Rule 4729:5-5-20 | Remote outpatient prescription processing.
(A) As used in this rule:
(1) "Remote prescription processing" means the processing of a prescription for an outpatient pharmacy licensed as a terminal distributor of dangerous drugs by a remote pharmacist. Remote prescription processing does not include the dispensing of a drug, but may include receiving, interpreting, evaluating, clarifying and approval of prescriptions. Additionally, remote prescription order processing may include order entry, other data entry, performing prospective drug utilization review, interpreting clinical data, performing therapeutic interventions, and providing drug information services. The requirements of this rule shall be limited to the processing of outpatient prescriptions dispensed in or into this state.
(2) "Remote pharmacy" means either:
(a) A pharmacy licensed as a terminal distributor of dangerous drugs that dispenses dangerous drugs; or
(b) A pharmacy licensed as a limited category II terminal distributor of dangerous drugs that does not stock, own, or dispense any dangerous drugs and whose sole business consists of entry, review, and/or verification of prescriber orders and consulting services under contract for outpatient pharmacies in this state.
(3) "Remote pharmacist" means any of the following:
(a) If performing remote prescription processing in this state: an Ohio licensed pharmacist, either employed or a contract employee of an outpatient pharmacy or remote pharmacy, who either processes prescriptions from a remote site, which may include the pharmacist's residence or other location where the pharmacist and the outpatient or remote pharmacy can ensure the confidentiality and integrity of patient information, or on the premises of a remote pharmacy or outpatient pharmacy; or
(b) If performing remote prescription processing outside of this state: a pharmacist licensed or registered in the state where the remote prescription processing is occurring, either employed or a contract employee of an outpatient pharmacy or remote pharmacy who holds a nonresident pharmacy license in accordance with Chapter 4729:5-8 of the Administrative Code, who either processes prescriptions from a remote site, which may include the pharmacist's residence or other location where the pharmacist and the outpatient or remote pharmacy can ensure the confidentiality and integrity of patient information, or on the premises of a remote pharmacy or outpatient pharmacy.
A pharmacist shall only be permitted to conduct remote prescription processing within the United States, to include the District of Columbia, the Commonwealth of Puerto Rico or a territory or insular possession subject to the jurisdiction of the United States.
(B) An outpatient pharmacy may outsource prescription processing to a remote pharmacy provided the pharmacies are under common ownership or control or the outpatient pharmacy has entered into a written contract or agreement with a pharmacy that outlines the services to be provided and the responsibilities and accountabilities of each party to the contract or agreement in compliance with federal and state statutes and regulations.
(C) The outpatient pharmacy and remote pharmacy must maintain a copy of the contract or agreement in a readily retrievable manner for inspection and review by an agent, inspector, or employee of the board.
(D) An outpatient pharmacy utilizing remote prescription processing shall ensure that all remote pharmacists providing such services have been trained on the outpatient pharmacy's policies and procedures relating to prescription processing. The training of each pharmacist shall be documented.
(1) Such training shall include, but is not limited to, policies on drug and food allergy documentation, abbreviations, substitution, and prospective drug utilization review requirements in accordance with rule 4729:5-5-08 of the Administrative Code. The outpatient pharmacy and the remote pharmacy shall jointly develop a procedure to communicate changes in policies and procedures related to prescription processing.
(2) A terminal distributor of dangerous drugs may utilize one training program for all outpatient pharmacies under the terminal distributor's common ownership and control.
(E) An outpatient pharmacy utilizing remote pharmacists shall maintain or have access to a record of the name and address of each pharmacist, evidence of current pharmacist licensure in the state where the pharmacist is performing remote order processing, and the address of each location where the pharmacist will be providing remote prescription processing services.
(F) The outpatient pharmacy shall ensure that any remote pharmacist shall have secure electronic access to the outpatient pharmacy's patient information system and to other electronic systems that the on-site pharmacist has access to when the pharmacy is open.
(G) The remote pharmacist must be able to contact the prescriber issuing a prescription to discuss any concerns identified during the pharmacist's review of patient information and the order. A procedure must be in place to communicate any problems identified with the prescriber and the outpatient pharmacy.
(H) Each remote entry record must comply with all recordkeeping requirements for outpatient pharmacies, including capturing the positive identification of the remote pharmacist involved in the review and verification of the prescription.
(I) An outpatient pharmacy utilizing remote prescription processing is responsible for maintaining records of all prescriptions entered into their information system, including orders entered by a remote pharmacist. The system shall have the ability to audit the activities of the remote pharmacists.
(J) An outpatient pharmacy utilizing remote prescription processing services shall develop and implement a policy and procedure manual. A remote pharmacy shall maintain a copy of those portions of the policy and procedure manual that relate to the remote pharmacy's operations. Each manual shall include all the following:
(1) Outline the responsibilities of the outpatient pharmacy and the remote pharmacy;
(2) Include a list of the names, addresses, telephone numbers, and all license numbers of the pharmacies/pharmacists involved in remote prescription processing; and
(3) Include policies and procedures for:
(a) Protecting the confidentiality and integrity of patient information;
(b) Ensuring that no patient information is duplicated, downloaded, or removed from the outpatient pharmacy's patient information system;
(c) Maintaining appropriate records of each pharmacist involved in prescription processing;
(d) Complying with federal and state statutes and regulations;
(e) Reviewing written policies and procedures at least every three years, or upon the implementation of a significant change of written policies and procedures, and documentation of the review; and
(f) Annually reviewing the competencies of pharmacists providing remote prescription processing services.
Last updated November 30, 2021 at 8:28 AM
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