When a woman requests emergency contraception:

• Reassure her that the consultation will remain confidential, and that there are safe and effective methods to prevent pregnancy after unprotected sex. It is important to reassure all people, particularly young people, that their consultation will remain confidential. However, information may needed to be shared with other health and social professionals if existing or potential abuse is disclosed (e.g. for child protection).
• Assess her:
• Current risk of pregnancy.
• Need for future contraception.
• Risk for sexually transmitted infection.
• Risk for non-consensual sexual intercourse/abuse.
• Vulnerability.
• Provide information (verbal and clarification):
• On the options that are available: the levonorgestrel pill, the ulipristal acetate pill, and the copper intrauterine device (IUD).
• Their pros and cons.
• Their mechanisms of action.
• To someone younger than 16 years of age who is requesting emergency contraception without parental consent.
• Counsel (but do not lecture) her on the emotional and physical implications of sexual activity, including the risks of, and consequences of, pregnancy and the risk of sexually transmitted infections.
• Assess her competency to make an independent consent to treatment, and document in her case notes that she meets (or does not meet) the Fraser criteria for competence to independently consent.
• Offer the appropriate method of emergency contraception.
• Levonorgestrel is licensed for use in women over 16 years of age. It can be used up to 72 hours (3 days) after unprotected sexual intercourse, but its effectiveness diminishes with time.
• Levonorgestrel emergency contraception may also be considered between 72 and 120 hours after unprotected sexual intercourse. Ideally it should be taken as soon as possible because its effectiveness diminishes with time.
• Levonorgestrel is easier to obtain than an IUD for emergency contraception.
• Ulipristal acetate is only available on prescription and can be used up to 120 hours (5 days) after unprotected sexual intercourse.
• Ideally, ulipristal acetate should be used as soon as possible but studies have shown that the efficacy of ulipristal acetate is maintained over the 120 hour interval.
• Safety and efficacy has only been established in women over 18 years of age.
• An IUD containing at least 380 mm² of copper is the most effective method.
• An IUD (or advice on how to obtain one) should be offered to all women attending for emergency contraception.
• An IUD can always be fitted anytime in the menstrual cycle up to 5 days after the first episode of unprotected sexual intercourse. If the timing of ovulation can be estimated, insertion can be beyond 5 days of unprotected sexual intercourse, as long as it does not occur beyond 5 days after ovulation.
• Ideally, an emergency IUD should be fitted at first presentation, but insertion can be offered later, at the woman's convenience; levonorgestrel or ulipristal emergency contraception should always be given in the interim.
• If facilities are unavailable for emergency IUD insertion, local referral mechanisms should facilitate timely access to a specialist who can provide this service.
• Address other related needs that have become apparent during the consultation.
• Offer to arrange ongoing regular contraception, if this is appropriate — see the CKS topic on Contraception.
• If the woman does not want ongoing regular contraception, offer advance provision of levonorgestrel to promote early use of emergency contraception.
• For women at higher risk for sexually transmitted infection, offer advice, one to one discussion on preventing sexually transmitted infection, testing (for Chlamydia trachomatis as a minimum if an IUD is to be inserted).
• Refer or manage adolescents or women who have been abused, or who are at risk for sexual abuse.
• Follow-up and aftercare for levonorgestrel, ulipristal acetate, and IUD:
• Vomiting soon after taking levonorgestrel or ulipristal acetate. The woman should return (as soon as possible) for another dose if she vomits within 2 hours of taking levonorgestrel or 3 hours of taking ulipristal acetate.
• Early bleeding. Advise the woman that she may have light bleeding or spotting after taking levonorgestrel or ulipristal acetate; her period may be earlier or later than normal.
• Pregnancy is suspected despite emergency contraception. Advise the woman to have a pregnancy test if her next menstruation is abnormally late (e.g. 5–7 days) or lighter than usual.

• Assess the woman's current risk for becoming pregnant [FFPRHC, 2006b].
• If she has not used any method of contraception and semen has been in contact with the external or internal genitalia, the risk of pregnancy is sufficiently high to warrant emergency contraception (provided that she is within the eligibility period for emergency contraception).
• If she is concerned about potential failure of a contraceptive method, ask for details (e.g. for missed oral contraceptive pills, ask how many were missed, and when in the cycle) and assess the validity of this concern — see When contraception might fail. If in any doubt about the risk of contraceptive failure, consider emergency contraception, as it is safe and the side effects are minimal.
• Assess her need for future contraception [DH, 2004; FFPRHC, 2006a; FFPRHC, 2006b].
• For example, ask:
• 'How often have you used emergency contraception?' — recurrent use of emergency contraception is a signal that a long-acting contraceptive method may be indicated.
• 'Could having unprotected sexual intercourse happen again?'
• 'Do you have a regular contraceptive method? Are you satisfied with it?'
• Assess her risk for sexually transmitted infection [FFPRHC, 2006b; NICE, 2007].
• Risk assessment should take into consideration local prevalence of sexually transmitted infections, the woman's age, and her sexual activity.
• Consider her risk for having been exposed to sexually transmitted infection, including HIV. Ask about her current circumstances, and current and recent sexual partners, age of onset of sexual activity, and use of alcohol and other substances.
• Assess her risk for non-consensual sexual intercourse.
• For example, ask 'Can you always choose when to have (or to not have) sexual intercourse?'
• With young people, it is important to be satisfied that sexual intercourse has been consensual and is not occurring in an abusive relationship [DH, 2004; HM Government, 2006].
• Assess if she is vulnerable [NICE, 2007].
• Under the age of 18 years, and
• From disadvantaged background; or
• In, or leaving, care; or
• Low educational attainment.

Table 1 lists the situations in which contraception is not reliable. Note that there is some controversy about the recommendations for missed combined oral contraceptive pills, and that some of the details differ from information given in the summary of product characteristics leaflets that manufacturers provide with their products.

Provide information (verbal and printed) on:

• The confidentiality of the consultation.
• The options that are available for emergency contraception: the levonorgestrel pill, the ulipristal acetate pill, and the copper intrauterine device (IUD).
• The pros and cons of the different emergency contraception methods, including their failure rates and complications/adverse effects.
• Their mechanisms of action.

• The information provided to the woman should:
• Reassure her that the consultation will remain confidential. However information may need to be passed to other services, for example if she has been raped, sexually abused or if there is a child protection issue.
• Help her with the immediate decision on emergency contraception.
• Help her with future decisions on contraception.
• Sources of printed information:
• Printed leaflets are available on request from the Family Planning Association: www.fpa.org.uk.
• Pros and cons of levonorgestrel, ulipristal acetate, and the copper IUD:
• The advantages and disadvantages of levonorgestrel, ulipristal acetate, and the copper IUD (including information on failure rates and ease of use) are compared in Table 1.
• For more information, see Effect of delay since intercourse.
• Decision aids for emergency contraception:
• A tool that health care professionals can use to help women make decisions about emergency contraception can be found on the website of the World Health Organization: www.who.int [WHO, 2005].

• These recommendations reflect guidelines published by the Faculty of Sexual and Reproductive Healthcare (FSRH), formerly the Faculty of Family Planning and Reproductive Healthcare (FFPRHC) [FFPRHC, 2006b]. The recommendations include the following:
• As a Good Practice Point, the clinician should summarize evidence of effectiveness and the need for emergency contraception in each woman's individual circumstance to allow her to make an informed choice regarding its use.
• Women should be given written and verbal information on the failure rates of oral and intrauterine emergency contraception to allow them to make informed choices and to increase compliance and efficacy.
• Confidentiality is important for people of all ages, however guidance from the Department of Health emphasizes that it is particularly important to reassure young people requesting sexual health services that their consultation will remain confidential. Concern about confidentiality remains the biggest deterrent to seeking advice about emergency contraception [DH, 2004].
• A study of the reasons women choose regular contraception found that the most important reasons for choosing a contraceptive were how well it works (53%) and ease of use (13%) [Steiner et al, 2003].
• Recently it has been suggested that the levonorgestrel is most likely to fail if it is taken after ovulation has occurred [Novikova et al, 2007]. As the date of ovulation cannot be accurately estimated without special investigations that are not practical to provide routinely, the results of this study suggest that it is particularly important to recommend an IUD for emergency contraception if unprotected sexual intercourse occurred during the fertile period.

• Options include levonorgestrel, ulipristal acetate, or a copper intrauterine device (IUD).
• The choice of emergency contraception should be made by the woman, taking into account her risk of becoming pregnant, her need to avoid pregnancy, which methods can be used in her current situation, and the availability of emergency contraception services.
• Levonorgestrel
• Levonorgestrel is available as a 1.5 g single dose tablet.
• Levonorgestrel can be used up to 72 hours (3 days) after unprotected sexual intercourse, but its effectiveness diminishes quite rapidly with time [FFPRHC, 2006b].
• Pharmacies will not provide levonorgestrel without a prescription when the time since unprotected sexual intercourse is greater than 72 hours, as this would be contrary to the product licence and guidance from the Royal Pharmaceutical Society [ABPI Medicines Compendium, 2004a; RPSGB, 2004].
• Levonorgestrel can be used more than once in a cycle if clinically indicated; however, if unprotected sexual intercourse occurs less than 12 hours after taking levonorgestrel, further emergency contraceptive treatment is not required [FFPRHC, 2006b].
• Ulipristal acetate
• Ulipristal acetate is available as a 30 mg single dose tablet.
• It can be used up to 120 hours (5 days) after unprotected sexual intercourse, and its efficacy is maintained over the 120 hours.
• Safety and efficacy of ulipristal acetate has only been established in women 18 years and older.
• It is not advisable to take ulipristal acetate more than once in a cycle as the safety and efficacy of repeated exposures has not been studied.
• Copper IUD
• A copper IUD (or advice on how to obtain one) should be offered to all women attending for emergency contraception, even if they present within 72 hours of unprotected sexual intercourse [FFPRHC, 2006b].
• Ideally, an emergency IUD should be fitted at first presentation, but insertion can be offered later, at the woman's convenience; in this case, levonorgestrel emergency contraception should always be given in the interim [FFPRHC, 2006b].
• If facilities are unavailable for emergency IUD insertion, local referral mechanisms should facilitate timely access to a specialist who can provide this service [FFPRHC, 2006b].
• The IUD can be used up to 5 days after unprotected sexual intercourse; it can also be used up to 5 days after ovulation and after multiple episodes of unprotected sexual intercourse [FFPRHC, 2006b].
• For more information, see:
• Issues for oral levonorgestrel.
• Issues for oral ulipristal acetate.
• Issues when advising an IUD.

Evidence indicates that levonorgestrel, ulipristal acetate, and copper IUDs are safe and effective, but that levonorgestrel and ulipristal acetate have a higher failure rate than copper IUDs. Women may find the higher failure rate of levonorgestrel or ulipristal acetate unacceptable in some circumstances.

There are no randomized controlled trials (RCTs) comparing the copper IUD with a hormonal method, no good RCTs comparing emergency contraceptive methods with placebo, and no cost-effectiveness studies. However, evidence from studies of IUDs used to provide long-term contraception can be applied to their use for emergency contraception. There is an indirect but convincing body of evidence on levonorgestrel emergency contraception.

• Levonorgestrel. There is a convincing body of evidence that levonorgestrel is effective, but its failure rate may be clinically important. There is no concern over its safety.
• Trials comparing different hormonal methods of emergency contraception provide evidence that levonorgestrel (a progestogen) is more effective than the Yuzpe method (combined oestrogen and progestogen). Furthermore, there is evidence that the Yuzpe method is more effective than no treatment [Trussell et al, 1999].
• Levonorgestrel becomes progressively less effective the longer the delay after unprotected sexual intercourse. See Effect of delay since intercourse.
• If the woman is already pregnant, repeated use of levonorgestrel will not induce abortion and is unlikely to harm the fetus [FFPRHC, 2006b]. This conclusion is based on clinical experience with levonorgestrel and other hormonal contraceptives (progestogen only, and combined oestrogen-progestogen formulations) [Grimes and Raymond, 2002].
• Ulipristal acetate. There is evidence that ulipristal acetate is effective when used up to 120 hours (5 days) after unprotected sexual intercourse, but its failure rate may be clinically important.
• One randomized controlled trial comparing ulipristal acetate with levonorgestrel provides evidence that it is at least as effective as levonorgestrel when used as emergency contraception within 72 hours of unprotected sexual intercourse.
• Limited evidence also shows that the efficacy of ulipristal acetate is maintained between 72 and 120 hours.
• Copper IUD. There is good evidence that the copper IUD is effective when used as long-acting contraception, with low failure rates and a low probability of serious complications or adverse effects.
• In trials of long-term contraceptive methods, IUDs with at least 380 mm² copper were more effective than IUDs with smaller areas of copper. The failure rates are low: fewer than 2 pregnancies would be expected in 100 women using the 380 mm² copper IUD for 5 years [National Collaborating Centre for Women's and Children's Health, 2005].
• The risk of pelvic inflammatory disease after IUD insertion is less than 1 in 100 in women who are at low risk of sexually transmitted infections [National Collaborating Centre for Women's and Children's Health, 2005].
• The risk of uterine perforation is less than 0.1% and is related to the skill of the person inserting the IUD [National Collaborating Centre for Women's and Children's Health, 2005].

For more information, see:

• Oral levonorgestrel
• Oral ulipristal acetate
• IUDs in emergency contraception

• Levonelle One Step^® is a pharmacy-only medicine [ABPI Medicines Compendium, 2004a].
• Levonelle 1500^® is the prescription-only medicine brand-name for levonorgestrel emergency contraception [ABPI Medicines Compendium, 2004b].
• Both Levonelle 1500^® and Levonelle One Step^® are dispensed with one levonorgestrel 1.5 mg tablet per pack.
• Oral levonorgestrel emergency contraception as two tablets containing 750 micrograms levonorgestrel is no longer available in the UK.

• Levonorgestrel emergency contraception is most effective if taken within 72 hours of unprotected sexual intercourse — the risk of failure increases with delay in taking it. It can also be taken up to 5 days after unprotected sexual intercourse, but pharmacies will require a prescription as this is outside the terms of its license.
• Because levonorgestrel is not 100% effective, the woman should have a pregnancy test if her next menstruation is more than 5–7 days late, if bleeding is lighter than usual, or if she feels that she might be pregnant [FFPRHC, 2006b].
• Guidelines from the Faculty of Sexual and Reproductive Healthcare (FSRH), formerly the Faculty of Family Planning and Reproductive Healthcare (FFPRHC), recommend 7 days' delay in onset of menstruation as the threshold for doing a pregnancy test [FFPRHC, 2006b]. However, the manufacturer of levonorgestrel recommends 5 days [ABPI Medicines Compendium, 2004a; ABPI Medicines Compendium, 2004b].
• If the date of last menses is unknown, tests for pregnancy should not be done before 21 days have elapsed since unprotected sexual intercourse [FFPRHC, 2006b].
• If the woman vomits soon after taking the levonorgestrel pill, she should take a second dose as soon possible.
• The FFPRHC guidelines recommend 2 hours as the safe limit for assuming that the dose has been absorbed [FFPRHC, 2006b]. However, the manufacturer of levonorgestrel recommends 3 hours as the safe limit [ABPI Medicines Compendium, 2004a; ABPI Medicines Compendium, 2004b].
• Pharmacies may require a prescription to provide a second dose of levonorgestrel.
• The next menstrual period might be different [ABPI Medicines Compendium, 2004a; ABPI Medicines Compendium, 2004b].
• If the woman has early mild bleeding or spotting, this is probably caused by the levonorgestrel and may not be the start of the next menstrual cycle. She should not regard this time as safe for unprotected sexual intercourse. In any case, no time is regarded as a completely safe time for unprotected sexual intercourse including time during menstruation.
• Most women will have a normal period at the expected time; some women will have their period later or earlier than normal.
• Levonorgestrel emergency contraception does not provide contraceptive cover for the remainder of the cycle; the woman should therefore use an effective contraceptive method or avoid sexual intercourse [FFPRHC, 2006b]:
• She can be advised that levonorgestrel emergency contraception can be used more than once in a cycle if clinically indicated [FFPRHC, 2006b].
• If she does not wish to use ongoing regular contraception, she can be offered advance provision of levonorgestrel to promote early use of emergency contraception [FFPRHC, 2006b].
• Oral levonorgestrel emergency contraception does not cause abortion. If the woman is already pregnant, levonorgestrel will not work, but it should not harm her or the fetus.
• Ongoing contraception (e.g. with an IUD or contraceptive pill) may be started at the same time or soon after levonorgestrel, provided that the UK Medical Eligibility Criteria are met [FFPRHC, 2006a] — see the CKS topic on Contraception.

• Contraindications
• Hypersensitivity. Apart from hypersensitivity to the ingredients, there are no medical contraindications to the use of oral levonorgestrel for emergency contraception [ABPI Medicines Compendium, 2004a; ABPI Medicines Compendium, 2004b; FFPRHC, 2006a; FFPRHC, 2006b].
• Pregnancy. Levonorgestrel should not be used if the woman is suspected or known to be pregnant, although it is probably safe for the fetus if used during pregnancy. See Safety during pregnancy.
• Cautions
• Severe malabsorption syndromes, such as Crohn's disease; decreased absorption of the drug might impair its efficacy.
• Cardiovascular disease (i.e. ischaemic heart disease, cerebrovascular disease, and other thromboembolic conditions), severe liver disease, migraine. The benefits of levonorgestrel outweigh the theoretical or proven risks [FFPRHC, 2006a]. However, the manufacturer recommends that levonorgestrel is not used in women with severe hepatic dysfunction [ABPI Medicines Compendium, 2004a; ABPI Medicines Compendium, 2004b].

• Oral levonorgestrel given to a breastfeeding mother for emergency contraception is not thought to harm her baby [FFPRHC, 2004b; FFPRHC, 2006a].
• The product licence states that levonorgestrel is not contraindicated in breastfeeding women [ABPI Medicines Compendium, 2004a; ABPI Medicines Compendium, 2004b].
• Levonorgestrel is excreted in small amounts in the breast milk. To minimize exposure to the infant, the manufacturer advises that the tablet should be taken immediately after breastfeeding [ABPI Medicines Compendium, 2004a; ABPI Medicines Compendium, 2004b].
• A copper intrauterine device may be more suitable than oral levonorgestrel for emergency contraception for women more than 4 weeks postpartum, as the former is more effective and provides ongoing contraception [FFPRHC, 2004b].

• Although oral levonorgestrel emergency contraception is not indicated for a woman with a known or suspected pregnancy, there is no known harm to the woman, the course of her pregnancy, or the fetus if it is used [FFPRHC, 2006a].
• Repeated use of oral levonorgestrel emergency contraception will not induce abortion if the woman is already pregnant [FFPRHC, 2006b].

For more information, see Risks in pregnant women.

Adverse effects from oral levonorgestrel emergency contraception are uncommon and are seldom severe.

• In a large randomized controlled trial, the most common adverse effects reported by women taking oral levonorgestrel for emergency contraception were nausea (14%), fatigue (14%), and bleeding not related to menses (16%). More than half the women had menses within 2 days of the expected date. More of the remaining women in the levonorgestrel group tended to have menses earlier than expected [von Hertzen et al, 2002]. For details, see Table 1.
• Ectopic pregnancies have been reported after the use of emergency contraception, but there is no concern that the risk of ectopic pregnancy is increased by emergency contraception.
• A Cochrane review of 48 trials on emergency contraception in 33,110 women identified 5 cases of ectopic pregnancy (2 in women taking oral levonorgestrel and 3 in women taking mifepristone) [Cheng et al, 2004]; in the 4 trials which reported ectopic pregnancies there were a total of 133 pregnancies.
• As with any pregnancy, should the woman fall pregnant, the possibility of ectopic implantation should be considered [ABPI Medicines Compendium, 2004a; ABPI Medicines Compendium, 2004b; FFPRHC, 2006b].

Interactions with liver enzyme-inducing drugs

• The most important drug interactions with oral levonorgestrel are those caused by drugs that induce the liver enzymes which metabolize levonorgestrel. These drugs are listed in Table 1.
• Management is discussed in Women on a liver enzyme-inducing drug.

Interactions with warfarin

• One case involving a possible interaction between warfarin and oral levonorgestrel emergency contraception has been reported. The international normalized ratio increased, but there was no bleeding, and values returned to normal 2 days after warfarin treatment was stopped [Ellison et al, 2000].

Drugs that induce liver enzymes (Table 1) can increase the metabolism of levonorgestrel. There is concern that increased metabolism of levonorgestrel could interfere with its contraceptive effects. Thus, a copper intrauterine device is the preferred option in women taking liver enzyme–inducing drugs who require emergency contraception [FFPRHC, 2005b]. However, if oral levonorgestrel emergency contraception is to be prescribed to a woman taking a liver enzyme–inducing drug:

• Double the dose of levonorgestrel to 3 mg (i.e. 2 tablets of levonorgestrel 1500 micrograms) [FFPRHC, 2006a; FFPRHC, 2006b].
• Explain to the woman that this recommendation is:
• Based not on research evidence, but on expert clinical judgement of the balance of risks and benefits.
• Is outside the product licence.

Oral levonorgestrel emergency contraception can safely be given more than once in a menstrual cycle [FFPRHC, 2006b].

• However, the manufacturer advises against repeated administration because of the possibility of disturbance of the menstrual cycle [ABPI Medicines Compendium, 2004a; ABPI Medicines Compendium, 2004b].
• Unprotected sexual intercourse within 12 hours of a dose of oral levonorgestrel emergency contraception does not require further treatment with an emergency contraception [FFPRHC, 2006b].
• Repeated use will not induce abortion if the woman is already pregnant [FFPRHC, 2006b].

• A woman who has taken oral levonorgestrel emergency contraception because of a possible failure with her usual hormonal contraceptive method should resume her usual method within 12 hours of taking levonorgestrel [FFPRHC, 2006b].

• After using levonorgestrel emergency contraception, hormonal contraception can be started immediately, unless the woman is already pregnant [FFPRHC, 2006b].

• Ulipristal acetate (ellaOne^®) is available only on prescription as a single 30 mg tablet.
• Safety and efficacy of ulipristal acetate has only been established in women 18 years and older.

• Ulipristal acetate emergency contraception should be taken within 120 hours of unprotected sexual intercourse.
• Because ulipristal acetate is not 100% effective, the woman should have a pregnancy test if her next menstruation is more than 7 days late, if bleeding in next menstrual period is abnormal or if she has symptoms of pregnancy [ABPI Medicines Compendium, 2009].
• The Faculty of Sexual and Reproductive Healthcare (FSRH), formerly the Faculty of Family Planning and Reproductive Healthcare (FFPRHC), new product review and the manufacturer of ulipristal acetate recommend 7 days delay in onset of menstruation as the threshold for doing a pregnancy test [FFPRHC, 2006b; ABPI Medicines Compendium, 2009].
• If the date of last menses is unknown, tests for pregnancy should not be fully relied upon before 21 days have elapsed since unprotected sexual intercourse [FFPRHC, 2006b].
• If the woman vomits within 3 hours of taking the ulipristal acetate pill, she should take a second dose as soon possible.
• Pharmacies will require another prescription to provide a second dose of ulipristal acetate.
• The next menstrual period might be different [ABPI Medicines Compendium, 2009].
• If the woman has early mild bleeding or spotting, this is probably caused by the ulipristal acetate and may not be the start of the next menstrual cycle. She should not regard this time as safe for unprotected sexual intercourse. In any case, no time is regarded as a completely safe time for unprotected sexual intercourse, including time during menstruation.
• Most women will have a normal period at the expected time; some women will have their period later or earlier than normal.
• Ulipristal acetate does not provide contraceptive cover for the remainder of the cycle; the woman should therefore use an effective contraceptive method or avoid sexual intercourse [FSRH Clinical Effectiveness Unit, 2009].
• She should be advised that repeated administration of ulipristal acetate within the same menstrual cycle is not advisable, as its safety and efficacy after repeated administration within the same cycle has not been investigated [ABPI Medicines Compendium, 2009].
• The available data on the effects to a fetus if exposure occurs are extremely limited, but there have been no reported problems with the very small number of pregnancies to date [ABPI Medicines Compendium, 2009].
• Ongoing contraception with an IUD may be started at the same time or soon after ulipristal acetate.
• Ongoing contraception with the contraceptive pill can be started at the same time or soon after taking ulipristal acetate. However, ulipristal acetate may reduce the contraceptive action of hormonal contraception, so a suitable barrier method should be used till the next period [ABPI Medicines Compendium, 2009].

• Contraindications
• Hypersensitivity. Apart from hypersensitivity to the ingredients, there are no medical contraindications to the use of oral ulipristal acetate for emergency contraception.
• Pregnancy. Ulipristal acetate should not be used is the woman is suspected or known to be pregnant.
• Cautions
• Hepatic impairment. As there have been no studies to monitor safety, ulipristal acetate is not recommended in those with severe hepatic impairment.
• Severe asthma. Ulipristal acetate is not recommended if severe asthma is insufficiently controlled by oral glucocorticoids, because ulipristal acetate has high affinity for glucocorticoid receptors and antiglucocorticoid effects have been observed in animal studies.
• Severe lactose intolerance, including galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption (all rare), as the tablet contains lactose.

[ABPI Medicines Compendium, 2009]

• It is not known whether ulipristal acetate is excreted in breast milk, so breastfeeding women are advised not to breastfeed for 36 hours after treatment [ABPI Medicines Compendium, 2009].
• Oral levonorgestrel can be considered in a breastfeeding mother for emergency contraception as it is not thought to be harmful to babies [FFPRHC, 2004b; FFPRHC, 2006a].
• A copper intrauterine device could also be considered for emergency contraception in women more than 4 weeks postpartum.

• Oral ulipristal acetate emergency contraception should not be given to a woman with a known or suspected pregnancy.
• There are extremely limited data available on the effects to a fetus if exposure occurs, but there have been no reported problems with the very small number of pregnancies to date [ABPI Medicines Compendium, 2009].
• The European Medicines Agency has requested that a pregnancy register is set up to collate further data on exposure during pregnancy to ulipristal acetate (including either undetected pregnancy before provision of ulipristal acetate or treatment failure) [HRA Pharma, 2010].
• Further information is available at www.hra-pregnancy-registry.com or by telephoning 0800 917 9548.

Safety data on ulipristal acetate are limited, but most adverse effects seem mild or moderate and resolve on their own.

• As yet there is little postmarketing experience with ulipristal acetate. It is a black triangle product, so all suspected adverse reactions should be reported to the Medicines and Healthcare products Regulatory Agency (MHRA) using the Yellow Card Reporting scheme.
• In one single arm, open-label study, undertaken to determine the efficacy of a single 30 mg dose of ulipristal acetate (n = 1533) [EMEA, 2009], the most common adverse effects reported were:
• Headaches (17% of women), nausea (12.2%) and abdominal pain (11.7%).
• Less common adverse effects were infections, mood disorders, headache, dizziness, nausea, vomiting, dyspepsia, muscle spasms, back pain, dysmenorrhoea, menorrhagia, metrorrhagia and fatigue (between 1 in 100 women and 1 in 10 women).
• No serious adverse reactions were reported in the study and no subjects were discontinued from the study due to adverse reactions.
• In the same study, about 80% of women taking ulipristal acetate had their next period at the expected time or within 7 days.
• 6.1% experienced menses more than 7 days earlier than expected.
• 19.2% had a delay of more than 7 days beyond the anticipated onset of menses. This delay was more than 20 days in 5.1% of these women and more than 60 days in 0.5% of these women.
• Menstrual volume was reported as normal in 79% of the women in the study, 16% reported it as heavy, 5% as spotting.
• Very few women (8.7%) reported intermenstrual bleeding lasting an average of 2 days. The majority of these women (92%) reported the bleeding as spotting. Five women in the study reported a heavy intermenstrual bleed.

Ulipristal acetate is metabolised via cytochrome P450, in particular CYP3A4.

• Liver enzyme inducers
• CYP3A4 inducers such as rifampicin, phenytoin, phenobarbital, carbamazepine, ritonavir, St John's wort, non-nucleoside reverse transcriptase inhibitors (such as efavirenz, nevirapine, etravirine) and modafinil, may reduce plasma concentrations of ulipristal acetate, resulting in a decrease in its efficacy.
• Enzyme induction wears off slowly and effects on the plasma concentrations of ulipristal acetate may occur even if the enzyme inducer was stopped 2–3 weeks before.
• Liver enzyme inhibitors
• CYP3A4 inhibitors such as protease inhibitors (ritonavir, indinavir, nelfinavir), macrolide antibiotics (erythromycin, clarithromycin), azole antifungals (ketoconazole, itraconazole, fluconazole), nefazodone, verapamil and cimetidine may increase exposure to ulipristal acetate. The clinical relevance of this is unknown.
• Drugs that increase gastric pH
• Concomitant use is not recommended. Drugs that increase gastric pH like proton pump inhibitors, antacids and H₂ receptor antagonists may reduce the plasma concentration of ulipristal acetate and may decrease its efficacy.
• Other contraceptives
• Ulipristal acetate binds with high affinity to the progesterone receptor so it may interfere with the action of progestogen-containing products.
• The contraceptive action of combined hormonal contraceptives and progesterone-only contraception may be reduced.
• Concomitant use of ulipristal acetate and emergency contraception containing levonorgestrel is not recommended.

[ABPI Medicines Compendium, 2009; FSRH Clinical Effectiveness Unit, 2009]

• Ulipristal acetate is not suitable for women taking a liver enzyme inducing drug.
• A copper IUD is preferred.
• Levonorgestrel can be given but the dose has to be doubled to 3 mg (i.e. 2 tablets of levonorgestrel 1500 micrograms). This is an unlicensed use [FFPRHC, 2006a; FFPRHC, 2006b].

• Regular hormonal contraception can be continued, but advise the woman that it may not be fully effective until the next menstrual period starts.
• A barrier method is recommended until the next menstrual period starts because ulipristal acetate may reduce the effectiveness of regular hormonal contraception.

[ABPI Medicines Compendium, 2009]

• Ongoing hormonal contraception may be started at the same time as giving oral emergency contraception (unlicensed) but with advice to use additional contraception (such as condoms) at least until the next period.
• Ulipristal acetate binds with high-affinity to the progesterone receptor, so may reduce the effectiveness of regular hormonal contraception.

[ABPI Medicines Compendium, 2009].

• What additional management is required by women at higher risk for sexually transmitted infection?
• Offer testing for Chlamydia trachomatis (at a minimum) before inserting the intrauterine device (IUD) [FFPRHC, 2006b].
• If results of the tests will not be available when the IUD is inserted, consider treating with an antibiotic (such as azithromycin) to prevent pelvic infection [FFPRHC, 2006b].
• What aftercare advice should I give the woman?
• Aftercare advice should include information about the risk of pelvic infection, how to check whether the IUD is still in place, and what to do if she feels that she might be pregnant. For more information see Aftercare advice.

• Intrauterine devices (IUDs) containing at least 380 mm² of copper are more effective than those containing less copper (based on studies of copper IUDs used for ongoing contraception) [FFPRHC, 2006b].
• A number of IUD products with at least 380 mm² of copper are available in the UK. They come in a range of dimensions to fit different sizes of uterus.

Advise a woman who has had an intrauterine device (IUD) inserted that:

• She should have a pregnancy test if her next menstruation is more than 5–7 days late, if bleeding is lighter than usual, or if she feels that she might be pregnant [FFPRHC, 2006b].
• She should check regularly that the IUD is still in place, and may need teaching how to do this.
• She should seek medical help if she suspects that she is pregnant.
• An emergency IUD can be removed (without increasing the risk of contraceptive failure) at any time after the next menstruation if no unprotected sexual intercourse has occurred since the previous menses, or if hormonal contraception was started within the first 5 days of that cycle [FFPRHC, 2006b].
• She should return for a follow-up assessment 3–6 weeks after insertion of the IUD to exclude infection, perforation, or expulsion [National Collaborating Centre for Women's and Children's Health, 2005].
• There is a small risk of pelvic infection in the 20 days after an IUD is inserted, but thereafter the risk is the same as for women not using an IUD [FFPRHC, 2006b].
• She should return at any time to discuss problems, if she wants to change her method of contraception, or if she wants the IUD removed [National Collaborating Centre for Women's and Children's Health, 2005].

• Sexually transmitted infections
• Offer testing for Chlamydia trachomatis (as a minimum) before inserting the IUD [FFPRHC, 2006b].
• If results of the tests will not be available when the IUD is inserted, consider treating with an antibiotic (such as azithromycin) to prevent pelvic infection [FFPRHC, 2006b].
• Sexual abuse and non-consensual sex
• Refer or manage women who have been raped or sexually assaulted or forced into unwanted sexual relationships.
• Refer or manage child protection issues in girls under the age of 18 years abused [HM Government, 2006].

The following issues need to be considered, and managed if appropriate, in all women requesting emergency contraception (even in those who did not end up using it):

• Ongoing regular contraception
• Offer to arrange ongoing, regular contraception, if appropriate [FFPRHC, 2006b].
• The following methods can be quick started after oral emergency contraception [FSRH, 2010]:
• Combined hormonal contraception (pill, patch, vaginal ring) — advise the woman to use barrier methods or abstain from sex for 7 days after levonorgestrel emergency contraception and for 14 days after ulipristal acetate emergency contraception.
• Progestogen-only pill — advise the woman to use barrier methods of abstain from sex for 2 days after levonorgestrel emergency contraception and for 9 days after ulipristal acetate emergency contraception.
• Progestogen-only implant.
• The woman should be informed of the potential risks and of the need to have a pregnancy test 3 weeks after the last episode of unprotected sex.
• Advance provision of emergency contraception
• Advance provision of levonorgestrel or ulipristal acetate can be offered to women to use when required [FFPRHC, 2006b; RPSGB, 2006]. This option should be considered only if other, more effective, methods are not acceptable.
• Sexually transmitted infection
• In women at higher risk for sexually transmitted infection (i.e. sexually active women younger than 25 years of age, those older than 25 years who have a new partner, those with more than one partner in the past year, women who abuse alcohol or other substances, and women whose sexual activity began at a young age):
• Consider opportunistic testing for Chlamydia trachomatis [SIGN, 2000; NICE, 2007].
• Have one to one structured discussions about preventing sexually trained infections if you are trained in sexual health, or arrange for these discussions to take place with a trained practitioner [NICE, 2007].
• Sexual abuse, rape and non-consensual sex
• With all people, but particularly with the young and/or vulnerable, it is important to be satisfied that sexual intercourse has been consensual and is not occurring in an abusive relationship [DH, 2004; HM Government, 2006].
• Consider informing young people of the law in relation to sexual activity [FFPRHC, 2004a].
• If it is suspected that force has been used or that any sexual abuse has occurred, health care professionals have a duty to follow national and local child protection procedures [DH, 2004; HM Government, 2006]. Follow appropriate child protection procedures and refer to a paediatrician if necessary.
• Consider the possibility of sexual abuse in any child or young person with gonorrhoea, particularly in the following circumstances [NICE, 2009]:
• The child is younger than 13 years of age, unless there is clear evidence of mother-to-child transmission during birth, or of blood contamination.
• The young person is 13 to 15 years of age, unless there is clear evidence of mother-to-child transmission during birth, blood contamination, or that the STI was acquired from consensual sexual activity with a peer.
• The young person is 16 to 17 years of age and there is no clear evidence of blood contamination or that the STI was acquired from consensual sexual activity and there is a clear difference in power or mental capacity between the young person and their sexual partner, in particular when the relationship is incestuous or with a person in a position of trust (such as a teacher, sports coach, minister of religion) or there is concern that the young person is being exploited.

• Consent to sexual activity
• The legal age of consent to sexual activity is 16 years in Scotland, England and Wales, and 17 years in in Northern Ireland.
• Sexual activity under the age of consent is an offence even if consensual.
• Offences are considered more serious (statutory rape) when the person is less than 13 years old [FFPRHC, 2004a].
• Consent to medical treatment
• In the UK, people over the age of 16 years are presumed to be competent to consent to medical treatment. In contrast, competence to consent to medical treatment must be demonstrated in children under the age of 16 years [FFPRHC, 2004a].
• In England and Wales, it is lawful to provide contraceptive advice and treatment to young people without parental consent, provided that the practitioner is satisfied that the Fraser criteria for competence are met [Teenage Pregnancy Unit, 2001; FFPRHC, 2004a; Wheeler, 2006]. The criteria are that:
• The young person understands the practitioner's advice.
• The young person cannot be persuaded to inform their parents, or will not allow the practitioner to inform the parents, that contraceptive advice has been sought.
• The young person is likely to begin or to continue having intercourse with or without contraceptive treatment.
• Unless she receives contraceptive advice or treatment, the young person's physical or mental health (or both) are likely to suffer.
• The young person's best interest requires the practitioner to give contraceptive advice or treatment (or both) without parental consent.
• In Scotland, statutory provision by way of The Age of Legal Capacity Act 1991 applies similar criteria. The Act actually appears to assign more legal rights to children under 16 years, in that parental responsibility cannot authorise procedures a competent child has refused [Sterrick, 2006; Wheeler, 2006].

• The levonorgestrel-releasing intrauterine system should not be used for emergency contraception. It is not licensed in the UK for this indication, and there is no evidence that it is effective for emergency contraception.
• Mifepristone is a progesterone antagonist that has been shown to be an effective emergency contraceptive agent. However, it is not licensed in the UK for this indication and is used only in research.