Mich. Admin. Code R. 338.588 - Automated devices
Rule 88.
(1)
"Automated device" means a mechanical system that performs an operation or
activity, other than compounding or administration, relating to the storage,
packaging, dispensing, or delivery of a drug and that collects, controls, and
maintains transaction information.
(2) An automated device may be used only in
the following locations:
(a) A pharmacy, or at
the same physical address as the pharmacy if the location of the automated
device is owned and operated by the same legal entity as the
pharmacy.
(b) A hospital.
(c) A county medical care facility.
(d) A hospice.
(e) A nursing home.
(f) Other skilled nursing facility, as that
term is defined in section 20109 of the code, MCL
333.20109.
(g) An office of a dispensing prescriber,
where the device is operated by the dispensing prescriber, not a
pharmacy.
(h) A location affiliated
with a hospital, but not at the same physical address as the pharmacy, which is
owned and operated by the hospital, consistent with section 17760 of the code,
MCL 333.17760.
(i) A location other than subdivisions (a) to
(h) of this subrule, where the automated device acts as an extension of a
pharmacy. In addition to the requirements in this rule, the automated device
must meet the requirements in
R 338.588a.
(3) Records and electronic data maintained by
automated devices must meet all of the following requirements:
(a) All events involving access to the
contents of the automated devices must be recorded electronically.
(b) Records must be maintained for 5 years by
the pharmacy or dispensing prescriber and must be retrievable on demand for
review by an agent of the board. The records must include all of the following
information:
(i) The unique identifier of the
automated device accessed.
(ii)
Identification of the individual accessing the automated device.
(iii) The type of transaction.
(iv) The name, strength, dosage form,
quantity, and name of the manufacturer of the drug accessed.
(v) The name of the patient for whom the drug
was ordered.
(vi) Identification of
the pharmacist responsible for the accuracy of the medications to be stocked or
restocked in the automated device.
(4) Except for devices allowed under R
388.588a(2), policy and procedures for the use of the automated device must
include a requirement for pharmacist review of the prescription or medication
order before removal of any medication. This subrule does not apply to the
following situations:
(a) The system is being
used as an after-hours cabinet for medication dispensing in the absence of a
pharmacist as provided in
R 338.486(4)(j). A
pharmacist shall review the orders and authorize any further dispensing within
48 hours.
(b) The system is being
used in place of an emergency kit as provided in
R 338.486(4)(c). A
pharmacist shall review the orders and authorize any further dispensing within
48 hours.
(c) The system is being
accessed to remove medication required to treat the emergent needs of a patient
as provided in R
338.486(4)(c). A sufficient quantity
to meet the emergent needs of the patient may be removed until a pharmacist is
available to review the medication order. A pharmacist shall review the orders
and authorize any further dispensing within 48 hours.
(d) The automated device is located in a
dispensing prescriber's office to facilitate dispensing by the dispensing
prescriber.
(5) A copy of
all policies and procedures related to the use of an automated device must be
maintained at the pharmacy responsible for the device's specific location or at
the dispensing prescriber's office and be available for review by an agent of
the board.
Notes
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
No prior version found.