BILL ANALYSIS                                                                                                                                                                                                    Ó



                                                                     AB 486


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          Date of Hearing:  April 21, 2015


                            ASSEMBLY COMMITTEE ON HEALTH


                                  Rob Bonta, Chair


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


          SUBJECT:  Centralized hospital packaging pharmacies:  medication  
          labels.


          SUMMARY:  Clarifies existing law regarding medication labeling  
          requirements for centralized hospital packaging pharmacies by  
          requiring any label for each unit dose medication produced by a  
          centralized hospital packaging pharmacy to include certain  
          information on a human-readable label.  Contains an urgency  
          clause to ensure that the provisions of this bill go into  
          immediate effect upon enactment.  Specifically, 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 medications administration software  
            permits health care practitioners to ensure, before medication  
            is administered to a patient, that it is the right  
            medications, for the right patient, in the right dose, and via  
            the right route of administration.











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          3)Requires any label for each unit dose medication produced by a  
            centralized hospital packaging pharmacy 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;



             c)   The quantity of each active ingredient;



             d)   Special storage or handling requirements;



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



             f)   The name of the centralized hospital packaging pharmacy.



          4)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,










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             c)   The National Drug Code Directory number.



          5)Clarifies that centralized hospital packaging pharmacies are  
            preparing sterile compounded unit dose drugs.
          EXISTING LAW:


          1)Provides for the practice of pharmacy and the licensing and  
            regulation of pharmacies and pharmacists by the Board of  
            Pharmacy (Board) within the Department of Consumer Affairs.





          2)Allows that a hospital pharmacy license to include a  
            centralized hospital pharmacy physically located outside of  
            the hospital or at a separate facility that is located within  
            a 75-mile radius and is under common ownership.



          3)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  








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               to inpatients.





          4)Specifies that a centralized hospital pharmacy may perform the  
            functions in 3) above only if the following information is  
            barcoded to be readable at the patient's bedside and the  
            following information is retrievable:  the date the medication  
            was prepared, the components used in the drug product, the lot  
            number or control number; the expiration date; the National  
            Drug Code Directory number; and, the name of the centralized  
            hospital packaging pharmacy.



          5)Requires the label for each unit dose medication produced by a  
            centralized hospital packaging pharmacy to contain the  
            expiration date, the established name of the drug, the  
            quantity of the active ingredient, and any special storage or  
            handling requirements.



          6)Requires all specialized compounding and packaging functions  
            to be performed only in the licensed centralized hospital  
            packaging pharmacy, and for the pharmacy to comply with all  
            applicable federal and state statutes and regulations.



          7)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.
          FISCAL EFFECT:  This bill has not been analyzed by a fiscal  
          committee.









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          COMMENTS: 


          1)PURPOSE OF THIS BILL.  According to the author, this bill is a  
            clean-up measure to AB 377 (Solorio), Chapter 687, Statutes of  
            2012, which requires specific data to be contained within  
            barcodes on medicine labels for use within centralized  
            hospital packaging pharmacies.  The author states that the  
            goal of AB 377 was to make it easier for hospitals to set up,  
            and invest in, high-tech central pharmacies in order to reduce  
            medication errors.  Unfortunately, hospital technology  
            development and procurement has not moved as quickly as  
            anticipated.  The author notes that, additionally, the Board  
            has opined that wording in current law requires that only  
            barcodes now be used on medication and this has resulted in  
            the Board spending staff time and money issuing waivers to  
            hospitals to allow them to operate while technology catches  
            up.  The author concludes that this bill clarifies that data  
            are allowed to be contained both within the barcode and in  
            human readable form, and includes much needed definitions that  
            will allow the Board to continue to provide oversight and  
            regulation in this area.

          2)BACKGROUND.  In 2012 the Governor signed AB 377 into law,  
            which allowed hospitals to create centralized hospital  
            packaging pharmacies (CHPPs) that can serve multiple  
            institutions under common ownership.  AB 377 also requires  
            that medications produced in a CHPP be barcoded and that the  
            barcode retrieve specific information, such as the expiration  
            date and lot number, which can be read when the barcode is  
            scanned at the patient's bedside.  However, as noted by the  
            author, the Board's new legal interpretation has suggested  
            that certain specific information required on the barcode,  
            also be immediately viewable on a screen.  This is problematic  
            because current technology does not allow for this, making it  
            difficult for hospitals to establish CHPPs. 

            The Board has subsequently created a waiver for which  








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            hospitals can apply that allows the required information to be  
            physically listed on the label rather than being accessible in  
            electronic, barcode format.  These waivers are only for a five  
            year term.  


          3)SUPPORT.  The California Society of Health-System Pharmacists  
            (CSHP), the sponsor of this bill, states it will address the  
            gap between current healthcare technologies and the new law  
            afforded by AB 377, improving patient safety and ensuring the  
            optimal use of medication.  CSHP notes that AB 377 was a  
            positive policy change in that it allowed hospitals to  
            establish these special pharmacies offsite of the main  
            hospital campus, allowing for the purchasing and placement of  
            large robotic packing and filling tools, which often are not  
            useable in hospitals simply due to space restrictions, and  
            that these tools dramatically decrease medication errors and  
            save lives.
            The California Hospital Association (CHA) states in support  
            that this bill ensures that centralized hospital packaging  
            pharmacies can continue to operate and serve their member  
            hospitals efficiently.  CHA notes that a new legal  
            interpretation has suggested that the specific retrievable  
            information from the barcode be immediately viewable on a  
            screen upon scanning the barcode is problematic because  
            current technology does not allow for this function.  By  
            requiring the information to be displayed on a human-readable  
            label, CHA concludes that this bill provides a long-term  
            solution while maintaining the original intent of the law.


          4)PREVIOUS LEGISLATION. 

             a)   AB 2757 (Bocanegra) of 2014, was substantially similar  
               to this bill.  AB 2757 passed the Senate Business,  
               Professions and Economic Development Committee, but was not  
               heard in any other policy or fiscal committee.

             b)   AB 377 authorizes a centralized hospital packaging  








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               pharmacy to prepare medications, 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.

             c)   AB 2077 (Solorio) of 2010, in its final version, was  
               virtually identical to AB 377.  AB 2077 was vetoed by  
               Governor Arnold Schwarzenegger.  In his veto message, the  
               Governor expressed concern that the bill could result in "a  
               greater likelihood of product mix-up, loss of product  
               identity, contamination and cross-contamination, and lack  
               of adequate control systems." 

             d)   AB 1370 (Solorio) of 2009 was similar to AB 377 but  
               would have created a separate licensing category for  
               centralized hospital pharmacies.  AB 1370 was held in the  
               Assembly Committee on Business, Professions and Consumer  
               Protection.

             e)   SCR 49 (Speier), Chapter 123, Statutes of 2005, creates  
               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.

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

          5)DOUBLE REFERRAL.  This bill is double referred; upon passage  
            in this Committee, this bill will be referred to the Assembly  
            Business & Professions Committee.
          
          REGISTERED SUPPORT / OPPOSITION:


          Support









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          California Society of Health-System Pharmacists (sponsor) 
          California Association of Physician Groups
          California Hospital Association
          California Pharmacists Association
          Providence Health & Services, Southern California Region


          Opposition


          None on file.


          Analysis Prepared by:Lara Flynn / HEALTH / (916) 319-2097