Filling the need for trusted information on health issues…

Trending on kff Enrollment Marketplaces Medicare Advantage

Emergency Contraception

Emergency contraception (EC), sometimes referred to as “the morning-after pill,” is a form of backup birth control that can be taken several days after unprotected intercourse or contraceptive failure and still prevent a pregnancy.  In 1999, Plan B® was the first product approved for use in the U.S. as an EC by the Food and Drug Administration (FDA).  In August 2010, the FDA approved a newer form of EC, known as ella® that is more effective and gives women an additional 48 hours to prevent unintended pregnancy than Plan B.1, 2  This fact sheet reviews current national and state policies around EC, including methods, patient awareness, access and availability, and insurance coverage.

What is EC?

Emergency contraception is used as a back-up birth control method to prevent unintended pregnancy in the event of unprotected sex, sexual assault, or a contraceptive failure, such as a condom breaking.  It is not intended for use as a regular contraceptive method.

Major Methods of Emergency Contraception, Availability and Policy in the U.S.

Table 1: Major Methods of Emergency Contraception, Availability and Policy in the U.S.

There are several methods of EC (Table 1), but only two forms are FDA approved to be used as EC in the U.S. The first form of EC to be made available in the U.S. was a pre-packaged dose of pills containing progestin levonorgestrel.  Progestins are hormones found in daily oral contraceptives. EC is marketed today under the name Plan B® ,Next Choice®, or Levonorgestrel® (generic).  Levonorgestrel-based EC is the most widely used form of EC.  In 2010, the FDA approved ulipristal acetate, marketed as ella®, for sale and use in the U.S.  This EC product is classified as a selective progesterone-receptor modulator.1, 2

Copper-T intra-uterine devices (IUD), such as Paragard®, are also extremely effective as emergency contraception when inserted within 5 days of unprotected sex, but have not been approved by the FDA for use as an EC.3

Plan B ® AND Next Choice®

  • Initially, the Plan B® regimen required two pills, taken 12 hours apart.  Since then, Plan B One-Step® and the generic Next Choice One Dose® have become available and only require one pill.  Both forms are still available, but the two-pill regimen is gradually being replaced by the one pill regimen.4
  • Progestin-based EC is to be taken within 72 hours of unprotected sex in order to be most effective.2  Plan B reduces the likelihood of pregnancy by 81 to 90% when taken within 72 hours of intercourse.5
  • Progestin-based EC pills do not interrupt or adversely impact an established pregnancy, nor are they medical abortion drugs like mifepristone or methotrexate that end an established pregnancy.  Plan B prevents pregnancy by inhibiting or delaying ovulation or by making it harder for sperm to reach an egg.6, 7, 8
  • While there have not been any studies that specifically examine the long-term effects of EC on established pregnancies, there are not any known long-term negative effects for women taking high-dose birth control pills while in the early stages of pregnancy. Studies of women who inadvertently continued to take their daily birth control pills (the same hormones as EC) during the early weeks of pregnancy have shown no evidence of negative effects on the fetus.9
  • Some studies have found that levonorgestrel is not as effective in preventing pregnancy in overweight and obese women.10 Women with Body Mass Index thresholds greater than 25 are recommended to take ella.11  The effectiveness of ella appears to diminish at Body Mass Index thresholds above 35.12
  • There are no known serious side effects associated with progestin-based EC; 50% of women experience nausea and 20% vomiting.2, 13

ella®

  • Ella is a single-dose ulipristal acetate pill that is effective in preventing pregnancy up to five days after unprotected intercourse, giving women a longer timeframe to prevent unintended pregnancy than Plan B.14  Ella became available in the U.S. in 2010, and unlike progestin-based EC, a prescription is required for ella for people of all ages.  Its mechanism of action is similar to that of progestin-based EC.  
  • Study findings show that side effects for ella are comparable to those for Plan B.15

Women’s Knowledge and Use of EC

Although health care providers have known about EC for several decades, awareness and use of this option among women are still lagging.

  • Despite numerous public health and education interventions to increase awareness of EC, significant knowledge gaps exist.  A survey of postpartum women in the U.S. showed that 25% were not aware of EC at the beginning of their pregnancies.16
  • Eleven percent of women ages 15 to 44 (5.8 million) reported ever using EC at least once between 2006 and 2010, an increase from 4% in 2002.17
  • Providing EC to women before it is required is one strategy to promote its timely use.  Research suggests that advance provision of EC has the potential to be cost-saving and cost-effective in averting unintended pregnancies.18 However, studies have found that women who have an advance prescription or supply of EC are not more likely than women without an advance prescription to have unprotected sex or to use EC repeatedly.19, 20

Access and Availability

At least one form of EC has been available in the U.S. for over a decade and there have been a number of efforts to broaden women’s access to and awareness of EC, particularly since its effectiveness window is time-limited.

Over the Counter Access

  • Since March 2009, Plan B and its generic equivalent have been available without a prescription for men and women 17 and older, but adolescents under 17 have needed a prescription.  This policy has required that consumers obtain the pills directly from the pharmacist (behind the counter) and in some cases show ID for proof of age, rather than obtaining the package directly from the pharmacy shelves.
  • Since then, numerous efforts have been made to make EC available over the counter for all persons, regardless of age. In 2011, the FDA recommended that “Plan B One-Step should be approved for all females of child-bearing potential” without age and point-of-sale restrictions, meaning without a prescription requirement.  However, this recommendation was overruled in December 2011 by the Department of Health and Human Services (HHS), thus maintaining the prescription requirement for those under 17.
  • In April 2013, a federal judge upheld the FDA’s 2011 recommendation and ordered HHS to remove the point of sale and age restrictions and make the drug available without a prescription.21 After initially appealing the ruling, the Department of Justice and the FDA agreed to make Plan B One Step available over the counter without age restrictions in June 2013. However, in its response to the federal judge, the DOJ has stated that the FDA does not intend to make the two-pill Plan B regimen available OTC.22  No formal date has been announced for when the one-dose progestin-based EC pills will be available over the counter.
  • A prescription is still required for ella®.

Cost and Coverage

  • Plan B® pills sell for between $35 and $60.23  Women 17 years and older can buy these pills from the pharmacy counter without a prescription.
  • The Affordable Care Act requires all new private health plans to cover, without cost-sharing, all FDA-approved contraceptive drugs and devices as prescribed.  Without a prescription, women accessing EC over the counter will be required to pay the retail price.
  • Medicaid programs in at least 26 states cover over-the-counter EC.24  In many states, Medicaid policy requires women to present a doctor’s prescription in order for Medicaid to pay for EC.  Given the limited time window of effectiveness, waiting to get a doctor’s prescription may not be an option for women on Medicaid.25

Health Care Settings

  • Several major medical and public health organizations, such as the American Academy of Pediatrics, American College of Obstetricians and Gynecologists, American Medical Association, American Nurses Association, and the American Public Health Association, endorse the use of EC and advocate for broader access to EC.26, 27
  • Despite efforts to improve and standardize EC prescribing practices, EC is still not discussed regularly with women in the clinical setting.  Approximately half (51%) of obstetricians/gynecologists surveyed in 2008 reported they offer EC to all of their patients.28
  • Timely counseling about and access to EC are critical for teens since a greater proportion of their pregnancies are unintended.29  One study found that only 26% of pediatric residents counseled teens on EC during routine visits while 56% counseled during contraception visits.30
  • There have been ongoing efforts to make EC more readily available to survivors of sexual assault. Currently, 17 states and the District of Columbia require that emergency room staff offer EC to women after sexual assault (Figure 1).31  Still, some local studies have documented that a sizable share of hospitals do not routinely offer counseling, referral, or dispensation of EC to sexual assault survivors.32, 33

    Emergency Contraception Policies, by State, 2013

    Figure 1: Emergency Contraception Policies, by State, 2013

Pharmacists

  • Pharmacies are a critical point of EC access. EC has been kept behind the pharmacy counter to enforce the age limits, requiring all women and men to request EC from a clerk or pharmacist.
  • Nine states – AK, CA, HI, MA, ME, NH, NM, VT, and WA – allow women of all ages, including those under age 17, to obtain EC directly from a pharmacist without obtaining a physician’s prescription (Figure 1).31
  • At least five states – CA, IL, NJ, WA, WI – have measures that require pharmacies or pharmacists to fill all valid prescriptions.34  These policies have been enacted in part to responses to reports of pharmacists refusing to fill prescriptions for EC because they oppose its use on moral or religious grounds.35  Some studies have found that many pharmacists did not understand how EC worked nor the time frame for its effectiveness.36, 37, 38
  • Seven states – AR, AZ, GA, ID, IL, MS, SD – have laws allowing pharmacies and/or pharmacists to refuse to dispense EC on the basis of moral or ethical objections. Similar legislation has been introduced in at least eleven other states.31

EC on the Global Market

Outside the U.S., access to, availability, knowledge, and use of EC vary by country. Some governments have taken proactive measures towards increasing the provision and availability of EC while others have either banned or restricted EC use.

  • Internationally, the availability of the four methods of EC (combined pills, progestin-only pills, ulipristal acetate, copper IUD) depends on the policies of the country’s government or the donor organization’s leadership.39  A majority of countries (152) have registered at least one EC product.
  • Awareness of EC is also lagging in other countries.  Among married women ages 15 to 44, EC is the least known and used contraceptive method in 35 developing countries.40
Endnotes
  1. U.S. Food and Drug Administration, FDA News Release: FDA approves ella tablets for prescription emergency contraception, 2010.

    ← Return to text

  2. Trussell J et al., Preventing unintended pregnancy: the cost-effectiveness of three methods of emergency contraception, AJPH, 1997.

    ← Return to text

  3. Office of Population Affairs, Emergency Contraception Fact Sheet

    ← Return to text

  4. Office of Population Research at Princeton University, Plan B.

    ← Return to text

  5. Rodrigues I et al., Effectiveness of emergency contraceptive pills between 72 and 120 hours after unprotected sexual intercourse, Amer. J. of OB/GYN, 2002.

    ← Return to text

  6. Glasier A and Baird D, Emergency postcoital contraception, NEJM, 1997.

    ← Return to text

  7. Trussell J and Raymond EG, Statistical evidence concerning the mechanism of action of the Yuzpe regimen of emergency contraception, Ob/Gyn, 1999.

    ← Return to text

  8. Orlando Women’s Center, How does Emergency Contraception Work- FAQ’s

    ← Return to text

  9. Raman-Wilms L, et al., Fetal genital effects of first-trimester sex hormone exposure: a meta analysis, Ob/Gyn, 1995.

    ← Return to text

  10. Glasier A, Cameron ST, Blithe D, Scherrer B, Mathe H, Levy D, Gainer E, Ulmann A. Can we identify women at risk of pregnancy despite using emergency contraception? Data from randomized trials of ulipristal acetate and levonorgestrel. Contraception. 2011;84:363-7.

    ← Return to text

  11. Office of Population Research at Princeton University, Efficacy, May 2013.

    ← Return to text

  12. Moreau C, Trussell J. Results from pooled Phase III studies of ulipristal acetate for emergency contraception. Contraception. 2012;86:673-680.

    ← Return to text

  13. Task Force on Postovulatory Methods of Fertility Regulation, Randomised controlled trial of levonorgestrel versus the Yuzpe regimen of combined oral contraceptives for emergency contraception, The Lancet, 1998.

    ← Return to text

  14. Reproductive Health Technologies Project, A New Option for Emergency Contraception: The Facts on Ulipristal Acetate, 2010.

    ← Return to text

  15. Glasier A et al., Ulipristal acetate versus levonorgestrel for emergency contraception: a randomized non-inferiority trial and meta-analysis, The Lancet, 2010.

    ← Return to text

  16. Goldsmith KA et al., Unintended childbearing and knowledge of emergency contraception in a population-based survey of postpartum patients, Maternal and Child Health, 2008.

    ← Return to text

  17. Daniels K, Jones J, Abma, J, Use of Emergency ContraceptionAmong Women Ages 15-44: United States, 2006-2010, National Center for Health Statistics, Vital Health Stat 112, 2013.

    ← Return to text

  18. Foster D. et al., Should Providers Give Women Advance Provision of Emergency Contraceptive Pills? A Cost-Effectiveness Analysis, Women’s Health Issues, 2010.

    ← Return to text

  19. Raine T. et al., Direct access to emergency contraception through pharmacies and effect on unintended pregnancy and STIs: a randomized controlled trial, JAMA, 2005.

    ← Return to text

  20. Marston C et al., Impact of Contraceptive Practice of Making Emergency Hormonal Contraception Available Over the Counter in Great Britain: Repeated Cross-Sectional Surveys, British Medical Journal, 2005.

    ← Return to text

  21. Korman, Edward, “Annie Tummino, et al., v. Margaret Hamburg, Commissioner of Food and Drugs, et al.” United States District Court Eastern District of New York, 2013.

    ← Return to text

  22. U.S. Department of Justice, “Tumino v. Hamburg.” Document 103, June 10, 2013.

    ← Return to text

  23. Office of Population Research at Princeton University, How to Get Emergency Contraception: How much do emergency contraceptive pills cost? 

    ← Return to text

  24. Kaiser Family Foundation, State Medicaid Coverage of Family Planning Services: Summary of State Survey Findings, 2009.

    ← Return to text

  25. National Institute for Reproductive Health, Expanding Medicaid Coverage for EC on the State Level, 2007.

    ← Return to text

  26. Agency for Healthcare Research and Quality, National Guideline Clearinghouse, 2010.

    ← Return to text

  27. Letter to President Obama

    ← Return to text

  28. Lawrence RE, Rasinski KA, Yoon JD, Curlin FA. Obstetrician-gynecologist physicians’ beliefs about emergency contraception: a national survey, Contraception, 2010.

    ← Return to text

  29. Guttmacher Institute, Facts on American Teens’ Sexual and Reproductive Health, 2010.

    ← Return to text

  30. Lim SW, Emergency Contraception: are pediatric residents counseling and prescribing to teens? Journal of Pediatric and Adolescent Gynecology, 2008.

    ← Return to text

  31. Guttmacher Institute, States Policies in Brief: Emergency Contraception, 2013.

    ← Return to text

  32. Patel A et al., Under-use of Emergency Contraception of Victims of Sexual Assault, International Journal of Fertility and Women’s Health, 2004.

    ← Return to text

  33. Polis C, Schaffer K, Harrison T, Accessibility of Emergency Contraception in California’s Catholic Hospitals, Ibis Reproductive Health, 2005.

    ← Return to text

  34. Guttmacher Institute, Monthly State Update: Major Developments in 2010, 2010.

    ← Return to text

  35. Davison LA et al., Religion and conscientious objection: a survey of pharmacists’ willingness to dispense medications, Social Science Medicine, 2010.

    ← Return to text

  36. Ragland D et al, Pharmacy students’ knowledge, attitudes, and behaviors regarding emergency contraception, American Journal of Pharmaceutical Education, 2009.

    ← Return to text

  37. Shacter HE et al., Variation in availability of emergency contraception in pharmacies, Contraception, 2007.

    ← Return to text

  38. Bennett W et al., Pharmacists’ Knowledge and the Difficulty of Obtaining Emergency Contraception, Contraception, 2003.

    ← Return to text

  39. International Consortium for Emergency Contraception, EC Status and Availability by Country, 2013.

    ← Return to text

  40. Macro International, Contraceptive Trends in Developing Countries: DHS Comparative Reports 16, USAID, 2007.

    ← Return to text