Family planning: a global handbook for providers: evidence-based guidance developed through worldwide collaboration, 2018 edition

Publication date: 2018

2018 EDITION NEW 2018 2018 New family planning recommendations from WHO New coverage in this edition Expanded or updated coverage  Women who are breastfeeding can start progestin- only pills or implants at any time postpartum (pp. 35 and 139)  New Selected Practice Recommendations on the levonorgestrel implant Levoplant (Sino-Implant (II)) (p. 131), subcutaneous DMPA (p. 65), the combined patch (p. 119), the combined vaginal ring (p. 123), and ulipristal acetate for emergency contraception (p. 49)  When to start a family planning method after taking emergency contraceptive pills (all chapters)  Human rights: Family Planning Providers’ Contribution (p. xii)  “How Can a Partner Help?” (in most chapters)  Giving the Injection with Subcutaneous DMPA in Uniject (Sayana Press) (p. 81)  Teaching Clients to Self-Inject (p. 83)  Progesterone-releasing vaginal ring (p. 127)  Clients with disabilities (p. 327)  Safer Conception for HIV Serodiscordant Couples (p. 333)  “LIVES”—5 steps for helping women subjected to violence (p. 363)  Counseling About Effectiveness (p. 371)  Task-Sharing: WHO Recommendations (p. 374)  Considering Progestin-Only Injectables Where HIV Risk Is High: Counseling Tips (p. 438)  Ruling Out Pregnancy (p. 439)  Instructions on implant insertion (p. 142)  Levonorgestrel IUD (p. 181)  Prenatal care (p. 345)  Infant feeding for women with HIV (p. 352)  Infertility (p. 364)  Effectiveness of family planning methods (p. 383)  Medical Eligibility Criteria for Contraceptive Use (p. 388) What’s New in This Edition? Pregnancy Checklist Ask the client questions 1–6. As soon as the client answers “yes” to any question, stop and follow the instructions below. If the client answered YES to at least one of the questions, you can be reasonably sure she is not pregnant. If the client answered NO to all of the questions, pregnancy cannot be ruled out using the checklist. Rule out pregnancy by other means. NO YES Did your last monthly bleeding start within the past 7 days?* Have you abstained from sexual intercourse since your last monthly bleeding, delivery, abortion, or miscarriage? Have you been using a reliable contraceptive method consistently and correctly since your last monthly bleeding, delivery, abortion, or miscarriage? Have you had a baby in the last 4 weeks? Did you have a baby less than 6 months ago, are you fully or nearly-fully breastfeeding, and have you had no monthly bleeding since then? Have you had a miscarriage or abortion in the past 7 days?* 1 2 3 4 5 6 * If the client is planning to use a copper-bearing IUD, the 7-day window is expanded to 12 days. World Health Organization Department of Reproductive Health and Research Johns Hopkins Bloomberg School of Public Health Center for Communication Programs Knowledge for Health Project Family Planning A GLOBAL HANDBOOK FOR PROVIDERS Evidence-based guidance developed through worldwide collaboration Updated 3rd edition 2018 United States Agency for International Development Bureau for Global Health Office of Population and Reproductive Health JHU HBk18 - A1 - Front matter.indd 1 1/26/18 09:41 ii Family Planning: A Global Handbook for Providers How to Obtain More Copies The Knowledge for Health Project at Johns Hopkins Center for Communication Programs offers copies of Family Planning: A Global Handbook for Providers free of charge to readers in developing countries. All others, please contact the Knowledge for Health Project for more information. To order by e-mail, write orders@jhuccp.org and include your name, complete mailing address, and telephone number. To order via the Web, visit http://www.fphandbook.org/order-form. The website http://www.fphandbook.org also offers downloads of printable files and files for e-readers in various languages of the Global Handbook and the updated wall chart, Do You Know Your Family Planning Choices?. The updates have been prepared in English. As they are translated into other languages, the translations will appear on the website. © 2007, 2008, 2011, 2018 World Health Organization and Johns Hopkins Bloomberg School of Public Health/Center for Communication Programs ISBN 13: 978-0-9992037-0-5 Suggested citation: World Health Organization Department of Reproductive Health and Research (WHO/RHR) and Johns Hopkins Bloomberg School of Public Health/Center for Communication Programs (CCP), Knowledge for Health Project. Family Planning: A Global Handbook for Providers (2018 update). Baltimore and Geneva: CCP and WHO, 2018. Published with support from the United States Agency for International Development, Global, GH/SPBO/OPS, under the terms of Grant No. AID-OAA-A-13-00068. Opinions expressed herein are those of the authors and do not necessarily reflect the views of USAID, The Johns Hopkins University, or the World Health Organization. Requests to translate, adapt, or reprint: The publishers welcome requests to translate, adapt, reprint, or otherwise reproduce the material in this document for the purposes of informing health care providers, their clients, and the general public and improving the quality of sexual and reproductive health care. Inquiries should be addressed to WHO Press, World Health Organization, 20 Avenue Appia, 1211 Geneva 27, Switzer- land (fax: +41 22 791 48 06; e-mail: permissions@who.int) and the Knowledge for Health Project, Center for Communication Programs, Johns Hopkins Bloomberg School of Public Health, 111 Market Place, Suite 310, Baltimore, Maryland 21202, USA (fax: +1 410 659-6266; e-mail: orders@jhuccp.org). Disclaimer: The mention of specific companies or of certain manufacturers’ products does not imply that the World Health Organization, The Johns Hopkins University, or the United States Agency for International Development endorses or recommends them in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. The publishers have taken all reasonable precautions to verify the information in this publication. The published material is being distributed, however, without warranty of any kind, either express or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the publishers be liable for damages arising from its use. JHU HBk18 - A1 - Front matter.indd 2 1/26/18 09:41 1 Combined Oral Contraceptives . 1 2 Progestin-Only Pills . 29 3 Emergency Contraceptive Pills . 49 4 Progestin-Only Injectables . 65 5 Monthly Injectables . 97 6 Combined Patch .119 7 Combined Vaginal Ring .123 8 Progesterone-Releasing Vaginal Ring .127 9 Implants .131 10 Copper-Bearing Intrauterine Device .155 11 Levonorgestrel Intrauterine Device .181 12 Female Sterilization .211 13 Vasectomy .231 14 Male Condoms .247 15 Female Condoms .261 16 Spermicides and Diaphragms .271 17 Cervical Caps .289 18 Fertility Awareness Methods .291 19 Withdrawal .307 20 Lactational Amenorrhea Method .309 Contents What’s New in This Handbook? . inside front cover How to Obtain More Copies .ii Forewords .vi Acknowledgements . viii WHO’s Family Planning Guidance . x Human Rights: Family Planning Providers’ Contribution .xii Collaborating and Supporting Organizations . xiv Family Planning A GLOBAL HANDBOOK FOR PROVIDERS iiiContents JHU HBk18 - A1 - Front matter.indd 3 2/9/18 09:16 Family Planning: A Global Handbook for Providersiv Searchable online at www.fphandbook.org 21 Serving Diverse Groups.319 Adolescents .319 Men .323 Women Near Menopause .325 Clients with Disabilities .327 22 Sexually Transmitted Infections, Including HIV .329 23 Maternal and Newborn Health .345 24 Reproductive Health Issues .357 Family Planning in Postabortion Care .357 Violence Against Women .360 Infertility .364 25 Family Planning Provision .368 Importance of Selected Procedures for Providing Family Planning Methods .368 Successful Counseling .370 Who Provides Family Planning? .372 Infection Prevention in the Clinic .376 Managing Contraceptive Supplies .380 BACK MATTER Appendix A. Contraceptive Effectiveness .383 Appendix B. Signs and Symptoms of Serious Health Conditions .384 Appendix C. Medical Conditions That Make Pregnancy Especially Risky.386 Appendix D. Medical Eligibility Criteria for Contraceptive Use .388 Glossary.400 Index .408 Methodology .420 WHO Guidance Documents .422 Illustration and Photo Credits .424 JHU HBk18 - A1 - Front matter.indd 4 2/9/18 09:17 JOB AIDS AND TOOLS Comparing Contraceptives Comparing Combined Methods .426 Comparing Injectables .427 Comparing Implants .428 Comparing Condoms .428 Comparing IUDs .430 If You Miss Pills .431 Female Anatomy .432 Male Anatomy .435 Identifying Migraine Headaches and Auras .436 Considering Progestin-Only Injectables Where HIV Risk Is High: Counseling Tips .438 Ruling Out Pregnancy .439 How and When to Use the Pregnancy Checklist and Pregnancy Tests .440 Pregnancy Checklist . Inside back cover Effectiveness Chart . Back cover Contents v JHU HBk18 - A1 - Front matter.indd 5 2/9/18 09:18 vi Family Planning: A Global Handbook for Providers From the World Health Organization Access to high-quality, affordable sexual and reproductive health services and information, including a full range of contraceptive methods, is fundamental to realizing the rights and well-being of women and girls, men and boys. Universal access to effective contraception ensures that all adults and adolescents can avoid the adverse health and socioeconomic consequences of unintended pregnancy and have a satisfying sexual life. Key global initiatives, including the Sustainable Development Goals and the Global Strategy for Women’s, Children’s and Adolescents’ Health, call for universal access to family planning services as a right of women and girls and crucial to a healthy life. However, reducing the vast unmet need for family planning remains a massive challenge to countries and the global health community. Services are still poor-quality or unavailable in many settings, while service delivery and social constraints persist. Family planning providers are at the core of health system responses to these challenges. The Global Handbook offers clear, up-to-date information and advice to help providers meet clients’ needs and inform their choice and use of contraception. The Handbook is also an excellent resource for training and can help to reinforce supervision. The 2018 edition of the Handbook includes new WHO recommendations that expand contraceptive choices. For example, WHO now recommends that breastfeeding women can start progestogen-only pills or contraceptive implants any time after childbirth. More contraceptive options are now included: ulipristal acetate for emergency contraception; sub-cutaneous injection of DMPA; and the progesterone-releasing vaginal ring. Also, guidance on starting ongoing contraception following emergency contraception is provided. An important message throughout is WHO’s recommendation that adolescent girls and young women are medically eligible to use any contraceptive method. In addition, the Handbook highlights opportunities for task sharing among providers to make contraceptive methods more available. This edition also includes the latest WHO guidance on hormonal contraception and HIV and advice for counselling clients at risk of HIV infection on their contraceptive choices. WHO encourages all national health systems and other organizations providing family planning to consider this new edition of the Global Handbook a key document to help ensure the quality and safety of family planning services. WHO appreciates the contributions of the many people, named in the Acknowledge- ments, who supported the updating and expanding this edition of the Handbook. Also, WHO thanks the Johns Hopkins Bloomberg School of Public Health/Center for Communication Programs for management and the United States Agency for International Development for financial and technical support of the Handbook. Ian Askew, PhD Director, Department of Reproductive Health and Research World Health Organization JHU HBk18 - A1 - Front matter.indd 6 2/9/18 09:18 From the United States Agency for International Development Access to voluntary family planning and reproductive health services for everyone, inclusive of women, men, couples, and adolescents, supports the health and well-being of individuals and can have positive economic, environmental, and social benefits for families and communities. This handbook provides updated accurate and practical guidance to support program managers and providers in delivering high-quality family planning counseling, services and care. Prior editions were widely used to support strong programs: Over 500,000 copies have been distributed through USAID to governments and their partners. We anticipate this 2018 edition will continue to help family planning providers across the globe provide high-quality counseling and services. Since the 2011 edition, many contraceptive methods have become more available in a range of markets. This edition updates information about these methods and covers new methods, including the LNG-IUD and implants, two long-acting reversible methods; subcutaneous depot medroxyprogesterone acetate (DMPA- SC), with the potential for self-injection; and the new progesterone-releasing vaginal ring for breastfeeding women. This update confirms that all women can safely use almost any method and that providing most methods is typically not complicated. Indeed, most methods can be provided even where resources are limited. This handbook provides basic information that providers need to assist women and couples to choose, use, and change family planning methods as they move through their lives. As always, program managers and providers play a central role in supporting clients to make voluntary and informed choices from a range of safe and available methods. The client–provider relationship, grounded in evidence-based and skillful counseling, can help inform the client’s understanding of family planning benefits in general and of the chosen method in particular. New clients may have a method already in mind, but they may not be aware of other options; continuing clients may have concerns with their current method, and knowledgeable counseling can help prevent discontinuation or help clients switch methods effectively. With the information in this book and the right resources, providers can ensure that a client’s reproductive intentions, life situation, and preferences govern family planning decisions. This update was developed in collaboration with the World Health Organization and experts from many organizations. USAID is proud to support its publication. We look forward to continuing the work with our many partners to empower women, men, couples, and adolescents to plan their families and their future. Ellen H. Starbird Director, Office of Population and Reproductive Health Bureau for Global Health United States Agency for International Development viiForewords JHU HBk18 - A1 - Front matter.indd 7 1/26/18 09:41 viii Family Planning: A Global Handbook for Providers Family Planning: A Global Handbook for Providers first appeared in 2007. It was updated in 2011 and now again in 2018. All 3 editions have benefited from the contributions of many people in many different organizations. The publishers wish to thank all these contributors. Without the collaboration and commitment of all involved, this book would not be possible. First edition, 2007 Vera Zlidar, Ushma Upadhyay, and Robert Lande of the INFO Project, Center for Communication Programs at Johns Hopkins Bloomberg School of Public Health were the principal technical writers and led the handbook development process, together with Ward Rinehart from the INFO Project and Sarah Johnson of the World Health Organization, who also served as editors. Other contributors to the research and writing from the INFO Project include Fonda Kingsley, Sarah O’Hara, Hilary Schwandt, Ruwaida Salem, Vidya Setty, Deepa Ramchandran, Catherine Richey, Mahua Mandal, and Indu Adhikary. Key technical advisors throughout the development of the book included Robert Hatcher, Roy Jacobstein, Enriquito Lu, Herbert Peterson, James Shelton, and Irina Yacobson. Kathryn Curtis, Anna Glasier, Robert Hatcher, Roy Jacobstein, Herbert Peterson, James Shelton, Paul Van Look, and Marcel Vekemans conducted final technical review of this book. The following people provided their expertise during expert meetings in Baltimore in October 2004, Geneva in June 2005, or both: Yasmin Ahmed, Marcos Arevalo, Luis Bahamondes, Miriam Chipimo, Maria del Carmen Cravioto, Kathryn Curtis, Juan Diaz, Soledad Diaz, Mohammad Eslami, Anna Glasier, John Guillebaud, Ezzeldin Othman Hassan, Robert Hatcher, Mihai Horga, Douglas Huber, Carlos Huezo, Roy Jacobstein, Enriquito Lu, Pisake Lumbiganon, Pamela Lynam, Trent MacKay, Olav Meirik, Isaiah Ndong, Herbert Peterson, John Pile, Robert Rice, Roberto Rivera, Lois Schaefer, Markku Seppala, James Shelton, Bulbul Sood, Markus Steiner, James Trussell, Marcel Vekemans, and Wu Shangchun. The key contributors to this handbook, who are listed above, declared no conflicts of interest. The following organizations made extraordinary technical contributions to the creation of this handbook: The Centre for Development and Population Activities, EngenderHealth, Family Health International (now FHI360), Georgetown University Institute for Reproductive Health, Jhpiego, Management Sciences for Health, the Population Council, and the United States Agency for International Development. Many others also contributed their expertise on specific topics and participated in the development of consensus on technical content. Contributors include Christopher Armstrong, Mark Barone, Mags Beksinska, Yemane Berhane, Ann Blouse, Julia Bluestone, Paul Blumenthal, Annette Bongiovanni, Débora Bossemeyer, Nathalie Broutet, Ward Cates, Venkatraman Chandra-Mouli, Kathryn Church, Samuel Clark, Carmela Cordero, Vanessa Cullins, Kelly Culwell, Johannes van Dam, Catherine d’Arcangues, Barbara Kinzie Deller, Sibongile Dludlu, Mary Drake, Paul Feldblum, Ron Frezieres, Claudia Garcia-Moreno, Kamlesh Giri, Patricia Gómez, Pio Iván Gómez Sánchez, Vera Halpern, Robert Hamilton, Theresa Hatzell, Helena von Hertzen, John Howson, Carol Joanis, Robert Johnson, Adrienne Kols, Deborah Kowal, Jan Kumar, Anne MacGregor, Luann Martin, Matthews Mathai, Noel McIntosh, Manisha Mehta, Kavita Nanda, Ruchira Tabassum Naved, Francis Ndowa, Nuriye Ortayli, Elizabeth Raymond, Heidi Reynolds, Mandy Rose, Sharon Rudy, Joseph Ruminjo, Dana Samu, Julia Samuelson, Harshad Sanghvi, George Schmid, Judith Senderowitz, Jacqueline Sherris, Nono Simelela, Irving Sivin, Jenni Smit, David Sokal, Jeff Spieler, Kay Stone, Maryanne Stone-Jimenez, Fatiha Terki, Kathleen Vickery, Lee Warner, Mary Nell Wegner, Peter Weis, and Tim Williams. Family planning providers in Bangladesh, Brazil, China, Ghana, India, Indonesia, Kenya, Pakistan, the Philippines, and Zambia offered comments on draft covers and chapters of the book in Acknowledgements JHU HBk18 - A1 - Front matter.indd 8 1/26/18 09:41 sessions organized by Yasmin Ahmed, Ekta Chandra, Miriam Chipimo, Sharmila Das, Juan Diaz, Carlos Huezo, Enriquito Lu, Isaiah Ndong, Samson Radeny, Mary Segall, Sarbani Sen, Nina Shalita, Bulbul Sood, and Wu Shangchun. John Fiege, Linda Sadler, and Rafael Avila created the layout of the book. Mark Beisser created the cover and initial design along with Linda Sadler, the staff at Prographics, and John Fiege. Rafael Avila managed the photographs and illustrations. Ushma Upadhyay, Vera Zlidar, and Robert Jacoby managed the book’s production. Heather Johnson managed printing and distribution of the handbook along with Mandy Liberto, Tre Turner, Roslyn Suite-Parham, and Quan Wynder. Second edition, 2011 The 2011 update incorporated all guidance from the WHO expert Working Group meeting in April 2008 for the Medical Eligibility Criteria and the Selected Practice Recommendations, and two Technical Consultations related to these guidelines in October 2008 and January 2010. It also incorporated guidance from an expert Working Group meeting on HIV and infant feeding in October 2009 and a Technical Consultation on community-based provision of injectable contraceptives in June 2009. Selected members of the expert Working Group that met in 2005, experts who contributed to the handbook, and WHO staff contributed to and reviewed the update. They included Mario Festin, Mary Lyn Gaffield, Lucy Harber, Douglas Huber, Roy Jacobstein, Kirsten Krueger, Enriquito Lu, James Shelton, Jeff Spieler, and Irina Yacobson. Ward Rinehart and Sarah Johnson of Jura Editorial Services managed and edited the 2011 update. Third edition, 2018 This update of the Global Handbook has involved a complete review of the contents of the 2011 edition and updating as needed. All chapters reflect the latest relevant WHO guidance. Thus, this update includes the recommendations of the fifth edition of the Medical Eligibility Criteria for Contraceptive Use, published in 2016, and of the third edition of the Selected Practice Recommendations for Contraceptive Use, published in 2016. (The bibliography on p. 422 lists WHO guidance documents.) The following people contributed to this edition of the Global Handbook: Afeefa Abdur-Rahman, Moazzam Ali, Avni Amin, Ian Askew, Michal Avni, Rachel Baggaley, Beth Balderston, Pritha Biswas, Nathalie Broutet, Levent Cagatay, Heather Clark, Carmela Cordero, Jane Cover, Margaret D’Adamo, Hugo de Vuyst, Juan Diaz, Jennifer Drake, Jill Edwardson, Mohammed Eslami, Mario Festin, Melissa Freeman, Mary Lyn Gaffield, Victoria Graham, Metin Gulmezoglu, Denise Harrison, Roy Jacobstein, James Kiarie, Maggie Kilbourne-Brook, Robert Lande, Catherine Lane, Candace Lew, Enriquito (Ricky) Lu, Patricia MacDonald, Baker Maggwa, Shawn Malarcher, Judy Manning, Rachel Marcus, Jennifer Mason, Ruth Merkatz, Maureen Norton, Stephen Nurse- Findlay, Sarah Onyango, Kevin Peine, Rabab Petit, Kate Rademacher, Andrea Roe, Nigel Rollins, Vicky Samantha Rossi, Frans Roumen, Abdulmumin Saad, James Shelton, Jacqueline Sherris, Katherine Simmons, Regine Sitruk-Ware, Shelley Snyder, Jeff Spieler, Markus Steiner, Petrus Steyn, Melanie Taylor, Caitlin Thistle, Sara Tifft, John Townsend, James Trussell, Sheryl van der Poel, Elizabeth Westley, Teodora Wi, and Irina Yacobson. Sarah Johnson and Ward Rinehart of Jura Editorial Services managed and edited the 2018 update. Several groups contributed new content to this edition. Beth Balderston, Jane Cover, Jenifer Drake, and Sara Tifft at PATH contributed the sections on giving subcutaneous injections in Chapter 4, Progestin-only Injectables. Heather Clark at the Population Council prepared Chapter 8, Progesterone-Releasing Vaginal Ring. Roy Jacobstein at Intrah and Markus Steiner at FHI 360 developed the section on counseling about effectiveness in Chapter 25, Family Planning Provision. John Stanback, Irina Yacobson, and Lucy Harber at FHI 360 created the job aids and text in the section on ruling out pregnancy (pages 439–440). The Knowledge for Health Project at the Johns Hopkins Bloomberg School of Public Health, Center for Communication Programs, manages the production of the handbook and its distribution, with support from the United States Agency for International Development. Tara Sullivan is Project Director. As Operations Manager, Heather Finn oversaw development of this update. Susan Krenn directs the Center for Communication Programs. ixAcknowledgements JHU HBk18 - A1 - Front matter.indd 9 1/26/18 09:41 WHO’s Family Planning Guidance The World Health Organization (WHO) develops guidance through a process that begins with systematic review and assessment of research evidence on key public health questions. Then, WHO convenes working groups of experts from around the world. The working groups assess the implications of the evidence and make recommendations for health care services and practice. Policy-makers and program managers can use these recommendations to write or update national guidelines and program policies. Using this process, the Department of Reproductive Health and Research issues guidance on specific issues as important questions arise. It also maintains 2 sets of guidance that are updated and expanded periodically:  The Medical Eligibility Criteria for Contraceptive Use provides guidance on whether people with certain medical conditions can safely and effective- ly use specific contraceptive methods.  The Selected Practice Recommendations for Contraceptive Use answers questions about how to use various contraceptive methods. This book, Family Planning: A Global Handbook for Providers, offers technical information to help health care providers deliver family planning methods appropriately and effectively. It incorporates and reflects the Medical Eligibility Criteria and the Selected Practice Recommendations as well as other WHO guidance. This third edition brings the Global Handbook up to date with current WHO guidance on all topics covered. A thorough reference guide, the handbook provides specific and practical guidance on 21 family planning methods. It also covers health issues that may arise in the context of family planning services. The intended primary audience for this handbook is health care providers who offer family planning in resource-limited settings around the world. Health care managers, supervisors, and policy-makers also may find this book helpful. The Decision-Making Tool for Family Planning Clients and Providers incorporates WHO guidance into a tool that helps family planning providers and clients to discuss family planning choices and helps clients make informed decisions. This flipchart tool leads provider and client through a structured yet tailored process that facilitates choosing and using a family planning method. The tool also helps to guide return visits by family planning clients. x Family Planning: A Global Handbook for Providers JHU HBk18 - A1 - Front matter.indd 10 1/26/18 09:41 WHO’s Family Planning Guidance Together, these 4 publications—the Medical Eligibility Criteria, the Selected Practice Recommendations, the Global Handbook, and the Decision-Making Tool—are known as the 4 Cornerstones of WHO’s family planning guidance. On the Internet:  Medical Eligibility Criteria: www.who.int/reproductivehealth/publications/ family_planning/MEC-5/en/  Selected Practice Recommendations: www.who.int/reproductivehealth/ publications/family_planning/SPR-3/en/  Family Planning: A Global Handbook for Providers: www.fphandbook.org  Decision-Making Tool for Family Planning Clients and Providers: www.who. int/reproductivehealth/publications/family_planning/9241593229index/en/ xi JHU HBk18 - A1 - Front matter.indd 11 1/26/18 09:41 Human Rights: Family Planning Providers’ Contribution All people deserve the right to determine, as best they can, the course of their own lives. Whether and when to have children, how many, and with whom are important parts of this right. Family planning providers have the privilege and responsibility to help people to make and carry out these decisions. Furthermore, programs that honor their clients’ human rights contribute to positive sexual health outcomes. Thus, high-quality family planning services and the people who deliver them respect, protect, and fulfill the human rights of all their clients. Everyone working at every level of the health system plays an important part. Health care providers express their commitment to human rights every day in every contact with every client. Nine human rights principles guide family planning services. As a family planning provider, you contribute to all of them. Non-discrimination What you can do: Welcome all clients equally. Respect every client’s needs and wishes. Set aside personal judgments and any negative opinions. Promise yourself to give every client the best care you can. Availability of contraceptive information and services What you can do: Know the family planning methods available and how to provide them. Help make sure that supplies stay in stock. Do not rule out any method for a client, and do not hold back information. Accessible information and services What you can do: Help make sure that everyone can use your facility, even if they have a physical disability. Participate in outreach, when possible. Do not ask clients, even young clients, to get someone else’s permission to use family planning or a certain family planning method. Principle 1 Principle 2 Principle 3 xii Family Planning: A Global Handbook for Providers JHU HBk18 - A1 - Front matter.indd 12 1/26/18 09:41 Acceptable information and services What you can do: Be friendly and welcoming, and help make your facility that way. Put yourself in the client’s shoes. Think what is important to the clients—what they want and how they want it provided. Quality What you can do: Keep your knowledge and skills up-to-date. Use good communication skills. Check that contraceptives you provide are not out-of-date. Informed decision-making What you can do: Explain family planning methods clearly, including how to use them, how effective they are, and what side effects they may have, if any. Help clients consider what is important to them in a family planning method. Privacy and confidentiality What you can do: Do not discuss your clients with others except with permission and as needed for their care. When talking with clients, find a place where others cannot hear. Do not tell others what your clients have said. Promptly put away clients’ records. Participation What you can do: Ask clients what they think about family planning services. Act on what they say to improve care. Accountability What you can do: Hold yourself accountable for the care that you give clients and for their rights. Principle 4 Principle 5 Principle 6 Principle 7 Principle 8 Principle 9 These human rights principles guide WHO’s work and serve as the framework for WHO’s guidance on contraceptive methods. The full statement of these principles can be found in Ensuring human rights in the provision of contraceptive information and services: Guidance and recommendations; 2014 (http://www.who.int/reproductivehealth/ publications/family_planning/human-rights-contraception/en/). Human Rights: Family Planning Providers’ Contribution xiii JHU HBk18 - A1 - Front matter.indd 13 1/26/18 09:41 xiv Family Planning: A Global Handbook for Providers Collaborating and Supporting Organizations Abt Associates African Population and Health Research Center (APHRC) Afrihealth Optonet Association (CSOs Network), Nigeria Al-Mustafa Welfare Association (CSOs Network), Sindh Amref Health Africa Ansul-India Health & Management Services (AIHMS) Asesorías Internacionales en Salud Integral y Desarrollo (ASID), Costa Rica Asociación Hondureña de Planificación de Familia (ASHONPLAFA) Asociación Pro Bienestar de la Familia de Guatemala (APROFAM) Asociación TAN UX’IL, Guatemala Associação Moçambicana de Obstetras e Ginecologistas (AMOG) Association Burkinabè pour le bien être familal (ABBEF) du Burkina Faso Association for the Well-Being of the Colombian Family (Profamilia) Association of Reproductive Health Professionals (ARHP) Association for Reproductive and Family Health Balanced Stewardship Development Association Bill & Melinda Gates Institute for Population and Reproductive Health Bixby Center for Global Reproductive Health, University of California, San Francisco Bridges of Hope Training CARE International CARE USA Carolina Population Center, University of North Carolina at Chapel Hill Centre for the Development of People (CEDEP), Ghana Centro de Investigación y Promoción para América Central de Derechos Humanos – CIPAC, Costa Rica Chemonics CILSIDA, Togo Civil Society for Family Planning in Nigeria (CiSFP) Concept Foundation Consortium of Reproductive Health Associations (CORHA). CORE Group Croatian Society for Reproductive Medicine and Gynecologic Endocrinology of Croatian Medical Association Cultural Practice, LLC East European Institute for Reproductive Health EngenderHealth Equilibres & Populations Family Guidance Association of Ethiopia Family Planning Association of Swaziland Federation of Obstetric & Gynecological Societies of India Female Health Company FHI 360 Foundation for Integrated Rural Development (FIRD), Uganda FP2020 FUSA AC, Argentina Georgetown University, Institute for Reproductive Health JHU HBk18 - A1 - Front matter.indd 14 1/26/18 09:41 Human Rights: Family Planning Providers’ Contribution xv Grameen Foundation USA (GF USA) Guttmacher Institute Health NGOs Network (HENNET) Health, Development and Performance (HDP), Rwanda Hesperian Health Guides Hindustan Latex Family Planning Promotion Trust (HLFPPT) Implementing Best Practices (IBP) Consortium Initiative Supporting Adolescents & Youths in Education and Sexual Health (ISAYES), Nigeria Institute of Health Management, Pachod (IHMP) Institute of Tropical Medicine, Antwerp, Belgium Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán. Intensive Rescue Foundation International (IRFI) International Community of Women Living with HIV International Community of Women Living with HIV – Eastern Africa (ICWEA) International Confederation of Midwives International Consortium for Emergency Contraception (ICEC) International Federation of Gynecology and Obstetrics (FIGO) International Islamic Center for Population Studies and Research (IICPSR) – Al Azhar University. International Medical Corps International Planned Parenthood Federation (IPPF) International Planned Parenthood Federation/Western Hemisphere Region (IPPF/WHR) IntraHealth International, Inc. Investigación en Salud y Demografía, S.C. (INSAD) Ipas Africa Alliance Jhpiego John Snow, Inc (JSI) Johns Hopkins Bloomberg School of Public Health Kwa-Zulu Natal Maternal Women, Child and Nutrition Directorate Last Mile Health and Development Association, Nigeria LiveWell Initiative LWI, Nigeria Management Sciences for Health (MSH) Marie Stopes International Ministry of Health and Medical Services, Solomon Islands Ministry of Health Belize Ministry of Health of the Republic of Zambia Mozambican Association for Family Development (AMODEFA) Muslim Family Counselling Services National Population and Family Planning Board, Indonesia Network of People Living with HIV/AIDS in Nigeria (NEPHWAN) NGALAKERI Options Consultancy Services Overseas Strategic Consulting, Ltd Palladium Pan African Positive Women’s Coalition, Zimbabwe Pan American Health Organization, Latin American Center for Perinatology, Women and Reproductive Health (CLAP/WR-PAHO/WHO) PATH Pathfinder International PLAFAM, Asociación Civil de Planificación Familiar Plan International Planned Parenthood Association of Ghana (PPAG) JHU HBk18 - A1 - Front matter.indd 15 1/26/18 09:41 xvi Family Planning: A Global Handbook for Providers Planned Parenthood Association of Zambia (PPAZ) Planned Parenthood Global Population Council Population Foundation of India (PFI) Population Media Center (PMC) Population Reference Bureau Population Services International (PSI) Princeton University, Office of Population Research PT Tunggal Idaman Abdi Public Health Informatics Foundation (PHIF) Public Health Institute (PHI) Real Agency for Community Development (RACD), Uganda Reproductive Health Supplies Coalition (RHSC) Reproductive Health Uganda (RHU) Réseau Siggil Jigéen Sénégal Romanian Family Planning Network Rotarian Action Group for Population & Development (RFPD) Salud y Famila Save the Children SOCOBA Inc. (Society for Children Orphaned by AIDS) Trust Women Foundation Tulane University School of Public Health and Tropical Medicine Uganda Youth Alliance for Family Planning and Adolescent Health (UYAFPAH) United Nations Population Fund University of Gadjah Mada (UGM), Indonesia University of North Carolina Gillings School of Global Public Health University of the Witwatersrand, Reproductive Health and HIV Institute University Research Co., LLC Venture Strategies for Health and Development We Care Solar Wellbeing Foundation Africa West African Health Organization (WAHO) WINGS/ALAS Guatemala YLabs Zimbabwe National Family Planning Council (ZNFPC) COLLABORATING AND SUPPORTING ORGANIZATIONS (continued) JHU HBk18 - A1 - Front matter.indd 16 1/26/18 09:41 1 C o m b in ed O r a l C o n t r a c ep t iv es 1 What Are Combined Oral Contraceptives?  Pills that contain low doses of 2 hormones—a progestin and an estrogen—like the natural hormones progesterone and estrogen in a woman’s body.  Combined oral contraceptives (COCs) are also called “the Pill,” low-dose combined pills, OCPs, and OCs.  Work primarily by preventing the release of eggs from the ovaries (ovulation). How Effective? Effectiveness depends on the user: Risk of pregnancy is greatest when a woman starts a new pill pack 3 or more days late, or misses 3 or more pills near the beginning or end of a pill pack. Combined Oral Contraceptives CHAPTER 1 Combined Oral Contraceptives Key Points for Providers and Clients  Take one pill every day. For greatest effectiveness a woman must take pills daily and start each new pack of pills on time.  Take any missed pill as soon as possible. Missing pills risks pregnancy and may make some side effects worse.  Bleeding changes are common but not harmful. Typically, there is irregular bleeding for the first few months and then lighter and more regular bleeding.  Can be given to a woman at any time to start now or later. 1 JHU HBk18 - Chapter 1.indd 1 1/26/18 09:48 2 Family Planning: A Global Handbook for Providers  As commonly used, about 7 pregnancies per 100 women using COCs over the first year. This means that 93 of every 100 women using COCs will not become pregnant.  When no pill-taking mistakes are made, less than 1 pregnancy per 100 women using COCs over the first year (3 per 1,000 women). Return of fertility after COCs are stopped: No delay Protection against sexually transmitted infections (STIs): None Side Effects, Health Benefits, and Health Risks Side Effects (see also Managing Any Problems, p. 20) Some users report the following:  Changes in bleeding patterns,† including: – Lighter bleeding and fewer days of bleeding – Irregular bleeding – Infrequent bleeding – No monthly bleeding  Headaches  Dizziness  Nausea  Breast tenderness  Weight change (see Question 6, p. 25)  Mood changes  Acne (can improve or worsen, but usually improves) Other possible physical changes:  Blood pressure increases a few points (mm Hg). When increase is due to COCs, blood pressure declines quickly after use of COCs stops. Why Some Women Say They Like Combined Oral Contraceptives  Are controlled by the woman  Can be stopped at any time without a provider’s help  Do not interfere with sex  Are easy to use  Easy to obtain, for example, in drug shops or pharmacies More effective Less effective Bleeding changes are normal and not harmful. If a woman finds them bothersome, counseling and support can help. † For definitions of bleeding patterns, see “vaginal bleeding,” page 407. JHU HBk18 - Chapter 1.indd 2 1/26/18 09:48 1 C o m b in ed O r a l C o n t r a c ep t iv es 3Combined Oral Contraceptives Known Health Benefits Known Health Risks Help protect against:  Risks of pregnancy  Cancer of the lining of the uterus (endometrial cancer)  Cancer of the ovary  Symptomatic pelvic inflammatory disease May help protect against:  Ovarian cysts  Iron-deficiency anemia Reduce:  Menstrual cramps  Menstrual bleeding problems  Ovulation pain  Excess hair on face or body  Symptoms of polycystic ovarian syndrome (irregular bleeding, acne, excess hair on face or body)  Symptoms of endometriosis (pelvic pain, irregular bleeding) Very rare:  Blood clot in deep veins of legs or lungs (deep vein thrombosis or pulmonary embolism) Extremely rare:  Stroke  Heart attack See also Facts About Combined Oral Contraceptives and Cancer, p. 4. Correcting Misunderstandings (see also Questions and Answers, p. 25) Combined oral contraceptives:  Do not build up hormones in a woman’s body. Women do not need a “rest” from taking COCs.  Must be taken every day, whether or not a woman has sex that day.  Do not make women infertile after they stop taking COCs.  Do not cause birth defects or multiple births.  Do not change women’s sexual behavior.  Do not collect in the stomach. Instead, the pill dissolves each day.  Do not disrupt an existing pregnancy. JHU HBk18 - Chapter 1.indd 3 1/26/18 09:48 4 Family Planning: A Global Handbook for Providers Facts About Combined Oral Contraceptives and Cancer Overall risk of developing cancer over a lifetime is similar among women who have used COCs and women who have not used COCs. COC users may have small increases in risk of some types of cancer, but they also have long-term reductions in other types of cancer. Ovarian and endometrial cancer  Use of COCs helps protect users from 2 important kinds of cancer—cancer of the ovaries and cancer of the lining of the uterus (endometrial cancer).  This protection continues for 15 years or more after stopping use of COCs. Breast cancer  Research findings about COCs and breast cancer are difficult to interpret: – Studies find that women who used COCs more than 10 years ago face the same risk of breast cancer as similar women who have never used COCs. In contrast, some studies find that current users of COCs and women who have used COCs within the past 10 years are slightly more likely to be diagnosed with breast cancer. On balance, there may be little difference in lifetime risk. It is unclear whether these findings are explained by earlier detection of existing breast cancers among COC users or by a biologic effect of COCs on breast cancer. – Previous use of COCs does not increase the risk of breast cancer later in life, when breast cancer is more common. – When a current or former COC user is diagnosed with breast cancer, the cancers generally are less advanced than cancers diagnosed in other women. – COC use does not increase risk of breast cancer for women whose relatives have had breast cancer. Cervical cancer  Cervical cancer is caused by certain types of human papillomavirus (HPV). HPV is a common sexually transmitted infection that usually clears on its own without treatment, but sometimes it persists and sometimes leads to cervical cancer. A vaccine can help to prevent cervical cancer. (See Cervical Cancer, p. 340.) If cervical screening is available, providers can advise all women to be screened every 3 years (or as national guidelines recommend).  Use of COCs for 5 years or more appears to increase slightly the risk of cervical cancer. After a woman stops using COCs, this risk decreases. By 10 years after stopping COCs, a former COC user has the same risk of cervical cancer as a woman who has never used COCs. The number of cervical cancers associated with COC use is small. Other cancers  Use of COCs may decrease the risk of colorectal cancer.  There is no clear evidence that COC use either decreases or increases the risk of any other type of cancer. JHU HBk18 - Chapter 1.indd 4 1/26/18 09:48 1 C o m b in ed O r a l C o n t r a c ep t iv es 5 Who Can and Cannot Use Combined Oral Contraceptives Safe and Suitable for Nearly All Women Nearly all women can use COCs safely and effectively, including women who:  Have or have not had children  Are married or are not married  Are of any age, including adolescents and women over 40 years old  After childbirth and during breastfeeding, after a period of time  Have just had an abortion, miscarriage, or ectopic pregnancy  Smoke cigarettes—if under 35 years old  Have anemia now or had in the past  Have varicose veins  Are living with HIV, whether or not on antiretroviral therapy Avoid Unnecessary Procedures (see Importance of Procedures, p. 368) Women can begin using COCs:  Without a pelvic examination  Without any blood tests or other routine laboratory tests  Without cervical cancer screening  Without a breast examination  Without a pregnancy test. A woman can begin using COCs at any time, even when she is not having monthly bleeding at the time, if it is reasonably certain she is not pregnant (see Pregnancy Checklist, inside back cover). Who Can and Cannot Use Combined Oral Contraceptives Blood pressure measurement is desirable before starting a hormonal method. However, where the risks of pregnancy are high and few methods are available, a woman should not be denied a hormonal method simply because her blood pressure cannot be measured. If possible, she can have her blood pressure measured later at a time and place convenient for her. JHU HBk18 - Chapter 1.indd 5 1/26/18 09:48 6 Family Planning: A Global Handbook for Providers Ask the client the questions below about known medical conditions. Examinations and tests are not necessary. If she answers “no” to all of the questions, then she can start COCs if she wants. If she answers “yes” to a question, follow the instructions. In some cases she can still start COCs. These questions also apply for the combined patch (see p. 117) and the combined vaginal ring (see p. 123). Medical Eligibility Criteria for Combined Oral Contraceptives 1. Are you breastfeeding a baby less than 6 months old? R NO R YES  If fully or nearly fully breastfeeding: Give her COCs and tell her to start taking them 6 months after giving birth or when breast milk is no longer the baby’s main food—whichever comes first (see Fully or nearly fully breastfeeding, p. 11).  If partially breastfeeding: She can start COCs as soon as 6 weeks after childbirth (see Partially breastfeeding, p. 12). 2. Have you had a baby in the last 3 weeks and you are not breastfeeding? R NO R YES Give her COCs now and tell her to start taking them 3 weeks after childbirth. (If there is an additional risk that she might develop a blood clot in a deep vein (deep vein thrombosis, or VTE), then she should not start COCs at 3 weeks after childbirth, but start at 6 weeks instead. These additional risk factors include previous VTE, thrombophilia, caesarean delivery, blood transfusion at delivery, postpartum hemorrhage, pre-eclampsia, obesity (>_30 kg/m2), smoking, and being bedridden for a prolonged time.) 3. Do you smoke cigarettes? R NO R YES If she is 35 years of age or older and smokes, do not provide COCs. Urge her to stop smoking and help her choose another method, but not patch or ring if she smokes fewer than 15 cigarettes a day, and also not monthly injectables if more than 15 cigarettes a day. JHU HBk18 - Chapter 1.indd 6 1/26/18 09:48 1 C o m b in ed O r a l C o n t r a c ep t iv es 7 4. Do you have cirrhosis of the liver, a liver infection, or liver tumor? Have you ever had jaundice when using COCs? R NO R YES If she reports serious liver disease (such as severe cirrhosis or liver tumor), acute or flare of viral hepatitis, or ever had jaundice while using COCs, do not provide COCs. Help her choose a method without hormones. (She can use monthly injectables if she has had jaundice only with past COC use.) 5. Do you have high blood pressure? R NO R YES If you cannot check blood pressure and she reports a history of high blood pressure, or if she is being treated for high blood pressure, do not provide COCs. Refer her for a blood pressure check if possible or help her choose a method without estrogen. Check blood pressure if possible:  If her blood pressure is below 140/90 mm Hg, provide COCs. No need to retest before starting COCs.  If blood pressure is 160/100 mm Hg or higher, do not provide COCs. Help her choose a method without estrogen, but not a progestin-only injectable.  If blood pressure is 140–159/90–99 mm Hg, one measurement is not enough to diagnose high blood pressure. Give her a backup method* to use until she can return for another blood pressure measurement, or help her choose another method. − If her next blood pressure measurement is below 140/90 mm Hg, she can start COCs. − However, if her next blood pressure measurement is 140/90 mm Hg or higher, do not provide COCs. Help her choose a method without estrogen, but not a progestin-only injectable if systolic blood pressure is 160 or higher or diastolic pressure is 100 or higher. (See also Question 18, p. 28.) * Backup methods include abstinence, male and female condoms, spermicides, and withdrawal. Tell her that spermicides and withdrawal are the least effective contraceptive methods. If possible, give her condoms. (Continued on next page) Who Can and Cannot Use Combined Oral Contraceptives JHU HBk18 - Chapter 1.indd 7 1/26/18 09:48 8 Family Planning: A Global Handbook for Providers 6. Have you had diabetes for more than 20 years or damage to your arteries, vision, kidneys, or nervous system caused by diabetes? R NO R YES Do not provide COCs. Help her choose a method without estrogen but not progestin-only injectables. 7. Do you have gallbladder disease now or take medication for gallbladder disease? R NO R YES Do not provide COCs. Help her choose another method but not the combined patch or combined vaginal ring. 8. Have you ever had a stroke, blood clot in your leg or lungs, heart attack, or other serious heart problems? R NO R YES If she reports heart attack, heart disease due to blocked or narrowed arteries, or stroke, do not provide COCs. Help her choose a method without estrogen but not progestin-only injectables. If she reports a current blood clot in the deep veins of the legs (not superficial clots) or lungs, help her choose a method without hormones. 9. Do you have or have you ever had breast cancer? R NO R YES Do not provide COCs. Help her choose a method without hormones. 10. Do you sometimes see a bright area of lost vision in the eye before a very bad headache (migraine aura)? Do you get throbbing, severe head pain, often on one side of the head, that can last from a few hours to several days and can cause nausea or vomiting (migraine headaches)? Such headaches are often made worse by light, noise, or moving about. R NO R YES If she has migraine aura at any age, do not provide COCs. If she has migraine headaches without aura and is age 35 or older, do not provide COCs. Help these women choose a method without estrogen. If she is under 35 and has migraine headaches without aura, she can use COCs (see Identifying Migraine Headaches and Auras, p. 436). Medical Eligibility Criteria for Combined Oral Contraceptives (continued) (Continued on next page)JHU HBk18 - Chapter 1.indd 8 1/26/18 09:48 1 C o m b in ed O r a l C o n t r a c ep t iv es 9 Combined Oral Contraceptives for Women With HIV  Women living with HIV or on antiretroviral therapy can safely use COCs.  Urge these women to use condoms along with COCs. Used consistently and correctly, condoms help prevent transmission of HIV and other STIs. Who Can and Cannot Use Combined Oral Contraceptives 11. Are you taking medications for seizures? Are you taking rifampicin or rifabutin for tuberculosis or other illness? R NO R YES If she is taking barbiturates, carbamazepine, lamotrigine, oxcarbazepine, phenytoin, primidone, topiramate, rifampicin, or rifabutin, do not provide COCs. They can make COCs less effective. Help her choose another method but not progestin-only pills, patch, or combined ring. If she is taking lamotrigine, help her choose a method without estrogen. 12. Are you planning major surgery that will keep you from walking for one week or more? R NO R YES If so, she can start COCs 2 weeks after she can move about again. Until she can start COCs, she should use a backup method. 13. Do you have several conditions that could increase your chances of heart disease (coronary artery disease) or stroke, such as older age, smoking, high blood pressure, or diabetes? R NO R YES Do not provide COCs. Help her choose a method without estrogen but not progestin-only injectables. Also, women should not use COCs if they report having thrombogenic mutations or lupus with positive (or unknown) antiphospholipid antibodies. For complete classifications, see Medical Eligibility Criteria for Contraceptive Use, p. 388. Be sure to explain the health benefits and risks and the side effects of the method that the client will use. Also, point out any conditions that would make the method inadvisable, when relevant to the client. JHU HBk18 - Chapter 1.indd 9 1/26/18 09:48 10 Family Planning: A Global Handbook for Providers Using Clinical Judgment in Special Cases Usually, a woman with any of the conditions listed below should not use COCs. In special circumstances, however, when other, more appropriate methods are not available or acceptable to her, a qualified provider who can carefully assess a specific woman’s condition and situation may decide that she can use COCs. The provider needs to consider the severity of her condition and, for most conditions, whether she will have access to follow-up.  Not breastfeeding and less than 3 weeks since giving birth, without addi- tional risk that she might develop a blood clot in a deep vein (VTE)  Not breastfeeding and between 3 and 6 weeks postpartum with additional risk that she might develop VTE  Primarily breastfeeding between 6 weeks and 6 months since giving birth  Age 35 or older and smokes fewer than 15 cigarettes a day  High blood pressure (systolic blood pressure between 140 and 159 mm Hg or diastolic blood pressure between 90 and 99 mm Hg)  Controlled high blood pressure, where continuing evaluation is possible  History of high blood pressure, where blood pressure cannot be taken (including pregnancy-related high blood pressure)  History of jaundice while using COCs in the past  Gallbladder disease (current or medically treated)  Age 35 or older and has migraine headaches without aura  Younger than age 35 and has migraine headaches without aura that have developed or have gotten worse while using COCs  Had breast cancer more than 5 years ago, and it has not returned  Diabetes for more than 20 years or damage to arteries, vision, kidneys, or nervous system caused by diabetes  Multiple risk factors for arterial cardiovascular disease such as older age, smoking, diabetes, and high blood pressure  Taking barbiturates, carbamazepine, oxcarbazepine, phenytoin, primidone, topiramate, rifampicin, or rifabutin. A backup contraceptive method should also be used because these medications reduce the effectiveness of COCs.  Taking lamotrigine. Combined hormonal methods may make lamotrigine less effective. JHU HBk18 - Chapter 1.indd 10 1/26/18 09:48 1 C o m b in ed O r a l C o n t r a c ep t iv es 11 Providing Combined Oral Contraceptives When to Start IMPORTANT: A woman can start using COCs any time she wants if it is reasonably certain she is not pregnant. To be reasonably certain she is not pregnant, use the Pregnancy Checklist (see inside back cover). Also, a woman can be given COCs at any time and told when to start taking them. * Backup methods include abstinence, male and female condoms, spermicides, and withdrawal. Tell her that spermicides and withdrawal are the least effective contraceptive methods. If possible, give her condoms. Woman’s situation When to start Having menstrual cycles or switching from a nonhormonal method Any time of the month  If she is starting within 5 days after the start of her monthly bleeding, no need for a backup method.  If it is more than 5 days after the start of her monthly bleeding, she can start COCs any time it is reasonably certain she is not pregnant. She will need a backup method* for the first 7 days of taking pills. (If you cannot be reasonably cer- tain, see How and When to Use the Pregnancy Checklist and Pregnancy Tests, p. 440.)  If she is switching from an IUD, she can start COCs immediately (see Copper-Bearing IUD, Switching From an IUD to Another Method, p. 172). Switching from a hormonal method  Immediately, if she has been using the hormonal method consistently and correctly or if it is otherwise reasonably certain she is not pregnant. No need to wait for her next monthly bleeding. No need for a backup method.  If she is switching from injectables, she can begin taking COCs when the repeat injection would have been given. No need for a backup method. Fully or nearly fully breastfeeding Less than 6 months after giving birth  Give her COCs and tell her to start taking them 6 months after giving birth or when breast milk is no longer the baby’s main food— whichever comes first. Providing Combined Oral Contraceptives JHU HBk18 - Chapter 1.indd 11 1/26/18 09:48 12 Family Planning: A Global Handbook for Providers † Where a visit 6 weeks after childbirth is routinely recommended and other opportunities to obtain contraception are limited, some providers and programs may give COCs at the 6-week visit, without further evidence that the woman is not pregnant, if her monthly bleeding has not yet returned. Woman’s situation When to start Fully or nearly fully breastfeeding (continued)  If her monthly bleeding has not returned, she can start COCs any time it is reasonably certain she is not pregnant. She will need a backup method for the first 7 days of taking pills. (If you cannot be reasonably certain, see How and When to Use the Pregnancy Checklist and Pregnancy Tests, p. 440.)  If her monthly bleeding has returned, she can start COCs as advised for women having menstrual cycles (see previous page). More than 6 months after giving birth Partially breastfeeding  Give her COCs and tell her to start taking them 6 weeks after giving birth.  Also give her a backup method to use until 6 weeks since giving birth if her monthly bleeding returns before this time. Less than 6 weeks after giving birth More than 6 weeks after giving birth  If her monthly bleeding has not returned, she can start COCs any time it is reasonably certain she is not pregnant.† She will need a backup method for the first 7 days of taking pills. (If you cannot be reasonably certain, see How and When to Use the Pregnancy Checklist and Pregnancy Tests, p. 440.)  If her monthly bleeding has returned, she can start COCs as advised for women having menstrual cycles (see previous page). JHU HBk18 - Chapter 1.indd 12 1/26/18 09:48 1 C o m b in ed O r a l C o n t r a c ep t iv es 13Providing Combined Oral Contraceptives More than 4 weeks after giving birth  If her monthly bleeding has not returned, she can start COCs any time it is reasonably certain she is not pregnant.† She will need a backup method for the first 7 days of taking pills. (If you cannot be reasonably certain, see How and When to Use the Pregnancy Checklist and Pregnancy Tests, p. 440.)  If her monthly bleeding has returned, she can start COCs as advised for women having menstrual cycles (see p. 11). No monthly bleeding (not related to childbirth or breastfeeding)  She can start COCs any time it is reasonably certain she is not pregnant. She will need a backup method for the first 7 days of taking pills. After miscarriage or abortion  Immediately. If she is starting within 7 days after first- or second-trimester miscarriage or abortion, no need for a backup method.  If it is more than 7 days after first- or second- trimester miscarriage or abortion, she can start COCs any time it is reasonably certain she is not pregnant. She will need a backup method for the first 7 days of taking pills. (If you cannot be reasonably certain, see How and When to Use the Pregnancy Checklist and Pregnancy Tests, p. 440.) Woman’s situation When to start Not breastfeeding  She can start COCs at any time on days 21–28 after giving birth. Give her pills any time to start during these 7 days. No need for a backup method. (If additional risk for VTE, wait until 6 weeks. See Question 2, p. 6.) Less than 4 weeks after giving birth JHU HBk18 - Chapter 1.indd 13 1/26/18 09:48 14 Family Planning: A Global Handbook for Providers After taking emergency contraceptive pills (ECPs) After taking progestin-only or combined ECPs:  She can start or restart COCs immediately after she takes the ECPs. No need to wait for her next monthly bleeding. – A continuing user who needed ECPs due to pill-taking errors can continue where she left off with her current pack.  If she does not start immediately but returns for COCs, she can start at any time if it is reason- ably certain she is not pregnant.  All women will need to use a backup method for the first 7 days of taking pills. Woman’s situation When to start SUN MON TUES WED THU FRI SAT WEEK 1 WEEK 2 WEEK 3 WEEK 4 28 DAY Take all colored pills before taking any w hite pills After taking ulipristal acetate (UPA) ECPs:  She can start or restart COCs on the 6th day after taking UPA-ECPs. No need to wait for her next monthly bleeding. COCs and UPA interact. If COCs are started sooner, and thus both are present in the body, one or both may be less effective.  Give her a supply of pills and tell her to start them on the 6th day after taking the UPA-ECPs.  She will need to use a backup method from the time she takes the UPA-ECPs until she has been taking COCs for 7 days.  If she does not start on the 6th day but returns later for COCs, she may start at any time if it is reasonably certain she is not pregnant. JHU HBk18 - Chapter 1.indd 14 1/26/18 09:48 1 C o m b in ed O r a l C o n t r a c ep t iv es 15Providing Combined Oral Contraceptives Giving Advice on Side Effects IMPORTANT: Thorough counseling about bleeding changes and other side effects is an important part of providing the method. Counseling about bleeding changes may be the most important help a woman needs to keep using the method without concern. Describe the most common side effects  In the first few months, bleeding at unexpected times (irregular bleeding). Then lighter, shorter, and more regular monthly bleeding.  Headaches, breast tenderness, weight change, and possibly other side effects. Explain about these side effects  Side effects are not signs of illness.  Most side effects usually become less or stop within the first few months of using COCs.  Common, but some women do not have them. Explain what to do in case of side effects  Keep taking COCs. Skipping pills risks pregnancy and can make some side effects worse.  Take each pill at the same time every day to help reduce irregular bleeding and also help with remembering.  Take pills with food or at bedtime to help avoid nausea.  The client can come back for help if side effects bother her or if she has other concerns. SUN MON TUES WED THU FRI SAT WEEK 1 WEEK 2 WEEK 3 WEEK 4 28 DAY Take all colored pills before taking any w hite pills SUN MON TUES WED THU FRI SAT WEEK 1 WEEK 2 WEEK 3 WEEK 4 28 DAY Take all colored pills before taking any w hite pills JHU HBk18 - Chapter 1.indd 15 1/26/18 09:48 16 Family Planning: A Global Handbook for Providers Explaining How to Use 1. Give pills  Give up to 1 year’s supply (13 packs) depending on the woman’s preference and planned use. 2. Explain pill pack  Show which kind of pack—21 pills or 28 pills. With 28-pill packs, point out that the last 7 pills are a different color and do not contain hormones (some brands may differ).  Show how to take the first pill from the pack and then how to follow the directions or arrows on the pack to take the rest of the pills. 3. Give key instruction  Take one pill each day— until the pack is empty.  Discuss cues for taking a pill every day. Linking pill-taking to a daily activity—such as cleaning her teeth—may help her remember.  Taking pills at the same time each day helps to remember them. It also may help reduce some side effects. 4. Explain starting next pack  28-pill packs: When she finishes one pack, she should take the first pill from the next pack on the very next day.  21-pill packs: After she takes the last pill from one pack, she should wait 7 days—no more— and then take the first pill from the next pack.  It is very important to start the next pack on time. Starting a pack late risks pregnancy. 5. Provide backup method and explain use  Sometimes she may need to use a backup method, such as when she misses pills.  Backup methods include abstinence, male or female condoms, spermicides, and withdrawal. Tell her that spermicides and withdrawal are the least effective contraceptive methods. Give her condoms, if possible.  If she misses 3 or more hormonal pills, she can consider ECPs. JHU HBk18 - Chapter 1.indd 16 1/26/18 09:48 1 C o m b in ed O r a l C o n t r a c ep t iv es 17Providing Combined Oral Contraceptives Supporting the User Managing Missed Pills It is easy to forget a pill or to be late in taking it. Adolescents are more likely to forget pills and so may need extra support and guidance. COC users should know what to do if they forget to take pills. If a woman misses one or more pills, she should follow the instructions below. Use the tool on p. 431 to help explain these instructions to the client. Making Up Missed Pills With 30–35 µg Estrogen‡ Key message  Take a missed hormonal pill as soon as possible.  Keep taking pills as usual, one each day. (She may take 2 pills at the same time or on the same day.) Missed 1 or 2 pills? Started new pack 1 or 2 days late?  Take a hormonal pill as soon as possible.  Little or no risk of pregnancy. Missed pills 3 or more days in a row in the first or second week? Started new pack 3 or more days late?  Take a hormonal pill as soon as possible.  Use a backup method for the next 7 days.  Also, if she had sex in the past 5 days, she can consider ECPs (see Emergency Contraceptive Pills, p. 49). Missed 3 or more pills in the third week?  Take a hormonal pill as soon as possible.  Finish all hormonal pills in the pack. Throw away the 7 nonhormonal pills in a 28-pill pack.  Start a new pack the next day.  Use a backup method for the next 7 days.  Also, if she had sex in the past 5 days, she can consider ECPs (see Emergency Contraceptive Pills, p. 49). ‡ For pills with 20 µg of estrogen or less, women missing one pill should follow the same guidance as for missing one or two 30–35 µg pills. Women missing 2 or more pills should follow the same guidance as for missing 3 or more 30–35 µg pills. (Continued on next page) JHU HBk18 - Chapter 1.indd 17 1/26/18 09:48 18 Family Planning: A Global Handbook for Providers Missed any non- hormonal pills? (last 7 pills in 28-pill pack)  Discard the missed nonhormonal pill(s).  Keep taking COCs, one each day. Start the new pack as usual. Severe vomiting or diarrhea  If she vomits within 2 hours after taking a pill, she should take another pill from her pack as soon as possible, then keep taking pills as usual.  If she has vomiting or diarrhea for more than 2 days, follow instructions for 3 or more missed pills, above. How Can a Partner Help? The client’s partner is welcome to participate in counseling and learn about the method and what support he can give to his partner. A male partner can:  Support a woman’s choice of COCs  Help her to remember to take a pill each day and to start a new pack on time  Show understanding and support if she has side effects  Help her to make sure that she has a new pill pack on hand to start on time  Help to make sure she has ECPs on hand in case she misses pills or starts a new pill pack late  Use condoms consistently in addition to COCs if he has an STI/HIV or thinks he may be at risk of an STI/HIV JHU HBk18 - Chapter 1.indd 18 1/26/18 09:48 1 C o m b in ed O r a l C o n t r a c ep t iv es 19 “Come Back Any Time”: Reasons to Return Assure every client that she is welcome to come back any time—for example, if she has problems, questions, or wants another method; she has any major change in health status; or she thinks she might be pregnant. Also if:  She needs more pills.  She wants ECPs because she started a new pack 3 or more days late or missed 3 or more hormonal pills or, if she is using pills with 20 µg of estrogen or less, because she started a new pack 2 or more days late or missed 2 or more hormonal pills. General health advice: Anyone who suddenly feels that something is seriously wrong with her health should immediately seek medical care from a nurse or doctor. Her contraceptive method is most likely not the cause of the condition, but she should tell the nurse or doctor what method she is using. Planning the Next Visit 1. Encourage her to come back for more pills before she uses up her supply of pills. 2. An annual visit is recommended. 3. Some women can benefit from contact after 3 months of COC use. This offers an opportunity to answer any questions, help with any problems, and check on correct use. Helping Continuing Users 1. Ask how the client is doing with the method and whether she is satisfied. Ask if she has any questions or anything to discuss. 2. Ask especially if she is concerned about bleeding changes. Give her any information or help that she needs (see Managing Any Problems, next page). 3. Ask if she often has problems remembering to take a pill every day. If so, discuss ways to remember, making up missed pills, and ECPs, or choosing another method. Adolescents may need extra support. 4. Give her more pill packs—a full year’s supply (13 packs), if possible. Plan her next resupply visit before she will need more pills. 5. Every year or so, check blood pressure if possible (see Medical Eligibility Criteria, Question 5, p. 7). 6. Ask a long-term client if she has had any new health problems since her last visit. Address problems as appropriate. For new health problems that may require switching methods, see p. 22. 7. Ask a long-term client about major life changes that may affect her needs—particularly plans for having children and STI/HIV risk. Follow up as needed. Helping Continuing Users of Combined Oral Contraceptives JHU HBk18 - Chapter 1.indd 19 1/26/18 09:48 20 Family Planning: A Global Handbook for Providers Managing Any Problems Problems Reported as Side Effects or Problems With Use May or may not be due to the method.  Problems with side effects affect women’s satisfaction and use of COCs. They deserve the provider’s attention. If the client reports side effects or problems, listen to her concerns, give her advice, and support, and, if appropriate, treat. Make sure she understands the advice and agrees.  Encourage her to keep taking a pill every day even if she has side effects. Missing pills can risk pregnancy and may make some side effects worse.  Many side effects will subside after a few months of use. For a woman whose side effects persist, give her a different COC formulation, if available, for at least 3 months.  Offer to help the client choose another method—now, if she wishes, or if problems cannot be overcome. Missed pills  See Managing Missed Pills, p. 17. Irregular bleeding (bleeding at unexpected times that bothers the client)  Reassure her that many women using COCs experience irregular bleeding. It is not harmful and usually becomes less or stops after the first few months of use.  Other possible causes of irregular bleeding include: – Missed pills – Taking pills at different times each day – Vomiting or diarrhea – Taking anticonvulsants, rifampicin, or rifabutin (see Starting treatment with anticonvulsants, rifampicin or rifabutin, p. 23)  To reduce irregular bleeding: – Urge her to take a pill each day and at the same time each day. – Teach her to make up for missed pills properly, including after vomiting or diarrhea (see Managing Missed Pills, p. 17). – For modest short-term relief, she can try 800 mg ibuprofen 3 times daily after meals for 5 days or other nonsteroidal anti-inflammatory drug (NSAID), beginning when irregular bleeding starts. NSAIDs provide some relief of irregular bleeding for implants, progestin-only injectables, and IUDs, and they may also help for COCs. – If she has been taking the pills for more than a few months and NSAIDs do not help, give her a different COC formulation, if available. Ask her to try the new pills for at least 3 months. JHU HBk18 - Chapter 1.indd 20 1/26/18 09:48 1 C o m b in ed O r a l C o n t r a c ep t iv es 21Helping Continuing Users of Combined Oral Contraceptives  If irregular bleeding continues or starts after several months of normal or no monthly bleeding, or you suspect that something may be wrong for other reasons, consider underlying conditions unrelated to method use (see Unexplained vaginal bleeding, next page). No monthly bleeding  Ask if she is having any bleeding at all. (She may have just a small stain on her underclothing and not recognize it as monthly bleeding.) If she is, reassure her.  Reassure her that some women using COCs stop having monthly bleeding, and this is not harmful. There is no need to lose blood every month. It is similar to not having monthly bleeding during pregnancy. She is not pregnant or infertile. Blood is not building up inside her. (Some women are happy to be free from monthly bleeding, and for some women this may help prevent anemia.)  Ask if she has been taking a pill every day. If so, reassure her that she is not likely to be pregnant. She can continue taking her COCs as before.  Did she skip the 7-day break between packs (21-day packs) or skip the 7 nonhormonal pills (28-day pack)? If so, reassure her that she is not pregnant. She can continue using COCs.  If she has missed hormonal pills or started a new pack late: − She can continue using COCs. − Tell a woman who has missed 3 or more pills or started a new pack 3 or more days late to return if she has signs and symptoms of early pregnancy. − See p. 17 for instructions on how to make up for missed pills. Ordinary headaches (nonmigrainous)  Try the following (one at a time): – Suggest aspirin (325–650 mg), ibuprofen (200–400 mg), paracetamol (325–1000 mg), or other pain reliever. – Some women get headaches during the hormone-free week (the 7 days a woman does not take hormonal pills). Consider extended use (see Extended and Continuous Use of Combined Oral Contraceptives, p. 24).  Any headaches that get worse or occur more often during COC use should be evaluated. Nausea or dizziness  For nausea, suggest taking COCs at bedtime or with food. If symptoms continue:  Consider locally available remedies.  Consider extended use if her nausea comes after she starts a new pill pack (see Extended and Continuous Use of Combined Oral Contraceptives, p. 24). JHU HBk18 - Chapter 1.indd 21 1/26/18 09:48 22 Family Planning: A Global Handbook for Providers Breast tenderness  Recommend that she wear a supportive bra (including during strenuous activity and sleep).  Try hot or cold compresses.  Suggest aspirin (325–650 mg), ibuprofen (200–400 mg), paracetamol (325–1000 mg), or other pain reliever.  Consider locally available remedies. Weight change  Review diet and counsel as needed. Mood changes or changes in sex drive  Some women have changes in mood during the hormone-free week (the 7 days when a woman does not take hormonal pills). Consider extended use (see Extended and Continuous Use of Combined Oral Contraceptives, p. 24).  Ask about changes in her life that could affect her mood or sex drive, including changes in her relationship with her partner. Give her support as appropriate.  Clients who have serious mood changes such as major depression should be referred for care.  Consider locally available remedies. Acne  Acne usually improves with COC use. It may worsen for a few women.  If she has been taking pills for more than a few months and acne persists, give her a different COC formulation, if available. Ask her to try the new pills for at least 3 months.  Consider locally available remedies. New Problems That May Require Switching Methods May or may not be due to the method. Unexplained vaginal bleeding (that suggests a medical condition not related to the method) or heavy or prolonged bleeding  Refer or evaluate by history and pelvic examination. Diagnose and treat as appropriate.  She can continue using COCs while her condition is being evaluated.  If bleeding is caused by sexually transmitted infection or pelvic inflammatory disease, she can continue using COCs during treatment. JHU HBk18 - Chapter 1.indd 22 1/26/18 09:48 1 C o m b in ed O r a l C o n t r a c ep t iv es 23 Starting treatment with anticonvulsants, rifampicin, or rifabutin  Barbiturates, carbamazepine, oxcarbazepine, phenytoin, primidone, topiramate, rifampicin, and rifabutin may make COCs, patch, and combined vaginal ring less effective. Combined hormonal methods, including combined pills and monthly injectables, may make lamotrigine less effective. If using these medications long-term, she may want a different method, such as a progestin-only injectable, implant, a copper- bearing IUD, or an LNG-IUD.  If using these medications short-term, she can use a backup method along with COCs for greater protection from pregnancy. Migraine headaches (see Identifying Migraine Headaches and Auras, p. 436)  Regardless of her age, a woman who develops migraine headaches, with or without aura, or whose migraine headaches become worse while using COCs should stop using COCs.  Help her choose a method without estrogen. Circumstances that will keep her from walking for one week or more  If she is having major surgery, or her leg is in a cast, or for other reasons she will be unable to move about for several weeks, she should: – Tell her doctors that she is using COCs. – Stop taking COCs and use a backup method during this period. – Restart COCs 2 weeks after she can move about again. Certain serious health conditions (suspected heart or serious liver disease, high blood pressure, blood clots in deep veins of legs or lungs, stroke, breast cancer, damage to arteries, vision, kidneys, or nervous system caused by diabetes, or gallbladder disease). See Signs and Symptoms of Serious Health Conditions, p. 384.  Tell her to stop taking COCs.  Give her a backup method to use until the condition is evaluated.  Refer for diagnosis and care if not already under care. Suspected pregnancy  Assess for pregnancy.  Tell her to stop taking COCs if pregnancy is confirmed.  There are no known risks to a fetus conceived while a woman is taking COCs (see Question 5, p. 25). Helping Continuing Users of Combined Oral Contraceptives JHU HBk18 - Chapter 1.indd 23 1/26/18 09:48 24 Family Planning: A Global Handbook for Providers Extended and Continuous Use of Combined Oral Contraceptives Some COC users do not follow the usual cycle of 3 weeks taking hormonal pills followed by one week without hormones. Some women take hormonal pills for 12 weeks without a break, followed by one week of nonhormonal pills (or no pills). This is extended use. Other women take hormonal pills without any breaks at all. This is continuous use. Monophasic pills are recommended for such use (see Question 16, p. 27). Women easily manage taking COCs in different ways when properly advised how to do so. Many women value controlling when they have monthly bleeding—if any—and tailoring pill use as they wish. Benefits of Extended and Continuous Use  Women have vaginal bleeding only 4 times a year or not at all.  Reduces how often some women suffer headaches, premenstrual syndrome, mood changes, and heavy or painful bleeding during the week without hormonal pills. Disadvantages of Extended and Continuous Use  Irregular bleeding may last as long as the first 6 months of use— especially among women who have never before used COCs.  More supplies needed—15 to 17 packs every year instead of 13. Extended Use Instructions  Take 84 hormonal pills in a row, one each day. (These are the hormonal pills in 4 monthly packs.) Users of 28-pill packs do not take the non- hormonal pills.  After 84 hormonal pills, wait 7 days and start the next pack of pills on the 8th day. (Users of 28-pill packs can take the nonhormonal pills in the 4th pack if they wish and start the hormonal pills the day after the last nonhormonal pill.) Expect some bleeding during this week of not taking the hormonal pills. Continuous Use Instructions A woman should take one hormonal pill every day for as long as she wishes to use COCs. If bothersome irregular bleeding occurs, she can stop taking pills for 3 or 4 days and then start taking hormonal pills continuously again. JHU HBk18 - Chapter 1.indd 24 1/26/18 09:48 1 C o m b in ed O r a l C o n t r a c ep t iv es 25Questions and Answers about Combined Oral Contraceptives Questions and Answers About Combined Oral Contraceptives 1. Should a woman take a “rest” from COCs after taking them for a time? No. There is no evidence that taking a “rest” is helpful. In fact, taking a “rest” from COCs can lead to unintended pregnancy. COCs can safely be used for many years without having to stop taking them periodically. 2. If a woman has been taking COCs for a long time, will she still be protected from pregnancy after she stops taking COCs? No. A woman is protected only as long as she takes her pills regularly. 3. How long does it take to become pregnant after stopping COCs? Women who stop using COCs can become pregnant as quickly as women who stop nonhormonal methods. COCs do not delay the return of a woman’s fertility after she stops taking them. The bleeding pattern a woman had before she used COCs generally returns after she stops taking them. Some women may have to wait a few months before their usual bleeding pattern returns. 4. Do COCs cause abortion? No. Research on COCs finds that they do not disrupt an existing pregnancy. They should not be used to try to cause an abortion. They will not do so. 5. Do COCs cause birth defects? Will the fetus be harmed if a woman accidentally takes COCs while she is pregnant? No. Good evidence shows that COCs will not cause birth defects and will not otherwise harm the fetus if a woman becomes pregnant while taking COCs or accidentally starts to take COCs when she is already pregnant. 6. Do COCs cause women to gain or lose a lot of weight? No. Most women do not gain or lose weight due to COCs. Weight changes naturally as life circumstances change and as people age. Because these changes in weight are so common, many women think that COCs cause these gains or losses in weight. Studies find, however, that, on average, COCs do not affect weight. A few women experience sudden changes in weight when using COCs. These changes reverse after they stop taking COCs. It is not known why these women respond to COCs in this way. JHU HBk18 - Chapter 1.indd 25 1/26/18 09:48 26 Family Planning: A Global Handbook for Providers 7. Do COCs lower women’s mood or sex drive? Generally, no. Some women using COCs report these complaints. The great majority of COC users do not report any such changes, however, and some report that both mood and sex drive improve. It is difficult to tell whether such changes are due to the COCs or to other reasons. Providers can help a client with these problems (see Mood changes or changes in sex drive, p. 22). There is no evidence that COCs affect women’s sexual behavior. 8. What can a provider say to a client asking about COCs and breast cancer? The provider can point out that both COC users and women who do not use COCs can have breast cancer. In scientific studies breast cancer was slightly more common among women using COCs and those who had used COCs in the past 10 years than among other women. Scientists do not know whether or not COCs actually caused the slight increase in breast cancers. It is possible that the cancers were already there before COC use but were found sooner in COC users (see Facts About Combined Oral Contraceptives and Cancer, p. 4). 9. Can COCs be used as a pregnancy test? No. A woman may experience some vaginal bleeding (a “withdrawal bleed”) as a result of taking several COCs or one full cycle of COCs, but studies suggest that this practice does not accurately identify who is or is not pregnant. Thus, giving a woman COCs to see if she has bleeding later is not recommended as a way to tell if she is pregnant. COCs should not be given to women as a pregnancy test of sorts because they do not produce accurate results. 10. Must a woman have a pelvic examination before she can start COCs or at follow-up visits? No. A pelvic examination to check for pregnancy is not necessary. Instead, asking the right questions usually can help to make reasonably certain that a woman is not pregnant (see Pregnancy Checklist, inside back cover). No other condition that could be detected by a pelvic examination rules out COC use. 11. Can women with varicose veins use COCs? Yes. COCs are safe for women with varicose veins. Varicose veins are enlarged blood vessels close to the surface of the skin. They are not dangerous. They are not blood clots, nor are these veins the deep veins in the legs where a blood clot can be dangerous (deep vein thrombosis). A woman who has or has had deep vein thrombosis should not use COCs. JHU HBk18 - Chapter 1.indd 26 1/26/18 09:48 1 C o m b in ed O r a l C o n t r a c ep t iv es 27 12. Can a woman safely take COCs throughout her life? Yes. There is no minimum or maximum age for COC use. COCs can be an appropriate method for most women from onset of monthly bleeding (menarche) to menopause (see Women Near Menopause, p. 325). COCs can be an appropriate method for adolescents. Adolescents may need extra support and encouragement to use COCs consistently and effectively. 13. Can women who smoke use COCs safely? Women younger than age 35 who smoke can use COCs. Women age 35 and older who smoke should choose a method without estrogen or, if they smoke fewer than 15 cigarettes a day, monthly injectables. Older women who smoke can take the progestin-only pill if they prefer pills. All women who smoke should be urged to stop smoking. 14. What if a client wants to use COCs but it is not reasonably certain that she is not pregnant after using the pregnancy checklist? A woman who answers “No” to all 6 questions on the Pregnancy Checklist (see inside back cover) can still start taking COCs. Ask her to come back for a pregnancy test if her next monthly bleeding is late. See Ruling Out Pregnancy, p. 439. 15. Can COCs be used as emergency contraceptive pills (ECPs) after unprotected sex? Yes. As soon as possible, but no more than 5 days after unprotected sex, a woman can take COCs as ECPs (see Pill Formulations and Dosing for Emergency Contraception, p. 55). Progestin-only pills, however, are more effective and cause fewer side effects such as nausea and stomach upset. 16. What are the differences among monophasic, biphasic, and triphasic pills? Monophasic pills provide the same amount of estrogen and progestin in every hormonal pill. Biphasic and triphasic pills change the amount of estrogen and progestin at different points of the pill-taking cycle. For biphasic pills, the first 10 pills have one dosage, and then the next 11 pills have another level of estrogen and progestin. For triphasic pills, the first 7 or so pills have one dosage, the next 7 pills have another dosage, and the last 7 hormonal pills have yet another dosage. All prevent pregnancy in the same way. Differences in side effects, effectiveness, and continuation appear to be slight. Questions and Answers about Combined Oral Contraceptives JHU HBk18 - Chapter 1.indd 27 1/26/18 09:48 28 Family Planning: A Global Handbook for Providers 17. Is it important for a woman to take her COCs at the same time each day? A woman can take her COCs at different times of day, and they will still be effective. However, taking them at the same time each day can be helpful for 2 reasons. Some side effects may be reduced by taking the pill at the same time each day. Also, taking a pill at the same time each day can help women remember to take their pills more consistently. Linking pill taking with a daily activity also helps women remember to take their pills. 18. Should women who choose COCs and certain other hormonal contraceptives be routinely tested for high blood pressure? It is desirable for all women to have blood pressure measurements taken routinely before starting a hormonal method of contraception. However, in some settings blood pressure measurements are unavailable. In many of these settings, pregnancy-related morbidity and mortality risks are high, and these methods are among the few methods that are widely available. In such settings women should not be denied use of these methods simply because their blood pressure cannot be measured. Women with high blood pressure or very high blood pressure should not use combined hormonal methods—COCs, monthly injectables, patch, or combined ring. Where blood pressure cannot be measured, women with a history of high blood pressure should not use these methods. Women with very high blood pressure should not use progestin-only injectables. Women can use progestin-only pills (POPs), implants, and LNG-IUDs even if they have high or very high blood pressure readings or a history of high or very high blood pressure. High blood pressure is defined as systolic pressure 140 mm Hg or higher or diastolic pressure 90 mm Hg or higher. Very high blood pressure is defined as systolic pressure 160 mm Hg or higher or diastolic pressure 100 mm Hg or higher. For more guidance concerning blood pressure, see the Medical Eligibility Criteria checklists in the chapters on COCs (p. 6), progestin-only injectables (p. 72), and monthly injectables (p. 101). JHU HBk18 - Chapter 1.indd 28 1/26/18 09:48 29 2 P r o g es t in - O n ly P il ls What Are Progestin-Only Pills?  Pills that contain very low doses of a progestin like the natural hormone progesterone in a woman’s body.  Do not contain estrogen, and so can be used throughout breastfeeding and by women who cannot use methods with estrogen.  Progestin-only pills (POPs) are also called “minipills” and progestin-only oral contraceptives.  Work primarily by: – Thickening cervical mucus (this blocks sperm from meeting an egg) – Disrupting the menstrual cycle, including preventing the release of eggs from the ovaries (ovulation) Progestin-Only Pills CHAPTER 2 Progestin-Only Pills Key Points for Providers and Clients  Take one pill every day. No breaks between packs.  Safe for breastfeeding women and their babies. Progestin-only pills do not affect milk production.  Add to the contraceptive effect of breastfeeding. Together, they provide effective pregnancy protection.  Bleeding changes are common but not harmful . Typically, pills lengthen how long breastfeeding women have no monthly bleeding. For women having monthly bleeding, frequent or irregular bleeding is common.  Can be given to a woman at any time to start now or later. This chapter on progestin-only pills focuses on breastfeeding women. Women who are not breastfeeding also can use progestin-only pills. Guidance that differs for women who are not breastfeeding is noted. JHU HBk18 - Chapter 2.indd 29 1/26/18 09:49 30 Family Planning: A Global Handbook for Providers How Effective? Effectiveness depends on the user: For women who have monthly bleeding, risk of pregnancy is greatest if pills are taken late or missed completely. Breastfeeding women:  As commonly used, about 1 pregnancy per 100 women using POPs over the first year. This means that 99 of every 100 women will not become pregnant.  When pills are taken every day, less than 1 pregnancy per 100 women using POPs over the first year (3 per 1,000 women). Less effective for women not breastfeeding:  As commonly used, about 7 pregnancies per 100 women using POPs over the first year. This means that 93 of every 100 women will not become pregnant.  When pills are taken every day at the same time, less than 1 pregnancy per 100 women using POPs over the first year (3 per 1,000 women). Return of fertility after POPs are stopped: No delay Protection against sexually transmitted infections (STIs): None Why Some Women Say They Like Progestin-Only Pills  Can be used while breastfeeding  Can be stopped at any time without a provider’s help  Do not interfere with sex  Are controlled by the woman More e�ective Less e�ective Breastfeeding Not breastfeeding JHU HBk18 - Chapter 2.indd 30 1/26/18 09:49 31 2 P r o g es t in - O n ly P il ls Progestin-Only Pills Side Effects, Health Benefits, and Health Risks Side Effects (see also Managing Any Problems, p. 42) Some users report the following:  Changes in bleeding patterns,† including: – For breastfeeding women, longer delay in return of monthly bleeding after childbirth (lengthened postpartum amenorrhea) – Frequent bleeding – Irregular bleeding – Infrequent bleeding – Prolonged bleeding – No monthly bleeding Breastfeeding also affects a woman’s bleeding patterns.  Headaches  Dizziness  Mood changes  Breast tenderness  Abdominal pain  Nausea Other possible physical changes:  For women not breastfeeding, enlarged ovarian follicles Correcting Misunderstandings (see also Questions and Answers, p. 46) Progestin-only pills:  Do not cause a breastfeeding woman’s milk to dry up  Must be taken every day, whether or not a woman has sex that day  Do not make women infertile  Do not cause diarrhea in breastfeeding babies  Reduce the risk of ectopic pregnancy Known Health Benefits Known Health Risks Help protect against:  Risks of pregnancy None Bleeding changes are normal and not harmful. If a woman finds them bothersome, counseling and support can help. † For definitions of bleeding patterns, see “vaginal bleeding,” p. 407. JHU HBk18 - Chapter 2.indd 31 1/26/18 09:49 32 Family Planning: A Global Handbook for Providers Who Can and Cannot Use Progestin-Only Pills Safe and Suitable for Nearly All Women Nearly all women can use POPs safely and effectively, including women who:  Are breastfeeding (she can start immediately after childbirth)  Have or have not had children  Are married or are not married  Are of any age, including adolescents and women over 40 years old  Have just had an abortion, miscarriage, or ectopic pregnancy  Smoke cigarettes, regardless of woman’s age or number of cigarettes smoked  Have anemia now or had in the past  Have varicose veins  Are living with HIV, whether or not on antiretroviral therapy Avoid Unnecessary Procedures (see Importance of Procedures, p. 368) Women can begin using POPs:  Without a pelvic examination  Without any blood tests or other routine laboratory tests  Without cervical cancer screening  Without a breast examination  Without a pregnancy test. A woman can begin using POPs at any time, even when she is not having monthly bleeding at the time, if it is reasonably certain she is not pregnant (see Pregnancy Checklist, inside back cover). Blood pressure measurement is desirable before starting a hormonal method. However, where the risks of pregnancy are high and few methods are available, a woman should not be denied a hormonal method simply because her blood pressure cannot be measured. If possible, she can have her blood pressure measured later at a time and place convenient for her. JHU HBk18 - Chapter 2.indd 32 1/26/18 09:49 33 2 P r o g es t in - O n ly P il ls Who Can and Cannot Use Progestin-Only Pills Ask the client the questions below about known medical conditions. Examinations and tests are not necessary. If she answers “no” to all of the questions, then she can start POPs if she wants. If she answers “yes” to a question, follow the instructions. In some cases she can still start POPs. 1. Do you have severe cirrhosis of the liver or severe tumor? R NO R YES If she severe cirrhosis or severe liver tumor, such as liver cancer), do not provide POPs. Help her choose a method without hormones. 2. Do you have a serious problem now with a blood clot in your leg or lungs? R NO R YES If she reports a current blood clot in a leg (affecting deep veins, not superficial veins) or in a lung, and she is not on anticoagulant therapy, do not provide POPs. Help her choose a method without hormones. 3. Are you taking medication for seizures? Are you taking rifampicin or rifabutin for tuberculosis or other illness? R NO R YES If she is taking barbiturates, carbamazepine, oxcarbazepine, phenytoin, primidone, topiramate, rifampicin, or rifabutin, do not provide POPs. They can make POPs less effective. Help her choose another method but not combined oral contraceptives. 4. Do you have or have you ever had breast cancer? R NO R YES Do not provide POPs. Help her choose a method without hormones. Also, women should not use POPs if they report having thrombogenic mutations or lupus with positive (or unknown) antiphospholipid antibodies. For complete classifications, see Medical Eligibility Criteria for Contraceptive Use, p. 388. Be sure to explain the health benefits and risks and the side effects of the method that the client will use. Also, point out any conditions that would make the method inadvisable, when relevant to the client. Medical Eligibility Criteria for Progestin-Only Pills JHU HBk18 - Chapter 2.indd 33 1/26/18 09:49 34 Family Planning: A Global Handbook for Providers Using Clinical Judgment in Special Cases Usually, a woman with any of the conditions listed below should not use POPs. In special circumstances, however, when other, more appropriate methods are not available or acceptable to her, a qualified provider who can carefully assess a specific woman’s condition and situation may decide that she can use POPs. The provider needs to consider the severity of her condition and, for most conditions, whether she will have access to follow-up.  Acute blood clot in deep veins of legs or lungs  Had breast cancer more than 5 years ago, and it has not returned  Severe cirrhosis or severe liver tumor  Systemic lupus erythematosus with positive (or unknown) antiphospho- lipid antibodies  Taking barbiturates, carbamazepine, oxcarbazepine, phenytoin, primidone, topiramate, rifampicin, or rifabutin. A backup contraceptive method should also be used because these medications reduce the effectiveness of POPs. Progestin-Only Pills for Women With HIV  Women living with HIV or on antiretroviral therapy can safely use POPs.  Urge these women to use condoms along with POPs. Used consistently and correctly, condoms help prevent transmission of HIV and other STIs.  For appropriate breastfeeding practices for women with HIV, see Maternal and Newborn Health, Preventing Mother-to-Child Transmission of HIV, p. 352. JHU HBk18 - Chapter 2.indd 34 1/26/18 09:49 35 2 P r o g es t in - O n ly P il ls Providing Progestin-Only Pills When to Start IMPORTANT: A woman can start using POPs any time she wants if it is reasonably certain she is not pregnant. To be reasonably certain she is not pregnant, use the Pregnancy Checklist (see inside back cover). Also, a woman can be given POPs at any time and told when to start taking them. Providing Progestin-Only Pills Woman’s situation When to start Fully or nearly fully breastfeeding Less than 6 months after giving birth  If her monthly bleeding has not returned, she can start POPs any time between giving birth and 6 months. No need for a backup method.  If her monthly bleeding has returned, she can start POPs as advised for women having menstrual cycles (see next page). More than 6 months after giving birth  If her monthly bleeding has not returned, she can start POPs any time it is reasonably certain she is not pregnant. She will need a backup method* for the first 2 days of taking pills. (If you cannot be reasonably certain, see How and When to Use the Pregnancy Checklist and Pregnancy Tests, p. 440.)  If her monthly bleeding has returned, she can start POPs as advised for women having menstrual cycles (see next page). Partially breastfeeding If her monthly bleeding has not returned If her monthly bleeding has returned  She can start POPs any time it is reasonably certain she is not pregnant.† She will need a backup method for the first 2 days of taking pills. (If you cannot be reasonably certain, see How and When to Use the Pregnancy Checklist and Pregnancy Tests, p. 440.)  She can start POPs as advised for women having menstrual cycles (see next page). * Backup methods include abstinence, male and female condoms, spermicides, and withdrawal. Tell her that spermicides and withdrawal are the least effective contraceptive methods. If possible, give her condoms. † Where a visit 6 weeks after childbirth is routinely recommended and other opportunities to obtain contraception are limited, some providers and programs may allow a woman to start POPs at the 6-week visit, without further evidence that the woman is not pregnant, if her monthly bleeding has not yet returned. JHU HBk18 - Chapter 2.indd 35 1/26/18 09:49 36 Family Planning: A Global Handbook for Providers Woman’s situation When to start Not breastfeeding Less than 4 weeks after giving birth  She can start POPs at any time. No need for a backup method. More than 4 weeks after giving birth  If her monthly bleeding has not returned, she can start POPs any time it is reasonably certain she is not pregnant.† She will need a backup method for the first 2 days of taking pills. (If you cannot be reasonably certain, see How and When to Use the Pregnancy Checklist and Pregnancy Tests, p. 440.)  If her monthly bleeding has returned, she can start POPs as advised for women having menstrual cycles (see below). Switching from a hormonal method  Immediately, if she has been using the hormonal method consistently and correctly or if it is otherwise reasonably certain she is not pregnant. No need to wait for her next monthly bleeding. No need for a backup method.  If she is switching from injectables, she can begin taking POPs when the repeat injection would have been given. No need for a backup method. Having menstrual cycles or switching from a nonhormonal method Any time of the month  If she is starting within 5 days after the start of her monthly bleeding, no need for a backup method.  If it is more than 5 days after the start of her monthly bleeding, she can start POPs any time it is reasonably certain she is not pregnant. She will need a backup method for the first 2 days of taking pills. (If you cannot be reasonably certain, see How and When to Use the Pregnancy Checklist and Pregnancy Tests, p. 440.)  If she is switching from an IUD, she can start POPs immediately (see Copper-Bearing IUD, Switching From an IUD to Another Method, p. 172). † Where a visit 6 weeks after childbirth is routinely recommended and other opportunities to obtain contraception are limited, some providers and programs may allow a woman to start POPs at the 6-week visit, without further evidence that the woman is not pregnant, if her monthly bleeding has not yet returned. JHU HBk18 - Chapter 2.indd 36 1/26/18 09:49 37 2 P r o g es t in - O n ly P il ls No monthly bleeding (not related to childbirth or breastfeeding)  She can start POPs any time it is reasonably certain she is not pregnant. She will need a backup method for the first 2 days of taking pills. After miscarriage or abortion  Immediately. If she is starting within 7 days after first- or second-trimester miscarriage or abortion, no need for a backup method.  If it is more than 7 days after first- or second- trimester miscarriage or abortion, she can start POPs any time it is reasonably certain she is not pregnant. She will need a backup method for the first 2 days of taking pills. (If you cannot be reasonably certain, see How and When to Use the Pregnancy Checklist and Pregnancy Tests, p. 440.) After taking emergency contraceptive pills (ECPs) After taking progestin-only or combined ECPs:  She can start or restart POPs immediately after she takes the ECPs. No need to wait for her next monthly bleeding. – A continuing user who needed ECPs due to pill-taking errors can continue where she left off with her current pack.  If she does not start immediately, but returns for POPs, she can start at any time if it is reasonably certain she is not pregnant.  All women will need to use a backup method for the first 2 days of taking pills. Providing Progestin-Only Pills Woman’s situation When to start After taking ulipristal acetate (UPA) ECPs:  She can start or restart POPs on the 6th day after taking UPA-ECPs. No need to wait for her next monthly bleeding. POPs and UPA interact. If POPs are started sooner, and thus both are present in the body, one or both may be less effective.  Give her a supply of pills and tell her to start them on the 6th day after taking the UPA-ECPs.  She will need to use a backup method from the time she takes UPA-ECPs until she has been taking POPs for 2 days.  If she does not start on the 6th day but returns later for POPs, she may start at any time if it is reasonably certain she is not pregnant. JHU HBk18 - Chapter 2.indd 37 1/26/18 09:49 38 Family Planning: A Global Handbook for Providers Giving Advice on Side Effects IMPORTANT: Thorough counseling about bleeding changes and other side effects is an important part of providing the method. Counseling about bleeding changes may be the most important help a woman needs to keep using the method without concern. Describe the most common side effects  Breastfeeding women normally do not have monthly bleeding for several months after giving birth. POPs lengthen this period of time.  Women who are not breastfeeding may have frequent or irregular bleeding for the first several months, followed by regular bleeding or continued irregular bleeding.  Headaches, dizziness, breast tenderness, and possibly other side effects. Explain about these side effects  Side effects are not signs of illness. Lack of bleeding does not mean pregnancy.  Usually become less or stop within the first few months of using POPs. Bleeding changes, however, usually persist.  Common, but some women do not have them. Explain what to do in case of side effects  Keep taking POPs. Skipping pills risks pregnancy.  Try taking pills with food or at bedtime to help avoid nausea.  The client can come back for help if side effects bother her or if she has other concerns. JHU HBk18 - Chapter 2.indd 38 1/26/18 09:49 39 2 P r o g es t in - O n ly P il ls Providing Progestin-Only Pills Explaining How to Use 1. Give pills  Give as many packs as possible—even as much as a year’s supply (11 packs of 35 pills each or 13 packs of 28 pills each). 2. Explain pill pack  Show which kind of pack—28 pills or 35 pills.  Explain that all pills in POP packs are the same color and all are active pills, containing a hormone that prevents pregnancy.  Show how to take the first pill from the pack and then how to follow the directions or arrows on the pack to take the rest of the pills. 3. Give key instruction  Take one pill each day—until the pack is empty.  Women who are not breastfeeding should take a pill at the same time each day. Taking a pill more than 3 hours late makes it less effective.  Discuss cues for taking a pill every day. Linking pill-taking to a daily activity—such as cleaning her teeth— may help her remember. 4. Explain starting next pack  When she finishes one pack, she should take the first pill from the next pack on the very next day.  It is very important to start the next pack on time. Starting a pack late risks pregnancy. 5. Provide backup method and explain use  Sometimes she may need to use a backup method, such as when she misses pills or is late taking a pill.  Backup methods include abstinence, male or female condoms, spermicides, and withdrawal. Tell her that spermicides and withdrawal are the least effective contraceptive methods. Give her condoms, if possible. 6. Explain that effectiveness decreases when breastfeeding stops  Without the additional protection of breastfeeding itself, POPs are not as effective as most other hormonal methods.  When she stops breastfeeding, she can continue taking POPs if she is satisfied with the method, or she is welcome to come back for another method. JHU HBk18 - Chapter 2.indd 39 1/26/18 09:49 40 Family Planning: A Global Handbook for Providers Supporting the User Managing Missed Pills It is easy to forget a pill or to be late in taking it. Adolescents are more likely to forget pills and so may need extra support and guidance. POP users should know what to do if they forget to take pills. If a woman is 3 or more hours late taking a pill (12 or more hours late taking a POP containing desogestrel 75 mg), or if she misses a pill completely, she should follow the instructions below. For breastfeeding women, whether missing a pill places her at risk of pregnancy depends on whether or not her monthly bleeding has returned. Making Up Missed Progestin-Only Pills Key message  Take a missed pill as soon as possible.  Keep taking pills as usual, one each day. (She may take 2 pills at the same time or on the same day.) Do you have monthly bleeding regularly?  If yes, she also should use a backup method for the next 2 days.  Also, if she had sex in the past 5 days, she can consider taking ECPs (see Emergency Contraceptive Pills, p. 49). Severe vomiting or diarrhea  If she vomits within 2 hours after taking a pill, she should take another pill from her pack as soon as possible, and keep taking pills as usual. How Can a Partner Help? The client’s partner is welcome to participate in counseling and learn about the method and what support he can give to his partner. A male partner can:  Support a woman’s choice of POPs  Help her to remember to take a pill at about the same time each day  Show understanding and support if she has side effects  Help her to make sure that she has a new pill pack on hand to start on time  Help to make sure she has ECPs on hand in case she misses pills or starts a new pill pack late  Use condoms consistently in addition to POPs if he has an STI/HIV or thinks he may be at risk of an STI/HIV JHU HBk18 - Chapter 2.indd 40 1/26/18 09:49 41 2 P r o g es t in - O n ly P il ls “Come Back Any Time”: Reasons to Return Assure every client that she is welcome to come back any time—for example, if she has problems, questions, or wants another method; she has a major change in health status; or she thinks she might be pregnant. Also if:  She has stopped breastfeeding and wants to switch to another method.  For a woman who has monthly bleeding: If she took a pill more than 3 hours late or missed one completely, and also had sex during the last 5 days, she may wish to consider ECPs (see Emergency Contraceptive Pills, p. 49). General health advice: Anyone who suddenly feels that something is seriously wrong with her health should immediately seek medical care from a nurse or doctor. Her contraceptive method is most likely not the cause of the condition, but she should tell the nurse or doctor what method she is using. Planning the Next Visit 1. Encourage her to come back for more pills before she uses up her supply of pills. 2. Contacting women after the first 3 months of POP use is recommended. This offers an opportunity to answer any questions, help with any problems, and check on correct use. Helping Continuing Users 1. Ask how the client is doing with the method and whether she is satisfied. Ask if she has any questions or anything to discuss. 2. Ask especially if she is concerned about bleeding changes. Give her any information or help that she needs (see Managing Any Problems, p. 42). 3. Ask if she often has problems remembering to take a pill every day. If so, discuss ways to remember, making up for missed pills, and ECPs, or choosing another method. Adolescents may need extra support. 4. Give her more pill packs—as much as a full year’s supply (11 or 13 packs), if possible. Plan her next resupply visit before she will need more pills. 5. Ask a long-term client if she has had any new health problems since her last visit. Address problems as appropriate. For new health problems that may require switching methods, see p. 45. 6. Ask a long-term client about major life changes that may affect her needs— particularly plans for having children and STI/HIV risk. Follow up as needed. Helping Continuing Users of Progestin-Only Pills JHU HBk18 - Chapter 2.indd 41 1/26/18 09:49 42 Family Planning: A Global Handbook for Providers No monthly bleeding  Breastfeeding women: − Reassure her that this is normal during breastfeeding. It is not harmful.  Women not breastfeeding: − Reassure her that some women using POPs stop having monthly bleeding, and this is not harmful. There is no need to lose blood every month. It is similar to not having monthly bleeding during pregnancy. She is not pregnant or infertile. Blood is not building up inside her. (Some women are happy to be free from monthly bleeding.) Irregular bleeding (bleeding at unexpected times that bothers the client)  Reassure her that many women using POPs experience irregular bleeding—whether breastfeeding or not. (Breastfeeding itself also can cause irregular bleeding.) It is not harmful and sometimes becomes less or stops after the first several months of use. Some women have irregular bleeding the entire time they are taking POPs, however.  Other possible causes of irregular bleeding include: − Vomiting or diarrhea − Taking anticonvulsants or rifampicin (see Starting treatment with anticonvulsants, rifampicin, or rifabutin, p. 45)  To reduce irregular bleeding: − Teach her to make up for missed pills properly, including after vomiting or diarrhea (see Managing Missed Pills, p. 40). − For modest short-term relief she can try 800 mg ibuprofen 3 times daily after meals for 5 days, or other nonsteroidal anti-inflammatory drug (NSAID), beginning when irregular bleeding starts. NSAIDs Managing Any Problems Problems Reported as Side Effects or Problems With Use May or may not be due to the method.  Problems with side effects affect women’s satisfaction and use of POPs. They deserve the provider’s attention. If the client reports side effects or problems, listen to her concerns, give her advice and support, and, if appropriate, treat. Make sure she understands the advice and agrees.  Encourage her to keep taking a pill every day even if she has side effects. Missing pills can risk pregnancy.  Many side effects will subside after a few months of use. For a woman whose side effects persist, give her a different POP formulation, if available, for at least 3 months.  Offer to help the client choose another method—now, if she wishes, or if problems cannot be overcome. JHU HBk18 - Chapter 2.indd 42 1/26/18 09:49 43 2 P r o g es t in - O n ly P il ls provide some relief of irregular bleeding for implants, progestin-only injectables, and IUDs, and they may also help POP users. − If she has been taking the pills for more than a few months and NSAIDs do not help, give her a different POP formulation, if available. Ask her to try the new pills for at least 3 months.  If irregular bleeding continues or starts after several months of normal or no monthly bleeding, or you suspect that something may be wrong for other reasons, consider underlying conditions unrelated to method use (see Unexplained vaginal bleeding, p. 45). Heavy or prolonged bleeding (twice as much as usual or longer than 8 days)  Reassure her that some women using POPs experience heavy or prolonged bleeding. It is generally not harmful and usually becomes less or stops after a few months.  For modest short-term relief she can try NSAIDs, beginning when heavy bleeding starts. Try the same treatments as for irregular bleeding (see previous page).  To help prevent anemia, suggest she take iron tablets and tell her it is important to eat foods containing iron, such as meat and poultry (especially beef and chicken liver), fish, green leafy vegetables, and legumes (beans, bean curd, lentils, and peas).  If heavy or prolonged bleeding continues or starts after several months of normal or no monthly bleeding, or you suspect that something may be wrong for other reasons, consider underlying conditions unrelated to method use (see Unexplained vaginal bleeding, p. 45). Missed pills  See Managing Missed Pills, p. 40. Ordinary headaches (nonmigrainous)  Suggest aspirin (325–650 mg), ibuprofen (200–400 mg), paracetamol (325–1000 mg), or other pain reliever.  Any headaches that get worse or occur more often during POP use should be evaluated. Mood changes or changes in sex drive  Ask about changes in her life that could affect her mood or sex drive, including changes in her relationship with her partner. Give her support as appropriate.  Some women experience depression in the year after giving birth. This is not related to POPs. Clients who have serious mood changes such as major depression should be referred for care.  Consider locally available remedies. Helping Continuing Users of Progestin-Only Pills JHU HBk18 - Chapter 2.indd 43 1/26/18 09:49 44 Family Planning: A Global Handbook for Providers Breast tenderness  Breastfeeding women: − See Maternal and Newborn Health, Sore Breasts, p. 356.  Women not breastfeeding: − Recommend that she wear a supportive bra (including during strenuous activity and sleep). − Try hot or cold compresses. − Suggest aspirin (325–650 mg), ibuprofen (200–400 mg), paracetamol (325–1000 mg), or other pain reliever. − Consider locally available remedies. Severe pain in lower abdomen  Abdominal pain may be due to various problems, such as enlarged ovarian follicles or cysts. − A woman can continue to use POPs during evaluation and treatment. − There is no need to treat enlarged ovarian follicles or cysts unless they grow abnormally large, twist, or burst. Reassure the client that they usually disappear on their own. To be sure the problem is resolv- ing, see the client again in 6 weeks, if possible.  With severe abdominal pain, be particularly alert for additional signs or symptoms of ectopic pregnancy, which is rare and not caused by POPs, but it can be life-threatening (see Question 13, p. 48).  In the early stages of ectopic pregnancy, symptoms may be absent or mild, but eventually they will become severe. A combination of these signs or symptoms should increase suspicion of ectopic pregnancy: − Unusual abdominal pain or tenderness − Abnormal vaginal bleeding or no monthly bleeding—especially if this is a change from her usual bleeding pattern − Light-headedness or dizziness − Fainting  If ectopic pregnancy or other serious health condition is suspected, refer at once for immediate diagnosis and care. (See Female Sterilization, Managing Ectopic Pregnancy, p. 227, for more on ectopic pregnancies.) Nausea or dizziness  For nausea, suggest taking POPs at bedtime or with food.  If symptoms continue, consider locally available remedies. JHU HBk18 - Chapter 2.indd 44 1/26/18 09:49 45 2 P r o g es t in - O n ly P il ls New Problems That May Require Switching Methods May or may not be due to the method. Unexplained vaginal bleeding (that suggests a medical condition not related to the method)  Refer or evaluate by history and pelvic examination. Diagnose and treat as appropriate.  She can continue using POPs while her condition is being evaluated.  If bleeding is caused by a sexually transmitted infection or pelvic inflammatory disease, she can continue using POPs during treatment. Starting treatment with anticonvulsants, rifampicin, or rifabutin  Barbiturates, carbamazepine, oxcarbazepine, phenytoin, primidone, topiramate, rifampicin, rifabutin, and ritonavir may make POPs less effective. If using these medications long-term, she may want a different method, such as progestin-only injectables or a copper-bearing IUD or LNG-IUD.  If using these medications short-term, she can use a backup method along with POPs. Migraine headaches (see Identifying Migraine Headaches and Auras, p. 436)  A woman who has migraine headaches with or without aura can safely start POPs.  If she develops migraine headaches without aura while taking POPs, she can continue to use POPs if she wishes.  If she develops migraine aura while using POPs, stop POPs. Help her choose a method without hormones. Certain serious health conditions (suspected blood clots in deep veins of legs or lungs, liver disease, or breast cancer). See Signs and Symptoms of Serious Health Conditions, p. 384.  Tell her to stop taking POPs.  Give her a backup method to use until the condition is evaluated.  Refer for diagnosis and care if not already under care. Heart disease due to blocked or narrowed arteries (ischemic heart disease) or stroke  A woman who has one of these conditions can safely start POPs. If, however, the condition develops after she starts using POPs, she should stop. Help her choose a method without hormones.  Refer for diagnosis and care if not already under care. Suspected pregnancy  Assess for pregnancy, including ectopic pregnancy.  Tell her to stop taking POPs if pregnancy is confirmed.  There are no known risks to a fetus conceived while a woman is taking POPs (see Question 4, p. 46). Helping Continuing Users of Progestin-Only Pills JHU HBk18 - Chapter 2.indd 45 1/26/18 09:49 46 Family Planning: A Global Handbook for Providers Questions and Answers About Progestin-Only Pills 1. Can a woman who is breastfeeding safely use POPs? In 2016 WHO considered this question and updated its guidance to allow a woman to use progestin-only pills after childbirth regardless of how recently she gave birth. She does not need to wait until 6 weeks postpartum. POPs are safe for both the mother and the baby and do not affect milk production. 2. What should a woman do when she stops breastfeeding her baby? Can she continue taking POPs? A woman who is satisfied with using POPs can continue using them when she has stopped breastfeeding. She is less protected from pregnancy than when breastfeeding, however. She can switch to another method if she wishes. 3. Can a woman take POPs at any age? Yes. There is no minimum or maximum age for POP use. POPs can be an appropriate method for adolescents. Adolescents who are breastfeeding have the same need for an effective way to space births as older women. They may need extra support and encouragement to use POPs consistently and effectively. 4. Do POPs cause birth defects? Will the fetus be harmed if a woman accidentally takes POPs while she is pregnant? No. Good evidence shows that POPs will not cause birth defects and will not otherwise harm the fetus if a woman becomes pregnant while taking POPs or accidentally takes POPs when she is already pregnant. 5. How long does it take to become pregnant after stopping POPs? Women who stop using POPs can become pregnant as quickly as women who stop nonhormonal methods. POPs do not delay the return of a woman’s fertility after she stops taking them. The bleeding pattern a woman had before she used POPs generally returns after she stops taking them. Some women may have to wait a few months before their usual bleeding pattern returns. JHU HBk18 - Chapter 2.indd 46 1/26/18 09:49 47 2 P r o g es t in - O n ly P il ls Questions and Answers About Progestin-Only Pills 6. If a woman does not have monthly bleeding while taking POPs, does this mean that she is pregnant? Probably not, especially if she is breastfeeding. If she has been taking her pills every day, she is probably not pregnant and can keep taking her pills. If she is still worried after being reassured, she can be offered a pregnancy test, if available, or referred for one. If not having monthly bleeding bothers her, switching to another method may help—but not to another progestin-only method. These methods sometimes stop monthly bleeding. 7. Must the POP be taken every day? Yes. All of the pills in the POP package contain the hormone that prevents pregnancy. If a woman does not take a pill every day— especially a woman who is not breastfeeding—she could become pregnant. (In contrast, the last 7 pills in a 28-pill pack of combined oral contraceptives are not active. They contain no hormones.) 8. Is it important for a woman to take her POPs at the same time each day? Yes, for 2 reasons. POPs contain very little hormone, and taking a pill more than 3 hours late (more than 12 hours late with POPs containing desogestrel 75 mg) could reduce their effectiveness for women who are not breastfeeding. (Breastfeeding women have the additional protection from pregnancy that breastfeeding provides, and so taking pills late is not as risky.) Also, taking a pill at the same time each day can help women remember to take their pills more consistently. Linking pill taking with a daily activity also helps women remember to take their pills. 9. Do POPs cause cancer? No. Few large studies exist on POPs and cancer, but smaller studies of POPs are reassuring. Larger studies of implants have not shown any increased risk of cancer. Implants contain hormones similar to those used in POPs, and, during the first few years of implant use, at about twice the dosage. 10. Can POPs be used as emergency contraceptive pills (ECPs) after unprotected sex? Yes. As soon as possible, but no more than 5 days after unprotected sex, a woman can take POPs as ECPs (see Pill Formulations and Dosing for Emergency Contraception, p. 55). Depending on the type of POP, she will have to take 40 to 50 pills. This is many pills, but it is safe because there is very little hormone in each pill. JHU HBk18 - Chapter 2.indd 47 1/26/18 09:49 48 Family Planning: A Global Handbook for Providers 11. Do POPs lower women’s mood or sex drive? Generally, no. Some women using POPs report these complaints. The great majority of POP users do not report any such changes, however, and some report that both mood and sex drive improve. It is difficult to tell whether such changes are due to the POPs or to other reasons. Providers can help a client with these problems (see Mood changes or changes in sex drive, p. 43). There is no evidence that POPs affect women’s sexual behavior. 12. What should be done if a POP user has an ovarian cyst? The great majority of cysts are not true cysts but actually fluid-filled structures in the ovary (follicles) that continue to grow beyond the usual size in a normal menstrual cycle. They may cause some mild abdominal pain, but they require treatment only if they grow abnormally large, twist, or burst. These follicles usually go away without treatment (see Severe pain in lower abdomen, p. 44). 13. Do POPs increase the risk of ectopic pregnancy? No. On the contrary, POPs reduce the risk of ectopic pregnancy. Ectopic pregnancies are rare among POP users. The rate of ectopic pregnancy among women using POPs is 48 per 10,000 women per year. The rate of ectopic pregnancy among women in the United States using no contraceptive method is 65 per 10,000 women per year. On the uncommon occasions that POPs fail and pregnancy occurs, 5 to 10 of every 100 of these pregnancies are ectopic. Thus, the great majority of pregnancies after POPs fail are not ectopic. Still, ectopic pregnancy can be life-threatening, and so a provider should be aware that ectopic pregnancy is possible if POPs fail. JHU HBk18 - Chapter 2.indd 48 1/26/18 09:49 49 3 E m er g en c y C o n t r a c ep t iv e P il ls What Are Emergency Contraceptive Pills? • ECPs are sometimes called “morning after” pills or postcoital contraceptives. • Work by preventing or delaying the release of eggs from the ovaries (ovulation). They do not work if a woman is already pregnant. (The copper-bearing IUD also can be used for emergency contraception. See p. 166.) Emergency Contraceptive Pills CHAPTER 3 Emergency Contraceptive Pills Key Points for Providers and Clients • Emergency contraceptive pills (ECPs) help a woman avoid pregnancy after she has sex without contraception. • ECPs help to prevent pregnancy when taken up to 5 days after unprotected sex. The sooner they are taken, the better. • Do not disrupt an existing pregnancy. • Safe for all women—even women who cannot use ongoing hormonal contraceptive methods. • Provide an opportunity for women to start using an ongoing family planning method. • Several options can be used as emergency contraceptive pills. Dedicated products, progestin-only pills, and combined oral contraceptives all can act as emergency contraceptives. JHU HBk18 - Chapter 3.indd 49 1/26/18 09:51 50 Family Planning: A Global Handbook for Providers No ECPs 8 pregnancies 1 pregnancy 2 pregnancies Progestin- only ECPs Combined estrogen- progestin ECPs E�ectiveness of Emergency Contraceptive Pills (ECPs) If 100 women each had unprotected sex once during the second or third week of the menstrual cycle. <1 pregnancy Ulipristal acetate What Pills Can Be Used as Emergency Contraceptive Pills? • A special ECP product with levonorgestrel only, or ulipristal acetate (UPA) • Progestin-only pills with levonorgestrel or norgestrel • Combined oral contraceptives with estrogen and a progestin— levonorgestrel, norgestrel, or norethindrone (also called norethisterone) When to Take Them? • As soon as possible after unprotected sex. The sooner ECPs are taken after unprotected sex, the better they prevent pregnancy. • Can help to prevent pregnancy when taken any time up to 5 days after unprotected sex. How Effective? • If 100 women each had sex once during the second or third week of the menstrual cycle without using contraception, 8 women would likely become pregnant. • If all 100 women used ulipristal acetate ECPs, fewer than one woman would likely become pregnant. • If all 100 women used progestin-only ECPs, one woman would likely become pregnant. • If all 100 women used combined estrogen and progestin ECPs, 2 women would likely become pregnant. JHU HBk18 - Chapter 3.indd 50 1/26/18 09:51 51 3 E m er g en c y C o n t r a c ep t iv e P il ls Return of fertility after taking ECPs: No delay. A woman can become pregnant immediately after taking ECPs. Taking ECPs prevents pregnancy only from acts of sex that took place in the 5 days before. They will not protect a woman from pregnancy from acts of sex more than 24 hours after she takes ECPs. To stay protected from pregnancy, women must begin to use another contraceptive method (see Planning Ongoing Contraception, p. 61). Protection against sexually transmitted infections (STIs): None Side Effects, Health Benefits, and Health Risks Side Effects (see also Managing Any Problems, p. 61) Some users report the following: • Changes in bleeding patterns, including: – Slight irregular bleeding for 1–2 days after taking ECPs – Monthly bleeding that starts earlier or later than expected In the first several days after taking ECPs: • Nausea‡ • Abdominal pain • Fatigue • Headaches • Breast tenderness • Dizziness • Vomiting‡ Known Health Benefits Known Health Risks Help protect against: • Risks of pregnancy None Correcting Misunderstandings (see also Questions and Answers, p. 62) Emergency contraceptive pills: • Can be used by women of any age, including adolescents • Do not cause abortion • Do not prevent or affect implantation • Do not cause birth defects if pregnancy occurs • Are not dangerous to a woman’s health ‡ Women using progestin-only or ulipristal acetate ECP formulations are much less likely to experience nausea and vomiting than women using estrogen and progestin ECP formulations. Emergency Contraceptive Pills (Continued on next page) JHU HBk18 - Chapter 3.indd 51 1/26/18 09:51 52 Family Planning: A Global Handbook for Providers • Do not increase risky sexual behavior • Do not make women infertile • Can be used more than once in a woman’s cycle Avoid Unnecessary Procedures • A woman can take ECPs when needed without first seeing a health care provider. • No procedures or tests are needed before takings ECPs. The exception is that a woman who missed her last menses should have a pregnancy test before taking UPA-ECPs. Why Some Women Say They Like Emergency Contraceptive Pills • Can be used as needed • Offer a second chance at preventing unwanted pregnancy • Enable a woman to avoid pregnancy if sex was forced or she was prevented from using contraception • Are controlled by the woman • Reduce the need for abortion in the case of contraceptive errors or if contraception is not used • Can have on hand in case the need arises JHU HBk18 - Chapter 3.indd 52 1/26/18 09:51 53 3 E m er g en c y C o n t r a c ep t iv e P il ls Who Can Use Emergency Contraceptive Pills Safe and Suitable for All Women Tests and examinations are not necessary for using ECPs. Providing Emergency Contraceptive Pills ECPs may be needed in many different situations. Many women do not know about them, however. Women who use contraceptive methods that depend on the user, such as pills and condoms, particularly benefit from learning about ECPs. If possible, give all women who may need ECPs a supply in advance. If giving an advance supply is not possible, an advance prescription may be given in some settings or a woman can be told where to obtain them locally. An advance supply is helpful because a woman can keep them in case she needs them. Women are more likely to use ECPs if they already have them when needed. Also, having them on hand enables women to take them as soon as possible after unprotected sex, when they will be most effective. Medical Eligibility Criteria for Emergency Contraceptive Pills All women can use ECPs safely and effectively, including women who cannot use ongoing hormonal contraceptive methods. Because of the short-term nature of their use, there are no medical conditions that make ECPs unsafe for any woman. Providing Emergency Contraceptive Pills JHU HBk18 - Chapter 3.indd 53 1/26/18 09:51 54 Family Planning: A Global Handbook for Providers When to Use • Any time within 5 days after unprotected sex. The sooner after unprotected sex that ECPs are taken, the more effective they are. ECPs Appropriate in Many Situations ECPs can be used any time a woman is worried that she might become pregnant. For example, after: • Sexual assault • Any unprotected sex • Mistakes using contraception, such as: – Condom was used incorrectly, slipped, or broke – Couple incorrectly used a fertility awareness method (for example, failed to abstain or to use another method during the fertile days) – Man failed to withdraw, as intended, before he ejaculated – Woman has had unprotected sex after she has missed 3 or more combined oral contraceptive pills or has started a new pack 3 or more days late – IUD has come out of place – Woman has had unprotected sex when she is more than 4 weeks late for her repeat injection of DMPA, more than 2 weeks late for her repeat injection of NET-EN, or more than 7 days late for her repeat monthly injection JHU HBk18 - Chapter 3.indd 54 1/26/18 09:51 55 3 E m er g en c y C o n t r a c ep t iv e P il ls Providing Emergency Contraceptive Pills Pill Type and Hormone Formulation Pills to Take At First 12 Hours Later Dedicated ECP Products Progestin-only 1.5 mg LNG 1 0 0.75 mg LNG 2 0 Ulipristal acetate 30 mg ulipristal acetate 1 0 Oral Contraceptive Pills Used for Emergency Contraception Combined (estrogen-progestin) oral contraceptives 0.02 mg EE + 0.1 mg LNG 5 5 0.03 mg EE + 0.15 mg LNG 4 4 0.03 mg EE + 0.15 mg LNG 4 4 0.03 mg EE + 0.125 mg LNG 4 4 0.05 mg EE + 0.25 mg LNG 2 2 0.03 mg EE + 0.3 mg norgestrel 4 4 0.05 mg EE + 0.5 mg norgestrel 2 2 Progestin-only pills 0.03 mg LNG 50* 0 0.0375 mg LNG 40* 0 0.075 mg norgestrel 40* 0 Pill Formulations and Dosing for Emergency Contraception * Many pills, but safe. See Question 8, p. 63. LNG = levonorgestrel EE = ethinyl estradiol For information on brands of ECPs and oral contraceptive pills, see: The Emergency Contraception Website (http://ec.princeton.edu) and the International Consortium for Emergency Contraception (http://www.cecinfo.org). JHU HBk18 - Chapter 3.indd 55 1/26/18 09:51 56 Family Planning: A Global Handbook for Providers Giving Emergency Contraceptive Pills 1. Give pill (or pills) • She can take the pill or pills immediately. • If she is using a 2-dose regimen, tell her to take the next dose in 12 hours. 2. Describe the most common side effects • Nausea, abdominal pain, possibly others. • Slight bleeding or change in timing of monthly bleeding. • Side effects are not signs of illness and they do not last long. Most women have no side effects. 3. Explain what to do about side effects • Nausea: – Routine use of anti-nausea medications is not recommended. – Women who have had nausea with previous ECP use or with the first dose of a 2-dose regimen can take anti-nausea medication such as 25–50 mg meclizine hydrochloride (such as Agyrax, Antivert, Bonine, Postafene) one-half to one hour before taking ECPs. • Vomiting: – If the woman vomits within 2 hours after taking progestin-only or combined ECPs, she should take another dose. If she vomits within 3 hours of taking ulipristal acetate ECPs, she should take another dose. (She can use anti- nausea medication with this repeat dose, as above.) If vomiting continues, she can take a repeat dose of progestin-only or combined ECPs by placing the pills high in her vagina. If vomiting occurs more than 2 hours after taking progestin-only or combined ECPs, or 3 hours after taking UPA-ECPs, then she does not need to take any extra pills. 4. Give more ECPs and help her start an ongoing method • If possible, give her more ECPs to take home in case she needs them in the future. • See Planning Ongoing Contraception, p. 61. 5. Follow-up • Encourage her to return for an early pregnancy test if her monthly bleeding is more than 7 days late. JHU HBk18 - Chapter 3.indd 56 1/26/18 09:51 57 3 E m er g en c y C o n t r a c ep t iv e P il ls “Come Back Any Time”: Reasons to Return No routine return visit is required. Assure every client that she is welcome to come back any time, however, and also if: • She thinks she might be pregnant, especially if she has no monthly bleeding or her next monthly bleeding is delayed by more than 7 days. • She did not start a continuing method immediately and now wants one. Providing Emergency Contraceptive Pills How Can a Partner Help? The client’s partner is welcome to participate in counseling and learn about the method and what support he can give to his partner. A male partner can: • Support a woman’s decision to use ECPs • Understand and support her need to choose and use a continuing method • Help to make sure she has ECPs on hand in case she needs them again • If she needed ECPs because of a mistake with a method, understand and support correct use of the method or discuss using a different method JHU HBk18 - Chapter 3.indd 57 1/26/18 09:51 58 Family Planning: A Global Handbook for Providers Method When to start or restartWhen to Start or Restart Contraception After ECP Use Method When to start or restart Hormonal methods (combined oral contraceptives, progestin-only pills, progestin-only injectables, monthly injectables, implants, combined patch, combined vaginal ring) After taking progestin-only or combined ECPs: • Can start or restart any method immediately after she takes the ECPs. No need to wait for her next monthly bleeding. – The continuing user of oral contraceptive pills who needed ECPs due to error can resume use as before. She does not need to start a new pack. – Patch users should begin a new patch. – Ring users should follow the instructions for late replacement or removal on page 126. • All women need to abstain from sex or use a backup method* for the first 7 days of using their method. • If she does not start immediately, but instead returns for a method, she can start any method at any time if it is reasonably certain she is not pregnant. After taking ulipristal acetate (UPA) ECPs: • She can start or restart any method containing progestin on the 6th day after taking UPA-ECPs. No need to wait for her next monthly bleeding. (If she starts a method containing progestin earlier, both the progestin and the UPA could be less effective.) – If she wants to use oral contraceptive pills, vaginal ring, or patch, give her a supply and tell her to start on the 6th day after taking UPA-ECPs. If she wants to use injectables or implants, give her an appointment to return for the method on the 6th day after taking UPA-ECPs or as soon as possible after that. * Backup methods include abstinence, male and female condoms, spermicides, and withdrawal. Tell her that spermicides and withdrawal are the least effective contraceptive methods. If possible, give her condoms. JHU HBk18 - Chapter 3.indd 58 1/26/18 09:51 59 3 E m er g en c y C o n t r a c ep t iv e P il ls – All women need to use a backup method from the time they take UPA-ECPs until they have been using a hormonal method for 7 days (or 2 days for progestin-only pills). • If she does not start on the 6th day, but instead returns later for a method, she may start any method at any time if it is reasonably certain she is not pregnant. Levonorgestrel intrauterine device After taking progestin-only or combined ECPs: • She can have the LNG-IUD inserted at any time it can be determined that she is not pregnant (see Ruling Out Pregnancy, p. 439). • She should use a backup method* for the first 7 days after LNG-IUD insertion. After taking UPA-ECPs: • She can have the LNG-IUD inserted on the 6th day after taking UPA-ECPs if it can be determined that she is not pregnant. – If she wants to use the LNG-IUD, give her an appointment to return to have it inserted on the 6th day after taking UPA-ECPs or as soon as possible after that. • She will need to use a backup method from the time she takes UPA-ECPs until 7 days after the LNG-IUD is inserted. • If she does not have the LNG-IUD inserted on the 6th day, but instead returns later, she can have it inserted at any time if it can be determined she is not pregnant. Copper-bearing intrauterine device After taking progestin-only, combined, or UPA-ECPs: • If she decides to use a copper-bearing IUD after taking ECPs, she can have it inserted on the same day she takes the ECPs. No need for a backup method. Providing Emergency Contraceptive Pills Method When to start or restart JHU HBk18 - Chapter 3.indd 59 2/9/18 09:21 60 Family Planning: A Global Handbook for Providers Copper-bearing intrauterine device (continued) • If she does not have it inserted immediately, but instead returns for the method, she can have the copper-bearing IUD inserted any time if it can be determined that she is not pregnant. Note: The copper-bearing IUD can be used for emergency contraception. A woman who wants to use the IUD for regular contraception can have it inserted for emergency contraception within the first 5 days after unprotected sex and then continue using it (see Copper-Bearing IUD, p. 155). Female sterilization After taking progestin-only, combined, or UPA-ECPs: • The sterilization procedure can be done within 7 days after the start of her next monthly bleeding or any other time if it is reasonably certain she is not pregnant. Give her a backup method to use until she can have the procedure. Male and female condoms, spermicides, diaphragms, cervical caps, withdrawal After taking progestin-only, combined, or UPA-ECPs: • Immediately. Fertility awareness methods After taking progestin-only, combined, or UPA-ECPs: • Standard Days Method: With the start of her next monthly bleeding. • Symptoms-based methods: Once normal secretions have returned. • Give her a backup method to use until she can begin the method of her choice. Method When to start or restart JHU HBk18 - Chapter 3.indd 60 1/26/18 09:51 61 3 E m er g en c y C o n t r a c ep t iv e P il ls Helping Users of Emergency Contraceptive Pills Helping Users Planning Ongoing Contraception 1. Explain that ECPs will not protect her from pregnancy from acts of sex more than 24 hours after she takes them. Discuss the need for and choice of ongoing pregnancy prevention and, if at risk, protection from STIs including HIV (see Sexually Transmitted Infections, Including HIV, p. 329). 2. If she does not want to start a contraceptive method now, give her condoms or a cycle of oral contraceptives and ask her to use them if she changes her mind. Give instructions on use. Invite her to come back any time if she wants another method or has any questions or problems. 3. If possible, give her more ECPs to use in the future in case of unprotected sex. She may need them if she has unprotected sex again as soon as 24 hours after taking the previous ECPs. Managing Any Problems Problems Reported as Side Effects May or may not be due to the method. Slight irregular bleeding • Irregular bleeding due to ECPs will stop without treatment. • Assure the woman that this is not a sign of illness or pregnancy. Change in timing of next monthly bleeding or suspected pregnancy • Monthly bleeding may start a few days earlier or later than expected. This is not a sign of illness or pregnancy. • If her next monthly bleeding is more than 7 days later than expected after she takes ECPs, assess for pregnancy. There are no known risks to a fetus conceived if ECPs fail to prevent pregnancy (see Question 3, next page). JHU HBk18 - Chapter 3.indd 61 1/26/18 09:51 62 Family Planning: A Global Handbook for Providers Questions and Answers About Emergency Contraceptive Pills 1. How do ECPs work? ECPs prevent the release of an egg from the ovary or delay its release by 5 to 7 days. By then, any sperm in the woman’s reproductive tract will have died, since sperm can survive there for only about 5 days. If ovulation has occurred and the egg was fertilized, ECPs do not prevent implantation or disrupt an already established pregnancy. 2. Do ECPs disrupt an existing pregnancy? No. ECPs do not work if a woman is already pregnant. 3. Will ECPs harm the fetus if a woman accidentally takes them while she is pregnant? No. Evidence does not show that ECPs will cause birth defects or otherwise harm the fetus if a woman is already pregnant when she takes ECPs or if ECPs fail to prevent pregnancy. 4. How long do ECPs protect a woman from pregnancy? Women who take ECPs should understand that they could become pregnant the next time they have sex unless they begin to use another method of contraception at once. Because ECPs delay ovulation in some women, she may be most fertile soon after taking ECPs. If she wants ongoing protection from pregnancy, she must start using another contraceptive method by the next day, including a backup method if starting her continuing method requires it. In particular, a woman who has taken UPA-ECPs should wait until the 6th day to start a hormonal contraceptive. She should use a backup method during this period. 5. Can ECPs be used more than once? Yes. If needed, ECPs can be taken again, even in the same cycle. A woman who needs ECPs often may want to consider a longer-acting and more effective family planning method. 6. Should women use ECPs as a continuing method of contraception? A woman can use ECPs whenever she needs them, even more than once in the same cycle. However, relying on ECPs as an ongoing method should not be advised. It is not certain that ECPs, taken every time after sex, would be as effective as regular, continuing methods of contraception. Also, women who often take ECPs may have more side effects. Repeated use of ECPs poses no known health risks. It may be helpful, however, to screen women who take ECPs often for health conditions that can limit use of hormonal contraceptives. JHU HBk18 - Chapter 3.indd 62 1/26/18 09:51 63 3 E m er g en c y C o n t r a c ep t iv e P il ls 7. What oral contraceptive pills can be used as ECPs? Many combined (estrogen-progestin) oral contraceptives and progestin- only pills can be used as ECPs. Any pills containing the hormones used for emergency contraception—levonorgestrel, norgestrel, norethindrone, and any of these progestins together with estrogen (ethinyl estradiol)—can be used. 8. Is it safe to take 40 or 50 progestin-only pills as ECPs? Yes. Progestin-only pills contain very small amounts of hormone. Thus, it is necessary to take many pills in order to receive the total ECP dose needed. In contrast, the ECP dosage with combined (estrogen- progestin) oral contraceptives is generally only 2 to 5 pills in each of 2 doses 12 hours apart. Women should not take 40 or 50 combined (estrogen-progestin) oral contraceptive pills as ECPs. For women who have been continuing users of POPs, this may be the method of emergency contraception most convenient for her, or the only method available in time. 9. What is ulipristal acetate (UPA)? UPA is an anti-progestin—that is, it modifies the activity of the natural hormone progesterone in a woman’s monthly cycle. Thus, like other ECPs, UPA-ECPs probably work by blocking or delaying release of an egg from the ovary (ovulation). All ECPs should be taken as soon as possible for greatest effectiveness. UPA-ECPs may be more effective than other ECPs between 72 hours and 120 hours after unprotected sex. UPA-ECPs have been available in Europe since 2009 and received approval from the United States Food and Drug Administration in 2010 for use as an emergency contraceptive. They are now available in more than 50 countries. UPA-ECPs are not intended for use as a continuing oral contraceptive. 10. Are ECPs safe for women living with HIV? Can women on antiretroviral therapy safely use ECPs? Yes. Women living with HIV and those on antiretroviral therapy can safely use ECPs. 11. Are ECPs appropriate for adolescents? Yes. A study of ECP use among girls 13 to 16 years old found it safe. Furthermore, all of the study participants were able to use ECPs correctly. Also, access to ECPs does not influence sexual behavior. Adolescents might particularly need ECPs because of high rates of forced sex, stigma about obtaining contraceptives, limited ability to plan for sex, and errors in using contraceptives. Questions and Answers About Emergency Contraceptive Pills JHU HBk18 - Chapter 3.indd 63 1/26/18 09:51 64 Family Planning: A Global Handbook for Providers 12. Can a woman who cannot use combined (estrogen-progestin) oral contraceptives or progestin-only pills as an ongoing method still safely use ECPs? Yes. This is because ECP treatment is very brief and the dose is small. 13. If ECPs failed to prevent pregnancy, does a woman have a greater chance of that pregnancy being an ectopic pregnancy? No evidence suggests that ECPs increase the risk of ectopic pregnancy. Worldwide studies of progestin-only ECPs, including a US Food and Drug Administration review, have not found higher rates of ectopic pregnancy after ECPs failed than are found among pregnancies generally. 14. Why give women ECPs before they need them? Won’t that discourage or otherwise affect contraceptive use? No. Studies of women given ECPs in advance report these findings:  Women who had ECPs on hand took them sooner after having unprotected sex than women who had to seek out ECPs. Progestin-only ECPs are more likely to be effective when taken sooner.  Women given ECPs ahead of time were more likely to use them when needed than women who had to go to a provider to get ECPs.  Women continued to use other contraceptive methods as they did before obtaining ECPs in advance.  Women did not have unprotected sex more often. If ECPs require a prescription and cannot be given in advance, give a prescription that can be use as needed. 15. If a woman buys ECPs over the counter, can she use them correctly? Yes. Taking ECPs is simple, and medical supervision is not needed. Studies show that both young and adult women find the label and instructions easy to understand. In some countries ECPs are approved for over-the-counter sales or nonprescription use. These countries include Canada, China, India, the United States, and many others around the world. JHU HBk18 - Chapter 3.indd 64 1/26/18 09:51 4 P r o g es t in - O n ly I n je c t a b le s 65 Progestin-Only Injectables CHAPTER 4 Progestin-Only Injectables Key Points for Providers and Clients  Bleeding changes are common but not harmful. Typically, irregular bleeding for the first several months and then no monthly bleeding.  Return for injections regularly. Coming back every 3 months (13 weeks) for DMPA or every 2 months for NET-EN is important for greatest effectiveness.  Injection can be as much as 4 weeks late for DMPA or 2 weeks late for NET-EN. Even if later, she may still be able to have the injection.  Gradual weight gain is common, averaging 1–2 kg per year.  Return of fertility is often delayed. It takes several months longer on average to become pregnant after stopping progestin- only injectables than after stopping other methods. What Are Progestin-Only Injectables?  The injectable contraceptives depot medroxyprogesterone acetate (DMPA) and norethisterone enanthate (NET-EN) each contain a progestin like the natural hormone progesterone in a woman’s body. (In contrast, monthly injectables contain both estrogen and progestin. See Monthly Injectables, p. 97.)  Do not contain estrogen, and so can be used throughout breastfeeding, starting 6 weeks after giving birth, and by women who cannot use methods with estrogen.  Given by injection into the muscle (intramuscular injection) or, with a new formulation of DMPA, just under the skin (subcutaneous injection). The hormone is then released slowly into the bloodstream. (See DMPA for Subcutaneous Injection, p. 68.) JHU HBk18 - Chapter 4.indd 65 1/26/18 09:51 66 Family Planning: A Global Handbook for Providers  DMPA, the most widely used progestin-only injectable, is also known in its intramuscular form as “the shot,” “the jab,” the injection, Depo, Depo-Provera, and Petogen. The subcutaneous version in the Uniject injection system is currently marketed under the name Sayana Press and in prefilled single-dose disposable hypodermic syringes as depo-subQ provera 104.  NET-EN is also known as norethindrone enanthate, Noristerat, Norigest, and Syngestal. (See Comparing Injectables, p. 427, for differences between DMPA and NET-EN.)  Work primarily by preventing the release of eggs from the ovaries (ovulation). How Effective? Effectiveness depends on getting injections regularly: Risk of pregnancy is greatest when a woman misses an injection.  As commonly used, about 4 pregnancies per 100 women using progestin-only injectables over the first year. This means that 96 of every 100 women using injectables will not become pregnant.  When women have injections on time, less than 1 pregnancy per 100 women using progestin-only injectables over the first year (2 per 1,000 women). Return of fertility after injections are stopped: An average of about 4 months longer for DMPA and 1 month longer for NET-EN than with most other methods (see Question 8, p. 94). Protection against sexually transmitted infections (STIs): None More effective Less e�ective JHU HBk18 - Chapter 4.indd 66 1/26/18 09:51 4 P r o g es t in - O n ly I n je c t a b le s 67Progestin-Only Injectables Side Effects, Health Benefits, and Health Risks Side Effects (see also Managing Any Problems, p. 89) Most users report some changes in monthly bleeding. †  Typically, these include, with DMPA: First 3 months: – Irregular bleeding – Prolonged bleeding At one year: – No monthly bleeding – Infrequent bleeding – Irregular bleeding  NET-EN affects bleeding patterns less than DMPA. NET-EN users have fewer days of bleeding in the first 6 months and are less likely than DMPA users to have no monthly bleeding after one year. Some users report the following:  Weight gain (see Question 5, p. 93)  Headaches  Dizziness  Abdominal bloating and discomfort  Mood changes  Less sex drive Other possible physical changes:  Loss of bone density (see Question 11, p. 95) Why Some Women Say They Like Progestin-Only Injectables  Requires action only every 2 or 3 months. No daily pill-taking.  Do not interfere with sex  Are private: No one else can tell that a woman is using contraception  Stop monthly bleeding (for many women)  May help women to gain weight Bleeding changes are normal and not harmful. If a woman finds them bothersome, counseling and support can help. † For definitions of bleeding patterns, see “vaginal bleeding,” p. 407. JHU HBk18 - Chapter 4.indd 67 1/26/18 09:51 68 Family Planning: A Global Handbook for Providers Known Health Benefits Known Health Risks DMPA Helps protect against:  Risks of pregnancy  Cancer of the lining of the uterus (endometrial cancer)  Uterine fibroids May help protect against:  Symptomatic pelvic inflammatory disease  Iron-deficiency anemia Reduces:  Sickle cell crises among women with sickle cell anemia  Symptoms of endometriosis (pelvic pain, irregular bleeding) None NET-EN Helps protect against:  Risks of pregnancy  Iron-deficiency anemia None NET-EN may offer many of the same health benefits as DMPA, but this list of benefits includes only those for which there is available research evidence. DMPA for Subcutaneous Injection DMPA is now available in a special formulation, called DMPA-SC, that is meant only for subcutaneous injection (just under the skin) and not for injection into muscle. Subcutaneous injection is easier to learn than intramuscular injection. DMPA-SC is available in two injection systems—in the Uniject device and in prefilled, single-dose, conventional syringes. Both have short needles meant for injection just below the skin. With the Uniject system, the user squeezes a flexible reservoir that pushes the fluid through the needle. DMPA-SC in the Uniject system is marketed under the brand name Sayana Press. This product may be par- ticularly useful for community-based programs (see box, next page). Also, women can easily learn to give themselves subcutaneous injections with this system (see instructions on p. 84–85). JHU HBk18 - Chapter 4.indd 68 1/26/18 09:51 4 P r o g es t in - O n ly I n je c t a b le s 69 Correcting Misunderstandings (see also Questions and Answers, p. 92) Progestin-only injectables:  Can stop monthly bleeding, but this is not harmful and could help prevent anemia. It is similar to not having monthly bleeding during pregnancy. Blood is not building up inside the woman. Effectiveness is high regardless of the bleeding pattern.  Do not disrupt an existing pregnancy.  Do not make women infertile. Progestin-Only Injectables Delivering Injectable Contraception in the Community Injectable contraceptives are popular with many women. This method can be more widely available when it is offered in the community as well as in clinics. In 2012 WHO noted that using lay health workers to give injectable contraceptives may increase access to injectables and does not appear to raise safety concerns. WHO suggested that provision of injectables could be added to well-functioning programs that employ lay health workers. These recommendations are part of a global movement known as task-sharing—empowering more types of health care workers to provide various health services. The goal of task-sharing is to serve more people, especially where there are few highly trained health care providers (see Who Provides Family Planning?, p. 372). Lay health workers, auxiliary nurses, and other community-based providers of injectables should be trained and able to give injections safely. Also, they should be able to screen clients for pregnancy and for medical eligibility. They can inform women about delayed return of fertility and common side effects, including irregular bleeding, no monthly bleeding, and weight gain, and explain the importance of dual protection if a woman is at risk for sexually transmitted infections, including HIV. They also can inform women about the range of methods available, including methods available at the clinic. All providers of injectables need specific competency-based training and supportive supervision to carry out these tasks. WHO recommends specific monitoring and evaluation of the provision of injectables by lay health workers. (Continued on next page) JHU HBk18 - Chapter 4.indd 69 1/26/18 09:51 70 Family Planning: A Global Handbook for Providers Delivering Injectable Contraception in the Community (continued) Prefilled syringes aid community-based programs Prefilled single-dose, single-use injection devices make community and home delivery easier because providers do not have to draw a measured dose into the syringe from a vial. Also, these devices cannot be reused. DMPA is available in a number of prefilled single-dose injection systems: The older formulation for intramuscular injection (DMPA- IM) is available in auto-disable syringes. The newer subcutaneous formulation (DMPA-SC), which is suitable only for injection just under the skin, comes in the Uniject injection system under the brand name Sayana Press and in single-use conventional syringes (see DMPA for Subcutaneous Injection, p. 68). The new subcutaneous formulation, particularly in the Uniject system, is likely to make delivery of DMPA injections in the community and the home easier. In fact, women can learn to inject themselves with this formulation (see p. 83). Working together, in communities and clinics For success, clinic-based providers and community-based providers need to work together closely. Programs vary, but these are some ways that clinic-based providers can support community-based providers:  Managing side effects (see pp. 89–90)  Using clinical judgment concerning medical eligibility in special cases (see p. 74)  Ruling out pregnancy in women who are more than 4 weeks late for an injection of DMPA or 2 weeks late for NET-EN (see Managing Late Injections, p. 88)  Responding to concerns of clients referred by the community-based providers The clinic also can serve as “home” for the community-based providers, where they go for resupply, for supervision, training, and advice, and to turn in their records. JHU HBk18 - Chapter 4.indd 70 1/26/18 09:51 4 P r o g es t in - O n ly I n je c t a b le s 71 Who Can and Cannot Use Progestin-Only Injectables Safe and Suitable for Nearly All Women Nearly all women can use progestin-only injectables safely and effectively, including women who:  Have or have not had children  Are married or are not married  Are of any age, including adolescents and women over 40 years old  Have just had an abortion or miscarriage  Smoke cigarettes, regardless of woman’s age or number of cigarettes smoked  Are breastfeeding, starting as soon as 6 weeks after childbirth  Are living with HIV, whether or not on antiretroviral therapy (see Progestin-Only Injectables for Women With HIV, p. 74) Avoid Unnecessary Procedures (see Importance of Procedures, p. 368) Women can begin using progestin-only injectables:  Without a pelvic examination  Without any blood tests or other routine laboratory tests  Without cervical cancer screening  Without a breast examination  Without a pregnancy test. A woman can begin using a progestin-only injectable at any time, even when she is not having monthly bleeding at the time, if it is reasonably certain she is not pregnant (see Pregnancy Checklist, inside back cover). Who Can and Cannot Use Progestin-Only Injectables Blood pressure measurement is desirable before starting a hormonal method. However, where the risks of pregnancy are high and few methods are available, a woman should not be denied a hormonal method simply because her blood pressure cannot be measured. If possible, she can have her blood pressure measured later at a time and place convenient for her. JHU HBk18 - Chapter 4.indd 71 1/26/18 09:51 72 Family Planning: A Global Handbook for Providers Ask the client the questions below about known medical conditions. Examinations and tests are not necessary. If she answers “no” to all of the questions, then she can start progestin-only injectables if she wants. If she answers “yes” to a question, follow the instructions. In some cases she can still start progestin-only injectables. 1. Are you breastfeeding a baby less than 6 weeks old? R NO R YES She can start using progestin-only injectables as soon as 6 weeks after childbirth (see Fully or nearly fully breastfeeding or Partially breastfeeding, p. 76). 2. Do you have severe cirrhosis of the liver or severe liver tumor? R NO R YES If she reports severe cirrhosis or severe liver tumor, such as liver cancer, do not provide progestin-only injectables. Help her choose a method without hormones. 3. Do you have high blood pressure? R NO R YES Check her blood pressure if possible:  If she is currently being treated for high blood pressure and it is adequately controlled, or her blood pressure is below 160/100 mm Hg, provide progestin-only injectables.  If systolic blood pressure is 160 mm Hg or higher or diastolic blood pressure is100 or higher, do not provide progestin-only injectables. Help her choose another method, one without estrogen.  If she reports having high blood pressure in the past, and you cannot check blood pressure, provide progestin-only injectables. 4. Have you had diabetes for more than 20 years or damage to your arteries, vision, kidneys, or nervous system caused by diabetes? R NO R YES Do not provide progestin-only injectables. Help her choose another method, one without estrogen. Medical Eligibility Criteria for Progestin-Only Injectables JHU HBk18 - Chapter 4.indd 72 1/26/18 09:51 4 P r o g es t in - O n ly I n je c t a b le s 73Who Can and Cannot Use Progestin-Only Injectables 5. Have you ever had a stroke, blood clot in your leg or lungs, heart attack, or other serious heart problems? R NO R YES If she reports heart attack, heart disease due to blocked or narrowed arteries, or stroke, do not provide progestin-only injectables. Help her choose another method, one without estrogen. If she reports a current blood clot in legs (affecting deep veins, not superficial veins) or in a lung and she is not on anticoagulant therapy, help her choose a method without hormones. 6. Are you having vaginal bleeding that is unusual for you? R NO R YES If she has unexplained vaginal bleeding that suggests pregnancy or an underlying medical condition, progestin-only injectables could make diagnosis and monitoring of any treatment more difficult. Help her choose another method to use while being evaluated and treated (but not implants or a copper-bearing or hormonal IUD). After treatment, re-evaluate for use of progestin-only injectables. 7. Do you have or have you ever had breast cancer? R NO R YES Do not provide progestin-only injectables. Help her choose a method without hormones. 8. Do you have several conditions that could increase your chances of heart disease (coronary artery disease) or stroke, such as high blood pressure and diabetes? R NO R YES Do not provide progestin-only injectables. Help her choose another method, one without estrogen. Also, women should not use progestin-only injectables if they report having lupus with positive (or unknown) antiphospholipid antibodies and not on immunosuppressive treatment, or severe thrombocyto- penia. For complete classifications, see Medical Eligibility Criteria for Contraceptive Use, p. 388. Be sure to explain the health benefits and risks and the side effects of the method that the client will use. Also, point out any conditions that would make the method inadvisable, when relevant to the client. JHU HBk18 - Chapter 4.indd 73 1/26/18 09:51 74 Family Planning: A Global Handbook for Providers Using Clinical Judgment in Special Cases Usually, a woman with any of the conditions listed below should not use progestin-only injectables. In special circumstances, however, when other, more appropriate methods are not available or acceptable to her, a qualified provider who can carefully assess a specific woman’s condition and situation may decide that she can use progestin-only injectables. The provider needs to consider the severity of her condition and, for most conditions, whether she will have access to follow-up.  Breastfeeding and less than 6 weeks since giving birth (considering the risks of another pregnancy and that a woman may have limited further access to injectables)  Severe high blood pressure (systolic 160 mm Hg or higher or diastolic 100 mm Hg or higher)  Acute blood clot in deep veins of legs or lungs  History of heart disease or current heart disease due to blocked or narrowed arteries (ischemic heart disease)  History of stroke  Multiple risk factors for arterial cardiovascular disease such as diabetes and high blood pressure  Unexplained vaginal bleeding before evaluation for possible serious underlying condition  Had breast cancer more than 5 years ago, and it has not returned  Diabetes for more than 20 years or damage to arteries, vision, kidneys, or nervous system caused by diabetes  Severe cirrhosis or liver tumor  Systemic lupus erythematosus with positive (or unknown) antiphospholipid antibodies and not on immunosuppressive treatment, or severe thrombocytopenia. Progestin-Only Injectables for Women With HIV  Women who are living with HIV or are on antiretroviral (ARV) therapy can safely use progestin-only injectables.  The time between injections does not need to be shortened for women taking ARVs.  Urge these women to use condoms as well. Used consistently and correctly, condoms help prevent transmission of HIV and other STIs. JHU HBk18 - Chapter 4.indd 74 1/26/18 09:51 4 P r o g es t in - O n ly I n je c t a b le s 75Providing Progestin-Only Injectables Providing Progestin-Only Injectables When to Start IMPORTANT: A woman can start injectables any time she wants if it is reasonably certain she is not pregnant. To be reasonably certain she is not pregnant, use the Pregnancy Checklist (see inside back cover). Woman’s situation When to start Having menstrual cycles or switching from a nonhormonal method Any time of the month  If she is starting within 7 days after the start of her monthly bleeding, no need for a backup method.  If it is more than 7 days after the start of her monthly bleeding, she can start injectables any time it is reasonably certain she is not pregnant. She will need a backup method* for the first 7 days after the injection.  If she is switching from an IUD, she can start injectables immediately (see Copper-Bearing IUD, Switching From an IUD to Another Method, p. 172). Counseling Women Who Want a Progestin-Only Injectable Where HIV Risk Is High Some research has found that women who use a progestin-only injectable and are exposed to HIV are more likely than other women to get HIV infection (see Question 2, p. 92). It is not clear whether this is due to the progestin-only injectable or to the way that the research was conducted. In countries and programs where many family planning clients are at high risk of HIV, providers should discuss this finding with women interested in a progestin-only injectable. For counseling tips see Considering Progestin-Only Injectables Where HIV Risk Is High, p. 438. Women who are at high risk for HIV can still choose a progestin-only injectable if they wish (MEC Category 2). * Backup methods include abstinence, male and female condoms, spermicides, and withdrawal. Tell her that spermicides and withdrawal are the least effective contraceptive methods. If possible, give her condoms. JHU HBk18 - Chapter 4.indd 75 1/26/18 09:51 76 Family Planning: A Global Handbook for Providers Switching from a hormonal method  Immediately, if she has been using the hormonal method consistently and correctly or if it is otherwise reasonably certain she is not pregnant. No need to wait for her next monthly bleeding. No need for a backup method.  If she is switching from another injectable, she can have the new injectable when the repeat injection would have been given. No need for a backup method. Fully or nearly fully breastfeeding Less than 6 months after giving birth  If she gave birth less than 6 weeks ago, delay her first injection until at least 6 weeks after giving birth.  If her monthly bleeding has not returned, she can start injectables any time between 6 weeks and 6 months. No need for a backup method.  If her monthly bleeding has returned, she can start injectables as advised for women having menstrual cycles (see previous page). More than 6 months after giving birth  If her monthly bleeding has not returned, she can start injectables any time if it is reason- ably certain she is not pregnant. She will need a backup method for the first 7 days after the injection.  If her monthly bleeding has returned, she can start injectables as advised for women having menstrual cycles (see previous page). Partially breastfeeding Less than 6 weeks after giving birth  Delay her first injection until at least 6 weeks after giving birth. Woman’s situation When to start JHU HBk18 - Chapter 4.indd 76 1/26/18 09:51 4 P r o g es t in - O n ly I n je c t a b le s 77Providing Progestin-Only Injectables More than 6 weeks after giving birth  If her monthly bleeding has not returned, she can start injectables any time if it is reasonably certain she is not pregnant.† She will need a backup method for the first 7 days after the injection.  If her monthly bleeding has returned, she can start injectables as advised for women having menstrual cycles (see p. 75). Not breastfeeding Less than 4 weeks after giving birth  She can start injectables at any time. No need for a backup method. More than 4 weeks after giving birth  If her monthly bleeding has not returned, she can start injectables any time if it is reasonably certain she is not pregnant.† She will need a backup method for the first 7 days after the injection.  If her monthly bleeding has returned, she can start injectables as advised for women having menstrual cycles (see p. 75). No monthly bleeding (not related to childbirth or breastfeeding)  She can start injectables any time if it is reason- ably certain she is not pregnant. She will need a backup method for the first 7 days after the injection. After miscarriage or abortion  Immediately. If she is starting within 7 days after first- or second-trimester miscarriage or abortion, no need for a backup method.  If it is more than 7 days after first- or second- trimester miscarriage or abortion, she can start injectables any time if it is reasonably certain she is not pregnant. She will need a backup method for the first 7 days after the injection. † Where a visit 6 weeks after childbirth is routinely recommended and other opportunities to obtain contraception are limited, some providers and programs may give the first injection at the 6-week visit, without further evidence that the woman is not pregnant, if her monthly bleeding has not yet returned. Woman’s situation When to start Partially breastfeeding (continued) JHU HBk18 - Chapter 4.indd 77 1/26/18 09:51 78 Family Planning: A Global Handbook for Providers After taking emergency contraceptive pills (ECPs) After taking progestin-only or combined ECPs:  She can start or restart injectables on the same day as taking the ECPs. No need to wait for her next monthly bleeding to have the injection. – She will need to use a backup method for the first 7 days after the injection.  If she does not start immediately but returns for injectables, she can start at any time if it is reasonably certain she is not pregnant. After taking ulipristal acetate (UPA) ECPs:  She can start or restart injectables on the 6th day after taking UPA-ECPs. No need to wait for her next monthly bleeding to have the injection. Injectables and UPA interact. If an injectable is started sooner, and thus both are present in the body, one or both may be less effective.  Make an appointment for her to return for the injection on the 6th day after taking UPA-ECPs, or as soon as possible after that.  She will need to use a backup method from the time she takes UPA-ECPs until 7 days after the injection.  If she does not start on the 6th day but returns later for injectables, she may start at any time if it is reasonably certain she is not pregnant. Woman’s situation When to start JHU HBk18 - Chapter 4.indd 78 2/6/18 09:52 4 P r o g es t in - O n ly I n je c t a b le s 79 Giving Advice on Side Effects IMPORTANT: Thorough counseling about bleeding changes and other side effects must come before giving the injection. Counseling about bleeding changes may be the most important help a woman needs to keep using the method without concern. Describe the most common side effects  For the first several months, irregular bleeding, prolonged bleeding, frequent bleeding. Later, no monthly bleeding.  Weight gain (about 1–2 kg per year), headaches, dizziness, and possibly other side effects. Explain about these side effects  Side effects are not signs of illness.  Common, but some women do not have them.  The client can come back for help if side effects bother her. Giving Intermusclar Injection with a Conventional Syringe 1. Obtain one dose of injectable, needle, and syringe  DMPA: 150 mg for injections into the muscle (intramuscular injection). NET-EN: 200 mg for injections into the muscle.  For each injection use a prefilled single-use syringe and needle from a new, sealed package (within expiration date and not damaged), if available.  If a single-dose prefilled syringe is not available, use single-dose vials. Check expiration date. If using an open multidose vial, check that the vial is not leaking. – DMPA: A 2 ml syringe and a 21–23 gauge intramuscular needle. – NET-EN: A 2 or 5 ml syringe and a 19-gauge intramuscular needle. A narrower needle (21–23 gauge) also can be used. 2. Wash  Wash hands with soap and water, if possible. Let your hands dry in the air.  If injection site is dirty, wash it with soap and water.  No need to wipe site with antiseptic. Providing Progestin-Only Injectables JHU HBk18 - Chapter 4.indd 79 1/26/18 09:51 80 Family Planning: A Global Handbook for Providers 3. Prepare vial  DMPA: Gently shake the vial.  NET-EN: Shaking the vial is not necessary.  No need to wipe top of vial with antiseptic.  If vial is cold, warm to skin temperature before giving the injection. 4. Fill syringe  Pierce top of vial with sterile needle and fill syringe with proper dose. 5. Inject formula  Insert sterile needle deep into the hip (ventro- gluteal muscle), the upper arm (deltoid muscle), or the buttocks (gluteal muscle, upper outer portion), whichever the woman prefers. Inject the contents of the syringe.  Do not massage injection site. 6. Dispose of disposable syringes and needles safely  Do not recap, bend, or break needles before disposal.  Place in a puncture-proof sharps container.  Do not reuse disposable syringes and needles. They are meant to be destroyed after a single use. Because of their shape, they are very difficult to disinfect. Therefore, reuse might transmit diseases such as HIV and hepatitis.  If reusable syringe and needle are used, they must be sterilized again after each use (see Infection Prevention in the Clinic, p. 376). If using a prefilled syringe, skip to step 5. JHU HBk18 - Chapter 4.indd 80 1/26/18 09:51 4 P r o g es t in - O n ly I n je c t a b le s 81 Giving the Injection with Subcutaneous DMPA in Uniject (Sayana Press) 1. Gather the supplies Supplies include:  Uniject prefilled injection device at room temperature that has not passed its expiration date  Soap and clean water  Cotton swabs or cotton balls, if available  Safe puncture-proof container for sharps disposal 2. Wash Wash hands with soap and water, if possible.  Let your hands dry in the air.  If injection site is dirty, wash it with soap and water.  No need to wipe site with antiseptic. 3. Ask where the client wants the injection You can give the injection just under the skin:  in the back of the upper arm  in the abdomen (but not at the navel)  on the front of the thigh. 4. Open the pouch  Open the foil pouch and remove the device. 5. Mix the solution  Hold the device by the port (see picture 1).  Shake it hard for 30 seconds.  Check that the solution is mixed (granules distributed throughout the solution) and there is no damage or leaking. Providing Progestin-Only Injectables 1. Parts of Uniject device Port Cap Needle Reservoir (Continued on next page) JHU HBk18 - Chapter 4.indd 81 1/26/18 09:51 82 Family Planning: A Global Handbook for Providers 6. Close the gap  Hold the device by the port.  Take care not to squeeze the reservoir during this step.  Hold the device with the needle pointed upward to avoid spilling the drug.  Push the cap into the port (see part A of picture 2, below).  Continue to push firmly until the gap between the cap and port is closed (see part B of picture 2, below).  Take off the cap (see part C of picture 2, below). 7. Give the injection  Gently pinch the skin at the injection site (see picture 3).This helps to make sure that the drug is injected into fatty tissue just under the skin and not into muscle.  Hold the port. Gently push the needle straight into the skin with the needle pointing down (never upward) until the port touches the skin.  Squeeze the reservoir slowly. Take 5 to 7 seconds.  Pull out the needle and then release the skin.  Do not clean or massage the site after injecting. 8. Discard the used device  Do not replace the cap.  Place the device in a safety box. 2. Close the gap and take off the cap 3. Pinch the skin and inject A B C JHU HBk18 - Chapter 4.indd 82 1/26/18 09:51 4 P r o g es t in - O n ly I n je c t a b le s 83 Supporting the User Give specific instructions  Tell her not to massage the injection site.  Tell the client the name of the injection.  Agree on a date for her next injection and give her a paper with the date written on it. Self-injection Can Be an Option Women can learn to inject themselves with the new subcutaneous formulation of DMPA. Some women like self-injection better than injections by health workers. Self-injection may save women time and money. Research finds that 3 months after one-on-one training most women can competently give themselves their next injection. Women who inject themselves seem to be as likely to keep using injectable contraceptives as women who get their injections in clinics. WHO recommends making self-injection an option where appropriate information and training are made available, referral links to a health care provider are strong, and women who self-inject are monitored and followed up. In addition, safe storage of injection devices at home and their safe disposal are important. Teaching Clients to Self-Inject Some clients will want to give themselves the injections. You can teach them how to do this. The following steps apply to self-injection with DMPA-SC in the Uniject injection system (Sayana Press). 1. Discuss plan for storage and disposal Storage. Discuss where the client can store the devices for many months that is out of the reach of children and animals and in moderate temperatures (not in direct sunlight or in a refrigerator). Disposal. Discuss how the client can dispose of the device in a contain- er that has a lid and cannot be punctured and can be kept away from children. (Local programs should decide how to help women dispose of used needles.) Providing Progestin-Only Injectables Note: The instructions on the next 2 pages can be copied and given to a client. Steps in teaching clients to self-inject continue on p. 86. JHU HBk18 - Chapter 4.indd 83 1/26/18 09:51 84 How To Self-Inject How to give yourself an injection with Sayana Press Important steps How to do it 1. Choose a correct injection site Choose either:  the belly (but not the navel) OR  the front of the thigh. 2. Mix the solution  After washing hands, open the pouch and take out the injection device.  Hold the device by the port (not the cap) and shake it hard for about 30 seconds. Make sure the solution is completely mixed. 3. Push the cap and the port together to close the gap  Point the needle upward.  Hold the cap with one hand and the port with the other hand.  Press the cap down firmly until the gap is closed. 1. Where to give yourself the injection 2. Mix the solution 3. Close the gap Port Cap Needle Reservoir Parts of the Sayana Press injection device JHU HBk18 - Chapter 4.indd 84 1/26/18 09:51 4 P r o g es t in - O n ly I n je c t a b le s 85How To Self-Inject 4. Pinch your skin into a “tent”  Take the cap off the needle. Hold the device by the port.  With the other hand pinch about 4 cm (1½ inches) of skin. 5. Put the needle into the skin, and squeeze the reservoir slowly  Press the needle straight into the skin with the needle pointing downward.  Press the needle in until the port touches the skin completely.  Squeeze the reservoir slowly, for 5 to 7 seconds. 6. Dispose of the needle safely  Pull the needle out and then let go of the skin.  Put the device in a container that can be closed and cannot be punctured. 7. Plan for your next injection  Mark a calendar or other reminder for the same day of the month 3 months from today.  You can give yourself the next injection as early as 2 weeks before that date or as late as 4 weeks after.  If more than 4 weeks late, use another contracep- tive method and see a health worker.  Make sure you have another device for the next injection and that it will not expire before then. If you need help or more injection devices, contact: ______________________________________________________________ at ____________________________________________________________ 4 & 5. Pinch the skin and press in the needle Important steps How to do it JHU HBk18 - Chapter 4.indd 85 1/26/18 09:51 86 Family Planning: A Global Handbook for Providers 2. Explain and show how to self-inject. Show the device and describe its parts. (See picture in instructions, p. 84.) Give the client a copy of the instructions and pictures on the previous 2 pages, a similar instruction sheet, or a booklet of more detailed instructions. Explain the important steps. Use an injection model to explain and show the client how to do each step while helping the client follow along on the instruction sheet. (If an injection model is not available, you can use a condom filled with salt or sugar. Or you can use fruit or bread.) 3. Ask the client to try it. After you have used the injection model to show self-injection, ask the client to practice injecting the model. Watch her and then discuss what went well and what did not. Answer her questions. Invite the client to keep trying to inject the model until she can do all the steps correctly and feels ready to inject herself. 4. Ask the woman to inject herself while you are watching. Then give her injection devices to take home so that she can inject herself in the future. Make sure that she understands when her future injection dates are, and how to calculate those dates by noting the same day of the month every 3 months. If she is unable to inject herself, give her the injection. When she returns for her next injection, ask if she wants to try self-injection again. If so, repeat the training. 5. Tell the client where to get more injection devices. Invite her to contact you if she has any questions or problems with self-injection or getting more injection devices. Teaching Clients To Self-Inject (continued from p. 83) JHU HBk18 - Chapter 4.indd 86 1/26/18 09:51 4 P r o g es t in - O n ly I n je c t a b le s 87 “Come Back Any Time”: Reasons to Return Before the Next Injection Assure every client that she is welcome to come back any time—for example, if she has problems, questions, or wants another method; she has a major change in health status; or she thinks she might be pregnant. General health advice: Anyone who suddenly feels that something is seriously wrong with her health should immediately seek medical care from a nurse or doctor. Her contraceptive method is most likely not the cause of the condition, but she should tell the nurse or doctor what method she is using. Planning the Next Injection 1. Agree on a date for her next injection in 3 months (13 weeks) for DMPA, or in 2 months (8 weeks) for NET-EN. Give her a paper with the date written on it (or dates, if she is self-injecting and taking home more than one injection device). Discuss how to remember the date, perhaps tying it to a holiday or other event or circling a date on a calendar. 2. Ask her to try to come on time. With DMPA she may come up to 4 weeks after the scheduled injection date and still get an injection. With NET-EN she may come up to 2 weeks after the scheduled injection date and still get an injection. With either DMPA or NET-EN, she can come up to 2 weeks before the scheduled injection date. 3. She should come back no matter how late she is for her next injection. If more than 4 weeks late for DMPA or 2 weeks late for NET-EN, she should abstain from sex or use condoms, spermicides, or withdrawal until she can get an injection. Also, if she has had sex in the past 5 days without using another contraceptive method, she can consider emergency contraceptive pills (see Emergency Contraceptive Pills, p. 49). Providing Progestin-Only Injectables How Can a Partner Help? The client’s partner is welcome to participate in counseling and learn about the method and what support he can give to his partner. A male partner can:  Support a woman’s choice of a progestin-only injectable  Show understanding and support if she has side effects  Help her to remember to get her next injection on time  Help to make sure she has ECPs on hand in case she is late for an injection by more than 4 weeks for DMPA or more than 2 weeks for NET-EN  Use condoms consistently in addition to the progestin-only injectable if he has an STI/HIV or thinks he may be at risk of an STI/HIV JHU HBk18 - Chapter 4.indd 87 1/26/18 09:51 88 Family Planning: A Global Handbook for Providers Helping Continuing Users Repeat Injection Visits 1. Ask how the client is doing with the method and whether she is satisfied. Ask if she has any questions or anything to discuss. 2. Ask especially if she is concerned about bleeding changes. Give her any information or help that she needs (see Managing Any Problems, next page). 3. Give her the injection. Injection of DMPA can be given up to 4 weeks late. Injection of NET-EN can be given up to 2 weeks late. 4. Plan for her next injection. Agree on a date for her next injection (in 3 months or 13 weeks for DMPA, 2 months for NET-EN). Remind her that she should try to come on time, but she should come back no matter how late she is. (See Managing Late Injections, below.) 5. Every year or so, check her blood pressure if possible (see Medical Eligibility Criteria, Question 3, p. 72). 6. Ask a long-term client if she has had any new health problems. Address problems as appropriate. For new health problems that may require switching methods, see p. 91. 7. Ask a long-term client about major life changes that may affect her needs—particularly plans for having children and STI/HIV risk. Follow up as needed. Managing Late Injections  If the client is less than 4 weeks late for a repeat injection of DMPA, or less than 2 weeks late for a repeat injection of NET-EN, she can receive her next injection. No need for tests, evaluation, or a backup method.  A client who is more than 4 weeks late for DMPA, or more than 2 weeks late for NET-EN, can receive her next injection if: – She has not had sex since 2 weeks after the scheduled date of her injection, or – She has used a backup method or has taken emergency contraceptive pills (ECPs) after any unprotected sex since 2 weeks after the scheduled date of her injection, or – She is fully or nearly fully breastfeeding and she gave birth less than 6 months ago. She will need a backup method for the first 7 days after the injection.  If the client is more than 4 weeks late for DMPA, or more than 2 weeks late for NET-EN, and she does not meet these criteria, additional steps can be taken to be reasonably certain she is not pregnant (see Ruling Out JHU HBk18 - Chapter 4.indd 88 1/26/18 09:51 4 P r o g es t in - O n ly I n je c t a b le s 89Helping Continuing Users of Progestin-Only Injectables Managing Any Problems Problems Reported as Side Effects May or may not be due to the method.  Problems with side effects affect women’s satisfaction and use of injectables. They deserve the provider’s attention. If the client reports side effects, listen to her concerns, give her advice and support, and, if appropriate, treat. Make sure she understands the advice and agrees.  Offer to help the client choose another method—now, if she wishes, or if problems cannot be overcome. No monthly bleeding  Reassure her that most women using progestin-only injectables stop having monthly bleeding over time, and this is not harmful. There is no need to lose blood every month. It is similar to not having monthly bleeding during pregnancy. She is not infertile. Blood is not building up inside her. (Some women are happy to be free from monthly bleeding.)  If not having monthly bleeding bothers her, she may want to switch to monthly injectables, if available. Irregular bleeding (bleeding at unexpected times that bothers the client)  Reassure her that many women using progestin-only injectables experience irregular bleeding. It is not harmful and usually becomes less or stops after the first few months of use.  For modest short-term relief, she can take 500 mg mefenamic acid 2 times daily after meals for 5 days or 40 mg of valdecoxib daily for 5 days, beginning when irregular bleeding starts.  If irregular bleeding continues or starts after several months of normal or no monthly bleeding, or you suspect that something may be wrong for other reasons, consider underlying conditions unrelated to method use (see Unexplained vaginal bleeding, p. 91). Pregnancy, p. 439). These steps are helpful because many women who have been using progestin-only injectables will have no monthly bleeding for at least a few months, even after discontinuation. Thus, asking her to come back during her next monthly bleeding means her next injection could be unnecessarily delayed. She may be left without contraceptive protection.  Discuss why the client was late and solutions. Remind her that she should keep trying to come back every 3 months for DMPA, or every 2 months for NET-EN. If coming back on time is often a problem, discuss using a backup method when she is late for her next injection, taking ECPs, or choosing another method, such as an implant or IUD. JHU HBk18 - Chapter 4.indd 89 1/26/18 09:51 90 Family Planning: A Global Handbook for Providers Weight gain  Review diet and counsel as needed. Abdominal bloating and discomfort  Consider locally available remedies. Heavy or prolonged bleeding (twice as much as usual or longer than 8 days)  Reassure her that some women using progestin-only injectables experience heavy or prolonged bleeding. It is not harmful and usually becomes less or stops after a few months.  For modest short-term relief she can try (one at a time), beginning when heavy bleeding starts: – 500 mg of mefenamic acid twice daily after meals for 5 days – 40 mg of valdecoxib daily for 5 days – 50 µg of ethinyl estradiol daily for 21 days  If bleeding becomes a health threat or if the woman wants, help her choose another method. In the meantime, she can use one of the treatments listed above to help reduce bleeding.  To help prevent anemia, suggest she take iron tablets and tell her it is important to eat foods containing iron, such as meat and poultry (especially beef and chicken liver), fish, green leafy vegetables, and legumes (beans, bean curd, lentils, and peas).  If heavy or prolonged bleeding continues or starts after several months of normal or no monthly bleeding, or you suspect that something may be wrong for other reasons, consider underlying conditions unrelated to method use (see Unexplained vaginal bleeding, next page). Ordinary headaches (nonmigrainous)  Suggest aspirin (325–650 mg), ibuprofen (200–400 mg), paracetamol (325–1000 mg), or other pain reliever.  Any headaches that get worse or occur more often during use of injectables should be evaluated. Mood changes or changes in sex drive  Ask about changes in her life that could affect her mood or sex drive, including changes in her relationship with her partner. Give support as appropriate.  Clients who have serious mood changes such as major depression should be referred for care.  Consider locally available remedies. Dizziness  Consider locally available remedies. JHU HBk18 - Chapter 4.indd 90 1/26/18 09:51 4 P r o g es t in - O n ly I n je c t a b le s 91Helping Continuing Users of Progestin-Only Injectables New Problems That May Require Switching Methods May or may not be due to the method. Migraine headaches (see Identifying Migraine Headaches and Auras, p. 436)  If she has migraine headaches without aura, she can continue to use the method if she wishes.  If she has migraine aura, do not give the injection. Help her choose a method without hormones. Unexplained vaginal bleeding (that suggests a medical condition not related to the method)  Refer or evaluate by history and pelvic examination. Diagnose and treat as appropriate.  If no cause of bleeding can be found, consider stopping progestin-only injectables to make diagnosis easier. Provide another method of her choice to use until the condition is evaluated and treated (not implants or a copper-bearing or LNG-IUD).  If bleeding is caused by sexually transmitted infection or pelvic inflammatory disease, she can continue using progestin-only injectables during treatment. Certain serious health conditions (suspected blocked or narrowed arteries, serious liver disease, severe high blood pressure, blood clots

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