BILL ANALYSIS                                                                                                                                                                                                    Ó






                             SENATE COMMITTEE ON HEALTH
                          Senator Ed Hernandez, O.D., Chair

          BILL NO:       SB 1039
          AUTHOR:        Hernandez
          AMENDED:       April 10, 2014
          HEARING DATE:  April 30, 2014
          CONSULTANT:    Moreno

          SUBJECT  :  Pharmacies: furnishing drugs.
           
          SUMMARY  :  Makes a number of changes to the tasks that a pharmacy  
          technician is authorized to perform, under the direct  
          supervision or control of a pharmacist, including permitting  
          them to assist with emergency supply packaging for hospitals,  
          and stock, replenish and inspect a hospital's emergency  
          pharmaceutical supplies container.  Adds an advance practice  
          pharmacist to the list of those authorized to prescribe  
          controlled substances under existing law. 

          Existing law:
          1.Permits a pharmacy technician (PT) to perform packaging,  
            manipulative, repetitive or other non-discretionary tasks,  
            only while assisting, and under the direct supervision and  
            control of a pharmacist.  Prohibits a PT from performing any  
            act requiring the exercise of professional judgment by a  
            pharmacist.  

          2.Requires that a pharmacy with only one pharmacist to have no  
            more than one PT performing packaging, manipulative,  
            repetitive or other non-discretionary tasks.  Establishes a  
            ratio of two PTs for each additional pharmacist, except in  
            specified settings.  

          3.Defines "intern pharmacist" as a person licensed by the Board  
            of Pharmacy for a period of one to six years if he or she is  
            enrolled in a school of pharmacy recognized by the Board, two  
            years if he or she is a graduate of a school of pharmacy  
            recognized by the Board who has applied to become licensed as  
            a pharmacist, two years if he or she is a foreign graduate, or  
            one year if he or she has failed the pharmacist license exam  
            four times and has remained enrolled in a school of pharmacy.   


          4.Authorizes an advanced practice pharmacist (APP) recognized by  
            the Board to:  
                                                         Continued---



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             a.   Perform patient assessments;
             b.   Order and interpret drug-therapy related tests, ensuring  
               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.
             c.   Refer patients to other health care providers;
             d.   Participate in the evaluation or management of diseases  
               and health conditions in collaboration with other health  
               care providers; and, 
             e.   Initiate, adjust or discontinue drug therapy pursuant to  
               the authority established in current law for pharmacists to  
               perform certain procedures in a licensed health care  
               facility. 

          1.Establishes the California Uniform Controlled Substances Act  
            (Controlled Substances Act) which regulates controlled  
            substances.  Permits only specified persons to write or issue  
            a prescription for a controlled substance, including a:  
            physician; dentist; podiatrist; veterinarian;  naturopathic  
            doctor; pharmacist in certain settings or acting within the  
            scope of a health workforce pilot project authorized by the  
            Office of Statewide Health Planning and Development (OSHPD); a  
            registered nurse acting within the scope of a health workforce  
            pilot project authorized by OSHPD; a certified nurse-midwife,  
            if furnished or ordered incidentally to the provision of  
            family planning services, routine health care or perinatal  
            care, or care rendered consistent with the certified  
            nurse-midwife's practice, as specified; a nurse practitioner,  
            as specified; a physician assistant, as specified; an  
            optometrist, as specified; and, an out-of-state prescriber in  
            emergency situations, if his or her licensing classification  
            is same as a license in California that would permit  
            prescribing of drugs or devices. 

          This bill:
          1.Clarifies that PTs, in performing packaging, may perform  
            emergency supply packaging and sealing in or for hospitals,  
            hospital unit inspections, and other physical tasks, only  
            while assisting and under the direct supervision and control  
            of a pharmacist.





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          2.Permits a pharmacy to furnish a dangerous drug or dangerous  
            device to the emergency medical services system of a licensed  
            general acute care hospital for storage in a secured emergency  
            pharmaceutical supplies container maintained within the  
            hospital in accordance with its policies and procedures.   
            Permits a PT or intern pharmacist, under the direct  
            supervision and control of a pharmacist, to stock, replenish,  
            and inspect the hospital's emergency pharmaceutical supplies  
            container.

          3.Requires the hospital and the dispensing pharmacy to maintain  
            records of each request by, and dangerous drugs or dangerous  
            devices furnished to, the hospital's emergency medical  
            services system, for at least three years.

          4.Requires controlled substances to be furnished to the  
            hospital's emergency medical services system under this  
            section in accordance with the Controlled Substances Act. 

          5.Permits a pharmacy to furnish a dangerous drug or dangerous  
            device to a hospital pursuant to preprinted or electronic  
            standing orders, order sets, and protocols established under  
            the policies and procedures of the hospital, as approved  
            according to the policies of the hospital's governing body, if  
            the order is promptly dated, timed, and authenticated in the  
            medical record of the patient to whom the drug or device is  
            dispensed by the ordering practitioner or another practitioner  
            responsible for the care of that patient and authorized by the  
            hospital's policies and procedures to write orders.

          6.Requires the hospital to store and maintain drugs in  
            accordance with national standards regarding the storage area  
            and refrigerator or freezer temperature, and otherwise  
            pursuant to the manufacturer's guidelines.

          7.Requires a pharmacist, PT, or an intern pharmacist under the  
            direct supervision and control of a pharmacist, to inspect the  
            drugs maintained in the hospital at least once per month.   
            Requires the hospital to establish specific written policies  
            and procedures for inspections. Requires the person conducting  
            the inspection to report any irregularities to the director or  
            chief executive officer of the hospital, or other person  
            holding an equivalent position, and in accordance with the  
            hospital's policy.





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          8.Requires the hospital to adopt policies and procedures  
            regarding the responsibility for ensuring proper methods for  
            repackaging and labeling of bulk cleaning agents, solvents,  
            chemicals, and non-drug hazardous substances used throughout  
            the hospital according to state and federal law and standards.

          9.Adds an APP to the list of those authorized to prescribe  
            controlled substances under the Controlled Substances Act. 

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

           COMMENTS  :  
           1.Author's statement.  According to the author, in response to  
            the primary care shortage in California coupled with millions  
            of newly insured individuals entering the health care market  
            as a result of implementation of the Affordable Care Act  
            (ACA), SB 493 (Hernandez), Chapter 469, Statutes of 2013, was  
            enacted.  SB 493 gives health care facilities greater  
            flexibility to focus their pharmacist workforce on providing  
            patient-centered services as part of a multi-disciplinary  
            team. This is especially important given that previously  
            uninsured patients entering the health care system under the  
            ACA will likely suffer disproportionately from multiple  
            comorbidities and have low health literacy rates. However,  
            this flexibility is in conflict with existing regulatory  
            requirements on pharmacists that have been in place for  
            decades and that have long been outdated.   Removing the  
            burden of simple non-discretionary activities unrelated to  
            professional judgment of pharmacists, such as checking  
            expiration dates for drug stock or repackaging or labeling  
            cleaning agents,  will help redirect pharmacy resources where  
            they are needed most - the patient.  This bill makes more  
            efficient use of pharmacy personnel in the facility setting  
            expanding the types of non-discretionary tasks that pharmacy  
            technicians are permitted to perform, freeing up pharmacists  
            to focus on patient care.
            
          2.The ACA.  On March 23, 2010, President Obama signed the ACA  
            into law (Public Law 111-148), as amended by the Health Care  
            and Education Reconciliation Act of 2010 (Public Law 111-152).  
            The ACA greatly expands health insurance coverage in  
            California. Beginning in 2014, millions of low- and  
            middle-income Californians began gaining access to coverage  
            under the expansion of Medi-Cal, and through premium and  
            cost-sharing subsidies offered through the California Health  




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            Benefit Exchange (known as Covered California). As a result of  
            the coverage expansions under the ACA, between 89 and 91  
            percent of non-elderly Californians are predicted to have  
            health coverage, and the number of uninsured is projected to  
            decrease by between 1.8 and 2.7 million by 2019. The newly  
            insured will increase demand for health care on an already  
            strained system. Furthermore, the ACA aims to change how care  
            is delivered. It will provide incentives for expanded and  
            improved primary care, which may affect demand for some health  
            care professionals more than others, and create team-based  
            models of service delivery.  Research indicates that health  
            care reform will place higher skill demands on all members of  
            the health care workforce as systems try to improve quality  
            while limiting costs. The scale of change with health care  
            reform is unlike anything that the state has previously faced.  
             Many newly insured Californians will have a pent-up demand  
            for services and will create even more pressure on the already  
            strained health care system, particularly in medically  
            underserved areas.
               
          3.Primary Care Physician Workforce Shortage.  According to a  
            report commissioned by the California Health Care Foundation,  
            the number of primary care physicians actively practicing in  
            California is at or below the very bottom range of the state's  
            need based on Council on Graduate Medical Education estimates.  
            The distribution of these physicians is also poor. In 2008,  
            there were 69,460 actively practicing physicians in California  
            (this includes Doctors of Medicine and Doctors of Osteopathic  
            Medicine), and only 35 percent of these physicians reported  
            practicing primary care.  This equates to 63 active primary  
            care physicians in patient care per 100,000 persons.   
            According to the Council on Graduate Medical Education, a  
            range of 60 to 80 primary care physicians are needed per  
            100,000 in order to adequately meet the needs of the  
            population. When the same metric is applied regionally, only  
            16 of California's 58 counties fall within the needed supply  
            range for primary care physicians.  In other words, less than  
            one-third of Californians live in a community where they have  
            access to the health care services they need.

          4.Pharmacy Technicians.  According to the Board of Pharmacy, a  
            PT is an individual who, under the direct supervision and  
            control of a pharmacist, performs packaging, manipulative,  
            repetitive, or other non-discretionary tasks related to the  
            processing of a prescription in a licensed pharmacy, but  




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            excludes all functions restricted to a registered pharmacist.  
            The Board's regulations related to PTs define  
            "non-discretionary tasks" as removing the drug or drugs from  
            stock; counting, pouring, or mixing pharmaceuticals; placing  
            the product into a container; affixing the label or labels to  
            a container; and, packaging and repackaging.  To work as a PT  
            in California, current registration is required.  The Board  
            may issue a license to high school graduates or a person with  
            a general educational development (GED) certificate  
            equivalent, and has obtained an associate's degree in pharmacy  
            technology, has completed a course of training specified by  
            the Board, has graduated from a school of pharmacy recognized  
            by the Board, or is certified by the Pharmacy Technician  
            Certification Board.  PT applications are required to include  
            a description of the applicant's qualifications, along with  
            supporting documentation for those qualifications and  
            applicants are required to undergo a criminal background and  
            fingerprint check.  PTs must wear identification clearly  
            identifying themselves as a PT in a pharmacy and may only  
            perform duties under the direct supervision of a pharmacist,  
            ensuring that a pharmacist is fully aware of all activities  
            involved in the preparation and dispensing of medications,  
            including the maintenance of appropriate records. 

          5.Double referral. This bill was heard in the Senate Business,  
            Professions, and Economic Development Committee on April 21,  
            2014, and passed by a vote of 9-0.

          6.Prior legislation. SB 493 expands the scope of practice of a  
            pharmacist to recognize an APP; 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.

          7.Support.  The California Society of Health-System Pharmacists  
            states that this bill addresses several outdated regulations  
            that have not been updated since the 1960s, and will free up  
            hospital-based pharmacists to spend more time directly working  
            with physicians and nurses to assure the safest and most  
            effective care of the patient.  The California Hospital  
            Association and Providence Health & Services, Southern  
            California writes that unnecessary use of health care  
            personnel, such as those non-discretionary activities  
            pharmacists are required to do now, drive inefficiencies and  




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            high costs, which is contrary to ensuring continued  
            achievement of meeting the goals of the ACA to improve quality  
            and limit costs.  The California Pharmacy Technician  
            Association states that when utilized appropriately in  
            accordance with existing law, PTs increase the efficiency of  
            the healthcare system by allowing pharmacists to focus their  
            time and expertise on delivering direct patient care services.  


          8.Author's amendments.  The author request that the Committee  
            approve amendments to move language currently contained in  
            Business and Profession Code 4119.7 (d) to an appropriate  
            Health and Safety Code section and add language that states  
            that any regulations promulgated by the Board of Pharmacy that  
            are inconsistent with this bill are void and not enforceable.

           SUPPORT AND OPPOSITION  :
          Support:  California Chronic Care Coalition
                    California Hospital Association
                    California Pharmacy Technician Association
                    California Society of Health-System Pharmacists
                    Providence Health and Services, Southern California
                    48 individuals

          Oppose:   None received.


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