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Trust Guideline for the use of Emergency Contraception. A clinical guideline recommended for use: In: Contraception and Sexual Health, GU Medicine, Obstetrics & Gynaecology and Emergency Medicine By: Medical and Nursing staff For: Prevention of unplanned pregnancy Key words: Emergency Contraception, Levonelle, Levonorgestrel, Ulipristal Acetate, ellaOne, Intrauterine Device Written by: Dr Megan Griffiths, Specialist Registrar Community Sexual and Reproductive Health. Supported by: Dr Catherine Schunmann, Consultant, Sexual and Reproductive Health. Approved by: Gynaecology Guidelines Committee Reported as approved Clinical Effectiveness Committee to the: Date of approval 23rd January 2015 To be reviewed before: 23rd January 2018 To be reviewed by: Dr Schunmann Guideline supersedes: Previous Emergency Hormonal contraception guideline (G16) Guideline Reg. No: G16(v2) Emergency Hormonal contraception Jan 2015 G16 (v2) Review Jan 2018 1 Trust Guideline for the use of Emergency Contraception. 1) Quick reference guideline • • • • Key Messages Insertion of a copper intrauterine device (Cu IUD) is the gold standard form of Emergency Contraception (EC) – Patients must be advised of this and given the option to access it. (Further information on Page 8) If last menstrual period (LMP) was not normal in timing, duration or severity or > 4 weeks ago – consider a pregnancy test prior to EC as they may already be pregnant. There is no time in the cycle when there is no risk of pregnancy Unprotected sexual intercourse (UPSI) means potential exposure to Sexually Transmitted Infection (STI) – Provide GU clinic times for review Assess timing and number of episodes of UPSI since LMP Single or multiple UPSI <120 hours ago <72 hours ago? More than 120 hours ago? Assess regularity of menstruation e.g. 1st day approx every 28 days or every 31 days? 72 – 120 hours? Cu IUD or Levonelle 1.5mg single dose stat po Cu IUD or Ulipristal Acetate 30mg po stat Regular cycle – allows prediction of date of ovulation (See table 2 for help) If <5 days after date of predicted ovulation e.g. day 19 of 28 day cycle, a Cu IUD may still be fitted as EC – Contact CASH clinic asap. Vomits <3 hours after pill - see special considerations chart for further advice. Advise to perform pregnancy test if abnormal or no period 3 weeks after UPSI. Advise on future contraception. Emergency Hormonal contraception Jan 2015 Offer Chlamydia G16 (v2) screening in under 25s & provide Review GU Jan clinic 2018 times for review. Cycle irregular – i.e. no definable pattern of menstruation. Emergency contraception is not appropriate. Advise PT 3 – 4 weeks after UPSI Please note special considerations such as drug interactions, lactation, age <16 and effect on hormonal contraception are considered on Page 3, Table 1. 2 Trust Guideline for the use of Emergency Contraception. Special Considerations – Table 1 Scenario Breast feeding Levonorgestrel (Levonelle) Safe to use while breast feeding. Multiple doses in a single cycle If further UPSI <12 hours after dose no additional dose needed. Multiple doses in the same cycle are acceptable but patient should be warned that may already be pregnant. If using as their regular method, they should use additional precautions for 7 days. Oral hormonal contraception (as regular method but missed pill scenario) Age 13 - 16 Age under 13 Vomiting after EC. Enzyme inducing drugs (See page 6 for full list) Ulipristal Acetate (ellaOne) Unknown safety – advise to avoid breast feeding for 36 hours and dispose of expressed milk. Repeated use in same cycle not recommended as effect on early pregnancy unknown If current method, to use barrier methods for 14 days for Combined Oral Contraception, 9 days for Progesterone Only Pills & 16/7 for Qlaira. An assessment of their ability to consent to this should be performed and documented. See “Fraser Guidance” section on pages 7. AND Child safeguarding should be considered and action taken as appropriate. A child safeguarding issue IS present. Social Services must be informed as a minimum. Seek senior advice urgently. Vomits within 2 hours – Vomits within 3 hours – offer repeat dose or IUD & offer repeat dose or IUD & consider antiemetic. consider antiemetic. IUD is best option re risk IUD is best option. of failure. If declined, Ulipristal not Levonelle dose should be recommended in this doubled to 3mg. group. If IUD is declined, 3mg of Levonelle should be used. Emergency Hormonal contraception Jan 2015 G16 (v2) Review Jan 2018 3 Trust Guideline for the use of Emergency Contraception. Table 2 – Assessment of whether insertion of Copper IUD for emergency contraception may be appropriate in this cycle. Note must have a regular cycle length. Assess cycle length over preceding 3 months. Day 1 of menstruation is day 1 of cycle. No of days in cycle (n) Day of ovulation (n-14) Last possible day of IUD insertion for EC (n-14+5) 21 Day 7 Day 12 22 Day 8 Day 13 23 Day 9 Day 14 24 Day 10 Day 15 25 Day 11 Day 16 26 Day 12 Day 17 27 Day 13 Day 18 28 Day 14 Day 19 29 Day 15 Day 20 30 Day 16 Day 21 31 Day 17 Day 22 32 Day 18 Day 23 33 Day 19 Day 24 34 Day 21 Day 25 35 Day 22 Day 26 Emergency Hormonal contraception Jan 2015 G16 (v2) Review Jan 2018 4 Trust Guideline for the use of Emergency Contraception. 2) Objective Emergency contraception given within 120 hours of unprotected sexual intercourse (UPSI) or failed contraception will reduce the chance of pregnancy occurring. It is more effective when given earlier in that time period. The fitting of an emergency IUD is always more effective than oral EC. Oral EC includes 2 possible drug therapies, and this guideline will advise on the most appropriate agent according to the clinical scenario. 3) Rationale The copper IUD as emergency contraception works via its toxic effect on sperm and prevention of implantation. Working independently of ovulation, the insertion of a CuIUD can prevent implantation up to 5 days after unprotected intercourse, acting between fertilisation and earliest possible implantation. Ulipristal is a selective progesterone receptor modulator and its primary method of action is to delay or inhibit ovulation. Levonorgestrel has similar actions, but is also thought to act on endometrium to prevent implantation. The action of Levonorgestrel declines with increasing time following UPSI, whereas Ulipristal effects are maintained. The introduction of Ulipristal allows a pharmacological and licensed method of EC to be prescribed between 72 and 120 hours. It therefore replaces the unlicensed use of Levonelle at >72 hours and has a higher efficacy rate at preventing pregnancy during that time frame. Efficacy rates are given below for comparison between methods. Method of Emergency Contraception IUD Levonorgestrel <72 hours Levonorgestrel >72 hours Ulipristal <72 hours Ulipristal >72 hours Efficacy (%) 99% 84% 63% Unlicensed 85% Likely to be ≥ Levonorgestrel Licensed 4) Broad recommendations i. Women who present for emergency contraception should be seen and assessed as soon as possible. If oral emergency contraception is appropriate, tablets should be taken immediately. ii. Screening for STIs should be considered if risk factors are present (e.g. age <25, new partner, unprotected intercourse, or condom failure). iii. Excluding pregnancy predating current events a. History establishing timing of and number of episodes of Unprotected Sexual Intercourse (UPSI) elicit previous pregnancy risk. Emergency Hormonal contraception Jan 2015 G16 (v2) Review Jan 2018 5 Trust Guideline for the use of Emergency Contraception. b. Last menstrual period (LMP) - normal in timing and nature within the last 5 weeks. If not a pregnancy test (PT) should be done prior to giving Emergency contraception (EC). c. If UPSI 6 or more days ago within the same cycle as well as within 120 hours check PT is negative. d. If UPSI earlier in the same menstrual cycle as well as within 72 hours Levonelle may be given but the patient should be advised even with a negative PT she may already be pregnant. Ulipristal must not be given in this scenario as the effects on the fetus are not known. iv. Vomiting after taking oral emergency contraception is unusual but may affect absorption. Patients should return for a further dose if vomiting occurs within 2 hours of Levonelle or 3 hours of Ulipristal. An antiemetic may be given with the subsequent dose. v. Advice about future contraception should be given and, if possible, provided. vi. A pregnancy test should be performed if the patient has not had a normal period within 3 weeks. 5) Special groups i. Special groups - Interacting Medications Enzyme inducing medication (taken within the previous 4 weeks) may reduce the efficacy of emergency hormonal contraception. Examples of enzyme inducers are included in Table 3. The IUD is the only method unaffected by these but an increased dose of Levonelle (3 mg) can be given if the woman understands reduced efficacy is present. These drugs may also affect the action of Ulipristal and the current advice is that Ulipristal should not be used in women who are on or have used enzyme inducing drugs in the last 28 days. Antacids, Proton pump inhibitors and H2 receptor antagonists – Concomitant use may reduce the absorption of Ulipristal and therefore is not advised. Table 3 – Enzyme Inducing Drugs Drug Group Examples of Enzyme inducers Antiepileptics Antibiotics Carbamazepine, Eslicarbazepine, Oxcarbazepine, Phenobarbital, Phenytoin, Primidone, Rifinamide, Topiramate Ritonavir All other ritonavir boosted protease inhibitors (atazanavir, darunavir, nelfinavir, fosamprenavir, lopinavir, tipranivir, saquinavir), Efavirenz and Nevaripine. Rifampicin, Rifabutin, Herbal St Johns Wort Others Aprepitant (Nausea and vomiting esp chemotherapy), Bosentan (Pulmonary hypertension or systemic sclerosis), Sugammadex (Neuromuscular blockade reversal agent) Antiretrovirals ii. Special Groups – Postnatal and Breast feeding Emergency Hormonal contraception Jan 2015 G16 (v2) Review Jan 2018 6 Trust Guideline for the use of Emergency Contraception. Contraception not necessary until 21 days post partum. Lactating. If exclusively breastfeeding (ie no bottle top ups), amenorrhoea and within 6 months of delivery, risk of pregnancy is already low, but Levonelle can be used without restriction. Ulipristal is a newer drug and it is not known whether it is excreted in breast milk. Lactating women are advised to avoid breastfeeding, and discard expressed milk for 36 hours after using Ulipristal. iii. Special groups - age under 16 Child safeguarding should be considered and action taken as appropriate. An assessment of Fraser competence should be made and documented. Health professionals are able to give contraceptive advice and treatment to a young person under 16 without parental knowledge provided they are satisfied that: • • • • • The young person understands the advice being given The young person cannot be persuaded to tell their parents or allow the doctor to tell them, that they are seeking contraceptive advice The young person is likely to begin or continue to have sex without contraception The young person’s physical or mental health are likely to suffer unless they receive contraceptive advice or treatment It is in the young person’s best interests to receive contraceptive advice or treatment. 6) Contraindications There are not considered to be any absolute medical contraindications to Levonelle. Conditions for careful consideration include severe hepatic dysfunction, hypersensitivity to levonorgestrel and trophoblastic disease with an abnormal hCG. Use of Ulipristal is not recommended in the presence of severe hepatic impairment, galactose intolerance or malabsorption or in those with severe asthma not controlled by the use of oral glucocorticoid therapy. The most common drug interaction is with acid reducing medication eg proton pump inhibitors or H2 receptor antagonists and concomitant use is not advised. 7) Accessing Emergency Intrauterine Contraception The fitting of an IUD is more effective than either form of oral emergency contraception. It should be considered in all cases, particularly when there is a high risk of pregnancy (days 9-16 of 28 day cycle), when UPSI occurred more than 72 hours previously and when there are interacting medications which may affect the efficacy of oral EC. CASH clinic can be contacted on (01603) 287347 Monday, Tuesday, Thursday, Friday & Saturday morning to arrange this. Outside these hours Emergency Hormonal contraception Jan 2015 G16 (v2) Review Jan 2018 7 Trust Guideline for the use of Emergency Contraception. the patient should be given oral EC as an interim measure and the clinic contacted as soon as possible thereafter to arrange IUD insertion. Possible exposure to STI is not a contraindication to IUD insertion, as it can be inserted with antibiotic cover. 8) Clinical audit standards Pregnancy test performed appropriately pre-prescription of hormonal emergency contraception? Offered Intrauterine device (unless contraindicated) or reason for not offering? If IUD chosen but unable to fit at first presentation, were they given hormonal emergency contraception in the interim period? Target 100% Documentation of other drug history to exclude interactions. STI screening opportunity given? Target 100% Future contraception discussion documented? Target 100% 9) References 1. Faculty of Family Planning and Reproductive Health Care Clinical Effectiveness Unit. FFPRHC Guidance (April 2006) Emergency Contraception. J Fam Plann Reprod Health Care 2006; 32(2): 121-128. 2. Faculty of Sexual and Reproductive Health Care Clinical Effectiveness Unit. (January 2011) “Drug interactions with hormonal contraception.” Available on the Faculty Website http://www.fsrh.org/pdfs/CEUGuidanceDrugInteractionsHormonal.pdf 3. Faculty of Family Planning and Reproductive Health Care Clinical Effectiveness Unit. FFPRHC Guidance (July 2004) Contraceptive choices for breastfeeding women. J Fam Plann Reprod Health Care 2004; 30(3): 181-189. 4. Faculty of Sexual and Reproductive Healthcare Clinical Effectiveness unit Statement, December 2009, “Frequently asked questions on Ulipristal Acetate (ellaOne) Emergency Contraception” – available on Faculty Website http://www.fsrh.org/pdfs/UlipristalFAQsCEU.pdf 5. Faculty of Sexual and Reproductive Health Care Clinical Effectiveness Unit. “Ulipristal Acetate(ellaOne) – new product review” October 2009– available on Faculty Website http://www.fsrh.org/pdfs/ellaOneNewProductReview1009.pdf Emergency Hormonal contraception Jan 2015 G16 (v2) Review Jan 2018 8