The Board proposes the rule amendments to update consultant pharmacist licensure requirements due to statutory changes (HB599).

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NOS.:RULE TITLES:

64B16-26.300Consultant Pharmacist Licensure

64B16-26.301Subject Matter for Consultant Pharmacist Training Program

PURPOSE AND EFFECT: The Board proposes the rule amendments to update consultant pharmacist licensure requirements due to statutory changes (HB599).

SUMMARY: Consultant pharmacist licensure standards changed due to statutory changes (HB599).

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: During discussion of the economic impact of this rule at its Board meeting, the Board, based upon the expertise and experience of its members, determined that a Statement of Estimated Regulatory Costs (SERC) was not necessary and that the rule will not require ratification by the Legislature. 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: 456.013, 465.005, 465.0125 FS.

LAW IMPLEMENTED: 456.013, 465.0125 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: Jessica Sapp, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254; [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64B16-26.300 Consultant Pharmacist Licensure.

(1) through (2) No change.

(3) In order to be licensed as a consultant pharmacist, a person must meet the following requirements:

(a) Hold a license as a pharmacist which is active and in good standing; and

(b) Successfully complete a consultant pharmacist course of no fewer than twenty twelve (2012) hours, sponsored by an accredited college of pharmacy, and approved by the Florida Board of Pharmacy Tripartite Continuing Education Committee which is based on the Statement of the Competencies Required in Institutional Pharmacy Practice and covers the subject matter set forth in rule 64B16-26.301, F.A.C. The course shall be instructionally designed to include a cognitive test on which the applicant must score a passing grade for certification of successful completion of the course.

(c) Successfully complete a period of assessment and evaluation under the supervision of a preceptor within one (1) year of completion of the course set forth in paragraph (b), above. This period of assessment and evaluation shall be completed over no more than three (3) consecutive months and shall include at least 40 hours of training in the following practice areas, 60% of which shall occur on-site at an institution that holds a pharmacy permit. The training shall include:

Minimum Skills Required	Percent of Time	Hours
Minimum of 40 Hours in Maximum of Three Months
1. Regimen review, documentation and communication.	60%	24
a. Demonstrate ability to carry out process and understand documentation functions.
b. Understand and perform drug regimen review. Communicate findings to appropriate individuals or groups.
c. The applicant is responsible for learning other skills needed to perform in his/her type of facility where he/she is or will be the consultant Pharmacist of Record.
2. Facility review.	20%	8
Demonstrate areas that should be evaluated, documentation, and reporting procedures.
3. Committee and Reports.	5%	2
Review quarterly Quality of Care Committee minutes and preparation and delivery of pharmacist quarterly report.
4. Policy and Procedures.	5%	2
Preparation, review, updating Policy and Methods.
5. Principles of formulary management.	5%	2
Demonstrate ability to manage formulary.
6. Professional Relationships.	5%	2
Knowledge and interaction of facility administration and professional staff.

(4) In order to act as a preceptor, a person shall:

(a) Be a consultant pharmacist of record at an institutional pharmacy which is required to have a consultant pharmacist under the provisions of chapter 465, F.S., and these rules.

(b) Have a minimum of one (1) year of experience as a consultant pharmacist of record.

(c) Maintain all pharmacist licenses in good standing with the Board.

(d) Not act as a preceptor to more than two (2) applicants at the same time.

(5) Upon completion of the requirements set forth above, the applicant’s preceptor shall confirm that the applicant’s assessment and evaluation have met the requirements and that the applicant has successfully completed all required assignments under the preceptor’s guidance and supervision.

(6) through (7) renumbered (4) through (5) No change.

(8) An applicant who applies for a consultant pharmacist license after the effective date of this rule shall be required to complete the assessment and evaluation required in paragraph (3)(c), prior to being licensed as a consultant pharmacist.

Rulemaking Authority 456.013, 465.005, 465.0125 FS. Law Implemented 456.013, 465.0125 FS. History–New 5-19-72, Revised 4-19-74, Repromulgated 12-18-74, Amended 10-17-79, 4-8-80, 7-29-81, 7-1-83, 4-10-84, 4-30-85, Formerly 21S-1.26, 21S-1.026, Amended 7-31-91, 10-14-91, Formerly 21S-26.300, 61F10-26.300, Amended 9-19-94, 3-28-95, 3-10-96, Formerly 59X-26.300, Amended 5-22-01, 5-5-05, 11-29-06, 3-29-10, 6-23-16,                             .

 

64B16-26.301 Subject Matter for Consultant Pharmacist Course Training Program.

(1) Jurisprudence.

(a) through (b) No change.

(c) Laws and regulations, state and federal, pertaining to collaborative practice agreements.

(2) Policy and Procedures.

(a) No change.

(b) Record keeping and reports.

1. through 5. No change.

6. Written collaborative practice agreement records.

(c) Regimen review, documentation and communication.

1. Performing drug regimen review.

2. Documentation of drug regiment review.

3. Communication of findings to appropriate individuals or groups.

(3) Administrative Responsibilities.

(a) through (d) No change.

(e) Facility Review

1. Areas appropraite for evaluation

2. Documentation of evaluations

3. Reporting of evaluations

(4) Professional Responsibilities.

(a) through (f) No change.

(g)  Conducting patient assesments.

(h) Ordering and evaluating laboratory or clinical tests.

(i) Administration of medicinal drugs.

(5) through (6) No change.

Rulemaking Authority 465.005, 465.0125 FS. Law Implemented 465.0125 FS. History–New 5-19-72, Amended 12-18-74, 10-17-79, Formerly 21S-1.27, 21S-1.027, Amended 7-31-91, Formerly 21S-26.301, 61F10-26.301, 59X-26.301, Amended 5-5-05,____.

 

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: August 26, 2020

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: October 7, 2020