BILL ANALYSIS                                                                                                                                                                                                    



                                                                       


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                                 THIRD READING


          Bill No:  AB 2660
          Author:   Leno (D)
          Amended:  4/12/04 in Assembly
          Vote:     21

           
           SENATE BUSINESS & PROFESSIONS COMMITTEE  :  6-0, 6/14/04
          AYES:  Figueroa, Aanestad, Brulte, Cedillo, Machado,  
            Vincent
          NO VOTE RECORDED:  Murray

           SENATE APPROPRIATIONS COMMITTEE  :  Senate Rule 28.8

           ASSEMBLY FLOOR  :  72-0, 4/29/04 (Passed on Consent) - See  
            last page for vote


           SUBJECT  :    Prescriptions:  issuance by a pharmacist

           SOURCE  :     Kaiser Permanente


           DIGEST  :    This bill amends existing law to reinstate  
          pharmacists authority to register with the U.S. Drug  
          Enforcement Agency (DEA) and therefore initiate or adjust  
          controlled substance drug therapy under specified  
          conditions.

           ANALYSIS  :    Existing law:

          1.Provides for the licensure and regulation by the State  
            Board of Pharmacy (Board) of pharmacies, pharmacists, and  
            pharmacy practices.

                                                           CONTINUED





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          2.Defines "prescription," in part, as being issued by  
            designated healing arts practitioners, not including a  
            pharmacist.

          3.Makes specific requirements for issuing prescriptions for  
            a controlled substance, and requires a copy of the  
            prescription to be submitted to the Department of Justice  
            at the end of the month in which the prescription was  
            filled.

          4.Authorizes pharmacists to furnish, transmit, and  
            administer prescription medication.  Authorizes them to  
            perform routine drug therapy-related patient assessment  
            procedures, including temperature, pulse and respiration,  
            ordering drug therapy-related lab tests, administering  
            drugs and biologicals by injection, and initiating or  
            adjusting the drug regimen of a patient pursuant to an  
            order or authorization made by the patient's prescriber  
            in accordance with policies, procedures and protocols.   
            Allows pharmacists to furnish emergency contraception  
            drug therapy as long as the pharmacist completes a  
            training program on emergency contraception drug therapy.

          5.Allows certified nurse-midwives, nurse practitioners, and  
            physician assistants to order or furnish drugs or devices  
            under the supervision of a physician and surgeon.

          6.Allows a pharmacist, under physician supervision, who is  
            functioning as part of a multidisciplinary group in a  
            clinical setting, to initiate or adjust a drug therapy.

          7.Precludes any person from possessing a controlled  
            substance, unless a person has a valid prescription for  
            that drug.

          8.Prohibits the Board from issuing a pharmacy license to,  
            or renewing a pharmacy license of, specified persons,  
            including those who are authorized to write a  
            prescription.

          This bill:

          1.Revises the definition of "prescription" to include a  
            drug order issued by a pharmacist under conditions  







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            specified where the pharmacist is authorized to initiate  
            or adjust the drug regimen of a patient. 

          2.Requires a pharmacist who is authorized to issue an order  
            to initiate or adjust a controlled substance therapy to  
            personally register with the DEA.

          3.Authorizes a person to possess a controlled substance  
            furnished under a drug order by a pharmacist under  
            specified conditions.

          4.Authorizes the Board to issue or renew a license for a  
            pharmacy that is owned and operated by a pharmacist who  
            is authorized to issue a drug order under specified  
            conditions.

          5.Makes other nonsubstantive technical changes.

           Comments  

          According to the author's office, until recently the DEA  
          issued registration numbers to qualified California  
          pharmacists.  However, based on legislation unrelated to  
          pharmacists that specifically authorized other mid-level  
          practitioners to furnish drugs under physician protocols  
          (but unintentionally excluded pharmacists), the DEA  
          believes that California law no longer allows them to do  
          so.  The Author states that this bill continues  
          pharmacists' ability to help physicians manage prescription  
          drug therapies by restoring their ability to initiate or  
          adjust drug therapies under physician protocols.

           Background  

          The California Pharmacist Practice Act allows specifically  
          authorized and specially qualified pharmacists to initiate  
          and adjust prescription drug therapy under protocols  
          jointly developed by physicians and pharmacists.  This  
          authority applies to both controlled and non-controlled  
          substances.  Controlled substances are also regulated by  
          federal law, which requires anyone handling controlled  
          substances to have a DEA registration number.  DEA issues  
          registration numbers to mid-level practitioners, in  
          accordance with state law.







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          The DEA used to issue registration numbers to qualified  
          California pharmacists because they were considered  
          mid-level practitioners. In 1999, the Legislature passed SB  
          816 (Escutia), Chapter 749, Statutes of 1999, which  
          specifically designated certified nurse-midwives, nurse  
          practitioners and physician assistants as mid-level  
          practitioners, so that they could continue to exercise  
          there authority to furnish drugs under physician protocols.

          However, SB 816 did not include pharmacists in its  
          provisions. This legislation was unrelated to pharmacists  
          and no one thought to include pharmacists or knew that this  
          would prevent pharmacists from assisting physicians with  
          drug therapy involving controlled substances.  As a result,  
          pharmacists have been denied DEA registration numbers and  
          have been unable to assist physicians in managing  
          controlled substance drug therapies, though state law still  
          permits them to do so.  This bill simply rectifies the  
          oversight of not including pharmacists as mid-level  
          practitioners in SB 816 and re-establishes the ability of  
          qualified pharmacists to work under a physician in  
          adjusting controlled substance drug therapy.

          The inability of pharmacists to continue to assist  
          physicians in managing controlled substance drug therapies  
          unnecessarily burdens physicians, who are required to  
          personally approve even the slightest adjustment to any  
          controlled substance therapy.  According to the Author's  
          office, this is particularly problematic in managing pain  
          therapy, which a qualified pharmacist could assist with  
          under this bill.

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

           SUPPORT  :   (Verified  6/28/04)

          Kaiser Permanente (source) 
          California Association of Nurse Practitioners (CANP)
          California Association of Physician Groups (CAPG)
          California Medical Association (CMA)
          California Pharmacists Association (CPhA)  
          California Retailers Association (CRA)







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          California Society of Health-System Pharmacists (CSHP)
          California State Board of Pharmacy

           ARGUMENTS IN SUPPORT  :   According to Kaiser Permanente  
          (Kaiser), the sponsor of this bill, the bill will allow  
          pharmacists to continue to help physicians manage  
          prescription drug therapies by restoring their ability to  
          initiate or adjust controlled substance drug therapies  
          under physician protocols.  Kaiser's support notes that the  
          bill will rectify the oversight that left pharmacists out  
          of state law designation as mid-level practitioners that  
          the DEA requires as a prerequisite to issuing its  
          registration number. 

          The California Association of Physician Groups (CAPG)  
          supports the bill because it encourages the managed care  
          delegated model of health care.  CAPG states that by  
          allowing pharmacists to initiate or adjust controlled drug  
          therapies, healthcare resources and physician time are  
          maximized, resulting in controlled health care costs.

          The bill is also supported by others including the  
          California Medical Association (CMA), the California State  
          Board of Pharmacy, and the California Retailers Association  
          for the same reasons as stated by Kaiser and CAPG.

           ASSEMBLY FLOOR  :
          AYES:  Aghazarian, Bates, Benoit, Berg, Bermudez, Bogh,  
            Calderon, Campbell, Canciamilla, Chan, Chavez, Chu,  
            Cogdill, Cohn, Corbett, Correa, Cox, Daucher, Diaz,  
            Dutra, Dutton, Dymally, Firebaugh, Frommer, Garcia,  
            Goldberg, Hancock, Harman, Jerome Horton, Shirley Horton,  
            Houston, Jackson, Keene, Kehoe, Koretz, La Malfa, La  
            Suer, Laird, Leno, Levine, Lieber, Liu, Longville,  
            Lowenthal, Maddox, Matthews, Maze, McCarthy, Montanez,  
            Mountjoy, Mullin, Nakanishi, Nakano, Nation, Negrete  
            McLeod, Oropeza, Parra, Reyes, Richman, Ridley-Thomas,  
            Runner, Salinas, Samuelian, Simitian, Spitzer, Steinberg,  
            Strickland, Wesson, Wolk, Wyland, Yee, Nunez
          NO VOTE RECORDED:  Haynes, Leslie, Maldonado, Pacheco,  
            Pavley, Plescia, Vargas, Wiggins


          CP:nl  6/28/04   Senate Floor Analyses 







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                         SUPPORT/OPPOSITION:  SEE ABOVE

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