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ellaOne® is the most effective emergency contraceptive pill, remember that:

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And ellaOne® is now available directly from you, without a prescription.

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References
1. Wilcox AJ et al. BMJ 2000; 321: 1259-62.
2. Wilcox AJ et al. N Engl J Med 1995; 333: 1517-21.
3. Brache V et al. Contraception 2013; 88(5): 611-618.
4. Glasier AF et al. The Lancet 2010; 375: 555-562.

Current emergency contraception solutions are:

  • Intrauterine device (IUD), to be fitted in the womb
  • Oral emergency contraception, as a tablet

The IUD which is suitable for EC is a Copper-T IUD

IUDs are considered the most effective EC option,1 however they may not be a practical option for many women, as an IUD fitting takes time and involves an invasive procedure by a specifically trained healthcare professional. The advantage of an IUD is that it provides an ongoing contraceptive solution.1 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.2 Its use is restricted by its availability and the need to be inserted by a skilled healthcare professional.3

Women who would prefer a copper IUD for emergency contraception must be advised to contact a GP or family planning service as a matter of urgency.2 Pharmacists should direct women to a local service known to provide IUDs.2

It is also common practice to consider offering EHC to these women in case there are any problems obtaining or fitting the IUD, or indeed if they change their mind.

 

There are two oral ECs available4

  • One containing levonorgestrel which was first made available in 2005, and became available through pharmacy in 2011.
  • One containing ulipristal acetate (ellaOne®), which was launched in 2012.

The mechanism of action of oral ECs is to inhibit or postpone ovulation, so that no ovum is released.5,6

Mechanism of action of oral EC

EHCs work by inhibiting or delaying ovulation (the release of an egg), so that fertilisation cannot take place.5,6

Emergency contraceptive pills will not prevent pregnancy in 100% of cases.5 There is a chance that the woman has already ovulated when she takes an emergency contraceptive pill.7 Taking emergency contraceptive pills as soon as possible after unprotected sex gives the best chance of success.8 EHCs have no effect on fertilisation if ovulation has already happened. They do not interfere with an implanted egg (pregnancy)5,6 so they do not cause abortion8.

EHCs are suitable for women of reproductive age and are generally well tolerated.5,9 EHCs do not protect from sexually transmitted infections (STIs).8

EHCs are back-up contraception solutions, which do not replace a regular contraceptive method.

Pharmacists play a vital role in providing emergency contraception to customers, where the vast majority of women choose to visit a pharmacy over their GP. Emergency contraceptive pills are available without a prescription directly from pharmacists in Ireland, making pharmacists key EC providers.1

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The availability of emergency contraceptive pills from pharmacy without a prescription is critical to increase access and minimise delay of intake. This is especially significant given that emergency contraceptive pills are more effective the sooner they are taken after unprotected intercourse.

Women may also like the anonymity of the pharmacy as they can feel embarrassed about needing emergency contraception.3

  • Pharmacists promote dialogue on contraceptive alternatives and influence the beliefs and the outcomes through effective counselling on EHCs. The supply of emergency contraception from pharmacies can be accompanied by patient education from pharmacists, who have expertise on this topic4
  • Pharmacists provide information to patients at the time of EHC supply, which allows women to understand proper use of this medicine. Pharmacists ensure consistency of information about EHCs, in particular for women less than 17 years of age4

Pharmacy access to EHCs has not led to any negative consequences

When EHC is available through pharmacies without a prescription, the use of the medication increases compared to when it is available from doctors, clinics or hospitals.4 Increased access to EC through pharmacies does not have a negative impact on the use of other forms of contraception.4

Studies show that women and adolescents with greater access to EC are more likely to adopt an ongoing contraceptive method after EC use.9 Notably, it has been shown that greater level of use through non-prescription availability:

  • Does not lead to increased rates of STIs5
  • Does not increase sexual risk-taking behaviour in adolescents6,7
  • Does not lead to increased frequency of unprotected sex5
  • Does not lead to decreased use of other contraceptive methods5
  • Does not lead to decreased use of contraception, including the most common methods such as contraceptive pills and condoms5,8

Women’s EC experience is actually a motivating factor leading to more consistent use of regular contraception9

Good Pharmacy Practice can include:

  • Asking the right questions; avoiding unnecessary, personal or intrusive questioning
  • Providing quality advice in a sensitive way, without lecturing
  • Providing an environment where women feel comfortable and not judged, for example in the consultation room.

The quality of the pharmacy interaction is an important determinant of appropriate use of the product. It is also likely to be an important factor in a woman’s decision to take action in the event of a future UPSI.

References
1. International consortium for EC. Available at www.cecinfo.org. Accessed October 2013.
2. Taylor B. Journal of Family Planning and Reproductive Health Care 2003: 29(2): 7.
3. HRA data on file. Hamell research, Pharmacists’ recommending behaviour in emergency contraception. April 2013.
4. International Pharmaceutical Federation (FIP): FIP reference paper on the effective utilization of pharmacists in improving maternal, newborn and child health (MNCH) 2011. Available at http://www.fip.org/www/uploads/database_file.php?id=325&table_id=. Accessed October 2013
5. Polis et al. The Cochrane Library 2013, Issue 7.
6. Walker et al. J Adolesc Health 2004; 35(4): 329-34. Abstract only – please provide
7. Raine TR et al. JAMA 2005; 293: 54–62.
8. Moreau C et al. 2009. Am J Public Health. 2009; 99: 441–442.
9. Gainer E et al. Contraception 2003; 68(2): 117-24.
10. Good Pharmacy Practice. Joint FIP/WHO Guidelines on GPP: Standards for quality services 2012. Available at: http://www.fip.org/www/uploads/database_file.php?id=331&table_id=. Accessed October 2013.

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.1 Once implantation is complete, pregnancy is established.

uterus

Pregnancy begins when a fertilised egg 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. 2,3

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. But this mistaken understanding means that they can feel guilty about using EC because they wrongly believe it to be a form of abortion.4

 

After UPSI sperm can survive for approximately 5 days within the female reproductive tract.1 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.2

 

TIMING-OVULATION

So when is the fertile window? Current evidence challenges the simplified ‘text book’ understanding of the menstrual cycle.2 We now know that only about 12% of ovulations happen on day 14.3

The variability of ovulation is large – it can happen from day 11 to day 21.2 Because sperm stay viable for up to 5 days1, the period over which conception is likely to occur runs from day 6 to day 21 for regularly cycling women.2 If the cycle is not regular, there is a risk of ovulation happening even later in the cycle.2 The conception risk period does not end before day 28 of their cycle.2 This shows that there is no such thing as a risk free period.2

Ovulation also varies from cycle to cycle.2

Although the risk of pregnancy exists most of the time,2 women may underestimate the risk of pregnancy.4 This lack of awareness of pregnancy risk may be the most important barrier to EC use5

 

The highest risk of pregnancy is when ovulation happens shortly after UPSI6

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.6

Therefore, to avoid unwanted pregnancy, it is critical to avoid ovulation (happening shortly after UPSI while the sperm is still viable) by using EC as soon as possible.

OvulationUnpredictableGraph_070415

References
1. Pallone SR and Bergus GR. JABFM 2009; 22(2): 147-157.
2. Wilcox AJ et al. BMJ 2000; 321: 1259-62.
3. Baird DD et al. Epidemiology 1995; 6: 547-550.
4. HRA Pharma Report. Women and emergency contraception in 2012. A European Survey.
5. Moreau C et al. Contraception 2005; 71: 202-207.
6. Wilcox AJ et al. N Engl J Med 1995; 333: 1517-21.

Unintended pregnancy results from unprotected sexual intercourse (UPSI). UPSI is common.1

In a large European survey of over 7000 sexually active women, 30% reported having unprotected sex, at least once, in the last 12 months.1

These frequent acts of unprotected sexual intercourse are not happening in a distinct sub-population, but happen irrespective of age, income, education level and marital status.1

Unprotected sexual intercourse can happen, even when a couple consciously tries to prevent it.

Unprotected sexual intercourse can result from a couple not using any contraception,1 including ‘withdrawal’.2 It can also happen when they consciously try to prevent it. For example UPSI can happen as a result of:

– Accidental condom problem1 (breakage, slippage, not on in time)

– Oral contraceptive (OC) problems1 e.g. forgotten pill

– A temporary break from the usual contraceptive1

– Forgetting to apply a patch or insert a vaginal ring1

UPSI can also happen as a result of non consensual intercourse (rape).

The majority of women say that there are no particular circumstances that could explain their lack of contraception or contraception failure.1 Only a minority recognised that some factors may have influenced their behaviour, making contraceptive failure more likely.1

These factors included a new partner or relationship breakdown, travel, influence of alcohol or using a new contraceptive method.1

References
1. Nappi R et al. Eur J Contracept Reprod Health Care 2014; 19(2): 93-101.

A discussion guide has been developed to help you choose the most appropriate EHC for your customers. It is available here to download and is also available as a tear off pad to ensure you have all the information you need to make the right recommendation.eO_PharmaConsultationGuide_Pad_IE_280415P4P-1

As part of the support for women, we have developed an information leaflet to supplement the PIL. The leaflet is intended to be given to a woman when once it has been decided that ellaOne® is the appropriate product for her. It answers the most commonly asked questions, such as what to do if she vomits, whether further intercourse will be protected, what to expect with her next period and more.

eO_PostConsultationGuide_Pad_IE_v1_280415P4P-1

Step 1: Listen A woman comes to your pharmacy and asks for the morning after pill. Listen to her needs. Women can download an ellaOne® app, where they can display on their mobile phone screen a request for emergency contraception. They may use this if they are embarrassed to approach the counter when others are around, to request somewhere more private to talk, or that they wish to speak with the pharmacist. Ensure that you and your team are prepared to be approached in this way and be as discreet as possible.

she asks you for the MAP (1280x853)

Step 2: Reassure


Step 3: Encourage immediate action
  • Emergency contraception is most effective when used as soon as possible1,2 after unprotected sex3
Step 4:
Advise about sex after ellaOne®
  • 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).1,2
  • The emergency contraceptive pill is for occasional use only: it should not be used to replace a regular contraceptive method.1,2
  • If she requires advice, suggest she visit her GP or Family Planning Clinic for information about regular contraceptive options.
  • Oral emergency contraception is not 100% effective.
  • Emergency contraceptive pill does not protect from STIs.2,4
  • Only condoms protect against STIs.
Step 5:
Advise what to do if the woman is sick
  • If vomiting occurs within 3 hours of taking emergency contraception, you should take another tablet as soon as possible.1,2
Step 6:
Advise about the next menstrual period
  • After taking oral emergency contraception, menstrual periods can sometimes occur earlier or later than expected by a few days.1,2
  • If your period is more than seven days late or pregnancy is suspected for any other reason (symptoms of pregnancy, abnormal bleeding at the expected date of menstrual periods) or in case of doubt, you should do a pregnancy test or visit your doctor to make sure you are not pregnant.1,2

 

Pharmacists’ role when providing ellaOne®

Discussing emergency contraception can be distressing for women and it can also be uncomfortable for pharmacists.

You can help by:

  • Being matter-of-fact
  • Re-assuring them they have done the right thing
  • Offering them a more private place to talk if possible (e.g. the consultation room)
  • Using customer’s language (referring to the “Morning-after pill” or “Day-after pill” instead of EHC)
  • Having a warm and positive approach

You can use the good practice at the counter guide as a framework for your conversation.

Customer satisfaction and comfort in discussing ECPs with a pharmacist can be very high.

References
1. ellaOne® Summary of Product Characteristics. Available at: http://www.medicines.ie/medicine/15370/SPC/ellaOne+30+mg/. Accessed September 2015.
2. 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 levonorgestrel-alone emergency contraceptive pills. Available at: http://whqlibdoc.who.int/hq/2010/WHO_RHR_HRP_10.06_eng.pdf Accessed October 2013.
3. Taylor B. Journal of Family Planning and Reproductive Health Care 2003: 29(2): 7.

What is ellaOne® ?

  • ellaOne® is an emergency contraceptive pill intended to prevent pregnancy after unprotected sexual intercourse or contraceptive failure2
  • ellaOne® should be taken as soon as possible, but no later than 120 hours (5 days) after UPSI or contraceptive failure2
  • ellaOne® is the most effective oral emergency contraceptive2
  • ellaOne® is for women of reproductive age who want to avoid unintended pregnancy2

How to use ellaOne®

  • The treatment consists of one tablet to be taken orally as soon as possible after UPSI or contraceptive failure2
  • ellaOne® does not offer protection from pregnancy for subsequent acts of unprotected sex. Women should be advised to use a reliable barrier method until her next menstrual period.2
  • The tablet can be taken with or without food2
  • If vomiting occurs within 3 hours of ellaOne® intake, another tablet should be taken2
  • ellaOne® can be taken at any time during the menstrual cycle2

ELLAONE-UK-155-10-10-4

 

  • ellaOne® is not a regular contraceptive, it is for occasional use only2
  • ellaOne® does not cause abortion4
  • ellaOne® does not protect from sexually transmitted infections5

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 ‘morning-after pill’ or ‘day-after pill’.

When might EC be 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

  • Condom broke or slipped off
  • Missed pill, forgot to insert contraceptive ring or apply patch
  • Diaphragm or cap slipped out of place
  • Failure of withdrawal method
  • No contraception used
  • They were forced to have unprotected sex
References
1. Consensus statement on emergency contraception. Contraception 1995; 52: 211–3.
2. World Health Organization. (In association with the International Consortium for Emergency Contraception, International Federation of Gynaecology and Obstetrics, International Planned Parenthood Federation, Department of Reproductive Health and Research). Fact sheet on the safety of levonorgestrel-alone emergency contraceptive pills. Available at: http://whqlibdoc.who.int/hq/2010/WHO_RHR_HRP_10.06_eng.pdf Accessed October 2013.
3. Ellertson C. Fam Plann Perspect 1996; 28(2): 44-8.
4. Haspels AA and Andriesse R. Europ J Obstet Reprod Biol 1973; 3/4: 113-117.

The follicular phase (stages 1-4 on the diagram below)

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 egg.1 Usually, only one follicle will deliver an egg, while the others die.1 The growth of the follicles stimulates the endometrium to thicken in preparation for possible pregnancy.1

The ovulatory phase (stage 5 on the diagram below)

Ovulation is the release of a mature egg 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 egg: ovulation; with no LH surge, ovulation does not occur.1 The released egg is funnelled into the fallopian tube and towards the uterus by waves of small, hair-like projections. The life span of the typical egg 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 below)

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

EllaOnePharmacyBook_AnnotatedDiagrams_2301145

 

References
1. Aitkin RJ et al. The Journal of Clinical Investigation 2008; 118(4): 1330-1343.
2. Owen JA. Am J Clin Nutr 1975; 28: 333-338.
3. Pallone SR and Bergus GR. JABFM 2009; 22(2): 147-157.
4. Wilcox AJ et al. NEJM 1999; 340(23): 1796-1799.