BILL ANALYSIS ------------------------------------------------------------ |SENATE RULES COMMITTEE | SB 1169| |Office of Senate Floor Analyses | | |1020 N Street, Suite 524 | | |(916) 445-6614 Fax: (916) | | |327-4478 | | ------------------------------------------------------------ UNFINISHED BUSINESS Bill No: SB 1169 Author: Alpert (D), et al Amended: 9/4/01 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 SENATE FLOOR : 24-10, 6/6/01 AYES: Alarcon, Alpert, Bowen, Burton, Chesbro, Costa, Dunn, Figueroa, Karnette, Kuehl, Machado, McPherson, Murray, Ortiz, Peace, Perata, Polanco, Romero, Scott, Sher, Speier, Torlakson, Vasconcellos, Vincent NOES: Ackerman, Battin, Brulte, Haynes, Johannessen, Johnson, Knight, Margett, Oller, Poochigian ASSEMBLY FLOOR : 53-20, 9/6/01 - See last page for vote SUBJECT : Pharmacy SOURCE : Public Health Institute DIGEST : This bill permits a pharmacist to initiate emergency contraception drug therapy in accordance with standardized procedures or protocols developed by the pharmacist and an authorized prescriber. CONTINUED SB 1169 Page 2 Assembly amendments : 1. Require the pharmacist to complete a training program on emergency contraception. 2. Incorporate language included in AB 826 (Cohn), pending the Governor's signature, to avoid chaptering out if both bills are enacted and become law. 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: 1. Permits a pharmacist to initiate emergency contraception drug therapy in accordance with standardized procedures or protocols developed by the pharmacist and an authorized prescriber who is acting within his or her scope of practice. 2. Requires a pharmacist, prior to initiating emergency contraception drug therapy, to complete a training program on emergency contraception, delivered by an American Council on Pharmaceutical Education provider or another training program approved by the Board of Pharmacy. Requires this training program to include, but not be limited to, conduct of sensitive communications, quality assurance, referral to additional services, and documentation. 3. Requires a pharmacist, for each emergency contraception drug therapy initiated, 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. 4. Requires the board to develop the fact sheet required in #3 above in consultation with the Department of Health Services, the American College of Obstetricians and SB 1169 Page 3 Gynecologists (ACOG), the California Pharmacists Association, and other health care organizations. Specifies that this bill does not preclude the use of existing publications developed by nationally recognized medical organizations. 5. Incorporates changes proposed by AB 826 (Cohn), pending the Governor's signature, to avoid chaptering out if both bills are enacted and become law. Comments According to the author, this bill seeks to make emergency contraception available to women who are at risk of an unwanted pregnancy. The author states that making emergency contraception available to women will reduce the number of abortions. The author notes that emergency contraception differs from RU-486 in that it does not cause an abortion, but rather prevents a pregnancy. Under this bill, the author states that women who have had unprotected intercourse and do not want to risk becoming pregnant will be able to obtain emergency contraception in a pharmacy provided the pharmacy has a collaborative physician protocol. The net effect of this bill is to make emergency contraception available in a pharmacy, without first having to make an appointment with your physician to obtain a prescription. According to the Office of Population Research at Princeton University, which operates the Emergency Contraception World Wide Web server, emergency contraceptives are methods of preventing pregnancy after sexual intercourse. There are two types of emergency contraceptive pills. One type uses hormones that are the same type and dose as hormones used in some kinds of ordinary birth control pills. These hormones are called estrogen and progestin, and one brand name called Preven is especially packaged and labeled for emergency use, although other brands packaged for ongoing contraception can be used for emergency use as well. Use of this type of contraception cuts the chance of pregnancy by 75%. The other type of emergency contraceptive pill contains only the hormone progestin, and is specially packaged and labeled for use as the brand name Plan B. Plan B reduces the risk of pregnancy by 89%. Women can start SB 1169 Page 4 the pills right away or up to three days after unprotected sex, and it is more effective the earlier it is initiated within the 72 hour window. Depending on the time during the menstrual cycle that the emergency contraception pills are taken, emergency contraception pills may inhibit or delay ovulation, inhibit tubal transport of the egg or sperm, interfere with fertilization, or alter the endometrium (the lining of the uterus), thereby inhibiting implantation of a fertilized egg. Emergency contraception does not cause an abortion. Emergency contraception prevents pregnancy and thereby reduces the need for induced abortion. FISCAL EFFECT : Appropriation: No Fiscal Com.: Yes Local: No SUPPORT : (Verified 9/7/01) Public Health Institute (source) California Medical Association Planned Parenthood California Pharmacists Association American College of Obstetricians and Gynecologists California Society of Health System Pharmacists California Coalition of Nurse Practitioners California Coalition for Reproductive Freedom California Conference of Local Health Officers California State Board of Pharmacy California Women Lawyers California Women's and Children's Health Coalition Commission on the Status of Women Kaiser Permanente National Organization for Women ARGUMENTS IN SUPPORT : This bill is sponsored by the Public Health Institute (PHI), which states that more than three million unplanned pregnancies occur each year in the United States. Making emergency contraception easily accessible to women can dramatically reduce unintended pregnancies and abortions. PHI states that several medical organizations representing physicians have developed resolutions supporting emergency contraception pills being made available to women on an over-the-counter basis. SB 1169 Page 5 While the federal Food and Drug Administration has stated that emergency contraception pills are safe and effective, there is no indication it will change the class of these products from prescription to over-the-counter. PHI states that California has no authority to grant drugs over-the-counter status, but there are significant steps California can take to broaden access to emergency contraception pills. PHI states that under current law, pursuant to recent legislation, consumers can receive services such as emergency contraception in pharmacies, under limited protocols. The current protocol requirements must be patient-specific for a condition for which that patient has seen their physician. PHI states that while programs utilizing this authority to provide emergency contraception have been developed in several counties, these programs have found a significant limitation in the ability to provide service under the narrow protocol requirements of current law. For instance, women who do not have a physician cannot currently access this safe and effective service in a pharmacy. PHI states that this bill will broaden current law by allowing all women in need to obtain emergency contraception services in a pharmacy, provided the pharmacy has a collaborative physician protocol. ASSEMBLY FLOOR : AYES: Alquist, Aroner, Calderon, Canciamilla, Cardenas, Cardoza, Chan, Chavez, Chu, Cohn, Corbett, Correa, Daucher, Diaz, Dutra, Firebaugh, Frommer, Goldberg, Harman, Havice, Horton, Jackson, Keeley, Kehoe, Koretz, Liu, Longville, Lowenthal, Maldonado, Matthews, Migden, Nakano, Nation, Negrete McLeod, Oropeza, Rod Pacheco, Papan, Pavley, Reyes, Richman, Salinas, Shelley, Simitian, Steinberg, Strom-Martin, Thomson, Vargas, Wayne, Wesson, Wiggins, Wright, Zettel, Hertzberg NOES: Aanestad, Ashburn, Bogh, Briggs, Bill Campbell, John Campbell, Cox, Dickerson, Florez, Hollingsworth, Kelley, La Suer, Leonard, Leslie, Maddox, Mountjoy, Pescetti, Runner, Strickland, Wyman CP:sl 9/8/01 Senate Floor Analyses SUPPORT/OPPOSITION: SEE ABOVE SB 1169 Page 6 **** END ****