Mich. Admin. Code R. 338.588a

Current through Vol. 24-22, December 15, 2024

Section R. 338.588a - Automated devices in non-inpatient settings

Rule 88a.

(1) A pharmacy that operates an automated device to deliver prescription medication directly to an ultimate user that is not included in R 338.588(2)(a) to (h) shall comply with all of the following requirements:

(a) The automated device may only deliver non-controlled drugs.

(b) The automated device is operated as an extension of a pharmacy, under the control of a pharmacist.

(c) The automated device is secured, lockable, and privacy enabled.

(d) Prescriptions must contain a label that identifies the automated device where the medication was dispensed.

(e) In order for the automated device to be operable, a pharmacist shall be available to provide patient consultation through real-time audio and visual communication. The pharmacist may provide consultation from a remote location.

(f) Before the automated device is put into service, the pharmacy shall notify the department of the location of the automated device on a form provided by the department.

(g) Dispensing activities through the automated device must comply with all recordkeeping, drug utilization review, and patient counseling requirements that are applicable to a pharmacy.

(2) A pharmacy licensee may locate a non-dispensing storage and pick up device inside of the pharmacy that is used for a patient or agent of the patient to pick up prescription medication if the automated device is secured, lockable, and privacy enabled.

(3) If an automated device is used in a dispensing prescriber's office, and the automated device is not affiliated with a pharmacy, the device must be used only to dispense medications to the dispensing prescriber's patients and only under the control of the dispensing prescriber. All of the following apply to the use of an automated device in a dispensing prescriber's office:

(a) If a dispensing prescriber delegates the stocking of the automated device, then technologies must be in place and utilized to ensure that the correct drugs are stocked in their appropriate assignment utilizing a board-approved error prevention technology that complies with R 338.3154.

(b) A dispensing prescriber operating an automated device is responsible for all medications that are stocked and stored in that device, as well as removed from that device.

(c) If any medication or device is dispensed from an automated device in a dispensing prescriber's office, then documentation as to the type of equipment, serial numbers, content, policies, procedures, and location within the facility must be maintained by the dispensing prescriber for review by an agent of the board. This documentation must include all of the following information:

(i) Manufacturer name and model.

(ii) Quality assurance policy and procedure to determine continued appropriate use and performance of the automated device.

(iii) Policy and procedures for system operation that addresses, at a minimum, all of the following:

(A) Accuracy.

(B) Patient confidentiality.

(C) Access.

(D) Data retention or archival records.

(E) Downtime procedures.

(F) Emergency procedures.

(G) Medication security.

(H) Quality assurance.

Mich. Admin. Code R. 338.588a

2024 MR 5, Eff. 2/29/2024