BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                  SB 1329
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          SENATE THIRD READING
          SB 1329 (Simitian)
          As Amended June 26, 2012
          Majority vote

           SENATE VOTE  :38-0  
           
           HEALTH              18-0                                        
           
           -------------------------------- 
          |Ayes:|Monning, Logue, Ammiano,  |
          |     |Atkins, Bonilla, Eng,     |
          |     |Garrick, Gordon, Hayashi, |
          |     |Roger Hernández,          |
          |     |Bonnie Lowenthal,         |
          |     |Mansoor, Mitchell,        |
          |     |Nestande, V. Manuel       |
          |     |Pérez, Silva, Smyth,      |
          |     |Williams                  |
          |     |                          |
           -------------------------------- 
           SUMMARY  :  Revises existing law authorizing a voluntary, 
          county-option drug repository and distribution program (program) 
          to distribute surplus unused medications to medically indigent 
          persons to expand the categories of facilities that can dispense 
          and donate medications in the program; include these additional 
          entities in the immunities from civil and criminal liability 
          granted to entities participating in the program; and, modify 
          the method by which a county may establish the program.  
          Specifically,  this bill  :  

          1)Includes a licensed pharmacy that is owned and operated by a 
            licensed primary care clinic, and a licensed primary care 
            clinic that is licensed to administer and dispense drugs, in 
            the definition of eligible entities that are authorized to 
            dispense medication in the program.  Prohibits these 
            additional entities from being on probation with the Board of 
            Pharmacy (Board).

          2)Adds the following categories of facilities to the types of 
            entities authorized to donate medication under the program:

             a)   A general acute care hospital;









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             b)   An acute psychiatric hospital;

             c)   An intermediate care facility (ICF);

             d)   ICF/developmentally disabled facilities, as specified;

             e)   A correctional treatment center;

             f)   A psychiatric health facility;

             g)   A chemical dependency recovery hospital;

             h)   Residential care facilities for the elderly, as 
               specified; and,

             i)   A mental health rehabilitation center.

          3)Deletes existing law authorizing a county to establish the 
            program by local ordinance and, instead, allows a county to 
            establish the program through an action by the county board of 
            supervisors or through an action of the county public health 
            officer, as directed by the county board of supervisors.  
            Requires the county to notify the Board within 30 days after 
            establishing the program.

          4)Requires an entity that seeks to participate in the program to 
            inform the county health department and the Board in writing 
            of its intent and prohibits an entity from participating in 
            the program until it has received written or electronic 
            documentation from the county health department confirming 
            that its notice of intent has been received.

          5)Requires an entity participating in the program to disclose to 
            the county health department the name and location of the 
            source of all donated medication it receives, and requires a 
            participating primary care clinic to disclose to the county 
            health department the physician accountable to the Board for 
            the clinic's program operations.  Requires the physician to be 
            the clinic's professional director.

          6)Directs the county board of supervisors or county public 
            health officer to make available to the Board, upon request, 
            the information in 5) above.  









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          7)Allows the county board of supervisors, the county public 
            health officer, or the Board to prohibit an entity from 
            participating in the program if the entity does not comply 
            with the requirements of the program.  Requires the prohibited 
            entity to be notified in writing, as specified.

          8)Permits medication donated to the program to be transferred to 
            another entity participating in the program for dispensing to 
            eligible patients. 

          9)Exempts the additional facilities authorized by this bill to 
            dispense and donate medication from existing civil and 
            criminal liability when donating, accepting or dispensing 
            drugs in the program, except in cases of noncompliance with 
            existing law governing the program, bad faith, or gross 
            negligence.
           
          FISCAL EFFECT  :  None

           COMMENTS  :  According to the author, this bill is intended to 
          enhance efforts to implement prior legislation, SB 798 
          (Simitian), Chapter 444, Statutes of 2005, which allows counties 
          to set up drug collection and redistribution programs.  The 
          author notes that, under SB 798, only skilled nursing facilities 
          (SNFs), drug wholesalers, and drug manufacturers are allowed to 
          donate unused medications and only county-owned or 
          county-contracted pharmacies are authorized to receive and 
          dispense the donated drugs.  The author contends that this bill 
          is needed to allow health and care facilities, other than SNFs, 
          that also accumulate unused and unexpired drugs that would 
          otherwise be destroyed, to participate as drug donors in the 
          program.  Additionally, the author states that this bill will 
          enable clinics, which often serve the medically indigent, to 
          receive and dispense the donated drugs and will remove a 
          bureaucratic hurdle for many counties by eliminating the 
          requirement for a program to be initiated by a county ordinance 
          and instead allow it to be established through an action by the 
          county board of supervisors or the county public health officer. 
            

          The Board has taken a support if amended position on this bill 
          and requests clarifying amendments to ensure that this bill does 
          not inadvertently create drug diversion opportunities.  
          According to the Board, previously dispensed drugs donated to 








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          county programs are not subject to the normal controls built 
          into the distribution requirements for prescription medication 
          so preventing opportunities where these drugs, some of which are 
          very costly to purchase, could be illegally resold back into the 
          supply chain is a Board goal.  
              
          Supporters, representing counties, potential donor entities, 
          patient advocates, and environmental groups, state that this 
          bill will increase the accessibility of prescription drugs to a 
          greater number of low-income, uninsured Californians while 
          reducing the environmental impact of pharmaceutical waste.  
          Supporters agree that implementing more prescription recycling 
          programs for unused medications throughout the state is 
          especially important at a time when prescription drug costs 
          continue to rise as budgets for the health care safety net are 
          shrinking.  


           Analysis Prepared by  :    Cassie Royce / HEALTH / (916) 319-2097 

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