BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                  SB 493
                                                                  Page  1

          SENATE THIRD READING
          SB 493 (Ed Hernandez)
          As Amended  September 6, 2013
          Majority vote

           SENATE VOTE  :   34-4

           BUSINESS & PROFESSIONS     14-0 HEALTH              18-0        
           
           ----------------------------------------------------------------- 
          |Ayes:|Bonilla, Jones,           |Ayes:|Pan, Ammiano, Atkins,     |
          |     |Bocanegra, Campos,        |     |Bonilla, Bonta, Chesbro,  |
          |     |Dickinson, Eggman,        |     |Gomez,                    |
          |     |Gordon, Hagman, Holden,   |     |Roger Hernández,          |
          |     |Maienschein, Mullin,      |     |Lowenthal, Maienschein,   |
          |     |Skinner, Ting, Wilk       |     |Mansoor, Mitchell,        |
          |     |                          |     |Nazarian, Nestande, V.    |
          |     |                          |     |Manuel Pérez, Wagner,     |
          |     |                          |     |Wieckowski, Wilk          |
           ----------------------------------------------------------------- 

           APPROPRIATIONS         16-0                                     
           
           ----------------------------------------------------------------- 
          |Ayes:|Gatto, Harkey, Bigelow,   |     |                          |
          |     |Bocanegra, Bradford, Ian  |     |                          |
          |     |Calderon, Campos, Eggman, |     |                          |
          |     |Gomez, Hall, Holden,      |     |                          |
          |     |Linder, Pan, Quirk,       |     |                          |
          |     |Wagner, Weber             |     |                          |
          |-----+--------------------------+-----+--------------------------|
          |     |                          |     |                          |
           ----------------------------------------------------------------- 
           SUMMARY  :  Expands the scope of practice of a pharmacist to  
          recognize an "advanced practice pharmacist"; permits pharmacists  
          to furnish certain hormonal contraceptives, nicotine replacement  
          products, and prescription medications for travel, as specified;  
          and authorizes pharmacists to independently initiate and  
          administer certain vaccines and treatments for severe allergic  
          reactions.  Specifically,  this bill  :   

          1)Permits a pharmacist to provide clinical services if the  
            clinical services are provided to a health care professional  
            or to a patient.









                                                                  SB 493
                                                                  Page  2

          2)Permits a pharmacist to provide consultation, training, and  
            education to patients about drug therapy, disease management,  
            and disease prevention.

          3)Permits a pharmacist to participate in a multidisciplinary  
            review of patient progress, including appropriate access to  
            medical records. 

          4)Permits a pharmacist to furnish the following medications:

             a)   Self-administered hormonal contraceptives, as specified;

             b)   Nicotine replacement products, as specified; and,

             c)   Prescription medications not requiring a diagnosis that  
               are recommended by the federal Centers for Disease Control  
               and Prevention (CDC) for individuals traveling outside of  
               the United States.

          5)Requires a pharmacist to notify the patient's primary care  
            provider of any drugs or devices furnished to the patient, or  
            enter the appropriate information in a patient record system  
            shared with the primary care provider, as permitted by that  
            primary care provider.  If the patient does not have a primary  
            care provider, the pharmacist must provide the patient with a  
            written record of the drugs or devices furnished and advise  
            the patient to consult a physician of the patient's choice.

          6)Permits a pharmacist to order and interpret tests for the  
            purpose of monitoring and managing the efficacy and toxicity  
            of drug therapies, and requires a pharmacist who orders and  
            interprets tests to ensure that the ordering of those tests is  
            done in coordination with the patient's primary care provider  
            or diagnosing prescriber, as appropriate, including promptly  
            transmitting written notification to the patient's diagnosing  
            prescriber or entering the appropriate information in a  
            patient record system shared with the prescriber, when  
            available and as permitted by that prescriber.

          7)Requires a pharmacist to dispense self-administered hormonal  
            contraceptives legally prescribed or ordered for a patient  
            unless certain circumstances exist, including the absence of  
            stock, objection on personal religious grounds, or belief of  
            the pharmacist that a harmful drug interaction would result. 









                                                                  SB 493
                                                                  Page  3

          8)Permits a pharmacist to furnish self-administered hormonal  
            contraceptives in accordance with standardized procedures or  
            protocols developed and approved by both the Board of Pharmacy  
            (BOP) and the Medical Board of California (MBC) in  
            consultation with the American Congress of Obstetricians and  
            Gynecologists, the California Pharmacists Association, and  
            other appropriate entities. The standardized procedure or  
            protocol shall require that the patient use a self-screening  
            tool that will identify patient risk factors for use of  
            self-administered hormonal contraceptives, and that the  
            pharmacist refer the patient, as specified, upon furnishing a  
            self-administered hormonal contraceptive, or if it is  
            determined that use of a self-administered hormonal  
            contraceptive is not recommended.

          9)States that BOP and MBC are both authorized to ensure  
            compliance with the administration of hormonal contraceptives  
            by pharmacists, and each board is specifically charged with  
            the enforcement with respect to its respective licensees.   
            States that a pharmacist's ability to furnish  
            self-administered hormonal contraceptives does not expand the  
            authority of a pharmacist to prescribe any prescription  
            medication. 

          10)Requires a pharmacist to provide the recipient of  
            self-administered hormonal contraception with a standardized  
            fact sheet that includes, but is not limited to, the  
            indications and contraindications for use of the drug, the  
            appropriate method for using the drug, the need for medical  
            follow-up, and other appropriate information.  Requires BOP to  
            develop this form in consultation with the State Department of  
            Public Health, the American Congress of Obstetricians and  
            Gynecologists, the California Pharmacists Association, and  
            other health care organizations.  States that the use of  
            existing publications developed by nationally recognized  
            medical organizations is not precluded.

          11)Clarifies that this bill does not expand the authority of a  
            pharmacist to prescribe any prescription medication.

          12)Defines an "advanced practice pharmacist" (APP) as a licensed  
            pharmacist who has been recognized as an advanced practice  
            pharmacist by BOP, as specified.  

          13)Requires a pharmacist seeking recognition as an APP to meet  








                                                                  SB 493
                                                                  Page  4

            the following requirements:

             a)   Hold an active license to practice pharmacy issued  
               pursuant to this chapter that is in good standing.

             b)   Satisfy any two of the following criteria:

               i)     Earn certification in a relevant area of practice,  
                 including, but not limited to, ambulatory care, critical  
                 care, geriatric pharmacy, nuclear pharmacy, nutrition  
                 support pharmacy, oncology pharmacy, pediatric pharmacy,  
                 pharmacotherapy, or psychiatric pharmacy, from an  
                 organization recognized by the Accreditation Council for  
                 Pharmacy Education or another entity recognized by BOP;

               ii)    Complete a one-year postgraduate residency through  
                 an accredited postgraduate institution where at least 50%  
                 of the experience includes the provision of direct  
                 patient care services with interdisciplinary teams; or,

               iii)   Have provided clinical services to patients for at  
                 least one year under a collaborative practice agreement  
                 or protocol with a physician, APP, pharmacist practicing  
                 collaborative drug therapy management, or health system;  
                 and,

             c)   File an application and pay the applicable fee with BOP  
               for recognition as an APP.

          14)States that APP recognition shall be valid for two years,  
            coterminous with the certificate holder's license to practice  
            pharmacy.

          15)Requires BOP to adopt regulations establishing the means of  
            documenting completion of the requirements in this section.

          16)Requires BOP to adopt regulations setting the fee for the  
            issuance and renewal of APP recognition at the reasonable cost  
            of regulating APPs, which shall not exceed $300.

          17)Requires an APP to complete 10 hours of continuing education  
            each renewal cycle in a subject matter relevant to the  
            pharmacist's clinical practice.

          18)Permits a pharmacist recognized by BOP as an APP to do all of  








                                                                  SB 493
                                                                  Page  5

            the following:

             a)   Perform patient assessments;

             b)   Order and interpret drug therapy-related tests;

             c)   Refer patients to other health care providers;

             d)   Participate in the evaluation and management of diseases  
               and health conditions in collaboration with other health  
               care providers; and,

             e)   Initiate, adjust, or discontinue drug therapy, as  
               specified.

          19)Requires an APP who orders and interprets tests to ensure  
            that the ordering of those tests is done in coordination with  
            the patient's primary care provider or diagnosing prescriber,  
            as appropriate, including promptly transmitting written  
            notification to the patient's diagnosing prescriber or  
            entering the appropriate information in a patient record  
            system shared with the prescriber, when available and as  
            permitted by that prescriber.

          20)Requires an APP who initiates, adjusts, or discontinues drug  
            therapy to promptly transmit written notification to the  
            patient's diagnosing prescriber or enter the appropriate  
            information in a patient record system shared with the  
            prescriber, as permitted by that prescriber. 

          21)Requires an APP who initiates drug therapy to promptly  
            transmit written notification to, or enter the appropriate  
            information into, a patient record system shared with the  
            patient's primary care provider or diagnosing provider, as  
            permitted by that provider.

          22)States that an APP's abilities shall not interfere with a  
            physician's order to dispense a prescription drug as written,  
            or other order of similar meaning.

          23)Requires an APP to personally register with the federal Drug  
            Enforcement Administration (DEA) prior to initiating or  
            adjusting a controlled substance therapy.

          24)Permits a pharmacist to independently initiate and administer  








                                                                  SB 493
                                                                  Page  6

            vaccines listed on the routine immunization schedules  
            recommended by the federal Advisory Committee on Immunization  
            Practices (ACIP), in compliance with individual ACIP vaccine  
            recommendations, and published by the CDC for persons three  
            years of age and older if the pharmacist:

             a)   Completes an immunization training program endorsed by  
               the CDC or the Accreditation Council for Pharmacy Education  
               that, at a minimum, includes hands-on injection technique,  
               clinical evaluation of indications and contraindications of  
               vaccines, and the recognition and treatment of emergency  
               reactions to vaccines, and maintains that training;

             b)   Is certified in basic life support; and,

             c)   Complies with all state and federal recordkeeping and  
               reporting requirements, including providing documentation  
               to the patient's primary care provider and entering  
               information in the appropriate immunization registry  
               designated by the immunization branch of the State  
               Department of Public Health.

          25)Permits a pharmacist to initiate and administer epinephrine  
            or diphenhydramine by injection for the treatment of a severe  
            allergic reaction either pursuant to protocols, or under the  
            requirements for administering vaccines to persons three years  
            of age and older. 

          26)Permits a pharmacist to furnish nicotine replacement products  
            approved by the federal Food and Drug Administration for use  
            by prescription only in accordance with standardized  
            procedures and protocols developed and approved by both BOP  
            and MBC in consultation with other appropriate entities and  
            provide smoking cessation services if all of the following  
            conditions are met:

             a)   The pharmacist maintains records of all prescription  
               drugs and devices furnished for a period of at least three  
               years for purposes of notifying other health care providers  
               and monitoring the patient;

             b)   The pharmacist notifies the patient's primary care  
               provider of any drugs or devices furnished to the patient,  
               or enters the appropriate information in a patient record  
               system shared with the primary care provider, as permitted  








                                                                  SB 493
                                                                  Page  7

               by that primary care provider.  If the patient does not  
               have a primary care provider, the pharmacist provides the  
               patient with a written record of the drugs or devices  
               furnished and advises the patient to consult a physician of  
               the patient's choice;

             c)   The pharmacist is certified in smoking cessation therapy  
               by an organization recognized by BOP; and,

             d)   The pharmacist completes one hour of continuing  
               education focused on smoking cessation therapy biennially.

          27)Authorizes BOP and MBC to ensure that pharmacists are  
            compliant with the requirements for furnishing nicotine  
            replacement products, and states that each board is  
            specifically charged with the enforcement of this section with  
            respect to their respective licensees.  States that nothing in  
            the ability for pharmacists to furnish nicotine replacement  
            products shall be construed to expand the authority of a  
            pharmacist to prescribe any other prescription medication.   

          28)Authorizes an APP to practice advanced practice pharmacy  
            inside or outside of a licensed pharmacy, as specified.

          29)Makes a legislative declaration that pharmacists are health  
            care providers who have the authority to provide health care  
            services.

          30)Makes other technical and clarifying amendments.

          31)Adds language to avoid chaptering out issues with SB 205  
            (Corbett) of the current legislative session.

          32)States that no reimbursement is required because the only  
            costs that may be incurred by a local agency or school  
            district will be incurred because this act creates a new crime  
            or infraction, eliminates a crime or infraction, changes the  
            penalty for a crime or infraction, or changes the definition  
            of a crime.

           FISCAL EFFECT  :   According to Assembly Appropriations Committee,  
          all costs would accrue to the Pharmacy Board Contingent Fund.

          1)One-time costs to BOP of $100,000 for regulations establishing  
            APP recognition process, rules, and fees.  In addition,  








                                                                  SB 493
                                                                  Page  8

            one-time costs of $20,000 to modify information technology  
            systems to accommodate a new licensure type.

          2)Ongoing costs of approximately $300,000 annually for licensing  
            and regulation of APPs. 

          3)Potential fee revenues of approximately $300,000 annually.  

          4)Unknown potential increase in enforcement costs. Since the  
            activities permitted under this bill are newly allowed for  
            pharmacists outside the supervision of a physician, it is  
            unclear whether or how many increased complaints may occur.   
            The Department of Justice (DOJ) and/or the BOP may experience  
            increased enforcement costs; any DOJ costs would be reimbursed  
            by the Pharmacy Board Contingent Fund.

          5)The net effect on health care costs from expanding the role of  
            pharmacists in delivery of care is unclear.  Increased access  
            to care may result in increased costs due to greater  
            utilization, which could be counterbalanced by cost savings  
            related to improved medication adherence, reduced hospital  
            readmissions, and other benefits stemming from provision of  
            care pharmacists would provide.   

           COMMENTS  :   

           1)Purpose of this bill  .  This bill further develops the  
            pharmacists' role as part of a primary care team by expanding  
            pharmacists' scope of practice to allow for more autonomy in  
            furnishing certain drugs and devices pursuant to standardized  
            procedures and protocols.  It also provides for an expanded  
            scope for, the recognition of, advanced practice pharmacists.   
            This bill is author-sponsored.  

           2)The profession of pharmacy  .  California licensed pharmacists  
            are required to have at least a baccalaureate degree in  
            pharmacy from a specially accredited college of pharmacy  
            program, have completed 1,500 intern hours of pharmacy  
            practice experience, and have passed a national and state  
            exam.  There are 38,440 licensed pharmacists in California.  
             
             Pharmacists consistently rank amongst the most trusted  
            healthcare personnel in nationwide Gallup polls and have a  
            broader knowledge of medicines, both prescription and  
            over-the-counter, than any other member of the health care  








                                                                  SB 493
                                                                  Page  9

            team.  According to a 2012 report by the CDC, engaging  
            pharmacists as members of the health care system can  
            significantly improve treatment of diabetes, better control  
            high blood pressure, improve management of cholesterol, and  
            reduce overall health care costs.  Thirty-one states,  
            including California, have laws that allow physicians and  
            pharmacists to collaborate in providing advanced services such  
            as those authorized by this bill.  

            This bill will permit APPs to perform patient assessments,  
            order and interpret drug therapy-related tests, participate in  
            the evaluation and management of diseases and health  
            conditions in collaboration with other health care providers;  
            and initiate, adjust, or discontinue drug therapy in certain  
            circumstances.  

           3)The Affordable Care Act (ACA)  .  The federal Affordable Care  
            Act (ACA) was passed in March 2010 to provide affordable  
            healthcare for all Americans and improve the quality and  
            efficiency of that care.  The January 2014 implementation date  
            of ACA will result in millions more Californians entering the  
            primary care market.  

            The CDC argues that pharmacists are well positioned to augment  
            primary care teams and help manage patient's medications and  
            chronic conditions.  The U.S. Department of Health and Human  
            Services (HHS) authored a 2011 report, entitled "Improving  
            Patient and Health System Outcomes through Advanced Pharmacy  
            Practice, A Report to the U.S. Surgeon General," in which it  
            was demonstrated that "through evidence-based outcomes, many  
            expanded pharmacy practice models, implemented in  
            collaboration with physicians or as part of a health team,  
            improve patient and health system outcomes and optimize  
            primary care access and delivery."  The report recommended  
            that pharmacists work in collaboration with physicians and  
            primary care clinicians.

            This measure builds upon pharmacists' current scope of  
            practice to more fully enable them to participate in a  
            multidisciplinary patient management team, and provides for  
            the recognition of APPs, who would be able to provide many of  
            the advanced health management techniques recommended by the  
            HHS report.










                                                                  SB 493
                                                                  Page  10

           Analysis Prepared by  :    Sarah Huchel / B.,P. & C.P. / (916)  
          319-3301 


                                                                FN: 0002550