BILL ANALYSIS                                                                                                                                                                                                    






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


          BILL NO:       SB 490                                       
          S
          AUTHOR:        Alpert                                       
          B
          AMENDED:       March 27, 2003
          HEARING DATE:  April 2, 2003                                
          4
          FISCAL:        Business and Professions / Appropriations    
          9
                                                                      
          0
          CONSULTANT:  
          Hansel / ak
                                        

                                     SUBJECT
                                         
              Pharmacists:  Emergency contraception drug therapy.

                                     SUMMARY  

          This bill authorizes a licensed pharmacist to initiate  
          emergency contraception drug therapy in accordance with a  
          standardized procedure approved by the Board of Pharmacy  
          and the Medical Board.

                                     ABSTRACT  

          Existing law:
          1.Regulates the practice of pharmacy by the California  
            State Board of Pharmacy.

          2.Prohibits a pharmacist from furnishing a dangerous drug  
            except upon the prescription of a physician, dentist,  
            podiatrist, optometrist, or veterinarian.

          3.Allows a pharmacist to administer, orally or topically,  
            drugs and biologicals pursuant to a prescriber's order.

          4.Authorizes a pharmacist to initiate emergency  
            contraception drug therapy in accordance with  
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            standardized protocols developed by the pharmacist and an  
            authorized prescriber acting within his or her scope of  
            practice.

          This bill:
          1.Authorizes a pharmacist to initiate emergency  
            contraception drug therapy in accordance with a  
            standardized procedure or protocol approved by the  
            Medical Board of California and Board of Pharmacy, in  
            consultation with the American College of Obstetricians  
            and Gynecologists and other appropriate entities.

          2.Requires the Medical Board, for purposes of the procedure  
            or protocol to be developed, to designate an authorized  
            prescriber.

          3.Requires a pharmacist, prior to furnishing emergency  
            contraception, to receive training regarding the  
            appropriate use and indications for emergency  
            contraception.

                                  FISCAL IMPACT  

          Unknown, probably minor costs for the Medical Board and the  
          Pharmacy Board to develop a protocol for pharmacists to  
          administer emergency contraception.

                            BACKGROUND AND DISCUSSION  

          SB 1169 (Alpert, Chapter 900, Statutes of 2001) created  
          authority for a pharmacist to initiate emergency  
          contraception drug therapy in accordance with standardized  
          procedures or protocols developed by the pharmacist and an  
          authorized prescriber acting within their scope of  
          practice.  Emergency contraception therapy is a drug  
          regimen that reduces the chance of pregnancy significantly  
          if administered within 72 hours of unprotected intercourse.

          SB 1169 requires a pharmacist, prior to initiating  
          emergency contraception drug therapy, to complete a  
          training program on emergency contraception, covering the  
          conduct of sensitive communications, quality assurance,  
          referral to additional services, and documentation.  For  
          each therapy regimen initiated by the pharmacist, the  
          pharmacist must provide the recipient of the emergency  
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          contraception services with a standardized fact sheet,  
          developed by the Board of Pharmacy, that includes the  
          indications for the drug, the appropriate method for using  
          the drug, the need for medical follow-up, and other  
          information.  

          SB 490 adds a second process under which pharmacists can  
          provide emergency contraception therapy that is  
          standardized and does not require pharmacists to develop  
          their own protocol in conjunction with authorized  
          prescribers.

          The American Medical Association and the American College  
          of Obstetricians and Gynecologists have recommended that  
          emergency contraception be granted over-the-counter status  
          by the Food and Drug Administration. 

          Arguments in Support
          According to proponents, SB 490 will further expand access  
          to emergency contraception, thereby reducing unintended  
          pregnancies in California.  
























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          According to the author and proponents, although SB 1169 of  
          2001 allows pharmacists to provide emergency contraception  
          to patients under a protocol developed by the pharmacist  
          and an authorized prescriber, the current system is  
          cumbersome and presents significant barriers to  
          pharmacists.  In addition, few physicians have participated  
          in the development of protocols for pharmacist  
          administration of emergency contraception due to  
          malpractice concerns.  As a result, only about 14 percent  
          of all retail pharmacies in the state provide emergency  
          contraception.  This bill would address these problems by  
          establishing a standard protocol under which pharmacists  
          may provide emergency contraception to patients.

          According to the author, New Mexico currently permits its  
          Board of Pharmacy to develop a standard protocol for  
          emergency contraception.

          Comments
          The California Academy of Family Physicians opposed the  
          provision of the bill as introduced which made the Board of  
          Pharmacy principally responsible for developing the  
          alternative protocol for pharmacists to follow in  
          administering emergency contraception.  With the most  
          recent amendments to the bill, which require the protocol  
          to be developed by the Board of Pharmacy and the Medical  
          Board, in consultation with the American College of  
          Obstetricians and Gynecologists and other appropriate  
          entities, the Academy has removed their opposition.

          Related Bills
          SB 545 (Speier), currently in the Senate Business and  
          Professions Committee and scheduled to be referred to  
          Senate Health and Human Services Committee, would remove  
          the training requirement for pharmacists who wish to  
          provide emergency contraception.  The bill would also  
          prohibit pharmacists from charging a separate consultation  
          fee if they provide emergency contraception and limit the  
          dispensing fee charged for emergency contraception drugs to  
          the Medi-Cal dispensing fee. 

          Prior Legislation
          SB 1169 (Alpert), Chapter 900, Statutes of 2001
          AB 261 (Lempert) Chapter 375, Statutes of 1999

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                                    POSITIONS  

          Support:       Public Health Institute (sponsor)
                         American College of Obstetricians and  
          Gynecologists
                         California Abortion and Reproductive Rights  
          Action League
                         California Commission on the Status of Women
                         California Family Health Council
                         California Medical Association
                         California Women Lawyers
                         Institute for Health Policy Studies
                         Planned Parenthood, Los Angeles
                         Planned Parenthood Affiliates of California
                         San Francisco Health Plan
                         Six Rivers Planned Parenthood
                         Three individual

          Oppose:   None received.

                                   -- END --