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 SENATE APPROPRIATIONS COMMITTEE : Senate Rule 28.8 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. CONTINUED SB 1169 Page 2 The bill requires the pharmacist to provide the recipient 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 Obstetricians and Gynecologists issued a Practice Pattern on EC discussing the risk and benefits, administering pills, and identifying women who are SB 1169 Page 3 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 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.: Yes Local: No SUPPORT : (Verified 6/5/01) Public Health Institute (source) California Medical Association Planned Parenthood California Pharmacists Association SB 1169 Page 4 American College of Obstetricians and Gynecologists California Society of Health System Pharmacists ARGUMENTS IN SUPPORT : The Public Health Institute, the bill's sponsor, writes that there are over three million unplanned pregnancies each year in the U.S. and that the American College of Obstetricians and Gynecologists 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 Obstetricians and 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 6/5/01 Senate Floor Analyses SUPPORT/OPPOSITION: SEE ABOVE **** END ****