Iowa Admin. Code r. 657-21.10 - Automated medication distribution system (AMDS)
Any pharmacy that utilizes an
(1)
Policies and
procedures. Pursuant to the requirements regarding policies and
procedures in 657-subrule 8.3(5), each pharmacy utilizing an AMDS shall have
policies and procedures that address all aspects of the operation of the AMDS
to include, at a minimum:
a. Access to drugs
and patient information,
b.
Pharmacy personnel training in the proper operation of the AMDS ,
c. Methods to ensure accurate stocking of the
AMDS pursuant to subrule 21.10(2),
d. Confidentiality of patient
information,
e. Routine and
preventative maintenance of the AMDS according to manufacturer recommendations,
f. Packaging and labeling of
prescription drugs loaded into or dispensed from the AMDS that is in compliance
with federal and state laws, rules, and regulations, and
g. Security and control of the prescription
drugs maintained and utilized in the AMDS to include:
(1) Drug loading, storage, and
records.
(2) Drugs removed from
system components but not used.
(3)
Inventory.
(4) Cross
contamination.
(5) Lot number
control.
(6) Wasted or discarded
drugs.
(7) Controlled
substances.
(2)
Stocking the AMDS . The pharmacy shall have adequate procedures
in place to ensure the accurate stocking of drugs into an AMDS using barcode
scanning technology. Only a pharmacy technician, pharmacist-intern, or
pharmacist shall be allowed to participate in the stocking of the
AMDS .
(3)
Pharmacist
verification of drugs dispensed from AMDS .
a. When an AMDS only dispenses drugs that
were prepackaged and verified by a pharmacist prior to being stocked in the
AMDS and there was no further manipulation of the drug or package other than
affixing a patient-specific label, such drugs shall not require additional
pharmacist verification prior to administration or dispensing to the patient or
authorized representative.
b. When
a drug is stocked in an AMDS and undergoes further manipulation, such as
counting and packaging, such drugs shall require pharmacist verification prior
to dispensing to the patient. Such verification shall be
documented.
(4)
Placement of AMDS .
a. An
AMDS placed outside a pharmacist's direct supervision shall only dispense
pharmacist-verified packages in compliance with paragraph 21.10(3)
"a."
b. An AMDS
that manipulates, including but not limited to counting, packaging, or
labeling, prescription drugs for subsequent patient dispensing shall only be
utilized in a pharmacy under the direct supervision of a pharmacist, except in
an approved telepharmacy pursuant to 657-Chapter 13.
Notes
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