BILL ANALYSIS                                                                                                                                                                                                    



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          SENATE THIRD READING
          SB 669 (Huff)
          As Amended  September 3, 2013
          Majority vote 

           SENATE VOTE  :38-0  
           
           BUSINESS & PROFESSIONS  13-0    JUDICIARY           10-0        
           
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          |Ayes:|Gordon, Jones, Bocanegra, |Ayes:|Wieckowski, Wagner,       |
          |     |Campos, Dickinson,        |     |Alejo, Chau, Dickinson,   |
          |     |Eggman, Hagman, Holden,   |     |Garcia, Gorell,           |
          |     |Maienschein, Mullin,      |     |Maienschein, Muratsuchi,  |
          |     |Skinner, Ting, Wilk       |     |Stone                     |
          |     |                          |     |                          |
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           APPROPRIATIONS     17-0                                         
           
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          |Ayes:|Gatto, Harkey, Bigelow,   |     |                          |
          |     |Bocanegra, Bradford, Ian  |     |                          |
          |     |Calderon, Campos,         |     |                          |
          |     |Donnelly, Eggman, Gomez,  |     |                          |
          |     |Hall, Holden, Linder,     |     |                          |
          |     |Pan, Quirk, Wagner, Weber |     |                          |
          |     |                          |     |                          |
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           SUMMARY :  Permits a prehospital emergency medical care person 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 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 or a lay  
               rescuer: 

               i)     The physician and surgeon has issued the  








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                 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 "First Aid 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  
                 "First Aid 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, or lay rescuer, pursuant to this bill  
               or any other statute or regulation. 

             b)   The EA is only used on another person, with the  








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               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; 

             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;

             e)   The EA obtained by prehospital emergency medical care  
               personnel, as specified, shall be used only when  
               functioning outside the course of the person's occupational  
               duties, or as a volunteer, pursuant to this bill; and,

             f)   The Emergency Medical Services System is activated as  
               soon as practicable when an EA is used. 

          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 Emergency Medical  
            Services Authority (EMS). 

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

          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 Services 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;








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             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)Authorizes the EMS director to deny, suspend, or revoke any  
            approval issued by this bill or may place any approved  
            training provider on probation upon a finding by the director  
            of an imminent threat to public health and safety, as  
            evidenced by any of the following:

             a)   Fraud;

             b)   Incompetence;

             c)   The commission of any fraudulent, dishonest, or corrupt  
               act that is substantially related to the qualifications,  
               functions, or duties of training program directors or  
               instructors;

             d)   Conviction of any crime that is substantially related to  
               the qualifications, functions, or duties of training  
               program directors or instructors.  The record of conviction  
               or a certified copy of the record shall be conclusive  
               evidence of the conviction; or,

             e)   Violating or attempting to violate, directly or  
               indirectly, or assisting in or abetting the violation of,  
               or conspiring to violate, any provision of this section or  
               the regulations promulgated by the authority pertaining to  
               the review and approval of training programs in anaphylaxis  
               and the use and administration of EA. 









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          9)Requires EMS to assess a fee pursuant to regulation sufficient  
            to cover the reasonable costs incurred by EMS for the ongoing  
            review and approval of training and certification.  

          10)Requires the fee to be deposited in the Specialized First Aid  
            Training Program Approval Fund (Fund), which is created in the  
            State Treasury, and all monies deposited in the fund shall be  
            made available, upon appropriation, to the authority for  
            purposes of authorizing training providers.

          11)Permits EMS to transfer unused portions of the Fund to the  
            Surplus Money Investment Fund (SFund).  Funds transferred to  
            the SFund shall be placed in a separate trust account, and  
            shall be available for transfer to the Fund, together with the  
            interest earned, when requested by EMS.

          12)Requires EMS to maintain a reserve balance in the Fund of 5%  
            of annual revenues.  Any increase in the fees deposited in the  
            Fund shall be effective upon determination by EMS that  
            additional moneys are required.  

          13)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.  

          14)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.

          15)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.

          16)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  








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            who renders emergency care treatment by the use of an EA.

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

          18)Defines the terms "Anaphylaxis," "EA," "Lay rescuer," and  
            "Prehospital emergency medical care person." 

          19)Makes clarifying and technical amendments.

          20)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.

           FISCAL EFFECT  :  According to the Assembly Appropriations  
          Committee:

          1)One-time costs to EMSA of $500,000 General Fund (GF) over two  
            years to convene a task force, revise and create regulations  
            related to training standards, create an approval process for  
            training providers, and modify IT systems.  

           2)Ongoing costs to EMSA of $200,000 (special fund) annually to  
            review and update standards, and to approve training  
            providers.  
          3)Ongoing fee revenue of $200,000 to the Specialized First Aid  
            Training Approval special fund to support ongoing program  
            activities. 
           
           COMMENTS  :   

           1)Purpose of this bill  .  This bill authorizes prehospital  
            emergency medical care personnel and lay rescuers to obtain  
            and use an EA in emergency situations after receiving  
            certification of training.  This bill is aimed at expanding  
            the use of EA's by authorizing additional qualified personnel  
            to use them and granting immunity from civil liability when  








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            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 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  








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               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.

          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  








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            services director to administer an EA.  This bill would permit  
            prehospital emergency medical care persons, 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).


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


                                                                FN: 0002268