The Board proposes the creation of Chapter 64B16-31, F.A.C., in order to promulgate rules to implement Ch. 2020-7 Laws of Fla (CSHB 389) concerning collaborative practice and test and treat certifications.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NOS.:RULE TITLES:

64B16-31.001Collaborative Practice Certification (CPC).

64B16-31.003Collaborative Practice Certification: Initial Certification Course.

64B16-31.005Collaborative Practice Certification: Collaborative Pharmacy Practice Agreement Submission.

64B16-31.007Collaborative Practice Certification: Chronic Health Conditions.

64B16-31.009Collaborative Practice Certification: Mandatory Continuing Education.

64B16-31.033Test and Treat Certification (TTC).

64B16-31.035 Test and Treat Certification: Initial Certification Course.

64B16-31.037Test and Treat Certification: Written Protocol and Written Protocol Submission.

64B16-31.039Test and Treat Certification: Formulary of Medicinal Drugs.

64B16-31.041Test and Treat Certification: Patient Records.

64B16-31.043Test and Treat Certification: Follow-Up Care.

64B16-31.050Mandatory Review of Rule Chapter 64B16-31, F.A.C.

PURPOSE AND EFFECT: The Board proposes the creation of Chapter 64B16-31, F.A.C., in order to promulgate rules to implement Ch. 2020-7 Laws of Fla (CSHB 389) concerning collaborative practice and test and treat certifications.

SUMMARY: Rules will be promulgated to implement Ch. 2020-7 Laws of Fla (CSHB 389) concerning collaborative practice and test and treat certifications.

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 Committee meetings and Board meetings, 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. Further, the Board primarily determined all impacts are a direct result of the legislation and not the direct result of the Board’s mandatory rulemaking obligations and that the excepted impact is a net positive to business and increased access to care. 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: 465.1895 FS.

LAW IMPLEMENTED: 465.1895 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:

 

64B16-31.001 Collaborative Practice Certification (CPC).

Applicants for CPC shall submit an application using Form DH5059-MQA (eff. 08/20), “Application for Pharmacist Collaborative Practice Certification” that is hereby incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-            or http://floridaspharmacy.gov Applicants for certification shall meet and comply with all requirements in section 465.1865, F.S.

Rulemaking Authority 465.1865 F.S. Law Implemented 465.1865 F.S. History-New                 .

 

64B16-31.003 Collaborative Practice Certification: Initial Certification Course.

(1) Applicants for Initial Certification Course approval shall submit an application using Form DH5061-MQA (eff. 08/20) “Application for Initial Collaborative Practice Certification Course” that is hereby incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-            or http://floridaspharmacy.gov.

(2) Initial collaborative practice certification courses shall be a minimum of 20 hours in duration, and shall meet all the following mandatory requirements:

(a) The course may only be offered by a program provider who is accredited by the Accreditation Council for Pharmacy Education (ACPE), a program provider who is accredited to provide educational activities designated for the American Medical Association Physician’s Recognition Award Category I credit, or a program provider approved by the American Osteopathic Association to offer continuing medical education credits.

(b) The course content and objectives offered by an approved provider shall be developed in conjunction with an individual licensed to practice pharmacy and an individual who is a licensed allopathic or osteopathic physician.

(c) The course content shall include all those areas enumerated in section 465.1865(2)(c), F.S. and shall cover the following areas:

1. Laws and rules applicable to the collaborative practice for the treatment of chronic health care conditions; and

2. Writing and entering into a collaborative practice agreement.

(d) No less than 8 hours of the course shall be offered through a live seminar or a live video conference.

(3) A pharmacist who successfully completes a Board approved collaborative practice certification course shall be awarded 20 hours of general continuing education credits.

Rulemaking Authority 465.1865 F.S. Law Implemented 465.1865 F.S. History-New__________.

 

64B16-31.005 Collaborative Practice Certification: Collaborative Pharmacy Practice Agreement Submission.

(1) Prior to providing or implementing patient care services under a Collaborative Pharmacy Practice Agreement or immediately after the renewal of such an Agreement, the Pharmacist shall submit the executed Agreement to the Board Office through the pharmacist’s online licensure account at http://flhealthsource.gov or via U.S. Mail to 4052 Bald Cypress Way, Bin C-04, Tallahassee, FL 32399.

(2) In the event of an addendum to the material terms of an existing collaborative pharmacy practice agreement, the pharmacist shall maintain a copy of the addendum and the initial agreement pursuant to section 465.1865(3)(c), F.S. Material terms shall be defined as those terms enumerated in Section 465.1865(3)(a), F.S.

Rulemaking Authority 465.1865 F.S. Law Implemented 465.1865 F.S. History-New__________.

 

64B16-31.007 Collaborative Practice Certification: Chronic Health Conditions.

Pursuant to section 465.1865, F.S., the Board hereby adopts the following list of chronic health conditions for which a pharmacist certified pursuant to section 465.1865, F.S., can provide specified patient care services to patients of a collaborating physician pursuant to a pending Collaborative Pharmacy Practice Agreement:

(1) Hyperlipidemia;

(2) Hypertension;

(3) Anti-coagulation management;

(4) Smoking cessation;

(5) Opioid use disorder; and  

(6) Those chronic health conditions enumerated in section 465.1865(1)(b), F.S.

Rulemaking Authority 465.1865 F.S. Law Implemented 465.1865 F.S. History-New             .

 

64B16-31.009 Collaborative Practice Certification: Mandatory Continuing Education.

A licensee shall not be required to complete the 8-hour continuing education related to collaborative pharmacy practice if the initial certificate was issued less than 12 months prior to the expiration date of the license.

Rulemaking Authority 465.1865 F.S. Law Implemented 465.1865 F.S. History-New,             .

 

64B16-31.033 Test and Treat Certification (TTC).

Applicants for TTC shall submit an application using Form DH5060-MQA (eff. 08/20), “Application for Pharmacist Test and Treat Certification” that is hereby incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref-           or http://floridaspharmacy.gov. Applicants for certification shall meet and comply with all requirements in section 465.1895, F.S.

Rulemaking Authority 465.1895 F.S. Law Implemented 465.1895 F.S. History-New,            .

 

64B16-31.035 Test and Treat Certification: Initial Certification Course.

(1) Applicants for Initial Certification Course approval shall submit an application using Form DH5062-MQA  (eff. 08/20) “Application for Initial Test and Treat Certification Course” that is hereby incorporated by reference and available at http://www.flrules.org/Gateway/reference.asp?No=Ref                 or http://floridaspharmacy.gov.

(2) Initial test and treat certification courses shall be a minimum of 20 hours in duration, and shall meet all the following mandatory requirements:

(a) The course may only be offered by a program provider who is accredited by the Accreditation Council for Pharmacy Education (ACPE), a program provider who is accredited to provide educational activities designated for the American Medical Association Physician’s Recognition Award Category 1 credit, or a program provider approved by the American Osteopathic Association to offer continuing medical education credits.

(b) The course content and objectives offered by an approved provider shall be developed in conjunction with an individual licensed to practice pharmacy and an individual who is a licensed allopathic or osteopathic physician.

(c) The course content shall include all those areas enumerated in section 465.1895(2)(b), F.S., and shall also cover the following areas:

1. Laws and rules applicable to test and treat certifications; and

2. Writing and entering into a written protocol.

(d) No less than 8 hours of the course shall be offered through a live seminar or a live video teleconference.

(3) A pharmacist who successfully completes a Board approved test and treat certification course shall be awarded 20 hours of general continuing education credits.

Rulemaking Authority 465.1895 F.S. Law Implemented 465.1895 F.S. History-New               .

 

64B16-31.037 Test and Treat Certification; Written Protocol and Written Protocol Submission.

(1) Within 5 business days of entering into a written protocol with a supervising physician pursuant to section 465.1895, F.S., the pharmacist shall submit a copy of the written agreement to the Board Office through the pharmacist’s online licensure account at http://www.flhealthsource.gov or via U.S. Mail to 4052 Bald Cypress Way, Bin C-04, Tallahassee, FL 32399.

(2) In the event of an addendum to the material terms of an existing written protocol, the pharmacist shall maintain a copy of the addendum and the initial agreement. Material terms shall be defined as those terms enumerated in section 465.1895(5)(a), F.S.

Rulemaking Authority 465.1895 F.S. Law Implemented 465.1895 F.S. History-New                 .

 

64B16-31.039 Test and Treat Certification: Formulary of Medical Drugs.

(1) Pursuant to section 465.1895, F.S., the Board hereby incorporates all medicinal drugs approved by the United States Food and Drug Administration (“FDA”) as the formulary of medicinal drugs that a pharmacist may prescribe pursuant to a written test and treat protocol and all compounded medicinal drugs that utilize only active pharmaceutical ingredients approved by the FDA.

(2) A pharmacist may not prescribe controlled substances as described in s. 893.03 or 21 U.S.C. s. 812.

Rulemaking Authority 465.1895 Law Implemented 465.1895 History-New,                  .

 

64B16-31.041 Test and Treat Certifications: Patient Records.

Upon receipt of a patient request, a pharmacist shall furnish patient records to a health care practitioner designated by the patient within a reasonable time frame, not to exceed 5 business days.

Rulemaking Authority 465.1895 F.S. Law Implemented 465.1895 F.S. History-New,                             .

 

64B16-31.043 Test and Treat Certification: Follow-up Care.

A pharmacist must provide written information to a patient advising the patient when to seek follow-up care from his or her primary care physician. A pharmacist shall provide follow-up written information:

(1) Immediately prior to performing testing, screening, or treatment services on a patient for the first time; or

(2) As outlined in the written protocol; and

(3) When the pharmacist determines in his or her judgement that the patient should follow-up with his or her primary care provider.

Rulemaking Authority 465.1895 F.S. Law Implemented 465.1895 F.S. History-New,                       .

 

64B16-31.050 Mandatory Review of Rule Chapter 64B16-31, F.A.C.

(1) No later than 90 days prior to December 31, 2025, the Board shall review each rule in this Chapter and amend, modify or repeal any rule that creates barriers to entry for private business competition, is duplicative, outdated, obsolete, overly burdensome, or imposes excessive costs.

(2) In the event the Board fails to complete this review, the Board, for any rule that has not be reviewed in accordance with subsection (1), shall begin the rule repeal process in accordance with the Administrative Procedures Act.

Rulemaking Authority 465.1895 F.S. Law Implemented 465.1895 History-New                                .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Pharmacy Rules Committee

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: June 15, 2020