Over-the-Counter Access to Emergency Contraceptive Pills

This document was co-developed with the American Society for Emergency Contraception and the European Consortium for Emergency Contraception

 

Emergency contraceptive pills (ECPs) offer women a last chance to prevent pregnancy after sex. Because ECPs work by disrupting ovulation, the sooner they are taken the more likely they are to be able to work in the woman’s body before ovulation occurs; this is especially true for the most commonly used form of ECP, that containing levonorgestrel.1,2 For women who have had sex without contraception, who experience a contraceptive failure, or who have been forced to have sex, timely access to ECPs is crucial. Yet, in many countries around the world, regulatory limitations on the sale of ECPs (including prescription requirements and age restrictions) impede a woman’s ability to get ECPs when she urgently needs them. Restrictions on the sale of levonorgestrel ECPs are medically unnecessary and may present significant barriers that result in an unintended pregnancy; if women are able to access ECPs immediately without restriction, there is a greater chance that they will be able to prevent pregnancy.

This fact sheet addresses only levonorgestrel emergency contraception pills (LNG ECPs), which are the most commonly-available and widely-studied ECPs worldwide.

How are ECPs accessed throughout the world?

Access to ECPs in the pharmacy falls broadly into three categories: over-the-counter (OTC), behind-the-counter (BTC), and prescription-only, although these categories do not precisely describe the situation in each given country. Official regulations and practical realities vary significantly among countries and regions, and even among individual pharmacies and providers. For example, in some settings all products may be held behind the counter in a pharmacy to protect against theft, regardless of the regulatory status of the products sold. In other settings where a prescription is legally required for ECPs, in practical terms it may be possible to purchase the product without a prescription. This factsheet does not provide an exhaustive description of all of the ways in which ECPs are accessed globally, but provides a general overview of the regulatory status of ECPs and a justification for removing restrictions. While clinics, both public and private, are an important access point for ECPs throughout the world, they are not the focus of this factsheet.

Over-the-counter (OTC) sale of a medication means that the product is available at a retail outlet (including convenience stores and grocery stores as well as pharmacies), without the need to consult a healthcare provider, pharmacist, pharmacy technician, or clerk. ECPs are officially available OTC in a small handful of countries: Bangladesh, Canada (certain provinces only), Laos, India, and some European countries (including Bulgaria, Denmark, Estonia, the Netherlands, Norway, Portugal, Slovakia, and Sweden). As of August 2013, one brand of ECPs is available OTC in the United States. In 62 countries, ECPs are available behind-the-counter (BTC), which means that no prescription is required, but the product must be held behind the pharmacy counter and the customer must request it from a pharmacist, pharmacy technician or clerk. In more than 100 countries, EC is available by prescription only, meaning that unless a woman can obtain ECPs directly from a clinic, she must first get a prescription from a healthcare provider (such as a doctor, midwife, physician assistant or nurse) and then present the prescription at the pharmacy.3,4

In some countries, mechanisms such as collaborative practice agreements and patient group directives have been created to enable pharmacists to directly provide prescription-only medications through partnerships with physicians or other clinical healthcare providers. Such mechanisms authorizing pharmacists to directly provide ECPs exist in some parts of the United States and Canada, as well as the United Kingdom and Australia.5-8

Are LNG ECPs safe enough for OTC access?

Yes, LNG ECPs meet the standard criteria for OTC sale: they have no potential for overdose or addiction, have very low toxicity, are of uniform dosage, have no major drug interactions or contraindications, pose no danger to an existing pregnancy, and the user can determine her own need for the product.9-11 LNG ECPs have been extensively studied, and have been found to be extremely safe with no need for a clinical exam or pregnancy testing prior to their use.12 Indeed, LNG ECPs are much safer than many products sold over-the-counter, such as aspirin, which can be fatally toxic if overdosed.11 Side effects following use of ECPs are generally mild and temporary.13 LNG ECPs have no contraindications for any woman. LNG ECPs are safe and tolerable when used repeatedly, even within the same menstrual cycle.14

The latest scientific evidence shows that ECPs work by preventing or inhibiting ovulation, and do not disrupt an existing pregnancy.1,2 If a woman who is already pregnant takes LNG ECPs, there are no risks to the pregnancy.15,16 Major medical organizations, such as the World Health Organization and the U.S. Centers for Disease Control, agree that LNG ECPs can be taken by a breastfeeding woman with no adverse effects on her infant.17,18

Studies show that women of all ages, including adolescents, can clearly understand the purpose of the medication and its instructions for use, and are able to use it correctly.19-21 One objection to increasing access to ECPs has been that it would present a danger to adolescents; this argument was cited in the initial decision not to make ECPs available OTC in the United States. However, the consensus from the medical community, including the Commissioner of the US Food and Drug Administration, the American Academy of Pediatrics, the World Health Organization, and the International Federation of Gynecology and Obstetrics, is that ECPs are absolutely safe and appropriate for adolescents who need them.22-25

For more detail about the safety of levonorgestrel ECPs, please refer to the fact sheet by the World Health Organization and the International Consortium for Emergency Contraception, available at ICEC_WHO-Safety-Statement_2010-english.pdf.

Does improved access to ECPs increase the risk of unintended pregnancy and STIs?

Some argue that removing barriers to accessing ECPs will put women at greater risk of unintended pregnancy and sexually transmitted infections (STIs), citing concerns that women will be less likely to use effective ongoing contraceptives and condoms if ECPs are easily available. However, efforts to increase access to ECPs (such as providing women with EC in advance of need or expanding pharmacist provision through such mechanisms as collaborative practice agreements) have not been shown to increase rates of unintended pregnancy or STIs.26-32 The substantial evidence that improving access to ECPs does not lead to adverse outcomes at the population level should be considered by those charged with making public health decisions regarding access to ECPs.

How do restrictions on access to ECPs affect individual women?

Time is of the essence when women need ECPs. Because LNG ECPs do not work if a woman is very close to ovulation, they need to be taken as soon as possible after unprotected sex. When access to ECPs is restricted, these limitations put women at greater risk of unintended pregnancy by delaying the time between unprotected sex and taking ECPs; increasing barriers to access may also discourage women from using ECPs at all due to additional time and financial demands.

Prescription requirements: When a prescription is required to obtain ECPs, a woman must first find a healthcare provider or clinic willing and able to prescribe or provide ECPs (and whom she can afford to pay). If she obtains only the prescription, she must then find a pharmacy that has ECPs in stock, where a pharmacist is available and willing to dispense them.

Keeping ECPs behind the counter: Although pharmacy BTC access is certainly an improvement over prescription-only status, such settings still present barriers. When ECPs are available only behind the counter, the pharmacies’ characteristics (such as operating hours, pharmacist workload, privacy concerns, or willingness to provide ECPs) could make the difference between pregnancy and pregnancy prevention. Permitting ECPs to be purchased at a large number of retail outlets with expanded hours would greatly increase accessibility. Each woman is able to assess her own need for ECPs, as having had intercourse is the only indication for using the medication, and as such does not need to consult with a clerk or pharmacy technician unless she has specific questions.

Age restrictions: In a few countries, non-prescription sale of ECPs is restricted to women (and in some cases men) older than 15 to 18 years of age, depending on the country. Younger women must obtain a prescription to purchase ECPs (unless a collaborative practice agreement is in place which allows a pharmacist to directly provide ECPs). These restrictions affect access for women of all ages, as the age restriction necessitates that ECPs must be held behind the counter and that women must provide proof of age.

Recommendation

Removing restrictions on access to ECPs will facilitate women’s ability to take them as soon as possible after unprotected or inadequately protected sex. The overwhelming evidence of the safety of LNG ECPs for women of all ages supports the position that there is no reason to restrict or delay women’s access to this important contraceptive option. While BTC access is a tremendous improvement over prescription-only sale of LNG ECPs, BTC access may still be a substantial barrier for a woman who has experienced unprotected sex or sexual assault and is in need of ECPs. LNG ECPs are safe enough to be sold without restrictions at pharmacies and any other retail outlet that sells OTC medications, and should not be regulated differently than other OTC medications.

References

1 Noe G, Croxatto HB, Maria Salvatierra A, Reyes V, Villarroel C, Munoz C, Morales G, Retamales A. Contraceptive efficacy of emergency contraception with levonorgestrel given before or after ovulation. Contraception 2011; 84(5): 486-92.

2 Novikova N, Weisberg E, Stanczyk FZ, Croxatto HB, Fraser IS. Effectiveness of levonorgestrel emergency contraception given before or after ovulation — a pilot study. Contraception 2007; 75(2): 112-8.

3 International Consortium for Emergency Contraception. Emergency contraception status and availability database. 2013; available at: https://www.cecinfo.org/country-by-country-information/status-availability-database/ Accessed December 9, 2013.

4 The Emergency Contraception Website http://www.not-2-late.com. Types of emergency contraception. 2013; available at: http://ec.princeton.edu/worldwide/default.asp#country. Accessed December 9, 2013.

5 Farris KB, Ashwood D, McIntosh J, DiPietro NA, Maderas NM, Landau SC, Swegle J, Solemani O. Preventing unintended pregnancy: Pharmacists’ roles in practice and policy via partnerships. Journal of the American Pharmacists Association 2010; 50(5): 604-12.

6 Soon J, Levine M, Ensom M, Gardner J, Edmondson H, Fielding D. The developing role of pharmacists in patient access to emergency contraception. Disease Management & Health Outcomes 2002; 10(10): 601-11.

7 Bissell P, Anderson C. Supplying emergency contraception via community pharmacies in the UK: reflections on the experiences of users and providers. Social Science & Medicine 2003; 57(12): 2367-78.

8 Pharmaceutical Society of Australia. Guidance for provision of a pharmacist only medicine: Levonorgestrel. 2011.

9 Sambol NC, Harper C, Kim L, Liu CY, Darney P, Raine TR. Pharmacokinetics of single-dose levonorgestrel in adolescents. Contraception 2006; 74(2): 104-9.

10 Kook K, Gabelnick H, Duncan G. Pharmacokinetics of levonorgestrel 0.75 mg tablets. Contraception 2002; 66(1): 73-6.

11 Grimes DA, Raymond E, Scott Jones B. Emergency contraception over-the-counter: the medical and legal imperatives. Obstetrics & Gynecology 2001; 98(1): 151-5.

12 ACOG practice bulletin. Clinical management guidelines for obstetrician-gynecologists. Number 112, Emergency Contraception. Obstetrics & Gynecology 2010; 115(5): 1100-8.

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. Lancet 1998; 352(9126): 428-33.

14 Halpern V, Raymond EG, Lopez LM. Repeated use of pre- and postcoital hormonal contraception for prevention of pregnancy (Review). Cochrane Database of Systematic Reviews 2010(1): CD007595.

15 De Santis M, Cavaliere AF, Straface G, Carducci B, Caruso A. Failure of the emergency contraceptive levonorgestrel and the risk of adverse effects in pregnancy and on fetal development: an observational cohort study. Fertility and Sterility 2005; 84(2): 296-9.

16 Zhang L, Chen J, Wang Y, Ren F, Yu W, Cheng L. Pregnancy outcome after levonorgestrel-only emergency contraception failure: a prospective cohort study. Human Reproduction 2009; 1(1): 1-7.

17 Centers for Disease Control and Prevention. U.S. Medical Eligibility Criteria for Contraceptive Use, 2010. Morbidity and Mortality Weekly Report 2010; 59(4): 1-85.

18 World Health Organization. Medical eligibility criteria for contraceptive use. Geneva, Switzerland 2010; 4th ed.

19 Raymond E, Dalebout S, Camp S. Comprehension of a prototype over-the-counter label for an emergency contraceptive pill product. Obstetrics & Gynecology 2002; 100(2): 342-9.

20 Raymond EG, L’Engle KL, Tolley EE, Ricciotti N, Arnold MV, Park S. Comprehension of a prototype emergency contraception package label by female adolescents. Contraception 2009; 79(3): 199-205.

21 Raymond E, Chen P, Dalebout S. “Actual use” study of emergency contraceptive pills provided in a simulated over-the-counter manner. Obstetrics & Gynecology 2003; 102(1): 17-23.

22 American Academy of Pediatrics Committee On Adolescence. Emergency contraception. Pediatrics 2012; 130(6): 1174-82.

23 US Food and Drug Administration. Statement from FDA Commissioner Margaret Hamburg, M.D. on Plan B One-Step. 2011; available at: http://www.fda.gov/NewsEvents/Newsroom/ucm282805.htm. Accessed December 9, 2013.

24 World Health Organization. Emergency contraception, Fact Sheet No 244. 2012; available at: http://www.who.int/mediacentre/factsheets/en/. Accessed December 9, 2013.

25 International Consortium for Emergency Contraception and International Federation of Gynecology and Obstetrics. Emergency Contraceptive Pills: Medical and Service Delivery Guidelines. New York, NY 2012; 3rd ed.

26 Gold MA, Wolford JE, Smith KA, Parker AM. The effects of advance provision of emergency contraception on adolescent women’s sexual and contraceptive behaviors. Journal of Pediatric and Adolescent Gynecology 2004; 17(2): 87-96.

27 Raine TR, Harper C, Rocca CH, Fischer R, Padian N, Klausner JD, Darney PD. Direct access to emergency contraception through pharmacies and effect on unintended pregnancy and STIs: a randomized controlled trial. Journal of the American Medical Association 2005; 293(1): 54-62.

28 Raymond E, Stewart F, Weaver M, Monteith C, Van Der Pol B. Impact of increased access to emergency contraceptive pills: a randomized controlled trial. Obstetrics & Gynecology 2006; 108(5): 1098-106.

29 Schwarz EB, Gerbert B, Gonzales R. Computer-assisted provision of emergency contraception: a randomized controlled trial. Journal of General Internal Medicine 2008; 23(6): 794-9.

30 Raymond E, Trussell J, Polis CB. Population effect of increased access to emergency contraceptive pills: a systematic review. Obstetrics & Gynecology 2007; 109(1): 181-8.

31 Polis CB, Schaffer K, Blanchard K, Glasier A, Harper C, Grimes DA. Advance provision of emergency contraception for pregnancy prevention (full review). Cochrane Database of Systematic Reviews 2007(2): CD005497.

32 Sander PM, Raymond EG, Weaver MA. Emergency contraceptive use as a marker of future risky sex, pregnancy, and sexually transmitted infection. American Journal of Obstetrics and Gynecology 2009; 201(2): 146.e1,146.e6.

 

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Regimen Update: Timing and dosage of levonorgestrel-alone emergency contraceptive pills

Levonorgestrel-alone emergency contraceptive pills (LNG ECPs) are available in over 140 countries. Two kinds of LNG ECP packages are available: one contains a single pill with a dosage of 1.5 mg, and the other contains two pills of 0.75 mg each.

The labels on both kinds of ECP packages say that the treatment should be started within 72 hours (3 days) after unprotected intercourse. The labels on two-pill ECP packages specify that the second pill should be taken 12 hours after the first. However, these labels do not reflect current scientific information.

Dosage: A WHO-led study in 10 countries established that a single dose of 1.5 mg LNG is as effective as two doses of 0.75 mg.1 Two Nigerian studies found similar results.2,3 Taking only one dose is simpler for women than taking two doses 12 hours apart.

Timing: Data suggest that LNG ECPs have some efficacy 4 days or even 5 days after sex.4,5 Some6 but not all4 studies have found that LNG ECPs may be more effective the sooner they are taken after sex.

Conclusions

  • Women should take LNG ECPs as a single dose of 1.5 mg. If using a package that contains two pills of 0.75 mg LNG, a woman should take both pills at the same time.
  • Women should take the 1.5 mg LNG ECP dose as soon as possible after sex, but the treatment may be used up to five days after the coital act.

References

1 von Hertzen H, Piaggio G, Ding J, Chen J, Song S, Bartfai G, et al. Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO multicentre randomised trial. Lancet. 2002;360(9348):1803-10.

2 Arowojolu AO, Okewole IA, Adekunle AO. Comparative evaluation of the effectiveness and safety of two regimens of levonorgestrel for emergency contraception in Nigerians. Contraception. 2002;66(4):269-73.

3 Dada OA, Godfrey EM, Piaggio G, von Hertzen H. A randomized, double-blind, noninferiority study to compare two regimens of levonorgestrel for emergency contraception in Nigeria. Contraception. 2010;82(4):373-8.

4 Piaggio G, Kapp N, von Hertzen H. Effect on pregnancy rates of the delay in the administration of levonorgestrel for emergency contraception: a combined analysis of four WHO trials. Contraception. 2011;84(1):35-9.

5 Glasier A, Cameron ST, Blithe D, Scherrer B, Mathe H, Levy D, et al. Can we identify women at risk of pregnancy despite using emergency contraception? Data from randomized trials of ulipristal acetate and levonorgestrel. Contraception. 2011;84(4):363-7.

6 Creinin MD, Schlaff W, Archer DF, Wan L, Frezieres R, Thomas M, et al. Progesterone receptor modulator for emergency contraception: a randomized controlled trial. Obstetrics and Gynecology. 2006;108(5):1089-97.

Clinical Summary: Emergency contraceptive pills

Indication: Emergency Contraceptive Pills (ECPs) are indicated to prevent pregnancy after unprotected or inadequately protected sex.


ECP Regimens:
Three regimens are packaged and labeled specifically for emergency contraception (EC).

  • 1 tablet of levonorgestrel 1.5 mg, or 2 tablets of levonorgestrel 0.75 mg labeled to be taken twice 12 hours apart (but can safely be taken together)
  • 1 tablet of ulipristal acetate 30 mg
  • 1 tablet of mifepristone 10-25 mg (not widely available)

Certain types of ordinary birth control pills can also be used as EC (known as the “Yuzpe regimen”). Take the pills within 5 days after sex, as soon as possible after the sex act.


How ECPs Work:
The primary mechanism is disruption of ovulation. Other mechanisms have been postulated but are not well supported by data. No evidence supports the theory that ECPs interfere with the implantation of a fertilized egg. ECPs do not cause abortion of an existing pregnancy.


ECP Efficacy:
The levonorgestrel regimen reduces pregnancy risk by at least half and possibly by as much as 80-90% for one act of unprotected intercourse. The ulipristal and mifepristone regimens are more effective than the levonorgestrel regimen. Regular oral contraceptives used as EC (the “Yuzpe regimen”) are less effective.


Safety:
ECPs have no known medically serious complications. Side effects may include altered bleeding patterns, nausea, headache, abdominal pain, breast tenderness, dizziness, and fatigue. ECPs do not appear to be harmful if inadvertently taken in pregnancy.


Precautions and Contraindications:
ECPs have no medical contraindications. Do not take ECPs if you are pregnant because they will not work.


Clinical Screening:
You do not need any examinations or laboratory tests before taking ECPs.


Repeated ECP Use:
ECPs can be used as often as needed, but do not need to be taken more than once every 24 hours if multiple acts of unprotected sex occur. Repeat use of ECPs is perfectly safe, but ECPs are not recommended as a regular, routine contraceptive method because they are not the most effective contraceptive method available.


Drug Interactions:
Concurrent use of some drugs may reduce ECP efficacy. However, the ECP regimen is the same whether or not you are using these drugs.


Follow-up after ECP:
No scheduled follow-up is required after ECP use. But if you have not had a menstrual period by 3 weeks after taking ECPs, consider that you may be pregnant.


Starting or Resuming Regular Contraceptives after ECP Use:
ECPs are not designed to provide contraceptive protection at sex acts that occur in the future. Using a regular contraceptive after taking ECPs is CRITICAL to minimizing your pregnancy risk. Begin hormonal methods (oral contraceptives, patch, vaginal ring, injectables, implants, levonorgestrel intrauterine system) either immediately or after your next menstrual period; if you wait, use a barrier method such as condoms in the interim. Copper- bearing IUDs provide highly effective emergency contraception, so you do not need oral ECPs if you start using this type of IUD within 5 days after sex. Do not rely on fertility awareness methods until you have had at least one normal menstrual period.


Resources

  • International Consortium for Emergency Contraception website: www.emergencycontraception.org
  • The Emergency Contraception website, managed by Princeton University and the Association of Reproductive Health Professionals: www.not-2-late.com

Emergency Contraception for Rape Survivors: A Human Rights and Public Health Imperative

This document was co-developed with the Sexual Violence Research Initiative 

 

According to new estimates from the World Health Organization (WHO), one-third of women worldwide will experience violence in their lifetimes; an estimated 7.2% of women will be sexually assaulted by a stranger and many more (23-36%, depending on region) will experience unwanted sex from an intimate partner.1 To add to the physical and psychological trauma of rape, victims of sexual violence also risk unwanted pregnancy and exposure to sexually transmitted infections (STIs), including HIV/AIDS.

Sexually assaulted women (and men) require a range of emotional, psychological, and medical care. Medical services for post-rape care should include prophylaxis against STIs, including HIV, and emergency contraception (EC) to reduce the risk of pregnancy. While HIV prophylaxis is often provided, EC is not so frequently offered, despite the fact that the risk of pregnancy is higher than the risk of HIV.2,3 Emergency contraception must be readily available in emergency care facilities as both a human rights and public health imperative.

About emergency contraception

Emergency contraceptive pills (ECPs), sometimes called the “morning after pill,” can be used to prevent pregnancy for up to 120 hours (five days) after unprotected sex, as often occurs during forced or coerced sex. ECPs should be taken as soon as possible after unprotected intercourse because they are ineffective once a woman is close to ovulation; therefore, prompt access is critical. Levonorgestrel ECPs, the most commonly-available form, primarily work by preventing ovulation;4,5 they cannot terminate or interfere with an established pregnancy. ECPs reduce the risk of pregnancy by up to half and possibly by as much as 80-90% for one act of unprotected sex. If a dedicated EC product is not available, higher dosages of combined oral contraceptives, a regimen known as the “Yuzpe method,” can be used as emergency contraception instead. (For more information on the Yuzpe regimen, please visit www.not-2-late.com.)

Although some governments and providers impose age restrictions on ECP access, ECPs are safe and effective for females of all ages. Therefore, all female survivors of rape, no matter their age, can and should be offered emergency contraception, if they have reached puberty or are otherwise believed to be at risk of pregnancy.

Some countries require a pregnancy test before ECPs can be administered as part of post-rape care. However, guidance from the WHO and others does not support pregnancy testing; ECPs will not work if a woman is already pregnant and will not harm an existing pregnancy.6,7

In addition to ECPs, the Copper Intrauterine Device (IUD) can also be used as emergency contraception, including in post-rape care. The Copper IUD is the most effective method of emergency contraception, at close to 100% effectiveness, and it is safe for women of any age or parity, including those who have never had children. Although many providers and health care settings do not offer the IUD for post-rape care, IUDs can be offered as an EC option to survivors of sexual assault with simultaneous STI testing and prophylactic treatment, as long as informed consent protocols are carefully followed and collection of forensic evidence is not compromised.8 In settings in which providers are trained on IUD insertion, they can offer an IUD as one emergency contraceptive option, in addition to the option of EC pills, and allow women to choose their preferred method.

Global guidance and norms for EC after rape

The International Federation of Obstetrics and Gynecology supports rape survivors’ right to EC access.9 The WHO released new global guidance on sexual violence in 2013, including clear recommendations for the provision of EC as part of prompt and comprehensive women-centered care.8

The United Nations Committee against Torture, the treaty monitoring body for the Convention against Torture and Other Cruel, Inhuman or Degrading Treatment or Punishment (CAT), has also written that failure to legalize the distribution of oral EC to female rape survivors constitutes a violation of CAT.10 Additionally, in 2013, the 57th Session of the United Nations Commission on the Status of Women, a global policy-making body, concluded that all Member States must require first responders to include EC provision in post-rape care.11

A regional policy document from the Southern African Development Community (SADC) calls for states to ensure EC access for sexual assault survivors by 2015.12 The U.S. Agency for International Development (USAID) and the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) published guidelines for PEPFAR programs on the clinical management of child and adolescent sexual assault survivors that include EC provision as part of a comprehensive response to sexual violence, along with a description of the stage of development at which they recommend that girls be offered EC.13

Access to EC as part of post-rape care is often low

Dedicated ECP products are available in most countries, but not all public sector health systems (where many women seek post-rape care) carry ECPs.14 Moreover, a few national governments (including those in Costa Rica, Honduras, and the Philippines) still do not allow women to access a dedicated ECP product at all, including outside the public health system.

Even where ECPs are available in countries’ health systems, they are often not provided on-site to women who seek post-rape care. For instance, in South Africa, one study found that only 14% of girls between 12 and 17 received EC as part of post-rape care.15 Similarly, a survey of multi-sectoral response services (“one-stop centers”) for sexual assault survivors in Kenya and Zambia found that three out of five did not offer ECPs to survivors.16 In the US, surveys indicate that half of hospitals do not administer EC to sexual assault survivors on-site, and less than one-fifth provide comprehensive services to sexual assault patients.17 Another sampling of US emergency departments found no improvement in EC provision between 2004 and 2009.18

In areas where access to safe abortion is restricted, failure by emergency facilities to offer EC exposes a rape survivor to additional harm if she becomes pregnant and turns to unsafe abortion to end her pregnancy.

Increasing access to EC in post-rape care: policies, front-line health care, and enforcement

Ensuring EC for post-rape care in national and local laws and policies

Country-level policies and guidance on providing EC in post-rape care vary significantly. Some national governments, such as those in Kenya,19 Ecuador,20 South Africa,21 Brazil,22 and the United States,23 have published management guidelines for sexual assault survivors which recommend EC use. However, many governments do not have national guidelines for post-rape care, or have guidelines that do not specifically include EC. Ensuring that EC is explicitly included in national guidelines on post-rape care can help to standardize EC as an essential component of treatment.

Front-line provision of EC as part of post-rape care

Health care practitioners are often the first point of contact for rape survivors and, as a result, play a significant role in preventing unwanted pregnancy and protecting women’s human rights. They should be trained in EC provision and their facilities should stock EC so that providers can offer EC on-site as quickly as possible, rather than refer rape survivors to pharmacies. They should also be able to offer counseling about EC’s effectiveness and mechanism of action.

In many settings, however, police officers, emergency medical technicians, social workers, and other non-health professionals may be the first point of contact after a sexual assault and can thus play a critical role in providing medical care, including ECPs, to survivors. In settings where these professionals are not permitted by pharmaceutical regulations to provide ECPs, referral systems can be put in place.24 In some cases, policy changes to allow non-health providers to offer EC can increase women’s access following sexual assault. A study by Population Council in Zambia’s Copperbelt Province, for instance, found that training and equipping police to provide EC after rape (under community-based family planning distribution guidelines) increased access to EC, leading community members to say: “Now we quickly report to the police because we know we will find assistance like EC.”25 Reporting of rape increased by 48% in participating police stations from 2006-2007.

Enforcing laws and policies that protect sexual violence survivors

Even where standing policies require health care practitioners and other front-line responders to dispense EC to rape survivors, efforts must be made to ensure that these policies are enforced. Regular monitoring can help ensure that EC provision is not omitted.

Enforcement of these laws and policies must also address instances in which individuals, institutions, and/or governments have cited “conscientious objection” as the reason for not providing rape survivors with timely access to EC. Governments are responsible for ensuring that all medical facilities provide comprehensive post-rape care and that conscientious objection laws, policies, and/or practices do not obstruct rape survivors’ access to EC. Laws that allow public and private health care workers to conscientiously object to providing EC, even in cases of rape, without mandating alternative means to access EC, violate sexual violence survivors’ human rights and freedoms. While the Roman Catholic Church has often expressed opposition to EC, some Roman Catholic Church leaders have distinguished rape from other cases of unprotected sex.26 In the US, for example, Directive 36 of the Ethical and Religious Directives for Catholic Health Care Services supports the provision of EC in cases of sexual assault where it can be proven that pregnancy has not already occurred (i.e., through a pregnancy test).27

Recommendations

Emergency contraception can prevent pregnancy after rape and is safe in all circumstances and for females of all ages. Therefore:

  • Governments must implement and enforce policies that guarantee compassionate and comprehensive post-rape care, including prompt on-site provision of EC by both health and non-health professionals.
  • Health care institutions, health care policies, training, and supply systems should support provision of EC.
  • Where appropriate, non-health professionals should be authorized to provide ECPs or referrals.
  • Conscientious objection must not impede EC provision.

Failure to ensure that rape survivors receive EC may harm women’s physical and psychological health, especially in areas where safe abortion is illegal or unavailable, and violates women’s human rights.

References

1 World Health Organization, Department of Reproductive Health and Research, London School of Hygiene and Tropical Medicine, South African Medical Research Council. Global and regional estimates of violence against prevalence and women: health effects of intimate partner violence and non-partner sexual violence. 2013

2 Holmes MM, Resnick HS, Kilpatrick DG, Best CL. Rape-related pregnancy: Estimates and descriptive characteristics from a national sample of women. American Journal of Obstetrics and Gynecology 1996;175:320–325.

3 McFarlane J, Malecha A, Watson K, Gist J, Batten E, Hall I et al. Intimate partner sexual assault against women: frequency, health consequences, and treatment outcomes. Obstetrics and Gynecology 2005;105(1):99-108.

4 Noe G, Croxatto H, Salvatierra AM, Reyes V, Villarroel C, Munoz c, Morales G, Retamales A. Contraceptive efficacy of emergency contraception with levonorgestrel given before or after ovulation. Contraception 2011; 84(5): 486-92.

5 Novikova N, Weisberg E, Stanczyk FZ, Croxatto HB, Fraser IS. Effectiveness of levonorgestrel emergency contraception given before or after ovulation – a pilot study. Contraception 2007; 75(2): 112-118.

6 De Santis M, Cavaliere AF, Straface G, Carducci B, Caruso A. Failure of the emergency contraceptive levonorgestrel and the risk of adverse effects in pregnancy and on fetal development: an observational cohort study. Fertility and Sterility, 2005, 84:296-299.

7 Zhang L, Chen J, Wang Y, Ren F, Yu W, Cheng L. Pregnancy outcome after levonorgestrel-only emergency contraception failure: a prospective cohort study. Human Reproduction, 2009, 24:1605-1611.

8 World Health Organization, Department of Reproductive Health and Research. Responding to intimate partner violence and sexual violence against women: WHO clinical and policy guidelines. 2013.

9 Jina R, Jewkes R, Munjanja SP, Mariscal JD, Dartnall E, Gebrehiwot Y. Report of the FIGO Working Group on Sexual Violence/HIV: guidelines for the management of female survivors of sexual assault. International Journal of Gynecology and Obstetrics 2010;109:85–92.

10 United Nations Office of the High Commissioner for Human Rights, Committee against Torture. Concluding observations on the combined fifth and sixth periodic reports of Peru, adopted by the Committee at its forty-nine session. 29 October – 23 November, 2012. (http://reproductiverights.org/sites/crr.civicactions.net/files/documents/crr_Peru_CAT_concluding_observations.pdf).

11 UN Commission on the Status of Women (CSW), Agreed conclusions: Elimination and prevention of all forms of violence against women and girls. 2013, E/2013/27-E/CN.6/2013/11.

12 Southern African Development Community. SADC Protocol on Gender and Development. 2008. (http://www.sadc.int/files/8713/5292/8364/Protocol_on_Gender_and_Development_2008.pdf) Accessed 28 February 2014.

13 Day K, Pierce-Weeks, J. The Clinical Management of Children and Adolescents Who Have Experienced Sexual Violence: Considerations for PEPFAR Programs. USAID’s AIDS Support and Technical Assistance Resources, AIDSTAR-One, Task Order 1. 2013. (http://www.aidstar-one.com/sites/default/files/AIDSTAR-One_Report_PEPFAR_PRC_TechConsiderations.pdf) Accessed 28 February 2014.

14 USAID. Contraceptive Security Indicators. (https://www.k4health.org/toolkits/contraceptive-security-committees/contraceptive-security-indicators). Accessed 13 May 2013.

15 Sohaba N, Mullick S, Van Blerk L, and Khoza D. Evaluation of Post Rape Care Services for Children in Limpopo and North West Provinces. Presented at the XIX International AIDS Conference, Washington, D.C., July 22, 2012.

16 Keesbury J, Onyango-Ouma W, Undie C, Maternowska C, Mugisha F, Kageha E, Askew A. Review and Evaluation of Multi-Sectoral Response Services (“One-Stop Centers”) for Gender-Based Violence in Kenya and Zambia. Population Council. Nairobi, Kenya 2012.

17 Patel A, Roston A, Tilmon S, Patel D, Roston A, Keith L. Assessing the extent of provision of comprehensive medical care management for female sexual assault patients in US hospital emergency departments. Int J Gynaecol Obstet. 2013 Jul 10.

18 Patel A, Tilmon S, Bhogireddy V, Chor J, Patel D, Keith L. Emergency contraception after sexual assault: changes in provision from 2004 to 2009. J Reprod Med. 2012 Mar-Apr;57(3-4):98-104.

19 Ministry of Health, Kenya. Trainer’s manual on clinical care for survivors of sexual violence. 2007.

20 Ministerio de Salud Pública, Ecuador. Normative y protoco los de atencion Integral de la violencia de genero, intrafamilar y sexual por ciclos de vida. December 2008.

21 Ministry of Health, South Africa. National Management Guidelines for Sexual Assault. October 2003.

22 Ministério da Saúde, Brasília. Prevencao e tratamento dos agravos resultants da violencia sexual contra mulheres e adolescents. 2a edição. 2004.

23 United States Department of Justice Office on Violence Against Women. A National Protocol for Sexual Assault Medical Forensic Examinations: Adults/Adolescents, Second Edition. April 2013.

24 Vernon R, Schiavon R, Llaguno SA. Emergency contraception as an element in the care of rape victims. Mexico City. July, 1997.

25 Keesbury J, Zama M, Shreeniwas S. The Copperbelt model of integrated care for survivors of rape and defilement: Testing the feasibility of police provision of emergency contraceptive pills. Population Council, 2009.

26 Eddy, M. Germany: Morning-After Pill Allowed for the Victims of Rape, Bishops Say, New York Times, 21 February 2013. (http://www.nytimes.com/2013/02/22/world/europe/germany-morning-after-pill-allowed-for-the-victims-of-rape-bishops-say.html?_r=0.) Accessed 13 May 2013.

27 International Consortium for Emergency Contraception, Catholics for Choice. Emergency Contraception: Catholics in Favor, Bishops Opposed. 2010.

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Sexual Violence Research Initiative
Gender and Health Research Unit
Medical Research Council, South Africa
1 Soutpansberg Road, Pretoria, South Africa
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Emergency Contraception: Questions and Answers for Decision-Makers

A brief overview of emergency contraception


What is emergency contraception?

The term “emergency contraception” (EC) refers to several contraceptive methods that can be used to prevent pregnancy after sex. These methods include multiple kinds of emergency contraceptive pills (ECPs) as well as insertion of an intrauterine device (IUD).

EC offers women an important second chance to prevent pregnancy when a regular method fails, no method was used, or sex was forced. EC can be used up to 5 days after unprotected sex but is generally more effective the sooner it is used.

Currently the most common EC method, used in most countries around the world, is a special dose of a progestin called levonorgestrel (LNG) in pill form. LNG ECPs are marketed under many names and simply contain higher dosages of the same hormone found in many regular birth control pills. Other types of ECPs approved for use in some countries are ulipristal acetate and low-dose mifepristone.


What is the need for emergency contraception?

All contraceptive methods occasionally fail. Emergency contraception provides an important back-up when routine contraception does not work properly, such as when a condom breaks or pills are missed, or when it is not used at all. Young people in particular may not be prepared for their first sexual experience and may not be using another form of ongoing birth control. For couples who did not use any contraceptive but wish they had, EC also provides a vital second chance to prevent an unwanted pregnancy.

Another critical use for EC is in cases of sexual assault. EC should routinely be offered to sexual assault survivors to prevent the traumatic psychological and physical consequences of rape-related pregnancy.


Emergency contraception’s mechanism of action


How do emergency contraceptive pills work?

Emergency contraceptive pills work before pregnancy by preventing the release of an egg (ovulation) or by stopping the egg and sperm from meeting. Extensive research on how LNG ECPs, the most commonly used type of EC, work suggests that interference with ovulation is the primary and possibly the only mechanism of action.1 ECPs do not have any effects after fertilization.

ECPs cannot terminate or interrupt an established pregnancy and will not stop a fertilized egg from implanting in the uterus,2,3 nor can they harm a developing embryo.4,5,6 ECPs are ineffective once implantation has begun.


How does EC differ from abortion? Can EC cause an abortion?

ECPs are sometimes confused with medical abortion (sometimes referred to as the “abortion pill”), but the two treatments are very different. ECPs work after unprotected sex but before pregnancy, while medical abortion works after pregnancy starts (once the fertilized egg is implanted in the uterus). Like regular birth control pills, ECPs prevent pregnancy, rather than interrupting an established pregnancy.

While ECPs need to be taken within a few days after unprotected sex, medical abortion pills are taken after pregnancy has been established – after a woman misses her period.


Safety and effectiveness of emergency contraception


How safe are emergency contraceptive pills?

ECPs are very safe for all women and girls of reproductive age. Levonorgestrel, the active ingredient in the most common type of ECPs, has been extensively studied and widely used for over 30 years. It is well-tolerated, is not a known allergen, leaves the body quickly, is not addictive, and has demonstrated no toxic reactions.7,8,9 LNG ECPs pose no risk of overdose and there are no major drug interactions or contraindications.9 There have been no reported deaths or serious complications involving ECPs in over three decades of carefully monitored use.

Research also shows that LNG ECPs have no effect on future fertility10,11 and are not associated with increased risk of cancer12 or ectopic pregnancy.13 Because ECPs do not contain estrogen, they do not pose any risk of stroke or venous thromboembolism.


Can EC pills harm a fetus or cause birth defects if taken by a woman who is already pregnant?

ECPs will not harm a fetus if a woman is already pregnant, nor will they cause birth defects if the pills fail to prevent pregnancy.4,5,6 If ECPs are taken after a pregnancy has been established, they are simply ineffective and have no harmful effects on either the woman or the fetus.


How effective is emergency contraception?

EC can be effective up to five days after unprotected sex, but it is generally more effective the sooner it is used. Most efficacy estimates for LNG ECPs suggest that they prevent between 59% and 95% of expected pregnancies.14,15 In real life terms, that means that if 100 women had unprotected intercourse and then used LNG ECPs, only 1 to 2 of them would become pregnant; if all 100 women had not used LNG ECPS, however, about 8 of them would be expected to become pregnant.

Other types of ECPs (ulipristal acetate and mifepristone) are at least as efficacious as LNG ECPs, and potentially more so.16,17 Emergency insertion of an IUD is even more effective.18


What happens if a woman takes EC pills more than once?

Repeat use of ECPs does not pose any known health risks.19,20 ECPs remain safe and effective in preventing unwanted pregnancy over multiple uses (although using a regular, ongoing method is recommended as the most effective way to prevent pregnancy). Even among women who used ECPs more than once in the same menstrual cycle, no serious adverse outcomes were reported.21 Because of the health risks that pregnancy carries, taking ECPs is likely safer than carrying an unwanted pregnancy to term. As such, women should not be limited in the frequency or number of times they can access ECPs.

The World Health Organization’s 2012 fact sheet on EC states that ECPs’ “repeated use poses no known health risks,” aside from side-effects such as menstrual irregularities (although it recommends against regular use of ECPs as an ongoing contraceptive method because other methods are more effective).19 Earlier WHO guidelines on ECP service delivery further state that health risks of repeated use of ECPs “should never be cited as a reason for denying women access to treatment.”22

Professional support for emergency contraception


What do established medical and other health-related associations say about EC?

Leading health-related professional associations and organizations around the world support emergency contraception, including the World Health Organization (WHO),19 the International Federation of Gynecology and Obstetrics (FIGO),23 the United Nations Population Fund (UNFPA),24 and the American Academy of Pediatrics (AAP).25 Their endorsements of EC reflect confidence not only in EC’s safety and efficacy, but also in the belief that greater access to EC is vital.


Legal status and availability of emergency contraception


Is emergency contraception legal and available in my country?

Levonorgestrel emergency contraceptive pills are registered for sales and distribution in over 140 countries. Even in countries where no dedicated product has been registered, EC may sometimes be supplied with a special import license, and women can always use a higher dose of regular birth control pills for EC.26 To learn more about the status of EC in your country, see www.emergencycontraception.org.


Other concerns about emergency contraception


Should emergency contraceptive pills be provided over-the-counter?

ECPs are safe and appropriate for over-the-counter (OTC) purchase by all women and adolescents. OTC access is particularly critical because ECPs are more effective the sooner they are taken after unprotected intercourse. Requiring a prescription for ECPs often forces women to make two trips: one to a clinic to get the prescription and a second to a pharmacist to fill the prescription. This delays the process and presents a significant barrier for women who lack access to transportation or who live in rural areas without easy access to doctors or pharmacies. Moreover, requiring a prescription makes access to ECPs on weekends and at night (when many contraceptive mishaps occur) more difficult.

Studies show that women and teens alike can read and comprehend the ECP label and understand when and how to take ECPs without advice from a health care provider.27,28,29,30,31 Many national and international agencies recommend non-prescription access to EC. In countries where ECPs remain prescription-only, providers may consider offering advance prescription or provision.


Will access to emergency contraception encourage riskier sexual activity, such as:

• increased risk of pregnancy or STIs?
• increased frequency of unprotected sexual intercourse?
• decreased use of condoms or ongoing birth control methods?

There is no evidence to suggest that emergency contraception leads to increased risk of pregnancy or contraction of sexually transmitted infections (STIs), nor to any increased sexual or contraceptive risk-taking behavior. In order to approximate whether taking EC increases risky sexual behavior, several studies have compared women who receive advance provision of ECPs (and who, in turn, often use EC at a higher-than-average rate) against women who do not receive advance provision of EC.32 The studies have found that the women who received advance provision of EC were no different from those who did not in regard to frequency of unprotected intercourse,32 use of more effective methods of contraception,32 or use of condoms.32

Some of these studies focused specifically on younger women33,34,35,36 and have shown that enhancing access to LNG ECPs does not increase sexual or contraceptive risk-taking behavior in youth. When teens and young women receive advance supplies of LNG ECPs, they do not use the pills repeatedly in place of routine contraceptive methods.33,35,37 Moreover, those who received LNG ECPs in advance were more likely to use it when needed and to take it within 12 hours after sex, when it is most effective.33,35,37


Can and should teens and young women have access to EC?

Emergency contraception is a safe and important option for young women.7 While abstinence is a reliable way to prevent pregnancy and STIs, the reality is that the majority of people become sexually active by age 20. While not all young people are sexually active, in many cases those who are do not use regular contraceptive methods, as young women often lack information about and access to ongoing family planning methods and services.38,39 Unfortunately, young women also face social mores that discourage them from “planning” to have sex, experience sexual coercion, and have difficulty negotiating contraceptive use. For many adolescent girls, protection against pregnancy can be a matter of life and death, as complications from adolescent pregnancy and childbirth are a leading cause of death among adolescent girls ages 15-19 in low- and middle-income countries.40 These factors make EC a particularly critical option for young women by offering them a valuable second chance to avoid an unplanned pregnancy.

EC is safe for young women, with no contraindications and minimal side effects, and teens are able to understand EC product labeling.28,29,30 Moreover, ample evidence shows that improving access to EC among young women does not lead to higher rates of STIs or unintended pregnancies,32 or increase risk-taking behavior.


Increasing access to emergency contraception


How can my country increase women’s access to EC?

  • Register additional EC products (for countries that have few or no dedicated EC products).
  • Include EC in country-level essential medicines lists and national family planning guidelines.
  • Ensure that EC is included in country guidelines on post-rape care.
  • Encourage pharmacy access by making EC available over the counter without age restrictions.
  • Include EC in public sector procurement and supply systems.
  • Where appropriate, incorporate community-based distribution of EC into national protocols.
  • Track and reduce provider stock-out of EC.
  • Ensure that national-level professional bodies, including pharmacy associations, provide clear guidance on EC provision to their members.
  • Ensure that EC is included in pre-service provider training and ongoing professional development for pharmacists, doctors, nurses, and midwives.
  • Promote public education of EC to increase consumer-level knowledge.
  • Ensure that women at all income levels can afford EC.
  • Address poor quality and counterfeit EC products where they exist.


References

1 International Consortium for Emergency Contraception (ICEC) and International Federation of Gynecology & Obstetrics (FIGO). How do levonorgestrel-only emergency contraceptive pills (LNG ECPs) prevent pregnancy? Statement on mechanism of action. March 2012 (ICEC_MoA_Statement_3-28-12.pdf, accessed 23 October 2012).

2 Noe G, Croxatto H, Salvatierra AM, Reyes V, Villarroel C, Munoz C, Morales G, Retamales A. Contraceptive efficacy of emergency contraception with levonorgestrel given before or after ovulation. Contraception 2011;84:486-492.

3 Novikova N, Weisberg E, Stanczyk FZ, Croxatto HB, Fraser IS. Effectiveness of levonorgestrel emergency contraception given before or after ovulation – a pilot study. Contraception 2007;75(2):112-118.

4 De Santis M, Cavaliere AF, Straface G, Carducci B, Caruso A. Failure of the emergency contraceptive levonorgestrel and the risk of adverse effects in pregnancy and on fetal development: an observational cohort study. Fertility and Sterility 2005;84(2):296-9.

5 Zhang L, Chen J, Wang Y, Ren F, Yu W, Cheng L. Pregnancy outcome after levonorgestrel-only emergency contraception failure: a prospective cohort study. Human Reproduction 2009;24(7):1605-11.

6 World Health Organization. Fact sheet on the safety of levonorgestrel-alone emergency contraceptive pills (LNG ECPs). June 2010 (http://whqlibdoc.who.int/hq/2010/WHO_RHR_HRP_10.06_eng.pdf, accessed 23 October 2012).

7 Sambol NC, Harper CC, Kim L, Liu CY, Darney P, Raine TR. Pharmacokinetics of single dose levonorgestrel in adolescents. Contraception 2006;74(2):104-109.

8 Kook K, Gabelnick H, Duncan G. Pharmacokinetics of levonorgestrel 0.75 mg tablets. Contraception 2002;66(1): 73-76.

9 Grimes DA, Raymond EG, Scott Jones B. Emergency contraception over-the-counter: The medical and legal imperatives. Obstetrics and Gynecology 2001;98(1):151-155.

10 Norris Turner A, Ellertson C. How safe is emergency contraception? Drug Safety 2002;25:695-706.

11 Liskin L, Rutledge AH. After contraception: Dispelling rumors about later childbearing. Population Reports. Series J: Family Planning Programs 1984;(28):J697-731.

12 American College of Obstetricians and Gynecologists. Practice Bulletin, Clinical Management Guidelines for Obstetrician-Gynecologists, Number 69: Emergency Contraception. Obstetrics and Gynecology 2005;106:1443-1452.

13 Cleland K, Raymond E, Trussell J, Cheng L, Zhu H. Ectopic pregnancy and emergency contraceptive pills: a systematic review. Obstetrics and Gynecology 2010;115(6):1263-6.

14 Trussell J. Understanding contraceptive failure. Best Practice and Research Clinical Obstetrics and Gynaecology. 2009;23:199-209.

15 Dada OA, Godfrey EM, Piaggio G, von Hertzen H. A randomized, double-blind, noninferiority study to compare two regimens of levonorgestrel for emergency contraception in Nigeria. Contraception. 2010;82:373-378.

16 Cheng L, Gulmezoglu AM, Piaggio G, Ezcurra E, Van Look PF. Interventions for emergency contraception. Cochrane Database of Systematic Reviews 2008;(2):CD001324.

17 Glasier AF, Cameron ST, Fine PM, Logan SJ, Casale W, Van Horn J, Sogor L, Blithe DL, Scherrer B, Mathe H, Jaspart A, Ulmann A, Gainer E. Ulipristal acetate versus levonorgestrel for emergency contraception: a randomised non-inferiority trial and meta-analysis. Lancet. 2010;375:555-562.

18 International Consortium for Emergency Contraception. The Intrauterine Device for Emergency Contraception. September 2012 (ICEC_IUD-FactSheet_Sep-2012.pdf, accessed 23 January 2013).

19 World Health Organization. Emergency contraception fact sheet No. 244. July 2012 (http://www.who.int/mediacentre/factsheets/fs244/en/index.html, accessed 5 February 2013).

20 International Consortium for Emergency Contraception Repeated use of emergency contraception: the facts. July 2003 (ICEC_Repeat-Use_2003-English.pdf, accessed 2 March 2010).

21 Halpern V, Raymond EG, Lopez LM. Repeated use of pre- and post-coital hormonal contraception for prevention of pregnancy. Cochrane Database of Systematic Reviews 2010;(1):CD007595.

22 World Health Organization. Emergency Contraception: A guide for service delivery. 1998 (http://apps.who.int/iris/bitstream/10665/64123/1/WHO_FRH_FPP_98.19.pdf, accessed 5 February 2013).

23 International Federation of Gynecology and Obstetrics Committee for the Ethical Aspects of Human Reproduction and Women’s Health. Recommendations On Ethical Issues In Obstetrics And Gynecology. November 2003.

24 United Nations Population Fund Frequently Asked Questions. November 2008, from http://www.unfpa.org/public/about/faqs.

25 American Academy of Pediatrics. Policy Statement: Emergency Contraception. 26 November, 2012 (http://pediatrics.aappublications.org/content/130/6/1174).

26 Association of Reproductive Health Professionals. Clinical Proceedings: Update on Emergency Contraception. March 2011 (http://www.arhp.org/Publications-and-Resources/Clinical-Proceedings/EC/Methods, accessed 5 February 2013).

27 Raymond EG, Dalebout SM, Camp SI. Comprehension of a prototype over-the-counter label for an emergency contraceptive pill product. Obstetrics and Gynecology 2002;100(2):342-9.

28 Raine TR, Ricciotti N, Sokoloff A, Brown BA, Hummel A, Harper CC. An over-the-counter simulation study of a single-tablet emergency contraceptive in young females. Obstetrics and Gynecology 2012;119(4):772-9.

29 Raymond EG, L’Engle KL, Tolley EE, Ricciotti N, Arnold MV, Park S. Comprehension of a prototype emergency contraception package label by female adolescents. Contraception 2009;79(3):199-205.

30 Cremer M, Holland E, Adams B, Klausner D, Nichols S, Ram RS, Alonzo TA. Adolescent comprehension of emergency contraception in New York City. Obstetrics and Gynecology 2009;113(4):840-4.

31 Glasier A, Baird D. The effects of self-administering emergency contraception. New England Journal of Medicine 1998;339(1):1-4.

32 Polis CB, Schaffer K, Blanchard K, Glasier A, Harper CC, Grimes DA. Advance provision of emergency contraception for pregnancy prevention: a meta-analysis. Obstetrics and Gynecology 2007;110(6): 1379-88.

33 Gold MA, Wolford JE, Smith KA, Parker AM. The effects of advance provision of emergency contraception on adolescent women’s sexual and contraceptive behaviors. Journal of Pediatric and Adolescent Gynecology 2004;17(2):87-96.

34 Stewart HE, Gold MA, Parker AM. The impact of using emergency contraception on reproductive health outcomes: A retrospective review in an urban adolescent clinic. Journal of Pediatric and Adolescent Gynecology 2003;16(5):313-318.

35 Harper CC, Cheong M, Rocca CH, Darney PD, Raine TR. The effect of increased access to emergency contraception among young adolescents. Obstetrics and Gynecology 2005;106(3):481-491.

36 Belzer M, Sanchez K, Olson J, Jacobs AM, Tucker D. Advance supply of emergency contraception: a randomized trial in adolescent mothers. Journal of Pediatric and Adolescent Gynecology 2005;18(5):347-54.

37 Raine TR, Harper CC, Rocca CH, Fischer R, Padian N, Klausner JD, Darner PD. Direct access to emergency contraception through pharmacies and effect on unintended pregnancy and STIs: a randomized controlled trial. Journal of the American Medical Association 2005;293(1):55-62.

38 Weiss DC, Harper CC, Speidel JJ, Raine TR. Should Teens Be Denied Equal Access to Emergency Contraception? Bixby Center for Global Reproductive Health, University of California, San Francisco 2008.

39 Mosher WD, Jones J. Use of contraception in the United States: 1982–2008. Vital and Health Statistics, Series 23: Data from the National Survey of Family Growth 2010;(29):1-44.

40 World Health Organization. Adolescent pregnancy fact sheet No. 3644. May 2012 (http://www.who.int/mediacentre/factsheets/fs364/en/index.html, accessed 5 February 2013).

Emergency Contraception and Medical Abortion: What’s the Difference?

Emergency contraceptive pills (ECPs) are a safe and effective means of preventing pregnancy after unprotected sexual intercourse. They work by preventing ovulation (the release of an egg) or by stopping the egg and sperm from meeting. ECPs do not terminate or interrupt an established pregnancy.

ECPs are different from medical abortion regimens (which include mifepristone, sometimes referred to as the “abortion pill” or RU-486, and misoprostol, a prostaglandin). Both treatments are of critical importance for women’s reproductive health globally, but confusion between the two can present a barrier to broader emergency contraception access.

What is the difference between emergency contraception and medical abortion?

ECPs are a back-up contraceptive method used to prevent a pregnancy after unprotected sex or contraceptive failure. Medical abortion is a non-surgical option for terminating an established pregnancy.

Emergency contraception refers to contraceptive methods that work after unprotected sex but before pregnancy. These regimens can be taken up to 120 hours (5 days) after unprotected intercourse, well before a pregnancy begins. There are four main types of ECPs: Progestin-only (levonorgestrel), the Yuzpe method (higher doses of regular birth control pills containing estrogen and progestin), ulipristal acetate, and low-dose mifepristone. Mifepristone ECPs contain 10 to 25 mg of mifepristone and are available only in Armenia, China, Russia, and Vietnam.

Emergency contraceptive pills prevent pregnancy primarily, or perhaps exclusively, by delaying or inhibiting ovulation. They will not cause an abortion if a woman is already pregnant when she takes the pills. In the case of levonorgestrel, the most commonly available ECP, there is clear evidence that interference with ovulation is the primary mechanism of action. It is possible that levonorgestrel may interfere with other events prior to fertilization (such as impairing the migration of sperm), but it does not have effects after fertilization. No evidence supports the theory that levonorgestrel ECPs interfere with the implantation of a fertilized egg.1,2,3 The precise mechanisms of action for ulipristal acetate and mifepristone at doses used for EC have not been studied as extensively as those for progestin-only EC, so it is not possible to make definitive statements about how they work. However, evidence suggests that interference with ovulation is a primary effect of ulipristal acetate and mifepristone ECPs, and there is no positive evidence that they would prevent implantation of a fertilized egg. None of these regimens disrupt an established pregnancy.4

Medical abortion is used after a pregnancy has been established (when a fertilized egg implants in the uterine wall). While ECPs need to be taken within a few days after unprotected sex, medical abortion is administered after a pregnancy has already been confirmed. There are a couple of different regimens for medical abortion. The drug mifepristone (formerly known as “RU-486”) is approved for use in combination with misoprostol in a number of countries to terminate a pregnancy, but in these cases it is given in a much higher dose and at a different time than when it is used for EC. After a pregnancy is confirmed, the woman takes a large dose (200-600 mg) of mifepristone, typically followed by misoprostol, which causes uterine contractions.5 (If mifepristone is unavailable, a higher dose of misoprostol may be used alone for medical abortion.) The dose of mifepristone needed to induce an abortion is 8 to 60 times greater than the dose used for emergency contraception.

Why is this distinction important?

Confusion about the two methods has often led to barriers to accessing ECPs. Significant opposition to ECP access has emerged based on the assertion that ECPs cause abortion and therefore cannot be provided in settings where abortion is restricted. It is important that EC advocates are able to make a clear distinction between medical abortion regimens and ECPs while supporting access to both.

While mifepristone for medical abortion is administered under a health care provider’s supervision, use of ECPs does not require prior medical screening. Women can determine their own need for ECPs, which offer a safe, simple, self-administered method to prevent pregnancy after unprotected sex.6,7 ECPs are extremely safe for the user and will not cause birth defects if the method fails and pregnancy does occur.8,9,10 For this reason, LNG ECPs are available without a prescription in many countries and can be obtained directly from pharmacies.

Why is broader access to ECPs important to women’s reproductive rights and health?

ECPs are the only available contraceptive method that a woman can self-administer to prevent a pregnancy after unprotected intercourse. They are especially important in cases where women’s rights have already been violated, such as in cases of rape or coerced sex. No matter why a woman needs ECPs, every woman should have the right to unrestricted access to all forms of contraception, including emergency contraception.

Recommendation

No medical or legal barriers should limit the use of ECPs. ECPs are a safe and effective back up means of preventing, rather than ending, unintended pregnancy. Policy makers, medical professionals, and other health advocates should continue to promote ECPs and support their universal availability, timely access, and affordability to women and couples worldwide.

References

1 International Consortium for Emergency Contraception (ICEC) and International Federation of Gynecology & Obstetrics (FIGO). How do levonorgestrel-only emergency contraceptive pills (LNG ECPs) prevent pregnancy? Statement on mechanism of action, March 2012 (ICEC_MoA_Statement_3-28-12.pdf).

2 Noe G, Croxatto H, Salvatierra AM, Reyes V, Villarroel C, Munoz C, Morales G, Retamales A. Contraceptive efficacy of emergency contraception with levonorgestrel given before or after ovulation. Contraception 2011;84:486-492.

3 Novikova N, Weisberg E, Stanczyk FZ, Croxatto HB, Fraser IS. Effectiveness of levonorgestrel emergency contraception given before or after ovulation – a pilot study. Contraception 2007; 75(2):112-118.

4 Gemzell-Danielsson K, Berger C, Lalitkumar PGL. Emergency contraception – mechanisms of action. Contraception (in-press).

5 World Health Organization. Safe abortion: technical and policy guidance for health systems, 2nd edition, 2012. (http://apps.who.int/iris/bitstream/10665/70914/1/9789241548434_eng.pdf, accessed 23 January 2013).

6 Ellertson C, Trussell J, Stewart FH, Winikoff B. Should emergency contraceptive pills be available without prescription? Journal of the American Medical Women’s Association 1998;53 (5 Suppl 2):226-9,232.

7 Grimes DA, Raymond EG, Scott Jones B. Emergency contraception over the counter: the medical and legal imperatives. Obstetrics and Gynecology 2001;98:151-5.

8 De Santis M, Cavaliere AF, Straface G, Carducci B, Caruso A. Failure of the emergency contraceptive levonorgestrel and the risk of adverse effects in pregnancy and on fetal development: an observational cohort study. Fertility and Sterility 2005;84(2):296-9.

9 Zhang L, Chen J, Wang Y, Ren F, Yu W, Cheng L. Pregnancy outcome after levonorgestrel-only emergency contraception failure: a prospective cohort study. Human Reproduction 2009;24(7):1605-11.

10 World Health Organization. Fact sheet on the safety of levonorgestrel-alone emergency contraceptive pills (LNG ECPs), 2010 (ICEC_WHO-Safety-Statement_2010-english.pdf).