(a) Each of the following terms, as used in this regulation, shall have the meaning specified in this subsection:
- (1) "Automated drug delivery system" means an automated dispensing system, as defined by K.S.A. 2023 Supp. 65-1626, and amendments thereto, that is located in a long-term care facility, uses a robotic, mechanical, or computerized device to supply each drug to an individual licensed by the board of healing arts or the board of nursing, who shall administer the drug to a patient, and meets the requirements of K.A.R. 68-9-3.
- (2) "E-kit" means an emergency medication kit.
- (3) "Recognized technician" means a pharmacy technician who has passed a certification examination approved by the board in accordance with K.A.R. 68-5-17.
(b) Each pharmacist providing consulting services for a long-term care facility shall ensure that each e-kit contains only the drugs that are generally regarded by practitioners as essential to the prompt treatment of sudden and unforeseen changes in a patient's condition that present an imminent threat to the patient's life or well-being. Each pharmacy that supplies an e-kit to a long-term care facility shall have a written agreement that states:
- (1) Drugs in the e-kit shall be used for administration in emergency situations and not for routine care.
- (2) The e-kit contents shall only be administered by authorized personnel acting on the order of a prescriber which includes compliance with 21 C.F.R. 1306.11 and 21 C.F.R. 1306.21 for controlled substances.
(c) Each pharmacist providing consulting services for the long-term care facility shall ensure that the long-term care facility has policies and procedures that meet the following requirements:
- (1) Each pharmacy supplying an e-kit shall retain ownership of each drug until it is administered to the patient pursuant to the order of a prescriber.
(2) If the e-kit is not in an automated drug delivery system,
- (A) The e-kit shall be locked or sealed in a manner that indicates when the e-kit has been opened or tampered with; and
- (B) within 96 hours after the e-kit has been opened, a pharmacist or a recognized technician shall audit each drug in the e-kit.
- (3) If the e-kit is in an automated drug delivery system, the pharmacy shall audit the e-kit at least once every month.
- (4) The e-kit shall be securely locked in a sufficiently well-constructed cabinet, closet, or cart according to the pharmacist-in-charge's professional judgment or in an automated drug delivery system, with drugs properly stored according to the manufacturer's recommendations.
- (5) Each nurse identified by the pharmaceutical services committee, or its equivalent, may access the e-kit in accordance with a prescriber's order.
- (d) Each automated drug delivery system shall be registered and operated by a pharmacy located in Kansas.
(e) The pharmacist-in-charge or owner shall ensure the following e-kit requirements are met:
- (1) The e-kit shall have an expiration date equivalent to the earliest expiration date of any drugs within the kit.
- (2) At least once every six months, the pharmacist-in-charge or a pharmacist or recognized technician designated by the pharmacist-in-charge shall conduct an audit of each drug placed in the e-kit. Documentation of the audit shall be maintained in a readily retrievable format for a period of at least five years.
(Authorized by K.S.A. 65-1630; implementing K.S.A. 2024 Supp. 65-1637, K.S.A. 65-1642, and K.S.A. 65-1648; effective May 1, 1978; amended May 1, 1983; amended Sept. 9, 1991; amended Aug. 19, 2016; amended Jan. 4, 2019; amended Aug. 29, 2025.)