RELATES TO: KRS 315.010, 315.020, 315.030, 315.121
STATUTORY AUTHORITY: KRS 315.002, 315.005, 315.191
NECESSITY, FUNCTION, AND CONFORMITY: KRS 315.191(1) authorizes the Kentucky Board of Pharmacy to establish requirements to regulate and control pharmacies. KRS 315.002 and 315.005 require standards of practice in all settings where drugs are handled and require the board to ensure safety of all drug products provided to the citizens of Kentucky. This administrative regulation establishes requirements for pharmacy services in long-term care facilities.
Section 1. Definitions. (1) "Immediate supervision" is defined by KRS 315.010(11).
(2) "Long-term care facility" or "LTCF" means:
(a) An intermediate care facility;
(b) A skilled nursing facility;
(c) A hospital other than an acute care hospital licensed pursuant to 902 KAR 20:016;
(d) An intermediate care facility for intellectually and developmentally disabled; or
(e) A personal care facility.
(3) "Pharmacist-in-charge" means a pharmacist mandated as in charge under KRS 315.020 and who meets the requirements of 201 KAR 2:205.
(4) "Supervision" is defined by KRS 315.010(25).
Section 2. General Requirements. (1) The pharmacist-in-charge of the dispensing pharmacy shall be responsible for policy and procedures governing the procurement, distribution, and control of all drugs that are provided to a long-term care facility.
(a) Medications shall be dispensed only on the medical order (for a non-controlled substance) or a prescription drug order of a licensed practitioner.
(b) A medical order (for a non-controlled substance) shall be considered a prescription drug order if it is entered on the medical record of a patient at an LTCF and if the medical order contains the:
1. Name of patient;
2. Date of issuance;
3. Name, strength, and dosage form of drug prescribed;
4. Directions for use;
5. Quantity of length of therapy as defined in policy and procedures or as defined by medical order; and
6. Practitioner’s name.
(3) Emergency Drugs.
(a) The pharmacist-in-charge of the dispensing pharmacy shall establish policy and procedures for supplying emergency drugs.
(b) For expediency and efficiency, emergency drugs shall be limited in number to include controlled substances stocked pursuant to 902 KAR 55:070 that shall not exceed six (6) individual doses of six (6) different controlled substances and shall not exceed six (6) individual doses of thirty (30) different non-controlled substances, and whose prompt use and immediate availability are generally regarded as essential in the proper treatment of sudden and unforeseen patient emergencies.
(c) The pharmacist-in-charge may request from the board a waiver to increase the number of non-controlled substance items to be included in the emergency kit based upon evidence of use.
(d) Emergency drug stock shall be inspected by pharmacy personnel on at least a monthly basis and documentation maintained to determine if contents have become outdated and if the stocks are being maintained at adequate levels.
(e) Emergency drug stock shall not be stocked in a personal care facility.
(4) Long Term Care Facility Pharmacy Stock.
(a) Pharmacy stock of drugs in an LTCF shall not exceed fifteen (15) individual doses each of 150 non-controlled substances.
(b) Pharmacy stock of drugs in a personal care facility shall not exceed five (5) individual doses each of thirty (30) non-controlled substances.
(c) The pharmacist-in-charge may request from the board a waiver to increase the number of non-controlled substance items to be placed in pharmacy stock based upon evidence of use.
(d) The pharmacist-in-charge shall be responsible for authenticating the need for pharmacy stock.
(e) A pharmacist shall review the prescription drug or medical order before the release of medication.
(f) Pharmacy stock shall be inspected by pharmacy personnel on at least a monthly basis and documentation maintained to determine if contents have become outdated and if stocks are being maintained at adequate levels.
(g) Pharmacy stock shall be used for a patient for no more than the next business day.
(h) Except for pharmacy stock of intravenous fluids with no additive drugs or irrigation solutions, the pharmacy stock shall be replenished by:
1. A secure box delivered by the pharmacy; or
2. A pharmacist or a pharmacist intern, or a certified pharmacy technician, who shall be under the immediate supervision of a pharmacist on-site, unless there is a pharmacy on-site, then the pharmacy stock shall be replenished by a pharmacist or a pharmacist intern or a certified pharmacy technician under the supervision of a pharmacist on-site. (42 Ky.R. 630; Am. 1131; eff. 11-6-2015; TAm eff. 2-15-2016; 42 Ky.R. 273, 630, 1131, 2414; eff. 5-6-2016.)