Levonorgestrel (LNG) Emergency Contraceptive Pills Session I: Characteristics of LNG Emergency Contraceptive Pills

Objectives At the end of this session, participants will be able to: 1. Discuss the consequences of unintended pregnancy. 2. Describe the characteristics of emergency contraceptive pills (ECP) in a manner that clients can understand: a. What ECPs are and how they work (mechanism of action) b. Effectiveness c. Side effects d. Safety e. Who can use emergency contraceptive pills f. ECP regimens g. Key points for providers and clients At the end of this session, participants will be able to: By the end of this training session, participants will be able to: <click the mouse to advance through the objectives, reading each objective aloud>. Review the objectives with the participants. Solicit input about whether the planned objectives match the participant’s expectations.

Objectives (continued) 3. Describe the indications for use of LNG ECPs 4. Demonstrate how to screen clients for LNG ECP use 5. Demonstrate counseling LNG ECP clients including: a. Characteristics of LNG ECPs b. How to address common concerns, rumors and misconceptions about ECPs c. How to use LNG ECPs d. Possible side effects of LNG ECPs and how to manage them e. The importance of on-going contraception after ECP use

What is an unintended pregnancy? Definition: Unintended pregnancy is “a pregnancy that is mistimed, unplanned, or unwanted.” Unintended pregnancy mainly results from the lack of, inconsistent, or incorrect use of effective contraceptive methods. Unintended pregnancy does not mean unwanted births or unloved children. Before showing the slide, ask participants <What is unintended pregnancy> List participants’ responses on a flip chart before showing the slide. Write each idea without commenting.

What are the consequences of unintended pregnancy? The consequences may include: Health risks to mother. Unsafe abortion. Discontinuation of schooling (for adolescents). Emotional distress. Economic difficulties. Disapproval from the community, especially for young, unmarried women. Possible health risks to infants. Ask participants <What are the consequences of unintended pregnancy> Write participants’ responses on another flip chart. Reinforce ideas by showing the slide. • Explain that unintended pregnancy can have significant, negative consequences for individual women, their families and society as a whole. The consequences vary from country to country and the issue is complex, but in general, research findings show that women with mistimed and unwanted pregnancies initiate prenatal care at a later time than those whose pregnancies were intended. Mothers with unintended pregnancy are less likely to breastfeed. Mothers who have unintended births are at a greater risk of suffering negative mental health consequences during and after pregnancy. Women with unwanted, mistimed, or unplanned births demonstrate lower levels of general psychological well-being during pregnancy and following the birth, and a higher risk of depression, and they report lower levels of happiness than those with intended births. School age girls with unintended rarely complete their education and are economically disadvantaged as a result. According to the Guttenmacher Insitiute “In developing countries (where average desired family size is still relatively large), of the 182 million pregnancies occurring every year, an estimated 36% are unplanned, and 20% end in abortion.” Unintended births have implications for the child that last from early childhood through adolescence and even into adulthood. Overall, unintended pregnancy seems to be most clearly associated with the child’s poor physical and mental health, a less close mother-child relationship, and poorer educational outcomes. Conduct Values Clarification Exercise found in the Session Plan Discuss the legal framework for ECPs in your own country.

What are ECPs? ECPs are hormonal methods of contraception used to prevent pregnancy following an unprotected act of sexual intercourse. There are different types of ECPs. In this training, we will be focusing on the levonorgestrel-only ECPs. Ask participants to first come up with a definition for ECPs. Write one consolidated version of their definitions on the flip chart and then show the definition on the slide. Explain that ECPs provide An important back-up in cases of unprotected intercourse, rape or contraceptive accidents such as forgotten pills or condoms.

LNG ECPs: Mechanism of action LNG ECPs interfere with the process of ovulation ECPs do not inhibit implantation of a fertilized egg. LNG ECPs do not inhibit implantation of a fertilized egg. LNG ECPs do not cause abortion of an existing pregnancy do not cause aboECPs do not inhibit implantation of a fertilized egg. ECPs do not cause abortion of an existing pregnancy rtion of an existing pregnancy Illustration credit: Salim Khalaf/FHI Ask participants to brainstorm how ECPs work (mechanism of action). Write their responses on the flip chart and then show the slide Explain that there are several kinds of ECPs. During this training, we will focus on the levonorgestrel (LNG) ECP. Research studies have shown that LNG ECPs prevent or delay ovulation. If they are taken before ovulation, LNG ECPs inhibit the pre-ovulatory luteinizing hormone (LH) surge, which impedes follicular development and/or the release of the egg itself. ECPs do not inhibit implantation of a fertilized egg ECPs do not cause an abortion of an existing pregnancy. If ECPs are taken after a pregnancy is established, they will not work.

Effectiveness of ECPs The LNG regimen reduces a woman’s chance of pregnancy after a single sex act by at least half and possibly by as much as 80-90%. Effectiveness for an individual woman depends on where she is in her menstrual cycle, when she had unprotected sex and when she used ECPs. Some types of ECP such as ulipristal acetate (UPA) or mifepristone are more effective than LNG-only ECPs and some (regular contraceptives- the Yuzpe regimen) less effective. Effectiveness may be affected by use of certain medications (rifampicin, griseofulvin, Saint John’s Wort, anticonvulsant drugs or ritonavir). Explain that: The effectiveness of ECPs depends on the type of ECP used and when they are taken. It takes about 6 days after ovulation for a fertilized egg to begin to implant. Pregnancy is established after implantation has been achieved. Therefore, intervention within 72 hours or up to 5 days cannot result in abortion. Treatment should begin as soon as possible after unprotected sex because the efficacy declines with time. LNG ECPs appear to be effective for at least 4 days after sex and potentially up to 5 days. (although the label for LNG ECPs says that it is effective for up to 72 hours, or 3 days, it was written before evidence showed that it might work for longer). Some, but not all studies have found that LNG ECPs may be more effective the sooner they are taken after sex. No specific data are available about interactions of ECPs with other drugs. However, it is reasonable to assume that drug interactions with LNG ECPs may be similar to those with regular contraceptive pills. Efficacy could be affected by rifampicin, griseofulvin, Saint John’s wort, certain anticonvulsant drugs and certain antiretroviral drugs such as ritonavir.

Last Day of Menstruation Positive Pregnancy Test 1 First Day of Cycle Last Day of Menstruation Ovulation Starts Fertilization Implantation Positive Pregnancy Test EC pills work before fertilization EC pills have no effect after fertilization, do not cause abortion Effectiveness for an individual woman depends on where she is in her menstrual cycle. An important factor is when ECPs are given within a woman’s menstrual cycle and whether or not fertilization has occurred. We can see from slide 9 that LNG ECPs work before fertilization has occurred, but not after. This also helps us understand why LNG ECPs do not cause an abortion. They do not work once fertilization has occurred.

Side effects of ECPs LNG ECPs are well tolerated and leave the body within a few days. Some women experience mild and short-term side effects. These may include: Altered bleeding patterns Nausea (in up to 20% of women) Vomiting (rare) Headache Abdominal pain Breast tenderness Dizziness Fatigue Explain that LNG ECPs are well tolerated and leave the body within a few days. Some women experience mild and short-term side effects. Although side effects may be medically minor, they may be troublesome to some women. Use the slide to list possible side effects. Altered vaginal bleeding patterns- Most women have their next menstrual period within 7 days of the usual time they would normally expect it following the use of ECPs. Menstruation has been reported to occur an average of 1 day earlier than expected following the LNG regimen. Nausea and vomiting- Nausea, rarely accompanied by vomiting, occurs in less than 20% of women. These symptoms are uncommon enough that prophylactic administration of an antiemetic drug is not needed. If vomiting occurs within 2 hours after taking an ECP dose, some experts recommend a repeat ECP dose can be given vaginally. The other side effects (headache, abdominal pain, breast tenderness, dizziness, fatigue) usually do not occur for more than a few days after treatment and generally resolve within 24 hours.

Safety of ECPs ECPs have no known serious complications. ECPs do not cause abortion They are safe for use by all women including adolescents. ECPs are not harmful if taken by a woman who is already pregnant. ECPs have been widely used in various formulations for over 30 years. Ask participants <Do you think ECPs are safe?> Explain that ECPs are extraordinarily safe. No deaths or serious complications have ever been linked to any ECP regimen. ECPs do not appear to be harmful if accidentally taken once a woman is already pregnant. While estrogens contained in many contraceptive pills are associated with some (very low) of stroke and venous thromboembolism, especially in women over 35 who smoke, no such risks are associated with LNG ECPs because they do not contain estrogen. Research shows no association with increased risk of cancer. LNGs do not increase the risk of ectopic pregnancy. The use of ECPs have no effect on future fertility. LNG ECPs do not harm a developing fetus if they are mistakenly taken early in pregnancy and do not interrupt an established pregnancy. No risk of serious harm for moderate repeat use of ECPs appears to exist, and repeated use of ECPs is safer than pregnancy. The safety of ECPs does not change with age; therefore, they carry no added risks for those younger than 17 years.

No contraindications to the use of ECPs ECPs have no medical precautions or contraindications. No pregnancy test or physical examination is needed ECPs should not be taken if a woman is pregnant because they will not work. However they will not harm an existing pregnancy ECP effectiveness may be affected by use of certain medications Ask participants <Are there health conditions that would prevent you from providing ECPs to a woman?> Explain that according to the World Health Organization (WHO) there are no contraindications for ECPs because the amount of hormone is too small to have a clinically significant impact and the duration of use is very short. In addition, these ECPs do not contain estrogen, which is associated with some contraindications, particularly over long-term use. The WHO states that ECPs have no clinically significant impact on conditions such as cardiovascular disease, angina, acute focal migraine, or severe liver disease. Emphasize that there are no health conditions that would prevent you from giving ECPs. No pregnancy test or physical examination is needed before giving ECPs. Emphasize that ECPs should not be taken if a woman is pregnant because they will not work. The use of certain drugs such as rifampicin, griseofulvin, Saint John’s Wort, certain anticonvulsant drugs and certain antiretroviral drugs (ritonavir) may affect the effectiveness of ECPs.

ECP regimens Two LNG regimens are packaged and labeled specifically for emergency contraception 1 tablet levonorgestrel (LNG), 1.5 mg or 2 tablets of 0.75 mg LNG to be taken 12 hours apart (as labeled by the FDA) yet evidence shows that it is best if both pills are taken at the same time. Explain that during this training we are focused on the levonorgestrel ECPs, but there are also other types of ECPs, with different regimens. LNG ECPs appear to be effective for 4 days (96 hours) after sex and potentially up to 5 days (120 hours). It appears to be more effective the sooner it is taken after an act of unprotected sex. LNG Regimens levonorgestrel (LNG), 1 tablet 1.5 mg levonorgestrel (LNG), 2 tablets of 0.75 mg LNG labeled to be taken 12 hours apart, but can be taken together.

Other emergency contraceptive options Other types of emergency contraceptives include: Ulipristal acetate, 30 mg in a single dose Mifepristone, 10-25 mg in a single dose (not widely available) Combined hormonal contraceptive pills (both estrogen and progestin- Yuzpe regimen) Copper IUD Explain the other options for emergency contraception include: Ulipristal acetate, 30 mg in a single dose Mifepristone, 10-25 mg in a single dose (not widely available) Combined hormonal contraceptive pills (Yuzpe regimen). Combination Oral Contraceptive Pills (COCs), taken in higher-than usual- amounts can be used as ECPs, when a dedicated product, packaged as ECP is not available. The number of pills to be taken depends on the brand of COCs. one dose of 100 mcg ethinyl estradiol plus 0.5 mg levonorgestrel is followed by a second identical dose 12 hours later. Explain that the insertion of a copper IUD can also be used as emergency contraception, but this training focuses on LNG ECPs.

Key points for providers and clients ECPs are: The only currently available contraceptive method that prevents pregnancy after sexual intercourse and before implantation. Safe and effective. No medical precautions or contraindications. Few side effects. Must be taken within 120 hours (5 days) after unprotected sex. The sooner they are taken, the more effective they appear to be. Do not affect an existing pregnancy if taken when a woman is already pregnant. Briefly review these key points from session I, found on the slide. Ask participants for other important points that are not found on the slide, that they noted during this session. Explain that in Session II we will be discussing the indications for use of ECPs.