This docum ent does not reflect the intent or official position of the bill sponsor or House of Representatives. STORAGE NAME: h0883e.HHS DATE: 2/16/2024 HOUSE OF REPRESENTATIVES STAFF ANALYSIS BILL #: CS/CS/HB 883 Short-acting Bronchodilator Use in Public and Private Schools SPONSOR(S): Health & Human Services Committee, Choice & Innovation Subcommittee, Koster TIED BILLS: None. IDEN./SIM. BILLS: SB 962 REFERENCE ACTION ANALYST STAFF DIRECTOR or BUDGET/POLICY CHIEF 1) Choice & Innovation Subcommittee 16 Y, 0 N, As CS Dixon Sleap 2) PreK-12 Appropriations Subcommittee 11 Y, 0 N Potvin Potvin 3) Health & Human Services Committee 17 Y, 0 N, As CS Osborne Calamas SUMMARY ANALYSIS To provide access to life-saving interventions during a student’s respiratory distress at a public or private school, the bill authorizes a public or private school to acquire and stock a supply of short-acting bronchodilators and components from a wholesale distributor or to enter into an arrangement with a wholesale distributor or manufacturer, for short-acting bronchodilators and components at fair-market, free, or reduced prices. The bill specifies the requirements for storing and maintaining the stock supply of short-acting bronchodilators and components. The bill authorizes specified health care practitioners to prescribe short-acting bronchodilators and components in the name of a public school or private school. Additionally, the bill authorizes a licensed pharmacist to dispense short-acting bronchodilators and components to a prescription issued in the name of a public or private school. The bill allows public and private schools to acquire and stock a supply of short-acting bronchodilators and components from a wholesale distributor or to enter into an arrangement with a wholesale distributor or manufacturer, for short-acting bronchodilators and components at fair-market, free, or reduced prices. Under the bill, a public or private school may also accept short-acting bronchodilators and components as a donation or transfer if the items meet the U.S. Food and Drug Administration regulations and are in a new, unexpired, manufactured-sealed condition. The bill outlines criteria for individuals authorized to administer short-acting bronchodilators and components to students at public and private schools and requires schools to inform parents of the school’s adopted protocol and obtain parental permission before administering short-acting bronchodilators to a student in respiratory distress emergencies. The bill establishes immunity from civil and criminal liability for schools, trained school personnel, and health care practitioners who act in accordance with the provisions of the bill. The bill has no fiscal impact on state government and may have an insignificant, indeterminate, negative fiscal impact on school districts. See Fiscal Analysis. The bill provides an effective date of July 1, 2024. STORAGE NAME: h0883e.HHS PAGE: 2 DATE: 2/16/2024 FULL ANALYSIS I. SUBSTANTIVE ANALYSIS A. EFFECT OF PROPOSED CHANGES: Present Situation Management of Childhood Asthma in Schools Asthma is a chronic condition that involves inflammation of the airways. Individuals with asthma experience hyperresponsive airways, meaning their reactions to triggers such as colds, cigarette smoke, and exercise are faster and more intense than those with normal airways. This heightened reactivity leads to inflammation of the airway lining, tightening of surrounding muscles, airway narrowing, and increased production of mucus cells. These reactions reduce the airflow into the lungs and make breathing more challenging. 1 In Florida, approximately 1 in 8 adults and 1 in 9 children have asthma. 2 Nationally, asthma stands as one of the most common chronic childhood diseases, impacting the daily lives of millions of American children. 3 As children with asthma attend school, their safety and the management of their condition becomes the shared responsibility of the family, their healthcare providers, and school personnel. 4 While most schools are very cognizant of the seriousness of asthma, the distance from the classroom or playing field to the school health room can be perilously far for a child struggling to breathe. 5 As approximately 10 percent of school children have asthma and spend a significant amount of time at school, having access to a rescue inhaler is important. 6 Rescue inhalers, known as short-acting bronchodilators, are used for sudden, acute asthma symptoms and includes beta 2-agonists, which quickly open airways to stop asthma symptoms. Referred to as “reliever” or “rescue” medicines, they are the most effective for treating sudden, severe, or new asthma symptoms, working within 15 to 20 minutes and lasting for four to six hours. 7 According to the American Lung Association, despite all 50 states and the District of Columbia having laws allowing students to carry and use asthma inhalers at school, it is still crucial for schools to move fast to save the life of a child during asthma emergencies. Situations may arise that can keep a child from getting the medications they need in a timely manner, such as forgetting an inhaler at home or facing financial constraints preventing the family from affording a second inhaler to keep at school. 8 Given the unpredictable and potentially life-threatening nature of asthma exacerbations in children, timely access to rescue inhalers becomes a matter of life-saving significance. Addressing these concerns, in a 2021 policy statement on ensuring access to albuterol in schools, the American Thoracic 1 Florida Department of Health, What is Asthma? Available at https://www.floridahealth.gov/diseases-and-conditions/asthma/what-is- asthma.html (last visited February 5, 2024). 2 Id. 3 Asthma and Allergy Foundation of America, Childhood Asthma. Available at https://asthmaandallergies.org/asthma- allergies/childhood-asthma/ (last visited February 5, 2024). 4 American Lung Association, Improving Access to Asthma Medications in Schools (2014). Available at https://www.lung.org/getmedia/872c9b6a-5379-4321-8913-102d53182e29/improving-access-to-asthma.pdf.pdf (last visited February 5, 2024). 5 Id. 6 American Academy of Allergy, Asthma & Immunology, School stock inhaler program (2021). Available at https://www.aaaai.org/tools- for-the-public/latest-research-summaries/the-journal-of-allergy-and-clinical-immunology/2021/school-inhaler (last visited February 5, 2024). 7 Cleveland Clinic, Bronchodilator. Available at https://my.clevelandclinic.org/health/treatments/17575-bronchodilator (last visited February 5, 2024). The inhaled forms of short-acting beta 2-agonists medications include Albuterol, Levalbuterol, or a combination of albuterol and ipratropium bromide. 8 American Lung Association, Why Schools Should Stock Asthma Inhalers (2023). Available at https://www.lung.org/blog/why-schools- should-stock-inhalers (last visited February 5, 2024). STORAGE NAME: h0883e.HHS PAGE: 3 DATE: 2/16/2024 Society and others, 9 stated that for children with asthma, access to quick-relief medications is critical to minimizing morbidity and mortality. The policy statement included an approach a state legislature could take to ensure access at school through stock albuterol policies whereby a school maintains a supply of stock albuterol that can be used by any student who experiences respiratory distress. The statement concluded that stock albuterol in schools is a safe, practical, and potentially life-saving option for children with asthma, whether asthma is diagnosed or undiagnosed, who lack access to their personal quick-relief medication. 10 School Stock Albuterol Policies – Other States Efforts Several states 11 have passed legislation and guidelines addressing asthma management in schools. While many state policies allow asthmatic students to carry an inhaler with them at school, some states have implemented policies which allow schools to stock quick-relief medications to respond to a student in a respiratory distress emergency. For example, Virginia law requires each local school board to adopt and implement policies for the possession and administration of stock albuterol inhalers and valved holding chambers in every public school in the local school division. 12 Authorized personnel, such as a school nurse or employee of the school board, are responsible for administering the albuterol. In 2023, the Virginia Legislature expanded on those who could administer the albuterol inhalers to include authorized licensed athletic trainers under contract with a local school division. 13 In 2022, the Arizona Legislature authorized school districts and charter schools to accept monetary donations or apply for grants to purchase inhalers and spacers or holding chambers. Alternatively, the school districts and charter schools may directly accept donations of these items from the product manufacturer. 14 In Illinois, public and nonpublic schools are authorized to maintain a supply of asthma medication in any secure location that is accessible before, during, or after school where a person is most at risk. 15 Authorized personnel, such as school nurse or trained personnel, may administer the asthma medication to any person that the individual believed in good faith was in respiratory distress. School Health Services in Florida School health services are an important component of the public health system and help assure that Florida’s students are healthy and ready to learn. School health services are intended to minimize health barriers to learning for public school students in grades prekindergarten through twelve in all 67 Florida counties. 16 Asthma 9 The policy statement was a joint effort made by the American Thoracic Society (ATS), The Allergy and Asthma Network Mothers of Asthmatics (AANMA), American Lung Associations (ALA), and the National Association of School Nurses (NASN). 10 Anna Volerman, et al., Ensuring Access to Albuterol in Schools: From Policy to Implementation. An official ATS/AANMA/ALA/NASN Policy Statement, 204 American Journal of Respiratory and Critical Care Medicine 5 (2021). Available at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8491259/pdf/rccm.202106-1550ST.pdf (last visited February 5, 2024). 11 Examples of states that passed legislation and guidelines addressing asthma management in schools include Arkansas, ARK. CODE. § 6-18-707(d)-(h) (2019), California, CAL. CIVIL CODE § 49414.7 (2023), 105., Indiana, IND. CODE § 16-41-43-1, 16-41-43- 3.5, 20-34-4.5-0.2, and 20-34-4.5-0.6 (2017), Iowa, IOWA CODE § 280.16 (2022), Montana, MO. REV. STAT. § 167.635 (2012), New Hampshire, N.H. REV. STAT. § 200:53 (2016), New Mexico, N.M. REV. STAT. ANN. § 24-31-1 (2018), Ohio, OHIO REV. CODE. ANN. § 3313.7113 (2023), Oklahoma, OKLA. STAT. tit. 70, §70-1-116.3 (2020), Texas, TEX. General-LAW MUNICIPALITY CODE ANN. § 38.001 (2007), Utah, UTAH CODE ANN. § 26-41-101 to 107 (2020). 12 VA CODE.ANN. § 22.1-274.2, Virginia Law, Code of Virginia, § 22.1-274.2. Available at https://law.lis.virginia.gov/vacode/22.1- 274.2/ (last visited February 11, 2024). 13 VA CODE. ANN. § 8.01-225 (2023) 14 ARIZ. REV. STAT. § 15-158 and § 22.1-274.2 (2022) 15 Ill. COMP. STAT. 5/22-30 and 27A-5 (2017), see also Illinois Public Act, SB3015 Enrolled. Available at https://www.ilga.gov/legislation/publicacts/100/PDF/100-0726.pdf (last visited February 11, 2024). 16 Florida Department of Education, School Health Services. Available at https://www.fldoe.org/schools/k-12-public-schools/sss/sch- health-serv.stml (last visited February 11, 2024). Service are provided in accordance with a local school health services plan under s. 381.0056(4)(a), F.S. STORAGE NAME: h0883e.HHS PAGE: 4 DATE: 2/16/2024 In accordance with Florida law, asthmatic students attending public school may carry a metered dose inhaler with them while in school, provided they have obtained approval from both their parent and physician. The school principal must be provided a copy of the parent’s and physician’s approval. 17 Current law does not expressly authorize an asthmatic student attending a private school to carry a metered dose inhaler with them while at school. Epinephrine Use and Supply Florida law also addresses the use of epinephrine auto-injectors for public and private K-12 students, at risk of life-threatening allergic reactions, known as anaphylaxis. A public school student may carry and self-administer 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. 18 For each public school student authorized to carry an epinephrine auto- injector, the school nurse must develop an annual child-specific action plan for an anticipated health emergency in the school setting. 19 Additionally, both K-12 public and private schools in Florida may purchase and maintain a supply of epinephrine auto-injectors in a secure, locked location on school premises for use if a student has an anaphylactic reaction. 20 A participating school district or private school is required to adopt a protocol developed by a licensed physician for administration of the epinephrine by school personnel. 21 The epinephrine auto-injectors may be administered by school personnel or self-administered by the student. 22 K-12 public and private schools, their employees, agents, and physicians who provide the standing protocol are exempted from liability for any injury arising from the use of an epinephrine auto-injector if the epinephrine auto-injector is administered by trained school personnel who follows the protocol and reasonably believes that the student is having an anaphylactic reaction. 23 Florida law provides that the liability protections apply: 24 Even if the student’s parent has not been provided notice or has not signed a statement acknowledging that the school district is not liable; and Regardless of whether authorization has been given by the student’s parent or the student’s physician. However, the liability protections do not apply if the trained school personnel’s action is willful and wanton. 25 Prescribing and Dispensing Short-acting Bronchodilators Under current law, short-acting bronchodilators and components must be prescribed to a patient by a licensed health care practitioner who is duly authorized to prescribe drugs, such as allopathic and osteopathic physicians, and, in certain circumstances, physician assistants 26 and advanced practice 17 S. 1002.20(3)(h), F.S. 18 S. 1002.20(3)(i)1., F.S.; see also rule 6A-6.0251, F.A.C. 19 Rule 6A-6.0251, F.A.C.; see also rule 64F-6.004, F.A.C. 20 Ss. 1002.20(3)(i)2., F.S. and 1002.42(17)(a), F.S. 21 Id. 22 Id. 23 Ss. 1002.20(3)(i)3., F.S. and 1002.42(17)(b), F.S. 24 Id. 25 Id. 26 Physician assistants may prescribe drugs as delegated by a supervising physician. See, ss. 459.022(4)(e) and 458.347(4)(e), F.S. STORAGE NAME: h0883e.HHS PAGE: 5 DATE: 2/16/2024 registered nurses. 27 A pharmacist may then dispense 28 the short-acting bronchodilators and components according to the prescriber’s directions. A pharmacist may not alter a prescriber’s directions, diagnose or treat any disease, initiate any drug therapy, or practice medicine or osteopathic medicine, except as expressly permitted by law. 29 In certain circumstances, a pharmacist may order and dispense a drug without a pre-existing prescription. For example, pharmacists are authorized to order and dispense drugs that are included in a limited formulary developed by a committee composed of members of the Board of Medicine, the Board of Osteopathic Medicine, and the Board of Pharmacy. 30 The formulary does not include short- acting bronchodilators and components. 31 A pharmacist who has received the appropriate certification and training may also order and dispense specific drugs pursuant to a collaborative practice agreement with a licensed physician. 32 Collaborative practice agreements allow qualified pharmacists to actively assist in the maintenance and care of patients with chronic conditions, such as asthma. Under current law, pharmacists may not dispense short-acting bronchodilators and components without a prescription, unless they are expressly authorized to do so under a collaborative practice agreement with a physician. 33 Florida’s Good Samaritan Act The Good Samaritan Act (the Act) is established under s. 768.13, F.S. The Act provides civil immunity to any person, including those licensed to practice medicine, who gratuitously and in good faith renders emergency care or treatment in direct response an emergency situation. 34 Under the Act, a person may not be held liable for any civil damages resulting from such care or treatment, or failure to act in providing further medical treatment where the person acted as a reasonable person would. Effect of Proposed Changes CS/CS/HB 883 authorizes public and private schools to stock short-acting bronchodilators and components in order to provide efficient access to life-saving interventions during respiratory distress for children in school. The bill authorizes licensed physicians, 35 physician assistants, 36 and advanced practice registered nurse practitioners 37 to prescribe short-acting bronchodilators and components in the name of a public school or private school. The bill also allows a licensed pharmacist to dispense short-acting bronchodilators and components pursuant to a prescription issued in the name of a public or private school. The bill allows public and private schools to acquire and stock a supply of short-acting bronchodilators and components from a wholesale distributor 38 or to enter into an arrangement with a wholesale distributor or manufacturer, 39 for short-acting bronchodilators and components at fair-market, free, or 27 APRNs may prescribe drugs within the framework of a physician’s supervisory protocol, or without such protocol if they are registered for autonomous practice. See, ss. 464.003(2) and 464.012(3), F.S. 28 Dispensing a drug includes the assessment of the prescription for potential adverse effects and counseling the patient regarding the drug; see, S. 465.003(13), F.S. 29 S. 465.003, F.S. 30 S. 456.186, F.S. 31 Rule 64B16-27.220, F.A.C. 32 S. 465.1865, F.S. 33 See, s. 465.1865, F.S. 34 S. 768.113(2)(a) and (b), F.S., in this context, an emergency situation includes those arising out of a public health emergency declared pursuant to s. 381.00315, a state of emergency which has been declared pursuant to s. 252.36 or at the scene of an emergency outside of a medical facility. 35 Licensed under Chs. 458 or 459, F.S. 36 Id. 37 Licensed under Ch. 464, F.S. 38 S. 499.003(49), F.S. Wholesale distributor means a person, other than a manufacturer, a manufacturer’s co-licensed partner, a third- party logistics provider, or a repackager, who is engaged in wholesale distribution. 39 S. 499.003(29), F.S. Manufacturer means a person who holds a New Drug Application, an Abbreviated New Drug Application, a Biologics License Application, or a New Animal Drug Application approved under the federal act or license issued under s. 351 of the STORAGE NAME: h0883e.HHS PAGE: 6 DATE: 2/16/2024 reduced prices. The bill also allows public and private schools to accept short-acting bronchodilators and components as a donation or transfer if they are new, unexpired, manufacturer-sealed, not subject to recall, unadulterated, and in compliance with relevant regulations adopted by the United States Food and Drug Administration. A school which has elected to stock a supply of short-acting bronchodilators and components must maintain the supply in a secure location on the school's premises. The participating public or private school must adopt a protocol developed by a licensed physician 40 for administration of short-acting bronchodilators or components by school personnel who are trained to recognize symptoms of respiratory distress and to administer a short-acting bronchodilator and components. Each school or school district that adopts such a protocol must provide written notice of the protocol to the parent of each student enrolled in the school. The school must receive prior permission from a student’s parent to administer a short-acting bronchodilator or components in a respiratory distress emergency. A school nurse or other school personnel may only administer a short-acting bronchodilator or components if they have successfully completed the training and believe in good faith that the student is experiencing respiratory distress. The student does not need to have been diagnosed with asthma or have a pre-existing prescription in order for a short-acting bronchodilator or components to be administered under the provisions of the bill. Under the bill, school nurses and other appropriately trained school personnel who administer, or attempts to administer, a short-acting bronchodilator or components in compliance with the provisions of the bill and the Good Samaritan Act, 41 as well as the school district or private school that employs such individual, are immune from civil or criminal liability resulting from such administration. The bill grants immunity from civil and criminal liability for any authorized healthcare practitioner who prescribes, or pharmacist who fills, a prescription for a short-acting bronchodilator and components to a school under the provisions of this bill, and acts in good faith and exercises reasonable care, similarly the bill grants immunity from licensure discipline on the same basis. The bill updates the terminology for the type of device an asthmatic public school student may carry from a metered-dose inhaler to a short-acting bronchodilator and component and authorizes an asthmatic private school student, similar to a public school student, to carry a short-acting bronchodilator and components while in school. The private school student’s parent and physician must provide their approval to the private school’s principal. The bill defines the following terms: "Administer" to mean to give or to directly apply a short-acting bronchodilator or components to a student. "Asthma" to mean a chronic lung disease that inflames and narrows the airways, which can manifest as wheezing, chest tightness, shortness of breath, and coughing. "Authorized health care practitioner" to mean a physician, a physician assistant or an advanced practice registered nurse, each licensed as defined under the law. "Components" to mean devices used as part of clinically recommended use of short-acting bronchodilators, which may include spacers, valved holding chambers, or nebulizers. "Respiratory distress" to refer to an individual experiencing difficulty breathing, which can be caused by a multitude of medical factors, including chronic diseases such as asthma. "Short-acting bronchodilator" to mean a beta-2 agonist, such as albuterol, used for the quick relief of asthma symptoms and recommended by the National Heart, Lung, and Blood Institute's National Asthma Education and Prevention Program Guidelines for the Treatment Public Health Ser vice Act, 42 U.S.C. s. 262, for such drug or biologics, or if such drug or biologics are not the subject of an approved application or license, the person who manufactured the drug or biologics, a co-licensed partner or affiliates, and those manufacturing devices or cosmetics. 40 Such physician must be either an allopathic physician licensed under Ch. 458, F.S., or an osteopathic physician licensed under Ch. 459, F.S. 41 S. 768.13, F.S. STORAGE NAME: h0883e.HHS PAGE: 7 DATE: 2/16/2024 of Asthma. These bronchodilators may include an orally inhaled medication that contains a premeasured single dose of albuterol or albuterol sulfate delivered by a nebulizer or by a pressured metered-dose inhaler used to treat respiratory distress, including, but not limited to, wheezing, shortness of breath, and difficulty breathing, or another dosage of a short- acting bronchodilator recommended in the Guidelines for the Treatment of Asthma. The bill provides an effective date of July 1, 2024. B. SECTION DIRECTORY: Section 1: Amends s. 1002.20, F.S., relating to K-12 student and parent rights. Section 2: Amends s. 1002.42, F.S., relating to private schools. Section 3: Provides an effective date of July 1, 2024 II. FISCAL ANALYSIS & ECONOMIC IMPACT STATEMENT A. FISCAL IMPACT ON STATE GOVERNMENT: 1. Revenues: None. 2. Expenditures: None. B. FISCAL IMPACT ON LOCAL GOVERNMENTS: 1. Revenues: None. 2. Expenditures: See Fiscal Comments. C. DIRECT ECONOMIC IMPACT ON PRIVATE SECTOR: None. D. FISCAL COMMENTS: Schools that choose to act under the authority granted by the bill may incur costs associated with implementing the provisions of the bill. Schools that choose to exercise this authority may incur costs related to acquiring and storing a supply of short-acting bronchodilators and components, providing written notice to parents, and training personnel to administer the bronchodilators and their components. III. COMMENTS A. CONSTITUTIONAL ISSUES: 1. Applicability of Municipality/County Mandates Provision: None. 2. Other: None. B. RULE-MAKING AUTHORITY: STORAGE NAME: h0883e.HHS PAGE: 8 DATE: 2/16/2024 None. C. DRAFTING ISSUES OR OTHER COMMENTS: None. IV. AMENDMENTS/COMMITTEE SUBSTITUTE CHANGES On January 18, 2024, the Choice & Innovation Subcommittee adopted one amendment and reported the bill favorably as a committee substitute. The amendment authorizes a private school, similar to a public school, to accept short-acting bronchodilators and components as a donation or transfer if they are new, unexpired, manufacturer-sealed, not subject to recall, unadulterated, and in compliance with relevant regulations adopted by the United States Food and Drug Administration. On February 15, 2024, the Health & Human Services Committee adopted one amendment and reported the bill favorably as a committee substitute. The amendment: Revised the immunity provisions for schools, school personnel, health care practitioners and pharmacists related to the prescribing, dispensing and administration of short-acting bronchodilators. Specifies that the physician developing the protocol for the administration of a short-acting bronchodilator for schools must be a licensed allopathic or osteopathic physician. Revised the definition of authorized health care practitioner to include advanced practice registered nurses rather than registered nurses. The analysis is drafted to the committee substitute adopted by the Health & Human Services Committee.