BILL ANALYSIS                                                                                                                                                                                                    



                                                                  AB 977
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          Date of Hearing:   January 5, 2010

                            ASSEMBLY COMMITTEE ON HEALTH
                                  Dave Jones, Chair
                   AB 977 (Skinner) - As Amended:  January 4, 2010
           
          SUBJECT  :   Pharmacists:  immunization administration.

           SUMMARY  :   Permits pharmacists to administer pneumococcal and  
          influenza vaccines to persons 11 years and older.    
          Specifically,  this bill  :  

          1)Permits a pharmacist to administer influenza and pneumococcal  
            immunizations to persons 11 years and older pursuant to  
            standardized protocols developed and approved by the  
            California State Board of Pharmacy and the California Medical  
            Board, in consultation with public health officers, as  
            specified.

          2)Requires pharmacists, before initiating and administering  
            immunizations, to complete the American Pharmacists  
            Association's Pharmacy-Based Immunization Delivery Certificate  
            Training Program or another pharmacy-based immunization  
            training certificate program endorsed by the Centers for  
            Disease Control and Prevention (CDC) or the Accreditation  
            Council for Pharmaceutical Education.

          3)Requires pharmacists initiating and administering  
            immunizations pursuant to this bill to be certified in basic  
            life support and complete three hours of immunization-related  
            continuing education coursework annually.  Requires, in the  
            case that a pharmacist fails to satisfy this requirement, to  
            retake training as required in #2 above in addition to the  
            three hour training prior to initiating and administering any  
            further immunizations. Permits this three hour training to be  
            applied toward existing continuing pharmacy education  
            requirements.

          4)Requires pharmacists to obtain the consent of a parent or  
            guardian before administering immunizations to patients under  
            age 18.

          5)Requires pharmacists, at the time of administration of  
            immunizations, to provide the patient or the patient's agent  
            with the appropriate CDC Vaccine Information Statement for  
            each vaccine, provide documentation of immunization  







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            administration to the patient and the patient's physician or  
            primary care provider, if one can be identified, and provide  
            documentation of the immunization administration to the  
            appropriate immunization registry.

          6)Requires pharmacists to maintain immunization administration  
            records, as specified, for 10 years in the case of an adult  
            and for three years after the 18th birthday in the case of a  
            child.  

          7)Permits pharmacists administering immunizations to initiate  
            and administer epinephrine by injection for severe allergic  
            reactions and requires any adverse event to be reported to the  
            federal Vaccine Adverse Event Reporting System.

          8)Makes pharmacists who receive vaccines for administration  
            pursuant to this bill to be responsible for assuring that  
            proper vaccine temperatures are maintained during storage and  
            handling to preserve the potency of the vaccine.

           
          EXISTING LAW  :

          1)Provides for the licensing and regulation of pharmacists by  
            the Pharmacy Board in the Department of Consumer Affairs.

          2)Authorizes a pharmacist to, among other things, administer  
            prescribed drugs and biologicals orally and topically, and in  
            a licensed health care facility, administer prescribed drugs  
            and biologicals by injection, order or perform  
            drug-therapy-related patient assessment procedures and tests,  
            and initiate or adjust the drug regimen of a patient pursuant  
            to specific order by the patient's prescriber, as specified.   
            Permits a pharmacist to administer immunizations pursuant to a  
            protocol with a prescriber.  

           FISCAL EFFECT  :   This bill has not been analyzed by a fiscal  
          committee.

           COMMENTS  :   

           1)PURPOSE OF THIS BILL  .  According to the author, this bill is  
            needed to increase access to immunizations.  The author cites  
            a recent report by Families USA, which states more than 12  
            million, or about 37% of nonelderly Californians were  
            uninsured at some point in the two-year period from 2007-08,  







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            and three-quarters of these were uninsured for more than six  
            months.  Researchers at the University of California, Berkeley  
            Labor Center predict the number of uninsured Californians is  
            increasing significantly with the economic recession and,  
            absent health care reform, will increase by 4 million over  
            pre-recession levels by 2012.  The author states pharmacists  
            are on the front line of preventative care, and are currently  
            formally trained to screen, administer, and respond to the few  
            adverse events associated with administering immunizations.   
            The author argues pharmacists are the most accessible health  
            care provider, located in more than 6,000 pharmacies in over  
            1,100 Zip codes throughout the state, and often do not require  
            appointments. 

          The author states that since 1995, pharmacy law allowed a  
            pharmacist to administer immunizations pursuant to a protocol  
            with a physician, and as a result, pharmacists have safely  
            initiated and administered thousands of immunizations to  
            Californians.  However, the author states that the full  
            potential of pharmacist-delivered vaccines has not been  
            realized because many pharmacists are unable to obtain a  
            prescriber's signature on their vaccination protocol, making  
            them unable to administer vaccines.  According to the author,  
            even after extensive education of physicians regarding the  
            minimal liability incurred, many remain apprehensive and  
            choose not to sign immunization protocols with pharmacists.   
            Further, the author argues the need for a prescriber protocol  
            disproportionately affects independent pharmacies, which are  
            small businesses that often serve low-income, ethnically  
            diverse communities in suburban and rural locations throughout  
            California.  According to the author, by enabling more  
            pharmacists to administer vaccines, this bill will increase  
            access to care. 

           2)BACKGROUND  .  According to an article in the Journal of the  
            American Pharmaceutical Association, "Pharmacists and  
            Immunizations," Gallup Polls have consistently named the  
            pharmacist among the most trusted professionals.  People in  
            many communities, especially rural areas, look to their  
            community pharmacist for medical advice.  This respect can be  
            pivotal in helping educate parents and other adults about the  
            importance of timely immunization.  When patients pick up  
            prescriptions, pharmacists can take advantage of their  
            accessibility and reputation to ask them about their  
            immunization status and counsel them on the importance of  
            immunization.







                                                                  AB 977
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           3)EXISTING PRACTICE  . Currently, 49 states (including California)  
            allow a pharmacist to administer immunizations pursuant to a  
            protocol with a prescriber.  A protocol typically identifies:

             a)   The individual who has delegated activity;

             b)   The pharmacist authorized to administer vaccine;

             c)   Types of vaccines the pharmacist is authorized to  
               administer;

             d)   Procedures, decision criteria, or the plan a pharmacist  
               should follow, including when to refer a patient;

             e)   Procedure for emergency situations; and,

             f)   Record keeping and documentation procedures.

            This bill would, among other things, instead permit  
            pharmacists to administer immunizations under a statewide,  
            standardized protocol.

           4)AUTHOR'S AMENDMENT  .  The author intends to amend this bill in  
            committee to: a) Make the provisions of the bill a 4-year  
            pilot program under which pharmacists would be permitted to  
            administer only influenza vaccine to adults; and, b) Require  
            the Medical Board and the Board of Pharmacy to conduct an  
            evaluation of the program and report back to relevant Senate  
            and Assembly committees.

           5)DOUBLE REFERRAL  .  This bill, in a related but substantially  
            different form, was approved by the Assembly Business and  
            Professions Committee by a vote of 10-0 on May 5, 2009.  As a  
            result of the January 4, 2010 amendments, the bill will be  
            heard again by that Committee on January 12, 2010.

           REGISTERED SUPPORT / OPPOSITION  :   

           Support  (previous version)  
           
          California State Board of Pharmacy (sponsor)
          California Retailers Association
          National Association of Chain Drug Stores

           Opposition  (previous version)  
           







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          American College of Obstetricians and Gynecologists, District IX  

          California Medical Association
          California Nurses Association
           

          Analysis Prepared by  :    Melanie Moreno / HEALTH / (916)  
          319-2097