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OCs Provide Emergency Contraception Option

Women can prevent pregnancy even after unprotected sex by using certain types of oral contraceptives. Although not as effective as a regular method, OCs used after sex are safe and are 75 percent effective in preventing pregnancy.

Network: Summer 1996, Vol. 16, No. 4

NetworkCopyright Family Health International, 1996. 
Network is reprinted with permission from Family Health International
.

Women can prevent pregnancy even after unprotected sex by using a readily available contraceptive method: Certain types of oral contraceptives, when used as directed in high doses after unprotected intercourse, are safe and 75 percent effective in preventing pregnancy.1

Although not as effective as a regular method, this "emergency contraception" can prevent unwanted pregnancy among women who have been sexually assaulted, experienced a contraceptive failure, forgotten to use a regular contraceptive method or used it incorrectly. Emergency contraception can protect them from resorting to an unsafe abortion -- which kills up to 70,000 women in developing countries every year2 -- and it may prevent life-threatening complications of pregnancy among women who are too young or too old to bear a child safely.

"Emergency contraception should be emphasized as an option in family planning services," says Dr. Roberto Rivera, FHI's corporate director for international medical affairs. "It has an important role as a back-up method, particularly for the use of barrier methods, and it should be provided simultaneously with them." FHI considers the use of barrier methods with emergency contraception as a back-up to be a form of dual method use.

Oral contraceptives used for emergency contraception do not cause abortion because they act before pregnancy begins. These emergency contraceptive pills (ECPs) are thought to alter the uterine lining, or endometrium, thus preventing implantation.3 In some cases, they may also interfere with ovulation or fertilization or with the luteal phase. Using the pill on an emergency basis is safe, even for many women who should not use oral contraceptives routinely.

Combined oral contraceptives taken at a dose of at least 100 micrograms (mcg) ethinyl estradiol and 0.5 milligrams (mg) levonorgestrel can be used for emergency contraception if taken within 72 hours of unprotected intercourse and repeated 12 hours later, as can doses of progestin-only pills totaling 0.75 mg levonorgestrel if used within 48 hours and repeated 12 hours later.

In June, an advisory panel to the U.S. Food and Drug Administration (FDA) concluded unanimously that certain oral contraceptives approved for daily use are also safe and effective as emergency contraceptive pills. The panel said the following dosages of six brands were known to work: two tablets per dose of Wyeth's Ovral or four tablets of Wyeth's Nordette, Lo/Ovral or Triphasil (yellow pills only) brands, or four tablets of Berlex Laboratories' Levlen or Tri-Levlen (yellow pills only) brands.

Emergency contraception can be achieved in other ways: Within 72 hours by using an antiprogestin (a single dose of 600 mg mifepristone) or by inserting a copper-bearing intrauterine device (IUD) within five days.

Bellagio consensus

Despite the safety and effectiveness of emergency contraceptive pills, many providers are hesitant to offer them. At a 1995 international conference on emergency contraception held in Bellagio, Italy, experts from FHI, World Health Organization (WHO) and other organizations outlined three main reasons why emergency contraception is not widely available: Women and providers are uninformed about it, few products are marketed for it, and many health programs do not offer them.4

"Women everywhere should have access to these safe and effective ways to prevent unwanted pregnancy," the Bellagio consensus statement reads. "We must make access to emergency contraception a reality."

Many women's health advocates agree. Information on emergency contraception "is information every woman should have," says Judy Norsigian of the Boston Women's Health Book Collective, which publishes Our Bodies, Ourselves, a popular health manual for women.

Enthusiasm for emergency contraception is growing as international agencies, researchers and providers see its usefulness. "We already have the supplies for the method," says Dr. Charlotte Ellertson, a program associate at the Population Council in New York. "All it takes now is information. With emergency contraception, the information is the method. We just require a new mindset."

While some health-care workers eagerly offer emergency contraception, others have reasons for not providing it. A 1994 survey by the International Planned Parenthood Federation (IPPF) found that many providers are reluctant to offer emergency contraception because they are afraid it will be linked with abortion, their staffs have no training to offer it, women have not requested the service, and other reasons.5

Other providers have expressed concern that access to emergency contraception may make it less likely that some women could refuse unwanted sexual intercourse, or that women will substitute the method for regular contraception, thus exposing themselves to a greater risk of unwanted pregnancy and sexually transmitted diseases.

Dr. Ellertson points out that women are unlikely to use emergency contraceptive pills excessively. "The reason that women would not use emergency contraceptive pills as an ongoing method is that ECPs are less effective than other methods," she says. "ECPs also have some unpleasant side effects that we think would dissuade women from using them over and over again." Nausea, for example, is common among users. Studies are under way to find out how women use emergency contraception, she says.

These questions need to be addressed, but they should not keep providers from offering emergency contraception to women who need it, experts agree. "It is important not to deny women this method," says Dr. Pramilla Senanayake, IPPF assistant secretary general. Provider education is of prime importance, she says. Emergency contraception "should be built into the normal educational program for physicians, nurses, midwives and health-care providers."

Communicating with providers, policy-makers and women is a crucial step in changing attitudes, according to an FHI study.6 Communication can increase access, the authors say, by "strengthening providers' knowledge of emergency contraception, increasing women's awareness of its availability and where to obtain it, and overcoming political obstacles."

Women who seek emergency contraception are often embarrassed and frightened: They may be adolescents who have had their first sexual contact, or women who have been sexually assaulted.

Because of these special circumstances, providers' attitudes are very important in counseling potential users, according to guidelines developed by Pathfinder International.7 "Women in need of emergency contraception are facing a serious personal crisis," the guidelines read. "Make them feel confident that you are prepared to help. Avoid prolonged counseling that might make the woman uncomfortable."

The best counseling is nonjudgmental and includes information about the efficacy, advantages, disadvantages, side effects and other characteristics of emergency contraceptive pills. If appropriate, counselors should also present options for contraception following the use of emergency contraceptive pills, the guidelines say.

Clarifying guidelines

One reason more women do not use emergency contraceptive pills is that there is confusion about what they are and how they should be used.

Because they are commonly called "morning-after pills," some women and providers mistakenly believe that the pills cannot be taken later than the next morning or must be taken within a few hours after intercourse. Others confuse emergency contraception with RU 486 (mifepristone), which can be used for emergency contraception but is better known as a way of inducing abortion.

Combined oral contraceptive pills used postcoitally are the same ones used as a regular contraceptive method, but taken in higher doses of two or four tablets. Although the hormone doses in COCs when used for emergency contraception are relatively high, they are short-lived and can be used safely, even by women with cardiovascular problems. According to WHO, the only absolute contraindication for emergency oral contraceptive use is pregnancy.8 If a woman is already pregnant, she should not use emergency contraception. But if a pregnant woman mistakenly takes the pills, there is no evidence that they will harm the fetus.9

Emergency contraceptive pills have been used for decades, but guidelines for their use are inconsistent, says Dr. Linda Potter, an FHI public health scientist. Dr. Potter and Tara Nutley, an FHI program officer, have recently completed a comparison of ECP guidelines used by eight organizations and researchers. Suggested contraindications, drug interactions and other issues varied dramatically.

Improving availability

Emergency contraceptive pills are safe and effective, but they are not always convenient. Up to 50 percent of women who use COCs for emergency contraception have nausea, and many of those women vomit, potentially reducing the effectiveness of the pills.10 In addition, the short time limit for initiating ECPs may discourage women who must travel long distances to clinics or are unable to reach them soon enough to receive pills. For example, many clinics close on weekends, when emergency contraception is most often needed.

Several international studies are examining how to make emergency contraceptive methods more available and useful to a wide variety of women. For example, the South-to-South Cooperation in Reproductive Health is comparing vaginal delivery of emergency contraceptive pills with oral use, in a trial involving 600 women in six countries.

So far, the two delivery methods seem to be equally effective at preventing pregnancy, says Dr. Josue Garza-Flores, director of the Mexico City-based Center for Assistance in Human Reproduction and a researcher on the study.

But vaginal delivery doesn't seem to reduce nausea and vomiting, he says. Still, because vaginal delivery prevents vomiting of the pills themselves, it may prevent having to repeat a dose after vomiting.

WHO is also looking for a way to reduce side effects in a trial involving 2,200 women in 15 countries, says Dr. Paul Van Look, associate director of WHO's Special Programme of Research, Development and Research Training in Human Reproduction.

Dr. Fabienne Grou of the University of Montreal is examining whether combined oral contraceptives are effective as emergency contraception if initiated later than 72 hours after unprotected sex.

"If it works for only 40 or 50 percent of women, that would be good" for those who have no other choice, Dr. Grou says. She has found one difficulty in recruiting for the study: Women in Quebec receive education about emergency contraception in school, and few request it beyond 72 hours.

Dr. Ellertson of the Population Council is planning a similar study, which will test the effectiveness of different regimens, such as using other progestins, extending the 72-hour time limit or giving one dose of hormones instead of two.

Limited approval

So far, few products have been marketed or labeled for emergency contraception. In many countries, women or providers obtain the needed pills by simply using a portion of pills from a monthly packet of combined oral contraceptives.

In the United States, the June action by the FDA's Reproductive Health Drugs Advisory Committee paves the way for possible labeling of combined oral contraceptives for emergency use. However, no pharmaceutical company has formally requested FDA approval for marketing pills specifically for emergency contraception.

"There is probably enough information in the published literature to approve that use, if we should get an application [from a drug company]," says Dr. Philip Corfman, an FDA medical officer. The FDA cannot approve relabeling of drugs for new uses without an application.

In other countries, emergency contraceptive pills have been approved, and they have been packaged and labeled differently from monthly cycles of oral contraceptives to make their use clear. Berlin-based Schering sells two products -- PC4 and Tetragynon -- for emergency contraception, primarily in western Europe. Each packet includes a user information leaflet and four pills containing levonorgestrel and ethinyl estradiol.

Schering believes ECPs should be offered by prescription only, says Lutz Schaffran, Schering's head of international family planning. For that reason, the pharmaceutical company does not sell ECPs in Asia and Latin America, where oral contraceptives are typically bought in pharmacies without prescription.

In spite of these restrictions, emergency contraceptive pills are becoming more widely available. For example, Schering is selling the pills to African governments that request them because in Africa, unlike Latin America and Asia, clinics and medical professionals are more likely to provide the pills, Schaffran says. Zaire requested the first shipment, which will primarily be used in refugee camps, he says.

The Consortium for Emergency Contraception, a group of seven organizations, plans to work with industry to produce an inexpensive emergency contraceptive product. It will help introduce the product in up to 15 developing countries over the next five years.

The first model introduction will begin in Kenya soon. Model service delivery guidelines and other materials will be field-tested in Kenya and three other countries. "The thing that has surprised us the most is the extraordinary level of interest in these methods and the relative lack of controversy," says Dr. Sharon L. Camp, the consortium's acting coordinator.

"Many health-care providers see this as an important addition to the range of choices they have to give women who want control over childbearing," she says. "It is a method that could reduce the need for abortion, and in Kenya, illegal abortion is a very serious health problem."

Vietnam and Latin America

In Vietnam, health-care providers rarely offer emergency contraception. A 1995 Population Council survey in Ho Chi Minh City found that providers knew little about emergency contraceptive pills, says Dr. Nguyen thi Nhu Ngoc, vice-director of Hungvuong Hospital and a principal investigator on the study.

But Vietnam has been moving to broaden its contraceptive choices -- once limited primarily to IUDs and tubal ligation -- to include oral contraceptive pills. At a recent meeting of 300 Vietnamese providers, Dr. Nguyen says, many showed an interest in bringing emergency contraception to their practices. Before doing so, they must learn how to provide the method correctly, she says.

Pathfinder International is beginning this type of education in Hanoi. This year, Pathfinder will provide training on emergency contraceptive pills to 300 pharmacists, the health-care workers who provide the bulk of oral contraceptives in Vietnam. The organization will also produce client instructions, says Cathy Solter, a Pathfinder medical services associate.

In most of Latin America, emergency contraception is virtually unavailable, primarily because it is confused with abortion, says Dr. Garza-Flores of Mexico City. Abortion is restricted and stigmatized in Latin America.

For the past 18 months, Dr. Garza- Flores has been offering emergency contraception at his clinic, and about 80 women, mostly young, have requested it. In order to reach more women, Dr. Garza-Flores is working with Mexico's national human rights commission, which helps victims of sexual assault. He is hoping to convince the commission to make information on emergency contraception available to women, he says.

Brazil is also moving toward making emergency contraception accessible. In March, the Ministry of Health and the Population Council organized a nationwide meeting to follow up on last year's Bellagio conference. Out of the meeting came policy recommendations that will be distributed throughout the country, says Dr. Juan Díaz, a Population Council senior associate in Brazil.

The group recommended that emergency contraception be included in the Ministry's technical norms; that combined oral contraceptives be the emergency method of choice in Brazil; and that access to emergency contraception be promoted.11 According to the group, "All women of reproductive age at risk of developing an unwanted pregnancy should have access to emergency contraception."

-- Carol Lynn Blaney

Carol Lynn Blaney, a former Network staff writer, is a free-lance science writer who lives in San Jose, CA, USA.

Footnotes:

  1. Trussell J, Ellertson C, Stewart F. The effectiveness of the Yuzpe regimen of emergency contraception. Fam Plann Perspect 1996;28(2):58-64, 87.
  2. World Health Organization. Abortion: A Tabulation of Available Data on the Frequency and Mortality of Unsafe Abortion, 2nd ed. Geneva: World Health Organization, 1994.
  3. Grou F, Rodrigues I. The morning-after pill -- How long after? Am J Obstet Gynecol 1994;171(6):1529-34.
  4. Consensus statement on emergency contraception. Contraception 1995;52:211-13.
  5. Senanayake P. Emergency contraception: The International Planned Parenthood Federation's experience. Int Fam Plann Perspect 1996;22(2):69-70.
  6. Robinson ET, Metcalf-Whittaker M, Rivera R. Introducing emergency contraceptive services: Communications strategies and the role of women's health advocates. Int Fam Plann Perspect 1996;22(2):71-75, 80.
  7. Pathfinder International. Emergency contraceptive pills (ECPs) service delivery guidelines. Unpublished paper.
  8. Improving Access to Quality Care in Family Planning: Medical Eligibility Criteria for Contraceptive Use. (Geneva: World Health Organization, 1996) 32.
  9. Webb A. How safe is the Yuzpe method of emergency contraception? Fertil Control Rev 1995;4(2):16-18.
  10. Trussell.
  11. Population Council, Brazilian Ministry of Health. Final Report of the 1st Brazilian Workshop on Emergency Contraception: A Technical Advisory Group for Its Use in Brazil. Brasilia: Brazilian Ministry of Health, 1996.

For more information, visit Family Health International's Website at www.fhi.org

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