BILL ANALYSIS                                                                                                                                                                                                    



                                                                  SB 669
                                                                  Page  1

          Date of Hearing:  August 13, 2013
                          
                           ASSEMBLY COMMITTEE ON JUDICIARY
                                Bob Wieckowski, Chair
                      SB 669 (Huff) - As Amended:  July 3, 2013

                                  Proposed Consent

           SENATE VOTE  :  38-0
           
          SUBJECT  :  Emergency Medical Care: Epinephrine Auto-Injectors

           KEY ISSUe  :  Should prehospital emergency care providers, first  
          responders and lay rescuers who complete certain training  
          requirements be permitted to carry and administer epinephrine  
          auto-injectors to members of the public experiencing  
          anaphylaxis?  
           
           FISCAL EFFECT  :  As currently in print this bill is keyed fiscal.

                                      SYNOPSIS

          This noncontroversial bill would authorize a trained prehospital  
          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  
          would grant them qualified immunity from liability, as  
          specified. This bill would also provide qualified immunity to  
          specified entities that are authorized to train these persons in  
          the emergency administration of epinephrine auto-injectors for  
          any civil damages alleged to result from those training  
          requirements or standards. Additionally, this bill would, among  
          other things, provide minimal training requirements and require  
          that the California Emergency Medical Services Authority  
          establish and approve authorized training providers and minimum  
          standards for training in the use and administration of  
          epinephrine auto-injectors. This bill is supported by a host of  
          groups including the American Academy of Pediatrics, California  
          Advocates, Inc., California Medical Association and Food Allergy  
          Research and Education. There is no known opposition and the  
          measure has had no "no" votes. 

           SUMMARY  :  Sponsored by the Conference of California Bar  
          Associations, this noncontroversial bill aims to expand the  
          availability of treatment by epinephrine auto-injector to those  








                                                                  SB 669
                                                                  Page  2

          experiencing an anaphylactic reaction. Specifically,  this bill  ,  
          among other things:  
           
           1)Permits a prehospital emergency medical care person, first  
            responder, or lay rescuer to use an epinephrine auto-injector  
            to render emergency care if specified training requirements  
            are met. 

          2)Permits a pharmacy to dispense epinephrine auto-injectors to a  
            prehospital emergency medical care person, first responder, or  
            lay rescuer for the purpose of rendering emergency care with a  
            physician's prescription.

          3)Specifies that the authorized training providers and minimum  
            standards for training and the use and administration of  
            epinephrine auto-injectors shall be established and approved  
            by the California EMS Authority. Training standards shall  
            include techniques for recognizing circumstances, signs, and  
            symptoms of anaphylaxis as well as standards and procedures  
            for proper storage and emergency use of epinephrine  
            auto-injectors.

          4)Provides that any prehospital emergency medical care person,  
            first responder, or lay rescuer who administer an epinephrine  
            auto-injector to another person who appears to be experiencing  
            anaphylaxis at the scene of an emergency situation, in good  
            faith and not for compensation, is not liable for any civil  
            damages resulting from his or her acts or omissions in  
            administering the epinephrine auto-injector as long as he or  
            she has complied with the requirements and standards of this  
            bill, as specified.  This bill would not grant immunity from  
            civil damages to any person whose conduct in rendering  
            emergency care constitutes gross negligence. 

          5)Provides qualified immunity to any local agency, governmental  
            entity, or other organization that sponsors, authorizes,  
            supports, finances, or supervises the training of those  
            persons, or develops standards in accordance with this bill.

           EXISTING LAW  :  

          1)Requires the Emergency Medical Services (EMS) Authority to  
            establish training and standards for all prehospital emergency  
            care personnel, as defined, regarding the characteristics and  
            method of assessment and treatment of anaphylactic reactions  








                                                                  SB 669
                                                                  Page  3

            and the use of epinephrine.  Existing law requires the  
            authority to promulgate regulations regarding these matters  
            for use by all prehospital emergency medical care personnel.   
            (Health and Saf. Code Sec. 1797.197.)

          2)Provides that, notwithstanding any other provision of law, a  
            pharmacy may furnish epinephrine auto-injectors to a school  
            district or county office of education pursuant to specified  
            law, if all of the following are met: (1) the epinephrine  
            auto-injectors are furnished exclusively for use at a school  
            district site or county office of education; and (2) a  
            physician and surgeon provides a written order that specifies  
            the quantity of epinephrine auto-injectors to be furnished.   
            (Bus. & Prof. Code Sec. 4119.2(a).) 

          3)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.  (Ed. Code  
            Sec. 49414(a).)

          4)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: (1) 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 (2)  
            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).)  

          5)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.  Existing law 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).)  Existing law also  
            provides minimum training requirements and standards, as  
            specified.  (Ed. Code Sec. 49414(e)(2).)

           COMMENTS  :  This non-controversial bill would facilitate the  








                                                                  SB 669
                                                                  Page  4

          administration of epinephrine auto-injectors by trained  
          pre-hospital emergency medical care persons, first responders,  
          or lay rescuers, in emergency situations that extend beyond  
          school grounds in order to allow more individuals in the  
          community to be treated with epinephrine auto-injectors to save  
          lives.  The bill would provide these individuals with a  
          qualified immunity from civil liability.  In order to encourage  
          training, this bill would also provide qualified immunity to  
          specified entities who train these individuals in the emergency  
          administration of epinephrine auto-injectors. 

          In support, the author states:   
           
               SB 669 would create a training program for first responder  
               and group leader volunteers on the recognition and  
               emergency care of anaphylactic shock.  The proposal calls  
               for the development of standards for the safe and proper  
               use of epinephrine auto-injectors (EpiPens).  It would make  
               these auto-injectors available to trained first responders  
               and group leaders on prescription, and allow them to use it  
               in an emergency situation on a person suffering from a  
               potentially fatal anaphylactic reaction.  It would provide  
               Good Samaritan immunity from civil liability if the care is  
               rendered at the scene of an emergency in good faith,  
               without gross negligence and not for compensation. 

               Despite all improvements in the law expanding Good  
               Samaritan protection fostering trained first responders and  
               group supervisors to provide emergency care (first aid,  
               cardiopulmonary resuscitation and automatic external  
               defibrillation) for someone with a life-threatening  
               allergic reaction, there is effectively nothing anyone can  
               do in cases of anaphylaxis to prevent cardio-pulmonary  
               shutdown unless the victim happens to have an EpiPen and is  
               able to self-administer epinephrine before losing  
               consciousness-outside of a medical or school environment. 

               Unless specifically used by and for the person for whom it  
               was prescribed, an EpiPen may not be administered by  
               non-physicians-even if an auto-injector is on the scene.   
               Until recent passage of enabling legislation, this was even  
               a problem for school nurses. [ . . . ]  Yet, death from  
               anaphylaxis remains a real and pervasive problem outside of  
               school, in the wilderness and even in the community, when  
               group leaders overseeing the welfare of others, and even  








                                                                  SB 669
                                                                  Page  5

               trained first responders at the scene of an emergency,  
               cannot obtain or administer this miraculous life-saving  
               device---a device which even little children are trained to  
               safely use.  In the case of anaphylactic shock, death  
               through suffocation can occur in a matter of minutes.   
               Definitive medical care cannot always be timely obtained. [  
               . . . ] 

               Anaphylaxis is a pervasive lethal threat, both to those  
               with known allergies and those who suddenly become  
               sensitized to a substance - such as a simple bee-sting,  
               ingestion of shellfish, or coming into contact with  
               peanuts.  While an anaphylactic attack cannot always be  
               prevented, the worrisome consequences of it can be.

          In support the sponsor states: 

               SB 669 would enable California to join a growing group of  
               states that provide training in the proper use and  
               administration of epinephrine auto-injectors, and which  
               make these auto-injectors available by prescription to  
               individuals who have successfully completed the training.   
               The purpose of the bill is to increase the chances that if  
               a person suffers life-threatening allergic reaction, there  
               will be someone close by with an epinephrine auto-injector  
               who knows the proper way to use it.  

           Background  :  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 anaphylaxis.  
          Anaphylaxis is a severe, whole-body allergic reaction to an  
          allergen. Anaphylaxis happens quickly after the exposure, is  
          severe, and involves the whole body. Anaphylaxis is  
          life-threatening and can occur at any time. Risk factors include  
          a history of any type of allergic reaction.

          Epinephrine auto-injectors can be obtained by prescription only,  
          and current California law generally does not authorize  
          non-physicians to administer an epinephrine auto-injector to  
          another person.  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  








                                                                  SB 669
                                                                  Page  6

          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).)  
           
          Need for Legislation  : There are benefits to putting more  
          epinephrine auto-injectors in more trained hands. While ideally  
          any individuals prone to anaphylaxis would themselves be  
          carrying an epinephrine auto-injector, research shows that this  
          is not always the case. Often the individual has only  
          experienced mild anaphylaxis in the past and their health care  
          provider did not find it necessary to prescribe an epinephrine  
          auto-injector.  (Simons, Keith J., and F. Estelle R. Simons.  
          "Epinephrine and its use in anaphylaxis: current issues."  
          Current opinion in allergy and clinical immunology 10.4 (2010):  
          354-361.)  However, life-threatening anaphylaxis can manifest  
          itself after only minor attacks in the past.  (Simons, 2010.)  A  
          community member carrying and trained to use an epinephrine  
          auto-injector could be lifesaving in this instance where the  
          patient had no idea such a serious reaction was possible. 

           Civil Liability Provisions  : Under current law, everyone is  
          generally appropriately held responsible, not only for the  
          result of his or her willful acts, but also for an injury  
          occasioned to another by his or her want of ordinary care or  
          skill in the management of his or her property or person, except  
          so far as the latter has, willfully or by want of ordinary care,  
          brought the injury upon himself.  (Civ. Code Sec. 1714(a).)   
          However, the Legislature has authorized certain actions to be  
          immune from civil liability in order to promote good public  
          policy and actions that benefit the public generally. For  
          instance, California law already applies qualified immunity to  
          those who use an AED device in emergency settings as long as  
          they have undergone certain training and maintenance  
          requirements.  (See Civil Code Sec. 1714. 21.) 

          In the context of AEDs, lawmakers have granted qualified  
          immunity for lay operators because AEDs save lives and have been  
          proven very safe.  Studies have shown misuse is nearly  
          impossible because the device will not operate except in the  
          case of actual cardiac arrest.  (Mitchell, K. Blake, Leo  
          Gugerty, and Eric Muth. "Effects of brief training on use of  
          automated external defibrillators by people without medical  
          expertise." Human Factors: The Journal of the Human Factors and  








                                                                  SB 669
                                                                  Page  7

          Ergonomics Society 50.2 (2008): 301-310.)  Additionally, the  
          device 'walks' the operator through proper use with audio and  
          visual cues, and manual overrides are impossible (such as to  
          intentionally shock someone not experiencing cardiac arrest). 

          Here, epinephrine auto-injectors also clearly save lives and  
          similarly present only minimal risk of injury through misuse.   
          Newer designs integrate important safety features such as voice  
          prompts, and research reveals that the health risks presented by  
          accidental injection are, as with AEDs, insignificant.  For  
          example, the February 2010 issue of the Journal of Allergy and  
          Clinical Immunology reports that between 1994 and 2007 over  
          15,000 unintentional injections were reported to U.S. Poison  
          Control. Of those, 40% occurred while the operators were trying  
          to inject themselves or someone else experiencing an allergic  
          reaction. But only in the case of .2% of those unintentional  
          injections were the clinical effects considered 'major.'   
          (Simons, F., et al. "Voluntarily reported unintentional  
          injections from epinephrine auto-injectors." Journal of Allergy  
          and Clinical Immunology 125.2 (2010): 419-423.)

           ARGUMENTS IN SUPPORT  :  In support of the bill the California  
          Hospital Association states:

               Existing law authorizes a school district or county office  
               of education to provide emergency epinephrine  
               auto-injectors to trained personnel, and authorizes that  
               trained personnel to utilize the epinephrine auto-injector  
               to provide emergence medical aid to those suffering from an  
               anaphylactic reaction. SB 669 would broaden the existing  
               provisions concerning epinephrine auto-injector in the  
               school setting? Death from anaphylaxis remains a real and  
               widespread problem. Currently, anaphylaxis leads to  
               500-1,000 deaths/per 2.4 million in the United States.  
               While mortality rates have decreased, the incidence of  
               anaphylaxis appear to be increasing from 20 per 100,000 per  
               year in the 1980's to 50 per 100,000 per year in the  
               1990's. Presently there is no effective treatment to  
               prevent anaphylactic cardiac arrest in the community unless  
               the victim has an epinephrine auto-injector and is able to  
               self- administer the injection before losing consciousness.  
               Unless specifically used by and for the person who it was  
               prescribed, an epinephrine auto-injector may not be  
               administered by a non-physician, even if the auto-injector  
               is on the scene. Until recent enabling legislation, this  








                                                                  SB 669
                                                                  Page  8

               was a problem for school nurses who were unable to assist a  
               child in anaphylactic shock. 

               So while increased protection is available in schools,  
               death from anaphylaxis outside of schools in community  
               venues is a real and pervasive problem since those  
               overseeing the welfare of others, trained first responders  
               and group leaders, are unable to obtain or administer the  
               auto-epinephrine devise.

          Further, the organization Food Allergy Research & Education  
          writes: 

               It has been well documented that the prevalence of food  
               allergies is on the rise. In 2007, the Centers for Disease  
               Control and Prevention reported that approximately 3  
               million children had a food allergy. A 2011 study published  
               in the medical journal Pediatrics showed that the  
               prevalence had grown to 5.9 million, or one in every 13  
               children. That's roughly two per classroom. There are 15  
               million food allergic Americans?While there is currently no  
               cure for food allergies, epinephrine is the only medication  
               that can arrest the symptoms and save the lives of those  
               experiencing a severe reaction. A study in Pediatrics  
               showed that 24% of epinephrine use in a school district was  
               on those without a previous diagnosis of food allergy.  
               There are many children who may not know they are allergic  
               and therefore do not have a prescribed epinephrine  
               auto-injector. Keeping this life-saving mediation on hand  
               is a matter of first aid. Precious minutes can be lost  
               waiting for emergency responders. 

           PRIOR RELATED LEGISLATION  :  SB 911 (Figueroa, Ch. 163, Stats.  
          1999), among other things, provides immunity from civil  
          liability to any person who, in good faith and not for  
          compensation renders emergency care or treatment by the use of  
          an automated external defibrillator at the scene of an  
          emergency, has completed a basic CPR and automated external  
          defibrillator (AED) use course that complies with regulations  
          adopted by the Emergency Medical Services (EMS).


          AB 559 (Wiggins, Ch. 458, Stats. 2001), authorized school  
          districts or county offices of education to provide emergency  
          epinephrine auto-injectors to trained personnel, and to permit  








                                                                  SB 669
                                                                  Page  9

          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 2041 (Vargas, Ch. 718, Stats. 2002), revises provisions  
 
          enacted by SB 911 (above) by deleting the requirement that a  
 
          person complete a basic CPR or AED course, and providing  
 
          immunity from civil liability to a person or entity that  
 
          acquires an AED for emergency use and renders emergency care, if  
 
          that person or entity is in compliance with specified  
 
          requirements.


          AB 1791 (Wiggins, 1999) was similar to AB 559, above, but was  
          ultimately vetoed.
           
          REGISTERED SUPPORT / OPPOSITION  :   

           Support 
           
          American Academy of Pediatrics
          Association of Regional Center Agencies
          Conference of California Bar Associations (sponsor)
          California Advocates, Inc. 
          California Association of Joint Powers Authorities
          California Hospital Association
          California Justice Association of California
          California Medical Association
          Civil Justice Association of America
          Food Allergy Research and Education
          Hospital Corporation of America

           Opposition 
           
          None on file
           
          Analysis Prepared by  :  Drew Liebert and Kelly Bradfield / JUD. /  








                                                                  SB 669
                                                                  Page  10

          (916) 319-2334