What is the story with The Morning After Pill? In this conference I would like to bring you up to date on the current status of Emergency Contraception (EC), as I would like to call it. In developing this information I have had the pleasure of consulting another Dr. Stewart.

Dr. Felicia Stewart (no relation) is currently Director of Reproductive Health Programs at the Kaiser Family Foundation and the former Deputy Assistant Secretary for Population Affairs in the Department of Health and Human Services, where she was the senior national official responsible for family planning and population issues. An obstetrician-gynecologist, Dr. Stewart has had extensive experience in both clinical practice and research and is considered an authority on contraception and family planning.

Introduction

Although it is well-studied and safe and has the potential of reducing unplanned pregnancy by at least 75%, and, derivatively, induced abortions, Emergency Contraception (EC) is not well known by patients in America nor is it frequently prescribed by physicians. Even among obstetrician-gynecologists, who have a high degree of knowledge (99%) and minimal reluctance to prescribe EC, a poll showed that a majority (75%) prescribed EC fewer than five times a year.(1)

Among women who might have need for EC, poll data showed that only 1% had used the technique, even though over one half of the women at risk indicated they would be willing to try such a method if they needed it. Fully two thirds of the women surveyed did not know that anything could be done on an emergency basis to reduce the risk of an unplanned pregnancy.(2)

My goal for this conference is to make every physician and clinician with prescribing privileges sufficiently knowledgeable about EC that they would be comfortable prescribing it for a woman who needs it. This means a friend, a wife, a daughter, as well as a patient. I also think that information about EC should be included in conversations about sexual history during medical examinations of both men and women and in routine gynecological care.

In countries like the Netherlands, where sex education and contraceptive counseling are well accepted, EC is included in routine medical counseling and three-quarters of the prescriptions are provided by general practitioners. In a number of European countries, packets of EC pills with instructions for their use are available.(3) In the United States, even though a number of contraceptive pill formulations are suitable for the Yuzpe regimen (see below), this use is not described in the package inserts, nor are special EC packets made up. The reason for this is not because there is inadequate data on the safety and effectiveness of this method. There is plenty of data.

The FDA has the authority to require pharmaceutical companies to include EC instructions in the labeling but has not invoked this authority. Just recently, in the February 25, 1997 Federal Register, the FDA published an entry attesting to the safety of hormonal EC, a description of the method, and an invitation for NDAs (New Drug Applications) for appropriately labeled products based on currently available studies and not requiring further research.(4)

Indications

Emergency Contraception is indicated in any situation in which a woman has had unprotected intercourse, but does not wish to become pregnant. This can include failed contraception, intercourse with no contraception for any reason, or forced intercourse.

The Methods

There are two currently well accepted methods of Emergency Contraception. One consists of various formulations of estrogen and progestins or progestins alone; the other is the emergency insertion of the copper-containing IUD (Intrauterine Device). The latter can be used up to five days after unprotected coitus and is highly effective. It has the advantage of working as an ongoing contraceptive for up to ten years. Its use is limited by the requirement for special training for insertion, the initial expense, and the fact that some women are not candidates for IUDs.

The Yuzpe Method

In the mid 1970s, Dr. Albert Yuzpe of Canada began publishing his research on a combination of an estrogen, ethinyl estradiol, and a progestin, dl-norgestrel.(5) This medication is administered in two doses started within 72 hrs. after unprotected intercourse. A number of studies have shown that the use of EC reduces the risk of pregnancy by 75%. This means that of the expected eight pregnancies that would occur in 100 women after an act of unprotected intercourse in mid cycle (second or third week), six would be prevented.(6)

How does it work? The combination hormonal therapy is thought to work through a number of mechanisms: interference with ovulation, fertilization, fallopian tube motility, and endometrial receptiveness to implantation. It is not just a morning after pill. There is a well-documented 72-hour window for effectiveness of this regimen.

EC is emphatically not a substitute for a regular contraception. Reducing the risk of pregnancy by 75% for one cycle does not compare with an effectiveness rate of over 99% for a year, as is seen with oral contraceptives, when used perfectly.(7) Furthermore, if there were multiple acts of intercourse during the cycle, a pregnancy could result from the coitus not followed by the EC regimen. Finally, there are significant side effects to EC, most prominently nausea and vomiting, which make it sufficiently unpleasant that women do not want to use it requently.

How Do You Prescribe Emergency Contraception?

There are at least six contraceptive formulations available in the United States that can be adapted to the Yuzpe formulation. In the Yuzpe regimen originally tested, each of the two doses of EC contained 100 mcg of ethinyl estradiol (EE) and 1.0 mg of norgestrel (NG). One dose was taken within 72 hours after unprotected intercourse, and the second 12 hours later. This added up to a total regimen of 200mcg of EE and 2.0 mg of NG. You need to know that some of the currently available contraceptives contain levonorgestrel (LNG), which has twice the potency of norgestrel, so 1.0 mg of LNG is the correct amount for the full regimen (0.5 mg for each dose).

Equivalents in American OCs

Each pill of the contraceptive Ovral contains 50 mcg of EE and 0.5 mg of NG. Two Ovral pills contain 100mcg EE and 1.0 mg of NG, the exact equivalent for each dose of the Yuzpe regimen. Other contraceptives may contain half (25 mcg) or approximately half (30 mcg) the amount of EE that is in Ovral and half (0.125 mg LNG), approximately half (0.15 mg LNG) or the equivalent of half (0.3 mg NG) of the amount of progestin in Ovral, so four of these types of tablets are equivalent to one dose (see Table 1). In the Pill packets with sequential formulations of different combinations of estrogen and progestin, you must be sure that the correct color pill is used.

*For consistency, micrograms are used for all doses of EE.

What Should You Do About Side Effects of Nausea and Vomiting?

In the meta-analysis studies, reports of nausea ranged from 30 to 70% and vomiting from 12 to 20%, with an average close to 20%.(6) Since vomiting within two hours of pill ingestion could interfere with absorption of the dose, many clinicians include the option of an antiemetic one hour before the dose of EC. Such medications as diphenhydramine (Benadryl) 25-50 mg or meclizine (Bonine) 25-50 mg can be used. Patients should be warned about the side effect of drowsiness from anti-emetics and cautioned about driving or operating hazardous machinery. Should a woman vomit within one hour of taking a dose of EC, she should call her clinician. It may be advisable to take a repeat dose, probably preceded by an antiemetic. Patients should also be informed about other temporary side effects of headache, breast tenderness, dizziness and fluid retention.

Are There Contraindications to EC?

Originally the usual contraindications to birth control pills -- estrogen-dependent cancer, thromboembolic disease, migraine, etc. -- were adopted wholesale for EC. Most authorities now agree that the risks from two doses of the estrogen/progestin combination are in no way comparable to those from a month-in month-out ingestion of birth control pills. At least one study has demonstrated no effect on clotting factors from EC.(9) Both the World Health Organization and the International Planned Parenthood Federation have in effect stated that there are no contraindications to EC except an established pregnancy. WHO considers EC pills in Category 2 of its eligibility criteria for patients with potential contraindications. "Current evidence suggests that the amount of COCs (combined oral contraceptives) used is too small to have a clinically significant import."(10) A recent ACOG publication reiterated the lack of known evidence of harm, but also noted that deliberate studies directed at patients with possible risks have not been done.(11)

An Alternative Hormonal Regimen

For patients and clinicians who feel that a regimen containing estrogen simply cannot be used, there is a hormonal alternative. Levonorgestrel (LNG), in a dose of 0.75mg in two doses 12 hours apart within 48 hours of unprotected intercourse, has been shown to be equivalent to the Yuzpe method and is currently the subject of a rigorous study sponsored by WHO that should be available sometime in 1997.(12) A 0.75mg dose of LNG is not currently available in the United States. The equivalent in a currently available contraceptive is somewhat awkward. The minipill Ovrette contains 0.075 mg of NG, or 0.0375 mg of LNG. Therefore 20 pills of Ovrette would have to be taken as an equivalent dose and two packets would have to be purchased to make up the total of 40 pills.(13) The good news is that the progestins are much less likely to cause nausea and vomiting.

Follow Up Advice for the EC Regimen

Women should be cautioned to avoid unprotected coitus until their menses occur, because if EC delayed ovulation, ovulation may yet occur for that cycle. Women should also be told that, if they had unprotected coitus earlier in the cycle, there is a risk that they might already be pregnant.

Some cycle disruption can occur after EC, making the subsequent menstrual period either a few days early or a few days late. If menses have not started within three weeks after EC, a woman should see her clinician for an exam and a pregnancy test.

If the woman is found to be pregnant, there should be no adverse effect on the pregnancy from taking EC. Birth control pills have frequently been taken in early pregnancy without adverse effects on the fetus, and the FDA required manufacturers to remove warnings about increased risk to the fetus several years ago.(4)

A follow up visit after successful EC is always advisable. It presents an opportunity to review contraceptive needs and insure maintenance or initiation of an effective on-going program for women who wish it. It is also a chance to educate and institute protection against STDs (sexually transmitted diseases).

New Initiatives to Educate the Public and the Profession

Emergency Contraception Hotline - 1-800-584-9911

On Valentine's Day (2/14/96), a Hotline was established by the Reproductive Health Technologies Project. The hotline is set up to provide the caller with information about EC and, just as important, the names of providers in nearby areas that will prescribe the treatment and follow up. One of the biggest difficulties for women is finding a practitioner who is able to prescribe the treatment in the short time there is to act. To date over 40,000 calls have been received. Written information can be obtained by calling 1-202-530-2970.

Emergency Contraception Website

There are a number of Web addresses on this subject: http://opr.princeton.edu/ec/ is operated by James Trussell, Ph.D., Director of the Office of Population Research at Princeton University. It is academically on the mark, hooks up with the Federal Register article and contains the information about the Hotline EC providers all over the country. The Website has received over 100,000 hits. Dr. Trussell is a world authority on this subject and can be reached through the website.

The Kaiser Family Foundation Practitioner Education Project

An information packet about Emergency contraception is being developed for U.S. providers, sponsored by the Henry J. Kaiser Family Foundation and co-sponsored by ACOG. This packet will have a manual with all the scientific background and documentation and practical information about prescribing EC and counseling patients. Staff training information, a poster, and brochures for patients are included. Providers receiving education through this resource can be placed in the provider network on the Hotline and in the website.

An initial offering of this packet will be made by participating organizations with primary mission in reproductive health. It will be previewed at the ACOG meeting in April 1997. In May 1997, the packet will be available for purchase through the Planned Parenthood Federation of America. I will be posting further information as it becomes available, or check the websites above.