201 Ky. Admin. Regs. 2:360

Current through Register Vol. 51, No. 5, November 1, 2024

Section 201 KAR 2:360 - Opioid antagonist dispensing

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.

201 KAR 2:360

41 Ky.R. 2691; Am. 42 Ky.R. 273 eff. 9-4-2015; 48 Ky.R. 101, 1112; eff. 10-20-2021; 49 Ky.R. 862, 1754; eff. 3/9/2023.

STATUTORY AUTHORITY: KRS 217.186, KRS 315.191(1)(a)