BILL ANALYSIS                                                                                                                                                                                                    



                                                                  AB 2660
                                                                  Page  1

          Date of Hearing:   April 13, 2004

                   ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS
                                  Lou Correa, Chair
                     AB 2660 (Leno) - As Amended:  April 12, 2004
           
          SUBJECT  :  Prescriptions: issuance by a pharmacist.  

           SUMMARY :  Amends existing law to reinstate pharmacists'  
          authority to register with the US Drug Enforcement Agency (DEA)  
          and therefore initiate or adjust controlled substance drug  
          therapy under specified conditions.  Specifically,  this bill  :  

          1)Authorizes a pharmacist to initiate and adjust prescription  
            drug therapies using controlled substances under specific  
            physician protocols; 

          2)Requires a pharmacist initiating or adjusting controlled  
            substances to register with the DEA; 

          3)Authorizes the Board of Pharmacy to issue new or renewal  
            licenses to pharmacists who initiate or adjust drug therapies  
            under specific circumstances; and, 

          4)Makes other nonsubstantive technical changes.

           EXISTING LAW  :

          1)Defines "prescription" and sets requirements on how medication  
            is dispensed and who is authorized to issue a prescription. 

          2)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.  

          3)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.  Allows pharmacists to furnish emergency  
            contraception drug therapy as long as the pharmacist completes  
            a training program on emergency contraception drug therapy.







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

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

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










































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          7)Existing federal law requires any person who dispenses or  
            proposes to dispense any controlled substance to obtain a  
            registration number from the Attorney General annually.

           FISCAL EFFECT  :  Unknown  

           COMMENTS  : 

          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.  Without DEA  
          numbers, qualified pharmacists cannot assist physicians with  
          drug therapy involving controlled substances, although they are  
          still permitted to initiate or adjust drug therapy involving  
          non-controlled substances.  

          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, but left out pharmacists.  
           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.  

          Without DEA numbers, qualified pharmacists are no longer allowed  
          to assist physicians with drug therapy involoving controlled  
          substances.  This, in turn, 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.

          Pharmacists were overlooked in 1999, although they had  







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          previously been allowed to adjust controlled substance drug  
          therapy.  This bill simply rectifies this oversight and  
          re-establishes the ability of qualified pharmacists to work  
          under a physician in adjusting controlled substance drug  
          therapy.

           REGISTERED SUPPORT / OPPOSITION  :  

           Support 
           
          Kaiser Permanente Medical Care Program (sponsor)
          California Association for Nurse Practitioners
          California Association of Physician Groups
          California Pharmacists Association

           Opposition 
           
          None on file.
           Analysis Prepared by  :    Rene? L. Brooks / B. & P. / (916)  
          319-3301