Current through Register Vol. 50, No. 9, March 1, 2024
RELATES TO:
KRS
13B.050,
13B.080,
13B.090,
13B.110,
13B.120,
218A.010(39),
218A.200(6),
315.335
NECESSITY, FUNCTION, AND CONFORMITY:
KRS
194A.050(1) requires the
Secretary of the Cabinet for Health and Family Service to promulgate
administrative regulations necessary to implement programs mandated by federal
law, or to qualify for the receipt of federal funds and cooperate with other
state and federal agencies for the proper administration of the cabinet and its
programs.
KRS
218A.250 requires the Cabinet for Health and
Family Services to promulgate administrative regulations for carrying out the
provisions of KRS Chapter 218A. This administrative regulation establishes
requirements related to the placement of emergency medication kits with
controlled substances in long-term care facilities.
Section 1. Definitions.
(1) "Emergency medication kit" or "EMK" is
defined by
201
KAR 2:370, Section 1(3).
(2) "Practitioner" is defined by
KRS
218A.010(39).
Section 2. Storage of Controlled
Substances in an EMK.
(1) A pharmacy provider
may place one (1) EMK that contains controlled substances in:
(a) A residential hospice facility licensed
in accordance with
902
KAR 20:380;
(b) A nursing home licensed in accordance
with
902 KAR
20:048;
(c) A nursing facility licensed in accordance
with
902 KAR
20:300;
(d) An intermediate care facility licensed in
accordance with
902 KAR
20:051;
(e) A personal care home pursuant to
201
KAR 2:370, Section 2(4)(i); or
(f) An intermediate care facility for
individuals with intellectual disabilities licensed in accordance with
902
KAR 20:086.
(2) A long-term care facility with an EMK
shall:
(a) Implement and maintain on-site a
copy of written policies and procedures developed in consultation with the
pharmacy provider, including responsibilities specific to the facility and the
pharmacy as it relates to procuring, using, storing, securing, and replacing
controlled substances in the kit;
(b) Maintain a complete and accurate record
of all controlled substances to be kept in the EMK, including the disposition
of the controlled substances; and
(c) Ensure that the EMK is stored in a
limited access area such as a securely locked:
1. Substantially constructed cabinet;
or
2. Room with restricted
access.
(3)
Controlled substances in the EMK shall be the property of the pharmacy
provider.
(4) The pharmacy provider
shall:
(a) Implement and maintain a copy of
the written policies and procedures required by subsection (2)(a) of this
section;
(b) Maintain a complete
and accurate record of all controlled substances to be kept in the EMK,
including the disposition of the controlled substances;
(c) Be responsible for the labeling, storage,
security, and accountability of all controlled substances in the EMK;
(d) Document completion of a physical
inventory of the controlled substances no less than one (1) time per month;
and
(e) Report theft or loss of
controlled substances from the EMK pursuant to:
1.
KRS
218A.200(6);
2.
KRS
315.335; and
3.
201 KAR
2:205, Section 2(3)(g).
(5) Controlled substances stored
in the EMK shall be selected by the facility's:
(a) Medical director or other
physician;
(b) Consultant
pharmacist; and
(c) Director of
nursing.
(6) Controlled
substances in the EMK shall not exceed six (6) individual doses each of ten
(10) different controlled substances, plus two (2) multi-dose packages in the
smallest unit that is commercially available.
(7) A controlled substance from the EMK shall
be administered only upon the prescription order of an authorized practitioner
who determines that the resident has an immediate medical need.
(8) Access to a controlled substance in the
EMK shall be limited to a:
(a)
Practitioner;
(b) Registered nurse;
or
(c) Other person authorized by
law in this state to access and administer the prescribed medication.
(9) If an EMK is opened for any
reason, the facility shall notify the pharmacy provider within twenty-four (24)
hours after the kit has been opened for the pharmacy to restock and reseal the
kit promptly, if necessary.
Section
3. Adverse Action.
(1) The
Cabinet for Health and Family Services shall deny, suspend, or revoke the
privilege of supplying or possessing an EMK if the cabinet finds substantial
noncompliance with Section 2 of this administrative regulation.
(2) The pharmacy provider or facility may
file an appeal with the cabinet within (10) calendar days of the cabinet's
notice of denial, suspension, or revocation.
(3) If the pharmacy provider or facility
requests an administrative hearing, the cabinet shall:
(a) Appoint a hearing officer; and
(b) Proceed pursuant to
KRS
13B.050.
(4) The administrative hearing shall be
conducted by a hearing officer appointed by the secretary and held in
accordance with
KRS 13B.080,
13B.090,
and
13B.110.
(5) The secretary shall issue a final order
in accordance with
KRS
13B.120.
