BILL ANALYSIS                                                                                                                                                                                                    



                                                                  AB 977
                                                                  Page  1

          Date of Hearing:   January 12, 2010

                   ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS
                                 Mary Hayashi, Chair
                   AB 977 (Skinner) - As Amended:  January 6, 2010
           
          SUBJECT  :   Pharmacists: immunization protocols with physicians. 

           SUMMARY  :  Creates a pilot project that will permit pharmacists  
          to administer influenza immunizations pursuant to standardized  
          protocols developed and approved by both the Board of Pharmacy  
          (BOP) and the Medical Board of California (MBC) in consultation  
          with public health officers, to any person 18 years or older.   
           Specifically  , this bill:

          1)Creates a pilot project in which pharmacists may administer  
            influenza immunizations pursuant to standardized protocols  
            developed and approved by both BOP and MBC, in consultation  
            with public health officers, to any person 18 years or older.   


          2)Requires that the protocols be consistent with protocols  
            developed by the Advisory Committee on Immunizations Practices  
            of the federal Centers for Disease Control and Prevention  
            (CDC).  

          3)Requires a pharmacist initiating and administering any  
            immunization pursuant to the pilot to:

             a)   Complete the American Pharmacists Association's  
               Pharmacy-Based Immunization Delivery Certificate Training  
               Program or another pharmacy-based immunization training  
               certificate program endorsed by the CDC or the  
               Accreditation Council for Pharmaceutical Education;   

             b)   Complete three hours of immunization-related continuing  
               education coursework annually, which may be applied to the  
               existing continuing education requirement; and,

             c)   Be certified in basic life support.

          4)States that if a pharmacist fails to satisfy the three hours  
            of immunization-related continuing education coursework  
            annually, the pharmacist must, in addition to any other  
            applicable disciplinary action, retake the immunization  








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            training certificate program in addition to the three hours of  
            immunization-related continuing education coursework prior to  
            initiating any further immunizations. 

          5)Requires a pharmacist, at the time of immunization  
            administration, to:

             a)   Provide the patient or the patient's agent with the  
               appropriate Vaccine Information Statement (VIS), produced  
               by the CDC, for each immunization administered;  

             b)   Provide documentation of administration of the  
               immunization to the patient and the patient's physician or  
               primary care provider, if one can be identified; and,


             c)   Provide documentation of administration of the  
               immunization to the appropriate immunization registry.

          6)Requires a pharmacist to maintain an immunization  
            administration record, which shall include, but not be limited  
            to:

             a)   The name of the vaccine;

             b)   Vaccine's expiration date;

             c)   Date of administration;

             d)   The manufacturer and lot number;

             e)   The administration site and route;

             f)   The VIS date; and,

             g)   The name and title of the person administering the  
               vaccination, for 10 years from the date of administration.

          7)Permits a pharmacist initiating and administering vaccines to  
            initiate and administer epinephrine by injection for severe  
            allergic reactions.

          8)Requires any adverse event be reported to the Vaccine Adverse  
            Event Reporting System within the United States Department of  
            Health and Human Services.








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          9)States that, upon receipt, a pharmacist is responsible for  
            ensuring that proper temperatures are maintained during the  
            subsequent storage and handling of the vaccine to preserve its  
            potency.  

          10)Sunsets the pilot project on January 1, 2015.  

          11)Requires the MBC and BOP complete an evaluation of the pilot  
            program's effectiveness and report back to the relevant Senate  
            and Assembly committees by January 1, 2012. 

          12)Makes Legislative findings and declarations.

           FISCAL EFFECT  :   Unknown 

           COMMENTS  :   

           Purpose of this bill  .  According to the author's office, "In  
          1995, pharmacy law allowed a pharmacist to administer  
          immunizations pursuant to a protocol with a physician.  Since  
          that time, pharmacists have safely initiated and administered  
          thousands of immunizations to Californians.  However, the full  
          impact of pharmacist delivered vaccines has not been realized.   
          Many pharmacists are unable to obtain a prescriber's signature  
          on their vaccination protocol, making them unable to administer  
          vaccines.  Even after extensive education of physicians  
          regarding the minimal liability incurred, many remain  
          apprehensive and choose not to sign immunization protocols with  
          pharmacists.  Further, independent pharmacies are the hardest  
          hit by the need for a prescriber protocol.  These small  
          businesses often serve low-income, ethnically diverse  
          communities in suburban and rural locations throughout  
          California." 

           Background  .  Currently, 49 states including California allow a  
          pharmacist to administer immunizations pursuant to a protocol  
          with a prescriber.  A protocol typically identifies:  

           The individual who has delegated activity
           The pharmacist authorized to administer vaccine
           Types of vaccines pharmacist is authorized to administer
           Procedures, decision criteria, or the plan a pharmacist should  
            follow, including when to refer a patient
           Procedure for emergency situations








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           Record keeping and documentation procedures

          This bill would permit pharmacists to administer one vaccine  
          without a protocol.  There is concern that this protocol is  
          essential for public health.  The CDC currently recommends that  
          certain individuals should not be vaccinated for influenza  
          without first consulting a physician. 

          Some argue that immunizations are a key entry point into the  
          doctor's office for children, especially teenagers.  Permitting  
          pharmacists to provide immunizations would result in missed  
          opportunities to see a doctor and get other preventive care. 

           REGISTERED SUPPORT / OPPOSITION  :   

           Support 
           
          California Board of Pharmacy (sponsor)

           Opposition 
           
          None on file.
           
          Analysis Prepared by  :    Sarah Huchel / B. & P. / (916) 319-3301