he newest hormonal emergency contraception (ulipristal acetate, branded EllaOne) is now available without prescription. Dr Helen Calabretto updates pharmacists on what to consider when helping patients
The newcomer: Ulipristal acetate
Ulipristal acetate (UPA) is a synthetic selective progesterone receptor modulator demonstrated to have an agonist and antagonist effect on the progesterone receptor.2
It became Schedule 3 (Pharmacist Only) in February and is not currently listed on the PBS.
UPA should be taken as soon as possible after unprotected intercourse, though it is indicated for emergency contraception (EC) up to 120 hours (five days) afterwards.
UPA comes in a single, 30mg dose and should be administered orally.4
Side effects from UPA include headache, fatigue, dizziness, delay of menses, dysmenorrhoea, nausea, vomiting, breast tenderness, abdominal pain and back pain, which are typically mild to moderate and occur at similar rates to levonorgestrel.5, 6
The old favourite: Levonorgestrel
Levonorgestrel (LNG) EC has been available in Australia as a Schedule 3 medicine for over a decade. There are a number of brands of LNG EC available in Australia, including NorLevo-1, Postinor-1 and Levonelle-1.
All of these products are administered orally and have the progestogen hormone LNG as their active ingredient.
In Australia, the approved product information for LNG EC cites administration up to 72 hours, although studies have recommended its efficacy up to 120 hours and, in the absence of another choice of EC, LNG can be taken for EC up to 120 hours after unprotected sex.7
Mechanism of action and efficacy
The mechanism of action of both LNG and UPA EC is to inhibit, prevent, postpone or delay ovulation.
However, LNG is able to prevent ovulation only before the luteinising hormone (LH) surge whereas UPA is able to do so in 100% of cases before the (LH) surge and in 79% of cases when given between the LH surge and the LH peak.9
When unprotected sex happens around the time of the LH surge and LH peak, the risk of pregnancy is significantly increased.10 Therefore, UPA is more efficacious than LNG EC.11,12
Clinical and practical considerations
Women should be advised to take UPA or LNG as soon as possible after unprotected sex as this is when it is most effective.14,15,16
Breastmilk should be expressed and discarded for seven days after taking UPA.17 Therefore, LNG may be more appropriate for women who are breastfeeding.
Concomitant use of LNG and UPA EC is not recommended.18
Drugs that induce CYP3A4 have the potential to decrease the efficacy of UPA and LNG EC. UPA is not recommended and the copper intra-uterine device (IUD) is the best alternative as is LNG EC.19 A recent recommendation is to increase the dose of LNG EC to 3mg when women are taking these medications. They should be referred ongoing contraception that is unaffected by hepatic enzyme-inducing medications.20
Repeat the dose if vomiting occurs within three hours of ingestion of UPA21 or within two hours of LNG intake22.
Education and resources for pharmacists
- The Pharmaceutical Society of Australia EC guidelines and associated resources will be updated to include both UPA and LNG from February 2017. These are available online at psa.org.au.
- The Pharmacy Guild of Australia have an educational module on EllaOne, which is accessible at www.cpd.mycpd.org.au.
- The 2017 edition of Contraception: An Australian Clinical Practice Handbook will include detailed information on LNG and UPA, including mention of rescheduling.25
- The Royal Australian and New Zealand College of Obstetricians and Gynaecologists have information on LNG and UPA in their EC guidelines.
- UPA information, videos and factsheets are available to healthcare professionals at ellaone.com.au.
Take home messages
- There are now three EC options in Australia: the copper IUD, LNG emergency contraceptive pill and UPA emergency contraceptive pill. Remember that the copper IUD is the most effective method of EC. UPA is more efficacious than LNG in reducing the risk of pregnancy because it can inhibit ovulation when the LH surge has started.26, 27, 28
- For emergency contraceptive pills (UPA and LNG), the earlier they are taken, the better.
- There are many myths, which may be worth dispelling with your staff and colleagues as well as with women seeking EC. EC is not only available the ‘morning after’ unprotected sex. ECs are not abortifacients. Use of EC does not lead to sexual and contraceptive risk-taking behaviour.29, 30
- Women seeking EC must be treated non-judgementally and, where appropriate, encouraged to visit their doctor or local family planning and sexual health clinic for ongoing contraceptive management and STI testing.
- It is important that the client understands that no EC method is 100% effective and she should have a pregnancy test if her next period is more than seven days late.
- Consider and check the individual woman’s preference when using a checklist or client engagement guide as well as in regards to privacy and discretion.
Table 1 / Efficacy of emergency contraceptive pills depending on administration relative to unprotected sexual intercourse
|Risk of pregnancy
||Within 24 hours 2.3%
||Within 24 hours 0.9%
||Within 72 hours 2.2%
||Within 72 hours 1.4%
||Within 120 hours 2.2%
||Within 120 hours 1.3%
For women who
|Offer this EC
||For ongoing contraception
|Need EC because of missed (active) oral contraceptive pills
||Continue pill pack if it was in the last week of pills (inactive pills)
|Want to commence oral contraception, the contraceptive patch or the contraceptive ring
||Wait for five days after taking UPA to commence new method (UPA is a progestin agonist and is thus unsuitable for progestin-containing hormonal contraceptives after taking it). Schedule a follow-up appointment with a doctor, if required.
|Want to commence
a levonorgestrel intra-uterine system, contraceptive injectable or contraceptive implant
||Schedule a follow-up appointment with a doctor for five days after unprotected sex
Editor’s note: Dr Calabretto is Director – Research,
Sexual Health Information Networking & Education
SA Inc (SHine SA). References available on request