ellaOne® can be used by all women of childbearing potential, i.e. from the
first period to the menopause.
This will include requests from women less than 16 years of age. Although it is legal to supply ellaOne® to those under 16, it is important that you have undertaken the appropriate training (e.g. CPPE module on safeguarding children and vulnerable adults) and are fully aware of the guidelines surrounding consent and confidentiality in sexual health services in under 16s.
Gillick Competency & Fraser Guidelines
It is considered best practice for healthcare professionals to ensure young women are mature enough to make decisions and are capable of fully understanding the nature and possible consequences of any treatment.
When deciding whether a young woman is competent to make decisions regarding their contraception, sexual and reproductive health, the terms “Gillick Competency” and “Fraser Guidelines” are commonly used.
The criteria below, applies specifically to contraceptive advice and is known as the “Fraser Guidelines.” This guidance allows healthcare professionals to give advice and treatment provided they are satisfied that:
- The young person will understand the advice and understands what is involved
- The young person cannot be persuaded to inform their parents, or allow them to inform their parents
- The young person is very likely to begin, or continue to have sexual intercourse without contraception
- Without contraceptive advice or treatment, the young person’s physical or mental health (or both) would suffer
You may also wish to review the following documents. These are available on the GPhC website: https://pharmacyregulation.org/standards/guidance
- GPhC: Patient confidentiality April 2012
- GPhC: Maintaining clear sexual boundaries
- GPhC: The provision of pharmacy services affected by religions and moral beliefs
- If there is any reason to believe that the woman may already have an established pregnancy, she should be referred to a doctor.1
ellaOne® is not intended for use during pregnancy and should not be taken by any woman suspected or known to be pregnant.1
However, ellaOne® does not interrupt an existing pregnancy.1
Women may not understand when pregnancy begins. They 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.
- ellaOne® does not prevent pregnancy in every case.
- 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.
- CYP3A4 inducers (e.g. rifampicin, phenytoin, phenobarbital, carbamazepine, efavirenz, fosphenytoin, nevirapine, oxcarbazepine, primidone, rifabutin, St John’s wort) may result in a decreased efficacy.
- Absorption may be altered by products that raise gastric pH and the clinical relevance is not known.
- May reduce action of combined hormonal contraceptives and progestogen-only contraception.
- Use in women with severe asthma treated by oral glucocorticoid is not recommended.
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
EHC is not contraindicated to 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 package leaflet is also available online .
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.
Your team should know:
- Your pharmacy offers EHC
- Whether women requesting EHC must be referred to a pharmacist or if it can be dispensed by any team member
- Your aim is to offer women EHC in a reassuring way
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 least embarrassing as possible. They should recognise that this may be an emotional time for the woman. In a large EU 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.
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.
Customers should always feel like they can talk to you openly and, in your role as a pharmacist, it is important to be able to have a professional conversation without judgement. There may be certain values and beliefs that you hold, but they must
never affect the advice you give. Always adhere to the General Pharmaceutical Council’s standards of conduct, ethics and performance. Principles such as “make patients your first concern” and “show respect to others” have particular relevance in the supply of ellaOne®.
|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)
ellaOne® is contra-indicated for women who:
Are hypersensitive to the active substance or to any of the excipients1
Always refer to the ellaOne® Summary of Product Characteristics 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
• For women with long-term use of ritonavir1
• Concomitant use of EC containing levonorgestrel1
• Breastfeeding is not recommended for one week after ellaOne® intake1
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.
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.
|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.
|Step 2: Reassure
|Step 3: Encourage immediate action
- Emergency contraception is most effective when used as soon as possible1,2 after unprotected sex3
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.
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
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.
ellaOne® ( 30mg ulipristal acetate) is an emergency contraceptive pill (ECP), now available in pharmacy without a prescription in the UK.
The OTC availability of emergency contraception 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 website has been developed to help you learn more about ellaOne®. This website is for healthcare professionals only. It is aimed at community pharmacists in the UK, pharmacy assistants and anyone in the pharmacy team who may dispense emergency contraception.
It will help you make responsible, confident recommendations and give appropriate advice to women requesting emergency contraception in your pharmacy.
It will help you give appropriate counselling on ellaOne® as well as subsequent contraceptive care, to support the best health outcomes.