BILL ANALYSIS                                                                                                                                                                                                    �



                                                                            



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                                    THIRD READING


          Bill No:  AB 635
          Author:   Ammiano (D)
          Amended:  6/24/13 in Senate
          Vote:     21

           
           SENATE JUDICIARY COMMITTEE  :  6-0, 6/18/13
          AYES:  Evans, Walters, Corbett, Jackson, Leno, Monning
          NO VOTE RECORDED:  Anderson

           ASSEMBLY FLOOR  :  77-0, 4/15/13 - See last page for vote


           SUBJECT  :    Drug overdose treatment:  liability

           SOURCE  :     California Society of Addiction Medicine
                      Harm Reduction Coalition 


           DIGEST  :    This bill expands an existing pilot program which  
          provides a qualified immunity to licensed health care providers  
          who prescribe naloxone, by removing the sunset, removing the  
          restriction to only seven counties, authorizing licensed health  
          care providers to also prescribe naloxone to third parties  
          (family members, friends, or other persons in a position to  
          assist a person at risk of an opioid-related overdose), as well  
          as to issue standing orders for the distribution and/or  
          administration of naloxone.  This bill also amends the program's  
          limited liability provisions to instead confer (1) qualified  
          immunity from civil liability, criminal prosecution, or  
          professional review to licensed health care providers who issue  
          prescriptions or standing orders pursuant to the program; and  
          (2) immunity from civil action or criminal prosecution, or  
                                                                CONTINUED





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          professional review, to any persons who possess or distribute  
          naloxone pursuant to a prescription or standing order, or acting  
          with reasonable care in administering naloxone, as specified.   
          This bill also requires that a trained person who is prescribed  
          naloxone or possesses it pursuant to a standing order receive  
          training, as defined. 

           ANALYSIS  :   

          Existing law:

          1.The California Uniform Controlled Substances Act, strictly  
            regulates the distribution of controlled substances within  
            California.

          2.Prohibits the prescription, administration, or dispensing of a  
            controlled substance to an addict, except under certain  
            circumstances. 

          3.Provides that a licensed health care provider who is permitted  
            by law to prescribe an opioid antagonist may, if acting with  
            reasonable care, prescribe and subsequently dispense or  
            distribute an opioid antagonist in conjunction with an opioid  
            overdose prevention and treatment training program, without  
            being subject to civil liability or criminal prosecution.   
            This immunity applies to the licensed health care provider  
            even when the opioid antagonist is administered by and to  
            someone other than the person to whom it is prescribed. 

          4.Permits a person who is not otherwise licensed to administer  
            an opioid antagonist to administer an opioid antagonist in an  
            emergency without fee if the person has received the training  
            information as specified and believes in good faith that the  
            other person is experiencing a drug overdose.  The person  
            shall not, as a result of his or her acts or omissions, be  
            liable for any violation of any professional licensing  
            statute, or subject to any criminal prosecution arising from  
            or related to the unauthorized practice of medicine or the  
            possession of an opioid antagonist.  

          5.Requires that each local health jurisdiction that operates or  
            registers an opioid overdose prevention and treatment training  
            program, by January 1, 2015, collect, and report to the Senate  
            and Assembly Judiciary Committees, specified data on programs  







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            within the jurisdiction, including, among other things: the  
            number of opioid antagonist doses prescribed, the number of  
            opioid antagonist doses administered, the number of  
            individuals who received opioid antagonist injections who were  
            properly revived and the number who were not revived, as well  
            as the number of adverse events associated with an opioid  
            antagonist dose that was distributed as part of an opioid  
            overdose prevention and treatment training program.

          6.Limits the application of this law to the Counties of Alameda,  
            Fresno, Humboldt, Los Angeles, Mendocino, San Francisco, and  
            Santa Cruz and includes a January 1, 2016 sunset.

          7.Defines for these purposes "opioid antagonist" and "opioid  
            overdose prevention and treatment training program." 

          This bill:

          1.Removes the restriction to the counties above and repeals the  
            sunset date.  

          2.Authorizes a licensed health care provider who is authorized  
            by law to prescribe an opioid antagonist to, if acting with  
            reasonable care, prescribe and subsequently dispense or  
            distribute an opioid antagonist to a person at risk of an  
            opioid-related overdose or to a family member, friend, or  
            other person in a position to assist a person at risk of an  
            opioid-related overdose. 

          3.Permits a licensed health care provider who is authorized by  
            law to prescribe an opioid antagonist to issue standing orders  
            for:

             A.   The distribution of an opioid antagonist to a person at  
               risk of an opioid-related overdose or to a family member,  
               friend, or other person in a position to assist a person at  
               risk of an opioid-related overdose; and

             B.   The administration of an opioid antagonist to a person  
               at risk of an opioid-related overdose by a family member,  
               friend, or other person in a position to assist a person  
               experiencing or reasonably suspected of experiencing an  
               opioid overdose.








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          1.Provides that a licensed health care provider who acts with  
            reasonable care shall not be subject to professional review,  
            found liable in a civil action, or be subject to criminal  
            prosecution for issuing a prescription or standing order  
            pursuant to the bill. 

          2.Provides that, notwithstanding any other law, a person who  
            possesses or distributes an opioid antagonist pursuant to a  
            prescription or standing order shall not be subject to  
            professional review, be found liable in a civil action, or be  
            subject to criminal prosecution for this possession or  
            distribution. 

          3.Provides that notwithstanding any other law, a person not  
            otherwise licensed to administer opioid antagonist, but  
            trained as specified, who acts with responsible care in  
            administering an opioid antagonist in good faith and not for  
            compensation, to a person who is experiencing or is suspected  
            of experiencing an overdose shall not be subject to  
            professional review, be liable in a civil action, or be  
            subject to criminal prosecution for this administration.

          4.Requires that a person who is prescribed an opioid antagonist  
            or possesses it pursuant to a standing order shall receive the  
            training provided by an opioid overdose prevention and  
            treatment training program.
          
           Background
           
          Opioid overdoses are characterized by central nervous system and  
          respiratory depression, leading to coma and death.  While there  
          are various opioid antagonists, the most popular appears to be  
          naloxone, which has the ability to counteract depression of the  
          central nervous and respiratory system caused by an opioid  
          overdose.  Naloxone is administered by either injection into  
          vein or muscle or via a nasal atomizer.  Once administered,  
          naloxone takes effect after around a minute, with effects  
          lasting around 45 minutes, potentially saving the person's life.  
           The New York Times August 21, 2005 article entitled The Shot  
          That Saves, noted:

               If given early enough, naloxone can prevent damage to the  
               brain caused by lack of oxygen and leave the victim  
               unharmed.  According to research ? at least 75% of overdose  







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               deaths involve multiple drugs, usually mixtures of heroin  
               and other depressants like alcohol.  Removing the opioid  
               from the mix with naloxone is often enough to revive  
               victims.  

               Naloxone itself is virtually harmless.  Its most common  
               side effects are withdrawal symptoms like nausea, shakiness  
               and agitation in those who are physically dependent on  
               opioids.  While uncomfortable, these symptoms are not  
               dangerous.  Rarely, seizures can occur, but this risk is  
               far lower than the risk to those who are not treated.  The  
               drug has no effect on those who haven't taken opioids. 

               According to a study published in the journal Drug and  
               Alcohol Dependence, 57% of 1,184 hard drug users  
               interviewed had witnessed at least one overdose.  Medical  
               help was sought in only two-thirds of the instances, and  
               this was usually only after efforts to revive the victim by  
               hitting him or rubbing him with ice had failed?.  More than  
               half of the drug users in the study cited fear of arrest as  
               the main reason for delaying or failing to seek help.

          In 2007, in order to facilitate the prescription of naloxone to  
          trained individuals in California, SB 767 (Ridley-Thomas,  
          Chapter 477, Statutes of 2007) established a seven county pilot  
          program through January 1, 2010, that provided licensed health  
          care providers with a qualified immunity from civil liability or  
          criminal prosecution when they prescribed naloxone. That  
          immunity only applies where the health care provider dispensed  
          that drug in connection with an opioid overdose prevention and  
          training program, those programs, either registered or run by a  
          local health jurisdiction, train individuals for how to  
          recognize and respond to an opiate overdose.  AB 2145 (Ammiano,  
          Chapter 545, Statutes of 2010) has since extended the sunset  
          date for the program to January 1, 2016, extended the deadline  
          for the reporting requirements to January 1, 2015, and added a  
          new qualified immunity for unlicensed trained persons who  
          administer an opioid antidote in emergency situations where they  
          believe, in good faith, that the other person is experiencing a  
          drug overdose.  

           FISCAL EFFECT  :    Appropriation:  No   Fiscal Com.:  No   Local:  
           No








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           SUPPORT  :   (Verified  6/21/13)

          California Society of Addiction Medicine (co-source) 
          Harm Reduction Coalition (co-source) 
          Berkeley Needle Exchange Emergency Distribution
          California Association of Alcohol and Drug Program Executives,  
          Inc. 
          California Attorneys for Criminal Justice
          California Opioid Maintenance Providers
          California Public Defenders Association
          City and County of San Francisco
          Civil Justice Association of California 
          Common Ground, the Westside HIV Community Center
          County Alcohol and Drug Program Administrators Association of  
          California 
          Drug Policy Alliance 
          Harm Reduction Therapy Center
          Homeless Health Care Los Angeles
          Medical Board of California
          National Coalition Against Prescription Drug Abuse
          San Francisco Drug Users Union
          Shasta Community Health Center


           ARGUMENTS IN SUPPORT  :    According to the author: 

               Drug overdoses are now the leading cause of injury death in  
               the United States, surpassing motor vehicle crash deaths.   
               According to the most recent data released by the Centers  
               for Disease Control and Prevention [(CDC)], there were  
               37,000 drug overdose deaths in the United States in 2009.   
               In 2008, the most recent year data is available, there were  
               4,334 drug poisoning deaths in California. Counties  
               experiencing the highest numbers of overdose deaths are:  
               Alameda, Fresno, Kern, Los Angeles, Orange, Riverside,  
               Sacramento, San Bernardino, San Diego, San Francisco, and  
               Santa Clara Counties. 

               According to the CDC, in 2009, 28,754 (91%) of all  
               unintentional poisoning deaths were caused by drugs.  The  
               class of drugs known as prescription opioids, which  
               includes such drugs as methadone, hydrocodone (Vicodin),  
               and oxycodone (Oxycontin), was most commonly involved,  
               followed by cocaine and heroin. Drug poisoning is the  







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               leading cause of injury death in California and its effects  
               are felt throughout all sectors of the state.

               When a person overdoses on opioids he/she experiences  
               depression of the central nervous system and is in danger  
               of dying because the opioids slow down, and eventually  
               stop, the person's breathing. Naloxone (also known as  
               Narcan) is routinely used in hospitals and by paramedics in  
               the field to revive individuals who are suspected to be  
               overdosing on opioids.

               In California, overdose prevention programs operate in a  
               handful of cities and counties, but have limited reach in  
               terms of addressing the overdose issue statewide. Both SB  
               767 [(Ridley-Thomas, Ch. 477, Stats. 2007)] and AB 2145  
               [(Ammiano, Ch. 545, Stats. 2010)] only covered the  
               [c]ounties of Alameda, Fresno, Humboldt, Los Angeles,  
               Mendocino, San Francisco, and Santa Cruz. These counties  
               were designated as pilot counties because they had existing  
               overdose prevention programs in place already, through  
               their local syringe access and disposal programs.  The Harm  
               Reduction Coalition is working with health advocates in  
               Stanislaus, San Joaquin, Sacramento, Sonoma, San Diego,  
               Kern, Santa Clara, Ventura and Orange counties who are  
               either already doing independent naloxone distribution as  
               part of an overdose prevention program, or would like to  
               start, as they are now considered 'best practice'  
               components of high quality programs that focus on the  
               health of drug users.

               AB 635 safely expands the availability and distribution of  
               this life-saving drug.


           ASSEMBLY FLOOR  : 77-0, 04/15/13
          AYES: Achadjian, Alejo, Allen, Ammiano, Atkins, Bigelow, Bloom,  
            Blumenfield, Bocanegra, Bonilla, Bonta, Bradford, Brown,  
            Buchanan, Ian Calderon, Campos, Chau, Ch�vez, Chesbro, Conway,  
            Cooley, Dahle, Daly, Dickinson, Donnelly, Eggman, Fong, Fox,  
            Frazier, Beth Gaines, Garcia, Gatto, Gomez, Gordon, Gorell,  
            Gray, Grove, Hagman, Hall, Roger Hern�ndez, Holden, Jones,  
            Jones-Sawyer, Levine, Linder, Logue, Maienschein, Mansoor,  
            Medina, Melendez, Mitchell, Morrell, Mullin, Muratsuchi,  
            Nazarian, Nestande, Olsen, Pan, Patterson, Perea, V. Manuel  







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            P�rez, Quirk, Quirk-Silva, Rendon, Salas, Skinner, Stone,  
            Ting, Torres, Wagner, Waldron, Weber, Wieckowski, Wilk,  
            Williams, Yamada, John A. P�rez
          NO VOTE RECORDED: Harkey, Lowenthal, Vacancy


          AL:nl  6/24/13   Senate Floor Analyses 

                           SUPPORT/OPPOSITION:  SEE ABOVE

                                   ****  END  ****