UNITED NATIONS POPULATION INFORMATION NETWORK (POPIN)
UN Population Division, Department of Economic and Social Affairs,
with support from the UN Population Fund (UNFPA)

OCs Provide Emergency Contraception Option

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

Oral Contraceptives





Copyright 1996, Family Health International





OCs Provide Emergency Contraception Option



Although not as effective as a regular method, OCs used after sex may

achieve contraception.



     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 backup 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 backup 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 (mg) 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 it 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 ECP 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 can not approve relabling 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 extrodinary 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.12/ 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



     Editor's note: 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. World Health Organization. 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.





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