Widespread availability of emergency contraception—a concentrated dose of ordinary birth control pills that can prevent pregnancy if taken within the first few days following unprotected sexual intercourse—would represent a tremendous advancement for women's health and the public health in general. Not only do emergency contraceptive pills (ECPs) have the potential to help women who have had unprotected sex, experienced contraceptive failure or been sexually assaulted to avoid the trauma of an unwanted pregnancy, but they could cut the number of unintended pregnancies in this country by as much as one-half, thereby drastically reducing recourse to abortion.
Yet three years after the U.S. Food and Drug Administration (FDA) approved the first product specifically packaged for postcoital use, awareness of ECPs in this country remains low among patients and health care professionals alike. Many women do not know to request ECPs, and only a small percentage of health care professionals routinely discuss them with their patients. This has prompted at least one member of Congress to take the initial steps necessary to launch a federally funded public education campaign designed to promote awareness of emergency contraception.
What are ECPs?
Beginning in the mid-1960s, research showed that postcoital use of birth control pills could significantly reduce a woman's risk of unwanted pregnancy. (In the mid-1970s, the first IUDs were inserted successfully for that purpose as well.) In those early days, provision of "emergency contraception" was largely limited to women who were raped, but over time it became more generally available, and by the end of the 1980s, several European countries approved specific regimens of oral contraceptives packaged for postcoital use by women who had had unprotected intercourse for any reason and did not want to become pregnant.
It was not until 1997, however, that the FDA officially declared specific regimens of oral contraceptives safe and effective for postcoital use. Since these regimens were simply recommended dosages of regular oral contraceptives that were not specifically labeled for use as ECPs, health care providers were still obliged to prescribe them "off-label"—as they had for decades. However, the FDA also encouraged drug manufacturers to submit an application for approval of dedicated ECP products. The next year, the FDA approved the first such product, Preven, which was followed by the approval of a second dedicated product, Plan B, in 1999.
Although often referred to in the media as "the morning-after pill," both Preven and Plan B actually contain two doses of pills that should be initiated within 72 hours of unprotected sex and taken 12 hours apart. It is estimated that ECPs can reduce a woman's risk of pregnancy by as much as 89%. Their effectiveness, however, diminishes with time—they are most effective when taken within 24 hours of intercourse—so women are encouraged to take the first dose as soon as possible within the 72-hour window. However, new research published in the March issue of the American Journal of Obstetrics and Gynecology suggests that ECPs can significantly reduce the risk of pregnancy up to 120 hours (five days) following unprotected sex.
Since ECPs contain the same hormones as ordinary birth control pills, they share the same modes of action. Most often, they work by inhibiting ovulation. But depending on the timing of intercourse in relation to a woman's hormonal cycle, they also may prevent fertilization or alter the lining of the uterus to prevent implantation of a fertilized egg—as is the case with all other hormonal methods of contraception.
ECPs could cut the number of unintended pregnancies in this country by as much as one-half, thereby drastically reducing recourse to abortion.
While many antichoice advocates have successfully exploited confusion between emergency contraception and the early abortion pill mifepristone (commonly known as RU-486), ECPs will not cause an abortion under any circumstance. If a woman takes ECPs after she is already pregnant (which is to say, a fertilized egg has successfully implanted in her uterine lining), the pills will not disrupt the pregnancy or harm the fetus in any way. She will remain pregnant—whether she likes it or not.
ECP Awareness Remains Low
"The biggest challenge remaining with respect to emergency contraception is that women don't know about it, and they don't know how or where to get it," says Kirsten Moore, director of the Reproductive Health Technologies Project, a Washington, DC-based nonprofit organization dedicated to bringing new reproductive health technologies to market. For despite their tremendous potential to reduce rates of unintended pregnancy, awareness and use of emergency contraception among women remain low. In fact, according to a November 2000 telephone survey of over 500 women conducted by the Kaiser Family Foundation and Lifetime Television, only 2% of women aged 18-44 have ever used ECPs, and one in four had never heard of the method. And many of those who had heard of ECPs are not aware that they are available in this country, that they require a prescription or how soon they need to be taken following sex.
Moore attributes this low level of public awareness about ECPs, in part, to health care providers who wait for their patients to raise the issue at their moment of need, rather than proactively offering them to women during their annual exam in the event they need a backup method at some point during the year. This is confirmed by the findings of another Kaiser Family Foundation survey of over 750 obstetrician-gynecologists (ob-gyns) and family practice physicians, which found that only 31% of ob-gyns and 17% of family physicians said they had prescribed ECPs more than five times in the previous year. Moreover, only 20% of ob-gyns and 23% of family physicians reported that they routinely discussed emergency contraception with patients. Kaiser also found that only 5% of women who were aware of ECPs reported learning about them from their health care provider. Similarly, a recent survey by The Alan Guttmacher Institute found that while almost eight in 10 (78%) publicly funded family planning agencies offer emergency contraception, only small numbers of women currently receive ECPs from family planning clinics (2% of all clients).
Says Moore, "Women are caught in a catch-22. They are not aware that emergency contraception is an option for them, so they don't request the method from their health care provider. At the same time, health care providers are waiting for women to raise the issue with them. And what it comes down to is that many women who could benefit tremendously from emergency contraception aren't getting it."
Promotion Efforts Abound
To rectify this, the incoming president of the American College of Obstetricians and Gynecologists (ACOG) issued a call to action to the college's 40,000 ob-gyns in April, urging them to help cut the nation's rate of unintended pregnancy by offering women an advance prescription for ECPs during their routine gynecologic visit. While ACOG President-Elect Thomas Purdon said that it would take a variety of measures to improve women's access to emergency contraception, he acknowledged that "a major step is for ob-gyns to discuss EC with the women they see and offer an advance prescription for their emergency needs....if enough of us are talking about this fallback method, we may find emergency contraception to be as common in most women's homes as a first aid kit." His action is also consistent with Healthy People 2010, published by the Office of the U.S. Surgeon General last year, which establishes a 10-year national public health goal of increasing the proportion of health care providers who provide emergency contraception to their patients.
Meanwhile, in some states pharmacists are playing an increasingly important role in facilitating access to ECPs. In 1997, Washington became the first state in the nation to enable women to obtain emergency contraception from a pharmacist, without having to first visit a physician. Through "collaborative agreements"—authorized by laws in over 30 states to permit physicians or nurse practitioners to delegate their authority to prescribe medication to a pharmacist—Washington pharmacists by the end of 2000 had provided ECPs to nearly 30,000 women.
The success of the Washington State program has inspired other states to follow suit: legislation is pending in California that would extend prescriptive authority for ECPs to pharmacists, and a similar bill in Virginia passed both houses of the state legislature but died in conference (over the issue of minors' access). On top of these efforts, the American Medical Association and ACOG, as well as numerous other medical, public health and women's health advocacy groups, have called on the FDA to eliminate the prescription requirement entirely for ECPs, allowing them to be made available to women over the counter (see box). Finally, a national Emergency Contraception Hotline (1-888-not-2-late), operated by the Reproductive Health Technologies Project and the Office of Population Research at Princeton University, provides a 24-hour automated service that will direct callers to health care providers in their area who offer emergency contraception.
On the Political Front
With her home state at the forefront of state efforts to improve access to emergency contraception, one member of Congress is hoping to do even more. Sen. Patty Murray (D-WA) has requested report language to accompany an annual funding bill instructing the Department of Health and Human Services to conduct education outreach regarding ECPs. She is also considering introducing legislation to provide federal funding to support public education campaigns targeting health care providers as well as the public about emergency contraception.
Advocates hope to use such legislation to educate members of Congress about emergency contraception, thereby possibly heading off potential legislative efforts by family planning opponents designed to confuse emergency contraception with abortion and to restrict access for teenagers. "This is one area where the science is way ahead of politics," says Murray aide Anne Grady. "Rather than restricting access, we need to do everything we can to ensure that people understand that emergency contraception can help women avoid unintended pregnancy, and to take steps to ensure that they can access this important drug in a timely way."
Movement Underway to Bring ECPs Over the Counter
In February, over 60 medical, public health and advocacy groups signed a citizens' petition urging the Food and Drug Administration (FDA) to make ECPs available over the counter (OTC). The petition, spearheaded by the Center for Reproductive Law and Policy (CRLP) and the Reproductive Health Technologies Project, is designed to "put this safe and effective product into the hands of women so that they can avoid unintended pregnancy," says Bonnie Scott Jones, a staff attorney at CRLP.
According to the petition, federal law compels the FDA to lift a prescription-only requirement when medical supervision (and thus a prescription) is not necessary to protect the public health from a drug's toxicity or potential for harmful side-effects and when the drug is simple enough to use that instructions on its packaging are sufficient to ensure safe and correct self-medication. Says Jones, "Preven and Plan B clearly meet these conditions."
In addition to the citizen's petition, the manufacturer and distributor of Plan B is taking her case directly to the FDA. Sharon Camp, CEO of Women's Capital Corporation, explains, "From a public health perspective, OTC status makes sense because ECPs are extremely safe but are only effective for a short period after unprotected sex. Yet obtaining a prescription within such a narrow time frame can present problems for some women. OTC status will ultimately allow more women to use ECPs and therefore avoid unwanted pregnancies." As part of her application to the FDA for OTC status, Camp has planned a number of studies that she expects will demonstrate that women can use Plan B safely and correctly based on existing labeling information and in an OTC setting. Camp hopes for FDA approval by the end of 2002.
