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 1 FISCAL: NonFiscal 1 6 CONSULTANT: 9 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 Continued--- STAFF ANALYSIS OF SENATE BILL 1169 (Alpert) Page 2 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 Continued--- STAFF ANALYSIS OF SENATE BILL 1169 (Alpert) Page 3 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. Continued--- STAFF ANALYSIS OF SENATE BILL 1169 (Alpert) Page 4 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 Continued--- STAFF ANALYSIS OF SENATE BILL 1169 (Alpert) Page 5 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 Continued--- STAFF ANALYSIS OF SENATE BILL 1169 (Alpert) Page 6 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. Continued--- 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 Continued--- STAFF ANALYSIS OF SENATE BILL 1169 (Alpert) Page 8 -- END --