BILL ANALYSIS                                                                                                                                                                                                    



                                                                  AB 2660
                                                                  Page  1

          Date of Hearing:   March 30, 2004

                            ASSEMBLY COMMITTEE ON HEALTH
                                 Rebecca Cohn, Chair
                     AB 2660 (Leno) - As Amended:  March 26, 2004
           
          SUBJECT  :   Prescriptions: issuance by a pharmacist.

           SUMMARY  :   Revises existing law that permits qualified  
          pharmacists to initialize and adjust drug therapies in clinical  
          settings for the purpose of registering with the United States  
          Drug Enforcement Agency (DEA).   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  








                                                                  AB 2660
                                                                  Page  2

            a training program on emergency contraception drug therapy.

          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 a person has a valid prescription for that drug.

           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  :   

           1)PURPOSE OF THE BILL  .  This bill would make the appropriate  
            changes to qualify pharmacists to register for a DEA number  
            and therefore initiate or adjust controlled substance drug  
            therapy.

           2)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.  The 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.  

          The DEA issued registration numbers to qualified California  
            pharmacists prior to the passage of SB 816 (Escutia) Chapter  
            749, Statutes of 1999.  SB 816 specifically designated  
            certified nurse-midwives, nurse practitioners and physician  








                                                                  AB 2660
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            assistants as mid-level practitioners, but left out  
            pharmacists.  This exclusion resulted in the DEA categorizing  
            pharmacists apart from other health providers who otherwise  
            are permitted to initiate or adjust controlled or  
            non-controlled substances.  As a result, pharmacists have been  
            denied DEA registration numbers have been unable to assist  
            physicians in managing controlled substance drug therapies.  

           3)SUPPORT  .  According to Kaiser Permanente Medical Care Program  
            (KPMCP), this bill would allow pharmacists to continue to help  
            physicians manage prescription drug therapies by restoring  
            their ability to initiate or adjust drug therapies under  
            physician protocols.  KPMCP states that the DEA formerly  
            issued registration numbers to California pharmacists but  
            stopped after the Legislature passed a law that recognized  
            nurse practitioners and physician assistants as mid-level  
            practitioners.  Since pharmacists were not included in that  
            designation, the DEA implied that pharmacists are not  
            mid-level practitioners and therefore were not entitled to  
            registration numbers. 

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

           REGISTERED SUPPORT / OPPOSITION  :   

           Support 
           
          California Association of Physician Groups
          Kaiser Permanente Medical Care Program 

           Opposition 
           
          None
           
          Analysis Prepared by :    Clara Craven / HEALTH / (916) 319-2097