Current through Register Vol. 51, No. 3, September 1, 2024
RELATES TO:
KRS
315.010(25),
315.121(1)(a),
315.191(1)(a),
(f)
NECESSITY, FUNCTION, AND CONFORMITY:
KRS
315.010(25) defines a
prescription drug order, which includes orders issued through protocols
authorized by the board.
KRS
315.191(1)(a) authorizes the
board to promulgate administrative regulations necessary to regulate and
control all matters pertaining to pharmacists, pharmacist interns, pharmacy
technicians, and pharmacies.
KRS
315.191(1)(f) authorizes the
board to promulgate administrative regulations that are necessary to control
the dispensing of prescription drug orders. This administrative regulation
establishes procedures for board authorized protocols by which pharmacists may
initiate the dispensing of noncontrolled medications or other professional
services.
Section 1. Definitions.
(1) "Fully executed" means a protocol has
been signed and dated by the prescriber and the pharmacist or pharmacists who
are the party or parties to the protocol agreement as required by Section 3 of
this administrative regulation.
(2)
"Prescriber" means any Kentucky licensed physician or advanced practice
registered nurse practitioner.
(3)
"Protocol" means a written agreement between a pharmacist or pharmacists and a
prescriber that outlines the plan to initiate the dispensing of noncontrolled
medications, over-the-counter medications, or other professional services
within the prescriber's statutory scope of practice.
(4) "Protocol registry" means the records
maintained by the board of any fully executed protocol that is being utilized
to initiate the dispensing of noncontrolled medications, over-the-counter
medications, or other professional services.
Section 2. Procedures. A pharmacist or
pharmacists utilizing a protocol may initiate the dispensing of noncontrolled
medications, over-the-counter medications, or other professional services under
the following conditions:
(1) The protocol:
(a) Meets the minimum requirements in Section
3 of this administrative regulation;
(b) Directs the care, based on current
clinical guidelines, for conditions listed in Section 5 of this administrative
regulation;
(c) States the permit
number of the Kentucky permitted pharmacy where the protocol will be
utilized;
(d) Has been reviewed and
authorized by the board prior to its execution; and
(e) Has been fully executed and submitted to
the board for inclusion in the protocol registry, which shall be made available
to the prescriber's licensing board upon request.
(2) The pharmacist or pharmacists documents
the dispensing event in the pharmacy management system, including:
(a) Documentation as required by
201 KAR 2:171 for the dispensing
of prescription medication; and
(b)
Documentation that the individual receiving the medication or other
professional service was provided with education pursuant to Section 3(4) of
this administrative regulation;
(3) A pharmacist shall request the
individual's primary care provider's information, provided one exists, and
shall provide notification to the primary care provider within two (2) business
days;
(4) Any pharmacist not party
to the fully executed protocol shall not utilize the protocol;
(5) A pharmacist utilizing the protocol shall
be employed by or contracted with the permit holder;
(6) A fully executed protocol shall not be
used to initiate the dispensing of medications or to provide other professional
services until it has been submitted to the board for inclusion in the protocol
registry; and
(7) The
pharmacist-in-charge shall be responsible for:
(a) Submitting the fully executed protocol to
the board for inclusion into the registry; and
(b) Submitting a written notification to the
board to remove a protocol from the registry no later than thirty (30) days
after discontinuing a protocol.
Section 3. Minimum Requirements of Protocol.
Protocols shall contain the following elements:
(1) Criteria for identifying persons eligible
to receive medication therapies or other professional services under the
protocol, and referral to an appropriate prescriber if the patient is high-risk
or treatment is contraindicated;
(2) A list of the medications, including
name, dose, route, frequency of administration, and refills authorized to be
dispensed under the protocol;
(3)
Procedures for how the medications are to be initiated and monitored, including
a care plan implemented in accordance with clinical guidelines;
(4) Education to be provided to the person
receiving the dispensed medications, including aftercare instructions, if
appropriate;
(5) Procedures for
documenting in the pharmacy management system all medications dispensed,
including notification of the prescriber signing the protocol, if
requested;
(6) Length of time
protocol is in effect;
(7) Date and
signature of prescriber approving the protocol;
(8) Dates and signatures of the pharmacists
authorized to initiate dispensing of medications or other professional services
under the protocol; and
(9) The
date, and education or training of the pharmacist as referenced in Section 4 of
this administrative regulation.
Section 4. Pharmacist Education and Training
Required. A pharmacist who dispenses medication pursuant to a
prescriber-approved protocol shall first receive education and training in the
subject matter of the protocol from a provider accredited by the Accreditation
Council for Pharmacy Education or by a comparable provider approved by the
board. Documentation of education shall be provided to the board upon request.
Education shall be obtained prior to initiating care under the protocol. A
failure to be educated and trained before utilizing the prescriber-approved
protocol may result in disciplinary action pursuant to
KRS
315.121(1)(a).
Section 5. Authorized Conditions.
Board-authorized protocols may be established for the following conditions:
(1) Acute influenza infection pursuant to
recommendations by the Centers for Disease Control and Prevention
(CDC);
(2) Acute streptococcal
pharyngitis infection;
(3) Acute,
uncomplicated urinary tract infection;
(4) Acute cutaneous or mucocutaneous fungal
infection;
(5) Alcohol use disorder
utilizing naltrexone-based therapy pursuant to recommendations from the
American Psychiatric Association;
(6) Allergic rhinitis;
(7) Anaphylaxis;
(8) Colorectal cancer prevention and
screening;
(9) HCV infection
screening;
(10) HIV infection
prophylaxis, pre-exposure and post-exposure pursuant to recommendations by the
CDC;
(11) HIV infection screening
pursuant to recommendations by the CDC;
(12) Nutritional supplementation with
vitamins and minerals;
(13) Opioid
use disorder pursuant to recommendations by the American Society of Addiction
Medicine;
(14) Tobacco use
disorder;
(15) Traveler's health
pursuant to recommendations by the CDC;
(16) Tuberculosis prevention and control
through skin testing, and referral as necessary, pursuant to recommendations by
the CDC;
(17) Self-care conditions
appropriately treated with over-the-counter medications and products;
and
(18) Covid-19 infection
pursuant to recommendations by the CDC.
Section 6. Protocol Review Committee.
(1) The board shall form a committee
comprised of four (4) pharmacists and one (1) physician. This committee shall
meet no less than quarterly to:
(a) Evaluate
new protocols proposed for board approval to ensure compliance with Section
2(1)(b) and Section 3 of this administrative regulation; and
(b) Review previously authorized protocols no
later than three (3) years from the authorization date to ensure alignment with
current practice guidelines.
(2) The protocol review committee may consult
with an expert with relevant practice experience.
(3) The pharmacists shall be appointed by the
Board of Pharmacy and the physician by the Kentucky Board of Medical
Licensure.
(4) Terms for the
pharmacist and physician members on the committee shall be for a term of four
(4) years.
(5) The chair of the
committee shall be a pharmacist member.
STATUTORY AUTHORITY:
KRS
315.010(25),
315.191(1)(a),
(f)
