Ohio Administrative Code 4730 — State Medical Board - Physician Assistant Licensing

Chapter 4730-1 Regulation of Physician Assistants

Ohio Adm.Code 4730-1-01 Definitions.

(A) For purposes of Chapter 4730. of the Administrative Code:

(1) "On-site supervision" means the supervising physician is required to be physically present in the same location as the physician assistant, but does not require the supervising physician's physical presence in the same room.

(2) "Health care facility" means either of the following:

(a) A hospital registered with the department of health under section 3701.07 of the Revised Code;

(b) A health care facility licensed by the department of health under section 3702.30 of the Revised Code.

(3) "Office-based practice" means medical practice in a location other than a health care facility.

(4) "Service" means a medical function, task, or activity which requires training in the diagnosis, treatment or prevention of disease, including the use and administration of drugs.

(5) "Board" means the state medical board of Ohio.

(6) "Local anesthesia" means the injection of a drug or combination of drugs to stop or prevent a painful sensation in a circumscribed area of the body where a painful procedure is to be performed, and is limited to local infiltration anesthesia, digital blocks, and pudendal blocks. Local anesthesia does not include regional anesthesia or any systemic sedation.

(7) "Medical order" means one or more diagnostic or treatment directives generated by a physician or physician assistant that commands the execution of specific activities to be performed or delivered as part of a diagnostic or therapeutic regimen of a patient.

(8) "CME" means continuing medical education.

(9) "Licensure period" means the period between granting of the initial or renewed license and the next scheduled renewal date for the license.

(B) For purposes of Chapter 4730. of the Revised Code: "Being readily available to the physician assistant through some means of telecommunication and in a location that is a distance from the location where the physician assistant is practicing that reasonably allows the physician to assure proper care of patients" as used in section 4730.21 of the Revised Code means the physician is available to the physician assistant for direct communication via telephone or other real-time electronic, active communication.

Last updated January 30, 2025 at 12:41 PM

History

• Effective: September 30, 2018
• Promulgated Under: 119.03

Ohio Adm.Code 4730-1-05 Quality assurance system.

(A) A quality assurance system shall be developed to assess the physician assistant's performance.

(B) The quality assurance system shall describe the process to be used for all of the following:

(1) Review by the physician of selected patient record entries made by the physician assistant and selected medical orders issued by the physician assistant, to include, at a minimum, all of the following:

(a) Assessment of the medical history and physical examination documented in the record;

(b) Assessment of the appropriateness of the diagnosis and treatment plan based on the medical history and physical examination documented in the record;

(c) Feedback to the physician assistant concerning appropriateness of the physician assistant's prescriptive decisions; and

(d) Assessment of whether the physician assistant is practicing according to the supervisory plan or the policies of the health care facility, as applicable.

(2) Discussion of complex cases;

(3) Discussion of new medical developments relevant to the practice of the physician and physician assistant, including new pharmaceuticals;

(4) Performance of any other quality assurance activities that the supervising physician considers to be appropriate.

(C) The quality assurance assessment shall be conducted at least twice per year during the first year of a physician assistant's practice and at least once per year thereafter.

(D) Each supervising physician and physician assistant shall keep records of their quality assurance activities for at least seven years, and shall make the records available to the board and any health care professional working with the supervising physician and physician assistant.

(E) The quality assurance system developed pursuant to this rule shall not preclude a health care facility or other entity in which physician assistants practice from conducting quality assurance activities involving the assessment of physician assistant performance.

(F) This provision allows, and does not preclude, multiple supervising physicians to assign the quality assurance process to one supervising physician.

Last updated January 30, 2025 at 12:41 PM

History

• Effective: October 31, 2007
• Promulgated Under: 119.03

Ohio Adm.Code 4730-1-06 Licensure as a physician assistant.

(A) All applicants for a physician assistant license shall submit an application under oath in the manner prescribed by the board and provide such other facts and materials as the board requires.

(B) An application shall be considered complete when all of the following requirements are met:

(1) The fee required pursuant to section 4730.10 of the Revised Code has been received by the board;

(2) Verification of the applicant's current certification has been received by the board directly from the "National Commission on Certification of Physician Assistants";

(3) All information required by section 4730.10 of the Revised Code, including such other facts and materials as the board requires, has been received by the board; and

(4) The applicant has complied with the requirements of paragraph (A) of rule 4731-4-02 of the Administrative Code and the board has received the results of the criminal records checks.

(5) The board is not conducting an investigation, pursuant to section 4730.26 of the Revised Code, of evidence appearing to show that the applicant has violated section 4730.25 of the Revised Code or applicable rules adopted by the board.

(C) All application materials submitted to the board will be thoroughly investigated. The board will contact individuals, agencies, or organizations for information about applicants as the board deems necessary. As part of the application process, an applicant may be requested to appear before the board or a representative thereof to answer questions or provide additional information.

(D) Applications received from service members, veterans, or spouses of service members or veterans shall be identified and processed in accordance with rule 4731-36-03 of the Administrative Code.

(E) The following processes apply when an application is not complete within six months of the date the application is filed with the board:

(1) If an applicant fails to complete the application process within six months of initial application filing, the board may notify the applicant in writing of its intention to consider the application abandoned. If no response to that notice is received by the board within thirty days, the board shall consider the application as abandoned and no further processing shall be undertaken with respect to that application.

(2) If the application is not complete because the board is investigating, pursuant to section 4730.26 of the Revised Code, evidence appearing to show that the applicant has violated Chapter 4730. of the Revised Code or applicable rules adopted by the board, the board shall do both of the following:

(a) Notify the applicant that although otherwise complete, the application will not be processed pending completion of the investigation; and

(b) Upon completion of the investigation and the determination that the applicant is not in violation of statute or rule, process the application, including requiring updated information as it deems necessary.

(F) A physician assistant license must be renewed in the manner and according to the requirements of section 4730.14 of the Revised Code.

(G) To qualify for renewal of a physician assistant license, the holder shall comply with the following:

(1) Each applicant for renewal shall certify that the applicant has completed the requisite hours of CME since the start of the licensure registration period.

(2) Except as provided in paragraph (H)(4) of this rule, a physician assistant shall have completed one hundred hours of CME during the licensure registration period.

(3) Pursuant to the provisions of section 4745.04 of the Revised Code, the board shall permit a physician assistant to earn one hour of CME for each sixty minutes spent providing health care services in Ohio, as a volunteer, to indigent and uninsured persons, up to a maximum of thirty-three hours per CME period. Physician assistants seeking to receive credit toward CME requirements shall maintain a log of their qualifying activities. The log shall indicate the dates the health care services were provided, the number of hours spent providing health care services on those dates, the location where the health care services were provided, and the signature of the medical director or the medical director's designee.

(4) Proration of hours required:

(a) If the physician assistant license is initially issued prior to the first day of the second year of a licensure period, the licensee shall be required to earn fifty total hours; if the license is issued on or after the first day of the second year of the licensure period and prior to the first day of the eighteenth month of that licensure period, the licensee shall be required to earn twenty-five total hours; if the license is issued on or after the first day of the eighteenth month of a licensure period, the licensee shall not be required to earn any hours of CME for that licensure period.

(b) Pursuant to the provisions of section 4745.04 of the Revised Code, the board shall permit a physician assistant to earn one hour of CME for each sixty minutes spent providing health care services in Ohio, as a volunteer, to indigent and uninsured persons, when it is documented as required by paragraph (H)(3) of this rule, up to the following maximums:

(i) For a physician assistant required to earn fifty total hours, a maximum of sixteen hours for that CME period.

(ii) For a physician assistant required to earn twenty-five total hours, a maximum of eight hours for that CME period.

(5) Only those hours earned from the date of licensure to the end of the licensure period shall be used towards the total hour requirement as contained in this rule.

(6) Completion of the CME requirement may be satisfied by courses acceptable for the individual to maintain NCCPA certification.

(H) To qualify for renewal of a physician assistant license with a valid prescriber number, the physician assistant shall comply with all of the following requirements:

(1) Completion of the requirements in paragraph (G) of the rule;

(2) Except as provided in paragraph (H)(4) of this rule, completion of at least twelve hours of category I continuing education in pharmacology.

(3) If the physician assistant prescribes opioid analgesics or benzodiazepines, the applicant for renewal shall certify having been granted access to OARRS, unless one of the exemptions in section 4730.49 of the Revised Code is applicable.

(4) If the renewal of the license with a valid prescriber number is the first renewal after the holder has completed the five hundred hours of on site supervision required by section 4730.44 of the Revised Code, the requisite hours of pharmacology continuing education are as follows:

(a) If the five hundred hours were completed prior to the first day of the second year of the licensure period, the licensee shall be required to earn six total hours of pharmacology continuing education;

(b) If the five hundred hours were completed on or after the first day of the second year of the licensure period and prior to the eighteenth month of that licensure period, the licensee shall be required to earn three total hours;

(c) If the five hundred hours were completed on or after the first day of the eighteenth month of a licensure period, the licensee shall not be required to earn any hours of pharmacology continuing education for that licensure period.

Last updated November 4, 2025 at 2:14 PM

History

• Effective: October 31, 2025
• Promulgated Under: 119.03

Ohio Adm.Code 4731-36-03

(A) The board shall include questions on all applications for licensure, renewal, reinstatement or restoration of licensure for all applicants for licensure or certificate to practice pursuant to Chapters 4730., 4731., 4759., 4761., 4762., 4774., and 4778. that inquire as to whether the applicant is:

(1) A service member;

(2) A veteran; or

(3) The spouse or surviving spouse of a service member or veteran.

(B) If the applicant for licensure, biennial renewal, reinstatement, or restoration of licensure responds affirmatively to any of the questions discussed in paragraph (A) of this rule, the board shall process the application in the following manner:

(1) Route the application to a board staff member who is responsible for monitoring the application and communicating with the applicant regarding the status of the application, including informing the applicant of any documentation needed for the board to process the application;

(2) Expedite the processing of the application, even if the application was received later in time than other applications that are pending processing;

(3) Provide information regarding available continuing education waivers to applicants if the applicant or the applicant's spouse will be imminently deployed; and

(4) Track, on an annual basis, the total number of applications submitted by service members, veterans, spouses or surviving spouses of service members or veterans, and the average number of business days expended by the board to process those applications.

Last updated November 19, 2025 at 11:21 AM

History

• Effective: December 31, 2020
• Promulgated Under: 119.03

Ohio Adm.Code 4730-1-07 Miscellaneous provisions.

For purposes of Chapter 4730. of the Revised Code and Chapters 4730-1 and 4730-2 of the Administrative Code:

(A) An adjudication hearing held pursuant to the provisions of Chapter 119. of the Revised Code shall be conducted in conformance with the provisions of Chapter 4731-13 of the Administrative Code.

(B) The provisions of Chapters 4731-4, 4731-11, 4731-13, 4731-14, 4731-15, 4731-16, 4731-17, 4731-18, 4731-23, 4731-25, 4731-26, 4731-28, 4731-29, 4731-35, 4731-37 and rule 4731 38-02 of the Administrative Code are applicable to the holder of a physician assistant license issued pursuant to section 4730.12 of the Revised Code, as though fully set forth in Chapter 4730-1 or 4730-2 of the Administrative Code.

Last updated November 30, 2023 at 8:26 AM

History

• Effective: November 30, 2023
• Promulgated Under: 119.03

Chapter 4730-2 Physician-Delegated Prescriptive Authority

Ohio Adm.Code 4730-2-01 Definitions.

As used in Chapter 4730-2 of the Administrative Code:

(A) "ARC-PA" means the "Accreditation Review Commission on Education for the Physician Assistant."

(B) "CHEA" means the "Council for Higher Education Accreditation."

(C) "AAPA" means the "American Academy of Physician Assistants."

(D) "NCCPA" means the "National Commission on Certification for Physician Assistants."

(E) "CME" means continuing medical education.

(F) "ACCME" means the "Accreditation Council for Continuing Medical Education."

(G) "Contact hour" means a minimum of fifty minutes of education.

(H) "Licensure registration period" means the period between granting of the initial or renewed license and the next scheduled renewal date for the license.

(I) "Board" means the state medical board of Ohio.

Last updated June 22, 2026 at 7:50 AM

History

• Effective: September 30, 2018
• Promulgated Under: 119.03

Ohio Adm.Code 4730-2-04 Period of on-site supervision of physician-delegated prescriptive authority.

(A) The following definitions are applicable to this rule:

(1) "Supervision" means the supervising physician maintains oversight of the physician assistant's prescriptive decisions and provides timely review of prescriptions written by the physician assistant.

(2) "On-site supervision" means the supervising physician is required to be physically present within the facility where the physician assistant is practicing and available for consultation. The supervising physician is not necessarily required to personally evaluate a patient to whom a physician assistant is providing service.

(3) "Supervising physician" includes a primary supervising physician in instances where the physician assistant has supervision agreements with multiple supervising physicians and one supervising physician is designated to have primary responsibility for the supervision of the physician assistant's prescribing activities during the on-site supervision period.

(B) Except as provided in division (B) of section 4730.44 of the Revised Code, the first five hundred hours of a physician assistant's exercise of physician-delegated prescriptive authority shall be under the on-site supervision of a supervising physician with whom the physician assistant has a supervision agreement.

(1) The supervising physician shall review and evaluate the physician assistant's competence, knowledge, and skill in pharmacokinetic principles and the application of these principles to the physician assistant's area of practice. The supervising physician shall document the review and evaluation by signing patient charts in a legible manner or documenting the review and evaluation by the use of an electronically generated signature provided that reasonable measures have been taken to prevent the unauthorized use of the electronically generated signature.

(2) The supervising physician shall maintain a record evidencing that the physician assistant has completed at least five hundred hours of on-site supervision and make the record available to the board upon request.

(C) On-site supervision period hours completed may be transferred to an on-site supervision period under a subsequent supervising physician pursuant to the following criteria:

(1) Hours completed may be transferred, not more than one time, when both of the following criteria are met:

(a) The initial supervising physician provides written verification of the activities and number of hours successfully completed by the physician assistant during the period; and

(b) The subsequent supervising physician approves the transfer of the period hours.

(2) Hours completed under the supervision of the subsequent supervising physician may be transferred to an on-site supervision period under a third supervising physician only upon the board's approval when all of the following conditions are met:

(a) The subsequent supervising physician provides both of the following:

(i) Written verification of the activities and number of hours successfully completed during the period to date; and

(ii) Written explanation of why the transfer of hours is being requested;

(b) The third supervising physician approves the transfer of the hours;

(c) The failure to transfer the hours would result in undue hardship to the physician assistant; and

(d) The granting of the transfer would not jeopardize patient care.

(D) Where the exemption of division (B) of section 4730.44 of the Revised Code is claimed, the supervising physician shall maintain documentation establishing that the physician assistant practiced with prescriptive authority in the other jurisdiction for not less than one thousand hours. The documentation may include a letter from one or more physicians who supervised the physician assistant's prescribing in that jurisdiction verifying that the physician assistant practiced with prescriptive authority in that jurisdiction for not less than one thousand hours or a letter from an appropriate facility administrator verifying that the physician assistant practiced with prescriptive authority for not less than one thousand hours based upon documentation in the physician assistant's personnel file.

Last updated August 14, 2025 at 10:12 AM

History

• Effective: September 30, 2020
• Promulgated Under: 119.03

Ohio Adm.Code 4730-2-05 Addition of valid prescriber number after initial licensure.

(A) All applicants for a prescriber number subsequent to initial licensure shall submit an endorsement application in the manner determined by the board.

(B) An endorsement application shall be considered complete when all of the following requirements are met:

(1) The records of the board establish that the applicant holds a current, valid license to practice as a physician assistant in Ohio;

(2) All information required by section 4730.15 of the Revised Code, including evidence of meeting the educational requirements or practice requirements, as applicable, has been received by the board;

Last updated August 14, 2025 at 10:25 AM

History

• Effective: September 30, 2020
• Promulgated Under: 119.03

Ohio Adm.Code 4730-2-07 Standards for prescribing.

(A) A physician assistant who holds a prescriber number and who has been granted physician-delegated prescriptive authority by a supervising physician may prescribe a drug or therapeutic device provided the prescription is in accordance with all of the following:

(1) The extent and conditions of the physician-delegated prescriptive authority, granted by the supervising physician who is supervising the physician assistant in the exercise of the authority;

(2) The requirements of Chapter 4730. of the Revised Code;

(3) The requirements of Chapters 4730-1, 4730-2, 4730-4, 4731-11, 4731-35, and 4731-37 of the Administrative Code; and

(4) The requirements of state and federal law pertaining to the prescription of drugs and therapeutic devices.

(B) A physician assistant who holds a prescriber number who has been granted physician-delegated prescriptive authority by a supervising physician shall prescribe in a valid prescriber-patient relationship. This includes, but is not limited to:

(1) Obtaining a thorough history of the patient;

(2) Conducting a physical examination of the patient;

(3) Rendering or confirming a diagnosis;

(4) Prescribing medication, ruling out the existence of any recognized contraindications;

(5) Consulting with the supervising physician when necessary; and

(6) Properly documenting these steps in the patient's medical record.

(C) The physician assistant's prescriptive authority shall not exceed the prescriptive authority of the supervising physician under whose supervision the prescription is being written, including but not limited to, any restrictions imposed on the physician's practice by action of the United States drug enforcement administration or the state medical board of Ohio.

(D) A physician assistant holding a prescriber number and who has been granted physician-delegated prescriptive authority by a supervising physician to prescribe controlled substances shall apply for and obtain the United States drug enforcement administration registration prior to prescribing any controlled substances.

(E) A physician assistant holding prescriber number and who has been granted physician-delegated prescriptive authority by a supervising physician shall not prescribe any drug or device to perform or induce an abortion.

(F) A physician assistant holding prescriber number and who has been granted physician-delegated prescriptive authority by a supervising physician shall include on each prescription the physician assistant's license number, and, where applicable, shall include the physician assistant's DEA number.

Last updated February 28, 2023 at 8:52 AM

History

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

Ohio Adm.Code 4730-2-10 Standards and procedures for review of "Ohio Automated Rx Reporting System" (OARRS).

(A) For 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 the physician assistant.

(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) "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 section 4729.75 of the Revised Code, including controlled substances in schedules II, III, IV, and V.

(B) Standards of care:

(1) The accepted and prevailing minimal standards of care require that when prescribing a reported drug, a physician assistant shall take into account all of the following:

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

(b) The possibility that use of the reported drug may lead to dependence;

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

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

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

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

(1) A physician assistant shall obtain and review an OARRS report before prescribing an opioid analgesic or benzodiazepine to a patient, unless an exception listed in paragraph (H) of this rule is applicable.

(2) A physician assistant 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 (H) of this rule is applicable.

(3) A physician assistant shall obtain and review and 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 screen result that is inconsistent with the treatment plan or refusing to participate in a drug screen;

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

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

(i) Traveling with a group of other patients to the physician assistant'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 physician assistant'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) A physician assistant 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 the opioid analgesic, benzodiazepine, or other reported drug:

(1) Review and document in the patient record the reasons why the physician assistant 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 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) Frequency for follow-up OARRS reports:

(1) For a patient whose treatment with an opioid analgesic or benzodiazepine lasts more than ninety days, a physician assistant 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 physician assistant 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 (H) of this rule is applicable.

(F) When a physician assistant or their delegate requests an OARRS report in compliance with this rule, a physician assistant shall document receipt and review 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 physician assistant practices primarily in a county of this state that adjoins another state, the physician assistant 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 physician assistant 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) Review of the physician assistant's compliance with this rule shall be included as an activity in the quality assurance plan required by division (F) of section 4730.21 of the Revised Code and rule 4730-1-05 of the Administrative Code.

(H) A physician assistant shall not be required to review and assess an OARRS report when prescribing an opioid analgesic, benzodiazepine, or other reported drug under the following circumstances, unless a physician assistant believes or has reason to believe that a patient may be abusing or diverting reported drugs:

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

(4) The reported drug is prescribed for the treatment of cancer or another condition associated with cancer.

Last updated August 14, 2025 at 10:26 AM

History

• Effective: September 30, 2020
• Promulgated Under: 119.03

Ohio Adm.Code 4730-1-05

(A) A quality assurance system shall be developed to assess the physician assistant's performance.

(B) The quality assurance system shall describe the process to be used for all of the following:

(1) Review by the physician of selected patient record entries made by the physician assistant and selected medical orders issued by the physician assistant, to include, at a minimum, all of the following:

(a) Assessment of the medical history and physical examination documented in the record;

(b) Assessment of the appropriateness of the diagnosis and treatment plan based on the medical history and physical examination documented in the record;

(c) Feedback to the physician assistant concerning appropriateness of the physician assistant's prescriptive decisions; and

(d) Assessment of whether the physician assistant is practicing according to the supervisory plan or the policies of the health care facility, as applicable.

(2) Discussion of complex cases;

(3) Discussion of new medical developments relevant to the practice of the physician and physician assistant, including new pharmaceuticals;

(4) Performance of any other quality assurance activities that the supervising physician considers to be appropriate.

(C) The quality assurance assessment shall be conducted at least twice per year during the first year of a physician assistant's practice and at least once per year thereafter.

(D) Each supervising physician and physician assistant shall keep records of their quality assurance activities for at least seven years, and shall make the records available to the board and any health care professional working with the supervising physician and physician assistant.

(E) The quality assurance system developed pursuant to this rule shall not preclude a health care facility or other entity in which physician assistants practice from conducting quality assurance activities involving the assessment of physician assistant performance.

(F) This provision allows, and does not preclude, multiple supervising physicians to assign the quality assurance process to one supervising physician.

Last updated January 30, 2025 at 12:41 PM

History

• Effective: October 31, 2007
• Promulgated Under: 119.03

Chapter 4730-4 Opioid Addiction Treatment

Ohio Adm.Code 4730-4-01 Definitions.

(A) "Office-based opioid treatment" or "OBOT" means pharmacotherapy, in a private office or public sector clinic that is not otherwise regulated by practitioners authorized to prescribe outpatient supplies of medications approved by the United States food and drug administration for the treatment of opioid use disorder. OBOT includes treatment with all controlled substance medications approved by the United States food and drug administration for such treatment. OBOT does not include treatment that occurs in the following settings:

(1) A state or local correctional facility, as defined in section 5163.45 of the Revised Code;

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

(3) 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;

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

(5) A youth services facility, as defined in section 103.75 of the Revised Code; and

(6) An emergency medical services agency as authorized under Chapter 4729. of the Revised Code.

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

(C) "Addiction specialist physician" means a physician who holds one of the following medical subspecialty certifications:

(1) Subspecialty board certification in addiction medicine by the American board of preventative medicine ("ABPM");

(2) Subspecialty board certification in addiction psychiatry by the American board of psychiatry and neurology ("ABPN");

(3) Subspecialty board certification in addiction medicine by the American osteopathic association ("AOA"); or

(4) Certification by the American board of addiction medicine ("ABAM")

(D) "Medications for Opioid Use Disorder or MOUD" refers to all medications approved by the United States food and drug administration for the treatment of opioid use disorder.

(E) "Substance use disorder" indicates a problematic pattern of substance use leading to clinically significant impairment or distress, as determined by application of the diagnostic criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition-Text Revision" or "DSM-5-TR."

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

(G) For purposes of the rules in this chapter:

(1) "Qualified behavioral healthcare provider" means the following healthcare providers practicing within the scope of the professional license:

(a) Addiction medicine specialist physician or board certified psychiatrist, licensed under Chapter 4731. of the Revised Code;

(b) Psychologist, as defined in division (A) of section 4732.01 of the Revised Code, licensed under Chapter 4732. of the Revised Code;

(c) Licensed independent chemical dependency counselor-clinical supervisor, licensed independent chemical dependency counselor, licensed chemical dependency counselor III, licensed chemical dependency counselor II, or licensed chemical dependency counselor assistant licensed under Chapter 4758. of the Revised Code;

(d) 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;

(e) Advanced practice registered nurse, licensed as a clinical nurse specialist under Chapter 4723. of the Revised Code, who holds certification as a psychiatric mental health clinical nurse specialist issued by the American nurses credentialing center;

(f) Advanced practice registered nurse, licensed as a nurse practitioner under Chapter 4723. of the Revised Code, who holds certification as a psychiatric mental health nurse practitioner issued by the American nurses credentialing center; and

(g) Advanced practice registered nurse, licensed under Chapter 4723. of the Revised Code, who holds subspecialty certification as a certified addiction registered nurse-advanced practice issued by the addictions nursing certification board.

(2) Nothing in this paragraph shall be construed to prohibit a physician assistant licensed under Chapter 4730. of the Revised Code who practices under a supervision agreement with a board certified addiction psychiatrist, board certified addiction medicine specialist, or psychiatrist who is licensed as a physician under Chapter 4731. of the Revised Code, from providing services within the normal course of practice and expertise of the supervising physician, including addiction services, other mental health services, and physician delegated prescriptive services in compliance with Ohio and federal laws and rules.

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

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

(J) "Induction phase" means the phase of MOUD during which the patient is started on an FDA-approved medication for substance use disorder treatment.

(K) "Stabilization phase" means the period of time following the induction phase, when medication doses are adjusted to target a reduction in substance use disorder symptoms.

(L) "Maintenance phase" means the ongoing period of time when the patient's medication dose reaches a therapeutic level, allowing the patient to focus on other recovery activities.

(M) "Withdrawal management" is a set of medical interventions aimed at managing the acute physical symptoms of intoxication and withdrawal. Withdrawal management occurs when the patient has a substance use disorder and either evidence of the characteristic withdrawal syndrome produced by withdrawal from that substance, or evidence that supports the expectation that such a syndrome would develop without the provision of medical withdrawal management services. Withdrawal management alone does not constitute completed substance use disorder treatment or rehabilitation.

(N) "Ambulatory withdrawal management" means withdrawal management delivered in a medical office, public sector clinic, or urgent care facility by trained practitioners authorized to prescribe outpatient supplies of drugs approved by the United States food and drug administration for the treatment of substance use disorder. Ambulatory withdrawal management is the provision of medically supervised evaluation, treatment, and referral services without extended onsite monitoring. For purpose of rule 4730-4-02 of the Administrative Code, ambulatory withdrawal management does not include withdrawal management that occurs in the following settings:

(1) A state or local correctional facility, as defined in section 5163.45 of the Revised Code;

(2) In-patient treatment in a hospital, as defined in section 3727.01 of the Revised Code;

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

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

(5) A youth services facility, as defined in section 103.75 of the Revised Code; and

(6) An emergency medical services agency as authorized under Chapter 4729. of the Revised Code.

Last updated October 31, 2024 at 8:45 AM

History

• Effective: October 31, 2024
• Promulgated Under: 119.03

Ohio Adm.Code 4730-4-02

(A) In order to provide ambulatory withdrawal management, as that term is defined in rule 4730-4-01 of the Administrative Code, a physician assistant shall comply with the following requirements:

(1) The physician assistant shall hold a valid prescriber number;

(2) The physician assistant shall provide withdrawal management under the supervision of a physician who provides withdrawal management as part of the physician's normal course of practice and with whom the physician assistant has a supervision agreement;

(3) The physician assistant shall comply with all state and federal laws and rules applicable to prescribing; and

(4) The physician assistant who practices in a healthcare facility shall comply with all policies of the healthcare facility concerning the provision of withdrawal management.

(B) Prior to providing ambulatory withdrawal management for any substance use disorder the physician assistant shall inform the patient that ambulatory withdrawal management alone is not complete treatment for a substance use disorder. If the patient prefers continuing treatment for a substance use disorder, the physician assistant shall comply with the requirements of section 3719.064 of the Revised Code.

(C) The physician assistant shall provide accurate, objective and complete documentation of all patient encounters, including referrals, test results, and significant changes to the treatment plan.

(D) When providing withdrawal management for opioid use disorder a physician assistant may be authorized to use a medical device that is approved by the United States food and drug administration as an aid in the reduction of opioid withdrawal symptoms.

(E) Ambulatory withdrawal management for opioid use disorder.

(1) The physician assistant shall provide ambulatory withdrawal management only when the following conditions are met:

(a) The patient has adequate social, medical, and psychiatric stability to engage in and safely complete ambulatory withdrawal management; and

(b) There is little risk of medication diversion.

(2) The physician assistant shall provide ambulatory withdrawal management under a defined set of policies and procedures or medical protocols, with patient placement in outpatient or residential settings consistent with American society of addiction medicine's level of care criteria. Such services are designed to treat the patient's level of clinical severity, to achieve safe and comfortable withdrawal from a drug, and to effectively facilitate the patient's transition into treatment and recovery. In the event that ambulatory withdrawal management is unsafe or inappropriate for a patient, referral to a higher level of care, such as inpatient hospitalization shall be completed. The ASAM criteria can be obtained from the website of the American society of addiction medicine at https://www.asam.org/. A copy of the ASAM criteria may be reviewed at the medical board office, 30 East Broad street, third floor, Columbus, Ohio, during normal business hours.

(3) Prior to providing ambulatory withdrawal management, the physician assistant shall perform an assessment of the patient to gather sufficient information and data to justify the use of this treatment intervention. The assessment shall include a thorough medical history and physical examination sufficient to assure safety in commencing ambulatory withdrawal management and shall include a review of the patient's prescription history in OARRS. The assessment must focus on signs and symptoms associated with opioid use disorder and include assessment with a nationally recognized scale, such as one of the following:

(a) "Objective Opioid Withdrawal Scale" (OOWS);

(b) "Clinical Opioid Withdrawal Scale" (COWS); or

(c) "Subjective Opioid Withdrawal Scale" (SOWS).

(4) If any part of the assessment cannot be completed prior to the initiation of treatment, the physician assistant shall complete as soon as possible following initiation of treatment.

(5) The physician assistant shall inform the patient about the following before treatment for opioid withdrawal is initiated:

(a) The withdrawal management process and importance of subsequent treatment for substance use disorder, including information about all medications approved by the United States food and drug administration for use in MOUD treatment;

(b) The risk of relapse and lethal overdose following completion of withdrawal without entry into continuation of MOUD treatment;

(c) The safe storage and disposal of prescribed medications.

(6) The physician assistant shall not establish standardized regimens of medications for management of substance withdrawal symptomatology but shall formulate an individualized treatment plan based on the needs of the specific patient.

(7) For persons projected to be involved in withdrawal management for six months or less, the physician assistant shall offer the patient counseling as described in paragraph (D) of rule 4730-4-03 of the Administrative Code.

(8) The physician assistant shall require the patient to undergo urine and/or other toxicological screenings during withdrawal management in order to assess for use of licit and/or illicit drugs. The physician assistant shall consider revising the treatment plan or referring a patient who has a positive toxicological screening result to a higher level of care, and shall confer with the supervising physician prior to prescribing the buprenorphine/naloxone combination product to the patient.

(9) The physician assistant shall comply with the following requirements for the use of medication:

(a) The physician assistant may treat the patient's withdrawal symptoms with any of the following medications as determined to be most appropriate for the patient.

(i) A medication that is specifically FDA approved for the alleviation of withdrawal symptoms. Methadone may only be utilized with strict adherence to the stipulations of 21 C.F.R. 1306.07(b).

(ii) An alpha-2 adrenergic agent along with other non-narcotic medications as recommended in the American society of addiction medicine's "National Practice Guideline" (https://www.asam.org/), which is available from the medical board's website at https://med.ohio.gov;

(iii) A combination of buprenorphine and low dose naloxone (buprenorphine/naloxone combination product), unless contraindicated, in which case buprenorphine mono-product may be utilized.

(b) The physician assistant shall not use anesthetic agents to treat the patient's withdrawal symptoms.

(c) The physician assistant shall comply with the following:

(i) Treatment with a buprenorphine product must be in compliance with the United States food and drug administration approved "Risk Evaluation and Mitigation Strategy" for buprenorphine products, which can be found on the United States food and drug administration website at the following address: https://www.accessdata.fda.gov/scripts/cder/rems/index.cfm.

(ii) The physician assistant shall determine on an individualized basis the appropriate dosage of medication to ensure stabilization during withdrawal management.

(a) The dosage level shall be that which is effective in suppressing withdrawal symptoms and is well tolerated by the patient.

(b) The dosage level shall be consistent with the currently accepted standards of care.

(iii) In withdrawal management programs of thirty days or less duration, the physician assistant shall not prescribe nor dispense more than one week of unsupervised or take-home medications for the patient.

(10) The physician assistant shall offer the patient a prescription for an overdose reversal drug, directly provide them with the overdose reversal drug, or direct the patient to an easily accessible source to obtain the overdose reversal drug, such as http://www.naloxone.ohio.gov, a local health department, or other agency or facility that provides overdose reversal drugs.

(a) The physician assistant shall ensure that the patient and, if possible, those residing with the patient receive instruction on the drug's use including, but not limited to, recognizing the signs and symptoms of overdose and calling 911 in an overdose situation.

(b) The physician assistant shall offer the patient a new prescription for an overdose reversal drug upon expiration or use.

(c) The physician assistant shall be exempt from this requirement if the patient refuses the prescription. If the patient refuses the prescription the physician assistant shall provide the patient with information on where to obtain the overdose reversal drug without a prescription.

(11) The physician assistant shall take steps to reduce the risk of medication diversion by doing one or more of the following: frequent office visits, pill counts, urine drug screening, and frequent checks of OARRS.

(F) The physician assistant who provides ambulatory withdrawal management for benzodiazepines or other sedatives shall comply with paragraphs (A), (B), and (C) of this rule and "TIP 45, A Treatment Improvement Protocol for Detoxification and Substance Abuse Treatment" by the substance abuse and mental health services administration available from the substance abuse and mental health services administration website at the following link: https://store.samhsa.gov/. (Search for "TIP 45") and available on the medical board's website at: https://med.ohio.gov.

(1) The physician assistant shall provide ambulatory withdrawal management for benzodiazepines with medication only when a patient has sufficient social, medical, and psychiatric stability when their use of benzodiazepines was primarily in therapeutic dose ranges and when they do not have polysubstance dependence. The patient should exhibit no more than mild to moderate withdrawal symptoms, have no comorbid medical condition or severe psychiatric disorder, and no history of withdrawal seizures or withdrawal delirium.

(2) Prior to providing ambulatory withdrawal management, the physician assistant shall perform an assessment of the patient that focuses on signs and symptoms associated with benzodiazepine or other sedative use disorder and include assessment with a nationally recognized scale, such as the "Clinical Institute Withdrawal Assessment for Benzodiazepines" ("CIWA-B").

(3) Prior to providing ambulatory withdrawal management, the physician assistant shall conduct and document a biomedical and psychosocial evaluation of the patient to gather sufficient information and data to justify the use of this treatment intervention.

(4) The physician assistant shall instruct the patient about the following before treatment for benzodiazepine withdrawal management is initiated:

(a) Not to drive or operate dangerous machinery during treatment;.

(b) The withdrawal management process and importance of subsequent treatment for substance use disorder, including information about all medications approved by the United States food and drug administration for use in substance use disorder treatment;

(c) The risk of relapse and lethal overdose following completion of withdrawal without entry into continuation of treatment for substance use disorder; and

(d) The safe storage and disposal of prescribed medications.

(5) During the ambulatory withdrawal management, the physician assistant shall regularly assess the patient so that medication dosage can be adjusted if needed.

(a) The physician assistant shall require the patient to undergo urine and/or other toxicological screenings during withdrawal management in order to assess for the use of licit and/or illicit drugs.

(b) The physician assistant shall consider revising the treatment plan or referring the patient who has a positive toxicology screening to a higher level of care.

(c) The physician assistant shall take steps to reduce the chances of diversion by doing one or more of the following: frequent office visits, pill counts, urine drug screening, and frequent checks of OARRS.

(G) The physician assistant who provides ambulatory withdrawal management for withdrawal from alcohol addiction shall comply with paragraphs (A), (B), and (C) of this rule and "Clinical Practice Guideline on Alcohol Withdrawal Management" by the American society of addiction medicine available from the American society of addiction medicine website at the following link: http://www.asam.org/quality-care/clinical-guidelines/alcohol-withdrawal- management-guideline.

(1) The physician assistant shall provide ambulatory withdrawal from alcohol only when:

(a) The patient has sufficient social, medical, and psychiatric stability to adhere to prescribed treatments and successfully complete withdrawal with minimal risk of complications;

(b) The patient is not at risk for serious withdrawal from substances other than alcohol; and

(c) The patient has no history of withdrawal seizures or withdrawal delirium.

(2) Prior to providing ambulatory withdrawal management, the physician assistant shall perform an assessment of the patient. The assessment must focus on signs and symptoms associated with alcohol use disorder and include assessment with a nationally recognized scale, such as the "Clinical Institute Withdrawal Assessment for Alcohol-revised" ("CIWA-AR").

(3) Prior to providing ambulatory withdrawal management, the physician assistant shall perform a biomedical and psychosocial evaluation to gather sufficient information and data to justify the use of this treatment intervention.

(4) During the ambulatory withdrawal management, the physician assistant shall regularly assess the patient so that the dosage can be adjusted if needed.

(a) The physician assistant shall require the patient to undergo toxicological screenings in order to assess for the presence of alcohol metabolites, licit or illicit drugs;

(b) The physician assistant shall consider revising the treatment plan or referring a patient who has a positive toxicological screening test to a higher level of care; and

(c) The physician assistant shall take steps to reduce the risk of diversion by doing one or more of the following: frequent office visits, pill counts, urine drug screening, and frequent checks of OARRS.

Last updated October 31, 2024 at 8:45 AM

History

• Effective: October 31, 2024
• Promulgated Under: 119.03

Ohio Adm.Code 4730-4-03

(A) A physician assistant who provides office-based opioid treatment ("OBOT") shall comply with the following requirements:

(1) Before initiating OBOT, the physician assistant shall comply with section 3719.064 of the Revised Code.

(2) Comply with all federal and state laws and regulations governing the prescribing of the medication;

(3) Complete at least eight hours of "Category 1" continuing medical education relating to substance use disorder and addiction every two years. Courses completed in compliance with this requirement shall be accepted toward meeting the continuing medical education requirement for biennial renewal of the physician assistant's license;

(4) Only provide OBOT if the provision of OBOT is within the supervising physician's normal course of practice and expertise;

(5) The physician assistant who provides OBOT shall perform an assessment of the patient to gather sufficient information and data to justify the use of this treatment intervention. The assessment shall include a thorough medical history, examination, and laboratory testing. If any part of the assessment cannot be completed prior to the initiation of OBOT, the physician assistant shall complete as soon as possible following initiation of treatment; and

(6) The physician assistant shall provide accurate, objective, and complete documentation of all patient encounters, including referrals, test results, and significant changes to the treatment plan.

(B) The physician assistant who provides OBOT shall establish a treatment plan that includes the following:

(1) The physician assistant's rationale for selection of the specific drug to be used in the treatment based upon discussion of all MOUDs and non-medication options with the patient;

(2) Patient education;

(3) Random urine-drug screens;

(4) A signed treatment agreement that outlines the responsibilities of the patient and the physician assistant, and documents the patient's consent for treatment;

(5) Documentation regarding psychosocial intervention, pursuant to paragraph (D) of this rule; and

(6) The treatment plan shall be revised if the patient does not show improvement with the original plan.

(C) The physician assistant shall provide OBOT in accordance with an acceptable treatment protocol for assessment, induction, stabilization, maintenance, and tapering. Acceptable protocols are any of the following:

(1) TIP 63 "Medications for Opioid Use Disorder" (2021) available from the https://store.samhsa.gov/product/TIP-63-Medications-for-Opioid-Use-Disorder- Full-Document/PEP21-02-01-002.

(2) "ASAM National Practice Guideline for the Treatment of Opioid Use Disorder: 2020 Focused Update" available from the website of the American society of addiction medicine at: https://www.asam.org/quality-care/clinical-guidelines/national-practice-guideline.

(D) The physician assistant shall do the following with respect to psychosocial treatment for patients receiving OBOT:

(1) Assess for psychosocial treatment needs in addition to medication;

(2) Offer psychosocial interventions or referrals for psychosocial interventions to all patients, but OBOT should not be declined or discontinued if the patient is unable or unwilling to engage in psychosocial interventions;

(3) Ensure that psychosocial interventions are person-centered and tailored to the patient's insight, motivation, and stage of recovery;

(4) Focus the psychosocial interventions on retaining the patient in treatment, stabilizing the patient and assisting with progress in the patient's treatment and recovery;

(5) If the psychosocial interventions are not available or if the patient declines to participate, the physician assistant shall continue to treat the patient with OBOT provided that the patient adheres to all other treatment requirements;

(6) Psychosocial treatment or intervention includes the following:

(a) Cognitive behavioral treatment;

(b) Community reinforcement approach;

(c) Contingency management and motivational incentives;

(d) Motivational interviewing;

(e) Behavioral couples counseling;

(f) Twelve-step facilitation; and

(g) Other therapies based on the patient's individual needs;

(7) When necessary, the physician assistant may make referrals for psychosocial treatment to qualified behavioral healthcare providers, community addiction services or community mental health services providers as defined in rule 4730-4-01 of the Administrative Code; and

(8) The physician assistant may also refer patients for treatment with non-licensed paraprofessionals such as case managers and peer support specialists if the physician assistant determines such intervention would benefit the patient.

(E) The physician assistant who provides OBOT shall offer the patient a prescription for an overdose reversal drug, directly provide the patient with the overdose reversal drug, or direct the patient to an easily accessible source to obtain overdose reversal drugs, such as http://www.naloxone.ohio.gov, a local health department, or other agency or facility that provides overdose reversal drugs.

(1) The physician assistant shall ensure that the patient and, if possible, those residing with the patient, receive instruction on the overdose reversal drug's use including, but not limited to, recognizing the signs and symptoms of opioid overdose and calling 911 in an overdose situation.

(2) The physician assistant shall offer the patient a new prescription for an overdose reversal drug upon expiration or use.

(3) The physician assistant shall be exempt from this requirement if the patient refuses the prescription. If the patient refuses the prescription the physician assistant shall provide the patient with information on where to obtain overdose reversal drugs without a prescription.

(F) In addition to paragraphs (A) to (E) of this rule, the physician assistant who provides OBOT using buprenorphine products shall comply with the following requirements:

(1) Treatment with a buprenorphine product must be in compliance with the United States food and drug administration approved "Risk Evaluation and Mitigation Strategy" for buprenorphine products, which can be found on the United States food and drug administration website at the following address: https://www,accessdata.fda.gov/scripts/cder/rems/index.cfm. With the exception of those conditions listed in paragraph (G)(2) of this rule, a physician assistant who treats opioid use disorder with a buprenorphine product shall only prescribe buprenorphine/naloxone combination products for use in OBOT.

(2) The physician assistant may prescribe buprenorphine without naloxone (buprenorphine mono-product) only in the following situations:

(a) When a patient is pregnant or breast-feeding;

(b) When converting a patient from buprenorphine mono-product to buprenorphine/naloxone combination product;

(c) In formulations other than tablet or film form for indications approved by the United States food and drug administration; or

(d) When the patient has a genuine allergy to or intolerance of a buprenorphine/naloxone combination product.

(3) Due to a higher risk of fatal overdose when buprenorphine is prescribed with other opioids, benzodiazepines, sedative hypnotics, carisoprodol, gabapentin, or tramadol, the physician assistant shall only co-prescribe these substances when it is medically necessary.

(a) The physician assistant shall verify the diagnosis for which the patient is receiving the other drug and coordinate care with the prescriber for the other drug, including whether acceptable alternative treatments are available and whether it is possible to lower the dose or discontinue the drug. If the physician assistant prescribing buprenorphine is the prescriber of the other drug, the physician assistant shall also consider these options and consider consultation for another healthcare provider. The physician assistant shall educate the patient about the serious risks of the combined use.

(b) The physician assistant shall document the rationale for discontinuing, lowering, or continuing the medication given potential risks and benefits.

(4) During the induction phase the physician assistant shall not prescribe a dosage that exceeds the recommendation in the United States food and drug administration approved labeling, except for medically indicated circumstances as documented in the medical record. The physician assistant shall see the patient at least once a week during this phase.

(5) During the maintenance phase, the physician assistant shall prescribe a dosage of buprenorphine that avoids intoxication or sedation, prevents withdrawal, and suppresses significant drug craving. For the first twelve months of treatment, the physician assistant shall prescribe no more than a one-month supply of the buprenorphine product unless utilizing a formulation with duration of action exceeding one month, such as injections or implants.

(6) The physician assistant shall reduce the risk of buprenorphine diversion by using the lowest effective dose, and by using one or more of the following: scheduling appropriate frequency of office visits, conducting random pill counts, and checking OARRS and utilizing drug testing, serum medication levels, and oral fluid testing to assess for patient adherence to prescribed buprenorphine treatment.

(7) When using any sublingual formulation of buprenorphine, the physician assistant shall not prescribe a dosage exceeding twenty-four milligrams of buprenorphine per day, unless the physician assistant obtains a consultation from a addiction specialist physician recommending the higher dose. Dosage shall not exceed thirty-two milligrams of buprenorphine per day.

(8) The physician assistant shall incorporate relapse prevention strategies into the counseling or assure that they are addressed by a qualified behavioral healthcare provider, as defined in rule 4730-4-01 of the Administrative Code, who has the education and experience to provide substance use disorder counseling.

(9) The physician assistant may treat a patient using the administration of an extended-release, injectable, or implanted buprenorphine product.

(a) The physician assistant shall strictly comply with any required risk evaluation and mitigation strategy for the drug.

(b) The physician assistant shall prescribe an extended-release buprenorphine product strictly in accordance with the United States food and drug administration's approved labeling for the drug's use.

(c) The physician assistant shall document in the patient record the rationale for the use of the extended-release buprenorphine product.

(d) The physician assistant who orders or prescribes an extended release, injectable, or implanted buprenorphine product shall require it to be administered by an Ohio licensed health care provider acting in accordance within the scope of their professional license.

Last updated October 31, 2024 at 8:45 AM

History

• Effective: October 31, 2024
• Promulgated Under: 119.03

Ohio Adm.Code 4730-4-04 Medication-assisted treatment using naltrexone.

(A) In addition to the requirements in paragraphs (A) to (E) of rule 4730-4-03 of the Administrative Code, the physician assistant using naltrexone to treat opioid use disorder shall comply with the following requirements:

(1) Before initiating naltrexone, the physician assistant shall take measures to ensure that the patient is opioid abstinent for an adequate period of time after completing opioid withdrawal to avoid precipitated withdrawal. The physician assistant shall alert the patient of the risk of potentially lethal opioid overdose if they stop naltrexone and use opioids.

(2) The physician assistant shall use oral naltrexone only for treatment of patients who are highly motivated.

(a) The dosage regime shall strictly comply with the United States food and drug administration approved labeling for naltrexone hydrochloride tablets.

(b) The patient shall be encouraged to have a support person administer and supervise the medication. Examples of a support person are a family member, close friend, or employer.

(c) The physician assistant shall require urine drug screens, serum medication levels, or oral fluid drug testing at least every three months for the first year of treatment and at least every six months thereafter.

(d) The physician assistant shall incorporate relapse prevention strategies into counseling or assure that they are addressed by a qualified behavioral healthcare provider, as defined in rule 4730-4-01 of the Administrative Code, who has the education and experience to provide substance use disorder counseling.

(B) The physician assistant may treat a patient with extended-release naltrexone for opioid or alcohol dependence or for co-occurring opioid and alcohol use disorders.

(1) The physician assistant should consider treatment with extended-release naltrexone for patients who have difficulties with treatment adherence.

(2) The dosage shall strictly comply with the United States food and drug administration approved labeling for extended-release naltrexone.

(3) The physician assistant shall determine the effectiveness of treatment with extended-release naltrexone by utilizing drug testing, serum medication levels, and oral fluid testing throughout the course of treatment.

(4) The physician assistant shall incorporate relapse prevention strategies into counseling or assure that they are addressed by a qualified behavioral healthcare provider, as defined in rule 4730-4-01 of the Administrative Code, who has the education and experience to provide substance use disorder counseling.

Last updated October 31, 2024 at 8:45 AM

History

• Effective: October 31, 2024
• Promulgated Under: 119.03