(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 schedule II controlled substance or 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 approved by the "Food and Drug Administration" subsequent to the effective date of this rule 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.