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 Continued--- STAFF ANALYSIS OF SENATE BILL 490 (ALPERT) Page 2 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 Continued--- STAFF ANALYSIS OF SENATE BILL 490 (ALPERT) Page 3 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. Continued--- 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 Continued--- STAFF ANALYSIS OF SENATE BILL 490 (ALPERT) Page 5 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 --