BILL ANALYSIS                                                                                                                                                                                                    Ó



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          Date of Hearing:   June 23, 2015


                   ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS


                                Susan Bonilla, Chair


                       SB 738(Huff) - As Amended May 13, 2015


          SENATE VOTE:  36-0


          NOTE: This bill is double referred, and if it passes this  
          Committee, it will be referred to the Assembly Judiciary  
          Committee.
          
          SUBJECT:  Pupil health: epinephrine auto-injectors: liability  
          limitation.


          SUMMARY:  Provides that an authorizing physician and surgeon  
          will not be subject to professional review, liable in a civil  
          action or be the subject of criminal prosecution for issuing a  
          prescription or order, as specified, for an epinephrine  
          auto-injector (EAI), unless the physician or surgeon's issuance  
          constitutes gross negligence or willful or malicious conduct.  


          EXISTING LAW:   


          1)Authorizes a pharmacy to furnish an EAI to a school district,  
            county office of education (COE), or charter school, as  
            specified, if the following conditions are met:  (Business and  
            Professions Code (BPC) Section 4119.2(a))









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             a)   The EAIs are furnished exclusively for use at a school  
               site, as specified; and, 
             b)   A physician and surgeon provides a written order that  
               specifies the quantity of EAIs to be furnished.


          2)Requires the records regarding the acquisition and disposition  
            of EAIs to be maintained by the school district, COE, or  
            charter school for a period of three years from the date the  
            records were created and requires the school district, COE, or  
            charter school to be responsible for monitoring the supply of  
            EAIs and ensuring the destruction of expired EAIs.  (BPC  
            Section 4119.2(b))
          3)Establishes the responsibilities of the Medical Board of  
            California (MBC) which include: the enforcement of the  
            disciplinary and criminal provisions of the Medical Practice  
            Act (Act); the administration and hearing of disciplinary  
            actions; carrying out disciplinary actions appropriate to  
            findings made by a panel or an administrative law judge (ALJ);  
            suspending, revoking, or otherwise limiting certificates after  
            the conclusion of disciplinary actions; and reviewing the  
            quality of medical practice carried out by physician and  
            surgeon certificate holders under the MBC's jurisdiction.   
            (BPC Section 2004 (a)-(e))


          4)Requires school districts, COEs, and charter schools to  
            provide emergency EAIs to school nurses or trained personnel  
            who have volunteered, as specified, and authorizes school  
            nurses or trained personnel to use EAIs to provide emergency  
            medical aid to persons suffering, or reasonably believed to be  
            suffering, from an anaphylactic reaction.  (Education Code  
            (EDC) Section 49414 (a))


          5)Permits each private elementary and secondary school in the  
            state to voluntarily determine whether or not to make EAIs and  
            trained personnel available at its school, as specified.  (EDC  








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            Section 49414(c))


          6)Permits each public and private elementary and secondary  
            school in the state to designate one or more volunteers to  
            receive initial and annual refresher training, based on  
            specified standards, regarding the storage and emergency use  
            of an EAI from the school nurse or other qualified person  
            designated by an authorizing physician and surgeon.  (EDC  
            Section 49414(d))


          7)Requires the Superintendent to review the minimum standards of  
            training for the administration of EAIs, every five years or  
            sooner, as determined by the Superintendent. (EDC 49414(e)(1))


          THIS BILL: 


          8)States that an authorized physician and surgeon is not subject  
            to professional review, liable in a civil action, or subject  
            to criminal prosecution for the issuance of a prescription or  
            order, as specified, for an EAI unless the physician and  
            surgeon's issuance of the prescription or order constitutes  
            gross negligence or willful or malicious conduct.  


          9)Updates the name of the Stanford Allergy Center to reflect its  
            current name, the Sean N. Parker Center for Allergy Research.


          FISCAL EFFECT:  None.  This bill is keyed non-fiscal by the  
          Legislative Counsel. 


          COMMENTS:  










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          Purpose.  This bill is sponsored by the  California Society for  
          Allergy, Asthma and Immunology  .  According to the author, "My  
          office has been informed that this medication was recently used  
          in the San Marcos School District and potentially saved a  
          child's life.  This policy is important and is working.   We  
          need this last part of the equation to make sure this policy is  
          workable to its full extent and for all schools, not just for  
          schools who have been lucky enough to find a physician willing  
          to go out on a limb. This is a narrowly focused bill in an  
          attempt to make getting prescriptions easier for school nurses  
          and is consistent with current law for similar situations.   
          Without the prescription, this important health policy cannot  
          work."


          Background.  An EAI is used for the emergency treatment of  
          severe allergic reactions, including anaphylaxis, to insect  
          bites or stings, medicines, foods, or other substances.  It is  
          also used to treat anaphylaxis caused by unknown substances or  
          triggered by exercise.  


          As a result of SB 1266 (Huff), Chapter 321, Statutes of 2014, it  
          is now required that school districts, COEs, and charter schools  
          provide emergency EAIs to school nurses or trained personnel who  
          have volunteered, and those school nurses or trained personnel  
          may use the EAIs to provide emergency medical aid to persons  
          suffering, or reasonably believed to be suffering, from an  
          anaphylactic reaction.  BPC Section 4119.2 permits a pharmacy to  
          furnish EAIs to a school district, COE or charter school, as  
          specified in the EDC, as long as the following conditions are  
          met: 1) the EAI is furnished exclusively for use at the school  
          site, and 2) a physician and surgeon provides a written order  
          that specifies the quantity of EAIs to be furnished.  


          In addition to establishing the processes and procedures for the  
          program, SB 1266 also provided specified liability protections  
          for the employees who volunteer under the program by requiring  








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          the school district, COE or charter school to provide defense  
          and indemnification by for any and all civil liability, as  
          specified.  This bill would also provide liability protection to  
          a physician and surgeon by exempting them from professional  
          review for the issuance of a prescription or order for an EAI  
          unless the prescription or order constituted gross negligence or  
          willful or malicious misconduct.  


          In 2013, AB 635 (Ammiano), Chapter 707, Statutes of 2013,  
          provided similar protections from civil liability or from  
          professional review for licensed health care providers who issue  
          prescriptions or standing orders, as specified, for naloxone  
          hydrochloride, which is an opioid antagonist used to treat  
          opioid overdose. 

          Medical Board.  The MBC is the regulatory entity responsible for  
          regulating physician and surgeons and a number of other allied  
          health professionals.  The jurisdiction of the MBC includes  
          issuing licenses and certificates, the administration and  
          hearing of disciplinary actions, and carrying out disciplinary  
          actions as determined by the appropriate panel or ALJ including  
          suspending, revoking, or otherwise limiting certificates after  
          the conclusion of disciplinary actions.  According to the  
          author, since the enactment of SB 1266, many physicians have  
          begun to raise questions about liability concerns with respect  
          to issuing a generic prescription for the purposes of providing  
          EAIs to school sites.  This bill will exempt a physician and  
          surgeon from both professional review by the MBC and civil  
          liability for the issuance of a prescription or order for EAIs  
          in school settings as required by the EDC, unless the physician  
          and surgeon's order constitutes gross negligence or willful or  
          malicious conduct.  

          Current Related Legislation.  AB 1386 (Low), of 2015, permits a  
          pharmacy to furnish EAIs to an authorized agency, as specified,  
          if the EAIs are furnished exclusively for use at or in  
          connection with an authorized entity, an authorized health care  
          provider provides a prescription, and the records are maintained  








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          by the authorized agency for three years.  This bill also  
          contains specified immunity provisions.  STATUS: This bill is  
          pending in the Assembly Business and Professions Committee. 

          Prior Related Legislation.  SB 1266 (Huff), Chapter 321,  
          Statutes of 2014, requires school districts, COEs, and charter  
          schools to provide emergency EAIs to school nurses or trained  
          personnel who have volunteered, and authorizes school nurses or  
          trained personnel to use EAIs to provide emergency medical aid  
          to persons suffering, or reasonably believed to be suffering,  
          from an anaphylactic reaction.  

          SB 669 (Huff), Chapter 725, Statutes of 2013, permitted a  
          prehospital emergency medical care person, first responder, or  
          lay rescuer to obtain and use an EAI in emergency situations  
          with certification of training, as specified.  

          AB 635 (Ammiano), Chapter 707, Statutes of 2013, revised  
          provisions from the current pilot program authorizing  
          prescription of opioid antagonists for treatment of drug  
          overdose and limiting civil and criminal liability, expanded  
          these provisions statewide, and removed the 2016 sunset date.  

          AB 559 (Wiggins), Chapter 458, Statutes of 2001, allowed school  
          districts or COEs to provide emergency EAIs to trained  
          personnel, and permitted trained personnel to utilize EAIs to  
          provide emergency medical aid to persons suffering from an  
          anaphylactic reaction.   

          ARGUMENTS IN SUPPORT: 


          The  American College of Allergy, Asthma and Immunology  (ACAAI)  
          and the  Advocacy Council  (Council) of the Colleges writes in  
          support, "[the] ACAAI and the Council firmly believe in the  
          concept of making undesignated [EAIs] available to appropriately  
          trained school personnel."










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          The  California Chapter of the American College of Emergency  
          Physicians  writes in support, "[this bill] will provide  
          physicians the necessary liability protections to fully  
          implement current law.  It is similar to what is already in law  
          for other medication and medical devices; applying liability  
          protection to [EAIs] makes sense."


          The  Medical Board of California  writes in support, "this bill  
          will help school districts obtain standing order prescriptions  
          so they can benefit from SB 1266 from last year.  These standing  
          order prescriptions will allow the schools to obtain the [EAIs]  
          which will provide emergency medical aid to students suffering  
          from anaphylactic reactions." 


          ARGUMENTS IN OPPOSITION:


          None on file. 


          REGISTERED SUPPORT:


          California Society for Allergy, Asthma and Immunology (sponsor)
          American Academy of Allergy, Asthma, and Immunology
          American College of Allery, Asthma, and Immunology 
          Association of Regional Center Agencies
          California Chapter of the American College of Emergency  
          Physicians
          California School Nurses Organization
          Civil Justice Association of California
          Los Angeles Unified School District
          Medical Board of California
          Sanofi
          Santa Clara County Office of Education
          4 individuals 









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          REGISTERED OPPOSITION:


          None on file. 


          Analysis Prepared by:Elissa Silva / B. & P. / (916)  
          319-3301