902 KAR 55:070. Storage of controlled substances in an emergency medication kit in certain long-term care facilities.

 

      RELATES TO: KRS 218A.180, 218A.200

      STATUTORY AUTHORITY: KRS 194A.050 194.050, 218A.250

      NECESSITY, FUNCTION, AND CONFORMITY: KRS 218A.250 directs the Cabinet for Health and Family Services to adopt rules and administrative regulations for carrying out the provisions of KRS Chapter 218A relating to controlled substances. This administrative regulation authorizes the storage in an emergency medication kit in certain long-term care facilities of limited quantities of controlled substances to be administered if prescribed by an authorized practitioner.

 

      Section 1. Storage of Controlled Substances in an Emergency Medication Kit. A pharmacy provider may store controlled substances in an emergency medication kit in a residential hospice facility, nursing home, nursing facility, skilled nursing facility, intermediate care facility, or intermediate care facility for the mentally retarded if the following conditions are met:

      (1) Written policies and procedures of the facility regarding the procurement, use, storage, security, replacement, and recordkeeping of controlled substances in the kit shall be filed with the facility and with the provider pharmacy;

      (2) Controlled substances in the kit shall be the property of the provider pharmacy, which is responsible for their proper labeling, storage, security, and accountability;

      (3) Controlled substances stored in the kit shall be selected jointly by the facility's medical director or other physician, consultant pharmacist, and the director of nursing;

      (4) Controlled substances in the kit shall not exceed six (6) individual doses each of six (6) different controlled substances;

      (5) Controlled substances in the kit shall be administered only upon the order of an authorized practitioner who determines that the patient has an immediate medical need;

      (6) Access to the controlled substances in the kit shall be limited to a physician, pharmacist, registered nurse, or other person authorized by law in this state to access and administer the prescribed medication;

      (7) The provider pharmacy shall be notified by the facility within twenty-four (24) hours after the kit has been opened;

      (8) The prescribing practitioner shall issue a written prescription for the controlled substances to the provider pharmacy within seventy-two (72) hours after administration of a controlled substance from the kit;

      (9) The facility shall maintain a record of the administration of controlled substances from the kit in accordance with applicable state and federal laws;

      (10) The provider pharmacy shall document documents a physical inventory of the controlled substances in the kit at least monthly; and

      (11) The loss of any controlled substance from the kit shall be reported to the Cabinet for Health and Family Services in accordance with KRS 218A.200(6) and to the Federal Drug Enforcement Administration in accordance with 21 C.F.R. 1301.74(c).

 

      Section 2. The Cabinet for Health and Family Services may deny, suspend, or revoke the privilege of storing controlled substances in an emergency medication kit if any provision in Section 1 of this administrative regulation is violated. All administrative hearings shall be conducted in accordance with 902 KAR 1:400. (15 Ky.R. 1352; eff. 12-13-88; Am. 20 Ky.R. 2227; eff. 3-14-94; 22 Ky.R. 2481; eff. 8-1-96; 33 Ky.R 2218; 2973; eff. 4-6-07.)