Mechanism of Action: How do levonorgestrel-only emergency contraceptive pills (LNG ECPs) prevent pregnancy?

This document was co-developed with the International Federation of Gynecology & Obstetrics (FIGO)

Levonorgestrel-only emergency contraceptive pills:

  • Interfere with the process of ovulation;
  • May possibly prevent the sperm and the egg from meeting.

The evidence shows that LNG ECPs:

Impair ovulation:

  • A number of studies provide strong direct evidence that LNG ECPs prevent or delay ovulation. If taken before ovulation, LNG ECPs inhibit the pre-ovulatory luteinizing hormone (LH) surge, impeding follicular development and maturation and/or the release of the egg itself.1,2,3,4,5,6,7,8 This is the primary mechanism of action for LNG ECPs.

Do not inhibit implantation:

  • Two studies have estimated effectiveness of LNG ECPs by confirming the cycle day by hormonal analysis (other studies used women’s self-reported cycle date). In these studies, no pregnancies occurred in the women who took ECPs before ovulation, while pregnancies occurred only in women who took ECPs on or after the day of ovulation, providing evidence that ECPs were unable to prevent implantation.9,10
  • A number of studies have evaluated whether ECPs produce changes in the histological and biochemical characteristics of the endometrium. Most studies show that LNG ECPs have no such effect on the endometrium, indicating that they have no mechanism to prevent implantation.1,2,11,12,13 One of these studies found that following administration of double the standard dose of LNG, there are only minor or no alterations in endometrial receptivity.12 One study found a single altered endometrial parameter only when LNG was administered prior to the LH surge, at a time when ECPs inhibit ovulation.14
  • One study showed that levonorgestrel did not prevent the attachment of human embryos to a simulated (in vitro) endometrial environment.15
  • Animal studies demonstrated that LNG ECPs did not prevent implantation of the fertilized egg in the endometrium.16,17

May affect sperm:

  • Contradictory results exist regarding whether LNG taken post-coitally and in doses used for EC affects sperm function.
  • Early studies suggested that LNG ECPs interfere with sperm motility by thickening cervical mucus.18,19 However, two in vitro studies found that LNG in doses used for EC has no direct effect on sperm function.20,21 Recent in vivo studies found no effect of LNG on the number of viable sperm found in the female genital tract 24-28 hours after taking LNG.22 Interference in sperm migration is also a possible explanation in women who took LNG ECP before ovulation, but had documented follicle rupture in the following 5 days, yet did not get pregnant.9
  • New evidence about the interaction between sperm and progesterone suggests a possible deleterious effect of high concentrations of the progestin LNG on sperm function, that may cause sperm to be hyperactive in the absence of an egg or interfere with directionality of the sperm movement.23,24,25,26,27
  • Given these results, this mechanism of action is still uncertain and warrants further studies.

Do not have an effect on pregnancy:

  • Two studies of women who became pregnant in cycles when they took LNG ECPs found no difference between pregnancy outcomes of women who had taken LNG ECPs and those who had not. Variables included miscarriage, birth weight, malformations, and sex ratio, indicating that LNG ECPs have no effect on an established pregnancy even at very early stages.28,29

Other facts:

  • Emergency contraception is not the same as early medical abortion. LNG ECPs are effective only in the first few days following intercourse before the ovum is released from the ovary and before the sperm fertilizes the ovum. Medical abortion is an option for women in the early stage of an established pregnancy, but requires a different drug from levonorgestrel.
  • LNG ECPs cannot interrupt an established pregnancy or harm a developing embryo.

Implications of the research:

  • Inhibition or delay of ovulation is LNG ECPs principal and possibly only mechanism of action.
  • Review of the evidence suggests that LNG ECPs cannot prevent implantation of a fertilized egg. Language on implantation should not be included in LNG ECP product labeling.
  • The fact that LNG ECPs have no demonstrated effect on implantation explains why they are not 100% effective in preventing pregnancy, and are less effective the later they are taken. Women should be given a clear message that LNG ECPs are more effective the sooner they are taken.
  • LNG ECPs do not interrupt a pregnancy (by any definition of the beginning of pregnancy). However, LNG ECPs can prevent abortions by reducing unwanted pregnancies.

References

1 Marions L, Hultenby K, Lindell I, Sun X, Stabi B, Gemzell-Danielsson K. Emergency contraception with mifepristone and levonorgestrel: mechanism of action. Obstetrics and Gynecology 2002; 100(1): 65-71.

2 Durand M, del Carmen Cravioto M, Raymond EG, Duran-Sanchez O, De la Luz Cruz-Hinojosa M, Castell-Rodriguez A, Schiavon R, Larrea F. On the mechanisms of action of short-term levonorgestrel administration in emergency contraception. Contraception 2001; 64(4): 227-234.

3 Hapangama D, Glasier AF, Baird DT. The effects of peri-ovulatory administration of levonorgestrel on the menstrual cycle. Contraception 2001; 63(3): 123-129.

4 Marions L, Cekan SZ, Bygdeman M, Gemzell-Danielsson K. Effect of emergency contraception with levonorgestrel or mifepristone on ovarian function. Contraception 2004; 69(5): 373-377.

5 Croxatto HB, Brache V, Pavez M, Cochon L, Forcelledo ML, Alvarez F, Massai R, Faundes A, Salvatierra AM. Pituitary-ovarian function following the standard levonorgestrel emergency contraceptive dose or a single 0.75 mg dose given on the days preceding ovulation. Contraception 2004; 70(6): 442-450.

6 Okewole IA, Arowojolu AO, Odusoga OL, Oloyede OA, Adeleye OA, Salu J, Dada OA. Effect of single administration of levonorgestrel on the menstrual cycle. Contraception 2007; 75(5): 372-377.

7 Croxatto HB, Devoto L, Durand M, Ezcurra E, Larrea F, Nagle C, Ortiz ME, Vantman D, Vega M, von Hertzen H. Mechanism of action of hormonal preparations used for emergency contraception: a review of the literature. Contraception 2001; 63(3): 111-121.

8 Massai MR, Forcelledo ML, Brache V, Tejada AS, Salvatierra AM, Reyes MV, Alvarez F, Faundes A, Croxatto HB. Does meloxicam increase the incidence of anovulation induced by single administration of levonorgestrel in emergency contraception? A pilot study. Human Reproduction 2007; 22: 434-9.

9 Noe G, Croxatto H, Salvatierra AM, Reyes V, Villarroel C, Munoz C, Morales G, Retamales A. Contraceptive efficacy of emergency contraception with levonorgestrel given before or after ovulation. Contraception 2011; 84 486-492.

10 Novikova N, Weisberg E, Stanczyk FZ, Croxatto HB, Fraser IS. Effectiveness of levonorgestrel emergency contraception given before or after ovulation – a pilot study. Contraception 2007; 75(2): 112-118.

11 Meng CX, Andersson K, Bentin-Ley U, Gemzell-Danielsson K, Lalitkumar PG. Effect of levonorgestrel and mifepristone on endometrial receptivity markers in a three-dimensional human endometrial cell culture model. Fertility and Sterility 2009; 91(1): 256-64.

12 Meng CX, Marions L, Bystrom B, Gemzell-Danielsson K. Effects of oral and vaginal administration of levonorgestrel emergency contraception on markers of endometrial receptivity. Human Reproduction 2010; 25(4): 874-883.

13 Palomino W, Kohen P, Devoto L. A single midcycle dose of levonorgestrel similar to emergency contraceptive does not alter the expression of the L-selectin ligand or molecular markers of endometrial receptivity. Fertility and Sterility 2010; 94(5): 1589-1594.

14 Durand M, Seppala M, Cravioto M del C, Koistinen H, Koistinen R, Gonzalez-Macedo J, Larrea F. Late follicular phase administration of levonorgestrel as an emergency contraceptive changes the secretory pattern of glycodelin in serum and endometrium during the luteal phase of the menstrual cycle. Contraception 2005; 71(6): 451-457.

15 Lalitkumar PG, Lalitkumar S, Meng CX, Stavreus-Evers A, Hambiliki F, Bentin-Ley U, Gemzell-Danielsson K. Mifepristone, but not levonorgestrel, inhibits human blastocyst attachment to an in vitro endometrial three-dimensional cell culture model. Human Reproduction 2007; 22(11): 3031-3037.

16 Müller AL, Llados CM, Croxatto HB. Postcoital treatment with levonorgestrel does not disrupt postfertilization events in the rat. Contraception 2003; 67(5): 415-419.

17 Ortiz ME, Ortiz RE, Fuentes A, Parraguez VH, Croxatto HB. Post-coital administration of levonorgestrel does not interfere with post-fertilization events in the new world monkey Cebus apella. Human Reproduction 2004; 19(6): 1352-1356.

18 Kesseru E, Camacho-Ortega P, Laudahn G, Schopflin G. In vitro action of progestogens on sperm migration in human cervical mucus. Fertility and Sterility 1975; 26(1): 57-61.

19 Kesseru E, Garmendia F, Westphal N, Parada J. The hormonal and peripheral effects of d-norgestrel in postcoital contraception. Contraception 1974; 10(4): 411-24.

20 Brito KS, Bahamondes L, Nascimento JA, de Santis L, Munuce MJ. The in vitro effect of emergency contraception doses of levonorgestrel on the acrosome reaction of human spermatozoa. Contraception 2005; 72(3): 225-8.

21 Yeung WS, Chiu PC, Wang CH, Yao YQ, Ho PC. The effects of levonorgestrel on various sperm functions. Contraception 2002; 66(6): 453-7.

22 Do Nascimento JA, Seppalla M, Perdigao A, Espejo-Arce X, Munuce MJ, Hautala L, Koistinen R, Andrade L, Bahamondes L. In vivo assessment of the human sperm acrosome reaction and the expression of glycodeling-A in human endometrium after levonorgestrel-emergency contraceptive pill administration. Human Reproduction 2007; 22(8): 2190-5.

23 Holt WV and Fazeli A. The oviduct as a complex mediator of mammalian sperm function and selection. Molecular Reproduction & Development 2010; 77: 934-43.

24 Kolle S, Reese S, Kummer W. New aspects of gamete transport, fertilization, and embryonic development in the oviduct gained by means of live cell imaging. Thermiogenology 2010; 73: 786-95.

25 Strunker T, Goodwin N, Brenker C, Kashikar ND, Weyand I, Seifert R, Kaupp UB. The CatSper channel mediates progesterone-induced Ca2+ influx in human sperm. Nature 2011; 471: 382-6.

26 Lishko PV, Botchkina IL, Kirichok Y. Progesterone activates the principal Ca2+ channel of human sperm. Nature 2011; 471: 387-91.

27 Teves ME, Guidobaldi HA, Unates DR, Sanchez R, Miska W, Publicover SJ, Morales Garcia AA, Giojalas LC. Molecular mechanism for human sperm chemotaxi mediated by progesterone. PlosOne 2009; 4 (12): e8211; 1-11.

28 Zhang L, Chen J, Wang Y, Fangming R, Yu W, Cheng L. Pregnancy outcome after levonorgestrel-only emergency contraception failure: a prospective cohort study. Human Reproduction 2009; 24(7): 1605-1611.

29 De Santis M, Cavaliere AF, Straface G, Carducci F, Caruso A. Failure of the emergency contraceptive levonorgestrel and the risk of adverse effects in pregnancy and on fetal development: an observational cohort study. Fertility and Sterility 2005; 84(2): 296-299.

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Emergency Contraception for Crisis Settings: Key Resources

This document highlights resources – including websites, technical guidelines, and articles – that provide information on the provision of EC in crisis-settings, including for refugee and internally displaced persons (IDP) populations.

Contents:

I. Websites
II. Fact Sheets & Policy Statements
III. Tools & Guidelines
IV. Journal Articles
V. Country Program Reports

I. Websites

1. Women’s Refugee Commission http://womensrefugeecommission.org/

The Women’s Refugee Commission advocates for laws, policies and programs to improve the lives and protect the rights of refugee and internally displaced women, children and young people, including those seeking asylum—bringing about lasting, measurable change.

Tools and Guidelines that have information about EC can be found on their website: http://womensrefugeecommission.org/programs/gender-based-violence

See the documents below for further details:

NOTE: Their website also contains several individual country baseline studies on family planning in refugee settings, including South Sudan, Burmese refugees in Malaysia, and Somali refugees in Djibouti.

2. Reproductive Health Response in Crisis (RHRC) Consortium http://www.rhrc.org/

The RHRC Consortium is dedicated to the promotion of reproductive health for all persons affected by humanitarian crises. The RHRC Consortium promotes sustained access to comprehensive, high quality RH programs in emergencies and advocates for policies that support RH of persons affected by armed conflict. Member agencies include: American Refugee Committee, CARE, Heilbrunn Department of Population and Family Health at Columbia University‘s Mailman School of Public Health, International Rescue Committee, JSI Research & Training Institute, Marie Stopes International, and Women‘s Refugee Commission.

There is a section of their website dedicated to Statistics and Key Messages on EC, including:

  • Key Messages: http://www.rhrc.org/rhr_basics/eckeymessages.html
  • Overview: http://www.rhrc.org/rhr_basics/ecoverview.html
  • Facts & Statistics: http://www.rhrc.org/rhr_basics/ecfacts.html
  • Stories from the Field: http://www.rhrc.org/rhr_basics/eccasestudies.html

Their website also provides a list of guidelines and tools that were developed by other organizations: http://www.rhrc.org/resources/index.cfm?type=guidelines; many of these resources can also be found on the WRC website.

3. Reproductive Health Access, Information and Services in Emergencies (RAISE) http://www.raiseinitiative.org/home/

Developed by Columbia University’s Heilbrunn Department of Population and Family Health in the Mailman School of Public Health and Marie Stopes International (MSI), the RAISE Initiative aims to address the full range of RH needs for refugees and internally displaced persons (IDPs) by building partnerships with humanitarian and development agencies, governments, United Nations (UN) bodies, advocacy agencies and academic institutions. The website gives a description of each of their country projects, has a library database of related material, and compiles relevant publications and resources for advocacy.

4. Sexual Violence Research Initiative (SVRI) http://www.svri.org/

SVRI is a global research initiative that aims to promote priority driven, good quality research in the area of sexual violence, particularly in developing countries. It consists of a network of researchers, policy makers, activists, and donors that believe that prevention and service provision must be informed by sound research and evidence.

One of the sections of the website compiles research on sexual violence in conflict settings. It includes recent news items, Research Reports, Academic Journal Articles, and Links to relevant documents. http://www.svri.org/our-priorities/conflict-and-postconflict/responses-0?link-section=reports

5. What Works for Women & Girls, Addressing Violence Against Women http://www.whatworksforwomen.org/chapters/21/sections/59/evidence

This website provides strategies and evidence on a full range of gender-sensitive programming for women and girls.

II. Fact Sheets & Policy Statements

  • There are several two-page fact sheets on Reproductive Health in Displaced Settings on the RHRC Consortium website. http://www.rhrc.org/rhr_basics/factsheet.html
    • Title: RAISE Fact Sheet: Family Planning
      Location: https://www.mailman.columbia.edu/sites/default/files/pdf/fs_familyplan.pdf
      Developed by: RAISE Initiative
      Year: N/A
      Purpose: Explaining the issues within a context of crisis settings
      Target audience: Humanitarian agencies, donors, general population
      Additional information: Under the ‘Priorities for Action’ section, EC is listed as a necessary intervention in emergencies
    • Title: RAISE Fact Sheet: Gender-Based Violence
      Location: https://www.mailman.columbia.edu/sites/default/files/pdf/fs_gbv_uk.pdf
      Developed by: RAISE Initiative
      Year: N/A
      Purpose: Explaining the issue within a context of crisis settings
      Target audience: Humanitarian agencies, donors, general population
      Additional information: Under the ‘Priorities for Action’ section, EC to prevent pregnancy is included as appropriate care for GBV survivors
  • Title: Minimum Initial Service Package (MISP) for Reproductive Health
    Location: http://iawg.net/wp-content/uploads/2015/09/MISP-cheat-sheet-rev.04-2010.pdf
    Developed by: Women‘s Refugee Commission
    Year: 2006
    Purpose: A short 2-page “MISP Cheat Sheet” which summarizes the objectives on the first page and gives a basic overview of the subject areas. It also gives information on the reproductive health kits available from UNFPA for organizations providing services in crisis settings; these kits contain essential supplies and equipment.There is information on how to order the kits, and other resources.
    Target audience: Humanitarian actors
    Additional information: The Minimum Initial Service Package (MISP) for Reproductive Health is a priority set of life-saving activities to be implemented at the onset of every humanitarian crisis. It forms the starting point for sexual and reproductive health programming and should be sustained and built upon with comprehensive sexual and reproductive health services throughout protracted crises and recovery. This is taken directly from a fact sheet on the WRC website titled “What is the MISP and why is it important?” (2009). Supplies and equipment needed for providing reproductive health services for refugee and war-affected persons are available from UNFPA

 

  • Title: Governments Worldwide Put Emergency Contraception into Women‘s Hands: A GLOBAL REVIEW OF LAWS AND POLICIES
    Location: http://reproductiverights.org/sites/crr.civicactions.net/files/documents/pub_bp_govtswwec_0.pdf
    Developed by: Center for Reproductive Rights
    Year: 2004
    Purpose: The briefing paper examines government initiatives worldwide aimed at making EC more accessible (registering EC products, making EC available over the counter, and ensuring that EC is available to women at greatest risk of unwanted pregnancy, including rape survivors and adolescents).
    Target audience: general population, law/policy makers, governments
    Additional information: In Section C of the document (Governments Should Make Emergency Contraception Provision a Standard Component of Care for Rape Survivors), there is a paragraph which outlines the policies that focus on EC provision for refugees, citing the UNHCR document Clinical Management of Survivors of Rape: A Guide to the Development of Protocols for Use in Refugee and Internally Displaced Person Situations (included below in Tools & Guidelines section). It also references the UNHCR‘s Sexual and Gender-Based Violence against Refugees, Returnees and Internally Displaced Persons: Guidelines for Prevention (included below in Tools & Guidelines section). All of these documents include providing EC pills for care following rape. Additionally, the document mentions that UNFPA provides EC in emergency reproductive health kits given to refugees and women who are rape victims in camps

  • Title: A Statement on Family Planning for Women and Girls as a Life-saving Intervention in Humanitarian Settings
    Location: http://iawg.net/wp-content/uploads/2016/08/IAWG_-FP-Statement_Final.pdf
    Developed by: Inter-Agency Working Group
    Year: 2010
    Purpose: This 4-page document outlines why family planning in humanitarian settings is important. It explains how family planning is part of an individual‘s reproductive rights, how it contributes to achieving the Millennium Development Goals, how it contributes to early recovery, post-crisis development, and economic stability. Gives recommendations on the action that should be taken by governments, donors, and implementing agencies (humanitarian & government).
    Target audience: Governments, donors, implementing agencies
    Additional information: EC is highlighted in the context of how important it is to “make contraceptive methods, such as condoms, pills, injectables, emergency contraceptive pills and intrauterine devices (IUDs) available to meet demand.” EC is also mentioned in the context of having comprehensive contraceptive services available in order to meet the demand in a humanitarian setting. It is also mentioned in the section as necessary for preventing unwanted or unintended pregnancy and unsafe abortion.

III. Tools & Guidelines

** The first document is the most comprehensive resource on EC in crisis situations. The rest of the tools are listed in chronological order, with the most recent first.

  • Title: Emergency Contraception for Conflict-Affected Settings: A Reproductive Health Response in Conflict Consortium – Distance Learning Module
    Location: http://iawg.net/wp-content/uploads/2016/08/8D85E33AB589277AC1256FF00039AAAC-WCRWC_may_2004.pdf
    Developed by: Women‘s Refugee Commission, on behalf of the RHRC Consortium
    Year: 2004
    Purpose: To meet the need for increased awareness and knowledge about EC among health service providers working with refugee and internally displaced populations
    Target audience: Providers working in conflict-affected situations, including family planning staff, community health workers, health educators, counselors, trainers, program managers, nurses, doctors, midwives, other health personnel working in conflict affected settings. It can also be used by protection officers, NGO and government authorities, and humanitarian partners.
    Additional information: The module outlines several important objectives: to define EC, explain how the method works, explain the distinction between EC and abortion, list reasons why displaced women and girls of reproductive age may need EC, describe appropriate use, list possible side effects, list precautions and considerations, describe the role of counseling around issue of family planning, GBV, and STIs/HIV, and knowledge of where to access other EC resources. Chapter 4 (pg.16) is all about EC service delivery in conflict affected settings. This includes providing the right information in advocacy efforts and having effective outreach, the screening protocol, information about counseling, where to order EC supplies, and instructions on follow-up care. It also includes sections on frequently asked questions, EC service delivery scenarios and a pots-test. The updated 2008 distance learning module is available in English and French.
  • Title: Inter-Agency Reproductive Health Kits for Crisis Situations
    Location: http://www.unfpa.org/sites/default/files/resource-pdf/RH%20kits%20manual_EN_0.pdf
    Developed by: Inter-Agency Working Group (IAWG) on Reproductive Health in Refugee Situations
    Year: 2011, 5th edition
    Purpose: Comprehensive guide on the essential drugs, equipment and supplies to implement the MISP that have been assembled into a set of specially designed prepackaged kits (the Inter-Agency Reproductive Health Kits) The kits complement the objectives laid out in Reproductive Health in Humanitarian Settings: An Inter-agency Field Manual. These kits are intended to speed up the provision of appropriate reproductive health services in emergency and refugee situations
    Target audience: Humanitarian agencies.
    Additional information: As this is a document that is constantly being modified/improved, there have been major changes since the 4th addition. Two kits have been combined to form Kit 3: Post rape treatment, which gives all survivors a comprehensive package of post-rape care, including STI presumptive treatment, emergency contraception and PEP for HIV prevention, when appropriate. Pg 17 of the document lists the contents of Kit 3. Includes both 55 packets of Levonorgestrel tablets, and EC patient information leaflets. Kit 4: Oral and Injectable Contraception, also contains EC (around 60 packets of Levonorgestrel tablets) for women who may require it.

  • Title: Reproductive Health in Humanitarian Settings: An Inter-agency Field Manual
    Location: http://www.who.int/reproductivehealth/publications/emergencies/field_manual_rh_humanitarian_settings.pdf?ua=1
    Developed by: Inter-Agency Working Group on Reproductive Health in Crisis
    Year: 2010
    Purpose: Updated from the original 1996 version provides guidance on reproductive health interventions in humanitarian settings. Includes information on implementing the Minimum Initial Service Package, new guidance on HIV programming, additional chapters on post-abortion care, emphasis on M&E and adolescent reproductive health, and human rights/legal considerations integrated in each of the chapters. Based on technical guidance of the WHO, and reflects the best practices documented in crisis setting around the world.
    Target audience: Reproductive Health Officers and Reproductive Health Program Managers in humanitarian settings. Also can guide Reproductive Health service providers, community service officers, protection officers
    Additional information: Information on EC is included in the following chapters: Chapter 2- Minimum Initial Service Package, Chapter 5- Family Planning, Chapter 8- Gender-based Violence:

  • Chapter 2: One of the main objectives of the MISP is to prevent and manage the consequence of sexual violence. This involves making clinical care available for survivors of rape (pgs. 25-29).
  • Chapter 5: Outlines the various contraceptive methods available for family planning, including EC (pgs. 116-117).
  • Chapter 8: References for clinical management of survivors of GBV
  • Title: IEC Materials for Communities
    Location: http://www.rhrc.org/iec/f.html
    Developed by: Women‘s Refugee Commission
    Purpose: “Universal” and adaptable information, education, communication materials on when to take emergency contraception.
    Target audience: Community members
    Additional information: Universal and adaptable IEC templates are also available for survivors of sexual assault. The templates are available for health program staff to inform communities on the benefits of seeking care and where to access services.
  • Title: Post-Rape Care Checklist for Women, Men and Children
    Location: http://www.iawg.net/resources/jobaids.html#postrape
    Developed by: PATH and UNFPA
    Year: 2010
    Purpose: Job aid to improve the correct use of reproductive health technologies in crisis settings. These job aids will be included in the Interagency Reproductive Health Kits for Emergency Situations by the end of 2010. Health workers who use these kits reported that certain technologies are underutilized because health workers do not know how to use them properly or community members are unaware of their importance. The job aids aim to provide clear and simple guidance on how to provide post-rape care for adults and children.
    Target/Audience: Health care providers
    Additional information: The job aids are provided ready to print and use with English text, or with the relevant spaces left blank for you to add the appropriate text in your own or the local language(s) (note: while it may be helpful to provide multiple language versions of the job aids, it is not advise that you include several languages on a single copy of the posters)
  • Title: Caring for Survivors of Sexual Violence in Emergencies Training Pack
    Location: The training guide and manuals are located on the RHRC website. http://www.rhrc.org/resources/index.cfm?sector=gbv#209
    Developed by: Inter-Agency Standing Committee, Gender-based Violence Area of Responsibility Working Group
    Year: 2010
    Purpose: Provides information and skill development in various aspects related to communication and engagement with sexual violence survivors in conflict-affected countries or complex emergencies.
    Target audience: Is designed for professional health care providers such as physicians, health workers as well as for members of the legal profession, police, women’s groups and other concerned community members, such as community workers, teachers and religious workers. Some of the participants in this training will directly serve adults and children who have been raped. They will offer medical or psychosocial support, help survivors to seek justice or ensure their protection. Other participants will help bring together support groups or receive disclosures of sexual violence in their communities
    Additional information: The document is focused on medical treatment, mentions reviewing national treatment protocols for EC provision (there is also a psychosocial module). The facilitator manual, participant manual, powerpoints, and additional handouts can all be found on the RHRC Consortium website.
  • Title: Handbook for Coordinating Gender-based violence interventions in Humanitarian Settings
    Location: https://www.unicef.org/protection/files/GBV_Handbook_Long_Version.pdf
    Developed by: Family Health International, RHRC Consortium, IRC
    Year: 2010
    Purpose: The manual covers the basics of GBV, engagement strategies for working with GBV survivors, service provider responsibilities, community referrals, methods to support service providers, and the evaluation process
    Target audience: For service providers attending to gender-based-violence (GBV) survivors
    Additional information: On pg 191. Beginning of the section, Health Sector: GBV Key Actions – provision of EC is under the section “Provide compassionate and confidential treatment.” It is also listed on the Checklist of Supplies.
  • Title: Report of the FIGO Working Group on Sexual Violence/HIV: Guidelines for the management of female survivors of sexual assault
    Location: Is a journal article in the International Journal of Gynecology and Obstetrics, 109: 85-92.
    Developed by: Ruxana J, et al. FIGO Working Group
    Year: 2010
    Purpose/target audience: For health care professionals. To review the evidence and provide guidelines on the management of sexual violence against women, specifically, rape. Outcomes evaluated include effectiveness of post-rape care provision.
    Additional information: EC is mentioned in the recommendations section.
  • Title: Adolescent Sexual and Reproductive Health Toolkit for Humanitarian Settings
    Location: http://www.unfpa.org/public/publications/pid/4169
    Developed by: UNFPA and Save the Children
    Year: 2009
    Purpose/target audience: This document is a companion to the Inter-Agency Field Manual on Reproductive Health in Humanitarian Settings
    Additional information: Adolescents that are living in crisis situations fall into a “high- risk” subgroup (especially girls). On pg. 30, under the section: Adolescent-friendly services, the clinical care for sexual assault survivors should be based on WHO/UNHCR Clinical Management of Rape Survivors guidelines—EC is included in these. On pg 39, there is a section that describes the MISP: Adolescents and Family Planning Fact Sheet, which includes very general background information about Emergency Contraception.
  • Title: SPRINT Facilitator‘s Manual
    Location: https://www.k4health.org/toolkits/rh-humanitarian-settings/sprint-facilitators-manual
    Developed by: The Sexual and Reproductive Health Programme in Crisis and Post- Crisis Situations in East, Southeast Asia and the Pacific (SPRINT)
    Year: 2009
    Purpose: A facilitator’s manual on priority sexual and reproductive health (SHR) services in humanitarian emergencies, including prevention and response to sexual violence
    Target audience: It can be used by persons from agencies, organizations or governments who provide training on SRH in crises and emergencies and who are familiar with the concepts.
    Additional information: Part 1 Is a training manual for implementing MISP, which includes EC provision. Also provides information on the clinical care of victims who are children (EC important even for pre-pubertal girls) Part 2 is about the general family planning response in an emergency, and also mentions EC use.
  • Title: Clinical Care for Sexual Assault Survivors: Facilitator‘s Guide. A multi-media training tool
    Location: http://iawg.net/wp-content/uploads/2015/04/facguide.pdf
    Developed by: International Rescue Committee, University of California-Los Angeles
    Year: 2008
    Purpose: To improve clinical care for and general treatment of sexual assault survivors by providing medical instruction and encouraging competent, compassionate, confidential care. This material comes with a DVD, so not very helpful without the audio/video, mostly facilitator notes
    Target audience: Intended for clinical care providers and non-clinician health facility staff (meant to be delivered in a group setting with facilitators guiding the discussion)
    Additional information: Section 3d: Treatment and Disease Prevention, describes the correct provision of EC.

  • Title: Handbook for the Protection of Women and Girls
    Location: http://www.unhcr.org/en-us/protection/women/47cfa9fe2/unhcr-handbook-protection-women-girls-first-edition-complete-publication.html
    Developed by: UNHCR
    Year: 2008
    Purpose: Designed to promote gender equality by using a rights- and community-based approach, by mainstreaming age, gender and diversity, and through targeted actions to empower women and girls in the civil, political and economic sectors. The handbook is tool that “describes the protection challenges faced by refugee women and ways of resolving them.”
    Target audience: Handbook for UNHCR staff and partner organizations in the field
    Additional information: Sections to focus on: 5.3.1 (pg.199) Sexual and gender based violence (SGBV), specifically Responding to and preventing SGBV, and Section 5.5 Health (pg.267), specifically Reproductive Health. Does not specifically mention EC, but provides several other resources.
  • Title: Reproductive Health Assessment Toolkit for Conflict-Affected Women
    Location: https://www.unscn.org/web/archives_resources/files/ToolkitforConflictAffectedWomen.pdf
    Developed by: CDC
    Year: 2007
    Purpose: Assessing RH needs of a population requires gathering information and technical knowledge about how to conduct a survey. The Toolkit includes sampling instructions, training manual, questionnaire, data entry program, analysis guide, and suggestions for data use. It allows field staff to collect data to inform program planning, monitoring, evaluation, and advocacy. Information can be gathered about safe motherhood, family planning, sexual history, STIs, HIV/AIDS, GBV, and female genital cutting.
    Target audience: Intended for organizations such as government, non-governmental, and United Nations agencies that provide or are interested in providing reproductive health services to conflict-affected women. Field staff who use this Toolkit should be familiar with survey work, but it is designed to be used by staff with limited survey skills.
    Additional information: The questionnaire and assessment tools have been updated in 2011. The Family Planning Section refers to EC in the questions pertaining to “Awareness, Ever Use, and Problems with Family Planning.”

  • Title: Gender Handbook in Humanitarian Action
    Location: http://www.who.int/hac/network/interagency/news/gender_handbook_draft/en/
    Developed by: Inter-Agency Standing Committee
    Year: 2006
    Purpose: To improve gender equality programming in humanitarian action
    Target audience: Field practitioners responding to humanitarian emergencies, also to assist donors in holding humanitarian actors accountable for integrating gender perspectives and promoting equality
    Additional information: Pg. 77 “Gender and Health in Emergencies” Under the section on ‘Provision of health services,’ includes guidelines on using the MISP, and the distribution of emergency health kits that include EC.

  • Title: Inter-agency Standing Committee Guidelines for Gender-Based Violence Interventions in Humanitarian Settings Focusing on Prevention of and Response to Sexual Violence in Emergencies
    Location: http://www.unhcr.org/453492294.pdf
    Developed by: Various collaborators from the Inter-agency Standing Committee
    Year: 2005
    Purpose: To enable humanitarian actors and communities to plan, establish, and coordinate a set of minimum multisectoral interventions to prevent and respond to sexual violence during the early phase of an emergency.
    Target audience: Designed for humanitarian organizations, including UN agencies, NGOs, community based organizations, and gov‘t authorities working in emergency settings
    Additional information: Pg 67. (Action Sheet 8.2) This section gives information on providing sexual related health services. Provision of EC is recommended in the treatment bullet point under Key Action. EC is also listed in the checklist of supplies on pg. 68.
  • Title: Clinical Management of Rape Survivors: Developing Protocols for use with Refugees and Internally Displaced Persons
    Location: http://apps.who.int/iris/bitstream/10665/43117/1/924159263X.pdf
    Developed by: WHO, UNHCR
    Year: 2004
    Purpose/target audience: Provides guidance to health care providers for medical management after rape of women, men, and children. Designed to assist qualified health care providers (medical co-ordinators, medical doctors, clinical officers, midwives, and nurses) to develop protocols for the management of rape survivors, based on available resources, materials, drugs, and national policies and procedures. Managers and trainers of health care services can also benefit, as they may use the guide to plan for survivor care and train health care providers accordingly
    Additional information: EC is mentioned throughout the clinical management steps (Step 1: Making preparation to offer medical care to rape survivors, Step 6: Prescribing treatment, etc.) Also, Annex 11 is the ‘Protocols for Emergency Contraception.’
  • Title: Sexual and gender-based violence against refugees, returnees and internally displaced persons: guidelines for prevention and response
    Location: Sexual and Gender-Based Violence against Refugees, Returnees and Internally Displaced Persons
    Developed by: UNHCR
    Year: 2003
    Purpose: These Guidelines offer practical advice on how to design strategies and carry out activities aimed at preventing and responding to sexual and gender-based violence. They also contain information on basic health, legal, security and human rights issues relevant to those strategies and activities.
    Target audience: Intended for use by UNHCR staff and members of operational partners involved in protection and assistance activities for refugees and the internally displaced. They have been tested in 32 countries around the world with the participation of more than 60 partners.
    Additional information: Appendix 4 is a Medical History and Examination Form, which includes EC in the treatments section.

IV. Journal Articles

There is a library on the Reproductive Health Access, Information and Services in Emergencies (RAISE) website where related manuals, reports, articles, book chapters, and conference material can be accessed.

  • Casey, SE. et al. (2011). Care-seeking behavior by survivors of sexual assault in the Democratic Republic of the Congo. American Journal of Public Health, 101 (6): 1054- 1055.
    In February 2008, trained female interviewers collected data on sexual violence and use of medical services following sexual assault from 607 women in the Democratic Republic of the Congo (DRC). Exposure to sexual violence during the DRC’s civil war was reported by 17.8% of the women; 4.8% of the women reported exposure to sexual violence after the war. Few sexual-assault survivors accessed timely medical care. Facility assessments showed that this care was rarely available. Clinical care for sexual-assault survivors must be integrated into primary health care for DRC women.
  • McGinn, T. (2009). Barriers to reproductive health and access to other medical services in situations of conflict and migration. Women, Migration, and Conflict. 129-143. (Book Chapter)
    People living in situations of conflict and forced migration do not receive the healthcare they need and want, and to which they have a right. There are many factors contributing to this lack of adequate care. The purpose of this paper is to examine these factors, using reproductive health care as the lens through which barriers to providing and using health care are reviewed.
  • Austin, J. Guy, S. Lee-Jones, L. McGinn, T. Schlechte, J. (2008). Reproductive health: a right for refugees and internally displaced persons. Reproductive Health Matters, 16 (31): 10-21.
    NOTE: While it contains no specific references to EC, this article provides an overview of the 5-year RAISE Initiative that brought together UN agencies and NGOs in the development and relief fields to work together on reproductive health provision in crises. Based on the experiences of these groups, priorities for reproductive health in crises have been identified and there have been collaborative efforts to ensure service delivery, plan advocacy campaigns, and invest in clinical training and research. It has also been a priority to make sure that reproductive health is not excluded from the current “cluster” approach, which aims to enhance coordination and collaboration among humanitarian actors in the field. It also includes sections on family planning, maternal health and STI/HIV-related needs of refugees and IDPs, gender-based violence, special needs of adolescents and remaining gaps.
  • Roberts B, Guy S, Sondorp E, et al. (2008). A basic package of health services in post- conflict countries – implications for reproductive health. Reproductive Health Matters, 16 (31): 57-64.
    The article gives an overview of the health service infrastructure in post-conflict countries, centering on the challenges faced by providing quality reproductive health. The approach outlined here is the joint effort by the country government and international donors to contract NGOs to provide a Basic Package of Health Services (BPHS) for the country‘s population, with an aim to scale-up these services quickly. While this package provides a significant increase in the sexual and reproductive health services offered in these regions (for example, Afghanistan and South Sudan), there is still a major lack in services addressing sexual and gender-based violence. Evidence shows the high rates of this type of violence during and after conflict, yet it is not sufficiently addressed.
  • Chynoweth, SK. (2008). The need for priority reproductive health services for displaced Iraqi women and girls. Reproductive Health Matters, 16 (31): 93-102.
    Disregarding reproductive health in situations of conflict or natural disaster has serious consequences, particularly for women and girls affected by the emergency. In an effort to protect the health and save the lives of women and girls in crises, international standards for five priority reproductive health activities that must be implemented at the onset of an emergency have been established for humanitarian actors: humanitarian coordination, prevention of and response to sexual violence, minimisation of HIV transmission, reduction of maternal and neonatal death and disability, and planning for comprehensive reproductive health services. The extent of implementation of these essential activities is explored in this paper in the context of refugees in Jordan fleeing the war in Iraq. Significant gaps in each area exist, particularly coordination and prevention of sexual violence and care for survivors. Recommendations for those responding to this crisis include designating a focal point to coordinate implementation of priority reproductive health services, preventing sexual exploitation and providing clinical care for survivors of sexual violence, providing emergency obstetric care for all refugees, including a 24-hour referral system, ensuring adherence to standards to prevent HIV transmission, making condoms free and available, and planning for comprehensive reproductive health services.
  • N. Howard et al. Reproductive health services for refugees by refugees in Guinea I: family planning (2008). Conflict and Health http://www.biomedcentral.com/content/pdf/1752-1505-2-12.pdf
    Comprehensive studies of family planning (FP) in refugee camps are relatively uncommon. This paper examines gender and age differences in family planning knowledge, attitudes, and practices among Sierra Leonean and Liberian refugees living in Guinea
  • Jewkes R. (2007). Comprehensive response to rape needed in conflict settings. Lancet, 369 (9580): 2140-41.
    An article in the Lancet found that there is insufficient data to support the argument that conflict/forced displacement increases HIV prevalence. The findings emphasize that post-rape services need to be integrated in the comprehensive sexual and reproductive health-care services, rather than overly focusing on prevention of HIV infection. Post-rape care is not ideal in refugee settings, and needs to be responsive to the survivors‘ needs (prevention/termination of pregnancy, treatment for STIs, psychological support, treatment for injuries including reconstructive surgery)
  • Morrison, V. (2000). Contraceptive need among Cambodian refugees in Khao Phlu camp. International Family Planning Perspectives, 26 (4): 188.
    This was a study on the contraceptive knowledge, beliefs, and practices of women living in the Khao Phlu refugee camp in Thailand. Also, interviews with midwives, and focus groups with married males and traditional birth attendants in the camps were conducted. The results focused on a broad range of contraceptive methods and reproductive health in general. Before the study began, there were reports of unmet contraceptive need by women in the camps, and almost no women had received emergency contraception. There was a special interest in examining the barriers to EC, because of the problem of sexual and gender-based violence faced by married Cambodian women. Focusing specifically on EC, the women were asked about knowledge and use of EC, and midwives were asked who they would consider an appropriate candidate for EC. None of the women were familiar with EC, but the majority (98%) expressed interest in seeing this option available at the camp. Although the women unanimously felt that it was acceptable in cases of rape, most had reservations when it came to allowing access to younger or unmarried women.

V. Country Program Reports

  • Comprehensive Responses to Gender Based Violence in Low-Resource Settings: Lessons Learned from Implementation, Lusaka, Zambia (2010). Keesbury J and Askew I, Population Council. This document reviews the findings, lessons learned, and promising practices in the provision of comprehensive gender-based violence (GBV) services in Zambia.
  • PEPFAR Special Initiative on Gender-Based Violence: A Baseline Report (2009). USAID. The PEPFAR Special Initiative on Sexual and Gender-Based Violence aims to strengthen care for survivors of sexual violence (SV) in 18 pilot sites in Uganda and Rwanda. This report contains results of the baseline assessment conducted between September and November 2009 in eight facilities in Rwanda and nine facilities in Uganda. A poster presentation which highlights the results of the baseline assessment can be found here:
    Health Care Providers in Uganda and Rwanda are Knowledgeable about Sexual Violence and HIV, but Few are Equipped to Provide Comprehensive Services (2010). Keesbury J and Elson L. USAID. http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.296.5534&rep=rep1&type=pdf
  • The Copperbelt Model of Integrated Care for Survivors of Rape and Defilement. (2008). Population Council. From 2005–2008, the Zambian Ministry of Home Affairs (Police Service), Ministry of Health (MOH) and Population Council collaborated on an operations research study designed to improve services for survivors of gender-based violence (GBV). Specifically, the study tested the feasibility of police provision of emergency contraception (EC).
  • Caring for Survivors of Sexual Assault and Rape: A training programme for health care providers in South Africa (2007). Department of Health, South Africa. A power point presentation from a training programme for health care providers in South Africa. This presentation is focused on Prevention and Management of Pregnancy after Rape (Module 3, Session 3.2).

How Social Marketing and NGOs are Expanding Access to Emergency Contraception

The private, non-profit sector, which includes NGOs and social marketing organizations, has a unique role to play in making EC and other family planning methods available to women in developing countries.

The term “social marketing” has a host of meanings, but here we refer to the selling of EC products by a non-profit/NGO organization. The sale of the EC products can take a number of forms, such as:

  • A commercial partner distributes the product through commercial outlets while the NGO provides support such as advocacy with policy makers, advertising, training of providers, and outreach to women.
  • An NGO registers, imports and distributes the product either through commercial outlets or through branded or “franchised” clinics, pharmacies, or drug sellers.

Social marketing programs successfully provide reproductive health products and services around the world. They work through existing commercial channels, normalize these products by placing them on the shelf along with other health and household related items, and innovate in their branding, advertising and marketing. Social marketing agencies bring experience in reproductive health and a passion for social good to commercial partners and products. With a special focus on the poor, social marketing programs sometimes subsidize a product in order to provide it at an affordable price.

To learn about how this sector is expanding access to EC and what additional steps could be taken, we conducted a survey of four international social marketing organizations (DKT International, Marie Stopes International, Population Services International, and ProSalud Interamericana) and the International Planned Parenthood Federation. We investigated a variety of indicators to assess how successful each program is and why; we also explored barriers to providing EC in programs that have not incorporated EC into their method mixes or have not done so successfully. Our four main findings are:

  1. There is potential for great success with EC in the social marketing sector.
  2. The majority of social marketing family planning programs do not include EC.
  3. A variety of barriers exist that prevent programs from providing EC.
  4. We need to learn more about the interaction between social marketing organizations and the commercial sector.

GREAT POTENTIAL

There are at least ten social marketing programs that have been very successful with EC provision as demonstrated by high volume sales. The driving forces behind these achievements range from government support to advertising and public education to other more general factors that affect contraceptive uptake and preference for EC. Country program examples with factors theorized to be driving these successes include:

  • INDIA (MSI): a) Government approval of OTC sales; b) mass media advertising; c) large urban population; and d) introduction of a single pill product.
  • VIETNAM (DKT): a) Women like the price and convenience of EC; b) competitive pricing; and c) government support for EC and social marketing programs as part of its population policy.
  • VENEZUELA (PROSALUD): a) Word of mouth; b) widespread high purchasing power; c) high use of oral contraceptives and low use of other contraceptive methods, especially long-acting methods; and d) high rates of unprotected sex.
  • ETHIOPIA (DKT): DKT’s EC sales in Ethiopia were substantially higher than projected, for reasons that are unclear. Possible contributing factors include: a) rapid urbanization; b) low use of regular methods of contraception coupled with a desire to avoid pregnancy; and c) convenience and discretion of private sector marketing.
  • PAKISTAN – GREENSTAR (PSI): a) Continuous promotion among providers in social franchise clinic network; and b) promotion within the commercial market. There are two other products available besides ecp® (Greenstar’s product): emkit® (a local product) & Postinor.® Greenstar estimates having 85% of the EC market.

In addition, some countries have not had very high EC sales but are showing growth and potential for continued improvement. Programs that appear to be growing include:

  • INDONESIA (DKT): a) Wider availability of the product in pharmacies due to improved distribution; and b) greater awareness by shop owners, shop staff and customers.
  • EGYPT (DKT): a) “Rebranding” of EC as a responsible choice for couples; b) direct-to-consumer educational campaigns and promotional activities; and c) doctor/pharmacist education.

EC IS STILL NOT INCLUDED IN MAJORITY OF PROGRAMS

Only 33% of social marketing family planning programs have substantial EC programs:

  • DKT: 39% (7/18) of family planning programs include EC.
  • MSI: 74% (28/38) of family planning programs include EC but if we only include programs that sold at least 1,000 EC packs in 2010, the percentage drops to 37% (14/38).
  • PSI: 18% (7/39) of family planning programs include EC.
  • PROSALUD: 100% (5/5) of family planning programs include EC.

MULTIPLE BARRIERS TO EC PROVISION

There are multiple reasons for why social marketing country programs have not included EC in their method mixes, ranging from lack of prioritization at the organizational level to limited program scope to political/legislative barriers. Other programs are in the process of registering an EC product and hopefully will be adding EC soon. Finally, there are many country programs that have included EC in their family planning programs, but with very minimal success. Barriers to successful EC provision (with country examples) include:

Policy Barriers

  • PHILIPPINES (DKT): EC delisted by the Philippines Food and Drug Authority. DKT Philippines will not pursue EC unless FDA reverses their position. Main barriers are thus a) regulatory environment; and b) the Catholic Church.
  • PERU (PROSALUD): (Program with minimal success.) Court decision declaring EC an abortifacient and prohibiting public sector distribution has had a dampening effect in the private sector.
  • CHILE (PROSALUD): (Program with minimal success.) Prescription requirement plus taboo history make it hard to successfully promote EC.

Funding Barriers

  • MALAWI (PSI): EC not yet introduced due to lack of funding. (The public sector already has EC; generally accepted but very few efforts to market or promote, resulting in very low uptake.)
  • MULTIPLE COUNTRIES: Lack of donor funding to socially market EC is limiting the ability of some social marketing organizations to promote EC in more countries. The Funders’ Network, which analyzes RH spending by US private foundations, estimated that grants supporting EC made up 0.2% of all population-related funding in 2007 (the last year for which such data is available).

Institutional Barriers

  • MALAYSIA (DKT): Condom-only program
  • MULTIPLE COUNTRIES: Some major social marketing organizations do not see EC as a priority (they are focused on other family planning and/or abortion services) and thus have not included EC in many of their country programs.

Knowledge Barriers

  • CAMBODIA (MSI): (Program with minimal success.) There is very little demand for EC in Cambodia. A key barrier is lack of client knowledge that EC is an option. It’s also possible that some clients are getting EC direct from pharmacies.

Multiple Barriers

  • MADAGASCAR (MSI): Barriers are a) the authorization process as it can take a very long time; b) the cost for potential clients who are mostly young; and c) lack of EC knowledge among the population.

EC in the Pipeline

  • BRAZIL (DKT): In the process of registering EC (which is widely accepted in Brazil).
  • CAMBODIA (PSI): In the process of introducing EC by using PSI program income as a revolving fund; hoping product will arrive June 2012.

SOCIAL MARKETING AND THE COMMERCIAL SECTOR

In some countries, EC access may be fairly widespread through the commercial sector, making it harder (and also less necessary) for social marketing agencies to provide the product. Three examples:

  • MEXICO (DKT): In 2010, pharmaceutical companies decided to distribute directly in the retail market, ending their relationship with most distributors at that time (including DKT). On the other hand, EC, in particular Postinor-2, is apparently widely available and successfully offered via the commercial sector.
  • INDIA (PSI): Decline in social marketing sales is mainly due to the fact that there are more than 10 commercial companies promoting EC in a highly competitive commercial market. Additionally, free supply is provided through the public health system. Overall, EC sales are growing in India; however, PSI does not currently have any donor funding to socially market EC.
  • CAMBODIA (MSI): It’s possible that some clients are getting EC direct from pharmacies.

INTERNATIONAL PLANNED PARENTHOOD FEDERATION

IPPF was an innovator in providing EC through its clinic networks in a number of countries early in EC’s history. As EC has moved to over-the-counter status and the commercial sector has become more interested in supplying EC, the role of these networks has changed. Over 75 of IPPF’s country programs now include EC provision. The majority of these programs are clinic networks that provide direct healthcare services. Within these systems, there is a wide range of EC provision.

High Volume Programs

  • SRI LANKA: This affiliate was among the very first providers of EC worldwide and has a mature program. It introduced EC through its clinic networks but realized very early that women prefer to access EC through pharmacies and so established a distribution system of Postinor-2 to private pharmacies. In this way, the Sri Lankan affiliate is acting much as a commercial distributor. Factors behind the success of this program include: a) EC has been available without a prescription/over the counter since introduction; b) island-wide distribution by more than 3,000 pharmacies; c) the government family planning program includes EC, indicating high-level support; and d) numerous promotional activities, especially at the time of EC introduction (dedicated hotline, jingle on Postinor-2, dealer incentives, promotion with pharmacists and doctors).

Low Volume Programs

  • NIGERIA: IPPF-affiliated FP programs focus on provision of long-acting contraceptive methods. Barriers to provision of EC: a) Lack of funding for EC programs; and b) stock-out. At the same time, PSI has highly successful social marketing programs that provide EC widely at pharmacies and drug-sellers, so access is still assured for Nigerian women.
  • BOTSWANA: Uptake of EC has been low due to lack of public knowledge on the availability of this service. In addition, the previous President of Botswana ordered EC’s status changed from an over-the-counter to a prescription drug; this has negatively impacted access.
  • GHANA: The gradual increase in EC provision can be attributed to the educational programs and campaigns done during the inception of their EC project. In addition, information on EC has been integrated into family planning (and other) counseling. EC (and another hormonal product, not EC but used post-coitally by Ghanaian women) is widely available through pharmacies.
  • KENYA: Private sector pharmacies dominate EC provision. Overall country success attributed to: a) role of private sector distribution; b) public education; and c) open market.

DISCUSSION

As EC has become more available and accepted, the commercial sector has become increasingly involved in selling EC in some countries. In some cases this reduces the “share” of the EC market for social marketing and NGO programs. However, there are still many countries with inadequate access to EC and in these settings, the NGO/social marketing sector can play an important role in expanding access. A number of barriers to incorporating EC into NGO/social marketing programs have been identified, but the majority of these can be addressed. We hope to see additional EC programs in this sector in the coming years.

The Intrauterine Device (IUD) for Emergency Contraception

Emergency contraception (EC) is a woman’s only chance to prevent pregnancy after unprotected intercourse, when precoital contraception methods were not used or were forgotten, when a problem was experienced with a barrier method, or in cases of sexual assault. While emergency contraceptive pills (ECPs) are commonly used, a copper intrauterine device (IUD) placed after unprotected sex is the most effective form of EC. Although a copper IUD must be inserted by a trained clinician, the copper IUD has three main advantages over ECPs:
• IUDs are much more effective than ECPs at reducing a woman’s chance of pregnancy after unprotected intercourse.
• IUDs can be inserted up to 5 days after unprotected intercourse with no reduction in effectiveness over time.
• IUDs can be left in place for as long as 12 or more years to provide reversible contraception that is as effective as sterilization.1

IUDs have been safely used to prevent pregnancy by millions of women around the world, and have been used as emergency contraception for at least 35 years.2 The effectiveness of using a levonorgestrel-releasing IUD (LNG IUD, “Mirena©”) alone for EC has not been studied and is not recommended at this time.3

Clinical Considerations

How effective is the copper IUD for EC?

Pregnancy rates in the month following placement of a copper-bearing IUD for EC are very low. A systematic review of IUDs used as EC including 7,034 women found a pregnancy rate of less than 0.1%.4 So, if 1,000 women have a copper IUD inserted for EC, zero or 1 would be expected to become pregnant that month.5 Alternatively, for every 1,000 women who used ECPs after a contraceptive emergency at least 14 users of ulipristal acetate or 20 users of levonorgestrel would face an unintended pregnancy.6,7 Thus, the failure rates for ECPs are 14 to 20 times greater than for the copper IUD. ECP failure rates may be even higher for obese women while IUD EC failure rates should not be affected by weight.8

Although current labeling recommends copper T380 IUD use for 10 years, there is evidence of efficacy to 12 years and beyond.1,9 IUDs are one of the most effective long-term contraceptive methods; in the first year of use, less than 1 pregnancy will occur per 100 women using an IUD.10 Over 12 years of IUD use, the pregnancy rate is about 2 pregnancies per 100 women.11 Women seeking EC who chose the copper IUD over ECPs are more likely to be using highly effective contraception and less likely to have a pregnancy 12 months later.12,13

How does the IUD work as EC?

The copper-bearing IUD primarily works by inhibiting fertilization, although the mechanism of action when inserted post-coitally is less clear.14 These IUDs release copper particles that disrupt the sperm and ovum function before they meet and cause physiologic changes in the uterus and Fallopian tubes. Post-coital placement of an IUD for EC likely involves the same mechanisms of interference with fertilization, but may also prevent implantation of a fertilized egg.15

Are there side effects to using an IUD?

After insertion of a copper IUD, some women may experience irregular bleeding, cramps, pain and heavier menses for the first few months. Most women find that these symptoms diminish over time. In the first year of use, about 5% of women will experience an expulsion,16,17 and they must have an IUD replaced or use another form of contraception if they desire pregnancy prevention. Rarely (<1%) a woman can develop an infection18 or the uterus can be injured when the IUD is placed.19

Who can use an IUD?

Any woman who is not pregnant and wishes to avoid a pregnancy can use an IUD.

Can women at risk of STIs use IUDs?

The risk of infection following copper IUD insertion for EC is low. Women presenting for emergency contraception are likely to be at some risk for sexually transmitted infections (STIs) as they probably have not used barrier methods effectively. Clinicians should assess the individual’s STI risk, and test as needed. Women diagnosed with gonorrhea or Chlamydia infections should be rapidly treated along with their partners, and tested for reinfection three months after treatment.

Current guidelines recommend against IUD insertion in women known to currently have pelvic inflammatory disease (PID), purulent cervicitis, active gonorrhea or Chlamydia infection.20 However, IUD insertion in the presence of asymptomatic Chlamydia or gonorrhea can be considered safe, as research supports that it is the presence of infection, not the placement of an IUD, which increases risk of PID.21 The absolute risk of PID is low regardless of infection status, 0-5%,22 and is only elevated through the first 20 days after insertion.18 Use of a copper IUD is not associated with an increased risk of tubal infertility among women.23

The judgment of the provider and the preference of the patient should guide clinical practice if an STI is present or suspected. Given the very low risk of PID, requiring two visits (one to test for STI and another to place the IUD) may place significant and unnecessary burdens of inconvenience and cost on the patient. Therefore, simultaneous STI testing and IUD insertion may be the optimal treatment plan for most patients presenting for an emergency IUD.

Women who have been sexually assaulted may be at particular risk of STIs. Thus, screening should be done routinely at the time of IUD EC insertion for any women presenting for EC after rape.

Can women infected with HIV safely use IUDs?

Current evidence suggests that IUDs are a safe and effective contraceptive method for HIV-infected women who have consistent access to medical care.24 Among women with HIV, disease progression is slower in copper IUD users compared to women using hormonal contraception.25 When compared to uninfected IUD users, HIV-positive women are not at significantly increased risk of complications or cervical shedding of infectious cells and have been shown to safely use IUDs over a 2-year period.26,27 Overall, IUD use does not appear to make HIV positive women more infectious to their sexual partners.27

Will IUDs affect future fertility?

The current evidence shows that a woman can become pregnant once the IUD is removed just as quickly as a woman who has never used an IUD.28 Use of a copper IUD is not associated with an increased risk of tubal infertility among women.23 Whether or not a woman has an IUD, if she develops PID and it is not treated, there is a chance that she will become infertile.21

Can the IUD be placed at any time during the menstrual cycle?

Current guidelines recommend inserting the copper IUD for EC within 5 days of unprotected intercourse.29 However, with a negative urine pregnancy test at any time in the menstrual cycle the risk of pregnancy following insertion of the copper IUD for EC remains extremely low.5 Some providers place IUDs only during menses to facilitate ease of insertion and assure that the woman is not pregnant; however, this practice is not supported by evidence and absence of menses should not be a barrier to placement of an emergency IUD.15,30 An IUD can be placed any time in the cycle as long as pregnancy has been ruled out.

Can adolescents use IUDs?

IUDs are a safe and effective method of EC for adolescents and offer the added benefit of continued highly effective contraception. IUDs can be used by women who have not previously had a pregnancy.20 IUDs may be a highly effective birth control method for adolescents given that adolescents have higher birth control continuation rates and lower unintended pregnancy rates with methods that do not require daily adherence or decisions at the time of intercourse.31 Providers should clearly explain to clients how to identify signs of expulsion and how to proceed if the IUD is no longer in place.

The American College of Obstetricians and Gynecologists (ACOG) encourages providers to consider the IUD as a first-line choice of contraception for adolescents.32 However, studies have shown that very few adolescents and young women use IUDs, many physicians do not offer the IUD to their younger patients, and knowledge of IUDs is low among adolescents and young women.33,34,35,36

Service Delivery Considerations

Are potential EC users interested in the IUD?

Surveys of EC users demonstrate that for every 8 women who present for EC in a clinic setting one is interested in using the copper IUD for EC.37,38

How can women obtain an IUD for EC?

For a number of reasons it is often more difficult for a woman to obtain an IUD than ECPs. In many countries, ECPs can be obtained directly from a pharmacy without a prescription. The IUD has significantly more service delivery requirements: it must be inserted by a trained health care provider in a clinic, which often requires making an appointment. Not all providers are trained in IUD insertion or aware of the possibility of using IUDs for EC. In addition, although it is not medically necessary, many providers require two or more visits for an IUD insertion.39

What about the cost of using the IUD for EC?

While many countries have low-cost options to provide IUDs for EC, the cost of IUD insertion in some countries, including the United States, can be a major obstacle to women seeking EC ($500-$1000 in the US).40 A survey of EC users determined that a major obstacle was the price of IUDs, which can have especially high out-of-pocket costs for uninsured women.37 Even though the IUD is extremely cost-effective if placed for EC and used for more than 4 months,41 the upfront cost of IUD insertion may be prohibitive in some settings.

Conclusion

The copper IUD for EC is the most effective way to prevent pregnancy after unprotected intercourse and can protect a woman from unintended pregnancy for many years. Because of these advantages, the copper IUD should be regularly offered to women who seek EC.

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