Current through Vol. 24-16, September 15, 2024
Rule 16.
(1) As
used in this rule:
(a) "Medical institution"
means a hospital, skilled nursing facility, county medical care facility,
nursing home, freestanding surgical outpatient facility, hospice, or other
health facility that is licensed or approved by the state, which directly or
indirectly provides or includes pharmacy services.
(b) "Pharmacy services" means the direct and
indirect patient care services for patients in a medical institution,
associated with the practice of pharmacy.
(2) Pharmacy services in a medical
institution must be directed and provided by a licensed pharmacist.
(3) Pharmacy personnel who assist the
pharmacist by performing delegated functions in the care of patients of a
medical institution are supervised by a pharmacist who is on the premises of
the medical institution.
(4) The
pharmacist who directs the pharmacy services shall develop, implement,
supervise, and coordinate the services provided, including, at a minimum, all
of the following:
(a) Dispensing medications
in a form that minimizes additional preparation before administration to the
patient, including the admixture of parenterals.
(b) Obtaining the prescriber's original
medication order, a direct carbonized copy, an electromechanical facsimile, or
other electronic order transmission. Security measures must be in place to
ensure that system access by unauthorized individuals is not allowed.
(c) Interpreting and reviewing the
prescriber's medication orders and communicating problems with these orders to
the prescriber before the administration of first doses. If the interpretation
and review will cause a delay that would adversely affect a patient's medical
condition, a limited number of medications may be stocked at the patient care
areas for the administration of first doses. Medications must be provided in a
manner that ensures security and immediate availability, including sealed or
secured medication kits, carts, or treatment trays. A pharmacist shall
routinely inspect the medications and, after use, shall verify the contents and
replace the medications as necessary.
(d) Furnishing medications for administration
to registered patients under
R 338.588 and 338.588b.
(e) Monitoring medication therapy to promote
positive patient outcomes while evaluating clinically significant chemical and
therapeutic incompatibilities.
(f)
Establishing the specifications for the procurement of all pharmaceuticals and
related biologicals and chemicals approved for use in the medical
institution.
(g) Inspecting all
areas in the medical institution where medications are stored to verify
compliance with the standards for the safe use and storage of the medications,
not less than once every 6 months.
(h) Maintaining proper security for all
medications stored or maintained within the medical institution.
(i) Providing educational programs that
include, but are not limited to, medications used by the medical institution
and their safe use.
(j) Providing a
process by which medications can be obtained during the absence of a pharmacist
in a medical institution where a pharmacist is not available 24 hours a day.
The process must comply with all of the following:
(i) Minimize the potential for medication
error.
(ii) During the absence of a
pharmacist, the services of a pharmacist must be available on an on-call
basis.
(iii) Only a limited number
of medications that are packaged in units of use must be available.
(iv) The medications must be approved and
reviewed periodically as determined necessary, but not less than once a year,
by an appropriate interdisciplinary practitioner committee of the medical
institution.
(v) The medication
must be maintained in a securely locked, substantially constructed cabinet or
its equivalent in an area of limited access in a centralized area outside the
pharmacy.
(vi) Each medication must
be labeled to include the name of the medication; the strength; the expiration
date, if dated; and the lot number.
(vii) A written order and a proof of removal
and use document are obtained for each medication unit removed and reviewed by
the pharmacist within 48 hours of removing medication from the cabinet or its
equivalent.
(viii) The pharmacist
who directs pharmacy services in the medical institution shall designate the
practitioners who are allowed to remove the medication.
(ix) A pharmacist shall audit the storage
locations as often as needed to guarantee control, but not less than once every
30 days.
(5) On
the recommendation of an interdisciplinary practitioners' committee, the
pharmacist who directs pharmacy services in the medical institution shall adopt
written policies and procedures to promote safe medication practices, to
conduct medication utilization review, to approve medications for the medical
institution's formulary or medication list, and to promote positive patient
outcomes. A pharmacist shall meet with the committee not less than quarterly to
conduct assigned responsibilities.
(6) A pharmacy shall ensure that every
medication dispensed is identified with its name and strength labeled on the
container in which it is dispensed or on each single unit package. A pharmacy
that is engaged in drug distribution to medical institutions which use
unit-of-use packaging shall place identification on the label of its package to
allow the package to be readily traced. The name of the patient, or a unique
identifier, must be labeled on the medication container. The container may be
the individual patient's assigned medication drawer. The directions for use
must be on the label of the container if the directions are not communicated in
another effective manner. If the medication is to be self-administered, then
directions for use must be on the container. The provisions of this subrule are
minimum labeling standards only and do not supersede other applicable laws or
rules.
(7) A pharmacist shall
supervise the destruction of unused portions of prescription medication, other
than controlled substances under part 71 of the code, MCL
333.7101 to
333.7125, dispensed to patients.
However, medications in single-unit packages and intravenous solutions that are
designed to be tamper-evident, and show no evidence that tampering has
occurred, may be returned to stock. Medications that leave the medical
institution or its legal affiliates must not be returned to stock for
dispensing.
(8) The licensed
pharmacist that directs pharmacy services in the medical institution shall make
the policies and procedures required by this rule available to an agent of the
board, on request.
