Emergency Contraceptive Pills, Population Reports, Series A, Number 9

SPECIAL FEATURE	Emergency Contraceptive Pill

More and more women and their health care providers are becoming aware that some oral contraceptive pills, or the same hormones used in these OCs, can serve as emergency contraception. That is, they can help to prevent pregnancy when taken after unprotected intercourse. Emergency contraceptive pills (ECPs) offer a chance to avoid pregnancy to women who did not or could not use contraception or who suspect that their regular method failed. Both progestin-only and combined estrogen-progestin formulations are effective. According to recent research, progestin-only ECPs are more effective and cause less nausea and vomiting.

ECPs are safe and easy to use. Virtually all women can use them, even women who have medical conditions that rule out ongoing use of OCs. Pills from an ordinary OC pill packet can be used for emergency contraception, so long as the pills contain the progestin levonorgestrel, or norgestrel. Thus in effect ECPs are available wherever these combined oral contraceptive pills or progestin-only pills are available. ECPs are not as effective as correct and consistent use of most other modern contraceptive methods, however, and they are more likely to cause nausea and vomiting than OCs taken daily. Therefore ECPs should not be used regularly as a substitute for ongoing contraception.

Poster—Just had sex? Worried about pregnancy? You have 3 days to act. In several countries telephone hotlines offer ready information about emergency contraception and where to obtain it.

Long History, New Attention

The use of combined oral contraceptive pills for emergency contraception is not new. Sometimes referred to as the Yuzpe regimen after its developer, Canadian researcher Albert Yuzpe (549, 550), combined pills have been used for emergency contraception safely and effectively—but not widely—for over 30 years.

The US Food and Drug Administration declared in 1997 that six brands of combined oral contraceptives could be used safely and effectively as ECPs.

Now ECPs are emerging from their status as a “well-kept secret” (204). As a part of efforts to make emergency contraception better known and more available, in April 1995, 24 medical experts from around the world met in Bellagio, Italy. They made recommendations on research, policy, information, and communication intended to increase access to emergency contraception (129). Later that year seven organizations involved in women’s reproductive health formed the Consortium for Emergency Contraception. The Consortium advocates worldwide development and distribution of dedicated emergency contraceptive pills—packaged especially for emergency contraception—and offers a variety of informational materials (85) (see below). In December 1995 the World Health Organization (WHO) added the Yuzpe regimen of combined OCs for emergency contraception to the WHO model list of essential drugs (541). The US Food and Drug Administration (USFDA) declared in 1997 that six brands of combined oral contraceptives could be used safely and effectively as ECPs (481). Several more have been approved since. In 1998 USFDA approved Preven, the first estrogen-progestin regimen marketed in the US specifically as ECPs. USFDA approval for a two-pill progestin-only regimen, Plan B, came in 1999; it had already been approved in 39 other countries.

ECPs are becoming increasingly available around the world. In some countries combined and progestin-only OCs are packaged specifically for use as emergency contraception. These packages contain the appropriate dosage along with instructions for the user and the provider. In some places ECPs are sold over-the-counter or with the referral of a pharmacist, while other places require a physician’s prescription.

Effectiveness of ECPs

Progestin-only ECPs may be more effective than combined pills. ECPs containing estrogen probably prevent at least three-fourths of pregnancies that would have otherwise occurred (472). Typically, if 100 women had unprotected sex once during the second or third week of their menstrual cycles, 8 of them would become pregnant. If these same women all used ECPs containing estrogen, however, only two would become pregnant (518).

A recent WHO study found that women using progestin-only ECPs were one-third as likely to become pregnant as women using combined ECPs (453). Thus, if the same 100 women used progestin-only ECPs, only 1 would become pregnant. This is an 88% reduction in the chance of pregnancy compared with not using ECPs (469). It is important to remember that these failure rates are per use and cannot be compared with failure rates for ongoing contraception, including daily use of OCs.

How Do ECPs Work?

The precise mode of action of ECPs is uncertain and may be related to the time they are used in a woman’s cycle (133, 471). It is thought that in the beginning of the cycle they may prevent ovulation just as OCs taken daily would, or they may delay ovulation. After ovulation, they may interfere with fertilization and/or, in theory, prevent implantation of a fertilized egg in the wall of the uterus (175, 448, 518). ECPs are not effective once the process of implantation has begun.

ECPs will not disrupt an established pregnancy. Furthermore, there is no evidence that combined or progestin-only contraceptives harm a developing fetus (133, 160, 518). Studies examining the effects of exposure to oral contraceptives early in pregnancy have not linked such exposure to congenital malformations (40). Only one study has looked specifically at pregnancy outcomes after failed emergency contraception. It found no evidence that ECPs would adversely affect a fetus (60).

ECPs offer no protection against sexually transmitted infections (STIs). When indicated, as in cases of rape, preventive STI treatment should be provided (190).

Timing of ECP Use

The sooner treatment is started, the better. The first dose should be taken no later than 72 hours after intercourse. The second dose should follow 12 hours after the first dose. A recent study found that, even within the 72-hour period, effectiveness decreased dramatically as time since intercourse increased (453). With each additional 12 hours, the chances of pregnancy increased by almost 50%. Thus ECPs were eight times more effective when begun in the first 12 hours than when begun 60 to 72 hours after intercourse (357).

How effective ECPs would be if started 72 hours or more after intercourse has not been well studied. It is biologically plausible that ECPs would be effective after 72 hours because there are approximately six days between ovulation and implantation (175, 456). Women who request ECPs more than 72 hours after unprotected intercourse may be given pills, but they should be told that pregnancy may already have begun, and therefore ECPs may not be effective (133, 517). For women who request emergency contraception between 72 and 120 hours and are appropriate IUD candidates, a copper IUD may be a better option (517). An international study, conducted by the Population Council and partner clinics, is underway to determine more accurately the effectiveness of ECPs beyond 72 hours. The study also seeks to determine whether pills containing the progestin norethindrone may be used for emergency contraception and whether the second dose is really necessary (370).

Safety and Side Effects

ECPs are safe for virtually all women, including those who may have health conditions that rule out daily use of OCs. ECPs have not been found to increase the risk of the complications associated with ongoing OC use (85, 123, 456, 486). One study specifically examined the risk of venous thromboembolism—which is associated with continuing use of combined OCs (see Thromboembolism, Chapter 4.1)—and found no increase in risk among ECP users (488). WHO medical eligibility criteria for contraceptive use list no medical conditions that rule out use of ECPs (557).

Women taking ECPs sometimes experience nausea, dizziness, fatigue, headache, heavier or lighter menstrual bleeding, breast tenderness, and/or abdominal pain. These side effects usually subside within a day or two. In the WHO study, about 50% of women using combined ECPs reported nausea compared with 23% of women using progestin-only ECPs. Approximately 20% of women who used combined OCs and 6% of those who used progestin-only pills vomited (453). Antinausea medication containing meclizine hydrochloride can help prevent nausea and vomiting (381). Diphenhydramine hydrochloride and dimenhydinate also have been recommended (486). Taking the pills with food or milk also may help (133, 541). If a woman vomits within two hours after taking ECPs, she should take another dose. For women who vomit more than two hours after taking ECPs, another dose is not necessary (380, 517). This advice is based upon medical care providers’ best guess rather than scientific data and is, therefore, a topic of debate (456, 517). In cases of severe vomiting, vaginal administration of a second dose of ECPs has been recommended.

Little research has been done on possible drug interactions involving ECPs. Continuing oral contraception is known to be less effective for women taking carbamazepine, paramethadione, phenytoin, or phenobarbital (for seizures), rifampin (for tuberculosis), or griseofulvin (for fungal infections) (see Chapter 4.3). Some experts recommend assuming that the same interactions occur with ECPs and therefore doubling the dose of ECPs (85). It is unlikely that broad-spectrum antibiotics reduce the efficacy of ECPs (456).

Increasing Access to ECPs

More women and more providers need to know about ECPs. Also, access to ECPs should be improved both for women in general and for groups with special needs.

Educate about ECPs

Women. The public—and women in particular—need to know about ECPs and how to get them. Emergency contraception should be discussed with women at routine health care visits, although at this point it seldom is (229). A study of US college students found that those who had correct information about ECPs—particularly about their ingredients and side effects—had more favorable attitudes toward their use (186, 453). The mass media can tell the public about this “new” way to avoid unwanted pregnancy, explain where to get ECPs and how to use them, stress the need to take the first dose as soon as possible and within 72 hours after intercourse, and clarify that ECPs do NOT cause abortion. Health care providers can tell women how to use their usual brand of OCs as emergency contraception, if their brand contains norgestrel or levonorgestrel. Women can be encouraged to keep an extra packet of pills on hand specifically for emergency use if needed. Where prescriptions are required for OCs and ECPs, the prescriptions can be provided ahead of time. Providers may give women an Emergency Contraception Kit consisting of instructions and pills or else a prescription that can be filled either immediately or when needed (518).

Providers. All women’s health care providers should know about ECPs, including which pills to use, correct regimens, and possible side effects. In some places, however, many health care providers do not know that some of the same pills used for ongoing contraception can also be used for emergency contraception. Other providers may confuse ECPs with abortifacient drugs, which, in contrast to ECPs, act after implantation to disrupt an established pregnancy (9, 79, 110, 149, 157, 231, 259, 316, 326, 406, 513). In either case women may be denied information or access to ECPs because providers are not well informed. At facilities that provide ECPs, all staff members—including those who first greet clients—should know that ECPs are available.

Make access to ECPs easy

Make referrals simple. Easy referrals lead to quicker treatment. Where telephones are widely accessible, hotlines can provide information about ECPs and referrals to providers. In the US and Mexico, nationwide 24-hour-a- day, toll-free hotlines provide information and referrals: 1-888-NOT-2-LATE in the US and 01-800-EN-3-DIAS in Mexico. The British Pregnancy Advisory Service maintains an “action line”—08457 304030—that offers referrals. In China hospitals have set up their own information and referral lines (32). Women in Sri Lanka can dial 501 315 on weekdays between 8:00 am and 4:30 pm for ECP information and referrals (1).

Train a range of providers. Pharmacists, as well as others, can provide ECPs on a woman’s request. A pilot project in the US state of Washington allows pharmacists to provide ECPs according to a clear written protocol. Within the first several months the pharmacists had prescribed over 2,000 courses of ECPs, and users reported no adverse outcomes (65, 212, 226). A survey of women who had received ECPs through these pharmacists found that half obtained them on a weekend or in the evening—times when they could not usually visit a doctor’s office for a prescription (212). A similar pilot project is underway in the UK, where chemists in 16 pharmacies have undergone training and are giving ECPs to women according to a specific protocol. The project will be evaluated, and a decision will be made whether to extend it (187).

Remove unnecessary medical barriers to access. Some providers continue to require a gynecological examination and/or pregnancy test before dispensing ECPs. These procedures are costly, use precious time, and may actually discourage some women from using ECPs (470). Likewise, the inclusion of a urine pregnancy test in commercial emergency contraception kits may deter some women from using ECPs. The test adds to the cost of the kit, requires instructions that may confuse or discourage women with limited literacy, or, if the test is negative, may falsely reassure women that their recent act of unprotected intercourse did not result in pregnancy (174).

Offer ECPs over the counter. Most women decide for themselves when they need emergency contraception, and a physical exam is not necessary. Therefore, well-labeled ECPs should not require a prescription and can be offered over the counter (123, 473). Over-the-counter access can make treatment more effective because women can get ECPs sooner. On June 1, 1999, the progestin-only ECP NorLevo was granted over-the-counter status in France. This is the first dedicated EC product to become available over the counter in a major market (52). A study conducted by the Population Council in India found strong support for over-the-counter provision of ECPs among women themselves (230). Some argue that contact with a health care provider for ECPs is an important point of entry into the health care system for some women, as well as an opportunity to discuss ongoing contraceptive needs (25). While counseling is valuable when providing any contraceptive method, access to ECPs should not be denied because a health care provider cannot counsel the woman face to face. Women can learn about ECPs in other ways. If necessary, pharmacists can give women ECPs and refer them elsewhere, if they wish, for later counseling about ongoing contraception.

Serve groups with special needs

Youth. There are many reasons that adolescents especially need ready access to ECPs. The psychological, social, and health risks of an unwanted pregnancy are especially great for adolescents (298, 541). At the same time, sexual activity among youth tends to be more sporadic and less likely to be planned for than among adults, and young people may be more likely to take risks. Furthermore, as US research finds, adolescents tend to wait some time between starting sexual activity and seeking reproductive health care, including contraception (6, 136). Because family, school, and society at large often disapprove of adolescent sexual activity, many young people lack adequate and appropriate information on sexuality and family planning as well as access to reproductive health care (541). Not only can emergency contraception help prevent unwanted pregnancies and abortions in this vulnerable group, but also providing ECPs sometimes can create opportunities to offer other reproductive health services and counseling about healthy sexual behavior (53, 541).

Women suffering domestic violence. Emergency contraception is a pressing need for many battered women (33). Women abused by their husbands or boyfriends often are unable to negotiate the timing or the terms of sexual intercourse (see Population Reports, Ending Violence Against Women, Series L, No. 11, December 1999). A violent sexual partner may prevent a woman from using ongoing contraception, thus putting her at risk of an unintended pregnancy (292). Some women cannot discuss contraception with their partners for fear that it would spark abuse (193). An unintended pregnancy can also prompt a violent episode from an abusive partner (266). Thus access to ECPs is especially critical for battered women. ECPs should be available wherever women may seek help or refuge, such as hospital emergency rooms, counseling centers, and women’s shelters (129).

Refugees. Refugees often are cut off from a supply of contraceptives. Furthermore, women are targets for sexual violence both while fleeing and once they arrive in refugee camps. For example, an International Rescue Committee assessment of Burundi refugees in an established camp found that 26% of women ages 12 to 49 had experienced sexual violence since becoming refugees (322). Thus emergency contraception should be available as a part of reproductive and mental health services for refugees (165). Humanitarian aid groups increasingly are making ECPs available in times of crisis (151, 476). The WHO New Emergency Health Kit (NEHK ‘98) and the Minimal Initial Service Package (MISP) both include written guidelines and supplies for emergency contraception (338). The High Commissioner for Refugees, the United Nations Population Fund, and WHO have produced a refugee reproductive health manual that includes guidelines for counseling and treating refugee women who are victims of sexual violence. The manual covers provision of ECPs (477).

For More Information
The Consortium for Emergency Contraception operates an Internet website in English, French, Spanish, and Portuguese. The site offers information and advocacy materials as well as a newsletter on the status of ECPs worldwide (http://www.path.org/projects/ec_featured_publications.php). The Consortium also produces Emergency Contraceptive Pills: A Resource Packet for Health Care Providers and Programme Managers. This packet contains a training curriculum, sample client brochures, a medical guide, answers to common questions about EC, guidelines for introduction, and a list of selected references. Contact: Elisa Wells, Consortium Coordinator, 3224 Purdue Street, Anchorage, AK 99508, USA. By e-mail: ewells@path.org.
Princeton University Office of Population Research operates a website with information on emergency contraception, a guide to US clinicians who provide emergency contraception, and country-specific information on dosages of commonly available combined and progestin-only pills for emergency use (http://ec.princeton.edu/).
MEXFAM runs a website in Spanish and English with information on contraception, including ECPs. The site includes dosages and instructions for emergency use of pills common in Mexico (http://www.mexfam.org.mx/).
Pathfinder International publishes a comprehensive reproductive health and family planning training curriculum with a module (Module 5) that specifically addresses emergency contraception. The manual is available on the Pathfinder International website (http://www.pathfind.org) or by writing to Medical Services Division, Pathfinder International, 9 Galen Street, Suite 217, Watertown, MA 02172, USA.
The Program for Appropriate Technology in Health (PATH) and the Northwest Emergency Contraception Coalition produce the publication Emergency Contraception: A Resource Manual for Providers (http://www.path.org/projects/ec_featured_publications.php). They also provide a website that features two client brochures available in 13 languages and adaptable to suit local audiences (http://www.path.org/projects/ec_featured_publications.php). (See illustrations on the guide.)
Women’s Capital Corporation runs a website in English and Spanish about Plan B, the only dedicated progestin-only emergency contraceptive pill approved by the US Food and Drug Administration (http://www.go2planb.com/). Or contact Women’s Capital Corporation, P.O. Box 5026, Bellevue, WA 98009-5026, USA; Tel: 1-800-330-1271.
Family Health International (FHI) publishes a teaching module entitled Emergency Contraceptive Pills in English, Spanish, and French. Contact: CTU Modules Project Administrator, FHI, P.O. Box 13950, Research Triangle Park, NC 21109, USA.
The Population Council, through its INOPAL III project, produces copies of the Consortium for Emergency Contraception’s EC packet in Spanish and Portuguese. For Spanish-language materials contact: Ricardo Vernon, The Population Council Latin America and the Caribbean, Escondida no. 110, Col. Villa Coyoacán, México 04000 D.F., México; Tel: (52-5) 659-8541/8537; Fax: (52-5) 554-1226. For Portuguese-language materials contact: Loren Galvão, The Population Council Brasil, Rua Ruy Vicente de Mello, 1047 Cidade Universitária 13084-050, Campinas, São Paulo, Brasil; Tel: (55 19) 289-2495 or 249-0122. The Population Council also maintains a Spanish-language website.
Johns Hopkins Program for International Education in Reproductive Health (JHPIEGO) produces the website Reproductive Health Online (ReproLine) (http://www.reproline.jhu.edu). The site has a section on ECPs, including presentation graphics and supporting documentation.

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