201 KAR 2:300. Common database.

 

      RELATES TO: KRS 315.020, 315.035, 315.0351

      STATUTORY AUTHORITY: KRS 315.035, 315.0351, 315.191(1)(a), (f)

      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. (34 Ky.R. 2252; 2390; eff. 6-6-2008.)