Current through Register Vol. 51, No. 3, September 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.
STATUTORY AUTHORITY:
KRS
315.035,
315.0351,
315.191(1)(a),
(f)
