Notice of Development of Rulemaking

DEPARTMENT OF HEALTH
Board of Pharmacy
RULE NO: RULE TITLE
64B16-26.1031: Influenza Immunization Certification Program
PURPOSE AND EFFECT: The Board proposes the rule promulgation to provide a criteria for approval of influenza immunization certification programs.
SUBJECT AREA TO BE ADDRESSED: Influenza Immunization Certification Program.
SPECIFIC AUTHORITY: 465.189(5) FS.
LAW IMPLEMENTED: 465.189, 465.005 FS.
IF REQUESTED IN WRITING AND NOT DEEMED UNNECESSARY BY THE AGENCY HEAD, A RULE DEVELOPMENT WORKSHOP WILL BE NOTICED IN THE NEXT AVAILABLE FLORIDA ADMINISTRATIVE WEEKLY.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE DEVELOPMENT AND A COPY OF THE PRELIMINARY DRAFT, IF AVAILABLE, IS: Rebecca Poston, Executive Director, Board of Pharmacy/MQA, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254

THE PRELIMINARY TEXT OF THE PROPOSED RULE DEVELOPMENT IS:

64B16-26.1031 Influenza Immunization Certification Program.

The Board shall approve for initial certification of pharmacist administration of influenza immunizations, programs of study not less than 20 hours that includes coursework covering all of the following;

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

(2) Immunization Schedules;

(3) 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 herein incorporated by reference;

(4) Vaccine storage and handling;

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

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

(7) Community immunization resources and programs;

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

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

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

(11) Administration techniques;

(12) The current influenza immunization guidelines and recommendations of the United States Department of Health Centers for Disease Control and Prevention;

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

(14) 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.

Specific Authority 465.189(5) FS. Law Implemented 465.189, 465.005 FS. History–New_________.