ICEC - Emergency Contraceptive Pills: Medical and Service Delivery Guidelines, Third Edition, 2012
Publication date: 2012
EMERGENCY CONTRACEPTIVE PILLS Medical and Service Delivery Guidelines Third Edition 2012 International Federation of Gynecology & Obstetrics (FIGO) Acknowledgements This third edition of the Medical and Service Delivery Guidelines supersedes the first two editions, which were published in 2000 and 2004. For their contributions to this update, the Consortium thanks: Elizabeth Raymond, Elizabeth Westley, Diana Blithe, Dalia Brahmi, Sharon Cameron, Kelly Cleland, Francine Coeytaux, Daniel Davis, Donald Downing, Anibal Faundes, Mary Fjerstad, Angel Foster, Ian Fraser, Ann Furedi, Kristina Gemzell Danielsson, Anna Glasier, Sharif Hossain, Beth Jordan, Nathalie Kapp, Delphine Levy, Patricia A. Lohr, Caroline Moreau, Matthew Reeves, Ilka Rondinelli, Karen Shea, Jeffrey Spieler, John Townsend, Nguyen-Toan Tran, James Trussell, Paul Van Look, and Helena von Hertzen. The Consortium also wishes to thank the UK Faculty of Sexual and Reproductive Healthcare of the Royal College of Obstetricians and Gynecologists for sharing their 2011 guidelines on emergen- cy contraception ahead of publication. The International Consortium for Emergency Contraception (ICEC) unites organizations and individuals committed to a common mission: to expand access to emergency contraception, with an emphasis on developing countries. For more information about ICEC, visit our website at: www.emergencycontraception.org. These guidelines may be freely reviewed, abstracted, and translated in part or whole, provided that publication credit is given to ICEC. Printing support by the HRA Phama Foundation. These guidelines were created by a group of experts working with the International Consortium for Emergency Contraception. They have been endorsed by the International Federation of Gynecology and Obstetrics (FIGO), whose representatives participated in reviewing the guidelines. Em ergency Contraceptive Pills: M edical and Service Delivery Guidelines 3 1. Introduction.6 2. Indications.6 3. ECP Regimens .7 4. Mode of Action.7 5. Efficacy.8 6. Side Effects.8 6.1 Altered vaginal bleeding patterns.8 6.2 Nausea and vomiting.9 6.3 Other symptoms.9 7. Effects on Pregnancy.9 8. Precautions and Contraindications.9 9. Clinical Screening.9 10. Special Issues.9 10.1 Use in Adolescents.9 10.2 Breastfeeding.9 10.3 Use of ECPs before sex.10 10.4 Use after more than one unprotected act.10 10.5 Repeated use.10 10.6 Use of ECPs during the “infertile period”.10 10.7 Drug interactions.10 10.8 Ectopic pregnancy.11 11. Service Delivery Systems.11 11.1 Advance education.11 11.2 ECP provision settings.11 12. Providing ECPs.12 12.1 Selecting and providing the method.12 12.2 Optional additional services.12 12.3 Follow-up.12 13. Starting or Resuming Regular Contraceptives after ECP Use.13 14. If the User Becomes Pregnant.13 References.14 Table of Contents Em er ge nc y C on tra ce pt ive P ills : M ed ica l a nd S er vic e De liv er y G uid eli ne s 4 Foreword The mission of the International Consortium for Emergency Contraception is to expand access to emergency contraception, with an emphasis on developing countries. Founded in 1996 by seven international organizations (the Concept Foundation, International Planned Parenthood Federation, the Pacific Institute for Women’s Health, PATH, Pathfinder International, the Population Council, and WHO’s Special Programme of Research, Development and Research Training in Human Reproduction), the Consortium now brings together several dozen agencies and hundreds of individuals in support of its mission. The Consortium first produced guidelines in 2000, based on guidelines initially created by Pathfinder, PATH and IPPF. The guidelines were revised in 2004 and again now, in 2012. Despite more than 15 years of efforts to expand access to EC, this contraceptive method still remains out of reach for many women. The Consortium has produced these medical and service delivery guidelines about oral emergency contraceptive pills to assist family planning programs and providers in assuring that the women they serve can use these regimens effectively and safely. This document reflects the latest available evidence and has been reviewed by internationally recognized reproductive health experts. Local pro- grams are welcome to adapt these guidelines as needed to comply with national or other requirements. These guidelines do not discuss the use of the copper-bearing intrauterine device for emergency contraception. This device is the most effective emergency contraceptive option and should be offered to women when appropriate. Further information about this option is available on the ICEC website (www.emergencycontraception.org) and the Emergency Contraception website managed by Princeton University and the Association of Reproductive Health Professionals (www.not-2-late.com). We hope these updated guidelines will help you in your work, whether you are a pharmacist or pharmacy worker, health provider, program manager, policy maker or advocate. We welcome your participation in our community of practice, which is open to all committed to ICEC’s mission of expand- ing access to EC; please feel free to contact us via our website at www.emergencycontraception.org. Em ergency Contraceptive Pills: M edical and Service Delivery Guidelines 5 Summary Service Protocol Indication: Emergency Contraceptive Pills (ECPs) are indicated to prevent pregnancy after unprotected or inadequately protected sex. ECP Regimens: Three regimens are packaged and labeled specifically for emergency contraception (EC). • 1 tablet of levonorgestrel 1.5 mg, or 2 tablets of levonorgestrel 0.75 mg labeled to be taken twice 12 hours apart (but can safely be taken together) • 1 tablet of ulipristal acetate 30 mg • 1 tablet of mifepristone 10-25 mg (not widely available) Certain types of ordinary birth control pills can also be used as EC (known as the “Yuzpe regimen”). Take the pills within 5 days after sex, as soon as possible after the sex act. How ECPs Work: The primary mechanism is disruption of ovulation. Other mechanisms have been postulated but are not well supported by data. No evidence supports the theory that ECPs interfere with the implantation of a fertilized egg. ECPs do not cause abortion of an existing pregnancy. ECP Efficacy: The levonorgestrel regimen reduces pregnancy risk by at least half and possibly by as much as 80-90% for one act of unprotected intercourse. The ulipristal and mifepristone regimens are more effective than the levonorgestrel regimen. Regular oral contraceptives used as EC (the “Yuzpe regimen”) are less effective. Safety: ECPs have no known medically serious complications. Side effects may include altered bleeding patterns, nausea, headache, abdominal pain, breast tenderness, dizziness, and fatigue. ECPs do not appear to be harmful if inadvertently taken in pregnancy. Precautions and Contraindications: ECPs have no medical contraindications. Do not take ECPs if you are pregnant because they will not work. Clinical Screening: You do not need any examinations or laboratory tests before taking ECPs. Repeated ECP Use: ECPs can be used as often as needed, but do not need to be taken more than once every 24 hours if multiple acts of unprotected sex occur. Repeat use of ECPs is perfectly safe, but ECPs are not recommended as a regular, routine contraceptive method because they are not the most effective contraceptive method available. Drug Interactions: Concurrent use of some drugs may reduce ECP efficacy. However, the ECP regimen is the same whether or not you are using these drugs. Follow-up after ECP: No scheduled follow-up is required after ECP use. But if you have not had a menstrual period by 3 weeks after taking ECPs, consider that you may be pregnant. Starting or Resuming Regular Contraceptives after ECP Use: ECPs are not designed to provide contraceptive protection at sex acts that occur in the future. Using a regular contraceptive after taking ECPs is CRITICAL to minimizing your pregnancy risk. Begin hormonal methods (oral contraceptives, patch, vaginal ring, injectables, implants, levonorgestrel intrauterine system) either immediately or after your next menstrual period; if you wait, use a barrier method such as condoms in the interim. Copper-bearing IUDs provide highly effective emergency contraception, so you do not need oral ECPs if you start using this type of IUD within 5 days after sex. Do not rely on fertility awareness methods until you have had at least one normal menstrual period. Resources • International Consortium for Emergency Contraception website: www.emergencycontraception.org • The Emergency Contraception website, managed by Princeton University and the Association of Reproductive Health Professionals: www.not-2-late.com EMERGENCY CONTRACEPTIVE PILLS: MEDICAL AND SERVICE DELIVERY GUIDELINES Em er ge nc y C on tra ce pt ive P ills : M ed ica l a nd S er vic e De liv er y G uid eli ne s 6 1. INTRODUCTION Despite the availability of highly effective methods of contraception, many pregnancies are mistimed or unwanted. These pregnancies may carry a high risk of morbidity and mortality, particularly in settings where safe abortion is not accessible or where quality obstetric services are not available for those women continuing a pregnancy to term. Many of these unintended pregnancies can be avoided using emergency contraceptive pills (ECPs). 2. INDICATIONS ECPs are drugs taken orally that can be used to prevent pregnancy after an unprotected or inadequately protected sex act. ECPs are sometimes referred to as “morning after pills” or “postcoital oral contraceptives.” ECPs are indicated when: • no contraceptive was used; • a contraceptive was used incorrectly; • a contraceptive was used correctly but was immediately observed to have failed. Examples of common situations in which ECPs may be needed by a woman who is using a routine contraceptive method are listed below. A woman should consider using ECPs after sex if… • she started the method later in the menstrual cycle than instructed. • she did not use the method consistently as instructed during the cycle. • she used drugs that might have reduced the effectiveness of the method. • she started the method later in the menstrual cycle than instructed. • the period of contraceptive protection from the last injection ended before the sex act. • the period of contraceptive protection from the implant ended before the sex act. • the device had been expelled. • she cannot feel the string. • the period of contraceptive protection from the device ended before the sex act. • the condom broke, slipped, or was used incorrectly. • the device dislodged or was removed before or during sex. • the device dislodged or was removed earlier after sex than instructed. • she did not insert the spermicide before sex as instructed. • the spermicide tablet or film failed to melt before sex. • she was in the fertile period when she had sex. • she is uncertain about whether or not she was in the fertile period when she had sex. • ejaculation occurred in the vagina or on the external genitalia. Method Oral contraceptives, contraceptive patch, vaginal ring Progestin-only injections Implant Intrauterine device or system Condoms Diaphragm or cap Spermicide Fertility awareness methods Coitus interruptus Because of the difficulties in determining the risk of pregnancy in any particular situation and the serious consequences of a mistimed or unwanted pregnancy, a woman who does not want to be Em ergency Contraceptive Pills: M edical and Service Delivery Guidelines 7 pregnant should consider taking ECPs after any sex act during which contraceptive protection was not reasonably assured. ECPs are particularly indicated in cases of non-consensual sex (rape) when the woman was not protected by an effective contraceptive method. 3. ECP REGIMENS These guidelines focus primarily on two oral ECP regimens, one containing the progestin hormone levonorgestrel, and the other containing the progesterone receptor modulator ulipristal acetate: • Levonorgestrel regimen: 1.5 mg levonorgestrel in a single dose or in two doses of 0.75 mg taken 12 hours apart; • Ulipristal acetate regimen: 30 mg ulipristal acetate in a single dose. The levonorgestrel regimen appears to be effective for at least 4 days after sex1 and potentially up to 5 days. The ulipristal regimen appears to be effective for 5 days after sex.2,3 Taking either regimen as promptly as possible within these time frames is prudent and is strongly recommended. Both regimens are marketed as dedicated products specifically packaged and labeled for emergency contraception. Products based on the levonorgestrel regimen are currently available in most countries in the world. Ulipristal-based ECP products are all produced by a single manufacturer. These products were first sold in Europe in 2009, in the USA in 2010, and are now also available elsewhere. Two other ECP regimens have been well studied, one containing mifepristone, a progesterone receptor modulator, and the other containing a combination of estrogen and progestin hormones: • Mifepristone regimen: 10-25 mg mifepristone as a single dose; • Combined hormonal (Yuzpe) regimen: one dose of 100 mcg ethinyl estradiol plus 0.5 mg levonorgestrel followed by a second identical dose 12 hours later. Mifepristone ECPs are available as dedicated ECP products in only a few countries, including China, Vietnam, and Russia. The combined hormonal regimen is not currently marketed anywhere, but it can be made up from many brands of widely available oral contraceptive pills. This regimen may be useful in settings where none of the dedicated products are available. Some data suggest that both the mifepristone and combined hormonal regimens are effective up to 3 days after sex and possibly up to 5 days.4,5 Listings of ECP products and regimens by country are available at www.emergencycontraception.org and www.not-2-late.com. 4. MODE OF ACTION The primary documented mechanism of action for both the levonorgestrel and ulipristal regimens is interference with the process of ovulation.6-9 If taken before the pre-ovulatory luteinizing hormone surge has started, levonorgestrel can inhibit the surge, impeding follicular development and maturation and/ or the release of the egg itself. Ulipristal has been shown to prevent ovulation both before and after the surge has started, delaying follicular rupture for at least 5 days.8 These regimens have been shown not to prevent implantation of a fertilized egg into the uterus in sev- eral studies.6,9-11 Additional postulated mechanisms include interference with corpus luteum function; thickening of the cervical mucus resulting in trapping of sperm; and alterations in the tubal transport of sperm or egg. If taken after implantation has occurred, the levonorgestrel regimen has no effect on an existing pregnancy and does not increase rates of miscarriage.12,13 Early data on ulipristal do not show any effect on existing pregnancies. Em er ge nc y C on tra ce pt ive P ills : M ed ica l a nd S er vic e De liv er y G uid eli ne s 8 5. EFFICACY Twelve studies of the levonorgestrel regimen that included a total of more than 13,500 women con- cluded that this regimen reduced a woman’s chance of pregnancy after a single sex act by between 52% and 100%.2,4,14-23 A rigorous analysis of data from two randomized trials demonstrated that the levonorgestrel regimen reduces the absolute risk of pregnancy after an unprotected sex act by at least 49% (95% confidence interval 17-69%).24 Some data suggest that the efficacy of the levonorgestrel regimen decreases with time since coitus.18,25 In contrast, a combined analysis of data from four large trials did not find a significant decline in effica- cy of this regimen over the first 4 days after sex. In this analysis, the regimen appeared to have minimal or no efficacy if taken on day 5.1 Several studies have found that both the efficacy and the side effects of the levonorgestrel regimen are equivalent whether the hormone is taken as a single 1.5 mg dose or as 2 doses of 0.75 mg either 12 or 24 hours apart.4,14,15 Two randomized trials have found that the ulipristal regimen is at least as effective as the levonorgestrel regimen when used within 72 hours after sex.2,18 An analysis that combined data from these trials suggested that the ulipristal regimen is more effective through five days after sex.2 No decline in efficacy of the ulipristal regimen was apparent within 5 days after sex. With any EC regimen, the risk of pregnancy is substantially higher if the woman has subsequent unprotected sex acts in the same menstrual cycle than if she does not. Some data from Europe and North America suggest that the levonorgestrel regimen may be less ef- fective in obese women than in thinner women.2 Whether the same is true for the ulipristal regimen is not yet clear. Increasing the dose of either regimen in obese women has never been studied and is not recommended. The mifepristone regimen is more effective than the levonorgestrel regimen26 but it has never been di- rectly compared to the ulipristal regimen. A recent systematic review indicated that doses of 25-50 mg mifepristone may be significantly more effective for emergency contraception than a dose of 10 mg.26 The combined hormonal regimen is the least effective of the four ECP regimens.26 Although ECPs are effective in reducing pregnancy risk after unprotected sex, increasing the avail- ability of this method to populations has not been shown to reduce rates of unintended pregnancy or abortion.27,28 The reason for this apparent discrepancy is likely at least in part because even with ready access to ECPs, women do not use them after every unprotected sex act. In addition, one study sug- gested that easy access may encourage some women to substitute ECPs for other, more effective contraceptive methods.29 Tackling the public health problem of unintended pregnancy requires a multi- dimensional approach of which provision of ECPs is only one aspect. 6. SIDE EFFECTS ECPs are extraordinarily safe. No deaths or serious complications have been causally linked to any ECP regimen. Side effects that are medically minor but may be troublesome to some users are described below. 6.1 Altered vaginal bleeding patterns Most women who have used ECPs have their next menstrual period within 7 days of the expected time. Menstruation has been reported to occur on average 1 day earlier than expected after use of the levo- norgestrel regimen and 2 days later than expected after use of ulipristal. About 24% of women in clini- cal trials of ulipristal reported a delay of more than 7 days.2 Some women experience irregular bleeding Em ergency Contraceptive Pills: M edical and Service Delivery Guidelines 9 or spotting after taking ECPs.30,31 The proportion with this side effect varies between different studies. Bleeding alterations due to ECPs are not dangerous and will resolve without treatment. 6.2 Nausea and vomiting Nausea, rarely accompanied by vomiting, occurs in less than 20% of women using the levonorgestrel regimen4,20 and in about 12% of women using the ulipristal regimen.2,3 These symptoms are uncommon enough that prophylactic administration of an antiemetic drug is not routinely warranted before use of these regimens. If vomiting occurs within two or three hours after taking an ECP dose, some experts recommend that the dose should be repeated.32 6.3 Other symptoms Other symptoms that may occur in users of ECPs include headache, abdominal pain, breast tenderness, dizziness, or fatigue. These side effects usually do not occur more than a few days after treatment, and they generally resolve within 24 hours. 7. EFFECTS ON PREGNANCY Studies of women who became pregnant despite using the levonorgestrel regimen or who used it inadvertently after becoming pregnant indicate that this regimen does not harm either a pregnant woman or her fetus; in particular, it does not increase rates of miscarriage, low birth weight, congenital malformations, or pregnancy complications.12,13 According to the ulipristal ECP product manufacturer, few pregnancies have been reported to date after the ulipristal regimen, but no complications have been noted in those pregnancies. 8. PRECAUTIONS AND CONTRAINDICATIONS ECPs are not dangerous under any known circumstances or in women with any particular medical conditions. Recognized contraindications to oral contraceptives do not apply to ECPs. In particular, the following conditions are NOT contraindications to ECPs: young age, obesity, personal or family history of venous thromboembolism, prior or current breast cancer, prior ectopic pregnancy, breastfeeding, migraine headaches, cardiovascular disease, liver disease, diabetes, hypertension, and prior ECP use in the same menstrual cycle. ECPs are not indicated for a woman who has a confirmed pregnancy because they will have no benefit. However, if an evaluation for pregnancy has not been performed or if pregnancy status is unclear, ECPs may be used, as no evidence exists suggesting harm to a developing fetus. 9. CLINICAL SCREENING Because ECPs are safe for all women and women can determine for themselves whether they have had unprotected or inadequately protected sex, no provider screening is needed before use of ECPs. Clinical assessments (e.g., pregnancy tests, blood pressure measurements, laboratory tests, pelvic examination) are not necessary. 10. SPECIAL ISSUES Several issues commonly raised regarding ECPs are discussed below. 10.1 Use in Adolescents Adolescents’ access to ECPs should not be limited by clinical or programmatic concerns. ECPs are safe for all women regardless of age. Adolescents do not suffer greater rates of side effects33 and are able to comprehend the label and other instructions about how to use the method.34 10.2 Breastfeeding A woman who is less than six months postpartum, is exclusively breastfeeding, and has not had a menstrual period since delivery is unlikely to be ovulating and therefore is unlikely to need ECPs. How- ever, a woman who does not meet all three criteria may be at risk for pregnancy. The levonorgestrel Em er ge nc y C on tra ce pt ive P ills : M ed ica l a nd S er vic e De liv er y G uid eli ne s 10 regimen of ECPs is not contraindicated during lactation. The manufacturer of the ulipristal ECP product recommends that nursing mothers should feed the baby immediately before taking the tablet and then express and discard the milk for the next 36 hours, or she should use another ECP regimen. 10.3 Use of ECPs before sex No data are available about how long the contraceptive effect of ECPs persists after the pills have been taken. Presumably, ECPs taken immediately before sex are as effective as ECPs taken immediately afterwards. However, if a woman has the opportunity to plan to use a contraceptive method before sex, a method other than ECPs, such as condoms or another barrier method, is recommended. 10.4 Use after more than one unprotected act Women should try to use ECPs as promptly as possible after each unprotected sex act; waiting until a series of acts has occurred is not recommended. However a woman should not refrain from taking ECPs simply because she has had multiple unprotected sex acts, although she should be aware that the efficacy of the ECPs may be limited if the earliest unprotected act was more than 4-5 days earlier. She should use only one ECP treatment at a time regardless of the number of prior unprotected acts. 10.5 Repeated use ECPs are not intended for deliberate repeated use or use as a regular, routine contraceptive method. After using ECPs, women who do not wish to become pregnant in the future are advised to initiate or resume using an established ongoing contraceptive. No specific data are available about the efficacy or safety of frequent use of current ECP regimens. However, at least 10 studies have confirmed that levo- norgestrel 0.75 mg administered multiple times per cycle causes no serious adverse effects; the most common side effect was irregular bleeding.35 These data provide reassurance that women may safely use the levonorgestrel regimen as many times or as often as needed. Some experts recommend that no more than one dose is needed in a 24 hour period.32 The manufacturer of the ulipristal ECP product recommends that it should not be used more than once in a cycle, although no evidence is provided to support this recommendation. Whether the efficacy of the levonorgestrel regimen is reduced by recent or subsequent use of ulipristal, which is a progesterone receptor modulator, is unknown. Therefore, if a woman who has recently used the levonorgestrel regimen has a subsequent need for emergency contraception, she should probably use the levonorgestrel regimen again. If a woman who has recently used the ulipristal regimen needs emergency contraception a second time, she should consider having a copper-bearing IUD inserted. If that is unacceptable, inappropriate, or unavailable, then no data are available to guide her as to which ECP regimen she should use. Repeated use of ECPs is safer than pregnancy. 10.6 Use of ECPs during the “infertile period” Studies have shown that fertilization can result from sex only during a 5-7 day interval around the time of ovulation.36 Theoretically, ECPs should not be needed if unprotected sex occurs at other times in the cycle, because the chance of pregnancy even without ECPs would be zero. However, in practice, deter- mining whether a specific act occurred on a fertile or infertile cycle day is often impossible. Therefore, women should not refrain from using ECPs because of the assumption that a particular sex act occurred on a nonfertile day. 10.7 Drug interactions No specific data are available about interactions of ECPs with other drugs. However, it seems reason- able to assume that drug interactions with the levonorgestrel regimen might be similar to those with regular daily oral contraceptive pills. Thus, efficacy of this regimen may be reduced by concomitant use of drugs that may reduce oral contraceptive efficacy (including but not limited to rifampicin, griseofulvin, certain anticonvulsant drugs, Saint John’s wort, and certain antiretroviral drugs). Em ergency Contraceptive Pills: M edical and Service Delivery Guidelines 11 The packaging of the ulipristal regimen lists potential interactions with these same drugs and also with bosentan and medicines used to treat acidity of the stomach or ulcers (for example, omeprazole). Women who are using these drugs or have taken them in the past month and need emergency contracep- tion should consider using a copper-bearing IUD. If the levonorgestrel ECP regimen is selected, some experts recommend taking double the dose (3 mg levonorgestrel).32 The manufacturer of the ulipristal ECP product does not recommend changing the dose if this regimen is chosen. Because ulipristal is a progesterone receptor modulator, it may in theory reduce the efficacy of other hormonal contraceptives containing progestin hormones. However, no data are available on this matter. 10.8 Ectopic pregnancy All contraceptive methods reduce the absolute risk of ectopic pregnancy by preventing pregnancy in general. A systematic review of world literature found that 1% of pregnancies occurring after use of the levonorgestrel regimen and 0.6% of pregnancies occurring after use of the mifepristone regimen were ectopic. These figures are similar to the risk that pregnancies not exposed to ECPs will be ectopic. Thus, the review concluded that neither regimen increases the chance that a pregnancy will be ectopic.37 11. SERVICE DELIVERY SYSTEMS Because of the short timeframe during which ECPs are effective, unique service delivery issues arise in ensuring that women can benefit maximally from ECPs. 11.1 Advance education Every effort should be made to ensure that all women and men are informed about ECPs before the need arises. Key messages include: • A woman who does not want to be pregnant should consider using ECPs any time she has sex that was not adequately protected by effective contraception; • She should try to obtain and use the emergency contraceptive as promptly as possible; • ECPs are not intended for ongoing, routine contraception; an established method is recommended for that purpose. In addition, every woman should know where and how she can obtain ECPs in her community. To ensure that she will have ECPs available whenever she needs them, she may consider obtaining a package in advance. Providers and programs may disseminate these messages by numerous approaches. These include: • Routinely informing women about ECPs at all visits to clinics, pharmacies, or other facilities where health care is provided; • Informing abortion clients about ECPs; • Including information about ECPs on clinic or pharmacy websites and telephone answering machines; • Distributing information about ECPs with other contraceptive supplies or medications; • Including information about ECPs in health education programs in schools, youth centers, or other venues; • Instituting mass media informational and advertising campaigns for ECP products and services. 11.2 ECP provision settings To facilitate access, ECPs should be readily available. Because no clinician screening or assessment is needed and women can decide on their own whether the treatment is needed, ECPs may appropriately be sold over- the-counter, as they are in most countries. However, if women may have difficulty obtaining ECPs because a prescription is required or for some other reason, providers and programs may use the following approaches to ensure that women can obtain and use this treatment quickly: • Provide an advance prescription or supply; • Prescribe by telephone without seeing the woman; Em er ge nc y C on tra ce pt ive P ills : M ed ica l a nd S er vic e De liv er y G uid eli ne s 12 • Allow non-physician personnel, such as pharmacy staff, nurses, and community health workers, to provide ECPs; • Ensure that all personnel who provide care or counseling to women presenting after sexual assault routinely offer ECPs to these women; • Distribute ECPs in non-clinical settings, like schools, non-pharmacy commercial outlets, and social service offices. 12. PROVIDING ECPS Because many women who use ECPs will obtain them over-the-counter, input from a health profes- sional may not be available. However, if a provider is present, the following guidelines may be useful. 12.1 Selecting and providing the method • A copper IUD is the most effective emergency contraceptive, and it offers the added benefit of ongoing contraception for at least 10 years. Therefore, consider offering this alternative to oral ECPs if it is readily available and the woman is medically eligible to receive it. • If the woman chooses to use oral ECPs and if both ulipristal and levonorgestrel ECP products are readily available, inform her that the ulipristal regimen may be more effective, particularly if 4-5 days have elapsed since the first unprotected sex act. However, if only one of these products is available, the client should consider using that product immediately rather than delaying treatment in order to obtain an alternate product. • If the levonorgestrel regimen is selected and the particular product provided contains two tablets of 0.75 mg levonorgestrel, advise the woman to take both tablets at once rather than 12 hours apart as on the package label. Taking the two pills together will not compromise efficacy or increase side effects, but it is more convenient and will avoid the possibility that a second dose will be lost or forgotten. • If possible, provide the desired ECPs and recommend that the woman swallow them immediately. Alternatively, provide a prescription and instructions about where in the community the woman can obtain the product. • Tell the client that if she does not have a menstrual period within 3 weeks after taking the pills, she should consider the possibility that she may be pregnant and seek appropriate evaluation and care. 12.2 Optional additional services Additional services are not necessary but should be provided if the client desires. These services may include: • Provision of a regular contraceptive method (see Section 13); • Pregnancy testing; • Testing, prophylaxis, or treatment for sexually transmitted infections. (Inform the woman that tests will not necessarily diagnose very recent infections, in particular infections that she may have acquired at the most recent unprotected sex act. If that is a concern, recommend retesting after an appropriate time interval.) ECPs should not be withheld from clients who decline these additional services. 12.3 Follow-up No scheduled follow-up is required after ECP use unless the client identifies a problem or question. However, she should be encouraged to seek follow-up care if she: • Needs ongoing contraception or wishes to switch methods; • Has not had a menstrual period by 3 weeks after taking the ECPs, as this could be a sign of pregnancy; Em ergency Contraceptive Pills: M edical and Service Delivery Guidelines 13 • Has irregular bleeding with lower abdominal pain more than a few days after taking ECPs, as these could be symptoms of an ectopic pregnancy; • Desires evaluation for sexually transmitted infections; • Needs management of issues related to rape; • Has any other health concerns. 13. STARTING OR RESUMING REGULAR CONTRACEPTIVES AFTER ECP USE ECPs do not provide contraception for later sex acts. Therefore, after using ECPs, a woman should select another method to use before she resumes sexual activity. The following table indicates when a woman may start a regular method after ECPs. 14. IF THE USER BECOMES PREGNANT A woman who has used ECPs may later find herself to be pregnant because the ECPs have failed, because she was already pregnant before taking the ECPs, or because sex acts after taking the ECPs led to pregnancy. In any of these cases, she should be aware that ECPs have no known adverse effects on a pregnancy. Whether she chooses to continue the pregnancy or to seek abortion, she should know that she does not need any special management because of exposure to ECPs. When to initiate • Start using immediately at the next sex act. • Start using immediately – that is, the same day as the ECPs, or the following day. Use a barrier method for 7 days after the levonorgestrel ECP regimen or for 14 days after the ulipristal ECP regimen. • Alternatively, start after the next menstrual period, but use a barrier method in the interim. • Before insertion of implants or the hormonal intrauterine system, a pregnancy test to rule out preexisting pregnancy may be advisable for practical or cost reasons (not for safety reasons). • A copper-bearing IUD inserted within 5 days after sex will provide highly effective emergency contraception. Therefore, oral ECPs are not needed if this type of IUD is inserted in this time interval. • If a woman wants a copper-bearing IUD more than 5 days after using ECPs, it may be inserted after the start of the next menstrual period. • Initiate after the first normal menstrual period following ECP use. Note that the first bleeding episode after taking ECPs may not be a “normal” menstrual period. • Use a barrier method until the first normal period. • Perform the procedure after the start of the menstrual period following ECP use. • Use a barrier method until the sterilization is completed. Desired method Condoms or other barrier methods Hormonal methods: Oral contraceptives Contraceptive patch Vaginal ring Injectables Implants Levonorgestrel intrauterine system Copper-bearing intrauterine device Fertility awareness methods Sterilization Em er ge nc y C on tra ce pt ive P ills : M ed ica l a nd S er vic e De liv er y G uid eli ne s 14 1. Piaggio G, Kapp N, von Hertzen H. Effect on pregnancy rates of the delay in the administration of levonorgestrel for emergency contraception: a combined analysis of four WHO trials. Contraception 2011;84(1):35-9. 2. Glasier AF, Cameron ST, Fine PM, et al. Ulipristal acetate versus levonorgestrel for emergency contraception: a randomised non-inferiority trial and meta-analysis. Lancet 2010;375(9714):555-62. 3. Fine P, Mathe H, Ginde S, Cullins V, Morfesis J, Gainer E. Ulipristal acetate taken 48-120 hours after intercourse for emergency contraception. Obstet Gynecol 2010;115(2 Pt 1):257-63. 4. von Hertzen H, Piaggio G, Ding J, et al. Low dose mifepristone and two regimens of levonorgestrel for emergency contraception: a WHO multicentre randomised trial. Lancet 2002;360(9348):1803-10. 5. Ellertson C, Evans M, Ferden S, et al. Extending the time limit for starting the Yuzpe regimen of emergency contraception to 120 hours. Obstet Gynecol 2003;101(6):1168-71. 6. Stratton P, Levens ED, Hartog B, et al. Endometrial effects of a single early luteal dose of the selective progesterone receptor modulator CDB-2914. Fertil Steril 2010;93(6):2035-41. 7. Croxatto HB, Devoto L, Durand M, et al. Mechanism of action of hormonal preparations used for emergency contraception: a review of the literature. Contraception 2001;63(3):111-21. 8. Brache V, Cochon L, Jesam C, et al. Immediate pre-ovulatory administration of 30 mg ulipristal acetate significantly delays follicular rupture. Hum Reprod 2010;25(9):2256-63. 9. Marions L, Hultenby K, Lindell I, Sun X, Stabi B, Gemzell Danielsson K. Emergency contraception with mifepristone and levonorgestrel: mechanism of action. Obstet Gynecol 2002;100(1):65-71. 10. Meng CX, Marions L, Bystrom B, Gemzell-Danielsson K. Effects of oral and vaginal administration of levonorgestrel emergency contraception on markers of endometrial receptivity. Hum Reprod 2010;25(4):874-83. 11. Passaro MD, Piquion J, Mullen N, et al. Luteal phase dose-response relationships of the antiprogestin CDB-2914 in normally cycling women. Hum Reprod 2003;18(9):1820-7. 12. De Santis M, Cavaliere AF, Straface G, Carducci B, Caruso A. Failure of the emergency contraceptive levonorgestrel and the risk of adverse effects in pregnancy and on fetal development: an observational cohort study. Fertil Steril 2005;84(2):296-9. 13. Zhang L, Chen J, Wang Y, Ren F, Yu W, Cheng L. Pregnancy outcome after levonorgestrel-only emergency contraception failure: a prospective cohort study. Hum Reprod 2009;24(7):1605-11. 14. Arowojolu AO, Okewole IA, Adekunle AO. Comparative evaluation of the effectiveness and safety of two regimens of levonorgestrel for emergency contraception in Nigerians. Contraception 2002;66(4):269-73. 15. Ngai SW, Fan S, Li S, et al. A randomized trial to compare 24 h versus 12 h double dose regimen of levonorgestrel for emergency contraception. Hum Reprod 2005;20(1):307-11. 16. Wu S, Wang C, Wang Y. [A randomized, double-blind, multicentre study on comparing levonorgestrel and mifepristone for emergency contraception]. Zhonghua Fu Chan Ke Za Zhi 1999;34(6):327-30. 17. Hamoda H, Ashok PW, Stalder C, Flett GM, Kennedy E, Templeton A. A randomized trial of mifepristone (10 mg) and levonorgestrel for emergency contraception. Obstet Gynecol 2004;104(6):1307-13. 18. Creinin MD, Schlaff W, Archer DF, et al. Progesterone receptor modulator for emergency contraception: a randomized controlled trial. Obstet Gynecol 2006;108(5):1089-97. 19. Ho PC, Kwan MS. A prospective randomized comparison of levonorgestrel with the Yuzpe regimen in post-coital contraception. Hum Reprod 1993;8(3):389-92. 20. Task Force on Postovulatory Methods of Fertility Regulation. Randomised controlled trial of levonorgestrel versus the Yuzpe regimen of combined oral contraceptives for emergency contraception. Lancet 1998;352(9126):428-33. 21. Dada OA, Godfrey EM, Piaggio G, von Hertzen H. A randomized, double-blind, noninferiority study to compare two regimens of levonorgestrel for emergency contraception in Nigeria. Contraception 2010;82(4):373-8. 22. Farajkhoda T, Khoshbin A, Enjezab B, Bokaei M, Karimi Zarchi M. Assessment of two emergency contraceptive regimens in Iran: levonorgestrel versus the Yuzpe. Niger J Clin Pract 2009;12(4):450-2. 23. Noe G, Croxatto HB, Salvatierra AM, et al. Contraceptive efficacy of emergency contraception with levonorgestrel given before or after ovulation. Contraception 2011;84(5):486-92. 24. Raymond E, Taylor D, Trussell J, Steiner MJ. Minimum effectiveness of the levonorgestrel regimen of emergency contraception. Contraception 2004;69(1):79-81. References Em ergency Contraceptive Pills: M edical and Service Delivery Guidelines 15 25. Piaggio G, von Hertzen H, Grimes DA, Van Look PF. Timing of emergency contraception with levonorgestrel or the Yuzpe regimen. Task Force on Postovulatory Methods of Fertility Regulation. Lancet 1999;353(9154):721. 26. Cheng L, Gulmezoglu AM, Piaggio G, Ezcurra E, Van Look PF. Interventions for emergency contraception. Cochrane Database Syst Rev 2008(2):CD001324. 27. Raymond EG, Trussell J, Polis CB. Population effect of increased access to emergency contraceptive pills: a systematic review. Obstet Gynecol 2007;109(1):181-8. 28. Polis CB, Schaffer K, Blanchard K, Glasier A, Harper CC, Grimes DA. Advance provision of emergency contraception for pregnancy prevention (full review). Cochrane Database Syst Rev 2010(2):CD005497. 29. Raymond EG, Weaver MA. Effect of an emergency contraceptive pill intervention on pregnancy risk behavior. Contraception 2008;77(5):333-6. 30. Raymond EG, Goldberg A, Trussell J, Hays M, Roach E, Taylor D. Bleeding patterns after use of levonorgestrel emergency contraceptive pills. Contraception 2006;73(4):376-81. 31. Gainer E, Kenfack B, Mboudou E, Doh AS, Bouyer J. Menstrual bleeding patterns following levonorgestrel emergency contraception. Contraception 2006;74(2):118-24. 32. Faculty of Sexual and Reproductive Healthcare. Clinical Guidance: Emergency Contraception: Faculty of Sexual and Reproductive Healthcare; 2011. 33. Harper CC, Rocca CH, Darney PD, von Hertzen H, Raine TR. Tolerability of levonorgestrel emergency contraception in adolescents. Am J Obstet Gynecol 2004;191(4):1158-63. 34. Raine TR, Ricciotti N, Sokoloff A, Brown BA, Hummel A, Harper CC. An Over-the-Counter Simulation Study of a Single-Tablet Emergency Contraceptive in Young Females. Obstet Gynecol 2012;119(4): 772-9. 35. Raymond EG, Halpern V, Lopez LM. Pericoital oral contraception with levonorgestrel: a systematic review. Obstet Gynecol 2011;117(3):673-81. 36. Wilcox AJ, Weinberg CR, Baird DD. Timing of sexual intercourse in relation to ovulation. Effects on the probability of conception, survival of the pregnancy, and sex of the baby. N Engl J Med 1995;333(23):1517-21. 37. Cleland K, Raymond E, Trussell J, Cheng L, Zhu H. Ectopic pregnancy and emergency contraceptive pills: a systematic review. Obstet Gynecol 2010;115(6):1263-6. Hosted by Family Care International 588 Broadway, Suite 503 New York, NY 10012 Phone: +1 212 941 5300 Further information about specific issues of interest, including listings of specific ECP products by country, may be found through the following websites: • International Consortium for Emergency Contraception website: www.emergencycontraception.org • The Emergency Contraception website, managed by Princeton University and the Association of Reproductive Health Professionals: www.not-2-late.com International Federation of Gynecology & Obstetrics (FIGO) Suite 3 - Waterloo Court 10 Theed Street London SE1 8ST Phone: +44 20 7928 1166 These guidelines were created by a group of experts working with the International Consortium for Emergency Contraception. They have been endorsed by the International Federation of Gynecology and Obstetrics (FIGO), whose representatives participated in reviewing the guidelines.