BILL ANALYSIS                                                                                                                                                                                                    Ó






                      SENATE COMMITTEE ON PUBLIC SAFETY
                            Senator Loni Hancock, Chair              S
                             2013-2014 Regular Session               B

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          SB 1438 (Pavley)                                           8
          As Amended:  April 10, 2014 
          Hearing date:  April 29, 2014
          Civil Code and Health and Safety Code
          JM:sl

                                  OPIOID ANTAGONISTS  

                                       HISTORY

          Source:  Author

          Prior Legislation: AB 635 (Ammiano) - Ch. 707, Stats. 2013
                       SB 767 (Ridley-Thomas) - Ch. 477, Stats. 2007
                       SB 1695 (Escutia), Chapter 678, Statutes of 2002

          Support:  Drug Policy Alliance; California State Sheriffs'  
                    Association; Emergency Medical Services  
                    Administrators' Association of California; California  
                    Chapter of the American College of Emergency  
                    Physicians Association 

          Opposition:None known


                                        KEY ISSUES
           
          SHOULD PEACE OFFICERS BE SPECIFICALLY ADDED TO THE LIST OF PERSONS -  
          SUCH AS FAMILY MEMBERS OF AN OVERDOSE VICTIM - AUTHORIZED TO  
          ADMINISTER AN OPIOID ANTAGONIST TO REVERSE AN OVERDOSE?

          SHOULD THE STATE EMERGENCY MEDICAL SERVICES AUTHORITY DEVELOP  
          STANDARDS AND PUBLISH REGULATIONS FOR ADMINISTRATION OF THE OPIOID  
          ANTAGONIST NALOXONE BY ALL PREHOSPITAL EMERGENCY CARE PERSONNEL?

          SHOULD LOCAL EMERGENCY MEDICAL SERVICE AGENCIES BE AUTHORIZED TO  
          DEVELOP THEIR OWN STANDARDS AND REGULATIONS IN LIEU OF ADOPTION OR  
          USE OF THE STATE STANDARDS?
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                                       PURPOSE

          The purposes of this bill are to 1) specifically include peace  
          officers in a list of persons, including family members of a  
          person at risk of an opioid overdose, authorized to administer  
          the opioid antagonist naloxone; 2) direct the State Emergency  
          Medical Services Authority to develop standards and promulgate  
          regulations for administration of naloxone by all prehospital  
          emergency care personnel; and 3) authorize local emergency  
          medical agencies to adopt their own standards and promulgate  
          regulations for administration of naloxone by prehospital  
          emergency care personnel under jurisdiction of the local agency.  

          
           Existing law  (Civil Code § 1714.22) provisions relevant to this  
          bill: 
           
                 An opioid antagonist is defined as naloxone  
               hydrochloride (naloxone) that is approved by the Federal  
               Food and Drug Administration (FDA) for the treatment of an  
               opioid overdose.  

                 A licensed health care provider who is authorized to  
               prescribe naloxone to prescribe and dispense or distribute  
               the medication to a person at risk of an overdose or to a  
               family member, friend, or other person in a position to  
               assist the person at risk of overdose.  A licensed health  
               care provider to issue standing orders for these purposes. 

                 A person who is prescribed or possesses naloxone  
               pursuant to a standing order to receive training by an  
               overdose prevention and treatment training program, as  
               specified.  A person who is prescribed naloxone directly  
               from a licensed prescriber, and not through a standing  
               order, is not subject to the training requirement.

                 A health care provider who acts with reasonable care in  
               issuing a prescription for naloxone and any person who  

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               possesses, distributed, or administers naloxone, with  
               reasonable care, from professional review, civil action, or  
               criminal prosecution. 

          Relevant Health and Safety Code Provisions in Existing Law

                 The Emergency Medical Services Authority (EMSA) shall  
               establish training and standards for all prehospital  
               emergency care personnel, as defined, regarding the  
               characteristics and method of assessment and treatment of  
               anaphylactic reactions and the use of epinephrine.  EMSA  
               shall promulgate regulations for use by all prehospital  
               emergency care personnel.  (Health & Saf. Code § 1797.197.)

                 The Attorney General shall encourage research on the  
               misuse and abuse of controlled substances. Allows the  
               Attorney General to develop new and improved approaches,  
               techniques, systems, equipment, and devices to strengthen  
               enforcement of the Controlled Substances Act, and to enter  
               into contracts entities, as specified, to conduct  
               demonstrations or special projects that bear directly on  
               the misuse and abuse of controlled substances.  (Health &  
               Saf. Code § 11601.)


           This bill  adds peace officers to the list of people who can  
          receive a prescription for an opioid antagonist for the purpose  
          of assisting a person at risk of an opioid-related overdose.

           This bill  adds peace officers to the list of people who can  
          receive standing orders for the distribution of an opioid  
          antagonist for this purpose. 

           This bill  requires EMSA to establish training and standards for  
          all prehospital emergency care personnel on the use and  
          administration of naloxone and other opioid antagonists and to  
          promulgate regulations for this purpose.

           This bill  allows EMSA to designate existing training and  
          standards for this purpose. 

           This bill  allows a local emergency medical services agency to  

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          develop training and standards and to promulgate regulations for  
          prehospital emergency medical care personnel under its  
          jurisdiction who use and administer naloxone in lieu of those  
          developed by EMSA. 

           This bill  authorizes hospitals and trauma centers to share  
          information with local law enforcement and local emergency  
          medical services agencies about controlled substance overdose  
          trends. Specifies that this information shall only include the  
          number of overdoses and the substances suspected as the primary  
          cause of the overdoses and shall ensure patient confidentiality.  


                    RECEIVERSHIP/OVERCROWDING CRISIS AGGRAVATION

          For the last several years, severe overcrowding in California's  
          prisons has been the focus of evolving and expensive litigation  
          relating to conditions of confinement.  On May 23, 2011, the  
          United States Supreme Court ordered California to reduce its  
          prison population to 137.5 percent of design capacity within two  
          years from the date of its ruling, subject to the right of the  
          state to seek modifications in appropriate circumstances.   

          Beginning in early 2007, Senate leadership initiated a policy to  
          hold legislative proposals which could further aggravate the  
          prison overcrowding crisis through new or expanded felony  
          prosecutions.  Under the resulting policy, known as "ROCA"  
          (which stands for "Receivership/ Overcrowding Crisis  
          Aggravation"), the Committee held measures that created a new  
          felony, expanded the scope or penalty of an existing felony, or  
          otherwise increased the application of a felony in a manner  
          which could exacerbate the prison overcrowding crisis.  Under  
          these principles, ROCA was applied as a content-neutral,  
          provisional measure necessary to ensure that the Legislature did  
          not erode progress towards reducing prison overcrowding by  
          passing legislation, which would increase the prison population.  
            

          In January of 2013, just over a year after the enactment of the  
          historic Public Safety Realignment Act of 2011, the State of  
          California filed court documents seeking to vacate or modify the  
          federal court order requiring the state to reduce its prison  

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          population to 137.5 percent of design capacity.  The State  
          submitted that the, ". . .  population in the State's 33 prisons  
          has been reduced by over 24,000 inmates since October 2011 when  
          public safety realignment went into effect, by more than 36,000  
          inmates compared to the 2008 population . . . , and by nearly  
          42,000 inmates since 2006 . . . ."  Plaintiffs opposed the  
          state's motion, arguing that, "California prisons, which  
          currently average 150% of capacity, and reach as high as 185% of  
          capacity at one prison, continue to deliver health care that is  
          constitutionally deficient."  In an order dated January 29,  
          2013, the federal court granted the state a six-month extension  
          to achieve the 137.5 % inmate population cap by December 31,  
          2013.  

          The Three-Judge Court then ordered, on April 11, 2013, the state  
          of California to "immediately take all steps necessary to comply  
          with this Court's . . . Order . . . requiring defendants to  
          reduce overall prison population to 137.5% design capacity by  
          December 31, 2013."  On September 16, 2013, the State asked the  
          Court to extend that deadline to December 31, 2016.  In  
          response, the Court extended the deadline first to January 27,  
          2014 and then February 24, 2014, and ordered the parties to  
          enter into a meet-and-confer process to "explore how defendants  
          can comply with this Court's June 20, 2013 Order, including  
          means and dates by which such compliance can be expedited or  
          accomplished and how this Court can ensure a durable solution to  
          the prison crowding problem."

          The parties were not able to reach an agreement during the  
          meet-and-confer process.  As a result, the Court ordered  
          briefing on the State's requested extension and, on February 10,  
          2014, issued an order extending the deadline to reduce the  
          in-state adult institution population to 137.5% design capacity  
          to February 28, 2016.  The order requires the state to meet the  
          following interim and final population reduction benchmarks:

                 143% of design bed capacity by June 30, 2014;
                 141.5% of design bed capacity by February 28, 2015; and,
                 137.5% of design bed capacity by February 28, 2016. 

          If a benchmark is missed the Compliance Officer (a position  
          created by the February 10, 2016 order) can order the release of  

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          inmates to bring the State into compliance with that benchmark.   


          In a status report to the Court dated February 18, 2014, the  
          state reported that as of February 12, 2014, California's 33  
          prisons were at 144.3 percent capacity, with 117,686 inmates.   
          8,768 inmates were housed in out-of-state facilities.

          The ongoing prison overcrowding litigation indicates that prison  
          capacity and related issues concerning conditions of confinement  
          remain unresolved.  While real gains in reducing the prison  
          population have been made, even greater reductions may be  
          required to meet the orders of the federal court.  Therefore,  
          the Committee's consideration of ROCA bills -bills that may  
          impact the prison population - will be informed by the following  
          questions:

                 Whether a measure erodes realignment and impacts the  
               prison population;
                 Whether a measure addresses a crime which is directly  
               dangerous to the physical safety of others for which there  
               is no other reasonably appropriate sanction; 
                 Whether a bill corrects a constitutional infirmity or  
               legislative drafting error; 
                 Whether a measure proposes penalties which are  
               proportionate, and cannot be achieved through any other  
               reasonably appropriate remedy; and,
                 Whether a bill addresses a major area of public safety  
               or criminal activity for which there is no other  
               reasonable, appropriate remedy.
                                      COMMENTS

          1.  Need for This Bill  

          According to the author:

               California and the nation are in the midst of a drug  
               abuse crisis. Addiction to heroin and other opiates -  
               including prescription pain-killers - is impacting the  
               lives of Californians across the state.  Drug  
               overdoses are now the most common cause of accidental  
               death, with an estimated 16,651 fatalities linked to  

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               opioid painkillers in 2010.  While heroin overdoses  
               have increased nationwide, prescription opioids, such  
               as Vicodin and OxyContin, have caused more deaths than  
               heroin and cocaine overdoses combined.  

               This bill would expand the pool of emergency  
               responders who carry the drug naloxone that helps  
               resuscitate victims from an opiate overdose.   While  
               naloxone, an opiate antidote that reverses opiate  
               overdoses, has been used by paramedics and advanced  
               emergency medical technicians (EMTs) to save lives for  
               the last few decades in the state, current law is  
               unclear about the ability of other first emergency  
               responders, such as law enforcement, to use this  
               medication.

               Recently, California has taken several steps to  
               prevent overdose fatalities. Legislation enacted last  
               year expanded the use of naloxone for health care  
               providers, family, friends and other persons who may  
               assist overdose victims, but the law has been  
               interpreted to lack specific clarity about law  
               enforcement's ability to carry and administer the  
               drug. 

               While paramedics and EMTs are often the first to  
               respond to a medical emergency, some localities report  
               that peace officers are increasingly the first to  
               encounter an overdose victim.  A recent internal  
               survey within the San Diego Sheriff's Department found  
               that Sheriff's deputies responded to over 200  
               overdose-related emergency calls in the first nine  
               months of 2013, and in over 50 percent of those cases,  
               the Sheriff's deputy was the first emergency responder  
               on the scene. 

               Last month, in recognition of the nationwide surge in  
               opiate overdoses, U.S. Attorney General Eric Holder  
               echoed the plea made by the director of the White  
               House Office of National Drug Control Policy, to train  
               and equip law enforcement officers with naloxone.  


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               First responder expansion might not be needed in every  
               jurisdiction, but communities should assess their  
               current resources and local needs.  In Ventura County,  
               a portion of which the author represents, from  
               2008-2011, opioid overdoes-related emergency room  
               visits increased 49 percent, and accidental  
               opioid-related deaths increased 35 percent in the same  
               time frame.  The rising rates in the County propelled  
               the start of an organization called "Not One More" by  
               two mothers who lost their children to drug overdoses.  
                They now provide community training on the use of  
               naloxone and some off-duty police have attended the  
               recent trainings.  Since their last training, new  
               trainees have already been credited with saving two  
               lives. 

               SB 1438 is intended to save lives by making naloxone  
               available to all first responders, including law  
               enforcement personnel.  When a person overdoses,  
               unless these is rapid action to reverse the opioid's  
               effects, getting the overdose victim to a hospital is  
               frequently too late. 

          2.  Deaths Related to Opioid Overdose  
          
          According to the Centers for Disease Control and Prevention  
          (CDC), there were nearly 37,000 drug overdose deaths in the  
          United States in 2008 and approximately 4,300 drug poisoning  
          deaths in California.  Counties experiencing the highest numbers  
          of overdose deaths were Alameda, Fresno, Kern, Los Angeles,  
          Orange, Riverside, Sacramento, San Bernardino, San Diego, San  
          Francisco, and Santa Clara.  In 2009, 28,754 (91 percent) of all  
          unintentional poisoning deaths were caused most commonly by  
          prescription opioids, which include such drugs as methadone,  
          hydrocodone (Vicodin), and oxycodone (Oxycontin), followed by  
          cocaine and heroin. 

          3.   Naloxone Background
           
          According to the FDA, naloxone, which is not a controlled  
          substance, rapidly reverses the effects of opioid overdose and  
          is the standard treatment for overdose, which is characterized  

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          by decreased breathing or heart rate or loss of consciousness.  
          The National Institute on Drug Abuse's Web site states that, as  
          of March 2014, 17 states have passed laws that allow for wider  
          prescribing of naloxone to those who can help prevent overdoses,  
          such as family and friends of drug addicts and a wide array of  
          emergency personnel, like police and firefighters.  Some  
          overdose prevention programs use syringes fitted with atomizers  
          to enable the medication to be sprayed into the nose. 

          In April 2014, the FDA announced the approval of a new hand-held  
          auto-injector to reverse opioid overdose.  The medication is  
          injected into the muscle or under the skin.  The new device  
          provides verbal instruction, similar to an automated  
          defibrillator.  The FDA granted a fast-track designation, which  
          is designed to facilitate development and to expedite the review  
          of drugs to treat serious conditions and fill unmet medical  
          need, according to the FDA's Web site.

          4.  Results of Naloxone Distribution and Administration  
          
          A 2012 CDC report on programs known to distribute naloxone  
          documented the reversal of more than 10,000 heroin overdoses.   
          The programs provided opioid overdose education and naloxone to  
          drug users and to those who might be present during a drug  
          overdose in order to help reduce overdose deaths. However, of  
          the 48 programs that responded, nearly half reported problems in  
          obtaining naloxone related to cost and a shortage of supply. 

          According to the Drug Policy Alliance's (DPA) Web site, naloxone  
          has been safely and effectively used for more than 40 years in  
          ambulances and emergency rooms across the country. Naloxone has  
          no potential for abuse and side effects are rare.  DPA also  
          cites ongoing research showing that expanding access to naloxone  
          does not promote increased drug use or risk-taking behavior that  
          results in unintended overdoses.

          5.  Related Pending and Prior Legislation  
          
          AB 1535 (Bloom) would authorize a pharmacist to furnish naloxone  
          if the pharmacist provides a consultation to ensure the  
          education of the person to whom the drug is furnished and  
          notification to the patient's primary care provider of drugs or  

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          devices furnished to the patient.  The bill would prohibit a  
          pharmacist from permitting a person to waive the consultation  
          and requires a pharmacist to complete a training program on the  
          use of opioid antagonists prior to furnishing naloxone.  AB 1535  
          is currently in the Assembly Appropriations Committee. 

          AB 635 (Ammiano), Chapter 707, Statutes of 2013, expanded the  
          program in AB 2145 (Ammiano) Chapter 545, Statues of 2010  
          statewide, deleted the sunset date and the reporting  
          requirements and modified the limited liability provisions for  
          both licensed health care professionals who prescribe, dispense,  
          or distribute naloxone and unlicensed persons who act with  
          reasonable care to administer naloxone to a person who is  
          experiencing or is suspected to be experiencing an overdose. 

          AB 2145 (Ammiano) extended the sunset date of the seven-county  
          pilot program established under SB 767 (Ridley-Thomas), Chapter  
          477, Statutes of 2007, to January 1, 2016, extended to January  
          1, 2015, the deadline for the requirement of local health  
          jurisdictions operating an overdose prevention program to  
          report, as specified, to the Senate and Assembly Committees on  
          Judiciary and added immunity for unlicensed trained people who  
          administer an opioid antidote in emergency situations during  
          which they believe that a person is experiencing a drug  
          overdose. 

          SB 767 (Ridley-Thomas) established a seven-county pilot program  
          until January 1, 2010, in which licensed health care providers  
          were given immunity from civil liability or criminal prosecution  
          when they prescribed naloxone to a person in connection with an  
          opioid overdose prevention and training program on how to  
          recognize and respond to an opiate overdose.  SB 767 required  
          local health jurisdictions operating an overdose prevention  
          program to report, as specified, to the Senate and Assembly  
          Committees on Judiciary by January 1, 2010. 

          SB 1695 (Escutia), Chapter 678, Statutes of 2002, authorized  
          counties to establish training and certification programs to  
          permit an EMT-I to administer naloxone by means other than  
          intravenous injection if he or she has completed training and  
          passed a test.  SB 1695 required EMSA to develop guidelines  
          relating to the county certification programs. 

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          6.  Amendment accepted by Author in Health Committee to be Taken  
          in Public Safety  








































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          The Senate Health Committee suggested an amendment to prevent  
                                                                                conflicts in the provisions concerning standards and regulations  
          developed by the California EMSA and local emergency medical  
          service authorities.  The author agreed to take the amendments  
          in this committee.  The Senate Health Committee analysis  
          described the amendment as follows:


               This bill allows a local EMS agency to develop  
               training, standards, and regulations for prehospital  
               emergency medical care personnel for the use and  
               administration of naloxone, in lieu of those developed  
               by the EMSA. To help prevent a conflict, Committee  
               staff suggests the following amendment to ensure that  
               both local EMS agency and EMSA training, standards,  
               and regulations are in line with best practices in the  
               Substance Abuse and Mental Health Administration's  
               Opioid Overdose Prevention Toolkit. 

               The amendments are in bold italics:

               Section 1797.197 of the Health and Safety Code: 
               (a) The authority shall establish training and  
               standards for all prehospital emergency care  
               personnel, as defined pursuant to in paragraph (2) of  
               subdivision (a) of Section 1797.189, regarding the  
               characteristics and method of assessment and treatment  
               of anaphylactic reactions and the use of epinephrine.  
               The authority shall promulgate regulations regarding  
               these matters for use by all prehospital emergency  
               care personnel. 
               (b) (1) The authority shall establish training and  
               standards for all prehospital emergency care  
               personnel, as defined in paragraph (2) of subdivision  
               (a) of Section 1797.189, regarding the use and  
               administration of naloxone hydrochloride and other  
               opioid antagonists. The authority shall promulgate  
               regulations regarding these matters for use by all  
               prehospital emergency care personnel. The authority  
               may designate existing training and standards for the  
               use and administration of naloxone hydrochloride or  
               another opioid antagonist to satisfy the requirements  
               of this section. 

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               (2) A local EMS agency may develop its own training  
               and standards, and may promulgate regulations, in lieu  
               of the training and standards and regulations  
               developed by the authority pursuant to paragraph (1),  
               for the purpose of considering local need, regarding  
               the use and administration of naloxone hydrochloride  
               and other opioid antagonists by prehospital emergency  
               care personnel under the jurisdiction of that local  
               EMS agency. 
               (3) The training, standards, and regulations in  
               paragraphs (1) and (2) of subdivision (b) shall be in  
               line with best practices in the Substance Abuse and  
               Mental Health Services Administration's Opioid  
               Overdose Prevention Toolkit. 
               (34) The training described in paragraphs (1) and (2)  
               shall satisfy the requirements of paragraph (1) of  
               subdivision (d) of Section 1714.22 of the Civil Code. 


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