Hello, and welcome to the online learning session, Emergency Contraception, Ella versus Plan B. I am Gail Horner. I'm a forensic nursing specialist with IFN. I joined IFN about a year ago, prior to working for the International Association of Forensic Nurses. I practiced as a pediatric nurse practitioner in a hospital-based child abuse program for over 25 years and coordinated and took call in our pediatric sexual assault nurse examiner program in the emergency department. So welcome to Emergency Contraception. I have no conflicts of interest to disclose. You need to attend the entire session and then complete a course evaluation to receive continuing nursing education contact hours. The International Association of Forensic Nurses is accredited as a provider of continuing nursing education by the American Nurses Credentialing Centers Commission on Accreditation. So the learning outcomes for the next half hour or so will be to take a look at Ella and Plan B and to describe the efficacy, mode of action, and side effects for each of these drugs, and also a brief discussion of research related to emergency contraception. We greatly acknowledge the indigenous peoples on whose ancestral homelands we live. We as forensic nurses realize that emergency contraception is an essential element of medical forensic care following sexual assault. All menstruating females who in the course of their sexual assault experienced genital to genital contact, meaning a penis to the vagina, are often offered emergency contraception. It is vital that we also offer emergency contraception to menstruating trans males and to tanner three to four females, girls who have breast buds, pubic hair, and estrogen changes to the hymen and other genital structures who have not yet begun having periods. Because remember that a girl can become pregnant before her first period. The indications for emergency contraception are basically that an individual has participated in unprotected sexual intercourse within the past three to five days. And certainly this is true in cases of sexual assault and sexual abuse where the individual is not participating in the unprotected sexual intercourse but has unwillingly participated. The copper IUD is the most effective form of emergency contraception and it is the only emergency contraception method effective after ovulation has taken place. Pregnancy rate with copper IUD is less than 0.1% when it is inserted within five days, and it does not disrupt an existing pregnancy. But let's face it, the insertion of a copper IUD is just often not a realistic form of emergency contraception, given the method of insertion and the skill level of provider that it takes to insert the IUD. When considering which type of emergency contraception is most effective, it is important to note the following. The overall pregnancy rate after use of oral emergency contraception has been reported at 1 to 2% per single emergency contraception use. Obviously, a large portion of emergency contraception users would not have become pregnant really without even the use of emergency contraception, depending on the cycle, day, and many other factors. But other options for emergency contraception and really more practical options are two oral tablets, Plan B and Ella. Let's compare and contrast Plan B and Ella. Look at the efficacy. Plan B prevents 95% of pregnancies when taken within 24 hours, 85% between 25 to 48 hours, and 58% between 49 and 72 hours. Take a look at the efficacy of Ella. The pregnancy rate is 0.9 to 2.1%, and it's equally effective at 120 hours as it was in less than 24 hours. Mode of action. Plan B works by preventing follicular rupture and ovulation, and it may inhibit implantation. It does not have an effect on the endometrium and is not effective if implantation has already occurred. Studies show that Plan B is more effective when taken prior to ovulation. Plan B is a progestin. Ella is a selective progesterone receptor modulator. It may act as a progesterone agonist or antagonist, depending on the level of progesterone and presence of coactivators or co-inhibitors of gene expression. Ella may inhibit implantation, but does not affect an existing pregnancy. And Ella, like Plan B, inhibits follicular development and prevents ovulation. When considering availability, Plan B versus Ella, it's important to note that Plan B is the only emergency contraceptive medication available over-the-counter. Ella is available by prescription only. Access to Ella is impinged upon by the need for a prescription and also limited provider familiarity. When we look at side effects, both Plan B and Ella are typically well-tolerated by patients and have similar side effects. Nausea and vomiting, delay in the next period, heavier menstrual bleeding, and again, overall well-tolerated. Ella may result in less nausea and vomiting than Plan B. Ella appears to be more effective than Plan B in patients with a higher BMI. In one study in women with a BMI of 30, Plan B resulted in a 5.8% failure rate, meaning that a pregnancy occurred, and Ella, 2.6%. Currently, obesity is not a contraindication for use of Ella or Plan B. Another consideration when considering Plan B versus Ella is the ability to quick start another method of birth control, like oral contraceptives. You can do that with Plan B, but not with Ella. The reason for this is that Ella works by affecting progesterone receptors. It can affect the progestin component of oral contraceptive products. With Ella, you must wait five days to begin oral birth control. Unlike Plan B, Ella is a Category X drug when taken in pregnancy, as there is a risk of fetal loss when taken in the first trimester of pregnancy. With Plan B, there is no harm to existing pregnancy. Although Ella is technically considered a Category X drug, there is some controversy regarding the accuracy of this statement. Lee and company conducted a study in 2019, and these were academics from the University of Hong Kong, from France, University of Illinois, Sweden, and the United Kingdom, so an international study. Conducted a meta-analysis looking at, does Ella interfere with implantation? Because the feeling is that perhaps women might be hesitant to take Ella in fear that it is an abort effect, and that it would cause an abortion if they were indeed pregnant. And their findings indicated that Ella does not appear to have a direct effect on the embryo. Changes in endometrial histology are small and not consistent, varying among studies. While Ella affects the profile of gene expression in human endometrium, the findings vary between studies, and it is not clear that these changes affect endometrial receptivity or prevent implantation. Ella does not appear to have any inhibitory effect on embryo attachment. Ella is no more effective in preventing pregnancy than chance alone if used after ovulation, and does not increase miscarriage rates. So the study by Lee and I conducted that Ella does not affect the developing fetus, and that it does not increase miscarriage rates. There was another study by Bullard and company that looked to estimate the cost-effectiveness of Ella and Plan B as emergency contraception on pregnancy prevention among individuals that were using oral contraceptive pills. So we will talk about their study. So again, they wanted to look at the cost-effectiveness of Ella versus Plan B on women who were using oral contraceptive products. And let me tell you, this study is probably a little bit above my intellectual bandwidth, but I'll describe it to you. So what they did is they built a decision analytic model using 3H software to evaluate the optimal oral emergency contraceptive strategy in a hypothetical cohort of 100,000 25-year-old women mid-cycle with a prolonged missed pill episode of 8 to 14 days. They used a five-year time horizon and 3% discount rate. From a healthcare perspective, they obtained probabilities, utilities, and costs inflated to $2,018 from the literature. They set the threshold for cost-effectiveness at a standard $100,000 per quality-adjusted life year. They included the following clinical outcomes, number of protected cycles, unintended pregnancies, abortions, deliveries, and cost. They found that Ella was the optimal method of oral emergency contraception as it resulted in 720 fewer unintended pregnancies, 736 fewer abortions, and 80 fewer deliveries at a total cost savings of $50,323 and 79 additional adjusted life years. Ella continued to be the optimal strategy even in the case of obesity or the oral contraceptive pills impacting Ella efficacy. They also found that Ella was the dominant choice in which an oral contraceptive interaction would have to change efficacy of Ella by 160% before Plan B was the dominant strategy. Their model found that Ella was the dominant choice of oral contraceptive use even among oral contraceptive users with a prolonged missed pill episode regardless of body mass index. Ella is the dominant choice of oral emergency contraception use among combined oral contraceptive users. Now let's talk about some case studies. Let's think about Melissa. She's a 10-year-old female who presents to the emergency department with a concern of sexual abuse. She's giving a history that her father put his penis in her vagina four days ago. Melissa has never had a period, but on physical exam you note breast buds, a moderate amount of coarse pubic hair, and her hymen has begun to estrogenize. Should you consider emergency contraception for Melissa? Yes, we should consider emergency contraception. Melissa is clearly Tanner III stage development, and remember, a girl can ovulate prior to her first menses. Melissa needs emergency contraception. Would Ella or Plan B be the better choice for Melissa? Let's think about the differences in Ella and Plan B, especially the differences in effectiveness, and we know that Plan B's effectiveness decreases as time goes on, and especially at the 73-hour mark where Melissa is, Ella would be the better choice. Audrey is a 25-year-old female who presents to the emergency department with concerns of sexual assault. She states she was at a party last night and was drinking alcohol. She passed out and woke to a strange man on top of her with his penis in her vagina. She's not currently using any birth control. She's unsure if he wore a condom. Her BMI is 30. Should you consider emergency contraception for Audrey? Yes, emergency contraception should be offered to Audrey. Would Ella or Plan B be the better choice for Audrey? The answer is Ella. We know that in patients with a BMI over 25, Ella is more effective in preventing pregnancy than Plan B. Kara, a 24-year-old female, presents to the emergency department with concerns of sexual assault. She states she was walking down the street tonight and was pulled into an alley. An unknown male put his penis in her vagina. He did not use a condom, and he ejaculated. Her BMI is 20. She's currently taking oral birth control, but missed the last two days. Should you consider emergency contraception for Kara? Yes, Kara should be offered emergency contraception. Would Plan B or Ella be the better choice for Kara? Well, let's take a look at things. We know that Ella is more effective than Plan B in preventing pregnancy. However, we know that Ella can decrease the effectiveness of oral contraception. If we give Kara Ella, we must also let her know that she needs to use a barrier method of birth control, like a condom, until she begins her next menstrual cycle. These are the references used for this presentation. If you have any questions, please shoot me an email. I would love to chat about any of your questions or concerns about the presentation. Take care, complete your evaluation, and thank you for choosing emergency contraception, Ella versus Plan B.

emergency contraception

Ella

Plan B

copper IUD

side effects

cost-effectiveness