The Board proposes the rule amendment to update the rule regarding the registered pharmacy technician to pharmacist ratio.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-27.410Registered Pharmacy Technician, to Pharmacist Ratio

PURPOSE AND EFFECT: The Board proposes the rule amendment to update the rule regarding the registered pharmacy technician to pharmacist ratio.

SUMMARY: The registered pharmacy technician to pharmacist ratio will be updated.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION: The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: The Board has determined that the rule amendments, as required by Chapter 2014-113, Laws of Florida, will result in an overall cost reduction to small business and regulated entities, since it will allow supervision in excess of 3:1 in certain circumstances. Since the Board expects the amendment to result in an overall cost reduction to all entities, including small business and government, no SERC was required, nor is legislative ratification required. No person or interested party submitted additional information regarding the economic impact at that time.

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.

RULEMAKING AUTHORITY: 465.005 FS.

LAW IMPLEMENTED: 465.014, 893.07(1)(b) FS.

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Patrick Kennedy, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

(Substantial rewording of Rule 64B16-27.410 follows. See Florida Administrative Code for present text.)

 

64B16-27.410 Registered Pharmacy Technician to Pharmacist Ratio.

When the pharmacist delegates tasks to a registered pharmacy technician, such delegation must enhance the ability of the pharmacist to practice pharmacy to serve the patient population. A pharmacist shall not supervise greater than one (1) registered pharmacy technician nor shall a pharmacy allow a supervision ratio of greater than one (1) registered pharmacy technician to one (1) pharmacist (1:1), unless specifically authorized to do so pursuant to the provisions of this rule.

(1) General Conditions: Regardless of the technician ratio, every pharmacy, pharmacist, Prescription Department Manager (PDM) or Consultant Pharmacist (CP) that employs or utilizes registered pharmacy technicians must comply with the following conditions:

(a) Establish and maintain a written Policy and Procedures Manual regarding the number of registered pharmacy technician positions and their utilization that includes the specific scope of delegable tasks of the technicians, job descriptions, and task protocols. The Policy and Procedures Manual or Manuals must include policies and the procedures for implementing the policies for each category enumerated below:

1. Supervision by a pharmacist;

2. Minimum qualifications of the registered pharmacy technician as established by statue and rule;

3. In-service education or on-going training and demonstration of competency specific to the practice site and job function;

4. General duties and responsibilities of the registered pharmacy technicians;

5. All functions related to prescription processing;

6. All functions related to prescription legend drug and controlled substance ordering and inventory control, including procedures for documentation and recordkeeping;

7. All functions related to retrieval of prescription files, patient files, patient profile information and other records pertaining to the practice of pharmacy;

8. All delegable tasks and non-delegable tasks as enumerated in Rule 64B16-27.420, F.A.C.;

9. Confidentially and privacy laws and rules;

10. Prescription refill and renewal authorization;

11. Registered pharmacy technician functions related to automated pharmacy systems; and

12. Continuous Quality Improvement Program.

(b) Establish and maintain documentation that is signed by the registered pharmacy technician acknowledging they have reviewed the Policy and Procedures Manual(s).  Each registered pharmacy technician shall have 90 days from the effective date of this rule, [insert effective date], to comply with this provision and all registered pharmacy technicians hired subsequent to this rule's effective date shall have 90 days from the date of hire.

(c) Establish and maintain documentation that demonstrates the registered pharmacy technician is knowledgeable in the established job description, delegable tasks, task protocols, and policy and procedures in the specific pharmacy setting where the delegable tasks will be performed.

(2) The Policy and Procedures Manual(s) required by subsection (1) must be maintained on-site where the registered pharmacy technician will perform the delegable tasks and must be available during a Department inspection or at the request of the Board of Pharmacy. However, any and all documentation required by paragraphs (1)(b) and (c) must be maintained and must be provided to the Board of Pharmacy or a Department inspector within 72 hours of a request.

(3) Three to One (3:1) Ratio: Registered pharmacy technicians assisting with delegable tasks involving sterile compounding shall not exceed a ratio of up to three (3) registered pharmacy technicians to one (1) pharmacist (3:1).

(4) Four to One (4:1) Ratio: Any pharmacist or any pharmacy may allow a supervision ratio up to four (4) registered pharmacy technicians to one (1) pharmacist (4:1), as long as the delegable tasks do not involve sterile compounding.

(5) Six to One (6:1) Ratio: A pharmacy which does not dispense medicinal drugs, and the pharmacist(s) employed by such pharmacy, may allow a supervision ratio up to six (6) registered pharmacy technicians to one (1) pharmacist (6:1), as long as the delegable tasks do not involve sterile compounding.

Rulemaking Authority 465.005, 465.0125, 465.022 FS. Law Implemented 465.0125, 465.014, 465.022, 893.07(1)(b) FS. History–New 2-14-77, Amended 3-31-81, Formerly 21S-4.02, Amended 8-31-87, Formerly 21S-4.002, Amended 9-9-92, Formerly 21S-27.410, 61F10-27.410, Amended 1-30-96, Formerly 59X-27.410, Amended 2-23-98, 10-15-01, 1-1-10,_________.

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Pharmacy

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Board of Pharmacy

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: October 8, 2014

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: October 3, 2014