Despite significant declines over the past 2 decades, the United States continues to have teen birth rates that are significantly higher than other industrialized nations. Use of emergency contraception can reduce the risk of pregnancy if used up to 120 hours after unprotected intercourse or contraceptive failure and is most effective if used in the first 24 hours. Indications for the use of emergency contraception include sexual assault, unprotected intercourse, condom breakage or slippage, and missed or late doses of hormonal contraceptives, including the oral contraceptive pill, contraceptive patch, contraceptive ring (ie, improper placement or loss/expulsion), and injectable contraception. Adolescents younger than 17 years must obtain a prescription from a physician to access emergency contraception in most states. In all states, both males and females 17 years or older can obtain emergency contraception without a prescription. Adolescents are more likely to use emergency contraception if it has been prescribed in advance of need. The aim of this updated policy statement is to (1) educate pediatricians and other physicians on available emergency contraceptive methods; (2) provide current data on safety, efficacy, and use of emergency contraception in teenagers; and (3) encourage routine counseling and advance emergency-contraception prescription as 1 part of a public health strategy to reduce teen pregnancy. This policy focuses on pharmacologic methods of emergency contraception used within 120 hours of unprotected or underprotected coitus for the prevention of unintended pregnancy. Emergency contraceptive medications include products labeled and dedicated for use as emergency contraception by the US Food and Drug Administration (levonorgestrel and ulipristal) and the “off-label” use of combination oral contraceptives.
Background
Despite significant declines over the past 2 decades, the United States continues to have teen birth rates that are significantly higher than other industrialized nations.1,2 The most recent birth data available indicate a birth rate of 34.3 per 1000 among 15- to 19-year-olds.3 The most current pregnancy outcomes data indicate that 57% of teen pregnancies ended in live births, 27% ended in induced abortion, and 16% ended in miscarriage or stillbirth.4,5 Pediatricians have an important role, through their interactions with adolescents, to address the major public health objective of continuing to reduce adolescent pregnancy in the United States.6
The current decrease in teen pregnancies since the 1990s has resulted from both increased abstinence and increased use of contraception,7,8 but large numbers of teenagers continue to engage in unprotected sexual activity. The rate of “ever having intercourse” among 15- to 19-year-old females is 43%, and, among males of the same age range, this rate is 42%.9 The rate increases between early and late adolescence, from 13% of 15-year-olds to 70% of 19-year-olds. Although most teenagers report first intercourse with a steady partner and consensual sex, approximately 10% report being forced to have sex. Rates of sexual assault among teenagers and young adults are higher than in any other group,10 another factor increasing the risk of unintended pregnancy.11
Nearly 80% of pregnancies in adolescents are unintended12 and result from contraceptive failure or nonuse. The most commonly used method of contraception reported by teenagers who have had intercourse is the condom, followed by withdrawal and the oral contraceptive pill.9 Research has shown, however, that many teenagers use contraceptive methods inconsistently.13 In addition to the risk of sexually transmitted infections (STIs), the pregnancy rate for withdrawal is particularly high (27% of women who use the withdrawal method will have an unintended pregnancy in the first year of using this method).14 Although condoms are important for protection against STIs as well as pregnancy and the pill can be a very effective method for pregnancy prevention, both methods require strict adherence by the user to be maximally effective.
Emergency contraception can reduce the risk of pregnancy if used up to 120 hours after unprotected intercourse15,16 or contraceptive failure and is most effective if used in the first 24 hours.17,18 In August 2007, the US Food and Drug Administration (FDA) authorized nonprescription access to Plan B (levonorgestrel, manufactured by Teva Women’s Health, Woodcliff Lake, NJ) for women 18 years of age and older and then in 2009 changed the age limit to females 17 years of age and older. Prescription for emergency contraception is required for teenagers younger than 17 years in most states.19 As of the date of publication, males 17 years or older can also access Plan B with or without a prescription.
Studies have shown that adolescents are more likely to use emergency contraception if it has been prescribed in advance of need.20 However, a majority of practicing pediatricians and pediatric residents do not routinely counsel patients about emergency contraception and have not prescribed it.21,–24 This policy statement will focus on pharmacologic methods of emergency contraception used within 120 hours of unprotected or underprotected coitus for the prevention of unintended pregnancy (Table 1).
| Brand . | First Dose . | Second Dose . | Ethinyl Estradiol per Dose, μg . | Levonorgestrel per Dose, mg . |
|---|---|---|---|---|
| Progestin-only pills | ||||
| Next Choice or Plan B | 2 pills | None | 0 | 1.5 |
| Plan B One-Step | 1 pill | None | 0 | 1.5 |
| Ovrette | 20 pills | 20 pill | 0 | 0.75 |
| Other emergency contraception | ||||
| ella | 30 mg of ulipristal acetate | |||
| Combined estrogen and progestin pills | ||||
| Ovral | 2 white pills | 2 white pills | 100 | 0.5 |
| Levora | 4 white pills | 4 white pills | 120 | 0.6 |
| Nordette | 4 light orange pills | 4 light orange pills | 120 | 0.6 |
| Seasonale | 4 pink pills | 4 pink pills | 120 | 0.6 |
| Triphasil | 4 yellow pills | 4 yellow pills | 120 | 0.5 |
| Alesse | 5 pink pills | 5 pink pills | 120 | 0.5 |
| Brand . | First Dose . | Second Dose . | Ethinyl Estradiol per Dose, μg . | Levonorgestrel per Dose, mg . |
|---|---|---|---|---|
| Progestin-only pills | ||||
| Next Choice or Plan B | 2 pills | None | 0 | 1.5 |
| Plan B One-Step | 1 pill | None | 0 | 1.5 |
| Ovrette | 20 pills | 20 pill | 0 | 0.75 |
| Other emergency contraception | ||||
| ella | 30 mg of ulipristal acetate | |||
| Combined estrogen and progestin pills | ||||
| Ovral | 2 white pills | 2 white pills | 100 | 0.5 |
| Levora | 4 white pills | 4 white pills | 120 | 0.6 |
| Nordette | 4 light orange pills | 4 light orange pills | 120 | 0.6 |
| Seasonale | 4 pink pills | 4 pink pills | 120 | 0.6 |
| Triphasil | 4 yellow pills | 4 yellow pills | 120 | 0.5 |
| Alesse | 5 pink pills | 5 pink pills | 120 | 0.5 |
Additional combinations are available at: http://ec.princeton.edu.
Definition of Emergency Contraception
Emergency contraception is the only contraceptive method designed to prevent pregnancy after intercourse. Indications for use of emergency contraception include sexual assault, unprotected vaginal sexual intercourse, and contraceptive failures, such as broken condoms and missed or late doses of other hormonal methods (ie, missing 3 consecutive doses of active birth control pills, patch off for more than 24 hours during ‘patch-on’ week, or vaginal ring out for more than 3 hours during ‘ring-in’ week). Emergency contraceptive medications include products labeled and approved for use as emergency contraception by the FDA (levonorgestrel and ulipristal acetate) and the “off-label” use of combination oral contraceptives—the Yuzpe method—described in the literature since 1974.25 Pediatricians should also be aware that insertion of a copper intrauterine device within 5 days of unprotected intercourse is an additional method of emergency contraception available in the United States. This statement does not cover the intrauterine device method in more detail, because it is not an option available to most pediatricians in their offices.
Emergency-Contraception Methods
Progestin-Only Regimens
Levonorgestrel emergency contraception was approved by the FDA in 1999 under the brand name Plan B and is currently marketed as Plan B, Plan B One Step (Teva Women’s Health, Woodcliff Lake, NJ), and Next Choice (Watson Pharma Inc, Corona, CA). Plan B and Next Choice consist of 2 pills containing 0.75 mg of levonorgestrel each. Although prescribing directions indicate that patients should take each of the 2 pills 12 hours apart, recent data suggest that both pills taken together as a single dose (total treatment dose of 1.5 mg levonorgestrel) is equally effective and without increased adverse effect.15 To this effect, the next generation of emergency contraception, Plan B One Step, is packaged as a single pill with 1.5 mg levonorgestrel to be taken 1 time.26 Pharmacies may stock both 0.75-mg and 1.5-mg levonorgestrel versions. Package labeling indicates that all 3 brands of levonorgestrel emergency contraception should be taken within 72 hours of unprotected intercourse; however, data support that use up to 120 hours after intercourse may prevent pregnancy.15,16
The FDA-labeled levonorgestrel methods are currently the preferred emergency contraception for teenagers because of their improved adverse effect profile and increased effectiveness in comparison with combination oral contraceptive methods. Adolescents should be instructed to take 1.5 mg of levonorgestrel as soon as possible and up to 120 hours after unprotected intercourse. No physical examination or pregnancy testing is required before use. Adolescents are advised to have a pregnancy test done if they do not have a normal period within 3 weeks of emergency-contraception use.
Ulipristal Acetate Progesterone Agonist/Antagonist
In August 2010, the FDA approved a progesterone agonist/antagonist ulipristal acetate (ella, Watson Pharma Inc, Corona, CA) for use as an emergency contraceptive.27 Ulipristal binds to the human progesterone receptor, thereby preventing the binding of progesterone. Ulipristal is a single pill containing 30 mg of ulipristal acetate and is indicated up to 120 hours after unprotected intercourse.28 Unlike with hormonal emergency contraception, existing pregnancy must be excluded before prescribing ulipristal because of the risk of fetal loss if used in the first trimester of pregnancy.28 Patients should be counseled that a pregnancy test is indicated if their period is more than 7 days later than expected after taking ulipristal. Patients should also be instructed to return for evaluation of the rare but possible occurrence of ectopic pregnancy if severe abdominal pain occurs 3 to 5 weeks after the dose. Ulipristal is available only by prescription regardless of age.
Combined Hormonal Regimens (Yuzpe Method)
The use of combination oral contraceptives for emergency contraception is commonly referred to as the “Yuzpe method.”25 Commonly used since 1974, its acceptability and efficacy was limited by adverse effects of nausea and vomiting. The Yuzpe method involves taking 2 doses of pills, each containing a minimum of 100 µg of ethinyl estradiol and a minimum of 500 µg of levonorgestrel. Levonorgestrel is the active isomer of norgestrel, so equivalent dosing of any pill containing norgestrel requires doubling the dose of progestin. Other pill formulations used for emergency contraception are included in Table 1. Similar information is available from the Office of Population Research at Princeton University, which maintains a comprehensive source of information on emergency contraception (http://ec.princeton.edu/). The availability of many combination oral contraceptives with norgestrel or levonorgestrel makes this alternative particularly helpful when there is no or limited access to an emergency-contraception product. Although combination oral contraceptives have not been labeled specifically for emergency contraception, the FDA Reproductive Health Advisory Committee and professional organizations such as the American College of Obstetricians and Gynecologists have declared the use of combination oral contraceptives safe and effective for emergency contraception.29,30
Mechanism of Action
Hormonal emergency contraception, including combined and progestin-only methods, inhibits ovulation, disrupts follicular development, and interferes with the maturation of the corpus luteum.31,–37 These are the same mechanisms by which other hormonal methods of contraception prevent pregnancy. Results of studies evaluating the effect of hormonal emergency contraception on the endometrium are conflicting. Some studies suggest that endometrial histologic or biochemical alterations occur after emergency contraception by which endometrial receptivity to the implantation of a fertilized egg is impaired.31,38,39 Other studies demonstrate little to no effect on the endometrium.32,33,35,37,40,41 Suggested mechanisms, including alteration of sperm or egg transport, interference with the fertilization process, and/or cervical mucus changes, have not been verified by clinical data.42,43 Hormonal emergency contraception does not interrupt established pregnancies and has not been linked to teratogenic effects.44,–47
Ulipristal acetate inhibits follicular development and rupture, so its primary mechanism of action as an emergency contraceptive is considered to be inhibition or delay of ovulation.28 It also decreases endometrial thickness and may have a direct effect on implantation. Ulipristal is in pregnancy category X, because data from animal studies suggest that fetal loss is a risk of use during the first trimester. Therefore, pregnancy should be excluded before a dose is given.
Efficacy
The efficacy of combined hormonal or progestin-only emergency contraception depends on the timing of use within the menstrual cycle.48,49 A randomized controlled trial has shown that the progestin-only method, Plan B, is more effective at preventing pregnancy than combination hormone methods. When the 2 regimens were started within 72 hours, the overall pregnancy rate was 1.1% in the levonorgestrel-only group in comparison with 3.2% in the combination oral contraceptive (Yuzpe method) group.17 The proportion of pregnancies prevented in this study was 85% with levonorgestrel and 57% with the combination oral contraceptive (Yuzpe) method in comparison with the expected number when no treatment was given. The effectiveness of emergency contraception might be summarized as follows: if 100 female adolescents have unprotected coitus in the middle of their menstrual cycles, estimates suggest that approximately 8 will become pregnant. Appropriate use of emergency contraception would reduce this number to approximately 2 pregnancies.14
Compared with 1.5 mg of levonorgestrel, ulipristal acetate has been shown to be equally efficacious when taken within 72 hours of unprotected intercourse. Glasier and colleagues50 observed no statistically significant difference in pregnancy rates between women taking 30 mg of ulipristal (1.8%) or 1.5 mg of levonorgestrel (2.6%) within 72 hours of unprotected intercourse (odds ratio, 0.69%; 95% confidence interval, 0.35–1.31). This finding was consistent with a previous study.51 Between 72 and 120 hours, the Glasier study showed some evidence that ulipristal may be more effective at preventing pregnancy.
Adverse Effects and Contraindications
Levonorgestrel-Only Methods (Plan B, Plan B One Step, and Next Choice)
The only contraindication to use of levonorgestrel emergency contraception is known pregnancy because of lack of utility, not concern for teratogenicity or fetal loss. Young women with contraindications to estrogen may use levonorgestrel. The rate of nausea and vomiting with levonorgestrel emergency contraception is approximately half that with the combination oral contraceptive (Yuzpe) method, and routine use of antiemetics is not indicated.17 Package labeling for the newest levonorgestrel emergency-contraception product, Plan B One Step, indicates that the most common adverse effect reported after use was heavier menstrual bleeding.26
Repeated use of levonorgestrel emergency contraception is associated with the same adverse effects as 1-time use. A recent Cochrane review of the subject found no serious adverse effects in trials of repeated use.52
Ulipristal
The most common adverse effects reported by users of ulipristal include headache (18%), nausea (12%), and abdominal pain (12%).28 As previously noted, animal studies suggest that fetal loss is a risk of use during the first trimester. No fetal malformations have been reported.28 It is recommended to redose ulipristal if vomiting occurs within 3 hours of the initial dose.
Yuzpe/Estrogen-Containing Methods
The most common adverse effects that occur during the first 24 to 48 hours of using estrogen-containing emergency-contraception methods are nausea (approximately 50%) and vomiting (approximately 20%), which seem unaffected by food intake.53,–55 Other adverse effects might include fatigue, breast tenderness, headache, abdominal pain, and dizziness.14 The severity and incidence of nausea and vomiting can be decreased significantly by using an antiemetic 1 hour before an estrogen-containing regimen.55 Antiemetics are ineffective if taken after nausea is present.55 Effective oral antiemetics include meclizine, 25 to 50 mg, and metoclopramide, 10 mg by mouth, taken once before combination-hormone methods.55,56 Patients with contraindications to estrogen use such as history of thromboembolism should not use the combination oral contraceptive (Yuzpe) method.
Other Clinical Considerations
The discussion of emergency-contraception methods with patients must also include the fact that none of these methods will protect from STIs. Patients should be encouraged to contact their physician after use to schedule follow-up visits for STI testing or treatment, as indicated. In addition, these follow-up visits are an important time to discuss options for ongoing contraception, abstinence, and consensual intercourse. It should be emphasized to patients that emergency contraception is intended for emergency use and that routine use of emergency contraception to prevent pregnancy is not as effective as the regular use of other forms of contraception. Although emergency contraception is exclusively for use by females, young men should be counseled on this method so that they may also suggest use to their female partners if needed.
Adolescents and Emergency Contraception: Awareness and Access
The regulatory changes and public discourse surrounding emergency contraception have increased the public’s awareness of the methods; however, large numbers of teenagers still do not have much knowledge about correct use. In 2002, Aiken and colleagues57 reassessed the awareness and knowledge of emergency contraception among 13- to 21-year-old females recruited from the same Pittsburgh clinic and drug treatment center from which they recruited participants for a 1996 study of emergency-contraception knowledge. Their study showed that, in 2002, 73% of teenagers were aware of emergency contraception, an increase from 44% in 1996. Although 95% of teenagers who were aware also knew where to get emergency contraception in 2002, up from 78% in 1996, only 52% were aware of the correct time frame for use (up from only 20% in 1996). Recent studies conducted in New York City and Hawaii found the percentage of teenagers aware of emergency contraception was closer to 50%.58,59
Data from the most recent 2006–2008 National Survey of Family Growth indicate that 14% of sexually experienced adolescent girls have ever used emergency contraception,9 up from 8% in the 2002 survey. Reasons for use of emergency contraception by teenagers were examined by Alford et al60 in a retrospective cohort study published in 2010. The most common reason for use was condom failure. Importantly, 13% of adolescents’ use of emergency contraception during the study period was for nonconsensual penetration. A qualitative study conducted in Philadelphia aimed to explore teenagers’ attitudes about the use of emergency contraception in more detail. Themes that emerged as barriers to emergency contraception use among the teenagers included worries about confidentiality, ability to get emergency contraception depending on age, worries about adverse effects, and lack of transportation to obtain the medication.61 In a recent study of college-aged students, fewer than 16% knew that emergency contraception was available in their college health center.62
One important strategy to increase timely access to emergency contraception for adolescent girls is advanced prescribing. Advanced prescription for emergency contraception means providing a teenager with a supply or a prescription for emergency contraception before it is needed. Advanced prescribing facilitates access for teenagers in states that require prescriptions and also reduces the cost of obtaining emergency contraception for adolescents of all ages whose insurance provides coverage for emergency contraception with a prescription. In a 2010 review of 7 randomized trials of emergency contraception that included teenagers, it was shown that advanced prescription increased the use of emergency contraception and decreased time to use.20 None of the studies showed an increase in sexual activity or decrease in ongoing contraceptive use in adolescents given advanced access to emergency contraception.
Despite evidence that improved access to emergency contraception (through advanced prescribing and allowing nonprescription access) increases the likelihood of use, no studies have demonstrated that improved access to emergency contraception reduces the pregnancy rate in a population.63,64 There may be statistical reasons for this related to sample size of the studies, but it also may be that pregnancy rates remain unchanged overall because unprotected intercourse remains more frequent than emergency contraceptive use, despite increased access. The lack of demonstrated population level impact does not negate the potential for the method to reduce the risk of unintended pregnancy for an individual woman, however.
Ethical Dilemmas for Physicians and Pharmacists
Despite multiple studies showing no increased risk behavior and evidence that hormonal emergency contraception will not disrupt an established pregnancy, public and medical discourse reflects that personal values of physicians and pharmacists continue to affect emergency-contraception access, particularly for adolescents.65,–70 Some physicians refuse to provide emergency contraception to teenagers, regardless of the circumstance, and others may provide emergency contraception only if nonconsensual penetration has occurred. Both of these choices by physicians have important adverse consequences for adolescents in their ability to access emergency contraception.
A study published in 2009 demonstrated that the decision to provide emergency contraception at a time of need but not in advance of need may be related to the physician’s beliefs about whether it is okay for teenagers to have sex.24 Often, physicians hold conflicting values when approaching reproductive health issues with teenagers. Physicians may object to unprotected intercourse or intercourse outside of marriage, but they may also feel the need to prevent teen pregnancy. Pediatricians should strive to be aware of the ways in which the underlying beliefs they bring to their clinical practice affect the care that they provide.
The American Academy of Pediatrics has issued a policy statement on refusal to provide information or treatment on the basis of conscience.71 According to the policy, pediatricians have a duty to inform their patients about relevant, legally available treatment options to which they object and have a moral obligation to refer patients to other physicians who will provide and educate about those services. Failure to inform/educate about availability and access to emergency-contraception services violates this duty to their adolescent and young adult patients.
Summary and Recommendations
Pediatricians should be aware that sexual behavior is prevalent among teenagers and that as many as 10% of sexually active teenagers may be the victims of sexual assault.
Effective contraceptive use with dual methods (condoms in addition to hormonal contraception/intrauterine device) or abstinence are the best ways for teenagers to avoid pregnancy. Many teenagers are at high risk of contraceptive failure, however, and emergency contraception is an important backup method for all teenagers. Emergency contraception is most effective in decreasing risk of pregnancy when used as soon as possible, but it may be used 120 hours after unprotected or underprotected intercourse.
Indications for use of emergency contraception include sexual assault, -unprotected intercourse, condom breakage or slippage, and missed or late doses of hormonal contraceptives, including the oral contraceptive pill, contraceptive patch, contraceptive ring, and injectable contraception.
Pediatricians should provide levonorgestrel 1.5 mg (Plan B, Plan B One Step, or Next Choice) for teenagers in immediate need of emergency contraception and provide prescriptions/supply for teenagers to have on hand in case of future need (ie, advanced provision). No pregnancy test is required before the use of levonorgestrel.
The levonorgestrel method has an improved adverse effect profile and increased effectiveness compared with combined hormonal emergency-contraception methods. The rate of nausea and vomiting with levonorgestrel emergency contraception is approximately half that with the combination oral contraceptive (Yuzpe) method, and routine use of antiemetics is not indicated. Advanced provision increases the likelihood that teenagers will use emergency contraception when needed, reduces the time to use, and does not decrease condom or other contraceptive use. Both males and females 17 years or older may obtain levonorgestrel without a prescription, but must show proof of age.
Other emergency-contraception methods include ulipristal (ella) and estrogen-containing (Yuzpe) emergency-contraception methods. Adverse effects of ulipristal include headache, nausea, and abdominal pain. Existing pregnancy must be excluded before prescribing ulipristal. The adverse effects of the estrogen-containing emergency contraception (Yuzpe) method include nausea, vomiting, and abdominal pain. Patients with contraindications to estrogen use, such as history of thromboembolism, should not use the combination oral contraceptive (Yuzpe) method.
All adolescents, males and females, and families of disabled adolescents should be counseled on emergency contraception as part of routine anticipatory guidance in the context of a discussion on sexual safety and family planning regardless of current intentions for sexual behavior. All contraceptive and STI counseling for adolescents should include education and counseling regarding the use and availability and advance prescription of emergency contraception wherever these visits occur, including emergency departments, clinics, and hospitals. Adolescents should be instructed to use emergency contraception as soon as possible after unprotected intercourse and to then schedule a follow-up appointment with their primary provider to address the need for STI testing and ongoing contraception.
At the policy level, pediatricians should advocate for increased nonprescription access to emergency contraception for teenagers regardless of age and for insurance coverage of emergency contraception to reduce cost barriers.
Lead Authors
Krishna K. Upadhya, MD, MPH
Cora C. Breuner, MD, MPH
Contributing Author
Maria E. Trent, MD, MPH
Committee on Adolescence, 2010–2011
Margaret J. Blythe, MD, Chairperson
William P. Adelman, MD
Cora C. Breuner, MD, MPH
David A. Levine, MD
Arik V. Marcell, MD, MPH
Pamela J. Murray, MD, MPH
Rebecca F. O’Brien, MD
Warren M. Seigel, MD
Liaisons
Rachel Miller, MD – American College of Obstetricians and Gynecologists
Jorge L. Pinzon, MD – Canadian Pediatric Society
Benjamin Shain, MD, PhD – American Academy of Child and Adolescent Psychiatry
Staff
Karen Smith
Mark Del Monte, JD
This document is copyrighted and is property of the American Academy of Pediatrics and its Board of Directors. All authors have filed conflict of interest statements with the American Academy of Pediatrics. Any conflicts have been resolved through a process approved by the Board of Directors. The American Academy of Pediatrics has neither solicited nor accepted any commercial involvement in the development of the content of this publication.
All policy statements from the American Academy of Pediatrics automatically expire 5 years after publication unless reaffirmed, revised, or retired at or before that time.
Comments
A clarification of these drugs' mechanism of action
The statement, made twice in this report, that "hormonal emergency contraception does not interrupt established pregnancies", while technically accurate, is incomplete and misleading. Although there are contradictory data, there is significant evidence that these medications have post-ovulatory effects, including interference with the implantation of the blastocyst, and can thereby interrupt the natural development of the formed zygote.
In their discussion on the mechanism of action, the authors describe these drugs' pre-ovulatory effects, then cite conflicting data on their post-ovulatory ones before jumping to the conclusion that they do "not interrupt established pregnancies". Their consideration of the post- ovulatory effects is worryingly incomplete.
To better understand these drugs' mechanism of action, Mikolajczyk et al. analyzed data from published studies and showed that the disruption of ovulation alone would result in a 50% reduction of pregnancy at best if given immediately after intercourse [1]. This number decreases sharply to 8% at 72 hours and is 0% at 120. All of these numbers are significantly lower than the published reductions of between 59% and 95%, leading the authors to conclude that "The gap between effectiveness of levonorgestrel EC estimated from clinical studies and what can be attributed to disruption of ovulation may be explained by overestimation of actual effectiveness and supplementary mechanisms of action, including postfertilization effects [1]." Significant among these postfertilization effects is the disruption of implantation.
The use of the term "established pregnancy" (meaning post- implantation) attempts to circumvent this point. While this may be a convenient and accepted delineation, it represents a point in time after the formation the fertilized zygote and certainly not the beginning of the process of human life. This is introductory textbook material: "Although human life is a continuous process, fertilization is a critical landmark because, under ordinary circumstances, a new, genetically distinct human organism is thereby formed [2]." When acting by blocking implantation, these medications result in the loss of the developing child at the blastocyst stage.
Given the evidence that these medications can, when given after ovulation has been initiated, disrupt implantation, and understanding that this disruption results in the loss of the developing child, the statement "hormonal emergency contraception does not interrupt established pregnancies", while being technically accurate, is a truth but not the whole truth. A more precise way to say this would be:
"If given before the initiation of ovulation, hormonal emergency contraception can prevent pregnancy. If given after the woman has ovulated, one of the effects of these products may include prevention of the implantation of the blastocyst, resulting in the loss of the developing child."
This is an especially important point to make from an informed consent standpoint, as many feel strongly that this latter mechanism of action is tantamount to an induced abortion. I urge the Academy to amend its policy accordingly, and for physicians to consider this information when prescribing and include it when discussing this topic with their patients.
1. Mikolajczyk RT, Stanford JB. Levonorgestrel emergency contraception: a joint analysis of effectiveness and mechanism of action. Fertil Steril. 2007;88(3):565-71
2. O'Rahilly R, Muller F. Human Embryology and Teratology, 2nd edition. New York: Wiley-Liss;1996:8
Conflict of Interest:
None declared
Emergency Contraception - updates on mechanism and efficacy
The Committee on Adolescence is to be congratulated on writing a much needed review on Emergency Contraception (EC). With the inevitable delay of publication, additional studies have further clarified several important issues raised in the review: (1) the mechanism of action of levonorgestrel (LNG) EC; (2) the duration of efficacy for LNG EC and ulipristal; and (3) the impact of obesity on efficacy. First, two clinical studies have demonstrated that LNG EC interferes with follicular rupture and ovulation. Using hormonal determination of ovulation in 99 women, Novikova et al[1] found that no pregnancies occurred when LNG was given -5 to -2 days prior to ovulation, but those with unprotected intercourse on day -1 or the day of ovulation had the expected pregnancy rate. Noe et al[2] confirmed this observation; among 87 women taking EC -5 to -1 days before ovulation, none became pregnant, compared to 13 expected; in the 35 women taking LNG EC on the day of ovulation (day 0) or beyond there were 6 pregnancies and 7 expected. Given the lack of post-ovulatory efficacy of LNG EC and normal endometrial histology women with ovulatory cycles,[3] there is no evidence for interference with implantation or any abortifacient effect. There is no impact on a pre-existing pregnancy. Addressing these common myths is important because lack of understanding of the mechanism of action continues to be a barrier to evidence-based prescribing and dispensing of EC for pediatricians, pharmacists, Emergency Department doctors and others.
Second, ulipristal has efficacy to 5 days. While LNG EC is approved for 72 hours after intercourse and commonly used to 120 hours, a recent analysis combining 4 WHO trials found that LNG efficacy was maintained from days 1 to 4 but that the pregnancy rate was 5.8x higher for LNG EC given on day 5 (96-120 hours) than on day 1;[4] ulipristal has continued efficacy on day 5 [5]. Ulipristal delays follicular rupture when given before the onset of the LH surge but also has efficacy after the onset of the surge but before the LH peak and a direct inhibitory effect on follicular rupture [6]. Since follicular rupture is delayed by 4 to 10 days, unprotected intercourse later in the same cycle could result in pregnancy risk. Because ulipristal binds progesterone receptors, it could potentially interfere with progestin contraceptives such as progestin-only pills or even combined oral contraceptives, and these users should be counseled about the need to use backup barrier contraceptives until the next menstrual period. Pregnancy should be excluded before prescribing ulipristal. Thirdly, ulipristal and particularly LNG EC appear to have less efficacy in obese women[7] and thus careful follow-up is important after use.
Pediatricians have an important role to play in increasing access to EC not only in their offices but as advocates for evidence based use including removing the age restriction for LNG EC, as was recommended by the FDA panel. The Policy Statement emphasizes the importance of EC as a component of comprehensive adolescent health.
S. Jean Emans, MD
Chief, Division of Adolescent/Young Adult Medicine
Boston Children's Hospital, Boston MA
Minor errata, the ethinyl estradiol dose for 5 Avianne tablets is 100 ug not 120 ug as listed in Table 1.
1. Novikova N, Weisberg E, Stanczyk FZ, et al. Effectiveness of levonorgestrel emergency contraception given before or after ovulation--a pilot study. Contraception 2007;75:112. 2. Noe G, Croxato HB, Salvatierra AM, et al. Contraceptive efficacy of emergency contraception with levonorgestrel given before or after ovulation. Contraception 2010;81:414-420. 3. Durand M, del Carmen Cravioto M, Raymond EG, et al. On the mechanisms of action of short-term levonorgestrel administration in emergency contraception. Contraception 2001;64:227. 4. 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;84:35-39. 5. Moreau C, Trussell J. Results from pooled Phase III studies of ulipristal acetate for emergency contraception. Contraception. 2012;86(6):673-80. . 6. Brache V, Cochan L, Jesam C, et al. Immediate pre-ovulatory administration of 30 mg ulipristal acetate significantly delays follicular rupture. Hum Reprod 2010;25:2256-2263. 7. Glasier A, Cameron ST, Blithe D, Scherrer B, Mathe H, Levy D, Gainer E, Ulmann A. Can we identify women at risk of pregnancy despite using emergency contraception? Data from randomized trials of ulipristal acetate and levonorgestrel. Contraception. 2011;84:363-7.
Conflict of Interest:
None declared
Return to an old paradigm needed for teen sexual health
As I gain experience and reflect on articles like the Academy's paper on emergency contraception in teens, I am more convinced that a return to the old paradigm of sexual health is needed.
Since the 1960s with the advent of contraception intended to liberate our patients, espescially our women, we now see dramtically higher rates of sexual activity, STD and teen pregnancy.Going to the CDC website on teen STDs I see these sobering data regarding teens:
47.4% have had sexual intercourse
33.7% have had sexual intercourse during the previous 3 months, and, of these
15.3% had had sex with four or more people during their life
An estimated 8,300 young people aged 13-24 years in the 40 states reporting to CDC had HIV infection in 20092
Nearly half of the 19 million new STDs each year are among young people aged 15-24 years3
More than 400,000 teen girls aged 15-19 years gave birth in 2009.
And these are only these physical consequnces. Emotional fallout is now being documented by work like Dr Miriam Grossman's "Unprotected". And we often advocate our youth treading these difficult waters without knowledge of their parents. We have led our teens to a state of dependency on our medical establishment for pills,shots, procedures, STD treatments, vaccines and abortions.
We need a return to the 1950s when the cultural paradigm was one of mature sexual activity within a secure, committed relationship...may I dare say ,within marriage. Rather than give up on our teens and say they are not capable, we should start the process of empowering them to take on this paradigm with the freedom it brings to build healthier, more fulfilling futures which much less need for medical interventions and the costs and resources involved. They will need support from family, school,church, and the popular culture as well as physicians . It's time we trust our teens, put their sexuality into their own hands and begin to see the data dramatically improve. I hope many leaders in medicine including the Academy will seriously consider this new "old" approach. Dr Daniel Benz
Conflict of Interest:
None declared
For informed consent, don't forget the more efficacious Copper IUD as emergency contraception
Congratulations to the American Academy of Pediatrics (AAP) for the November 26 policy statement, "Emergency Contraception." The AAP deserves praise for following science and promoting public health. However, the policy statement omits a critical point: the copper intrauterine device (IUD) is considerably more effective than emergency contraception pills (EC)--99% effective versus 90% effective.(1) Shouldn't pediatricians be encouraged to talk to their patients about the most efficacious method of EC?
Part of the goal of the updated AAP policy statement is to "educate pediatricians and other physicians on available EC methods." In order to reach this important goal, physicians and their patients need to know two key things:
1. Using a copper IUD as EC is a safe and effective option for adolescents (and older women as well) and that it is considerably more effective than EC pills; and 2. Offering the copper IUD as EC can address not only the patient's immediate need for EC, but also the underlying and ongoing need for a highly effective contraceptive method.
The policy statement says that the copper IUD is not discussed because it is not "available to most pediatricians in their offices." That may be true, but in order for patients to give informed consent to receive EC pills, physicians must inform their clients about the more effective alternative, the copper IUD as EC. Imagine you went to see your primary care doctor about a recently discovered cancer. Even though your primary care doctor probably does not perform surgery, he/she would still tell you that surgery is one of the treatment options for cancer. Doctors cannot restrict the treatments they mention to only those that they themselves offer.
Some may worry that providing adolescents with highly effective contraceptive method will lead to promiscuity and thus more teen births. However, the AAP policy statement notes that a 2010 review of 7 randomized trials of emergency contraception that included teenagers found that advanced prescription did not increase sexual activity. Furthermore, a recent large study in St. Louis documented a teen birth rate of only 6.3 per 1,000 girls enrolled in the study, far below the U.S. rate of 34.3 per 1,000 for girls the same age.(2) The reason for the lower birth rate? Adolescent girls in the study were given access to free contraception and a majority chose IUDs or Implants, the most effective methods.
Encouraging routine counseling about emergency contraception and advanced provision of prescriptions for adolescents, as AAP has done, is an important step forward. But without making providers and patients aware of the advantages of the copper IUD--both as a more effective EC method and one that prevents future unplanned pregnancies--it is an incomplete step.
References
1. Belden P, Harper CC, Speidel JJ. The copper IUD for emergency contraception, a neglected option. Contraception. 2012 Apr; 85(4):338-9.
2. Peipert JF, Madden T, Allsworth JE, Secura GM. Preventing Unintended Pregnancies by Providing No-Cost Contraception. Obstet Gynecol. 2012 Oct 3.
Conflict of Interest:
None declared
Prescribe Abstinence First and Foremost Before Prescribing Morning After Pill
The AAP policy statement on emergency contraception barely mentions the idea of abstinence in it's current publication. The statement affirms that one reason for the decline in teenage pregnancy is abstinence. Why not captilize on that? In the conluding summary and recommendations abstinence is again listed almost as an after thought. What are we teaching our children?
The statement also makes reference to studies in which advanced presciptions of emergency contraception did not reduce the rate of teenage pregnancy -- why does the Academy have reason to believe this is a good means of prevention in the future?
Have long term studies shown there there are no long term adverse effects with the use of emergency contraception in teenagers? What about the long term emotional effects that may come with the use of this drug?
There are no side effects of abstinence and I believe this should be the first recommendation of the Academy.
Conflict of Interest:
None declared