BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                  AB 635
                                                                  Page  1

          CONCURRENCE IN SENATE AMENDMENTS
          AB 635 (Ammiano)
          As Amended August 22, 2013
          Majority vote 
           
           ----------------------------------------------------------------- 
          |ASSEMBLY:  |77-0 |(April 15,      |SENATE: |36-0 |(September 6,  |
          |           |     |2013)           |        |     |2013)          |
           ----------------------------------------------------------------- 
            
           Original Committee Reference:    JUD.  

           SUMMARY  :  Revises provisions from the current pilot program  
          authorizing prescription of opioid antagonists for treatment of  
          drug overdose and limiting civil and criminal liability, expands  
          these provisions statewide, and removes the 2016 sunset date.   
          Specifically,  this bill  :   

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

          2)Permits the licensed health care provider to issue a standing  
            order for 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.  

          3)Permits the licensed health care provider to issue a standing  
            order for 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 the  
            person at risk.

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

          5)Provides that any person who possesses or distributes an  
            opioid antagonist pursuant to a prescription or standing  








                                                                  AB 635
                                                                  Page  2

            order, or any person who acts with reasonable care in  
            administering an opioid antagonist to a person experiencing an  
            overdose, shall not be subject to professional review, be  
            found liable in a civil action, or be subject to criminal  
            prosecution for that act.

          6)Requires a person who is prescribed or possesses an opioid  
            antagonist pursuant to a standing order to receive the  
            training provided by an opioid overdose prevention and  
            treatment training program, except that this does not apply to  
            a person who is prescribed an opioid antagonist directly from  
            a licensed prescriber.

          7)Deletes provisions restricting the scope of these provisions  
            to seven pilot counties and establishing a 2016 sunset date,  
            extending these provisions indefinitely and expanding  
            authority for the program statewide.

          8)Deletes the requirement that each local health jurisdiction  
            that operates or registers an opioid overdose prevention and  
            treatment training program must report specified data by  
            January 1, 2015, to the Senate and Assembly Judiciary  
            Committees.
          The Senate amendments  revise the qualified immunity provisions  
          for administration of an opioid antagonist, to provide that the  
          immunity applies to a person not otherwise licensed to  
          administer an opioid antagonist, but who has received the  
          required training and who acts with reasonable care, in good  
          faith and not for compensation.  In addition, they clarify that  
          a person who is prescribed an opioid antagonist directly from a  
          licensed prescriber shall not be required to receive training  
          from an opioid prevention and treatment training program.
           
          FISCAL EFFECT  :  None

           COMMENTS  :  Current law authorizes licensed health care providers  
          to prescribe and distribute opioid antagonists for emergency  
          treatment of drug overdose, if done in conjunction with an  
          overdose prevention and treatment training program ("overdose  
          prevention program"), without being subject to civil liability  
          or criminal prosecution.  This pilot authority, however, is  
          currently limited to health care providers in only seven  
          counties and is set to expire in 2016.  This bill, co-sponsored  
          by Harm Reduction Coalition and the California Society of  
          Addiction Medicine, seeks to expand this authority statewide and  








                                                                  AB 635
                                                                  Page  3

          remove the 2016 sunset date.  Among other things, this bill  
          would allow health care providers to independently prescribe or  
          issue standing orders for the distribution or administration of  
          naloxone, as specified, but not necessarily in conjunction with  
          a local overdose prevention program.

          Opioid antagonists are a group of drugs routinely used in  
          hospitals and in pre-hospital settings (i.e., by paramedics in  
          the field) on patients who are suspected to be overdosing on  
          opioids such as heroin, methadone, or oxycodone.  The most  
          common type of opioid antagonist is known as naloxone  
          hydrochloride (or its brand name "Narcan"), and is approved by  
          the federal Food and Drug Administration for the treatment of an  
          opioid overdose.  (Hereafter, this analysis will use the term  
          "naloxone" interchangeably with the term "opioid antagonist.")

          Opioid overdoses are characterized by central nervous system and  
          respiratory depression, leading to coma and death.  Naloxone,  
          like other opioid antagonists, has the ability to counteract  
          depression of the central nervous and respiratory system caused  
          by an opioid overdose.  Naloxone is administered by injection  
          into a vein or muscle, with intravenous injection providing for  
          the fastest action.  Once injected, naloxone takes effect after  
          around two minutes, with effects lasting around 45 minutes,  
          potentially saving the person's life.

          This bill would eliminate the pilot status of the naloxone  
          project and its associated reporting requirements, extending  
          these provisions statewide with no sunset date.  According to  
          the author and sponsor, additional data reported by  
          participating pilot counties since 2010 demonstrates that the  
          project has achieved a high rate of success in preventing  
          overdose, coupled with the near total lack of any adverse events  
          associated with administration of naloxone.  In short,  
          proponents of this bill contend that pilot project data  
          demonstrate that naloxone prescription is safe and effective in  
          saving lives without producing significant adverse events, thus  
          justifying removal of the sunset date and pilot program status.

          Supporters contend that because naloxone cannot be  
          self-administered by the person experiencing the overdose, it is  
          wise to extend protection from liability to third parties who  
          are trained to administer naloxone, or else they will simply  
          avoid employing naloxone in an emergency even when it is  
          available.  They also report that county health workers who  








                                                                  AB 635
                                                                  Page  4

          operate or who desire to operate a naloxone prescription program  
          report are having difficulty finding health care providers who  
          are comfortable writing prescriptions for a medication that  
          will, by necessity, be administered by a third party, without  
          reasonable liability protection.  Furthermore, supporters assert  
          that even so-called "frontline workers" who have taken overdose  
          prevention trainings, and who often are in close contact with  
          drug users at sites like homeless shelters and drug treatment  
          facilities, nevertheless are reluctant to keep the naloxone  
          close at hand for emergency response, without any legal  
          protection for a third party who administrates naloxone.

          Under existing law, a licensed health care provider may  
          prescribe naloxone "in conjunction with an opioid overdose  
          prevention and treatment training program."  This bill would  
          strike that requirement and instead permit the health care  
          provider to prescribe the drug as long as he or she acts with  
          reasonable care and is authorized by law to prescribe an opioid  
          antagonist.  In order for naloxone to be available to  
          potentially save lives outside the seven pilot counties, the  
          author recognizes that its prescription cannot be limited to  
          only those doctors working in conjunction with overdose  
          prevention programs-particularly when such programs do not exist  
          in many counties in the state, often because of lack of  
          financial resources.  

          The author notes that naloxone is:  1) non-addictive and  
          regulated at the same level as prescription ibuprofen; 2) has no  
          effect on a person if opioids are absent in their system; and,  
          3) can be safely administered by minimally trained laypeople, as  
          has been demonstrated by data reported through the SB 767 pilot  
          project.  In addition, physicians who prescribe medications  
          already have a professional duty to explain those medications to  
          their patients and families, including indications, use, risks  
          and benefits.  For these reasons, the author contends that  
          naloxone prescriptions need not be limited to only doctors  
          operating in conjunction with a local overdose prevention  
          program.

          This bill also authorizes licensed health care providers to  
          issue a standing order for the distribution or the  
          administration of the opioid antagonist to the person at risk,  
          or his or her family member, friend or other person in  
          assistance.  Unlike a prescription, which facilitates direct  
          access of the drug to the person for whose use it is intended, a  








                                                                  AB 635
                                                                  Page  5

          standing order is a type of physician's order that allows other  
          health care workers to exercise the order when certain  
          predetermined conditions are met.  

          Under this bill, an authorized physician may issue one of two  
          kinds of standing orders.  The first authorizes naloxone to be  
          distributed to a person at risk for overdose, or a family  
          member, friend, or other person in a position to assist in the  
          case of an overdose.  Distribution in this context is a  
          preventive measure to increase the chance that naloxone will be  
          available should an overdose event occur.  The second type of  
          standing order under this bill authorizes naloxone to be  
          administered (i.e., injected) to help save the life of a person  
          experiencing or reasonably suspected of experiencing an opioid  
          overdose.
           
           With respect to liability for issuing a prescription or standing  
          order, this bill provides that a licensed health care provider  
          who acts with reasonable care shall not be subject to  
          professional review, be found liable in a civil action, or be  
          subject to criminal prosecution for issuing a prescription or  
          standing order if he or she complies with the standards set  
          forth by this bill.  With respect to liability for possession of  
          naloxone, this bill reasonably limits liability for any person  
          who possesses or distributes naloxone if it was done pursuant to  
          a prescription or standing order.  At the same time, this bill  
          requires a person who is prescribed or possesses an opioid  
          antagonist pursuant to a standing order to receive the training  
          provided by an opioid overdose prevention and treatment training  
          program, except that this does not apply to a person who is  
          prescribed an opioid antagonist directly from a licensed  
          prescriber.  Finally, with respect to the administration of  
          naloxone, the bill limits civil and criminal liability for a  
          person not otherwise licensed to administer an opioid  
          antagonist, but who has received the required training and who  
          acts with reasonable care in administering an opioid antagonist,  
          in good faith and not for compensation, to someone who is  
          experiencing or is suspected of experiencing an overdose.

          By limiting liability for naloxone prescription and use strictly  
          pursuant to a prescription or standing order issued by a  
          licensed health care professional, this bill seeks to encourage  
          and enable more health care providers to prescribe naloxone,  
          where appropriate, to certain patients at risk of opioid  
          overdose-particularly important in light of evidence of a  








                                                                  AB 635
                                                                  Page  6

          substantial epidemic of prescription drug overdoses.  In  
          addition, the author contends, this bill will remove an obstacle  
          to the creation and expansion of more overdose prevention  
          programs in California.


           Analysis Prepared by  :    Anthony Lew / JUD. / (916) 319-2334 


          FN:  
          0001912