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 and 41977.
NECESSITY, FUNCTION, AND CONFORMITY: 85 Fed. Reg. 15198, 85
Fed. Reg. 52136 and 86 Fed. Reg 9516, 10588 and 41977 require the Board of
Pharmacy to promulgate an administrative regulation to conform state law to
federal law during the period of this national public health emergency
resulting from the coronavirus (COVID-19) pandemic.
KRS
315.010(22) does not
authorize pharmacists to order 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 order and to
administer vaccinations to children between the ages of three (3) and seventeen
(17) and that state-registered pharmacist interns and pharmacy technicians be
authorized to administer vaccinations to children between the ages of three (3)
and seventeen (17). 85 Fed. Reg. 79190 requires that technicians be authorized
to administer childhood vaccinations and COVID-19 vaccinations and requires
that state law establish a training requirement for all pharmacists,
technicians, and interns 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 ordering 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) "Pharmacist intern" is defined by
KRS
315.010(18).
(4) "Pharmacy technician" is defined by
KRS
315.010(21).
(5) "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 to treat emergency reactions to vaccines.
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 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 treatment of emergency reactions to vaccines;
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
pursuant to a prescription drug order.
Section 3. Pharmacist Intern Requirements. A
pharmacist intern under the general supervision of a pharmacist may administer
a vaccine to an individual if the pharmacist intern:
(1) Completes, or has completed as part of
pharmacy school curriculum, a practical training program accredited by the
Accreditation Council for Pharmacy Education (ACPE) that includes hands-on
injection technique and the recognition and treatment of emergency reactions to
vaccines; and
(2) Possesses a
current certificate in basic cardiopulmonary resuscitation.
Section 4. Pharmacy Technician
Requirements. A pharmacy technician may administer a vaccine under the general
supervision of a pharmacist to an individual, if the pharmacy technician:
(1) Completes a minimum of two (2) hours of
immunization-related continuing education accredited by the Accreditation
Council for Pharmacy Education (ACPE) per each state registration
period;
(2) Completes, or has
completed, a practical training program accredited by the Accreditation Council
for Pharmacy Education (ACPE) that includes hands-on injection technique and
the recognition and treatment of emergency reactions to vaccines; and
(3) Possesses a current certificate in basic
cardiopulmonary resuscitation.
Section 5. Effective Date.
(1) This administrative regulation shall
become effective at 5 p.m. on the date it is filed.
(2) In accordance with
KRS
13A.190, this administrative regulation shall
remain in effect until:
(a) Expiration of the
time period established by
KRS
13A.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
