Chapter 4723-9 Prescriptive Authority

4723-9-01 Definitions.

For purposes of this chapter the following definitions shall apply:

(A) "Collaboration or collaborating" means in the case of a certified nurse practitioner, a clinical nurse specialist or a certified nurse-midwife, that a physician has entered into a standard care arrangement with the nurse and is continuously available to communicate with the nurse either in person, or by electronic communication .

(B) "Consultation" means the discussion or communication between a clinical nurse specialist, certified nurse-midwife, or certified nurse practitioner with a physician prior to initiating the prescription for a drug. The consultation relative to drug therapy shall be documented in the patient's record and shall include the consulting physician's name and the date the consultation took place.

(C) "Controlled substance" means a drug, compound, mixture, preparation, or substance included in schedule I, II, III, IV, or V pursuant to the provisions of Chapter 3719. of the Revised Code.

(D) "Contact hour" means a minimum of sixty minutes of continuing education. For credit hours earned on an academic quarter system, one credit hour is equivalent to ten contact hours. For credit hours earned on an academic trimester system, one credit hour is equivalent to twelve contact hours. For credit hours earned on an academic semester system, one credit hour is equivalent to fifteen contact hours.

(E) "Course of study" means an advanced level instructional program in pharmacology required by section 4723.482 of the Revised Code for advanced practice registered nursing licensure, that is either:

(1) Offered by an accredited educational institution acceptable to the board. Accredited educational institutions acceptable to the board include programs that are required to obtain approval, authorization, or accreditation from one of the following:

(a) The Ohio board of regents under section 3333.07 of the Revised Code;

(b) The Ohio department of education under section 3313.90 of the Revised Code;

(c) The Ohio state board of career colleges and schools under section 3332.05 of the Revised Code;

(d) The higher learning commission of the north central association of colleges and schools;

(e) The accrediting council for independent colleges and schools; or

(f) Any other national or regional post-secondary education accreditation entity recognized by the board; or

(2) A continuing education course that meets the requirements of Chapter 4723-14 of the Administrative Code.

(F) "Dangerous drug' has the same meaning as in section 4729.01 of the Revised Code.

(G) "Jurisdiction" means any state, territory, or political subdivision of the United States in which a board or legal approving authority regulates nurse licensure and nursing practice and maintains membership in the national council of state boards of nursing.

(H) "Physician" means an individual who holds a current valid license to practice medicine and surgery, osteopathic medicine and surgery, or podiatric medicine and surgery issued by the Ohio state medical board, or, in the case of applicants who hold a current valid certificate of authority to prescribe drugs and therapeutic devices from another jurisdiction, or who have been employed by the United States government and authorized to prescribe in conjunction with that employment, the physician's license may be issued by another jurisdiction as defined in this chapter.

(I) "Sample drug" has the same meaning as in section 2925.01 of the Revised Code.

(J) "Types of drugs" means therapeutic drug class.

Effective: 1/1/2018
Five Year Review (FYR) Dates: 10/15/2020
Promulgated Under: 119.03
Statutory Authority: 4723.50
Rule Amplifies: 4723.48, 4723.49, 4723.50
Prior Effective Dates: 10/01/2001, 02/01/2002, 02/01/2006, 02/01/2011, 11/05/2012, 02/01/2016

4723-9-02 Requirements for a course of study in advanced pharmacology.

(A) To be acceptable to the board, a course of study shall meet the following requirements:

(1) Be a minimum of forty-five contact hours in length and include content which ensures sufficient preparation for the safe and effective prescribing of drugs and therapeutic devices;

(2) Include content which is specific to the participant's nursing specialty and which includes all of the following:

(a) A minimum of thirty-six hours of training, obtained from a single provider, in:

(i) Pharmacokinetic principles and clinical application; and

(ii) Principles of the use of drugs and therapeutic devices in the prevention of illness and maintenance of health;

(b) The fiscal and ethical implications of prescribing drugs and therapeutic devices;

(c) The state and federal laws that apply to the authority to prescribe;

(d) Instruction that is specific to schedule II controlled substances, including instruction in all of the following:

(i) Indications and contraindications for the use of schedule II controlled substances in drug therapies, including risk, evaluation and mitigation strategies for the use of opiates in the treatment of chronic pain for non-terminal conditions, and the need for periodic assessment and documentation of the patient's functional status;

(ii) The most recent guidelines and recommendations for pain management therapies and education, as established by state and national organizations such as the Ohio pain initiative, the American pain society, the governor's cabinet opiate action team (GCOAT), and the United States food and drug administration (FDA), and the centers for disease control (CDC);

(iii) The most recent guidelines and recommendations for stimulant therapies utilized in the management of attention-deficit or hyperactivity disorder, as adopted by state and national organizations such as the American academy of pediatrics;

(iv) Fiscal and ethical implications of prescribing schedule II controlled substances;

(v) State and federal laws that apply to the authority to prescribe schedule II controlled substances, including state medical board of Ohio rules governing controlled substances and the treatment of chronic pain, and Ohio state board of pharmacy rules governing the manner of issuance of a prescription, and rules set forth in Chapters 4723-1 to 4723-27 of the Administrative Code;

(vi) Prevention of abuse and diversion of schedule II controlled substances, including identification of the risk of abuse, addiction and diversion, recognition of abuse, addiction and diversion, types of assistance available for prevention of abuse, addiction and diversion, the use of the Ohio automated rx reporting system (OARRS), including standards and procedures for OARRS access and review established in section 4729.75 of the Revised Code and rule 4723-9-12 of the Administrative Code, and other methods of establishing safeguards against abuse and diversion; and

(e) Instruction specific to schedule II controlled substances as set forth in paragraph (A)(2)(d) of this rule may be integrated with areas of instruction required by paragraphs (A)(2)(a), (A)(2)(b) and (A)(2)(c) of this rule.

(3) Include a process for interaction of the participants with instructional personnel;

(4) Include a process for evaluating the participants' learning of the content required by this rule that may include :

(a) Successful completion of case studies or written assignments;

(b) Successful completion of a comprehensive written examination or a series of sequential examinations completed by topic area;

(c) A mechanism to assure the security of the evaluation process; and

(5) May be provided online, but must be faculty-directed or independent study and, as defined in rule 4723-14-01 of the Administrative Code, is offered by either an accredited educational institution acceptable to the board or a continuing education course that meets the requirements of Chapter 4723-14 of the Administrative Code.

Effective: 1/1/2018
Five Year Review (FYR) Dates: 10/15/2020
Promulgated Under: 119.03
Statutory Authority: 4723.50
Rule Amplifies: 4723.482
Prior Effective Dates: 10/01/2001, 02/01/2002, 02/01/2003, 04/01/2006, 02/01/2011, 11/05/2012, 02/01/2016, 04/01/2017

4723-9-03 Completing a course of study in advanced pharmacology.

Applicants seeking an advanced practice registered nurse license , with designation as a clinical nurse specialist, certified nurse practitioner, or certified nurse-midwife, who do not meet the requirements set forth in division (C) of section 4723.482 of the Revised Code, shall complete, within the five years immediately preceding the application, a course of study, as defined in rule 4723-9-01 of the Administrative Code, that meets the requirements of rule 4723-9-02 of the Administrative Code.

Effective: 1/1/2018
Five Year Review (FYR) Dates: 10/15/2020
Promulgated Under: 119.03
Statutory Authority: 4723.50
Rule Amplifies: 4723.482
Prior Effective Dates: 10/01/2001, 02/01/2003, 02/01/2006, 02/01/2011

4723-9-04 [Rescinded] Externship experience.

Effective: 1/1/2018
Five Year Review (FYR) Dates: 10/12/2017
Promulgated Under: 119.03
Statutory Authority: 4723.50
Rule Amplifies: 4723.48, 4723.482, 4723.484
Prior Effective Dates: 02/01/2002, 02/01/2003, 02/01/2006, 02/01/2009, 02/01/2011, 02/01/2016

4723-9-05 [Rescinded] Standards and procedures for obtaining an externship certificate to prescribe.

Effective: 1/1/2018
Five Year Review (FYR) Dates: 10/12/2017
Promulgated Under: 119.03
Statutory Authority: 4723.50
Rule Amplifies: 4723.48, 4723.482, 4723.484
Prior Effective Dates: 10/01/2001, 02/01/2002, 02/01/2006, 02/01/2011, 02/01/2014, 02/01/2016

4723-9-06 [Rescinded] Standards and procedures for obtaining an initial certificate to prescribe and certificate renewal.

Effective: 1/1/2018
Five Year Review (FYR) Dates: 10/12/2017
Promulgated Under: 119.03
Statutory Authority: 4723.50
Rule Amplifies: 4723.47, 4723.48, 4723.482, 4723.484, 4723.50
Prior Effective Dates: 02/01/2002, 02/01/2006, 02/01/2010, 02/01/2011, 02/01/2014, 02/01/2016, 04/01/2017

4723-9-07 [Rescinded] Certificate to prescribe renewal.

Effective: 1/1/2018
Five Year Review (FYR) Dates: 10/12/2017
Promulgated Under: 119.03
Statutory Authority: 4723.50
Rule Amplifies: 4723.485
Prior Effective Dates: 02/01/2002, 02/01/2006, 02/01/2011, 11/05/2012, 02/01/2014, 02/01/2015, 02/01/2016

4723-9-08 Safety standards for personally furnishing drugs and therapeutic devices.

(A) A clinical nurse specialist, certified nurse-midwife, or certified nurse practitioner who holds a current, valid advanced practice registered nurse license issued by the board may personally furnish to a patient a drug or therapeutic device, whether as a sample drug or a complete or partial supply, only if the following requirements are met:

(1) The drug or therapeutic device is not excluded by the formulary, located at http://www.nursing.ohio.gov/Practice-Prescribing.htm(effective 2017) , established according to rule 4723-9-10 of the Administrative Code;

(2) If the drug furnished is a controlled substance, the requirements of section 4729.291 of the Revised Code are met, including limiting the amount of the controlled substance to a seventy-two hour supply, and, in any thirty-day period, not personally furnishing to or for patients, taken as a whole, an amount that exceeds two thousand five hundred dosage units;

(3) If the drug furnished is a dangerous drug, other than a sample drug, the nurse affixes labeling to the container as specified in rule 4729-5-17 of the Administrative Code;

(4) The nurse complies with rule 4723-9-12 of the Administrative Code regarding standards and procedures for review of OARRS reports;

(5) The nurse maintains a written record of all drugs and therapeutic devices personally furnished by the nurse as required by rule 4729-5-17 of the Administrative Code; and

(6) The nurse maintains current knowledge of and complies with all applicable state and federal laws or rules related to personally furnishing drugs and therapeutic devices.

(B) A clinical nurse specialist, certified nurse-midwife, or certified nurse practitioner who holds a current, valid advanced practice registered nurse license issued by the board may personally furnish to a patient a sample drug only if, in addition to the requirements set forth in paragraph (A) of this rule, the following requirements are met:

(1) The sample drug is furnished in compliance with section 3719.81 of the Revised Code, including but not but limited to the requirement that the sample be provided free of charge; and

(2) If the sample is a dangerous drug, the requirements of rule 4729-5-17 of the Administrative Code are met.

(C) Notwithstanding the requirements of this rule, a clinical nurse specialist, certified nurse-midwife, or certified nurse practitioner who holds a current, valid advanced practice registered nurse license issued by the board may personally furnish a supply of naloxone according to section 4723.488 of the Revised Code.

(D) Notwithstanding the requirements of this rule, a clinical nurse specialist, certified nurse- midwife, or certified nurse practitioner who holds a current, valid advanced practice registered nurse license may personally furnish a complete or partial supply of a drug to treat chlamydia, gonorrhea, or trichomoniasis as specified in section 4723.4810 of the Revised Code.

Replaces: 4723-9-08

Effective: 1/1/2018
Five Year Review (FYR) Dates: 10/15/2020
Promulgated Under: 119.03
Statutory Authority: 4723.07
Rule Amplifies: 4723.481
Prior Effective Dates: 02/01/2002, 02/01/2006, 02/01/2011, 02/01/2012, 02/01/2016

4723-9-09 [Rescinded] Standards of prescribing for nurses with a certificate to prescribe.

Effective: 8/31/2017
Five Year Review (FYR) Dates: 6/16/2017
Promulgated Under: 119.03
Statutory Authority: 4723.50, 4723.07
Rule Amplifies: 4723.481, 4723.488
Prior Effective Dates: 2/01/2002, 2/01/2003, 4/01/2006, 2/01/2011, 2/01/2012, 2/01/2014

4723-9-10 Formulary; standards of prescribing for advanced practice registered nurses designated as clinical nurse specialists, certified nurse-midwives, or certified nurse practitioners.

(A) Definitions; for purposes of this rule and interpretation of the formulary, located at http://www.nursing.ohio.gov/Practice-Prescribing.htm (effective 2017):

(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.

(2) "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. "Chronic pain" does not include pain associated with a terminal condition or with a progressive disease that, in the normal course of progression, may reasonably be expected to result in a terminal condition.

(3) "Extended-release or long-acting opioid analgesic" means an opioid analgesic that:

(a) Has United States food and drug administration approved labeling indicating that it is an extended-release or controlled release formulation;

(b) Is administered via a transdermal route; or

(c) Contains methadone.

(4) "Family member" means a spouse, parent, child, sibling or other individual with respect to whom an advanced practice registered nurse's personal or emotional involvement may render the advanced practice registered nurse unable to exercise detached professional judgment in reaching diagnostic or therapeutic decisions.

(5) "Hospice care program" has the same meaning as in section 3712.01 of the Revised Code.

(6) "ICD-10-CM medical diagnosis code" means the disease code in the most current international classification of diseases, clinical modifications published by the United States department of health and human services.

(7) "Opioid analgesic" has the same meaning as in section 3719.01 of the Revised Code, and means a controlled substance that has analgesic pharmacological activity at the opioid receptors of the central nervous system, including but not limited to the following drugs and their varying salt forms or chemical congeners: buprenorphine, butorphanol, codeine (including acetaminophen and other combination products), dihydrocodeine, fentanyl, hydrocodone (including acetaminophen combination products), hydromorphone, meperidine, methadone, morphine sulfate, oxycodone (including acetaminophen, aspirin, and other combination products), oxymorphone, tapentadol, and tramadol.

(8) "Medication therapy management" has the same meaning as in rules adopted by agency 4729 of the Administrative Code.

(9) "Minor" has the same meaning as in section 3719.061 of the Revised Code.

(10) "Morphine equivalent daily dose (MED)" means a conversion of various opioid analgesics to a morphine equivalent dose by the use of accepted conversion tables provided by the state board of pharmacy at: https://www.ohiopmp.gov/MED_Calculator.aspx (effective 2017).

(11) "Palliative care" has the same meaning as in section 3712.01 of the Revised Code.

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

(13) "Terminal condition" has the same meaning as in section 2133.01 of the Revised Code.

(B) The committee on prescriptive governance shall establish a recommended exclusionary formulary, located at http://www.nursing.ohio.gov/Practice-Prescribing.htm (effective 2017), that may specify the exclusion of therapeutic devices, individual drugs or subtypes of individual drugs.

(C) The recommended exclusionary formulary shall not permit the prescribing or furnishing of any drug or device prohibited by federal or state law, or rules adopted by the board, including this rule.

(D) The formulary established by the committee on prescriptive governance shall be available on the Ohio board of nursing web site, located at http://www.nursing.ohio.gov/Practice-Prescribing.htm (effective 2017).

(E) The committee on prescriptive governance shall review the formulary, located at http://www.nursing.ohio.gov/Practice-Prescribing.htm (effective 2017), for additions or deletions at least twice a year.

(F) A clinical nurse specialist, certified nurse-midwife, or certified nurse practitioner may prescribe any drug or therapeutic device in any form or route of administration if:

(1) The ability to prescribe the drug or therapeutic device is within the scope of practice in the advanced practice registered nurse's specialty area;

(2) The prescription is consistent with the terms of a standard care arrangement entered into with a collaborating physician;

(3) The prescription would not exceed the prescriptive authority of the collaborating physician, including restrictions imposed on the physician's practice by action of the United States drug enforcement administration or the state medical board, or by the state medical board rules, including but not limited to rule 4731-11-09 of the Administrative Code;

(4) The individual drug or subtype or therapeutic device is not one excluded by the formulary, located at http://www.nursing.ohio.gov/Practice-Prescribing.htm (effective 2017);

(5) The prescription meets the requirements of state and federal law, including but not limited to this rule, and all prescription issuance rules adopted by agency 4729 of the Administrative Code and rule ;

(6) A valid prescriber-patient relationship exists. This relationship may include, but is not limited to:

(a) Obtaining a relevant history of the patient;

(b) Conducting a physical or mental examination of the patient;

(c) Rendering a diagnosis;

(d) Prescribing medication;

(e) Consulting with the collaborating physician when necessary; and

(f) Documenting these steps in the patient's medical records;

(7) Notwithstanding paragraph (F)(6) of this rule, a clinical nurse specialist, certified nurse-midwife, or certified nurse practitioner may prescribe or personally furnish a drug according to section 4723.4810 of the Revised Code to not more than a total of two individuals who are sexual partners of the advanced practice registered nurse's patient.

(8) If the patient is a family member, acceptable and prevailing standards of safe nursing care require that the advanced practice registerednurse maintain detached professional judgment. The advanced practice registered nurse shall not prescribe to a family member unless:

(a) The advanced practice registered nurse is able to exercise detached professional judgment in reaching diagnostic or therapeutic decisions;

(b) The prescription is documented in the patient's record.

(9) Controlled substances. For drugs that are a controlled substance:

(a) The advanced practice registered nurse has obtained a United States drug enforcement administration registration, except if not required to do so as provided in rules adopted by agency 4729 of the Administrative Code, and indicates the number on the prescription;

(b) The prescription indicates the ICD-10-CM medical diagnosis code of the primary disease or condition that the controlled substance is being used to treat. The code shall, at minimum, include the first four alphanumeric characters of the ICD-10 CM medical diagnosis code, sometimes referred to as the category and etiology (ex. M165);

(c) The prescription indicates the days' supply of the controlled substance prescription.

(d) The patient is not a family member; and

(e) The advanced practice registered nurse shall not self-prescribe a controlled substance.

(G) Schedule II controlled substances. Except as provided in paragraph (H) of this rule, a clinical nurse specialist, certified nurse-midwife, or certified nurse practitioner may prescribe a schedule II controlled substance only in situations where all of the following apply:

(1) A patient has a terminal condition;

(2) A physician initially prescribed the substance for the patient; and

(3) The prescription is for a quantity that does not exceed the amount necessary for the patient's use in a single, seventy-two hour period.

(H) Subject to the requirements set forth in paragraphs (I), (J), and (M) of this rule, a clinical nurse specialist, certified nurse-midwife, or certified nurse practitioner may prescribe a schedule II controlled substance, if not excluded by the formulary, located at http://www.nursing.ohio.gov/Practice-Prescribing.htm (effective 2017), if the advanced practice registered nurse issues the prescription to the patient from any of the following locations:

(1) A hospital registered under section 3701.07 of the Revised Code;

(2) An entity owned or controlled, in whole or in part, by a hospital or by an entity that owns or controls, in whole or in part, one or more hospitals;

(3) A health care facility operated by the department of mental health or the department of developmental disabilities;

(4) A nursing home licensed under section 3721.02 of the Revised Code or by a political subdivision certified under section 3721.09 of the Revised Code;

(5) A county home or district home operated under Chapter 5155. of the Revised Code that is certified under the medicare or medicaid program;

(6) A hospice care program;

(7) A community mental health agency, as defined in section 5122.01 of the Revised Code;

(8) An ambulatory surgical facility, as defined in section 3702.30 of the Revised Code;

(9) A freestanding birthing center, as defined in section 3702.141 of the Revised Code;

(10) A federally qualified health center, as defined in section 3701.047 of the Revised Code;

(11) A federally qualified health center look-alike, as defined in section 3701.047 of the Revised Code;

(12) A health care office or facility operated by the board of health of a city or general health district or the authority having the duties of a board of health under section 3709.05 of the Revised Code;

(13) A site where a medical practice is operated, but only if the practice is comprised of one or more physicians who also are owners of the practice; the practice is organized to provide direct patient care; and the clinical nurse specialist, certified nurse-midwife, or certified nurse practitioner providing services at the site has a standard care arrangement and collaborates with at least one of the physician owners who practices primarily at that site; or

(14) A residential care facility, as defined in section 3721.01 of the Revised Code.

(I) A clinical nurse specialist, certified nurse-midwife, or certified nurse practitioner shall not issue to a patient a prescription for a schedule II controlled substance from a convenience care clinic even if the clinic is owned or operated by an entity specified in paragraph (H) of this rule.

(J) Acute pain. For the treatment of acute pain, a clinical nurse specialist, certified nurse-midwife, or certified nurse practitioner shall comply with the following:

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

(2) Before prescribing an opioid analgesic, the advanced practice registered nurse shall first consider non-opioid treatment options. If opioid analgesic medications are required as determined by history and physical examination, the prescription should be 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;

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

(a) Except as provided in paragraph (J)(3)(a)(iii) of this rule, the duration of 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. As set forth in section 4723.481 of the Revised Code, the advanced practice registered nurse 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 analgesic medication was not appropriate to treat the patient's condition shall be documented in the patient's medical record; and

(iv) If a patient is intolerant of or allergic to an opioid medication initially prescribed, a prescription for a different opioid medication may be issued at any time during the initial seven-day or five-day dosing period, and the new prescription shall be subject to the requirements of this rule. The patient's intolerance or allergy shall be documented in the patient's medical record, and the patient advised to safely dispose 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 medical 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:

(i) The circumstances set forth in paragraph (A)(3)(c) of rule 4731-11-13 of the Administrative Code exist; and

(ii) The patient's treating physician has entered a standard care arrangement with the advanced practice registered nurse that states the understanding of the physician as to when the advanced practice registered nurse may exceed the thirty MED average, and when the advanced practice registered nurse must consult with the physician prior to exceeding the thirty MED average. The standard care arrangement in this circumstance must comply with rule 4731-11-13 of the Administrative Code, and the advanced practice registered nurse must document in the patient's record the reason for exceeding the thirty MED average and the reason it is the lowest dose consistent with the patient's medical condition.

(K) The requirements of paragraph (J) 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 in a hospice care program;

(2) To an individual who is receiving palliative care;

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

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

(L) The requirements of paragraph (J) of this rule do not apply to:

(1) Prescriptions for opioid analgesics for the treatment of opioid addiction utilizing a controlled substance that is approved by the FDA for opioid detoxification or maintenance treatment; or

(2) Inpatient prescriptions as defined in rules adopted by agency 4729 of the Administrative Code.

(M) Sub-acute and chronic pain. As specified in section 4723.481 of the Revised Code, for treatment of sub-acute and chronic pain, a clinical nurse specialist, certified nurse-midwife, or certified nurse practitioner shall prescribe in a manner not exceeding the prescriptive authority of the collaborating physician or podiatrist. Prescribing parameters specifically include, but are not limited to, the following requirements set forth in rule 4731-11-14 of the Administrative Code:

(1) Prior to treating, or continuing to treat sub-acute or chronic pain with an opioid analgesic, the advanced practice registered nurse shall first consider and document non-medication options. If opioid analgesic medications are required as determined by a history and physical examination, the advanced practice registered nurse shall prescribe the minimum quantity and potency needed to treat the expected duration of pain and improve the patient's ability to function;

(2) Before prescribing an opioid analgesic for sub-acute or chronic pain, the advanced practice registered nurse shall complete or update and document in the patient record assessment activities to assure the appropriateness and safety of the medication, as required by rule 4731-11-14 of the Administrative Code, including but not limited to:

(a) Completing an OARRS check in compliance with rule 4723-9-12 of the Administrative Code;

(b) Offering the patient a prescription for naloxone if the following circumstances exist:

(i) The patient has a prior history of opioid overdose;

(ii) The patient is co-prescribed a benzodiazepine, sedative hypnotic drug, carisprodal, tramadol, or gabapentin;

(iii) The patient has a concurrent substance use disorder; or

(iv) The dosage exceeds eighty MED as discussed in paragraph (M)(5) of this rule;

(c) The advanced practice registered nurse shall consider offering the patient a prescription for naloxone if the dosage exceeds fifty MED as discussed in paragraph (M)(4) of this rule.

(3) During the course of treatment with an opioid analgesic at doses below the average of fifty MED per day, the advanced practice registered nurse 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 diversion, and any adverse drug effects.

(4) Fifty MED. Prior to increasing the opioid dosage to a daily average of fifty MED or greater, the advanced practice registered nurse shall complete and document in the patient record the activities and information set forth in rule 4731-11-14 of the Administrative Code, including but not limited to the following:

(a) Review and update the assessment completed in paragraph (M)(2) of this rule if needed. The advanced practice registered nurse may rely on an appropriate assessment completed within a reasonable time if the advanced practice registered nurse is satisfied that he or she may rely on that information for purposes of meeting the requirements of Chapter 4723-8 and Chapter 4723-9 of the Administrative Code;

(b) Except when the patient was prescribed an average daily dosage that exceeded fifty MED before the effective date of this rule, document consideration of:

(i) Consultation with a specialist in the area of the body affected by the pain;

(ii) Consultation with a pain management specialist;

(iii) Obtaining a medication therapy management review by a pharmacist;

(iv) Consultation with a specialist in addiction medicine or addiction psychiatry, if aberrant behaviors indicating medication misuse or substance use disorder are noted;

(c) The advanced practice registered nurse shall consider offering the patient a prescription for naloxone if the dosage exceeds fifty MED as discussed in paragraph (M)(4) of this rule;

(d) During the course of treatment with an opioid analgesic at doses at or above the average of fifty MED per day, the advanced practice registered nurse shall complete and document in the patient record all of the information and activities required by rule 4731-11-14 of the Administrative Code not less than every three months.

(5) Eighty MED. Prior to increasing the opioid dosage to a daily average of eighty MED or greater, the advanced practice registered nurse shall complete and document in the patient record the activities and information set forth in rule 4731-11-14 of the Administrative Code, including but not limited to the following:

(a) A written pain management agreement shall be entered with the patient that outlines the advanced practice registered nurse's and patient's responsibilities during treatment, which requires the patient or patient guardian's agreement to all of the provisions set forth in rule 4731-11-14 of the Administrative Code;

(b) The advanced practice registered nurse shall offer the patient a prescription for naloxone;

(c) Except when the patient was prescribed an average daily dosage that exceeded eighty MED before the effective date of this rule, the advanced practice registered nurse shall obtain at least one of the following based upon the patient's clinical presentation:

(i) Consultation with a specialist in the area of the body affected by the pain;

(ii) Consultation with a pain management specialist;

(iii) A medication therapy management review by a pharmacist; or

(iv) Consultation with a specialist in addiction medicine or addiction psychiatry, if aberrant behaviors indicating medication misuse or substance use disorder are noted.

(6) One hundred twenty MED. The advanced practice registered nurse shall not prescribe a dosage that exceeds an average of one hundred twenty MED per day. This prohibition shall not apply under the following circumstances:

(a) The advanced practice registered nurse holds national certification in pain management or hospice and palliative care by a national certifying organization approved according to section 4723.46 of the Revised Code;

(b) The advanced practice registered nurse 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 advanced practice registered nurse shall maintain the written recommendation in the patient's record; or

(c) The patient was receiving an average daily dose of one hundred twenty MED or more prior to the effective date of this rule. However, prior to escalating the patient's dose, the advanced practice registered nurse shall receive a written recommendation as set forth in paragraph (M)(6)(b) of this rule.

(7) The requirements of paragraph (M) of this rule do not apply when an opioid analgesic is prescribed:

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

(b) To an individual who has terminal cancer or another terminal condition; or

(c) As an inpatient prescription as defined in rules adopted by agency 4729 of the Administrative Code.

(N) Drugs approved by the FDA but not yet reviewed and approved by the committee on prescriptive governance may be prescribed, unless later disapproved by the committee on prescriptive governance, if:

(1) The drug type or subtype is not excluded on the formulary, located at http://www.nursing.ohio.gov/Practice.htm (effective 2017); and

(2) The collaborating physician has agreed in the standard care arrangement that the advanced practice registered nurse may prescribe drugs approved by the FDA, that meet the criteria set forth in paragraphs (N)(1) and (N)(2) of this rule, that have not yet been reviewed and approved by the committee on prescriptive governance.

(O) As specified in section 4723.44 of the Revised Code, a clinical nurse specialist, certified nurse-midwife, or certified nurse practitioner shall not prescribe any drug or device to perform or induce an abortion.

(P) As specified in section 4723.488 of the Revised Code, notwithstanding the requirements of this rule, a clinical nurse specialist, certified nurse-midwife, or certified nurse practitioner may prescribe or personally furnish naloxone.

(Q) The requirements of paragraph (F)(9)(c) of this rule apply to prescriptions for products that contain gabapentin.

Effective: 12/22/2018
Five Year Review (FYR) Dates: 10/15/2020
Promulgated Under: 119.03
Statutory Authority: 4723.50, 4723.07, 3719.062
Rule Amplifies: 4723.481, 4723.492, 4723.491, 4723.49 , 4723.488, 4723.487, 4723.486
Prior Effective Dates: 02/01/2002, 02/01/2003, 02/01/2006, 04/01/2006, 02/01/2008, 02/01/2011, 02/01/2012, 11/05/2012, 02/01/2014, 02/01/2016, 08/31/2017, 01/01/2018

4723-9-11 Course in Ohio law governing drugs and prescriptive authority.

(A) All applicants seeking an advanced practice registered nurse license who practiced or are practicing as a clinical nurse specialist, certified nurse-midwife, or certified nurse practitioner in another jurisdiction or as an employee of the United States government, in accordance with division (C) of section 4723.482 of the Revised Code, are required to complete a course of instruction in the laws of this state that govern drugs and prescriptive authority. To meet this requirement, the course of instruction must:

(1) Include content and instruction on rules 4723-9-08, 4723-9-10, and 4723-9-12 of the Administrative Code, and other state, or federal laws that apply to the authority to prescribe schedule II controlled substances;

(2) Include content and instruction concerning the indications and contraindications for the use of opioids and benzodiazepines in drug therapies, and alternatives to opioid therapies in the management of acute and chronic pain, including the guidelines issued by the governor's cabinet opiate action team (GCOAT);

(3) Be approved by the board, or by an OBN approver as defined in rule 4723-14-01 of the Administrative Code, or offered by an OBN approved provider unit, as defined in rule 4723-14-01 of the Administrative Code that is headquartered in the state of Ohio; and

(4) Be at minimum two hours in length.

(B) Applicants must submit documentation of successful completion to the board in the form of an original certificate, issued by the provider of the course of instruction that includes:

(1) Name of the attendee;

(2) Title of the program;

(3) Date of the program;

(4) Name and address of the provider and OBN approver number, if applicable; and

(5) Verification of completion of at least two hours of instruction, each of sixty minutes in duration.

Effective: 1/1/2018
Five Year Review (FYR) Dates: 10/15/2020
Promulgated Under: 119.03
Statutory Authority: 4723.50
Rule Amplifies: 4723.482
Prior Effective Dates: 02/01/2011, 11/05/2012, 04/01/2017

4723-9-12 Standards and procedures for review of OARRS.

(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.

Effective: 11/5/2018
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

4723-9-13 Medication-assisted treatment.

(A) Definitions; for purposes of this rule and interpretation of the formulary, located at http://www.nursing.ohio.gov/Practice-Prescribing.htm (effective May 17, 2017):

(1) "Community addiction services provider" has the same meaning as in section 5119.01 of the Revised Code.

(2) "Community mental health services provider" has the same meaning as in section 5119.01 of the Revised Code.

(3) "Controlled substance," "schedule III," "schedule IV," and "schedule V" have the same meanings as in section 3719.01 of the Revised Code.

(4) "FDA" means the United States food and drug administration.

(5) "Induction phase" means the phase of opioid treatment during which maintenance medication dosage levels are adjusted until a patient attains stabilization.

(6) "Medication-assisted treatment" means alcohol or drug addiction services that are accompanied by medication that has been approved by the United States food and drug administration for the treatment of substance use disorder, prevention of relapse of substance use disorder, or both.

(7) "Office-based opioid treatment" or "OBOT" means medication-assisted treatment of opioid dependence or addiction utilizing controlled substances, in a private office or public sector clinic that is not otherwise regulated, by practitioners who are authorized to prescribe outpatient supplies of drugs approved by the FDA for the treatment of opioid addiction or prevention of relapse. OBOT includes treatment with all controlled substance drugs approved by the FDA for such treatment. OBOT does not include treatment that occurs in the following settings:

(a) A state or local correctional facility, as defined in section 5163.45 of theRevised Code;

(b) A hospital, as defined in section 3727.01 of the Revised Code;

(c) A provider certified to provide residential and inpatient substance use disorder services, including withdrawal management, by the Ohio department of mental health and addiction services;

(d) An opioid treatment program certified by SAMHSA and accredited by an independent, SAMHSA-approved accrediting body; or

(e) A youth services facility, as defined in section 103.75 of the Revised Code.

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

(9) "Qualified behavioral healthcare provider" means the following who is practicing within the scope of professional licensure:

(a) A medical doctor or doctor of osteopathic medicine and surgery who holds board certification in addiction medicine or addiction psychiatry, or a psychiatrist, licensed under Chapter 4731. of the Revised Code;

(b) A licensed independent chemical dependency counselor-clinical supervisor, licensed independent chemical dependency counselor, licensed chemical dependency counselor, or licensed chemical dependency counselor II licensed under Chapter 4758. of the Revised Code;

(c) A professional clinical counselor, licensed professional counselor, licensed independent social worker, licensed social worker, or marriage and family therapist, licensed under Chapter 4757. of the Revised Code;

(d) An advanced practice registered nurse licensed as a clinical nurse specialist or certified nurse practitioner licensed by the board, who holds national certification in psychiatric mental health, or clinical nurse specialist who was not required to obtain national certification according to section 4723.41 of the Revised Code, and whose specialty is psychiatric mental health; or

(e) A psychologist, as defined in division (A) of section 4732.01 of the RevisedCode, licensed under Chapter 4732. of the Revised Code; or

(f) An advanced practice registered nurse licensed by the board who holds additional certification as a certified addictions registered nurse-advanced practice issued by the addictions nursing certification board.

(10) "SAMHSA" means the United States substance abuse and mental health services administration.

(11) "Stabilization phase" means the medical and psychosocial process of assisting the patient through acute intoxication and withdrawal management to the attainment of a medically stable, fully supported substance-free state, which may include the assistance of medications.

(B) A clinical nurse specialist or certified nurse practitioner who holds a current valid advanced practice registered nurse license may provide medication-assisted treatment, including prescribing controlled substances in schedule III, IV or V, if the clinical nurse specialist or certified nurse practitioner:

(1) Complies with all federal and state laws and regulations governing the prescribing of the medication, including but not limited to incorporating into the advanced practice registered nurse's practice knowledge of Chapter 4729. of the Revised Code, and Chapter 4731. of the Revised Code and rules adopted under that Chapter that govern the practice of the advanced practice registered nurse's collaborating physician;

(2) Completes at least eight hours of continuing nursing education in each renewal period related to substance abuse and addiction. Courses completed in compliance with this requirement shall be accepted toward meeting the continuing education requirements for biennial renewal of the advanced practice registered nurse license; and

(3) Only provides medication-assisted treatment if the treatment is within the collaborating physician's normal course of practice and expertise.

(C) In addition to the requirements for medication-assisted treatment set forth in paragraph (B) of this rule, a clinical nurse specialist or certified nurse practitioner may provide OBOT under the following circumstances:

(1) The standard care arrangement statement of services offered includes OBOT;

(2) The advanced practice registered nurse performs, or confirms the completion of, and documents a patient assessment that includes all of the following:

(a) A comprehensive medical and psychiatric history;

(b) A brief mental status history;

(c) Substance abuse history;

(d) Family history and psychosocial supports;

(e) Appropriate physical examination;

(f) Urine drug screen;

(g) Pregnancy test for women of childbearing age and ability;

(h) Review of patient's prescription information in OARRS;

(i) Testing for human immunodeficiency virus;

(j) Testing for hepatitis B;

(k) Testing for hepatitis C;

(l) Consideration of screening for tuberculosis.

(3) The advanced practice registered nurse establishes and documents a treatment plan that includes all of the following:

(a) The advanced practice registered nurse's rationale for selection of the specific drug to be used in the medication-assisted treatment;

(b) Patient education;

(c) The patient's written, informed consent;

(d) Random urine-drug screens;

(e) A signed treatment agreement with the patient that outlines the responsibilities of the patient and the advanced practice registered nurse;

(f) A plan for psychosocial treatment as discussed in paragraph (C)(5) of this rule;

(4) The advanced practice registered nurse shall provide OBOT in accordance with an acceptable treatment protocol for assessment, induction, stabilization, maintenance and tapering. Acceptable protocols are any of the following:

(a) SAMSHA treatment improvement protocol publications for medication-assisted treatment available from the SAMSHA website at: https://store.samhsa.gov/list/series?name=TIP-Series-Treatment-Improvement-Protocols-TIPS-&pageNumber=1;

(b) "National Practice Guideline for the Use of Medications in the Treatment of Addiction Involving Opioid Use," approved by the American society of addiction medicine in 2013, and available from the website of the Ohio department of mental health and addiction services at: https://asam.org/docs/default-source/practice-support/guidelines-and-consensus-docs/asam-national-practice-guideline-supplement.pdf.

(5) The advanced practice registered nurse shall refer and work jointly with a qualified behavioral healthcare provider, community mental health services provider, or community addiction services provider to determine the optimal type and intensity of psychosocial treatment for the patient and document the treatment plan in the patient record.

(a) The treatment shall at minimum include a psychosocial needs assessment, supportive counseling, links to existing family supports, and referral to community services;

(b) The treatment shall include at least one of the following interventions:

(i) Cognitive behavioral treatment;

(ii) Community reinforcement approach;

(iii) Contingency management/motivational incentives; or

(iv) Behavioral couples counseling;

(c) The treatment plan shall include a structure for renegotiation of the treatment plan if the patient does not adhere to the original plan.

(6) When clinically appropriate or if the patient refuses treatment from a qualified behavioral healthcare provider, community mental health services provider, or community addiction services provider, the advanced practice registered nurse shall ensure that the OBOT treatment plan requires the patient to participate in a twelve step program If the patient is required to participate in a twelve step program, the advanced practice registered nurse shall require the patient to provide documentation of on-going participation in the program.

(7) If the advanced practice registered nurse refers the patient to a qualified behavioral health service provider, community addiction services provider, or community mental health services provider, the advanced practice registered nurse shall document the referral and the advanced practice registered nurse's meaningful interactions with the provider in the patient record.

(8) The advanced practice registered nurse shall offer the patient a prescription for a naloxone kit.

(a) The advanced practice registered nurse shall ensure that the patient receives instruction on the kit's use including, but not limited to, recognizing the signs and symptoms of overdose and calling 911 in an overdose situation.

(b) The requirement set forth in paragraph (C)(8)(a) of this rule does not apply if the patient refuses the prescription. If the patient refuses the prescription the advanced practice registered nurse shall provide the patient with information on where to obtain a kit without a prescription.

(9) If the advanced practice registered nurse provides OBOT using buprenorphine products, the following additional requirements must be met:

(a) The provision shall comply with the FDA approved "Risk Evaluation andMitigation Strategy" for buprenorphine products. With the exception of those conditions listed in paragraph (C)(9)(b) of this rule, the advanced practice registered nurse shall prescribe a combination product of buprenorphine and naloxone for use in OBOT.

(b) The advanced practice registered nurse shall prescribe buprenorphine without naloxone (buprenorphine mono-product) only in the following situations, and shall fully document the evidence for the decision to use buprenorphine mono-product in the patient's record:

(i) When the patient is pregnant or breast-feeding;

(ii) When converting the patient from methadone or a buprenorphine mono-product to a buprenorphine containing naloxone for a period not to exceed seven days;

(iii) In formulations other than tablet or film form for indications approved by the FDA;

(iv) For withdrawal management when a combination product of buprenorphine and naloxone is contraindicated, with the contraindication documented in the patient record; or

(v) When the patient has an allergy to or intolerance of a combination product of buprenorphine and naloxone, after explaining to the patient the difference between an allergic reaction and symptoms of opioid withdrawal precipitated by buprenorphine or naloxone, and with documentation included in the patient record.

(c) Due to a higher risk of fatal overdose when buprenorphine is prescribed with other opioids, benzodiazepines, sedative hypnotics, carisoprodol, and tramadol, the advanced practice registered nurse shall only co-prescribe these substances when there are extenuating circumstances, and only if:

(i) The advanced practice registered nurse verifies the diagnosis for which the patient is receiving the other drug and coordinates care with the prescriber for the other drug, including discussing with the prescriber whether it is possible to taper the drug to discontinuation. If the advanced practice registered nurse prescribing buprenorphine is the prescriber of the other drug, the advanced practice registered nurse shall taper the other drug to discontinuation, if possible. The advanced practice registered nurse shall educate the patient about the serious risks of the combined use; and

(ii) The advanced practice registered nurse documents progress in achieving the tapering plan in the patient record.

(d) During the induction phase, the advanced practice registered nurse shall not prescribe a dosage that exceeds the recommendation in the FDA labeling, except for medically indicated circumstances as documented in the patient record. The advanced practice registered nurse shall see the patient at least once per week.

(e) During the stabilization phase, when using any oral formulation of buprenorphine, the advanced practice registered nurse shall increase the daily dosage of buprenorphine in safe and effective increments to achieve the lowest dose that avoids intoxication, withdrawal, or significant drug craving.

(i) During the first ninety days of treatment, the advanced practice registered nurse shall prescribe no more than a two-week supply of the buprenorphine product containing naloxone.

(ii) Starting with the ninety-first day of treatment and until the completion of twelve months of treatment, the advanced practice registered nurse shall prescribe no more than a thirty-day supply of the buprenorphine product containing naloxone.

(f) The advanced practice registered nurse shall take steps to reduce the chances of buprenorphine diversion by using the lowest effective dose, appropriate frequency of office visits, pill counts, and checks of OARRS. The advanced practice registered nurse shall also require urine drug screens or serum medication levels at least twice per quarter for the first year of treatment and once per quarter thereafter.

(g) When using any oral formulation of buprenorphine,the advanced practice registered nurse shall document in the patient record the rationale for prescribed doses exceeding sixteen milligrams of buprenorphine per day. The advanced practice registered nurse shall not prescribe a dose of buprenorphine exceeding twenty-four milligrams per day.

(h) The advanced practice registered nurse shall incorporate relapse prevention strategies into counseling or assure that they are addressed by a qualified behavioral healthcare provider who has the education and experience to provide substance abuse counseling.

(i) The advanced practice registered nurse may treat a patient using the administration of extended-release, injectable, or implanted buprenorphine under the following circumstances:

(i) The advanced practice registered nurse strictly complies with any required risk evaluation and mitigation strategy program for the drug;

(ii) The advanced practice registered nurse shall prescribe an extended-release buprenorphine product strictly in accordance with the FDA's approved labeling for the drug's use;

(iii) The advanced practice registered nurse documents in the patient record the rationale for the use of the extended-release product; and

(iv) The advanced practice registered nurse who orders or prescribes extended-release, injectable, or implanted buprenorphine product shall administer the drug, or require it to be administered by another Ohio licensed health care provider acting in accordance with the scope of their professional license.

(10) If the clinical nurse specialist or certified nurse practitioner is using naltrexone to treat opioid use disorder, the advanced practice registered nurse shall comply with the following additional requirements:

(a) Prior to treating a patient with naltrexone, the advanced practice registered nurse shall inform the patient about the risk of opioid overdose if the patient ceases naltrexone and then uses opioids. The advanced practice registered nurse shall take measures to ensure that the patient is adequately detoxified from opioids and is no longer physically dependent prior to treatment with naltrexone;

(b) The advanced practice registered nurse shall use oral naltrexone only for treatment of patients who can be closely supervised and who are highly motivated;

(i) The dosage regime shall strictly comply with the FDA approved labeling for naltrexone hydrochloride tablets;

(ii) The patient shall be encouraged to have a support person assist with the administration of the medication and supervise the medication. Examples of a support person are a family member, close friend, or employer;

(c) The advanced practice registered nurse shall require urine drug screens or serum medication levels at least every three months for the first year of treatment and at least every six months thereafter;

(d) The advanced practice registered nurse shall incorporate relapse prevention strategies into counseling or assure that they are addressed by a qualified behavioral healthcare or mental health services provider who has eduction and experience to provide substance abuse counseling.

(e) The advanced practice registered nurse may treat a patient with extended-release naltrexone for opioid dependence or for co-occurring opioid and alcohol use disorders.

(i) The advanced practice registered nurse should consider treatment with extended-release naltrexone for patients who have issues with treatment adherence;

(ii) The injection dosage shall strictly comply with FDA labeling for extended-release naltrexone; and

(iii) The advanced practice registered nurse shall incorporate relapse prevention strategies into counseling or assure that they are addressed by a qualified behavioral healthcare provider or mental health services provider who has the education and experience to provide substance abuse counseling.

Effective: 2/1/2019
Five Year Review (FYR) Dates: 10/15/2020
Promulgated Under: 119.03
Statutory Authority: 4723.51 ORC, 4723.50 ORC, 4723.07 ORC
Rule Amplifies: 4723.50 ORC, 4723.51 ORC