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.)