- CONDITION CENTERS
This recent uproar underscores a truth well known to pharmacists—medical and prescription drug decisions concerning sexual matters are often controversial. In fact, these drugs are controversial even among pharmacists. Regardless of religious beliefs, political persuasions, or personal opinion, emergency contraception is now available, and pharmacists need to know the basics of unwanted pregnancy and “morning after” contraception.
About half of all pregnancies are unplanned.1 Unwanted pregnancy is life-changing, especially for adolescents and young adults, the age demographic in which it is most likely to occur. In the United States, more than 1 million unwanted pregnancies occur annually.2 Women—and adolescents in particular—who become pregnant before they are ready or able to care for a child are faced with hard decisions: abort, carry the child and give it up for adoption, raise the child, live at home and ask their parents to care for it, etc. Whatever the decision, it has profound impact. Unplanned pregnancy often leads to poor perinatal care, unstable family dynamics, and financial distress.1 The Table provides current facts about young women’s sexual activity.
Emergency contraception (EC)—the morning after pill or the copper IUD— can prevent unintended pregnancy when more reliable forms of birth control were not used, were used improperly, or failed. To be effective, EC must be used soon after sexual activity; accessibility and convenience are key factors in successful use. Originally offered by prescription only, EC pills (ECPs) are now provided behind the counter or over the counter, offering several advantages compared with prescription-only products including convenience and availability during extended pharmacy hours outside of a clinic setting. They are not intended to be a routine birth control method, although most women seeking emergency contraception need, but have not used, regular contraception. They also cannot be used to terminate established pregnancy.7
In the United States, several ECPs have dual-label status (both OTC and prescription-only). Progestin-only options are available without prescription for women and men 17 years and older as Plan B One-Step, Next Choice, or Levonorgestrel (generic) tablets. No screening or counseling is required. Females who are younger than 17 years need a prescription. These are not the only emergency contraceptives available, however.
Standard Oral Contraceptives
Clinicians working in reproductive health have known for decades that certain regimens could be used for emergency contraception. These were refered to as post-coital contraception or the Yuzpe method and were admittedly off-label.8,9 Researchers at Yale University first determined that certain estrogenic drugs with progestin could prevent egg fertilization in macaques in 1966,10 and pursued research in humans. Once human regimens were identified, clinicians prescribed commercially available oral contraceptives, instructing the patient to take 2 appropriate doses 12 hours apart. This method is still used, and Princeton University’s Office of Population Research & Association of Reproductive Health Professionals maintains a website that explains which birth control pills can be used as EC (http://ec.princeton.edu/questions/dose.html#dose). Side effects are generally mild, and may include nausea and vomiting, cramping, breast tenderness, and menstrual changes.
Currently, levonorgestrel is used most often as an EC. Current research suggests that its primary mechanism of action is delaying ovulation. Any levonorgestrel-containing product should be taken as soon as possible, but no later than 72 hours after unprotected intercourse as either two 0.75 mg doses taken 12 hours apart or one 1.5 mg dose. Its efficacy is well established; pregnancy is still possible. In clinical trials, 20% to 30% of women who received levonorgestrel became pregnant.11,12 Side effects are generally mild and self-limiting. These pills cause less vomiting than standard oral contraceptives; other side effects are the same.
Ulipristal acetate is the latest FDA-approved ECP, available by prescription only. It, too, delays ovulation and delays follicular maturation. Ulipristal may modulate the endometrium. Given as a single oral dose, ulipristal acetate 30 mg effectively prevents pregnancy if taken within 120 hours (5 days) of unprotected sexual intercourse. Ulipristal may be more effective than levonorgestrel during the entire 5-day period following unprotected sexual intercourse.13 Ulipristal is generally well tolerated, with a similar tolerability profile to that of levonorgestrel. Menses may be delayed 2 to 3 days following treatment.
The Copper IUD
Although used less often than oral methods, the copper-releasing intrauterine device (IUD) can be used as emergency contraception. Other IUDs are not effective as EC. If inserted within 5 days after unprotected intercourse, it reduces risk of unwanted pregnancy by more than 99%—a rate significantly higher than that of the oral methods.14 Copper IUDs have several well-known risks and side effects, including pain and cramping at insertion, heavy bleeding in subsequent periods, and small risks of perforation, infection, and expulsion. When a skilled clinician inserts the device, risks are minimized.15
One barrier to using the copper IUD as EC is that the patient must schedule an appointment with a health care provider. This device is not cost-effective as a one-time emergency contraception. It is, however, an appropriate alternative for women also who also need regular contraception. It becomes cost-effective in 1 year, and within 5 years, it is considered the most cost-effective contraceptive available.16
This review does not cover the many issues that create controversy and stimulate discussion about morning after contraception. Pharmacists can find ample discussion of these issues elsewhere. Pharmacists will need to know their state’s specific regulations about dispensing ECPs—laws vary widely, and change often. In some states, pharmacists can prescribe progestin-only prescription ECPs for women who have public or private insurance coverage. In all states, pharmacists can provide patient support by making sure all employees know that ECPs are available.
Many patients will have questions and need comprehensive counseling, although some will not. Pharmacists will need to use their best counseling skills to determine if patients want information and then how much to provide.
1. Gold RB, Sonfield A, Richards CL, el al. Next steps for America’s family planning program: leveraging the potential of Medicaid and Title X in an evolving health care system. www.guttmacher.org/ pubs/NextSteps.pdf.
2. Center for Disease Control, National Vital Statistics Report (2009). Estimated pregnancy rates in the United States, 1990-2005: an update (Vol. 58). www.cdc.gov/nchs/data/nvsr/nvsr58/nvsr58_04.pdf.
3. Abma JC, Martinez GM, Copen CE. Teenagers in the United States: sexual activity, contraceptive use, and childbearing, national survey of family growth 2006-2008. Vital Health Stat 23. 2010;30:1-47.
4. Eaton DK, Kann L, Kinchen S, et al. Centers for Disease Control and Prevention (CDC). Youth risk behavior surveillance—United States, 2009. MMWR Surveill Summ. 2010;59:1-142.
5. Hamilton BE, Martin JA, Ventura SJ. Births: preliminary data for 2010. National Vital Statistics Reports. www.cdc.gov/nchs/data/nvsr/nvsr60/nvsr60_02.pdf. Published November 2011. Accessed December 13, 2011.
6. New government data finds sharp decline in teen births: increased contraceptive use and shifts to more effective contraceptive methods behind this encouraging trend [press release]. New York, NY: Guttmacher Institute; December 1, 2011. www.guttmacher.org/media/inthenews/2011/12/01/index.html. Accessed December 12, 2011.
7. Centers for Disease Control and Prevention. U.S. Medical Eligibility Criteria for Contraceptive Use, 2010. MMWR Morb Mortal Wkly Rep. 2010;59:1-85.
8. Barnett B. Emergency contraception as a backup method. Network. 1997;17:12-13.
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10. Kunjappu MJ. Pioneering studies of the “morning-after” pill. Yale J Biol Med. 2011;84:109-111.
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13. Sullivan JL, Bulloch MN. Ulipristal acetate: a new emergency contraceptive. Expert Rev Clin Pharmacol. 2011;4:417-427.
14. Cheng L, Gülmezoglu AM, Piaggio G, Ezcurra E, Van Look PF. Interventions for emergency contraception. The Cochrane Database of Systematic Reviews 2008, Issue 2. Art No.: CD001324. doi:10.1002/14651858.CD001324.pub3.
15. Wu S, Godfrey EM, Wojdyla D, et al. Copper T380A intrauterine device for emergency contraception: a prospective, multicentre, cohort clinical trial. BJOG. 2010;117:1205-1210.
16. Trussell J, Lalla AM, Doan QV, Reyes E, Pinto L, Gricar J. Cost effectiveness of contraceptives in the United States. Contraception. 2009;79:5-14.
17. Grimes DA, Raymond EG. Emergency contraception. Ann Intern Med. 2002;137:180-189.18. American Academy of Pediatrics Committee on Adolescence: emergency contraception. Pediatrics. 2005;116:1026-1035.