Or. Admin. R. 855-041-4120

Current through Register Vol. 63, No. 9, September 1, 2024

Section 855-041-4120 - Remote Dispensing Machine (RDM) - Drug Delivery and Control

(1) Each RDM must be registered with the Board, under the control of and connected via computer with a Responsible Pharmacy, but not located in a pharmacy. RDMs must be used only in settings with an established program of pharmaceutical care that ensures prescription orders are reviewed by a pharmacist before release to the patient. The Responsible Pharmacy must establish the policies and procedures necessary to fulfill the requirements of all applicable state and federal laws and regulations.

(2) The following must be conspicuously displayed at the site of the RDM:

(a) RDM license;

(b) DEA registration if required;

(c) A certified copy of the Responsible Pharmacy license; and

(d) A certified copy of the Pharmacist-In-Charge license.

(3) Documentation as to type of equipment, serial numbers, content, policies and procedures, and location shall be maintained in the pharmacy for review by the board. Such documentation must include, but is not limited to:

(a) Location of RDM(s);

(b) Manufacturer's name and model for each RDM;

(c) Description of how the RDM is used;

(d) Quality assurance procedures to determine continued appropriate use of the automated device; and

(e) Policies and procedures for training of appropriate personnel, system operation, safety, security, accuracy, patient confidentiality, oral counseling by a pharmacist or pharmacist-intern, access, and malfunction.

(4) Policies and procedures addressing the operation of the RDM must be maintained in the pharmacy responsible for the APS and at the location at which the RDM has been installed.

(5) All events involving the contents of the RDM must be recorded electronically. Records must be maintained by the pharmacy for a minimum of three years and must be readily available to the Board. Such records shall include:

(a) Identity of RDM accessed;

(b) Identification of the individual accessing the RDM;

(c) Type of transaction;

(d) Date and time of transaction;

(e) Name, strength, dosage form, and quantity of the drug accessed;

(f) Name of the patient for whom the drug was ordered;

(g) Name of the prescribing practitioner

(h) Such additional information as the pharmacist-in-charge may deem necessary; and

(6) Only an Oregon Licensed Pharmacist or Technician may have access to the RDM, except that a Registered Nurse, upon approval by the Board, may have access to the RDM.

(7) Only an Oregon licensed Pharmacist or Technician may stock medications in the RDM, except that a Registered Nurse, upon approval by the Board, may stock medications in the RDM.

(8) All containers of medications stored in the RDM shall be packaged and labeled in accordance with state and federal laws and regulations, including OAR 855-041-1130.

(9) All aspects of handling controlled substances shall meet the requirements of all state and federal laws and regulations.

(10) Oral counseling, as required by OAR 855-115-0145, shall be provided by the pharmacist at the time of dispensing by a two-way audio and video hookup with the Responsible Pharmacy.

(11) The Automated Pharmacy Systems shall provide a mechanism for securing and accounting for wasted, discarded or unused medications in accordance with existing state and federal laws and regulations.

(12) The RDM must be clearly marked with the name, address, and phone number of the Responsible Pharmacy and Pharmacist-In-Charge.

(13) A Responsible Pharmacy located outside of Oregon that operates a RDM in Oregon must be currently licensed and in good standing in Oregon. The Pharmacist-In-Charge must also be currently licensed and in good-standing both in Oregon and in the state in which the Responsible Pharmacy is located.

(14) A Responsible Pharmacy may apply for the use of an RDM in a licensed residential facility that it provides services to, but only when the facility provides 24 hour nursing care.

Or. Admin. R. 855-041-4120

BP 2-2005, f. 2-14-05, cert. ef. 3-1-05; Renumbered from 855-041-0620, BP 7-2012, f. & cert. ef. 12-17-12; BP 1-2017, f. & cert. ef. 2/23/2017; BP 44-2020, minor correction filed 08/06/2020, effective 8/6/2020; BP 28-2024, minor correction filed 04/10/2024, effective 4/10/2024

Statutory/Other Authority: ORS 689.205

Statutes/Other Implemented: ORS 689.205