BILL ANALYSIS Ó SB 1266 Page 1 Date of Hearing: June 25, 2014 ASSEMBLY COMMITTEE ON EDUCATION Joan Buchanan, Chair SB 1266 (Huff) - As Amended: June 17, 2014 [Note: This bill was double referred to the Judiciary Committee and was heard by that committee as it relates to issues under its jurisdiction.] SENATE VOTE : 37-0 SUBJECT : Pupil health: epinephrine auto-injectors. SUMMARY : Requires school districts, county offices of education (COE), and charter schools to provide emergency epinephrine auto-injectors to school nurses or trained personnel who have volunteered, and school nurses or trained personnel may use epinephrine auto-injectors to provide emergency medical aid to persons suffering, or reasonably believed to be suffering, from an anaphylactic reaction. Specifically, this bill : 1)Authorizes a pharmacy to furnish epinephrine auto-injectors to a charter school (in addition to a school district or COE) if all of the following are met: a) The epinephrine auto-injectors are furnished exclusively for use at a charter school. b) A physician and surgeon provides a written order that specifies the quantity of epinephrine auto-injectors to be furnished. 2)Specifies that records regarding the acquisition and disposition of epinephrine auto-injectors furnished shall be maintained by the school district, COE or charter school for a period of three years from the date the records were created. The school district, COE or charter school shall be responsible for monitoring the supply of epinephrine auto-injectors and ensuring the destruction of expired epinephrine auto-injectors. 3)Defines the following: a) "Anaphylaxis" means a potentially life-threatening hypersensitivity to a substance. Symptoms of anaphylaxis may include shortness of breath, wheezing, difficulty breathing, difficulty talking or swallowing, hives, SB 1266 Page 2 itching, swelling, shock, or asthma. Causes of anaphylaxis may include, but are not limited to, an insect sting, food allergy, drug reaction, and exercise. b) "Epinephrine auto-injector" means a disposable drug delivery system with a spring-activated needle that is designed for emergency administration of epinephrine to provide rapid, convenient first aid for persons suffering a potentially fatal reaction to anaphylaxis. c) "Volunteer" or "Trained personnel" means an employee who has volunteered to administer epinephrine auto-injectors to a person if the person is suffering, or reasonably believed to be suffering, from anaphylaxis, and has been designated by a school and has received training. 4)Requires every five years, or sooner as deemed necessary by the Superintendent of Public Instruction (SPI), the SPI to review minimum standards of training for the administration of epinephrine auto-injectors; and, requires the SPI to consult with organizations and providers with expertise in administering epinephrine auto-injectors and administering medication in a school environment, including, but not limited to, the State Department of Public Health, the Emergency Medical Services Authority, the American Academy of Allergy, Asthma and Immunology, the California School Nurses Organization, the California Medical Association, the American Academy of Pediatrics, Food Allergy Research and Education, the California Society of Allergy, Asthma and Immunology, the American College of Allergy, Asthma and Immunology, and others. 5)Requires the training be consistent with the most recent Voluntary Guidelines for Managing Food Allergies In Schools and Early Care and Education Programs published by the federal Centers for Disease Control and Prevention and the most recent guidelines for medication administration issued by the department; and, requires the training to include all of the following: a) Techniques for recognizing symptoms of anaphylaxis. b) Standards and procedures for the storage, restocking, and emergency use of epinephrine auto-injectors. c) Emergency followup procedures, including calling the emergency 911 telephone number and contacting, if possible, the pupil's parent and physician. d) Recommendation on the necessity of instruction and certification in cardiopulmonary resuscitation. SB 1266 Page 3 e) Instruction on how to determine whether to use an adult epinephrine auto-injector or a junior epinephrine auto-injector, which shall include consideration of the grade level or age as a guideline of equivalency for the appropriate pupil weight determination. f) Written materials covering the information required under this subdivision. 6)Requires a school district, COE or a charter school, to distribute a notice at least once per school year to all staff and that contains the following information: a) A description of the volunteer request, stating that the request is for volunteers to be trained to administer epinephrine auto-injector to a pupil if the pupil is suffering, or reasonably believed to be suffering from anaphylaxis. b) A description of the training that the volunteer will receive. 7)Requires a school nurse to obtain from a physician and surgeon employed by or contracting with the local educational agency, the medical director of the local health department, or the local emergency medical services director a prescription for epinephrine auto-injectors that, at a minimum, includes, for elementary schools, one regular epinephrine auto-injector and one junior epinephrine auto-injector, and for junior high or middle schools and high schools, if there are no pupils who require a junior epinephrine auto-injector, one regular epinephrine auto-injector. The prescription may be filled by local or mail order pharmacies or epinephrine auto-injector manufacturers. 8)Requires, if the school does not have a school nurse, a school administrator if an employee has volunteered, to obtain from a physician and surgeon employed by or contracting with the local educational agency, the medical director of the local health department, or the local emergency medical services director a prescription for epinephrine auto-injectors that, at a minimum, includes, for elementary schools, one regular epinephrine auto-injector and one junior epinephrine auto-injector, and for junior high or middle schools and high schools, if there are no pupils who require a junior epinephrine auto-injector, one regular epinephrine auto-injector. SB 1266 Page 4 9)Authorizes a school district, COE, or charter operator, on behalf of the school nurse or administrator in that school district, county or charter school, to obtain from a physician and surgeon employed by or contracting with the local educational agency, the medical director of the local health department, or the local emergency medical services director a prescription for epinephrine auto-injectors that, at a minimum, includes, for elementary schools, one regular epinephrine auto-injector and one junior epinephrine auto-injector, and for junior high or middle schools and high schools, if there are no pupils who require a junior epinephrine auto-injector, one regular epinephrine auto-injector. 10)Authorizes a school nurse, or if the school does not have a school nurse or the school nurse is not onsite or available, a volunteer to administer an epinephrine auto-injector to a person exhibiting potentially life-threatening symptoms of anaphylaxis at school or a school activity when a physician is not immediately available; specifies if the epinephrine auto-injector is used it shall be restocked as soon as reasonably possible, but no later than two weeks from the use; and, requires epinephrine auto-injectors to be restocked before their expiration date. 11)Requires a volunteer to initiate emergency medical services or other appropriate medical followup (calling 911) in accordance with the training materials; and, requires, no later than 72 hours after an incident, the school nurse or volunteer, in conjunction with a school administrator, to report the incident to the school district, COE, or chartering authority on a form developed by the department, California Nurses Association, the California Emergency Medical Services Authority and the American Academy of Pediatrics; requires the school district, COE or chartering authority to report the data using the California Longitudinal Pupil Achievement Data System; and, requires the department to annually publish a summary of the data on its Internet Web site. 12)Requires a school district, COE, or charter school to ensure that each employee who volunteers under this section will be provided defense and indemnification by the school district, COE, or charter school for any and all civil liability; and, specifies this information shall be reduced to writing, provided to the volunteer, and retained in the volunteer's SB 1266 Page 5 personnel file. 13)Authorizes a state agency, the department or a public school to accept gifts, grants, and donations from any source, including, but not limited to, the acceptance of epinephrine auto-injectors from a manufacturer or wholesaler. EXISTING LAW : 1)Authorizes a school district or COE to provide emergency epinephrine auto-injectors to trained personnel, and authorizes trained personnel to use an epinephrine auto-injector to provide emergency medical aid to a person suffering from an anaphylactic reaction. 2)Authorizes public schools to designate at least one school personnel on a voluntary basis to receive initial and annual training, based on specific standards, regarding the storage and emergency use of an epinephrine auto-injector. 3)Authorizes a school nurse, or if the school does not have a nurse, a person who has received training, to: a) Obtain a prescription for epinephrine auto-injectors from the school district physician, medical director of the local health department, or local emergency medical services director. b) Immediately administer an epinephrine auto-injector to a person exhibiting potentially life threatening symptoms of anaphylaxis at school or a school activity when a physician is not immediately available. 4)Requires a school district or COE electing to use epinephrine auto-injectors for emergency medical aid to create a plan to address all of the following issues: a) Designation of the person(s) who will provide the training. b) Designation of the school district physician, medical director of the local health department or local emergency medical services director who will be consulted for the prescription for epinephrine auto-injectors. c) Documentation as to who will obtain the prescription and the medication. d) Documentation regarding where the epinephrine auto-injector is stored and how the epinephrine auto-injector will be made readily available in case of an SB 1266 Page 6 emergency. 5)Requires the SPI to develop minimum standards of training, and requires the training to include all of the following: a) Techniques for recognizing symptoms of anaphylaxis. b) Standards and procedures for the storage and emergency use of epinephrine auto-injectors. c) Emergency follow-up procedures, including calling 911 and contacting, if possible, the student's parents and physician. d) Instruction and certification in cardiopulmonary resuscitation. e) Written materials covering the information described above. (Education Code (EC) 49414) 6)Authorizes, in the absence of a credentialed school nurse or other licensed nurse onsite at the school, non-medical school personnel to administer medication to a pupil in an emergency, after receiving specified training: a) Glucagon may be administered to students with diabetes suffering from severe hypoglycemia. (EC 49414.5) b) Emergency anti-seizure medication may be administered to students with epilepsy suffering from seizures. (EC 49414.7) FISCAL EFFECT : According to the Senate Appropriations Committee, "Mandate: Potentially substantial reimbursable state mandate on local education agencies to provide and maintain epinephrine auto-injectors, train volunteers, and adhere to reporting requirements. Annual costs will be in the millions of dollars (General Fund); the cost of purchasing epinephrine auto-injectors for the more than 10,000 district schools alone would exceed $2 million. Standards: Costs to the California Department of Education (CDE) to review and update minimum training standards would be minor and absorbable." COMMENTS : This bill requires school districts, COEs, and charter schools to provide emergency epinephrine auto-injectors to school nurses and trained personnel who have volunteered, who may use the epinephrine auto-injectors to provide emergency medical aid to persons suffering, or reasonably believed to be suffering, from an anaphylactic reaction. The bill requires a school nurse, if they are available and onsite, to obtain an epinephrine auto-injector. If a school nurse is not available and onsite, the bill requires an administrator to obtain an SB 1266 Page 7 epinephrine auto-injector, only if there is a volunteer willing to be responsible for injecting the epinephrine in an emergency. This bill requires all schools with a school nurse or trained volunteer to stock epinephrine auto-injectors. According to the author, "SB 1266 will require extra epinephrine injectors be stocked at schools when there is a volunteer willing to be trained to administer. The stocking of extra epinephrine injectors will allow for the administration of the medication if necessary to someone who is not aware of their life threatening condition. By requiring stock epinephrine, as described in SB 1266, we are enabling our State to possibly compete for federal dollars and provide our school health professionals the necessary tools and peace of mind to keep children safe. Ultimately, we know with certainty SB 1266 WILL be saving lives as there is ample evidence from schools that have stocked it, have had occasion to use it and in turn has resulted in saving the lives of children." Epinephrine Auto-Injector Dosing : Epinephrine auto-injectors are designed in two doses. One dose is designed for children between 33 pounds and 66 pounds and another dose is designed for children and adults over 66 pounds. The side effects of epinephrine include a fast/pounding heartbeat, nervousness, dizziness and shakiness, among others. If a full strength dose epinephrine auto-injector is used on a child less than 66 pounds, they may have more of these side effects, but should not experience any serious side effects unless they have a rare cardiac defect. Therefore it is safe to give a child less than 66 pounds the full strength dose of epinephrine. In fact, many allergists recommend the full dose epinephrine to children more than 50 pounds. With this in mind, the bill requires the expert panel to consider grade level guidelines so that employees are not faced with determining the approximate weight of a child and instead could determine with dose of epinephrine to give based on their grade level, or a combination of those things. EpiPen 4 Schools Program : EpiPen currently operates a program that offers four free EpiPen or EpiPen Jr Auto-Injectors to public and private schools in the United States, with a prescription. The program is scheduled to run until 2015, and the company is currently considering whether to extend the program beyond 2015. Committee Amendments : Staff recommends the following SB 1266 Page 8 amendments: 1)Clarify that qualified supervisors of health, or a designee, at school districts, COEs and charter operators shall be responsible for obtaining and stocking epinephrine auto-injectors for the schools they operate. 2)Clarify that the school district, COE or chartering school shall annually report the data regarding the use of epinephrine auto-injectors to the department. 3)Correct a drafting error by deleting references to surgeons in the bill. Arguments in Support : The Asthma and Allergy Foundation of America supports the bill and states, "SB 1266 would help ensure that all students, regardless of where they attend school, are protected in the event of a severe allergic reaction. Approximately 25% of epinephrine injections in schools involve a student with a previously undiagnosed allergy. Requiring schools to stock epinephrine auto-injectors would not only protect students with diagnosed food allergies, but also students who have an allergic reaction for the first time at school." Arguments in Opposition : The California Teachers Association oppose the bill and states, "SB 1266 does not sufficiently address costs associated with identifying potential volunteers, satisfactory training modules that lead to volunteer recruitment, or the level of training necessary to understand the consequences of potential negative unintended consequences." REGISTERED SUPPORT / OPPOSITION : Support Allergy & Asthma Association of Northern California Allergy & Asthma Association of Southern California Allergy & Asthma Medical Group & Research Center, A.P.C. Allergy Station @ Sacramento American Academy of Allergy Asthma and Immunology American Nurses Association\California chapter American Red Cross Asthma and Allergy Foundation of America Bay Area Food Allergy 5k Walk/Run in Memory of BJ HOM California Academy of Family Physicians California Academy of Physician Assistants California Advocates for Food Allergies California Chapter of American College of Emergency Physicians California Physicians United SB 1266 Page 9 California School Nurses Organization California Society of Allergy, Asthma and Immunology California Society of Health-System Pharmacists California State PTA Capital Allergy & Respiratory Disease Center Food Allergy and Anaphylaxis Connection Team Food Allergy Research and Education, sponsor Food Allergy Support of Sacramento Kids with Food Allergies Mylan Natalie Giorgi Sunshine Foundation Northern California Allergy & Asthma Advocates (NCAAA) Nut Free Wok Orange County Tax Payers Association San Clemente Food Allergy Support Group San Diego Food Allergy Support Group SF Bay Area Food Allergy Network Sanofi School Employers Association of California South Orange County Food Allergy Network Stanford Food Allergy & Food Sensitivity Center Community Council Sutter Medical Group Numerous individuals Opposition California Federation of Teachers California Teachers Association Analysis Prepared by : Chelsea Kelley / ED. / (916) 319-2087