The Board proposes the rule amendment to implement HB 279 changes to section 465.189, F.S.

 

DEPARTMENT OF HEALTH

Board of Pharmacy

RULE NO.:RULE TITLE:

64B16-26.1031Vaccine Certification Program

PURPOSE AND EFFECT: The Board proposes the rule amendment to implement HB 279 changes to section 465.189, F.S.

SUMMARY: Course content requirements will be updated for immunization administration certification of pharmacists and pharmacy interns.

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: 465.005 FS.

LAW IMPLEMENTED: 465.189 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: Allison Dudley, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254

 

THE FULL TEXT OF THE PROPOSED RULE IS:

 

64B16-26.1031 Vaccine Certification Program.

(1) All applications for vaccine certification programs shall be made on board approved form DH-MQA 1234, “Board of Pharmacy Immunization Certification Program Provider Application,” dated 08/15, “Vaccine Immunization Certification Program Application”, effective 01/13, which is hereby incorporated by reference. To obtain an application go to http://www.flrules.org/Gateway/reference.asp?No=Ref-02897 or contact the Board of Pharmacy at 4052 Bald Cypress Way, Bin #C04, Tallahassee, FL 32399-3254 or [phone], or download the application from the web at http://www.doh.state.fl.us/mqa/pharmacy.

(2) The Board shall approve for initial certification of pharmacist and pharmacy intern administration of vaccines, programs of study not less than 20 hours that include coursework covering all of the following;

(a) through (b) No change.

(c) Immunization screening questions, provision of risk/benefit information, informed consent, recordkeeping, and electronic reporting into the statewide immunization registry through enrollment application DH Form 1997 (effective 10/07) herein incorporated by reference and may be obtained from the Board office by writing to the Board of Pharmacy, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3254 or by telephoning 1(877)888-7468;

(d) through (k) No change.

(l) Administration of epinephrine using an autoinjector delivery system;.

(m) The immunization and vaccine guidelines in the February 1, 2015, Adult Immunization Schedule by the United States Centers for Disease Control and Prevention, entitled “Recommended Adult Immunization Schedule – United States – 2015; The current influenza, pneumococcal and shingles vaccine guidelines and recommendations of the United States Department of Health Centers for Disease Control and Prevention, which are entitled “Prevention and Control of Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices (ACIP) – United States, 2012-13 Influenza Season,” dated August 17, 2012, http://www.flrules.org/Gateway/reference.asp?No=Ref-02898; “Updated Recommendations for Prevention of Invasive Pneumococcal Disease Among Adults Using the 23-Valent Pneumococcal Polysaccharide Vaccine (PPSV23),” dated September 3, 2010, http://www.flrules.org/Gateway/reference.asp?No=Ref-02899;  “Prevention of Pneumococcal Disease Among Infants and Children – Use of 13-Valent Pneumococcal Conjugate Vaccine and 23–Valent Pneumococcal Polysaccharide Vaccine,” dated December 10, 2010, http://www.flrules.org/Gateway/reference.asp?No=Ref-02900; “Prevention of Herpes Zoster: Recommendations of the Advisory Committee on Immunization Practices (ACIP),” dated June 6, 2008, http://www.flrules.org/Gateway/reference.asp?No=Ref-02901; which are hereby incorporated by reference and published at http://www.cdc.gov/vaccines/pubs/ACIP-list.htm;

(n) The immunizations or vaccines recommended by the United States Centers for Disease Control and Prevention for international travel as of July 1, 2015;

(o) State of emergency administration of immunizations or vaccines;

(p)(n) No change.

(q)(o) No change.

Successful completion of the certification program must include a successful demonstration of competency in the administration technique and a cognitive examination.

Rulemaking Authority 465.005 FS. Law Implemented 465.189 FS. History–New 3-20-08, Amended 8-30-10, 7-29-13, _______________.

 

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 12, 2015

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: May 6, 2015