The Board proposes the rule promulgation in order to create instructions concerning pharmacies that utilize a common database.

DEPARTMENT OF HEALTH
Board of Pharmacy

RULE NO: RULE TITLE
64B16-28.451: Pharmacy Common Database
PURPOSE AND EFFECT: The Board proposes the rule promulgation in order to create instructions concerning pharmacies that utilize a common database.
SUMMARY: The creation of the rule will provide instructions concerning pharmacies that utilize a common database.
SUMMARY OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared.
Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.
SPECIFIC AUTHORITY: 465.05, 465.022 FS.
LAW IMPLEMENTED: 465.0266 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN FAW.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Rebecca R. Poston, Executive Director, Board of Pharmacy/MQA, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3253

THE FULL TEXT OF THE PROPOSED RULE 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 pharmacy’s 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 pharmacy’s 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 patient’s 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 Section 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 FS. Law Implemented 465.0266 FS. History–New___________.

NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Pharmacy
NAME OF SUPERVISOR OR PERSON WHO APPROVED THE PROPOSED RULE: Board of Pharmacy
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: August 15, 2006
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: September 15, 2006