Tài liệu Obstetrics and Gynecology Clinics of North America, 2007 pdf

1?Many factors create barriers to eﬀective contraceptive usage, but certain so-cial and public health barriers that are unique to the United States must berecognized and removed to reduc

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Consulting Editor

This issue of the Obstetrics and Gynecology Clinics of North America, pared by Guest Editor Eve Espey, MD, deals with a very timely update oncontraception and family planning Our specialty is inﬂuenced by social,religious, and political forces from outside the medical community In noother ﬁeld of medicine are these forces more obvious than in family planning.Most fertile women prefer to avoid pregnancy, and they and their providersare confronted continuously by these forces

pre-Women’s health care physicians must counsel and prescribe ception despite challenges such as: continual change; frequent confusion;ignorance of legal, legislative, and judicial communities despite scientiﬁc ev-idence; unbalanced media coverage; and health care providers themselves.Access is not universal Even in certain industrialized countries with moreadvanced contraception technologies, women are denied easy access to familyplanning services Roadblocks for indigent women to these services arefrequently attributed to religious or political issues rather than any medicalreason

contra-When contraception is not used by presumably fertile partners, mately 90% of women will conceive within 1 year Young women who donot want to become pregnant are advised to use contraception wheneverthey become sexually active, regardless of their age Women with certainmedical conditions require special consideration of contraception choice.Contraceptive advice for the woman nearing menopause can be diﬃcult,because it is impossible to predict when fertility has ended Oligomenorrhea

approxi-William F Rayburn, MD

34 (2007) xiii–xiv

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or increasing cycle length is associated with a diminished frequency, but notcessation of ovulation.

Current methods of contraception include oral steroidal contraceptives,injected or implanted steroidal contraceptives, intrauterine devices, barriertechniques, withdrawal, sexual abstinence around the time of ovulation,breastfeeding, and permanent sterilization This issue also highlights morerecent forms of contraception such as the contraceptive patch, vaginal ring,extended cycle hormonal contraceptive, transcervical sterilization, and im-plantable contraception Estimates of failure rates during the ﬁrst year of useare given for each technique

Those who prescribe contraceptives must be familiar with currently able drugs and methods and their side effects No method of fertility regu-lation is completely effective or without side effects and danger We muststrive to minimize these side effects and risks while appreciating that a majorrisk of contraception failure is unplanned pregnancy Effective sexual educa-tion, as well as motivation, undoubtedly reduces the cited failure rates Thisissue addresses behind-the-counter emergency contraception and its advan-tages and limitations Elective abortion is not a contraceptive technique;rather, it serves as a less-than-ideal remedy for contraceptive failure orneglect

avail-It is our desire that this issue will attract the attention of providers caringfor the many women of reproductive age who need contraception The prac-tical information provided herein by this distinguished panel of contributorswill hopefully aid in the development and implementation of more speciﬁcand individualized treatment plans

William F Rayburn, MDDepartment of Obstetrics and GynecologyUniversity of New Mexico School of Medicine

MSC10 55801University of New MexicoAlbuquerque, NM 87131-0001, USAE-mail address:wrayburn@salud.unm.edu

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Guest Editor

In the long run, injectable contraceptives and intrauterine devices mayprove more powerful weapons against conﬂict and terrorism than Abramstanks or F-16 war planes

dMalcolm Potts

The basic human right of self-determination is meaningless for womenwho do not have the ability to control reproduction Devoting an issue ofthis journal to contraception makes sense at this time when the unintendedpregnancy rate in the United States continues to hover at 50% Everywoman knows whether it is the right time for her to bear a child and forher and her family to commit the considerable personal and ﬁnancial re-sources necessary for raising that child But the impact of contraceptiontranscends the importance of individual choice It has dramatic implicationsfor the health, well-being, and survival of communities

Contraception is a means of promoting global health By decreasing intended pregnancy, contraception reduces maternal mortality, particularly

un-in developun-ing countries Unun-intended pregnancy leads to abortion, which isnot only illegal but also unsafe in much of the world Without contracep-tion, unchecked population growth creates poverty and the desperation peo-ple feel when they see no prospect of a fulﬁlling life Poverty and despairbreed violence and war

As one of the wealthiest developed nations, the United States enjoys anexpanding range of approaches to family planning and methods of contra-ception, yet access is not universal In this issue of Obstetrics and

Eve Espey, MD, MPH

34 (2007) xv–xvii

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Gynecology Clinics of North America, we address exciting new ments and research related to currently available contraceptives We alsofocus on the multiple social, political, public health, and medical barriersthat may deny women who most need the beneﬁts of these developmentsfrom accessing them.

develop-The issue begins with two articles about impediments to contraceptiveaccess, both medical and social Dr Cosgrove, Dr Ogburn, and I beginwith a review of the numerous social, public health, and political barriersthat limit access to the increasingly varied array of contraceptive options

Dr Leeman considers the medical roadblocks that women face in eﬀectivelyusing contraceptivesdroadblocks sometimes inadvertently put in place byphysicians themselves Dr Yael Swica reviews two new methods, the contra-ceptive patch and vaginal ring Dr Jody Steinauer and Dr Meg Autry dis-cuss the latest information on the increasingly popular extended-cycledosing regimens for hormonal contraceptives Dr Tony Ogburn and I ad-dress the current status of transcervical sterilization as well as future devel-opments Contraceptive implants disappeared in the United States afterthe removal of Norplant from the market in 2000 Dr Michelle Isley and

Dr Alison Edelman review implantable contraception with an emphasis

on Implanon, the newly Food and Drug Administration–approved 3-yearsingle-rod implant Dr Laura MacIsaac and I examine the evidence for ex-panding the use of intrauterine contraception with an emphasis on recentFood and Drug Administration label changes for the CuT380A Dr Stepha-nie Teal and Dr David Ginosar address the important task of identifyingappropriate contraception for women who have medical illnesses Dr LindaPrine writes on the current status of emergency contraception and addressesrecent concerns about its eﬀectiveness Dr David Turok concludes the issuewith a comprehensive review of contraceptive methods currently underdevelopment

The control of fertility is at the root of true equity for women If we are toachieve equality and justice for women globally, members of the family-planning community must commit to a social agenda that promotes sexualhealth by encouraging education about contraception and by providing freeaccess to contraceptives as a right for all women We have made a start inthis country Excellent methods are available and even more are on the ho-rizon In recent years, laws and Medicaid waivers have improved access for

at least some women Behind-the-counter access to emergency contraceptionhas ﬁnally been approved

It is our responsibility to advocate for universal coverage and universalaccess to contraception: no woman left behind Starting here in our ownbackyard and armed with injectable contraceptives and IUDs, we can ﬁghtconﬂict and terrorism And we can win

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I would like to thank all of my fellow authors for their outstanding tributions Special thanks to Carla Holloway from Elsevier for her invalu-able assistance in coordinating this eﬀort.

con-Eve Espey, MD, MPHAssociate ProfessorDepartment of Obstetrics and Gynecology

1 University of New Mexico, MSC10-5580

Albuquerque, NM 87131, USAE-mail address: eespey@salud.unm.edu

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Family Planning American Style: Why It’s So Hard to Control Birth in the US Eve Espey, MD, MPHa,* , Ellen Cosgrove, MDb,

Butch Hancock

The United States possesses the dubious distinction of having the highestteen pregnancy rate[1]and one of the highest overall unintended pregnancyrates (49%) among developed countries [2] Unintended pregnancy andabortion disproportionately aﬀect young, unmarried, low-income, and edu-cationally disadvantaged women[3] Sadly, unintended pregnancy rates areincreasing in these groups An infectious disease epidemic on this scalewould be met with a concerted public health campaign, including personalresponsibility approaches, health protection strategies, and public policymeasures Similar to unintended pregnancy, the US abortion rate of 21.3per 1,000 women aged 15 to 44 compares unfavorably with rates in otherdeveloped countries[4]

Why is it that other developed countries have managed to achieve muchlower rates of unintended pregnancy, teen pregnancy, and abortion (Fig 1)?Many factors create barriers to eﬀective contraceptive usage, but certain so-cial and public health barriers that are unique to the United States must berecognized and removed to reduce unintended pregnancy and abortion.These barriers include the abstinence-only approach to sex education,

* Corresponding author.

E-mail address: eespey@salud.unm.edu (E Espey).

Obstet Gynecol Clin N Am

34 (2007) 1–17

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acceptance of and support for teenage parenthood, reduced access to healthcare because of lack of insurance or hospital mergers, and reduction of ac-cess to family planning services from burdensome contraceptive dispensingpractices A relatively new and ominous anticontraception sentiment also isgaining momentum in this country, although polls demonstrate that it is anextremist position This article discusses each barrier and comments onstrategies for reducing each one to achieve an integrated, comprehensive,public health approach to this complex problem.

Abstinence-only education

Content and funding of sex education

The increasing emphasis on abstinence-only education reﬂects the largeinfusion of funding for this type of education appropriated under Title V,Section 510 of the Welfare Reform Act of 1996 Through this and otherprograms, more than $1.1 billion have been spent on abstinence-onlyeducation over the last two decades[5] To receive funds for sex educationunder Title V, states must provide $3 in matching funds for every $4 infederal funds They also must comply with an eight-item deﬁnition of

Fig 1 US teenagers have higher pregnancy, birth, and abortion rates than adolescents in other developed countries (From The Alan Guttmacher Institute (AGI) Teenage sexual and reproductive health in developed countries: can more progress be made? New York: AGI, 2001 Available at: http://www.guttmacher.org/presentations/progress_slides.html Accessed Febru- ary 7, 2007; used with permission.)

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abstinence-only education, which specifies that the exclusive purpose of sexeducation is to teach the benefits of abstaining from sexual activity, that ab-stinence is the only certain way to avoid pregnancy and sexually transmittedinfections (STIs), that sexual activity outside marriage is likely to haveharmful psychological and physical effects, and that a mutually faithful,monogamous relationship in the context of marriage is the expected stan-dard of human sexuality All states but California have accepted thesefunds No federal funds have been appropriated for comprehensive sexeducation, defined as a program that includes abstinence and contraceptionand STI education.

Although signiﬁcant federal and state funding is available for only education, no federal laws or policies mandate the oﬀering or content

abstinence-of sex education Thirty-nine states have developed their own laws or cies regarding sexuality or STI education or both Twenty-one states requirecoverage of sexuality and STIs, whereas 17 require only coverage of STIs.Only 1 state requires sex education but not STI coverage Eleven states leave

poli-it entirely to the local school districts to decide what will be taught[6] teen states, including some that have statewide mandates requiring educa-tion on sexuality, STIs, or both, give local school districts completediscretion over whether and how to teach abstinence and contraception.The remaining 34 states, regardless of whether they have mandates aboutsexuality and STI education, place some requirements on local school dis-tricts about the teaching of contraception and abstinence A national pref-erence for abstinence education is evidenced by the fact that 34 statesrequire that it be taught and 25 require that it be stressed In contrast,only 19 states require coverage of contraception, and none requires that it

Six-be stressed[6]

Support for comprehensive sex education

The Sexuality Information and Education Council of the United States,

a national organization that advocates for the right of all people to hensive and accurate sexuality information, reports that ‘‘89% of Americansbelieve it is important to teach young people about contraception and theprevention of STIs and that sex education programs should focus on how

compre-to avoid unintended pregnancies and STIs, including HIV and AIDS, sincethey are such pressing problems in America today’’[7]

Comprehensive sex education is broadly supported by professional nizations, including the American College of Obstetricians and Gynecolo-gists, the American Public Health Association, the American Academy ofPediatrics, and the American Medical Association[8–10] Perhaps most im-portantly, 95% of parents of junior high school students and 93% of parents

orga-of high school students believe that birth control and other methods orga-of venting pregnancy are appropriate topics for sex education programs inschools[7]

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Despite the tremendous public support for comprehensive sex education,the last decade has seen a major decline in formal instruction about birthcontrol methods From 1995 to 2002, formal instruction about birth controlmethods declined from 81% to 66% for adolescent boys and from 87% to70% for girls [11] Over the same time period, the number of adolescentswho received abstinence-only education increased from 9% to 24% forboys and from 8% to 21% for girls In 2002, only 62% of girls and 54%

of boys who were sexually experienced had received education about ceptive methods before ﬁrst intercourse

contra-Eﬀectiveness of sex education programs

Few studies have evaluated the eﬀectiveness of diﬀerent approaches tosex education Decisions to use abstinence-only versus comprehensive sexeducation are based almost exclusively on opinion

Douglas Kirby, PhD, of Education Training Research Associates is

a leading publisher of patient education, health promotion, and health cation pamphlets and other materials He performed a comprehensive re-view of 73 studies evaluating sex education programs [12] and found

edu-‘‘reasonably strong’’ evidence that comprehensive sex and HIV educationprograms may delay sex, increase contraceptive or condom use, or decreaseteen pregnancy Studies included in this review met predetermined criteria toinclude the most rigorously designed reports but fell short of the gold stan-dard of randomized controlled trials Of the 28 studies that reviewed com-prehensive sex education, 9 found that the programs delayed initiation ofintercourse, 18 found no impact, and 1 found an earlier age at initiation

of intercourse Results were similar for frequency of intercourse and number

of sex partners Dr Kirby concluded that the outcomes of comprehensivesex education programs are generally favorable

By contrast, studies of abstinence-only curricula have failed to show animpact on teen pregnancy or STI risk [12] In a meta-analysis of ﬁve ran-domized controlled trialsdfour evaluating abstinence-only programs andone evaluating comprehensive sex educationdabstinence-only programswere associated with a higher pregnancy rate in the partners of male partic-ipants of the programs [13] Overall, they have no eﬀect on changing teensexual behavior or contraceptive use either positively or negatively

In a report commissioned by Representative Henry Waxman nia), the Special Investigations Division of the House of Representatives ob-tained program summaries of abstinence-only curricula from organizationsthat received abstinence-only funding[14] The division reviewed 13 curric-ula and found that 80% contained inaccurate scientiﬁc and medical infor-mation and distorted information about reproductive health The reportconcluded that these curricula often promote religion, reinforce traditionalgender stereotypes, and focus on particular ideologies rather than on thetransfer of accurate information about sexuality and pregnancy prevention

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(D-Califor-The large amount of school funding for abstinence-only-until-marriageeducation implies that the goal of avoiding premarital sex is an achievableone A recent publication analyzing data from the National Survey of Fam-ily Growth conﬁrmed the near universality of premarital sex in the UnitedStates [11] Finer [11] reported that 75% of respondents had premaritalsex by age 20 and that 95% had had sex by age 44, regardless of whetherthey were married He concluded that because most Americans have sex be-fore marriage, we should provide education and interventions that provideskills and information necessary to prevent unintended pregnancy and STIsregardless of marital status By contrast, Sweden and the Netherlands, bothwith much lower rates of unintended pregnancy and abortion, are knownfor early and accurate sex education coupled with easy access to contracep-tives[15].

The future of sex education

The Responsible Education About Life (REAL) Act, introduced in gress by Representative Barbara Lee (D-California) and Senator FrankLautenberg (D-New Jersey), would provide federal money to support com-prehensive sex education in schools This education would include science-based, medically accurate, and age-appropriate public health informationabout abstinence and contraception In the recently convened 110th Con-gress, Senate Majority Leader Harry Reid (D-Nevada) introduced the Pre-vention First Act, which would increase access to and education aboutcontraception, support teen pregnancy prevention programs, and ensuremedical accuracy in sex education

Con-Because much of the content of sex education is determined at the locallevel, providers should be aware of their community’s sex education to un-derstand potential gaps in teens’ knowledge, inform adolescents and parents

of the importance of comprehensive sex education, and advocate for its clusion in local schools

in-Societal attitudes about sex and early childbearing

Inﬂuence of media on sexual behavior

A major chasm lies between the abstinence-only messages conveyed in theformal school-based education of teenagers and the implicit societal mes-sages about sexuality and sexual conduct embedded in media In a commen-tary on adolescent sexuality and the media, Strasburger[16]pointed out that

‘‘American media have arguably become the leading sex educator in theUnited States.’’ Children and teenagers spend an average of 6.5 hours perday with diﬀerent media, including approximately 4 hours per day watchingtelevision and videos/DVDs[17] Most media are packed full of sexual ref-erences and innuendo The number of sexual scenes on television has

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increased signiﬁcantly In 1998, 56% of all shows contained sexual content,with an average of 3.2 scenes per hour By 2005, the percentage of shows in-cluding sexual content increased to 70%, with an average of 5 scenes perhour[18] Of the top 20 teen television shows, more than 70% contain sex-ual content (Fig 2).

This content conveys a diﬀerent meaning from the marriage message of school education programs Common media messagesabout sex are that ‘‘everyone is having sex,’’ sex ‘‘just happens,’’ being

abstinence-only-until-‘‘swept away’’ is the natural way to have sex, and adults do not plan forsex and do not use contraception [16] Teen shows also typically containthe most sexual content (Fig 3) Only 14% of shows with sexual contenttouch on the real-life risks and consequences of sex Despite the enormoussexual content of television programs, the networks have highly restrictivepolicies about advertising for birth control Two major networks refuse con-dom ads, and three more accept such ads only after 9 or 11PM Birth controlpill ads are refused by some networks and aired on others but most oftenwith an emphasis on noncontraceptive beneﬁts, such as reduction of acne

or ease of use

Societal norms and teen pregnancy

The level of adolescent pregnancy varies by a factor of almost 10 acrossdeveloped countries; the United States has one of the highest rates[15] In

a study that examines trends over time, teenage childbearing has decreasedacross all countries over the past 25 years The decline of 20% in teenagefertility in the United States from 1970 to 1995 was among the smallest

Fig 2 Percent of shows with sexual content, over time (From Sex on TV 4, A Kaiser Family Foundation Report–Executive Summary (#7399), The Henry J Kaiser Family Foundation, November 2005 This information was reprinted with permission from the Henry J Kaiser Family Foundation The Kaiser Family Foundation, based in Menlo Park, CA, is a nonproﬁt, private operating foundation focusing on the major health care issues facing the nation and is not associated with Kaiser Permanente or Kaiser Industries.)

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declines of all countries studied, whereas the decline in abortion was amongthe largest (33%) Teenagers in the United States remain more likely thanteens in other countries to become pregnant and continue their pregnancies.Despite this high teen birth rate, US teens still have more abortions thanteens in other developed countries because of the high rate of unplannedpregnancy in US adolescents[15] The decline in US teen unintended preg-nancy over the last two decades is largely attributable to improvements incontraceptive use and an increase in sexual abstinence The percentage ofteens using condoms has increased, whereas the percentage of teens usingwithdrawal and no method has declined [19] The percentage using hor-monal contraceptiondgenerally, methods with higher eﬀectivenessdhas re-mained stable and relatively low compared with other countries.

Antecedents of teen pregnancy in the United States

Cultural diﬀerences between countries may account for the increasedbirth rates and abortion rates among US teens Surveys reveal that US teensare more likely to desire motherhood than teens in other countries[20] De-spite similar levels of sexual activity among teens across countries, US teensare more likely to have an earlier age at onset of intercourse (!15 years) andare more likely to have shorter and more sporadic sexual relationships Pov-erty and social disadvantage increase the risk of early childbearing and

Fig 3 Among shows in 2005 with sexual content, the number of sex-related scenes per hour (From Sex on TV 4, A Kaiser Family Foundation Report–Executive Summary (#7399), The Henry J Kaiser Family Foundation, November 2005 This information was reprinted with permission from the Henry J Kaiser Family Foundation The Kaiser Family Foundation, based in Menlo Park, CA, is a nonproﬁt, private operating foundation focusing on the major health care issues facing the nation and is not associated with Kaiser Permanente or Kaiser Industries.)

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unplanned pregnancy, but teens across the socioeconomic spectrum in theUnited States are more likely to experience unplanned pregnancy than theircounterparts in other countries.

Investigators have speculated that one factor explaining decreased teenchildbearing in other countries is the strong social support for the concept

of reserving parenting for adulthood Similarly, the acceptance of sexual tivity in young people and the pragmatic approach of making sex educationand contraceptives readily available are features of European countries thathave low unplanned pregnancy and abortion rates[20] In the United States,well-intentioned social supports are designed to assist young mothers Spe-cial schools allow young mothers to return to school, and ﬁnancial aidassists with health care and food purchases These supports may parad-oxically serve an enabling role and send a message that teen pregnancy isacceptable

ac-Strategies to reduce teen pregnancy

Solutions to the problem of teen pregnancy and social supports for it arecomplicated As outlined in the national campaign to prevent teen preg-nancy, ‘‘Emerging Answers,’’ research supports advocacy for evidence-based pregnancy prevention programs [21], including programs that focus

on sexual antecedents of pregnancy, emphasizing abstinence and use of traceptives and service learning programs that do not focus on sexual activ-ity at all

con-Service learning programsda form of youth developmentdultimatelymay have the best results in reducing teen pregnancy An example of such

a project, the Teen Outreach Program, consists of three components: vised community service, classroom discussion of service experiences, andactivities related to the social and developmental tasks of adolescence Out-comes data suggest a reduced teen pregnancy rate, a reduced risk of schoolsuspension, and a reduced risk of course failure[22]

super-Insurance barriers

Financial barriers to contraceptive access

Lack of adequate insurance is a barrier to contraceptive use mately 46 million Americans have no insurance and millions more are un-derinsured [23] Women who live in poverty rely on a patchwork quilt ofunderfunded family planning programs for their reproductive health care

Approxi-It is estimated that one in ﬁve reproductive-aged women was uninsured in

2003, an increase of 10% over the previous 2 years[24] Similarly, a 6% crease in the number of women who depend on publicly funded family plan-ning services occurred from 2000 to 2004, which brought total numbers toapproximately 17 million It is estimated that half of all reproductive-agedwomen who are sexually active rely on publicly funded family planning

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in-services [25] Public fundingdstate and federaldfor family planning vices falls mostly to two programs: Medicaid and Title X of the Public Ser-vice Act Despite the rapidly growing population segment that requiresassistance to access family planning, funding for family planning has beenreduced or remained ﬂat in 27 states [24] Even more worrisome is thefact that for the ﬁrst time in more than 30 years, changes to Medicaidlaws passed in February 2006 allow states to eliminate family planningfrom their Medicaid coverage for some recipients[26].

ser-Even individuals with insurance may not have coverage for tives; many do not cover the range of US Food and Drug Administration(FDA)–approved contraceptives Non-use of contraceptives has a dispropor-tionate impact on unintended pregnancy in the United States: the 7% of re-productive-aged women who do not use any contraceptive method areresponsible for 46% of the unintended pregnancies[27] Despite the currentepidemic of unintended pregnancy, debate continues about the appropriate-ness of insurance coverage of contraceptives

contracep-Federal and state contraceptive equity initiatives

A proposed federal bill, the Equity in Prescription Insurance and ceptive Coverage Act, would have required all insurance plans that oﬀerprescription drug coverage to cover contraceptives equally, but it hasmade little progress toward enactment Federal law, however, does requirecontraceptive coverage for federal employees and their dependents Healthplans that participate in the Federal Employees Health Beneﬁts Programare required by law to provide coverage of all prescription contraceptivesapproved by the US FDA at the same level as coverage for all other pre-scription drugs[28] The federal Healthy People 2010 goals include ‘‘increas-ing the proportion of health insurance policies that cover contraceptivesupplies and services’’[29]

Contra-Twenty-six states have enacted laws that require insurers that cover scription drugs to provide coverage for the full range of US FDA-approvedcontraceptives [30] Eighteen of these states, however, allow certain em-ployers and insurers to refuse to comply with the mandate on religious ormoral grounds Interpreting the rules for conscience clause exemptions iscomplex, and complicated state-based laws may be diﬃcult for individuals

pre-to navigate Although 13 states require employees pre-to be notiﬁed when theirhealth plan does not cover contraceptives and 26 states have contraceptivecoverage laws, these laws apply only to employers who purchase insurancefrom a commercial insurance carrier for their employees Approximatelyhalf of all workers are covered under employer-sponsored self-insuranceplans These self-insured plans, in which an employer provides medical cov-erage but does not purchase it from an outside commercial insurance com-pany, are typically not subject to state contraceptive coverage laws orinsurance regulations

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It seems that contraceptive equity laws have speciﬁcally been responsiblefor a major increase in better access to contraceptives from 1993 to 2002

[31] Compared to the scant coverage and narrow range of choices covered

in 1993, most insurers surveyed in 2002 covered a wide range of tive choices In 1993, only 28% of surveyed insurers covered the ﬁve leadingcontraceptive methods (ie, oral contraceptives, 1- and 3-month injectables,intrauterine device, and diaphragm) compared with 86% in 2002

contracep-Several factors led to improved contraceptive coverage In 2000, in a case

in which two employees sued their employers because of lack of coverage oforal contraceptives and Depo-Provera, the US Equal Employment Oppor-tunity Commission ruled that exclusion of contraceptives from prescriptiondrug coverage constituted sex discrimination under Title VII of the CivilRights Act as amended by the Pregnancy Discrimination Act [32] In

2001, in a highly publicized case, a district court ruled that excluding traceptives from a prescription drug plan was illegal[33] Media attentionhas focused increasingly on contraceptive coverage and other matters re-lated to contraception, such as the US FDA decision on over-the-counterPlan B

con-Contraceptive mandates were probably the most important factor in creasing coverage Most states that currently have contraceptive equity lawsadopted the legislation between 1993 and 2002 An analysis that comparedcoverage of contraceptives by insurers with locally determined policies instates with and without mandates showed that plans in nonmandate stateswere signiﬁcantly less likely to oﬀer the full range of contraceptives (56%)than plans in states with a mandate (90%) [31] A federal mandate such

in-as Equity in Prescription Insurance and Contraceptive Coverage Act would

be even more helpful, expanding coverage requirements not only tothe women who currently live in states without mandates but also requiringcoverage for the women who are currently covered by employers with self-insured plans

Out-of-pocket costs for contraceptives

Coverage of contraceptives by insurance companies is an important butnot suﬃcient condition to improve access to and eﬀectiveness of contra-ceptives Current coverage policies may be a major factor in noncompli-ance: high out-of-pocket costs in the form of copays and deductiblesand insurance plans with limited dispensing regulations are barriers to bet-ter usage A study using an Agency for Healthcare Research and Qualitydatabase (the Medical Expenditure Panel Survey) examined two importantfactors related to ability to comply with oral contraceptive regimens: out-of-pocket costs for the pills and number of packs obtained with eachpharmacy purchase [34] In this sample of approximately 500 users, theaverage out-of-pocket cost per pill pack was $14 The survey took place

at a time when the average retail price for lower priced oral contraceptive

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pills was approximately $15 Privately insured women without drug age and uninsured women paid the most for oral contraceptives Forty-sixpercent of women paid $15 or more per pill pack Overall, women paid

cover-a substcover-anticover-al cover-amount of the costs of orcover-al contrcover-aceptives Even womenwith private insurance paid approximately 60% of the total cost of thepill, compared with typical out-of-pocket costs for noncontraceptive drugs

a time, insurance regulations often limit the number obtained at the macy to a single pack Individuals who paid more for pills (O$15) weremore likely to obtain only one pack per visit This study emphasized thatcontraceptive equity laws are only partially eﬀective in improving access

phar-to contraceptives A recent publication conﬁrms that dispensing a year’ssupply of oral contraceptives is not only more cost eﬀective but also im-proves continuation of the method compared with dispensing 3 months at

a time[35]

Ample evidence documents the cost savings of contraceptive use in theprivate and public sectors[36,37] An analysis examining teenage contracep-tive use conﬁrms the reduction in costs from the use of various contraceptivemethods [38] Ironically, public and private insurance almost universallycovers the medical costs of continuing an unintended pregnancy, coststhat are substantially higher than the cost of a contraceptive insurancebeneﬁt

Strategies to reduce insurance barriers

One program that has shown beneﬁt is the Medicaid waiver program.This program allows states to develop and implement plans that extendMedicaid family planning coverage to certain groups of individuals aslong as the program is budget neutral or results in an overall cost savings

As of January 2007, 25 states had used the waiver program to extend familyplanning services to persons who otherwise would not be eligible Moststates provide services to individuals based on income requirements, typi-cally set at or near 200% of poverty level Other states have extended cov-erage to other groups, such as all postpartum women, women who lost theirMedicaid coverage for any reason, and even men[39] A study of waiverprograms in 2004 found that they increase the number of family planningproviders, increase family planning accessibility, decrease unintended preg-nancy rates, and provide overall cost savings[40]

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A systems level barrier to reducing unintended pregnancy is the negativeimpact on reproductive health services that occurs when nonsectarian hos-pitals merge with religious, particularly Catholic, hospitals More than 100such mergers occurred in the 1990s as hospitals sought to reduce costs andcompete for managed care contracts [41] Religious health care facilities,particularly Roman Catholic institutions, play a major role in the delivery

of health care in the United States The 615 Catholic hospitals represent12.5% of community hospitals in the United States and more than 15.5%

of all US hospital admissions[42] The threat to reproductive health servicesfrom Catholic mergers has been considered the most concerning because ofthe explicit requirements embodied in the Ethical and Religious Directivesfor Catholic Health Care Services [43] These directives explicitly opposeabortion, family planning, sterilization of men and women, emergency con-traception, and HIV counseling that includes information about condomuse

Countering these directives are various state and federal laws that quire the provision of some of these services Federal Medicaid, for exam-ple, requires that enrollees have access to family planning services Somestates have required private insurers to cover the cost of contraceptives,and some states have passed laws requiring the provision of emergencycontraception available to rape victims Making the equation even morecomplicated are state and federal conscience clause statutes that have ex-panded since 1997 These statutes cover various entitiesdfrom religious in-stitutions and payers to individual health care professionalsdprotectingpersons who object to providing reproductive health services, includingcontraception

re-The fact remains that mergers between nonsectarian and Catholic tals may result in the elimination or severe restriction of reproductive healthservices In a survey of 57 hospital mergers conducted by Catholics for

hospi-a Free Choice in 1995, 10 mergers resulted in exclusion of hospi-all reproductivehealth services, 6 preserved services in a free-standing clinic, 12 preserved ac-cess to all services except abortion, and 19 declined to complete the survey

[43] In contrast, of the 12 mergers that occurred in 2001, none resulted inthe complete discontinuation of reproductive health services The preserva-tion of services occurred in large part because of pressure from local and na-tional groups with an increased awareness of the potential negative impact

of mergers [44]

Activism to limit the impact of hospital mergers on reproductivehealth care services can be a successful strategy[45] Activists use variousmethods including media campaigns and education (Fig 4) Communityinvolvement and physician resistance to mergers have successfullyblocked transactions or promoted a compromise solution that preservesservices

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Anticontraception politics

A major barrier to eﬀective family planning in the United States derivesfrom political and ideologic opposition to contraception A New York Timesarticle brought attention to a view of contraception that could prove a majorthreat to improved access and use[46] The position held by a small but vo-cal minority is that contraception promotes several societal problems, such

as promiscuity, an anti-child attitude, and the undermining of male-femalerelationships

Until recently, most experts agreed that improved contraceptive use was

a major part of the solution to the high rate of unintended pregnancy andabortion in the United States A more radical view, articulated by the pres-ident of the Pro-Life Action League, Joseph Scheidler, is that ‘‘contracep-tion is more the root cause of abortion than anything else’’ [47] Theyhold that ‘‘contraception ushered in widespread promiscuity, divorce, sexu-ally transmitted diseases, single parent households and abortion.’’ Thisfringe view, increasingly articulated by religious social conservatives, has re-framed the debate around abortion With scientiﬁc misinformation aboutthe ‘‘abortifacient’’ action of many common contraceptives, the right wingopposition to abortion is evolving to include a strong opposition to contra-ception Conservatives who hold this view are open about the underlyingprinciple on which their opposition to contraception is based: the immoral-ity of any sexual activity that occurs outside of marriage and is not intendedfor procreation

Fortunately, access to contraception is protected by rulings of the USSupreme Court The case that decriminalized contraception was Griswold

v Connecticut(381 U.S 479 (1965), in which a law prohibiting use of anydrug or article for prevention of pregnancy was found unconstitutionalbased on a right to marital privacy [48] The reasoning and language of

Fig 4 A billboard commissioned by Save Our Services (Rhinebeck, NY), Preserve Medical Secularity (Cottekill, NY), and MergerWatch (New York, NY) (Courtesy of the MergerWatch Project, New York, NY, with permission.)

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Griswold was cited in support of the Court’s decision in Roe v Wade, 410U.S 113 (1973), which extended the ‘‘right of privacy’’ to cover abortion.

A restrictive atmosphere currently permeates most policy-making andregulatory bodies The US FDA has issued black box warnings for Depo-Provera and Ortho-Evra, both of which have had a chilling impact on theacceptability of these methods to patients and providers Many family plan-ning experts believe these warnings were not based on high-quality evidence.Similarly, the prolonged delay in approval of Plan B for ‘‘behind (not over)the counter’’ status despite overwhelming supporting scientiﬁc evidencesmacked of conservative political inﬂuence The appointments of ‘‘non-ex-pert’’ and ideologically conservative individuals for posts critically impor-tant to reproductive health are particularly concerning

It is impossible to underestimate the impact of politics on reproductivehealth Because politicians have a major say in the prioritization of publichealth goals, individuals who are unfriendly to the expansion of access tocontraception may cripple progress by cutting funding (eg, Title X), refusing

to appropriate funding (eg, comprehensive sex education), and withholdingsupport of helpful legislation

In June 2006, a letter from the US Department of Health and Human vices on behalf of the President was sent to the members of Congress conveyingthe administration’s support for ‘‘the availability of safe and eﬀective productsand services to assist responsible adults in making decisions about preventing

Ser-or delaying conception’’ [49] Such a paternalistic attitudedmaking raception available only to ‘‘responsible adults’’dfrom the most powerfulpolicy makers in our country undermines the stated goal of reducing the abor-tion rate

cont-Summary

The twin problems of unintended pregnancy and a high abortion rate can

be addressed successfully with a systems approach that focuses on nities and barriers Clearly, the ability to make real progress depends onmaking family planning services available to all Availability is ineﬀectivewithout education, however, and education alone is insuﬃcient without pol-icy change

opportu-Of the 98 state laws enacted in 2005, 22 were designed to expand access tocontraception[50] Continued grass roots efforts at the local level can shiftthe dynamic toward more balanced education approaches by tempering theAmerican ambivalence toward sex exemplified in the Butch Hancock quotewith American pragmatism Answering the question ‘‘What works?’’ withthe evidence of efficacy and outcomes offers a promising approach Compre-hensive sex education coupled with ready availability of contraception hasworked in other developed nations to reduce unintended pregnancy andabortion It is time to apply this proven public health strategy here

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[1] Darroch JE, Singh S, Frost JJ Diﬀerences in teenage pregnancy rates among ﬁve developed countries: the roles of sexual activity and contraceptive use Fam Plann Perspect 2001;33(6): 244–50, 281.

[2] Ventura SJ, Mosher WD, Curtin SC, et al Highlights of trends in pregnancies and pregnancy rates by outcome: estimates for the United States, 1976–1996 Natl Vital Stat Rep 1999;47: 1–9.

[3] Finer LB, Henshaw SK Disparities in rates of unintended pregnancy in the United States,

1994 and 2001 Perspect Sex Reprod Health 2006;38(2):91–6.

[4] Finer LB, Henshaw SK Abortion incidence and services in the United States in 2000 spect Sex Reprod Health 2003;35(1):6–15.

Per-[5] SIECUS A brief explanation of federal abstinence-only-until-marriage funding Available at: www.siecus.org/policy/states/2005/explanation Accessed January 14, 2007.

[6] Gold R, Nash E State level policies on sexuality, STD education Guttmacher Rep Public Policy 2001 Available at: http://www.guttmacher.org/pubs/tgr/04/4/gr040404.html [7] SIECUS Public support for sexuality education Available at: www.siecus.org/school/ sex_ed/sex_ed0002 Accessed January 14, 2007.

[8] Duberstein LL, Santelli JS, Singh S Changes in formal sex education: 1995–2002 Perspect Sex Reprod Health 2006;38(4):182–9.

[9] American Academy of Pediatrics Committee on psychosocial aspects of child and family health and committee on adolescence, sexuality education for children and adolescents Pediatrics 2001;108(2):498–502.

[10] American College of Obstetricians and Gynecologists Committee on adolescent healthcare strategies for adolescent pregnancy prevention ACOG statement Available at: http:// www.acog.org/departments/dept_notice.cfm?recno¼7&bulletin¼3271 Accessed Novem- ber 1, 2006.

[11] Finer LB Trends in premarital sex in the United States, 1954–2003 Public Health Rep 2007; 122:73–8.

[12] Kirby D Eﬀective approaches to reducing adolescent unprotected sex, pregnancy, and birth J Sex Res 2002;39(1):51–8.

child-[13] DiCenso A, Guyatt G, Willan A, et al Interventions to reduce unintended pregnancies among adolescents: systematic review of randomized controlled trials BMJ 2002;324: 1426.

[14] The content of federally funded abstinence-only education programs, prepared for Rep Henry A Waxman, 2004 Available at: www.democrats.reform.house.gov Accessed August

[20] Darroch JE, Frost J, Singh S, et-al Teenage sexual and reproductive behavior in developed countries: can more progress be made? Guttmacher occasional report #3 2001 Available at: http://www.guttmacher.org/pubs/eurosynth_rpt.pdf Accessed October 10, 2006 [21] Kirby D The national campaign to prevent teen pregnancy: emerging answers Research ﬁndings on programs to reduce teen pregnancy 2001 Available at: https://www.teenpreg nancy.org/product/pdf/emergingSumm.pdf Accessed November 1, 2006.

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[22] Alford S Science and success: sex education and other programs that work to prevent teen pregnancy, HIV and sexually transmitted diseases Advocates for youth, 2003 Available at: http://www.advocatesforyouth.org/PUBLICATIONS/ScienceSuccess.pdf Accessed De- cember 20, 2006.

[23] US Census Press Releases, 2006 Income climbs, poverty stabilizes, uninsured rate increases Available at: http://www.census.gov/Press-Release/www/releases/archives/income_wealth/ 007419.html Accessed November 3, 2006.

[24] Guttmacher Institute, News Release 2005 Gap widening between U.S women’s birth trol needs and government response Available at: http://www.guttmacher.org/media/nr/ 2005/02/22/index.html Accessed January 14, 2007.

[25] Guttmacher Policy Review, 2006 One million new women in need of publicly funded traception Available at: http://guttmacher.org/pubs/gpr/09/3/gpr090320.html Accessed November 3, 2006.

con-[26] Guttmacher Policy Review, 2006 New federal authority to impose Medicaid family ning cuts: a deal states should refuse Available at: http://guttmacher.org/pubs/gpr/09/2/ gpr090202.html Accessed November 3, 2006.

[27] Mosher WD, Martinez GM, Chandra A, et al Use of contraception and use of family ning services in the United States: 1982–2002 Adv Data 2004;350:1–35.

plan-[28] Cohen S Federal law urged as culmination of contraception insurance campaign Guttmacher Rep Public Policy 2001;4(5) Available at: http://www.guttmacher.org/pubs/tgr/04/5/gr040510.html [29] Healthy People 2010 Goals Available at: http://www.healthypeople.gov/document/ HTML/tracking/OD09.htm Accessed October 8, 2006.

[30] Guttmacher Institute State policies in brief: insurance coverage of contraceptives as of January 2007 Available at: http://www.guttmacher.org/statecenter/spibs/spib_ICC.pdf Accessed January 14, 2007.

[31] Sonﬁeld A, Benson R, Gold J, et al U.S insurance coverage of contraceptives and the impact

of contraceptive coverage mandates, 2002 Perspect Sex Reprod Health 2004;36(2):72–9 [32] US Equal Opportunity Commission Decision Available at: www.eeoc.gov/policy/docs/de cision-contraception.html Accessed January 14, 2007.

[33] Western District of Washington US District Court Jennifer Erickson v Bartell Drug pany, C.00–1213L., June 21, 2001.

Com-[34] Phillips KA, Stotland NE, Liang SY, et al Out-of-pocket expenditures for oral tives and number of packs per purchase J Am Med Womens Assoc 2004;59:36–42 [35] Foster DG, Parvataneni R, Thiel de Bocanegra H, et al Number of oral contraceptive pill packages dispensed, method continuation, and costs Obstet Gynecol 2006;108(5):1107–14 [36] Trussell J, Leveque J, Koenig J, et al The economic value of contraception: a comparison of

contracep-15 methods Am J Public Health 1995;85:494–503.

[37] Koenig J, Strauss M, Henneberry J, et al The social costs of inadequate contraception Int

J Technol Assess Health Care 1996;12:487–97.

[38] Trussell J, Koenig J, Stewart F, et al Medical care cost savings from adolescent tive use Fam Plann Perspect 1997;29(6):248–55.

contracep-[39] Guttmacher Institute State policies in brief as of January 2007: State Medicaid family planning eligibility expansions Available at: www.guttmacher.org/statecenter/spibs/ spib_SMFPE.pdf Accessed January 14, 2007.

[40] Gold R Doing more for less: study says state Medicaid family planning expansions are cost-eﬀective Guttmacher Rep Public Policy 2004;7:1 Available at: http://www guttmacher.org/pubs/journals/gr070101.html

[41] Donovan P Hospital mergers and reproductive health care Fam Plann Perspect 1996;28(6): 281–4.

[42] The Catholic Health Association of the United States Catholic health care in the United States 2005 Available at: www.chausa.org Accessed October 18, 2006.

[43] White KA Crisis of conscience: reconciling religious health care providers’ beliefs and patients’ rights Stanford Law Rev 1999;51(6):1703–49.

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[44] Catholics for a Free Choice Merger trends 2001: reproductive health care in Catholic tings Available at: www.catholicsforchoice.org/topics/healthcare/documents/2001merger trends.pdf Accessed January 14, 2007.

set-[45] National Women’s Law Center Health care provider mergers and the threat to women’s reproductive health services 2003 Available at: http://www.nwlc.org/pdf/ AntitrustUpdateApril2003.pdf Accessed October 18, 2006.

[46] Shorto R Contra-contraception New York Times May 7, 2006 p 48–55, 68, 83 [47] Graham J Abortion foes’ new rallying point, Christian conservatives unite to take on next target: contraception Chicago Tribune September 24, 2006.

[48] Wikipedia Griswold v Connecticut Available at: http://en.wikipedia.org/wiki/Griswold_v._ Connecticut Accessed January 14, 2007.

[49] Oﬃce of Congresswoman Carolyn Maloney Finally, an answer on birth control: tration breaks its silence, aﬃrms president’s support for birth control Press release June

adminis-22, 2006.

[50] Guttmacher Institute States focused on reproductive health in 2005: press release January

12, 2006 Available at: http://www.guttmacher.org/media/inthenews/2006/01/12/index html Accessed January 1, 2007.

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Medical Barriers to Eﬀective

Contraception Lawrence Leeman, MD, MPHDepartment of Obstetrics and Gynecology, and Department of Family and Community Medicine, University of New Mexico, 2400 Tucker NE, Albuquerque, NM 87131, USA

It would be a service to mankind if the pill were available in slot machinesand the cigarette were placed on prescription

dMalcolm Potts, MDFires and unintended pregnancies are important causes of morbidity,mortality, and financial loss in the United States Home fire extinguishersand emergency contraception are both effective preventive interventions.The disparity between access to fire extinguishers and emergency contra-ception is irrational and indirectly hurts women’s health

dDavid A Grimes[1]Medical barriers to the eﬀective use of contraception are a major cause ofunwanted pregnancy In 2001, 49% of pregnancies in the United States wereunintended [1a] and about half of the unintended pregnancies occurredamong the 11% of sexually active women who were not using contraception

[2,3] Medical barriers have been deﬁned by Shelton and colleagues[4] as

‘‘practices, derived at least partly from a medical rationale, that result in

a scientifically unjustifiable impediment to, or denial of, contraception.’’The barriers include delayed initiation based on a perceived need to havehad a recent menses, pelvic examination, or sexually transmitted infectionscreen before using contraception, inappropriate ‘‘contraindications,’’ limi-tations on the ability of medical providers to initiate contraceptive methods,provision of contraceptive misinformation to patients by medical providers,and regulatory or financial barriers limiting contraceptive dissemination tocertain populations such as adolescents or undocumented immigrants.Delayed initiation

The perceived need to delay initiation of contraception to ‘‘rule outpregnancy’’ can result in high rates of unwanted pregnancy when sexuallyE-mail address: lleeman@salud.unm.edu

34 (2007) 19–29

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active women wait for their next menses or a prolonged period of nence before initiating hormonal contraception These practice patterns of-ten stem from provider misconceptions regarding the potential forteratogenicity or adverse fetal eﬀects if hormonal contraception is initiatedduring the luteal phase of a cycle in which a woman has conceived Ameta-analysis has demonstrated that oral contraceptives are not terato-genic [5] Current World Health Organization (WHO) recommendationssupport starting oral contraceptives, hormonal patch, vaginal ring, or in-jectable medroxyprogesterone within the ﬁrst 5 days after each menseswithout need for additional contraceptive backup (eg, condoms) duringthat cycle [6] WHO supports starting these hormonal methods later inthe cycle if the clinician is ‘‘reasonably certain’’ (Box 1) that a woman isnot pregnant, with a recommendation to abstain from intercourse or use

absti-a contrabsti-aceptive babsti-ackup for 7 dabsti-ays [6] If these criteria are not met thewoman is not eligible for hormonal initiation until the next menstrual cy-cle per WHO recommendations

The Quick Start method of initiating oral contraceptives (OCs) is an ternative to the traditional approach of starting combined OCs on theSunday after a menses[7] The Quick Start approach was designed to ad-dress two problems: conception occurring during the delay in initiation re-quired by the conventional approach and the realization that many womennever initiated their prescribed contraceptives [8] In the Quick Startmethod women may start OCs any time during their cycle as long asthey have a negative urine pregnancy test The initial pill is taken in theclinic and the woman is instructed in use of a backup contraceptive forthe ﬁrst 7 days In a randomized controlled trial, short-term follow-up

al-Box 1 WHO criteria for ‘‘reasonable certainty’’ a woman

Abstinence from intercourse since the last menses

Within the first 4 postpartum weeks

Menses, miscarriage, or abortion within the last 7 days

Using a reliable contraceptive method correctly

* WHO Department of Reproductive Health and Research Selected Practice Recommendations for Contraceptive Use 2nd ed Geneva (Switzerland): World Health Organization; 2004.

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rates of women continuing OCs were signiﬁcantly higher in the QuickStart group than in the conventional start group The Quick Start patientshad an OR of 2.8 for continuation of OCs to the second cycle pack com-pared with women assigned to traditional start[7] A similar study demon-strated better compliance at 3 months in adolescents using Quick Startinitiation [9].

Quick Start has also been studied for the contraceptive patch, vaginalring, and long-acing progesterone injections[10–12] These studies do notdemonstrate the same improved compliance Use of a urine pregnancytest 2 weeks after Quick Start will detect any pregnancies and allow for pro-vision of pregnancy options counseling early on Contrary to a common be-lief (and part of the rationale for the Sunday after menses start), there is noincrease in intermenstrual bleeding with Quick Start compared with tradi-tional start[13]

Many clinicians have traditionally linked the provision of contraceptionwith the pelvic exam, the Papanicolaou (Pap) smear, and/or sexually trans-mitted infection (STI) screening This bundling of services has lead to anunwillingness to start or continue contraception if a woman does not agree

to a pelvic examination or the recommended screening As there is no ciation between use of OCs and cervical cancer or infection, such restric-tions needlessly decrease contraceptive access, particularly in groups such

asso-as sexually active adolescents who may fear pelvic exams The WHO, national Planned Parenthood Federation, and the American College of Ob-stetricians and Gynecologists (ACOG) now support unbundling theseservices, advocating that pelvic exams are not a requirement for initiatinghormonal contraception [14] The current recommendations to delay theinitial Pap smear until 3 years after initiating sexual activity or age 21

Inter-[15], and the use of urine chlamydia/gonorrhea screening tests should mit many young women to defer pelvic exams and still receive the contra-ception they need

per-Delayed initiation can occur with intrauterine devices (IUDs) when cians perceive a need to provide contraceptive counseling, STI screening,and IUD insertion at separate visits These barriers are often formalized

clini-in well-clini-intentioned but misguided protocols creatclini-ing unnecessary obstaclesfor patients For example, protocols may require that a patient is on hermenses The eﬀort to time insertion during or soon after menses is because

of the non–evidence based perception that insertion is easier at that time and

to prevent insertion after conception has occurred Another protocol rier, addressing the latter concern, is the requirement for two negative preg-nancy tests 2 weeks apart

bar-A well-informed patient can have the IUD inserted at the same visit ing which she receives information and receives STI and Pap smear screen-ing if indicated IUDs can be inserted at any time during the menstrual cycleand provide highly eﬀective emergency contraception if inserted within

dur-5 days of unprotected intercourse The copper IUD may be inserted

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immediately after the completion of an induced abortion[16]or postpartumwithin 10 minutes of the delivery of the placenta[17,18] Postpartum inser-tion is associated with a higher expulsion rate; however, the distributors ofthe IUDs in use in the United States will replace expelled IUDs if the pro-vider completes a product replacement form Immediate postpartum inser-tion oﬀers the potential to avoid insertion barriers that may occur at the6-week postpartum visit[19].

Inadequate contraceptive counseling

Higher rates of contraceptive continuation are associated with excellentcontraceptive care and counseling [20], the availability of the patient’smethod of choice[21], and access to follow-up care to discuss ongoing con-cerns Fifty-four percent of women obtaining an abortion had used a contra-ceptive method in the month during which they conceived, but had used themethod incorrectly or irregularly or were using a relatively ineﬀectivemethod [3] Women who choose long-acting methods including the IUD,Depo medroxyprogesterone acetate (DMPA) injection, or the patch can re-duce their risk of pregnancy as these methods are more eﬀective and easier

to adhere to than oral contraceptives Many of these methods are less wellknown than the pill Hence, women may present requesting OCs without in-formation about more eﬀective alternative methods Taking the time tocommunicate the full range of options to women may help them make a bet-ter choice, either then or in the future

OCs are the most popular reversible method of contraception in the UnitedStates, used by over 25% of women contraceptors[2]; however, many womenbecome pregnant as a result of discontinuation of OCs without initiation of analternative method A study examining method use in women 6 months afterinitiation of OCs revealed that 32% were no longer using them Forty-six per-cent stopped using OCs because of side eﬀects, 6% because they found thepills hard to use, and 5% because of concerns about hormones[22] Evenwomen who continue to use OCs are at high risk of unwanted pregnancy be-cause of the need to be adherent to a daily pill regimen In one study occurringover 5 weeks, 26% of women were found to miss pills[23]

A good relationship with a health care provider and the communication ofinformation about noncontraceptive beneﬁts has been associated with highermethod continuation rates[24] Women often need access to discuss side ef-fects after initiating OC use In one study of contraceptive continuation for

2 months after initiation, 22% of women called and 9% scheduled visits withtheir health care providers[24] Counseling regarding OCs should also ad-dress the benefits and misconceptions of their use Studies of highly educatedcollege students showed most were unaware of the majority of noncontracep-tive benefits Among the least known benefits were protection against ovar-ian cancer (77% unaware) and uterine cancer (81% unaware)[25]

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Inappropriate contraindications

An exaggerated concern about potential side eﬀects of contraceptivemethods has limited contraceptive choice for many women Physicianshave had concerns about use of combined OCs in women with diabetes;however, both WHO and ACOG permit the use of each of these methods

in diabetic women younger than 35 without end-organ damage [6,26].OCs may now be used in patients with systemic lupus erythematosus who

do not have antiphospholipid antibodies, vascular disease, or nephritis

[27] Hypertension is not an absolute contraindication to the use of oral traceptive as women under age 35 with well-controlled and monitored hy-pertension remain suitable candidates[27]

con-When the IUD was reintroduced in the United States in 1988, the indications listed by the manufacturer were broad and often without scien-tiﬁc evidence These restrictions included nulliparity and a remote history ofpelvic inﬂammatory disease, neither of which is currently listed as a contra-indication by the IUD manufacturer Use of an IUD is not associated withtubal infertility, and nulliparous women do not need to avoid IUD use topreserve their future fertility[28]

contra-Clinician limitations

A medical barrier to contraception may exist if restrictions are placed onwhich types of clinicians may prescribe or insert the contraceptive method.Several examples illustrate how certain contraceptives could be more avail-able if more clinicians were trained in their use IUDs may be safely inserted

by obstetricians/gynecologists (Ob/Gyns), family medicine physicians, andmidlevel providers[29]; however, family physicians and nurse-practitionersmay have less training and knowledge in IUD insertion than Ob/Gyns

[30] A 2002 survey of Ob/Gyns revealed that even among this cliniciangroup, 20% had not inserted an IUD in the past year[31] The dissemina-tion of a subdermal progestin contraceptive is occurring slowly in theUnited States because of restrictions placed on health care provider training

[32] Vasectomy can be easily learned by family physicians, who performabout 15% of vasectomies in the United States [33]; however, only 15%

of family physicians oﬀered the procedure in 1995[34]

Physicians may be unable to offer the full choice of contraceptivemethods because of inadequate family planning training in family medicine(FM) and Ob/Gyn residencies A 1999 study of all the FM and Ob/Gyn res-idents in Maryland revealed that 20% of Ob/Gyn residents had never in-serted an IUD, 16% had never inserted a contraceptive implant, and 20%had never fitted a diaphragm [35] The number of residents with limitedscope of contraceptive training was even higher for the FM residents Fiftypercent lacked training in IUD insertion and 30% had never fitted a dia-phragm or inserted contraceptive implants [35] The recent development

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of academic fellowships and rotations in family planning may increase traceptive training in Ob/Gyn and FM residency curricula Fifteen familyplanning fellowships have been established in Ob/Gyn departments, and

con-a bocon-arded subspecicon-alty in this con-arecon-a is on trcon-ack for development over thenext few years[36] The Center for Reproductive Health Education in Fam-ily Medicine was established in 2004 with the goal of integrating requiredfamily planning and abortion rotations in FM residencies in the UnitedStates by providing ﬁnancial support and technical expertise (www.rhedi.org)

Financial barriers to contraception

The unwillingness of many third-party payers to cover contraceptivemethods places a barrier that limits access to many women A study of tra-ditional indemnity plan insurance in 1999 demonstrated that 50% did notcover any reversible contraception and only 15% covered all ﬁve commonlyprescribed methods (IUD, pill, diaphragm, implant, and injection) [37].Women in health maintenance organizations (HMOs) fared better Only7% of HMOs did not cover any reversible contraceptives The litigious na-ture of medical care appears to have played a role in limiting expansion ofcoverage for contraceptive methods in the United States At various time pe-riods US women have lacked access to IUDs or subdermal progestin agentsdespite continued access throughout most of the developed world

Third party payers may limit the number of OC packs that can be pensed at each visit, most often requiring women to go to the pharmacy

dis-on a mdis-onthly basis for a reﬁll Women with child care and work respdis-onsi-bilities, lack of transportation, and limited economic means may ﬁnd this

responsi-a bresponsi-arrier to effective use of contrresponsi-aception Dispensing responsi-a yeresponsi-ar’s worth ofOCs at one visit results in higher method continuation, lower total cost,and appropriate STI screening[38] Ironically, financial barriers can also af-fect adolescent girls whose families have health insurance Girls may be re-luctant to use family insurance for contraceptive services because of loss ofconfidentiality but could be ineligible for contraception through Medicaid

in products (eg, diﬀerent risks between progestin-only pills and combinedOCs) or the gradual reduction of the estrogen dose in the 40 years since the in-troduction of the birth control pill An example of misleading information24

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occurs in the package labeling of OCs in which breastfeeding is listed as a traindication to the use of combined OCs No high-level evidence demon-strates a harmful impact of combined OCs on breastfeeding [39,40] AWHO trial demonstrated a decrease in pumped breast milk volume withoutsignificant effect on any infant growth parameters[41] ACOG’s 2006 practicebulletin states, ‘‘Use of combination hormonal contraception can be consid-ered once milk flow is well established.’’ Unfortunately, women who readthe package insert may be unwilling to initiate use of combined OCs A finalexample of labeling barriers to improved use of contraception is that no com-bined OCs contain package insert information describing their use for emer-gency contraception despite US Food and Drug Administration (FDA)approval of these drugs for such use in 1996.

con-Similar labeling issues have limited use of IUDs and injectable progesterone The copper IUD’s package insert included nulliparity, remotehistory of pelvic inﬂammatory disease, and immediate postpartum or post-abortion use as contraindications, despite a lack of evidence supportingthese as contraindications[42,43]

medroxy-The recent ‘‘black box’’ warning on injectable long-acting gesterone (DMPA) describes the potential for decreased bone mineral den-sity and recommends that DMPA only be used for more than 2 years ifother birth control methods are inadequate This warning was approved

medroxypro-by the FDA despite a lack of evidence that prolonged use of DMPA causes

an increase in fractures or has an eﬀect on postmenopausal bone health Themedical literature demonstrates that bone mineral density (BMD) returns tobaseline levels after cessation of DMPA [44] The black box warning, in-tended to communicate an imminent danger to health, has caused ambiva-lence among clinicians toward use of this method Experts in familyplanning [45] have called for the FDA to rescind the black box warningand both ACOG[27]and the WHO[46]support long-term use of DMPAfor contraception for women 18 to 45 years old Despite a lack of deﬁnitiveevidence for long-term safety in adolescents who have not reached theirmaximum BMD, ACOG and WHO also indicate that even in this popula-tion the advantages of DMPA likely outweigh the theoretical safety con-cerns[6,27,46]

The product labeling for contraceptive products can present a barrier inpart because of medical legal concerns The FDA created a bolded warningfor the contraceptive patch in 2005, which states that the total estrogen dose

is higher with the patch than with OCs, although the peak level is lower Thewarning adds that higher estrogen levels are usually associated with in-creased risk of blood clots although it acknowledges that it remains un-known whether risk is increased with the contraceptive patch Concernsthat a higher estrogen dose may increase the risk of venous thomboembo-lism (VTE) have led to a proliferation of media reports and lawsuits that ap-pear out of proportion to the potential increased absolute risk Only twostudies have examined the actual risk of VTE and the contraceptive patch

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compared with combined oral contraceptives The ﬁrst published study didnot demonstrate an increased risk (odds ratio 0.9, 95% conﬁdence interval[CI] 0.5–1.6)[47], whereas a second unpublished study demonstrated a 2.4-elevated odds ratio for clot (95% CI, 1.1–5.5)[47a] If this study is accuratethen the risk of thromboembolism increases from a 1 in 10,000 baseline to 3

to 4 per 10,000 with use of oral contraceptives[48]compared with an mated 7 to 10 per 10,000 with the contraceptive patch compared with an es-timated 1 to 2 per 1000 incidence in pregnancy [49] Unfortunately, theproduct labeling and media reports do not address absolute versus relativerisk Warnings about the potential increased relative risk of VTE should in-clude information that the absolute risk is low and that the risk likely re-mains less than the risk of VTE in pregnancy

esti-The need for a prescription limits access to OCs in the United States.Other nations including Mexico have developed programs to distributeoral contraceptives without requiring a prescription[50] The minimal risk

of modern low-dose pills has led to consideration of over-the-counter(OTC) status for OCs[51] Opponents of such use express concern about de-creased ability to screen women for contraindications such as uncontrolledhypertension, history of thromboembolic disease, or smoking in the over-

35 age group Diminished opportunity to oﬀer alternative contraceptivemethods such as IUDs, to screen and treat for STIs, and to screen for cervicaland breast cancer are additional arguments against OTC provision An eco-nomic argument against OTC provision lies in the logistics of insurance cov-erage Typically, insurers withdraw coverage of pharmaceuticals when theybecome OTC agents Pharmacy access for OCs (where pharmacists have au-thority to prescribe and dispense) provides a potential model in whichwomen are screened for current pregnancy, contraceptive contraindications,and hypertension[52] If the woman has no contraindications and has nor-mal blood pressure, the pharmacist prescribes and dispenses OCs In a recentsurvey of US women, 68% indicated that they would use pharmacy accessfor OCs, the contraceptive ring, and the contraceptive patch The majoritysupported pharmacist screening before contraceptive dispensing[53] Nota-bly, none of the medical concerns regarding possible OTC status for OCs ap-plied to the OTC provision of emergency contraception Yet the FDA hasonly recently approved emergency contraception for OTC use after a lengthypolitical process and it remains limited to women over age 18[54]

Lack of a reversible male contraceptive

The primary male methods for contraception are condoms and tomy Condom use has increased rapidly over the past 2 decades likely be-cause of the beneﬁt of prevention of STIs Unfortunately, the pregnancyrate with typical use is approximately 14% per year [55] Vasectomy ishighly eﬀective, less expensive than female sterilization, and requires lesser26

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vasec-anesthesia and surgical risk than tubal ligation Only 1% of men betweenages 25 and 49 have had a vasectomy [34] Unfortunately no reversibleand eﬀective hormonal contraceptive methods are yet available for men,nor are any on the near horizon Research continues with testosterone, pro-gestogen, and gonadotropin receptor antagonists as well as with nonhor-monal methods [56] Gossypol, a cotton plant derivative, is the moststudied agent Large randomized controlled trials from China demonstrategreater than 90% rates of azoospermia, unfortunately irreversible in 20% ofmen[57] Clinicians counseling women regarding their contraceptive choicesshould oﬀer referral of male partners for vasectomy by urologists or familymedicine physicians as a potential option.

Summary

Removal of medical barriers to contraception can decrease unwantedpregnancy and abortion rates as well as reduce the social problems resultingfrom women’s inability to achieve their family planning goals A number ofstrategies may reduce unintended pregnancy: improved family planning ed-ucation for physicians and midlevel clinicians, changes in individual clini-cian contraceptive provision and counseling, improved pharmaceuticalindustry labeling, removal of ﬁnancial restrictions of government and thirdparty payers, and improved access to male contraception

References

[1] Grimes DA Emergency contraception and ﬁre extinguishers: A prevention paradox Am J Obstet Gynecol 2002;187:1536–8.

[1a] Finer LB, Henshaw SK Disparities in rates of unintended pregnancy in the United States,

1994 and 2001 Perspect Sex Reprod Health 2006;38:90–6.

[2] Mosher WD, Martinez GM, Chandra A, et al Use of contraception and use of family ning services in the United States: 1982–2002 Adv Data 2004;1–36.

plan-[3] Jones RK, Darroch JE, Henshaw SK Contraceptive use among U.S women having tions in 2000–2001 Perspect Sex Reprod Health 2002;34:294–303.

abor-[4] Shelton JD, Angle MA, Jacobstein RA Medical barriers to access to family planning Lancet 1992;340:1334–5.

[5] Bracken MB Oral contraception and congenital malformations in oﬀspring: a review and meta-analysis of the prospective studies Obstet Gynecol 1990;76:552–7.

[6] WHO Department of Reproductive Health and Research Selected practice tions for contraceptive use 2nd edition Geneva (IL): World Health Organization; 2004 [7] Westhoﬀ C, Kerns J, Morroni C, et al Quick start: novel oral contraceptive initiation method Contraception 2002;66:141–5.

recommenda-[8] Oakley D, Sereika S, Bogue EL Oral contraceptive pill use after an initial visit to a family planning clinic Fam Plann Perspect 1991;23:150–4.

[9] Lara-Torre E, Schroeder B Adolescent compliance and side eﬀects with quick start initiation

of oral contraceptive pills Contraception 2002;66:81–5.

[10] Schafer JE, Osborne LM, Davis AR, et al Acceptability and satisfaction using quick start with the contraceptive vaginal ring versus an oral contraceptive Contraception 2006;73: 488–92.

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[11] Murthy AS, Creinin MD, Harwood B, et al Same-day initiation of the transdermal monal delivery system (contraceptive patch) versus traditional initiation methods Contra- ception 2005;72:333–6.

hor-[12] Sneed R, Westhoﬀ C, Morroni C, et al A prospective study of immediate initiation of depo medroxyprogesterone acetate contraceptive injection Contraception 2005;71:99–103 [13] Westhoﬀ C, Morroni C, Kerns J, et al Bleeding patterns after immediate vs conventional oral contraceptive initiation: a randomized, controlled trial Fertil Steril 2003;79:322–9 [14] Stewart FH, Harper CC, Ellertson CE, et al Clinical breast and pelvic examination requirements for hormonal contraception: current practice vs evidence JAMA 2001;285:2232–9 [15] ACOG practice bulletin Cervical Cytology screening Number 45, August 2003 Int J Gy- naecol Obstet 2003;83:237–47.

[16] Grimes D, Schulz K, Stanwood N Immediate postabortal insertion of intrauterine devices Cochrane Database Syst Rev 2004;Oct 18(4):CD001777.

[17] Grimes D, Schulz K, van Vliet H, et al Immediate post-partum insertion of intrauterine vices: a Cochrane review Hum Reprod 2002;17(3):549–54.

de-[18] O’Hanley K, Huber DH Postpartum IUDS: keys for success Contraception 1992;45: 351–61.

[19] Ogburn JA, Espey E, Stonehocker J Barriers to intrauterine device insertion in postpartum women Contraception 2005;72:426–9.

[20] RamaRao S, Lacuesta M, Costello M, et al The link between quality of care and tive use Int Fam Plann Perspect 2003;29:76–83.

contracep-[21] Pariani S, Heer DM, Van Arsdol MD Jr Does choice make a diﬀerence to contraceptive use? Evidence from east Java Stud Fam Plann 1991;22:384–90.

[22] Rosenberg MJ, Waugh MS Oral contraceptive discontinuation: a prospective evaluation of frequency and reasons Am J Obstet Gynecol 1998;179:577–82.

[23] Huber LR, Hogue CJ, Stein AD, et al Contraceptive use and discontinuation: findings from the contraceptive history, initiation, and choice study Am J Obstet Gynecol 2006;194:1290–5 [24] Rosenberg MJ, Waugh MS, Burnhill MS Compliance, counseling and satisfaction with oral contraceptives: a prospective evaluation Fam Plann Perspect 1998;30:89–92, 104 [25] Tessler SL, Peipert JF Perceptions of contraceptive effectiveness and health effects of oral contraception Womens Health Issues 1997;7:400–6.

[26] Steel JM, Duncan LJ Contraception for the insulin-dependent diabetic woman: the view from one clinic Diabetes Care 1980;3:557–60.

[27] ACOG practice bulletin No 73: Use of hormonal contraception in women with coexisting medical conditions Obstet Gynecol 2006;107:1453–72.

[28] Hubacher D, Lara-Ricalde R, Taylor DJ, et al Use of copper intrauterine devices and the risk of tubal infertility among nulligravid women N Engl J Med 2001;345:561–7 [29] Farr G, Rivera R, Amatya R Non-physician insertion of IUDs: clinical outcomes among TCu380A insertions in three developing-country clinics Adv Contracept 1998;14:45–57 [30] Espey E, Ogburn T, Espey D, et al IUD-related knowledge, attitudes and practices among Navajo Area Indian Health Service providers Perspect Sex Reprod Health 2003;35:169–73 [31] Stanwood NL, Garrett JM, Konrad TR Obstetrician-gynecologists and the intrauterine device: a survey of attitudes and practice Obstet Gynecol 2002;99:275–80.

[32] A new progestin implant (Implanon) for long-term contraception Med Lett Drugs Ther 2006;48:83–4.

[33] Marquette CM, Koonin LM, Antarsh L, et al Vasectomy in the United States, 1991 Am J Public Health 1995;85:644–9.

[34] Magnani RJ, Haws JM, Morgan GT, et al Vasectomy in the United States, 1991 and 1995.

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[37] Dailard C U.S policy can reduce cost barriers to contraception Issues brief New York: Alan Guttmacher Inst; 1999 p 1–4.

[38] Foster DG, Parvataneni R, de Bocanegra HT, et al Number of oral contraceptive pill ages dispensed, method continuation, and costs Obstet Gynecol 2006;108:1107–14 [39] Truitt ST, Fraser AB, Grimes DA, et al Combined hormonal versus nonhormonal versus progestin-only contraception in lactation Cochrane Database Syst Rev 2003;(2): CD003988.

pack-[40] Erwin PC To use or not use combined hormonal oral contraceptives during lactation Fam Plann Perspect 1994;26:26–30, 33.

[41] Eﬀects of hormonal contraceptives on breast milk composition and infant growth World Health Organization (WHO) Task Force on Oral Contraceptives Stud Fam Plann 1988; 19:361–9.

[42] Paladine HL, Blenning CE, Judkins DZ, et al What are contraindications to IUDs? J Fam Pract 2006;55:726–9.

[43] ACOG practice bulletin Clinical management guidelines for obstetrician-gynecologists Number 59, January 2005 Intrauterine device Obstet Gynecol 2005;105:223–32 [44] Scholes D, LaCroix AZ, Ichikawa LE, et al Injectable hormone contraception and bone density: results from a prospective study Epidemiology 2002;13:581–7.

[45] Kaunitz AM Depo-Provera’s black box: time to reconsider? Contraception 2005;72:165–7 [46] World Health Organization WHO statement on hormonal contraception and bone health Available at: http://www.who.int/reproductive-health/family_planning/bone_health html Accessed November 30, 2006.

[47] Jick SS, Kaye JA, Russmann S, et al Risk of nonfatal venous thromboembolism in women using a contraceptive transdermal patch and oral contraceptives containing norgestimate and 35 microg of ethinyl estradiol Contraception 2006;73:223–8.

[47a] Johnson & Johnson Pharmaceutical Research and Development, L.L.C Clinical Trial, Study Director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C Marketing study of the risk of venous thromboembolism (blood clots), myocardial infarc- tion (heart attacks), and stroke among women using ORTHO EVRA (Norelgestromin and Ethinyl Estradiol contraceptive patch) compared with women using oral contraceptives Available at: http://www.clinicaltrials.gov/ct/show/NCT00377988?order ¼1 Accessed March 2, 2007.

[48] Vandenbroucke JP, Rosing J, Bloemenkamp KW, et al Oral contraceptives and the risk of venous thrombosis N Engl J Med 2001;344:1527–35.

[49] Toglia MR, Nolan TE Venous thromboembolism during pregnancy: a current review of agnosis and mangement Obstet Gynecol Surv 1999;54:29–41.

di-[50] Zavala AS, Perez-Gonzales M, Miller P, et al Reproductive risks in a community-based tribution program of oral contraceptives, Matamoros, Mexico Stud Fam Plann 1987;18: 284–90.

dis-[51] Potts M, Denny C Safety implications of transferring the oral contraceptive from tion-only to over-the-counter status Drug Saf 1995;13:333–7.

prescrip-[52] Gardner J, Miller L Promoting the safety and use of hormonal contraceptives J Womens Health (Larchmt) 2005;14:53–60.

[53] Landau SC, Tapias MP, McGhee BT Birth control within reach: a national survey on women’s attitudes toward and interest in pharmacy access to hormonal contraception Con- traception 2006;74:463–70.

[54] Steinbrook R Waiting for plan B–the FDA and nonprescription use of emergency ception N Engl J Med 2004;350:2327–9.

contra-[55] Fu H, Darroch JE, Haas T, et al Contraceptive failure rates: new estimates from the 1995 National Survey of Family Growth Fam Plann Perspect 1999;31:56–63.

[56] Lopez LM, Grimes DA, Schulz KF Nonhormonal drugs for contraception in men: a atic review Obstet Gynecol Surv 2005;60:746–52.

system-[57] Anderson RA, Baird DT Male contraception Endocr Rev 2002;23:735–62.

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The Transdermal Patch and the Vaginal Ring: Two Novel Methods of Combined

Hormonal Contraception Yael Swica, MD, MPHColumbia University, Center for Family Medicine, 630 West 168th Street,

VC-12, New York City, New York 10032, USA

Half of all pregnancies in the United States are unplanned, and in proximately half of these unintended pregnancies, contraception was used

ap-at the time of intercourse (Raymond, 2004) The success of a contraceptivemethod has as much to do with user behaviors as with the inherent eﬃcacy

of the method Patient adherence to prescribed medications is notoriouslypoor, and contraception is no exception[1] As many as 50% of oral contra-ceptive users miss at least one pill per cycle Perfect-use failure rate for thepill is 0.3% With typical use, the failure rate is closer to 8%[2–4] Innova-tions to improve adherence could have a major impact in reducingunintended pregnancy

This article reviews two novel contraceptive methods that have recentlybecome available in the United States: the transdermal patch and the vagi-nal ring In general, newer methods of contraception are designed to makeadherence easier for patients The two contraceptive methods discussed inthis article may help patients achieve this goal

Weekly reversible hormonal contraception

The transdermal contraceptive patch (Ortho Evra; Ortho-McNeil maceuticals, Raritan, NJ) was introduced in the United States in 2002(Fig 1) It is pharmacologically similar to combination oral contraceptivesbut is applied topically The regimen requires only three weekly applicationsper month, compared with 21 days of active pill taking The patch is a small(2 cm2), thin, adhesive square that releases 150 mg of the progestin norelges-tromin and 20 mg of the estrogen ethinyl estradiol (EE) daily into the

Phar-E-mail address: yds3@columbia.edu

Obstet Gynecol Clin N Am

34 (2007) 31–42

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systemic circulation The patch can be applied to the upper outer arm, lowerabdomen, upper torso, or buttocks It should not be applied to the breasts.Limited data show that the patch may be less effective in women whoweigh 90 kg or more [5] Because hormonal contraceptive failure is sorare, it is difficult to assess any association between baseline body weightand combined hormonal contraceptive failure A meta-analysis of datapooled from three multicenter studies of 3319 women found that overalland method failure life-table estimates of contraceptive patch failurethrough 13 cycles were 0.8% (95% confidence interval [CI], 0.3–1.3) and0.6% (95% CI, 0.2–0.9), respectively [5] Corresponding Pearl indiceswere 0.88 (95% CI, 0.44–1.33) and 0.7 (95% CI, 0.31–1.10) These rateswere comparable to those of established oral contraceptive pill users Apost-hoc analysis of predictors of patch failure showed that higher weightwas associated with pregnancy; neither race nor age were important predic-tive factors Participants who had a baseline body weight of 90 kg (198 lb) orgreater accounted for 5 of the 15 on-treatment pregnancies that occurred inthe studies (P!.001) In women weighing less than 90 kg, no associationwas found Participant body mass index was not found to be associatedwith patch failure Based on these findings, some clinicians recommendmethods other than the patch to their obese patients seeking hormonal con-traception or recommend that they consider a backup method when usingthe patch Consistent use of the patch remains the most important predictor

of contraceptive eﬃcacy

In 2005, the U.S Food and Drug Association released a ‘‘black box’’advisory regarding the use of Ortho Evra A black box warning is themost serious warning placed in the labeling of a prescription medication.Black box warnings are meant to provide physicians with important insights

as to how to prescribe a drug that may be associated with serious side eﬀects

Fig 1 Ortho Evra contraceptive patch.

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in a way that maximizes its beneﬁts and minimizes its risks The following isthe warning placed by the FDA on Ortho Evra:

The pharmacokinetic (PK) profile for the ORTHO EVRAÒ patch is differentfrom the PK profile for oral contraceptives in that it has higher steady state con-centrations and lower peak concentrations AUC and average concentration atsteady state for ethinyl estradiol (EE) are approximately 60% higher in womenusing ORTHO EVRAÒ compared with women using an oral contraceptivecontaining EE 35 mg In contrast, peak concentrations for EE are approximately25% lower in women using ORTHO EVRAÒ Inter-subject variability results

in increased exposure to EE in some women using either ORTHO EVRAÒ ororal contraceptives However, inter-subject variability in women using ORTHOEVRAÒ is higher It is not known whether there are changes in the risk ofserious adverse events based on the diﬀerences in pharmacokinetic proﬁles of

EE in women using ORTHO EVRAÒ compared with women using oralcontraceptives containing 35 mg of EE Increased estrogen exposure mayincrease the risk of adverse events, including venous thromboembolism

This warning was based on the results of an open-label randomized trialthat compared the pharmacokinetics of EE from the contraceptive vaginalring (15 mg EE/d), the transdermal patch (20 mg EE/d), and a combinedoral contraceptive (30 mg EE/d)[6] Analysis of the EE area under the con-centration-versus-time curve after 21 days of use of one of these methods(n ¼ 24, eight in each of the three study arms) showed that exposure to

EE in the vaginal ring group was 3.4 times lower than in the patch group(P!.05) and 2.1 times lower than in the pill group (P!.05) Serum EElevels of subjects showed much lower variation with the vaginal ring thanwith the patch or the oral contraceptive pill Thus, exposure to EE was sig-niﬁcantly lower with the ring than with the patch and pill methods Theseresults demonstrate that the vaginal ring is a low-estrogen-dose contracep-tive method that results in low estrogen exposure Women using the patchare exposed to a higher concentration of EE than women who use a 30-mgpill or the vaginal ring The outcome measure of interest is not estrogenexposure, but the incidence of thromboembolic events

This pharmacokinetic study was not designed to reveal whether patch use

is associated with an increased risk of vascular events Consequently, noconclusions can be drawn regarding the risk of thromboembolism for users

of the pill, patch, or ring

Two recent case-control studies used insurance claims data and reviews ofmedical records to compare incidence rates of nonfatal deep venous thrombo-sis between patch users and oral contraceptive users The results were conﬂict-ing One study found no diﬀerence in the risk of venous thromboembolismbetween the pill and patch groups The other study (known as the ‘‘Ingenixstudy’’) found a twofold increased risk of thromboembolism in patch users(odds ratio, 2.2; CI, 1.3–3.8)[7–11] Data from the Ingenix study have notbeen published in a peer-reviewed journal Information about the study can

be found only on the Ortho Evra website Ortho Evra should continue to

33

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be recommended without restriction in patients for whom combinedhormonal contraception is indicated Not only is the evidence insuﬃcient

to support a change in clinical practice, but many believe that it is insuﬃcient

to warrant the black box warning placed on the package label Given theblack box intention to educate about important and serious health risks,contraceptive advocates believe that data conﬁrming these kinds of risksrelative to the contraceptive patch are missing Black box warnings mayadversely aﬀect clinician prescribing and could reduce access to this excellentcontraceptive option for many women

A Cochrane systematic review found that efficacy was similar between thepatch and the combined oral contraceptive pill[12,13] Patch users in clinicaltrials reported significantly more cycles of correct use than oral contracep-tive users Better adherence to the patch was also shown in a prospectivestudy of 1417 women who were followed for up to 13 cycles of patch ororal contraceptive use The number of cycles of perfect dosing was signifi-cantly higher with the patch than with daily oral contraception [14,15]

across all age groups By contrast, among oral contraceptive users, the centage of cycles with perfect dosing increased only with increasing age ofsubjects, so that older women were more likely to continue the pill thanwere younger women Data indicate that the weekly patch facilitates betteradherence to contraception in younger women

per-Patch users in clinical trials were significantly more likely to report breastdiscomfort than oral contraceptive users However, a recently publishedrandomized open-label clinical trial of 1489 women found that more userswere very satisfied with the patch than with oral contraception [16].Improvements in premenstrual symptoms and emotional and physicalwell-being were greater with the patch than with oral contraception Thistrial confirmed the findings of previous studies that the correct use of themethod was consistently better with the patch than with oral contraception.Better adherence to the patch improves its cost-effectiveness over pills.Use of the patch resulted in a savings of $249 and averted 0.03 pregnanciesper woman over 2 years compared with oral contraception[17]

Monthly reversible hormonal contraception

NuvaRing is a ﬂexible, single-size contraceptive vaginal ring that was troduced in the United States in 2001 (Fig 2) The ring releases 15 mg of EEand 120 mg of etonogestrel daily at constant rates The hormones areabsorbed readily through the vaginal epithelium, eﬀectively suppressingovulation Maximum concentrations of EE and etonogestrel are reachedwithin 1 week, and those concentrations remain constant throughout the

in-3 weeks of recommended use[18,19]

NuvaRing is small, light-weight, and transparent It is made of evatane,which is a vinyl polymer matrix, and its use is not associated with an

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increase in vaginal infections[20] Concurrent use of tampons, spermicides,

or antimycotic medications for the treatment of vaginitis does not seem todecrease efficacy [21] Insertion and removal of the ring is accomplishedeasily It does not require fitting by a health care provider, and the ringdoes not need to cover the cervix NuvaRing does not have to be removedbefore intercourse If users desire removal, it can be left out for up to 3hours without a loss of effectiveness

If the ring is left out of the vagina for more than 3 hours during the first 2weeks of the cycle, the woman should reinsert the ring as soon as possible Ifthis occurs during the third week of the cycle, she should discard the ringand insert a new one, thereby starting a new 3-week cycle The patientshould be instructed to use a back-up method of contraception, such as con-doms, during the first week of this new cycle Emergency contraception is animportant intervention for patients if vaginal intercourse occurred while thering was out for more than 3 hours Women should be counseled on the im-portance of replacing the vaginal ring after the ring-free week of each 3-week cycle If the ring-free interval exceeds 7 days, ovulation may occur[22].Contraceptive effectiveness of the vaginal ring is high, with a failure rate

of 1.18 (CI, 0.73–1.80) per 100 woman-years of use (ie, Pearl Index)[23] Theoverall cumulative rate of pregnancies that occurred during active use of themethod (derived from life table analysis) is 1.18% (95% CI, 0.68–1.69),comparable to the Pearl Index Weight does not seem to aﬀect the contra-ceptive eﬃcacy of the ring A retrospective secondary analysis of data ofvaginal ring use in phase III clinical trials suggests that the use of the vaginalring is not associated with an increased pregnancy risk among heavierwomen [24,25] Over the 1-year study period, 27 pregnancies occurred inthe intent-to-treat population (n ¼ 3259), and 12 pregnancies (0.43%)

Fig 2 NuvaRing (From Barnhart et al In vivo assessment of NuvaRing placement ception 2005;72:197; with permission.)

Contra-35

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occurred in the per-protocol population (n ¼ 2788) The baseline weightrange for women in whom pregnancies occurred was 48 to 85.3 kg (106–

188 lb) Pregnancies were distributed evenly over this weight range No nancies occurred among the 41 women in the study population who hadbaseline weights of 89.9 kg (198 lb)

preg-Lower levels of estrogen exposure are associated with the ring than withthe patch or pill[6] No epidemiologic data are available regarding the clin-ical risk of venous thromboembolism based on diﬀerences in pharmacoki-netic proﬁles of the pill, patch, or ring As with any estrogen-containingcontraception, women who have contraindications to estrogen use (eg,tobacco use over the age of 35, personal history of breast cancer, severe hy-pertension, or thromboembolic disorders) should not use the vaginal ring.Each ring is intended for one cycle of use A cycle is comprised of 3 weeks

of ring use followed by one ring-free week, during which women experience

a withdrawal bleed Bleeding usually starts 2 to 3 days after the ring isremoved; mean duration of withdrawal bleeding runs from 4.5 to 5.2 days

[23] Studies indicate that the ring has a high level of user acceptability.Compared with oral contraception, less breakthrough bleeding occurs dur-ing the initial cycles of ring use[24] A 1-year study of 2322 women followedfor 23,298 cycles found that the ring was well tolerated and had a low overallincidence of adverse events (2.5%) (Table 1) Eighty-ﬁve percent of womenwere satisﬁed with the ring, and 90% would recommend its use to others

a Comprising foreign body sensation, coital problems, and expulsion.

From: Dieben TOM, Roumen FJME, et al Eﬃcacy, cycle control, and user acceptability of

a novel combined contraceptive vaginal ring Obstet Gynecol 2002;100(3):585–93.

Tiêu đề	Foreword and Preface for Obstetrics and Gynecology Clinics of North America, 2007
Người hướng dẫn	William F. Rayburn, MD, Eve Espey, MD, MPH
Trường học	University of New Mexico School of Medicine
Chuyên ngành	Obstetrics and Gynecology
Thể loại	foreword and preface
Năm xuất bản	2007
Thành phố	Albuquerque

Định dạng
Số trang	168
Dung lượng	3,37 MB