BILL ANALYSIS                                                                                                                                                                                                    






                             SENATE COMMITTEE ON HEALTH
                          Senator Ed Hernandez, O.D., Chair

          BILL NO:       SB 669                                      
          AUTHOR:        Huff
          INTRODUCED:    February 22, 2013
          HEARING DATE:  April 17, 2013
          CONSULTANT:    Marchand

           SUBJECT  :  Emergency medical care: epinephrine auto-injectors.
           
          SUMMARY  :  Permits a prehospital emergency medical care person,  
          first responder, or a lay rescuer to use an epinephrine  
          auto-injector to render emergency care to another person if  
          certain requirements are met, including obtaining specified  
          training and certification. Permits a health care provider to  
          issue a prescription, and permits a pharmacy to dispense, an  
          epinephrine auto-injector to a person who presents current  
          certification as meeting the requirements of this bill. Provides  
          immunity from civil liability to a person who administers an  
          epinephrine auto-injector in conformance with this bill.

          Existing law:
          1.Permits a school district or county office of education to  
            provide emergency epinephrine auto-injectors to trained  
            personnel, and permits trained personnel to utilize these  
            epinephrine auto-injectors to provide emergency medical aid to  
            persons suffering from an anaphylactic reaction.

          2.Permits each elementary and secondary school to designate one  
            or more school personnel on a voluntary basis to receive  
            initial and annual refresher training, based on standards  
            developed by the Superintendent of Public Instruction in  
            consultation with organizations with expertise, including the  
            Emergency Medical Services Authority and others. 

          3.Permits a school nurse, or if the school does not have a nurse  
            then the person who has received the training, to 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.

          4.Permits a school nurse, or if the school does not have a nurse  
            then the person who has received the training, to immediately  
            administer an epinephrine auto-injector to a person exhibiting  
                                                         Continued---



          SB 669 | Page 2




            potentially life-threatening symptoms of anaphylaxis at school  
            or a school activity when a physician is not immediately  
            available.

          5.Provides civil liability immunity, with certain restrictions,  
            to persons who complete a basic cardiopulmonary resuscitation  
            course and who, in good faith, renders emergency  
            cardiopulmonary resuscitation at the scene of an emergency.
           
          6.Provides civil liability immunity 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.  Specifies that the protections in  
            this bill do not apply in the case of personal injury or  
            wrongful death that results from the gross negligence or  
            willful or wanton misconduct of the person who renders  
            emergency care by the use of an automated external  
            defibrillator.

          7.Provides civil liability immunity, as part of a pilot project  
            in seven counties, to a person who administers an opioid  
            antagonist, who is not otherwise licensed to do so, in an  
            emergency without fee if the person has received specified  
            training.  Sunsets this provision on January 1, 2016.

          8.Establishes the Emergency Medical Services Authority (EMSA)  
            within the California Health and Human Services Agency, and  
            requires EMSA, among other things, to develop planning and  
            implementation guidelines for emergency medical services  
            systems which address specified components, including manpower  
            and training, communications, transportation, system  
            organization and management, data collection and evaluation,  
            and disaster response.

          9.Defines pre-hospital emergency medical personnel as any of the  
            following: authorized registered nurse or mobile intensive  
            care nurse, emergency medical technician (EMT)-I EMT-II,  
            EMT-paramedic, lifeguard, firefighter, or peace officer, as  
            defined, or a physician who provides pre-hospital emergency  
            medical care or rescue services.
          
          This bill:
          1.Permits a pre-hospital emergency medical care person, first  
            responder, or a lay rescuer to use an epinephrine  
            auto-injector to render emergency care to another person if  
            all of the following requirements are met:




                                                             SB 669 | Page  
          3


          

             a.   The epinephrine auto-injector is legally obtained by  
               prescription from an authorized health care provider;
             b.   The epinephrine auto-injector is used on another person,  
               with the expressed or implied consent of that person, for  
               the treatment of anaphylaxis, as defined;
             c.   The epinephrine auto-injector is stored and maintained  
               as directed by the manufacturer's instructions; and,
             d.   The person using the epinephrine auto-injector has  
               successfully completed a course of training with an  
               authorized training provider, as described in this bill,  
               and has current certification of training issued by the  
               provider.

          2.Permits a pharmacy, notwithstanding any other provision of  
            law, to dispense epinephrine auto-injectors to a pre-hospital  
            emergency care person, first responder, or lay rescuer for the  
            purpose of rendering emergency care if both of the following  
            requirements are met:
             a.   A physician provides a written order that specifies the  
               quantity of epinephrine auto-injectors to be dispensed to a  
               person who has a current training certification, as  
               specified, and the prescription specifies that the  
               auto-injector is for "EMS Purposes Only" and that the named  
               recipient is a "Section 1797.197a Responder;"
             b.   The pharmacy includes the manufacturer's product  
               information sheet for the epinephrine auto-injector and  
               labels each epinephrine auto-injector with the following  
               information: the name of the person to whom the  
               prescription is issued; the designations "Section 1797.197a  
               Responder" and "EMS Purposes Only"; and, the dosage, use  
               and expiration date.

          3.Requires a person who is certified, pursuant to the provisions  
            of this bill, as being able to use an epinephrine  
            auto-injector to render emergency care to another person, to  
            make and maintain a record for five years reflecting the dates  
            of receipt, use, and destruction of each auto-injector  
            dispensed, the name of any person to whom epinephrine was  
            administered, and the circumstances and manner of destruction  
            of any auto-injectors.

          4.Limits the use of epinephrine auto-injectors dispensed  
            pursuant to this bill to only the purpose, and under the  
            circumstances, described in this bill.





          SB 669 | Page 4




          5.Permits an authorized health care provider to issue a  
            prescription for an epinephrine auto-injector to a person who  
            presents current certification demonstrating that person is  
            trained and qualified, under the provisions of this bill, to  
            administer an epinephrine auto-injector.

          6.Requires the authorized training providers, the minimum  
            standards for training, and the use and administration of  
            epinephrine auto-injectors under this bill to be established  
            and approved by EMSA in consultation with the local emergency  
            medical system agency, the county health department,  
            manufacturers, the Department of Health Care Services, the  
            American Academy of Allergy, Asthma and Immunology, the  
            American Academy of Pediatrics, the American Heart  
            Association, the American Red Cross, and the California  
            Medical Association.

          7.Requires the minimum training and requirements to include all  
            of the following components:
                  a.        Techniques for recognizing circumstances,  
                    signs, and symptoms of anaphylaxis;
             b.   Standards and procedures for proper storage and  
               emergency use of epinephrine auto-injectors;
             c.   Emergency follow-up procedures, including calling the  
               emergency 911 telephone number or otherwise alerting and  
               summoning more advanced medical personnel and services;
             d.   Compliance with all regulations governing the training,  
               indications, use, and precautions concerning epinephrine  
               auto-injectors;
             e.   Written material covering the required information,  
               including the manufacturer product information sheets on  
               commonly available models of epinephrine auto-injectors;
             f.   Completion of a training course in cardiopulmonary  
               resuscitation and the use of an automatic external  
               defibrillator for infants, children, and adults that  
               complies with regulations adopted by the Emergency Medical  
               Services Authority and the standards of the American Heart  
               Association or the American Red Cross, and a current  
               certification for that training; and
             g.   Training certification for no more than two years, after  
               which recertification with an authorized training provider  
               is required.

          8.Requires the minimum standards established and approved under  
            this bill to apply to a school district or county office of  
            education, and permits a school district or county office of  




                                                             SB 669 | Page  
          5


          

            education to adopt more stringent standards for training and  
            the use of epinephrine auto-injectors under specified  
            provisions of the Education Code pertaining to the use of  
            epinephrine in school settings.

          9.Provides immunity from civil liability to any person who is  
            certified under this bill who administers 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, as long as that person has  
            complied with the requirements and standards of this bill.  
            Specifies that this provision does not grant civil immunity to  
            any person whose conduct in rendering emergency care  
            constitutes gross negligence.

          10.Provides immunity from civil liability to any local agency,  
            entity of state or local government, or other public or  
            private organization that sponsors, authorizes, supports,  
            finances or supervises the training of persons to use  
            epinephrine auto-injectors under the provisions of this bill,  
            in order to encourage training. 

          11.Specifies that nothing in this bill relieves a manufacturer,  
            designer, developer, distributor, or supplier of an  
            epinephrine auto-injector of liability under any other  
            applicable law.

          12.Defines various terms for purposes of this bill, including:
             a.   "Anaphylaxis" as a potentially life-threatening  
               hypersensitivity or allergic reaction to a substance, with  
               causes including insect stings or bites, foods, drugs, and  
               other allergens;
             b.   "Epinephrine auto-injector" as a disposable drug  
               delivery system with a spring-activated concealed needle  
               that is designed for emergency administration of  
               epinephrine to provide rapid, convenient first aid for  
               persons suffering from anaphylaxis;
             c.   "First responder" as a police officer, firefighter,  
               rescue worker, or any other person who provides emergency  
               response, first aid care, or other medically related  
               assistance either in the course of the person's  
               occupational duties or as a volunteer; and
             d.   "Lay rescuer as a person not otherwise licensed or  
               certified to use an epinephrine auto-injector on another  
               person who has met the training standards and other  




          SB 669 | Page 6




               requirements of this bill.

           FISCAL EFFECT  :  This bill has not been analyzed by a fiscal  
          committee.

           COMMENTS  :  
           1.Author's statement.  California recently joined other states  
            in finally allowing school nurses to obtain and use  
            epinephrine auto-injectors on students suffocating from  
            anaphylactic shock who were not prescribed an epinephrine  
            auto-injector by their physician. While the use of epinephrine  
            auto-injectors to combat a potentially lethal anaphylactic  
            reaction mostly focuses on protecting kids in school, and even  
            training non-nurses or medical professionals---such as  
            teachers, coaches, group leaders - in how to use it, the same  
            analysis should apply to protecting children when they are not  
            in a school environment.  Both adults and children need  
            life-saving intervention when they are not on school grounds.   
            This is why we see states slowly moving to what is being  
            proposed by SB 669. We must allow first responders who receive  
            training to obtain and use these epinephrine auto-injectors -  
            just as they are authorized to do life-saving CPR or  
            administer an automatic external defibrillator, or apply  
            tourniquets.
            
          2.What is anaphylaxis? According to the National Institutes of  
            Health, anaphylaxis is a severe, whole-body allergic reaction  
            to a chemical that has become an allergen. After being exposed  
            to a substance such as bee sting venom, the person's immune  
            system becomes sensitized to it. When the person is exposed to  
            that allergen again, an allergic reaction may occur.  
            Anaphylaxis happens quickly after the exposure, is severe, and  
            involves the whole body. Tissues in different parts of the  
            body release histamine and other substances. This causes the  
            airways to tighten and leads to other symptoms. Some drugs  
            (morphine, x-ray dye, aspirin, and others) may cause an  
            anaphylactic-like reaction (anaphylactoid reaction) when  
            people are first exposed to them. These reactions are not the  
            same as the immune system response that occurs with "true"  
            anaphylaxis. However, the symptoms, risk for complications,  
            and treatment are the same for both types of reactions.  
            Anaphylaxis can occur in response to any allergen. Anaphylaxis  
            is life-threatening and can occur at any time. Risks include a  
            history of any type of allergic reaction.
               
          3.What is an epinephrine auto-injector? An epinephrine  




                                                             SB 669 | Page  
          7


          

            auto-injector is a medical device used to deliver a measured  
            dose of epinephrine (also known as adrenaline) using  
            autoinjector technology, most frequently for the treatment of  
            acute allergic reactions to avoid or treat the onset of  
            anaphylaxis.  The EpiPen (and the version for smaller  
            children, the EpiPen Jr.) are commonly used epinephrine  
            auto-injectors. According to Mylan, which makes the EpiPen and  
            EpiPen Jr., the EpiPen contains 0.3mg of epinephrine and is  
            intended for those who weigh 66 pounds or more, while the  
            EpiPen Jr. contains 0.15mg, and is intended for patients  
            weighing between 33 to 66 pounds.  Mylan's product information  
            states that it is not known if EpiPen and EpiPen Jr. are safe  
            and effective in children who weigh less than 33 pounds.  The  
            devices are intended to be injected into the middle of the  
            outer thigh, and patients are directed not to inject the  
            device into a vein, buttock, fingers, toes, hands or feet. 
               
          4.Study on unintentional injections.  An article published in  
            the February 2010 issue of the Journal of Allergy and Clinical  
            Immunology, Voluntarily reported unintentional injections from  
            epinephrine auto-injectors, found that from 1994 to 2007, a  
            total of 15,190 unintentional injections from epinephrine  
            auto-injectors were reported to US Poison Control Centers,  
            with 60% of those reported from 2003 to 2007.  Those  
            unintentionally injected had a median age of 14 years, and 85%  
            were injected in a home or other residence.  Management of the  
            individual was documented in only 4101 of the cases.  In these  
            4101 cases, 49% of the clinical effects were described as  
            "minor," 20% were described as "minimal clinical effects, not  
            followed," and 15% were described as "moderate." Only 27 cases  
            (0.2%) were reported as "major effect," which was described as  
            "significant signs or symptoms."  Most of the unintentional  
            injections (76%) were in a finger or thumb.
               
          5.Double referral. This bill is double referred.  Should it pass  
            out of this committee, it will be referred to the Senate  
            Judiciary Committee.
               
          6.Prior legislation.  AB 559 (Wiggins), Chapter 458, Statutes of  
            2001, established provisions of law that permit a school  
            district or county office of education to provide emergency  
            epinephrine auto-injectors to trained personnel, and permit  
            trained personnel to utilize these epinephrine auto-injectors  
            to provide emergency medical aid to persons suffering from an  
            anaphylactic reaction at a school or during a school activity.




          SB 669 | Page 8




            
          7.Support.  This bill is sponsored by the Conference of  
            California Bar Associations (CCBA), representing more than 25  
            metropolitan, regional and specialty bar associations. CCBA  
            states that like almost all states, California has responded  
            to the dangers of anaphylaxis in our schools by enacting  
            legislation to permit school districts or county offices of  
            education to provide emergency epinephrine auto-injectors to  
            trained personnel, and to permit those personnel to utilize  
            these auto-injectors to provide emergency medical aid to  
            students suffering from an anaphylactic reaction.  CCBA states  
            that this bill would enable California to join a growing group  
            of states that provide training in the proper use of  
            epinephrine auto-injectors and which makes these  
            auto-injectors available by prescription to individuals who  
            have successfully completed the training.  The purpose of this  
            bill is to increase the chances that if a person suffers a  
            life-threatening allergic reaction, there will be someone  
            close by with an epinephrine auto-injector. Additionally, if  
            the person already has their own epinephrine auto-injector but  
            is unable to use it, this bill will increase the odds there  
            will be someone close by who can assist in the proper  
            administration. 
            
            This bill is supported by the California Hospital Association  
            (CHA), which states that 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  
            appears to be increasing from 20 per 100,000 per year in the  
            1980s to 50 per 100,000 in the 1990s.  CHA states that 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.  

          8.Oppose unless amended.  The California School Employees  
            Association, AFL-CIO (CSEA) is opposed to this bill unless it  
            is amended to ensure that the provisions of this bill do not  
            in any way impact current epinephrine auto-injector laws  
            governing school districts and county offices of education and  
            their employees.  CSEA is requesting that the provision in  
            this bill applying the minimum standards created by this bill  
            to school districts and county offices of education be deleted  
            from the bill (p. 7, lines 16-20).  Additionally, CSEA is  
            requesting that a new provision be added which states the  




                                                             SB 669 | Page  
          9


          

            following "(d) This section shall not apply to school  
            districts and county offices of education and their personnel  
            in epinephrine auto-injector programs established pursuant to  
            Section 49914 of the Education Code."

          The Consumer Attorneys of California (CAC) have also written a  
            letter of concern, stating that this bill provides broad  
            immunities to persons who use an epinephrine auto-injector to  
            render emergency care to another person.  CAC states that  
            while it recognizes the benefit to have appropriately trained  
            personnel deliver life-saving injections, it would like to  
            work with the author and sponsor to narrow the bill if or as  
            it proceeds to the Senate Judiciary Committee.

          9.Prehospital emergency personnel may already have this ability.  
             This bill permits not only lay rescuers, but also prehospital  
            emergency medical care personnel and first responders to  
            administer an epinephrine auto-injector, but only if the  
            person is trained and certified under the provisions of this  
            bill.  This bill requires EMSA to establish and approve the  
            training standards.  However, some prehospital emergency  
            personnel already have it within their scope of practice to  
            administer epinephrine, and this bill could be interpreted to  
            require these personnel to get additional training and  
            certification before they are permitted to continue utilizing  
            this part of their training.  According to EMSA, epinephrine  
            auto-injectors are a local optional scope of practice item for  
            EMT-Is (meaning it would have to be approved by the local  
            emergency medical services agency), while EMT-II/Advanced EMTs  
            and EMT-Paramedics have the administration of epinephrine for  
            allergic reaction in their basic scopes of practice.  When it  
            is part of their scope of practice, EMSA states that the EMTs  
            employer would stock the epinephrine auto-injectors.

          The author may wish to consider amending this bill to ensure  
            that any professional who is already licensed to administer  
            epinephrine auto-injectors under their current scope of  
            practice may continue to do so without obtaining the  
            additional training and certification required by this bill.

          10.Technical amendments. On page 6, lines 23 through 25, this  
            bill requires EMSA to consult with "the local emergency  
            medical system agency, the county health department," and the  
            Department of Health Care Services.  Given that there are  
            multiple county health departments and multiple local  




          SB 669 | Page 10




            emergency medical services agencies, this bill should either  
            delete these references, or specify that EMSA consult with a  
            "representative from a local emergency medical services  
            agency" and "a representative from a county health  
            department."  Additionally, the bill should refer to the  
                                                                                       Department of Public Health, rather than the Department of  
            Health Care Services, which primarily governs the state's  
            Medi-Cal program.
          
           SUPPORT AND OPPOSITION  :
          Support:  Conference of California Bar Associations (sponsor)
                    California Hospital Association
          
          Oppose:   None received




















                                      -- END --