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Selected practice recommendations for contraceptive use. Third edition 2016. Web annex: Development of updated guidance for the third edition.
Geneva, Switzerland, WHO, Department of Reproductive Health and Research, 2016. 50 p.Over the past 40 years, there have been significant advances in the development of new contraceptive technologies, including changes in formulations and dosing, schedules for administration and novel delivery systems. However, current policies and health-care practices in some countries are based on scientific studies of contraceptive products that are no longer in wide use, on long-standing theoretical concerns that have never been substantiated or on the personal preference or bias of service providers. These outdated policies or practices often result in limitations to both the quality of and the access to family planning services for clients. The goal of this document is to improve access to and quality of family planning services by providing policy-makers and decision-makers with a set of recommendations on how to use family planning methods safely and effectively once they are deemed medically appropriate. Because country situations and programme environments vary so greatly, it is inappropriate to set firm international guidelines on criteria for contraceptive use. However, it is expected that national programmes will use these recommendations for updating or developing their own contraceptive guidelines according to national health policies, needs, priorities and resources, while reflecting upon local values and preferences. There are a total of four World Health Organization (WHO) guidance documents (cornerstones) pertaining to contraception: two focusing on evidenced-based recommendations (primarily targeted towards policy-makers and programme managers) and two focusing on application of the recommendations (primarily targeted towards health-care providers). All four cornerstones are best interpreted and used in a broader context of reproductive and sexual health care. These documents are updated periodically to reflect changes in medical and scientific knowledge. (excerpt)
Geneva, Switzerland, WHO, Department of Reproductive Health and Research, 2016. 72 p.This document is part of the process for improving the quality of care in family planning. Specifically, it is one of two evidence-based cornerstones (guidance documents) of the World Health Organization’s (WHO’s) initiative to develop and implement family planning guidelines for national programmes. The first cornerstone, the Medical eligibility criteria for contraceptive use (MEC, now in its fifth edition), provides thorough information and guidance on the safety of various contraceptive methods for use in the context of specific health conditions and characteristics. This document, Selected practice recommendations for contraceptive use, third edition (SPR third edition), is the second cornerstone; it provides guidance for how to use contraceptive methods safely and effectively once they are deemed to be medically appropriate. For recommendations issued in the SPR, safety considerations include common barriers to safe, correct and consistent use of contraception and the benefits of preventing unintended or unwanted pregnancy.
[New recommendations from the World Health Organization (WHO) for the use of contraceptive methods] Nuevas recomendaciones de la Organizacion Mundial de la Salud (OMS) para el uso de los metodos anticonceptivos.
Gaceta Medica De Mexico. 2016 Sep - Oct; 152(5):601-603.The Medical Eligibility Criteria for Contraceptive Use of the World Health Organization have been updated recently. These criteria constitute a guideline for the selection of family planning methods appropriated for women and men with known medical conditions or personal characteristics of medical relevance. The guidelines last updating incorporates recommendations for the use of a new emergency contraceptive pill and three long-acting hormonal methods, and revises some previously established recommendations. This article provides information on the last edition of such document and aims to contribute to its dissemination.
Contraception. 2016 Sep; 94(3):193-194.Add to my documents.
Research gaps identified during the 2014 update of the WHO medical eligibility criteria for contraceptive use and selected practice recommendations for contraceptive use.
Contraception. 2016 Sep; 94(3):195-201.Universal access to safe and effective contraception is an important public health goal. Family planning and prevention of unintended pregnancy are essential to securing the well-being and autonomy of individuals, while supporting the health and development of communities. The World Health Organization (WHO) recently undertook a process to update its global guidance on “who” can use contraception safely and “how” to use contraception safely and effectively to generate the fifth edition of the WHO Medical Eligibility Criteria for Contraceptive Use (MEC) and the third edition of the WHO Selected Practice Recommendations for Contraceptive Use (SPR). Overall, the MEC demonstrates that contraception is remarkably safe for most people; at least one highly effective contraceptive method is assigned a category “1” or “2” across the majority of conditions in the guidance, indicating no restrictions on use or that the advantages of using a particular method generally outweigh the theoretical or proven risks of use. Once a medically appropriate method is identified, the SPR offers critical guidance on safe and effective use, important for contraceptive management and service delivery. The major goal for producing these evidence-based recommendations is to help improve access to and strengthen the quality of family planning services worldwide. While these recommendations reflect a rigorous synthesis and interpretation of the best evidence to date and contribute significantly to medical and public health knowledge around the world, a number of recommendations in both the MEC and SPR are grounded in limited to no direct evidence. In the absence of direct evidence, indirect evidence and expert opinion inform assessments. Each revision of the MEC and SPR offers an opportunity to identify current knowledge gaps and promote research necessary to continually strengthen the guidelines. As part of the most recent revision of these guidelines, a Guideline Development Group convened in March and September 2014 to generate updated recommendations. During these meetings, we identified a number of key research questions for a variety of topics discussed during the technical consultations. The full list of research gaps is included in Table 1, not further prioritized. However, we present three important topics of global relevance to national programs and policies in greater detail: (a) intrauterine device (IUD) initiation among women at high risk for sexually transmitted infections (STIs); (b) bidirectional drug-drug interactions with use of hormonal contraception (HC) and antiretroviral therapy (ART); and (c) initiation of progestogen-containing contraception following use of ulipristal acetate (UPA) emergency contraception. Each section presents some background on the public health importance of the topic and discusses the limitations of existing data and considerations for future rigorous research. [Excerpts].
[Geneva, Switzerland], WHO, 2016 Feb.  p.Emergency contraception can prevent most pregnancies when taken after intercourse. Emergency contraception can be used in the following situations: unprotected intercourse, contraceptive failure, incorrect use of contraceptives, or in cases of sexual assault. There are 3 methods of emergency contraception: emergency contraceptive pills (ECPs), combined oral contraceptive pills or the Yuzpe method, and copper-bearing intrauterine devices (IUDs). A copper-bearing IUD is the most effective form of emergency contraception available when inserted within 5 days of unprotected intercourse. The emergency contraceptive pill regimen recommended by WHO is either: a. 1 dose of levonorgestrel 1.5 mg, or 1 dose of ulipristal 30 mg, taken within 5 days (120 hours) of unprotected intercourse; or b. 2 doses of combined oral contraceptive pills (also known as the Yuzpe regimen).
Geneva, Switzerland, WHO, 2015.  p. (WHO/RHR/15.07)This executive summary contains all the new recommendations that will be incorporated into the fifth edition of the Medical eligibility criteria for contraceptive use. In addition to the recommendations themselves, the summary provides an introduction to the guideline, a description of the methods used to develop the recommendations for this fifth edition, and a summary of changes (from the fourth edition to the fifth edition of the MEC). It is anticipated that the Medical eligibility criteria for contraceptive use, fifth edition will be available online by 1 July 2015. In the interim, the fourth edition of the guideline, along with this summary of new recommendations provides the complete set of WHO recommendations on medical eligibility criteria for contraceptive use.
[Geneva, Switzerland], WHO, 2012 Jul.  p. (Fact Sheet No. 244)Emergency contraception can prevent most pregnancies when taken after intercourse. Emergency contraception can be used following unprotected intercourse, contraceptive failure, incorrect use of contraceptives, or in cases of sexual assault. There are two methods of emergency contraception: emergency contraceptive pills (ECPs) and copper-bearing intrauterine devices (IUDs). When inserted within five days of unprotected intercourse, a copper-bearing IUD is the most effective form of emergency contraception available. The emergency contraceptive pill regimen recommended by WHO is one dose of levonorgestrel 1.5 mg, taken within five days (120 hours) of unprotected intercourse.
[Geneva, Switzerland], WHO, 2010 Mar.  p.Adapted from the WHO's Decision-Making Tool for Family Planning Clients and Poviders, this flip-chart is a tool to use during family planning counseling or in group sessions with clients. It can: help your clients choose and use the method of family planning that suits them best; give you the information you need for high-quality and effective family planning counselling and care; help you know who may need referral.
Journal of Family Planning and Reproductive Health Care. 2011 Jul; 37(3):128-31.This commentary focuses on guidance around 'missed pill' rules. It discusses the simplification of these rules taken on by the UK's Medicines and Healthcare products Regulatory Agency (MHRA) in 2010 with the aim to produce standardized guidance on the starting of combined hormonal contraceptives and on 'missed pills.'
Washington, D.C., Advocates for Youth, .  p. (From Research to Practice)This article defines and describes emergency contraception, its effectiveness, available forms, conditions of its availability in the United States, regimen specifics, efficacy, modes of action, safety and screening issues, side effects, and barriers and ways to dismantle them, especially for young women. Statements on emergency contraception from prominent health organizations are also provided.
Lancet. 2010 May 8; 375(9726):1607-8; author reply 1608.This author's reply defends their report on a randomized non-inferiority trial to compare the efficacy and safety of ulipristal acetate with levonorgestrel for emergency contraception. It concludes that there is good evidence that ulipristal acetate is much more effective than levonorgestrel at preventing ovulation at the time in the cycle when conception is most likely to occur.
[World Health Organization updates guidance on how to use contraceptives] OMS reactualizeaza recomandarile de practica pentru utilizarea contraceptivelor.
Targu-Mures, Romania, Institutul Est European de Sanatate a Reproducerii, 2006. 7 p. (Actualitati in planificarea familiala No. 2)The World Health Organization (WHO) issued new guidance in 2004 on how to use certain contraceptives safely and effectively, including the following: A woman who misses combined oral contraceptive pills should take a hormonal pill as soon as possible and then continue taking one pill each day. This basic guidance applies no matter how many hormonal pills a woman misses. Only if a woman misses three or more hormonal pills in a row will she need to take additional steps (see p.3). The new guidance simplifies the missed-pill rules issued by WHO in 2002. Men should wait three months after a vasectomy procedure before relying on it. Previous guidelines advised men to wait either three months after the procedure or until they had had at least 20 ejaculations, whichever occurred first. Recent studies have shown, however, that the 20-ejaculation criterion is not a reliable gauge of vasectomy effectiveness. (excerpt)
Contraception Report. 1999 Jan; 9(6): p..A recent WHO-sponsored study has demonstrated that the progestin levonorgestrel, used alone, is a highly effective and well-tolerated form of emergency contraception. With the proportion of pregnancies prevented up to 95% - depending on the timeliness of administration - the levonorgestrel regimen proved more effective than the most commonly used regimen, the Yuzpe method. The Yuzpe method employs a dual-hormone (ethinyl estradiol plus levonorgestrel) approach to preventing pregnancy. Despite the Yuzpe regimen's 75% efficacy rate (a weighted average from 10 studies) the method has been associated with drawbacks. About 50% of users experience nausea and 20% report vomiting, which can reduce patient compliance. (excerpt)
Comparison of three single doses of mifepristone as emergency contraception: a randomised controlled trial.
Australian and New Zealand Journal of Obstetrics and Gynaecology. 2005 Dec; 45(6):489-494.This is an analysis of the Australian component of a large World Health Organization multicentre dose-finding study of mifepristone for emergency contraception and the first clinical study of this controversial drug in Australia. The aims were to compare the effectiveness and side-effects of three single doses of mifepristone taken within 120 h after unprotected coitus as emergency contraception. Design: Double-blind, randomised controlled trial. One hundred fifty healthy women with regular menstrual cycles who requested emergency contraception. Participants were allocated randomly to one of the three doses (10, 50 and 600 mg). The primary outcome was confirmed pregnancy, and secondary outcome measures included side-effects and delay in the onset of the next menses. Pregnancy rates for mifepristone 10, 50 and 600 mg were 2.0, 2.1 and 2.1%, respectively, with no significant difference between groups. No major side-effects occurred, except an unpredictable delay in the onset of the next menses. Mifepristone 600 mg caused a significantly longer delay in the onset of the next menses than either the 10 or the 50 mg dose. Lowering the dose of mifepristone from 600 to 10 mg did not significantly impair its effectiveness as an emergency contraceptive, and caused less delay in the onset of the next menses. Therefore, a dose as low as 10 mg may be preferable to 600 mg for emergency contraception. This is very much lower than the dose required to terminate a pregnancy. (author's)
Baltimore, Maryland, Johns Hopkins Bloomberg School of Public Health, Center for Communication Programs, Information and Knowledge for Optimal Health Project [INFO], 2005 Apr. 8 p. (INFO Reports No. 4)The World Health Organization (WHO) issued new guidance in 2004 on how to use certain contraceptives safely and effectively, including the following: A woman who misses combined oral contraceptive pills should take a hormonal pill as soon as possible and then continue taking one pill each day. This basic guidance applies no matter how many hormonal pills a woman misses. Only if a woman misses three or more hormonal pills in a row will she need to take additional steps (see p.3). The new guidance simplifies the missed-pill rules issued by WHO in 2002. Men should wait three months after a vasectomy procedure before relying on it. Previous guidelines advised men to wait either three months after the procedure or until they had had at least 20 ejaculations, whichever occurred first. Recent studies have shown, however, that the 20-ejaculation criterion is not a reliable gauge of vasectomy effectiveness. (excerpt)
International Journal of Gynecology and Obstetrics. 2006; 92:5-9.The April 2005 edition of Population Reports provides a detailed summary of the different contraceptive choices that are currently available. The report focuses on effective, less costly, easier to deliver contraceptive innovations that have fewer side effects. While some of the new contraceptives discussed are already available in some countries, others are on the brink of introduction. Some of the new methods covered include vaginal rings, transdermal patches, spray-on contraceptives and new implants. Two new variations on fertility awareness-based methods -- the Standard Days Method and the Two-Day method -- are described. The Standard Days Method is reported to be as effective as barrier methods for women with regular cycles between 26 and 32 days long. The Two-Day method can be used by women with cycles of any length regardless of regularity. It however produces best results in couples who can avoid unprotected intercourse for about 10--15 days per cycle. (excerpt)
Lancet. 2005 May 28; 365(9474):1826.More than 2 months after a WHO expert committee recommended that mifepristone and misoprostol should be added to its Essential Medicines list, the file is still awaiting sign-off. A spokesperson for the Department of Medicines Policy and Standards within WHO told The Lancet that it was a “political matter”. We were urged to speak to the Director-General’s office; a spokesperson said she had no idea when a decision would be made. Every day’s delay results in women dying unnecessarily from complications of surgical abortions or use of unsafe medical methods for pregnancy termination. According to WHO statistics, 19 million women have an unsafe abortion worldwide every year; 18.5 million of these occur in developing countries. Deaths due to unsafe abortion are estimated to number around 68,000 a year. (excerpt)
Progress in Reproductive Health Research. 2005; (68):6-7.The preferred regimen for emergency contraceptive pills (ECPs) is 1.5 mg of levonorgestrel in a single dose. Alternatively, the levonorgestrel can be taken as two doses of 0.75 mg, at an interval of 12 hours. A third option is 2 doses of 100 µg of ethinylestradiol plus 0.5 mg of levonorgestrel, at an interval of 12 hours. 1. When should ECPs be taken? Ideally, the ECPs should be taken as early as possible after unprotected intercourse, within 72 hours. If this is not possible, the ECPs may be taken up to 120 hours after unprotected intercourse. However, the woman should be advised that the longer the delay, the lower the effectiveness of the pills; To ensure that women have ECPs available when they need them, they may be given an advance supply or an advance prescription. (excerpt)
Progress in Reproductive Health Research. 1995; (35):8.Emergency contraception should be available to all women who wish to use it, according to a recent conference of reproductive health specialists. In a consensus statement the group asserted that “millions of unwanted pregnancies could be averted” if emergency contraceptives were widely accessible. The conference called for further research on antiprogestogens for emergency contraceptive use. Emergency contraceptives are methods that women use after intercourse to prevent pregnancy. Several methods are known to be safe and effective, including higher doses of regular combined ethinyl estradiol/levonorgestrel contraceptives (the Yuzpe regimen) and the copper intrauterine device (IUD). Levonorgestrel may also be used, and mifepristone (an antiprogesterone drug that supresses ovulation and can inhibit implantation of the fertilized ovum in the uterus wall) is currently being studied to ascertain the optimal dose. “Any woman at risk of unwanted pregnancy may need these methods occasionally,” conference delegates agreed. (excerpt)
International Journal of Gynecology and Obstetrics. 2004 Nov; 87(2):111-113.In May 2004, the Food and Drug Administration of the United States ruled that emergency contraception would not be available over the counter. In December 2003, two FDA expert panels overwhelmingly recommended approval of the drug by a 23 to 4 vote after reviewing more than 15,000 pages of data for over 40 studies in support of the over the counter (OTC) application. The FDA typically follows the recommendations of the government scientific committees, and the experts in this case made it clear that use of emergency contraception does not increase promiscuity or unprotected sex among teenaged women. In an unusual decision written by Dr. Steven Galson, Acting Director of FDA’s Center for Drug Evaluation and Research, and not supported by other members of the FDA staff, a decision was deferred pending further information about the safety of emergency contraception in girls under the age of 16 or on the possibility raised by the manufacturer in their proposal that the drug be used over the counter for girls over the age of 16 and that there be an age limit to those who could get it without speaking to a pharmacist or without a prescription. (excerpt)
Meta-analyses of randomized trials comparing different doses of mifepristone in emergency contraception.
Contraception. 2003 Dec; 68(6):447-452.There is some evidence from randomized trials that different doses of mifepristone for emergency contraception do not differ in efficacy in the range from 10 mg to 600 mg. Lower doses have a better side effect profile and are cheaper and therefore they would be preferable in the absence of a dose effect. However, the lack of significance is not evidence of absence of an effect. More evidence can be obtained by combining results of trials. We present meta-analyses of randomized trials comparing doses of mifepristone for emergency contraception from 5 mg to 600 mg, with regard to the efficacy to prevent unwanted pregnancies. We use two approaches for analysis, one using only within-trial information and another one combining within-trial with between-trial information. We discuss the results in terms of equivalence. There is some evidence of a small dose effect on efficacy in the lower range of doses (<50 mg). The pregnancy rate increases by a factor of 1.6 when the dose of 10 mg is used instead of 25 mg (95% confidence interval: 1.1–2.4). In terms of the number of women needed to treat, however, using 10 mg in the place of 25 mg implies having one extra pregnancy every 146 women requesting emergency contraception, which might be a low cost compared to the benefit of more women having access to treatment. (author's)
Contraception. 2003 Dec; 68(6):439-446.The present paper combines the estimates of efficacy and side effects of 10 mg mifepristone for emergency contraception obtained from randomized trials. A total of 6083 women participating in 12 randomized trials and receiving 10 mg mifepristone for emergency contraception up to 120 h after intercourse, were analyzed for efficacy. Between 4188 and 5833 women were analyzed for side effects and 3601 for delay of menses of more than 7 days. Prevented fractions, the effect of delay and of further acts of intercourse after treatment administration were analyzed in 3440 women, using individual data. The combined pregnancy rate from all the 12 trials was 1.7% [101/6083, 95% confidence interval (CI): 1.3–2.2]. From the three trials providing individual data, the combined pregnancy rate was 1.3% (45/3440, 95% CI: 0.9 –1.7) and the estimate of pregnancies prevented was 83.4% (95% CI: 77.4–87.8). There was a sharp decline in efficacy when treatment was administered during the 5th day after intercourse compared to administration during the 1st day, the odds of pregnancy increasing by a factor of 5.3 (95% CI: 1.9 –14.9). The relative risk of pregnancy was about 28 times higher among women with unprotected acts of coitus between treatment administration and the onset of next menses, compared with women reporting none [odds ratio (OR) = 27.6, 95% CI: 12.7– 60.2]. The increase in risk for women reporting protected acts of intercourse during this interval was not statistically significant (OR = 1.8, 95% CI: 0.9 –3.8). There was a large heterogeneity among trials in all side effects and delay of menses of more than 7 days (all had p < 0.0001 for the test of homogeneity). The percentage of women with nausea ranged from 0.0–19.4% (highest upper 95% confidence limit: 23.0%), that of vomiting from 0.0–4.3% (highest upper 95% confidence limit: 6.1%), that of lower abdominal pain from 4.3–19.1% (highest upper 95% confidence limit: 22.7%). The percentage of women with delay of menses of more than 7 days ranged from 4.3–25.8% (highest upper 95% confidence limit: 34.1%). We conclude that 10 mg mifepristone is an effective emergency contraception regimen, with an acceptable side-effects profile. Postponing treatment until the 5th day seriously decreases efficacy. The risk of pregnancy is dramatically increased among women having unprotected acts of intercourse between treatment administration and the onset of next menses. This risk may be enhanced for women whose ovulation is postponed by treatment. (author's)
Geneva, Switzerland, WHO, Department of Reproductive Health and Research, . 3 p.The development of new and improved methods of contraception for both women and men is a key component of the strategy to improve the quality of family planning programmes. Family planning clients are often restricted by the choice of methods offered to them, or are deterred from using contraception due to the side effects related to use of available methods. (excerpt)
Summary of evidence and research needs on the use of mifepristone in fertility regulation: consensus from the conference.
Contraception. 2003 Dec; 68(6):401-407.The conference on the use of mifepristone to reduce unwanted pregnancy, sponsored by the World Health Organization, Concept Foundation and the Rockefeller Foundation, took place in Bellagio, Italy, between 24 and 28 September 2001. The objective of the conference was to review the scientific information and to evaluate the use of mifepristone for emergency contraception, luteal contraception and menstrual induction. Mifepristone is highly effective for emergency contraception but its advantages and disadvantages in comparison with levonorgestrel need to be further studied. Data indicate that mifepristone alone or in combination with misoprostol has potential for occasional use for women seeking help following repeated unprotected intercourse and/or when the interval between intercourse and treatment is more then 120 h. Administration of mifepristone immediately after ovulation seems to be an effective contraceptive method. However, before it can be used commonly, there is a need for a simple and inexpensive method to identify the right time in the cycle. Once-a-month treatment with mifepristone and misoprostol at the expected time of menstruation is not a practical method due to bleeding irregularities and timing of treatment. Menstrual induction with mifepristone and a suitable prostaglandin analogue is highly effective. A randomized comparison with manual vacuum aspiration is, however, needed before it can be recommended for routine use. (author's)