Chapter 4730-2 Physician-Delegated Prescriptive Authority

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 certificate to prescribe and the next scheduled renewal date for the certificate to prescribe.

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

R.C. 119.032 review dates: 03/19/2014 and 03/19/2019
Promulgated Under: 119.03
Statutory Authority: 4730.07 , 4730.39
Rule Amplifies: 4730.46
Prior Effective Dates: 10/31/2007

4730-2-02 Educational requirements for prescriptive authority.

(A) For purposes of division (B)(2)(b) of section 4730.46 of the Revised Code, a course of study is clinically relevant to the practice of physician assistants if it is a biological science related to the anatomy and physiology of the human body.

(1) The course of study may include, but is not necessarily limited to, the following: anatomy, biochemistry, physiology, microbiology, pharmacology, genetics, neuro-science and molecular biology, occupational therapy, physical therapy, exercise physiology, public health, physician assistant studies, athletic training, medical sciences, and psychology.

(2) Courses of study not acceptable include, but are not necessarily limited to, business, economics, ethics, history, and other fields not related to biological science.

(B) Pharmacology instruction required by division (A)(2) of section 4730.46 of the Revised Code shall be met by completion of a course of study consisting of planned classroom or continuing education and clinical study as follows:

(1) The course of study meets one of the following requirements:

(a) It is provided as part of a physician assistant education program accredited by the ARC-PA; or

(b) It is approved by the board pursuant to paragraphs (C), (D), and (E) of this rule.

(2) The content of the course of study includes all of the following:

(a) A minimum of thirty contact hours of training in pharmacology that includes pharmacokinetic principles and clinical application and the use of drugs and therapeutic devices in the prevention of illness and maintenance of health;

(b) A minimum of twenty contact hours of clinical training in pharmacology; and

(c) A minimum of fifteen contact hours including training in the fiscal and ethical implications of prescribing drugs and therapeutic devices and training in the state and federal laws that apply to the authority to prescribe.

(C) Coursework meeting the course content required in paragraph (B)(2)(a) of this rule shall be deemed approved by the board if it meets one of the following requirements:

(1) The coursework is approved for category I CME credit by AAPA or an institution or organization accredited to provide CME by the ACCME; or

(2) The coursework is approved as an advanced instructional program in pharmacology by the Ohio board of nursing pursuant to rule 4723-9-02 of the Administrative Code.

(D) Clinical training in pharmacology providing twenty contact hours in clinical pharmacology shall be deemed approved by the board for purposes of paragraph (B)(2)(b) of this rule, if it meets one of the following requirements:

(1) The clinical training meets all of the following requirements:

(a) The clinical training is conducted under the on-site supervision and direction of a supervising physician;

(b) The clinical training includes a process for regular interaction between the supervising physician and the physician assistant for on-going discussion concerning the physician assistant's prescriptive decisions;

(c) The clinical training includes evaluation of the physician assistant's learning of the principles of the use of drugs and therapeutic devices in the prevention of illness and maintenance of health; and

(d) The clinical training requires the physician assistant to apply pharmacologic principles and precepts in prescribing for a variety of medical conditions.

(2) The clinical training of a physician assistant who has been granted physician delegated prescriptive authority in another jurisdiction shall be deemed approved by the board upon receipt of an affidavit, from the physician licensed in that state who supervised the physician assistant in the exercise of physician delegated prescriptive authority, stating that the physician assistant has met the clinical training requirements provided in this rule.

(E) Coursework meeting the course content required in paragraph (B)(2)(c) of this rule shall be deemed approved by the board if it is approved for category I CME credit by AAPA or an institution or organization accredited to provide CME by the ACCME.

Replaces: 4730-2-02

Effective: 06/30/2014
R.C. 119.032 review dates: 03/19/2014 and 06/30/2019
Promulgated Under: 119.03
Statutory Authority: 4730.07 , 4730.39
Rule Amplifies: 4730.46
Prior Effective Dates: 10/31/2007

4730-2-03 Application for a provisional certificate to prescribe.

(A) All applicants for a provisional certificate to prescribe shall file a written application under oath on the forms prescribed by the board, and provide such other facts and materials as the board requires.

(B) No application shall be considered filed, and shall not be reviewed, until the fee required by section 4730.44 of the Revised Code has been received by the board.

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

(1) The fee required pursuant to section 4730.44 of the Revised Code has been received by the board;

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

(3) The board has received documentation providing proof satisfactory to the board of the applicant having completed the education and training required pursuant to section 4730.46 of the Revised Code;

(4) The board has received documentation providing the name, address, license number, and supervision agreement of the supervising physician who will be primarily responsible for supervising the physician assistant during the provisional period; and

(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.

(D) Applications shall be processed in compliance with the provisions of rule 4730-1-06 of the Administrative Code.

Effective: 10/31/2007
R.C. 119.032 review dates: 10/31/2012
Promulgated Under: 119.03
Statutory Authority: 4730.07 , 4730.39
Rule Amplifies: 4730.44

4730-2-04 Provisional period of physician-delegated prescriptive authority.

(A) Upon issuance of a provisional certificate to prescribe, the physician assistant is authorized to participate in a provisional period of physician-delegated prescriptive authority.

(B) The provisional period shall be conducted under the supervision of one or more supervising physicians with whom the physician assistant has a board-approved supervisory agreement.

(1) One supervising physician shall be designated as the primary supervising physician and shall have the primary responsibility for verifying the provisional period.

(2) The primary supervising physician shall, at all times during the provisional period, hold a certificate to practice medicine and surgery issued by the board pursuant to Chapter 4731. of the Revised Code that is not subject to restrictions, limitations, or probationary conditions and an unrestricted registration with the federal drug enforcement administration.

(C) The provisional period shall require a minimum of one thousand hours and a maximum of one thousand eight hundred hours, and last for at least six months but not longer than twelve months, except when a supervising physician has extended the provisional period for no longer than another twelve months.

(1) The first five hundred hours of the provisional period shall be under the on-site supervision, as that term is defined in rule 4730-1-01 of the Administrative Code, of one or more supervising physicians.

(2) The remaining hours of the provisional period may be conducted under off-site supervision, as that term is defined in rule 4730-1-01 of the Administrative Code, or the level of supervision specified by the supervising physician. With the consent of the supervising physician, physician assistants who have been granted physician delegated prescriptive authority in another jurisdiction may show proof of having met this requirement by providing an affidavit from their supervising physician licensed in that state that authorizes physician-delegated prescriptive authority for physician assistants stating that the physician assistant has completed one thousand hours of supervised prescribing.

(D) During the course of the provisional period, each supervising physician who supervises the physician assistant in the exercise of physician-delegated prescriptive authority 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 review and evaluation shall be documented by the supervising physician's signing of patient charts in a legible manner. In lieu of signing the patient charts, the supervising physician may document 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.

(1) During the first five hundred hours of the provisional period, the review and evaluation shall be completed and documented on every chart by each supervising physician who provided supervision within a reasonable period of time after the physician assistant rendered service to a patient.

(2) During the remainder of the provisional period, the review and evaluation shall be completed and documented on at least fifty percent of the patient charts by each supervising physician who provided supervision within a reasonable period of time after the physician assistant rendered service to a patient.

(E) Provisional period hours completed under the supervision of a primary supervising physician may be transferred to a provisional period under a subsequent primary supervising physician pursuant to the following criteria:

(1) Provisional period hours completed under the supervision of a primary supervising physician may be transferred, not more than one time, when both of the following criteria are met:

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

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

(2) Provisional period hours completed under the supervision of the subsequent primary supervising physician may be transferred to a provisional period under a third primary supervising physician only upon the board's approval when all of the following conditions are met:

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

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

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

(b) The third primary supervising physician approves the transfer of the provisional period 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.

(F) Successful completion of the provisional period requires that both of the following requirements be met:

(1) The physician assistant completed the provisional period in accordance with this rule; and

(2) The primary supervising physician certifies to the board that the physician assistant is capable of consistently making prescriptive decisions in accordance with the minimal standards of care.

(G) The primary supervising physician shall notify the board, on forms prescribed by the board, of any of the following:

(1) That the physician assistant successfully completed the provisional period;

(2) That the physician assistant's provisional period is being extended, including the number of additional hours and/or time period of the extension; or

(3) That the physician assistant did not successfully complete the provisional period and the provisional period is not being extended.

(H) Upon receipt of notice from the primary supervising physician that the physician assistant did not successfully complete the provisional period, the board shall immediately revoke the provisional certificate to prescribe. The revocation of the provisional certificate to prescribe based upon notice that the provisional period was not successfully completed is not subject to hearing rights or appeal under Chapter 119. of the Revised Code.

(I) A provisional certificate to prescribe shall be considered to be valid for up to one year after issuance, except that the provisional certificate may, upon the report of the primary supervising physician pursuant to paragraph (G)(2) of this rule, be extended in accordance with the number of additional hours and/or time period specified in the notice submitted by the supervising physician.

R.C. 119.032 review dates: 03/19/2014 and 03/19/2019
Promulgated Under: 119.03
Statutory Authority: 4730.07 , 4730.39
Rule Amplifies: 4730.45
Prior Effective Dates: 10/31/2007

4730-2-05 Certificate to prescribe.

(A) All applicants for a certificate to prescribe shall file a written application under oath on the forms prescribed by the board, and provide such other facts and materials as the board requires.

(B) No application shall be considered filed, and shall not be reviewed, until the fee required by section 4730.44 of the Revised Code has been received by the board.

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

(1) The fee required pursuant to section 4730.44 of the Revised Code has been received by the board;

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

(3) All information required by section 4730.44 of the Revised Code, including such other facts and materials as the board requires, has been received by the board;

(4) The board has received evidence satisfactory to the board of the applicant having successfully completed the provisional period of physician-delegated prescriptive authority required by section 4730.45 of the Revised Code; and

(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.

(D) Applications shall be processed according to the provisions of rule 4730-1-06 of the Administrative Code.

(E) A certificate to prescribe may be renewed in the manner and according to the standards sets forth in sections 4730.48 and 4730.49 of the Revised Code.

(1) The applicant shall submit a completed application prescribed by the board, including the payment of the fee required by section 4730.48 of the Revised Code;

(2) The applicant shall certify that the applicant has completed the requisite hours of continuing education in pharmacology in compliance with the following requirements:

(a) The applicant completed twelve hours of continuing education in pharmacology during the licensure registration period, or, if the certificate to prescribe was initially issued on or after the first day of the second year of the licensure registration period, at least six hours of continuing education in pharmacology; and

(b) The completed continuing education in pharmacology is category I CME as certified by the "Ohio Association of Physician Assistants," "Ohio State Medical Association," "Ohio Osteopathic Association," "Ohio Podiatric Medicine Association," or a CME provider accreditated by the ACCME and approved by the board. Certification is a process whereby the "Ohio State Medical Association," "Ohio Osteopathic Association," "Ohio Podiatric Medical Association," "Ohio Association of Physician Assistants," and other ACCME accredited providers define their respective CME program requirements for periodic submission to the board for approval. The board may approve each association's CME program requirements which consist of CME category I course and activities that are deemed acceptable for completing the requisite hours of continuing education in pharmacology by each licensee.

(F) A certificate to prescribe shall lapse when the physician assistant's certificate to practice expires. A lapsed certificate to prescribe may be reinstated upon conformance with the following requirements:

(1) The certificate to practice has been reinstated or restored;

(2) The applicant submits a completed application to reinstate the certificate to prescribe, as prescribed by the board;

(3) The applicant certifies that the applicant competed continuing education in pharmacology meeting the requirements of paragraph (E) of this rule for each licensure registration period since the last renewal of the certificate to prescribe; and

(4) The applicant submits payment of the renewal fee required by section 4730.48 of the Revised Code.

(G) A certificate to prescribe shall expire if not renewed at the time the certificate to practice is renewed. Once expired, a certificate to prescribe may be reinstated upon evidence of all of the following:

(1) The applicant holds a current certificate to practice issued pursuant to section 4730.12 of the Revised Code;

(2) The applicant submits a completed application to reinstate the certificate to prescribe, as prescribed by the board, including the payment of the renewal fee required by section 4730.48 of the Revised Code; and

(3) The applicant certifies that the applicant completed continuing education in pharmacology meeting the requirements of paragraph (E) of this rule for each licensure registration period since the last renewal of the certificate to prescribe.

Effective: 10/31/2007
R.C. 119.032 review dates: 10/31/2012
Promulgated Under: 119.03
Statutory Authority: 4730.07 , 4730.39
Rule Amplifies: 4730.44 , 4730.45 , 4730.47 , 4730.48 , 4730.49 , 4730.50

4730-2-06 Physician assistant formulary.

(A) This formulary, as contained in the appendix to this rule, is established for individuals who hold a current, valid certificate to practice as a physician assistant and either a current, valid provisional certificate to prescribe or a certificate to prescribe issued by the board, and who have been authorized to prescribe pursuant to a board approved supervisory plan or the policies of the health care facility in which the physician assistant is practicing. The formulary does not authorize a physician assistant to prescribe any drug or device used to perform or induce an abortion.

(B) For purposes of the physician assistant formulary:

(1) "CTP" means either a provisional certificate to prescribe or a certificate to prescribe issued by the board pursuant to section 4730.44 of the Revised Code.

(2) "CTP holder may not prescribe" means medications in the category may not be prescribed by any CTP holder for any indication.

(3) "CTP holder may prescribe" means medications in the category may be prescribed by any CTP holder as appropriate.

(4) "Physician initiated/consultation" means that either the supervising physician must initiate the drug after personally evaluating the patient or the physician assistant must consult with the supervising physician by direct, real time communication prior to initiating the drug.

(5) "Therapeutic device" means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is intended to affect the structure or any function of the body and which does not achieve any of its primary intended purposes through chemical action within or on the body and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes. Therapeutic device includes any device subject to regulation by the "Food and Drug Administration."

(C) All physician assistant prescribing shall be in compliance with the supervisory plan under which the physician assistant is prescribing or the policies of the health care facility in which the physician assistant is prescribing, as may be restricted by the supervising physician.

(D) All drugs and therapeutic devices shall be prescribed in accordance with the manufacturer's package insert, the "United States Parmacopoeia," and the minimal standard of care.

(E) Drugs may be prescribed for purposes other than "Food and Drug Administration" indications when both of the following requirements are met:

(1) The purpose is supported by current peer review literature, which emanates from a recognized body of knowledge; and

(2) Prescribing for the purpose is authorized by the supervising physician under whom the physician assistant is prescribing or the policies of the health care facility in which the physician assistant is prescribing.

(F) In order for a physician assistant to prescribe a combination medication, each component drug must be listed on the formulary as "CTP holder may prescribe" or the combination medication itself must be listed on the formulary as "CTP holder may prescribe."

(G) For medications that are denoted "Physician initiated/consultation," both of the following requirements apply:

(1) The supervising physician's initiation of the drug or the prior consultation between the physician assistant and the supervising physician shall be documented in the patient record; and

(2) The physician assistant shall consult with the supervising physician before changing the dosage of the drug or before renewing a prescription when there is a change in patient status. The consultation shall be documented in the patient record.

(H) A drug for which the classification is not included on the formulary shall not be prescribed by a physician assistant until it is reviewed and added to the formulary.

(I) The prescription of oxygen and plasma expanders is regulated by the Ohio state board of pharmacy and requires the physician assistant to hold a current, valid certificate to prescribe.

(J) A physician assistant's prescription of therapeutic devices shall be in compliance with both of the following:

(1) The physician assistant may only prescribe a therapeutic device that has been approved by the "Food and Drug Administration" and which the supervising physician prescribes in the routine course of practice for the specific use approved by the "Food and Drug Administration;" and

(2) The physician assistant shall not prescribe a therapeutic device that federal or state statute, rule, or regulation prohibits the physician assistant from using.

(K) A physician assistant, with or without physician delegated prescriptive authority, may order blood products with physician initiation or consultation, consistent with the physician assistant's supervisory plan or the policies of the health care facility, as applicable.

Click to view Appendix

Effective: 06/30/2014
R.C. 119.032 review dates: 03/19/2014 and 06/30/2019
Promulgated Under: 119.03
Statutory Authority: 4730.07 , 4730.39
Rule Amplifies: 4730.39 , 4730.40
Prior Effective Dates: 02/28/2008, 07/30/2012, 01/24/2012

4730-2-07 Standards for prescribing.

For purposes of this rule, the term "certificate to prescribe" includes the provisional certificate to prescribe and the full certificate to prescribe issued by the board pursuant to section 4730.44 of the Revised Code.

(A) A physician assistant who holds a current valid certificate to prescribe 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, for the prescription of drugs and devices listed on the formulary set forth rules promulgated by the board;

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

(3) The requirements of Chapters 4730-1, 4730-2, 4731-11, and 4731-21 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 current valid certificate to prescribe 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 current valid certificate to prescribe 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 a current valid certificate to prescribe 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 a current valid certificate to prescribe and who has been granted physician-delegated prescriptive authority by a supervising physician shall include on each prescription the certificate number of the physician assistant's certificate to prescribe, and, where applicable, shall include the physician assistant's DEA number.

Effective: 06/30/2014
R.C. 119.032 review dates: 03/19/2014 and 06/30/2019
Promulgated Under: 119.03
Statutory Authority: 4730.07 , 4730.39
Rule Amplifies: 4730.41
Prior Effective Dates: 10/31/2007

4730-2-08 Standards for personally furnishing drugs and therapeutic devices.

(A) The following general provisions apply for purposes of this rule:

(1) The term "certificate to prescribe" includes the provisional certificate to prescribe and the full certificate to prescribe issued by the board pursuant to section 4730.44 of the Revised Code.

(2) The physician assistant may personally furnish a complete or partial supply of a drug or therapeutic device only in accordance with this rule and any other applicable state or federal laws or rules relative to personally furnishing drugs and therapeutic devices, including, but not limited to, rules adopted by the Ohio board of pharmacy.

(B) A physician assistant who holds a certificate to prescribe and who has been granted physician-delegated prescriptive authority by a supervising physician may personally furnish to a patient a complete or partial supply of drugs and therapeutic devices, in accordance with all of the following conditions:

(1) The physician assistant shall not personally furnish drugs and devices in locations other than a health department 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, a federally funded comprehensive primary care clinic, or a nonprofit health clinic or program;

(2) The physician assistant may personally furnish only those types of drugs and devices that meet all of the following requirements:

(a) The drugs and devices are antibiotics, antifungals, scabicides, contraceptives, prenatal vitamins, antihypertensives, drugs and devices used in the treatment of diabetes, drugs and devices used in the treatment of asthma, or drugs used in the treatment of dyslipidemia;

(b) The drugs and devices are included among the drugs and devices set forth in the formulary established in rule 4730-2-06 of the Administrative Code; and

(c) The drugs and devices are included among the drugs and devices for which the supervising physician has granted prescriptive authority to the physician assistant.

(3) The physician assistant shall not personally furnish either of the following:

(a) Any schedule II controlled substance; or

(b) Any drug or device used to perform or induce an abortion.

(4) The physician assistant shall affix to the container or device a label showing all of the following information:

(a) The name, address, and certificate to prescribe number of the prescribing physician assistant;

(b) The name of the patient for whom the drug or device is intended;

(c) Name and strength of the drug;

(d) Directions for use; and

(e) Date furnished.

(C) The physician assistant who holds a certificate to prescribe and who has been granted physician-delegated prescriptive authority by a supervising physician shall maintain a written record of all drugs and devices personally furnished by the physician assistant.

R.C. 119.032 review dates: 03/19/2014 and 03/19/2019
Promulgated Under: 119.03
Statutory Authority: 4730.07 , 4730.39
Rule Amplifies: 4730.43
Prior Effective Dates: 10/31/2007

4730-2-09 Standards for personally furnishing samples of drugs and therapeutic devices.

(A) The following general provisions apply for purposes of this rule:

(1) The term "certificate to prescribe" includes the provisional certificate to prescribe and the full certificate to prescribe issued by the board pursuant to section 4730.44 of the Revised Code.

(2) The physician assistant may personally furnish a sample of a drug or therapeutic device only in accordance with this rule and any other applicable state or federal laws or rules relative to personally furnishing drugs and therapeutic devices, including, but not limited to, rules adopted by the Ohio board of pharmacy.

(B) A physician assistant who holds a certificate to prescribe and who has been granted physician-delegated prescriptive authority by a supervising physician may personally furnish to a patient a sample of drugs and therapeutic devices included within the physician-delegated prescriptive authority, in accordance with all of the following conditions:

(1) The physician assistant shall personally furnish the samples in accordance with the requirements of section 3719.81 of the Revised Code;

(2) The physician assistant shall not personally furnish samples of controlled substances or any drug or device used to perform or induce an abortion;

(3) The samples are of drugs and devices included among the drugs and devices set forth in the formulary established in rule 4730-2-06 of the Administrative Code;

(4) The samples are of drugs and devices included among the drugs and devices for which the supervising physician has granted prescriptive authority to the physician assistant;

(5) The amount of the sample furnished shall not exceed a seventy-two hour supply, except when the minimum available quantity of the sample is packaged in an amount that is greater than a seventy-two hour supply, in which case the physician assistant must furnish the sample in the packaged amount;

(6) The physician assistant shall not sell, impose a charge, or accept a fee for the sample or for furnishing it;

(7) Where the directions for use by a particular patient are different from the directions on or in the sample container, the physician assistant shall provide, in written format, the following:

(a) The name of the prescribing physician assistant and the name of the physician under whose supervision the physician assistant is authorized to write the prescription;

(b) The name of the patient; and

(c) Directions for use of the drug or therapeutic device.

(8) The physician assistant shall maintain a written record of all samples of drugs and devices personally furnished by the physician assistant.

R.C. 119.032 review dates: 03/19/2014 and 03/19/2019
Promulgated Under: 119.03
Statutory Authority: 4730.07 , 4730.39
Rule Amplifies: 4730.43
Prior Effective Dates: 10/31/2007

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

(A) For purposes of this rule:

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

(2) "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.

(3) "Personally furnish" means the distribution of drugs by a prescriber to the prescriber's patients for use outside the prescriber's practice setting.

(4) "Protracted basis" means a period in excess of twelve continuous weeks.

(5) "Reported drugs" means all the drugs listed in rule 4729-37-02 of the Administrative Code that are required to be reported to the drug database established and maintained pursuant to section 4729.75 of the Revised Code, including:

(a) Controlled substances in schedules II, III, IV, and V, and

(b) All dangerous drug products containing tramadol.

(B) If a physician assistant believes or has reason to believe that a patient may be abusing or diverting drugs, the physician assistant shall use sound clinical judgment in determining whether or not the reported drug should be prescribed to the patient under the circumstances.

(1) To assist in this determination, the physician assistant shall access OARRS and document receipt and assessment of the information received if the patient exhibits the following signs of drug abuse or diversion:

(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) Having a drug screen result that is inconsistent with the treatment plan or refusing to participate in a drug screen;

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

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

(h) 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.

(2) Other signs of possible abuse or diversion which may necessitate accessing OARRS include, but are not limited to the following:

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

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

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

(d) Frequently requesting early refills of reported drugs;

(e) Frequently losing prescriptions for reported drugs;

(f) A history of illegal drug use;

(g) Sharing reported drugs with another person; or

(h) Recurring emergency department visits to obtain reported drugs.

(C) A physician assistant prescribing reported drugs to treat a patient on a protracted basis shall, at a minimum, document receipt and assessment of an OARRS report in the following circumstances:

(1) Once the physician assistant has reason to believe that the treatment will be required on a protracted basis; and

(2) At least once annually, thereafter.

(D) A physician assistant shall document receipt and assessment of all OARRS reports in the patient record.

(1) Initial reports requested in compliance with this rule shall cover a time period of at least one year;

(2) Subsequent reports requested in compliance with this rule shall, at a minimum, cover the period from the date of the last report to present.

(E) In the event an OARRS report is not available prior to writing a prescription for a reported drug or personally furnishing the reported drug, the physician assistant shall document in the patient record why the OARRS report was not available.

(F) Paragraph (C) of this rule does not apply to a hospice patient in a hospice care program as those terms are defined in section 3712.01 of the Revised Code.

(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.

Effective: 06/30/2014
R.C. 119.032 review dates: 06/30/2019
Promulgated Under: 119.03
Statutory Authority: 4730.07 , 4730.53
Rule Amplifies: 4730.53