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Emergency Contraception

Emergency contraception (EC), sometimes referred to as “the morning-after pill,” is a form of backup birth control that can be taken up to several days after unprotected intercourse or contraceptive failure and still prevent a pregnancy.  In 1999, Plan B® was the first oral product approved for use in the U.S. as an EC by the Food and Drug Administration (FDA).  Since then, more EC products have been approved, and there has been extensive debate over access to EC, particularly over-the-counter availability for teenagers.1,2  This fact sheet reviews the methods of EC, known mechanisms of action, women’s awareness of EC, and current national and state policies affecting EC access.

WHAT IS EC?

Emergency contraception is used as a back-up birth control method to prevent unintended pregnancy after sex in the event of unprotected sex, sexual assault, or a contraceptive failure, such as a condom breaking.3  There are several methods of EC that are available in the U.S. including progestin-bases pills, ulipristal acetate, and copper IUDs (Table 1).  Unlike the copper IUD, EC pills are not intended for use as a regular contraceptive method.  ECs do not terminate an established pregnancy.

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

Brand Name

Efficacya

Timing after intercourse

Availability in the U.S.

Plan B® One-StepNext Choice One Dose® Levonorgestrel Tablet 1.5mg®Fallback Solo® 81 – 90% reduced pregnancy riskb Within 72 hours One dose versions approved for availability “over the counter” to individuals, without age restrictions. Generic versions require a label change in order to be available in front of the counter.
ella® 2.1% failure rate; reduced pregnancy risk is 65% lower than when using progestin-only pillsb Within 120 hours Prescription only
Combined pills (estrogen and progestin): 26 brandsc 75% reduced pregnancy risk Within 120 hours Prescription only
Paragard®, Copper intrauterine device (IUD) 99% reduced pregnancy risk Within 120 hours after ovulation Requires clinician visit
a. All percentages presented are approximations.
b. Decreased efficacy for women who are overweight and/or obese
c. For a complete listing, go to http://ec.princeton.edu/questions/dose.html
SOURCE: U.S. Food and Drug Administration, FDA News Release: FDA approves Plan B One-Step emergency contraceptive without a prescription for women 15 years of age and older, April 2013. Planned Parenthood, IUD; Trussell J, Raymond E, Emergency Contraception: A Last Chance to Prevent Unintended Pregnancy, Office of Population Research at Princeton University; U.S. Food and Drug Administration, FDA Briefing Information, Ulipristal Acetate, for the June 17, 2010 Meeting of the Advisory Committee for Reproductive Health Drugs, June 2010; Wertheimer RE, Emergency Postcoital Contraception, American Family Physician 2000;62:2287-92.
Progestin-Based Pills
  • Plan B was the first oral form of EC pills to be made available in the U.S. as a pre-packaged dose of pills containing the progestin, levonorgestrel. Progestin-based EC pills use the same hormones found in daily oral contraceptives. EC pills are marketed today under the brand name Plan B and generic names Next Choice, Levonorgestrel, or Fallback Solo.  Progestin-based EC pills are the most widely used form of EC.
  • Initially, the oral EC pill regimen required two pills, taken 12 hours apart. Since then, Plan B One-Step and the generic single dose versions 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.5 Plan B and the generic versions reduce the likelihood of pregnancy by 81 to 90% when taken within 72 hours of intercourse.6
  • 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 and the generics prevent pregnancy by inhibiting or delaying ovulation or by making it harder for sperm to reach an egg.7,8
  • While there have not been any studies that specifically examine the long-term effects of EC pills on established pregnancies, there are not any known long-term negative effects for women taking high-dose birth control pills, which contain the same hormones as EC pills, while in the early stages of pregnancy. Studies of women who inadvertently continued to take their daily birth control pills during the early weeks of pregnancy have shown no evidence of negative effects on the fetus.9
  • Recent studies have shown EC pills are less effective in preventing pregnancy in overweight and obese women. While these studies do not conclusively establish weight or body mass index (BMI) thresholds for progestin-based EC pills or ella (see next section), it is suggested that women with BMI thresholds greater than 25 take ella.10,11,12,13 However, the effectiveness of ella appears to diminish at BMI thresholds above 35.14
  • There are no known serious side effects associated with progestin-based EC; 50% of women experience nausea and 20% vomiting.15,16
ella®
  • Ulipristal acetate, marketed as ella®, was approved by the FDA in 2010 for sale and use in the U.S. This EC product is classified as a selective progesterone-receptor modulator.17,18
  • Ella is a single-dose 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®.19 Unlike progestin-based EC, a prescription is required for ella® for women of all ages.  Its mechanism of action is similar to that of progestin-based EC.20
  • Study findings show that side effects for ella® are comparable to those for Plan B®.21
Combined Pills
  • Certain daily oral contraceptive pills can also act as emergency contraception when taken in doses four or five times higher than the daily dose, although they are not specifically sold as emergency contraception. Daily birth control pills contain progestin and estrogen and are taken in two doses 12 hours apart to be effective as EC.22
  • Combined pills have been found safe and effective for preventing pregnancy within 5 days of intercourse.
Paragard® Copper-T IUD
  • Copper-T IUDs are the most effective forms of EC, reducing the risk of pregnancy by more than 99% when inserted within 5 days.23 These medical devices are inserted into the uterus by a health care provider and require a visit to a clinic or health care provider’s office. They also can be used to effectively prevent subsequent pregnancy for up to 12 years.
  • Efficacy of copper IUDs does not diminish in women who are overweight or obese.24
  • The hormone-free Copper-T IUD works by interfering with egg fertilization by preventing sperm from reaching the egg. Previous research suggests the copper IUD inhibits implantation of a fertilized egg, but this mechanism of action has not been conclusively proven.25
  • The copper IUD has been available to women as a form of long acting reversible contraception since the 1970s. In the early years it faced safety concerns, but improvements within the past decades have contributed to IUDs being one of the safest and most effective forms of contraception.26
  • Progestin-based hormone IUDs, such as Mirena and Skyla, are not effective as EC.

WOMEN’S KNOWLEDGE AND USE OF EC

There have been numerous public health and educational initiatives to increase awareness and use of EC.

  • Most women have heard of EC.  A recent survey by the Kaiser Family Foundation found that 86% of women ages 15 to 44 had heard of EC pills, but awareness was lower among teens compared to older women (Figure 1).27
  • Eleven percent of women ages 15 to 44 (5.8 million) reported using EC pills at least once between 2006 and 2010, an increase from 4% in 2002.28 More recent data from the Kaiser Women’s Health Survey found 5% of women reported taking EC pills within the last 12 months, with the highest rate among women ages 19-24 (12%).
  • Making EC available 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 increase utilization, but studies have not demonstrated decreased unintended pregnancy rates.29 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.30, 31
Most Women Have Heard of Emergency Contraceptive (EC) Pills, but Few Have Used Them

Figure 1: Most Women Have Heard of Emergency Contraceptive (EC) Pills, but Few Have Used Them

ACCESS AND AVAILABILITY

At least one form of oral 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 EC, particularly since its effectiveness window is time-limited.

Over the Counter Access of EC Pills
  •  Between 2006 and February 2014, Plan B and its generic equivalent were available without a prescription for men and women 17 and older, but adolescents under 17 needed a prescription. This policy 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. Prior to 2006, a prescription was needed for all individuals seeking EC pills.
  • In February 2014, the FDA announced it was removing point-of-sale age requirements for generic EC pills and its intention to make generic versions available over the counter (OTC).32 The FDA also announced labeling changes would be required for generics that would indicate the product is intended for women ages 17 and older, but proof of age would not be required to purchase the product. EC pill manufacturers need to apply for the new label in order to sell EC pills OTC.  Three generic versions of the EC pill have been approved for sale OTC with the new labels: Next Choice One Dose, Levonorgestrel Tablet, and Fallback Solo. Until they receive FDA approval, other generics will remain behind the counter requiring the pharmacist to provide the pills.
  • A prescription is still required for ella for women of all ages, the most effective form for women who are overweight or obese.
Cost and Coverage
  • Plan B pills and the generic versions sell for between $35 and $60 when purchased over the counter.33
  • The Affordable Care Act requires all new private health plans to cover without cost-sharing all FDA-approved contraceptive drugs and devices as prescribed, including ella.34 Without a prescription, women accessing EC over the counter will be required to pay the retail price.
  • Family planning services is a required benefit under Medicaid, but states have discretion in deciding which specific services are covered under this category. In 2008, Medicaid programs in at least 26 states reported paying for over-the-counter EC pills under the family planning benefit.35
  • Copper-T IUDs have high up-front costs, ranging between $500 and $1,000 for the device, insertion, and follow up visits.36,37 Under the ACA, private insurance plans and state Medicaid expansion programs must now cover the cost of IUDs and services related to insertion, follow up and removal are without cost-sharing.
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.38,39
  • 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.40
  • Timely counseling about and access to EC are critical for teens since a greater proportion of their pregnancies are unintended.41 One study found that only 26% of pediatric residents counseled teens on EC during routine visits while 56% counseled during contraception visits.42
  • There have been ongoing efforts to make EC more readily available to survivors of sexual assault.
  • Currently, 15 states and the District of Columbia require that emergency room staff provide EC to women after sexual assault (Figure 2).43 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.44, 45
  • Legislation introduced in the Senate in the Fall 2014 would require any hospital that receives any Medicare or Medicaid funding to provide survivors of sexual assault with information about emergency contraception (EC) and provide EC if the patient requests it, regardless of their ability to pay.46
Figure 2: State policies requiring Emergency Rooms (ERs) to provide information about Emergency Contraception (EC) or dispense EC upon request, 2014

Figure 2: State policies requiring Emergency Rooms (ERs) to provide information about Emergency Contraception (EC) or dispense EC upon request, 2014

Availability and Access in Pharmacies
  • Pharmacies are a critical point of access to progestin-based EC. These pills were kept behind the pharmacy counter to enforce the age limits, requiring all women and men to request them from a clerk or pharmacist. Since Plan B and generic versions became approved for availability without a prescription for women of all ages and are not subject to point-of-sale restrictions, women and men of all ages should be able to easily access them. However, a recent survey documenting their availability in pharmacies found progestin-based EC pills are not consistently stocked on store shelves or may be kept behind the counter or a locked display due to the high cost of the product.47
  • Nine states – AK, CA, HI, MA, ME, NH, NM, VT, WA – have laws that allow pharmacists to directly prescribe progestin based EC to women of all ages without obtaining a physician’s prescription.48 These laws provided access to progestin based EC pills for women under age 17 who previously needed a prescription. Now that progestin based EC pills are available OTC without a prescription, pharmacists in these states can continue to prescribe progestin based EC pills to women, enabling women with private insurance to obtain EC pills without paying the retail price and without cost-sharing as is required by the contraceptive coverage provisions of the Affordable Care Act.49  Two states, California and Washington, also allow pharmacists to prescribe ella to women.
  • At least five states – CA, IL, NJ, WA, WI – have measures that require pharmacies or pharmacists to fill all valid prescriptions.50 These policies have been enacted, in part, as responses to reports of pharmacists refusing to fill prescriptions for EC pills because they oppose its use on moral or religious grounds.51  Some studies have found that many pharmacists did not understand how EC worked nor the time frame for its effectiveness.52, 53, 54
  • Seven states – AR, AZ, GA, ID, IL, MS, SD – have laws allowing pharmacies and/or pharmacists to refuse to dispense EC pills on the basis of moral or ethical objections. Similar legislation has been introduced in at least eleven other states.55

***

Since EC first came to market in the U.S., awareness among women of EC pills has risen and availability has expanded as a result of the FDA granting over-the-counter status for progestin based EC pills.  While many believe that EC holds potential to reduce unintended pregnancy rates in the US,  only a small share of women say they have used EC pills and the unintended pregnancy rate in the U.S. remains among the highest among developed nations. Fifteen years after EC pills were first approved by the FDA, access to EC is still debated heavily by policymakers at both the state and federal level and will likely continue to be a focus of policy discussions in the years to come.

Endnotes
  1. U.S. Food and Drug Administration, FDA News Release: FDA approves ella tablets for prescription emergency contraception, August 2010.

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  3. Office of Women’s Health, Emergency Contraception Fact Sheet, May 2009.

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  4. Office of Population Research at Princeton University, Plan B, Accessed 8 July 2010.

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

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  7. Gemzell-Danielsson, K., Mechanism of Action of Emergency Contraception, Contraception, May 2010.

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  8. Ortiz, ME & Croxatto, HB. (2007). Copper-T Intrauterine Device and Levonorgestrel intrauterine system: Biological Bases of Their Mechanism of Action. Contraception 75: s16-s30..

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

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  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.

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  11. Zhang, L., et al., Pregnancy Outcome After Levonorgestrel-only Emergency Contraception Failure: A Prospective Cohort Study, Human Reproduction, 2009.

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  12. Food and Drug Administration, Prescription Drug Products; Certain Combined Oral Contraceptives for Use as Postcoital Emergency Contraception, Federal Registrar 1997; 62: 8610-2.

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

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

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

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  17. U.S. Food and Drug Administration, FDA News Release: FDA approves ella tablets for prescription emergency contraception, August 2010.

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  19. Reproductive Health Technologies Project, A New Option for Emergency Contraception: The Facts on Ulipristal Acetate, 7 June 2010.

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

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  22. Office of Population Research at Princeton University, Emergency Contraception, May 2014.

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  23. Office of Population Research at Princeton University, Copper-T IUD as Emergency Contraception, April 2014.

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  25. Ortiz, ME & Croxatto, HB. (2007). Copper-T Intrauterine Device and Levonorgestrel intrauterine system: Biological Bases of Their Mechanism of Action. Contraception 75: s16-s30.

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  26. Hubacher, D., The Checkered History and Bright Future of Intrauterine Contraception in the United States, Perspectives on Sexual and Reproductive Health 34(2): March/April 2002.

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  27. Kaiser Family Foundation, 2013 Kaiser Women’s Health Survey.

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

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  29. Rodriguez MI, Curtis KM, Gaffield ML, Jackson E & Kapp N, Advance Supply of Emergency Contraception: A Systematic Review, Contraception 87(5), May 2013.

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

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  31. 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, July 2005.

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  32. U.S. Department of Health and Human Services, Food and Drug Administration, Letter to NDA/ANDA applicant, February 25, 2014.

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  33. Office of Population Research at Princeton University, How to Get Emergency Contraception: How much do emergency contraceptive pills cost?, Accessed 11 April 2013.

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  34. Some employers are exempt from this requirement. For more information, see Kaiser Family Foundation, How Does Where You Work Affect Your Contraceptive Coverage?

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  35. KFF, State Medicaid Coverage of Family Planning Services: Summary of State Survey Findings, November 2009.

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  36. Paragard, What it Costs, 2014.

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  37. Planned Parenthood, IUD.

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  38. Agency for Healthcare Research and Quality, National Guideline Clearinghouse, Updated 5 July 2010.

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  39. Letter to President Obama, ACOG, June 7, 2013.

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  40. Lawrence RE, Rasinski KA, Yoon JD, Curlin FA. Obstetrician-gynecologist physicians’ beliefs about emergency contraception: a national survey. Contraception 2010;82:324–30.

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

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

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  43. Guttmacher Institute, States Policies in Brief: Emergency Contraception, March 2014.

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

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

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  47. American Society for Emergency Contraception, EC on the Shelf: Real-world Access in the OTC Era, April 2014.

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  48. Guttmacher Institute, State Policies in Brief: Emergency Contraception, March 2014.

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  49. U.S. Department of Health and Human Services, Health Resources and Services Administration, Women’s Preventive Services Guidelines.

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

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

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

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

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

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  55. Guttmacher Institute, State Policies in Brief: Emergency Contraception, March 2014.

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