1. Comprehensive Policy Analysis: Epinephrine Use and Supply in Florida Schools
Dianne Mennitt
NGR 6897L
This presentation provides an overview of the federal legislation approved by Congress in conjunction with state legislation approved by the Florida Legislature that has evolved over the past decade to address the increasing prevalence of students with life-threatening allergies. We appreciate the expertise each of you bring to the table for us to collaboratively identify recommended resources to guide the development of local policy and procedures regarding the use of epinephrine auto-injectors in Florida schools.

2. Learning Objectives
Synthesize the evolving federal and state legislation related to epinephrine use and supply in Florida schools
Analyze proposed policy development process for implementation of approved legislation
Consider stakeholder risks and benefits
Plan for policy adoption through interprofessional collaboration
These learning objectives reflect our workgroup goals.

3. 2004 Federal Legislation
Congress passed House Resolution (H.R.) 2023: Asthmatic Schoolchildren’s Treatment and Health Management Act
This federal law (Public Law No: ) gives preference in awarding certain federal grants to states that allow students to self-administer medication for asthma and anaphylaxis
Historical Context: In 2004, Congress passed “permissive” legislation to encourage states to allow students to self-administer medication for asthma & anaphylaxis.
Explain permissive.

4. 2005 Epinephrine Legislation in Florida
The 2005 Florida Legislature amended section , Florida Statutes (F.S.), to give public school students the right to carry and self-administer an epinephrine auto-injector if the school has been provided with parent and physician authorization
Prior to 2004, a provision in Florida Statutes allowed for students with asthma to carry an asthma inhaler. This legislation specifies that a public school student who has life-threatening allergic reactions may carry an epinephrine auto-injector and self-administer epinephrine by auto-injector while in school, participating in school-sponsored activities, or in transit to or from school or school-sponsored activities if the school has been provided with parental and physician authorization. This legislation became effective on January 1, 2006.

5. Epinephrine Policy Development in Florida
A provision of the 2005 epinephrine legislation provided the State Board of Education and the Department of Health with joint rulemaking authority for the use of epinephrine auto-injectors at school
Rule 6A , Florida Administrative Code (F.A.C.), was promulgated in order to implement the epinephrine legislation (i.e., Kelsey Ryan Act)
The Florida Department of Education, working in partnership with the Department of Health as well as public and private stakeholders, developed a technical assistance paper (TAP, 2006) to provide guidance to school districts for the development of local policy and procedures for the care of students with life-threatening allergies in accordance with the Kelsey Ryan Act and Rule 6A , F.A.C.
This legislation also required rulemaking in order to implement the use of epinephrine auto-injectors at school. After promulgation of the epinephrine rule, the interagency workgroup subsequently developed technical assistance to guide development of local policy and procedures in accordance with the Florida Statutes and Florida Administrative Code.

6. 2010 Federal Legislation
Congress passed H.R. 2751: FDA Food Safety Modernization Act (Public Law No: )
A provision in this legislation directs the Secretary of Health and Human Services to develop voluntary food allergy and anaphylaxis management guidelines for schools and early childhood education programs
Congress approved federal food safety legislation in 2010 includes a provision for the Department of Health and Human Services to develop voluntary food allergy guidelines & anaphylaxis management for schools and early childhood education programs to address the increasing prevalence of food allergies and anaphylaxis among school-age children, most of whom attend federal- and state-supported schools or early care and education programs every weekday.
State Priority Areas listed on page 2 of the FAQ

7. 2013 Epinephrine Legislation in Florida
The 2013 Florida Legislature amended sections & , F.S. to allow public and private schools the OPTION to purchase and maintain a supply of epinephrine auto-injectors from a “wholesale distributor” licensed in Florida, as defined in section , F.S.
The 2013 Florida Legislature approved “permissive” legislation to allow both public AND private schools the option to purchase and maintain a supply of epinephrine auto-injectors from a wholesale distributor as defined in statute.

8. 2013 Epinephrine Legislation Provisions…
Requires participating school districts and private schools to adopt a protocol by a physician
Requires the school-supplied epinephrine auto-injectors to be maintained in a locked location
Allows an authorized student to self-administer an auto-injector that was purchased by the school
The 2013 legislation provides an option for public and private schools to purchase and maintain a supply of stock prescription medication. However, even though the approved legislation is optional, public & private schools who opt to stock epinephrine auto-injectors are required to meet specific requirements. This legislation also allows students who are diagnosed with anaphylaxis to carry & self-administer an epinephrine auto-injector purchased by the school.

9. 2013 Epinephrine Legislation Provisions in Florida
Requires training for school personnel to recognize when a student is having an anaphylactic reaction
Allows trained school personnel to administer an epinephrine auto-injector without parent authorization
Removes school employees’ liability arising from administration of an epinephrine auto-injector and removes liability from the physician who developed the epinephrine protocol
In addition, this legislation does not require parent authorization and provides liability protection. However, schools have asked the question concerning liability in a situation when a school stocks epinephrine auto-injectors, but it was not administer when it should have been.

10. Epinephrine Workgroup
Name/Agency
Address
Julie Bacon
Emergency Medical Services for Children (EMSC) Advisory Committee Chairperson
Heather Diamond
Coordinator, USF Student Support Services Project
Jessica Hoag
Citrus Student Health Specialist
Peggy Howland
FDOH School Health Services Program Supervisor
Phillip Johnson
Florida Pharmacist
Melissa Keahey
EMSC Program Manager
Amanda Kraft
Osceola Supervisor of Health Services
Dianne Mennitt
USF Student Services
FSU DNP Student
Jamie Warrington
FDOE/School Transportation
Barbara Williams
Ask the Workgroup for comments as stakeholders regarding risks and benefits related to Florida’s 2013 epinephrine legislation.

11. Epinephrine Workgroup Topics…
Development of sample protocol and algorithm
School personnel training issues and recommendations
Parent notification to explain epinephrine
Clarification of legislative intent regarding the use of stock epinephrine auto-injectors
Key issues identified by the Workgroup

12. Epinephrine Workgroup Topics
Medication issues related to the donation, purchasing, storage, expiration date, and exchange program
Linkages to Emergency Medical Services (EMS) system at the local level
Involvement of the Florida Poison Network as a reporting system for anaphylactic situations and/or when an epinephrine auto-injector was administered in the school setting
These issues highlight the importance of interagency collaboration.

13. Epinephrine Workgroup Communication
Basecamp has been set-up for the Workgroup to review resources, references, and sample documents.

14. National Guidelines
Guidelines for the Diagnosis and Management of Food Allergy in the United States (2010) was developed over a 2-year timeframe through the combined efforts of an Expert Panel and Coordinating Committee representing 34 professional organizations, federal agencies, and patient advocacy groups. The Expert Panel drafted these Guidelines using an independent, systematic literature review and evidence report on the state of the science in food allergy, as well as their expert clinical opinion. These Guidelines establish consensus and consistency in definitions diagnostic criteria, and management practices. Based on quality of evidence assessments, these Guidelines provide concise recommendations on how to diagnose and manage food allergy and treatment of acute food allergy reactions. They are intended for a wide variety of health care professionals, including family practice physicians, clinical specialists, and nurse practitioners. However, these national guidelines do NOT address the management of allergies outside of clinical settings.

15. Position Statement
National Association of School Nurses Position Statements are considered to be an evidence-based paper that summarizes the historical, political, and/or scientific aspects regarding a topic related to student health issues. This position statement on allergy/anaphylaxis management in the school setting was updated in 2012.

16. Tool Kit
The Centers for Disease Control worked with NASN, the Food Allergy & Anaphylaxis Network, and the National School Boards Association to develop comprehensive guidance resources for food allergy and anaphylaxis management in school settings.

17. School Nurses: Partnering to Prevent & Respond to Anaphylaxis Video Series
NASN has produced video resources and materials for professional development and training activities.

18. Online Get Trained Program
This online tool provides a training program for the school nurse to utilize for unlicensed school personnel to administer an epinephrine auto-injector.

19. Epinephrine Training Materials
Likewise, this resource is intended to be utilized by the school nurse to communicate with students and parents as one component of the local allergy and anaphylaxis management program.

20. Epinephrine Resource School Nurse Program
We fortunate to have 2 Epinephrine Resource School Nurses in Florida who are part of our Epinephrine Workgroup.

21. 2013 Federal Legislation
Congress passed H.R. 2094: School Access to Emergency Epinephrine Act that President Obama signed into law on November 13, 2013
This federal law (Public Law No: ) gives preference in awarding certain federal grants to states that allow students to self-administer medication for asthma and anaphylaxis that includes civil liability protection for trained school personnel who administer epinephrine to a student reasonably believed to be having an anaphylactic reaction
The legislation passed by the 2013 Florida Legislature is consistent with the federal legislation in that our Florida legislation removes school employees liability arising from administration of an epinephrine auto-injector unless done in a willful or wanton manner, and removes liability from the physician who develop the protocol.

22. National Association of State Boards of Education
In November 2013, the National Association of State Boards of Education produced a discussion guide framework to address state, local, and individual school policy solutions. Discussion questions and worksheets are included.

23. Federal & State Epinephrine Legislation Timeline
Here we see how the federal & state legislation have intertwined to bring us where we are at this time with epinephrine auto-injectors for students with anaphylaxis.
Now that we have reviewed national guidelines and resources that may be utilized to implement the approved legislation, we invite your input regarding proposed recommendation (i.e., schools/districts utilize national guidelines to develop local policy and procedures for the care and management of students with life-threatening allergies).

24. Questions/Comments?
Thank you for your attention and we look forward to your comments/questions regarding next steps.

25. References…
Centers for Disease Control and Prevention. (2013). Voluntary Guidelines for Managing Food Allergies in Schools and Early Care and Education Programs. Retrieved from Chapter House Bill No (2005). Retrieved from Chapter (2013). Committee Substitute for Senate Bill No Retrieved from Definitions of terms used in this part. (2013). Section , Florida Statutes. Retrieved from Florida Department of Education. (2013). Department of Public Schools Memo: Legislation: Senate Bill 284. Retrieved from

26. References…
Implementing the Kelsey Ryan Act, Technical Assistance Paper. (2006). Retrieved from National Association of School Nurses. (2012). Allergy/ Anaphylaxis Management in the School Setting. Retrieved from National Association of School Nurses. (2012). Get Trained Program. Retrieved from National Association of School Nurses. (2013). Food Allergy and Anaphylaxis Tool Kit. Retrieved from

27. References…
National Association of School Nurses. (2013). Epinephrine Resource School Nurse Program. Retrieved from National Association of School Nurses. (2013). Saving Lives at School: Anaphylaxis and Epinephrine. Retrieved from National Association of School Nurses. (2013). School Nurses: Partnering to Prevent & Respond to Anaphylaxis. Retrieved from National Association of State Boards of Education [NASBE]. (2013). Anaphylaxis and Schools: Developing Policies for Treating Students with Severe Allergic Reactions. Retrieved from

28. References…
National Institutes of Health [NIH] National Institute of Allergy and Infectious Diseases [NIAID]. (2010). Guidelines for the Diagnosis and Management of Food Allergy in the United States. Retrieved from Public Law , H.R (2004). Retrieved from Public Law , H.R (2011). Section 112, Food Allergy and Anaphylaxis Management. Retrieved from Public Law , H.R (2013). School Access to Emergency Epinephrine Act. Retrieved from The Florida House of Representatives. (2005). Student and Parent Rights Bill Analysis. Retrieved from

29. References
The Florida Senate. (2013). Student Safety Bill Analysis and Fiscal Impact Statement. Retrieved from Russell, A.F. & Huber, M.M. (2013). Food allergy management in elementary school: Collaborating to maximize student safety. Journal of Asthma & Allergy Educators, 4(6), doi: / Use of Epinephrine Auto-Injectors. (2008). Rule 6A , Florida Administrative Code. Retrieved from