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, which is hereby incorporated by reference. To obtain an application go to http://www.flrules.org/Gateway/reference.asp?No=Ref-06807, 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 https://floridaspharmacy.gov.

(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) Mechanisms of action for vaccines, contraindications, drug interactions, and monitoring after vaccine administration;

(b) Immunization Schedules;

(c) Immunization screening questions, provision of risk/benefit information, informed consent, recordkeeping, and electronic reporting into the statewide immunization registry;

(d) Vaccine storage and handling;

(e) Bio-Hazardous waste disposal and sterile techniques;

(f) Entering, negotiating and performing pursuant to physician oversight protocols;

(g) Community immunization resources and programs;

(h) Identifying, managing and responding to adverse incidents including but not limited to potential allergic reactions associated with vaccine administration;

(i) Procedures and policies for reporting adverse events to the Vaccine Adverse Event Reporting System (VAERS);

(j) Reimbursement procedures and vaccine coverage by federal, state and local governmental jurisdictions and private third party payors;

(k) Administration techniques;

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

(m) The immunization and vaccine guidelines in the Immunization Schedule by the United States Centers for Disease Control and Prevention;

(n) The immunizations or vaccines recommended by the United States Centers for Disease Control and Prevention for international travel;

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

(p) Review of Section 465.189, F.S.; and,

(q) Cardiopulmonary Resuscitation (CPR) training.

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

(3) The Board shall approve for initial certification of registered pharmacy technician administration of vaccines, programs of study, accredited by the Accreditation Council for Pharmacy Education (ACPE), not less than 6 hours that include coursework covering all the following:

(a) Technique for preparing and administering immunizations in a safe and effective manner

(b) Administration routes

(c) Recognizing and responding to allergic vaccine reaction and other emergency situations

(d) Needle selection based on vaccines and patient size and age

(e) Documentation procedures

(f) A real time competency validation through the observation and return demonstration of a complete successful administration of an intramuscular and subcutaneous injection to a human being which shall include distraction techniques during the administration and universal precautions as they pertain to blood borne pathogens.

Rulemaking Authority 465.005 FS. Law Implemented 465.189 FS. History–New 3-20-08, Amended 8-30-10, 7-29-13, 5-29-16, 11-18-21, 10-19-22.