Current through Register Vol. 43, No. 52, December 26, 2024
(a) For purposes of this regulation,
"automated drug delivery system" shall mean an automated dispensing system, as
defined by
K.S.A.
65-1626 and amendments thereto, that is
located in a Kansas pharmacy and uses a robotic, mechanical, or computerized
device to perform operations or activities other than compounding or
administration, involving the storage, packaging, or labeling of, or any other
step before dispensing, drugs. Each prescription medication prepared by an
automated drug delivery system shall be verified and documented by a
Kansas-licensed pharmacist as part of the dispensing process.
(b) A pharmacist-in-charge of any licensed
pharmacy, licensed health care facility, or other location that is required to
be supervised by a pharmacist-in-charge and that uses an automated drug
delivery system shall perform the following before allowing the automated drug
delivery system to be used:
(1) Ensure that
the automated drug delivery system is in good working order and accurately
selects the correct strength, dosage form, and quantity of the drug prescribed
while maintaining appropriate recordkeeping and security safeguards;
(2) ensure that the automated drug delivery
system has a mechanism for securing and accounting for all drugs removed from
and subsequently returned to the system;
(3) ensure that the automated drug delivery
system has a mechanism for securing and accounting for all wasted or discarded
drugs, including a manual override for the pharmacist, pharmacy intern, or
pharmacy technician to clear a jammed, blocked, or malfunctioning automated
drug delivery system;
(4) ensure
compliance with an ongoing continuous quality improvement program pursuant to
K.S.A. 651695, and amendments thereto, or a risk management program that
monitors total system performance and includes the requirement for accuracy in
the drug and strength delivered;
(5) ensure that the automated drug delivery
system is loaded accurately and according to the original manufacturer's
storage requirements;
(6) approve
and implement an operational policy that limits the personnel responsible for
the loading and unloading of drugs to or from the automated drug delivery
system to any of the following:
(A) A
Kansas-licensed pharmacist;
(B) a
Kansas-registered pharmacy intern;
(C) a Kansas-registered pharmacy technician;
or
(D) a nurse with a license
issued pursuant to K.S.A. 651115, and amendments thereto;
(7) at the location of the automated drug
delivery system, maintain a current list of those approved individuals who are
authorized to unload any drug from the automated drug delivery
system;
(8) approve and implement
security measures that meet the requirements of all applicable state and
federal laws and regulations in order to prevent unauthorized individuals from
accessing or obtaining drugs;
(9)
preapprove all individuals who are authorized to unload any drug from the
automated drug delivery system;
(10) ensure that all drugs loaded in the
automated drug delivery system are packaged in the manufacturer's original
packaging or in repackaged containers, in compliance with
K.A.R.
68-7-15 and
K.A.R.
68-7-16, or in containers with the lot number
and expiration date tracked by the automated drug delivery system;
(11) provide the board with prior written
notice of the installation or removal of the automated drug delivery system;
and
(12) ensure that a system of
preventive maintenance and sanitation for the automated drug delivery system is
established and followed.
