BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                  AB 1535
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          CONCURRENCE IN SENATE AMENDMENTS
          AB 1535 (Bloom)
          As Amended  June 24, 2014
          Majority vote
           
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          |ASSEMBLY:  |73-0 |(May 8, 2014)   |SENATE: |35-0 |(August 7,     |
          |           |     |                |        |     |2014)          |
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           Original Committee Reference:    B., P. & C.P.  

           SUMMARY  :  Permits a pharmacist to furnish naloxone hydrochloride  
          (NH) pursuant to standardized procedures or protocols developed  
          and approved by the California Board of Pharmacy (BOP) and the  
          Medical Board of California (MBC).  

           The Senate amendments  authorize BOP to adopt emergency  
          regulations to establish the standardized procedures or  
          protocols. 

           FISCAL EFFECT  :  According to the Senate Appropriations  
          Committee: 
           
          1)One-time costs less than $75,000 to develop protocols and  
            adopt regulations by the MBC (Contingent Fund of the MBC).

          2)One-time costs less than $75,000 to develop protocols and  
            adopt regulations by the BOP (Pharmacy Board Contingent Fund).

          3)Minor anticipated enforcement costs to the BOP (Pharmacy Board  
            Contingent Fund).

           COMMENTS  :   

          1)Purpose of this bill.  This bill will allow a pharmacist to  
            furnish 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, pursuant to standardized procedures  
            or protocols developed and approved by BOP and MBC.  This bill  
            will enable the wider distribution of a safe,  
            easy-to-administer and life-saving drug in accordance with  
            recommendations from the United States Department of Health  
            and Human Services.  This bill is sponsored by the Drug Policy  








                                                                  AB 1535
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            Alliance. 

          2)Naloxone hydrochloride.  NH is an antidote to opioids. It is  
            traditionally used in the hospital setting to reverse the  
            effects of opiates given during surgery, and may be given to  
            newborns to decrease the effects of opiates received by the  
            pregnant mother prior to delivery.  It is currently available  
            by prescription only, but is not a scheduled drug.   
             
             NH reverses an overdose by blocking the central nervous system  
            effects of several types of opiate medications such as  
            morphine, oxycodone, methadone, or illegal substances such as  
            heroin.  According to its Food and Drug Administration (FDA)  
            approved label, NH only causes pharmacologic effects if there  
            are opioids in someone's body.  This means that if NH is  
            administered to someone who is not overdosing, nothing will  
            happen.  NH is not addictive and has not shown to produce  
            either physical or psychological dependence.  

            According to the Opioid Overdose Toolkit from the Substance  
            Abuse and Mental Health Services Administration, a division of  
            the United States Department of Health and Human Services: 

               The safety profile of NH 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, NH produces no  
               clinical effects, even at high doses.  Moreover, while  
               rapid opioid withdrawal in tolerant patients may be  
               unpleasant, it is not life-threatening.  

               NH can be safely be used to manage opioid overdose in  
               pregnant women.

            NH is administered by injection into a large muscle, such as  
            the thighs, buttocks, or shoulder, or through a nasal spray,  
            and can reverse the effects of an opioid overdose.  The  
            purpose is to restart the patient's breathing, but may not  
            necessarily cause complete revival.  NH is effective for 30 to  
            90 minutes, during which time emergency services should be  
            sought for the patient.  When injected into an overdose victim  
            whose heart is still beating, "it's virtually 100% effective,"  
            said Wilson Compton, deputy director at the National Institute  
            on Drug Abuse. 









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            According to the National Institute of Health, NH has a shelf  
            life of approximately two years and should be stored at room  
            temperature and away from direct light.  A typical injectable  
            or nasal spray NH kit costs $15 to $25 per dose. 

          3)Current California pharmacist furnishing laws.  California  
            pharmacists are currently authorized to furnish the following  
            medications without a prescription after appropriate training  
            and pursuant to specified conditions:

             a)   Emergency contraception drug therapy and  
               self-administered hormonal contraceptives;

             b)   Nicotine replacement products;

             c)   Prescription medications not requiring a diagnosis that  
               are recommended by the Centers for Disease Control and  
               Prevention (CDC) for individuals traveling outside of the  
               United States;

             d)   Administer immunizations; and,

             e)   Initiate and administer epinephrine.
              
          4)Calls for greater access.  There are several community-based  
            efforts underway (discussed further below) to encourage  
            physicians to prescribe NH concurrently with opioids for  
            patients who meet criteria for higher overdose risk.  However,  
            data on concurrent prescription rates are limited and not  
            suggestive of frequent application.  Medi-Cal data of 2013  
            provided by this bill's sponsors indicate that while 62% of  
            Medi-Cal prescribers prescribe opioids, less than two-tenths  
            of 1% prescribe NH.  

            The findings of a 2012 Morbidity and Mortality Weekly Report  
            (MMWR), a publication of the CDC, suggests that wider  
            distribution of NH and training in its administration might  
            prevent numerous deaths from opioid overdoses and save  
            thousands of dollars in public funds.  However, nearly half of  
            the responding NH programs reported problems obtaining NH due  
            to cost and supply chain availability.  The MMWR report framed  
            this as a significant public health issue:  "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  








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            and administer naloxone to those in need."

          5)Role of pharmacists in furnishing NH.  According to a March  
            2014 research letter published in the Journal of the American  
            Medical Association, the highest-risk and highest-use group of  
            opioid users is more likely to obtain opioids from a  
            physician's prescription than from a drug dealer.  And these  
            prescriptions are filled at pharmacies.  


            The Center for Pharmacy Services (CPS), a community pharmacy  
            in Pittsburgh, Pennsylvania, collaborated with the Overdose  
            Prevention Project to develop a model that enlists pharmacists  
            in overdose prevention.  The model uses pharmacists to educate  
            patients and physicians about opioid safety and the  
            effectiveness of prophylactic prescription of NH to prevent  
            fatal overdose. 



            Beginning in February 2011, patients presenting at CPS with a  
            prescription for an opioid analgesic were offered counseling  
            on opioid safety, including potential side effects, how to  
            take opioid pain relievers safely, possible signs of opioid  
            over-medication and/or overdose, and safe disposal of unused  
            prescription medicines.  Patients are also provided with  
            opioid safety educational materials.  The patient and/or  
            caregiver also receives instruction on how to identify and  
            effectively respond to an overdose and how to administer  
            naloxone.



            In the CPS program, a patient who receives the opioid safety  
            education can request a prescription for NH.  The pharmacist  
            facilitates this by fax, sending a simple form to the  
            prescribing physician requesting they sign an order to  
            prescribe NH along with the opioids prescribed.   



            This bill seeks to follow the CPS model by allowing  
            pharmacists to furnish NH pursuant to a protocol, thereby  
            streamlining the process by which an individual receives the  
            drug.  








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           Analysis Prepared by  :    Sarah Huchel / B., P.& C.P. / (916)  
          319-3301


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