BILL ANALYSIS                                                                                                                                                                                                    



                                                                       


           ------------------------------------------------------------ 
          |SENATE RULES COMMITTEE            |                  SB 1169|
          |Office of Senate Floor Analyses   |                         |
          |1020 N Street, Suite 524          |                         |
          |(916) 445-6614         Fax: (916) |                         |
          |327-4478                          |                         |
           ------------------------------------------------------------ 
           
                                         
                                 THIRD READING


          Bill No:  SB 1169
          Author:   Alpert (D)
          Amended:  5/30/01
          Vote:     21

           
           SENATE HEALTH & HUMAN SERV. COMMITTEE  :  7-1, 5/23/01
          AYES:  Ortiz, Chesbro, Figueroa, Kuehl, Romero,  
            Vasconcellos, Vincent
          NOES:  Haynes


           SUBJECT  :    Pharmacy

           SOURCE  :     Public Health Institute


           DIGEST  :    This bill authorizes pharmacists to initiate  
          emergency contraception drug therapy in certain  
          circumstances.

           ANALYSIS  :    Under existing law, a pharmacist may not, in  
          general, furnish a dangerous drug except upon the  
          prescription of a physician, dentist, podiatrist,  
          optometrist, or veterinarian.  However, existing law  
          provides for certain exemptions.

          This bill authorizes a pharmacist to initiate emergency  
          contraception drug therapy in accordance with written  
          guidelines or protocols previously established and approved  
          for his or her practice by a practitioner authorized to  
          prescribe drugs.

          The bill requires the pharmacist to provide the recipient  
                                                           CONTINUED





                                                               SB 1169
                                                                Page  
          2

          of the emergency contraception drugs with a standardized  
          fact sheet that includes, but is not limited to, the  
          indications for use of the drug, the appropriate method for  
          using the drug, the need for medical follow-up, and other  
          appropriate information.  Requires the Board of Pharmacy to  
          develop this form in consultation with the American College  
          of Obstetricians and Gynecologists, a state pharmacy  
          association, and other health care organizations.

           Comments  

          Emergency contraception (EC) drug therapy, commonly  
          referred to as the "morning after pill" are hormone pills  
          that when taken within 72 hours of unprotected intercourse,  
          reduce the chance of a woman becoming pregnant by about 75  
          percent.  The hormones are regular birth control pills  
          containing estrogen and progestin, taken in two doses.  In  
          California and Washington, there is also available an EC  
          pill known as "Plan B" made from synthetic progestin.  The  
          EC pills provide a short, high burst of hormone exposure  
          that disrupts the hormone patterns essential for pregnancy.  
           The EC pills reduce the hormone release from the ovary and  
          the development of the uterine lining is disturbed, the  
          disruptions are temporary, however, lasting only a few  
          days.  Depending on the time during the menstrual cycle  
          when the EC pills are taken, they prevent pregnancy by  
          inhibiting or delaying ovulation, or altering the lining of  
          the uterus thereby inhibiting implantation of a fertilized  
          egg.  The EC pills can also prevent sperm from fertilizing  
          an egg.  EC pills do not cause an abortion.  Because  
          implantation occurs five to seven days after fertilization,  
          EC pills work before implantation and not after a woman is  
          already pregnant.

          The U.S. Food and Drug Administration (FDA) has ruled that  
          birth control pills require a prescription and therefore  
          cannot be sold over the counter.  In 1996, the FDA ruled  
          that an oral contraceptive regimen is safe and effective  
          for emergency use.  Following that issuance, the American  
          College of Gynecologists and Obstetricians (ACOG) issued a  
          Practice Pattern on EC discussing the risk and benefits,  
          administering pills, and identifying women who are  
          candidates for EC.  In December, 2000, the American Medical  
          Association approved a resolution asking the government to  







                                                               SB 1169
                                                                Page  
          3

          consider making EC pills available over the counter.  The  
          AMA's Report on the Council on Medical Service, calls for  
          physicians and other health professionals to play a more  
          active role in providing education about access to  
          emergency contraception.

           Legislative History
           
          AB 261 (Lempert), Chapter 375 of 1999, expanded the duties  
          of pharmacists to include adjusting the drug regimen of a  
          patient pursuant to a specific written order or  
          authorization made by the patient's physician.  Previously,  
          pharmacists were authorized to do this by the patient's  
          prescriber for the individual patient, in accordance with  
          the policies, procedures, or protocols of a health care  
          facility, home health agency, licensed clinic, or health  
          plan.  

          This change has allowed the operation of the Pharmacy  
          Access Partnership.  The Partnership, funded by a $2.2  
          million grant from the David and Lucile Packard Foundation,  
          operates in approximately 40 pharmacies and clinics in  
          California.  The program matches neighborhood pharmacies  
          and clinics and sets up the proper authorizations for  
          patients to purchase the EC pills from the participating  
          pharmacies whenever they need it.  The project is modeled  
          after one in Washington state where over 30,000 women have  
          received EC pills direct from local pharmacies.  In  
          California, the participating pharmacies set aside a  
          private area where the druggists counsel women and the  
          pharmacists are required to notify the woman's clinic when  
          she receives the pills.

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

           SUPPORT  :   (Verified  5/23/01) (Unable to reverify support  
          and opposition at time of this writing)

          Public Health Institute (source)
          California Medical Association
          Planned Parenthood

           ARGUMENTS IN SUPPORT :    The Public Health Institute, the  







                                                               SB 1169
                                                                Page  
          4

          bill's sponsor, writes that there are over three million  
          unplanned pregnancies each year in the U.S. and that the  
          American College of Gynecologists and Obstetricians  
          estimates that readily available emergency contraception  
          could help eliminate over half of the abortions performed.   
          They also write that the American Medical Association, the  
          American College of Gynecologists, and the California  
          Medical Association have approved resolutions supporting  
          these products be made available on an over-the-counter  
          basis.  Planned Parenthood additionally notes that for  
          several decades, EC pills have been prescribed to women and  
          millions of women around the world have used EC safely and  
          effectively.


          CP:sl  5/30/01   Senate Floor Analyses 

                         SUPPORT/OPPOSITION:  SEE ABOVE

                                ****  END  ****