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<p>During the time period 1 January 2016 to 31 December 2016, it is estimated that
approximately 90,500 tablets of ellaOne 30mg were dispensed against a prescription
in pharmacies in the United Kingdom. In addition, it is estimated that there were
a further 39,000 tablets of ellaOne 30mg purchased ‘over the counter’ in pharmacies
(i.e. without a prescription) in the United Kingdom during the same time period.</p><p>
</p><p>This usage data does not capture provision of ellaOne via family planning clinics
or stock ordered directly from the manufacturer, via other hospitals or other wholesalers
not captured by the database, and therefore some usage for ellaOne will not be included
in these figures. For these reasons, the data should be interpreted with caution.</p><p>
</p><p>The source of this data is MIDAS Quintiles.</p><p> </p><p>EllaOne is an ulipristal
acetate-containing emergency hormonal contraceptive that is licensed for use within
five days of unprotected sexual intercourse or contraceptive failure. It is classified
as a female emergency contraceptive; it is not an abortifacient. It exerts its contraceptive
action by preventing or delaying ovulation. EllaOne has never been studied as an abortifacient.
It is not intended for use during pregnancy and should not be taken by any woman suspected
or known to be pregnant.</p><p> </p><p>Following a High Court ruling in 2002, emergency
contraception is a method of contraception not abortion. The decision confirms the
Government’s long held position that a pregnancy begins at implantation and not fertilisation.
This judgment means that this position is now established in law and is not a matter
of policy.</p><p> </p><p>As with all other licensed medicines, the Medicines and Healthcare
products Regulatory Agency (MHRA) keeps the safety of ellaOne under close review using
a wide number of data sources. These include reports of suspected adverse drug reactions
which include pregnancies; spontaneously provided by health professionals and patients
through the ‘Yellow Card scheme’. Other sources of data that the MHRA reviews on a
regular basis, and which may include information on safety and/or lack of efficacy
or inappropriate use, include periodic safety update reports, renewals and variations
to product licences. The MHRA also reviews important published medical literature
and the results of any new clinical trials or epidemiological studies as they become
available.</p><p> </p><p>As with all marketed medicines, the MHRA will continue to
monitor the use of ellaOne. In the event that these monitoring processes identify
information that suggest that ellaOne is used outside of its licensed indication,
advice will be sought from the Commission on Human Medicines and its expert advisory
groups. There are post-marketing regulatory measures in place to ensure that ellaOne
is used as safely as possible. These measures include a European Union-wide pregnancy
registry which collects data on pregnancy outcomes (including pregnancy maintenance
and effects on the foetus or newborn) following exposure to ellaOne for any reason.
The registry is available at the following link:</p><p><a href="http://www.hra-pregnancy-registry.com"
target="_blank">www.hra-pregnancy-registry.com</a></p><p>Women and healthcare professionals
involved in the care of pregnant women are asked to report ellaOne exposed pregnancies
to the registry via the ellaOne prescribing information and patient leaflet, as well
as via yearly letters sent by the marketing authorisation holder. Abortion clinics
in particular are requested to ensure that every pregnant woman is asked whether she
has taken emergency contraception and if so, to specify which product.</p><p> </p><p>The
world-wide data available to date, including data from the EU pregnancy registry,
do not suggest any safety concerns following exposure to ellaOne during pregnancy.</p><p>
</p><p> </p>
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