Current through Register Vol. 43, No. 52, December 26, 2024
(a) Each
of the following terms, as used in this regulation, shall have the meaning
specified in this subsection:
(1) "Automated
drug delivery system" means an automated dispensing system, as defined by
K.S.A. 2017 Supp.
65-1626
and amendments thereto, that is located in a facility outside of a managing
pharmacy and uses a robotic, mechanical, or computerized device to supply each
drug to an individual licensed by the board of healing arts or the board of
nursing, who shall administer the drug to a patient.
(2) "Facility" means any of the following:
(A) A medical care facility, as defined in
K.S.A.
65-1626 and amendments thereto;
(B) an institutional drug room, as defined in
K.S.A. 651626 and amendments thereto; or
(C) a long-term care facility, which shall
mean any of the following:
(i) A nursing
facility, as defined in
K.S.A.
39-923 and amendments thereto;
(ii) a nursing facility for mental health, as
defined in
K.S.A.
39-923 and amendments thereto; or
(iii) any other type of adult care home, as
defined in
K.S.A.
39-923 and amendments thereto, that is not
specified in paragraphs (a)(2)(C)(i) and (ii) and, after submitting an
application, is approved by the board for an automated drug delivery
system.
(3)
"Managing pharmacy" means a pharmacy located in Kansas.
(4) "Pharmacist-in-charge" means the
pharmacist-in-charge of the managing pharmacy.
(b) Before the initial stocking and use of an
automated drug delivery system to supply drugs for administration, the
pharmacist-in-charge shall meet the following requirements:
(1) Provide the board with at least 14-day
prior writen notice, on a form provided by the board; and
(2) ensure that all necessary licenses,
registrations, and authorizations, including a drug enforcement administration
registration if supplying controlled substances, have been obtained.
(c) The pharmacist-in-charge shall
consult with the pharmacy and therapeutics commitee or an equivalent commitee
in establishing the criteria and process for determining a formulary of
approved drugs that may be stored in the automated drug delivery
system.
(d) A bar code
verification, electronic verification, or similar verification process shall be
utilized to ensure the correct selection of drugs placed or to be placed into
each automated drug delivery system. The utilization of a bar code, electronic
verification, or similar verification process shall require an initial quality
assurance validation, followed by a quarterly assurance review by a
pharmacist.
(e) The
pharmacist-in-charge shall ensure that a policy exists requiring that if, at
the time of loading any controlled substance, a discrepancy in the count of
that drug in the automated drug delivery system exists, the discrepancy is
immediately reported to the pharmacist-in-charge.
Whenever the pharmacist-in-charge becomes aware of a
discrepancy regarding the count of a controlled substance in the automated drug
delivery system, the pharmacist-in-charge shall be responsible for
reconciliation of the discrepancy or proper reporting of the loss.
(f) The pharmacist-in-charge shall
be responsible for the following:
(1)
Controlling access to the automated drug delivery system;
(2) maintaining policies and procedures for
the following:
(A) Operating the automated
drug delivery system;
(B) providing
prior training and authorization of personnel who are authorized to remove any
drug from the automated drug delivery system;
(C) maintaining, at the location of the
automated drug delivery system, a list of those individuals who are authorized
to remove any drug from the automated drug delivery system;
(D) maintaining patient services whenever the
automated drug delivery system is not operating; and
(E) defining a procedure for a pharmacist to
grant access to the drugs in the automated drug delivery system;
(3) securing the automated drug
delivery system;
(4) ensuring that
each patient receives the pharmacy services necessary for appropriate
pharmaceutical care;
(5) ensuring
that the automated drug delivery system maintains the integrity of the
information in the system and protects patient confidentiality;
(6) ensuring compliance with all requirements
for packaging and labeling each medication pursuant to
K.A.R.
68-7-15 and
K.A.R.
68-7-16, unless the medication is already
packaged in the manufacturer's original container or in repackaged
containers;
(7) ensuring that a
system of preventive maintenance and sanitation exists and is implemented for
the automated drug delivery system;
(8) ensuring that a policy exists for
securing and accounting for all drugs that are wasted or discarded from the
automated drug delivery system;
(9)
ensuring that inspections are conducted and documented at least monthly to
ensure the accuracy of the contents of the automated drug delivery system;
and
(10) ensuring the accurate
loading and unloading of the automated drug delivery system by approving and
implementing an operational policy that limits the personnel responsible for
the loading and unloading of the automated drug delivery system to a
Kansas-licensed pharmacist or any of the following, each of whom shall be under
the supervision of a Kansas-licensed pharmacist:
(A) A Kansas-registered pharmacy
intern;
(B) a Kansas-registered
pharmacy technician; or
(C) a nurse
with a license issued pursuant to K.S.A. 651115, and amendments
thereto.
(g)
A pharmacist shall comply with the medication order review and verification
requirements specified in
K.A.R.
68-7-11.
(h) Except in the event of a sudden and
unforeseen change in a patient's condition that presents an imminent threat to
the patient's life or well-being, any authorized individual at a facility may
distribute patient-specific drugs utilizing an automated drug delivery system
without verifying each individual drug selected or packaged by the automated
drug delivery system only if both of the following conditions are met:
(1) The initial medication order has been
reviewed and approved by a pharmacist.
(2) The drug is distributed for subsequent
administration by a health care professional permitted by Kansas law to
administer drugs.
(i)
The pharmacist-in-charge shall be responsible for establishing a continuous
quality improvement program for the automated drug delivery system. This
program shall include written procedures for the following:
(1) Investigation of any medication error
related to drugs supplied or packaged by the automated drug delivery
system;
(2) review of any
discrepancy or transaction reports and identification of patterns of
inappropriate use of or access to the automated drug delivery system;
and
(3) review of the operation of
the automated drug delivery system.
(j) The pharmacist-in-charge shall ensure
that the managing pharmacy maintains, in a readily retrievable manner and for
at least five years, the following records related to the automated drug
delivery system:
(1) Transaction records for
all drugs or devices supplied by the automated drug delivery system;
and
(2) any report or analysis
generated as part of the continuous quality improvement program.
(k) A Kansas-registered pharmacy
technician, a Kansas-registered pharmacy intern, or a nurse with a license
issued pursuant to
K.S.A.
65-1115, and amendments thereto, who the
pharmacist-in-charge has determined is properly trained may be authorized by
that pharmacist-in-charge to perform the functions of loading and unloading an
automated drug delivery system utilizing a bar code verification, electronic
verification, or similar verification process as specified in subsection
(d).
(l) If any drug has been
removed from the automated drug delivery system, that drug shall not be
replaced into the automated drug delivery system unless either of the following
conditions is met:
(1) The drug's purity,
packaging, and labeling have been examined according to policies and procedures
established by the pharmacist-in-charge to determine that the reuse of the drug
is appropriate.
(2) The drug is one
of the specific drugs, including multidose vials, that have been exempted by
the pharmacy and therapeutics committee or an equivalent committee.
(m) Upon the removal of any
automated drug delivery system, the pharmacist-in-charge shall provide the
board with notification, on a form provided by the board.
