Policy Matters #3

UnderstandingMedical Abortion

Policy, Politics, and Women’s Health

S. Marie Harvey, Christy A. Sherman,

Sheryl Thorburn Bird, and Jocelyn Warren

Research Program on Women’s Health

Center for the Study of Women in Society

University of Oregon

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About the Series: Policy MattersThis series considers issues of public policy affecting women andtheir families and communities. While our emphasis is on Oregonand the Pacific Northwest, the issues we address often affectwomen across regions, national borders, and racial, ethnic, andclass lines. The goal of the series is to gather, analyze, and inter-pret information that will be valuable to the pubic, researchers,and those involved in the development of policies designed tocreate a brighter future for our communities.

This report was published by the Center for the Study of Womenin Society, University of Oregon. Copyright 2002.

Authors: S. Marie Harvey, Christy A. Sherman, Sheryl Thorburn Bird, and Jocelyn Warren

Designer and Graphic Artist: Christine BenedaPrice: $10.00

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About the Center for the Study of Women in SocietyThe Center for the Study of Women in Society (CSWS) is a multi-disciplinary research center founded at the University of Oregonin 1973. CSWS generates, supports, and disseminates research ongender and all aspects of women’s lives. Currently, CSWS sup-ports three major research initiatives: Women in the Northwest;the Feminist Humanities Project; and the Research Program onWomen’s Health. In addition, CSWS provides highly competitiveresearch grants to UO faculty members and graduate students.

Center for the Study of Women in Society1201 University of OregonEugene, Oregon 97403-1201(541) 346-5015csws@oregon.uoregon.eduhttp://csws.uoregon.edu/

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Understanding Medical Abortion

Policy, Politics, and Women’s Health

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Policy Matters Paper #3

S. Marie Harvey, Christy A. Sherman,

Sheryl Thorburn Bird, and Jocelyn Warren

Research Program on Women’s Health

Center for the Study of Women in Society

University of Oregon

November 2002

Series: Policy MattersA Publication of the Center for the Study of Women in SocietyUniversity of Oregon, Eugene, Oregon

Policy Matters Paper #3Understanding Medical AbortionPolicy, Politics, and Women’s Health

By S. Marie Harvey, Christy A. Sherman, Sheryl Thorburn Bird,and Jocelyn Warren

© Copyright 2002 by the University of Oregon. Eugene, Oregon.

All rights reserved. Printed in the United States.

Center for the Study of Women in Society1201 University of OregonEugene, Oregon 97403-1201(541) 346-5015csws@oregon.uoregon.eduhttp://csws.uoregon.edu/

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Contents

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Advisors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . VIII

Acknowledgments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IX

Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Section 1 – What is Medical Abortion? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5The 3 M’s: Mifepristone, Methotrexate, and MisoprostolWhat Do We Know About Mifepristone (RU 486)?What Do We Know About Methotrexate?

Section 2 – Why Medical Abortion and Why Now? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Access to AbortionOptions in Abortion Methods

Section 3 – Access to Medical Abortion in the United States: What Are the Political and Legal Barriers? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23

What Is the Role of Politics in Medical Abortion Legislation and Policy?What Are the Political Strategies Used to Limit Medical Abortion?What Are the Laws and Policies That May Restrict Access to Medical Abortion?What Are the Challenges Ahead?

Section 4 – Access to Medical Abortion in the United States: What Are the Barriers for Medical Abortion Providers? . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

Additional Staff Training and Time Needed to Counsel Women Regarding Medical AbortionMultiple Office Visits for Administration of Medical AbortionUltrasound ExaminationAccess to Surgical Back-up for Incomplete Medical AbortionMalpractice Insurance IssuesThird Party ReimbursementAdditional Obstacles for New Abortion Providers

Section 5 – Moving Forward . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35RecommendationsEnsuring Access to Medical Abortion

References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45

Resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

AdvisorsWe gratefully acknowledge the generous contributions of our advisors (listedbelow), without whom this project would not have been possible. While theydeserve much of the credit for what is right with Understanding Medical Abortion,they cannot be held responsible for mistakes, omissions, and other errors.Likewise, all opinions expressed are those of the authors.

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Katrina Abuabara, M.A.The Population Council, Inc.México City, México

Linda J. Beckman, Ph.D.Alliant International UniversityLos Angeles, California

Jennifer Blasdell, J.D.National Abortion FederationWashington, D.C.

Debra Bufton, M.P.H.Abortion Access ProjectPortland, Oregon

Henry P. David, Ph.D.Transnational Family Research InstituteBethesda, Maryland

Charlotte Ellertson, Ph.D.Ibis Reproductive HealthBoston, Massachusetts

Ann Gerhardt, M.P.H.National Abortion FederationWashington, D.C.

Stanley Henshaw, Ph.D.New York, New York

Jeffrey T. Jensen, M.D., M.P.HOregon Health and Science UniversityPortland, Oregon

Carole Joffe, Ph.D.The University of California, DavisDavis, California

Michael KlitschEngenderHealthNew York, New York

Kitty PiercyPlanned Parenthood Health Services ofSouthwestern OregonEugene, Oregon

Laureen Tews, M.P.H.National Abortion FederationWashington, D.C.

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AcknowledgementsIn addition to our advisors, the authors wish to thank the follow-ing people for their contributions to Understanding MedicalAbortion– Meredith Roberts Branch, Diana Taylor, Cheri Brooks,Beth Hege Piatote, Jan Emerson, and Sunshine McBride.

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About the AuthorsS. Marie Harvey, DrPH, MPH, is the Director of the Research Program onWomen’s Health at the Center for the Study of Women in Society andAssociate Professor of Public Health at the University of Oregon.

Christy A. Sherman, PhD, is a Research Scientist at the Oregon ResearchInstitute in Eugene, Oregon.

Sheryl Thorburn Bird, PhD, MPH, is Associate Professor in the Departmentof Public Health at Oregon State University in Corvallis, Oregon.

Jocelyn Warren, MPH, is a Research Assistant in the Research Program onWomen’s Health at the Center for the Study of Women in Society,University of Oregon, and a graduate student in the Department of PublicHealth, Oregon State University, Corvallis, Oregon.

Preface

P R E F A C E 1

Since the Roe v Wade decision legalizingabortion in 1973, perhaps no goal had beenmore eagerly anticipated by the abortionrights movement in the United States thanthe availability of mifepristone, commonlyknown as “RU-486,” or the “French abortionpill.” Approved for use in France in1988–with the French Minister of Health’sfamous assertion that the pill was the “moralproperty” of French women,1–the campaignto bring the drug to the U.S. took anothertwelve years, given the inevitable entangle-ment in domestic antiabortion politics. Now,two years since the FDA’s final approval inSeptember 2000, clearly the fondest hopes ofthe prochoice movement for this drug–that itwould dramatically increase the number ofnew abortion providers, and spread access tohistorically underserved areas–have not yetoccurred. (Nor for that matter, have the direpredictions of the antiabortion movementcome to pass: that this drug was dangerous,would be dispensed by untrained physi-cians, and would result in numerous injuriesand deaths from uncontrolled bleeding).

Rather what has transpired since September2000 is a widespread educational effortabout medical abortion within various sec-tors of the medical community. Groups suchas the National Abortion Federation (NAF)and Planned Parenthood Federation ofAmerica, whose clinics provide the majorityof abortions performed in the United States,have intensified their ongoing efforts to

introduce their membership to regimens gov-erning mifepristone use, as well as anotherform of medical abortion involving the drugmethotrexate, a cancer drug that has forsome time been used for the “off-label” pur-pose of pregnancy termination. Additionally,NAF and other prochoice medical groupssuch as Physicians for Reproductive Choiceand Health, the American Women’s MedicalAssociation and the Association ofReproductive Health professionals haveformed a consortium–the Medical AbortionEducation Project–whose purpose is to bringawareness of these new regimens to medicalcircles beyond the quite small world ofexisting abortion providers.

But these intensive educational effortswithin the medical community have not yetbeen matched by similar efforts orientedtoward the general public or policy makers.Many Americans still remain confusedbetween the “abortion pill” (mifepristone)and “the morning after pill” (emergencycontraception). The latter, if used within 72hours of unprotected intercourse, can pre-vent a pregnancy from occurring; it cannotterminate a pregnancy already established.Many legislators and policymakers, more-over–even those who are supporters ofabortion rights–are not aware of the variousregulatory and bureaucratic barriers thatmust be overcome to achieve the previouslymentioned goals of raising the numbers of“new” abortion providers, that is those who

Pre

face

are not currently providers of surgical abor-tion, and bringing abortion provision tosome of those 85% of U.S. counties current-ly without such services.2

Understaning Medical Abortion is thus aparticularly welcome addition to the litera-ture on medical abortion. In impressivelyclear and straightforward terms, the authorsreview the history of FDA approval ofmifepristone in the U.S., explain the med-ical regimens involved in both mifepristoneand methotrexate abortions, debunk themisinformation spread by antiabortionforces about the safety of these regimens,offer an overview of the current status ofabortion provision in this country, anddemonstrate the promise of medical abor-tion to improve an unacceptably low levelof access for many American women. Mostimportantly, however, this monograph out-lines the numerous challenges that exist forthose health care providers who wish tobegin to offer this service, and offers a num-ber of excellent recommendations to over-come these obstacles.

Reading Understanding Medical Abortionmakes clear that these new regimens, likesurgical abortion, are, medically speaking,relatively simple procedures with a veryhigh degree of efficacy and safety. But politi-cally speaking, there is no area of medicinein the United States that is more scrutinizedand more regulated than abortion services.As a colleague and I have recently written,the struggle to integrate mifepristone intomainstream medical circles in the U.S. isone of attempting to “normalize the excep-tional.”3 To put this issue in perspective,however, we can learn much from an impor-tant recent report on the experience ofmifepristone in Europe.4 Reporting onFrance, Great Britain, and Sweden, theauthors note that in those countries–in apolitical environment far less divided aboutabortion than our own–it took a full decade

for mifepristone provision to take hold with-in medical establishments. Most important-ly, though, in the European context mifepris-tone has started to live up to one of its majorpublic health promises–since the introduc-tion of this drug, a higher proportion of allabortions in each country are now takingplace earlier in pregnancy. In spite of theunique challenges abortion services face inthe United States, we can be optimistic thatin the long run, medical abortion will have asimilar impact here–and the intelligentanalysis and wise recommendations offeredby Understanding Medical Abortion willsurely contribute to this effort.

Carole Joffe, Ph.D.Professor of Sociology, University of California, Davis, and Adjunct Professor of Obstetrics and Gynecology, University of California, San Francisco.

P R E F A C E2

Early medical abortion has the potential toexpand women’s access to abortion servicesin the U.S. and provide women with achoice of abortion methods. Mifepristoneand methotrexate, the two drugs most oftenused in medical abortion, are safe and effec-tive in terminating early pregnancies.However, despite the attention given to theapproval of mifepristone (also known as RU-486 and Mifeprex™) by the U.S. Food andDrug Administration in 2000, many miscon-ceptions and gaps in understanding aboutmedical abortion persist.

This monograph synthesizes what is current-ly known about medical abortion and pro-vides an overview of the legal and politicalissues that have shaped its practice in theU.S. In order to address some of the needs ofnew providers, organizations such as theNational Abortion Federation offer trainingand other resources related to the practice ofmedical abortion. However, people outsidethe medical community, especially legisla-tors, policymakers, and the media, also canhave a significant impact on the accessibilityand acceptability of medical abortion. Thismonograph is intended for this latter group,with the intention of increasing understand-ing of medical abortion and providing infor-mation and discussion useful in creatingpolicy that supports the provision of med-ical abortion. Understanding MedicalAbortion: Policy, Politics, and Women’sHealth is shaped by the authors’ public

health background and belief that full repro-ductive choice, including the freedom tochoose abortion for termination of an unin-tended pregnancy, is essential to the healthand well-being of women.

The monograph is divided into five chap-ters. The first chapter defines medical abor-tion and provides information about mifepri-stone and methotrexate. It includes the med-ical regimens associated with both drugs.The second chapter examines obstacles tosurgical abortion provision in the U.S. andthe potential of medical abortion to expandaccess and increase options for women whochoose abortion. The third chapter addressesthe political and legal challenges to medicalabortion provision in the U.S., includingrestrictive laws that may extend to medicalabortion. The fourth chapter addresses thechallenges that providers who offer medicalabortion may face. Based on the informationand discussion in the previous chapters, therecommendations made in the final chapterare aimed at removing obstacles to medicalabortion, improving women’s knowledge ofmedical abortion regimens, and promotingthe diffusion of medical abortion practice inthe U.S.

If current trends continue, 43% of women inthe United States will have had an abortionby age 45.5 Although abortion services havebecome highly politicized in the U.S., thepublic health benefits of safe, legal abortion

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Introduction

I N T R O D U C T I O N

Intr

oduc

tion

I N T R O D U C T I O N4

are clear. Since abortion was legalized, thedeclines in abortion-related and pregnancy-related deaths and disability among U.S.women have been dramatic.6 We believe thatmedical abortion, like abortion in general,should be included in the full range ofreproductive health care services offered towomen. Besides giving women a choice ofmethods, medical abortion may also allowwomen to make pregnancy decisions earlierthan was the case previously.

We hope this monograph will contribute tothe understanding of medical abortionamong policymakers, legislators and themedia. Although this monograph focuses onspecific health care delivery and public pol-icy changes, these changes must beaddressed within the larger context ofwomen in society. The reproductive healthneeds of women are inextricably linked togender inequality, sexism, and racism, andthe increasing feminization of poverty.Thus, long term solutions to improving thehealth and well-being of women, men, andfamilies will require not only the implemen-tation of changes such as those outlined inthis monograph, but also the active involve-ment of public health professionals,women’s health advocates, and health careproviders in political and social change.Bringing medical abortion into the main-stream of American medicine couldimprove abortion practice in the U.S. andenhance women’s health.

Medical abortion is the termination of earlypregnancy using a drug or combination ofdrugs that are administered orally, intramus-cularly, and/or vaginally, first causing thepregnancy to terminate and then causing theuterus to expel the products of conception.In contrast to medical abortion, surgicalabortion involves inserting instrumentsthrough the cervix into the uterus andremoving the products of conception. Belowwe describe the two methods of medicalabortion available in the United States today.

The 3 M’s: Mifepristone,Methotrexate and MisoprostolThere are three medications used in the U.S.for medical abortion: mifepristone (alsoknown as RU-486 or “the French abortionpill”), methotrexate, and misoprostol.Mifepristone (brand name Mifeprex™) is ananti-progesterone that alters the uterine lin-ing and disrupts attachment of a fertilizedegg. Mifepristone has been approved by theU.S. Food and Drug Administration (FDA)for medical abortion. Methotrexate (brandname Folex®), an anti-metabolite, stops celldivision in the developing placenta therebyinterfering with cell growth and furtherattachment to the uterine lining.7, 8

Methotrexate was approved by the FDA in

1953 and has been used in the treatment ofcancer, severe psoriasis, severe arthritis, andectopic pregnancy. Both mifepristone andmethotrexate are most often used in con-junction with a third medication, misopros-tol. Misoprostol (brand name Cytotec®) is aprostaglandin analogue which softens thecervix and stimulates uterine contractions toexpel the products of conception.Misoprostol has been approved by the FDAfor the treatment of ulcers and is commonlyused in labor induction to thin, relax, softenand open the cervix.9, 10

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What is Medical

Abortion?

The use of methotrexate in medical abortion isan off-label use. Off-label refers to the use of adrug for a disease or condition other than theindication for which it was approved by theFDA. This does not mean that off-label use isinherently risky, experimental, or novel. Off-labeluse of drugs is an integral feature of medicalpractice and often reflects approaches thathave been extensively reported inmedical literature. The AmericanMedical Association (AMA) esti-mates that off-label uses accountfor 40% to 60% of the prescrip-tions written each year.*

Off-Label Use and Methotrexate

*Beck JM, Azari ED.FDA, off-label use, andinformed consent:Debunking myths andmisconceptions. FoodDrug Law J.1998;53(1):71-104.

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What Do We Know AboutMifepristone (RU 486)?

History of Mifepristone and its Journey to the U.S.Mifepistone was developed in 1981 by theFrench pharmaceutical firm, Roussel-Uclaf.Drug manufacturers in the U.S., however,were reluctant to be involved in the produc-tion and distribution of mifepristone becauseanti-choice groups threatened consumer boy-cotts.11 Therefore, despite overwhelming evi-

dence of the safety andeffectiveness* ofmifepristone for thetermination of earlypregnancy, the FDAdid not approvemifepristone untilSeptember, 2000. Thefollowing time lineprovides an overview

of key events in the journey from initial prod-uct development to FDA approval.12-15

What is Mifepristone and How Does it Work? Mifepristone is a synthetic steroid thatblocks the action of progesterone, which isnecessary to maintain pregnancy. Blockingthe action of progesterone is believed to pro-duce changes in the endometrium (uterinelining), inducing menstrual bleeding and theshedding of the uterine lining. In addition,the drop in progesterone causes the cervix tosoften and uterine contractions to begin.16

Misoprostol is then administered to furtherstimulate contractions, expelling the prod-ucts of conception.

How is Mifepristone Administered?

The FDA specified a regimen at the time itissued its approval of mifepristone.

However, other evidence-based regimens arecommonly used.

• FDA Regimen. The FDA-approved regi-men requires three office visits – one foradministration of mifepristone, one foradministration of the prostaglandin(misoprostol), and a final visit two weeksafter administration of mifepristone toconfirm completion of the abortion. Theregimen provides for medical abortion asearly as when a pregnancy can be con-firmed, and was approved for usethrough seven weeks, or 49 days, sincethe last menstrual period (LMP).17

Step 1: Mifepristone administration –The patient takes a single oral dose of600 mg of mifepristone.

Step 2: Misoprostol administration – Twodays after taking the mifepristone, thepatient returns to the provider. If a com-plete abortion has not yet occurred, thepatient takes a single oral dose of 400mcg of misoprostol.

Step 3: Post-treatment examination –Approximately two weeks after adminis-tration of mifepristone the patient returnsfor a clinical or ultrasound exam to con-firm that a complete abortion hasoccurred.

• Evidence-based Regimens. Research iscontinuing on new regimens for medicalabortion. Many providers are using regi-mens other than the FDA-specified regi-men for medical abortion with equal orgreater effectiveness. For example, someproviders allow home administration ofmisoprostol. These regimens differ inmode of administration of the misopros-tol, timing of administration, dose ofmedications, and gestational age at whichmifepristone can be given.

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*The terms effectiveness and efficacyare both used in presenting findingsfrom studies on medical abortion.Efficacy usually refers to a drug’sability to produce the intended resultin a clinical trial. Effectiveness usual-ly refers to a drug’s ability to pro-duce the intended result in a realworld setting. Within this document,we use effectiveness in reference toboth clinical and real world settings.

Mode of administration. Many studieshave demonstrated that vaginal adminis-tration of misoprostol (as opposed tooral) results in comparable or higherrates of complete abortion, sustainedeffectiveness at higher gestational ages,lower incidence of gastrointestinal sideeffects, and more rapid completion of theabortion.18-21

Dose of medications. Although the FDAregimen specifies 600 mg of mifepristoneand 400 mcg of misoprostol, studies haveshown comparable rates of effectivenesswith a lower dose of mifepristone (200mg) and a higher dose of misoprostol(e.g., 800 mcg).21-24

Gestational age of pregnancy. Studieshave shown mifepristone-induced abor-tions can be successfully performed up to56 days LMP with oral administration ofmisoprostol, compared with the shortertime frame specified by the FDA (up to49 days LMP).23 Abortions can also besuccessfully performed up to 63 daysLMP with vaginal administration of miso-prostol.23, 25

Timing of administration. Studies havedocumented that misoprostol can beadministered anywhere from 24 hours to72 hours after administration of mifepris-tone up through a gestational age of 63days or less.26, 27

How Long Does it Take?

A few women using the FDA-approvedmifepristone/misoprostol regimen willexperience expulsion of the pregnancy priorto the administration of misoprostol. Morethan half will experience a complete abor-tion within four hours of administration ofmisoprostol, and 70% to 80% within 24hours.22, 23, 26-29 Ninety-five to 97% of women

will have a complete abortion within twoweeks. However, for some women a com-plete abortion may take three to fourweeks.22, 23, 26, 27, 29, 30 There are several treat-ment options for women with an incom-plete abortion, including continued observa-tion, repeat administration of misoprostol,and surgical completion. Several factors,including the woman’s symptoms and herpreferences, will determine the course oftreatment for incomplete abortion.

Is Mifepristone Safe?

• Mifepristone Has Been Used Safely byMillions of Women Worldwide.Mifepristone has been used safely by mil-lions of women globally,31-35 includingthousands of women in the U.S.22, 23, 26, 27, 29

The most common side effects are bleed-ing and cramping. Many women alsoexperience nausea, vomiting, or diarrhea.36

• Serious Side Effects Are Rare. Seriouscomplications following a mifepristone/

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AustriaBelgiumChina DenmarkFinlandFranceGermanyGreat BritainGreeceIsraelLuxembourg

the NetherlandsNorwayRussiaSouth AfricaSpainSwedenSwitzerlandTunisiaUkraineUnited States

Countries WhereMifepristone has beenApproved for Use as anAbortifacient

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misoprostol-induced abortion areextremely rare; infection and surgicalintervention for serious medical compli-cations have occurred in fewer than 1%of women.21, 22, 26, 29, 36 A commonly report-ed outcome of medical abortion is heavybleeding. However less than 1% ofwomen undergoing a mifepristone/miso-prostol-induced abortion have requiredblood transfusions22, 24, 27, 29 or surgicalintervention23, 27, 37 due to heavy bleeding.Less than 0.2% of women have requiredtransfusions in three large clinicaltrials.29, 35, 38

A small number of cases of seriousadverse events have been reported,39, 40

including ruptured ectopic pregnancy,bacterial infection, and one case ofmyocardial infarction. Two patient deathshave occurred, one resulting from sys-temic bacterial infection and one follow-ing hemorrhage due to a ruptured ectopicpregnancy; however, no causal relation-ships have been established betweenthese events and the use of mifepris-tone/misoprostol.39

Is Mifepristone Effective?

Mifepristone with misoprostol is very effec-tive for termination of early pregnancy. Forpregnancies of seven weeks or less, effective-ness rates exceed 95%.22, 23 Effectiveness canbe slightly lower in pregnancies of longerduration depending upon the regimen used,but across many regimens the effectivenessaverages 85% or greater up to nine weeksLMP.21 In the trial conducted in the U.S. bythe Population Council, effectivenessreached 77% at 57-64 days LMP (approxi-mately eight to nine weeks LMP). Studiesusing vaginal administration of misoprostolhave achieved effectiveness rates up to 98%and 99%.21, 23

Who May Provide Medical AbortionsUsing Mifepristone?

Under FDA regulations, mifepristone(Mifeprex™) is distributed only to licensedphysicians who submit a signed Prescriber’sAgreement to the pharmaceutical distributor,Danco Laboratories. The Prescriber’sAgreement stipulates that mifepristone willbe provided by or under the supervision of aphysician who can accurately assess theduration of pregnancy, diagnose ectopicpregnancy, and provide surgical abortion incases of incomplete abortion or makearrangements for referral to a provider ofsurgical abortion. Some state laws allownon- physician providers (e.g., certifiedphysician assistants, nurse practitioners)who work under the supervision of a physi-cian to dispense mifepristone.17 Providersmust also have women who are seeking amedical abortion sign a Patient Agreementform that describes the regimen, give them aMedication Guide, and notify the distributorof mifepristone of any adverse events.

What Do We Know About Methotrexate?

History of Methotrexate

Methotrexate has been available in the U. S.since 1953 when it was approved by theFDA for the treatment of cancer. Since 1982,methotrexate also has been used to treatectopic pregnancy. Providers and researchersbegan to investigate and use methotrexatefor medical abortion in the 1990s when theybecame frustrated with the delays in bring-ing mifepristone to the U.S.41, 42 This drug isnot approved by the FDA for early pregnan-cy termination, but because it is available byprescription, physicians may legally pre-

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We are pleased that you wish to become aprovider of Mifeprex* (Mifepristone) Tablets, 200mg, which is indicated for the medical terminationof intrauterine pregnancy through 49 days fromthe first day of the patient’s last menstrual period(see full prescribing information). PrescribingInformation, Mifeprex Medication Guide andPATIENT AGREEMENT forms will be providedtogether with your order of Mifeprex.

Prior to establishing your account and receivingyour first order, you must sign and return this let-ter to the distributor, indicating that you have metthe qualifications outlined below and will observethe guidelines outlined below. If you overseemore than one office facility, you will need to listeach facility on your order form prior to shippingthe first order.

By signing the reverse side, you acknowledgereceipt of the PRESCRIBER’S AGREEMENTand agree that you meet these qualifications andthat you will follow these guidelines for use. Youalso understand that if you do not follow theseguidelines, the distributor may discontinue distri-bution of the drug to you.

Under Federal law, Mifeprex must be provided byor under the supervision of a physician whomeets the following qualifications:

• Ability to assess the duration of pregnancyaccurately.

• Ability to diagnose ectopic pregnancies.

• Ability to provide surgical intervention incases of incomplete abortion or severebleeding, or have made plans to provide suchcare through others, and are able to assurepatient access to medical facilities equippedto provide blood transfusions and resuscita-tion, if necessary.

• Has read and understood the prescribinginformation of Mifeprex. The prescribing infor-mation is attached to this letter, and is also

available by calling our toll free number, 1-877-4 Early Option (1-877-432-7596), or logging on to our website, www.earlyoption-pill.com.

In addition to these qualifications, you must pro-vide Mifeprex in a manner consistent with the fol-lowing guidelines.

• Under Federal law, each patient must be pro-vided with a Medication Guide. You must fullyexplain the procedure to each patient, pro-vide her with a copy of the Medication Guideand PATIENT AGREEMENT, give her anopportunity to read and discuss them, obtainher signature on the PATIENT AGREEMENT,and sign it yourself.

• The patient’s follow-up visit at approximately14 days is very important to confirm that acomplete termination of pregnancy hasoccurred and that there have been no com-plications. You must notify DancoLaboratories in writing as discussed in thePackage Insert under the heading DOSAGEAND ADMINISTRATION in the event of anon-going pregnancy which is not terminatedsubsequent to the conclusion of the treat-ment procedure.

• While serious adverse events associated withthe use of Mifeprex are rare, you must reportany hospitalization, transfusion or other seri-ous event to Danco Laboratories, identifyingthe patient solely by package serial numberto ensure patient confidentiality.

• Each package of Mifeprex has a serial num-ber. As part of maintaining complete recordsfor each patient, you must record this serialnumber in each patient’s record.

Danco Laboratories, LLCP.O. Box 4816New York, NY 101851-877-4 Early Option (1-877-432-7596)www.earlyoptionpill.com

Prescriber’s Agreement

MIFEPREXTM

(Mifepristone) Tablets, 200 mg

1. I have read the attached Medication Guidefor using Mifeprex and misoprostol to end mypregnancy.

2. I discussed the information with my healthcare provider (provider).

3. My provider answered all my questions andtold me about the risks and benefits of usingMifeprex and misoprostol to end my pregnan-cy.

4. I believe I am no more than 49 days (7weeks) pregnant.

5. I understand that I will take Mifeprex in myprovider’s office.

6. I understand that I will take misoprostol in myprovider’s office two days after I takeMifeprex (Day 3).

7. My provider gave me advice on what to do if Idevelop heavy bleeding or need emergencycare due to the treatment.

8. Bleeding and cramping do not mean that mypregnancy has ended. Therefore, I mustreturn to my provider’s office in about 2weeks (about Day 14) after I take Mifeprex tobe sure that my pregnancy has ended andthat I am well.

9. I know that, in some cases, the treatment willnot work. This happens in about 5 to 8women out of 100 who use this treatment.

10. I understand that if my pregnancy continuesafter any part of the treatment, there is achance that there may be birth defects. If mypregnancy continues after treatment withMifeprex and misoprostol, I will talk with myprovider about my choices, which mayinclude a surgical procedure to end my preg-nancy.

11. I understand that if the medicines I take donot end my pregnancy and I decide to have asurgical procedure to end my pregnancy, or ifI need a surgical procedure to stop bleeding,

my provider will do the procedure or refer meto another provider who will. I have theprovider’s name, address and phone number.

12. I have my provider’s name, address andphone number and know that I can call if Ihave any questions or concerns.

13. I have decided to take Mifeprex and miso-prostol to end my pregnancy and will followmy provider’s advice about when to takeeach drug and what to do in an emergency.

14. I will do the following:• return to my provider’s office in 2 days

(Day 3) to check if my pregnancy hasended. My provider will give me misopros-tol if I am still pregnant.

• return to my provider’s office about 14 daysafter beginning treatment to be sure that mypregnancy has ended and that I am well

Patient Signature:___________________________

Patient Name (print): ________________________

Date: _____________________________________

The patient signed the PATIENT AGREEMENT inmy presence after I counseled her and answeredall her questions. I have given her the MedicationGuide for mifepristone.

Provider’s Signature: ________________________

Name of Provider print: ______________________

Date: _____________________________________

After the patient and the provider sign thisPATIENT AGREEMENT, give 1 copy to thepatient before she leaves the office and put 1copy in her medical record. Give a copy of theMedication Guide to the patient.

Patient Agreement

MIFEPREXTM

(Mifepristone) Tablets, 200 mg

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scribe it for this use. Evidence supports itssafety and effectiveness for this purpose.Besides being widely available, methotrexateis relatively inexpensive, especially in theinjectable form.

What Is Methotrexate and How Does It Work?

Methotrexate is an anti-metabolite thatinhibits DNA synthesis and interferes with

cell growth.7, 41, 43 As such, methotrexate stopsthe process of fetal development.41

How Is Methotrexate Administered?

Methotrexate can be given by injection ortaken orally. As with mifepristone,methotrexate is followed by the administra-tion of misoprostol, which can be adminis-tered either orally or vaginally but is mostcommonly administered vaginally.21

Sources: Kahn JG, Becker BJ, MacIsaa L, et al. The effectiveness of medical abortion: A meta-analysis. Contraception. 2000;61:29-40;Stewart FH, Wells ES, Flinn SK, Weitz TA. Early Medical Abortion: Issues for Practice. San Francisco, CA: University of California, SanFrancisco, Center for Reproductive Health Research and Policy; 2000; US Food and Drug Administration. Mifepristone questions andanswers. Available at: http://fda.gov/cder/drug/infopage/mifepristone/mifepristone-qa.htm. Accessed January 15, 2001.

Flow Chart

Mifepristone

Step 1: 3 tablets of mifepris-tone (600 mg) are taken as asingle oral dose.

Step 1: 200 mg of mifepris-tone are taken as a single oraldose.

Step 2: 2 days after taking themifepristone, the patientreturns to the provider for oraladministration of 400 mcg ofmisoprostol

Step 2: 24-72 hours after tak-ing mifepristone, patient takes800 mcg of misoprostol orallyor vaginally, either in the clinicor at home.

Step 3: 2 weeks after admin-istration of mifepristone thepatient returns for follow upexamination to confirm by clin-ical exam or ultrasound examthat a complete abortion hasoccurred.

Step 3: Within 2 weeks afteradministration of misoprostol,the patient returns for a clini-cal exam or ultrasound to con-firm that a complete abortionhas occurred.

Methotrexate

Step 1: A dose ofmethotrexate is given, eitherorally (50 mg) or by injection(50 mg/m2).

Step 2: 3-7 days after themethotrexate is given, thepatient takes misoprostol (800mcg), which may be givenorally or inserted vaginally.

Step 3: The patient returnsto the provider about 14days after the methotrexatedose; a clinical exam or ultra-sound confirms that a com-plete abortion has occurred.

FDA Regimen Evidence-BasedRegimen

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Methotrexate regimens vary in dosage, inadministration (i.e., methotrexate taken oral-ly or by injection), and in the number ofdays between methotrexate and misoprostoladministration.

Step 1: Methotrexate administration –The patient is either given 50 mg/m2 ofmethotrexate by injection or takes 50 mgorally.

Step 2: Misoprostol administration – Threeto seven days after taking the methotrexate,the patient returns to the provider. If acomplete abortion has not occurred, thepatient is given 800 mcg of misoprostol,administered orally or vaginally.

Step 3: Post-treatment examination–Approximately two weeks after adminis-tration of methotrexate the patient returnsfor a clinical or ultrasound exam to con-firm that a complete abortion hasoccurred. This visit can occur earlier.

How Long Does it Take?

Few women expel the products of con-ception prior to the administration of themisoprostol. Fifty to 70% of womenexperience a complete abortion within24 hours of the administration of miso-prostol, with some differences in ratesresulting from mode of administration ofmethotrexate.21, 44 The percentage increas-es in the 24 hours following a seconddose of misoprostol, with the cumulativerate of complete abortion increasing to75% of women.7, 44 By the end of twoweeks up to 83% of women experience acomplete abortion,44, 45 and, after 21 days,rates of completed abortion exceed90%.7, 44 Women who are found to havean incomplete abortion at the post-treat-ment examination may opt for surgicalabortion or may continue to wait.46 Somewomen are willing to wait weeks for thebleeding to stop, while others are not.Surgical abortion is strongly recommend-ed for those women who have an ongo-

Comparison Chart for Mifepristone and Methotrexate

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Mifepristone/Misoprostol Methotrexate/Misoprostol

What is it?Blocks the progesterone hormoneneeded to maintain pregnancy.

Stops process of implantation.

How is it used?Both drugs are given orally, twodays apart, in the FDA-approvedregimen.

Methotrexate is injected or takenorally; misoprostol is taken orally orvaginally 3-7 days later.

Effectiveness 92%-96% 85%-96%

Common side effects Bleeding and cramping Bleeding and cramping

Availability in the U.S. FDA approved for early abortion.FDA approved for other uses.Evidence-based use for early abor-tion

ing pregnancy at the second week fol-low-up visit.7, 41, 47

Is Methotrexate Safe?

• Methotrexate Has Been Used Safely inthe U. S. for Years. Methotrexate hasbeen used safely since the 1950s for can-cer treatment and since the early 1980sfor ectopic pregnancy. There are substan-tial data regarding the safety and effec-tiveness of methotrexate for medical abor-tion.48-56 When used at dosages indicatedfor medical abortion, common side effectsof methotrexate include bleeding, cramp-ing, and gastrointestinal problems such asnausea, vomiting, and diarrhea.

• Serious Side Effects Are Rare. Whenmethotrexate is used for medical abor-tion, serious side effects occur in lessthan 1% of patients.21, 41 Like mifepris-tone/misoprostol induced abortion,bleeding is a commonly reported sideeffect. However, fewer than 1% of womenhave required intervention for heavybleeding.50, 52, 53

Is Methotrexate Effective?

Methotrexate with misoprostol is a veryeffective method of early pregnancy termina-tion. Similar to mifepristone, early (i.e., up to49 days LMP) methotrexate-induced abor-tions have effectiveness rates of greater than90%.21 Methotrexate is also effective for abor-tions after 49 days LMP.21, 44, 52 Although somestudies have shown slightly lower effective-ness rates using methotrexate after sevenweeks LMP (e.g., 85%),21, 51, 52 this may be dueto differences between the regimens in tim-ing of drug administration and the number ofdoses of misoprostol given, in addition togestational age. Although the effectiveness ofmethotrexate/misoprostol is comparable to

mifepristone/misoprostol, methotrexate-induced abortion can take longer, rangingfrom one to five weeks.7, 44, 51, 53, 57

Who May Provide Medical AbortionUsing Methotrexate?

An individual provider’s ability to prescribemethotrexate depends on the scope of his orher practice and whether there are adminis-trative rules or specific state laws that regu-late the prescription of methotrexate forabortion. Some states limit provision ofabortion to physicians, and the limits andconditions of prescribing privileges (e.g.,which drugs can be prescribed by whichtypes of providers – physicians, registerednurse practitioners, certified physician assis-tants, etc.) differ from state to state.

In summary, medical abortion is both safeand effective. Medical abortion usuallyinvolves a combination of drugs, eithermifepristone with misoprostol or methotrex-ate with misoprostol. Although mifepristonehas been approved by the FDA specificallyfor early pregnancy termination, methotrex-ate is also used for medical abortion. Inaddition to being safe and effective, medicalabortion has the potential to expandwomen’s access to abortion services and givethose who prefer it an alternative to surgicalabortion. The potential of medical abortionto expand access and increase options is dis-cussed in the following chapter.

13

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Abortion is one of the most frequently per-formed surgical procedures in the UnitedStates; data show that 43% of women willhave an abortion by the time they are 45years old.5 Many assume that the availabilityof surgical abortion in the U.S. is sufficient tomeet the needs of women wishing to termi-nate a pregnancy. However, despite the safetyand effectiveness of surgical abortion, manywomen have difficulty accessing abortionservices. In addition, women need diverse

options in abortion methods that fit with thecircumstances of their individual lives.

Medical abortion has the potential to expandboth women’s access to abortion servicesand choice among abortion methods. Belowwe address the obstacles of limited accessand limited options as they apply to conven-tional, surgical abortion. We then considerhow medical abortion could overcome someof these obstacles.

S E C T I O N I I : W H Y M E D I C A L A B O R T I O N A N D W H Y N O W ? 15

Why Medical Abortion

and Why Now?

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Map of U.S. Providers

> 75% of counties without an abortion provider

> 90% of counties without an abortion provider

_

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AL GA

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VA

MS

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Access to Abortion

The Obstacle: Access to Abortion is Limited

Many women in the U.S., especially those inrural areas, live in counties with no abortionprovider. A decline in providers and otherfactors that limit women’s access to abortionare described below.

• The Number of Providers Trained inPerforming Surgical Abortion is Low.Training in abortion procedures hasdeclined in part because fewer abortionsare performed in hospital settings wherethe majority of residency training occurs.Although the percentage of programs offer-ing training increased after theAccreditation Council for GraduateMedical Education began requiring abor-tion training as a part of OB/GYN residen-cy training in 1996 (for residents and pro-grams without moral or religious objec-tions), a 1998 survey found only 46% ofprograms made first trimester abortiontraining a routine part of their program.Only 26% of programs reported all theirresidents received training. Although manyprograms say they offer optional off-sitetraining in abortion procedures, the alreadyoverloaded OB/GYN resident is unlikely totake advantage of such an option.58

• Abortion Services are DistributedUnevenly. In most states, over three- quar-ters of counties do not have an abortionprovider, and the entire Midwestern U.S.lacks providers in 90% or more of itscounties.2 As a result, access to abortion isvery limited for many women living in theU.S. According to recent data, the highestrates of abortion (number of abortions per1,000 live births) are concentrated in thewestern U.S. (California, 38 abortions per1,000 live births) and along the East Coast(Delaware, 30 per 1,000; New York, 35 per

1,000; Washington, D.C., 68 per 1,000).Relatively lower rates of abortion (fewerthan 10 abortions per 1,000 live births)occur in the Midwest and the South.59, 60

State abortion rates vary due to multiplefactors (e.g., differential rates of pregnancy,differences in state laws), but the variationis also likely due to differences in theaccessibility of abortion services.

• Anti-abortion Harassment Impacts Useof Abortion Services. Most abortions areperformed in specialty abortion clinicswhere at least half of all patient visits arefor pregnancy termination services.60

These facilities are the most likely to betargeted for anti-abortion harassment.Women who feel intimidated or threat-ened by anti-abortion harassment may be

S E C T I O N I I : W H Y M E D I C A L A B O R T I O N A N D W H Y N O W ?16

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Picketing 580 6921 37,790

Bomb threats 196 74 223

Vandalism 174 341 324

Hate mail/harassing calls 166 1641 7149

Invasion 145 100 22

Death threats 43 155 112

Assault & battery 40 37 25

Arson 37 60 39

Attempted bomb/arson 26 27 16

Burglary 15 14 29

Bombing 6 4 11

Murder 0 5 2

Attempted murder 0 11 6

Kidnapping 0 0 1

Stalking* — 210 222

*Tabulation of stalking incidents began in 1993

Incidents of Violence and Disrutpion AgainstAbortion Providers

discouraged from seeking abortion servic-es at these clinics. Studies show thatwomen who come in contact with anti-abortion protestors view these encountersas adverse and tend to feel angry andintruded upon.61 In places where theseclinics are the sole providers of abortionservices, anti-abortion harassment can, ineffect, prevent women from accessingabortion services.

Anti-abortion harassment discouragessome providers from offering abortionservices. Fewer providers means women’saccess to abortion services is further limit-ed. Harassment aimed at providersincludes violence (e.g., murder andassault), threats of violence (e.g., attempt-ed murder, bomb threats, stalking), andclinic blockades.62 Providers may have dif-ficulty hiring clinic staff because of therisk of violence or harassment. Even lowlevel harassment has a dampening effecton the hiring of medical and nonmedicalstaff.61 Providers may also face other barri-ers as a result of harassment, such as costsof increased security, increased insurancerates, and legal fees to fight harassment.

The Potential Solution:Medical Abortion Could ImproveWomen’s Access to Abortion

• Medical Abortion Could Increase theNumber of Abortion Providers.Increasing the number of providers hasthe potential to increase access to abor-tion services. Providers who have beenafraid of being targeted by anti-abortionprotesters may feel safer offering medicalabortion because of its greater privacy.Prior to FDA approval many providersexpressed interest in providing mifepris-tone-induced abortions should theapproval be granted.63, 64

• Medical Abortion Could Increase theTypes of Providers. Medical abortion issafely administered by practitioners inspecialities outside of obstetrics/gynecol-ogy, such as family practice, as well as bynurse practitioners, nurse midwives, andphysician assistants. Continuing thisexpansion to providers of different spe-cialties and advanced practice clinicianscould make abortion services more wide-ly available.64-66 There is nothing uniqueto medical abortion that is outside thescope and practice of advanced practiceclinicians (e.g., pregnancy testing, coun-seling, estimating gestational age by examand ultrasound, medical screening,administering medications, post-abortionfollow-up care, performing uterine re-aspiration for incomplete abortion).However, the ability of advanced practiceclinicians to offer medical abortion variesby state (see Chapter 4).

• Medical Abortion Could Improve theGeographic Distribution of AbortionProviders/Services. By providing medicalabortion through advanced practice clini-cians and those who previously did notoffer surgical abortion, access to abortionservices could expand into geographicareas where service provision is limited orentirely lacking. Women in non-metropol-itan areas, rural areas, and in Midwesternand Southern states could see an increasein the number of abortion providers.

• Medical Abortion Could ExpandAbortion Services Beyond AbortionClinics. The majority of abortions are pro-vided at specialty abortion clinics.2

Medical abortion, however, could bemade available in private medical offices.Including abortion services with othergynecological care ensures that womenhave access to coordinated and compre-hensive health care.60

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• Medical Abortion Could DecreaseViolence and Harassment of Patients,Providers, and Clinic Staff. With medicalabortion, women may no longer be limit-ed to seeking care from a specialty abor-tion clinic with the potential for harass-ment by anti-abortion protesters. If thenumber and type of providers expands, itmight be possible for many more womento go to private practice physicians toobtain medical abortions. The increase inprivacy and confidentiality could meanless harassment of women seeking tohave an abortion. If abortion servicesmove into the practices of those provid-ing more general reproductive healthcare, abortion providers and clinic staffmay be less visible and identifiable. Lessvisibility could make it more difficult forabortion protesters to target those provid-ing abortion services.

Options in Abortion Methods

The Obstacle: Limited Options for Abortion

Clinical abortion services in the U.S. haveremained relatively unchanged for over adecade.67 For example, women are usuallyadvised to wait until at least six weeks gesta-tion to schedule an abortion. Also, the samesurgical techniques used for an abortion at 6-7 weeks gestation are also generally used at11-12 weeks gestation. However, women whohave had a choice of methods have reportedhigher levels of satisfaction with the abortionprocedure, regardless of the method chosen.68

• Women Need an Option That Can BeUsed Early in Pregnancy. As a generalrule, surgical abortion is not performedearlier than six weeks since the last men-strual period (LMP). Medical abortion canbe performed as soon as a woman knows

she is pregnant (as early as one week afterfertilization)69 and up to 63 days sinceLMP.30 This is important because abortionis safest when used early in pregnancy(<13-14 weeks), with the lowest rates ofcomplications occurring among womenundergoing abortion at eight weeks LMPor less.70 In addition, some women likeearly methods so they do not need to waitweeks to terminate a pregnancy.71

• Women Need Abortion OptionsAppropriate to Their Life Circumstances.Women need options that fit their person-al circumstances.72 Issues such as thedirect and indirect costs involved in hav-ing an abortion (e.g., cost of the proce-dure itself, time lost from work), theavailability of social support, the atti-tudes of intimate partners about abortion,personal religious and cultural beliefs,and phase of life (e.g., teenagers, youngadult, and mid-life women) influence awoman’s choice of abortion method.What a woman wants at one point in herlife may be different from what she wantslater in life, given the many ways inwhich women’s lives change over time.Women need to be able to choose amethod that is consistent with who theyare and what their circumstances are atthe time they are seeking an abortion.

• Women Differ in Their Preference forAbortion Methods. Women differ withrespect for their preferences for certaincharacteristics of abortion methods.49, 72-77

Some women prefer medical abortionbecause they say the experience feelsmore natural, is more private, and allowsthem more control over the experience.Other women prefer medical abortionbecause they prefer a method that can beused early in pregnancy or allows themto avoid surgery. Alternatively, somewomen prefer surgical abortion becausethey want anesthesia and a clinician inattendance. Some women also prefer sur-

S E C T I O N I I : W H Y M E D I C A L A B O R T I O N A N D W H Y N O W ?18

gical abortion because it is quick andcompleted in one visit.

The Potential Solution: MedicalAbortion Offers Women Options in Abortion Methods

• Women Find Medical AbortionAcceptable. In order for medical abortionto increase options for women, womenmust be willing to use it and find itacceptable. The majority of women whohave used medical abortion say they weresatisfied with the method. Studies haveshown that more than 85% of womenwho had either a mifepristone- ormethotrexate-induced abortion were

moderately or very satisfied with theirmedical abortion experience.22, 49, 55, 56, 73, 77, 78

• Medical Abortion Provides Women witha Choice of Abortion Method. Untilrecently, the only option women in theU.S. had for terminating a pregnancy wasa surgical abortion. Now women canchoose between surgical and non-surgicalmethods of pregnancy termination. Thisis a major breakthrough in abortion care.

Offering women options means womencan choose the method that is most suit-able to their needs and life circum-stances. Given a choice of abortionmethod, women are more satisfied withtheir abortion experience.68, 76

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These results were drawn from a nationally representative sample of U.S. healthcare providers, including obstetrician/gynecologists, family practice physicians,nurse practitioners, and physician assistants. The sample includes those who doand those do not perform surgical abortion.

Methotrexate

Mifepristone

Somewhat LikelyVery LikelyOBs

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NPs/PAs 23% 54%

32%

28%

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Likelihood of providing mifepristone and methotrexate in the next year

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• Medical Abortion Offers Women anOption That Can Be Used Early inPregnancy. Early abortion means saferabortion. The longer a pregnancy pro-gresses the greater the medical risks in

terminating the pregnancy.70 Althoughsurgical abortion can be performed safelyat six weeks or less LMP,79 one sourcesays many providers wait until a womanis seven weeks LMP to schedule an abor-tion.47 Medical abortion is a safe methodthat can be used as soon as a pregnancyis confirmed by clinical exam, a pregnan-cy test, or ultrasound examination.47, 69

Some providers and clinics require visu-alization of a gestational sac on ultra-sound prior to performing an abortion;80

the gestational sac becomes visible atapproximately 35 days LMP.81

• Providers Find Medical AbortionAcceptable. Because medical abortion isa relatively new procedure in the U.S.,there are few surveys of medical abortionproviders. The available evidence gener-ally indicates that providers have positiveattitudes regarding medical abortion.64, 65,

82-87 Medical abortion providers report thatthey like mifepristone and methotrexatebecause both are safe and effective in ter-minating early pregnancy. Manyproviders also like being able to offerwomen a choice of abortion methods.65, 88,

83 These providers believe that givingwomen a choice increases the quality ofcare that women receive and gives themgreater satisfaction.

In summary, medical abortion has the poten-tial to increase access to abortion services inthe U.S. and provide women with an alter-native to surgical abortion. However, neither

S E C T I O N I I : W H Y M E D I C A L A B O R T I O N A N D W H Y N O W ?20

“You have to process it through your own situa-tion. Maybe you have economic problems or

strong religious feel-ings or whatever. Idon’t think the medicalfacts are the be all endall of the situation.”

“I like the fact that you pass it yourself, whichis good. It is basically a miscarriage. Instead of

having it sucked outof you, you pass it outyourself, which is, I’msure, a little bit easieron your uterus . . .”

“...I feel like it’s easier for a person who is amother . . . it’s easier to take say 2 hours inone day rather than to save 2 days and manyhours in each of those days. Using [mifepris-

tone] takes moretime than is neces-sary . . . I think [sur-gical abortion] ismore convenient.”

What Women Say

Source: Harvey SM, Beckman LJ,Branch MR. The relationship of con-textual factors to women’s perceptionsof medical abortion. Health CareWomen Int. 2002;23(6-7):654-665.

Source: Harvey SM, Beckman LJ,Castle MA, Coeytaux F. Knowledgeand perceptions of medical abortionamong potential users. Fam PlannPerspect. 1995;27(5): 203-207.

Source: Harvey SM, Beckman LJ,Branch MR. The relationship of con-textual factors to women’s perceptionsof medical abortion. Health CareWomen Int. 2002;23(6-7):654-665.

A Women’s Perspective: “Give women a choice. If they’re

gonna both [RU 486 and vacuum aspiration] be there, I

mean, you can decide what’s right for you at the time.”

Data Source: Harvey SM, Beckman LJ, Branch MR. The relationship of contextual factors towomen’s perceptions of medical abortion. Health Care Women Int. 2002;23(6-7):654-665.

the potential of medical abortion to improvethe lives of women nor its proven safety andeffectiveness have ensured medical abor-tion’s availability. In the following chapter,

we discuss the role of politics and restrictivelegislation on abortion practice, and whatthe impact of these may be on the practice ofmedical abortion.

S E C T I O N I I : W H Y M E D I C A L A B O R T I O N A N D W H Y N O W ? 21

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Mifepristone

Author/s & Year Sample% that found the method satisfactory

% that wouldchoose the

method again

% that would recommend the

method to others

Schaff et al., 1999 933 women 94% 87% 85%

Winikoff et al., 1998 2121 women 88% 92% 96%

Beckman & Harvey, 1997 262 women 89% 87% 94%

Methotrexate

Author/s & Year Sample% that found the method satisfactory

% that wouldchoose the

method again

% that would recommend the

method to others

Harvey, Beckman, & Satre, 1999

186 women 82% 93% 78%

Wiebe, 1997 116 women Not reported Not reported 84%

Crenin & Park, 1995 86 women 79% 89% Not reported

A Provider’s Perspective: “I am really pleased with [methotrexate] . . . I like

that the woman is a participant in the procedure and she has control over

it. Not like surgery where the woman is just a passive observer having

something done to her body. I think it results in women who are ultimately

more satisfied with their decision since they were part of the process.”

Data source: Harvey SM, Beckman LJ, Satre SJ. Experiences and satisfaction with providing methotrexate-induced abortions among US providers. JAMWA. 2000;55(3 Supp):S161-163.

Acceptability of Mifepristone and Methotrexate to U.S. Women

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Authors Date Sample Relevant Findings

Ellertson, C., et al.,1999

1995-96

Interviews: n=78, focusgroups: n=18 providers(physicians, midlevel providers,counselors) from 17 sites

Providers reported being generally satisfied with mifepristone. Mostthought midlevel providers could perform mifepristone abortionswith physician backup. Staff at all but one site want to offer mifepri-stone if approved by the FDA.

Harvey, Beckman,& Satre, 2000

1997

N=76 providers from 17 sitesoffering methotrexate abor-tions (physicians, midlevelproviders, administrators,counselors)

80% were satisfied or extremely satisfied with methotrexate. Themean satisfaction rating was 3.9 on a scale from 1 to 5. No physi-cian or midlevel provider rated satisfaction as less than a 3. Five ofthe 12 respondents who voluntarily mentioned mifepristone had aclear preference for mifepristone over methotrexate.

Heilig, 1992 1991N=466 random sample ofOBs in California

48% had followed the RU-486 story "closely" and 45% followed it"somewhat closely." 14% were opposed to abortion and wouldn'tuse RU-486 if available. 69% thought RU-486 should be madeavailable now to patients for abortion. 91% of those who currentlyprovide abortions (n=255) would use RU-486. 32% of those whocurrently do not provide abortions (n=209) would use RU-486.

Joffe, 1999 1996

N=25 National AbortionFederation members (physi-cians, midlevel providers,counselors)

Providers who performed mifepristone and/or methotrexate abor-tions were generally satisfied with the process. All thought midlevelproviders could perform medical abortions. Providers' worst fears atthe outset were not realized (patient going to emergency room withhemorrhaging or patient not returning for required additional visits).Some providers saw the need for dating pregnancies (using ultra-sound machines) as an obstacle for providers who are not surgicalabortion providers.

McKee & Adams,1994

1991 N=1208 nurse-midwives

57% would want authority to prescribe RU-486 if approved by theFDA. 25% would incorporate abortion procedures into their ownpractices, if allowed. 19% would perform abortions in the an abor-tion clinic, if allowed. 52% would vote anonymously in favor ofallowing nurse-midwives to perform abortions.

Miller, Miller, &Pinkston Koenigs,1998

1996N=668 physician members ofthe Society for AdolescentMedicine

96% agreed that abortion should be available to pregnant adoles-cents under some or all circumstances. 42% would prescribemethotrexate or RU-486 for abortion if FDA-approved and physi-cian training was available; 34% were unsure. 54% believed that ifmedical abortion becomes routinely available in the United States,primary care physicians should be allowed to perform them.

Rosenblatt, Mattis,& Hart, 1995

1994N=138 providers in rural Idaho(FPs, OBs, general surgeons)

26% said they would definitely prescribe RU-486 if it became avail-able; 35% were unsure. About half of those morally opposed toabortion said they would not refer their patients to another providerfor RU-486.

Rosenblatt,Robinson, Larson,& Dobie, 1999

1996-97N=286 first- and second-yearmedical students at Universityof Washington

41% believed that RU-486 should be available under "most cir-cumstances," and 44% believed that it should be available "withlimitations." 62% expected that they would provide RU-486 infuture practice. Female students (69%) were more likely to expectto provide RU-486.

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Past Research on Health Care Providers' Knowledge, Attitudes,and Practices Regarding Mifepristone and Methotrexate.

Why is it that mifepristone, which hasbeen used safely and effectively by mil-lions of women worldwide, is so hotlydebated in the U.S.? Why has this drug hadsuch difficulty coming to market in theU.S. despite the consistent findings fromresearch on its safety, effectiveness, andacceptability? It’s simple: the underlyingobjections to mifepristone are not about thesafety and effectiveness of this drug,although it has often been described incor-rectly as dangerous by anti-abortion advo-cates.89 At their core, objections to mifepri-stone are objections to abortion itself.Because the right to abortion continues tobe debated so intensely in the U.S.,mifepristone – a safe and effective abortifa-cient – has taken two decades to reach U.S.women. Abortion politics have turned therather straightforward study and approvalof this regimen into a prolonged process,vulnerable to shifts in the political climate.Below we examine the role of politics inabortion policy and legislation and howspecific laws and policies may restrictaccess to medical abortion.

What Is the Role of Politics in Medical AbortionLegislation and Policy?It is not yet clear whether the practice ofmedical abortion will be subject to the samepolicies as surgical abortion, however somepolicy makers have targeted medical abor-tion specifically. An example of the role pol-itics plays in medical abortion policy is theproposal of the “RU-486 Patient Health andSafety Protection Act” (Legislative billsS251/HR482). First introduced in the U.S.House and Senate in October 2000, this billwould have limited access to mifepristoneby imposing restrictions that, according tothe FDA and numerous medical groups, areunnecessary and do not add to the safety ofmifepristone. These proposed restrictionsinclude requiring providers of mifepris-tone/misoprostol-induced abortion to betrained in surgical abortion, to be certified inultrasound dating of pregnancy, to completea training program regarding the prescriptionof mifepristone, and to have admitting privi-leges within a one-hour distance from theirprincipal medical office.90 It is important tonote that the current law and standard of

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Access to Medical Abortionin the United States:

What Are the Political and

Legal Barriers?

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care in the U.S. does not mandate that ahealth care practitioner who provides prena-tal care be capable of handling complica-tions from an incomplete abortion or ectopicpregnancy. As such, the requirement thatproviders of mifepristone be able to handlethese complications singles out theseproviders for more stringent regulations thanis standard for medical practice in the U.S.

What Are the PoliticalStrategies Used to LimitMedical Abortion? Political attacks upon the safety of mifepris-tone/misoprostol have been the primarymechanism to limit access to medical abor-tion. Methotrexate has received less atten-tion, perhaps due in part to its off-label sta-tus. The arguments against mifepristone/misoprostol have focused on essentiallythree basic myths: 1) mifepristone is a riskymedication which poses serious health risksto women; 2) mifepristone was rushedthrough the FDA approval process and didnot receive a thorough review of its safetyand effectiveness; and 3) misoprostol is dan-gerous and poses health risks to pregnantwomen. These myths are refuted below.

Myth #1: Mifepristone is a risky drug

Anti-choice advocates have repeatedly sug-gested that mifepristone poses serious healthrisks to women and that its use should belimited. They have asserted that mifepris-tone is a “dangerous drug” which createsserious and potentially fatal side effects.89, 91

However, a multitude of studies conductedin the U.S. and abroad which have rigorous-ly studied the safety and effectiveness ofmifepristone have demonstrated otherwise(see Chapter 2). The effectiveness of this

drug is precisely what abortion opponentsfind objectionable.90

Myth #2: Mifepristone was rushedthrough the FDA approval process

Anti-choice advocates claim that mifepris-tone was hurriedly approved without ensur-ing health protections for women whowould use it.92 Mifepristone was, in fact,approved under a special provision of theFDA review process known as “SubpartH”.93 Although Subpart H does have a provi-sion for accelerated review, it can also beused for the sole purpose of putting restric-tions on drug distribution. In the case ofmifepristone, Subpart H was not used toexpedite the review process but only toplace restrictions on mifepristone’s distribu-tion (for the details of these restrictions seeChapter 2). As a part of the approvalprocess, the FDA reviewed data from U. S.clinical trials of mifepristone involving over2,000 women, as well as numerousEuropean studies involving tens of thou-sands of women, which demonstrated boththe safety and effectiveness of this medica-tion for early pregnancy termination.

Myth #3: Misoprostol is dangerousto pregnant women

Myths about misoprostol, the drug used inconjunction with both mifepristone andmethotrexate, have also circulated. Withoutmisoprostol as a part of the regimen, theeffectiveness of both mifepristone andmethotrexate is significantly decreased.Therefore, the availability of misoprostol iscrucial for the practice of medical abortion.One myth about misoprostol is that it is dan-gerous to women. The story behind this par-ticular myth is told below.

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• The Searle Letter. In August 2000, G. D.Searle & Co., the pharmaceutical manu-facturer of the drug misoprostol (market-ed as Cytotec®), issued a letter in whichit warned physicians that misoprostolshould not be used with pregnantwomen because it can cause abortion.94

In addition, Searle argued that the risksto a developing fetus exposed to miso-prostol when used for labor induction orcervical ripening (the thinning, soften-ing, and opening of the cervix) had notbeen determined. The letter was imme-diately picked up by anti-choice advo-cates, including members of Congress,who reported that misoprostol was dan-gerous and could cause a woman’suterus to “explode”.95 Thus, the Searleletter was used to argue against medicalabortion, suggesting that it is dangerousand threatens the health of women inthe U.S.

• The Medical Community Responds. TheAmerican College of Obstetrics andGynecology (ACOG), the primary profes-sional organization of physicians engagedin the science and practice of women’sreproductive health care in the U.S.,responded to the Searle letter. In 1999ACOG had carried out its own review ofthe many published studies on the use ofmisoprostol for labor induction and con-cluded that misoprostol was safe andeffective for inducing labor.96 In October2000 ACOG sent the FDA an updatedreport of the research data on misopros-tol, including studies on its use for med-ical abortion. In a statement whichaccompanied the report,97, 98 ACOG notedthat the serious side effects cited in theSearle letter involved higher doses ofmisoprostol and were relatively rare.ACOG also highlighted the strong safetyrecord of misoprostol when used appro-priately and presented guidelines to min-imize the potential for adverse events,

although adverse events were alreadyrare. ACOG also questioned the timing ofthe Searle letter which had been issuedjust a few weeks prior to the FDAapproval of mifepristone. ACOG clarifiedthe important role of misoprostol as areproductive health drug beyond its roleas an abortifacient and included a point-by-point refutation of proposed FDArestrictions for the mifepristone/miso-prostol regimen put forth by anti-abortionCongressional representatives. The FDAultimately rejected these restrictions.

• FDA Gives Misoprostol A New Label. InApril 2002, the FDA announced that itchanged the label for misoprostol (knownby the brand name Cytotec®).99

Misoprostol is sometimes used to reducethe risk of stomach ulcers. In recognitionof this, the new label says pregnant

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“...The American College of Obstretricians andGynecologists (ACOG) is concerned by thecontent, timing, and tone of [the Searle] letter.Given that misoprostol is commonly employedin conjunction with mifepristone (RU 486) toachieve nonsurgical early pregnancy termina-tions, the arrival of the Searle letter withinweeks of the U.S. Food andDrug Administration’s (FDA’s)approval of mifepristone couldlimit the use of the new optionfor reproductive choice. Also,although the letter correctly points out thepotentially serious, but relatively rare, risks ofmisoprostol when employed for cervical ripen-ing and labor induction, it fails to comment onthe extensive clinical experience with thisagent and the large body of published reportssupporting its safety and efficacy when usedappropriately.”

Excerpt from ACOG letter

from a the ACOG letter byStanley Zinberg, MD,to Janet Woodcock, MD,Director of the FDA,October 26, 2000.

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women should not use the drug for thispurpose. The Searle label had stated thatpregnant women should not take the drugunder any circumstances. The FDA saidthat it clarified the warning to reflect that“the drug has a recognized use by obste-tricians and gynecologists to inducelabor, delivery and is part of the FDA-approved regimen for use with mifepris-tone to induce abortion.”99

What Are the Laws andPolicies That May RestrictAccess to Medical Abortion?Laws governing abortion, which may alsoapply to medical abortion, vary widely fromstate to state. However, several state lawsdeserve particular attention because they arelikely to be applied to medical abortion prac-tice. Although not a comprehensive reviewof state laws, the paragraphs below describeseveral types of legal statutes which havebecome common across the U.S. and thatmay impact the availability of medical abor-tion services. Anyone wishing to determinelegal issues pertaining to a particular stateshould check the laws governing that state.

Laws That Restrict the Provision of Medical Abortion

Physician-Only Laws

Most states have laws which restrict the pro-vision of abortion to licensed physicians.One survey found that only six states(Arizona, Kansas, New Hampshire, Oregon,Vermont, and West Virginia) did not havesuch laws.100 In some states, however, theselaws may not preclude non-physicians fromperforming medical abortion because their

statutes have defined abortion very narrowly(e.g., as a surgical procedure). In otherstates, such as New York, Montana, andRhode Island, rulings by administrativeagencies or state courts supercede physi-cian-only laws and permit certain non-physician practitioners to provide medicaland/or surgical abortions.101-104 In addition, iflaws are interpreted consistent with thestandard of care (i.e., standard medical prac-tice), physicians may delegate tasks to“qualified agents” such as physician assis-tants. Such a legal interpretation may allowfor the provision of medical abortion byadvanced practice clinicians working underthe supervision of a physician.105, 106

Dispensing Authority Laws

Physicians generally have authority to pre-scribe any FDA-approved drug, althoughsome states have enacted restrictions. Instates with restrictive dispensing authoritylaws, dispensing drugs for medical abortionmay be limited to licensed physicians.100, 106,

107 Several states have laws granting dispens-ing authority to advanced practice clini-cians (i.e., nurse practitioners, physicianassistants), either as independent practition-ers, under the supervision of a licensedphysician, or under collaborative prescrib-ing agreements with physicians. By restrict-ing dispensing authority, these laws directlyimpact the ability of advanced practice cli-nicians to engage in the provision of med-ical abortion.

TRAP Laws

Targeted Regulation of Abortion Providers(TRAP) laws consist of laws that single outabortion providers and facilities where abor-tions are performed and impose on them reg-ulations not applied to other physicians oroutpatient clinics. For example, TRAP lawscan restrict abortion practice when they

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require special licensing and/or physicalplant specifications that are burdensome tomeet. Requirements vary widely by state andcan include licensing of the abortionprovider, state inspections of the medicalfacility, room air exchange rates, and mini-mum space requirements surrounding bedsin recovery areas.100, 106, 108

Requirements sometimes are applied only tothose facilities that provide a certain volumeof abortion services.106 For new providers ofabortion in states with requirements target-ing only high volume abortion facilities, theexisting TRAP laws may not apply if thefacility only performs medical abortion onan occasional basis as a part of a generalhealth care practice. However, for providerswho perform higher numbers of medicalabortions, attempts may be made to applythese statutes to medical abortion as well.105

Laws Regarding Examination and Disposal of Fetal Tissue

Several states have laws that require theexamination of the aborted tissue by thephysician performing the abortion and/or apathologist. In a review of related laws,106 13states had fetal tissue examination lawswhich on their face may be applicable tomedical abortion. The person designated toexamine the tissue varies from state to state,with some laws specifying their applicabili-ty only to abortions performed in certaintypes of facilities. Many states also havelaws about the disposal of fetal tissue. Theselaws vary widely by state and may requireburial, cremation, or incineration. Theapplicability of these laws to medical abor-tion is unclear and to date they have notposed a barrier to medical abortion practice.Compliance with a fetal tissue examinationor disposal law would obviously be difficultfor a medical abortion provider if the

woman expels the tissue some place otherthan the provider’s office.100, 106

Laws That Restrict Women From Obtaining Medical Abortion

Abortion-related laws that on their faceappear to protect women’s health and safetymay, in practice, result in delaying womenfrom obtaining abortion. By delaying abor-tion, these laws may actually increase healthrisks to women.

Informed Consent Laws

The term informed consent refers to ensur-ing that a patient understands what isinvolved in a treatment or procedure, thepotential risks and benefits, and any avail-able alternatives. This process ensures thatthe patient has the information necessary tomake an informed choice about undergoingthe treatment or procedure. Informed con-sent is important to the health and safety ofwomen obtaining an abortion. Informed con-sent consists of a full description of the pro-cedure involved, the potential risks, and thetreatment alternatives. However, informedconsent laws written specifically for abortionrequire adding biased language and/or pro-cedures to the informed consent process.Many states have laws which specify in theconsent form scripted language unrelated tothe risks, benefits, or alternative treatmentsfor pregnancy termination, and in essenceact to discourage women from having anabortion.100 Discouraging a woman from hav-ing an abortion is outside the scope ofinformed consent and does nothing toimprove a woman’s understanding of therisks of a given abortion procedure and thealternative procedures that might be used.Furthermore, state-mandated informed con-sent procedures can also act as barriers to

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abortion. In some states this state-mandatedinformation must be provided by the physi-cian in person; in others it can be delegatedby the physician to other staff or providedvia written materials which can be mailed.107,

109 The practical results of this type of legis-lation are twofold: 1) the language in state-scripted informed consent compelsproviders to discourage women from choos-ing abortion, and 2) the added consent pro-cedures cause delays in access to abortion.Thus, informed consent legislation writtenspecifically for abortion makes the consentprocess biased and extremely cumbersome.

Waiting Period Laws

Waiting period laws require a delay of aspecified length between the request for anabortion and the provision of an abortion.The length varies from state to state (e.g.,Indiana, 18 hours; Tennessee, 48-72 hours)with the most common waiting period being24 hours.109 In some states, the waiting peri-od begins after state-mandated in-personabortion counseling has been performed.107, 109

Waiting period laws pose a significant barri-er to women seeking medical abortionbecause they delay the initiation of abortion.Medical abortion is a regimen that is mosteffective early in pregnancy and thereforeneeds to be done in a timely manner. Thedelays introduced by waiting periods maymake medical abortion impossible.

Parental Involvement Laws

Many states require some sort of parentalinvolvement when a minor seeks an abor-tion.106 At least one state (Tennessee) hasspecifically indicated the applicability ofparental notification to medical abortion.110

Parental involvement laws can delay accessto abortion. A young woman, for example,may put off her decision while struggling

with how to tell her parents. In addition,judicial bypass – whereby a young womanmay seek permission for abortion from ajudge rather than from one or both parents –also takes time. The delay introduced bythese parental notification laws is significantgiven that medical abortion can only be per-formed early in pregnancy.

Public Funding Issues

All states are prevented from providing fed-eral Medicaid funding for abortion for low-income women except in cases of rape,incest, or when the pregnant woman’s life isendangered (a provision known as “theHyde Amendment”).100, 107 Some states usestate money to provide funding for abortionsfor low-income women, either voluntarily orwhen state courts have interpreted theirrespective constitutions broadly on the issueof reproductive health rights. On March 30,2001 the U.S. Department of Health andHuman Services notified state Medicaiddirectors that the federal Medicaid fundingrestrictions for surgical abortion also applyto medical abortion.111 In addition to fundingthe procedure, use of public facilities hasalso been banned in state laws. In 1989 theU. S. Supreme Court upheld a Missouri statelaw which banned the use of public facilitiesfor the provision of abortion except to savethe life of the woman. In some states, courtshave struck down efforts to prevent the useof public or quasi-public facilities for theprovision of abortion services.107

What Are the ChallengesAhead?In the coming months and years, severallegal and political issues that may have animpact on access to and provision of med-

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ical abortion services will be debated. Someof these issues are described below.

FDA Approval of Mifepristone

The FDA may be pressured by anti-choiceadvocates to re-examine and possibly over-turn its approval of mifepristone, or at aminimum to increase the restrictions placedon its provision. A new commissioner of theFDA is appointed by each new administra-tion. Future commissioners may considerrevisiting the approval of mifepristone.Whether or not the FDA will yield to politi-cal pressures to undo its prior approval ofmifepristone is unclear.

Proposed Legislation to Limit the Use of Medical Abortion

Several types of legislative bills and otherpolicy changes have been proposed in bothfederal and state legislative bodies thatwould affect the availability of medical abor-tion. These include banning drugs used inmedical abortion regimens and refusal (“con-science”) clauses. These types of policiesand their relevance to medical abortionaccess are described below.

• Banning Drugs Used in MedicalAbortion Regimens. In some states therehave been attempts to ban drugs used inmedical abortion regimens. In Michigansuch an attempt was successfully chal-lenged. The Michigan bill would havebanned any drug for abortion that wasnot FDA-approved for a medically-induced abortion by banning such drugsfrom state-mandated abortioncounseling.107, 112 Although mifepristoneand misoprostol have since beenapproved by the FDA for use in medicalabortion, methotrexate is still used off-

label for medical abortion and wouldhave been banned by this statute.

• Refusal Clauses. Refusal clauses allowindividual health care professionals torefuse to provide services to which theysay they have moral objections, such asemergency contraception or abortion. Forexample, this type of legislation has beenintroduced in Kentucky113 to allow phar-macists to refuse to fill prescriptions formedications “whose primary purpose isto terminate a pregnancy.” Currently,mifepristone is distributed only to physi-cians who, in turn, dispense the drug topatients (see Chapter 2), therefore thistype of legislation is unlikely to impactaccess to mifepristone. However, shouldmisoprostol be prescribed for women totake at home, or if the FDA regimen werechanged to allow for provision of mifepri-stone through pharmacies, this type oflegislation could restrict women’s accessto medical abortion.

In summary, political and legal barriers con-tinue to threaten women’s access to medicalabortion services in the U.S. The main anti-choice argument against medical abortion isthat mifepristone is unsafe. However, thisaccusation is clearly refuted by the wealth ofavailable scientific studies that document itssafety and effectiveness. A common mecha-nism for limiting access to medical abortionis legislation introduced at both the federaland state levels. One of the primary ways inwhich laws impact medical abortion is bycreating delays in initiating an abortion (e.g.,waiting laws, informed consent laws,parental notification laws). Clear, under-standable information about the safety andeffectiveness of the two main medical abor-tion regimens (mifepristone/misoprostol,methotrexate/misoprostol) is crucial in thisongoing public debate. Next, we turn ourattention to barriers faced by health careproviders in the provision of medical abor-tion services.

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The practical realities of providing a newmedical technology to patients can be barri-ers to service provision. With medical abor-tion services, even surgical abortionproviders must learn new protocols, trainstaff, and adjust their practices to the newservice they are providing. More informationis needed regarding obstacles to initiatingmedical abortion services as well as reasonswhy some providers decide not to offer med-ical abortion. A study of abortion providersconducted in 2000 (prior to the FDAapproval of mifepristone) reveals that,although there were many who experiencedmore than one major obstacle to establishingmedical abortion services, most of thoseobstacles diminished or disappeared onceservices were in place.114 However, someobstacles to the provision of medical abor-tion remained. Barriers encountered byproviders initiating medical abortion servic-es are described below.

Additional Staff Training and Time Needed to CounselWomen Regarding theMedical Abortion Regimen Increased time for counseling patients andthe need for training in medical abortioncounseling are commonly reported obsta-

cles in establishing medical abortion servic-es.83, 88, 114 However, once begun, some abor-tion providers also reported that serviceprovision became routine after relativelyfew procedures.114 This finding suggests thatalthough training staff in medical abortioncounseling and the increased time neededto perform medical abortion counselingwere obstacles, these aspects of service pro-vision were less problematic once clini-cians and staff became accustomed to thenew procedures.

Multiple Office Visits for Administration of Medical AbortionBecause the FDA-approved regimen requiresin-office administration of both mifepristoneand misoprostol, a mifepristone-inducedabortion done according to this regimentakes a minimum of three office visits ascompared to the two recommended for sur-gical abortion. While the FDA regimenrequires in-office administration of miso-prostol, there are many studies which havedemonstrated the safety of home administra-tion.75, 115, 116 Abortion providers cited thelogistics of multiple office visits as one ofthe main obstacles to initiating abortion

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Access to Medical Abortionin the United States:

What Are the Barriersfor Medical Abortion Providers?

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services.88, 114 Simplifying the medical abor-tion regimen by reducing the number of vis-its (for example by allowing patients toadminister the misoprostol at home) couldeliminate this obstacle. There is anecdotalevidence that many providers are utilizingevidence-based regimens which eliminatethe second clinic visit.117 Eliminating the sec-ond visit can be done without compromisingsafety or effectiveness.36, 118 However, thepost-treatment examination is necessary toconfirm completion of a medical abortion. Ifa pregnancy continues after either a mifepri-stone/misoprostol or a methotrexate/miso-prostol abortion, birth defects are possible.

Ultrasound ExaminationNeither the FDA requirements nor thePrescriber’s Agreement stipulates ultra-sound use or training as a requirement forprescribing mifepristone. However, someproviders confirm an intrauterine pregnancyby ultrasound to avoid missing an ectopicpregnancy.119 Providers have cited additional

staff training in vaginal ultrasound as anobstacle to providing medical abortion serv-ices.83, 114 Anti-choice legislators have pro-posed requiring abortion providers to becertified in ultrasound evaluation as a con-dition for prescribing mifepristone,90 andsimilar proposals aim to restrict who mayperform the ultrasound examinations.Training needs and restrictions on the per-formance of ultrasonic examinations couldbe significant obstacles to the provision ofmedical abortion.

Access to Surgical Back-upfor Incomplete MedicalAbortionProviders of medical abortion need to beable to provide surgical abortion or have areferral plan for that service if a medicalabortion is incomplete. The availability ofback-up for those rare cases of complica-tions following medical abortion is impor-tant for protecting women’s health and safe-ty. Back-up arrangements are consistent

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Obstacle N* %**

Time for counseling 18 72

Training in counseling 16 64

Logistics of multiple visits 13 52

Training in vaginal ultrasound 10 40

Training in medical abortion procedure 9 36

* Total N=41** Total does not equal 100% because subjects were permitted to name multiple obstacles.

Top 5 Major Obstacles to Initiating Medical Abortion Services

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with the American College of Obstetrics andGynecology’s guidelines for provision ofmedical abortion9 and is an FDA require-ment for providing mifepristone.17 Mostproviders of women’s health care alreadyhave referral plans for their patients whoexperience a spontaneous abortion (i.e.,miscarriage) and need surgical completion.Nonetheless, securing back-up for medicalabortion may present difficulties for someproviders. Providers in rural areas, in par-ticular, may have difficulty finding access tosurgical back-up. Although surgical back-upusually refers to electric vacuum aspiration,manual vacuum aspiration (MVA) is anothersurgical abortion method which may be abetter option for some providers because itis an easy-to-learn method and the instru-ments are inexpensive and portable. MVAhas been used for many years throughoutthe world for spontaneous and incompletefirst trimester abortion and is as safe andeffective as electric vacuum aspiration.120

Because the provider uses a handheldsyringe as a source of suction, MVA can beused in many different settings, includingthose without the equipment necessary forelectric vacuum aspiration.121

Malpractice Insurance Issues Clinicians are required to notify their mal-practice insurance carriers of any significantadditions or changes to their medical prac-tice. New providers of medical abortion whohave not already been providing surgicalabortion will most likely have to report theaddition of medical abortion. Not all mal-practice insurance companies cover abortionservices, thus, some providers may need tochange carriers.100 In some cases, addingmedical abortion services may result inincreased malpractice insurance premiums,potentially discouraging providers fromadding this service to their practice.

Third Party ReimbursementReimbursement from third party payers (i.e.,Medicaid and commercial health plans) is apotential barrier particularly for primarycare providers because their reimbursementrates for office visits tend to be lower thanthose of specialists (such as obstetrician/

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Advantage N* %**

Clients want services 26 100

Staff likes new skills 24 92

Cutting edge of technology 23 88

Less stress for clients 21 84

Staff prefers earlier services 14 54

* Total N=41** Total does not equal 100% because subjects were permitted to name multiple obstacles.

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gynecologists) and may be insufficient torecover costs. Inadequate reimbursementmay discourage primary care practitionersfrom adding medical abortion services totheir medical practice.122, 123

Additional Obstacles for New Abortion Providers

Compared to those who are already provid-ing surgical abortion, practitioners who havenever before offered abortion services mayhave additional obstacles because they mayneed to address general issues related to theprovision of abortion services for the firsttime. These providers will need to train staffin abortion counseling, establish informedconsent procedures and forms, learn aboutand establish procedures to comply withstate laws regarding abortion practice, buyultrasound equipment and obtain training inits use, establish fees for medical abortionservices, and arrange for surgical back-up. Inaddition, the potential barriers of increasedmalpractice insurance premiums and third

party reimbursement are relevant to newabortion providers as well.

New practitioners may also have a variety ofconcerns about adding medical abortionservices, including reactions from their col-leagues, staff, family members, and commu-nity, as well as reactions of board membersat hospitals where they have admitting privi-leges.124 Taken together, the practical realitiesof setting up a new service and the politicaland personal costs of becoming an abortionprovider may discourage some providersfrom initiating medical abortion services.

In summary, health care providers whochoose to offer medical abortion services aspart of their practice may encounter thesame obstacles as they do when offering anynew medical technology, such as additionaltraining for themselves and their staff.However, other obstacles are unique to med-ical abortion, including the time associatedwith multiple office visits and financial con-siderations associated with malpracticeinsurance and third party reimbursement. Inthe following chapter, we outline recommen-dations for making medical abortion easierto provide and more accessible to women.

34

Medical abortion represents a significantadvance in abortion practice. Until recently,surgical abortion was the only type of abor-tion available to women seeking early preg-nancy termination. Now women can choosebetween surgical and medical abortionmethods. Whereas access to surgical abor-tion has become increasingly restricted,especially for women living in rural areas,medical abortion has the potential toincrease the number, types, and geographicdistribution of abortion providers andreduce other barriers to access.

Medical abortion could change the land-scape of abortion practice in the UnitedStates. If institutional and governmentaldecisions were based solely on scientificknowledge and consideration of women’shealth, medical abortion already would bewidely available and more commonly used.However, other factors influence, and attimes overwhelm, legislative and policy-making processes in the U.S. As a conse-quence, the laws, rules, and operational andjudicial decisions that constitute abortionpolicy (as well as the private policies ofhospitals and other health care organiza-tions) are subject to political bargaining,ideological biases, and the preferences ofpowerful interest groups.

In the previous chapters, we have exam-ined some of the barriers to the provisionof and access to medical abortion in the

U.S. In this chapter, we present recommen-

dations for policymakers and legislators

aimed at increasing the availability of med-

ical abortion.

Recommendations

Increase public awareness of the science and policiesregarding medical abortion

The following recommendations are intend-

ed to correct misinformation about medical

abortion, and to increase public awareness

and understanding of the safety and effec-

tiveness of medical abortion as demonstrated

by medical and pubic health research.

• Support the development of national

media campaigns to inform women about

the availability, safety, and effectiveness

of medical abortion.

• Support the availability of information

regarding medical abortion in public clin-

ics and health facilities, and publicly

funded outreach programs.

S E C T I O N V — M O V I N G F O R W A R D 35

Moving Forward

Sec

tion

5

• Provide the public with critical analysis ofthe impact of changes in laws and policyupon the availability of medical abortion.

Base policy decisions on thepublic health science of medicalabortion

The following recommendations are intend-ed to ensure that policy decisions at all lev-els of government are made in the interest ofwomen’s health.

• Develop policy statements based on sci-entific research that include the positionsof leading professional organizations(e.g., American College of Obstetrics andGynecology, American Medical Women’sAssociation, and the American PublicHealth Association).

• Rely on public health and medicalresearch findings when developing andevaluating laws that could affect theavailability of medical abortion.

Increase types of providers who perform medical abortion

The following recommendations are intend-ed to increase the types of providers whoperform medical abortion by expanding thepractice to advanced practice clinicians (i.e.,certified nurse-midwives, nurse practition-ers, and physician assistants).

• Oppose laws that bar advanced practiceclinicians from practicing medical abor-tion, such as physician-only laws andlaws that restrict prescriptive authority.

• Develop and support programs that pro-vide education and training for advancedpractice clinicians in medical abortionregimens.

• Urge professional organizations to devel-op and offer training, workshops, andother necessary support to advancedpractice clinicians who want to providemedical abortion services.

• Support policies that require training inmedical abortion in schools of nursing.

Increase the number ofphysicians who perform medical abortion

The following recommendations are intend-ed to increase the number of physicians whoprovide medical abortion services andenhance providers’ ability to provide med-ical abortion services.

• Develop and support policies that requiretraining in medical abortion in medicalschools.

• Support laws and policies that assistphysicians who do not provide abortion,especially gynecologists and family prac-titioners, in adding medical abortion totheir practices.

• Connect physicians with existingresources for the purposes of medicalabortion training and support (e.g.,National Abortion Federation and TheAbortion Access Project).

• Promote and support expansion of FDA-approved medical abortion regimens toinclude other evidence-based regimensthat have comparable or superior effec-

S E C T I O N V — M O V I N G F O R W A R D36

tiveness and side effects profiles (e.g.,methotrexate regimens, home administra-tion of misoprostol, vaginal administra-tion of misoprostol, changes in dosage,and timing of administration of medicalabortifacients).

• Oppose laws and policies that add legalbarriers to medical abortion practice, suchas TRAP laws, public funding restric-tions, and laws which attempt to effec-tively limit providers to use of the FDAapproved regimen (see Chapter 3“Banning Drugs Used in MedicalAbortion Regimens”).

Increase the number and types of health care settings in whichmedical abortion is provided

The following recommendations are intend-ed to increase the number and types ofhealth care settings in which medical abor-tion is provided, thereby increasing accessfor many women and their choice of abortionmethod.

• Overturn and oppose laws that placeunnecessary restrictions on facilities inwhich abortions are performed (i.e.,TRAP laws).

• Support laws and policies that encourageproviders to offer medical abortion servic-es in the same facilities as other repro-ductive health care.

• Develop and promote incentive programsto encourage and enable providers topractice medical abortion in rural areas.

Increase access by making it easier for women to obtainmedical abortion

The following recommendations are intend-ed to increase women’s access to medicalabortion.

• Overturn and oppose laws and other poli-cies that unnecessarily complicate anddelay the process of obtaining an abor-tion, such as informed consent laws thatintroduce delays in abortion care, manda-tory waiting period laws, and parentalinvolvement laws.

• Reform the federal law that prohibitsstates from using federal Medicaid moneyto fund abortions for low-income women.Oppose state and federal laws that placerestrictions on public funding and the useof public facilities in the provision ofabortion services.

Improve women’s knowledge of medical abortion

The following recommendations are intend-ed to increase the understanding of medicalabortion among women seeking early preg-nancy termination. The acceptability of amethod depends, in part, upon women hav-ing complete and accurate information.

• Promote laws and policies that providefor education and counseling of womenseeking abortion services; such educationand counseling must include informationabout all abortion methods.

• Develop and support laws and policiesthat provide public funding to make

S E C T I O N V — M O V I N G F O R W A R D 37

Sec

tion

5

available in public clinics medical abor-tion-related educational materials.

• Support and promote policies that ensurethat education and counseling are cultur-ally appropriate and specific to variousage, cultural, and social groups.

Ensuring Access to Medical Abortion

The above recommendations are aimed atmaking medical abortion easier to provideand more accessible to women.Implementing these recommendations willhelp create the conditions necessary forhealth care providers in the U.S. to offermedical abortion. Although women’s knowl-edge about medical abortion is important,knowledge itself will not improve access tomedical abortion. Access will be guaranteedby public policies that support women’shealth and the right of each woman todecide for herself if and when to have chil-dren. The goal of ensuring access to medicalabortion will be realized with the coopera-tion of public health professionals, women’shealth advocates, health care providers, poli-cy makers, journalists, media professionals,and others who recognize the importance ofabortion access to the health of women,men, and their families.

S E C T I O N V — N O N - E M P L O Y M E N T A N D U N E M P L O Y M E N T38

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109. Center for Reproductive Law and Policy. Mandatorydelays and biased information requirements: Statusof mandatory delay and biased information laws.April, 2002. Available at: http://www.crlp.org/pub_fac_manddelay1.html. Accessed July 24, 2002.

110. Henry J. Kaiser Family Foundation. Tennessee attor-ney general says RU-486 is subject to parental notifi-cation statutes. Kaiser Daily Reproductive HealthReport. March 13, 2001. Available at:http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=3362. Accessed May 21, 2001.

111. National Abortion Federation. NAF’s report on feder-al and state action on abortion issues. March 2001.Available at: http://www.prochoice.org/Legal/Legislation/GovRelReps/grp032001.htm. AccessedMay 4, 2001.

112. Henry J. Kaiser Family Foundation. CRLP challengesMichigan law that would ban mention of misoprostolin abortion pamphlets, Los Angeles Times reports.Kaiser Daily Reproductive Health Report. February27, 2001. Available at: http://www.kaisernetwork.org/Daily_reports/print_report.cfm?DR_ID=3056&dr_cat=2. Accessed May 21, 2001.

113. Henry J. Kaiser Family Foundation. Kentucky Senatepasses “conscience” bill allowing pharmacists torefuse dispensation of abortifacients. Kaiser DailyReproductive Health Report. March 5, 2001.Available at: http://www.kaisernetwork.org/daily_reports/rep_index.cfm?DR_ID=3191. AccessedMay 21, 2001.

114. Benson J, Clark KA, Gerhardt A, Randall L, Dudley S.Early abortion services in the United States: Ensuringservice availability, remaining on the cutting edge oftechnology and responding to client demand–Finalstudy report. Chapel Hill, NC: Ipas; 2001.

115. Ellertson C, Elul B, Winikoff B. Can women use med-ical abortion without medical supervision?. ReprodHealth Matters. 1997;9:149-159.

116. Schaff EA, Stadalius LS, Eisinger SH, Franks P.Vaginal misoprostol administered at home aftermifepristone (RU 486) for abortion. J Fam Pract.1997;44(4):353-360.

117. Henshaw SK. Personal communication, June 2, 2002.

118. Pymar HC, Creinin MD, Schwartz JL. Mifepristonefollowed on the same day by vaginal misoprostol forearly abortion. Contraception. 2001;64(2):87-92.

119. Jensen, J. Personal communication. February 11,2002.

120. Westfall JM, Sophocles A, Burggraf H, Ellis S.Manual vacuum aspiration for first-trimester abor-tion. Arch Fam Med. 1998;7:559-562.

121. MacIsaac, L, Darney P. Early surgical abortion: Analternative to and backup for medical abortion. Am JObstet Gynecol. 2000;183(2 Supp):S76.

122. Tews, L. Personal communication. June 15, 2001.

123. Gerhardt, A. Personal communication. June 19, 2001.

124. Tews, L. Personal communication. May 16, 2001.

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Abortion provider– An individual physicianor advanced practice clinician who offersabortion services.

Advanced practice clinicians– Health careprofessionals, including nurse practitioners,certified nurse-midwives, and physicianassistants, who are licensed to practice med-icine with physician supervision.

Anti-metabolite– A drug which interfereswith cell growth by blocking the chemicalreactions necessary for DNA production andnormal cell division.

Anti-progesterone– A drug which interfereswith the action of progesterone, the hormonenecessary to cease menstruation and main-tain pregnancy.

Cytotec®– The brand name for misoprostol(see Misoprostol).

Ectopic pregnancy– A pregnancy whichoccurs outside the uterus, also called anextrauterine pregnancy. An ectopic pregnan-cy occurs in about 1 in 60 pregnancies.Often called a “tubal pregnancy,” mostectopic pregnancies occur in the fallopiantubes. However, on rare occasions, the fertil-ized egg may implant in the ovaries, cervix,or abdomen. Since the fallopian tubes arenot large enough to accommodate a growingembryo, the pregnancy cannot continue nor-mally. If the problem is identified early, theembryo is removed. In some cases, the

embryo grows until the fallopian tube isstretched so much that the tube ruptures.Rupture of the tube is a true medical emer-gency because of maternal hemorrhage(severe blood loss).

Effectiveness– In research studies, effective-ness usually refers to a drug’s ability to pro-duce the intended result in a real world set-ting.

Efficacy– In research studies, efficacy usual-ly refers to a drug’s ability to produce theintended result in a clinical trial.

Electric vacuum aspiration– The most com-mon method of surgical abortion in which asmall tube, or cannula, is attached to anaspirator machine which is inserted into theuterus; the contents of the uterus are thenemptied by suction. Electric vacuum aspira-tion is a safe and effective abortion method.

Endometrium– The mucous membrane thatlines the inside of the uterus.

Evidence-based medicine– The process ofsystematically finding, appraising, and usingcontemporaneous research findings as thebasis for clinical decisions.

FDA– see United States Food and DrugAdministration.

FDA-approved– Pre-marketing approval ofnew drugs and certain medical devicesrequired by the FDA. Labels accompanying

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the products list only those uses approvedby the FDA, and authorized marketing bymanufacturers is limited to those uses.However, the FDA does not have the author-ity to control how doctors use the productsonce they pass the agency’s initial review.Physicians may–and frequently do–pre-scribe drugs or use devices in ways notincluded on the FDA-approved label (seeOff-label use).

Folex®– One of the brand names ofmethotrexate (see Methotrexate).

Informed consent– Except in the case of anemergency, a doctor must obtain a patient’sagreement (informed consent) to any courseof treatment. Doctors are required to tell thepatient anything that would substantiallyaffect the patient’s decision. Such informa-tion typically includes the nature and pur-pose of the treatment, its risks and conse-quences and alternative courses of treatment.

Last Menstrual Period (LMP)– The numberof days or weeks from the first day of thelast menstrual period. This number is usedby medical professionals to calculate thegestational age of the embryo or fetus.

Manual Vacuum Aspiration (MVA)– A sur-gical abortion method performed with ahandheld syringe as a source of suction forremoving uterine contents. MVA may be per-formed in settings such as doctors’ offices,clinics and emergency rooms that lack elec-tric surgical abortion equipment. MVA is assafe and effective as electric vacuum aspira-tion.

Medical abortion– The termination of earlypregnancy using a drug or combination ofdrugs that are usually administered orally,intramuscularly and/or vaginally, first caus-ing the pregnancy to terminate and thencausing the uterus to expel the products ofconception.

Methotrexate– A drug used for medicalabortion (usually in combination with miso-prostol) which stops cell division in thedeveloping placenta, thereby interferingwith cell growth and further attachment tothe uterine lining.

Mifeprex™– The brand name of mifepris-tone in the U.S. Mifepristone is also knownas RU-486 (see Mifepristone and RU- 486).

Mifepristone– A drug used for medical abor-tion (usually in combination with misopros-tol) which alters the uterine lining and dis-rupts attachment of a fertilized egg.Mifepristone is approved by the FDA formedical abortion.

Misopristol– A drug used in combinationwith mifepristone or methotrexate for med-ical abortion. Misoprostol softens the cervixand stimulates uterine contractions to expelthe products of conception.

Off-label use– The practice of prescribing adrug for a disease or a condition other thanthe indication for which it was approved bythe FDA. Off-label use is an integral featureof medical practice and often reflectsapproaches that have been extensivelyreported in medical literature. A substantialbody of medical and scientific literature hasdeveloped around off-label uses, includingarticles in peer-reviewed professional jour-nals, references in medical textbooks, anddiscussions and workshops at medical sym-posia. The American Medical Associationestimates that 40-60% of prescriptions arewritten for off-label uses. The FDA generallybars pharmaceutical and device manufactur-ers from communicating with physiciansand other health care professionals aboutoff- label uses.

Refusal clauses– State legislation, alsoknown as “conscience clauses,” explicitlyallowing some health care professionals or

G L O S S A R Y46

institutions, often on religious or moralgrounds, to refuse to provide or participatein some types of reproductive health care,such as abortion, contraceptive or steriliza-tion services.

RU-486– The chemical compound name formifepristone which was originally devel-oped by the French pharmaceutical compa-ny, Rousell-Uclaf (see Mifepristone andMifeprex).

Spontaneous abortion– The loss of a fetusduring pregnancy due to natural causes; amiscarriage is the spontaneous terminationof a pregnancy before the fetus has reached20 weeks.

Subpart H– An FDA rule which allows forthe regulation of new drugs and expeditedreview of drugs for serious or life-threaten-ing illnesses. According to the FDA,Mifepristone was approved under Subpart Hin order to place safety restrictions on itsdistribution. The approval of mifepristonewas not expedited. The FDA approvedmifepristone only after reviewing three com-plete phases of clinical trials, which is thestandard review process. Approval formifepristone was issued more than fouryears after the sponsor (Danco Laboratories)submitted its application.

Surgical back-up– In the case of medicalabortion, refers to arrangements made by aprovider for a patient to receive a surgicalabortion in the event of an incomplete med-ical abortion or ongoing pregnancy.

Ultrasound–a type of imaging which useshigh frequency sound waves; used in deter-mining the gestational age of a pregnancy.

United States Food and DrugAdministration (FDA)– An agency of theDepartment of Health and Human Servicesresponsible for enforcing laws enacted by

Congress which deal with the regulation offood (excluding meat, poultry and some eggproducts), drugs, medical devices, blood,biological products (such as vaccines andtissues for transplantation) and cosmetics.The FDA also monitors the safety of thenation’s food supply, reviews scientific evi-dence related to new drugs or medicaldevices and investigates the safety of com-monly used chemicals.

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R E S O U R C E S 49

The Abortion Access Project

552 Massachusetts Avenue, Suite 215

Cambridge, MA 02139

(617) 661-1161

www.abortionaccess.org

The Alan Guttmacher Institute

120 Wall Street, 21st Floor

New York, NY 10005

(212) 248-1111

www.agi-usa.org

American Civil Liberties Union (ACLU)

Reproductive Freedom Project

125 Broad Street, 18th Floor

New York, NY 10004

www.aclu.org/issues/reproduct/hmrr.html

American College of Nurse Midwives

818 Connecticut Avenue, NW, Suite 900

Washington, DC 20006

(202) 728-9860

www.midwife.org

American College of Obstetricians and

Gynecologists

409 12th Street, SW

P.O. Box 96920

Washington, DC 20090-6920

(202) 638-5577

www.acog.org

American Medical Women’s Association801 North Fairfax Street, Suite 400Alexandria, VA 22314-1767(703) 838-0500www.amwa-doc.org

American Public Health Association800 I Street, NWWashington, DC 20001(202) 777-2742www.apha.org

Association of Reproductive Health Professionals2401 Pennsylvania Avenue, NW, Suite 350Washington, DC 20037-1718(202) 466-3825www.arhp.org

Center for Reproductive Health Research & PolicyUCSF, 3333 California StreetSuite 335, Box 0744San Francisco, CA 94143-0744(415) 502-4098http://reprohealth.ucsf.edu

Center for Reproductive Law and Policy120 Wall Street, 14th FloorNew York, NY 10005(917) 637-3600www.crlp.org

Resources

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Clinicians for Choicec/o The National Abortion Federation1755 Massachusetts Avenue, NW, Suite 600Washington, DC 20036(202) 667-5881www.cliniciansforchoice.orgDanco Laboratories, LLC (maker of MifepreTM)(877) 432-7596www.earlyoptionpill.com

Henry J. Kaiser Family Foundation2400 Sand Hill Road Menlo Park, CA 94025 (650) 854-9400 www.kff.org

Ipas300 Market Street, Suite 200Chapel Hill, NC 27516(919) 967-7052, (800) 334-8446www.ipas.org

Medical Students for Choice2041 Bancroft Way, Suite 201Berkeley, CA 94704(510) 540-1195www.ms4c.org

National Abortion and Reproductive RightsAction League1156 15th Street, NW, Suite 700Washington, DC 20005(202) 973-3000www.naral.org

National Abortion Federation1755 Massachusetts Avenue, NW, Suite 600Washington, DC 20036(202) 667-5881www.prochoice.org

National Women’s Health Network514 10th Street, NW, Suite 400Washington, DC 20004(202) 347-1140www.womenshealthnetwork.org

National Women’s Law Center11 Dupont Circle, NW, Suite 800Washington, DC 20036(202) 588-5180www.nwlc.org

Physicians for Reproductive Choice and Health55 West 39th Street, 10th FloorNew York, NY 10018(646) 366-1890www.prch.org

Planned Parenthood Federation of America810 Seventh AvenueNew York, MY 10019(212) 541-7800, (800) 230-PLANwww.plannedparenthood.org

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