BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                      



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          |SENATE RULES COMMITTEE            |                  SB 1329|
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                                 THIRD READING


          Bill No:  SB 1329
          Author:   Simitian (D), et al.
          Amended:  5/14/12
          Vote:     21

           
           SENATE HEALTH COMMITTEE  : 9-0, 4/11/12
          AYES: Hernandez, Harman, Alquist, Anderson, Blakeslee, De 
            León, DeSaulnier, Rubio, Wolk

           SENATE BUSINESS, PROF. & ECON. DEV. COMMITTEE  :  8-0, 5/7/12
          AYES:  Price, Emmerson, Corbett, Correa, Hernandez, Negrete 
            McLeod, Vargas, Wyland
          NO VOTE RECORDED:  Strickland


           SUBJECT  :    Prescription drugs:  collection and 
          distribution program

           SOURCE  :     Supporting Initiatives to Redistribute Unused 
          Medication


           DIGEST  :    This bill expands the types of entities that can 
          donate and dispense medication in the prescription drug 
          depository and distribution program that provides donated 
          medication to medically indigent patients, includes these 
          additional entities within the immunity from criminal and 
          civil liability contained in existing law, and allows 
          counties to establish a program through an action by the 
          county board or through an action of the public health 
          officer of the county, instead of only through county 
          ordinance under existing law.
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           ANALYSIS :    

          Existing law:

          1. Authorizes counties, by ordinance, to establish a 
             prescription drug repository and distribution program 
             (program), subject to specified requirements, for 
             medically indigent patients to receive donated 
             prescription drugs free of charge.

          2. Allows the following entities to donate medication to a 
             program: a skilled nursing facility (SNF), a SNF 
             designated as an institution for mental disease (IMD), a 
             drug wholesaler or a drug manufacturer.  

          3. Limits the types of pharmacies that can dispense 
             medication through the program to county-owned 
             pharmacies and pharmacies that contract with the county. 


          4. Requires a county that elects to establish a program to 
             establish procedures for program eligibility for 
             medically indigent patients, and to ensure proper safety 
             and management of medications, among other requirements.

          5. Exempts prescription drug manufacturers, wholesalers, 
             participating pharmacies, SNFs, pharmacists and health 
             care professionals who accept or dispense prescription 
             drugs from criminal or civil liability for injury caused 
             when donating, accepting, or dispensing prescription 
             drugs in compliance the program provisions, except for 
             noncompliance with the program statute, bad faith or 
             gross negligence.  Prohibits the program statute from 
             affecting disciplinary actions taken by licensing and 
             regulatory agencies.

          This bill:

          1. Expands the types of entities that are authorized to 
             dispense medication in the program to include two 
             additional entities:  a licensed pharmacy that is owned 
             and operated by a licensed primary care clinic, and a 
             licensed primary care clinic that is licensed to 

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             administer and dispense drugs.

          2. Expands the types of facilities authorized to donate 
             medication to include the following:

             A.    A general acute care hospital.
             B.    An acute psychiatric hospital.
             C.    An intermediate care facility (ICF).
             D.    An ICF/developmentally disabled (DD) -habilitative 
                facility.
             E.    A licensed ICF /DD-nursing facility.
             F.    A correctional treatment center.
             G.    A psychiatric health facility.
             H.    A chemical dependency recovery hospital.
             I.    A residential care facility for the elderly 
                (RCFE).
             J.    A RCFE for persons with chronic, life-threatening 
                illness.
             K.    A mental health rehabilitation center.

          3. Allows a county public health officer to establish a 
             repository and distribution program, as directed by the 
             county board of supervisors.

          4. Requires the additional facilities authorized by this 
             bill to dispense and donate medication to receive the 
             exemption from civil and criminal liability established 
             under existing law when donating, accepting or 
             dispensing drugs in the program, except for 
             noncompliance with the program statute, bad faith or 
             gross negligence.

          5. Allows medication donated to the program to be 
             transferred to another entity participating in the 
             program for dispensing to eligible patients.

          6. Requires an entity that seeks to participate in the 
             program to inform the county health department in 
             writing of its intent to participate.  Prohibits an 
             entity from participating in the program until it has 
             received written or electronic documentation from the 
             county health department confirming that it has received 
             its notice of intent.


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          7. 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 of Pharmacy (Board) 
             for the clinic's program operations.

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

          9. Permits the county board of supervisors, the county 
             public health officer, and the Board to prohibit an 
             eligible or participating entity from participating in 
             the program if the entity does not comply with the 
             provisions of the program.

           Background
           
          According to the 2009 California Health Interview Survey 
          conducted by the University of California Los Angeles, 5.4 
          million Californians, or 14.5 percent of the state's 
          population, were uninsured.  Of the insured in California, 
          seven percent or 2.2 million people did not have coverage 
          for prescription drugs.  

          SB 798 (Simitian), Chapter 444, Statutes of 2005, 
          authorizes the establishment of a program.  Under the 
          program, counties can adopt an ordinance to establish such 
          a program, under which SNFs, SNFs that are IMDs, drug 
          wholesalers, and drug manufacturers can donate unused 
          medications to county-owned pharmacies, or pharmacies that 
          contract with the county for dispensing to medically 
          indigent patients free of charge.  Prior to the enactment 
          of SB 798, SNFs were required to either destroy the drugs 
          in the presence of a pharmacist or nurse, or return the 
          drugs to the issuing pharmacy (if unopened and in a sealed 
          container) for disposition.  To date, two counties (Santa 
          Clara and San Mateo) have established such a program, and 
          Santa Clara indicates it has saved approximately $5,000 
          through the program as of February 2012.   According to an 
          issue brief from the National Conference of State 
          Legislatures, 38 states have enacted laws as of 2010 

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          regarding prescription recycling programs for unused 
          medications.

          Counties establishing a program have to meet certain 
          requirements, including establishing eligibility for 
          medically indigent patients, developing a formulary of 
          medications appropriate for the program, ensuring the 
          privacy of patients donating medication to the program, and 
          ensuring proper safety and medication management.  
          Controlled substances (controlled substances are 
          prescription drugs with the potential for abuse) and 
          medication in the possession of a patient are not eligible 
          for donation.  Only medication that is donated in unopened, 
          tamper-evident packaging or modified unit dose containers 
          that meet specified standards is eligible for donation.  
          Donated medication cannot have been in the possession of a 
          patient or any individual member of the public, and 
          medication donated by a SNF must have been under the 
          control of the staff of the SNF.  

          Medication that is dispensed under the program is required 
          to be in a new and properly labeled container that is 
          specific to the eligible patient.  In addition, medication 
          donated to the program must be segregated from the 
          pharmacy's other drug stock by physical means, for 
          inventory, accounting, and inspection purposes.  Pharmacies 
          must also keep complete records of the acquisition and 
          disposition of medication donated to and dispensed under 
          the program.   Finally, a participating county-owned or 
          county-contracted pharmacy must follow the same procedural 
          drug pedigree requirements for donated drugs as it would 
          follow for drugs purchased from a wholesaler or directly 
          from a drug manufacturer.

           FISCAL EFFECT  :    Appropriation:  No   Fiscal Com.:  No   
          Local:  No

           SUPPORT  :   (Verified  5/10/12)

          Supporting Initiatives to Redistribute Unused Medication 
          (source)
          Aegis of Corte Madera
          Alameda County Health Care Services Agency
          American Cancer Society

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          Bethesda Home
          California Assisted Living Association
          California Association of Health Facilities
          California Medical Association
          California State Association of Counties
          Californians Against Waste
          Canyon Manor
          Children's Recovery Center of Northern California
          Community Care on Palm
          County Health Executives Association of California
          Crestwood Behavioral Health, Inc.
          Golden Age Convalescent Hospital
          Golden Empire Nursing and Rehab Center
          La Casa Mental Health Rehabilitation Center
          La Casa Psychiatric Health Facility
          Lincoln Glen Nursing Facility
          Marin Community Clinics
          Marlinda-Imperial Convalescent Hospital
          Masonic Homes of California
          National Federation of Independent Business
          ResCare Friendship Developmental Services
          Royal Oaks Manor - Bradbury Oaks
          San Francisco Towers
          Santa Clara County Board of Supervisors
          Sierra Club California
          Stanford University School of Medicine
          Stonebrook Healthcare Center
          Sunny View Retirement Community
          Villa Siena

           ARGUMENTS IN SUPPORT  :    This bill is sponsored by 
          Supporting Initiatives to Redistribute Unused Medicine 
          (SIRUM) to increase access to necessary, and in many cases 
          life-sustaining, prescription drugs for medically indigent 
          Californians while at the same time reducing the 
          environmental impact of pharmaceutical waste and producing 
          savings for state and local governments.  This bill builds 
          upon previous legislation to expand the types of health 
          facilities that can donate unused medicine, allowing 
          California to capture the staggering $100 million in usable 
          medicine from health facilities that ends up destroyed in 
          incinerators, or worse, dumped into our water supply.  
          Additionally, SIRUM states this bill enables non-profit 
          community clinics to receive and dispense donated medicine, 

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          greatly increasing the number of patients that can access 
          donated medicine.  Finally, only two counties currently 
          have overcome the bureaucratic hurdles of establishing 
          redistribution program, and SIRUM states this legislation 
          will streamline the process for counties by removing 
          unnecessary burdens.  With shrinking budgets for the health 
          care safety net and rising health care costs for all 
          Californians, SIRUM argues this bill allows California to 
          maximize quality patient care by reducing the financial 
          burden of medicine acquisition and promoting 
          environmentally sustainable health care practices.

          The California Association of Health Facilities (CAHF) 
          argues this bill would make it easier for counties to 
          approve programs to allow for the redistribution of unused 
          medication from health care providers to the uninsured.  
          CAHF states SNFs are estimated to destroy up to 15 percent 
          of their prescriptions each month, but that an increasing 
          number of SNFs (approximately 79 facilities) are taking 
          advantage of a unique program that allows these facilities 
          to donate surplus medications for redistribution to 
          uninsured residents.  The Sierra Club writes in support 
          that this will protect our environment, water supply and 
          people by reducing the amount of prescription drugs and 
          pharmaceutical waste that ends up in our drinking water, 
          lakes and rivers.


          CTW:do  5/16/12   Senate Floor Analyses 

                         SUPPORT/OPPOSITION:  SEE ABOVE

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