216-40-15 R.I. Code R. § 1.8

Current through June 20, 2024

Section 216-RICR-40-15-1.8 - Automated Storage and Distribution Devices

1.8.1Automated Storage and Distribution Devices

A. Automated storage and distribution devices may be utilized by nursing facilities, medical institutions, assisted living, rehabilitation, hospitals, hospice care or correctional facilities who maintain contracts for pharmaceutical services with licensed pharmacies and which provide contractual pharmaceutical services to patients or licensed pharmacies, in the case of prescriptions available for delivery; and shall comply with the following provisions:

1. Drugs stored in an automated storage and distribution device servicing nursing facilities, medical institutions, assisted living, rehabilitation centers, hospitals, hospice care or correctional facilities are part of the inventory of the pharmacy providing pharmaceutical services to that facility.

2. Documentation as to type of equipment, serial numbers, content, policies and procedures and location shall be maintained on-site in the pharmacy. Such documentation shall include:

a. Name and address of the pharmacy where the automated storage and distribution device is being used;

b. Manufacturer's name and model;

c. Description of how the device is used;

d. Quality assurance procedures to determine continued appropriate use of the automated device;

e. Policies and procedures for system operation, safety, security, accuracy, patient confidentiality, access and malfunction.

3. Automated storage and distribution devices shall have adequate security systems and procedures to prevent unauthorized access, to comply with Federal and State Regulations and maintain patient confidentiality.

4. Records and/or electronic data kept by automated storage and distribution devices shall meet the following requirements:

a. All events involving the contents of the automated storage and distribution device shall be recorded electronically

b. Records shall be maintained by the pharmacy and shall be readily available to the Department. Such records shall include:

(1) Identity of system accessed;

(2) Identification of the individual accessing the system;

(3) Type of transaction;

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

(5) Name of the patient for whom the drug was accessed;(6) Such additional information as the pharmacist-in-charge may deem necessary.

c. A record of medications filled/stocked into an automated storage and distribution device shall be maintained and shall include identification of the persons filling/stocking and checking for accuracy.

B. All containers of medications stored in the automated storage and distribution device shall be packaged and labeled in accordance with Federal and State laws and Regulations.

C. The pharmacy operating an automated storage and distribution device shall provide a mechanism for securing and accounting for medications removed from and subsequently returned to the automated storage and distribution device in accordance with existing Regulations.

D. The automated storage and distribution device shall provide a mechanism for storing and accounting for wasted medications or discarded medications in accordance with existing State and Federal law.

E. The pharmacist-in-charge shall establish policies and procedures that shall:

1. Assure that the automated storage and distribution device is in good working order and accurately dispenses the correct strength, dosage form, and quantity of the drug prescribed while maintaining appropriate recordkeeping and security safeguards.

2. Assure access to medications for the purposes of administration by authorized licensed personnel only, and provides a method to identify the patient and to release that patient's prescriptions correctly.

3. Authorize individuals and determine levels of access to automated storage and distribution devices and ensure security of the system.

4. Assure that the filling/stocking of all medications in the system shall be accomplished by qualified personnel as defined by pharmacy policy and procedure.

5. Implement an ongoing quality assurance program that monitors compliance to the established policies and procedures of the automated pharmacy system.

6. Assure that a pharmacist is available at all times to fulfill any patient counseling as required by law and Regulation during the operating hours of the pharmacy or telephonically during any hours that prescriptions are available for pick-up.

7. If an automated self-serve prescription delivery kiosk is located at the pharmacy, the kiosk shall be located either in a wall of a properly licensed pharmacy or within twenty feet (20') of a properly licensed pharmacy. The automated storage/distribution system shall be secured against a wall or floor in such a manner as to prevent the unauthorized removal of the system.

F. The pharmacist-in-charge shall establish policies and procedures for the process of dispensing and/or administering medications pursuant to a medication order.

216 R.I. Code R. § 216-RICR-40-15-1.8

Amended effective 5/17/2021
Amended effective 12/8/2022