Kansas Administrative Regulations › Agency 68 - KANSAS STATE BOARD OF PHARMACY › Article 9 - AUTOMATED PRESCRIPTION SYSTEMS › Section 68-9-2 - Automated drug delivery systems in pharmacies

Current through Register Vol. 43, No. 28, July 11, 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.