Kentucky Administrative Regulations › Title 201 - GENERAL GOVERNMENT CABINET › Chapter 2 - Board of Pharmacy › Section 201 KAR 2:300 - Common database

Current through Register Vol. 51, No. 1, July 1, 2024
RELATES TO:
				KRS
				315.020,
				315.035,
				315.0351
NECESSITY, FUNCTION, AND CONFORMITY:
				KRS
				315.035 and
				315.0351
				require that prescription drugs, medicines, and pharmaceuticals be dispensed or
				manufactured by a licensed pharmacist.
				KRS
				315.191(1)(a) and (f)
				authorize the Kentucky Board of Pharmacy to promulgate administrative
				regulations pertaining to pharmacies; pharmacists; and the storage, retrieval,
				dispensing, refilling, and transfer of prescription drug orders. This
				administrative regulation establishes minimum requirements for prescription
				drug orders within and between pharmacists and pharmacies.
Section 1. Definition. "Common Database"
			 means information shared among pharmacists and pharmacies for the purpose of
			 dispensing medications or providing other forms of pharmacist care to a
			 patient.
Section 2. The use of a
			 common database shall not constitute a transfer as established in
			 201 KAR
			 2:165, provided that the following conditions are met:
(1) All pharmacies involved in the
			 transactions pursuant to which the prescription is dispensed shall be under
			 common ownership and utilize a common database;
(2) All pharmacies involved in the
			 transactions pursuant to which the prescription is dispensed and all pharmacies
			 engaging in dispensing functions shall be properly permitted in Kentucky
			 pursuant to
			 KRS
			 315.035 or
			 315.0351;
(3) A pharmacist who provides a pharmacy
			 service on a prescription dispensed in Kentucky shall be licensed in
			 Kentucky;
(4) The common database
			 shall maintain a record of all pharmacists, pharmacist interns, and pharmacy
			 technicians involved in the process of dispensing a prescription;
(5) The owner of the common database shall
			 maintain a policy and procedure manual that governs its participating
			 pharmacies, pharmacists, and pharmacy employees and that is available to the
			 board or its agents upon request within five (5) business days and which shall
			 include:
(a) A procedure detailing how each
			 pharmacy and each pharmacist accessing the common database shall comply with
			 applicable federal and state laws, rules, and regulations;
(b) The procedure for maintaining appropriate
			 records for regulatory oversight for tracking a prescription during each stage
			 of the filling and dispensing process, identifying the pharmacists involved in
			 filling and dispensing the prescription and counseling the patient, and
			 responding to any requests for information made by the board;
(c) The policy and procedure for providing
			 adequate security to protect the confidentiality and integrity of patient
			 information; and
(d) A quality
			 assurance program designed to objectively and systemically monitor, evaluate,
			 and improve the quality and appropriateness of patient care through the use of
			 a common database; and
(6) A pharmacist dispensing a prescription
			 shall at all times exercise independent professional judgment and shall be
			 responsible for his or her actions and the professional actions of those
			 individuals the pharmacist is required to supervise.