Dear Mr. Froelich:
As Executive Director of the Kansas State Board of Pharmacy, you ask our opinion regarding the permissibility of the use of an automated medication dispensing machine in an adult care home, specifically the profile based automated dispensing machine named Pyxis RX Medstation. The specific question you pose is whether, pursuant to K.A.R. 68-7-10(d) concerning emergency medication kits, the Board may grant a "trial period" for use of this system.
Based on information provided to us, we understand that a hospital owns and operates an adult care home which currently receives residents who have higher acuity and shorter lengths of stay than in the past. This has created a need for frequent medication changes as well as timely administration of emergency and first doses. The hospital wishes to place in the adult care home a Pyxis RX Medstation from which the hospital's pharmacy would supply all medications needed for patient use at the adult care home, approximately 200 different types of medications.
Your specific question directs us to K.A.R. 68-7-10(d), emergency medication kits:
"(1) Emergency medication kits shall contain only the drugs which are generally regarded by practitioners as essential to the prompt treatment of sudden and unforeseen changes in a patient's condition which present an imminent threat to the patient's life or well-being.
"(2) Drugs to be contained within emergency medication kits shall be approved by the adult care home pharmaceutical services committee (or its equivalent) composed of at least a practitioner and a pharmacist.
"(3) The emergency medication kit shall conform to the following requirements:
"(A) The kit shall be supplied by a pharmacist who shall retain possession of the drug until it is administered to the patient upon the proper order of a practitioner.
"(B) The kit shall be locked or sealed in a manner that obviously reveals when the kit has been opened or tampered with.
"(C) The kit shall be securely locked in a sufficiently well-constructed cabinet or cart and access to the cabinet or cart shall be available only to the nurse or nurses as determined by the pharmaceutical services committee or its equivalent.
"(D) The kit shall have an expiration date equivalent to the earliest expiration date of drugs within the kit, but in no event more than one year after all of the drugs were placed in the kit.
"(E) All drugs contained within the emergency medication kit shall be returned to the pharmacy as soon as the kit is opened, along with the practitioner's drug order for medications administered."
This Kansas administrative regulation implements sections (b) and (c) of K.S.A. 65-1648 which provide as follows:
"(b) Nothing contained in this act shall be construed as prohibiting an adult care home which utilizes the services of a pharmacist, from maintaining an emergency medication kit approved by the adult care home's medical staff composed of a duly licensed practitioner and a pharmacist. The emergency medication kit shall be used only in emergency cases under the supervision and direction of a duly licensed practitioner, and a pharmacist shall have supervisory responsibility of maintaining said emergency medication kit.
"(c) Every adult care home which maintains an emergency medication kit under subsection (b) shall comply with the following requirements:
"(1) Drugs in an emergency medication kit shall be maintained under the control of the pharmacist in charge of the pharmacy from which the kit came until administered to the patient upon the proper order of a practitioner.
"(2) Drugs contained within the emergency medication kit may include controlled substances, but in such case a pharmaceutical services committee shall be responsible for specifically limiting the type and quantity of controlled substance to be placed in each emergency kit.
"(3) Administration of controlled substances contained within the emergency medication kit shall be in compliance with the provisions of the uniform controlled substances act.
"(4) The consultant pharmacist of the adult care home shall be responsible for developing procedures, proper control and accountability for the emergency medication kit and shall maintain complete and accurate records of the controlled substances, if any, placed in the emergency kit. Periodic physical inventory of the kit shall be required."
In our opinion the hospital's proposal to dispense all medications needed in an adult care facility through use of an automated dispensing machine is beyond the realm of an "emergency medication kit" as contemplated by K.S.A. 65-1648(b) and (c) and K.A.R. 68-7-10(d). Consequently, neither those subsections of the statute nor that subsection of the regulation are applicable to the situation presented and thus we need not reach your question concerning a "trial period." In light of your questions, however, we do remind and caution the Board that in the absence of adequate standards which provide guidance in the exercise of its discretion, it may not waive or make exceptions to regulations, in the form of a "trial period" or otherwise. See Attorney General Opinion No. 92-113.