Plan B OTC: What Pharmacists Need to Know
Seena Zierler-Brown, PharmD, FAACP
Jenny A. Van Amburgh, PharmD, CDE
The Food and Drug Administration (FDA) approved Plan B® (levonorgestrel 0.75mg) for nonprescription status on August 24, 2006. Plan B is the only form of emergency contraception (EC) approved to prevent pregnancy after unprotected intercourse. FDA officials had originally denied recommendations from the scientific advisor to move Plan B over-the-counter in 2003. The rejection was based on insufficient evidence of safety for self-administration among teenagers. Barr Pharmaceuticals, the manufacturer of Plan B, resubmitted an application for patients above the age of sixteen; however, the FDA compromised and elected to limit sales to women and men 18 years of age and older without a prescription. National distribution of the newly packaged product began in November 2006. Girls under the age of eighteen will still need a prescription unless they reside in a state that has collaborative practice based on a statewide protocol, which may also allow advanced provision. Currently there are nine states that allow women to obtain EC directly from a pharmacist without requiring a prescription from a physician or other health care provider. Washington was the first state, followed by California, Alaska, New Mexico, Hawaii, Maine, New Hampshire, Massachusetts, and Vermont.
Levonorgestrel is a synthetic form of progesterone which inhibits ovulation from occurring. Other purported mechanisms include interfering with fertilization, immobilizing sperm by altering uterine pH and preventing implantation by disrupting the uterine lining and thickening cervical mucus. According to the World Health Organization, there are no contraindications to the use of Plan B. However, patients should be advised that it does not protect against sexually transmitted infections (STIs). EC will not disrupt an established pregnancy.
Ideally, Plan B should be taken as soon as possible after unprotected intercourse. If the first dose is taken within 72 hours of unprotected intercourse, followed by a second dose 12 hours later, Plan B is 89% effective at preventing pregnancy. However, clinical evidence suggests some efficacy upwards of 120 hours after unprotected intercourse.1,2 Von Hertzen et al. and Arowojollu et al. compared efficacy and adverse events when both tablets were taken as a single dose (SD) versus the typical two dose (TD) regimen [1 dose followed by a 2nd dose 12 hours later]. In both studies, SD efficacy was comparable to TD efficacy (Arowojolu: 93.4% SD vs. 87.5% TD) (Von Hertzen: 82% SD vs. 77% TD).3,4
Adverse effects of Plan B include nausea (23%), vomiting (6%), breast tenderness (10-47%), abdominal pain/cramping (18%), headache (17%), and menstrual changes (50%). The incidence of adverse events is similar whether given as a SD versus TD, with a slight increase in headache, breast tenderness, and potential for a delay or early onset of menses by seven days with both doses are taken at once.
There remains some controversy over an individual pharmacist’s right to refuse to dispense medications they have moral opposition to. In July 1999, at the request of the American Pharmacists Association™, the New Jersey Pharmacists Association passed a resolution urging the Board of Pharmacy to recognize "the individual pharmacist's right to exercise conscientious refusal" while urging the establishment of a process that would ensure patients' access to legally prescribed therapy. Furthermore, 5 states (Illinois, Arkansas, Georgia, Mississippi, and South Dakota) have enacted conscience clause laws similar to those that shield physicians. A pharmacist conscience clause law permits a pharmacist to refuse to fill prescriptions for drugs he or she does not agree with and in some instances, this refusal may occur without having to ensure that the prescription can be realistically filled elsewhere.
Plan B is the first product to be marketed with "dual-status" (OTC for individuals 18 years of age or older and by prescription for women 17 years of age or younger) in the United States. Fortunately, this dual status places the product behind the counter, where pharmacists have a unique opportunity to educate and inform consumers about EC. Below are several key points for pharmacists:
- Plan B is used after intercourse to prevent pregnancy. A pelvic exam is not required before using EC.
- EC does not disrupt an established pregnancy.
- The first tablet should be taken by mouth as soon as possible after unprotected intercourse and a second dose taken 12 hours later. Plan B is FDA approved for use within 72 hours after unprotected intercourse. Available research indicates that Plan B is effective in reducing the risk of pregnancy when taken as 2 tablets in one dose and for up to 120 hours after unprotected intercourse.
- Common side effects of Plan B include nausea, vomiting, breast tenderness, abdominal pain or cramping, and headache. The patient should expect their period within one week of when it is normally due.
- There are no known contraindications for use.
- Women and men ages 18 and older may purchase Plan B with a government issued form of identification (for proof of age). Individuals are not required to provide photo identification or to sign a registry for pharmacy record keeping.
- If a woman is under 18 or has no government issued identification, she must present a prescription for Plan B unless she in one of the nine states with pharmacist-access to EC, in which case the pharmacist could provide the product under the established protocol.
- For more information:
References:
1. Ellertson C, Evans M, Ferden S, et al. Extending the time limit for starting the Yuzpe regimen of emergency contraception to 120 hours. Obstet Gynecol. 2003;101:1168-71.
2. Rodrigues I, Grou F, Joly J. Effectiveness of emergency contraception pills between 72 and 120 hours after unprotected sexual intercourse. Am J Obstet Gynecol. 2001;184:531-7.
3. Von Herzen H, Piaggio G, Ding J, et al. Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO multicentre randomized trial. Lancet. 2002; 360:1803-10.
4. Arowojulu AO, Okewolw IA, Adekunle AO. Comparative evaluations of the effectiveness and safety of two regimens of levonorgestrol for emergency contraception in Nigerians. Contraception. 2002;66:269-73.
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