Despite the widespread availability of highly effective methods of contraception, one-half of the pregnancies in the United States are unintended, and 28% of all pregnancies end in abortion.¹ Moreover, nearly one-half of the approximately three million unintended pregnancies each year occur among women who report using a contraceptive method,² suggesting that these pregnancies resulted from contraceptive failures. Experts agree that widening the menu of contraceptive choice is desirable, and that a method to prevent pregnancy after unprotected intercourse or after a contraceptive failure is critically needed.

Emergency contraceptive pills (also known as "morning-after pills") are a form of postcoital hormonal treatment intended to prevent pregnancy following unprotected sexual intercourse. It has been known since the mid-1970s that high doses of oral contraceptives given postcoitally are effective in preventing pregnancy.³ The Yuzpe method, the typical regimen, involves taking one dose containing estrogen and progestin (100 mcg of ethinyl estradiol and 1 mg of norgestrel or 0.5 mg of levonorgestrel) within 72 hours after unprotected intercourse, followed by another dose 12 hours later. The most recent data available confirm that compliance with this regime reduces the risk of pregnancy by 75%.⁴

Despite the demonstrated efficacy of oral contraceptives as emergency contraception, several problems have prevented the widespread distribution and use of this method. First, health care providers lack detailed knowledge of emergency contraception; surveys have uncovered misconceptions about such crucial issues as which medications can be used, the timing of doses and the method's mode of action.⁵ Second, potential consumers lack knowledge and awareness of this contraceptive method. For example, a national survey of 1,000 women aged 18-44 conducted in 1997 by the Kaiser Family Foundation indicated that while two-thirds of the sample had heard of emergency contraception or "the morning-after pill," only 28% knew it was available in the United States, 13% knew the treatment could be initiated up to 72 hours after sex and only 1% had ever used it.⁶

The primary reasons, however, why emergency contraceptive pills are rarely used are most likely the prescription-only status of standard oral contraceptives pill and the lack of availability (until recently) of a product specifically packaged by a pharmaceutical company for use as emergency contraception. This lack of a designated product contributed, in part, to a recent action by the U.S. Food and Drug Administration (FDA): In June 1996, the organization's Scientific Advisory Panel on Reproductive Health Drugs unanimously declared four regimens of oral hormonal contraceptives to be safe and effective for use as emergency contraception. When this statement was published in the February 1997 Federal Register,⁷ it served as a call to pharmaceutical manufacturers to enter New Drug Applications to make this additional contraceptive option available.

To date, two pharmaceutical companies have responded. In August 1998, Gynétics, Inc., announced that the FDA had approved its dedicated product, the PREVEN Emergency Contraceptive Kit^® for use as an emergency contraceptive method. The kit became available by prescription from doctors and other health care professionals in October 1998. And in July 1999, the Women's Capital Corporation announced FDA approval of the first progestin-only emergency contraceptive, Plan B™.⁸

While these developments removed a major barrier to the distribution of emergency contraceptive pills, a method's availability is only one of several factors that influence its use. For example, despite this general availability, additional obstacles have surfaced, since many pharmacists are unaware of the method and others refuse to dispense it, based on the erroneous belief that emergency contraception is an abortifacient; to date, one major pharmacy chain, Wal-Mart, has even refused to stock or dispense Preven.⁹

In addition,for any new technology to become a viable option for decreasing unintended pregnancies, potential users must know about it, be willing to use it and find it acceptable. Probably because emergency contraceptive pills have been such a well-kept secret and have not been widely used, very little is known about their acceptability, even though studies have assessed knowledge and attitudes among potential consumers.¹⁰ To date, one study that examined women's satisfaction with the method found that most participants were already practicing contraception, needed an emergency contraceptive because of condom failure and would use emergency pills again if necessary.¹¹

In the absence of a dedicated emergency contraception product, a large-scale demonstration project to evaluate the method's acceptability to providers and consumers was conducted in 1996-1998, in collaboration with a large health maintenance organization, Kaiser Permanente of Southern California.* The project consisted of three main components. First, oral contraceptive pills were repackaged into emergency contraception "kits" of six combined hormonal tablets (two tablets for each of two doses, and one extra dose in case of vomiting) of 0.5 mg dl-norgestrel and 50 mcg ethinyl estradiol, and four capsules of an antinauseant containing 25 mg of diphenhydramine.^†

Second, informational and educational brochures were developed for consumers. Third, an evaluation of the method's acceptability was conducted among women who received emergency contraceptive pills through the project. Since the kit that was distributed contained oral hormonal contraceptives that are pharmacologically equivalent to those in the Preven kits, the study results should also be relevant to Preven's manufacturers and users.

The major purpose of this study was to assess women's experience and satisfaction with emergency contraceptive pills. More specifically, the study examined how women found out about emergency contraceptive pills; their reasons for having had unprotected sex and needing emergency contraceptive pills; any side effects they experienced from taking the pills, such as nausea and vomiting; the method's acceptability and their satisfaction with it; their willingness to use the method in the future; and their attitudes regarding how emergency contraceptive pills should be distributed.

Data and Methods

Participants

Participants consisted of 235 women aged 18 or older who received emergency contraceptive pills through the demonstration project at one of 13 participating Kaiser Permanente medical offices in San Diego County. While the intention of the program was to make emergency contraception available on a needs basis, it did not attempt to limit provision to only women with needs. Because we did not do a chart review or have access to medical records, we only know whether women came in for a scheduled or unscheduled appointment.

Overall, the vast majority of women (93%) received their kit at a needs-based, unscheduled visit ("drop-in"). Only 7% of the 235 women who had taken the pills by the time of the interview reported receiving their kit at a regularly scheduled visit. Because these women had used the pills by the time of the interview, they too had a need for emergency contraception. Women received emergency contraceptive pills directly through one of the following departments: obstetrics and gynecology, family practice, urgent care and emergency. The project was reviewed and approved by the Kaiser Permanente Review Board for the Protection of Human Subjects.

The names of all adult women who received emergency contraceptive pills from these providers were collected every other week from January 1997 through February 1998. A member of the research team asked the providers for permission to contact their patients to ask them to participate in a telephone interview. These adult patients were then sent a letter explaining that they would be contacted by telephone to be interviewed regarding a recent clinic visit; the letter advised them that if they did not wish to be included in the study, they were to return a preaddressed postcard declining participation. The women who did not return the postcard were contacted by telephone and asked if they would participate in an interview.

Of the women whom health care providers had given permission to contact, the research team received the names of 375 who consented by default (i.e., they did not decline to participate via the postcard). Of these women, we were unable to reach 78 by phone. Of the 297 women we did reach, 49 declined to be interviewed at that time. Thus, we interviewed 248 women, for a response rate of 84% of those contacted. Of these 248 women, 13 had not taken the pills by the time they were contacted for the interview. Thus, our analyses are based on the remaining 235 women who had experience taking emergency contraceptive pills.

Data Collection and Analysis

Data were collected using structured telephone interviews conducted by trained female interviewers. The interview guide included both open- and closed-ended questions that covered the six areas mentioned earlier.

The guide was developed by members of the research team and was then reviewed by three Kaiser Permanente health care providers who were familiar with emergency contraception. Minor suggestions were made and incorporated into the final draft. The guide was then pretested with three women and appropriate changes were made. The interviews were confidential and lasted approximately 15-20 minutes. Participants were interviewed an average of 62 days following the day they obtained their emergency contraception kit. Data were entered into the Statistical Package for Social Sciences (SPSS) software program and simple frequencies and chi-square analyses were conducted.

Results

The women in the sample ranged in age from 18 to 48, with a mean age of 27 years.^‡ Nearly one-half (47%) of the women in the sample were non-Hispanic white, one-fourth (25%) were Hispanic and 11% were black (Table 1). These women were highly educated, as 46% had had some college education and 32% had graduated from college. The majority of the women were not married (77%), and nearly one-half (43%) had delivered at least one child; 47% reported having had an abortion, 20% had had a miscarriage and 15% had used emergency contraceptive pills in the past.

In response to the question on how they had found out about emergency contraception, 29% reported that they learned about it from Kaiser Permanente staff, 25% through brochures, posters and classes at Kaiser Permanente medical offices, 17% through family or friends, and 12% through the media (local newspapers and magazines). The remainder reported other sources of information, including human sexuality classes, Planned Parenthood clinics and other family planning and health care providers not affiliated with Kaiser Permanente. Most women learned of emergency contraception from Kaiser Permanente staff or educational materials (54% overall). When asked whether they had requested the pills themselves or had been offered them, a far higher proportion said they had asked their provider for the method (78% vs. 22%, not shown).

The majority (70%) responded "yes" to the question: "Before being given emergency contraceptive pills, were you using a method of contraception?" Among those who were using a method, 73% were using condoms, 17% were using the pill and the remaining 11% were using other methods (Table 1).

Thus, given the large number of women who were using condoms, it was not surprising that the most frequently cited situation leading to unprotected sex was that a condom broke or slipped (45%), followed by 23% who said they had had unplanned sex, 9% who forgot to use a method and 6% who replied that they did not want to use one (not shown). Small proportions cited other situations, including that contraception was not easily available, that they had been forced to have sex and that their partner had not wanted to use a contraceptive.

When asked how long after unprotected sex they had contacted Kaiser Permanente, most women (61%) said they had done so within 12 hours, 24% between 12 and 24 hours afterward and 15% more than 24 hours after. Overall, only 4% contacted their provider 72 hours or more after unprotected sex.

More than one-half of the sample (54%) received their kit through a Kaiser obstetrics and gynecology department, 44% through a family practice and only 2% in an emergency or urgent care clinic. One-third obtained their kit within four hours of contacting the clinic, and a total of 69% went home with a kit within one day of contacting a Kaiser Permanente office.

During the interview, the women were read a list of the method's potential side effects, such as dizziness, dry mouth, cramps, bleeding, headache and breast tenderness and were asked if they had experienced any of them in the 48 hours after taking the pills. Overall, 81% reported at least one side effect, with the proportions experiencing individual effects ranging from 9% to 48% (Table 2). Given that nausea and vomiting frequently occur, we asked women about their experience with these symptoms after each dose. While equal proportions reported nausea after each dose (34-35%), fewer than 10% reported vomiting after either one. We were unable to assess the effectiveness of the antinauseant by comparing women who did and did not take it, since too few women (15 with the first dose and 30 with the second dose) neglected to take the antinauseant.

The most frequently experienced side effect was drowsiness (48%). It seems reasonable to attribute this to diphenhydramine, the antinauseant used in the kit, and not to the emergency contraceptive pills themselves, because drowsiness is a well-known side effect of diphenhydramine, but does not occur with oral contraceptive use.

Women were asked several questions to assess the acceptability of and their satisfaction with emergency contraceptive pills. All but one woman—99.6% of the sample—responded "yes" when asked if they found emergency contraceptive pills easy to use. Similarly, a large majority (90%) reported that the pills were effective in preventing pregnancy. Although this study did not seek to assess the efficacy of the method in preventing pregnancy, six women who took the emergency contraceptive pills (3%) became pregnant.

Of these six women, one initiated treatment more than 72 hours after unprotected intercourse and two reported other episodes of unprotected sex between the time they took the emergency contraceptive pills and the time they were interviewed. The remaining three women, however, took both doses of the pills starting within 72 hours of sex and reported no other episodes of unprotected intercourse.

Overall, more than three-quarters of the women (77%) were very satisfied with their experience with emergency contraceptive pills, 14% were somewhat satisfied, 6% felt neutral about the experience, only 2% were somewhat dissatisfied and 1% were very dissatisfied. Five of the six women who indicated dissatisfaction had become pregnant. When asked the reasons for their dissatisfaction, four women cited side effects, and the fifth woman remarked that the pills had not worked, as she became pregnant. The sixth woman did not provide a reason for her dissatisfaction.

We compared the 183 women who indicated that they were very satisfied with the 53 other women (using chi-square analysis, with a p-value set at <.01 because of the multiple tests involved) to examine whether demographic characteristics differed significantly between the two groups. No significant differences emerged in the women's age, education, ethnicity, religion or history of abortion.

Almost all study participants (97%) responded affirmatively to the question "Would you recommend emergency contraceptive pills to a friend or a family member?" and 93% said they would use them again, if needed, in the future. These women were then asked about the circumstances in which they would use the method in the future. The overwhelming majority (97%) stated they would use it only in an emergency; 2% (five women) reported they would use them occasionally as a contraceptive method, and one woman said she would use them as a regular contraceptive method.

We also asked women if they had told their partner about their use of the method, and whether they thought that its use would make their partner less likely to use a condom. Among the 84% who had informed their partner, 92% agreed that using emergency contraceptive pills would not make their partner less willing to practice contraception. This suggests that male partners would not encourage regular use of emergency contraception as an alternative to other methods.

Finally, the responses to three yes-no questions assessing attitudes toward the provision of emergency contraceptive pills and efforts to make them more widely available indicate that only 28% believed that the method should be dispensed over the counter without a prescription, and an even lower proportion—6%—agreed that the pills should be made available in vending machines. However, more than two-thirds of the sample (69%) responded "yes" to the question asking whether emergency contraceptive pills should be given to women for future use in case of unprotected intercourse.

Discussion

Because no contraceptive is 100% effective, emergency contraception is a method that women will always need. It is noteworthy that 70% of this sample of women who used emergency contraceptive pills were using a contraceptive method. Moreover, when asked about the situation that led to unprotected intercourse, nearly one-half indicated that it had been a condom failure.

One study, conducted before Preven's approval, estimated that five million women would use emergency contraception each year if an FDA-approved dedicated product were available.¹² As family planning providers encourage more women to use condoms for the prevention of sexually transmitted diseases, including HIV, emergency contraceptive pills can be prescribed for use as a backup method in case of condom failure. Emergency contraceptive pills can play an important role in addressing the confusion and conflict that might result when young women use condoms to prevent both pregnancy and disease.

Researchers have suggested that condom packages could inform users that if the condom is used improperly or develops a leak, emergency contraception should be taken as soon as possible.¹³ Moreover, a recent survey found that 49% of women interviewed believed that condoms, combined with emergency contraception as a backup, were very effective at preventing pregnancy; one-quarter of this sample said they would be more likely to use condoms for contraception knowing they could use emergency contraceptive pills as a backup, if needed.¹⁴

Family planning providers should be encouraged to think of emergency contraceptive pills as a good adjunct to barrier methods, and to prescribe condoms with emergency contraceptive pills as a dual method. However, because condoms are the only contraceptive method available that also protects against the transmission of HIV and other sexually transmitted diseases, efforts at counseling and education need to teach skills for proper condom use, to reduce the likelihood of failure.

The side effects of emergency contraceptive pills, such as nausea, vomiting, dizziness, cramps, bleeding and headache, may influence their acceptability. The rates of nausea (34-35%) and vomiting (9%) in this project were considerably lower than those reported in the literature (50% and 20%, respectively).¹⁵ While this study was not designed to evaluate the method's side effects, the low rates of nausea and vomiting may be due to the inclusion of an antinauseant, with instructions, in the kit. The decision to include this additional medication was made because those few clinicians in the project setting who had experience providing emergency contraceptive pills routinely dispensed them with an antiemetic.

Taken together, the findings indicate that the women in this sample were very accepting of this method of contraception. More than nine out of 10 (91%) were very satisfied or somewhat satisfied with emergency contraceptive pills, an overwhelming majority (97%) said they would recommend them to a friend or a family member, and 93% would use the method again if they needed. Contrary to fears that women would substitute emergency contraceptive pills for consistent birth control use, almost all women said they would use emergency contraceptive pills again only in an emergency.

Another important finding is that with appropriate education, instructions and a dedicated product, women found emergency contraceptive pills easy to use, and they appeared to use the method correctly. Now women need to be made aware of the method and educated about it.

Interestingly, despite the fact that a media campaign promoting emergency contraception was conducted in the San Diego area in the summer of 1996, only 12% of the women learned about it through the media. Instead, the vast majority cited one or more sources within their health care organization (i.e., providers, clinic staff, educational materials, etc). Indeed, informational brochures and posters in the clinic were the most frequently cited source of information. Therefore, it appears that by making educational materials visible and available, the clinics reached more women than the media did. The effectiveness of aggressive promotion of emergency contraception is unknown. However, if providers were to initiate a discussion of emergency contraceptive pills, women's awareness of postcoital options could presumably increase. Ideally, all women of reproductive age should be made aware of emergency contraceptive pills.

While most respondents agreed that women should be given emergency contraceptive pills by their health care providers for future use, few women endorsed more extensive distribution of the method through over-the-counter sales (28%) or vending machine sales (6%). These results are consistent with findings from an earlier study, in which 26% of that sample agreed that the method should be available over the counter, and only 7% supported sales through vending machines.¹⁶ Given the urgency for immediate access to this method once a woman has had unprotected intercourse and the method's limited availability, the reasons why these women were reluctant to make the method more readily available need to be researched further, and more women need to be surveyed to see whether this response is truly representative.

It is important to note that our sample may have limited generalizability, because these self-selected women were members of a health maintenance organization who agreed to be interviewed, and no teenagers younger than 18 were included. In addition, these women took an antinauseant with their emergency contraceptive pills, which may have influenced the method's acceptability and women's satisfaction with it. This aspect of the study may make the findings less generalizable for users of the new Preven packaged product, which does not contain an antinauseant.