than ninety days if the treatment includes the prescribing or personally furnishing of reported drugs that are not opioid analgesics or benzodiazepines;
(2) Obtain and review an OARRS report at least annually thereafter until the course of treatment utilizing these reported drugs has ended; and
(3) In obtaining and reviewing OARRS reports, comply with paragraph (F) of this rule.
(F) OARRS reports; time period; adjoining state: for purposes of paragraphs (C), (D), and (E) of this rule:
(1) OARRS reports may be requested by the APRN's delegate but must be personally reviewed by the APRN;
(2) Receipt and assessment of the OARRS report information, including consultation with the collaborating physician that occurred based on the OARRS report information or as required by paragraph (H) of this rule, shall be documented in the patient record;
(3) Initial reports requested shall cover at least twelve months immediately preceding the date of the request;
(4) If the APRN practices in a county of this state that adjoins another state, the APRN or the APRN's 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 the county; and
(5) If an OARRS report regarding the patient is not available, the APRN 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) OARRS report exceptions: an APRN shall not be required to review and assess an OARRS report when prescribing or personally furnishing a reported drug under the following circumstances, unless the APRN believes or has reason to believe that the patient may be abusing or diverting reported drugs:
(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 ;
(2) The reported drug is prescribed or personally furnished to a patient who has been diagnosed with terminal cancer or another terminal condition, as defined in section 2133.01 of the Revised Code;
(3) The reported drug is prescribed for administration in a hospital, nursing home, or residential care facility;
(4) The reported drug is prescribed or personally furnished in an amount indicated for a period not to exceed seven days; or
(5) The reported drug is prescribed for treatment of non-terminal cancer or another condition associated with non-terminal cancer, except if prescribed for sub-acute or chronic pain and an OARRS report review is required by rule 4723-9-10 of the Administrative Code.
(H) Physician consultation: an APRN who prescribes or personally furnishes a reported drug to a patient following review of an OARRS report under paragraph (C), (D), or (E) of this rule, and determines, based on the OARRS report or red flags described in paragraph (C) of this rule that the patient may be abusing or diverting reported drugs, shall first consult with their collaborating physician prior to personally furnishing or prescribing a reported drug at the patient's next visit.
(1) Consultation shall include and result in:
(a) Review and documentation of the reasons why the APRN believes or has reason to believe that the patient may be abusing or diverting drugs;
(b) Review and documentation of the patient's progress toward treatment objectives over the course of treatment; and
(c) Review and documentation of the functional status of the patient, including activities for daily living, adverse effects, analgesia and aberrant behavior over the course of treatment.
(2) Consultation may include and result in:
(a) Utilization of a patient treatment agreement that includes more frequent and periodic review of OARRS reports, 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
(b) Consultation with or referral to a substance use disorder specialist.
Five Year Review (FYR) Dates: 10/15/2020
Promulgated Under: 119.03
Statutory Authority: 4723.50, 4723.487
Rule Amplifies: 4723.50, 4723.487
Prior Effective Dates: 03/19/2012, 11/05/2012, 02/01/2015, 02/01/2016, 01/01/2018