European Medicines Agency Review of Emergency Contraception and Weight:

Update from the Faculty of Sexual and Reproductive Healthcare

June 2014

Background
The European Medicines Agency (EMA) will soon report on a review of oral emergency
contraception (EC) and the effect of heavier body weight on contraceptive efficacy.
This statement from the Faculty of Sexual and Reproductive Healthcares (FSRH) Clinical
Effectiveness Unit (CEU) outlines existing recommendations and arrangements for EC provision in
the UK.
The information is provided to clarify the current situation and to facilitate planning and rapid
implementation of any changes to EC availability that may result from the 2014 EMA review. A
web link to NHS templates for Patient Group Directions (PGDs) is provided to facilitate
development of local PGDs. A decision-making guide for community pharmacists is included as
an appendix for quick reference. The guide may be easily amended to include weight criteria if
this is indicated by the outcome of the EMA review.
The FSRH will issue further guidance after the EMA report is published.

Types of EC
There are currently three forms of emergency contraceptives available in the UK.
Table 1 Methods of Emergency Contraception available in UK
Method

Products

Class

Recommended
dose / use

Indications

Mode of action

Copper
intrauterine
device (CuIUD)

Various types
licensed for
contraception
(only Gynefix
licensed for EC)

Intrauterine
contraceptive
method

Levonorgestrel

Levonelle One
Step (P)

Progestogen
hormone

IUD retained until

pregnancy
excluded (e.g.
onset of period) or
for licensed
duration of IUD (510 yrs)
1.5mg single oral
dose

Within the first 5

days (120 hours)
following first UPSI
in a cycle or within
5 days from the
earliest estimated
date of ovulation
Licensed for use
within 72 hours of
UPSI or
contraceptive
failure. Possibly
effective up to 96
hours after UPSI
Licensed for use
within 120 hours of
UPSI or
contraceptive
failure

Prevention of
fertilisation via
effects on sperm
and ovum. Can
have an antiimplantation
effect
Delay of
ovulation.

Levonelle 1500
(POM)

Ulipristal
acetate

ellaOne (POM)

Progesterone
receptor
modulator

30mg single oral

dose

Delay of
ovulation.
Endometrial
effect has not
been proven or
excluded

Key to abbreviations: EC Emergency contraception; P Pharmacy medicine; POM Prescription only

medicine; UPSI unprotected sexual intercourse

FSRH Update EC Provision June 2014

Efficacy of EC
The absolute effectiveness of EC is unknown. The copper IUD is considered to be the most
effective method as it has a low documented failure rate of <1%. For this reason the IUD should be
offered to all eligible women requesting EC between 0 and 120 hours of UPSI. The copper IUD can
also be used as EC if a woman needs EC more than 120 hours after UPSI and her menstrual cycle
date is within 5 days of the earliest expected date of ovulation, for example, up to day 19 of a 28
day cycle.
A published meta-analysis suggested that ulipristal acetate (UPA) is more effective than
levonorgestrel (LNG) EC(1). The meta-analysis did not include women using EC after hormonal
contraceptive failure, thus the findings may not be generalisable to clinical practice. Although
subgroup analysis indicated that efficacy may have been reduced in heavier women published
studies have been insufficiently powered to confirm an effect of body weight or to compare the
efficacy of ulipristal and levonorgestrel in women of normal weight(2).
Further information on the efficacy EC can be found in FSRH Clinical Guidance on Emergency
Contraception(3). FSRH Guidance on EC may be amended after the EMA report is issued. Current
recommendations for oral EC are:

The efficacy of UPA has been demonstrated up to 120 hours and can be offered to all
eligible women requesting EC during this time period. It is the only oral EC licensed for use
between 72 and 120 hours.

The efficacy of LNG has been demonstrated up to 96 hours; between 96-120 hours efficacy
is unknown. Use of LNG beyond 72 hours is outside the product licence.

In addition to efficacy, the decision as to which method to provide to a woman will be dictated
by a number of factors such as; patient choice, medical eligibility, number of episodes of
unprotected sex, and time since UPSI (see table 2).

How is oral EC provided in the UK?

Over the counter (OTC)
The levonorgestrel emergency contraceptive, Levonelle One Step is available to buy over the
counter (OTC) in most pharmacies. It costs approximately 25 per pack. Ulipristal acetate
(ellaOne) is not currently available over the counter.
Prescription-only medicine (POM)
Both Levonelle 1500 (levonorgestrel) and ellaOne are available as a prescription-only medicine
(POM). Currently prescriptions for contraception are free in the United Kingdom.
Patient Group Direction
Patient Group Directions allow the administration or supply of medicines by named regulated
healthcare professionals, e.g. nurses and pharmacists, to supply medicines to groups of people
who may not be individually identifiable before presentation. PGDs are signed off by a senior
doctor and pharmacists who will have been involved in the development of the PGDs. Individuals
who supply the medicines need to be named on the PGD. There is currently wide geographical
variation in PGD provision of oral EC. All women in Scotland and Wales have access to
levonorgestrel EC free of charge from pharmacies via PGD. Access in England and Northern
Ireland is more variable.

FSRH Update EC Provision June 2014

Templates for contraception PGDs can be accessed online via NHS resources (Weblink:
http://www.medicinesresources.nhs.uk/en/Communities/NHS/PGDs/Local-PGD-examples/).

How can a woman access a Cu-IUD?

Cu-IUDs are free of charge and can be fitted at most sexual health clinics and in some GP
surgeries. If a woman is unable to receive a Cu-IUD immediately but would like one, an oral
method of EC can be given in the interim period. All women who are eligible and wish a Cu-IUD
should be referred to an appropriate service as soon as possible.

When is a woman ineligible to use EC?

It is too late to offer emergency contraception if it is requested more than 5 days (120 hours) since
a womans most recent episode of UPSI and after the anticipated date of implantation (i.e. > 5
days since the earliest expected date of ovulation (e.g. day 19 of a 28 day cycle)).
Sexual intercourse that occurs several days after ovulation is unlikely to present a risk as there is no
ovum to fertilise. However, given the wide variability in ovulation and difficulties identifying when
ovulation has occurred, the FSRH supports administration of EC for a single episode of
unprotected sexual intercourse (UPSI) at any time during the cycle within the parameters for each
method.
If a woman has had multiple episodes of UPSI which include UPSI more than 120 hours prior to
requesting EC, an IUD can be inserted up to 5 days after the earliest expected date of ovulation.
LNG is not thought to cause harm if given in pregnancy therefore LNG can be considered for
multiple episodes of UPSI when the most recent episode has occurred within the last 120 hours. As
less is known about the safety of UPA in pregnancy the product licence advises that UPA can only
be given in this situation if all episodes of UPSI have occurred within the last 120 hours.
Other contraindications to EC are summarised in table 2.
A decision guide for community pharmacists is provided in the appendix.
Quick starting hormonal contraception after emergency contraception has been piloted in the
community pharmacy setting and may be an option in some areas. The decision to quick start
contraception may influence a womans choice of EC as additional contraception is required for
a longer period of time when quick starting a method after UPA. Further information is provided in
FSRH Clinical Guidance on Quick Starting Hormonal Contraception.(4).

FSRH Update EC Provision June 2014

Table 2: Eligibility for different methods of emergency contraception

Clinical Scenario
Single episode of
UPSI within 72 hours
Single episode of
UPSI between 72
and 120 hours

Multiple episodes
of UPSI within 120
hours
Multiple episodes
of UPSI
Sex occurred <5
days ago plus > 5
days

Using enzyme
inducing drugs

Breastfeeding

Already used oral

EC in same cycle

Women under 25
years of age
Nulliparous women

Cu-IUD

LNG

UPA

(outside product
licence)
FSRH supports use
up to 96 hours and
up to 120 hours if
no other method
appropriate

(3mg
recommendedoutside
product
licence)

/X
(Yes if presents
within 5 days of
ovulation. If
presents more than
5 days following
earliest estimated
time of ovulation
an IUD is not
suitable)

X
(unless all episodes
within 5 days of
earliest expected
ovulation)

(Can be given if
the woman is
willing to express for
7 days after taking)
X

Key to abbreviations: Cu-IUD copper intrauterine device; EC Emergency contraception; FSRH Faculty of
Sexual & Reproductive Healthcare; LNG levonorgestrel; UPA Ulipristal acetate; UPSI unprotected sexual
intercourse

FSRH Update EC Provision June 2014

References
(1) Glasier AF, Cameron ST, Logan SJS, Casale W, Van Horn J, Sogar L, et al. Ulipristal acetate
versus levonorgestrel for emergency contraception: a randomised non-inferiority trial and
meta-analysis. The Lancet 2010;375:555-62.
(2) Glasier A, Cameron ST, Blithe D, Scherrer B, Mathe H, Levy D, et al. Can we identify women at
risk of pregnancy despite using emergency contraception? Data from randomized trials of
ulipristal acetate and levonorgestrel. Contraception 2011;84:363-7.
(3) Faculty of Sexual & Reproductive Health Care Clinical Effectiveness Unit. Emergency
Contraception. 2011. Available at:
http://www.fsrh.org/pdfs/CEUguidanceEmergencyContraception11.pdf (Accessed:
26/06/14)
(4) Faculty of Sexual and Reproductive Healthcare CEU. Quick Starting Contraception. Available
at: http://www.fsrh.org/admin/uploads/678_CEUGuidanceQuickStartingContraception.pdf
(Accessed: 26/06/14)

FSRH Update EC Provision June 2014

Appendix

Emergency Contraception Decision Guide for Community Pharmacists

Assess eligibility for EC
Discuss with local sexual health service if unsure
unclearuncuncertain
Discuss all 3 options unless a method of
EC is clearly contraindicated

Consider IUD if:

<120 hours since UPSI or < 5 days since

earliest expected date of ovulation
Wants most effective method
Wants Cu-IUD as ongoing contraception
LNG and UPA contraindicated or
unavailable

Discuss IUD and where/when it can

be accessed.
Offer an appropriate method of oral
EC as a backup method

Consider LNG if IUD unacceptable and:

<72 hours since most recent UPSI
>72 and <120 hours and other methods
contraindicated or unavailable
Breastfeeding and not wishing to stop for
7 days after taking UPA
Taking enzyme inducing drugs (advise
3mg dose)

Consider UPA if IUD is unacceptable and:

<120 hours since all episodes of UPSI
Not on any enzyme inducing drugs
Does not have severe asthma insufficiently
controlled by oral glucocorticoids

Supply or signpost to LNG

provider if unable to supply
under local PGD or product
licence

Supply or signpost to UPA

provider if pharmacy supply
not possible

Signpost/refer to IUD service provider

Discuss / offer STI testing, condoms and future contraception

Consider quick starting hormonal contraception or signpost
to contraception provider
Key to abbreviations: Cu-IUD copper intrauterine device; EC Emergency contraception; FSRH Faculty of Sexual & Reproductive
Healthcare; LNG levonorgestrel; UPA Ulipristal acetate; UPSI unprotected sexual intercourse

FSRH Update EC Provision June 2014