Mich. Admin. Code 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.
Notes
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