All posts by spin-inter

  • Several studies have shown that facilitating access to EC does not increase sexual or contraceptive risk-taking behaviour1
  • 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 use2,3
  • Use of ECPs has no effect on future fertility1,4
  • There is no indication demonstrating that ECPs harm a developing foetus if they are mistakenly taken early in preg­nancy1,5
  • ECPs do not interrupt an existing pregnancy1,4
  • Women find the label and instructions easy to understand1,6
  • ECPs do not protect against STIs.7 Only condoms protect against sexually transmitted infections
  • ECPs do not provide contraceptive cover for unprotected intercourse in the days after intake7

 

References
1.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.
2.Polis et al. The Cochrane Library 2013, Issue 7.
3.Gainer E et al. Contraception 2003; 68(2): 117-24.
4.ellaOne® European Summary of Product Characteristics.
5.HRA Pharma Data on file. Clinical overview.
6.ellaOne® readability testing
7.NHS choices – emergency contraception. Available at http://www.nhs.uk/Conditions/contraception-guide/Pages/emergency-contraception.aspx. Accessed October 2013.

Unintended pregnancy happens at all reproductive ages, with a peak in women aged 20-24 years.1

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 recognize that these factors inevitably put women in this age bracket at risk of unintended pregnancy, despite responsible attitudes and sensible use of contraception.

4.Web unintended pregnancy by age

References

1. Finer L and Henshaw S. Perspectives on Sexual and Reproductive Health 2006; 38(2): 90-96.

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.1,2

In fact, over 30% of unintended pregnancies happened when women were using highly effective contraceptive methods like the Pill or IUD.1

2.Web  unintended can pregnancy happen

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.

References

1.Bajos N et al. Hum Reprod.2003; 18(5) 994 – 9.

2.Wynn LL and Trussell J. Contraception 2008; 77: 1-5.
3.Nappi et al. Eu J  Contracep and Repr Health Care 19.2 (2014): 93-101.

It is important that women understand that ellaOne® is not a regular form of contraception.1 EC is not 100% effective and it is not as effective as a regular contraceptive method.

It is critical women understand that ellaOne® will not protect them from pregnancy if they have unprotected sex again after taking ellaOne®. They should use a reliable barrier contraceptive method until their next menstrual period, even if they are taking a regular contraceptive pill.2 EC is not contraindicated in women using oral contraceptives but they should read the leaflet inside the pack to find out about continuing use of oral contraceptives in the month that they use ellaOne®.2 The EU package leaflet is also available online .

 

References
1.ellaOne® European Union Summary of Product Characteristics.
2.ellaOne® European Union Patient Information Leaflet.

Fast access to ellaOne® after UPSI is important. When women come to your pharmacy seeking emergency contraception it is essential that your team know how to respond, so that women get the help they need to avoid unintended pregnancy.

Portrait of Smiling Woman Pharmacist in Pharmacy

Your team should know :

  •  Your pharmacy offers EC
  •  Whether women requesting EC must be referred to a pharmacist or if it can be dispensed by any team member
  •  Your aim is to offer women EC with as little fuss as possible

 

In training sessions you could develop more examples or role-play the scenarios to build the team’s confidence so they can deal with requests for emergency contraception smoothly.
You can encourage your team to make the process of obtaining ellaOne® as fuss-free as possible. They should recognise that this may be an emotional time for the woman. In a large European Union survey, 50% of women said they found seeking EC embarrassing,1 so a welcoming, professional approach is appropriate. Other women may ask for EC in a way that may make you or your team members feel uncomfortable, maybe by providing too many intimate details or having a loud or brazen manner.  Exploring ways to deal with this can also form part of a training role-play.
References
1.HRA Data on File. Harris Interactive 2013.

Sexuality and sexual behaviour are sensitive topics. They are part of our most private lives. When a woman asks for emergency contraception, she is disclosing that she had sexual intercourse and that the couple did not use, or had a problem with, their contraception.

When it comes to emergency contraception, some pharmacists can be confronted with his or her own prejudices. It is important to remember that couples and individuals have a right to decide freely and responsibly the timing and number of their children.1 Women who seek emergency contraception are behaving responsibly by taking steps to avoid unintended pregnancy. They need a warm approach. Treating all women in this way is always good practice, especially as some women may have been coerced to have sex (but not necessarily be disclosing this fact to you).

Unprotected sex or contraceptive failure can happen to anyone, for a number of different reasons. 

HRA-Paharmacie-Situations-368 (1280x853)

 

It can happen to anyone
Over a woman’s fertile life it would be most unusual if there were not occasional lapses in contraceptive cover
Love (and sex) are unpredictable, but dealing with unexpected events sensibly is the responsible thing to do
Women may stop their regular contraception for many reasons, including because they have no established partner
Human behaviour is complex and sometimes unpredictable
If she’s having sex she needs reliable contraception – including emergency contraception (provided within national guidelines where they exist)

As with any drug, ellaOne® has some contraindications. ellaOne® should not be taken by women who:

• Are hypersensitive to the active substance or to any of the excipients1

Always refer to the ellaOne® product information if you are in any doubt.

Situations where ellaOne® is not recommended

• Severe asthma treated by oral glucocorticoids1

• Severe hepatic impairment1

• For women taking CYP3A4 inducers1

• Concomitant use of EC containing levonorgestrel1

• ellaOne® contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

• Breastfeeding is not recommended for one week after ellaOne® intake1

 

References
1.ellaOne® European Union Summary of Product Characteristics.

One of the criteria for a medecine to become available OTC is for it to be well tolerated.1

With ellaOne® :

• The vast majority of adverse events recorded during clinical trials in 2637 women were mild or moderate and resolved spontaneously3

• The most commonly reported adverse reactions were headache, nausea, abdominal pain and dysmenorrhea2

• The safety profile is comparable to levonorgestrel3

 

EllaOnePharmacyBook_AnnotatedDiagrams_12021416

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)

  • Early period – 6.8% had their period more than 7 days earlier than expected2
  • Late period – 18.5% had a delay of more than 7 days2

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 bleeding2

For full details of adverse events refer to the ellaOne® European 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 pharmacovigilance@hra-pharma.com.

ellaOne® significantly reduces the risk of unintended pregnancy vs levonorgestrel.1

A meta-analysis of the two, large, head-to-head trials comparing ellaOne® with levonorgestrel showed that the risk of pregnancy was significantly reduced with ulipristal acetate compared to levonorgestrel :1

more

For a woman who comes to you for help, what does this mean ?

trombonebackbottom
 

Her risk of getting pregnant is :

Intake within

  • 24h
  • 72h

of unprotected intercourse

  • With
    no intervention
  • With
    levonorgestrel
  • With
    ellaOne®
  • arrow
    5.5 %
    5.5 %
  • arrow
    2.3 %
    2.2 %
  • arrow
    0.9 %
    1.4 %

P- value: 0.035

P- value: 0.046

Two comparative non-inferiority studies showed ellaOne® is at least as effective in preventing pregnancy as levonorgestrel.1,2

 

References
1.Glasier AF et al. The Lancet 2010; 375: 555-562.
2.Creinin M et al. Obstet Gynecol 2006; 108(5): 1089–1097.
3.HRA Pharma Report. Women and emergency contraception in 2012. A European Survey.

Ovulation is a result of a surge in luteinising hormone (LH). ellaOne® delays ovulation by inhibiting or delaying the LH surge.1  

more

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

trombonebackbottom

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 effective1

Intake after LH surge, but before peak1

EllaOnePharmacyBook_AnnotatedDiagrams_2411142


more

If she is due to ovulate 3 or more days after unprotected intercourse, both ellaOne® and levonorgestrel can delay ovulation. 1 However, ellaOne® remains more effective in preventing follicle rupture and therefore unintended pregnancy.1

trombonebackbottom

Intake before LH surge1

EllaOnePharmacyBook_AnnotatedDiagrams_2411144


more

If the woman has already ovulated, or is due to ovulate, in the immediate 24 hours following unprotected intercourse, no emergency contraceptive pill will help1

trombonebackbottom

This is because the LH has already peaked, meaning the ovulation process is at a point where it cannot be stopped, or has already happened.

This explains why:

• Speed of emergency contraceptive pill intake is critical
• Emergency contraception is not 100% effective

Intake after LH peak 1

EllaOnePharmacyBook_AnnotatedDiagrams_2411143

ellaOne® can delay ovulation even when it is about to happen (when risk of fertilisation is highest)1

trombonebackbottom

pack ellaOne

 

 

References

1.Brache V et al. Contraception 2013; 88(5): 611-618.

2.Glasier AF et al. The Lancet 2010; 375: 555-562.