BILL ANALYSIS                                                                                                                                                                                                    






                                 SENATE HEALTH
                               COMMITTEE ANALYSIS
                        Senator Elaine K. Alquist, Chair


          BILL NO:       SB 1029                                      
          S
          AUTHOR:        Yee                                          
          B
          AMENDED:       March 17, 2010
          HEARING DATE:  April 14, 2010                               
          1
          CONSULTANT:                                                       
          0
          Orr/                                                        
          2              9                                           
                                     SUBJECT
                                         
                           Hypodermic needles and syringes


                                     SUMMARY  

          Allows individuals to obtain up to 30 syringes or needles  
          for personal use without a prescription from a pharmacy.  
          Authorizes pharmacists and physicians to distribute up to  
          30 needles to an individual without a prescription solely  
          for personal use.  Repeals the Disease Prevention  
          Demonstration Project, thereby removing a requirement for  
          local governments to first authorize participation in the  
          DPDP prior to a pharmacy's registration in the program.  


                             CHANGES TO EXISTING LAW  

          Existing law:
          Allows a pharmacist or physician to furnish hypodermic  
          needles or syringes for human use without a prescription or  
          permit if the person is known to the furnisher and the  
          furnisher has been previously provided with a prescription  
          or proof of legitimate medical need.

          Allows counties to authorize pharmacists to furnish or sell  
          10 or fewer hypodermic needles or syringes to persons 18  
          years of age or older, for the period commencing January 1,  
          2005 and ending December 31, 2010, if the pharmacy is  
                                                         Continued---



          STAFF ANALYSIS OF SENATE BILL  SB 1029 (Yee)  Page 2


          

          registered for the Disease Prevention Demonstration Project  
          (DPDP) and if the pharmacy complies with other specified  
          provisions. 

          Establishes the DPDP as a collaboration between pharmacies  
          and local and state health officials, for the purpose of  
          evaluating the long-term desirability of allowing licensed  
          pharmacists to furnish or sell nonprescription hypodermic  
          needles or syringes to prevent the spread of blood-borne  
          pathogens, including HIV and hepatitis C. 

          As part of the DPDP, requires participating pharmacies to  
          register with their local health department, and certify  
          that they will provide written or verbal information on  
          drug treatment, testing services, and safe sharps disposal  
          practices at the point of sale.

          Also as part of the DPDP, proscribes requirements for the  
          secure storage of needles and syringes in pharmacies, and  
          requires pharmacies to make safe disposal options available  
          to users. 

          Also as part of DPDP, requires the California Department of  
          Public Health (CDPH) to evaluate the effects of allowing  
          pharmacists to furnish or sell a limited number of  
          hypodermic needles or syringes without prescription, and to  
          provide a report to the Governor and the Legislature on or  
          before January 15, 2010. 

          Authorizes clean needle exchange programs in any city and  
          county, county, or city upon the action of a county board  
          of supervisors and the local health officer or health  
          commission of that county; the city council, the mayor, and  
          the local health officer of a city with a health  
          department; or, the city council and the mayor of a city  
          without a health department. 

          Requires that no person shall possess a hypodermic needle  
          or syringe except when acquired in accordance with  
          specified provisions of law.

          Stipulates that no public entity, its agents, or employees  
          will be subject to criminal prosecution for the  
          distribution of hypodermic needles or syringes to  
          participants in clean needle and syringe exchange projects  
          authorized by law.




          STAFF ANALYSIS OF SENATE BILL  SB 1029 (Yee)  Page 3


          

          
          This bill:
          Repeals the Disease Prevention Demonstration Project. 

          Repeals the prohibition on individual possession of a  
          hypodermic needle or syringe except under specified  
          circumstances, and instead allows individuals to obtain  
          from a physician or pharmacist up to 30 hypodermic needles  
          or syringes for personal use.

          As a public health measure, allows a physician or  
          pharmacist to furnish up to 30 hypodermic needles or  
          syringes to an adult without a prescription or permit for  
          personal use. 

          Removes the requirement for local government authorization  
          of pharmacists' distribution of needles or syringes.   

          Increases the cap from 10 to 30 needles or syringes that a  
          pharmacist may distribute to any one person without a  
          prescription. 

          Requires the Office of AIDS (OA), within CDPH to develop  
          and maintain information for consumers on its website  
          regarding how to access drug treatment, access testing and  
          treatment for viral Hepatitis and HIV, and regarding the  
          safe disposal of needles and syringes. Requires the State  
          Board of Pharmacy to also post this information on its  
          website. 
          Declares legislative intent to improve access to syringes  
          and hypodermic needles, in hopes of reducing the spread of  
          communicable diseases and protecting public health.


                                  FISCAL IMPACT  

          This bill has not been analyzed by a fiscal committee. 


                            BACKGROUND AND DISCUSSION  
          
          According to the author, the intent of this bill is to  
          improve access to syringes and hypodermic needles in order  
          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  




          STAFF ANALYSIS OF SENATE BILL  SB 1029 (Yee)  Page 4


          

          sterile injection equipment and education to adults,  
          thereby reducing the spread of communicable diseases and  
          protecting the public health.  According to CDPH Office of  
          AIDS (OA), scientific research continues to show that  
          access to sterile injection equipment is associated with  
          reduced risk of HIV infection and lower frequency of unsafe  
          injection practices, and is a vital component in the  
          struggle to reduce the spread of HIV, HCV, and other  
          blood-borne infections among injection drug users (IDUs),  
          their sex partners, and their children.  Numerous studies  
          concur that improved syringe access reduces the rate of HIV  
          transmission, without increasing rates of drug use, drug  
          injection, or crime. To date, no study has found otherwise.  

           
          Injection drug use and disease prevalence
          According to the CDPH/OA, injection drug use is the second  
          leading cause of HIV transmission and the leading cause of  
          hepatitis C virus (HCV) infection in California. Sharing of  
          contaminated syringes and other injection equipment is  
          linked to 19 percent of all reported AIDS cases in the  
          state. The shared use of syringes and needles was  
          recognized as being associated with HIV transmission among  
          injection drug users at the onset of the HIV/AIDS pandemic.  
          Nationwide, injection drug use accounted for 17 percent of  
          new HIV/AIDS diagnoses in adults and adolescents in 2007,  
          according to the Centers for Disease Control and Prevention  
          (CDC). California data suggests that over 1,500 new  
          syringe-sharing HIV infections occur annually.  The link  
          between injection drug use and HIV is particularly strong  
          for women and people of color. In California, 37 percent of  
          cumulative AIDS cases among women, 24.3 percent of cases  
          among African American men and women, and 22.4 percent of  
          cases among Latinas are directly attributable to syringe  
          sharing.

          In addition, there are an estimated 500,000 to 600,000  
          Californians currently infected with hepatitis C virus  
          (HCV) with an estimated 5,000 new infections annually due  
          to injection drug use. Viral hepatitis is a major cause of  
          liver cancer and the leading cause of liver transplants  
          nationwide. In the United States, there are more than 5  
          million people living with chronic hepatitis B virus (HBV)  
          or chronic HCV. In 2007 alone, HBV and HCV-related  
          hospitalization costs in California totaled $2 billion.  
          Over the next 20 years, annual medical costs for people  




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          with HCV nationwide are expected to increase more than 2.5  
          times, from $30 billion to more than $85 billion.  


          
          Clean Needle and Syringe Exchange Programs (SEPs)
          Clean needle exchange programs make sterile needles  
          available to intravenous drug users (IDUs), in order to  
          avoid acquiring and transmitting bloodborne diseases such  
          as HIV and HCV. SEPs provide a safe and accessible method  
          for IDUs to exchange used syringes for sterile ones. SEPs  
          use special puncture-proof containers to collect used  
          syringes, which are then collected and safely disposed of  
          according to special procedures designated for hazardous  
          waste. 

          Often, SEP programs also provide other public health  
          services, such as HIV testing, risk-reduction education,  
          and referrals for substance-abuse treatment. For some  
          California residents, a SEP is the only accessible provider  
          of medical or social services. According to the National  
          Institutes of Health, individuals in areas with syringe  
          exchange programs have an increased likelihood of entering  
          drug treatment programs. 

          SEPs have been shown to be effective in reducing the  
          sharing of syringes and the transmission of bloodborne  
          infections among drug users without increasing drug use.   
          SEPs can help lower the number of contaminated syringes  
          circulating in communities by decreasing syringe scarcity,  
          and in the case of an accidental needle stick, can lower  
          the likelihood of a needle being contaminated with a  
          potentially deadly disease. Since the implementation of  
          these programs in the late 1980s, new HIV infections among  
          IDUs have declined overall by 80 percent. One study  
          published in 2001 found that the mean HIV prevalence rate  
          among IDUs in metropolitan areas that banned  
          over-the-counter sales or purchases of needles and syringes  
          was twice as high as the mean HIV prevalence rate in metro  
          areas that allow over-the-counter sales (13.8 percent vs.  
          6.7 percent respectively). 

          Over the past four years, CDPH has awarded over $3.5  
          million in State General Funds to authorized syringe  
          exchange programs across the state to provide syringe  
          exchange, HIV and HCV testing, counseling and referral to  




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          needed services. Recent cuts in State General Funds for HIV  
          prevention have resulted in elimination of all state  
          funding of SEPs. HIV prevention in the state is now solely  
          funded by federal dollars, which precluded the funding of  
          SEPs.
          
          Local SEP implementation 
          According to the Center for Health Improvement, there were  
          41 authorized SEPs in California as of March 2009.   
          Currently, a public entity that receives State General Fund  
          money from CDPH for the purpose of HIV education and  
          prevention and, as part of an authorized clean needle and  
          syringe exchange program, can use those funds for the  
          purchase of sterile hypodermic needles and syringes. Cities  
          and counties are enabled to authorize a clean needle and  
          syringe exchange project as part of a comprehensive network  
          of services. Under current law, no public entity, its  
          agents, or employees will be subject to criminal  
          prosecution for the distribution of hypodermic needles or  
          syringes to participants in clean needle and syringe  
          exchange projects.

          Local government, local public health officials, and law  
          enforcement personnel and the public are supposed to be  
          given the opportunity to provide comments on the clean  
          needle and syringe exchange programs annually. The local  
          health officers are required to annually report to the  
          boards of supervisors or city councils, and to include a  
          detailed report on the status of local clean needle and  
          syringe exchange programs including, but not limited to,  
          relevant statistics on blood-borne infections associated  
          with needle-sharing activities and the use of public funds  
          for these programs. According to the Office of AIDS,  
          seventeen County Boards of Supervisors and four City  
          Councils so far have authorized SEPs, and several other  
          counties and cities are currently planning for  
          authorization.

          Pharmacy Sale of Syringes
          Until the 2004 signing of SB 1159 (Vasconcellos) that  
          started the Disease Prevention Demonstration Project,  
          California was one of only five states that still required  
          a prescription in order to purchase a syringe. In the early  
          80s insulin and allergy syringes could be bought in any  
          drugstore without a prescription. In spite of the available  
          supply, some drug users chose to reuse and share needles,  




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          and are believed to be partly responsible for the early  
          spread of the AIDS epidemic. In the 90s, some states began  
          requiring needles to be stored behind the pharmacy counter  
          and began requiring prescriptions, in hopes of cutting down  
          on illegal drug use by making syringes more scarce. Many  
          states abandoned that policy once a correlation was noted  
          between syringe scarcity and increased infectious disease  
          rates in IDUs. 

          To address and prevent the spread of blood-borne infectious  
          diseases among IDUs in California, the DPDP was established  
          to allow the sale of up to ten hypodermic needles or  
          syringes at pharmacies without a prescription. In order to  
          participate in the DPDP, pharmacies must register with  
          their local health department and provide a contact name  
          and related information. They must also certify that they  
          will provide written or verbal counseling at the time of  
          furnishing or selling needles or syringes. Additionally,  
          pharmacies must properly store needles and syringes so that  
          they are only available to authorized personnel, provide  
          on-site safe disposal of needles and syringes, or furnish  
          or sell mail-back state or federal standard personal sharps  
          disposal containers. In the absence of local authorization  
          of a DPDP, the sale and possession of syringes without a  
          prescription remains illegal in California.

          Under current law, pharmacies that participate in the DPDP  
          are required to register with their local health department  
          and certify that they will provide information to adult  
          purchasers of needles or syringes about drug treatment  
          programs, testing and treatment programs for HIV and HCV,  
          and safe disposal of sharps waste. They are also required  
          to store needles and syringes such that only authorized  
          pharmacy personnel may have access, provide on-site  
          collection and disposal options for used needles, and make  
          mail-back and personal sharps disposal containers available  
          to purchasers.  Participating local health departments are  
          required to maintain a list of all pharmacies registered  
          under the DPDP and make available to pharmacies written  
          information that can be provided at the time of furnishing  
          or selling nonprescription needles and syringes.

          CDPH evaluation of SB 1159
          CDPH was required to report to the Governor and to the  
          Legislature by January 15, 2010, on the impact of allowing  
          pharmacists to furnish or sell nonprescription hypodermic  




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          needles or syringes on rates of disease infection related  
          to syringe sharing, rates of crime in the vicinity of  
          pharmacies, rates of drug use, rates of needlestick injury  
          to law enforcement officers and waste management employees,  
          and rates of safe or unsafe discard of syringes, and  
          syringe sharing practice among IDUs. CDPH was also required  
          to convene an uncompensated evaluation panel.

          To date, CDPH/OA has conducted two surveys of local health  
          jurisdictions, examining questions ranging from syringe  
          disposal mechanisms to the level of pharmacist  
          participation in each county. The California HIV/AIDS  
          Research Program has funded a qualitative study of  
          facilitators and obstacles to SB 1159 implementation.  
          CDPH/OA has also funded a study of syringe disposal and  
          accidental needlestick injuries. CDPH/OA plans a detailed  
          analysis of HIV counseling and testing data to be included  
          in the final report. The report has not been made public,  
          and it is unclear when the report will be released. 

          However, CDPH has released separate, but related  
          recommendations in the California Adult Viral Hepatitis  
          Prevention Strategic Plan for 2010-2014 that promote  
          increased access to syringe exchange programs, and to  
          promote other strategies, such as encouraging pharmacists  
          to participate in pharmacy syringe sales programs, and  
          removing structural barriers to accessing syringes and  
          other safe drug-using equipment for IDUs. 

          Needlestick injuries 
          Access to sterile syringes can affect the occupational  
          health and safety of peace officers and waste management  
          employees because they are at risk of accidental  
          needlestick injuries. A recent study found that 29.7  
          percent of San Diego Police Officers surveyed had suffered  
          a needlestick injury on-duty, usually during a pat-down or  
          search incident to arrest. A study of police officers in  
          Rhode Island found that nearly 30 percent had been stuck by  
          a syringe at one point in their career, with over 27  
          percent experiencing two or more needle stick injuries.  
          Research has shown that accidental needlesticks to police  
          officers have decreased significantly following the  
          implementation of SEPs.  For instance, studies in  
          Connecticut and Massachusetts found that needlestick  
          injuries to officers were reduced 66 percent after syringe  
          deregulation. 




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          Related bills
          AB 1701 (Chesbro) would delete the December 31, 2010 sunset  
          date for the Disease Prevention Demonstration Project, and  
          would thereby reestablish the program indefinitely.

          AB 1858 (Blumenfield) would delete the prohibition against  
          any person possessing or having under his or her control  
          any hypodermic needle or syringe, delete the requirement of  
          authorization by a county or city for pharmacies to  
          participate in the Disease Prevention Demonstration  
          Project, and delete the December 31, 2010 sunset. This bill  
          would also raise the cap of hypodermic needles and syringes  
          for human use obtained or possessed without a prescription  
          or license to 30 or fewer. 

          This bill would permit CDPH to authorize entities to  
          provide hypodermic needle and syringe exchange services in  
          any location where the department determines that the  
          conditions exist for the rapid spread of HIV, viral  
          hepatitis, or other potentially deadly infections spread  
          through the sharing of used needles. The bill would require  
          CDPH to establish a process to allow local entities to  
          apply for authorization to provide hypodermic needle and  
          syringe exchange services, establish reporting standards  
          for these entities, and establish and maintain on its  
          website the addresses and contact information of programs  
          providing hypodermic needle and syringe exchange services. 

          
          Prior legislation
          AB 110 (Laird) Chapter 707, Statutes of 2007, permits a  
          public entity that receives General Fund (GF) money for  
          human immunodeficiency virus (HIV) prevention and education  
          from the Department of Public Health (DPH) to use that  
          money to support clean needle and syringe exchange projects  
          (NEPs), as specified. 

          SB 1305 (Figueroa) Chapter 64, Statutes of 2006, Prohibits  
          a person from knowingly placing home-generated sharps waste  
          in the commercial and residential solid waste collection  
          containers after September 1, 2008. 
          
          AB 1597 (Laird) of 2005 and AB 2076 (Laird) of 2006  
          contained provisions substantially similar to AB 110.  
          Governor Schwarzenegger vetoed AB 1597, stating   




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          "authorizing the use of state funds to purchase syringes,  
          without appropriate local controls, including mechanisms  
          for input from local law enforcement, and protections   
          against the use of state funds to supplant private or local  
          resources is not prudent."  The bill was held on the  
          Assembly Floor.
          
          AB 547 (Berg and Richman) Chapter 692, Statutes of 2005,  
          authorized clean NEPs in any city and county, county, or  
          city upon the action of a county board of supervisors and  
          the local health officer or health commission of that  
          county; the city council, the mayor, and the local health  
          officer of a city with a health department; or, the city  
          council and the mayor of a city without a health  
          department.
          
          SB 1159 (Vasconcellos) Chapter 608, Statutes of 2004  
          authorized the Disease Prevention Demonstration Project  
          (DPDP) to evaluate the long-term desirability of allowing  
          licensed pharmacies to sell or furnish nonprescription  
          hypodermic needles or syringes to prevent the spread of  
          blood-borne pathogens, authorized a licensed pharmacist,  
          until December 31, 2010 and subject to authorization by a  
          county or city, 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 in the DPDP with  
          a local health department. 

          SB 774 (Vasconcellos) 2003 was almost identical to SB 1159,  
          however the hypodermic needle and syringe limit was higher,  
          permitting a maximum of 30. Vetoed.

          SB 1785 (Vasconcellos) 2002 was nearly identical to SB 744,  
          however the bill included an additional provision that  
          would have mandated criminal penalties for discarding or  
          disposing of hypodermic needles or syringes on a  
          playground, public beach, public park, or the grounds of an  
          elementary school, vocational, junior high, or high school.  
           Vetoed

          AB 1292 (Aroner) 2001 would have authorized pharmacists in  
          a licensed pharmacy to furnish or sell at retail hypodermic  
          needles or syringes for human use without a           
          prescription.  This bill was substantively similar to SB  
          1785 and SB 744. The author chose not to move the bill  
          forward.




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          AB 136 (Mazzoni, Chapter 762, Statutes of 1999) exempts   
          from criminal prosecution 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 due to the existence of a  
          critical local public health crisis.

          Arguments in support
          The California Hepatitis Alliance claim that syringe  
          sharing among injection drug users who are not allowed to  
          buy syringes without a prescription, is the number one  
          cause of hepatitis C in the state, and the second most  
          common cause of new HIV and hepatitis B infections. They  
          contend 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 concurs with the claim that making  
          syringes and needles available without a prescription at  
          licensed pharmacies will help prevent the transmission of  
          diseases among IDUs. The California Retailers Association  
          represents many chain drug stores that chose to participate  
          in the DPDP, and agrees with the statewide expansion of  
          pharmacy syringe and needle access offered by this bill.   
          The County Alcohol and Drug Program Administrators  
          Association of California claims this bill is consistent  
          with their commitment to the reduction of individual and  
          community problems related to chronic disease of addiction.  
          
          
          Arguments in opposition
          The California Narcotics Association opposes the bill's  
          removal of the local option to approve or disapprove  
          authorization for pharmacy syringe sales. They believe this  
          bill will force needle furnishing programs on every  
          community in California, irrespective of the wishes of that  
          community's elected officials.  

          
                                     COMMENTS

           1.  Accountability measures and oversight.  The current  
          authorization for pharmacies to furnish syringes and  
          hypodermic needles contains several accountability measures  




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          that have not been carried over to this bill.  Among them  
          are a requirement that participating pharmacies register  
          with their local health department and a sunset date and  
          evaluation of the effects of the program on needle sharing,  
          rates of disease infection, drug crime, and needlestick  
          injuries.  Should the bill be amended to include these  
          provisions?

          2. Information and counseling of IDUs.  The current program  
          requires participating pharmacies to certify that they will  
          provide written or verbal information on drug treatment,  
          testing services, and safe sharps disposal practices at the  
          point of sale. This bill removes this requirement, and  
          instead requires information be provided on the OA website  
          and the Board of Pharmacy website. Should the bill maintain  
          the requirement for pharmacists provide information or  
          counseling at the point of sale?

          3.  Double referral.  This bill is double referred to  
          Business, Professions and Economic Development Committee.





                                         

                                   POSITIONS  


          Support:  Drug Policy Alliance (Co-sponsor)
                    San Francisco AIDS Foundation (Co-sponsor)
                    AIDS Project Los Angeles
                 American Civil Liberties Union
                 California Hepatitis Alliance
                 California Medical Association
                 California Opioid Maintenance Providers
                 California Psychiatric Association
                 California Retailers Association
                 California Society of Addiction Medicine
                 County Alcohol and Drug Program Administrators  
          Association of 
                    California
                 County of Alameda
                 Project Inform
                 San Francisco HIV/AIDS Provider Network




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                 San Francisco Mayor's Hepatitis C Task Force
                 Three individuals
                 
          Oppose:  California Narcotics Officers' Association

                                   -- END --