Family planning: a global handbook for providers: 2011 update: evidence-based guidance developed through worldwide collaboration

Publication date: 2011

2011 UPDATE 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 A WHO Family Planning Cornerstone 2011 United States Agency for International Development Bureau for Global Health Office of Population and Reproductive Health ii Family Planning: A Global Handbook for Providers 1 Combined Oral Contraceptives . 1 2 Progestin-Only Pills . 25 3 Emergency Contraceptive Pills . 45 4 Progestin-Only Injectables . 59 5 Monthly Injectables . 81 6 Combined Patch .101 7 Combined Vaginal Ring .105 8 Implants .109 9 Copper-Bearing Intrauterine Device .131 10 Levonorgestrel Intrauterine Device .157 11 Female Sterilization .165 12 Vasectomy .183 13 Male Condoms .199 14 Female Condoms .211 15 Spermicides and Diaphragms .221 16 Cervical Caps .237 17 Fertility Awareness Methods .239 18 Withdrawal .255 19 Lactational Amenorrhea Method .257 20 Serving Diverse Groups Adolescents .267 Men .270 Women Near Menopause .272 21 Sexually Transmitted Infections, Including HIV .275 22 Maternal and Newborn Health .289 Contents Forewords .iv Acknowledgements .vi What’s New in This Handbook? . viii World Health Organization’s 4 Cornerstones of Family Planning Guidance .xi How to Obtain More Copies of This Book .xii ii Family Planning: A Global Handbook for Providers Family Planning A GLOBAL HANDBOOK FOR PROVIDERS iiiiiiContents 23 Reproductive Health Issues Family Planning in Postabortion Care . 297 Violence Against Women . 300 Infertility . 304 24 Family Planning Provision Importance of Selected Procedures for Providing Family Planning Methods . 307 Successful Counseling . 308 Who Provides Family Planning? . 310 Infection Prevention in the Clinic . 312 Managing Contraceptive Supplies . 316 BAcK MAttER Appendix A. Contraceptive Effectiveness . 319 Appendix B. Signs and Symptoms of Serious Health Conditions . 320 Appendix C. Medical Conditions That Make Pregnancy Especially Risky . 322 Appendix D. Medical Eligibility Criteria for Contraceptive Use . 324 Glossary . 335 Index . 343 Methodology . 354 JOB AIDS AND tOOLS Comparing Contraceptives Comparing Combined Methods . 358 Comparing Injectables. 359 Comparing Implants . 360 Comparing Condoms . 360 Comparing IUDs . 362 Correctly Using a Male Condom . 363 Female Anatomy and the Menstrual Cycle . 364 Male Anatomy . 367 Identifying Migraine Headaches and Auras . 368 Further Options to Assess for Pregnancy . 370 Pregnancy Checklist . 372 If You Miss Pills . Inside back cover Effectiveness Chart. Back cover Searchable online at www.fphandbook.org iv Family Planning: A Global Handbook for Providers Forewords From the World Health Organization The job of family planning remains unfinished. Despite great progress over the last several decades, more than 120 million women worldwide want to prevent pregnancy, but they and their partners are not using contraception. Reasons for unmet need are many: Services and supplies are not yet available everywhere or choices are limited. Fear of social disapproval or partner’s opposition pose formidable barriers. Worries of side effects and health concerns hold some people back; others lack knowledge about contraceptive options and their use. These people need help now. Millions more are using family planning to avoid pregnancy but fail, for a variety of reasons. They may not have received clear instructions on how to use the method properly, could not get a method better suited to them, were not properly prepared for side effects, or supplies ran out. These people need better help now. Moreover, the job of family planning never will be finished. In the next 5 years about 60 million girls and boys will reach sexual maturity. Generation after generation, there will always be people needing family planning and other health care. While current challenges to health throughout the world are many and serious, the need to control one’s own fertility probably touches more lives than any other health issue. It is crucial to people’s well-being, particularly that of women—and fundamental to their self-determination. How can this book help? By enabling health care providers to give better care to more people. In a straightforward, easily used way, this book translates scientific evidence into practical guidance on all major contraceptive methods. This guidance reflects the consensus of experts from the world’s leading health organizations. With this book in hand, a provider can confidently serve clients with many different needs and knowledgeably offer a wide range of methods. The World Health Organization (WHO) appreciates the many contributions to this book made by people from around the world. The collaboration to develop, by consensus, an evidence-based book of this scope and depth is a remarkable achievement. WHO would like to thank particularly the Johns Hopkins Bloomberg School of Public Health/Center for Communication Programs for its invaluable partnership in the preparation of this book. WHO also appreciates the commitment of the many organizations—United Nations agencies, members of the Implementing Best Practices Consortium, and many others—that are adopting this handbook and disseminating it to health care providers throughout the world with the financial support of a wide range of government agencies and other development partners. These concerted efforts attest that the job of improving the world’s health lies in good hands. Paul F.A. Van Look, MD PhD FRCOG Former Director, Department of Reproductive Health and Research World Health Organization vForewords From the United States Agency for International Development The practical, up-to-date guidance in this new handbook will help to improve the quality of family planning services and maximize people’s access to them. It can help family planning providers to assist clients choosing a family planning method, to support effective use, and to solve clients’ problems. Managers and trainers can use this book, too. While this handbook covers many topics, 4 overall themes emerge: 1. Almost everyone can safely use almost any method, and providing most methods is usually not complicated. Thus, methods can be made widely available and offered even where health care resources are quite limited. This book defines and explains the many opportunities for people to choose, start, and change family planning methods appropriately. 2. Family planning methods can be effective when properly provided. For greatest effectiveness some methods, such as pills and condoms, require the user’s conscientious action. The provider’s help and support often can make the difference, such as discussing common possible side effects. Some methods require the provider to perform a procedure correctly, such as sterilization or IUD insertion. Short of giving instructions on performing procedures, this handbook offers the guidance and information that providers need to support effective and continuing contraceptive use. 3. New clients usually come for services with a method already in mind, and this is usually the best choice for them. Within the broad range of methods that a client can use safely, the client’s purposes and preferences should govern family planning decisions. To find and use the most suitable method, a client needs good information and, often, help thinking through choices. This book provides information that client and provider may want to consider together. 4. Many continuing clients need little support, and for them convenient access is key. For ongoing clients who encounter problems or concerns, help and support are vital. This handbook provides counseling and treatment recommendations for these clients. With the collaboration of the World Health Organization and many organizations, many experts worked together to create this book. The United States Agency for International Development is proud to support the work of many of the contributors’ organizations and the publication of this book, as well as to have participated in developing its content. Together with the providers of family planning who use this book, we all endeavor to make the world a better place. James D. Shelton, MD Science Advisor, Bureau for Global Health United States Agency for International Development vi Family Planning: A Global Handbook for Providers 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 include 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, Georgetown University Institute for Reproductive Health, JHPIEGO, Management Sciences for Health, 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 Acknowledgements viiAcknowledgements 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 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. © 2007, 2008, 2011 World Health Organization and Johns Hopkins Bloomberg School of Public Health/Center for Communication Programs ISBN 13: 978-0-9788563-7-3 ISBN 10: 0-9788563-0-9 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 (2011 update). Baltimore and Geneva: CCP and WHO, 2011. Published with support from the United States Agency for International Development, Global, GH/SPBO/OPS, under the terms of Grant No. GPO-A-00-08-00006-00. 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. viii Family Planning: A Global Handbook for Providers What’s New in This Handbook? This new handbook on family planning methods and related topics is the first of its kind: Through an organized, collaborative process, experts from around the world have come to consensus on practical guidance that reflects the best available scientific evidence. The World Health Organization (WHO) convened this process. Many major technical assistance and professional organizations have endorsed and adopted this guidance. This book serves as a quick-reference resource for all levels of health care workers. It is the successor to The Essentials of Contraceptive Technology, first published in 1997 by the Center for Communication Programs at Johns Hopkins Bloomberg School of Public Health. In format and organization it resembles the earlier handbook. At the same time, all of the content of Essentials has been re-examined, new evidence has been gathered, guidance has been revised where needed, and gaps have been filled. This handbook reflects the family planning guidance developed by WHO. Also, this book expands on the coverage of Essentials: It addresses briefly other needs of clients that come up in the course of providing family planning. New WHO Guidance Since 2007 Since the handbook was first published in 2007, the Department of Reproductive Health and Research of WHO convened an expert Working Group in April 2008 and two technical consultations in October 2008 and January 2010 to address questions for the Medical Eligibility Criteria (MEC) and the Selected Practice Recommendations and a technical consultation in June 2009 on the provision of progestin-only injectables by community health workers. Also, the HIV Department of WHO convened an expert Working Group in October 2009 to update guidance on infant feeding and HIV. This 2011 printing of the Global Handbook reflects new guidance developed in these meetings. (See p. 354.) Updates include: A woman may have a repeat injection of depot-medroxyprogesterone y acetate (DMPA) up to 4 weeks late. (Previous guidance said that she could have her DMPA reinjection up to 2 weeks late.) The guidance for reinjection of norethisterone enanthate (NET-EN) remains at up to 2 weeks late. (See p. 74.) During breastfeeding, antiretroviral (ARV) therapy for the mother, for y the HIV-exposed infant, or for both can significantly reduce the chances of HIV transmission through breast milk. HIV-infected mothers should receive the appropriate ARV therapy and should exclusively breastfeed their infants for the first 6 months of life, then introduce appropriate complementary foods and continue breastfeeding for the first 12 months of life. (See p. 294.) ixWhat’s New in This Handbook Postpartum women who are not breastfeeding can generally start com- y bined hormonal methods at 3 weeks (MEC category 2). However, some women who have additional risk factors for venous thromboembolism (VTE) generally should not start combined hormonal methods until 6 weeks after childbirth, depending on the number, severity, and combina- tion of the risk factors (MEC category 2/3). These additional risk factors include previous VTE, thrombophilia, caesarean delivery, blood transfusion at delivery, postpartum hemorrhage, pre-eclampsia, obesity, smoking, and being bedridden. (See p. 325.) Women with deep vein thrombosis who are established on anticoagulant y therapy generally can use progestin-only contraceptives (MEC category 2) but not combined hormonal methods (MEC category 4). (See p. 327.) Women with systemic lupus erythematosus generally can use any y contraceptive except that: (a) A woman with positive (or unknown) antiphospholipid antibodies should not use combined hormonal methods (MEC category 4) and generally should not use progestin-only methods (MEC category 3). (b) A woman with severe thrombocytopenia generally should not start a progestin-only injectable or have a copper-bearing IUD inserted (MEC category 3). (See p. 328.) Women with AIDS who are treated with ritonavir-boosted protease inhibi- y tors, a class of ARV drugs, generally should not use combined hormonal methods or progestin-only pills (MEC category 3). These ARV drugs may make these contraceptive methods less effective. These women can use progestin-only injectables, implants, and other methods. Women taking only other classes of ARVs can use any hormonal method. (See p. 330.) Women with chronic hepatitis or mild cirrhosis of the liver can use any y contraceptive method (MEC category 1). (See p. 331.) Women taking medicines for seizures or rifampicin or rifabutin for y tuberculosis or other conditions generally can use implants. (See p. 332.) New Guidance for Community-Based Provision of Injectables Community-based provision of progestin-only injectable contraceptives y by appropriately trained community health workers is safe, effective, and acceptable. Such services should be part of a family planning program offering a range of contraceptive methods. (See p. 63.) Other content Addressing Important Questions Combined Oral Contraceptives (COCs) y Facts about COCs and cancer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Extended and continuous use of COCs . . . . . . . . . . . . . . . . . . . . . . . 21 x Family Planning: A Global Handbook for Providers Emergency Contraceptive Pills (ECPs) y New guidance on taking ECPs up to 5 days after unprotected sex . . 49 New guidance on providing contraceptive methods after ECP use . . 52 Updated list of oral contraceptives that can be used as ECPs . . . . . . 56 Progestin-Only Injectables y Includes NET-EN as well as DMPA . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 New information on subcutaneous DMPA . . . . . . . . . . . . . . . . . . . . . 63 New guidance on managing late injections . . . . . . . . . . . . . . . . . . . . . 74 New research on bone density and DMPA . . . . . . . . . . . . . . . . . . . . . 80 Implants y Includes Jadelle, Implanon, and Sino-Implant (II) . . . . . . . . . . . . . . . . 109 Copper-Bearing Intrauterine Device y New checklist questions on AIDS, antiretroviral therapy, and sexually transmitted infections (STIs) . . . . . . . . . . . . . . . . . . . . . . . 136 Screening questions for pelvic examination before IUD insertion . . 137 New guidance on assessing STI risk for potential IUD users . . . . . . 138 Vasectomy y Most effective vasectomy techniques . . . . . . . . . . . . . . . . . . . . . . . . . 190 New guidance on when a man can rely on his vasectomy . . . . . . . . 192 Male Condoms y New criteria on severe allergic reaction to latex rubber . . . . . . . . . 202 Revised guidance on what can be done if a condom breaks, slips off the penis, or is not used . . . . . . . . . . . . . . . . . . . . . . . . . . 206 New guidance for managing clients with mild or severe allergic reaction to condom . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207 Fertility Awareness Methods y Includes Standard Days and TwoDay Methods . . . . . . . . . . . . . . . . . 239 Lactational Amenorrhea Method (LAM) y Revised guidance on using LAM for women with HIV . . . . . . . . . . . 260 Sexually Transmitted Infections, Including HIV y Contraception for clients with STIs, HIV, AIDS, or on antiretroviral therapy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 282 New information on hormonal contraceptives and risk of HIV . . . . 288 xi World Health Organization’s 4 Cornerstones of Family Planning Guidance This handbook is one of the World Health Organization’s (WHO) 4 cornerstones of family planning guidance. Together, the 4 cornerstones support the safe and effective provision and use of family planning methods. The first 2 cornerstones provide policy-makers and program managers with recommendations that can be used to establish or update national guidelines and program policies. The Medical Eligibility Criteria for Contraceptive Use (4th edition, 2010) provides guidance on whether people with certain medical conditions can safely and effectively use specific contraceptive methods. The Selected Practice Recommendations for Contraceptive Use (2nd edition, 2005) and the Selected Practice Recommendations for Contraceptive Use: 2008 Update answer specific questions about how to use various contraceptive methods. Both sets of guidance come from expert Working Group meetings convened by WHO. The third cornerstone, the Decision-Making Tool for Family Planning Clients and Providers, incorporates the guidance of the first 2 cornerstones and reflects evidence on how best to meet clients’ family planning needs. It is intended for use during counseling. The tool leads the provider and client through a structured yet tailored process that facilitates choosing and using a family planning method. The Decision-Making Tool also helps to guide return visits. As the fourth cornerstone, Family Planning: A Global Handbook for Providers offers technical information to help health care providers deliver family planning methods appropriately and effectively. A thorough reference guide, the handbook provides specific guidance on 20 family planning methods and addresses many of providers’ different needs, from correcting misunderstandings to managing side effects. Like the Decision-Making Tool, this handbook incorporates the guidance of the first 2 cornerstones. It also covers related health issues that may arise in the context of family planning. The 4 cornerstones can be found on the WHO Web site at http://www. who.int/reproductionhealth/publications/family_planning/. The handbook can also be found on the Knowledge for Health Project Web site at http://www.fphandbook.org. Updates to the handbook and news about translations are posted on these Web sites. For information on ordering printed copies, see next page. World Health Organization’s 4 Cornerstones of Family Planning Guidance xii 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, Switzerland (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. How to Obtain More Copies of This Book The Knowledge for Health Project at Johns Hopkins Bloomberg School of Public Health/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, please send your name, mailing address, e-mail address, and telephone number. To order by e-mail: orders@jhuccp.org To order by fax: +1 410 659-6266 To order by phone: +1 410 659-6315 To order via the Web: http://www.fphandbook.org/ To order by mail: Orders, Knowledge for Health Project Center for Communication Programs Johns Hopkins Bloomberg School of Public Health 111 Market Place, Suite 310 Baltimore, MD 21202, USA 1 What Are combined Oral contraceptives? Pills that contain low doses of 2 hormones—a y 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,” y low-dose combined pills, OCPs, and OCs. Work primarily by preventing the release of eggs from the ovaries y (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. y For greatest effectiveness a woman must take pills daily and start each new pack of pills on time. Bleeding changes are common but not harmful. y Typically, irregular bleeding for the first few months and then lighter and more regular bleeding. take any missed pill as soon as possible. y Missing pills risks pregnancy and may make some side effects worse. can be given to women at any time to start later. y If pregnancy cannot be ruled out, a provider can give her pills to take later, when her monthly bleeding begins. 1 C o m b in ed O ra l C o n tr ac ep ti ve s 2 Family Planning: A Global Handbook for Providers As commonly used, about 8 pregnancies per 100 women y using COCs over the first year. This means that 92 of every 100 women using COCs will not become pregnant. When no pill-taking mistakes are made, less than 1 pregnancy y 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 Managing Any Problems, p. 17) Some users report the following: y Changes in bleeding patterns including: – Lighter bleeding and fewer days of bleeding – Irregular bleeding – Infrequent bleeding – No monthly bleeding y Headaches y Dizziness y Nausea y Breast tenderness y Weight change (see Question 6, p. 22) y Mood changes y 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 y COCs, blood pressure declines quickly after use of COCs stops. Why Some Women Say they Like combined Oral contraceptives Are controlled by the woman y Can be stopped at any time without a provider’s help y Do not interfere with sex y More effective Less effective 3Combined Oral Contraceptives 1Known Health Benefits Known Health Risks Help protect against: Risks of pregnancy y Cancer of the lining of the uterus y (endometrial cancer) y Cancer of the ovary Symptomatic y pelvic inflammatory disease May help protect against: y Ovarian cysts Iron-deficiency y anemia Reduce: y Menstrual cramps Menstrual bleeding problems y Ovulation pain y Excess y hair on face or body Symptoms of y polycystic ovarian syndrome (irregular bleeding, acne, excess hair on face or body) Symptoms of y endometriosis (pelvic pain, irregular bleeding) Very rare: y Blood clot in deep veins of legs or lungs (deep vein thrombosis or pulmonary embolism) Extremely rare: y Stroke y Heart attack C o m b in ed O ra l C o n tr ac ep ti ve s See also Facts About Combined Oral Contraceptives and Cancer, p. 4. Correcting Misunderstandings (see also Questions and Answers, p. 22) Combined oral contraceptives: Do not build up in a woman’s body. Women do not need a “rest” from y taking COCs. Must be taken every day, whether or not a woman has sex that day. y Do not make women y infertile. Do not cause y birth defects or multiple births. Do not change women’s sexual behavior. y Do not collect in the stomach. Instead, the pill dissolves each day. y Do not disrupt an existing pregnancy. y 4 Family Planning: A Global Handbook for Providers Facts About combined Oral contraceptives and cancer Ovarian and endometrial cancer Use of COCs helps y protect users from 2 kinds of cancer—cancer of the ovaries and cancer of the lining of the uterus (endometrial cancer). This protection continues for 15 or more years after stopping use. y Breast cancer Research findings about COCs and breast cancer are difficult y to interpret: – Studies find that women who have used COCs more than 10 years ago face the same risk of breast cancer as similar women who have never used COCs. In contrast, 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. – When a current or former COC user is diagnosed with breast cancer, the cancers are less advanced than cancers diagnosed in other women. – 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. cervical cancer Cervical cancer is caused by certain types of human papillomavirus y (HPV). HPV is a common sexually transmitted infection that usually clears on its own without treatment, but sometimes persists. Use of COCs for 5 years or more appears to speed up the y development of persistent HPV infection into cervical cancer. The number of cervical cancers associated with COC use is thought to be very small. If cervical screening is available, providers can advise COC users— y and all other women—to be screened every 3 years (or as national guidelines recommend) to detect any precancerous changes on the cervix, which can be removed. Factors known to increase cervical cancer risk include having many children and smoking (see Cervical Cancer, p. 284.) 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 y Are not married y Are of any age, including adolescents and women over 40 years old y Have just had an abortion or y miscarriage Smoke y cigarettes—if under 35 years old Have y anemia now or had in the past Have y varicose veins Are infected with HIV, whether or not on antiretroviral therapy, unless y that therapy includes ritonavir (see Combined Oral Contraceptives for Women With HIV, p. 9) Women can begin using COCs: Without a pelvic examination y Without any blood tests or other routine laboratory tests y Without y cervical cancer screening Without a y breast examination Even when a woman is not having monthly bleeding at the time, if it is y reasonably certain she is not pregnant (see Pregnancy Checklist, p. 372) Who Can and Cannot Use Combined Oral Contraceptives 1 C o m b in ed O ra l C o n tr ac ep ti ve s 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. 102) and the combined vaginal ring (see p. 106). Medical Eligibility criteria for combined Oral contraceptives 1. Are you breastfeeding a baby less than 6 months old? NO ❏ YES ❏ y 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. 10). If partially breastfeeding: She can start COCs as soon as y 6 weeks after childbirth (see Partially breastfeeding, p. 11). 2. Have you had a baby in the last 3 weeks and you are not breastfeeding? NO ❏ 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? NO ❏ 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. 4. Do you have cirrhosis of the liver, a liver infection, or liver tumor? (Are her eyes or skin unusually yellow? [signs of jaundice]) Have you ever had jaundice when using cOcs? NO ❏ YES ❏ If she reports serious active liver disease (jaundice, active hepatitis, severe cirrhosis, liver tumor) 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.) 7Who Can and Cannot Use Combined Oral Contraceptives 5. Do you have high blood pressure? NO ❏ 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 y COCs. y If her systolic blood pressure is 140 mm Hg or higher or diastolic blood pressure is 90 or higher, do not provide COCs. Help her choose a method without estrogen, but not progestin-only injectables if systolic blood pressure is 160 or higher or diastolic pressure is 100 or higher. (One blood pressure reading in the range of 140–159/ 90–99 mm Hg is not enough to diagnose high blood pressure. Give her a backup method* to use until she can return for another blood pressure check, or help her choose another method now if she prefers. If her blood pressure at next check is below 140/90, she can use COCs.) 6. Have you had diabetes for more than 20 years or damage to your arteries, vision, kidneys, or nervous system caused by diabetes? NO ❏ 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? NO ❏ 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 legs or lungs, heart attack, or other serious heart problems? NO ❏ 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 or lungs (not superficial clots), help her choose a method without hormones. (Continued on next page) 1 C o m b in ed O ra l C o n tr ac ep ti ve s * 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. 8 Family Planning: A Global Handbook for Providers Medical Eligibility Criteria for Combined Oral Contraceptives (continued) 9. Do you have or have you ever had breast cancer? NO ❏ 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. NO ❏ 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. 368). 11. Are you taking medications for seizures? Are you taking rifampicin or rifabutin for tuberculosis or other illness? NO ❏ YES ❏ If she is taking barbiturates, carbamazepine, lamotrigine, oxcarbazepine, phenytoin, primidone, topiramate, rifampicin, rifabutin, or ritonavir, do not provide COCs. They can make COCs less effective. Help her choose another method but not progestin-only pills. 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? NO ❏ YES ❏ If so, she can start COCs 2 weeks after the surgery. 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? NO ❏ 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. 324. 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. 9 combined Oral contraceptives for Women With HIV Women can safely use COCs even if they are infected with HIV, have y AIDS, or are on antiretroviral (ARV) therapy unless their therapy includes ritonavir. Ritonavir may reduce the effectiveness of COCs. (See Medical Eligibility Criteria, p. 330.) Urge these women to use condoms along with COCs. Used consis- y tently and correctly, condoms help prevent transmission of HIV and other STIs. Condoms also provide extra contraceptive protection for women on ARV therapy. 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 y breastfeeding and less than 3 weeks since giving birth Not breastfeeding and between 3 and 6 weeks postpartum with additional y risk that she might develop a blood clot in a deep vein (VTE) Primarily breastfeeding between 6 weeks and 6 months since giving birth y Age 35 or older and smokes fewer than 15 y cigarettes a day High blood pressure (systolic blood pressure between 140 and 159 mm Hg y or diastolic blood pressure between 90 and 99 mm Hg) Controlled high y blood pressure, where continuing evaluation is possible History of high blood pressure, where blood pressure cannot be taken y (including pregnancy-related high blood pressure) History of jaundice while using COCs in the past y y Gall bladder disease (current or medically treated) Age 35 or older and has migraine headaches without aura y Younger than age 35 and has migraine headaches without aura that have y developed or have gotten worse while using COCs Had y breast cancer more than 5 years ago, and it has not returned y 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, y smoking, diabetes, and high blood pressure Taking barbiturates, carbamazepine, oxcarbazepine, phenytoin, primidone, y topiramate, rifampicin, rifabutin, or ritonavir or ritonavir-boosted protease inhibitors. A backup contraceptive method should also be used because these medications reduce the effectiveness of COCs. Taking lamotrigine. Combined hormonal methods may make lamotrigine y less effective. Who Can and Cannot Use Combined Oral Contraceptives 1 C o m b in ed O ra l C o n tr ac ep ti ve s 10 Family Planning: A Global Handbook for Providers 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 p. 372). 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 y monthly bleeding, no need for a backup method. If it is more than 5 days after the start of her y 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 certain, give her COCs now and tell her to start taking them during her next monthly bleeding.) If she is switching from an IUD, she can start y COCs immediately (see Copper-Bearing IUD, Switching From an IUD to Another Method, p. 148). Switching from a hormonal method Immediately, if she has been using the hormonal y 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 y 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 y 6 months after giving birth or when breast milk is no longer the baby’s main food—whichever comes first. 11 † Where a visit 6 weeks after childbirth is routinely recommended and other opportunities to obtain contraception 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) More than 6 months after giving birth If her monthly bleeding has not returned, she y 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, give her COCs now and tell her to start taking them during her next monthly bleeding.) If her monthly bleeding has returned, she can y start COCs as advised for women having menstrual cycles (see previous page). Partially breastfeeding Less than 6 weeks after giving birth Give her COCs and tell her to start taking them y 6 weeks after giving birth. Also give her a backup method to use until 6 y weeks since giving birth if her monthly bleeding returns before this time. More than 6 weeks after giving birth If her monthly bleeding has not returned, she can y 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, give her COCs now and tell her to start taking them during her next monthly bleeding.) If her monthly bleeding has returned, she can y start COCs as advised for women having menstrual cycles (see previous page). Not breastfeeding Less than 4 weeks after giving birth She can start COCs at any time on days 21–28 y 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 p. 6, Question 2.) Providing Combined Oral Contraceptives 1 C o m b in ed O ra l C o n tr ac ep ti ve s 12 Family Planning: A Global Handbook for Providers Woman’s situation When to start Not breastfeeding (continued) More than 4 weeks after giving birth If her monthly bleeding has not returned, she can y 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, give her COCs now and tell her to start taking them during her next monthly bleeding.) If her monthly bleeding has returned, she can y start COCs as advised for women having menstrual cycles (see p. 10). No monthly bleeding (not related to childbirth or breastfeeding) She can start COCs any time it is reasonably y 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 y first- or second-trimester miscarriage or abortion, no need for a backup method. If it is more than 7 days after first- or second- y 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, give her COCs now and tell her to start taking them during her next monthly bleeding.) After taking emergency contraceptive pills (ECPs) She can start COCs the day after she finishes y taking the ECPs. There is no need to wait for her next monthly bleeding to start her pills. – A new COC user should begin a new pill pack. – A continuing user who needed ECPs due to pill-taking errors can continue where she left off with her current pack. – All women will need to use a backup method for the first 7 days of taking pills. † Where a visit 6 weeks after childbirth is routinely recommended and other opportunities to obtain contraception 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. 13Providing 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. Describe the most common side effects In the first few months, bleeding at unexpected y times (irregular bleeding). Then lighter, shorter, and more regular monthly bleeding. y Headaches, breast tenderness, weight change, and possibly other side effects. Explain about these side effects Side effects are not signs of illness. y Most side effects usually become less or stop y within the first few months of using COCs. Common, but some women do not have them. y Explain what to do in case of side effects Keep taking COCs. Skipping pills risks pregnancy y and can make some side effects worse. Take each pill at the same time every day to y help reduce irregular bleeding and also help with remembering. Take pills with food or at bedtime to help avoid y nausea. The client can come back for help if side effects y bother her. 1 C o m b in ed O ra l C o n tr ac ep ti ve s 14 Family Planning: A Global Handbook for Providers Explaining How to Use Give pills1. Give as many packs as possible—even as much y as a year’s supply (13 packs). Explain pill pack2. Show which kind of pack—21 pills or 28 pills. y With 28-pill packs, point out that the last 7 pills are a different color and do not contain hormones. Show how to take the first pill from the pack y and then how to follow the directions or arrows on the pack to take the rest of the pills. Give key 3. instruction take one pill each day y — until the pack is empty. Discuss cues for taking a pill y every day. Linking pill-taking to a daily activity—such as cleaning her teeth—may help her remember. Taking pills at the y same time each day helps to remember them. It also may help reduce some side effects. Explain starting 4. next pack 28-pill packs: When she finishes one pack, she y should take the first pill from the next pack on the very next day. 21-pill packs: After she takes the last pill from y 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 y time. Starting a pack late risks pregnancy. Provide backup 5. method and explain use Sometimes she may need to use a backup y method, such as when she misses pills. Backup methods include abstinence, male or y female condoms, spermicides, and withdrawal. Tell her that spermicides and withdrawal are the least effective contraceptive methods. Give her condoms, if possible. 15Providing Combined Oral Contraceptives Supporting the User Managing Missed Pills It is easy to forget a pill or to be late in taking it. 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 the inside back cover 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 y possible. Keep taking pills as usual, one each day. (She may y 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. y Little or no risk of pregnancy. y 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. y Use a backup method for the next 7 days. y Also, if she had sex in the past 5 days, can consider y ECPs (see Emergency Contraceptive Pills, p. 45). Missed 3 or more pills in the third week? Take a hormonal pill as soon as possible. y Finish all hormonal pills in the pack. Throw away y the 7 nonhormonal pills in a 28-pill pack. Start a new pack the next day. y Use a backup method for the next 7 days. y Also, if she had sex in the past 5 days, can consider y ECPs (see Emergency Contraceptive Pills, p. 45). Missed any non- hormonal pills? (last 7 pills in 28-pill pack) Discard the missed nonhormonal pill(s). y Keep taking COCs, one each day. Start the new y pack as usual. Severe vomiting or diarrhea If she vomits within 2 hours after taking a pill, she y 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, y follow instructions for 3 or more missed pills, above. ‡ 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. 1 C o m b in ed O ra l C o n tr ac ep ti ve s 16 Family Planning: A Global Handbook for Providers “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 lost her pills or started a new pack more than 3 days late and also y had sex during this time. She may wish to consider ECPs (see Emergency Contraceptive Pills, p. 45). 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 Encourage her to come back for more pills before she uses up her 1. supply of pills. An annual visit is recommended. 2. Some women can benefit from contact after 3 months of COC use. 3. This offers an opportunity to answer any questions, help with any problems, and check on correct use. Helping Continuing Users Ask how the client is doing with the method and whether she is 1. satisfied. Ask if she has any questions or anything to discuss. Ask especially if she is concerned about bleeding changes. Give her any 2. information or help that she needs (see Managing Any Problems, next page). Ask if she often has problems remembering to take a pill every day. If so, 3. discuss ways to remember, making up missed pills, and ECPs, or choosing another method. Give her more pill packs—a full year’s supply (13 packs), if possible. Plan 4. her next resupply visit before she will need more pills. Every year or so, check 5. blood pressure if possible (see Medical Eligibility Criteria, Question 5, p. 7). Ask a long-term client if she has had any new 6. health problems since her last visit. Address problems as appropriate. For new health problems that may require switching methods, see p. 19. Ask a long-term client about major life changes that may affect her 7. needs—particularly plans for having children and STI/HIV risk. Follow up as needed. 17Helping Continuing Users of Combined Oral Contraceptives 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. y They deserve the provider’s attention. If the client reports side effects or problems, listen to her concerns, give her advice, and, if appropriate, treat. Encourage her to keep taking a pill every day even if she has side effects. y 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 y 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 y problems cannot be overcome. Missed pills See Managing y Missed Pills, p. 15. Irregular bleeding (bleeding at unexpected times that bothers the client) Reassure her that many women using COCs experience irregular y 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: y – Missed pills – Taking pills at different times every day – Vomiting or diarrhea – Taking anticonvulsants or rifampicin (see Starting treatment with anticonvulsants or rifampicin, p. 20) To reduce irregular bleeding: y – 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. 15). – 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. 1 C o m b in ed O ra l C o n tr ac ep ti ve s 18 Family Planning: A Global Handbook for Providers If irregular bleeding continues or starts after several months of normal y 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 y 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 y 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 infertile. Blood is not building up inside her. (Some women are happy to be free from monthly bleeding.) Ask if she has been taking a pill every day. If so, reassure her that she is y 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 y 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: y − 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. 371 for common signs and symptoms of pregnancy). − See p. 15 for instructions on how to make up for missed pills. Ordinary headaches (nonmigrainous) Try the following (one at a time): y – 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. 21). Any headaches that get worse or occur more often during COC use y should be evaluated. Nausea or dizziness For y nausea, suggest taking COCs at bedtime or with food. If symptoms continue: Consider locally available remedies. y Consider extended use if her nausea comes after she starts a new pill pack y (see Extended and Continuous Use of Combined Oral Contraceptives, p. 21). 19Helping Continuing Users of Combined Oral Contraceptives Breast tenderness Recommend that she wear a supportive bra (including during strenuous y activity and sleep). Try hot or cold compresses. y Suggest y aspirin (325–650 mg), ibuprofen (200–400 mg), paracetamol (325–1000 mg), or other pain reliever. Consider locally available remedies. y Weight change Review y diet and counsel as needed. Mood changes or changes in sex drive Some women have y 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. 21). Ask about changes in her life that could affect her mood or sex drive, y including changes in her relationship with her partner. Give her support as appropriate. Clients who have serious mood changes such as major y depression should be referred for care. Consider locally available remedies. y Acne y 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, y give her a different COC formulation, if available. Ask her to try the new pills for at least 3 months. Consider locally available remedies. y 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 y appropriate. She can continue using COCs while her condition is being evaluated. y If bleeding is caused by y sexually transmitted infection or pelvic inflammatory disease, she can continue using COCs during treatment. 1 C o m b in ed O ra l C o n tr ac ep ti ve s 20 Family Planning: A Global Handbook for Providers Starting treatment with anticonvulsants, rifampicin, rifabutin, or ritonavir y Barbiturates, carbamazepine, oxcarbazepine, phenytoin, primidone, topiramate, rifampicin, rifabutin, and ritonavir may make COCs 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 or a copper-bearing or LNG-IUD. If using these medications short-term, she can use a backup method along y with COCs for greater protection from pregnancy. Migraine headaches (see Identifying Migraine Headaches and Auras, p. 368) Regardless of her age, a woman who develops migraine headaches, with y or without aura, or whose migraine headaches become worse while using COCs should stop using COCs. Help her choose a method without estrogen. y circumstances that will keep her from walking for one week or more If she is having major y 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 gall bladder disease). See Signs and Symptoms of Serious Health Conditions, p. 320. Tell her to stop taking COCs. y Give her a backup method to use until the condition is evaluated. y Refer for diagnosis and care if not already under care. y Suspected pregnancy Assess for pregnancy. y Tell her to stop taking COCs if pregnancy is confirmed. y There are no known risks to a fetus conceived while a woman is taking y COCs (see Question 5, p. 22). 21Helping Continuing Users of Combined Oral Contraceptives 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. 24). 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. y Reduces how often some women suffer headaches, premenstrual y syndrome, mood changes, and heavy or painful bleeding during the week without hormonal pills. Disadvantages of Extended and continuous Use y 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. y Extended Use Instructions Skip the last week of pills (without hormones) in 3 packs in a row. (21- y day users skip the 7-day waits between the first 3 packs.) No backup method is needed during this time. Take all 4 weeks of pills in the 4th pack. (21-day users take all 3 weeks y of pills in the 4th pack.) Expect some bleeding during this 4th week. Start the next pack of pills the day after taking the last pill in the 4th y pack. (21-day users wait 7 days before starting the next pack.) continuous Use Instructions Take one hormonal pill every day for as long as she wishes to use COCs. If bothersome irregular bleeding occurs, a woman can stop taking pills for 3 or 4 days and then start taking hormonal pills continuously again. 1 C o m b in ed O ra l C o n tr ac ep ti ve s 22 Family Planning: A Global Handbook for Providers 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. 23Questions and Answers About Combined Oral Contraceptives 7. Do cOcs change 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. 19). 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. Instead, asking the right questions usually can help to make reasonably certain that a woman is not pregnant (see Pregnancy Checklist, p. 372). No 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. 1 C o m b in ed O ra l C o n tr ac ep ti ve s 24 Family Planning: A Global Handbook for Providers 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. 272). 13. can women who smoke use cOcs safely? Women younger than age 35 who smoke can use low-dose 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? If pregnancy tests are not available, a woman can be given COCs to take home with instructions to begin their use within 5 days after the start of her next monthly bleeding. She should use a backup method until then. 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 Emergency Contraceptive Pills, Pill Formulations and Dosing, p. 56). 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. 17. Is it important for a woman to take her cOcs at the same time each day? Yes, 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. 25 What Are Progestin-Only Pills? Pills that contain very low doses of a y progestin like the natural hormone progesterone in a woman’s body. Do not contain estrogen, and so can be used throughout breastfeeding y and by women who cannot use methods with estrogen. y Progestin-only pills (POPs) are also called “minipills” and progestin-only oral contraceptives. Work primarily by: y – 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. y No breaks between packs. Safe for breastfeeding women and their babies. y Progestin- only pills do not affect milk production. Add to the contraceptive effect of breastfeeding. y Together, they provide effective pregnancy protection. Bleeding changes are common but not harmful y . 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 later. y If pregnancy cannot be ruled out, a provider can give her pills to take later, when her monthly bleeding begins. This chapter focuses on progestin-only pills for breastfeeding women. Women who are not breastfeeding also can use progestin-only pills. Guidance that differs for women who are not breastfeeding is noted. 2 P ro g es ti n -O n ly P ill s 26 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 y 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 y per 100 women using POPs over the first year (3 per 1,000 women). Less effective for women not breastfeeding: As commonly used, about 3 to 10 pregnancies per y 100 women using POPs over the first year. This means that 90 to 97 of every 100 women will not become pregnant. When pills are taken every day at the same time, less than 1 pregnancy y per 100 women using POPs over the first year (9 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 y Can be stopped at any time without a provider’s help y Do not interfere with sex y Are controlled by the woman y More effective Less effective Breastfeeding Not breastfeeding 27Progestin-Only Pills Side Effects, Health Benefits, and Health Risks Side Effects (see Managing Any Problems, p. 38) Some users report the following: y 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. y Headaches y Dizziness y Mood changes y Breast tenderness y Abdominal pain y Nausea Other possible physical changes: For women not breastfeeding, enlarged y ovarian follicles Correcting Misunderstandings (see also Questions and Answers, p. 42) Progestin-only pills: Do not cause a breastfeeding woman’s milk to dry up. y Must be taken every day, whether or not a woman has sex that day. y Do not make women y infertile. Do not cause y diarrhea in breastfeeding babies. Reduce the risk of y ectopic pregnancy. 2 Known Health Benefits Known Health Risks Help protect against: Risks of pregnancy y None P ro g es ti n -O n ly P ill s 28 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 (starting as soon as 6 weeks after childbirth) y Have or have not had children y Are not married y Are of any age, including adolescents and women over 40 years old y Have just had an abortion, y miscarriage, or ectopic pregnancy Smoke y cigarettes, regardless of woman’s age or number of cigarettes smoked Have y anemia now or had in the past Have y varicose veins Are infected with HIV, whether or not on antiretroviral therapy, unless y that therapy includes ritonavir (see Progestin-Only Pills for Women With HIV, p. 30) Women can begin using POPs: Without a pelvic examination y Without any blood tests or other routine laboratory tests y Without y cervical cancer screening Without a y breast examination Even when a woman is not having monthly bleeding at the time, if it is y reasonably certain she is not pregnant (see Pregnancy Checklist, p. 372) 29Who 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. Are you breastfeeding a baby less than 6 weeks old? NO ❏ YES ❏ She can start taking POPs as soon as 6 weeks after childbirth. Give her POPs now and tell her when to start taking them (see Fully or nearly fully breastfeeding or Partially breastfeeding, p. 31). 2. Do you have severe cirrhosis of the liver, a liver infection, or liver tumor? (Are her eyes or skin unusually yellow? [signs of jaundice]) NO ❏ YES ❏ If she reports serious active liver disease (jaundice, severe cirrhosis, liver tumor), do not provide POPs. Help her choose a method without hormones. 3. Do you have a serious problem now with a blood clot in your legs or lungs? NO ❏ YES ❏ If she reports a current blood clot (not superficial clots), and she is not on anticoagulant therapy, do not provide POPs. Help her choose a method without hormones. 4. Are you taking medication for seizures? Are you taking rifampicin or rifabutin for tuberculosis or other illness? NO ❏ YES ❏ If she is taking barbiturates, carbamazepine, oxcarbazepine, phenytoin, primidone, topiramate, rifampicin, rifabutin, or ritonavir, do not provide POPs. They can make POPs less effective. Help her choose another method but not combined oral contraceptives. 5. Do you have or have you ever had breast cancer? NO ❏ YES ❏ Do not provide POPs. Help her choose a method without hormones. 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 2 P ro g es ti n -O n ly P ill s 30 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. Breastfeeding and less than 6 weeks since giving birth y Acute blood clot in deep veins of legs or lungs y Had y breast cancer more than 5 years ago, and it has not returned Severe y liver disease, infection, or tumor Systemic lupus erythematosus with positive (or unknown) antiphospho- y lipid antibodies Taking barbiturates, carbamazepine, oxcarbazepine, phenytoin, y primidone, topiramate, rifampicin, rifabutin. or ritonavir or ritonavir- boosted protease inhibitors. A backup contraceptive method should also be used because these medications reduce the effectiveness of POPs. Progestin-Only Pills for Women With HIV Women can safely use POPs even if they are infected with HIV, have y AIDS, or are on antiretroviral (ARV) therapy unless their therapy includes ritonavir. Ritonavir may reduce the effectiveness of POPs. (See Medical Eligibility Criteria, p. 330.) Urge these women to use condoms along with POPs. Used y consistently and correctly, condoms help prevent transmission of HIV and other STIs. Condoms also provide extra contraceptive protection for women on ARV therapy. For appropriate breastfeeding practices for women with HIV, see y Maternal and Newborn Health, Preventing Mother-to-Child Transmission of HIV, p. 294. 31 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 p. 372). 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 she gave birth less than 6 weeks ago, give her y POPs and tell her to start taking them 6 weeks after giving birth. If her monthly bleeding has not returned, she y can start POPs any time between 6 weeks and 6 months. No need for a backup method. If her monthly bleeding has returned, she y can start POPs as advised for women having menstrual cycles (see p. 33). More than 6 months after giving birth If her monthly bleeding has not returned, she can y 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, give her POPs now and tell her to start taking them during her next monthly bleeding.) If her monthly bleeding has returned, she y can start POPs as advised for women having menstrual cycles (see p. 33). Partially breastfeeding Less than 6 weeks after giving birth Give her POPs and tell her to start taking them y 6 weeks after giving birth. Also give her a backup method to use until 6 y weeks since giving birth if her monthly bleeding returns before this time. 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. P ro g es ti n -O n ly P ill s 32 Family Planning: A Global Handbook for Providers Woman’s situation When to start Partially breastfeeding (continued) More than 6 weeks after giving birth If her monthly bleeding has not returned, she y 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, give her POPs now and tell her to start taking them during her next monthly bleeding.) If her monthly bleeding has returned, she y can start POPs as advised for women having menstrual cycles (see next page). Not breastfeeding Less than 4 weeks after giving birth She can start POPs at any time. No need for a y backup method. More than 4 weeks after giving birth If her monthly bleeding has not returned, she y 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, give her POPs now and tell her to start taking them during her next monthly bleeding.) If her monthly bleeding has returned, she y can start POPs as advised for women having menstrual cycles (see next page). Switching from a hormonal method Immediately, if she has been using the y 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 y begin taking POPs when the repeat injection would have been given. No need for a backup method. † Where a visit 6 weeks after childbirth is routinely recommended and other opportunities to obtain contraception 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. 33 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 y of her monthly bleeding, no need for a backup method. If it is more than 5 days after the start of y 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, give her POPs now and tell her to start taking them during her next monthly bleeding.) If she is switching from an IUD, she can start y POPs immediately (see Copper-Bearing IUD, Switching From an IUD to Another Method, p. 148). No monthly bleeding (not related to childbirth or breastfeeding) She can start POPs any time it is reasonably y 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 y 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- y 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, give her POPs now and tell her to start taking them during her next monthly bleeding.) After taking emergency contraceptive pills (ECPs) She can start POPs the day after she finishes y taking the ECPs. There is no need to wait for her next monthly bleeding to start her pills. – A new POP user should begin a new pill pack. – A continuing user who needed ECPs due to pill-taking errors can continue where she left off with her current pack. – All women will need to use a backup method for the first 2 days of taking pills. Providing Progestin-Only Pills 2 P ro g es ti n -O n ly P ill s 34 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. Describe the most common side effects Breastfeeding women normally do not have y monthly bleeding for several months after giving birth. POPs lengthen this period of time. Women who are not breastfeeding may have y frequent or irregular bleeding for the first several months, followed by regular bleeding or continued irregular bleeding. y Headaches, dizziness, breast tenderness, and possibly other side effects. Explain about these side effects Side effects are not signs of illness. y Usually become less or stop within the first y few months of using POPs. Bleeding changes, however, usually persist. Common, but some women do not have them. y Explain what to do in case of side effects Keep taking POPs. Skipping pills risks pregnancy. y Try taking pills with food or at bedtime to help y avoid nausea. The client can come back for help if side effects y bother her. 35Providing Progestin-Only Pills Explaining How to Use Give pills1. Give as many packs as possible—even as much y as a year’s supply (11 or 13 packs). Explain pill pack2. Show which kind of pack—28 pills or 35 pills. y Explain that all pills in POP packs are the same y color and all are active pills, containing a hormone that prevents pregnancy. Show how to take the first pill from the pack y and then how to follow the directions or arrows on the pack to take the rest of the pills. Give key 3. instruction take one pill each day y — until the pack is empty. Discuss cues for taking y 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 y time each day helps to remember them. Explain starting 4. next pack When she finishes one pack, she should take the y first pill from the next pack on the very next day. It is very important to start the next pack on y time. Starting a pack late risks pregnancy. Provide backup 5. method and explain use Sometimes she may need to use a backup y method, such as when she misses pills. Backup methods include abstinence, male or y female condoms, spermicides, and withdrawal. Tell her that spermicides and withdrawal are the least effective contraceptive methods. Give her condoms, if possible. Explain that 6. effectiveness decreases when breastfeeding stops Without the additional protection of y breastfeeding itself, POPs are not as effective as most other hormonal methods. When she stops breastfeeding, she can continue y taking POPs if she is satisfied with the method, or she is welcome to come back for another method. 2 P ro g es ti n -O n ly P ill s 36 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. 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. y Keep taking pills as usual, one each day. (She may y 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 y the next 2 days. Also, if she had sex in the past 5 days, can y consider taking ECPs (see Emergency Contraceptive Pills, p. 45). Severe vomiting or diarrhea If she vomits within 2 hours after taking a pill, y she should take another pill from her pack as soon as possible, and keep taking pills as usual. If her y vomiting or diarrhea continues, follow the instructions for making up missed pills above. “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. y For a woman who has monthly bleeding: If she took a pill more than 3 y hours late or missed one completely, and also had sex during this time, she may wish to consider ECPs (see Emergency Contraceptive Pills, p. 45). 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. 37 Planning the Next Visit Encourage her to come back for more pills before she uses up her 1. supply of pills. Contacting women after the first 3 months of POP use is recommended. 2. This offers an opportunity to answer any questions, help with any problems, and check on correct use. Helping Continuing Users Ask how the client is doing with the method and whether she is 1. satisfied. Ask if she has any questions or anything to discuss. Ask especially if she is concerned about bleeding changes. Give her any 2. information or help that she needs (see Managing Any Problems, p. 38). Ask if she often has problems remembering to take a pill every day. If 3. so, discuss ways to remember, making up for missed pills, and ECPs, or choosing another method. Give her more pill packs—as much as a full year’s supply (11 or 4. 13 packs), if possible. Plan her next resupply visit before she will need more pills. Ask a long-term client if she has had any new health problems since her 5. last visit. Address problems as appropriate. For new health problems that may require switching methods, see p. 41. Ask a long-term client about major life changes that may affect her 6. needs—particularly plans for having children and STI/HIV risk. Follow up as needed. Helping Continuing Users of Progestin-Only Pills 2 P ro g es ti n -O n ly P ill s 38 Family Planning: A Global Handbook for Providers No monthly bleeding Breastfeeding women: y − Reassure her that this is normal during breastfeeding. It is not harmful. Women not breastfeeding: y − 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 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 y 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: y − Vomiting or diarrhea − Taking anticonvulsants or rifampicin (see Starting treatment with anticonvulsants or rifampicin, p. 41) To reduce irregular bleeding: y − Teach her to make up for missed pills properly, including after vomiting or diarrhea (see Managing Missed Pills, p. 36). − 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. y They deserve the provider’s attention. If the client reports side effects or problems, listen to her concerns, give her advice, and, if appropriate, treat. Encourage her to keep taking a pill every day even if she has side effects. y Missing pills can risk pregnancy. Many side effects will subside after a few months of use. For a woman y 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 y problems cannot be overcome. 39 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 y 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. 41). Heavy or prolonged bleeding (twice as much as usual or longer than 8 days) Reassure her that some women using POPs experience heavy or y 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 y NSAIDs, beginning when heavy bleeding starts. Try the same treatments as for irregular bleeding (see previous page). To help prevent y 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 y 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. 41). Missed pills See Managing Missed Pills, p. 36. y Ordinary headaches (nonmigrainous) Suggest y 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 y should be evaluated. Mood changes or changes in sex drive Ask about changes in her life that could affect her mood or sex drive, y including changes in her relationship with her partner. Give her support as appropriate. Some women experience y 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. y Helping Continuing Users of Progestin-Only Pills 2 P ro g es ti n -O n ly P ill s 40 Family Planning: A Global Handbook for Providers Breast tenderness Breastfeeding women: y − See Maternal and Newborn Health, Sore Breasts, p. 295. Women not breastfeeding: y − 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 y 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 resolving, see the client again in 6 weeks, if possible. With severe y 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 p. 44, Question 12). In the early stages of ectopic pregnancy, symptoms may be absent or y 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, y refer at once for immediate diagnosis and care. (See Female Sterilization, Managing Ectopic Pregnancy, p. 179, for more on ectopic pregnancies.) Nausea or dizziness For nausea, suggest taking POPs at bedtime or with food. y If symptoms continue, consider locally available remedies. y 41 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 y appropriate. She can continue using POPs while her condition is being evaluated. y If bleeding is caused by a y sexually transmitted infection or pelvic inflammatory disease, she can continue using POPs during treatment. Starting treatment with anticonvulsants, rifampicin, rifabutin, or ritonavir Barbiturates, carbamazepine, oxcarbazepine, phenytoin, primidone, topiramate, y 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 y with POPs. Migraine headaches (see Identifying Migraine Headaches and Auras, p. 368) If she has migraine headaches without y aura, she can continue to use POPs if she wishes. If she has y migraine aura, 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. 320. Tell her to stop taking POPs. y Give her a backup method to use until the condition is evaluated. y Refer for diagnosis and care if not already under care. y 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, y 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. y Suspected pregnancy Assess for pregnancy, including ectopic pregnancy. y Tell her to stop taking POPs if pregnancy is confirmed. y There are no known risks to a fetus conceived while a woman is taking y POPs (see Question 3, p. 42). Helping Continuing Users of Progestin-Only Pills 2 P ro g es ti n -O n ly P ill s 42 Family Planning: A Global Handbook for Providers Questions and Answers About Progestin-Only Pills 1. can a woman who is breastfeeding safely use POPs? Yes. This is a good choice for a breastfeeding mother who wants to use pills. POPs are safe for both the mother and the baby, starting as early as 6 weeks after giving birth. They 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. 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. 4. 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. 43Questions and Answers About Progestin-Only Pills 5. 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 a progestin-only injectable. 6. 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.) 7. 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, 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. 8. 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. 9. 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 Emergency Contraceptive Pills, Pill Formulations and Dosing, p. 56). 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. 2 P ro g es ti n -O n ly P ill s 44 Family Planning: A Global Handbook for Providers 10. Do POPs change 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. 39). There is no evidence that POPs affect women’s sexual behavior. 11. 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 only require treatment if they grow abnormally large, twist, or burst. These follicles usually go away without treatment (see Severe pain in lower abdomen, p. 40). 12. 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, so a provider should be aware that ectopic pregnancy is possible if POPs fail. 45 What Are Emergency contraceptive Pills? Pills that contain a y progestin alone, or a progestin and an estrogen together—hormones like the natural hormones progesterone and estrogen in a woman’s body. Emergency contraceptive pills (ECPs) are sometimes called “morning after” y pills or postcoital contraceptives. Work primarily by preventing or delaying the release of eggs from the y ovaries (ovulation). They do not work if a woman is already pregnant (see Question 1, p. 54). Emergency Contraceptive Pills CHAPTER 3 Emergency Contraceptive Pills Key Points for Providers and clients Emergency contraceptive pills help to prevent pregnancy y when taken up to 5 days after unprotected sex. The sooner they are taken, the better. Do not disrupt an existing pregnancy. y Safe for all women y —even women who cannot use ongoing hormonal contraceptive methods. Provide an opportunity for women to start using an y ongoing family planning method. Many options can be used as emergency contraceptive y pills. Dedicated products, progestin-only pills, and combined oral contraceptives all can act as emergency contraceptives. 3 E m er g en cy C o n tr ac ep ti ve P ill s 46 Family Planning: A Global Handbook for Providers 100 100 100 No ECPs 8 pregnancies 1 pregnancy 2 pregnancies Progestin-only ECPs Combined estrogen- progestin ECPs Effectiveness of Emergency Contraceptive Pills (ECPs) If 100 women each had unprotected sex once during the second or third week of the menstrual cycle. What Pills can Be Used as Emergency contraceptive Pills? A special ECP product with levonorgestrel only, or estrogen and y levonorgestrel combined, or ulipristal acetate Progestin-only pills with y levonorgestrel or norgestrel Combined oral contraceptives with estrogen and a progestin— y levonorgestrel, norgestrel, or norethindrone (also called norethisterone) When to take them? As soon as possible y after unprotected sex. The sooner ECPs are taken after unprotected sex, the better they prevent pregnancy. Can prevent pregnancy when taken any time up to 5 days after y unprotected sex. How Effective? If 100 women each had sex once during the second or third week of y the menstrual cycle without using contraception, 8 would likely become pregnant. If all 100 women used progestin-only ECPs, one would likely become y pregnant. If all 100 women used estrogen and progestin ECPs, 2 would likely y become pregnant. 47 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 after she takes ECPs—not even on the next day. To stay protected from pregnancy, women must begin to use another contraceptive method at once (see Planning Ongoing Contraception, p. 51). Protection against sexually transmitted infections (STIs): None Side Effects, Health Benefits, and Health Risks Side Effects (see Managing Any Problems, p. 53) Some users report the following: y 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 week after taking ECPs: Nausea y ‡ y Abdominal pain y Fatigue y Headaches y Breast tenderness y Dizziness y Vomiting‡ Known Health Benefits Known Health Risks Help protect against: Risks of pregnancy y None ‡ Women using progestin-only ECP formulations are much less likely to experience nausea and vomiting than women using estrogen and progestin ECP formulations. Emergency Contraceptive Pills 3 E m er g en cy C o n tr ac ep ti ve P ill s 48 Family Planning: A Global Handbook for Providers Correcting Misunderstandings (see also Questions and Answers, p. 54) Emergency contraceptive pills: Do not cause abortion. y Do not cause y birth defects if pregnancy occurs. Are not dangerous to a woman’s health. y Do not promote sexual risk-taking. y Do not make women y infertile. Who Can Use Emergency Contraceptive Pills Safe and Suitable for All Women Tests and examinations are not necessary for using ECPs. They may be appropriate for other reasons—especially if sex was forced (see Violence Against Women, Provide Appropriate Care, p. 302). 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. Why Some Women Say they Like Emergency contraceptive Pills Offer a second chance at preventing pregnancy y Are controlled by the woman y Reduce seeking out abortion in the case of contraceptive errors or y if contraception is not used Can have on hand in case an emergency arises y 49 Providing Emergency Contraceptive Pills ECPs may be needed in many different situations. Therefore, if possible, give all women who want ECPs a supply in advance. 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 to Use Any time within 5 days after unprotected sex. The sooner after y 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: Sex was forced ( y rape) or coerced Any unprotected sex y Contraceptive mistakes, such as: y – 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 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 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 Providing Emergency Contraceptive Pills 3 E m er g en cy C o n tr ac ep ti ve P ill s 50 Family Planning: A Global Handbook for Providers Pill type total dosage to provide Levonorgestrel- only dedicated product 1.5 mg of y levonorgestrel in a single dose. § Estrogen- progestin dedicated product 0.1 mg ethinyl estradiol + 0.5 mg y levonorgestrel. Follow with same dose 12 hours later. Progestin-only pills with levonorgestrel or norgestrel Levonorgestrel pills: 1.5 mg y levonorgestrel in a single dose. Norgestrel pills: 3 mg y norgestrel in a single dose. combined (estrogen- progestin) oral contraceptives containing levonorgestrel, norgestrel, or norethindrone Estrogen and y levonorgestrel pills: 0.1 mg ethinyl estradiol + 0.5 mg levonorgestrel. Follow with same dose 12 hours later. Estrogen and y norgestrel pills: 0.1 mg ethinyl estradiol + 1 mg norgestrel. Follow with same dose 12 hours later. Estrogen and norethindrone pills: 0.1 mg y ethinyl estradiol + 2 mg norethindrone. Follow with same dose 12 hours later. Ulipristal acetate dedicated product 30 mg of ulipristal acetate in a single dose. y Dosing Information For specific products and number of pills to provide, see Pill Formulations and Dosing, p. 56. Giving Emergency contraceptive Pills Give pills1. She can take them at once. y If she is using a 2-dose regimen, tell her to take y the next dose in 12 hours. Describe the 2. most common side effects y Nausea, abdominal pain, possibly others. Slight bleeding or change in timing of y monthly bleeding. Side effects are not signs of illness. y § Alternatively, clients can be given 0.75 mg levonorgestrel at once, followed by the same dose 12 hours later. One dose is easier for the client to take and works just as well as 2 doses. 51Providing Emergency Contraceptive Pills “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 y no monthly bleeding or her next monthly bleeding is delayed by more than one week. Explain what 3. to do about side effects Nausea: y – 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 50 mg meclizine (Agyrax, Antivert, Bonine, Postafene) one-half to one hour before taking ECPs. y Vomiting: – If the woman vomits within 2 hours after taking ECPs, she should take another dose. (She can use anti-nausea medication with this repeat dose, as above.) If vomiting continues, she can take the repeat dose by placing the pills high in her vagina. If vomiting occurs more than 2 hours after taking ECPs, she does not need to take any extra pills. Give more 4. EcPs and help her start an ongoing method If possible, give her more ECPs to take home in y case she needs them in the future. See Planning Ongoing Contraception, below. y Planning Ongoing contraception Explain that ECPs will not protect her from pregnancy for any future 1. sex—even the next day. 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. 275). If she does not want to start a contraceptive method now, give her 2. condoms or 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. If possible, give her more ECPs to use in the future in case of 3. unprotected sex. 3 E m er g en cy C o n tr ac ep ti ve P ill s 52 Family Planning: A Global Handbook for Providers When to Start contraception After EcP Use Method When to start combined oral contraceptives, progestin-only pills, combined patch, combined vaginal ring Can begin the day after she takes the ECPs. No need to wait for her next monthly bleeding. Oral contraceptives and vaginal ring: y – New users should begin a new pill pack or ring. – A continuing user who needed ECPs due to error can resume use as before. Patch: y – All users should begin a new patch. All women need to use a backup method y * for the first 7 days of using their method. Progestin-only injectables She can start progestin-only injectables on the y same day as the ECPs, or if preferred, within 7 days after the start of her monthly bleeding. She will need a backup method for the first 7 days after the injection. She should return if she has signs or symptoms of pregnancy other than not having monthly bleeding (see p. 371 for common signs and symptoms of pregnancy). Monthly injectables She can start monthly injectables on the same y day as the ECPs. There is no need to wait for her next monthly bleeding to have the injection. She will need a backup method for the first 7 days after the injection. Implants After her monthly bleeding has returned. Give y her a backup method or oral contraceptives to use until then, starting the day after she finishes taking the ECPs. Intrauterine device (copper-bearing or hormonal IUDs) A copper-bearing IUD can be used for y emergency contraception. This is a good option for a woman who wants an IUD as her long- term method (see Copper-Bearing IUD, p. 131). If she decides to use an IUD after taking ECPs, y the IUD can be inserted on the same day she takes the ECPs. No need for a backup method. * 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. 53 Slight irregular bleeding Irregular bleeding due to ECPs will stop without treatment. y Assure the woman that this is not a sign of illness or pregnancy. y change in timing of next monthly bleeding or suspected pregnancy Monthly bleeding may start earlier or later y than expected. This is not a sign of illness or pregnancy. If her next y monthly bleeding is more than one week later than expected after taking ECPs, assess for pregnancy. There are no known risks to a fetus conceived if ECPs fail to prevent pregnancy (see Question 2, p. 54). Helping Users of Emergency Contraceptive Pills 3 E m er g en cy C o n tr ac ep ti ve P ill s Method When to start Male and female condoms, spermicides, diaphragms, cervical caps, withdrawal Immediately. y Fertility awareness methods Standard Days Method: With the start of her y next monthly bleeding. Symptoms-based methods: Once normal y secretions have returned. Give her a backup method or oral contraceptives y to use until she can begin the method of her choice. Helping Users Managing Any Problems Problems Reported as Side Effects or Method Failure May or may not be due to the method. 54 Family Planning: A Global Handbook for Providers Questions and Answers About Emergency Contraceptive Pills 1. Do EcPs disrupt an existing pregnancy? No. ECPs do not work if a woman is already pregnant. When taken before a woman has ovulated, 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. 2. Do EcPs cause birth defects? Will the fetus be harmed if a woman accidentally takes EcPs while she is pregnant? No. Good evidence shows that ECPs will not cause birth defects and will not otherwise harm the fetus if a woman is already pregnant when she takes ECPs or if ECPs fail to prevent pregnancy. 3. 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 at once. 4. 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 these progestins together with estrogen (ethinyl estradiol) —can be used. (See Pill Formulations and Dosing, p. 56, for examples of what pills can be used.) 5. 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. 6. Are EcPs safe for women with HIV or AIDS? can women on antiretroviral therapy safely use EcPs? Yes. Women with HIV, AIDS, and those on antiretroviral therapy can safely use ECPs. 55Questions and Answers About Emergency Contraceptive Pills 7. Are EcPs safe 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. 8. 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. 9. If EcPs failed to prevent pregnancy, does a woman have a greater chance of that pregnancy being an ectopic pregnancy? No. To date, no evidence suggests that ECPs increase the risk of ectopic pregnancy. Worldwide studies of progestin-only ECPs, including a United States Food and Drug Administration review, have not found higher rates of ectopic pregnancy after ECPs failed than are found among pregnancies generally. 10. 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 have ECPs on hand took them sooner after having y unprotected sex than women who had to seek out ECPs. Taken sooner, the ECPs are more likely to be effective. Women given ECPs ahead of time were more likely to use ECPs than y women who had to go to a provider to get ECPs. Women continued to use other contraceptive methods as they did y before obtaining ECPs in advance. 11. Should women use EcPs as a regular method of contraception? No. Nearly all other contraceptive methods are more effective in preventing pregnancy. A woman who uses ECPs regularly for contraception is more likely to have an unintended pregnancy than a woman who uses another contraceptive regularly. Still, women using other methods of contraception should know about ECPs and how to obtain them if needed—for example, if a condom breaks or a woman misses 3 or more combined oral contraceptive pills. 12. 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 young and adult women find the label and instructions easy to understand. ECPs are approved for over-the- counter sales or nonprescription use in many countries. 3 E m er g en cy C o n tr ac ep ti ve P ill s 56 Family Planning: A Global Handbook for Providers Hormonal and Pill Type Formu- lation Common Brand Names Pills to Take At First 12 Hours Later Progestin-only Progestin- only dedicated EcPs 1.5 mg LNG An Ting 1.5, Anlitin 1.5, Bao Shi Ting, D-Sigyent 1, Dan Mei, Emkit DS, Emkit Plus, Escapel, Escapel-1, Escapelle, Escapelle 1.5, Escinor 1.5, Glanique 1, Hui Ting 1.5, i-pill, Impreviat 1500, Jin Yu Ting, Jin Xiao, Ka Rui Ding, Ladiades 1.5, Levonelle 1500, Levonelle-1, Levonelle One Step, Levonorgestrel Biogaran 1500, Mergynex Plus, Nogestrol 1, Norgestrel Max Unidosis, NorLevo 1.5, Ovulol UD, Plan B One Step, PostDay 1, Postinor-1, Postinor 1.5, Postinor 1500, Postinor 2 SD, Postinor-2 Unidosis, Postinor New, Postinor Uno, Pozato Uni, Pregnon 1.5, Prikul 1, Secufem Plus, Segurite UD, Silogen 1.5, Tace 1.5, Tibex 1.5, Unlevo 1500, Unofem, Velor 1.5, Vikela, Xian Ju 1 0 0.75 mg LNG Ai Wu You, Alterna, An Ting 0.75, Anthia, Auxxil, Bao Shi Ting (Postinor-2), Ceciora T, Contraplan II, D-Sigyent, Dan Mei, Dia-Post, Dia-Post Gold, Diad, Duet, E Pills, EC, ECee2, ECP, Escinor 0.75, Emergyn, Emkit, Escapel-2, Estinor, Evital, Evitarem, Glanique, Glanix, Gynotrel 2, Hui Ting, Imediat, Imediat-N, Impreviat 750, Jin Xiao, L Novafem, Ladiades 0.75, Le Ting, Lenor 72, Levogynon, Levonelle, Levonelle-2, LNG-Method 5, Longil, Madonna, Me Tablet, Minipil 2, Next Choice, Nogestrol, Nogravide, Norgestrel-Max, NorLevo 0.75, Nortrel 2, Novanor 2, Nuo Shuang, Optinor, Ovocease, Ovulol, P2, Pilem, Pill 72, Pillex, Plan B, Poslov, PostDay, Postinor, Postinor-2, Postinor Duo, Postpill, Pozato, PPMS, Pregnon, Prevemb, Preventol, Prevyol, Prikul, Pronta, Rigesoft, Safex, Secufem, Seguidet, Segurité, Silogin 0.75, Smart Lady (Pregnon), Tace, Tibex, Velor 72, Vermagest, Vika, Yi Ting, Yu Ping, Yu Ting, Zintemore 2 0 Pill Formulations and Dosing for Emergency Contraception LNG = levonorgestrel EE = ethinyl estradiol 57 Progestin- only pills 0.03 mg LNG 28 Mini, Follistrel, Microlut, Microlut 35, Microluton, Microval, Mikro-30, Norgeston, Nortrel 50* 0 0.0375 mg LNG Neogest, Norgeal 40* 0 0.075 mg norgestrel Minicon, Ovrette 40* 0 Estrogen and Progestin Estrogen- progestin dedicated EcPs 0.05 mg EE + 0.25 mg LNG Control NF, Fertilan, Tetragynon 2 2 combined (estrogen- progestin) oral contra- ceptives 0.02 mg EE + 0.1 mg LNG Alesse, Anulette 20, April, Aviane, Femexin, Leios, Lessina, Levlite, Loette, Loette-21, Loette-28, Loette Suave, LoSeasonique, Lovette, Lowette, Lutera, Microgynon 20, Microgynon Suave, Microlevlen, Microlite, Miranova, Norvetal 20, Sronyx 5 5 0.03 mg EE + 0.15 mg LNG Anna, Anovulatorios Microdosis, Anulette CD, Anulit, Charlize, Ciclo 21, Ciclon, Combination 3, Confiance, Contraceptive L.D., Eugynon 30ED, Famila-28, Femigoa, Femranette mikro, Follimin, Gestrelan, Gynatrol, Innova CD, Jolessa, Lady, Levlen, Levlen 21, Levlen 28, Levonorgestrel Pill, Levora, Logynon (take ochre pills only), Lorsax, Ludéal Gé, Mala-D, Microfemin, Microfemin CD, Microgest, Microgest ED, Microgyn, Microgynon, Microgynon-21, Microgynon-28, Microgynon-30, Microgynon 30ED, Microgynon CD, Microgynon ED, Microgynon ED 28, Microsoft CD, Microvlar, Minidril, Minigynon, Minigynon 30, Minivlar, Mithuri, Monofeme, Neomonovar, Neovletta, Nociclin, Nordet, Nordette, Nordette 150/30, Nordette-21, Nordette-28, Norgylene, Norvetal, Nouvelle Duo, 4 4 Emergency Contraceptive Pill Formulations and Dosing 3 E m er g en cy C o n tr ac ep ti ve P ill s * Many pills, but safe. See p. 54, Q&A 5. LNG = levonorgestrel EE = ethinyl estradiol (continued) Hormonal and Pill Type Formu- lation Common Brand Names Pills to Take At First 12 Hours Later 58 Family Planning: A Global Handbook for Providers combined (estrogen- progestin) oral contra- ceptives (continued) 0.03 mg EE + 0.15 mg LNG Ologyn-micro, Ovoplex 3, Ovoplex 30/50, Ovranet, Ovranette, Ovranette 30, Perle Ld, Portia, Primafem, Quasense, R-den, Reget 21+7, Riget, Rigevidon, Rigevidon 21, Rigevidon 21+7, Roselle, Seasonale, Seasonique, Seif, Sexcon, Stediril 30, Suginor 4 4 0.03 mg EE + 0.125 mg LNG Enpresse, Minisiston, Mono Step, Trivora, Trust Pills 4 4 0.05 mg EE + 0.25 mg LNG Contraceptive H.D., Control, D-Norginor, Denoval, Denoval-Wyeth, Duoluton, Duoluton L, Dystrol, Evanor, Evanor-d, FMP, Follinette, Neogentrol, Neogynon, Neogynon 21, Neogynon 50, Neogynon CD, Neogynona, Neovlar, Noral, Nordiol, Nordiol 21, Normamor, Novogyn 21, Ogestrel, Ologyn, Ovidon, Ovoplex, Ovran, Stediril-D 2 2 0.03 mg EE + 0.3 mg norgestrel Anulette, Cryselle, Lo-Femenal, Lo-Gentrol, Low-Ogestrel, Lo/Ovral, Lo-Rondal, Minovral, Min-Ovral, Segura 4 4 0.05 mg EE + 0.5 mg norgestrel Anfertil, Eugynon, Eugynon CD, Femenal, Jeny FMP, Ovral, Planovar, Stediril 2 2 Ulipristal acetate Ulipristal acetate dedicated EcPs 30 mg ulipristal acetate ella, ellaOne 1 0 LNG = levonorgestrel EE = ethinyl estradiol Sources: The Emergency Contraception Web site, the International Planned Parenthood Federation Directory of Hormonal Contraceptives, and the International Consortium for Emergency Contraception Hormonal and Pill Type Formu- lation Common Brand Names Pills to Take At First 12 Hours Later 59 Progestin-Only Injectables CHAPTER 4 Progestin-Only Injectables Key Points for Providers and clients Bleeding changes are common but not harmful. y Typically, irregular bleeding for the first several months and then no monthly bleeding. Return for injections regularly. y 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 y weeks late for NEt-EN. Client should come back even if later. Gradual weight gain is common. y Return of fertility is often delayed. y It takes several months longer on average to become pregnant after stopping progestin- only injectables than after other methods. What Are Progestin-Only Injectables? The injectable contraceptives depot medroxyprogesterone acetate y (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. 81.) Do not contain estrogen, and so can be used throughout breastfeeding y and by women who cannot use methods with estrogen. y DMPA, the most widely used progestin-only injectable, is also known as “the shot,” “the jab,” the injection, Depo, Depo-Provera, Megestron, and Petogen. NET-EN is also known as norethindrone enanthate, Noristerat, and y Syngestal. (See Comparing Injectables, p. 359, for differences between DMPA and NET-EN.) 4 P ro g es ti n -O n ly In je ct ab le s 60 Family Planning: A Global Handbook for Providers Given by y injection into the muscle (intramuscular injection). The hormone is then released slowly into the bloodstream. A different formu- lation of DMPA can be injected just under the skin (subcutaneous injec- tion). See New Formulation of DMPA, p. 63. Work primarily by preventing the release of eggs from the ovaries y (ovulation). How Effective? Effectiveness depends on getting injections regularly: Risk of pregnancy is greatest when a woman misses an injection. As commonly used, about 3 pregnancies per 100 women using y progestin-only injectables over the first year. This means that 97 of every 100 women using injectables will not become pregnant. When women have injections on time, less than 1 pregnancy per y 100 women using progestin-only injectables over the first year (3 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 7, p. 79). Protection against sexually transmitted infections (STIs): None More effective Less effective 61Progestin-Only Injectables Side Effects, Health Benefits, and Health Risks Side Effects (see Managing Any Problems, p. 75) Some users report the following: y Changes in bleeding patterns including, 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. y NET-EN users have fewer days of bleeding in the first 6 months and are less likely to have no monthly bleeding after one year than DMPA users. y Weight gain (see Question 4, p. 78) y Headaches y Dizziness y Abdominal bloating and discomfort y Mood changes Less sex drive y Other possible physical changes: Loss of y bone density (see Question 10, p. 80) Why Some Women Say they Like Progestin-Only Injectables Do not require daily action y Do not interfere with sex y Are private: No one else can tell that a woman is using y contraception Cause no monthly bleeding (for many women) y May help women to gain weight y 4 P ro g es ti n -O n ly In je ct ab le s 62 Family Planning: A Global Handbook for Providers Correcting Misunderstandings (see also Questions and Answers, p. 78) Progestin-only injectables: Can stop monthly bleeding, but this is not harmful. It is similar to not y having monthly bleeding during pregnancy. Blood is not building up inside the woman. Do not disrupt an existing pregnancy. y Do not make women y infertile. Known Health Benefits Known Health Risks DMPA Helps protect against: Risks of pregnancy y Cancer of the lining of the uterus y (endometrial cancer) y Uterine fibroids May help protect against: Symptomatic y pelvic inflammatory disease Iron-deficiency anemia y Reduces: Sickle cell crises among women y with sickle cell anemia Symptoms of y endometriosis (pelvic pain, irregular bleeding) None NEt-EN Helps protect against: Risks of pregnancy y Iron-deficiency y 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. 63Progestin-Only Injectables 4 P ro g es ti n -O n ly In je ct ab le s Delivering injectable contraception in the community More and more women are asking for injectable contraceptives. This method can be more widely available when it is offered in the commu- nity as well as in clinics. A WHO technical consultation in 2009 reviewed evidence and program experience and concluded that “community-based provision of progestin- only injectable contraceptives by appropriately trained community health workers is safe, effective, and acceptable” to clients. Community-based providers of injectables should be able to screen clients for pregnancy and for medical eligibility. Also, they should be able to give injections safely and to inform women about delayed return of fertility and common side effects, including irregular bleeding, no monthly bleeding, and weight gain. They also should be able to counsel women about their choice of methods, including methods available at the clinic. All providers of injectables need specific performance-based training and supportive supervision to carry out these tasks. It is desirable, if possible, to check blood pressure before a woman starts an injectable (see p. 65, Question 3). However, in areas where the risks of pregnancy are high and few other methods are available, blood pressure measurement is not required. For success, clinic-based providers and community-based providers must work closely together. Programs vary, but these are some ways that clinic-based providers can support community-based providers: treating side effects (see pp. 75–77), using clinical judgment concerning medical eligibility in special cases (see p. 67), ruling out pregnancy in women who are more than 4 weeks late for an injection of DMPA or 2 weeks late for NET-EN, and responding to any 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. New formulation of DMPA A new type of prefilled, single- use syringe could be particularly useful to provide DMPA in the community. These syringes have a short needle meant for subcu- taneous injection (that is, injec- tion just below the skin). They contain a special formulation of DMPA, called DMPA-SC. It is (Continued on next page) 64 Family Planning: A Global Handbook for Providers 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 y Are not married y Are of any age, including adolescents and women over 40 years old y Have just had an abortion or y miscarriage Smoke y cigarettes, regardless of woman’s age or number of cigarettes smoked Are breastfeeding (starting as soon as 6 weeks after childbirth; however, y see p. 129, Q&A 8) Are infected with HIV, whether or not on antiretroviral therapy (see y Progestin-Only Injectables for Women With HIV, p. 67) Women can begin using progestin-only injectables: Without a pelvic examination y Without any blood tests or other routine laboratory tests y Without y cervical cancer screening Without a y breast examination Even when a woman is not having monthly bleeding at the time, if it is y reasonably certain she is not pregnant (see Pregnancy Checklist, p. 372) Delivering injectable contraception in the community (continued) meant only for subcutaneous injection and not for injection into muscle. This formulation of DMPA is available in conventional prefilled auto- disable syringes and in the Uniject system, in which squeezing a bulb pushes the fluid through the needle (see photo on previous page). Like all single-use syringes, these syringes should be placed in a sharps box after use, and then the sharps box should be disposed of properly (see Infection Prevention in the Clinic, p. 312). 65Who Can and Cannot Use Progestin-Only Injectables 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? NO ❏ 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. 69). 2. Do you have severe cirrhosis of the liver, a liver infection, or liver tumor? (Are her eyes or skin unusually yellow? [signs of jaundice]) NO ❏ YES ❏ If she reports serious active liver disease (jaundice, severe cirrhosis, liver tumor), do not provide progestin- only injectables. Help her choose a method without hormones. 3. Do you have high blood pressure? NO ❏ YES ❏ If you cannot check blood pressure and she reports having high blood pressure in the past, provide progestin-only injectables. Check her blood pressure if possible: If she is currently being treated for high blood pressure y 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 y diastolic blood pressure 100 or higher, do not provide progestin-only injectables. Help her choose another method without estrogen. 4. Have you had diabetes for more than 20 years or damage to your arteries, vision, kidneys, or nervous system caused by diabetes? NO ❏ YES ❏ Do not provide progestin-only injectables. Help her choose another method without estrogen. (Continued on next page) Medical Eligibility criteria for Progestin-Only Injectables 4 P ro g es ti n -O n ly In je ct ab le s 66 Family Planning: A Global Handbook for Providers Medical Eligibility Criteria for Progestin-Only Injectables (continued) 5. Have you ever had a stroke, blood clot in your legs or lungs, heart attack, or other serious heart problems? NO ❏ YES ❏ If she reports heart attack, heart disease due to blocked or narrowed arteries, or stroke, do not pro- vide progestin-only injectables. Help her choose another method without estrogen. If she reports a current blood clot in the deep veins of the leg or in the lung (not super- ficial clots), and she is not on anticoagulant therapy, help her choose a method without hormones. 6. Do you have vaginal bleeding that is unusual for you? NO ❏ 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 a 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? NO ❏ 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? NO ❏ YES ❏ Do not provide progestin-only injectables. Help her choose another method without estrogen. 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. 67Who Can and Cannot Use Progestin-Only Injectables 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. y 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 y 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 y History of heart disease or current heart disease due to y blocked or narrowed arteries (ischemic heart disease) History of y stroke Multiple risk factors for arterial cardiovascular disease such as diabetes y and high blood pressure y Unexplained vaginal bleeding before evaluation for possible serious underlying condition Had y breast cancer more than 5 years ago, and it has not returned y Diabetes for more than 20 years or damage to arteries, vision, kidneys, or nervous system caused by diabetes Severe y liver disease, infection, or tumor Systemic lupus erythematosus with positive (or unknown) antiphospholipid y antibodies or, if starting a progestin-only injectable, severe thrombocytopenia Progestin-Only Injectables for Women With HIV Women who are infected with HIV, have AIDS, or are on y antiretroviral (ARV) therapy can safely use progestin-only injectables. Urge these women to use condoms along with progestin-only y injectables. Used consistently and correctly, condoms help prevent transmission of HIV and other STIs. 4 P ro g es ti n -O n ly In je ct ab le s 68 Family Planning: A Global Handbook for Providers 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 p. 372). 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 y of her monthly bleeding, no need for a backup method. If it is more than 7 days after the start of her y 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 y injectables immediately (see Copper-Bearing IUD, Switching From an IUD to Another Method, p. 148). Switching from a hormonal method Immediately, if she has been using the hormonal y 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 y can have the new injectable when the repeat injection would have been given. No need for a backup method. * 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. 69Providing Progestin-Only Injectables Woman’s situation When to start Fully or nearly fully breastfeeding Less than 6 months after giving birth If she gave birth less than 6 weeks ago, delay her y first injection until at least 6 weeks after giving birth. (See p. 129, Q&A 8.) If her monthly bleeding has not returned, she can y start injectables any time between 6 weeks and 6 months. No need for a backup method. If her monthly bleeding has returned, she can y 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 y start injectables any time it is reasonably cer- tain 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 y 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 y after giving birth. (See p. 129, Q&A 8.) More than 6 weeks after giving birth If her monthly bleeding has not returned, she can y 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 her monthly bleeding has returned, she can y start injectables as advised for women having menstrual cycles (see previous page). † Where a visit 6 weeks after childbirth is routinely recommended and other opportunities to obtain contraception 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. 4 P ro g es ti n -O n ly In je ct ab le s 70 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 injectables at any time. No need y for a backup method. More than 4 weeks after giving birth If her monthly bleeding has not returned, she can y 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 her monthly bleeding has returned, she can y start injectables as advised for women having menstrual cycles (see p. 68). No monthly bleeding (not related to childbirth or breastfeeding) She can start injectables any time it is reasonably y 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 y first- or second-trimester miscarriage or abortion, no need for a backup method. If it is more than 7 days after first- or second- y trimester miscarriage or abortion, 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. After taking emergency contraceptive pills (ECPs) She can start injectables on the same day as the y ECPs, or if preferred, within 7 days after the start of her monthly bleeding. She will need a backup method for the first 7 days after the injection. She should return if she has signs or symptoms of pregnancy other than not having monthly bleeding (see p. 371 for common signs and symp- toms of pregnancy). † Where a visit 6 weeks after childbirth is routinely recommended and other opportunities to obtain contraception 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. 71 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. Describe the most common side effects For the first several months, y irregular bleeding, prolonged bleeding, frequent bleeding. Later, no monthly bleeding. y 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. y Common, but some women do not have them. y The client can come back for help if side effects y bother her. Giving the Injection Obtain one 1. dose of injectable, needle, and syringe y DMPA: 150 mg for injections into the muscle (intramuscular injection). NET-EN: 200 mg for injections into the muscle. If possible, use single-dose vials. Check y 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 y intramuscular needle. y NET-EN: A 2 or 5 ml syringe and a 19-gauge intramuscular needle. A narrower needle (21–23 gauge) also can be used. For each injection use a disposable auto-disable y syringe and needle from a new, sealed package (within expiration date and not damaged), if available. Wash2. y Wash hands with soap and water, if possible. If injection site is dirty, wash it with soap and y water. No need to wipe site with antiseptic. y Providing Progestin-Only Injectables 4 P ro g es ti n -O n ly In je ct ab le s 72 Family Planning: A Global Handbook for Providers Prepare vial 3. y DMPA: Gently shake the vial. y NET-EN: Shaking the vial is not necessary. No need to wipe top of vial with antiseptic. y If vial is cold, warm to skin temperature before y giving the injection. Fill syringe4. Pierce top of vial with sterile needle and fill y syringe with proper dose. Inject formula5. Insert sterile needle deep into the hip y (ventrogluteal 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. y Dispose of 6. disposable syringes and needles safely Do not recap, bend, or break needles before y disposal. Place in a puncture-proof sharps container. y Do not reuse disposable syringes y 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 y reusable syringe and needle are used, they must be sterilized again after each use (see Infection Prevention in the Clinic, p. 312). 73 “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 Agree on a date for her next injection in 3 months (13 weeks) for 1. DMPA, or in 2 months (8 weeks) for NET-EN. Discuss how to remember the date, perhaps tying it to a holiday or other event. Ask her to try to come on time. With DMPA she may come up to 4 2. weeks late and still get an injection. With NET-EN she may come up to 2 weeks late and still get an injection. With either DMPA or NET-EN, she can come up to 2 weeks early. She should come back no matter how late she is for her next injection. 3. 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 emer- gency contraceptive pills (see Emergency Contraceptive Pills, p. 45). Supporting the User Give specific instructions Tell her not to massage the injection site. y Tell the client the name of the injection and y agree on a date for her next injection. Providing Progestin-Only Injectables 4 P ro g es ti n -O n ly In je ct ab le s 74 Family Planning: A Global Handbook for Providers Helping Continuing Users Repeat Injection Visits Ask how the client is doing with the method and whether she is 1. satisfied. Ask if she has any questions or anything to discuss. Ask especially if she is concerned about bleeding changes. Give her any 2. information or help that she needs (see Managing Any Problems, next page). Give her the injection. Injection of DMPA can be given up to 4 weeks late. 3. Injection of NET-EN can be given up to 2 weeks late. Plan for her next injection. Agree on a date for her next injection (in 4. 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. Every year or so, check her 5. blood pressure if possible (see Medical Eligibility Criteria, Question 3, p. 65). Ask a long-term client if she has had any new health problems. Address 6. problems as appropriate. For new health problems that may require switching methods, see p. 77. Ask a long-term client about major life changes that may affect her needs—7. 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 y 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 y late for NET-EN, can receive her next injection if: – She has not had sex since 2 weeks after she should have had her last injection, or – She has used a backup method or has taken emergency contraceptive pills (ECPs) after any unprotected sex since 2 weeks after she should have had her last 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 y for NET-EN, and she does not meet these criteria, additional steps can be taken to be reasonably certain she is not pregnant (see Further Options to Assess for Pregnancy, p. 370). 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 75Helping 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. y They deserve the provider’s attention. If the client reports side effects, listen to her concerns, give her advice, and, if appropriate, treat. Offer to help the client choose another method—now, if she wishes, or if y problems cannot be overcome. No monthly bleeding Reassure her that most women using progestin-only injectables stop y 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 y monthly injectables, if available. Irregular bleeding (bleeding at unexpected times that bothers the client) Reassure her that many women using progestin-only injectables experience y irregular bleeding. It is not harmful and usually becomes less or stops after the first few months of use. For modest short-term relief, take 500 mg mefenamic acid 2 times daily y 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 y 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. 77). Weight gain Review y diet and counsel as needed. Abdominal bloating and discomfort Consider locally available remedies. y 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 y 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. 4 P ro g es ti n -O n ly In je ct ab le s 76 Family Planning: A Global Handbook for Providers Heavy or prolonged bleeding (twice as much as usual or longer than 8 days) Reassure her that some women using progestin-only injectables y 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 y 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, beginning when heavy bleeding starts. If bleeding becomes a health threat or if the woman wants, help her y choose another method. In the meantime, she can use one of the treatments listed above to help reduce bleeding. To help prevent y 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 y 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 y 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 y 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, y including changes in her relationship with her partner. Give support as appropriate. Clients who have serious y mood changes such as major depression should be referred for care. Consider locally available remedies. y Dizziness Consider locally available remedies. y 77 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. 368) If she has migraine headaches without y aura, she can continue to use the method if she wishes. If she has migraine y 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 y appropriate. If no cause of bleeding can be found, consider stopping progestin-only y 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 hormonal IUD). If bleeding is caused by y 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 in deep veins of legs or lungs, stroke, breast cancer, or damage to arter- ies, vision, kidneys, or nervous system caused by diabetes). See Signs and Symptoms of Serious Health Conditions, p. 320. Do not give next injection. y Give her a backup method to use until the condition is evaluated. y Refer for diagnosis and care if not already under care. y Suspected pregnancy Assess for pregnancy. y Stop injections if pregnancy is confirmed. y There are no known risks to a fetus conceived while a woman is using y injectables (see Question 11, p. 80). Helping Continuing Users of Progestin-Only Injectables 4 P ro g es ti n -O n ly In je ct ab le s 78 Family Planning: A Global Handbook for Providers Questions and Answers About Progestin-Only Injectables 1. can women who could get sexually transmitted infections (StIs) use progestin-only injectables? Yes. Women at risk for STIs can use progestin-only injectables. The few studies available have found that women using DMPA were more likely to acquire chlamydia than women not using hormonal contraception. The reason for this difference is not known. There are few studies available on use of NET-EN and STIs. Like anyone else at risk for STIs, a user of progestin-only injectables who may be at risk for STIs should be advised to use condoms correctly every time she has sex. Consistent and correct condom use will reduce her risk of becoming infected if she is exposed to an STI. 2. If a woman does not have monthly bleeding while using progestin-only injectables, does this mean that she is pregnant? Probably not, especially if she is breastfeeding. Eventually most women using progestin-only injectables will not have monthly bleeding. If she has been getting her injections on time, she is probably not pregnant and can keep using injectables. 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. 3. can a woman who is breastfeeding safely use progestin-only injectables? Yes. This is a good choice for a breastfeeding mother who wants a hormonal method. Progestin-only injectables are safe for both the mother and the baby starting as early as 6 weeks after childbirth. They do not affect milk production. 4. How much weight do women gain when they use progestin-only injectables? Women gain an average of 1–2 kg per year when using DMPA. Some of the weight increase may be the usual weight gain as people age. Some women, particularly overweight adolescents, have gained much more than 1–2 kg per year. At the same time, some users of progestin-only injectables lose weight or have no significant change in weight. Asian women in particular do not tend to gain weight when using DMPA. 5. Do DMPA and NEt-EN cause abortion? No. Research on progestin-only injectables 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. 79Questions and Answers About Progestin-Only Injectables 6. Do progestin-only injectables make a woman infertile? No. There may be a delay in regaining fertility after stopping progestin- only injectables, but in time the woman will be able to become pregnant as before, although fertility decreases as women get older. The bleeding pattern a woman had before she used progestin-only injectables generally returns several months after the last injection even if she had no monthly bleeding while using injectables. Some women may have to wait several months before their usual bleeding pattern returns. 7. How long does it take to become pregnant after stopping DMPA or NEt-EN? Women who stop using DMPA wait about 4 months longer on average to become pregnant than women who have used other methods. This means they become pregnant on average 10 months after their last injection. Women who stop using NET-EN wait about one month longer on average to become pregnant than women who have used other methods, or 6 months after their last injection. These are averages. A woman should not be worried if she has not become pregnant even as much as 12 months after stopping use. The length of time a woman has used injectables makes no difference to how quickly she becomes pregnant once she stops having injections. After stopping progestin-only injectables, a woman may ovulate before her monthly bleeding returns—and thus can become pregnant. If she wants to continue avoiding pregnancy, she should start another method before monthly bleeding returns. 8. Does DMPA cause cancer? Many studies show that DMPA does not cause cancer. DMPA use helps protect against cancer of the lining of the uterus (endometrial cancer). Findings of the few studies on DMPA use and breast cancer are similar to findings with combined oral contraceptives: Women using DMPA were slightly more likely to be diagnosed with breast cancer while us- ing DMPA or within 10 years after they stopped. It is unclear whether these findings are explained by earlier detection of existing breast cancers among DMPA users or by a biologic effect of DMPA on breast cancer. A few studies on DMPA use and cervical cancer suggest that there may be a slightly increased risk of cervical cancer among women using DMPA for 5 years or more. Cervical cancer cannot develop because of DMPA alone, however. It is caused by persistent infection with human papillomavirus. Little information is available about NET-EN. It is expected to be as safe as DMPA and other contraceptive methods containing only a progestin, such as progestin-only pills and implants. 4 P ro g es ti n -O n ly In je ct ab le s 80 Family Planning: A Global Handbook for Providers 9. can a woman switch from one progestin-only injectable to another? Switching injectables is safe, and it does not decrease effectiveness. If switching is necessary due to shortages of supplies, the first injection of the new injectable should be given when the next injection of the old formulation would have been given. Clients need to be told that they are switching, the name of the new injectable, and its injection schedule. 10. How does DMPA affect bone density? DMPA use decreases bone density. Research has not found that DMPA users of any age are likely to have more broken bones, however. When DMPA use stops, bone density increases again for women of reproductive age. Among adults who stop using DMPA, after 2 to 3 years their bone density appears to be similar to that of women who have not used DMPA. Among adolescents, it is not clear whether the loss in bone density prevents them from reaching their potential peak bone mass. No data are available on NET-EN and bone loss, but the effect is expected to be similar to the effect of DMPA. 11. Do progestin-only injectables cause birth defects? Will the fetus be harmed if a woman accidentally uses progestin-only injectables while she is pregnant? No. Good evidence shows that progestin-only injectables will not cause birth defects and will not otherwise harm the fetus if a woman becomes pregnant while using progestin-only injectables or accidentally starts injectables when she is already pregnant. 12. Do progestin-only injectables change women’s mood or sex drive? Generally, no. Some women using injectables report these complaints. The great majority of injectables users do not report any such changes, however. It is difficult to tell whether such changes are due to progestin- only injectables or to other reasons. Providers can help a client with these problems (see Mood changes or changes in sex drive, p. 76). There is no evidence that progestin-only injectables affect women’s sexual behavior. 13. What if a woman returns for her next injection late? In 2008 WHO revised its guidance based on new research findings. The new guidance recommends giving a woman her next DMPA injection if she is up to 4 weeks late, without the need for further evidence that she is not pregnant. A woman can receive her next NET-EN injection if she is up to 2 weeks late. Some women return even later for their repeat injec- tion, however. In such cases providers can use Further Options to Assess for Pregnancy, p. 370. Whether a woman is late for reinjection or not, her next injection of DMPA should be planned for 3 months later, or her next injection of NET-EN should be planned for 2 months later, as usual. 81 What Are Monthly Injectables? Monthly injectables contain 2 hormones—a y progestin and an estrogen— like the natural hormones progesterone and estrogen in a woman’s body. (Combined oral contraceptives also contain these 2 types of hormones.) Also called combined injectable contraceptives, CICs, the injection. y Information in this chapter applies to y medroxyprogesterone acetate (MPA)/estradiol cypionate and to norethisterone enanthate (NET-EN)/estradiol valerate. The information may also apply to older formulations, about which less is known. y MPA/estradiol cypionate is marketed under the trade names Ciclofem, Ciclofemina, Cyclofem, Cyclo-Provera, Feminena, Lunella, Lunelle, Novafem, and others. NET-EN/estradiol valerate is marketed under the trade names Mesigyna and Norigynon. Work primarily by preventing the release of eggs from the ovaries y (ovulation). Monthly Injectables CHAPTER 5 Monthly Injectables Key Points for Providers and clients Bleeding changes are common but not harmful y . Typically, lighter monthly bleeding, fewer days of bleeding, or irregular or infrequent bleeding. Return on time. y Coming back every 4 weeks is important for greatest effectiveness. Injection can be as much as 7 days early or late. y Client should come back even if later. 5 M o n th ly In je ct ab le s 82 Family Planning: A Global Handbook for Providers How Effective? Effectiveness depends on returning on time: Risk of pregnancy is greatest when a woman is late for an injection or misses an injection. As commonly used, about 3 pregnancies per 100 women using y monthly injectables over the first year. This means that 97 of every 100 women using injectables will not become pregnant. When women have injections on time, less than 1 pregnancy y per 100 women using monthly injectables over the first year (5 per 10,000 women). Return of fertility after injections are stopped: An average of about one month longer than with most other methods (see Question 11, p. 100). Protection against sexually transmitted infections (STIs): None Why Some Women Say they Like Monthly Injectables Do not require daily action y Are private: No one else can tell that a woman is using y contraception Injections can be stopped at any time y Are good for y spacing births More effective Less effective 83 Side Effects, Health Benefits, and Health Risks Side Effects (see Managing Any Problems, p. 95) Some users report the following: Changes in bleeding patterns including: y – Lighter bleeding and fewer days of bleeding – Irregular bleeding – Infrequent bleeding – Prolonged bleeding – No monthly bleeding y Weight gain y Headaches y Dizziness y Breast tenderness Known Health Benefits and Health Risks Long-term studies of monthly injectables are limited, but researchers expect that their health benefits and health risks are similar to those of combined oral contraceptives (see Combined Oral Contraceptives, Health Benefits and Health Risks, p. 3). There may be some differences in the effects on the liver, however (see Question 2, p. 98). Correcting Misunderstandings (see also Questions and Answers, p. 98) Monthly injectables: Can stop y monthly bleeding, but this is not harmful. It is similar to not having monthly bleeding during pregnancy. Blood is not building up inside the woman. Are not in experimental phases of study. Government agencies have y approved them. Do not make women y infertile. Do not cause early y menopause. Do not cause y birth defects or multiple births. Do not cause itching. y Do not change women’s sexual behavior. y Monthly Injectables 5 M o n th ly In je ct ab le s 84 Family Planning: A Global Handbook for Providers Who Can and Cannot Use Monthly Injectables Safe and Suitable for Nearly All Women Nearly all women can use monthly injectables safely and effectively, including women who: Have or have not had children y Are not married y Are of any age, including adolescents and women over 40 years old y Have just had an abortion or y miscarriage Smoke any number of y cigarettes daily and are under 35 years old Smoke fewer than 15 y cigarettes daily and are over 35 years old Have y anemia now or had anemia in the past Have y varicose veins Are infected with HIV, whether or not on antiretroviral therapy, unless y that therapy includes ritonavir (see Monthly Injectables for Women With HIV, below) Women can begin using monthly injectables: Without a pelvic examination y Without any blood tests or other routine laboratory tests y Without y cervical cancer screening Without a y breast examination Even when a woman is not having monthly bleeding at the time, if it is y reasonably certain she is not pregnant (see Pregnancy Checklist, p. 372) Monthly Injectables for Women With HIV y Women can safely use monthly injectables even if they are infected with HIV, have AIDS, or are on antiretroviral (ARV) therapy unless their therapy includes ritonavir. Ritonavir may reduce the effectiveness of monthly injectables. (See Medical Eligibility Criteria, p. 330.) Urge these women to use condoms along with monthly injectables. y Used consistently and correctly, condoms help prevent transmission of HIV and other STIs. Condoms also provide extra contraceptive protection for women on ARV therapy. 85Who Can and Cannot Use Monthly Injectables 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 monthly injectables if she wants. If she answers “yes” to a question, follow the instructions. In some cases she can still start monthly injectables. 1. Are you breastfeeding a baby less than 6 months old? NO ❏ YES ❏ If fully or nearly fully breastfeeding: She can start 6 y 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. 89). If partially y breastfeeding: She can start monthly injectables as soon as 6 weeks after giving birth (see Partially breastfeeding, p. 90). 2. Have you had a baby in the last 3 weeks and you are not breastfeeding? NO ❏ YES ❏ She can start monthly injectables as soon as 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 monthly injectables at 3 weeks after childbirth, but can start at 6 weeks instead. These additional risk factors include previous VTE, throm- bophilia, 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 15 or more cigarettes a day? NO ❏ YES ❏ If she is 35 years of age or older and smokes more than 15 cigarettes a day, do not provide monthly injectables. Urge her to stop smoking and help her choose another method. 4. Do you have severe cirrhosis of the liver, a liver infection, or liver tumor? (Are her eyes or skin unusually yellow? [signs of jaundice]) NO ❏ YES ❏ If she reports serious active liver disease (jaundice, active hepatitis, severe cirrhosis, liver tumor), do not provide monthly injectables. Help her choose a method without hormones. (If she has mild cirrhosis or gall bladder disease, she can use monthly injectables.) (Continued on next page) Medical Eligibility criteria for Monthly Injectables 5 M o n th ly In je ct ab le s 86 Family Planning: A Global Handbook for Providers Medical Eligibility Criteria for Monthly Injectables (continued) 5. Do you have high blood pressure? NO ❏ 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 monthly injectables. Refer her for a blood pressure check if possible or help her choose another method without estrogen. Check her blood pressure if possible: If blood pressure is below 140/90 mm Hg, provide y monthly injectables. If systolic blood pressure is 140 mm Hg or higher or y diastolic blood pressure is 90 or higher, do not provide monthly injectables. Help her choose a method without estrogen, but not progestin-only injectables if systolic blood pressure is 160 or higher or diastolic pressure is 100 or higher. (One blood pressure reading in the range of 140–159/90–99 mm Hg is not enough to diagnose high blood pressure. Provide a backup method* to use until she can return for another blood pressure check, or help her choose another method now if she prefers. If blood pressure at next check is below 140/90, she can use monthly injectables.) 6. Have you had diabetes for more than 20 years or damage to your arteries, vision, kidneys, or nervous system caused by diabetes? NO ❏ YES ❏ Do not provide monthly injectables. Help her choose a method without estrogen but not progestin-only injectables. 7. Have you ever had a stroke, blood clot in your legs or lungs, heart attack, or other serious heart problems? NO ❏ YES ❏ If she reports heart attack, heart disease due to blocked or narrowed arteries, or stroke, do not provide monthly injectables. 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 leg or in the lung (not superficial clots), help her choose a method without hormones. * 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. 87Who Can and Cannot Use Monthly Injectables 8. Do you have or have you ever had breast cancer? NO ❏ YES ❏ Do not provide monthly injectables. Help her choose a method without hormones. 9. 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. NO ❏ YES ❏ If she has migraine aura at any age, do not provide monthly injectables. If she has migraine headaches without aura and is age 35 or older, do not provide monthly injectables. Help these women choose a method without estrogen. If she is under 35 and has migraine headaches without aura, she can use monthly injectables (see Identifying Migraine Headaches and Auras, p. 368). 10. Are you planning major surgery that will keep you from walking for one week or more? NO ❏ YES ❏ If so, she can start monthly injectables 2 weeks after the surgery. Until she can start monthly injectables, she should use a backup method. 11. 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? NO ❏ YES ❏ Do not provide monthly injectables. Help her choose a method without estrogen, but not progestin-only injectables. 12. Are you taking lamotrigine or ritonavir? NO ❏ YES ❏ Do not provide monthly injectables. Monthly in- jectables can make lamotrigine less effective. Ritonavir can make monthly injectables less effective. Help her choose a method without estrogen. Also, women should not use monthly injectables 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. 324. 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. 5 M o n th ly In je ct ab le s 88 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 monthly 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 monthly inject- ables. 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 y Not breastfeeding and between 3 and 6 weeks postpartum with y additional risk that she might develop a blood clot in a deep vein (VTE) Primarily y breastfeeding between 6 weeks and 6 months since giving birth Age 35 or older and smokes more than 15 y cigarettes a day High y 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 y possible History of high blood pressure, where blood pressure cannot be y taken (including pregnancy-related high blood pressure) Severe y liver disease, infection, or tumor Age 35 or older and has migraine headaches without aura y Younger than age 35 and has migraine headaches that have devel- y oped or have gotten worse while using monthly injectables Had y breast cancer more than 5 years ago, and it has not returned Diabetes for more than 20 years or damage to arteries, y vision, kidneys, or nervous system caused by diabetes Multiple risk factors for arterial cardiovascular disease, such as y older age, smoking, diabetes, and high blood pressure Taking lamotrigine. Monthly injectables may reduce the effective- y ness of lamotrigine. Taking ritonavir or ritonavir-boosted protease inhibitors. A backup y contraceptive method should also be used because these medica- tions reduce the effectiveness of monthly injectables. 89Providing Monthly Injectables Providing Monthly 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 p. 372). 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 y of her monthly bleeding, no need for a backup method. If it is more than 7 days after the start of her y 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 y injectables immediately (see Copper-Bearing IUD, Switching From an IUD to Another Method, p. 148). Switching from a hormonal method Immediately, if she has been using the hormonal y 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 y 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 Delay her first injection until 6 months after y giving birth or when breast milk is no longer the baby’s main food—whichever comes first. 5 * 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. M o n th ly In je ct ab le s 90 Family Planning: A Global Handbook for Providers Woman’s situation When to start Fully or nearly fully breastfeeding (continued) More than 6 months after giving birth If her monthly bleeding has not returned, she can y 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 her monthly bleeding has returned, she can y start injectables as advised for women having menstrual cycles (see p. 89). Partially breastfeeding Less than 6 weeks after giving birth Delay her first injection until at least 6 weeks y after giving birth. More than 6 weeks after giving birth If her monthly bleeding has not returned, she can y 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 her monthly bleeding has returned, she can y start injectables as advised for women having menstrual cycles (see p. 89). Not breastfeeding Less than 4 weeks after giving birth She can start injectables at any time on days y 21–28 after giving birth. No need for a backup method. (If additional risk for VTE, wait until 6 weeks. See p. 85, Question 2.) More than 4 weeks after giving birth If her monthly bleeding has not returned, she can y 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 her monthly bleeding has returned, she can y start injectables as advised for women having menstrual cycles (see p. 89). † Where a visit 6 weeks after childbirth is routinely recommended and other opportunities to obtain contraception 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. 91Providing Monthly Injectables 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. Describe the most common side effects Lighter bleeding and fewer days of bleeding, y irregular bleeding, and infrequent bleeding. y Weight gain, headaches, dizziness, breast tenderness, and possibly other side effects. Explain about these side effects Side effects are not signs of illness. y Usually become less or stop within the first few y months after starting injections. Common, but some women do not have them. y The client can come back for help if side effects y bother her. Woman’s situation When to start No monthly bleeding (not related to childbirth or breastfeeding) She can start injectables any time it is reasonably y 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 y first- or second-trimester miscarriage or abortion, no need for a backup method. If it is more than 7 days after first- or second- y trimester miscarriage or abortion, 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. After taking emergency contraceptive pills (ECPs) She can start injectables on the same day as y the ECPs. There is no need to wait for her next monthly bleeding to have the injection. She will need a backup method for the first 7 days after the injection. 5 M o n th ly In je ct ab le s 92 Family Planning: A Global Handbook for Providers Giving the Injection Obtain one 1. dose of injectable, needle and syringe 25 mg y MPA/estradiol cypionate or 50 mg NET-EN/estradiol valerate, intramuscular injection needle, and 2 ml or 5 ml syringe. (NET-EN/estradiol valerate is sometimes available in prefilled syringes.) For each injection use a disposable y auto-disable syringe and needle from a new sealed package (within expiration date and not damaged), if available. Wash2. y Wash hands with soap and water, if possible. If y injection site is dirty, wash it with soap and water. No need to wipe site with antiseptic. y Prepare vial3. y MPA/estradiol cypionate: Gently shake the vial. NET-EN/estradiol valerate: Shaking the vial is y not necessary. No need to wipe top of vial with antiseptic. y If vial is cold, warm to skin temperature before y giving the injection. Fill syringe4. Pierce top of vial with sterile needle and fill y syringe with proper dose. (Omit this step if syringe is preloaded with injectable formulation.) Inject formula5. Insert sterile needle deep into the hip y (ventrogluteal muscle), the upper arm (deltoid muscle), the buttocks (gluteal muscle, upper outer portion), or outer (anterior) thigh, whichever the woman prefers. Inject the contents of the syringe. Do not massage injection site. y 93 “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. Supporting the User Give specific instructions Tell her not to massage the injection site. y Tell the client the name of the injection and y agree on a date for her next injection in about 4 weeks. Providing Monthly Injectables Dispose of 6. disposable syringes and needles safely Do not recap, bend, or break needles before y disposal. Place in a puncture-proof sharps container. y Do not reuse disposable syringes y 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 y reusable syringe and needle are used, they must be sterilized again after each use (see Infection Prevention in the Clinic, p. 312). 5 M o n th ly In je ct ab le s 94 Family Planning: A Global Handbook for Providers Planning the Next Injection Agree on a date for her next 1. injection in 4 weeks. Ask her to try to come on time. 2. She may come up to 7 days early or 7 days late and still get an injection. She should come back no matter 3. how late she is for her next injection. If more than 7 days late, she should abstain from sex or use condoms, spermicides, or withdrawal until she can get an injection. She can also consider emergency contraceptive pills if she is more than 7 days late and she has had unprotected sex in the past 5 days (see Emergency Contraceptive Pills, p. 45). Helping Continuing Users Repeat Injection Visits Ask how the client is doing with the method and whether she is 1. satisfied. Ask if she has any questions or anything to discuss. Ask especially if she is concerned about bleeding changes. Give her 2. any information or help that she needs (see Managing Any Problems, next page). Give her the injection. Injection can be given up to 7 days early or late.3. Plan for her next injection. Agree on a date for her next injection (in 4. 4 weeks). Remind her that she should try to come on time, but she should come back no matter how late she is. Every year or so, check her 5. blood pressure if possible (see Medical Eligibility Criteria, Question 5, p. 86). Ask a long-term client if she has had any 6. new health problems. Address problems as appropriate. For new health problems that may require switching methods, see p. 97. Ask a long-term client about major life changes that may affect her 7. needs—particularly plans for having children and STI/HIV risk. Follow up as needed. 95Helping Continuing Users of Monthly 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 y injectables. They deserve the provider’s attention. If the client reports side effects, listen to her concerns, give her advice, and, if appropriate, treat. Offer to help the client choose another method—now, if she wishes, or if y problems cannot be overcome. Irregular bleeding (bleeding at unexpected times that bothers the client) Reassure her that many women using monthly injectables experience y 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 try 800 mg y 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 monthly injectables. If irregular bleeding continues or starts after several months of normal y 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. 97). Managing Late Injections If the client is less than 7 days late for a repeat injection, she can receive y her next injection. No need for tests, evaluation, or a backup method. A client who is more than 7 days late can receive her next injection if: y – She has not had sex since 7 days after she should have had her last injection, or – She has used a backup method or has taken emergency contraceptive pills (ECPs) after any unprotected sex since 7 days after she should have had her last injection. She will need a backup method for the first 7 days after the injection. If the client is more than 7 days late and does not meet these criteria, y additional steps can be taken to be reasonably certain she is not pregnant (see Further Options to Assess for Pregnancy, p. 370). Discuss why the client was late and solutions. If coming back on time is y often a problem, discuss using a backup method when she is late for her next injection, taking ECPs, or choosing another method. 5 M o n th ly In je ct ab le s 96 Family Planning: A Global Handbook for Providers Heavy or prolonged bleeding (twice as much as usual or longer than 8 days) Reassure her that many women using monthly injectables experience y 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 800 mg y ibuprofen 3 times daily after meals for 5 days or other NSAID, beginning when heavy bleeding starts. NSAIDs provide some relief of heavy bleeding for implants, progestin- only injectables, and IUDs, and they may also help for monthly injectables. To help prevent y 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 y 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 Reassure her that some women using monthly injectables stop having y monthly bleeding, and this 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.) Weight gain Review y diet and counsel as needed. Ordinary headaches (nonmigrainous) Suggest aspirin (325–650 mg), ibuprofen (200–400 mg), y paracetamol (325–1000 mg), or other pain reliever. Any headaches that get worse or occur more often during use of y injectables should be evaluated. Breast tenderness Recommend that she wear a supportive bra (including during strenuous y activity and sleep). Try hot or cold compresses. y Suggest y aspirin (325–650 mg), ibuprofen (200–400 mg), paracetamol (325–1000 mg), or other pain reliever. Consider locally available remedies y . Dizziness Consider locally available remedies. y 97Helping Continuing Users of Monthly Injectables 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 y appropriate. She can continue using monthly injectables while her condition is being evaluated. y If bleeding is caused by y sexually transmitted infection or pelvic inflammatory disease, she can continue using monthly injectables during treatment. Migraine headaches (see Identifying Migraine Headaches and Auras, p. 368) Regardless of her age, a woman who develops migraine headaches, with y or without aura, or whose migraine headaches become worse while using monthly injectables, should stop using injectables. Help her choose a method without estrogen. y circumstances that will keep her from walking for one week or more If she is having major y 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 monthly injectables. – Stop injections one month before scheduled surgery, if possible, and use a backup method during this period. – Restart monthly injectables 2 weeks after she can move about again. certain serious health conditions (suspected heart or liver disease, high blood pressure, blood clots in deep veins of legs or lungs, stroke, breast cancer, or damage to arteries, vision, kidneys, or nervous system caused by diabetes). See Signs and Symptoms of Serious Health Conditions, p. 320. Do not give the next injection. y Give her a backup method to use until the condition is evaluated. y Refer for diagnosis and care if not already under care. y Suspected pregnancy Assess for pregnancy. y Stop injections if pregnancy is confirmed. y There are no known risks to a fetus conceived while a woman is using y injectables (see Question 3, p. 98). Starting treatment with lamotrigine or ritonavir Combined hormonal methods, including monthly injectables, can make y lamotrigine less e

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