315.300 Placement of drugs by pharmacy with authorized employees of home health agencies and hospices -- Protocol -- Allowable legend drugs -- Administrative regulations. (1) A pharmacy shall be allowed to place drugs with a home health agency's authorized employees and with a hospice's authorized employees for the betterment of public health. The pharmacy shall remain the legal owner of the drugs. (2) A written agreement between the pharmacy and home health agency or hospice shall document the protocol for the handling and storage of the drugs by authorized employees and shall be approved by the pharmacist in charge. (3) The pharmacist in charge shall review the protocol to assure that safe, secure and accountable handling of controlled legend drugs is maintained under the protocol before giving approval. (4) The pharmacist in charge or a pharmacist designee shall physically inspect and review the drug storage and handling at the home health agency and the hospice not less than annually. (5) The home health agency and the hospice protocol shall include but not be limited to the following: (a) Safe and secure storage of drugs; (b) Access to drugs limited to authorized employees; (c) Records of drugs checked out to authorized employees and records of drugs, amounts, and to whom and by whom administered; (d) Prompt notification of the pharmacy when a drug is used, including the prescriber, patient, drug, dosage form, directions for use and other pertinent information; (e) Billing information; (f) Procedures for handling drugs beyond their expiration date; and (g) Inventory control. (6) The following legend drugs shall be allowed under these agreements: (a) Sterile water for injection or irrigation; (b) Sterile saline solution for injection or irrigation; (c) Heparin flush solution; (d) Diphenhydramine injectable; (e) Epinephrine injectable; (f) Glucagon; (g) Influenza vaccine; and (h) Pneumonia vaccine. (7) As used in this section: (a) "Authorized employee" means any employee of a home health agency or hospice who, in the course of the employee's duties, is licensed by the employee's appropriate licensing agency to administer legend drugs; (b) (c) "Home health agency" means an entity required to be licensed under KRS Chapter 216; and "Hospice" means an entity authorized to hold itself out to the public as a hospice or as a licensed hospice pursuant to KRS Chapter 216. (8) The cabinet shall promulgate administrative regulations to implement the provisions of this section. (9) Nothing in this section shall preclude or prevent a pharmacy from providing pharmacy services through an automated pharmacy system to a residential hospice facility in accordance with KRS 315.295. Effective: July 12, 2006 History: Amended 2006 Ky. Acts ch. 153, sec. 2, effective July 12, 2006. -- Created 1998 Ky. Acts ch. 531, sec. 5, effective July 15, 1998.