BILL ANALYSIS                                                                                                                                                                                                    



                                                                  SB 1266
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          Date of Hearing:  June 17, 2014

                           ASSEMBLY COMMITTEE ON JUDICIARY
                                Bob Wieckowski, Chair
                      SB 1266 (Huff) - As Amended:  May 27, 2014

           SENATE VOTE :  37-0
           
          SUBJECT  :  Pupil health: epinephrine auto-injectors

           KEY ISSUE  :  SHOULD existing provisions authorizING public and  
          private schools in California to make LIFE-SAVING emergency  
          epinephrine auto-injectors available to trained personnel to  
          voluntarily provide critically-needed emergency medical aid to  
          persons, often children, suffering from anaphylactic reaction,  
          BE MADE MANDATORY FOR PUBLIC SCHOOLS?

                                      SYNOPSIS
                                          
          This is an important public health measure dealing with  
          individuals afflicted with anaphylactic reaction.  Anaphylaxis  
          is a potentially lethal allergic reaction.  It can happen when a  
          person, often in this case a child at school, is stung by a bee,  
          ingests food such as shellfish or nuts, or maybe even just comes  
          in contact with something as simple as latex.  Epinephrine is  
          the first line of treatment for someone who is experiencing  
          anaphylaxis.  It can be easily administered and has very little  
          side-effect.  Reactions can be so severe, even fatal, without  
          prompt use of epinephrine.   

          Existing law authorizes public and private schools in California  
          to voluntarily make emergency epinephrine auto-injectors  
          available to trained personnel to voluntarily provide  
          critically-needed emergency medical aid to persons, often  
          children, suffering from anaphylactic reaction.  This bipartisan  
          bill would make the existing discretionary provisions mandatory  
          by requiring public schools to provide emergency epinephrine  
          auto-injectors to trained personnel who have volunteered to  
          provide emergency medical aid to persons suffering, or  
          reasonably believed to be suffering, from an anaphylactic  
          reaction.  The bill also sets forth various procedures for  
          tracking the use of such auto-injectors in such school  
          emergencies, and it requires public schools to ensure that each  
          employee who volunteers is provided defense and indemnification  
          by the school district, county office of education, or charter  








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          school for any and all civil liability, as specified.  Finally,  
          the bill would also authorize a public school to accept gifts,  
          grants, and donations from any source for the support of the  
          public school carrying out these provisions.  

          The measure is supported by a broad coalition of medical,  
          emergency and other groups who state that it will save lives,  
          especially of children, who are afflicted with anaphylactic  
          reactions that can cause unnecessary harm and even death without  
          speedy medical assistance.  It is opposed by some teacher groups  
          who state among other concerns that reactions to epinephrine  
          could go beyond the scope of training provided to school  
          personnel, and this bill creates a "one size fits all statute"  
          by individuals without necessary medical and pharmaceutical  
          expertise to take into account potential unintended  
          consequences.  The bill received no "no" votes in the Senate.  

           SUMMARY  :  Seeks to require public schools to provide emergency  
          epinephrine auto-injectors to trained personnel who have  
          volunteered to provide emergency medical aid to persons  
          suffering, or reasonably believed to be suffering, from an  
          anaphylactic reaction.  Specifically,  this bill  :  

          1)Requires school districts, county offices of education, and  
            charter schools to provide emergency epinephrine  
            auto-injectors to trained personnel who have volunteered, as  
            specified, and would authorize trained personnel to use those  
            epinephrine auto-injectors to provide emergency medical aid to  
            persons suffering, or reasonably believed to be suffering,  
            from an anaphylactic reaction.

          2)Requires a school nurse, or a school administrator if an  
            employee has volunteered, as specified, and the school does  
            not have a school nurse or the school nurse is not onsite or  
            available, to obtain the prescription for epinephrine  
            auto-injectors, as specified, and would authorize the  
            prescription for epinephrine auto-injectors to be filled by  
            local or mail order pharmacies or epinephrine auto-injector  
            manufacturers.  The bill authorizes a pharmacy to also furnish  
            epinephrine auto-injectors to a charter school if certain  
            conditions are met.  The bill requires an epinephrine  
            auto-injector to be restocked as soon as possible after it is  
            used and before its expiration date.

          3)Requires the school nurse or voluntarily designated employee  








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            to report any incident of epinephrine auto-injector use to the  
            school district, county office of education, or chartering  
            authority on a form developed by the State Department of  
            Education within 30 days after the last day of each school  
            year.  The bill requires the school district, county office of  
            education, or chartering authority to report any incident of  
            epinephrine auto-injector use to the department on those  
            forms.  The bill requires a school district, county office of  
            education, or charter school to ensure that each employee who  
            volunteers is provided defense and indemnification by the  
            school district, county office of education, or charter school  
            for any and all civil liability, as specified.  The bill  
            authorizes a public school to accept gifts, grants, and  
            donations from any source for the support of the public school  
            carrying out these provisions.

           EXISTING LAW  :

          1)Under the Government Tort Claims Act, specifies rules of civil  
            liability that apply to public entities and public employees  
            in California.  (Gov. Code Sec. 810 et seq.)

          2)In relevant part, permits a school district or county office  
            of education to provide emergency epinephrine auto-injectors  
            to trained personnel, and permits trained personnel to utilize  
            those epinephrine auto-injectors to provide emergency medical  
            aid to persons suffering from an anaphylactic reaction.   
            Prohibits any school district or county office of education  
            choosing to exercise this authority from receiving funds  
            specifically for these purposes.  (Ed. Code Sec. 49414(a).) 

          3)In relevant part, authorizes each public and private  
            elementary and secondary school in the state to voluntarily  
            determine, as specified, whether or not to make emergency  
            epinephrine auto-injectors and trained personnel available at  
            its school.  (Ed. Code Sec. 49414(c).)
           
           4)Permits each public and private school to designate one or  
            more personnel on a voluntary basis to receive initial and  
            annual refresher training, based on specified standards,  
            regarding the storage and emergency use of an epinephrine  
            auto-injector from the school nurse or other qualified person  
            designated by the school district physician, the medical  
            director of the local health department, or the local  
            emergency medical services director.  Existing law prohibits  








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            any school choosing to exercise this authority from receiving  
            state funds for these purposes.  (Ed. Code Sec. 49414(d).)

          5)Permits a school nurse, or if the school does not have a  
            school nurse, a person who has received training, as  
            specified, to do the following:

             a)   Obtain from the school district physician, the medical  
               director of the local health department, or the local  
               emergency medical services director a prescription for  
               epinephrine auto-injectors; and
             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.  (Ed. Code Sec. 49414(f).)  

          6)Requires the Superintendent of Public Instruction to establish  
            minimum standards of training for the administration of  
            epinephrine auto-injectors that satisfy the minimum statutory  
            training requirements, as specified.  Requires that the  
            Superintendent consult with specified organizations and  
            providers with expertise in administering epinephrine  
            auto-injectors and administering medication in a school  
            environment.  (Ed. Code Sec. 49414(e)(1).)  Also provides  
            minimum training requirements and standards, as specified.   
            (Ed. Code Sec. 49414(e)(2).)

          7)Authorizes a school district, county office of education, or  
            charter school, in the absence of a credentialed school nurse  
            or other licensed nurse onsite at the school, to participate  
            in a program, as specified, to allow non-medical school  
            personnel to administer anti-seizure medication to a pupil  
            with epilepsy in an emergency, after receiving certain  
            training.  (Ed. Code Sec. 49414.7.) 

          8)Provides that if a school district, county office of  
            education, or charter school elects to participate pursuant to  
            this section, the school district, county office of education,  
            or charter school shall ensure that each employee who  
            volunteers will be provided defense and indemnification by the  
            school district, county office of education, or charter school  
            for any and all civil liability, in accordance with, but not  
            limited to, that provided under the Government Tort Claims  
            Act.  This information shall be reduced to writing, provided  
            to the volunteer, and retained in the volunteer's personnel  








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            file.  (Ed. Code Sec. 49414.7(i).) 

           FISCAL EFFECT  :  As currently in print this bill is keyed fiscal.

           COMMENTS  :  An epinephrine auto-injector is a disposable medical  
          drug delivery device that delivers a single measured dose of  
          epinephrine, most frequently for the treatment of acute allergic  
          reactions to avoid or treat the onset of anaphylactic shock.   
          Anaphylactic shock can quickly result in death if untreated.   
          Epinephrine auto-injectors can be obtained by prescription only,  
          and California law does not authorize non-physicians to  
          administer an epinephrine auto-injector to another person,  
          except in limited circumstances.   

          In recent years, California law has been amended to, among other  
          things, permit school districts or county offices of education  
          to provide emergency epinephrine auto-injectors to trained  
          personnel, and to permit trained personnel to utilize the  
          auto-injectors to provide emergency medical aid to persons  
          suffering from an anaphylactic reaction, as it is not uncommon  
          for children to come into contact with specific allergens (such  
          as bee stings) or accidentally ingest foods they are allergic to  
          at school.  (AB 559 (Wiggins, Ch. 458, Stats. 2001).)  

          This bill would require, as opposed to simply authorize, school  
          districts, county offices of education, and charter schools to  
          public schools to provide emergency epinephrine auto-injectors  
          to trained personnel who have volunteered to provide emergency  
          medical aid to persons suffering, or reasonably believed to be  
          suffering, from an anaphylactic reaction.  The bill also sets  
          forth various procedures for tracking the use of such  
          auto-injectors in such school emergencies, and it requires  
          public schools to ensure that each employee who volunteers is  
          provided defense and indemnification by the school district,  
          county office of education, or charter school for any and all  
          civil liability, as specified.  Finally, the bill would also  
          authorize a public school to accept gifts, grants, and donations  
          from any source for the support of the public school carrying  
          out these provisions.   

          According to the author: 

               Approximately 6 million children under the age of 18 suffer  
               from life threatening allergies.  That is one in every 13  
               children - or [two] in every classroom.  Approximately 25  








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               percent of first time allergic reactions that require  
               epinephrine happen at school.  Because they have no  
               knowledge of this, they do not have the necessary  
               lifesaving medication on hand.  Also, children with known  
               allergies are being sent to school without epinephrine for  
               several reasons including cost, non-understanding of the  
               severity of the allergy by parents, the prohibitive nature  
               of the school process for leaving medication.  

               Anaphylaxis is a potentially lethal allergic reaction.  It  
               can happen when a person is stung by a bee, ingests food  
               such as shellfish or nuts, or maybe even just comes in  
               contact with something as simple as latex.  Epinephrine is  
               the first line of treatment for someone who is experiencing  
               anaphylaxis.  It can be easily administered and has very  
               little side-effect.  Reactions can be so severe, even  
               fatal, without prompt use of epinephrine.  

               Current law requires prescription for epinephrine be made  
               to a specific student in order for the medication to be  
               stored at schools so it can be used in case of a  
               anaphylactic reaction during school hours.  Current  
               California law also allows schools to stock epinephrine,  
               but has not required it.

               SB 1266 will require extra epinephrine injectors be  
               prescribed as a "standing order" so epinephrine can be on  
               hand in all public schools in the event of an severe  
               allergic reaction.  SB 1266 will allow volunteers to be  
               trained for identifying anaphylaxis and administering the  
               necessary medication, epinephrine.  It will also provide  
               defense and indemnification for those volunteering to  
               administer (this language came from existing law as  
               provided under [Ed. Code Sec.] 49414.7 (i)).
           
          The sponsor of this bill, Food Allergy Research & Education  
          (FARE), adds, "[e]pinephrine is the only medication that can  
          arrest the symptoms of a severe reaction."  FARE cites a study  
          in a medical journal (Pediatrics) that "showed that 24 percent  
          of epinephrine use in a school district was on those without a  
          previous diagnosis of food allergy.  Many children may not know  
          they are allergic and do not have prescribed epinephrine.   
          Precious minutes can be lost waiting for emergency responders.   
          There are no counter-indications to administering epinephrine,  
          but delaying its use may have catastrophic results."








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           Indemnification And Defense For Volunteers  :  As noted, all  
          private and public schools in this state are authorized under  
          existing California law to voluntarily determine whether or not  
          to make epinephrine available at their schools.  This bill would  
          not modify this existing authorization for private schools but  
          would require all public schools to provide emergency  
          epinephrine auto-injectors to trained personnel who have  
          volunteered to provide emergency medical aid to persons  
          suffering, or reasonably believed to be suffering, from an  
          anaphylactic reaction.  

          As noted above, this bill would require that a school district,  
          county office of education, or charter school ensure that each  
          employee who volunteers be provided defense and indemnification  
          by the school district, county office of education, or charter  
          school for any and all civil liability.  This language is  
          modeled upon an existing provision of the Education Code that  
          provides authorization for schools to allow nonmedical employees  
          to administer medical assistance to pupils with epilepsy  
          suffering from seizures.  (See Ed. Code Sec. 49414.7(i).)  The  
          language would appear to preserve any recourse that the students  
          and their families might have under existing law for injuries  
          suffered as a result of the administration of the epinephrine  
          auto-injector, while still affording adequate protection from  
          the costs of litigation and any liability for damages thereof to  
          volunteering employees who attempt to render life-saving  
          emergency care in accordance with their training.  

           ARGUMENTS IN SUPPORT  :  The measure is supported by a broad  
          coalition of medical, emergency and other groups who state that  
          it will save lives, especially of children, who are afflicted  
          with anaphylactic reactions that can cause unnecessary harm and  
          even death without speedy medical assistance.  Reflecting these  
          organizations' support, the California School Nurses  
          Organization writes that "[t]his bill will serve to protect  
          those children who are not known to have allergies by providing  
          a safety mechanism-the epinephrine auto-injectors (epi-pens)  
          which will protect them from any severe reaction.  Many school  
          children fall prey to undiagnosed allergies and those with  
          asthma or poorly controlled asthma are at a higher risk of  
          allergic reactions."

          Another supporter of the bill, the CA Allergy Support &  
          Anaphylaxis Prevention argues that even though California law  








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          authorizes school districts to stock epinephrine in schools,  
          "very few have actually taken advantage of implementing this."  

          An organization stating that it writes on behalf of Californian  
          families and individuals living with food allergies, California  
          Advocates for people with Food Allergies (CAFA), states among  
          other things that:

               Anaphylaxis is a severe medical condition that is  
               unfortunately reaching epidemic proportions, with 1 in  
               13 children being diagnosed with life-threatening  
               allergies that can lead to anaphylaxis.  Our community  
               as a whole needs to become more proactive in caring  
               for people with food allergies, especially vulnerable  
               children in schools? The best outcome for someone  
               experiencing anaphylaxis occurs when epinephrine is  
               administered as soon as anaphylaxis is noticed.  If  
               California school children experience anaphylaxis and  
               do not have their own medication, the cost can be  
               enormous, with loss of life or permanent disability  
               being potential outcomes?  

           ARGUMENTS IN OPPOSITION  :  Two organizations, the California  
          Teachers Association (CTA) and the California Federation of  
          Teachers continue to oppose the bill.  CTA's letter raises  
          concerns that: (1) reactions to epinephrine could go beyond the  
          scope of training provided to school personnel; (2) probationary  
          or temporary and/or classified employees could be "highly  
          encouraged" to volunteer against their will; and (3) this bill  
          creates a "one size fits all statute" by individuals without  
          necessary medical and pharmaceutical expertise to take into  
          account potential unintended consequences.  The California  
          Federation of Teachers continues to contend that a mandate  
          requiring all schools to have this device, where they are  
          already authorized to do so, is unnecessary and costly.

           Prior Legislation  :  SB 669 (Huff, Ch. 725, Stats. 2013), among  
          other things, authorized a trained pre-hospital emergency  
          medical care person, first responder, or lay rescuer to obtain  
          and use epinephrine auto-injectors to render emergency care to  
          another person, pursuant to specified requirements, and granted  
          them limited liability, as specified.  

          SB 161 (Huff, Ch. 560, Stats. 2011) authorized a school  
          district, county office of education, or charter school to  








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          participate in a program to provide nonmedical school employees  
          with voluntary emergency medical training to provide, in the  
          absence of a credentialed school nurse or other licensed nurse  
          onsite at the school or charter school, emergency medical  
          assistance to pupils with epilepsy suffering from seizures, in  
          accordance with specified guidelines.  SB 161 also provided each  
          employee who volunteers under the bill with defense and  
          indemnification by the school district, county office of  
          education, or charter school, for any and all civil liability,  
          as specified. 

          AB 559 (Wiggins, Ch. 458, Stats. 2001), See above. 

          AB 1791 (Wiggins, 1999) was similar to AB 559, above, but was  
          ultimately vetoed by the Governor. 

           REGISTERED SUPPORT / OPPOSITION  :

           Support 
           
          American Academy of Allergy, Asthma and Immunology (AAAI)
          American Red Cross
          Asthma and Allergy Foundation of America (AAFA)
          Bay Area Allergy Advisory Board
          Bay Area Food Allergy 5k Walk/Run in Memory of BJ HOM
          California Advocates for people with Food Allergies (CAFA)
          California Allergy Support & Anaphylaxis Prevention (CAASAP)
          California Chapter of the American College of Emergency  
          Physicians (California ACEP)
          California Society of Allergy, Asthma and Immunology (CSAAI)
          California School Nurses Organization (CSNO)
          Food Allergy and Anaphylaxis Connection Team (FAACT)
          Food Allergy Support of Sacramento (FASS)
          Kids with Food Allergies (KFA)
          Natalie Giorgi Sunshine Foundation
          Northern California Allergy & Asthma Advocates (NCAAA)
          Nut Free Wok
          Orange County Taxpayers Association
          San Diego Food Allergy Support Group
          San Francisco Bay Area Food Allergy Network
          Sanofi
          South Orange County Food Allergy Network
          San Clemente Food Allergy Support Group
          Stanford Food Allergy & Food Sensitivity Center Community  
          Council








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          Sutter Medical Group
          Numerous individuals
           
            Opposition 
           
          California Federation of Teachers
          California Teachers Association

           Analysis Prepared by  :   Drew Liebert / JUD. / (916) 319-2334