Current through Register Vol. 50, No. 9, March 1, 2024
RELATES TO:
KRS
315.010,
315.020,
315.050,
315.065,
315.135,
315.205,
42 U.S.C.
247d-6d,
85 Fed. Reg. 15198, 52136, 79190,
86 Fed. Reg. 7872, 9516, 10588, 14462, 41977
NECESSITY, FUNCTION, AND CONFORMITY: 85 Fed. Reg. 15198, 85
Fed. Reg. 52136 and 6 Fed. Reg. 9516, 10588, and 41977, require the Board of
Pharmacy to promulgate an administrative regulation to conform state law to
federal law while the PREP Act declaration remains in effect for COVID-19.
KRS
315.010(22) does not
authorize pharmacists to prescribe vaccinations, nor does
KRS
315.010(22) authorize the
use of prescriber-approved protocols for pharmacists or pharmacist interns to
administer vaccinations to children under the age of nine (9). 85 Fed. Reg.
52136 requires that state-licensed pharmacists be authorized to prescribe and
to administer vaccinations to children between the ages of three (3) and
seventeen (17). 85 Fed. Reg. 79190 requires that state law establish a training
requirement for all pharmacists that will be ordering or administering
vaccinations pursuant to the declaration. The Prep Act (42 U.S.C.
247d-6d(8)) preempts any
state law that would prohibit or effectively prohibit activities authorized by
the secretary in a PREP Act Declaration. This administrative regulation
establishes requirements for Kentucky to comply with 85 Fed. Reg. 15198, 52136,
79190 and 86 Fed. Reg. 7872, 9516, 10588, 14462, and 41977 and ensures a robust
pool of pharmacist for prescribing and administering vaccines.
Section 1. Definitions.
(1) "Administer" is defined by
KRS
315.010(1).
(2) "Pharmacist" is defined by
KRS
315.010(17).
(3) "Prescribe" means to issue an original or
new order from a pharmacist for an FDA-approved or authorized vaccination or
medication, including but not limited to, epinephrine, diphenhydramine, and
corticosteroids for the emergency treatment of acute vaccine
reactions.
Section 2.
Pharmacist Requirements.
(1) A pharmacist may
administer a vaccine to an individual pursuant to the Advisory Committee on
Immunization Practices (ACIP) standard immunization schedule in accordance with
KRS
315.010(22).
(2) A pharmacist may administer a vaccine to
a child, age three (3) through eight (8), pursuant to a prescriber-approved
protocol.
(3) A pharmacist may
prescribe and administer a vaccine to an individual eighteen (18) and under,
pursuant to the ACIP standard immunization schedule, a seasonal flu vaccine to
any individual aged nineteen and over, a COVID-19 vaccine to any individual,
and medications necessary for the emergency treatment of acute vaccine
reactions, if the pharmacist:
(a) Completes or
has completed practical training on administering vaccinations. This may
include:
1. Completion of a practical
training program from an education provider accredited by the Accreditation
Council for Pharmacy Education (ACPE) that includes hands-on injection
technique and the recognition and emergency treatment of acute
reactions;
2. Graduation from an
ACPE accredited pharmacy school in which hands-on immunization training was
part of the curriculum; or
3.
Training via hands-on experience immunizing in current or previous pharmacy
practice; and
(b)
Possesses a current certificate in basic cardiopulmonary
resuscitation.
(4) No
provision in this regulation affects the ability of a pharmacist to administer
a vaccination to any individual pursuant to a prescription drug
order.
Section 3.
Effective Date.
(1) This administrative
regulation shall become effective at 5 p.m. on the date it is filed.
(2) In accordance with
KRS
31A.190, this administrative regulation shall
remain in effect until:
(a) Expiration of the
time period established by
KRS
31A.190; or
(b) Withdrawn in accordance with
KRS
13A.190(12).
(3) The Board of Pharmacy shall
regularly consult with the Governor's Office, the Centers for Disease Control
and Prevention, and other public health authorities to determine if this
administrative regulation shall be withdrawn prior to its expiration under
KRS
13A.190.
STATUTORY AUTHORITY:
KRS
315.191
