Title 201 | Chapter 002 | Regulation 360


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(5)(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.

Section 4.

Education to be Provided to Person Receiving Naloxone Prescription Under Protocol. 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.

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.

HISTORY: (41 Ky.R. 2691; Am. 42 Ky.R. 273 eff. 9-4-2015; 48 Ky.R. 101, 1112; eff. 10-20-2021.)

7-Year Expiration: 9/4/2022

Last Updated: 12/15/2021


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