BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                    AB 1748


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          CONCURRENCE IN SENATE AMENDMENTS


          AB  
          1748 (Mayes)


          As Amended  August 1, 2016


          Majority vote


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          |ASSEMBLY:  |74-3  |(May 23, 2016) |SENATE: |37-0  |(August 19,      |
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          Original Committee Reference:  ED.




          SUMMARY:  Authorizes school nurses and other trained personnel  
          to use naloxone hydrochloride (naloxone) or another opioid  
          antagonist to provide emergency medical aid to persons  
          suffering, or reasonably believed to be suffering, from an  
          opioid overdose.  Specifically, this bill:  


          1)Authorizes, in the Business and Professions Code, a pharmacy  
            to furnish naloxone or another opioid antagonist to a school  
            district, county office of education (COE), or charter school  
            if all the naloxone or another opioid antagonist is furnished  
            exclusively for use at a school district schoolsite, COE  
            schoolsite, or charter school, and a physician and surgeon  
            provides a written order that specifies the quantity of  
            naloxone or another opioid antagonist to be furnished.









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          2)Requires records regarding the acquisition and disposition of  
            naloxone or another opioid antagonist furnished to be  
            maintained by the school district, COE, or charter school for  
            a period of three years from the date the records were  
            created.  Requires the school district, COE, or charter school  
            to be responsible for monitoring the supply of naloxone or  
            another opioid antagonist and ensuring the destruction of  
            expired naloxone or another opioid antagonist.


          3)Authorizes school districts, COEs and charter schools to  
            provide emergency naloxone or another opioid antagonist to  
            school nurses or trained personnel for the purpose of  
            providing emergency medical aid to persons suffering, or  
            reasonably believed to be suffering, from an opioid overdose.   
            Establishes the following definitions:


             a)   "Authorizing physician and surgeon" may include, but is  
               not limited to, a physician and surgeon employed by, or  
               contracting with, a local educational agency, a medical  
               director of the local health department, or a local  
               emergency medical services director.


             b)   "Auto-injector" means a disposable delivery device  
               designed for the automatic injection of a premeasured dose  
               of an opioid antagonist into the human body and approved by  
               the federal Food and Drug Administration (FDA) for  
               layperson use.


             c)   "Opioid antagonist" means naloxone or another drug  
               approved by the federal FDA that, when administered,  
               negates or neutralizes in whole or in part the  
               pharmacological effects of an opioid in the body, and has  
               been approved for the treatment of an opioid overdose.


             d)   "Qualified supervisor of health" may include, but is not  
               limited to, a school nurse.








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             e)   "Volunteer" or "trained personnel" means an employee who  
               has volunteered to administer naloxone or another opioid  
               antagonist to a person if the person is suffering, or  
               reasonably believed to be suffering, from an opioid  
               overdose, has been designated by a school, and has received  
               specified training.


          4)Authorizes each public and private elementary and secondary  
            school to voluntarily determine whether or not to make  
            emergency naloxone or another opioid antagonist and trained  
            personnel available at its school.  Requires a school to  
            evaluate the emergency medical response time to the school and  
            determine whether initiating emergency medical services is an  
            acceptable alternative to naloxone or another opioid  
            antagonist and trained personnel.  Prohibits a private  
            elementary or secondary school choosing to exercise the  
            authority provided by this bill from receiving state funds for  
            this purpose.


          5)Authorizes each public and private elementary and secondary  
            school to designate one or more volunteers to receive initial  
            and annual refresher training regarding the storage and  
            emergency use of naloxone or another opioid antagonist from  
            the school nurse or other qualified person designated by an  
            authorizing physician and surgeon.  Specifies that a benefit  
            shall not be granted to or withheld from any individual based  
            on his or her offer to volunteer and prohibits retaliation  
            against any individual for rescinding his or her offer to  
            volunteer, including after receiving training.  Specifies that  
            a school district, COE, or charter school choosing to exercise  
            the authority provided by this bill shall provide the training  
            for the volunteers at no cost to the volunteer and during the  
            volunteer's regular working hours.


          6)Specifies that an employee who volunteers may rescind his or  
            her offer to administer emergency naloxone or another opioid  
            antagonist at any time, including after receipt of training.  








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          7)Requires the Superintendent of Public Instruction (SPI) to  
            establish minimum standards of training for the administration  
            of naloxone or another opioid antagonist and to review the  
            minimum standards of training every five years, or sooner as  
            deemed necessary by the SPI.  Requires the SPI to consult with  
            organizations and providers with expertise in administering  
            naloxone or another opioid antagonist and administering  
            medication in a school environment, including, but not limited  
            to, the California Society of Addiction Medicine, the  
            Emergency Medical Services Authority, the California School  
            Nurses Organization, the California Medical Association, the  
            American Academy of Pediatrics, and others.


          8)Requires the training to include all of the following:


             a)   Techniques for recognizing symptoms of an opioid  
               overdose; 


             b)   Standards and procedures for the storage, restocking,  
               and emergency use of naloxone or another opioid antagonist;  



             c)   Basic emergency follow-up procedures, including, but not  
               limited to, a requirement for the school or charter school  
               administrator or, if the administrator is not available,  
               another school staff member to call the emergency 911  
               telephone number and to contact the pupil's parent or  
               guardian;


             d)   Recommendations on the necessity of instruction and  
               certification in cardiopulmonary resuscitation (CPR); and, 


             e)   Written materials covering the information required in  
               the training.








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          9)Requires training to be consistent with the most recent  
            guidelines for medication administration issued by the  
            California Department of Education (CDE).
          10)Requires a school to retain for reference the written  
            materials developed for the training.


          11)Requires the CDE to include on its Internet Web site a  
            clearinghouse for best practices in training nonmedical  
            personnel to administer naloxone or another opioid antagonist  
            to pupils.


          12)Requires any school district, COE, or charter school electing  
            to utilize naloxone or another opioid antagonist for emergency  
            aid to distribute a notice at least once per school year to  
            all staff containing the following information:


             a)   A description of the volunteer request stating that the  
               request is for volunteers to be trained to administer  
               naloxone or another opioid antagonist to a person if the  
               person is suffering, or reasonably believed to be  
               suffering, from an opioid overdose;
             b)   A description of the training that the volunteer will  
               receive;


             c)   The right of an employee to rescind his or her offer to  
               volunteer; and, 


             d)   A statement that no benefit will be granted to or  
               withheld from any individual based on his or her offer to  
               volunteer and that there will be no retaliation against any  
               individual for rescinding his or her offer to volunteer,  
               including after receiving training.


          13)Requires a qualified supervisor of health at a school  








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            district, COE, or charter school electing to utilize naloxone  
            or another opioid antagonist for emergency aid to do the  
            following:
             a)   Obtain from an authorizing physician and surgeon a  
               prescription for each school for naloxone or another opioid  
               antagonist.
             b)   Be responsible for stocking the naloxone or another  
               opioid antagonist and restocking it if it is used.


          14)Specifies that if a school district, COE, or charter school  
            does not have a qualified supervisor of health, an  
            administrator at the school district, COE, or charter school  
            shall carry out the duties.
          15)Provides that a prescription may be filled by local or mail  
            order pharmacies or naloxone or another opioid antagonist  
            manufacturer.


          16)Specifies that an authorizing physician and surgeon shall not  
            be subject to professional review, be liable in a civil  
            action, or be subject to criminal prosecution for the issuance  
            of a prescription or order pursuant to this bill, unless the  
            physician and surgeon's issuance of the prescription or order  
            constitutes gross negligence or willful or malicious conduct.


          17)Specifies that a school nurse or, if the school does not have  
            a school nurse or the school nurse is not onsite or available,  
            a volunteer may administer naloxone or another opioid  
            antagonist to a person exhibiting potentially life-threatening  
            symptoms of an opioid overdose at school or a school activity  
            when a physician is not immediately available.  Provides that  
            if the naloxone or another opioid antagonist is used it shall  
            be restocked as soon as reasonably possible, but no later than  
            two weeks after it is used.  Naloxone or another opioid  
            antagonist shall be restocked before their expiration date.


          18)Specifies that volunteers may administer naloxone or another  
            opioid antagonist only by nasal spray or by auto-injector.









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          19)Specifies that volunteers shall be allowed to administer  
            naloxone or another opioid antagonist in the authorized form  
            the volunteer is most comfortable with.  


          20)Requires a school district, COE, or charter school electing  
            to utilize naloxone or another opioid antagonist for emergency  
            aid to ensure that each employee who volunteers under this  
            section will be provided defense and indemnification by the  
            school district, COE, or charter school for any and all civil  
            liability, in accordance with, but not limited to, that  
            provided in Government Code, Division 3.6 (commencing with  
            Section 810) of Title 1.  Requires this information to be  
            reduced to writing, provided to the volunteer, and retained in  
            the volunteer's personnel file.


          21)Specifies that a person trained to provide naloxone or  
            another opioid antagonist who administers naloxone or another  
            opioid antagonist, in good faith and not for compensation, to  
            a person who appears to be experiencing an opioid overdose  
            shall not be subject to professional review, be liable in a  
            civil action, or be subject to criminal prosecution for his or  
            her acts or omissions in administering the naloxone or another  
            opioid antagonist.  Specifies that the protection shall not  
            apply in as case of gross negligence or willful and wanton  
            misconduct of the person who renders emergency care treatment  
            by the use of naloxone or another opioid antagonist.   
            Specifies that any public employee who volunteers to  
            administer naloxone or another opioid antagonist is not  
            providing emergency medical care "for compensation"  
            notwithstanding the fact that he or she is a paid public  
            employee.  


          22)Authorizes a state agency, the CDE, or a public school to  
            accept gifts, grants, and donations from any source for the  
            support of the public school carrying out the provisions of  
            this bill, including, but not limited to, the acceptance of  
            naloxone or another opioid antagonist from a manufacturer or  
            wholesaler.








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          The Senate amendments:


          1)Authorize volunteers to administer naloxone hydrochloride or  
            another opioid antagonist by auto-injector, in addition to  
            nasal spray.


          2)Establish the definition for "auto-injector."


          3)Strike the requirement for the SPI to consult with the State  
            Department of Public Health and instead require the SPI to  
            consult with the California Society of Addition Medicine,  
            among others, in establishing minimum standards for training.


          4)Strike the provision specifying that the requirement for the  
            school or charter school administrator or other staff member  
            to call 911 shall not require a pupil to be transported to an  
            emergency room.


          FISCAL EFFECT:  According to the Senate Appropriations  
          Committee, CDE anticipates one-time costs to implement this bill  
          of about $60,000 (General Fund) for a half of a position.  This  
          position would develop the minimum training standards, consult  
          with specified entities in developing those standards, and  
          develop a clearinghouse on its website for best practices in  
          training nonmedical personnel to administer an emergency opioid  
          antagonist.  There are minor ongoing costs to review the minimum  
          standards at least every five years.


          COMMENTS:  This bill authorizes school districts, COEs and  
          charter schools to obtain naloxone or another opioid antagonist  
          and allow school nurses or other trained volunteer personnel to  
          provide naloxone or another opioid antagonist to persons  
          suffering, or reasonably believed to be suffering from an opioid  
          overdose, if a prescription is received from a physician and  








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          surgeon.  This bill requires the SPI to establish minimum  
          standards for training, in consultation with specified  
          organizations.


          This bill is modeled after the provisions allowing school nurses  
          or trained personnel to use epinephrine auto-injectors to  
          provide emergency medical aid to persons suffering, or  
          reasonably believed to be suffering, from an anaphylactic  
          reaction.  The major difference is that this bill simply  
          authorizes local educational agencies to obtain and administer  
          opioid antagonist while school districts, COEs and charter  
          schools are required to stock epinephrine auto-injectors.


          Symptoms of drug overdose.  The Opioid Overdose Toolkit from the  
          Substance Abuse and Mental Health Services Administration  
          (SAMHSA), a division of the United States Department of Health  
          and Human Services, states that symptoms of drug overdose may  
          include extreme sleepiness, slow heartbeat and/or low blood  
          pressure, very small pupils in the eyes, fingernails or lips  
          turning blue/purple and breathing problems.      


          Naloxone hydrochloride.  Naloxone is approved by the FDA as an  
          antidote to reverse opioid overdose.  According to SAMHSA, "The  
          safety profile of naloxone is remarkably high, especially when  
          used in low doses and titrated to effect.  When given to  
          individuals who are not opioid-intoxicated or opioid-dependent,  
          naloxone produces no clinical effects, even at high doses.   
          Moreover, although rapid opioid withdrawal in tolerant patients  
          may be unpleasant, it is not life-threatening."  


          Naloxone is administered by a syringe or an auto-injector into a  
          large muscle or given under the skin.  It was recently approved  
          by the FDA in a nasal spray form.  Naloxone can reverse the  
          effects of an opioid overdose very quickly.  As communities and  
          states throughout the country increased the use of naloxone,  
          prices have increased, particularly for the nasal spray.   
          According to the author, the Clinton Health Matters Initiative  
          has partnered with the manufacturer of the nasal spray version  








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          to offer a discounted public interest price and provide two free  
          doses to every high school in the United States.  This bill  
          allows a school to obtain naloxone from a pharmacy or a  
          manufacturer, including accepting donations from a manufacturer.  
              


          Volunteers.  According to the California School Nurses  
          Association, the ratio of school nurse to student in 2014-15 was  
          1:3,048, with just a total of 2,391 nurses for 6.2 million  
          students in the state.  Without a nurse located at each  
          schoolsite, several recent new laws have tapped volunteers to  
          administer medical aid for varying conditions, including  
          epilepsy, diabetes, and anaphylactic reactions.  When this bill  
          passed the Assembly, volunteers were allowed to use nasal spray  
          only in the administration of naloxone. Senate amendments added  
          auto-injectors.    


          Analysis Prepared by:                                             
                          Sophia Kwong Kim / ED. / (916) 319-2087  FN:   
          0004136  FN: