Plan B Q & A

Lorie Rice, MPH, associate dean for external affairs, UCSF School of Pharmacy, and assistant clinical professor in the Department of Clinical Pharmacy, and Shareen El-Ibiary, PharmD, assistant professor in the department, answer our questions about Plan B emergency contraception and the FDA. Q. What is emergency contraception? A. Emergency contraception (EC) is a therapy to prevent pregnancy in women who have had unprotected intercourse. The sooner it is used, the more effective it is. EC is best used within 72 hours after unprotected intercourse, and is still effective within 120 hours after intercourse. Q. How does emergency contraception work? A. Emergency contraception is higher doses of hormones contained in oral birth control pills. Emergency contraception works by inhibiting ovulation and preventing fertilization of the egg. Emergency contraception will not disrupt an established pregnancy. It will not harm the fetus. Hormonal emergency contraception is not the same as mifepristone (RU-486). Q. How effective is emergency contraception in preventing pregnancy? A. Emergency contraception is effective, but not nearly as effective as some other methods, such as oral contraception taken daily. Depending on the method used, EC reduces the risk of pregnancy by 75 percent to 89 percent for each incident. It appears that emergency contraception is more effective the sooner it is started after unprotected sex. Q. What is the current status of Plan B? A. In general, Plan B is available to all women as a prescription drug. In California, emergency contraception, or Plan B, may be obtained from a pharmacist by anyone, regardless of age, without a physician's prescription, after consultation with a pharmacist on the proper use of emergency contraception. This provision stems from a bill passed by the California Legislature in 2001, which went into effect in 2002. Eight others states have Plan B pharmacy access programs, but some require parental consent at certain ages. Q. What is the FDA proposing regarding Plan B? A. Before anyone gets really excited, the FDA is only planning a second review of switching Plan B to an OTC (over-the-counter) drug. There is no assurance that this switch will be approved. In a 2005 press release from the FDA, then Commissioner Lester M. Crawford described the complication of this switch - issues beyond the usual safety and efficacy - and how this switch would be precedent-setting. Although the age restriction is one of the issues under discussion, it appears that the FDA is leaning toward Plan B being available to persons 18 or older as an OTC. This would raise questions - e.g., how would this be regulated? Would Plan B actually be in the OTC section of a pharmacy, or would it be behind the counter? Would a consumer have to show ID? Q. What would a switch mean in California? A. It would mean that consumers over the specified age would be able to purchase Plan B as an OTC. Consumers under the specified age would have to ask the pharmacist for the drug, and the pharmacist would dispense the drug under the current protocol in effect in the state since 2002. Q. How available has Plan B been without prescription in California pharmacies? A. A 2004 study found that 1,200 out of the state's 5,500 retail pharmacies offer emergency contraception without a physician's prescription. According to the study, as of 2004, pharmacy access to emergency contraception was available in 49 out of the state's 58 counties. "FDA Announces Plan to Review Plan B Contraceptive for Women 18 and Over" "Pharmacists Dispense with Conscience - Or Not?"