U S. Medical Eligibility Criteria for Contraceptive Use, 2010

Adapted from the World Health Organization Medical Eligibility Criteria for Contraceptive Use, 4th edition

Prepared by

Division of Reproductive Health, National Center for Chronic Disease Prevention and Health Promotion

Corresponding preparer: Kathryn M. Curtis, PhD, Division of Reproductive Health, CDC, MS K-34, 4770 Buford Highway NE, Atlanta, GA 30341; Telephone 770-488-6397; Fax: 770-488-6391; E-mail kmc6@cdc.gov

Summary

CDC created U.S. Medical Eligibility Criteria for Contraceptive Use, 2010, from guidance developed by the World Health Organization (WHO) and finalized the recommendations after consultation with a group of health professionals who met in Atlanta, Georgia, during February 2009. This guidance comprises recommendations for the use of specific contraceptive methods by women and men who have certain characteristics or medical conditions. The majority of the U.S. guidance does not differ from the WHO guidance and covers >60 characteristics or medical conditions. However, some WHO recommendations were modified for use in the United States, including recommendations about contraceptive use for women with venous thromboembolism, valvular heart disease, ovarian cancer, and uterine fibroids and for postpartum and breastfeeding women. Recommendations were added to the U.S. guidance for women with rheumatoid arthritis, history of bariatric surgery, peripartum cardiomyopathy, endometrial hyperplasia, inflammatory bowel disease, and solid organ transplantation. The recommendations in this document are intended to assist health-care providers when they counsel women, men, and couples about contraceptive method choice. Although these recommendations are meant to serve as a source of clinical guidance, health-care providers should always consider the individual clinical circumstances of each person seeking family planning services.

Introduction

In 1996, the World Health Organization (WHO) published the first edition of the Medical Eligibility Criteria for Contraceptive Use (MEC), which gave evidence-based guidance on the safety of contraceptive method use for women and men worldwide who had specific characteristics and medical conditions. Since that time, WHO has regularly updated its guidance on the basis of new evidence, and the WHO MEC is now in its fourth edition (1).

CDC, through close collaboration with WHO, has contributed substantially during the last 15 years to creation of WHO's global family planning guidance, which includes four documents: the medical eligibility criteria for contraceptive use, the selected practice recommendations for contraceptive use, a decision-making tool for clients and providers, and a global family planning handbook. This WHO guidance has been based on the best available scientific evidence, and CDC has served as the lead for establishing that evidence base and presenting the evidence to WHO for use during its expert working group meetings to create and update the guidance.

WHO has always intended for its global guidance to be used by local or regional policy makers, managers of family planning programs, and the scientific community as a reference when they develop family planning guidance at the country or program level. The United Kingdom is one example of a country that has adapted the WHO MEC for its own use (2).

CDC undertook a formal process to adapt the WHO MEC at this time because the fourth edition of the WHO guidance is unlikely to undergo major revisions in the near future. Although the WHO guidance is already available in the United States through inclusion in textbooks, use by professional organizations, and incorporation into training programs, the adaptation of the guidance ensures its appropriateness for use in the United States and allows for further dissemination and implementation among U.S. health-care providers. Most of the U.S. guidance does not differ from the WHO guidance and covers approximately 60 characteristics or medical conditions. However, several changes have been made, including adaptations of selected WHO recommendations, addition of recommendations for new medical conditions, and removal of recommendations for contraceptive methods not currently available in the United States (Appendix A).

This document contains recommendations for health-care providers for the safe use of contraceptive methods by women and men with various characteristics and medical conditions. It is intended to assist health-care providers when they counsel women, men, and couples about contraceptive method choice. These recommendations are meant to be a source of clinical guidance; health-care providers should always consider the individual clinical circumstances of each person seeking family planning services.

Methods

The process for adapting the WHO MEC for the United States comprised four major steps: 1) determination of the scope of and process for the adaptation, including a small meeting; 2) preparation and peer review of systematic reviews of the evidence to be used for the adaptation; 3) organization of a larger meeting to examine the evidence and provide input on the recommendations; and 4) finalization of the recommendations by CDC.

In June 2008, CDC held a 2-day meeting of eight key partners and U.S. family planning experts to determine the scope of and process for a U.S. adaptation of the WHO MEC. Participants were family planning providers, who also had expertise in conducting research on contraceptive safety and translating research evidence into guidance. WHO guidance is used widely around the world, including in the United States, and contains approximately 1,800 separate recommendations. In most cases, the evidence base would be the same for the U.S. and the WHO recommendation, and---because of the extensive collaboration between WHO and CDC in creating the international guidance---the process for determining the recommendations also would be the same. Therefore, CDC determined that the global guidance also should be the U.S. guidance, except when a compelling reason existed for adaptation, and that CDC would accept the majority of WHO guidance for use in the United States.

During the June 2008 meeting, CDC identified specific WHO recommendations for which a compelling reason existed to consider modification for the United States because of the availability of new scientific evidence or the context in which family planning services are provided in the United States. CDC also identified areas in which WHO guidance was inconsistent with current U.S. practice by contacting numerous professional and service organizations and individual providers. In addition, CDC assessed the need for adding recommendations for medical conditions not currently included in the WHO MEC. Through this process, a list was developed of existing WHO recommendations to consider adapting and new medical conditions to consider adding to the guidance.

A systematic review of the scientific evidence was conducted for each of the WHO recommendations considered for adaptation and for each of the medical conditions considered for addition to the guidance. The purpose of these systematic reviews was to identify direct evidence about the safety of contraceptive method use by women (or men) with selected conditions (e.g., risk for disease progression or other adverse health effects in women with rheumatoid arthritis who use combined oral contraceptives). Information about indirect evidence (e.g., evidence from healthy women or animal studies) or theoretical considerations was obtained when direct evidence was not available. CDC conducted systematic reviews following standard guidelines (3,4), included thorough searches of PubMed and other databases of the scientific literature, and used the U.S. Preventive Services Task Force system to grade the strength and quality of the evidence (5). Each systematic review was peer-reviewed by two or three experts before being used in the adaptation process. These systematic reviews have been submitted for publication in peer-reviewed journals.

For most recommendations in this document, a limited number of studies address the use of a specific contraceptive method by women with a specific condition. Therefore, within the WHO guidance, as well as with this U.S. adaptation of the guidance, most of the decisions about medical eligibility criteria were often necessarily based on 1) extrapolations from studies that primarily included healthy women, 2) theoretical considerations about risks and benefits, and 3) expert opinion. Evidence was particularly limited for newer contraceptive methods. The total body of evidence for each recommendation included evidence based on direct studies or observations of the contraceptive method used by women (or men) with the condition and may have included 1) evidence derived from effects of the contraceptive method used by women (or men) without the condition and 2) indirect evidence or theoretical concerns based on studies of suitable animal models, human laboratory studies, or analogous clinical situations.

In February 2009, CDC held a meeting of 31 experts who were invited to provide their individual perspective on the scientific evidence presented and the discussions on potential recommendations that followed. This group included obstetricians/gynecologists, pediatricians, family physicians, nurse-midwives, nurse practitioners, epidemiologists, and others with expertise in contraceptive safety and provision. For each topic discussed, the evidence from the systematic review was presented; for most of the topics, an expert in the specific medical condition (e.g., rheumatoid arthritis) also gave a brief presentation on the condition and specific issues about contraceptive safety. CDC gathered input from the experts during the meeting and finalized the recommendations in this document. CDC plans to develop a research agenda to address topics identified during the meeting that need further investigation.

How to Use This Document

These recommendations are intended to help health-care providers determine the safe use of contraceptive methods among women and men with various characteristics and medical conditions. Providers also can use the synthesis of information in these recommendations when consulting with women, men, and couples about their selection of contraceptive methods. The tables in this document include recommendations for the use of contraceptive methods by women and men with particular characteristics or medical conditions. Each condition was defined as representing either an individual's characteristics (e.g., age, history of pregnancy) or a known preexisting medical/pathologic condition (e.g., diabetes and hypertension). The recommendations refer to contraceptive methods being used for contraceptive purposes; the recommendations do not consider the use of contraceptive methods for treatment of medical conditions because the eligibility criteria in these cases may differ. The conditions affecting eligibility for the use of each contraceptive method were classified under one of four categories (Box 1).

Using the Categories in Practice

Health-care providers can use these categories when assessing the safety of contraceptive method use for women and men with specific medical conditions or characteristics. Category 1 comprises conditions for which no restrictions exist for use of the contraceptive method. Classification of a method/condition as Category 2 indicates the method generally can be used, but careful follow-up may be required. For a method/condition classified as Category 3, use of that method usually is not recommended unless other more appropriate methods are not available or acceptable. The severity of the condition and the availability, practicality, and acceptability of alternative methods should be taken into account, and careful follow-up will be required. Hence, provision of a method to a woman with a condition classified as Category 3 requires careful clinical judgement and access to clinical services. Category 4 comprises conditions that represent an unacceptable health risk if the method is used. For example, a smoker aged <35 years generally can use combined oral contraceptives (COCs) (Category 2). However, for a woman aged ≥35 years who smokes <15 cigarettes per day, the use of COCs usually is not recommended unless other methods are not available or acceptable to her (Category 3). A woman aged ≥35 years who smokes ≥15 cigarettes per day should not use COCs because of unacceptable health risks, primarily the risk for myocardial infarction and stroke (Category 4). The programmatic implications of these categories may depend on the circumstances of particular professional or service organizations (e.g., in some settings, a Category 3 may mean that special consultation is warranted).

The recommendations address medical eligibility criteria for the initiation and continued use of all methods evaluated. The issue of continuation criteria is clinically relevant whenever a woman develops the condition while she is using the method. When the categories differ for initiation and continuation, these differences are noted in the columns Initiation and Continuation. Where Initiation and Continuation are not denoted, the category is the same for initiation and continuation of use.

On the basis of this classification system, the eligibility criteria for initiating and continuing use of a specific contraceptive method are presented in tables (Appendices A--M). In these tables, the first column indicates the condition. Several conditions were divided into subconditions to differentiate between varying types or severity of the condition. The second column classifies the condition for initiation and/or continuation into Category 1, 2, 3, or 4. For some conditions, the numeric classification does not adequately capture the recommendation; in this case, the third column clarifies the numeric category. These clarifications were determined during the discussions of the scientific evidence and the numeric classification and are considered a necessary element of the recommendation. The third column also summarizes the evidence for the recommendation, where evidence exists. The recommendations for which no evidence is cited are based on expert opinion from either the WHO or U.S. expert working group meetings and may be based on evidence from sources other than systematic reviews and presented at those meetings. For selected recommendations, additional comments appear in the third column and generally come from the WHO or the U.S. expert working group participants.

Recommendations for Use of Contraceptive Methods

The classifications for whether women with certain medical conditions or characteristics can use specific contraceptive methods are provided for combined hormonal contraceptive methods, including low-dose (containing ≤35 μg ethinyl estradiol) combined oral contraceptive pills, combined hormonal patch, and combined vaginal ring (Appendix B); progestin-only contraceptive methods, including progestin-only pills, depot medroxyprogesterone acetate injections, and etonogestrel implants (Appendix C); emergency contraceptive pills (Appendix D); intrauterine contraception, including the copper intrauterine device (IUD) and the levonorgestrel IUD (Appendix E); use of copper IUDs for emergency contraception (Appendix F); barrier contraceptive methods, including male and female condoms, spermicides, diaphragm with spermicide, and cervical cap (Appendix G); fertility awareness-based methods (Appendix H); lactational amenorrhea method (Appendix I); coitus interruptus (Appendix J); and female and male sterilization (Appendix K). Tables at the end of the document summarize the classifications for the hormonal and intrauterine methods (Appendix L) and the evidence about potential drug interactions between hormonal contraceptives and antiretroviral therapies (Appendix M).

Contraceptive Method Choice

Many elements need to be considered by women, men, or couples at any given point in their lifetimes when choosing the most appropriate contraceptive method. These elements include safety, effectiveness, availability (including accessibility and affordability), and acceptability. The guidance in this document focuses primarily on the safety of a given contraceptive method for a person with a particular characteristic or medical condition. Therefore, the classification of Category 1 means that the method can be used in that circumstance with no restrictions with regard to safety but does not necessarily imply that the method is the best choice for that person; other factors, such as effectiveness, availability, and acceptability, may play a key role in determining the most appropriate choice. Voluntary informed choice of contraceptive methods is an essential guiding principle, and contraceptive counseling, where applicable, may be an important contributor to the successful use of contraceptive methods.

In choosing a method of contraception, the risk for sexually transmitted infections (STIs), including human immunodeficiency virus (HIV), also must be considered. Although hormonal contraceptives and IUDs are highly effective at preventing pregnancy, they do not protect against STIs. Consistent and correct use of the male latex condom reduces the risk for STIs (6). When a male condom cannot be used properly for infection prevention, a female condom should be considered (7). Women who use contraceptive methods other than condoms should be counseled about the use of condoms and the risk for STIs (7). Additional information about prevention and treatment of STIs is available from CDC's Sexually Transmitted Diseases Treatment Guidelines (http://www.cdc.gov/std/treatment) (7).

Contraceptive Method Effectiveness

Contraceptive method effectiveness is critically important in minimizing the risk for unintended pregnancy, particularly among women for whom an unintended pregnancy would pose additional health risks. The effectiveness of contraceptive methods depends both on the inherent effectiveness of the method itself and on how consistently and correctly it is used (Table 1). Methods that depend on consistent and correct use have a wide range of effectiveness.

Unintended Pregnancy and Increased Health Risk

For women with conditions that may make unintended pregnancy an unacceptable health risk, long-acting, highly effective contraceptive methods may be the best choice (Table 1). Women with these conditions should be advised that sole use of barrier methods for contraception and behavior-based methods of contraception may not be the most appropriate choice because of their relatively higher typical-use rates of failure (Table 1). Conditions included in the U.S. MEC for which unintended pregnancy presents an unacceptable health risk are identified throughout the document (Box 2).

Keeping Guidance Up to Date

As with any evidence-based guidance document, a key challenge is keeping the recommendations up to date as new scientific evidence becomes available. CDC will continue to work with WHO to identify and assess all new relevant evidence and to determine whether changes to the recommendations are warranted (4). In most cases, the U.S. MEC will follow any updates in the WHO guidance, which typically occur every 3--4 years (or sooner if warranted by new data). However, CDC will review any WHO updates for their application in the United States. CDC also will identify and assess any new literature for the recommendations and medical conditions that are not included in the WHO guidance. CDC will completely review the U.S. MEC every 3--4 years as well. Updates to the guidance will appear on the CDC U.S. MEC website: http://www.cdc.gov/reproductivehealth/UnintendedPregnancy/USMEC.htm.

Acknowledgements

This report is based in part on the work of the Promoting Family Planning Team, Department of Reproductive Health and Research, World Health Organization, and its development of the WHO Medical Eligibility Criteria for Contraceptive Use, 4th edition.

References

1. WHO. Medical eligibility criteria for contraceptive use. 4th ed. Geneva: WHO; 2009. Available at http://www.who.int/reproductivehealth/publications/family_planning/9789241563888/en/index.html.
2. Faculty of Family Planning and Reproductive Health Care, Royal College of Obstetricians and Gynecologists. UK medical eligibility criteria for contraceptive use, 2005--2006. London: Faculty of Family Planning and Reproductive Health Care, 2006.
3. Stroup DF, Berlin JA, Morton SC, et al. Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group. JAMA 2000;283:2008--12.
4. Mohllajee AP, Curtis KM, Flanagan RG, et al. Keeping up with evidence a new system for WHO's evidence-based family planning guidance. Am J Prev Med 2005;28:483--90.
5. Harris RP, Helfand M, Woolf SH, et al. Current methods of the US Preventive Services Task Force: a review of the process. Am J Prev Med 2001;20:21--35.
6. CDC. Condom fact sheet in brief. Available at http://www.cdc.gov/condomeffectiveness/docs/Condom_fact_Sheet_in_Brief.pdf.
7. CDC. Sexually transmitted diseases treatment guidelines, 2006. MMWR 2006;55(RR No. 11).

Abbreviations and Acronyms

A	accept
AIDS	acquired immunodeficiency syndrome
ARV	antiretroviral
BMD	bone mineral density
BMI	body mass index
C	caution
CDC	Centers for Disease Control and Prevention
CHC	combined hormonal contraceptive
CI	coitus interruptus
COC	combined oral contraceptive
Cu-IUD	copper intrauterine device
D	delayed
DMPA	depot medroxyprogesterone acetate
DVT	deep venous thrombosis
ECP	emergency contraceptive pills
EE	ethinyl estradiol
E-IUD	emergency intrauterine device
ETG	etonogestrel
FAB	fertility awareness--based methods
hCG	human chorionic gonadotropin
HDL	high-density lipoprotein
HIV	human immunodeficiency virus
HPV	human papillomavirus
IBD	inflammatory bowel disease
IUS	intrauterine system
IUD	intrauterine device
LNG	levonorgestrel
LNG-IUD	levonorgestrel-releasing intrauterine device
MEC	Medical Eligibility Criteria
NET-EN	norethisterone enantate
NGM	norgestimate
NNRTI	non-nucleoside reverse transcriptase inhibitor
NRTI	nucleoside reverse transcriptase inhibitor
P	combined hormonal contraceptive patch
PE	pulmonary embolism
PID	pelvic inflammatory disease
POC	progestin-only contraceptive
POI	progestin-only injectable
POP	progestin-only pill
R	combined hormonal vaginal ring
SLE	systemic lupus erythematosus
STI	sexually transmitted infection
VTE	venous thromboembolism
WHO	World Health Organization

U.S. Medical Eligibility Criteria for Contraceptive Use, 2010

Atlanta, GA, February 17--19, 2009

Chairpersons: Herbert B. Peterson, MD, University of North Carolina, Chapel Hill, North Carolina; Kathryn M. Curtis, PhD, Centers for Disease Control and Prevention, Atlanta, Georgia.

CDC Steering Committee: Kathryn M. Curtis, PhD (Chair), Denise Jamieson, MD, John Lehnherr, Polly Marchbanks, PhD, Centers for Disease Control and Prevention, Atlanta, Georgia.

Systematic Review Authors and Presenters: Sherry Farr, PhD, Suzanne Gaventa Folger, PhD, Melissa Paulen, MPH, Naomi Tepper, MD, Maura Whiteman, PhD, Lauren Zapata, PhD, Centers for Disease Control and Prevention, Atlanta, Georgia; Kelly Culwell, MD, Nathalie Kapp, MD, World Health Organization, Geneva, Switzerland; Catherine Cansino, MD, Johns Hopkins Bayview Medical Center, Baltimore, Maryland.

Invited Participants: Abbey Berenson, MD, University of Texas Medical Branch, Nassau Bay, Texas; Paul Blumenthal, MD, Stanford University, Palo Alto, California (not able to attend); Willard Cates, Jr., MD, Family Health International, Research Triangle Park, North Carolina (not able to attend); Mitchell Creinin, MD, University of Pittsburgh, Pittsburgh, Pennsylvania; Vanessa Cullins, MD, Planned Parenthood Federation of America, New York, New York; Philip Darney, MD, University of California, San Francisco, California; Jennifer Dietrich, MD, Baylor College of Medicine, Houston, Texas; Linda Dominguez, Southwest Women's Health, Albuquerque, New Mexico; Melissa Gilliam, MD, The University of Chicago, Chicago, Illinois; Marji Gold, MD, Albert Einstein College of Medicine, Bronx, New York; Alisa Goldberg, MD, Brigham and Women's Hospital and Planned Parenthood of Massachusetts, Boston, Massachusetts; David Grimes, MD, Family Health International, Research Triangle Park, North Carolina (not able to attend); Robert Hatcher, MD, Emory University, Atlanta, Georgia; Stephen Heartwell, DrPH, Susan Thompson Buffett Foundation, Omaha, Nebraska; Andrew Kaunitz, MD, University of Florida, Jacksonville, Florida; Uta Landy, PhD, University of California, San Francisco, California (not able to attend); Hal Lawrence, MD, American College of Obstetricians and Gynecologists, Washington, DC; Ruth Lawrence, MD, American Academy of Pediatrics and University of Rochester, Rochester, New York; Laura MacIsaac, MD, Albert Einstein School of Medicine, New York, New York; Trent MacKay, MD, National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD (not able to attend); Daniel Mishell, Jr, MD, University of Southern California, Los Angeles, California; Mary Mitchell, American College of Obstetricians and Gynecologists, Washington, DC; Susan Moskosky, MS, US Department of Health and Human Services, Rockville, Maryland; Patricia Murphy, DrPH, University of Utah, Salt Lake City, Utah; Kavita Nanda, MD, Family Health International, Research Triangle Park, North Carolina; Jeffrey Peipert, MD, Washington University, St. Louis, Missouri; Michael Policar, MD, University of California, San Francisco, California; Robert Rebar, MD, American Society of Reproductive Medicine, Birmingham, Alabama; Pablo Rodriquez, MD, Providence, Rhode Island (not able to attend); John Santelli, MD, Columbia University, New York, New York (not able to attend); Sharon Schnare, MSN, University of Washington, Seattle, Washington; David Soper, MD, University of South Carolina, Charleston, South Carolina; Lisa Soule, MD, Food and Drug Administration, Silver Spring, Maryland; James Trussell, PhD, Princeton University, Princeton, New Jersey; Carolyn Westhoff, MD, Columbia University, New York, New York (not able to attend); Susan Wysocki, National Association of Nurse Practitioners in Women's Health, Washington, DC; Mimi Zieman, MD, Emory University, Atlanta, Georgia.

Consultants: Wendy Book, MD, Emory University, Atlanta, Georgia; Shinya Ito, Hospital for Sick Children, Toronto, Canada; Beth Jonas, MD, University of North Carolina, Chapel Hill, North Carolina; Miriam Labbok, MD, University of North Carolina, Chapel Hill, North Carolina; Frederick Naftolin, MD, New York University, New York, New York; Lubna Pal, Yale University, New Haven, Connecticut; Robin Rutherford, MD, Emory University, Atlanta, Georgia; Roshan Shrestha, MD, Piedmont Hospital, Atlanta, Georgia; Kimberley Steele, MD, Johns Hopkins University, Baltimore, Maryland; Michael Streiff, MD, Johns Hopkins University, Baltimore, Maryland; Christine Wagner, PhD, University of Albany, Albany, New York; Joan Walker, MD, University of Oklahoma, Oklahoma City, Oklahoma.

CDC Attendees: Janet Collins, PhD, Susan Hillis, PhD, Dmitry Kissin MD, Sam Posner, PhD, Natalya Revzina, MD, Cheryl Robbins, PhD, Lee Warner, PhD.

This work was conducted within the Women's Health and Fertility Branch (Maurizio Macaluso, Branch Chief), in the Division of Reproductive Health (John Lehnherr, Acting Director), National Center for Chronic Disease Prevention and Health Promotion (Ursula Bauer, Director).

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