BILL ANALYSIS                                                                                                                                                                                                    Ó







         ----------------------------------------------------------------------- 
        |Hearing Date:July 6, 2011          |Bill No:AB                         |
        |                                   |389                                |
         ----------------------------------------------------------------------- 


                      SENATE COMMITTEE ON BUSINESS, PROFESSIONS 
                               AND ECONOMIC DEVELOPMENT
                          Senator Curren D. Price, Jr., Chair
                                           

                         Bill No:        AB 389Author:Mitchell
                     As Amended:March 30, 2011          Fiscal:Yes

        
        SUBJECT:    Bleeding disorders.
        
        SUMMARY:  Establishes standards for the proper storage and delivery of 
        blood clotting factor, a prescribed biologic, and other related 
        equipment and supplies for home usage by people with hemophilia or 
        other bleeding disorders.

         NOTE  :  This bill was heard in the Senate Committee on Health on June 
        22, 2011 and passed 8-0.  


        Existing law:
        
        1) Provides for the practice of pharmacy and the licensing and 
           regulation of pharmacies, and pharmacists by the Board of Pharmacy 
           (Board) within the Department of Consumer Affairs (DCA).

        2) Specifies certain requirements regarding the proper storage, 
           handling, dispensing, and disposal of drugs, staff training 
           protocols, drug and supply inventory, labeling, and maintenance of 
           patient confidentiality.

        3) Authorizes pharmacists to administer drugs and biologics pursuant 
           to a prescriber's order.

        4) Prohibits pharmacies from leaving, picking up from, accepting, or 
           delivering prescriptions to any place not licensed as a retail 
           pharmacy, with certain exceptions, including a patient's residence 
           or workplace, or a licensed health facility, as specified.






                                                                         AB 389
                                                                         Page 2



        5) Creates the Holden-Moscone-Garamendi Genetically Handicapped 
           Person's Program, which requires the Director of Health Services to 
           establish and administer a program for the medical care of persons 
           with genetically handicapping conditions, including hemophilia.

        This bill:

        1)Creates the Standards of Service for Providers of Blood Clotting 
          Products for Home Use Act (Act).

        2) Establishes findings and declarations about bleeding disorders and 
           treatment for bleeding disorders.

        3) Specifies that the purposes of the Act is to establish standards of 
           service for providers of blood clotting supplies and promoting 
           access to a full range of essential blood clotting products and 
           equipment for use at home by people with hemophilia and other 
           bleeding disorders.

        4) Applies definitions for the purpose of this Act, specifically:

           a)   "Assay" as the amount of a particular constituent of a mixture 
             or of the biological or pharmacological potency of a drug.

           b)   "Ancillary infusion equipment and supplies" as the equipment 
             and supplies required to infuse a blood clotting product into a 
             human vein, including, but not limited to, syringes, needles, 
             sterile gauze, field pads, gloves, alcohol swabs, numbing creams, 
             tourniquets, medical tape, sharps or equivalent biohazard waste 
             containers, and cold compression packs.

           c)   "Bleeding disorder" as a medical condition characterized by a 
             deficiency or absence of one or more essential blood clotting 
             proteins in the human blood, often called "factors," including 
             all forms of hemophilia and other bleeding disorders that result 
             in uncontrollable bleeding or abnormal blood clotting without 
             treatment.

           d)   "Blood clotting product" as an intravenously administered 
             medicine manufactured from human plasma or recombinant 
             biotechnology techniques, approved for distribution by the 
             federal Food and Drug Administration (FDA), that is used for the 
             treatment and prevention of symptoms associated with bleeding 
             disorders.

           e)   "Emergency" as a situation in which a prudent layperson could 





                                                                         AB 389
                                                                         Page 3



             reasonably believe that the consumer's condition requires 
             immediate medical attention.

           f)   "Hemophilia" as a human bleeding disorder caused by a 
             hereditary deficiency of the Factors I, II, V, VIII, IX, XI, XII, 
             or XIII blood clotting protein in human blood.

           g)   "Hemophilia treatment center" as a facility for the treatment 
             of bleeding disorders, including, but not limited to, hemophilia, 
             that receives funding from federal government sources.

           h)   "Home nursing services" as specialized nursing care provided 
             in the home setting to assist a patient in the reconstitution and 
             administration of blood clotting products.

           i)   "Home use" as infusion or other use of a blood clotting 
             product in a place other than a state-recognized hemophilia 
             treatment center, including a home or physician's office.

           j)   "Patient" as a person needing a blood clotting product for 
             home use.

           aa)  "Provider of blood clotting products for home use" as 
             including but not limited to any hospital pharmacies, health 
             system pharmacies, pharmacies affiliated with hemophilia 
             treatment centers, specialty home care pharmacies, and retail 
             pharmacies that provide blood clotting products for home use.  
             Allows these providers to offer home nursing services for persons 
             with bleeding disorders.  Specifies that a health care service 
             plan and all its affiliated providers are included as providers.  


        5)Provides that each provider of blood clotting products for home use 
          shall meet all of the following requirements:

           a)   Have sufficient knowledge and understanding of bleeding 
             disorders and the medical and  psychological management thereof, 
             including, but not limited to, home therapy.

           b)   Have access to a provider with sufficient clinical experience 
             serving people with bleeding disorders so he or she knows when 
             patients have an appropriate supply of clotting factor on hand 
             and knows about proper refrigeration of clotting factors.

           c)   Maintain 24-hour on-call service seven days a week for every 
             day of the year, adequately screen telephone calls for 





                                                                         AB 389
                                                                         Page 4



             emergencies, acknowledge all telephone calls within one hour or 
             less and have access to knowledgeable pharmacy staff on call 24 
             hours a day in the event of need to provide emergency clotting 
             factors.

           d)   Have the ability to obtain all brands of blood clotting 
             products approved by the FDA in multiple assay and vial sizes, 
             including products manufactured from human plasma and those 
             manufactured with recombinant biotechnology techniques, provided 
             manufacturer supply exists and payer authorization is approved.

           e)   Supply all necessary ancillary infusion equipment and supplies 
             with each prescription, as needed.

           f)   Store and ship, or otherwise deliver, all blood clotting 
             products in conformity with all state and federally mandated 
             standards, including, but not limited to, the standards set forth 
             in the product's approved package insert.

           g)   When home nursing services are prescribed by the treating 
             physician, to offer these services either directly or through a 
             qualified third party with experience in infusing bleeding 
             disorders and coordinate pharmacy services with the third party 
             when one is used to provide home nursing services.

           h)   Upon receiving approved authorization for a non-emergency 
             prescription, provided manufacturer supply exists, to ship the 
             prescribed blood clotting products and ancillary infusion 
             equipment and supplies to the patient within two business days or 
             less for established and new patients.

           i)   Upon receiving approved authorization to dispense a 
             prescription for an emergency situation, provided manufacturer 
             supply exists, to deliver prescribed blood products, ancillary 
             infusion equipment and supplies, medications, and home nursing 
             services to the patient within 12 hours for patients living 
             within 100 miles of a major metropolitan airport, and within one 
             day for patients living more than 100 miles from a major 
             metropolitan airport.


           j)   Provide patients who have ordered their products a designated 
             contact phone number for reporting problems with a delivery and 
             respond to these calls within a reasonable time period.

           aa)  Provide patients notification of Class 1 and Class 2 recalls 





                                                                         AB 389
                                                                         Page 5



             and withdrawals of blood clotting products and ancillary infusion 
             equipment within 24 hours of the provider receiving notification 
             and requires providers to participate in the National Patient 
             Notification System for blood clotting product recalls.

           bb)  Provide language translation services, over the phone or in 
             person, as needed by the consumer.

           cc)  Have a detailed plan for meeting their requirements in the 
             event of a natural or manmade disaster or other disruption of 
             normal business operations.

           dd)  Provide appropriate and necessary recordkeeping and 
             documentation as required by state and federal law and retain 
             copies of the patient's prescriptions.

           ee)  Comply with the privacy and confidentiality requirements of 
             the Health Insurance Portability and Accountability Act of 1996 
             (HIPAA).

        6)Requires the Board to enforce and administer the provisions of the 
          Act.

        7)Clarifies that the Act does not apply to hospital pharmacies or 
          health system pharmacies that dispense blood clotting products for 
          emergency, urgent care, or inpatient encounters, or if an inpatient 
          is discharged with a supply of blood clotting products for home use.

        FISCAL EFFECT:  According to the Assembly Committee on Appropriations 
        analysis dated April 13, 2011, this bill will result in minor 
        absorbable workload to the California Board of Pharmacy to provide 
        oversight related to requirements the bill establishes.

        COMMENTS:
        
        1. Purpose.  This bill is sponsored by the  Hemophilia Council of 
           California  (Sponsor).  According to the Author and Sponsor, there 
           are currently no standards of service in state law governing the 
           proper storage and delivery of blood clotting products and this 
           bill will protect the health of people with coagulation disorders 
           who use these products at home.  

        2. Background.  According to information provided by the Sponsors, 
           hemophilia is a rare, hereditary bleeding disorder affecting close 
           to 17,000 people in the United States, about 4,000 of which live in 
           California.  Von Willebrand disease, another bleeding disorder, 





                                                                         AB 389
                                                                         Page 6



           affects about 360,000 Californians.  People born with hemophilia 
           have little or no clotting factor, the protein needed for normal 
           blood clotting.  Until the 1970s, people with severe hemophilia 
           suffered from uncontrollable internal bleeding, orthopedic 
           deformities and a shortened lifespan.  Recent inventions and 
           production of highly purified blood clotting factors have helped 
           give additional quality of life to those living with bleeding 
           diseases.  Factor products on the market today are usually free 
           from previous risks like HIV and hepatitis as a result of 
           contaminated material.

           Bleeding diseases are not curable but are treatable, often through 
           intraveneous (IV) injection or infusion of prescription blood 
           clotting products several times per week.  A variety of blood 
           clotting products, produced by various pharmaceutical manufactures, 
           can be prescribed so as to temporarily replace the missing clotting 
           factors in order to prevent or correct bleeding episodes.  To 
           properly administer blood clotting factors, patients must often use 
           ancillary supplies and equipment, such as syringes, tourniquets, 
           gauze, and alcohol swabs.  Blood clotting products are generally 
           expensive and require special handling, including storage at 
           certain temperatures, and sensitivity to extreme exposure to light. 
            The Centers for Disease Control (CDC) recommends timely access to 
           hemophilia treatment and the products and services related to that 
           treatment.

           Treatment is available to people with hemophilia and others 
           suffering bleeding disorders at federally funded Hemophilia 
           Treatment Centers (HTCs) or by prescription at pharmacies licensed 
           in the state.  The CDC reports that patients treated at HTCs 
           significantly reduce their morbidity and mortality.  There are over 
           140 HTCs in the nation which provide both diagnostic and treatment 
           services to people with hemophilia and other bleeding disorders, 
           combining the efforts of physicians, nurses, social workers, 
           physical therapists, orthopedists and dentists to comprehensively 
           serve patients.

           In California, many blood clotting product providers are specialty 
           care pharmacies.  While these pharmacies may specialize in the 
           provision of treatments and supplies to individuals with specific 
           chronic diseases, they are not licensed according to different 
           standards than other pharmacies.  Specialty pharmacies often ship 
           or deliver blood clotting products to the homes of individuals with 
           hemophilia, and other bleeding disorders, and when necessary, 
           provide or arrange for nursing services to patients who may need 
           assistance with infusion of the blood clotting products.





                                                                         AB 389
                                                                         Page 7




           Various other states including California have attempted to 
           establish standards for blood clotting products, including 
           Massachusetts, Missouri, Pennsylvania and New Jersey.  New Jersey 
           enacted that state's "Standards of Care in Hemophilia Homecare Law" 
           that was enacted in 2000.  The primary issue was a requirement by 
           insurers that people with hemophilia worked with certain home care 
           companies with which they had contracts.  The  Hemophilia 
           Association of New Jersey  found that often times, not all home care 
           companies were familiar with hemophilia care, needs, and 
           complications.  New Jersey now requires all insurance carriers that 
           provide coverage for the home treatment of hemophilia to contract 
           with home care providers that comply with certain minimum standards 
           of care developed by their Department of Health & Senior Services, 
           in consultation with the Hemophilia Association.

           Sponsors cite, as a need for a state standard, a recent situation 
           in which a Northern California pharmacy delivered clotting factor 
           product to a patient and left it on their doorstep where the 
           product subsequently spoiled in the heat.  The Author and Sponsor 
           also note that pharmacies and other entities specializing in the 
           delivery of blood clotting products for home use form a growing 
           segment in California and standards will "benefit people with 
           hemophilia and other bleeding disorders, as well as maintain the 
           current cost effective model for care for future generations."  The 
           Sponsor also states that California needs to have equal standards 
           for all companies distributing clotting factor in order to protect 
           people with bleeding disorders from companies that may not properly 
           store or distribute clotting factor.

        3. Prior Similar Legislation.   SB 971  (Pavley) of 2010, and  SB 1594  
           (Steinberg) of 2008, were also almost identical to this bill.  The 
           bills stemmed from conversations between the Hemophilia Council of 
           California and pharmacies that distribute blood clotting products 
           for home use.  SB 971 was vetoed by the Governor and SB 1594 was 
           held in the Senate Committee on Appropriations.

        4. Arguments in Support.  Supporters like the  California Medical 
           Association  and the  California Society of Health-System Pharmacists  
           believe that this bill will establish important standards for the 
           storage and delivery of highly sensitive medication while also 
           promoting access to cost effective, life-saving, products and 
           related equipment.   Baxter Healthcare  , a global medical products 
           and services company in support of universal standards for clotting 
           products, indicates that due to the sensitivity of the blood 
           clotting medication and related products, "suboptimal treatment may 





                                                                         AB 389
                                                                         Page 8



           even lead to uncontrolled internal bleeding, crippling joint 
           malfunction, and chronic pain."   Taleeris Biotherapeutics  , a 
           producer of biological therapies from blood plasma, also support 
           this bill, stating that they heartily agree with the bill's 
           objective of standardizing the pharmacy requirement of serving both 
           publicly-supported and private pay individuals needing clotting 
           products.   
        
        SUPPORT AND OPPOSITION:
        
         Support:  

        Hemophilia Council of California (Sponsor)
        Baxter Healthcare
        California Medical Association
        California Pharmacists Association
        California Society of Health-System Pharmacists
        Community Healthcare Services
        CSL Behring
        Federal Hemophilia Treatment Centers, Region IX
        Grifols
        Hemophilia Foundation of Northern California
        Meyer Family Cellars
        National Cornerstone Healthcare Services Inc.
        Pfizer
        Plasma Protein Therapeutics Association
        Taleeris Biotherapeutics
        University of California, Davis Medical Center
        Walgreens
        Numerous individual pharmacies and individuals 

         Opposition:  None received as of June 28, 2011.



        Consultant:Sarah Mason