BILL ANALYSIS                                                                                                                                                                                                    Ó



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          Date of Hearing: April 28, 2015   


                   ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS


                                Susan Bonilla, Chair


          AB 486  
          (Bonilla) - As Introduced February 23, 2015


          NOTE:  This bill is double-referred, having been previously  
          heard by the Assembly Committee on Health on April 21, 2015 and  
          approved on a 19-0 vote.  


          NOTE: This bill adds an urgency clause.  


          SUBJECT:  Centralized hospital packaging pharmacies:  medication  
          labels.


          SUMMARY:  Requires labels on medications produced by centralized  
          hospital packaging pharmacies (CHPP) to also include specific  
          information on the label in human readable form. 


          EXISTING LAW:


          1)Provides for the practice of pharmacy and licensing and  
            regulation of pharmacies and pharmacists by the Board of  
            Pharmacy (Board) within the Department of Consumer Affairs  
            (DCA). (Business and Professions Code (BPC) § 4001 et seq.)

          2)Provides that a CHPP may prepare medications, by performing  








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            specialized functions, for administration only to inpatients  
            within its own general acute care hospital and one or more  
            general acute care hospitals if the hospitals are under common  
            ownership and located within a 75-mile radius of each other.  
            (Business and Professions Code (BPC) § 4128)





          3)Defines "hospital pharmacy" as a pharmacy licensed by the  
            Board, located within any licensed hospital, institution, or  
            establishment that maintains and operates organized facilities  
            for the diagnosis, care, and treatment of human illnesses to  
            which persons may be admitted for overnight stay. (BPC § 4029)



          4)Provides that "hospital pharmacy" also includes a pharmacy  
            that may be located outside of the hospital, in another  
            physical plant that is regulated under a hospital's  
            consolidated license issued by the California Department of  
            Corrections or California Department of Youth Authority.  (BPC  
            § 4029)



          5)Specifies that the pharmacy in another physical plant shall  
            provide pharmaceutical services only to registered hospital  
            patients who are on the premises of the same physical plant in  
            which the hospital is located.  (BPC § 4029)



          6)Specifies that the pharmacy services provided shall be  
            directly related to the services or treatment plan  
            administered in the physical plant.  (BPC § 4029)
           
          7)Requires any unit dose medication produced by a CHPP to  








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            display a readable barcode at the inpatients bedside. The  
            readable barcode will display the following information:  (BPC  
            § 4128.4)



             a)   The date the medication was prepared;



             b)   The components used in the drug product;



             c)   The lot number or control number; 



             d)   The expiration date;



             e)   The National Drug Code Directory number; and,



             f)   The name of the centralized hospital packaging pharmacy.  




          8)Requires the label for each unit dose medication produced by a  
            centralized hospital packaging pharmacy contain the following  
            information:  (BPC § 4128.5)



             a)   The expiration date;









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             b)   The established name of the drug;



             c)   The quantity of the active ingredient; and,



             d)   Special storage or handling requirements. 



          9)Permits a centralized hospital pharmacy to perform the  
            following specialized functions:

             a)   Preparing unit dose packages for single administration  
               to inpatients from bulk containers;



             b)   Preparing compounded unit dose drugs for parenteral  
               therapy administration (e.g. by subcutaneous,  
               intramuscular, intrasternal or intravenous injection) to  
               inpatients; and, 

             c)   Preparing compounded unit dose drugs for administration  
               to inpatients.





          10)Requires all specialized compounding and packaging functions  
            to be performed only in the licensed CHPP, and for the  
            pharmacy to comply with all applicable federal and state  
            statutes and regulations.  (BPC § 4128.6)









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          11)Specifies that the pharmacy and the pharmacists working in  
            the pharmacy are responsible for the integrity, potency,  
            quality, and labeled strength of any unit dose drug product  
            prepared by the pharmacy.  (BPC § 4128.7)
          THIS BILL:


          1)Clarifies that any unit dose medication produced by a  
            centralized hospital packaging pharmacy be barcoded to be  
            machine readable at the patient's bedside using barcode  
            medication administration software.



          2)Specifies that barcode medication administration software  
            permits health care practitioners to ensure, before medication  
            is administered to an inpatient, that it is the right  
            medications, for the right patient, in the right dose, and via  
            the right route of administration.





          3)Defines "barcode medication administration software" to mean a  
            computerized system designed to prevent medication errors in  
            health care settings.  

          4)Requires any label for each unit dose medication produced by a  
            CHPP to display a human-readable label that contains all of  
            the following:



             a)   The date that the medication was prepared;

             b)   The beyond-use date;








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             c)   The established name of the drug;

             d)   The quantity of each active ingredient;



             e)   Special storage or handling requirements;



             f)   The lot number or control number assigned by the  
               centralized hospital packaging pharmacy; and,



             g)   The name of the centralized hospital packaging pharmacy.



          5)Requires, for quality control and investigative purposes, a  
            pharmacist be able to retrieve all of the following  
            information using the lot number or control number: 

             a)   The components used in the drug product;

             b)   The expiration date of each of the drug's components;  
               and,



             c)   The National Drug Code Directory number.











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          6)Clarifies that CHPPs are preparing sterile compounded unit  
            dose drugs.
          FISCAL EFFECT:  Unknown.  This bill is keyed fiscal by the  
          Legislative Counsel.


          COMMENTS:


          1)Purpose. This bill is sponsored by the  California Society of  
            Health System Pharmacists  .  According to the author, "In 2012,  
            AB 377 was signed into law.  This bill required that  
            medications produced in [CHPPs] have a barcode which retrieves  
            specific information, such as medication expiration date and  
            lot number, which can be read when the barcode is scanned at  
            the patient's bedside.  There is also a requirement that  
            patient information be scanned by barcode as well.  In an  
            effort to assist hospitals that do not have the technology  
            infrastructure to provide certain patient information via  
            barcode, the Board of Pharmacy has created a waiver that  
            allows information to be listed in text form on the label.   
            These waivers are only for a five year term.  AB 486 creates a  
            long-term solution while maintaining the intent of current  
            law." 


          2)Background.  Business and Professions Code § 4128.4 allows  
            hospitals to set up and invest in high-tech central pharmacies  
            utilizing the latest in technological innovations, such as  
            robotics, effectively lowering rates of medication errors and  
            reducing unnecessary costs.


            The term "retrievable" within BPC § 4128.4 has caused  
            confusion and different interpretations between the Board of  
            Pharmacy and hospital chains.  The intent of the word  
            "retrievable" was not that the elements be immediately  
            readable on the label, but instead that the data elements on  
            the barcode be able to be linked to a database where the  








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            elements would be retrievable.  

            Several hospitals approached the Board of Pharmacy and  
            highlighted limitations in their software that would prohibit  
            full compliance with the barcode requirements.  According to  
            the hospitals, hospital information technology vendors will  
            have to reconfigure their systems to make all the elements  
            listed in BPC § 4128.4 immediately readable upon scan.  These  
            medical groups requested that the Board of Pharmacy interpret  
            the meaning of the provisions more broadly to allow for ample  
            time following licensure to fully comply with the  
            requirements. 

            The Board of Pharmacy ultimately approved five-year waivers to  
            organizations who have fallen out of compliance - allowing the  
            requisite information elements to be physically listed on the  
            label rather than having them in electronic barcode format.

          3)Prior Related Legislation.  AB 2757 (Bocanegra) of 2014, was  
            substantially similar to this bill.  NOTE: The bill passed the  
            Senate Committee on Business, Professions and Economic  
            Development but was not heard in any policy or fiscal  
            committee in the Assembly.



            AB 377 (Solario), Chapter 687, Statutes of 2012, authorized a  
            centralized hospital packaging pharmacy to prepare  
            medications, by performing specified functions for  
            administration only to inpatients within its own general acute  
            care hospital, or one or more general acute care hospitals  
            under the same ownership and located within 75 miles of each  
            other.





            AB 2077 (Solario) of 2010, in its final version, was virtually  








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            identical to AB 377 (Solario). NOTE:  This bill was vetoed by  
            Governor Schwarzenegger due to concern that the bill would  
            result in, "a greater likelihood of product mix-up, loss of  
            product identity, contamination and cross-contamination, and  
            lack of adequate control systems."





            AB 1370 (Solario) of 2009, was similar to AB 377, but created  
            a separate licensing category for centralized hospital  
            pharmacies.  NOTE:  The bill was held in the Assembly  
            Committee on Business and Professions and Consumer Protection.





            SCR 49 (Speier), Chapter 123, Statutes of 2005, created a  
            panel to study the causes of medication errors and recommend  
            changes in the health care system that reduces errors  
            associated with the delivery of prescription and over the  
            counter medication to consumers. 





            SB 1875 (Speier), Chapter 816, Statutes of 2000, required  
            hospitals to adopt a formal plan to eliminate or substantially  
            reduce medication-related errors.  





          









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          ARGUMENTS IN SUPPORT:


          The  California Association of Health-System Pharmacists   
          (sponsor) support the bill and write in their letter, "AB 486  
          amends [BPC] section 4128 to be less proscriptive than the  
          original law - replacing the word "retrievable" with more  
          clarifying language about barcode medication administration  
          software capabilities and giving centralized hospital packaging  
          pharmacies the flexibility to work with existing technology and  
          adapt to new technology as it becomes available.  AB 486 also  
          clarifies that this technology can be used for multiple purposed  
          and at multiple locations within the hospital, improving patient  
          safety."


          The  California Hospital Association  echoes the expressed support  
          for the bill and they write in their letter, "AB 486 provides a  
          long-term solution while maintaining the original intent of the  
          law."


          The  California Pharmacists Association  writes, "AB 486 creates  
          and effective system for bar-coding medications while clarifying  
          that this technology can be used for multiple purposes within a  
          hospital in order to reduce the rates of medication errors and  
          improve patient safety."


           Providence Health & Services of Southern California  writes in  
          their letter, "Providence appreciates this reasonable solution  
          to assure that centralized hospital packaging pharmacies can  
          continue to operate as intended and have essential elements for  
          patient safety readily available." 


          The  California Association of Joint Powers Authorities  supports  
          the bill and writes, "Many public acute care hospitals in  








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          California participate in public entity risk pools.  CAJPA  
          believes that AB 486 provides clarity to existing law and  
          provides centralized hospital packaging pharmacies the  
          flexibility to work with existing technology and adapt to new  
          technology as it becomes available." 


          The  California Council for the Advancement of Pharmacy  supports  
          the bill, "?because its long-term care pharmacy members have  
          experienced similar challenges with the California State Board  
          of Pharmacy's regulations regarding patient-centered labeling,  
          where by exemptions from the regulation must be sought on an  
          individual basis...AB [486] would remedy the onerous task of  
          requesting waivers while still maintaining the security of a  
          hospital patient's information and providing more efficient,  
          safe and effective patient care." 


          ARGUMENTS IN OPPOSITION:


          None on file.


          REGISTERED SUPPORT:





          California Society of Health-System Pharmacists (sponsor)


          California Association of Joint Powers Authorities


          California Association of Physician Groups










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          California Council for the Advancement of Pharmacy


          California Hospital Association


          California Pharmacists Association


          Providence Health & Services Southern California




          




          REGISTERED OPPOSITION:


          None on file.




          Analysis Prepared by:Le Ondra Clark Harvey, Ph.D. / B. & P. /  
          (916) 319-3301


















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