Monday, August 20, 2012

California Senate Rules Committee: Proposed Law Regarding Compounding At Centralized Hospital Packaging Pharmacy


SENATE RULES COMMITTEE            |                   AB 377|
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                                 THIRD READING


          Bill No:  AB 377
          Author:   Solorio (D)
          Amended:  8/6/12 in Senate
          Vote:     21

           
           SENATE BUSINESS, PROF. & ECON. DEV. COMM. :  9-0, 6/13/11
          AYES:  Price, Emmerson, Corbett, Correa, Hernandez, Negrete 
            McLeod, Vargas, Walters, Wyland

           SENATE APPROPRIATIONS COMMITTEE  :  6-0, 8/13/12
          AYES:  Kehoe, Walters, Alquist, Lieu, Price, Steinberg
          NO VOTE RECORDED:  Dutton

           ASSEMBLY FLOOR :  70-0, 5/12/11 (Consent) - See last page 
            for vote


           SUBJECT  :    Pharmacy

           SOURCE  :     California Hospital Association


           DIGEST  :    This bill authorizes 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.

           ANALYSIS  :    

          Existing law:
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          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. 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.

          3. 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 Department 
             of Corrections and Rehabilitations or Department of 
             Youth Authority.  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.  Specifies that the pharmacy 
             services provided shall be directly related to the 
             services or treatment plan administered in the physical 
             plant. 

          4. State that any pharmacy that contracts to compound a 
             drug for parenteral therapy, pursuant to a prescription, 
             for delivery to another pharmacy, must report that 
             contractual arrangement to the Board within 30 days of 
             commencing that compounding.

          This bill:

          1. This bill allows a centralized hospital packaging 
             pharmacy to prepare medications 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.

          2. Authorizes a centralized hospital to perform the 
             following specialized functions if each unit dose is 



 



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             barcoded as specified:

             A.    Preparing unit dose packages for single 
                administration to inpatients from bulk containers.

             B.    Preparing compounded unit dose drugs for 
                parenteral therapy for administration to 
                inpatients.

             C.    Preparing compounded unit dose drugs for 
                administration to inpatients.

          3. Defines "common ownership" to mean that the ownership 
             information on file with the Board for the licensed 
             pharmacy is consistent with the ownership information on 
             file for the other licensed pharmacy or pharmacies.

          4. Requires, in addition to pharmacy license requirement 
             described in current law, a centralized hospital 
             packaging pharmacy to obtain a specialty license from 
             the Board prior to engaging in the functions authorized 
             by this bill.

          5. Requires the Board, before issuing and renewing the 
             specialty license, to inspect the pharmacy and ensure 
             that the pharmacy is in compliance with this bill and 
             regulations it has established.

          6. States a license to perform the functions described in 
             this bill shall only be issued to a pharmacy that is 
             licensed by the Board as a hospital pharmacy, and that 
             the license shall be renewed annually and is not 
             transferrable.

          7. Sets the fee for issuance or annual renewal of a 
             centralized hospital packaging pharmacy license at $600 
             and allows it to be increased by the Board to $800.

          8. Allows a centralized hospital packaging pharmacy to 
             prepare and store a limited quantity of the unit dose 
             drugs in advance of receipt of a patient-specific 
             prescription in a quantity as is necessary to ensure 
             continuity of care for an identified population of 
             inpatients of the general acute care hospital based on a 



 



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             documented history of prescriptions for that patient 
             population.

          9. Requires any unit dose medication produced by a 
             centralized hospital packaging pharmacy to be barcoded 
             to be readable at the inpatient's bedside.  Upon reading 
             the barcode, the following information shall be 
             retrievable:

             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 lot number.

             F.    The name of the centralized hospital packaging 
                pharmacy.

          10.Requires the label for each unit dose medication 
             produced by a centralized hospital packaging pharmacy to 
             contain all of the following:

             A.    The expiration date.

             B.    The established name of the drug.

             C.    The quantity of the active ingredient.

             D.    Special storage or handling requirements.

          11.Requires all compounding and packaging functions be 
             performed only in the licensed centralized hospital 
             packaging pharmacy and that pharmacy shall comply with 
             all applicable federal and state statutes and 
             regulations, including, but not limited to, regulations 
             regarding compounding and, when appropriate, sterile 
             injectable compounding.

          12.Requires a centralized hospital packaging pharmacy and 
             the pharmacists working in the pharmacy be responsible 



 



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             for the integrity, potency, quality, and labeled 
             strength of any unit dose drug product prepared by the 
             centralized hospital packaging pharmacy.

           Background
           
          Existing law requires medications for a hospital's patients 
          to be prepared by a licensed pharmacy located on the 
          hospital's premises.  Automated processes implemented by a 
          hospital or health system have the potential to provide 
          additional patient protection through a reduction in 
          medication errors.  Many medication errors in hospitals 
          have resulted from inadequate and inconsistent labeling and 
          a lack of proper mechanisms to track medication through the 
          distribution process to the patient.  Recent reports show 
          that technology like bar-coding facilitates more efficient 
          medication administration and decreases medication errors.  
          According to a study published in the New England Journal 
          of Medicine, "Effect of Bar-Code Technology on the Safety 
          of Medication Administration," use of the bar-code 
          substantially decreased the rate of errors as well as 
          potential adverse drug events.  The report also concluded 
          that the bar-code electronic medication administration is 
          an important intervention to improve patient safety. 

           Food and Drug Administration (FDA).   Repackaging, 
          distribution, and compounding in advance of a patient 
          prescription are activities currently available only to 
          licensed manufacturers, which are regulated by the United 
          States FDA.  Last year, in an email pertaining to a 
          Virginia hospital using a model as proposed in this bill, 
          which is virtually identical to AB 2077 (Soloria, 2010), 
          the FDA stated that "Ýthe proposed health facility 
          pharmacy] system does not need to register as a 
          repacker/relabeler as long as they are servicing their own 
          hospitals within the state of California and repackaged 
          drugs are not commercially distributed and used only within 
          your hospital facilities."  While there has not been an 
          official change in FDA policy, it is clear in the FDA's 
          Compliance Policy Guide (460.200) as follows:  "FDA will 
          continue to defer to state authorities regarding pharmacy 
          compounding of human drugs."

           Board Compounding Regulations  .   New regulations governing 



 



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          compounding took effect last summer.  According to the 
          Board, a Workgroup on Compounding was formed in 2004 
          comprised of board members, Board staff and industry 
          representatives.  The workgroup recognized that current 
          pharmacy regulations addressing compounding only govern the 
          physical circumstances, procedures and record keeping 
          requirements for general compounding and do not address 
          quality, strength or purity.

          The Board adopted regulations in Article 7 of Division 17 
          of Title 16 of the California Code of Regulations 
          (commencing with Section 1751) to implement provisions for 
          pharmacies that compound sterile injectable products as 
          required in statute.  As there were no similar provisions 
          in regulation for general compounding, the Board approved 
          the addition of language that will establish parameters and 
          provide uniformity for pharmacies that carry out 
          compounding in general (including sterile injectable).  
          Pharmacies that compound sterile injectable products must 
          go above and beyond the requirements for compounding in 
          general.

           FISCAL EFFECT  :    Appropriation:  No   Fiscal Com.:  Yes   
          Local:  Yes

          According to the Senate Appropriations Committee, minor 
          costs annually to the Board from the Pharmacy Board 
          Contingent Fund, offset by fees.  Potentially major costs 
          annually to the Department of Public Health from the 
          Licensing and Certification Program Fund.

           SUPPORT  :   (Verified  8/14/12)

          California Hospital Association (source)
          AmerisourceBergen
          Board of Pharmacy
          California Pharmacists Association
          California Society of Health-System Pharmacists
          Los Angeles County
          Mercy
          Sharp
          University of California, San Francisco School of Pharmacy





 



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           ASSEMBLY FLOOR  : 
          AYES: Achadjian, Allen, Ammiano, Atkins, Beall, Bill 
            Berryhill, Block, Blumenfield, Bonilla, Bradford, 
            Brownley, Buchanan, Butler, Charles Calderon, Campos, 
            Carter, Chesbro, Cook, Davis, Dickinson, Donnelly, Eng, 
            Feuer, Fletcher, Fong, Fuentes, Furutani, Beth Gaines, 
            Galgiani, Gatto, Gordon, Grove, Hagman, Halderman, Hall, 
            Harkey, Hayashi, Hill, Huber, Hueso, Huffman, Jeffries, 
            Jones, Knight, Lara, Logue, Ma, Mansoor, Mendoza, Miller, 
            Monning, Morrell, Nestande, Nielsen, Norby, Olsen, Pan, 
            Perea, V. Manuel Pérez, Silva, Skinner, Smyth, Solorio, 
            Swanson, Valadao, Wagner, Wieckowski, Williams, Yamada, 
            John A. Pérez
          NO VOTE RECORDED: Alejo, Cedillo, Conway, Garrick, Gorell, 
            Roger Hernández, Bonnie Lowenthal, Mitchell, Portantino, 
            Torres


          JJA:do  8/14/12   Senate Floor Analyses 

                         SUPPORT/OPPOSITION:  SEE ABOVE

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