Current through Register Vol. 51, No. 3, September 1, 2024
RELATES TO:
KRS
217.186
NECESSITY, FUNCTION, AND CONFORMITY:
KRS
217.186(6) requires the
Board of Pharmacy to promulgate administrative regulations governing dispensing
of an opioid antagonist by a pharmacist pursuant to a physician-approved
protocol. This administrative regulation establishes the minimum requirements
for the pharmacist to be able to dispense an opioid antagonist pursuant to a
physician-approved protocol; and provides the requirements for a pharmacy to
stock an opioid antagonist to an emergency department.
Section 1. Certification.
(1) A pharmacist desiring to achieve
certification to initiate the dispensing of an opioid antagonist shall complete
and submit an Application for Pharmacist Certification for Opioid Antagonist
Dispensing, Form 1, with the board and provide the following:
(a) Name;
(b) Address;
(c) Phone number; and
(d) Pharmacist license number.
(2) The board shall issue the
certification to a pharmacist within thirty (30) days of the receipt of the
application.
Section 2.
Procedures for Dispensing of an Opioid Antagonist. A pharmacist may initiate
the dispensing of an opioid antagonist under the following conditions:
(1) The pharmacist has met the requirements
of Section 1 of this administrative regulation;
(2) The pharmacist has received his or her
certification;
(3) The pharmacist
has a physician-approved protocol that meets the minimum requirements of
Section 3 of this administrative regulation; and
(4) The pharmacist documents the dispensing
event in the pharmacy management system including:
(a) Documentation as required in
201 KAR 2:171 for the dispensing
of prescription medication; and
(b)
Documentation that the individual receiving an opioid antagonist was provided
with the required training and education pursuant to Section 4 of this
administrative regulation, unless the recipient of the opioid antagonist is a
person or agency operating a harm reduction program.
(5) A pharmacist may dispense an opioid
antagonist to any person or agency who provides training on the mechanism and
circumstances for the administration of an opioid antagonist to the public as
part of a harm reduction program, regardless of whom the ultimate user of the
opioid antagonist may be. The documentation of the dispensing of an opioid
antagonist to any person or agency operating a harm reduction program shall
satisfy any general documentation or recording requirements.
Section 3. Protocol Minimum
Requirements. A physician-approved protocol authorizing a pharmacist to
initiate the dispensing of an opioid antagonist shall contain:
(1) Criteria for identifying persons or
agencies eligible to receive an opioid antagonist under the protocol;
(2) Opioid antagonist products authorized to
be dispensed, including:
(a) Name of
product;
(b) Dose; and
(c) Route of administration;
(3) Specific education to be
provided to the person whom the opioid antagonist is dispensed;
(4) Procedures for documentation of opioid
antagonist dispensation, including procedures for notification of the physician
authorizing the protocol, if desired by the physician in accordance with
KRS
217.186(6)(b) 3.;
(5) The length of time the protocol is in
effect;
(6) The date and signature
of the physician approving the protocol;
(7) The names and work addresses of
pharmacists authorized to initiate dispensing of an opioid antagonist under the
protocol; and
(8) Authorization for
an opioid antagonist to be supplied to an emergency department for dispensing
under the protocol.
Section
4. Education to be Provided to Person Receiving an Opioid
Antagonist Prescription Under Protocol. Except as described in Section 2(5) of
this administrative regulation, a pharmacist dispensing an opioid antagonist to
a person or agency not operating a harm reduction program shall provide verbal
counseling and written educational materials appropriate to the dosage form of
an opioid antagonist dispensed.
Section
5.
(1) A pharmacist may supply
an opioid antagonist to an emergency department to be dispensed per the
physician approved protocol if:
(a) The
pharmacist is providing the opioid antagonist from a pharmacy other than the
institutional pharmacy, the pharmacy is under common ownership, or has a
written service agreement with the hospital;
(b) The opioid antagonist is stored in a
locked drug storage area or automated pharmacy system;
(c) Access to the opioid antagonist storage
area is monitored and approved per a service agreement or hospital
policy;
(d) There is a monthly
documented check of the opioid antagonist storage area for proper storage,
labeling, educational material, and expiration dating;
(e) With the exception of patient name, the
pharmacist labels the opioid antagonist in accordance with
KRS
217.065 prior to supplying to the emergency
department;
(f) An opioid
antagonist from this supply is provided to the patient by a licensed health
care provider as described in
KRS
217.186(2);
(g) The patient is provided written
educational materials appropriate to the dosage form of the opioid antagonist
which includes the telephone number of the supplying pharmacy;
(h) A record of each provision to a patient
is communicated to the providing pharmacy and documented in the pharmacy
management system; and
(i) The
dispensing record is reviewed by a pharmacist at the supplying pharmacy within
one (1) pharmacy business day.
(2) Dispensing from an emergency drug stock
shall not require a prospective drug use review.
Section 6. Incorporation by Reference.
(1) "Application for Pharmacist Certification
for Opioid Antagonist Dispensing", Form 1, 12/2022, is incorporated by
reference.
(2) This material may be
inspected, copied, or obtained, subject to applicable copyright law, at the
Kentucky Board of Pharmacy, 125 Holmes Street, Suite 300, State Office Building
Annex, Frankfort, Kentucky 40601, Monday through Friday, 8 a.m. to 4:30 p.m. or
on the Web site at:
https://pharmacy.ky.gov/Forms/Documents/Application%20for%20Pharmacist%20Certification%20for%20OPIOID%20ANTAGONIST%20Dispensing%20%2812-2022%29.pdf.
STATUTORY AUTHORITY:
KRS
217.186,
KRS
315.191(1)(a)
