Title 201 | Chapter 002 | Regulation 360
SUPERSEDED
This document is no longer current.
PREVIOUS VERSION
The previous document that this document is based upon is available.
BOARDS AND COMMISSIONER
Board of Pharmacy
(Amendment)
201 KAR 2:360.Naloxone dispensing.
Section 1.
Certification.(1)
A pharmacist desiring to achieve certification to initiate the dispensing of naloxone shall complete and submit an Application for Pharmacist Certification for Naloxone 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 Naloxone. A pharmacist may initiate the dispensing of naloxone 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 naloxone was provided with the required training and education pursuant to Section 4 of this administrative regulation, unless the recipient of the Naloxone is a person or agency operating a harm reduction program.(5)
A pharmacist may dispense naloxone to any person or agency who provides training on the mechanism and circumstances for the administration of naloxone to the public as part of a harm reduction program, regardless of whom the ultimate user of the naloxone may be. The documentation of the dispensing of naloxone 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 naloxone shall contain:(1)
Criteria for identifying persons or agencies eligible to receive naloxone under the protocol;(2)
Naloxone 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 naloxone is dispensed;(4)
Procedures for documentation of naloxone 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; and(7)
The names and work addresses of pharmacists authorized to initiate dispensing of naloxone under the protocol.(8)
Authorization for naloxone to be supplied to an emergency department for dispensing under the protocol.Section 4.
Education to be Provided to Person Receiving Naloxone Prescription Under Protocol. Except as described in Section 5(e), a pharmacist dispensing naloxone 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 naloxone dispensed.Section 5.
(1)
Nothing shall prohibit a pharmacist from supplying naloxone to an emergency department to be dispensed per the physician approved protocol provided that:(a)
If the pharmacist is providing the naloxone 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 naloxone is stored in a locked drug storage area or automated pharmacy system;(c)
Access to the naloxone storage area is monitored and approved per a service agreement or hospital policy;(d)
There is a monthly documented check of the naloxone storage area for proper storage, labeling, education material, and expiration dating;(e)
With the exception of patient name, the pharmacist labels the naloxone in accordance with KRS 217.065 prior to supplying to the emergency department;(f)
Naloxone 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 education materials appropriate to the dosage form of naloxone 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.Section 5.
Incorporation by Reference.(1)
"Application for Pharmacist Certification for Naloxone Dispensing", Form 1, 6/2021, 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/Documents/APPLICATION%20FOR%20PHARMACIST%20CERTIFICATION%20FOR%20NALOXONE%20DISPENSING.pdf.CHRISTOPHER HARLOW, Pharm.D., Executive Director
APPROVED BY AGENCY: September 14, 2022
FILED WITH LRC: September 14, 2022 at 3:15 p.m.
PUBLIC HEARING AND COMMENT PERIOD: A public hearing on this administrative regulation shall be held on November 30, 2022, at 9:00 a.m. Eastern Time via zoom teleconference and at the Kentucky Transportation Cabinet Auditorium, 200 Mero Street, Frankfort, Kentucky 40601. Individuals interested in being heard at this hearing shall notify this agency in writing by five workdays prior to the hearing, of their intent to attend. If no notification of intent to attend the hearing is received by that date, the hearing may be canceled. This hearing is open to the public. Any person who wishes to be heard will be given an opportunity to comment on the proposed administrative regulation. A transcript of the public hearing will not be made unless a written request for a transcript is made. If you do not wish to be heard at the public hearing, you may submit written comments on the proposed administrative regulation. Written comments shall be accepted through November 30, 2022. Send written notification of intent to be heard at the public hearing or written comments on the proposed administrative regulation to the contact person.
CONTACT PERSON: Christopher Harlow, Executive Director, Kentucky Board of Pharmacy, 125 Holmes Street, Suite 300, State Office Building Annex, Frankfort, Kentucky 40601, phone (502) 564-7910, fax (502) 696-3806, email Christopher.harlow@ky.gov.
REGULATORY IMPACT ANALYSIS AND TIERING STATEMENT
Contact Person:
Christopher Harlow
(1) Provide a brief summary of:
(a) What this administrative regulation does:
This administrative regulation establishes the minimum requirements for the pharmacist to be able to dispense naloxone pursuant to a physician-approval protocol to an individual, agency or hospital emergency room stock.
(b) The necessity of this administrative regulation:
This administrative regulation is necessary to enable the dispensing of naloxone as part of harm reduction programs.
(c) How this administrative regulation conforms to the content of the authorizing statutes:
This administrative regulation, authorized by KRS 217.186, establishes the minimum requirements for the pharmacist to dispense naloxone pursuant for harm reduction programs and pursuant to a physician approved protocol.
(d) How this administrative regulation currently assists or will assist in the effective administration of the statutes:
KRS 217.186 enables the Board of Pharmacy to promulgate an administrative regulation to identify the appropriate procedures for the dispensing of naloxone by a pharmacist to an individual or an agency.
(2) If this is an amendment to an existing administrative regulation, provide a brief summary of:
(a) How the amendment will change this existing administrative regulation:
This amendment authorizes emergency departments to stock naloxone so that patients treated in the emergency department can be dispensed naloxone before being discharged in situations when the outpatient pharmacy is closed.
(b) The necessity of the amendment to this administrative regulation:
This amendment is necessary to ensure patients have access to a lifesaving drug even if the outpatient pharmacy is closed.
(c) How the amendment conforms to the content of the authorizing statutes:
KRS 217.186 requires the Board of Pharmacy to promulgate administrative regulations governing dispensing of naloxone by a pharmacist. KRS 315.191(1)(a) authorizes the board to promulgate regulations.
(d) How the amendment will assist in the effective administration of the statutes:
The amendment will further promote, preserve, and protect public health by ensuring that patients discharged from the emergency department when outpatient pharmacies are closed are provided with take-home naloxone to possibly prevent a future overdose.
(3) List the type and number of individuals, businesses, organizations, or state and local governments affected by this administrative regulation:
The board anticipates pharmacists, individual persons, and agencies will be minimally impacted by this regulation amendment.
(4) Provide an analysis of how the entities identified in question (3) will be impacted by either the implementation of this administrative regulation, if new, or by the change, if it is an amendment, including:
(a) List the actions that each of the regulated entities identified in question (3) will have to take to comply with this administrative regulation or amendment:
Pharmacists, individual persons, and agencies will have to familiarize themselves with the amended language.
(b) In complying with this administrative regulation or amendment, how much will it cost each of the entities identified in question (3):
There are no expected costs for the entities identified to comply with the amendment.
(c) As a result of compliance, what benefits will accrue to the entities identified in question (3):
This amendment will provide ensure that pharmacists can best serve their patients that need access to naloxone to prevent a potential overdose. (5) Provide an estimate of how much it will cost to implement this administrative regulation:
(5) Provide an estimate of how much it will cost the administrative body to implement this administrative regulation:
(a) Initially:
No costs will be incurred.
(b) On a continuing basis:
No costs will be incurred.
(6) What is the source of the funding to be used for the implementation and enforcement of this administrative regulation:
Board revenues from pre-existing fees provide the funding to enforce the regulation.
(7) Provide an assessment of whether an increase in fees or funding will be necessary to implement this administrative regulation, if new, or by the change if it is an amendment:
No increase in fees or funding will be required because of this new regulation.
(8) State whether or not this administrative regulation establishes any fees or directly or indirectly increases any fees:
This administrative regulation does not establish fees or directly or indirectly increase any fees.
(9) TIERING: Is tiering applied?
Tiering is not applied because this regulation is applicable to all pharmacists, individual persons, and agencies which seek to dispense naloxone as part of a harm reduction program.
FISCAL NOTE
(1) What units, parts, or divisions of state or local government (including cities, counties, fire departments, or school districts) will be impacted by this administrative regulation?
Pharmacies and private and public agencies will be impacted by this administrative regulation amendment.
(2) Identify each state or federal statute or federal regulation that requires or authorizes the action taken by the administrative regulation.
KRS 217.186, KRS 315.191(1)(a).
(3) Estimate the effect of this administrative regulation on the expenditures and revenues of a state or local government agency (including cities, counties, fire departments, or school districts) for the first full year the administrative regulation is to be in effect.
(a) How much revenue will this administrative regulation generate for the state or local government (including cities, counties, fire departments, or school districts) for the first year?
This administrative regulation will not generate revenue for the Board in the first year.
(b) How much revenue will this administrative regulation generate for the state or local government (including cities, counties, fire departments, or school districts) for subsequent years?
This administrative regulation will not generate revenue for the Board in subsequent years.
(c) How much will it cost to administer this program for the first year?
No costs are required to administer this program for the first year.
(d) How much will it cost to administer this program for subsequent years?
No costs are required to administer this program for subsequent years. Note: If specific dollar estimates cannot be determined, provide a brief narrative to explain this fiscal impact of the administrative regulation.
Note: If specific dollar estimates cannot be determined, provide a brief narrative to explain the fiscal impact of the administrative regulation.
Revenues (+/-):
0
Expenditures (+/-):
0
Other Explanation:
(4) Estimate the effect of this administrative regulation on the expenditures and cost savings of regulated entities for the first full year the administrative regulation is to be in effect.
(a) How much cost savings will this administrative regulation generate for the regulated entities for the first year?
There is no cost savings from this administrative regulation.
(b) How much cost savings will this administrative regulation generate for the regulated entities for subsequent years?
There is no cost savings for this administrative regulation in subsequent years.
(c) How much will it cost the regulated entities for the first year?
There is no cost.
(d) How much will it cost the regulated entities for subsequent years?
There is no cost in subsequent years Note: If specific dollar estimates cannot be determined, provide a brief narrative to explain the fiscal impact of the administrative regulation.
Note: If specific dollar estimates cannot be determined, provide a brief narrative to explain the fiscal impact of the administrative regulation.
Cost Savings (+/-):
0
Expenditures (+/-):
0
Other Explanation:
n/a
(5) Explain whether this administrative regulation will have a major economic impact, as defined below.
"Major economic impact" means an overall negative or adverse economic impact from an administrative regulation of five hundred thousand dollars ($500,000) or more on state or local government or regulated entities, in aggregate, as determined by the promulgating administrative bodies. [KRS 13A.010(13)] This administrative regulation will not have a major economic impact.
BOARDS AND COMMISSIONER
Board of Pharmacy
(Amendment)
201 KAR 2:360.Naloxone dispensing.
Section 1.
Certification.(1)
A pharmacist desiring to achieve certification to initiate the dispensing of naloxone shall complete and submit an Application for Pharmacist Certification for Naloxone 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 Naloxone. A pharmacist may initiate the dispensing of naloxone 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 naloxone was provided with the required training and education pursuant to Section 4 of this administrative regulation, unless the recipient of the Naloxone is a person or agency operating a harm reduction program.(5)
A pharmacist may dispense naloxone to any person or agency who provides training on the mechanism and circumstances for the administration of naloxone to the public as part of a harm reduction program, regardless of whom the ultimate user of the naloxone may be. The documentation of the dispensing of naloxone 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 naloxone shall contain:(1)
Criteria for identifying persons or agencies eligible to receive naloxone under the protocol;(2)
Naloxone 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 naloxone is dispensed;(4)
Procedures for documentation of naloxone 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; and(7)
The names and work addresses of pharmacists authorized to initiate dispensing of naloxone under the protocol.(8)
Authorization for naloxone to be supplied to an emergency department for dispensing under the protocol.Section 4.
Education to be Provided to Person Receiving Naloxone Prescription Under Protocol. Except as described in Section 5(e), a pharmacist dispensing naloxone 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 naloxone dispensed.Section 5.
(1)
Nothing shall prohibit a pharmacist from supplying naloxone to an emergency department to be dispensed per the physician approved protocol provided that:(a)
If the pharmacist is providing the naloxone 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 naloxone is stored in a locked drug storage area or automated pharmacy system;(c)
Access to the naloxone storage area is monitored and approved per a service agreement or hospital policy;(d)
There is a monthly documented check of the naloxone storage area for proper storage, labeling, education material, and expiration dating;(e)
With the exception of patient name, the pharmacist labels the naloxone in accordance with KRS 217.065 prior to supplying to the emergency department;(f)
Naloxone 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 education materials appropriate to the dosage form of naloxone 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 Naloxone Dispensing", Form 1, 6/2021, 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/Documents/APPLICATION%20FOR%20PHARMACIST%20CERTIFICATION%20FOR%20NALOXONE%20DISPENSING.pdf.CHRISTOPHER HARLOW, Pharm.D., Executive Director
APPROVED BY AGENCY: September 14, 2022
FILED WITH LRC: September 14, 2022 at 3:15 p.m.
PUBLIC HEARING AND COMMENT PERIOD: A public hearing on this administrative regulation shall be held on November 30, 2022, at 9:00 a.m. Eastern Time via zoom teleconference and at the Kentucky Transportation Cabinet Auditorium, 200 Mero Street, Frankfort, Kentucky 40601. Individuals interested in being heard at this hearing shall notify this agency in writing by five workdays prior to the hearing, of their intent to attend. If no notification of intent to attend the hearing is received by that date, the hearing may be canceled. This hearing is open to the public. Any person who wishes to be heard will be given an opportunity to comment on the proposed administrative regulation. A transcript of the public hearing will not be made unless a written request for a transcript is made. If you do not wish to be heard at the public hearing, you may submit written comments on the proposed administrative regulation. Written comments shall be accepted through November 30, 2022. Send written notification of intent to be heard at the public hearing or written comments on the proposed administrative regulation to the contact person.
CONTACT PERSON: Christopher Harlow, Executive Director, Kentucky Board of Pharmacy, 125 Holmes Street, Suite 300, State Office Building Annex, Frankfort, Kentucky 40601, phone (502) 564-7910, fax (502) 696-3806, email Christopher.harlow@ky.gov.
REGULATORY IMPACT ANALYSIS AND TIERING STATEMENT
Contact Person:
Christopher Harlow
(1) Provide a brief summary of:
(a) What this administrative regulation does:
This administrative regulation establishes the minimum requirements for the pharmacist to be able to dispense naloxone pursuant to a physician-approval protocol to an individual, agency or hospital emergency room stock.
(b) The necessity of this administrative regulation:
This administrative regulation is necessary to enable the dispensing of naloxone as part of harm reduction programs.
(c) How this administrative regulation conforms to the content of the authorizing statutes:
This administrative regulation, authorized by KRS 217.186, establishes the minimum requirements for the pharmacist to dispense naloxone pursuant for harm reduction programs and pursuant to a physician approved protocol.
(d) How this administrative regulation currently assists or will assist in the effective administration of the statutes:
KRS 217.186 enables the Board of Pharmacy to promulgate an administrative regulation to identify the appropriate procedures for the dispensing of naloxone by a pharmacist to an individual or an agency.
(2) If this is an amendment to an existing administrative regulation, provide a brief summary of:
(a) How the amendment will change this existing administrative regulation:
This amendment authorizes emergency departments to stock naloxone so that patients treated in the emergency department can be dispensed naloxone before being discharged in situations when the outpatient pharmacy is closed.
(b) The necessity of the amendment to this administrative regulation:
This amendment is necessary to ensure patients have access to a lifesaving drug even if the outpatient pharmacy is closed.
(c) How the amendment conforms to the content of the authorizing statutes:
KRS 217.186 requires the Board of Pharmacy to promulgate administrative regulations governing dispensing of naloxone by a pharmacist. KRS 315.191(1)(a) authorizes the board to promulgate regulations.
(d) How the amendment will assist in the effective administration of the statutes:
The amendment will further promote, preserve, and protect public health by ensuring that patients discharged from the emergency department when outpatient pharmacies are closed are provided with take-home naloxone to possibly prevent a future overdose.
(3) List the type and number of individuals, businesses, organizations, or state and local governments affected by this administrative regulation:
The board anticipates pharmacists, individual persons, and agencies will be minimally impacted by this regulation amendment.
(4) Provide an analysis of how the entities identified in question (3) will be impacted by either the implementation of this administrative regulation, if new, or by the change, if it is an amendment, including:
(a) List the actions that each of the regulated entities identified in question (3) will have to take to comply with this administrative regulation or amendment:
Pharmacists, individual persons, and agencies will have to familiarize themselves with the amended language.
(b) In complying with this administrative regulation or amendment, how much will it cost each of the entities identified in question (3):
There are no expected costs for the entities identified to comply with the amendment.
(c) As a result of compliance, what benefits will accrue to the entities identified in question (3):
This amendment will provide ensure that pharmacists can best serve their patients that need access to naloxone to prevent a potential overdose. (5) Provide an estimate of how much it will cost to implement this administrative regulation:
(5) Provide an estimate of how much it will cost the administrative body to implement this administrative regulation:
(a) Initially:
No costs will be incurred.
(b) On a continuing basis:
No costs will be incurred.
(6) What is the source of the funding to be used for the implementation and enforcement of this administrative regulation:
Board revenues from pre-existing fees provide the funding to enforce the regulation.
(7) Provide an assessment of whether an increase in fees or funding will be necessary to implement this administrative regulation, if new, or by the change if it is an amendment:
No increase in fees or funding will be required because of this new regulation.
(8) State whether or not this administrative regulation establishes any fees or directly or indirectly increases any fees:
This administrative regulation does not establish fees or directly or indirectly increase any fees.
(9) TIERING: Is tiering applied?
Tiering is not applied because this regulation is applicable to all pharmacists, individual persons, and agencies which seek to dispense naloxone as part of a harm reduction program.
FISCAL NOTE
(1) What units, parts, or divisions of state or local government (including cities, counties, fire departments, or school districts) will be impacted by this administrative regulation?
Pharmacies and private and public agencies will be impacted by this administrative regulation amendment.
(2) Identify each state or federal statute or federal regulation that requires or authorizes the action taken by the administrative regulation.
KRS 217.186, KRS 315.191(1)(a).
(3) Estimate the effect of this administrative regulation on the expenditures and revenues of a state or local government agency (including cities, counties, fire departments, or school districts) for the first full year the administrative regulation is to be in effect.
(a) How much revenue will this administrative regulation generate for the state or local government (including cities, counties, fire departments, or school districts) for the first year?
This administrative regulation will not generate revenue for the Board in the first year.
(b) How much revenue will this administrative regulation generate for the state or local government (including cities, counties, fire departments, or school districts) for subsequent years?
This administrative regulation will not generate revenue for the Board in subsequent years.
(c) How much will it cost to administer this program for the first year?
No costs are required to administer this program for the first year.
(d) How much will it cost to administer this program for subsequent years?
No costs are required to administer this program for subsequent years. Note: If specific dollar estimates cannot be determined, provide a brief narrative to explain this fiscal impact of the administrative regulation.
Note: If specific dollar estimates cannot be determined, provide a brief narrative to explain the fiscal impact of the administrative regulation.
Revenues (+/-):
0
Expenditures (+/-):
0
Other Explanation:
(4) Estimate the effect of this administrative regulation on the expenditures and cost savings of regulated entities for the first full year the administrative regulation is to be in effect.
(a) How much cost savings will this administrative regulation generate for the regulated entities for the first year?
There is no cost savings from this administrative regulation.
(b) How much cost savings will this administrative regulation generate for the regulated entities for subsequent years?
There is no cost savings for this administrative regulation in subsequent years.
(c) How much will it cost the regulated entities for the first year?
There is no cost.
(d) How much will it cost the regulated entities for subsequent years?
There is no cost in subsequent years Note: If specific dollar estimates cannot be determined, provide a brief narrative to explain the fiscal impact of the administrative regulation.
Note: If specific dollar estimates cannot be determined, provide a brief narrative to explain the fiscal impact of the administrative regulation.
Cost Savings (+/-):
0
Expenditures (+/-):
0
Other Explanation:
n/a
(5) Explain whether this administrative regulation will have a major economic impact, as defined below.
"Major economic impact" means an overall negative or adverse economic impact from an administrative regulation of five hundred thousand dollars ($500,000) or more on state or local government or regulated entities, in aggregate, as determined by the promulgating administrative bodies. [KRS 13A.010(13)] This administrative regulation will not have a major economic impact.