National Survey Results on Public Knowledge/Opinions and OB/GYN Practice/Attitudes on Emergency Contraceptives (“Morning-After Pills”) – Policy Brief
EMERGENCY CONTRACEPTION:
The Answer to America’s Unplanned Pregnancy Problem?
March, 1995
OVERVIEW
For approximately 20 years, emergency contraceptive pills (ECPs), high-dose oral contraceptivesalso referred to as “morning-after pills,” have been known to prevent pregnancy after unprotectedsex and available in the United States. Findings from a new Kaiser Family Foundation/LouisHarris and Associates, Inc. national public knowledge and opinion survey, however, indicate thatmost American women are uninformed or misinformed about the contraceptive alternative andfew have ever used it. Many reproductive health experts believe that the number of unplannedpregnancies in this country could be significantly reduced by wide-spread use of ECPs. Furthermore, a companion Kaiser Family Foundation/Fact Finders, Inc. survey finds that whilemost obstetricians/gynecologists practicing in the United States consider ECPs safe and effectiveand the vast majority have no objections or concerns about prescribing them, most haveprescribed them for only a handful of their patients.
Some believe the fact that no manufacturer of oral contraceptives has sought approval from theFood and Drug Administration (FDA) to re-label their product for emergency use is a majorfactor contributing to Americans’ lack of knowledge about ECPs and physicians’ reasons for notprescribing them more widely. While physicians may legally prescribe oral contraceptives for anoff-label use such as emergency contraception, additional liability issues are raised when drugs areprescribed for unlabeled purposes–those may make some clinicians reluctant toprescribe them. Furthermore, because pharmaceutical companies cannot advertise products forunlabeled purposes, many of the usual public and professional sources of information aboutcontraception are not available for ECPs.
ECPs engender opposition from some on health and moral grounds. Some are concerned aboutthe potential health risks to women in taking high doses of hormones or the potential for ECPs toreplace a woman’s regular method of contraception. Others have moral objections to anyprocedure that may interfere with the course of a potential pregnancy.
Those who believe knowledge of and access to ECPs should be increased are employing a varietyof strategies, including: petitioning the FDA to re-label oral contraceptives for emergency use;distributing ECPs as a part of regular reproductive health care; advocating over-the-counteravailability of ECPs; anddeveloping directories of providers of ECPs to provide referrals to women who need them.
This brief explores the policy issues regarding ECPs in the United States, reasons behind theirlimited use, and the potential for wider use of emergency contraception to reduce the number ofunplanned pregnancies.
WHAT ARE EMERGENCYCONTRACEPTIVE PILLS?
I. The Potential Impact on Reducing UnplannedPregnacies
II. Public and Provider Knowledge andAttitudes
- Knowledge and Attitudes Among American Public
- Attitudes and Practices Among Health Professionals
- Likelihood of American Women Most Likely to Face an Unplanned Pregnancy to use ECPs
- Who is likely to use ECPs?
- Most Americans Do Not Have Ethical or Safety Concerns
- Physicians’ Who Don’t Perform Abortions, Do Not Have Objections or Concerns AboutPrescribing ECPs
III. Political, Economic, and Policy Factors Contributing toLimited Use
- Off-Label Use and the FDA
- Liability Fears
- Reluctance From Manufacturers
- Limited Access
IV. Strategies by Proponents to Increase Use
- Distribution of ECPs as Part of Regular Reproductive Health Care
- Over-the-Counter Availibility
- Petitioning the FDA For Re-Labeling
- A Directory of Providers of ECPs
- A Bibliography
WHAT ARE EMERGENCY CONTRACEPTIVE PILLS?
Emergency contraceptive pills must be taken within 72 hours of unprotected sex, followed with asecond dose 12 hours later to prevent pregnancy. ECPs must be taken before a fertilized egg isimplanted in the uterine lining, which usually occurs approximately 5-7 days after intercourse. Emergency contraception prevents pregnancy by temporarily disrupting a woman’s hormonalpatterns. High-dose oral contraceptives are the most commonly used form of emergencycontraceptive pills. The efficacy and side-effectsof ECPs have been studied extensively in other countries, including Canada and the Netherlands. Nausea (50%) and vomiting (20%) are common among women using emergency contraceptivepill treatment.Webb AMC, Russell J, Elstein M. Comparison of Yuzpe regimen,danazol and mifepristone (RU 486) in oral postcoital contraception. British Medical Journal. 1992;305(6859).
Over-the-counter remedies for nausea are available and can be given to women undergoing ECPtreatment.A number of drugs other than oral contraceptives can also be used as emergency contraceptivepills. Mifepristone (also known as “RU-486”) can be used as an emergency contraceptive pill,though it is more commonly usedas an abortifacient – a drug that induces medical abortions – and iscurrently under trial in the United States for both uses. Other forms of emergency contraceptivepills include drug therapies such as danazol and progestin-only mini-pills. Intrauterine devices(IUDs) inserted within 5-7 days after unprotected intercourse can also reduce the risk ofpregnancy by more than 99.9 percent.Trussell J and Ellertson C. Efficacy of Emergency Contraception. Fertility Control Reviews. 1995;4(2)(forthcoming).This brief focuses on high-dose oral contraceptives, which are currently available and the mostcommonly used form of emergency contraception.
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I. THE POTENTIAL IMPACT ON REDUCING UNPLANNEDPREGNANCIES
Americans overwhelmingly believe unplanned pregnancies are a major problem facing this country(Kaiser/Harris Survey on Contraception and Unplanned Pregnancy, 1995). In fact, women in theUnited States are almost twice as likely as women in the Netherlands.
Jones EF, Forrest JD, Henshaw SK, Silverman J and Torres A. Unintended Pregnancy, Contraceptive Practice and Family Planning Services in DevelopedCountries. Family Planning Perspectives 1988;20(2):53.
Approximately 3.5 million unplanned pregnancies occur each year in the United States. Whileslightly more than half of unplannedpregnancies in the United States occur among the 10 percent of women who do not use anycontraception, 1.7 million (47%) occur among women who experience contraceptive failure orimproperly use contraceptives. It is estimated that ECPs could be theoretically used by about 75percent of women whose pregnancies result from method failure or improper use, and by allwomen whose pregnancies result from non-use of contraception.
Trussell J, Stewart F, Guest F, Hatcher RA. Emergencycontraceptive pills: A simple proposal to reduce unintended pregnancies. Family PlanningPerspectives 1992;24(6):269-273.The results of ten published studies indicate that emergency contraceptive pill treatment reducesthe risk of pregnancy by approximately 75 percent.
Trussell J, Stewart F. The effectiveness of postcoital hormonalcontraception. Family Planning Perspectives 1992;24(6):262-264.
Trussell J, Ellertson C, Stewart F. The effectiveness of the Yuzpe regimen of postcoitalcontraception. Princeton, NJ: Office of Population Research, Princeton University,1994.
While ECPs may be highly effective from a clinical standpoint — that is, assuming perfect use –they may not be a viable practical alternative for some women, for example, those who experiencepregnancies from unnoticed contraceptive failure. Furthermore, sexually active women notseeking pregnancy who nevertheless do notuse contraception may also not elect to use ECPs.
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II. PUBLIC AND PROVIDER KNOWLEDGE ANDATTITUDES
Because ECPs are intended to be used as a back-up method for contraceptive emergencies – suchas failure of a regular method or failure to use any method – their potential use relies heavily on aninformed public. A woman must be aware that something is possible to prevent pregnancy afterunprotected sex in order to seek the care of a clinician.
The Kaiser Family Foundation investigated Americans’ knowledge about ECPs as part of anational survey on public knowledge and attitudes on contraception and unplanned pregnancy. American adults were questioned about their familiarity with emergency contraception; whetheror not they had ethical concerns with the method; and, their previous use of and future likelihoodto use ECPs. The Foundation also surveyed obstetrician/gynecologists to assess their attitudesand practices regarding emergency contraception as part of a broader survey on attitudes andpractices relating to contraception and family planning.
KNOWLEDGE AND ATTITUDES AMONG AMERICAN PUBLIC
Slightly more than five out of ten Americans (54%) say they have “heard of” emergencycontraceptive pills (ECPs) — also referred to as “morning-after pills.”
ECPs are commonly known as “morning after pills,” though experts nowprefer to use the term “emergency contraceptive pills” to avoid the incorrect implication that thetreatment must be delayed until the morning following unprotected intercourse, or that it must betaken within 24 hours. Yet, only a little more than a third (36%) indicate that they, in fact, know”anything” could be done within a few days after unprotected sex to prevent pregnancy. ECPs area contraceptive method that can prevent pregnancy up to 72 hours after intercourse. (A quarterhave both heard of ECPs and know anything can be done.)
Among those who say they have heard of ECPs, only 9% know that the method is effective up to72 hours after intercourse — most (69%) believe pills must be taken in 24 hours or less (16% arenot sure), indicating that among those who have heard of ECPs, few understand how it works.
METHODOLOGY:
The Kaiser/Harris Survey on Public Knowledge and Attitudeson Contraception and Unplanned Pregnancy was a random-sample, telephone survey of adultsnationwide. The national sample consisted of 2,002 adults, 18 years and older. It was conductedbetween October 12 and November 13, 1994 for the Foundation by Louis Harris and Associates,Inc. The margin of error in the national sample is plus or minus 3 percent. The margin of erroramong the sample of women “at risk” of unplanned pregnancy is plus or minus 6 percent.
ATTITUDES AND PRACTICES AMONG HEALTH PROFESSIONALS
Obstetricians/gynecologists are “familiar” with the emergency contraceptive option (77.5% say”very familiar” and 22% “somewhat familiar”) and most do not have “objections or concerns”about prescribing ECPs (72%). Among those who say they are “very familiar” with the method,the overwhelming majority consider ECPsto be “very safe” (88%) and “very effective” (85%).
Seven out of ten the obstetricians/gynecologists surveyed say they have prescribed ECPs withinthe last year, but on a very infrequent basis: more than three quarters of those who prescribedECPs did so five or fewer times (77%). Even among physicians who say they have “objections orconcerns about prescribing [ECPs],” an overwhelming majority (70%) have done so at least oncewithin thelast year.
Obstetricians/gynecologists questioned in the Kaiser/Fact Finders, Inc. survey say that discussionsabout ECPs with their patients generally occurred in response to an emergency situation ratherthan during routine contraceptive counseling. Because ECPs are intended to be used as a back-upmethod for contraceptive emergencies — such as failure of a regular method or failure to use anymethod — their potential use relies heavily on an informed public: anindividual must be aware that something is possible to prevent pregnancy after unprotected sex inorder to seek the care of a clinician in the first place. The public knowledge survey finds thatmost women are unaware of this emergency contraceptive option.
METHODOLOGY:
The Kaiser/Fact Finders, Inc. Survey onObstetricians/Gynecologists’ Attitudes and Practices on Contraception and Family Planning was arandom-sample, telephone survey of obstetricians/gynecologists drawn from lists purchased froma company licensed by the American Medical Association to maintain the AMA PhysiciansMasterfile. The national sampleconsisted of 300 obstetricians/gynecologists, and was conducted between February 1 and March21, 1995. The margin of error ranges from plus or minus 3.4 and 5.7 percent.
LIKELIHOOD OF AMERICAN WOMEN MOST LIKELY TO FACE AN UNPLANNEDPREGNANCY TO USE ECPs
At any given time, two thirds of American women of reproductive age – some 39 million women -have the potential of experiencing an unplanned pregnancy, defined as those who are sexuallyactive, fertile (and whose partners are fertile), and not pregnant or trying to get pregnant.
After being told “morning-after pills (ECPs) are a particular kind of birth control pills that aretaken after sexual intercourse [and that] if several of the pills are taken at the same time within 72hours of sex, they may reduce the chance of pregnancy by up to 75 percent,” these women wereasked: “would you be very likely, somewhat likely, or not at all likely to take them if you hadunprotected sex and wanted to prevent pregnancy?” More than half of the women (52%) whohad never previously heard of ECPs say they would in fact be likely to use them to prevent anunplanned pregnancy (25% say “very,” 27%, “somewhat”).
WHO IS LIKELY TO USE ECPs?
Although single women are more likely to have unplanned pregnancies (69% of pregnancies toformerly married women and 88% of pregnancies to never-married women are unplanned), 4 in10 of pregnancies to married women are unplanned.
Nearly six in ten currently unmarried women (57%) say that they would be either “very” or”somewhat” likely to use ECPs. By comparison, only 3 out ECPs are women who live with butare not married to their partners (77%).
Adolescents are not the only age group to have high unplanned pregnancy rates (82%): morethan three-quarters (77%) of pregnancies to women 40-44 are unplanned compared with four often (42%) of those to women 30-34.
Women of all age groups are generally equally likely to use ECPs – half of those under 30 years ofage said they would be likely to use ECPs (52%).
Current data are not available for the rates at which women of different races experienceunplanned pregnancy. However, other data indicate that Hispanic and black women experiencegreater numbers of unplanned births (among births, 48% and 66% were unplanned, repsectively)than their white counterparts (among births, 37% were unplanned). Furthermore, while theoverall abortion rate in 1988 was 27.3 per 1,000 women, 57/1,000 nonwhite as compared to21/1,000 white women underwent abortion.
A majority of black and hispanic women would be willing to consider ECPs (56%): among blackwomen, 39 percent say “very likely” and 17 percent say “somewhat likely” and among Hispanicwomen, 34 percent say “very” and 20 percent say “somewhat.” In comparison, white womenwere slightly less likely to use ECPs, although four in ten (41%) still say they would (15% use”very”, 26% “somewhat”) Three quarters of pregnancies to women below 100 percent of thepovertylevel are unplanned, compared with 45 percent of those at 200 percent or above. Few differencesin likelihood of use exist among women with different household incomes. Slightly less than half(46%) of women with household incomes below $15,000 would be likely to use ECPs. Womenwith higher household incomes are similarly likely (52% of women with incomes of$15,001-35,000 are likely, while 45% of women with incomes of $35,000 plus are likely).
MOST AMERICANS DO NOT HAVE ETHICAL OR SAFETY CONCERNS …
Nearly two-thirds of Americans say emergency contraception poses no “ethical concerns” forthem (61% say it does not vs. 36% say it does). Among those who expressed an ethical concernabout ECPs, a third still say they are likely to use the method if potentially faced with a pregnancythey wanted to prevent.
Among Americans who think birth control pills are “somewhat unsafe,” 45% say they would belikely to use ECPs if faced with a pregnancy they wanted to prevent. Forty percent of those whothink the pill is very unsafe also would be likely to use the method. Most (55%) Americans whoview the pill as somewhat or very safe would be likely to use ECPs.Most Americans (58%) think ECPs should be available only by prescription, as opposed to being”widely available, like condoms.”
PHYSICIANS’ WHO DON’T PERFORM ABORTIONS, DO NOT HAVE OBJECTIONSOR CONCERNS ABOUT PRESCRIBING ECPS …
Of the two-thirds of obstetricians/ gynecologists who say in their own practice they do not “everperform abortions as elective terminations of pregnancy” – with more than a third (35%) citingmoral or religious objections as a main reason – a majority (64%) say they have no “objections orconcerns” about prescribing ECPs for their patients. In fact, two-thirds (65%) of the physiciansciting an objection or concern did prescribe ECPs at least once within the last year.
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III. POLITICAL, ECONOMIC, AND POLICY FACTORSCONTRIBUTING TO LIMITED USE
The previous section of this brief reported on surveys indicating that many American women,once informed, say they would be likely to use ECPs and that most obstetricians/gynecologistsbelieve the method is safe and effective and have no objections or concerns about prescribing it. Yet, pharmaceutical companies havebeen reluctant to seek FDA relabeling of oral contraceptives which would allow them to marketthem as an emergency contraceptive product. And, although physicians may prescribe oralcontraceptives for emergency purposes, most do so on a limited basis. Most physicians makeonly a handful of their patients aware of ECPs and then, generally, in response to an emergencysituation rather thanduring routine counseling. A number of factors contribute to this limited use:
OFF-LABEL USE AND THE FDA
The use of oral contraceptives as emergencycontraception is not yet approved by the FDA. In general, however, health care providers withprescribing privileges can prescribe any drug licensed by the FDA for unlabeled purposes. Forexample, oral contraceptives are often prescribed to correct menstrual irregularities or to treatacne. A drug manufacturer is not allowed to advertise any of itsproducts for unlabeled purposesto doctors or to the general public, which increasingly has been the target of direct advertising byprescription drug manufacturers. To secure FDA approval for a new indication, a drug companymust submit a formal application, including clinical studies demonstrating the safetyand efficacy ofa proposed indication.
LIABILITY FEARS
Even if a clinician knows about emergency contraceptive pills,legal concerns may make her or him hesitant to prescribe them. Although clinicians withprescribing privileges may prescribe an approved drug for an unlabeled purpose, in doing so, theresponsibility for liability rests with the physician rather than the manufacturer of the drug. Though there is no evidence that a fetus exposed to ECPs will experience birth defects, along-term scientific study has yet to be done. A study of the risk of congenital malformationsfrom oral contraceptive exposure in early pregnancy found a lack of an association between oralcontraceptives and birth defects.Bracken, MB. Oral Contraception and Congenital Malformations inOffspring: A Review and Meta-Analysis of the Prospective Studies. Obstetrics and Gynecology1990;76(3 part 2):552-557.Furthermore, women who have contraindications for oral contraceptives such as history of strokeor heart attack will have the same contraindications for ECPs and under many circumstancesshould not take them, although some clinicians may make exceptions for some women for onetime use. While this fear of legal liability may prevent others from prescribing emergencycontraceptive pills (Trussell, et al., 1992), it may also contribute to a reluctanceamong manufacturers to relabel their oral contraceptive products for emergency use.
RELUCTANCE FROM MANUFACTURERS
There are several reasons why nopharmaceutical company has sought approval for relabeling from the FDA: that many physiciansalready use oral contraceptives as emergency contraceptive pills; that from a business standpointmanufacturers would prefer women become regular pill users rather than emergency users; and,that the considerable costs of gathering data for an application for approval are not likely to beoffset by increased sales. In addition, pharmaceutical companies worry that marketing oralcontraceptive pills for this use will increase their vulnerability to product liability suits (overunknown affects onthe fetus that may come to term) and encourage a boycott of their products by anti-abortioncustomers objecting to any drug treatment that may interfere with the course of a potentialpregnancy. No other manufacturers have come forward.
LIMITED ACCESS
Women’s access to emergency contraceptive is impeded inpractice by many factors, including the need for a clinician to write a prescription and someclinicians’requirements for physical exams and pregnancy tests prior to prescription. For women who havelimited access to health care in general, who are uninsured and have no established relationshipwith a health provider, these requirements can be an overwhelming obstacle. Even for thosewomen with insurance, coverage isoften limited to FDA approved drugs and regimens.
There is little information about where women can get ECPs. Past research has indicated thatuniversity health services provide ECPs regularly. ECPs are also thought to be available in asmall number of family planning organizations and private physicians offices. Other clinics andemergency rooms offer ECPs only to women who claim to be victims of rape. Catholic healthsystems (which deliver16% of the health care services in the United States) tend to view ECPs as abortifacients; in suchcases, for women seeking or in need of emergency contraception from these providers within theirsystems, neither prescriptions nor referrals for ECPs are available.
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IV. STRATEGIES BY PROPONENTS TO INCREASE USE
Organizations seeking to expand awareness and access to emergency contraceptive pills haveemployed a variety of strategies toward this end. Some examples of
DISTRIBUTION OF ECPs AS PART OF REGULAR REPRODUCTIVE HEALTHCARE
Except among a few family planning organizations, ECPs have been given to women only at thetime of emergency; that is, within 72 hours of unprotected sex. Some experts argue that ifwomen had greater access to emergency contraceptive pills, that is, before an emergency occurs,they would be more likely to take them when they are needed.Trussell J, Stewart F, Guest F, Hatcher RA. Emergencycontraceptive pills: A simple proposal to reduce unintended pregnancies. Family Planning Perspectives 1992;24(6):269-273.This kind of access could be facilitated by prescribing ECPsin non-emergency situations, such as during a patients annual exam, for future possibleemergencies.
The National Medical Committee of Planned Parenthood Federation of America recentlyapproved a policy to allow local affiliates to provide ECPs on an on-demand basis, includingdispensing them to women who do not have an immediate need but wish to have such a resourceavailable without having to visit a medicalprovider at the time of emergency. This policy recommendation provides a unique opportunity tocollect data on how such emergency contraceptives work in day-to-day practice.
OVER-THE-COUNTER AVAILABILITY
Access to the regimen could be increased by providing it without prescription. This way, a womanat risk for an unwanted pregnancy need not seek the care of a physician within 72 hours ofunprotected intercourse. This change in policy is likely to be dependent on the prescription statusof oral contraceptives.
While there is currently no organized effort to change policy, many in the reproductive healthcommunity have argued for and against over the counter availability for oral contraceptives. Bothsides’ arguments hinge, in part, on their views of emergency contraception.
PETITIONING THE FDA FOR RE-LABELING
The Center for Reproductive Law and Policy is representing the American Medical Women’sAssociation, Planned Parenthood of New York City, and the American Public Health Associationin a petition to the FDA to require relabeling of several oral contraceptives for use as emergencycontraceptive pills. The mechanisms for enforcing this “requirement” are not clear.
A DIRECTORY OF PROVIDERS OF ECPs
The authors of Emergency Contraception: The Nation’s Best Kept Secret have developed anational directory of providers willing to counsel about and prescribe emergency contraception. The directory is also available on the internet and the authors hope to make it accessible throughan 800 number service. The intention of the book and the directory is to inform women aboutECPs and provide referral to information and services in their own communities.
Bibliography
(to include, potentially):
- 2 Trussell articles
- U Health Study (not in yet)
- Princeton Study
- Sharon Camp international report
- Harris Survey
- Fact Finders Survey
- CRLP petition news coverage
Survey on OB/GYN Practice/Attitudes on Emergency Contraceptives:
Press Release Survey Policy Brief