BILL ANALYSIS                                                                                                                                                                                                    Ó



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          Date of Hearing:  June 21, 2011

                            ASSEMBLY COMMITTEE ON HEALTH
                              William W. Monning, Chair
                       SB 41 (Yee) - As Amended:  May 24, 2011

           SENATE VOTE  :  24-13
           
          SUBJECT  :  Hypodermic needles and syringes.

           SUMMARY  :  Suspends certain provisions of the Disease Prevention 
          Demonstration Project (DPDP), including the ability for a city 
          or county to authorize pharmacists to provide up to 10 
          hypodermic needles and syringes without a prescription, until 
          January 1, 2015, and until then permits pharmacists and 
          physicians to furnish up to 30 hypodermic needles and syringes 
          for human use, without a prescription or city/county 
          authorization, to a person 18 years or older, as specified.   
          Specifically,  this bill  :   

          1)Suspends certain provisions of the DPDP, including the ability 
            for a city or county to authorize pharmacists to provide up to 
            10 hypodermic needles and syringes without a prescription, 
            until January 1, 2015, and until then:

             a)   Permits pharmacists and physicians to furnish up to 30 
               hypodermic needles and syringes for human use, without a 
               prescription or city/county authorization, to a person 18 
               years or older if the person is known to the furnisher and 
               the furnisher has previously been provided a prescription 
               or other proof of a legitimate medical need requiring a 
               hypodermic needle or syringe to administer a medicine or 
               treatment.  Permits a person 18 years of age or older, 
               without a prescription or license, to obtain 30 or fewer 
               hypodermic needles and syringes solely for personal use 
               from a physician or pharmacist.

             b)   Requires pharmacies that furnish nonprescription 
               hypodermic needles and syringes to store them in a manner 
               that ensures that they are available only to authorized 
               personnel and to provide consumers with one or more of the 
               following disposal options:

               i)     An onsite, safe, hypodermic needle and syringe 
                 collection and disposal program;








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               ii)    Mail-back sharps disposal containers authorized by 
                 the United States Postal Service that meet applicable 
                 state and federal requirements, and that provide tracking 
                 forms to verify destruction at a certified disposal 
                 facility; and,

               iii)   A personal medical sharps disposal container that 
                 meets applicable state and federal standards for disposal 
                 of medical sharps waste.

             c)   Requires pharmacies that furnish nonprescription 
               syringes to provide written information or verbal 
               counseling to consumers at the time of furnishing or sale 
               of nonprescription hypodermic needles or syringes on how to 
               access drug treatment and testing and treatment for HIV and 
               hepatitis C, and how to safely dispose of sharps waste.

          2)Requires the Department of Public Health (DPH) Office of AIDS 
            to develop and maintain specified information regarding HIV 
            and hepatitis testing and treatment, safe needle disposal, and 
            drug treatment on its Internet Website.  Requires the 
            California State Board of Pharmacy to also post, or maintain a 
            link to, that information on its Internet Website.

           EXISTING LAW  :

          1)Regulates the sale, possession, and disposal of hypodermic 
            needles and syringes; and, requires a prescription to purchase 
            a hypodermic needle or syringe for human use, except to 
            administer adrenaline or insulin.

          2)Permits a city or county to authorize a licensed pharmacist to 
            sell or furnish 10 or fewer hypodermic needles or syringes to 
            a person for human use without a prescription if the pharmacy 
            is registered with a local health jurisdiction (LHJ) in the 
            DPDP.

          3)Prohibits the possession and sale of drug paraphernalia; but 
            allows a person, if authorized by a city or county, to possess 
            10 or fewer hypodermic needles or syringes if acquired through 
            an authorized source.

           FISCAL EFFECT  :  According to the Senate Appropriations 
          Committee, pursuant to Senate Rule 28.8 negligible state costs.








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          COMMENTS  :   

           1)PURPOSE OF THIS BILL  .  According to the author, California is 
            suffering an unnecessarily high rate of HIV and viral 
            hepatitis due to syringe scarcity.  The author states that 
            California is one of only three states in the US that prohibit 
            a pharmacist from furnishing a syringe to an adult without a 
            prescription.  Most states never required a prescription to 
            purchase a sterile syringe, and of those that did, most 
            amended their laws in light of the AIDS epidemic and the clear 
            evidence that shows that allowing adults to access sterile 
            syringes prevents the transmission of HIV, hepatitis C virus 
            (HCV), and other blood-borne diseases, without contributing to 
            increased drug use, drug injection, crime, or unsafe discard 
            of syringes.  The author states that while many states allow 
            an unlimited number of syringes to be sold to an adult, this 
            bill is an incremental move away from complete prohibition of 
            sale and possession of syringes, allowing an adult to purchase 
            and possess 30 or fewer syringes for personal use.  The author 
            states that the intent of this bill is to improve access to 
            syringes and hypodermic needles so as to remove significant 
            barriers for persons seeking to protect their health and the 
            health of other persons, and to remove barriers for programs 
            or businesses to provide sterile injection equipment and 
            education to adults, thereby reducing the spread of 
            communicable diseases and protecting the public health.  

           2)BACKGROUND  .  According to the DPH Office of AIDS, in 2009 
            injection drug use (IDU) was associated with approximately 19% 
            of the 190,000 reported HIV/AIDS cases, and it is estimated 
            that approximately 750 new HIV infections may be attributed to 
            IDU each year.  The link between IDU and HIV transmission is 
            particularly strong for women and minorities.  It is also 
            estimated that at least 60% of prevalent cases of HCV 
            infection are associated with IDU.  HCV affects approximately 
            600,000 people in California (2% of the state's population).  
            Complications of liver disease associated with HCV have 
            resulted in an estimated 8,000 to10,000 deaths per year in the 
            United States.


          Public health experts, including the Centers for Disease Control 
            and Prevention, have identified access to sterile syringes as 
            one component of a comprehensive HIV prevention strategy 








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            designed to reduce HIV transmission among IDUs.  In the last 
            10 years, a number of national organizations have endorsed 
            deregulation to allow IDUs to purchase and possess syringes 
            and needles without a prescription, including the American 
            Medical Association, the American Pharmaceutical Association, 
            the National Association of Boards of Pharmacy, the National 
            Alliance of State and Territorial AIDS Directors, and the 
            Association of State and Territorial Health Officials. 

           3)DPDP  .  SB 1159 (Vasconcellos), Chapter 608, Statutes of 2004, 
            establishes a five-year pilot program to allow California 
            pharmacies, when authorized by a local government, to sell up 
            to 10 syringes to adults without a prescription.  According to 
            the DPH Office of AIDS, 16 counties and four cities in 
            California have authorized a DPDP (counties: Alameda, Contra 
            Costa, Humboldt, Los Angeles, Mendocino, Marin, San Francisco, 
            San Luis Obispo, San Mateo, Santa Barbara, Santa Clara, Santa 
            Cruz, Solano, Sonoma, Yolo, and Yuba; cities: Long Beach, Los 
            Angeles, Sacramento, and West Hollywood).  One other county is 
            currently considering implementation of the program, and four 
            County Boards of Supervisors have rejected authorization of a 
            DPDP.  According to DPH, in 2005, the first wave of LHJs and 
            pharmacies in California began to authorize and implement 
            local DPDPs.  By February 2010, over 650 pharmacies were 
            registered to participate in the program.  Among the LHJs not 
            planning to authorize DPDP, the top four reasons were: limited 
            time (38%), limited interest (31%), pharmacy disinterest 
            (29%), and law enforcement opposition (22%).  While the 
            proportion of LHJs that authorized a DPDP is relatively small, 
            those that have implemented one are home to 70% of 
            Californians currently living with HIV/AIDS.

            According to an evaluation of DPDP published in July 2010 by 
            DPH, SB 1159 appears to be having the desired effect of 
            augmenting access to sterile syringes to prevent transmission 
            of HIV and other blood-borne viral infections among IDUs 
            without many of the negative consequences that some had 
            feared.  DPH's evaluation suggests that counties authorizing 
            over-the-counter (OTC) sale of syringes without a prescription 
            possess lower syringe sharing levels among IDUs than counties 
            that have not authorized OTC sale.  Additionally, since 
            implementation of SB 1159, fewer clients presenting for 
            testing for HIV at state-funded testing sites report injecting 
            illegal drugs, suggesting that authorization of OTC syringe 
            sales did not have the negative impact of increased injection 








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            drug activity, a concern expressed by some prior to 
            authorization.  DPH's evaluation found that, following 
            implementation of SB 1159, accidental needle-stick injury to 
            law enforcement officers remained rare in California. Between 
            2005 and 2009, post-authorization of DPDPs, 19 accidental 
            needle-stick injuries were reported among law enforcement in 
            LHJs that had authorized DPDPs and 15 accidental needle-stick 
            injuries were reported among law enforcement in LHJs that had 
            not authorized DPDPs. The variation in recent years is not 
            great enough to suggest a statistically significant 
            relationship to the authorization of DPDP.  DPH's evaluation 
            found no increase in unsafe discard of syringes since 
            implementation of SB 1159.  Finally, comparing time periods 
            prior to and following SB 1159 authorization, DPH found no 
            evidence of an increase in drug use or crime in the state of 
            California as a whole or in areas that authorized sale of 
            syringes without a prescription.  The overall findings are 
            consistent with those of other states that have transitioned, 
            as California has, from a complete prohibition on sale and 
            possession of syringes, to allowing a limited number to be 
            sold to adults.

           4)RELATED LEGISLATION  .  AB 604 (Skinner) permits DPH to 
            authorize specified entities to provide hypodermic needle and 
            syringe exchange services consistent with state and federal 
            standards, including those of the United States Public Health 
            Service, in any location where DPH determines that the 
            conditions exist for the rapid spread of HIV, viral hepatitis, 
            or any other potentially deadly or disabling infections that 
            are spread through the sharing of used hypodermic needles and 
            syringes.  AB 604 is set to be heard in the Senate Health 
            Committee on June 22, 2011.

           5)PREVIOUS LEGISLATION .  AB 1701 (Chesbro), Chapter 667, Statues 
            of 2010, establishes, indefinitely, the DPDP, permitting 
            cities or counties to authorize licensed pharmacists to sell 
            or furnish 10 or fewer hypodermic needles or syringes to a 
            person for use without a prescription, as specified.  

            AB 1858 (Blumenfield) of 2010 was substantially similar to AB 
            604 and was vetoed by Governor Schwarzenegger, who stated, "I 
            signed legislation in 2005 that reflected a careful balance 
            between good public health policy and local decision-making 
            authority.  I remain comfortable with that original decision 
            and do not believe it is appropriate to change this balance 








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            and instead give authority to the state Department of Public 
            Health to overrule local decisions regarding syringe exchange 
            programs."

            SB 1029 (Yee) of 2010 contained similar provisions to those 
            contained in this bill, and was vetoed by Governor 
            Schwarzenegger who stated, "When I signed legislation my first 
            year in office allowing for a pilot program to allow the sale 
            of syringes through participating counties and registered 
            pharmacies, I was seeking to balance the competing public 
            health, law enforcement and local control issues that this 
            issue requires.  I believe this balance was achieved and SB 
            1029 would remove the ability of local officials to best 
            determine policies in their jurisdiction."  

            AB 110 (Laird), Chapter 707, Statutes of 2007, permits a 
            public entity that receives General Fund money from the 
            Department of Health Services (now DPH) for HIV prevention and 
            education to use that money to support needle exchange 
            programs.  AB 1597 (Laird) of 2005 contained substantially 
            similar provisions to AB 110, but was vetoed by Governor 
            Schwarzenegger.

            AB 547 (Berg), Chapter 692, Statutes of 2005, creates the 
            Clean Needle and Syringe Exchange Program to permit needle 
            exchange programs without a local declaration of emergency.  
            AB 946 (Berg) of 2003 and AB 2871 (Berg) of 2004 would also 
            have repealed the requirement that a city or county authorize 
            its needle exchange program through a declaration of a local 
            emergency.  Both bills were vetoed by Governor Davis and 
            Governor Schwarzenegger, respectively.

            SB 774 (Vasconcellos) of 2003 and SB 1785 (Vasconcellos) of 
            2002 would have permitted the furnishing of syringes without a 
            prescription.  Both measures were vetoed by Governor Davis.

            AB 136 (Mazzoni), Chapter 762, Statutes of 1999, exempts 
            public entities and their agents and employees who distribute 
            hypodermic needles or syringes to participants in clean needle 
            and syringe exchange projects authorized by the public entity 
            pursuant to a declaration of a local emergency from criminal 
            prosecution. 
           6)SUPPORT  .  The California Hepatitis Alliance (CHA) states that 
            syringe sharing among injection drug users who are not allowed 
            to buy syringes without a prescription, is the number one 








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            cause of hepatitis C in the state, and the second most common 
            cause of new HIV and hepatitis B infections.  CHA contends 
            that allowing adults to spend their own money to access 
            equipment that prevents the spread of infectious diseases will 
            save California taxpayers hundreds of millions of dollars in 
            healthcare costs.  The California Medical Association supports 
            making syringes and needles available without a prescription 
            at licensed pharmacies in order to prevent the transmission 
            HIV and hepatitis among IDUs.  Equality California writes that 
            allowing for an increase in the number of needles an 
            individual can obtain, as well as decriminalizing the 
            possession of needles and syringes will together help in the 
            fight against the spread of HIV and AIDS.  The Health Officers 
            Association of California states that this bill will protect 
            public health without sacrificing public safety.  The 
            California Retailers Association and the National Association 
            of Chain Drug Stores writes that over 200 studies have found 
            that improved syringe access reduces the rate of HIV 
            transmission without increasing rates of drug use, drug 
            injection or crime and that preventing disease before it 
            spreads is sound fiscal policy, particularly in light of 
            California's current recession and budget cuts.  The County 
            Alcohol and Drug Program Administrators Association of 
            California states that expanding access to sterile syringes 
            statewide will reduce costs to taxpayers for health care costs 
            of those infected with blood-borne diseases. 

           7)OPPOSITION  .  The opposition states that the removal of the 
            local option forces needle furnishing programs on every 
            community in California, irrespective of the wishes of that 
            community's elected officials.  They further state that the 
            quality of life implications of this bill are significant, 
            since local communities and their wishes are removed from the 
            equation and pharmacies would be permitted to distribute 
            needles irrespective of community sentiment.  The opposition 
            contends that there have been too many instances of needle 
            users dumping their used needles in the shelves of stores, in 
            parking lots adjacent to stores, and even one instance where a 
            needle user, caught shoplifting, threatened to stick the store 
            manager with a needle.  The opposition asserts that this type 
            of behavior is of interest to local communities, and the 
            removal of any local determination before needle furnishing 
            pharmacies maybe authorized flies in the face of those 
            concerns.
           








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          REGISTERED SUPPORT / OPPOSITION  :

           Support 
           
          Drug Policy Alliance (sponsor)
          AIDS Project Los Angeles
          Alameda County Board of Supervisors
          Alliance for a Better District 6
          American Civil Liberties Union
          American Federation of State, County and Municipal Employees, 
          AFL-CIO
          California Academy of Family Physicians
          California Association of Alcohol and Drug Program Executives, 
          Inc.
          California Communities United Institute
          California Family Health Council
          California Hepatitis Alliance
          California Medical Association
          California Nurses Association
          California Opioid Maintenance Providers
          California Pharmacists Association
          California Psychiatric Association
          California Public Defenders Association
          California Retailers Association
          Central City Democrats
          City and County of San Francisco
          County Alcohol and Drug Program Administrators Association of 
          California
          Equality California
          Friends Committee on Legislation of California
          Health Officers Association of California
          Los Angeles Gay and Lesbian Center
          Milk Club
          National Association of Chain Drug Stores
          Planned Parenthood Advocacy Project of Los Angeles County
          Planned Parenthood Affiliates of California
          Planned Parenthood Mar Monte
          Rite Aid
          Ross Mirkarimi, San Francisco District 5 Supervisor
          San Francisco Mayor's Hepatitis C Task Force
          Santa Clara County Board of Supervisors
           
            Opposition 
           
          California Chief Probation Officers of California








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          California District Attorneys' Association
          California Narcotic Officers Association
          California Peace Officers' Association
          California Police Chiefs' Association
          California State Sheriffs' Association
          International Faith Based Coalition
          Peace Officers Research Association of California

           Analysis Prepared by  :    Melanie Moreno / HEALTH / (916) 
          319-2097