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Thursday, May 23, 2013

Fact Sheet: What is Emergency Contraception?

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 a longer window of time 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.
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 the hormone progestin, the same hormone found in daily oral contraceptives, and is marketed today under the name Plan B®, Next Choice®, or Levonorgestrel® (generic).  Plan B 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. and 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 not a FDA approved as an EC device.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
  • The first dose of 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 affect 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.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
  • There are no known serious side effects associated with progestin-based EC; 50% of women experience nausea and 20% vomiting.2, 10

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.11  Ella  became available in the U.S. in 2010, and unlike progestin-based EC, a prescription is required for ella for all ages.  Its method of action is similar to that of progestin-based EC as it also works by stopping or delaying ovulation and may also inhibit implantation. 
  • Study findings show that side effects for ella are comparable to those for Plan B.12

 

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.13
  • 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 2002.14
  • 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.15 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.16, 17

 

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

  • 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.
  • 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 2012, 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 to all.18 The Department of Justice is appealing this ruling and has applied for a “stay” which would delay their requirement to comply with this ruling until there is a ruling on the appeal.
  • Shortly before filing the appeal, the FDA accepted an amended application by Teva Pharmaceutical Industries for the over-the-counter distribution of Plan B One-Step, lowering the age of availability for this product from 17 years to 15 years and older without a prescription.   This new policy would allow the Plan B One-Step to be available on the shelves, but the packaging would include a scanning code that would require that consumers show proof of age at the checkout which could be a barrier for teens and other women without legal documentation of their age.19 The generic alternatives will still be available behind the pharmacy counter to those 17 and older, but will not be sold off the shelves.
  • A prescription is still required for ella®.

 

Cost and Coverage

  • Plan B® pills sell for between $35 and $60.20  Women 17 years and older can buy these pills from a pharmacy 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.  Women who don’t obtain a prescription for EC will be able get the pills but will need to pay out-of-pocket for the pills.
  • Medicaid programs in at least 26 states cover over-the-counter EC.21  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.22

 

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.23
  • 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.24
  • Timely counseling about and access to EC are critical for teens since a greater proportion of their pregnancies are unintended.25  One study found that only 26% of pediatric residents counseled teens on EC during routine visits while 56% counseled during contraception visits.26
  • 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).27  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.28, 29 
    Emergency Contraception Policies, by State, 2013
    Figure 1

 

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).27
  • At least five states – CA, IL, NJ, WA, WI – have measures that require pharmacies or pharmacists to fill all valid prescriptions.30  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.31  Some studies have found that many pharmacists did not understand how EC worked nor the time frame for its effectiveness.32, 33, 34
  • 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.27

 

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.35  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.36
Footnotes
  1. U.S. Food and Drug Administration, FDA News Release: FDA approves ella tablets for prescription emergency contraception, 2010.
  2. Trussell J et al., Preventing unintended pregnancy: the cost-effectiveness of three methods of emergency contraception, AJPH, 1997.
  3. Office of Population Affairs, Emergency Contraception Fact Sheet.
  4. Office of Population Research at Princeton University, Plan B.
  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.
  6. Glasier A and Baird D, Emergency postcoital contraception, NEJM, 1997.
  7. Trussell J and Raymond EG, Statistical evidence concerning the mechanism of action of the Yuzpe regimen of emergency contraception, Ob/Gyn, 1999.
  8. Orlando Women’s Center, How does Emergency Contraception Work- FAQ’s.
  9. Raman-Wilms L, et al., Fetal genital effects of first-trimester sex hormone exposure: a meta analysis, Ob/Gyn, 1995.
  10. 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.
  11. Reproductive Health Technologies Project, A New Option for Emergency Contraception: The Facts on Ulipristal Acetate, 2010.
  12. Glasier A et al., Ulipristal acetate versus levonorgestrel for emergency contraception: a randomized non-inferiority trial and meta-analysis, The Lancet, 2010.
  13. Goldsmith KA et al., Unintended childbearing and knowledge of emergency contraception in a population-based survey of postpartum patients, Maternal and Child Health, 2008.
  14. 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.
  15. Foster D. et al., Should Providers Give Women Advance Provision of Emergency Contraceptive Pills? A Cost-Effectiveness Analysis, Women’s Health Issues, 2010.
  16. Raine T. et al., Direct access to emergency contraception through pharmacies and effect on unintended pregnancy and STIs: a randomized controlled trial, JAMA, 2005.
  17. 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.
  18. 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.
  19. 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, 2013.
  20. Office of Population Research at Princeton University, How to Get Emergency Contraception: How much do emergency contraceptive pills cost?
  21. Kaiser Family Foundation, State Medicaid Coverage of Family Planning Services: Summary of State Survey Findings, 2009.
  22. National Institute for Reproductive Health, Expanding Medicaid Coverage for EC on the State Level, 2007.
  23. Agency for Healthcare Research and Quality, National Guideline Clearinghouse, 2010.
  24. Lawrence RE, Rasinski KA, Yoon JD, Curlin FA. Obstetrician-gynecologist physicians’ beliefs about emergency contraception: a national survey, Contraception, 2010.
  25. Guttmacher Institute, Facts on American Teens’ Sexual and Reproductive Health, 2010.
  26. Lim SW, Emergency Contraception: are pediatric residents counseling and prescribing to teens? Journal of Pediatric and Adolescent Gynecology, 2008.
  27. Guttmacher Institute, States Policies in Brief: Emergency Contraception, 2013.
  28. Patel A et al., Under-use of Emergency Contraception of Victims of Sexual Assault, International Journal of Fertility and Women’s Health, 2004.
  29. Polis C, Schaffer K, Harrison T, Accessibility of Emergency Contraception in California’s Catholic Hospitals, Ibis Reproductive Health, 2005.
  30. Guttmacher Institute, Monthly State Update: Major Developments in 2010, 2010.
  31. Davison LA et al., Religion and conscientious objection: a survey of pharmacists’ willingness to dispense medications, Social Science Medicine, 2010.
  32. Ragland D et al, Pharmacy students’ knowledge, attitudes, and behaviors regarding emergency contraception, American Journal of Pharmaceutical Education, 2009.
  33. Shacter HE et al., Variation in availability of emergency contraception in pharmacies, Contraception, 2007.
  34. Bennett W et al., Pharmacists’ Knowledge and the Difficulty of Obtaining Emergency Contraception, Contraception, 2003.
  35. International Consortium for Emergency Contraception, EC Status and Availability by Country, 2013.
  36. Macro International, Contraceptive Trends in Developing Countries: DHS Comparative Reports 16, USAID, 2007.