But emergency contraception has. Pharmacy training to support ellaone. effective when it matters most ELA-WEBPHARMA-0813-EU

Transcription

1 But emergency contraception has. effective when it matters most ELA-WEBPHARMA-0813-EU This booklet contains content for Healthcare Professionals only. The information on this booklet is based on the European Product Information and may contain information that is not approved elsewhere. Pharmacy training to support ellaone ellaone 30mg tablet contains ulipristal acetate and is indicated for emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure.

2 Pharmacy training to support ellaone ellaone (30mg ulipristal acetate) is an emergency contraceptive pill (ECP), now available in pharmacy without a prescription in Europe. The OTC availability of emergency contraceptive pills is critical to increase access and minimise any delay in taking them. This is especially significant given that emergency contraceptive pills are more effective the sooner they are taken after unprotected intercourse. The advice of pharmacy staff and emergency contraceptive efficacy are the two most important factors in the choice of emergency contraceptive pill. 1 This brochure has been developed to help you learn more about ellaone. This brochure is for healthcare professionals only. It is aimed at community pharmacists in the European Union, pharmacy assistants and anyone in the pharmacy team who may dispense emergency contraception. It will help you to be fully informed, make confident recommendations and give appropriate advice to women requesting emergency contraception in your pharmacy. It will also help you give appropriate counselling on ellaone as well as subsequent contraceptive care, to support the best health outcomes. ellaone effective when it matters most has been authorised with central European marketing authorisation allowing it to be available as a nonprescription medicine in 29 European Union countries. 2

3 Top ten things you should know about ellaone 1 ellaone should be taken as soon as possible after unprotected sexual intercouse (UPSI), but no later than 120 hours (5 days) after UPSI or contraceptive failure 2 2ellaOne is not an abortifacient Contains 30mg ulipristal acetate, 2 and was specifically developed for emergency contraception 4 ellaone is an emergency contraceptive pill intended to prevent pregnancy after unprotected sexual intercourse (UPSI) or contraceptive failure 2 ellaone is for women of child bearing age who want to avoid unintended pregnancy 2 ellaone can delay ovulation even when ovulation is about to happen (when risk of fertilisation is highest) 5 ellaone is the most effective emergency contraceptive pill in preventing unintended pregnancy when used in the first 72 hours after unprotected sex 2,5,6 8 ellaone is well tolerated 2, After using ellaone it is recommended that a reliable barrier method of contraception is used until the next menstrual period starts, even if the woman is taking regular hormonal contraception 2 ellaone should not be taken by women who are hypersensitive to the active substance or to any of the excipients 2 References 1. HRA Data on File. Harris Interactive ellaone European Union Summary of Product Characteristics. 3. ellaone European Union Patient Information Leaflet. 4. HRA Pharma Data on file. Clinical overview. 5. Brache V et al. Contraception 2013; 88(5): Glasier AF et al. The Lancet 2010; 375:

4 Useful terms and acronyms EC Emergency Contraception ECP Emergency Contraceptive Pill FSH Follicle Stimulating Hormone GP General Practitioner (family doctor) GPP Good Pharmacy Practice IUD IntraUterine Device LH Luteinising Hormone OC Oral Contraceptive OTC Over The Counter SPRM Selective Progesterone Receptor Modulator UPSI UnProtected Sexual Intercourse 4

5 Chapter 1: Overview This booklet is divided into chapters. It has been written so that you can use it as a complete training package on emergency contraception, or if you just wish to update your knowledge about ellaone, you can start at chapter 5. Here is a brief overview of what each chapter contains: Chapter 2: unintended pregnancies, a public health challenge - page 7 n Definition and frequency of unintended pregnancy n Causes of unintended pregnancy n Unintended pregnancy often happens when contraception is being used n Impact of unintended pregnancy n Unintended pregnancy and age Chapter 3: reproductive physiology: the theory - page 13 n Menstrual cycle theory n Unpredictability of ovulation n The concept of conception risk period n From ovulation, to fertilisation, to pregnancy Chapter 4: emergency contraception - page 20 n Definition of emergency contraception (EC) n Overview of emergency contraception history n The different EC options in Europe n Mechanism of action of oral EC n Emergency contraception myths n Conditions under which women can access EC n Level of use in Europe n The role of the pharmacist in providing emergency contraception 5

6 Overview Chapter 5: ellaone (30mg ulipristal acetate) - Page 32 n What is ellaone : indication, posology and precautions for use n Why is ellaone an advance? n ellaone delays ovulation when it matters most n Efficacy of ellaone vs levonorgestrel n ellaone safety profile n Contraindications Chapter 6: Pharmacist s role - Page 41 n Good practice at the counter - key messages for your counselling n Cases to learn from n A positive attitude n Training your pharmacy team n Avoiding confusion with regular contraception Chapter 7: self-test - Page 50 n Self-test questions 6

7 Chapter 2: Unintended pregnancies, a public health challenge Unintended pregnancies result from unprotected sex where no children, or no more children are desired. 44% It has been estimated that 44% of pregnancies in Europe are unintended. 1 This figure may seem surprising. However, during most of a woman s reproductive life she is likely to be trying to avoid pregnancy. Therefore the period during which a pregnancy would be considered unintended is much longer than the period during which she would be actively trying to become pregnant. Two thirds of unintended pregnancies end via abortion, a quarter end in birth and about 11% miscarry. 1 In [Country name Ref to be added at localisation stage TBC] xx% of pregnancies are unintended. Unintended pregnancy results from unprotected sexual intercourse (UPSI). UPSI is common. 3 These frequent acts of UPSI are not happening in a distinct sub-population, but happen in women irrespective of age, income, education level and marital status. 3 30% In a large European survey of over 7000 sexually active women, 30% reported having unprotected sex, at least once, in the last 12 months 3 7

8 Unprotected sexual intercourse can happen, even when a couple consciously tries to prevent it UPSI can result from a couple not using any contraception, 3 including withdrawal. 4 It can also happen when they consciously try to prevent it. For example UPSI can happen as a result of: n Accidental condom problems 3 (breakage, slippage, not on in time) n Oral contraceptive (OC) problems 3 e.g. forgotten pill n A temporary break from the usual contraceptive 3 n Forgetting to apply a patch or insert a vaginal ring 3 UPSI can also happen as a result of violence (rape). The majority of women say that there are no particular circumstances that could explain their lack of contraception or contraception failure. 3 Only a minority recognised that some factors may have influenced their behaviour, making contraceptive failure more likely. 3 These factors included a new partner or relationship breakdown, travel, influence of alcohol or using a new contraceptive method. 3 8

9 Unintended pregnancy often happens when contraception is being used Although unintended pregnancy happens most often when no contraception is used, two studies show that it also happens when it is claimed that contraception is being used. 5,6 In fact, over 30% of unintended pregnancies happened when women were using highly effective contraceptive methods like the pill or IUD. 5 Contraception used when unintended pregnancy happened 5 40 Percentage who said this was the method used Contraceptive Pill IUD Condom No contraception Adapted from Bajos N et al This study included 897 unintended pregnancies. Reasons for contraceptive pill failure included taking tablets late, missed pills, illness, medication, vomiting or no explanation. Reasons for IUD failure included wrong position, the IUD falling out, illness or medication, or no explanation. Reasons for condom failure included tearing, slipping off, no contraception used on that occasion or no explanation. It can be calculated that contraceptive interruption is inevitable in a woman s life, where she is trying to prevent pregnancy from the time she is about 17 years old (mean age of first sexual intercourse) until she is about 50. If she is on the pill she will need to take about 8000 tablets correctly. It is unsurprising that she sometimes forgets tablets or makes mistakes. 9

10 Impact of unintended pregnancies on public health For individual women and their partners, families, and communities the consequences of unintended pregnancy are significant Compared with intended pregnancy, unintended pregnancies have a potential public health impact. POTENTIAL HEALTH IMPACT, COMPARED WITH INTENDED PREGNANCY Women n More likely to behave in a way that could increase the risks to their baby e.g. smoking and alcohol use during pregnancy 7 n Later pre-natal care 8 n Increased risk of antenatal and postnatal depression 7 n Greater mood disturbance e.g. greater anxiety at 12 months post partum 7 n Disruption of the life of a woman, education missed, careers missed, stress and consequences for her life 8 Children n Increased risk of poor school performance or neglect 7 n Where the mother is <17 years their children start school with deficits in cognition, knowledge and language development (even where background characteristics are accounted for) 9 n More likely to require psychiatric treatment (including in-patient) at any time in life (this study followed children for up to 35 years) 10 Relationships n In couples, lower levels of positive interaction at 3, 12 and 24 months after birth 7 On the macro level, the public health, health systems, and economic impact of unintended pregnancy are also considerable 11 A US study shows the positive effect, on health and welfare costs, of reducing unintended pregnancy: Through the provision of effective methods of contraception to low-income individuals who have limited access to these services elsewhere, California s family planning program averted an estimated 205,000 unintended pregnancies, averting nearly 94,000 live births and 79,000 abortions. The program saved federal, state, and local governments over $1.1 billion within 2 years after a pregnancy and $2.2 billion up to 5 years after

11 Unintended pregnancy can affect women of all ages Unintended pregnancy happens at all reproductive ages, with a peak in women aged years. 13 During a woman s mid- 20s it is quite usual for relationships and contraception to be changing. Condoms are frequently used. It is important to recognise that these factors inevitably put women in this age bracket at risk of unintended pregnancy, despite responsible attitudes and sensible use of contraception. Unintended pregnancy by age Unintended pregnancies / 1000 women < Age of women in years Adapted from Finer and Henshaw US study of unintended pregnancy rates in 7643 women. 11

12 Key message summary for Chapter 2 n 44% of pregnancies in Europe are unintended 1 n Anyone can experience UPSI - even those who normally use contraception responsibly 3 30% of sexually active women aged report having at least one UPSI in the last 12 months 3 References 1. Singh S et al. Stud Fam Plann 2010; 41: Individual country unintended pregnancy rate. Local sources to be added at localisation stage. 3. Data on file. HRA Pharma Report. Women and emergency contraception in A European Survey. 4. Trussel J. Contraception 2011; 83: Bajos N et al. Hum Reprod. 2003; 18(5): Wynn LL and Trussell J. Contraception 2008; 77: Grussu P et al. Birth 2005; 32(2): Committee on Unintended Pregnancy, Institute of Medicine and the National Academy of Science. Brown S and L Einsenberg, editors. The Best Intentions: Unintended Pregnancy and the Well-Being of Children and Families. ISBN Terry-Humen E et al. Playing catch-up: How children born to teenage mothers fare. Available at: resources/pdf/pubs/playingcatchup.pdf. Accessed January David HP. Health Matters 2006; 14(27): UNFPA State of world population Available at: Accessed January Amaral G et al. Health Serv Res 2007; 42(5): Finer L and Henshaw S. Perspectives on Sexual and Reproductive Health 2006; 38(2):

13 Chapter 3: Reproductive physiology: the theory Menstrual cycle The follicular phase (stages 1-4 on the diagram) The follicular phase starts on the first day of menstruation and ends with ovulation. 1 Prompted by the hypothalamus, the pituitary gland releases follicle stimulating hormone (FSH). 2 This hormone stimulates the ovary to produce several follicles (tiny nodules or cysts) on the surface. 1 Each follicle houses an immature ovum. 1 Usually, only one follicle will deliver an ovum, while the others die. 1 The growth of the follicles stimulates the endometrium to thicken in preparation for possible pregnancy. 1 Pituitary hormone cycle 2. FSH increases slightly, stimulating the development of several oocyte-containing follicles. 3. FSH levels decrease - only one or two follicles continue to develop. Follicle stimulating hormone 5. LH and FSH levels increase dramatically. High LH stimulates ovulation. Luteinising hormone Sex hormone cycle 6. The ruptured follicle forms the corpus luteum, which produces large amounts of progesterone. Oestrogen Progesterone Ovarian cycle Oocyte Follicle Ovulation Corpus luteum 7. In the absence of fertilisation, the corpus luteum degenerates. The loss of progesterone production, combined with decreased levels of oestrogen, initiates a new menstrual cycle. Endometrial cycle 1. Bleeding begins on day one of the follicular phase. 4. Developing follicles release oestrogen - thickens the endometrium in the rest of the menstrual cycle. Uterine lining Menstruation Follicular phase Ovulatory phase Luteal phase LH Luteinising Hormone FSH Follicle Stimulating Hormone 13

14 The ovulatory phase (stages 5 on the diagram) Ovulation is the release of a mature ovum from the ovary s surface in response to rising levels of luteinising hormone (LH) and FSH. 1 When the LH reaches a peak it triggers the rupture of the developing follicle to release the mature ovum: ovulation; with no LH surge, ovulation does not occur. 1 The released ovum is funnelled into the fallopian tube and towards the uterus by waves of small, hair-like projections. The life span of the typical ovum is only around 24 hours. 3 Unless it meets a sperm during this time, it will die. The luteal phase (stages 6-8 on the diagram) Upon the release of the ovum, the ruptured follicle stays on the surface of the ovary. The follicle transforms into a structure known as the corpus luteum, which releases progesterone and small amounts of oestrogen. 1,2 The thickened lining of the uterus is maintained and waits for a fertilised ovum to implant. 1 If this happens the implanted ovum will start to produce human chorionic gonadotropin, detectable in a urine test for pregnancy. 4 If pregnancy doesn t happen, the corpus luteum regresses, usually around day 22 in a 28-day cycle. 1 The drop in progesterone levels causes the endometrium to break down and menstruation begins again. 1 14

15 The reality: the timing of ovulation is unpredictable After unprotected sexual intercourse sperm can survive for approximately 5 days within the female reproductive tract. 3 This means that during the average woman s menstrual cycle there are six days when intercourse can result in pregnancy; this fertile window is the five days before ovulation plus the day of ovulation. 5 Women are at risk of conception during: The 5 days before ovum release......and the day of ovum release So when is the fertile window? Current evidence challenges the simplified text book understanding of the menstrual cycle shown on the previous page. 5 We now know that ovulation only happens on day 14 of a 28 day cycle in about 12% of cases. 6 The variability of ovulation is large - it can happen from day 11 to day Because sperm stay viable for up to 5 days 3, the period over which conception is likely to occur runs from day 6 to day 21 for regularly cycling women. 5 If the cycle is not regular, there is a risk of ovulation happening even later in the cycle. 5 The conception risk period does not end before day 28 of their cycle. 5 This shows that there is no such thing as a risk free period. 5 15

16 Ovulation also varies from cycle to cycle 5 Ovulation is unpredictable 5 Conception risk period* Sperm viability 5 days Ovulation probable (Regular menstrual cycle) Ovulation probable (Irregular menstrual cycle) Days of menstrual cycle Regular *Period in which a woman has a higher than 10% risk of being in her fertile window. Although the risk of pregnancy exists most of the time, 5 women may underestimate the risk of pregnancy. 7 This lack of awareness of pregnancy risk may be the most important barrier to emergency contraception use 8 16

17 The highest risk of pregnancy is when ovulation happens shortly after UPSI 9 Sperm viability declines over time. This means that the risk of conception is highest during the first three days following unprotected sex or contraceptive failure. 9 Probability of conception (%) Unprotected sex Day of ovulation post unprotected sex Adapted from Wilcox A et al A US study of 625 menstrual cycles in 221 women planning to become pregnant. Therefore, to avoid unwanted pregnancy, it is critical to avoid ovulation (happening shortly after UPSI) by using EC as soon as possible 17

18 From ovulation, to fertilisation, to pregnancy Since a woman can never know when she has ovulated, working out the exact point of fertilisation is also impossible. What we do know is that implantation occurs 6-12 days after fertilisation. 4 Once implantation is complete, pregnancy is established. 10 Pregnancy begins once the fertilised ovum is implanted in the womb. 10 This happens 6-12 days after intercourse Fertilisation - when the ovum and sperm fuse 3. As the fertilised ovum moves along the fallopian tube it divides Day 1 Day 2 Day 3 Day 4 4. Pregnancy begins when the fertilised ovum implants in the womb 1. An ovum is released during ovulation Day 0 Day 6-12 Embryo Pregnancy begins when a fertilised ovum has been implanted in the wall of a woman s uterus. This definition is critical to distinguishing between a contraceptive that prevents pregnancy and an abortifacient that terminates it. 10,11 When women have unprotected intercourse, they are not immediately pregnant. Pregnancy can only occur a minimum of 6 days after intercourse (when a fertilised egg implants in the uterus) Many women don t understand when pregnancy begins. They believe it starts the moment they had UPSI. Within 5 days of UPSI a woman cannot be pregnant from that UPSI, because implantation cannot yet have occurred. Due to misunderstandings about this, women can feel guilty about using EC because they wrongly believe it to be a form of abortion. 7 18

19 Key message summary for Chapter 3 n Ovulation is highly unpredictable 5 n Conception risk is present during most of the cycle 5 n The highest risk of pregnancy is when ovulation happens shortly after UPSI 9 n Pregnancy begins when a fertilised egg has been implanted in the wall of a woman s uterus, days after intercourse 4 n Within 5 days of UPSI a woman cannot be pregnant from that UPSI, because implantation cannot yet have occurred 10 References 1. Aitkin RJ et al. The Journal of Clinical Investigation 2008; 118(4): Owen JA. Am J Clin Nutr 1975; 28: Pallone SR and Bergus GR. JABFM 2009; 22(2): Wilcox AJ et al. NEJM 1999; 340(23): Wilcox AJ et al. BMJ 2000; 321: Baird DD et al. Epidemiology 1995; 6: HRA Pharma Report. Women and emergency contraception in A European Survey. 8. Moreau C et al. Contraception 2005; 71: Wilcox AJ et al. N Engl J Med 1995; 333: Gold RB. The Guttmacher Report on Public Policy Available at Accessed January Faculty of Sexual and Reproductive Healthcare. Guideline on Emergency contraception Available at CEUguidanceEmergencyContraception11.pdf. Accessed January

20 Chapter 4: Emergency contraception Definition Emergency contraception (EC) is defined as the use of any drug or device after unprotected intercourse to prevent an unintended pregnancy. 1 It is an after-sex or back-up contraception solution. It is also commonly known as the morning-after pill or day-after pill. When emergency contraception is used? Emergency contraception can best prevent pregnancies when used soon after intercourse. It provides an important back-up in cases of unprotected intercourse, or contraceptive accident (such as forgotten pills, torn condoms) and after rape or coerced sex. 2 How women might explain their need for EC n Condom broke or slipped off n Missed pill, forgot to insert contraceptive ring or apply patch n Diaphragm or cap slipped out of place n Failure of withdrawal method n No contraception used n They were forced to have unprotected sex 20

21 Overview of EC history The idea of EC is not new. Investigation into post-coital contraception began in the 1920s. 1920s It was first discovered that high-dose oestrogens interfered with pregnancy in mammals. 3,4 1970s In 1972 Dr Albert Yuzpe, a Canadian physician, described a post-coital contraceptive regimen comprising both an oestrogen and a progestin; The Yuzpe method. In 1976, the Copper IUD was first used for EC. 1980s The Yuzpe method was still the dominant form of EC even if it was not a dedicated product (specifically dosed, packaged and marketed for post-coital use) and had a high level of some side effects. 1990s The World Health Organization (WHO) conducted a clinical trial comparing the Yuzpe regimen with a progestin-only method. The progestin used in the method was levonorgestrel. In 1999, levonorgestrel was manufactured and sold as EC in several countries. ellaone was specifically developed for emergency contraception. This advanced product was launched in 2009 in the EU and is now available in 70 countries. 21

22 Types of emergency contraception Current EC solutions are: n Fitted, as an intrauterine device n Oral, as a tablet The IUD which is suitable for EC is a Copper-T IUD IUDs are considered the most effective EC option 5, but they may not be a practical option for many women. The advantage of an IUD is that it provides an ongoing contraceptive solution. 5 But when speed is of the essence, women may not want to rush a decision to fit this long acting reversible contraceptive (LARC). The Copper-T IUD can be fitted up to 120 hours (5 days) after unprotected sex. 6 Its use is restricted by its availability and the need to be inserted by a skilled healthcare professional. 7 Women who may need a copper IUD for emergency contraception must be advised to contact a GP or family planning service as a matter of urgency. 6 Pharmacists should direct women to a local service known to provide IUDs. 6 Copper IUD is considered the most effective EC method, 5 but in a situation where you need to act very quickly, IUD fitting takes time and involves an invasive and sometimes uncomfortable procedure. 7 There are two oral ECs available 8 n One containing levonorgestrel, which was first made available in 1999 n One containing ulipristal acetate (ellaone ), which was launched in Unlike other ECs, it was specifically developed for EC The mechanism of action of oral ECs is to inhibit or postpone ovulation, so that no ovum is released. 2,9 Oral ECs are also called ECPs (Emergency Contraceptive Pills). 22

23 Mechanism of action of emergency contraceptive pills ECPs work by inhibiting or delaying ovulation (the release of an ovum), so that fertilisation cannot take place. 2,9 Emergency contraceptive pills will not prevent pregnancy in 100% of cases. 9 This is because there is a chance that the woman has already just ovulated when she takes an emergency contraceptive pill. 10 Taking emergency contraceptive pills as soon as possible after unprotected sex gives the best chance of success. 11 ECPs have no effect on fertilisation if ovulation has already happened. They do not interfere with an implanted ovum (pregnancy), 2,9 so they do not cause abortion. 11 ECPs are suitable for women of reproductive age and have a good safety profile. 2,9 ECPs do not protect from sexually transmitted infections (STIs). 11 A decade of experience with levonorgestrel has shown that pharmacy access allows women to use EC quickly and appropriately without medical supervision. 8 As ECPs work by inhibiting or delaying ovulation, they are not 100% effective. If ovulation has just occurred before unprotected intercourse, ECPs will not be effective. Therefore, ECPs are back-up contraception solutions, which do not replace a regular contraceptive method. Dispelling myths about oral, or hormonal emergency contraception n Several studies have shown that facilitating access to EC does not increase sexual or contraceptive risk-taking behaviour 2 n A number of studies show that women and adolescents with greater access to EC are not more likely to engage in unprotected intercourse, and are more likely to adopt an ongoing contraceptive method after EC use 12,13 n Use of ECPs has no effect on future fertility 2,9 n There is no indication that ECPs harm a developing foetus if they are mistakenly taken early in pregnancy 2,8 n ECPs do not interrupt an existing pregnancy 2,9 n Women find the label and instructions easy to understand 2,14 n ECPs do not protect against STIs. 11 Only condoms protect against sexually transmitted infections n ECPs do not provide contraceptive cover for unprotected intercourse in the days after intake 11 23

24 Level of EC use in the European Union 30% 30% of women aged year old reported at least one UPSI in the last 12 months % 76% of these did not use emergency contraception, putting themselves at risk of unintended pregnancy. 15 Use of EC after UPSI in women aged Percentage of women % 24% 10 0 Women who did not use EC (n=1621) Women who used EC (n=508) Adapted from HRA data on file: HRA Pharma Report. Women and emergency contraception in A European Survey. UPSI was defined as sex without contraception, or contraception failure, in women who did not intend to get pregnant. (n=2129) 15 24

25 The reasons given for not using EC included: 15 n Lack of awareness of pregnancy risk n Lack of immediate connection to EC did not think about it n Lack of knowledge about time-related efficacy n Access issues n Misconceptions about EC or fear of being judged/embarrassment EC provides women with a last chance to prevent pregnancy after unprotected sex, yet it is still largely underused. Women who take EC understand they need to act fast 15 n Of those who took EC, the vast majority (87%) took it within 24 hours with just 10% waiting until the second day. 15 Intake of EC after 72 hours is rare 15 n To ensure maximum efficacy, it is important to take EC as soon as possible after UPSI 25

26 Pharmacists play a key role in providing ECPs Pharmacists are front line health care providers around the world. For many people they are the first point of contact with the health system. ECPs are available without a prescription directly from pharmacists in most European countries, making pharmacists key EC providers in these settings ellaone is the only ECP with European marketing authorisation allowing it to be available as a non-prescription medicine in 29 European Union countries. It is readily available over the counter, either directly from a store shelf (Sweden, Norway and the Netherlands) or from a pharmacist, without a prescription. The OTC availability of ECPs is critical to increase access and minimise delay of intake. This is especially significant given that ECPs are more effective the sooner they are taken after unprotected intercourse. When a woman must visit a doctor or other appropriate healthcare provider before she can get an ECP, she often has to make two trips: n One to a clinic to obtain a prescription n A second to a pharmacist to fill the prescription This presents a significant barrier for many women, especially those who do not have transport, or who live in rural areas, without easy access to doctors or pharmacies. Having to make two trips before she can obtain an ECP causes a delay in intake. In addition, the need for a prescription makes access to ECPs on weekends and at night (when many contraceptive mishaps occur) more difficult. 26

27 Pharmacists offer advantages in terms of location, convenience and opening times. 17 OTC availability of ECPs means that women only have to make one trip. This means women can get an ECP within 24 hours of unprotected intercourse, when treatment is known to be most effective. 17 Women may also like the anonymity of the pharmacy as they can feel embarrassed about needing emergency contraception. 18 An International Pharmaceutical Federation (FIP) paper on the pharmacists role in improving maternal, newborn, and child health highlights the benefits of pharmacy ECP involvement: 19 n When women obtain ECP from a pharmacy instead of a physician or clinic, there are cost-savings for both private and public payers 19 n Pharmacists promote dialogue on contraceptive alternatives and influence the beliefs and the outcomes through effective counselling on ECPs. The supply of emergency contraception from pharmacies is accompanied by patient education from pharmacists, who have expertise on this topic 19 n Pharmacists provide information to patients at the time of ECP dispensing, which allows women to understand proper use of this medicine. Pharmacists ensure consistency of information about ECPs, in particular for women less than 16 years of age 19 27

28 Pharmacy access to ECPs has not led to negative consequences When EC is available through pharmacies without a prescription, the use of the medication increases compared to when it is available from doctors, clinics or hospitals. 20 Increased access to EC through pharmacies does not have a negative impact on the use of other forms of contraception. 19 Studies show that women and adolescents with greater access to EC are more likely to adopt an ongoing contraceptive method after EC use. 13 It has been shown that nonprescription availability leads to greater levels of use. However, this increase in use: Does not lead to increased rates of STIs12 Does not increase sexual risk-taking behavior in adolescents20,21 Does not lead to increased frequency of unprotected sex12 Does not lead to decreased use of other contraceptive methods12 Does not lead to decreased use of contraception, including the most effective methods such as hormonal methods, and condoms 12,22 n Women s EC experience is actually a motivating factor leading to more consistent use of regular contraception 13 Contraceptive use change to more reliable methods after ECP intake 22 Highly effective methods 46% 61% Non-highly effective methods No method 11% 15% 28% 39% Contraceptive use at the time of emergency contraception intake Contraceptive use after 6 months after emergency contraception intake Percentages Adapted from Moreau C et al A cohort study of 2863 women in France, with 272 instances of ECP use. Highly effective methods: birth control pill and long acting methods. Non-highly effective methods: condoms and other barrier methods. 28

29 Good Pharmacy Practice is defined as: the practice of pharmacy that responds to the needs of the people who use the pharmacists services to provide optimal, evidence-based care. 23 International Pharmaceutical Federation (FIP) Good Pharmacy Practice can include: n Asking the right questions; avoiding unnecessary, personal or intrusive questioning n Providing quality advice in a sensitive way, without lecturing n Providing an environment where women feel comfortable and not judged The quality of the pharmacy interaction is an important determinant of proper use, leading to fewer unwanted pregnancies and appropriate use of the product. It is also likely to be an important factor in the event of a future UPSI. 29

30 Key message summary for Chapter 4 n Emergency contraception (EC) is defined as the use of any drug or device after an unprotected intercourse or contraceptive failure to prevent an unintended pregnancy 1 n There are three types of emergency contraception; copper T-IUD, levonorgestrel (2x 0.75mg / 1.5mg) and ellaone (ulipristal acetate 30mg) n ECPs work by inhibiting or delaying ovulation. 2,9 It should be taken as soon as possible after unprotected intercourse or contraceptive failure 11 n Oral emergency contraception is an emergency method that works after unprotected sex but before pregnancy. It does not interrupt an existing pregnancy. 2,8 It does not cause abortion. 2,8 n EC is underused - 76% of women who had at least one UPSI did not use EC 15 n Women who use EC understand that they need to act fast with 87% taking it in the first 24 hours after UPSI 15 n The ability of pharmacists to dispense emergency contraception without prescription increases the number of women that receive this medication within 24 hours. It is all the more important because ECPs are more effective the sooner they are taken after unprotected intercourse References 1. Consensus statement on emergency contraception. Contraception 1995; 52: World Health Organization. (In association with the International Consortium for Emergency Contraception, International Federation of Gynacology and Obstetrics, International Planned Parenthood Federation, Department of Reproductive Health and Research). Fact sheet on the safety of levonorgestrelalone emergency contraceptive pills. Available at: Accessed January Ellertson C. Fam Plann Perspect 1996; 28(2): Haspels AA and Andriesse R. Europ J Obstet Reprod Biol 1973; 3/4: Cheng L et al. Cochrane Database Syst Rev. 2012; 8: CD Royal Pharmaceutical Society of Great Britain. Practice guidance on the supply of emergency hormonal contraception Glasier AF et al. The Lancet 2010; 375: HRA Pharma Data on file. Clinical overview. 9. ellaone European Union Summary of Product Characteristics. 10. Faculty of Sexual and Reproductive Healthcare. Guideline on Emergency contraception Available at CEUguidanceEmergencyContraception11.pdf. Accessed January NHS choices Emergency contraception. Available at Accessed January Polis et al. The Cochrane Library 2013, Issue Gainer E et al. Contraception 2003; 68(2): ellaone readability testing TBC 15. HRA Pharma Report. Women and emergency contraception in A European Survey. 16. International consortium for EC. Available at Accessed August Taylor B. Journal of Family Planning and Reproductive Health Care 2003: 29(2): HRA data on file. Hamell research, Pharmacists recommending behaviour in emergency contraception. April International Pharmaceutical Federation (FIP): FIP reference paper on the effective utilization of pharmacists in improving maternal, newborn and child health (MNCH) Available at Last accessed January Walker et al. J Adolesc Health 2004; 35(4): Raine TR et al. JAMA 2005; 293: Moreau C et al Am J Public Health. 2009; 99: Good Pharmacy Practice. Joint FIP/WHO Guidelines on GPP: Standards for quality services Available at: Accessed January

31 Chapter 5: ellaone (30mg ulipristal acetate) ellaone - specifically developed for emergency contraception 1 n ellaone is an emergency contraception pill which contains 30mg ulipristal acetate 2, which was specifically developed for EC 1 n Ulipristal acetate is an orally-active selective progesterone receptor modulator (SPRM) 2 n Having undergone a centralised European Union (EU) authorisation process, it first became available as a prescription medicine in the EU in n Since then it has been made available in over 50 countries as a prescription medicine and now for pharmacy supply, without prescription across the EU n ellaone works by inhibiting or delaying ovulation 2 What is ellaone? n ellaone is an emergency contraceptive pill intended to prevent pregnancy after unprotected sexual intercourse or contraceptive failure 2 n ellaone should be taken as soon as possible, but no later than 120 hours (5 days) after UPSI or contraceptive failure 2 n ellaone is for women of reproductive age who want to avoid unintended pregnancy 2 How to use ellaone n The treatment consists of one tablet to be taken orally as soon as possible after UPSI or contraceptive failure 2 n ellaone does not offer protection from pregnancy for subsequent acts of unprotected sex. Women should be advised to use a reliable barrier method until their next menstrual period. 2 Although the use of ellaone does not contraindicate the continued use of regular hormonal contraception, ellaone may reduce its contraceptive action. 2 Therefore, if a woman wishes to start or continue using hormonal contraception, she can do so after using ellaone, however, she should be advised to use a reliable barrier method until the next menstrual period. 2 n The tablet can be taken with or without food 2 n If vomiting occurs within 3 hours of ellaone intake, another tablet should be taken 2 n ellaone can be taken at any time during the menstrual cycle 2 31

32 What ellaone is not: 2 n ellaone is not a regular contraceptive, it is for occasional use only. 2 In any case, women should be advised to adopt a regular method of contraception n ellaone does not cause an abortion. It does not interrupt an existing pregnancy 2 n ellaone does not protect from sexually transmitted infections 3 Why is ellaone an advance? To understand better why ellaone is an advanced ECP solution, remember that: n Despite the common textbook definition of the menstrual cycle, the timing of ovulation is unpredictable (See chapter 3) 4 n The highest risk of becoming pregnant is when unprotected intercourse happens close to ovulation (See chapter 3) 5 n Unlike other ECPs, ellaone can inhibit or delay ovulation when ovulation is close to happening 6 And ellaone is now available directly from pharmacy without prescription. n ellaone has been granted OTC status in the European Union 7 32

33 ellaone delays ovulation when it matters most Ovulation is a result of a surge in luteinising hormone (LH). ellaone delays ovulation by inhibiting or delaying the LH surge. 6 n If the woman is due to ovulate tomorrow, or the next day, after unprotected sex, when the risk of pregnancy is highest, only ellaone can delay ovulation 6 n This is when LH has started to surge but has not yet peaked. At this time levonorgestrel will not prevent the follicle from rupturing, whereas ellaone is highly effective 1 Intake after LH surge, but before peak 6 She could ovulate tomorrow or the day after 100 p= % 14% 10% Ovum remains in the follicle Proportion of unruptured follicles 5 days post treatment 50 0 Ovum released while sperm still viable ellaone n=34 Levonorgestrel n=48 Placebo n=50 Adapted from Brache V et al A pooled analysis of three studies including a total of 163 cycles. ellaone intake has a 79% chance of delaying ovulation beyond the lifespan of the sperm 6 33

34 n If she is due to ovulate 3 or more days after unprotected intercourse, both ellaone and levonorgestrel can delay ovulation. 6 However, ellaone remains more effective in preventing follicle rupture and therefore unintended pregnancy Intake before LH surge 6 Even if she ovulates more than 3 days later, ellaone is more effective 100 p= % 25% 0% Ovum remains in the follicle Proportion of unruptured follicles 5 days post treatment 50 0 Ovum released while sperm still viable ellaone n=34 Levonorgestrel n=48 Placebo n=50 Adapted from Brache V et al A pooled analysis of three studies including a total of 163 cycles. 34

35 n If the woman has already ovulated, or is due to ovulate, in the immediate 24 hours after unprotected intercourse, no emergency contraceptive pill will help 6 This is because LH has already peaked, meaning the ovulation process is at a point where it cannot be stopped, or has already happened. This explains why: n Speed of emergency contraceptive pill intake is critical n Emergency contraception is not 100% effective Intake after LH peak Neither ellaone nor levonorgestrel will be effective if she ovulates today 100 8% 9% 4% Ovum remains in the follicle Proportion of unruptured follicles 5 days post treatment 50 0 Ovum released while sperm still viable ellaone n=34 Levonorgestrel n=48 Placebo n=50 Adapted from Brache V et al A pooled analysis of three studies including a total of 163 cycles. ellaone can delay ovulation even when it is about to happen (when risk of fertilisation is highest) 6 35

36 Efficacy of ellaone vs levonorgestrel ellaone significantly reduces the risk of unintended pregnancy vs levonorgestrel 8 A meta-analysis of the two head-to-head trials comparing ellaone with levonorgestrel showed that the risk of pregnancy was significantly reduced with ulipristal acetate compared with levonorgestrel. 8 For a woman who comes to you for help, what does this mean? Her risk of getting pregnant: Intake within 24 hours of unprotected intercourse WITH NO INTERVENTION WITH LEVONORGESTREL WITH ellaone DIFFERENCE BETWEEN ellaone AND LEVONORGESTREL 5.5% 2.3% 0.9% p=0.035 Intake within 72 hours of unprotected intercourse WITH NO INTERVENTION WITH LEVONORGESTREL WITH ellaone DIFFERENCE BETWEEN ellaone AND LEVONORGESTREL 5.5% 2.2% 1.4% p=0.046 Two comparative non-inferiority studies showed ellaone is at least as effective in preventing pregnancy as levonorgestrel 8,9 36

37 ellaone is well tolerated One of the criteria for a medicine to become available as an OTC is to be well tolerated. 10 With ellaone : n The vast majority of adverse events recorded during clinical trials in 2637 women were mild or moderate and resolved spontaneously 8 n The most commonly reported adverse reactions were headache, nausea, abdominal pain and dysmenorrhea 2 n The safety profile is comparable to levonorgestrel 8 Most frequent adverse events in clinical trials Ulipristal acetate (n=1104) Proportion of women (%) n=213 n=211 n=142 n=160 n=141 n=126 n=61 n=44 n=57 n=55 Levonorgestrel (n=1117) n=56 n=75 n=37 n=46 n=35 n=27 Headache Dysmenorrhoea Nausea Fatigue Dizziness Abdominal pain Upper abdominal pain Back pain Adapted from Glasier A et al A randomised, multicentre, non-inferiority trial of 2221 women. ellaone effect on the menstrual cycle Most women had their next menstrual period at the expected time (74.6 % within ± 7 days of expected time). 2 n Early period 6.8% had their period more than 7 days earlier than expected 2 n Late period 18.5% had a delay of more than 7 days 2 A minority of women (8.7%) reported intermenstrual bleeding lasting an average of 2.4 days. The majority was reported as spotting (88.2%). 2 Only 0.4% reported heavy intermenstrual bleeding. 2 37

38 For full details of adverse events refer to the ellaone European Union Summary of Product Characteristics. Adverse events should be reported. Healthcare professionals are asked to report any suspect adverse events via their national reporting system. Adverse events should also be reported to HRA Pharma at Use of ellaone by minors ellaone can be used by women of reproductive age. Adolescent pregnancy is a recognised public health concern. EC constitutes an important tool in the arsenal of contraceptive option to reduce the risk of unintended pregnancies. ellaone is suitable for any woman of childbearing age, including adolescents. 2 38

39 Precautions for use Potential pregnancy If there is any reason to believe that the woman may already have an established pregnancy, she should be referred to a doctor. 2 ellaone is not intended for use during pregnancy and should not be taken by any woman suspected or known to be pregnant. 2 However, ellaone does not interrupt an existing pregnancy 2 Women may believe they are pregnant from the moment of unprotected sex, so asking Could you be pregnant? is unhelpful. More specific questions e.g. Is your menstrual period due or late? will be more helpful. If the woman s period is late, or in case of symptoms of pregnancy, she should do a pregnancy test or be referred to a doctor before taking ellaone. ellaone does not prevent pregnancy in every case If the woman s next menstrual period is more than 7 days late, or abnormal in character, or if there are symptoms suggestive of pregnancy, or in case of doubt, a pregnancy test should be performed. It is important that any pregnancy in a woman who has taken ellaone be reported to The purpose of this web-based registry is to collect safety information from women who have taken ellaone during pregnancy or who become pregnant after ellaone intake. All patient data collected will remain anonymous. ellaone is for occasional use only It should in no instance replace a regular contraceptive method. In any case, women should be advised to adopt a regular method of contraception. After using ellaone, women should be advised to use a reliable barrier method until their next menstrual period. If a woman wishes to initiate or continue using hormonal contraception, she can do so after using ellaone, however she should be advised to use a reliable barrier method until her next menstrual period. 39

40 Women who must not take ellaone As with any drug, ellaone has some contraindications. ellaone should not be taken by women who: n Are hypersensitive to the active substance or to any of the excipients 2 Always refer to the ellaone European Union Summary of Product Characteristics if you are in any doubt. Situations where ellaone is not recommended n Severe asthma treated by oral glucocorticoids 2 n Severe hepatic impairment 2 n For women taking CYP3A4 inducers 2 n For women with long-term use of ritonavir 2 n Concomitant use of EC containing levonorgestrel 2 n Breastfeeding is not recommended for one week after ellaone intake 2 40

41 Key message summary for Chapter 5 ellaone : n Contains 30mg ulipristal acetate, and was specifically developed for EC 1 n Is taken as a single tablet, which can prevents pregnancy by delaying ovulation 2 n Should be taken as soon as possible after UPSI, but no later than 120 hours after UPSI 2 n Is most effective within the first 24 hours 8, which is when most women seek EC 11 n Is the only ECP which can delay ovulation close to ovulation, when the risk of pregnancy is highest 6 n Is well tolerated 2,8 n Is the most effective solution 6,8 you can give to a woman who wants to avoid unintended pregnancy n Three million doses taken in prescription use now licensed for use without prescription in 29 EU countries 7 References 1. HRA Pharma Data on file. Clinical overview. 2. ellaone European Union Summary of Product Characteristics. 3. ellaone Patient Information Leaflet. 4. Wilcox AJ et al. BMJ 2000; 321: Wilcox AJ et al. N Engl J Med 1995; 333: Brache V et al. Contraception 2013; 88(5): European Medicines Agency. EMA recommends availability of ellaone emergency contraceptive without prescription. Available at: Accessed January Glasier AF et al. The Lancet 2010; 375: Creinin M et al. Obstet Gynecol 2006; 108(5): European Commission. A guideline on changing the classification for the supply of a medicinal product for human use Available at Accessed January HRA Pharma Report. Women and emergency contraception in A European Survey. 41

42 Chapter 6: Pharmacist s role Good practice at the counter guide STEP 1: Listen A woman comes to your pharmacy and asks for the morning-after pill STEP 2: Reassure n If you had unprotected sex in the last 5 days, and you wish to avoid becoming pregnant, you are right to ask for the emergency contraception pill 1,2 n Emergency contraception pills work by inhibiting or postponing ovulation (release of an egg) 1,2 so sperm will not find an egg to fertilise before they die n Ask her when her last period was and whether it was normal for her n Ask if she takes other medication STEP 3: Encourage immediate action You should take emergency contraception as soon as possible 1,2 because it is most effective when used as soon as possible after unprotected sex 3 STEP 4: Advise about sex after EC intake A rapid return to fertility is likely following treatment with an emergency contraceptive pill. A barrier method of contraception must be used until your next period even if you are continuing with an oral method of contraception (OC). 1 The emergency contraceptive pill is for occasional use only: it should not be used to replace a regular contraceptive method. 1,2 Oral emergency contraception is not 100% effective and its efficacy is lower than a regular contraceptive method. 1,2 Please see your doctor to discuss the various regular contraceptive options. You should continue or start regular contraception to prevent pregnancy in the future. 1 Emergency contraceptive pills do not protect from STIs. 4 Only condoms protect against STIs. STEP 5: Advise what to do if the woman is sick If vomiting occurs within 3 hours of emergency contraception intake, you should take another tablet as soon as possible. 1 STEP 6: Advise about the next menstrual period After taking an emergency contraceptive pill, menstrual periods can sometimes occur earlier or later than expected by a few days. 1 If your period is more than five days late or pregnancy is suspected for any other reason (symptoms of pregnancy, abnormal bleeding at the expected date of menstrual period) or in case of doubt, you should do a pregnancy test or visit your doctor to make sure you are not pregnant. 1 42