BILL ANALYSIS                                                                                                                                                                                                    







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        |Hearing Date:June 16, 2014         |Bill No:AB                         |
        |                                   |1535                               |
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                      SENATE COMMITTEE ON BUSINESS, PROFESSIONS 
                               AND ECONOMIC DEVELOPMENT
                              Senator Ted W. Lieu, Chair
                                           

                          Bill No:        AB 1535Author:Bloom
                    As Amended:April 1, 2014           Fiscal:  Yes

        
        SUBJECT:  Pharmacists: Naloxone Hydrochloride.
        
        SUMMARY: Permits a pharmacist to furnish naloxone hydrochloride (NH)  
        without a prescription pursuant to standardized procedures and  
        protocols developed and approved jointly by the California Board of  
        Pharmacy (Board) and the Medical Board of California (MBC).

        Existing law:
        
        1)Establishes the Pharmacy Law which provides for the licensure and  
          regulation of pharmacies, pharmacists and wholesalers of dangerous  
          drugs or devices by the Board of Pharmacy (Board) within the  
          Department of Consumer Affairs (DCA). 

        2)Licenses and regulates physicians and surgeons under the Medical  
          Practice Act (Act) by the Medical Board of California (MBC).

        3)Permits pharmacists to perform the following procedures under  
          physician protocols in licensed health care facilities:  (BPC  
          4052.1)

           a)   Order and perform routine drug therapy-related patient  
             assessment procedures.

           b)   Order drug therapy-related laboratory tests.

           c)   Administer drugs and biologicals by injection pursuant to a  
             prescriber's order.

           d)   Initiate or adjust a patient's drug regimen pursuant to  





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             authorization or order by the patient's prescriber.

        1)Permits pharmacists in a number of specified settings to do the  
          following:  (BPC  4052.2)

           a)   Order and perform routine drug therapy-related patient  
             assessment procedures.

           b)   Order drug therapy-related laboratory tests.

           c)   Administer drugs and biologicals by injection pursuant to a  
             prescriber's order.

           d)   Initiate or adjust a patient's drug regimen pursuant to  
             authorization or order by the patient's treating prescriber.  
             Prohibits the substitution or selection of a different drug  
             unless authorized by protocol and requires prescriber  
             notification of initiated drug regimens to be transmitted within  
             24 hours.

           e)   Specifies that a patient's treating prescriber may prohibit  
             pharmacists from making any changes or adjustments to patients'  
             drug regimens.

           f)   Requires the governing policies, procedures and protocols to  
             be developed by specified health professionals and established  
             minimum requirements for those policies, procedures and  
             protocols.

           g)   Requires pharmacists performing procedures authorized by this  
             section to have successfully completed clinical residency  
             training or demonstrated clinical experience in direct patient  
             care delivery.

        5) Authorizes an advanced practice pharmacist (APP) recognized by the  
           Board to do all of the following:  (BPC  4052.6)

           a)   Perform patient assessments.

           b)   Order and interpret drug-therapy related tests, ensuring that  
             the ordering of those tests is done in coordination with the  
             patient's primary care provider or diagnosing prescriber, as  
             appropriate, including promptly transmitting written notification  
             to the patient's diagnosing prescriber or entering the  
             appropriate information in a patient record system shared with  
             the prescriber, when available and as permitted by that  





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             prescriber.

           c)   Refer patients to other health care providers.

           d)   Participate in the evaluation or management of diseases and  
             health conditions in collaboration with other health care  
             providers.

           e)   Initiate, adjust or discontinue drug therapy pursuant to the  
             authority established in current law for pharmacists to perform  
             certain procedures in a licensed health care facility. 

        1) Provides that an APP who adjusts or discontinues drug therapy shall  
           promptly transmit written notification to the patient's diagnosing  
           prescriber or enter the appropriate information into a patient  
           record system shared with the prescriber.  Provides that an APP who  
           initiates drug therapy shall promptly transmit written notification  
           or enter the appropriate information into a patient record system  
           shared with the patient's primary care provider or diagnosing  
           provider.  (Id.)

        2) Requires an APP to register with the DEA prior to initiating or  
           adjusting a controlled substance.  (Id.)

        8)Authorizes a licensed health care provider to prescribe and dispense  
          NH 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.  (Civil Code (CC)  1714.22)

        9)Authorizes a licensed health care provider to issue standing orders  
          for the administration of NH to a person at risk of an  
          opioid-related overdose, a family member, friend, or other person in  
          a position to assist a person experiencing or reasonably suspected  
          of experiencing an overdose. (Id.)

        10)Requires a person who is prescribed or possesses NH pursuant to a  
          standing order to receive training provided by an opioid overdose  
          prevention and treatment training program operated by a local health  
          jurisdiction or that is registered by a local health jurisdiction  
          that provides, at a minimum, training in (Id.): 

           a)   The causes of an opiate overdose.

           b)   Mouth to mouth resuscitation.

           c)   How to contact appropriate emergency medical services.





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           d)   How to administer NH.

        11)Does not require a person who is prescribed NH directly from a  
          licensed prescriber to receive training from an opioid prevention  
          and treatment training program.  (Id.)

        This bill:

        1) Permits a pharmacist to furnish NH in accordance with standardized  
           procedures or protocols developed and approved by the Board and  
           MBC.  

        2) Permits a pharmacist to furnish NH in accordance with standardized  
           procedures or protocols developed and approved by both the Board  
           and MBC, in consultation with the California Society of Addiction  
           Medicine, the California Pharmacists Association, and other  
           appropriate entities.  

        3) Requires the Board and MBC to include in the standardized  
           procedures or protocols:

           a)   Procedures to ensure education of the person to whom the drug  
             is furnished, including, but not limited to opioid overdose  
             prevention, recognition, and response, safe administration of NH,  
             potential side effects or adverse events, and the imperative to  
             seek emergency medical care for the patient. 

           b)   Procedures to ensure the education of the person to whom the  
             drug is furnished regarding the availability of the drug  
             treatment programs.

           c)   Procedures for the notification of the patient's primary care  
             provider with patient consent of any drugs or devises furnished  
             to the patient, or entry of appropriate information in a patient  
             record system shared with the primary care provider, as permitted  
             by that primary care provider, and with patient consent. 

        1) Prohibits a pharmacist furnishing NH from allowing a person  
           receiving NH to waive the drug consultation. 

        2) Requires a pharmacist to complete a training program on the use of  
           opioid antagonists that consists of at least one hour of approved  
           continuing education on the use NH.  
        3) Authorizes Board and MBC to ensure compliance with this bill, and  
           states that each board is charged with enforcing this bill with  





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           respect to its respective licensees. 

        4) States that this bill does not expand the authority of a pharmacist  
           to prescribe any prescription medication. 

        
        FISCAL EFFECT:  This measure is keyed "fiscal" by Legislative Counsel.  
         According to the Assembly Appropriations Committee analysis dated  
        April 30, 2014, this bill will result in minor one-time costs, under  
        $100,000, to the MBC and to the Board to jointly develop standardized  
        procedures and protocols and related training and educational content.  
         The analysis also stated that the bill will result in minor and  
        absorbable ongoing costs to both boards for enforcement.

        
        COMMENTS:
        
        1.Purpose.  This bill is sponsored by the  Drug Policy Alliance  and the  
           California Pharmacists Association  .  According to the Author, "Drug  
          overdose deaths by prescription pain pills and heroin have reached  
          the point of becoming a public health crisis in California.  We  
          urgently need an environmental, public health intervention right now  
          to reduce these deaths.  This bill, which authorizes the Medical  
          Board of California and the Board of Pharmacy to develop a statewide  
          protocol for pharmacists to furnish naloxone, will widen access to  
          this successful and safe live-saving drug.  Naloxone reverses an  
          opioid overdose, and should be widely available in order to combat  
          the drug overdose crisis.  Pharmacists are highly trained  
          professionals who are readily accessible to the public in many  
          communities, and allowing them to do this is of enormous importance  
          to families across California and to public health as a whole."

        2.Prescription Drug Deaths. A 2013 Centers for Disease Control (CDC)  
          analysis found that drug overdose deaths increased for the 11th  
          consecutive year in 2010 and prescription drugs, particularly opioid  
          analgesics, are the top drugs leading the list of those responsible  
          for fatalities.  According to CDC, 38,329 people died from a drug  
          overdose in 2010, up from 37,004 deaths in 2009, and 16,849 deaths  
          in 1999.  CDC found that nearly 60 percent of the overdose deaths in  
          2010, involved pharmaceutical drugs, with opioids associated with  
          approximately 75 percent of these deaths.  Nearly three out of four  
          prescription drug overdoses are caused by opioid pain relievers.      


        3.Naloxone Hydrochloride.  Naloxone Hydrochloride (NH), better known  
          as Narcan, is an opioid antidote that can reverse a drug overdose.   





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          NH reverses depression of the central nervous system and respiratory  
          systems that have shut down during an overdose.  NH is commonly used  
          when a person excessively uses morphine, oxycodone, methadone, or  
          illegal substances such as heroin.  NH is meant to sustain breathing  
          for 30-90 minutes, during which time emergency medical services  
          should be sought for the patient.  The drug is non-narcotic, does  
          not produce intoxication, and has no potential for addiction or  
          abuse.  NH also only causes pharmacological effects if there are  
          opioids in someone's body.  If NH is administered to someone who is  
          not overdosing, no adverse effects will happen.

          NH is typically administered intramuscularly, which causes the drug  
          to act within one minute and last up to 45 minutes.  The emergency  
          treatment works like the well-known EpiPen, an epinephrine  
          auto-injector for serious allergic reactions, as it is injected into  
          the muscle and does not require training, making it more  
          user-friendly.  NH may also be administered via intravenously,  
          subcutaneous (under the skin), or intranasally.   A typical  
          injectable or nasal spray NH kit costs $15-$25 per dose.

          California is one of a number of states that have recently enacted  
          legislation to address the public health concern of prescription  
          drug overdose.  17 states and the District of Columbia, have enacted  
          laws expanding access to NH.  Most notably, programs that have  
          required police officers to carry NH have been proven successful at  
          curbing overdose deaths.  According to a report by CNN, "The police  
          department in Quincy, Massachusetts was the first in the nation to  
          require its officers to carry naloxone and has successfully reversed  
          211 overdoses with a success rate of over 95%."  New York recently  
          implemented a similar idea in Suffolk County, where 563 lives were  
          saved last year alone.

          Community based programs have existed since 1996 to get NH into the  
          hands of those able to help.  The national advocacy organization  
          Harm Reduction Coalition (HRC) reports that there are currently over  
          200 take-home NH programs in communities throughout the United  
          States that help to increase access to NH and training education on  
          overdose.    

          In 2010, HRC surveyed 50 of these programs and reported the results  
          in the February 17, 2012 issue of Morbidity and Mortality Weekly  
          Report (MMWR), a publication of the CDC.  The survey found that  
          since these programs first began, 53,032 persons were trained on the  
          use of NH and the programs received reports of 10,171 overdose  
          reversals.  Other community based projects like Project Lazarus and  
          Operation OpioidSAFE in North Carolina are working to increase the  





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          accessibility of NH.  Education is provided by these programs about  
          opioid safety and the administration of NH however these programs  
          are limited in their funding and geographic reach.  

          Despite evidence that shows widening distribution of NH helps  
          decrease drug overdose deaths, its implementation faces some  
          difficulties.  MMWR reports that "nearly half (43.7%) of the  
          responding opioid overdose programs reported problems obtaining  
          naloxone related to cost and the supply chain. Price increases of  
          some formulations of naloxone appear to restrict current program  
          activities and the possibility of new programs. Economic pressures  
          on state and local budgets could decrease funding of opioid overdose  
          prevention activities.  To address the substantial increases in  
          opioid-related drug overdose deaths, public health agencies could  
          consider comprehensive measures that include teaching laypersons how  
          to respond to overdoses and administer naloxone to those in need."

        4.The Role of Pharmacists in Expanding Access to Naloxone.  The Center  
          for Pharmacy Services (CPS), a community pharmacy in Pittsburg,  
          Pennsylvania recently collaborated with the Overdose Prevention  
          Project to enlist pharmacists in overdose prevention.  This project  
          used pharmacists to educate patients and physicians about opioid  
          safety and the effectiveness of NH to prevent fatal overdose.  After  
          training, patients that showed up at CPS with a NH prescription were  
          offered counseling on opioid safety, taught how to take opioid pain  
          relievers safely, and demonstrated how to safely dispose of unused  
          prescription medicines.  The caregiver and patient were additionally  
          taught how to identify an overdose and how to administrate NH.  This  
          program is unique in that any person that goes through the CPS  
          program and receives the opioid safety education can request a  
          prescription for naloxone.  The pharmacist facilitates this by fax,  
          sending a simple form to the prescribing physician requesting they  
          sign an order to prescribe naloxone along with the opioids  
          prescribed.

          This bill mirrors this approach to expand the distribution of NH. 

        5.Related Legislation This Year.   SB 500  (Lieu) requires MBC to update  
          prescriber standards for controlled substances once every five years  
          and adds the American Cancer Society, specialists in pharmacology  
          and specialists in addiction medicine, to the entities MBC may  
          consult with in developing the standards.  (  Status:   The bill is  
          currently pending in the Assembly Business, Professions, and  
          Consumer Protection.)  
          
           SB 1438  (Pavley) requires the Emergency Medical Services Authority  





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          (EMSA) to develop and adopt training and standards, and promulgate  
          regulations, for all prehospital emergency care personnel, regarding  
          the use and administration of naloxone hydrochloride and other  
          opioid antagonists.  This bill also permits, at the discretion of  
          the medical director of the local EMS agency, that pertinent  
          training completed by pre-hospital emergency care personnel may be  
          used to satisfy part of the training requirements regarding the use  
          and administration of naloxone hydrochloride and other opioid  
          antagonists by pre-hospital emergency care personnel. Both types of  
          training satisfy specified requirements allowing for immunity from  
          criminal and civil liability for administering an opioid antagonist.  
           Lastly, this bill would permit the Attorney General to authorize  
          hospitals and trauma centers to share information with local law  
          enforcement and medical service agencies about controlled  
          substances.  SB 1438 would limit the data that may be provided by  
          hospitals and trauma centers to the number of overdoses and the  
          substances suspected as the primary cause of the overdoses.   
          (  Status:  This bill is currently pending in the Assembly).
         
         6.Prior Related Legislation.   AB 635  (Ammiano, Chapter 707, Statutes  
          of 2013) expanded an existing pilot program which provides qualified  
          immunity to licensed health care providers who prescribe NH by  
          removing the program's sunset date, expanding the program's reach  
          from seven to all counties, authorizing licensed health care  
          providers to prescribe NH 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 NH.   
          
           AB 831  (Bloom) of 2013 would have established, within the California  
          Health and Human Services Agency, a temporary working group to  
          develop a plan to reduce the rate of fatal drug overdoses in the  
          state. The bill would have also required the temporary working group  
          to make recommendations to the Chair of the Senate Committee on  
          Health and the Chair of Assembly Committee on Health on or before  
          January 1, 2015. (  Status:  This bill was held under submission in the  
          Assembly Committee on Appropriations.)
          
           AB 2145  (Ammiano, Chapter 545, Statutes of 2010) authorized a person  
          who is not otherwise licensed to administer an opioid antagonist in  
          an emergency without fee if the person has received specified  
          training information and believes in good faith that the other  
          person is experiencing a drug overdose. The bill prohibited a  
          person, as a result of his or her acts or omissions, from being  
          liable for any violation of any professional licensing statute, or  
          subject to any criminal prosecution arising from or related to the  





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          unauthorized practice of medicine or the possession of an opioid  
          antagonist.
           
          AB 767  (Ridley-Thomas, Chapter 477, Statutes of 2007) authorized,  
          until January 1, 2011, a licensed health care provider, who is  
          already permitted to prescribe an opioid antagonist and if acting  
          with reasonable care, to 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. The bill also  
          required a local health jurisdiction that operates or registers an  
          opioid overdose prevention and treatment training program to collect  
          prescribed data and report it to the Senate and Assembly Committees  
          on Judiciary by January 1, 2010. The bill only applied to certain  
          counties. 
         
         7.Arguments in Support.  Supporters of this measure write that "public  
          health experts agree that increasing access to naloxone is a key  
          strategy in preventing drug overdose deaths."  They note that in  
          California, naloxone is currently available only by prescription and  
          from a very small number of programs operating under standing orders  
          from a physician and the next logical step in combating the epidemic  
          of overdose in California is to allow community pharmacies to  
          provide naloxone and counseling to at-risk patients.  Supporters  
          also cite the recognition that pharmacists are "among the most  
          highly trusted healthcare professionals" who are trained experts at  
          working with "patients at risk of the harms associated with  
          prescription medications.  Pharmacists interact with patients and  
          their family members more often than many physicians.  They are well  
          positioned to provide overdose prevention information and naloxone  
          to patients on long-term or high-dose opioid therapies, their  
          caregivers and others who may witness an accidental overdose."   
          Supporters believe this bill is a simple, low-to-no-cost solution  
          that would move California in the right direction toward reducing  
          accidental overdose fatalities.  

        SUPPORT AND OPPOSITION:
        
        Support:  

        California Pharmacists Association (Sponsor) 
        Drug Policy Alliance (Sponsor) 
        A New PATH 
        Addiction Research and Treatment
        Amity Foundation
        Bay Area Addiction Recovery Treatment (BAART)





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        Behind the Orange Curtain
        Broadway Treatment Center
        Broken No More 
        California Hospital Association
        California Mental Health Directors Association
        California Narcotic Officers' Association
        California Opioid Maintenance Providers 
        California Retailers Association
        California Society of Addiction Medicine
        Center for Living and Learning
        County Alcohol and Drug Program Administrators Association of  
        California
        CRI-HELP, Inc.
        Drug and Alcohol Addiction Awareness and Prevention Program
        Families ACT!
        Fred Brown Recovery Services
        Gateways Hospital and Mental Health Center
        Grief Recovery After a Substance Passing 
        Health Officers Association of California 
        Health Right 360  
        Hillview Mental Health Center
        Homeless Health Care Los Angeles
        Hope of the Valley Rescue Mission
        In Depth
        Legal Services for Prisoners with Children
        Los Angeles Centers for Alcohol and Drug Abuse
        Los Angeles Community Action Network
                                                                     Los Angeles HIV Drug and Alcohol Task Force
        Mary Magdalene Project
        Medical Board of California
        National Federation of Independent Business
        Not One More
        Paramedics Plus
        Paving the Way Foundation
        Phoenix House of Los Angeles
        Primary Purpose Sober Living Homes
        San Fernando Recovery Center
        SANE (Safer Alternatives Through Networking and Education)
        SHIELDS For Families
        Soberspace
        Solace

         Opposition:  

        None on file as of June 11, 2014.






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        Consultant: Mark Mendoza