BILL ANALYSIS                                                                                                                                                                                                    



                                                                  SB 669
                                                                  Page  1

          Date of Hearing:   July 2, 2013

              ASSEMBLY COMMITTEE ON BUSINESS, PROFESSIONS AND CONSUMER  
                                     PROTECTION
                              Richard S. Gordon, Chair
                      SB 669 (Huff) - As Amended:  May 28, 2013

           SENATE VOTE  :   38-0
           
          SUBJECT  :   Emergency medical care: epinephrine auto-injectors.

           SUMMARY  :   Permits a prehospital emergency medical care person,  
          first responder, or lay rescuer to obtain and use an epinephrine  
          auto-injector (EA) in emergency situations with certification of  
          training, as specified.  Specifically,  this bill  :   

          1)Permits a pharmacy to dispense EAs to a prehospital emergency  
            medical care person, first responder, or lay rescuer for the  
            purpose of rendering emergency care, as specified, if both of  
            the following requirements are met:

             a)   A physician and surgeon provides a written order, as  
               follows, that specifies the quantity of EAs to be dispensed  
               to prehospital emergency medical care person, first  
               responder, or a lay rescuer: 

               i)     The physician and surgeon has issued the  
                 prescription upon presentation of a current certificate  
                 demonstrating that the person is trained and qualified,  
                 as specified, to administer an EA to another person in an  
                 emergency situation; and,

               ii)    The prescription specifies that the dispensed EA is  
                 for "EMS [California Emergency Medical Services  
                 Authority] Purposes Only" and that the named recipient is  
                 a "Section 1797.197a Responder;" and a new prescription  
                 is required for any additional EAs; and,

             b)   The pharmacy labels each EA dispensed with all of the  
               following:

               i)     The name of the person to whom the prescription was  
                 issued;

               ii)    The designations "Section 1797.197a Responder" and  








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                 "EMS Purposes Only"; and,

               iii)   The dosage, use, and expiration date.

             c)   Requires each dispensed prescription to include the  
               manufacturer's product information sheet for the EA.

          2)Requires each person receiving EAs according to this bill to  
            make and maintain a record for five years reflecting dates of  
            receipt, use, and destruction of each EA dispensed, the name  
            of any person to whom epinephrine was administered using an  
            EA, and the circumstances and manner of destruction of any  
            EAs.

          3)States that the EAs dispensed pursuant to this bill may only  
            be used for the following purposes and circumstances:

             a)   The EA is legally obtained by prescription from an  
               authorized health care provider for the purpose of  
               rendering emergency care to another person, upon  
               presentation of current certification demonstrating that  
               person is trained and qualified to administer an  
               epinephrine auto-injector as a prehospital emergency  
               medical care person, first responder, or lay rescuer;

             b)   The EA is only used on another person, with the  
               expressed or implied consent of that person, to treat  
               anaphylaxis;  

             c)   The EA is stored and maintained as directed by the  
               manufacturer's instructions for that product; and,

             d)   The person using the EA has successfully completed a  
               course of training with an authorized training provider, as  
               specified, and has current certification of training issued  
               by the provider.

          4)Requires authorized training providers to be approved, and the  
            minimum standards for training and the use and administration  
            of EAs to be established and approved, by EMS. 

          5)Permits EMS to designate existing training standards for the  
            use and administration of EAs by first responders and  
            prehospital emergency medical care personnel to satisfy the  
            requirements of this section.








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          6)Requires the following to be included in the minimum training  
            and requirements:

             a)   Techniques for recognizing circumstances, signs, and  
               symptoms of anaphylaxis;

             b)   Standards and procedures for proper storage and  
               emergency use of EAs;

             c)   Emergency follow-up procedures, including activation of  
               the Emergency Medical System, by 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 EAs;

             e)   Written material covering the information required under  
               this bill, including the manufacturer product information  
               sheets on commonly available models of EAs; and,

             f)   Completion of a training course in cardiopulmonary  
               resuscitation (CPR) and the use of an automatic external  
               defibrillator for infants, children, and adults that  
               complies with regulations adopted by EMS and the standards  
               of the American Heart Association or the American Red  
               Cross, and a current certification for that training.

          7)States that certification of training shall be valid for no  
            more than two years, after which recertification with an  
            authorized training provider is required.

          8)Exempts certain provisions of this bill for a school district  
            or county office of education, or its personnel, which  
            provides and utilizes EAs to provide emergency medical aid, as  
            specified.  

          9)States that this bill shall not be construed to limit or  
            restrict the ability of prehospital emergency medical care  
            personnel, under any other statute or regulation, to  
            administer epinephrine, including the use of EAs, or to  
            require additional training or certification beyond what is  
            already required under the other statute or regulation.









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          10)States that any person authorized by this bill who  
            administers an EA, in good faith and not for compensation, to  
            another person who appears to be experiencing anaphylaxis at  
            the scene of an emergency situation is not liable for any  
            civil damages resulting from his or her acts or omissions in  
            administering the EA, if that person has complied with the  
            requirements and standards of this bill.

          11)States that the liability exemption shall not apply in a 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 treatment by the use of an EA.

          12)States that to encourage the training of authorized persons  
            in the emergency administration of EAs, and to encourage that  
            emergency care, a local agency, entity of state or local  
            government, or other public or private organization that  
            sponsors, authorizes, supports, finances, or supervises the  
            training of those persons, or develops standards in accordance  
            with this bill, including, but not limited to, EMS; the local  
            emergency medical system agency; the county department of  
            health; the State Department of Public Health; the American  
            Academy of Allergy, Asthma & Immunology; the American Academy  
            of Pediatrics; the American Heart Association; the American  
            Red Cross; and the California Medical Association; shall not  
            be liable for civil damages alleged to result from those  
            training programs or standards.

          13)States that the protection for training groups shall not  
            apply when it is alleged that the personal injury or wrongful  
            death was proximately caused by an authorized training  
            provider's failure to meet the minimal statutory training  
            requirements and standards established, or it is alleged that  
            the authorized training provider otherwise demonstrated gross  
            negligence in the training or certification of an individual  
            whose subsequent actions caused personal injury or wrongful  
            death in the rendering of emergency care treatment by the use  
            of an EA.

          14)States that nothing in this bill relieves a manufacturer,  
            designer, developer, distributor, or supplier of an EA of  
            liability under any other applicable law.

             a)   Defines the terms "Anaphylaxis," "EA," "First  
               responder," "Lay rescuer," and "Prehospital emergency  








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               medical care person." 

          15)States that no reimbursement is required by this act pursuant  
            to Section 6 of Article XIIIB of the California Constitution  
            because the only costs that may be incurred by a local agency  
            or school district will be incurred because this act creates a  
            new crime or infraction, eliminates a crime or infraction, or  
            changes the penalty for a crime or infraction, within the  
            meaning of Section 17556 of the Government Code, or changes  
            the definition of a crime within the meaning of Section 6 of  
            Article XIIIB of the California Constitution.

           EXISTING LAW  :

          1)Requires EMS to establish training and standards for all  
            prehospital emergency care personnel regarding the  
            characteristics and method of assessment and treatment of  
            anaphylactic reactions and the use of epinephrine.  Existing  
            law also requires EMS to promulgate regulations regarding  
            these matters for use by all prehospital emergency medical  
            care personnel.  (Health and Safety Code Section 1797.197)

          2)Permits a pharmacy to furnish EAs to a school district or  
            county office of education if all of the following are met:

             a)   The EAs are furnished exclusively for use at a school  
               district site or county office of education; and

             b)   A physician and surgeon provides a written order that  
               specifies the quantity of EAs to be furnished.  (Business  
               and Professions Code Section 4119.2(a)) 

          3)Permits a school district or county office of education to  
            provide emergency EAs to trained personnel, and permits  
            trained personnel to utilize those EAs to provide emergency  
            medical aid to persons suffering from an anaphylactic  
            reaction.  (Education Code (EC) Section 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:

             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 EAs;  








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               and,

             b)   Immediately administer an EA to a person exhibiting  
               potentially life-threatening symptoms of anaphylaxis at  
               school or a school activity when a physician is not  
               immediately available.  (EC 49414) 

          5)Requires the Superintendent of Public Instruction to establish  
            minimum standards of training for the administration of EAs  
            that satisfy minimum statutory training requirements, as  
            specified, and requires that the Superintendent consult with  
            specified organizations and providers with expertise in  
            administering EAs and administering medication in a school  
            environment.  (EC 49414(e)(1))   

           FISCAL EFFECT  :   Unknown

           COMMENTS  :   

           1)Purpose of this bill  .  This bill authorizes prehospital  
            emergency medical care personnel, first responders and lay  
            rescuers to obtain and use an EA in emergency situations after  
            receiving certification of training.  SB 669 is aimed at  
            expanding the use of EA's by authorizing additional qualified  
            personnel to use them and granting immunity from civil  
            liability when used properly.  This bill is sponsored by  
            Conference of California Bar Associations.   

           2)Author's statement  .  According to the author's office,

               "California law permits school nurses and trained personnel  
               to obtain and use [EAs] to provide emergency medical aid to  
               students experiencing anaphylactic shock, where authorized  
               by local school board or county offices of education, and  
               permits school nurses and designated personnel to assist a  
               student in the self-administration of an epinephrine  
               auto-injector provided a current authorization and release  
               is on file. These laws are consistent with laws adopted  
               across the nation reflecting the understanding that the  
               timely administration of epinephrine is essential to  
               avoiding serious injury or death in cases of anaphylaxis,  
               and that epinephrine auto-injectors - which contain  
               carefully metered doses of this life-saving medication -  
               are safe to administer by properly trained individuals.  
               [EAs] are safe, consumer-friendly, in widespread  








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               distribution, intended to be carried and self-administered  
               by adults and even children to protect against  
               life-threatening anaphylactic shock.

               "The problem is that the risk of anaphylaxis is not limited  
               to children, nor is it limited to school or home.  
               Suffocation and death from an anaphylactic reaction to  
               substances can occur anywhere, anytime, to anyone, without  
               warning or adequate time to obtain definitive medical care.  
               Under current law, it is illegal for first responders to  
               possess or carry [EAs] to save lives for anyone else  
               suffering anaphylaxis, be it in the wilderness, or even in  
               the community where medical care cannot be timely obtained.  
                Not everyone who has been prescribed an [EA] will have it  
               at the time of need.  Not everyone who has one will be able  
               to self-administer it in time. Further, not everyone who  
               suffers a potentially lethal anaphylactic reaction will  
               have known of their allergic predisposition in advance,  
               much less have had an [EA] prescribed.  Yet, people are  
               unnecessarily exposed to the real risk of death. People die  
               from anaphylaxis because what they need---epinephrine---is  
               not always readily available by someone who can legally  
               administer it. 

               "SB 669 addresses this real but unnecessary problem. It  
               allows those group leaders or first responders who  
               successfully complete a certified training course, to  
               obtain and use [EA] to provide life-saving first aid in the  
               event of anaphylaxis, just as many are already trained and  
               authorized to do in rendering immediate CPR, administering  
               a shock from an automatic external defibrillator, applying  
               tourniquets for unremitting life-threatening hemorrhage,  
               and effectuating emergency evacuations even in face of  
               spinal injuries.  And, like other Good Samaritan laws, it  
               provides immunity to properly certified individuals from  
               civil liability, except in cases of gross negligence."

           3)Epinephrine and auto-injectors  . According to the National  
            Institutes of Health, an epinephrine injection is used along  
            with emergency medical treatment to treat life-threatening  
            allergic reactions caused by insect bites or stings, foods,  
            medications, latex, and other causes. Epinephrine works by  
            relaxing the muscles in the airways and tightening the blood  
            vessels.









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          An auto-injector is usually a type of easy-to-use spring-loaded  
            syringe, intended for self-administration by the patient or by  
            untrained personnel. 

           4)Providers currently authorized to administer EAs  .  In addition  
            to certain licensed healthcare professionals, existing law  
            permits a 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 to administer an EA.  This bill would permit  
            prehospital emergency medical care persons, first responders,  
            and lay rescuers to obtain and administer EAs with proper  
            training and certification as well.
             
           
            5)EA authorization in other states  .  According to information  
            provided by the author's office, seven states (Arkansas,  
            Florida, Maryland, Missouri, North Carolina, North Dakota, and  
            South Carolina) have certificate programs for lay rescuers,  
            typically providing for the training and certification of  
            persons who reasonably expect to have responsibility for  
            others as a result of occupational or volunteer status, such  
            as camp counselors, forest rangers, and tour guides. Certified  
            persons are authorized to obtain EAs and are granted "Good  
            Samaritan" liability protection.

            Six other states also provide some form of immunity for EA  
            use.  Three states provide Good Samaritan immunity for persons  
            who have received authorized training (Connecticut, New York,  
            and Oregon), and more three states deem that the  
            administration of epinephrine by a volunteer rescuer in an  
            emergency is entitled to Good Samaritan protection (Arizona,  
            Rhode Island, and Virginia).

           6)Arguments in support  .  The Hospital Corporation of America  
            writes in support, "Death from anaphylaxis remains a real and  
            widespread problem.  Currently, anaphylaxis leads to 500 -  
            1,000 deaths per 2.4 million people 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 1980s to 50 per 100,000 per year in the 1990s.   
            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.   








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            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 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 device." 

           7)Suggested technical amendments  .  The following are technical  
            and clarifying amendments:

               Amend HSC 1797.197a (b)(2) to read: "The epinephrine  
               auto-injector is used on another, with the expressed or  
               implied consent of that person, for relief of the  
               conditions described in (a)(1)(A) due to anaphylaxis."

               Amend HSC1797.197a (c)(2)(G) should be renumbered to  
               section (d), and read: "Training certification shall be  
               valid for nor more than two years, after which...." 

           8)Prior legislation  . AB 559 (Wiggins) Chapter 458, Statutes of  
            2001, allowed school districts or county offices of education  
            to provide emergency EAs to trained personnel, and permits  
            trained personnel to utilize EAs to provide emergency medical  
            aid to persons suffering from an anaphylactic reaction.   

           REGISTERED SUPPORT / OPPOSITION  :

           Support 
           
          Conference of California Bar Associations (sponsor)
          California Association of Joint Powers Authorities
          California Hospital Association
          California Medical Association
          Civil Justice Association of California
          Food Allergy Research and Education
          Hospital Corporation of America
           
            Opposition 
           








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          None on file.

           Analysis Prepared by  :    Sarah Huchel / B.,P. & C.P. / (916)  
          319-3301