Notice of Proposed Rule

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.
SUMMARY: The rule promulgation will set criteria for approval of influenza immunization certification programs.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared.
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.
SPECIFIC AUTHORITY: 465.189(5) FS.
LAW IMPLEMENTED: 465.189, 465.005 FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN FAW.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Rebecca R. Poston, Executive Director, Board of Pharmacy/MQA, 4052 Bald Cypress Way, Bin #C04, Tallahassee, Florida 32399-3253

THE FULL TEXT OF THE PROPOSED RULE 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________.


NAME OF PERSON ORIGINATING PROPOSED RULE: Board of Pharmacy
NAME OF SUPERVISOR OR PERSON WHO APPROVED THE PROPOSED RULE: Board of Pharmacy
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: October 16, 2007
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: December 21, 2007