64B16-28.451: Pharmacy Common Database
PURPOSE AND EFFECT: The Board proposes the rule promulgation in order to create instructions concerning pharmacies who utilize a common database.
SUBJECT AREA TO BE ADDRESSED: Pharmacy Common Database.
SPECIFIC AUTHORITY: 465.05, 465.022 FS.
LAW IMPLEMENTED: 465.0266 FS.
IF REQUESTED IN WRITING AND NOT DEEMED UNNECESSARY BY THE AGENCY HEAD, A RULE DEVELOPMENT WORKSHOP WILL BE NOTICED IN THE NEXT AVAILABLE FLORIDA ADMINISTRATIVE WEEKLY.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE DEVELOPMENT AND A COPY OF THE PRELIMINARY DRAFT, IF AVAILABLE, IS: Rebecca Poston, Executive Director, Board of Pharmacy/MQA, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254.
THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT IS:
64B16-28.451 Pharmacy Common Database.
(1) A pharmacy licensed under this chapter may perform prescription drug processing for other pharmacies, provided that all pharmacies are under common ownership, utilize a common database, and are properly licensed, permitted or registered in this state or another state. Nothing in this subsection shall prohibit a pharmacist employee of said pharmacies who is licensed in Florida from remotely accessing the pharmacys electronic database from outside the pharmacy in order to process prescriptions, provided the pharmacy establishes controls to protect the privacy and security of confidential records.
(2) Prescription drug processing does not include the dispensing of a prescription drug but includes any of the following:
(a) Receiving, interpreting, or clarifying a prescription;
(b) Entering prescription data into the pharmacys record;
(c) Verifying or validating a prescription;
(d) Performing prospective drug review as defined by the Board;
(e) Obtaining refill and substitution authorizations;
(f) Interpreting or acting on clinical data;
(g) Performing therapeutic interventions;
(h) Providing drug information concerning a patients prescription;
(i) Providing patient counseling.
(3) Each pharmacy performing prescription drug processing pursuant to this section must maintain a policy and procedure manual, which shall be made available to the Board or its agent upon request. The policy and procedures manual shall include the following information:
(a) A description for how each pharmacy will comply with federal and state laws, rules and regulations;
(b) The procedure for maintaining appropriate records to identify the pharmacies and pharmacists responsible for the prescription drug processing and dispensing of the prescription;
(c) The policy and procedure for providing adequate security to protect the confidentiality and integrity of patient information;
(d) The procedure to be used by the pharmacy in implementing and operating a quality assurance program designed to objectively and systematically monitor, evaluate, and improve the quality and appropriateness of patient care.
(4) The prescription drug processing of a prescription by one pharmacy for another pursuant to this section shall not be construed as the transferring of a prescription as set forth in 465.026, F.S.
(5) In addition to all record requirements of Rule 64B16-28.140, F.A.C., all pharmacies participating in prescription drug processing, shall maintain appropriate records which identify, by prescription, the name(s), initials, or identification code(s) of each pharmacist or pharmacy technician who performs a processing function for a prescription. Such records shall be maintained:
(a) Separately by each pharmacy and pharmacist; or
(b) In a common electronic file, as long as the records are maintained in such a manner that the data processing system can produce a printout which lists the functions performed by each pharmacy, pharmacist, pharmacy intern and pharmacy technician.
Specific Authority: 465.05, 465.022, F.S. Law Implemented 465.0266, F.S. History-New ____________.
