Kan. Admin. Regs. § 68-7-10 - Pharmacy-based drug distribution systems in long-term care facilities; emergency medication kits
(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 long-term care facility, 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, and meets the requirements of
K.A.R.
68-9-3.
(2) "Formulary" means a prescription drug
list approved by the pharmacy and therapeutics committee or an equivalent
committee governing the security, control, and distribution of drugs within a
long-term care facility.
(3)
"Long-term care facility" means "nursing facility," as defined in
K.S.A.
39-923 and amendments thereto.
(4) "Traditional system" means a drug
distribution system in which the pharmacist receives a prescription order for
an individual patient and fills the prescription in any manner other than
packaging individual doses in unit-dose containers.
(5) "Unit-dose container" means a single-unit
or multiple-unit container for articles intended for administration in single
doses and directly from the container, by other than parenteral route.
(A) "Multiple-unit container" means a
container that permits the withdrawal of successive portions of the contents
without changing the strength, quality, or purity of the remaining
portion.
(B) "Single-unit
container" means a container that is designed to hold a quantity of a drug
intended for administration as a single dose promptly after the container is
opened.
(6) "Unit-dose
system" means a drug distribution system that is pharmacy-based and uses
unit-dose containers that enable distribution of packaged doses in a manner
that preserves the identity of the drug until the time of
administration.
(b) Each
pharmacy-based drug distribution system for a long-term care facility shall
meet the following requirements:
(1) Be
consistent with the medication needs of each patient;
(2) conform to all federal and state laws and
regulations pertaining to pharmacies; and
(3) meet the following additional
requirements:
(A) Each prescription shall be
dispensed from a pharmacy within a time period that reasonably meets the needs
of the patient, considering the following factors:
(i) The need for the drug as an
emergency;
(ii) the availability of
the drug;
(iii) the pharmacy's
hours of operation; and
(iv) the
stability of the drug;
(B) the supplying pharmacy shall be
responsible for the safe delivery of drugs to a designated person or persons in
the long-term care facility;
(C)
the supplying pharmacy shall provide a method of identifying the date and
quantity of medication dispensed;
(D) a patient medication profile record
system shall be maintained for each long-term care facility patient serviced by
the supplying pharmacy and shall contain the information necessary to allow the
pharmacist to monitor each patient's drug therapy; and
(E) each medication distribution system
container shall be labeled to permit the identification of the drug
therapy.
(c)
Each unit-dose system shall meet the following requirements, in addition to the
requirements in subsection (b):
(1) All
medication shall be packaged in unit-dose containers as far as practicable and
the packaging shall meet the requirements of
K.A.R.
68-7-15 and
68-7-16,
unless the manufacturer specifies a different type of packaging to be used to
prevent adulteration as defined by
K.S.A.
65-668, and amendments thereto.
(2) The pharmacist shall be responsible for
filling and refilling prescriptions or prescriber's orders, or both, according
to the directions of the prescriber by relying on the original prescription or
prescriber's order or a copy thereof.
(3) The pharmacist shall comply with all
requirements for prescription orders, including inventory and recordkeeping
requirements, under the following:
(A) The
Kansas uniform controlled substances act,
K.S.A.
65-4101 et seq. and amendments
thereto;
(B) the Kansas pharmacy
act,
K.S.A.
65-1625 et seq. and amendments
thereto;
(C) the board's applicable
regulations in articles 1 and 20; and
(D) all federal laws and regulations
applicable to prescriptions or medication orders.
(4) Packaging for the unit-dose system shall
take place at the address of the pharmacy providing the unit-dose
system.
(5) Container requirements
for unit-dose systems may include trays, bins, carts, and locked cabinets if
the requirements of
K.A.R.
68-7-14 are met. If these options are used,
all patient medication trays or drawers shall be sufficiently labeled to
identify each patient.
(6) Each
unit-dose system shall provide a verification check at the point of patient
administration in order to ensure proper drug utilization.
(7) The delivery time-cycle or hours of
exchange shall not be limited to a specific time, but shall depend upon the
pharmacist's discretion, the needs of the long-term care facility, the
stability of the drug, and the type of container used.
(8) The pharmacist shall have sole
responsibility for dispensing under the unit-dose system.
(d)
(1)
Each emergency medication kit shall contain only the drugs that are generally
regarded by practitioners as essential to the prompt treatment of sudden and
unforeseen changes in a patient's condition that present an imminent threat to
the patient's life or well-being.
(2) Each drug to be contained within an
emergency medication kit shall be approved by the long-term care facility's
pharmaceutical services committee or its equivalent, either of which shall be
composed of at least a practitioner and a pharmacist.
(3) The pharmacist providing each emergency
medication kit shall ensure that the following requirements are met:
(A) The kit shall be supplied by a
pharmacist, who shall retain possession of the drug until it is administered to
the patient upon the valid order of a prescriber.
(B) If the kit is not in an automated drug
delivery system, the kit shall be locked or sealed in a manner that indicates
when the kit has been opened or tampered with.
(C) The kit shall be securely locked in a
sufficiently well-constructed cabinet or cart or in an automated drug delivery
system, with drugs properly stored according to the manufacturer's
recommendations. Access to the cabinet or cart shall be available only to each
nurse specified by the pharmaceutical services committee or its
equivalent.
(D) The kit shall have
an expiration date equivalent to the earliest expiration date of the drugs
within the kit, but in no event more than one year after all of the drugs were
placed in the kit.
(E) Unless the
kit is in an automated drug delivery system, all drugs contained within the
emergency medication kit shall be returned to the pharmacy as soon as the kit
has been opened, along with the prescriber's drug order for medications
administered.
Notes
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