BILL ANALYSIS ---------------------------------------------------------- |Hearing Date:April 28, 2003 |Bill No:SB | | |490 | ---------------------------------------------------------- SENATE COMMITTEE ON BUSINESS AND PROFESSIONS Senator Liz Figueroa, Chair Bill No: SB 490Author:Alpert As Amended:April 24, 2003 Fiscal: Yes SUBJECT: Pharmacy; prescriptions. SUMMARY: Authorizes a pharmacist to furnish emergency contraception drug therapy in accordance with standardized procedures or protocol developed and approved by both the Board of Pharmacy and the Medical Board in consultation with the appropriate entities. Existing law: 1)Provides for the licensing and regulation of pharmacists under the jurisdiction of the Board of Pharmacy. 2)Provides for the licensing and regulation of physicians under the jurisdiction of the Medical Board. 3)Requires a pharmacist to provide consultation when furnishing drugs, with certain exceptions. 4)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. 5)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, SB 490 Page 2 quality assurance, referral to additional services, and documentation. 6)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. SB 490 Page 3 7)Requires the Board of Pharmacy to develop the fact sheet in consultation with the Department of Health Services, the American College of Obstetricians and Gynecologists, the California Pharmacists Association, and other health care organizations. This bill: 1)Additionally authorizes a pharmacist to furnish emergency contraception drug therapy in accordance with standardized procedures or protocol developed and approved by both the Board of Pharmacy and the Medical Board, in consultation with the American College of Obstetricians and Gynecologists, the California Pharmacist Association and other appropriate entities. 2)Provides that the Medical Board shall have the authority, with the Board of Pharmacy, to ensure compliance and that these boards are specifically charged with the enforcement of this provision with respect to their respective licensees. 3)Provides that the new law created by this measure shall not be construed to expand the authority of the pharmacist to prescribe any prescription medication. FISCAL EFFECT: Unknown. COMMENTS: 1.Purpose. According to information provided by the Author's office, the intent of this measure is to further expand access to emergency contraception thereby preventing unintended pregnancy and reducing abortion in California. While existing law (created by SB 1169 and discussed in Comment #2b below) 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. 2.Background. a) What is emergency contraception? According to the Office of Population Research at Princeton University, which operates an emergency contraception website, SB 490 Page 4 emergency contraceptives are methods of preventing pregnancy after unprotected 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. 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 called progestin, and is specially packaged and labeled for use as the brand name Plan B . Plan B reduces the risk of pregnancy by 89%. Some people call emergency contraception pills "morning after pills." But women can start the pills right away or up to five days after unprotected sex. Therapy is more effective the earlier it is initiated within the 120-hour window . b) SB 1169 (Alpert, Chap. 900, Statutes of 2001). SB 1169 authorizes a pharmacist, who has completed a specified training program, to initiate emergency contraception in accordance with standardized procedures or protocols developed by the pharmacist and an authorized prescriber. Additionally, requires the pharmacist, for each emergency contraception drug therapy initiated, to provide the recipient of the emergency contraception drugs with a standardized fact sheet (created by the Board of Pharmacy) 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. SB 1169 was sponsored by the Public Health Institute and was intended to make emergency contraception easily accessible to women in order to dramatically reduce unintended pregnancies and abortions. c) Existing Protocol Structure Not Resulting in Adequate Participation. According to proponents of the measure, each pharmacist in California must locate and secure protocols with an individual medical doctor. Only about 14% of all retail pharmacies open SB 490 Page 5 to the public provide emergency contraception therapy. About 40% of the pharmacies that offer emergency contraception therapy experience occasions when they cannot provide this service due to a lack of pharmacists with protocols. About 85% of the more than 700 emergency contraception protocols in use in California have been signed by a handful of public-spirited physicians. d) This measure heard by the Senate Health and Human Services Committee. This is the second policy committee hearing on this measure. This measure was heard by the Senate Health and Human Services on April 2, 2003, and was approved by a vote of 7 to 1. 1.Related Measure This Session. SB 545 (Speier) among other things, provides that a pharmacist can initiate emergency contraception drug therapy without having to complete a training program and that the pharmacist cannot charge a separate consultation fee to a patient seeking the therapy. SB 545 is sponsored by the American College of Obstetricians and Gynecologists. It was heard by this Committee on April 7, 2003, and was approved by a vote of 4 to 1. SB 490 Page 6 SUPPORT AND OPPOSITION: Support (to the March 27, 2003 version): Public Health Institute (Sponsor) American College of Obstetricians and Gynecologists California Commission on the Status of Women California Medical Association California Pharmacist Association California National Organization for Women California Women Lawyers Planned Parenthood, Golden Gate Planned Parenthood, Los Angeles Planned Parenthood, Mar Monte Planned Parenthood of Santa Barbara, Ventura and San Luis Obispo Counties Opposition :None reported to the Committee as of April 22, 2003. Consultant:Kristin J. Triepke