BILL ANALYSIS                                                                                                                                                                                                    






                        SENATE HEALTH AND HUMAN SERVICES
                               COMMITTEE ANALYSIS
                        Senator Deborah V. Ortiz, Chair


          BILL NO:       SB 1169                                      
          S
          AUTHOR:        Alpert                                       
          B
          AMENDED:       May 15, 2001
          HEARING DATE:  May 23, 2001                                 
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          FISCAL:        NonFiscal                                    
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          CONSULTANT:                                                 
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          Flores / ak
                                        

                                     SUBJECT
                                         
                                    Pharmacy

                                     SUMMARY  

          This bill would authorize pharmacists to initiate emergency  
          contraception drug therapy in certain circumstances.

                                     ABSTRACT  

          Existing law:
          1.Authorizes pharmacists, notwithstanding any other  
            provision of law, to perform the following tasks:
            a.   Furnish a reasonable quantity of compounded  
               medication to a prescriber for office use by the  
               prescriber.
            b.   Transmit a valid prescription to another pharmacist.
            c.   Administer, orally or topically, drugs and  
               biologicals pursuant to a prescriber's orders.
            d.   Manufacture, measure, fit to the patient, or sell  
               and repair dangerous devices or furnish instructions  
               to the patient or the patient's representative  
               concerning the use of the device.
            e.   Provide consultation to patients and professional  
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               information or consultation to other health care  
               professionals.

          1.Authorizes pharmacists, notwithstanding any other  
            provision of law, to perform the following procedures in  
            a licensed health care facility in accordance with  
            policies, procedures, or protocols developed by health  
            professionals, including physicians, pharmacists, and  
            registered nurses, provided the pharmacists have received  
            appropriate training as prescribed in the policies and  
            procedures of the licensed health care facility:
            a.   Order or perform routine drug therapy-related  
               patient assessment procedures including temperature,  
               pulse, and respiration.
            b.   Order drug therapy-related patient laboratory tests.
            c.   Administer drugs and biologicals by injection  
               pursuant to a prescriber's order.
            d.   Initiate or adjust the drug regimen of a patient  
               pursuant to an order or authorization made by the  
               patient's prescriber.

          1.Authorizes pharmacists, notwithstanding any other  
            provision of law, to perform the following procedures as  
            part of the care provided by a health care facility,  
            licensed home health agency, licensed clinic, a provider  
            who contracts with a licensed health care service plan  
            with regard to care provided to plan enrollees, or a  
            physician in accordance with policies, procedures, or  
            protocols provided the pharmacist has either successfully  
            completed clinical residency training or demonstrated  
            clinical experience in direct patient care delivery:
            a.   Order or perform routine drug therapy-related  
               patient assessment procedures including temperature,  
               pulse, and respiration.
            b.   Order drug therapy-related patient laboratory tests.
            c.   Administer drugs and biologicals by injection  
               pursuant to a prescriber's order.
            d.   Adjust the drug regimen of a patient pursuant to a  
               specific written order or authorization made by the  
               patient's prescriber for the individual patient, and  
               in accordance with the policies, procedures, or  
               protocols of the facility, agency, clinic, health  
               plan, or physician.

          1.Specifies that a patient's prescriber may prohibit, by  
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            written instruction, any adjustment or change in the  
            patient's drug regimen by the pharmacist.

          2.Requires the policies, procedures, or protocols referred  
            to in point 3 above be developed by health care  
            professionals, including physicians, pharmacists, and  
            registered nurses, and meet specific requirements  
            including that the pharmacist function as part of a  
            multidisciplinary group that includes physicians and  
            direct care registered nurses and that the group  
            determine the appropriate participation of the pharmacist  
            and direct care registered nurse.  

          3.With respect to the authority granted under point 3  
            above, requires the following:
            a.   Medical records of the patient be available to both  
               the patient's prescriber and the pharmacist.
            b.   The procedures to be performed by the pharmacist  
               relate to a condition for which the patient has first  
               been seen by a physician.
            c.   Except for procedures provided by a health care  
               facility, licensed clinic in which there is physician  
               oversight, or a provider who contracts with a licensed  
               health care plan, requires the procedures to be  
               performed in accordance with a written,  
               patient-specific protocol approved by the treating or  
               supervising physician.  Requires any change to an  
               approved preexisting treatment or drug therapy be  
               provided in writing to the treating or supervising  
               physician within 24 hours.
          
          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.

                                  FISCAL IMPACT  

          The bill would have no direct fiscal impact; however, the  
          bill could result in unknown savings to the extent it  
          results in fewer unwanted pregnancies among individuals  
          receiving Medi-Cal and/or CalWORKs benefits.

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                            BACKGROUND AND DISCUSSION  

          What is Emergency Contraception Drug Therapy?
          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. (  http://ec.princeton.edu.html  )

          Side effects are similar to those associated with prolonged  
          use of birth control pills.  Temporary side effects include  
          nausea and vomiting, headache, breast tenderness,  
          dizziness, and fluid retention.  No serious health problems  
          have been reported with EC pills, however, similar to the  
          rare complications cited in birth control pill use,  
          complications include blood clots in the legs, heart  
          attack, stroke, liver damage, liver tumor, gallbladder  
          disease, and high blood pressure. Plan B has been shown to  
          be better tolerated by women and be more effective than  
          with a combined estrogen and progestin bill.  For both  
          pills, the earlier treatment is initiated, the greater the  
          rate of efficacy.  (Patient Care, March 15, 2001, Page 20;  
           http://ec.princeton.edu.html  )

          In a study published in the New England Journal of Medicine  
          in July, 1998, titled The Effects of Self-Administering  
          Emergency Contraception, the authors concluded that there  
          were no serious adverse effects and "making emergency  
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          contraception more easily obtainable does no harm and may  
          reduce the rate of unwanted pregnancies."

          Can EC Pills Cause Birth Defects?
          There have been no reliable studies of births to women who  
          were already pregnant when they took EC pills or following  
          the failure of them to prevent pregnancy.  However, studies  
          of births to women who were pregnant and continued to take  
          oral contraceptives have found no increased risk of birth  
          defects.  In fact, the U.S. Food and Drug Administration  
          removed warnings about adverse effects of oral  
          contraceptives on the fetus from the birth control pills'  
          insert several years ago.   
          (  http://ec.princeton.edu/questions/bdfect.html  )

          What is the Difference between EC Pills and RU-486?
          RU-486 is a completely different drug from that used in  
          birth control pills and in EC pills.  RU-486 is  
          mifepristone and belongs to a new class of drugs known as  
          antiprogestins.  Mifepristone blocks the hormone  
          progesterone that is needed for pregnancy to continue.   
          Mifepristone, when used together with another medicine  
          called misoprostol, is used to end an early pregnancy (49  
          days or less since the last menstrual period began).  The  
          drugs break down the lining of a woman's uterus and make  
          the uterus eject the embryo.  RU-486 is known as the  
          "abortion pill" because it works after implantation in the  
          uterus has occurred.   
          (http://www.fda.gov/cder/drug/infopage/mifepristone/mifepris 
          tone-qa.htm)

          U.S. Food and Drug Administration
          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  
          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  
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          active role in providing education about access to  
          emergency contraception.  (Contraceptive Technology Update,  
          Gebruary, 2001, pages 17-18)

          Legislative History
          In 1999, AB 261 (Lempert) was passed and signed into law.   
          AB 261 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.   
















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          Letters in Support
          The Public Health Institute, the bill's sponsor, writes  
          that there are over 3 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 ACOG, 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. 
                              QUESTIONS AND COMMENTS  

          1.Current law allows pharmacists to dispense EC pills for  
            patients for whom they have a written authorization by  
            the patient's physician.  SB 1169 would allow pharmacists  
            to dispense EC pills for any woman, based on established  
            written guidelines or protocols by a practitioner  
            authorized to prescribe drugs.  This change would allow  
            women to receive the EC pills directly from the  
            pharmacist without having first to see their doctor.

          2.EC pills are covered under the state's Medi-Cal and  
            Family PACT programs.   

          3.Although birth control pills have been used as EC since  
            the mid-nineteen sixties, drug manufacturers were  
            unwilling to seek official FDA approval for their use as  
            an EC.  In 1994, the FDA was petitioned to force oral  
            contraceptive manufacturers to add emergency use to its  
            labeling, but the FDA did not order the firms to do this,  
            and instead issued the advisory on their safe and  
            effective use.  [Lancet, July 6, 1996; 348 (9019): 53]

                                    POSITIONS  

          Support:       Public Health Institute (sponsor)
                         California Medical Association
                         Planned Parenthood

          Oppose:   None received

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