Current through all regulations passed and filed through August 12, 2024
Section 4729:5-5-25 - Remote prescription entry - technician(A) As used in this rule: (1) "Direct supervision" and "personal supervision" have the same meaning as in rule 4729:3-1-01 of the Administrative Code.(2) "Remote prescription entry" means the entry of prescriptions for an outpatient pharmacy licensed as a terminal distributor of dangerous drugs by a remote technician under the direct supervision or remote supervision of a pharmacist. Remote prescription entry does not include dispensing, interpreting, evaluating, or approval of prescriptions or any other activities not permitted by state or federal laws, rules, and regulations. Remote prescription entry may include clarifying prescriptions and other data entry, including the processing of insurance coverage. The requirements of this rule shall be limited to the entry of prescriptions dispensed in or into this state.(3) "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 which 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.(4) "Remote supervision" means that a pharmacist directs and controls the actions of remote technicians through the use of technology that ensures a supervising pharmacist can meet the requirements listed in this paragraph. A pharmacist providing remote supervision shall: (a) Be readily available to answer questions of a remote technician; and(b) Be fully responsible for the practice and accuracy of the remote technician.(5) "Remote technician" means any of the following: (a) If performing remote prescription entry in this state: an Ohio registered certified pharmacy technician, registered pharmacy technician, or pharmacy technician trainee, either employed or a contract employee of an outpatient pharmacy or remote pharmacy, who either conducts prescription entry from a remote site, which may include the technician's residence or other location where the technician 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 entry outside of this state: a pharmacy technician who meets the following criteria: (i) The pharmacy technician is licensed or registered in the state where the remote prescription entry is occurring, or if working in a state that has not yet implemented a technician registration process, has received training and is working as a pharmacy technician in accordance with of the laws and regulations of their state of practice; and(ii) The pharmacy technician is 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 conducts prescription entry from a remote site, which may include the technician's residence or other location where the technician 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.(c) A nonresident pharmacy shall be responsible for ensuring all actions performed by an unregistered technician comply with the applicable requirements for conducting remote prescription entry.(d) A remote technician shall only be permitted to conduct remote prescription entry 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 entry 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 entry shall ensure that all remote technicians providing such services have been trained on the outpatient pharmacy's policies and procedures relating to prescription entry.(1) The training of each remote technician shall be documented. The outpatient pharmacy and the remote pharmacy shall jointly develop a procedure to communicate changes in policies and procedures related to prescription entry.(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 technicians shall maintain or have access to a record of the name and address of each technician, evidence of current licensure or registration, and the address of each location where the technician will be providing remote prescription entry services.(F) The outpatient pharmacy shall ensure that any remote technician shall have secure electronic access to the outpatient pharmacy's patient information system and to other electronic systems that an on-site technician has access to when the pharmacy is open.(G) Each remote entry record must comply with all recordkeeping requirements for outpatient pharmacies, including capturing the positive identification of the remote technician involved in the entry of the prescription.(H) An outpatient pharmacy utilizing remote prescription entry is responsible for maintaining records of all prescriptions entered into their information system, including prescriptions entered by a remote technician.(I) An outpatient pharmacy utilizing remote prescription entry 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) An overview of the responsibilities of the outpatient pharmacy and the remote pharmacy;(2) A list of the names, addresses, telephone numbers, and all license numbers of the pharmacies and remote technicians involved in remote prescription entry; and(3) 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 technician involved in prescription entry;(d) Complying with federal and state statutes and regulations; and(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.(J) A pharmacy intern that is licensed in this or any other state may engage in remote prescription entry pursuant to the requirements of this rule.Ohio Admin. Code 4729:5-5-25
Effective: 11/30/2021
Five Year Review (FYR) Dates: 11/30/2026
Promulgated Under: 119.03
Statutory Authority: 4729.94, 4729.26
Rule Amplifies: 4729.90, 4729.96, 4729.95, 4729.94, 4729.93, 4729.921, 4729.92, 4729.91, 4729.901