Draft National Template
Patient Group Direction for the supply of:
ulipristal acetate 30mg tablet (ellaOne®) by Community Pharmacists
This direction was prepared by Mr G Holyfield (Public Health Wales) as lead
author with advice, comment and support from EHC expert group: - Mr T
Banner (Hywel Dda UHB), Dr N Bryant and Ms E Hinks (Cwm Taf UHB), Mr M
Curson (Aneurin Bevan UHB), Ms C Poulter (Cardiff University) and Mr A
Evans (Welsh Government) as a template to assist organisations to prepare
their own documents. It is the responsibility of local organisations to check the
accuracy of the information, that the information is up to date, and to amend
as required for local use.
PGD EHC Ulipristal v1
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Patient Group Direction for the Supply of:
ulipristal acetate 30mg tablet (ellaOne®)
Name and address of organisation:
Date PGD comes into effect:
Review date:
(2 years or less)
Expiry date:
(2 years or less)
Name of Medicine
Approved name:
ulipristal acetate 30mg tablet
ellaOne®
Proprietary name:
Professionals to whom PGD applies
Community pharmacists
Lead Doctor’s name, job title,
signature and date:
Lead Pharmacist’s name, job title,
signature and date:
Lead Nurse's name, job title,
signature and date:
On behalf of the Health Organisation
name, job title, signature and date:
PGD EHC Ulipristal v1
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Emergency contraception within 72 – 120
hours of unprotected sexual intercourse (UPSI)
or failure of other contraceptive method.
Clinical Condition
Note on mid-cycle use: The PGD emphasises
the importance of additional referral for IUD for
women presenting having had UPSI in mid cycle
(see mid cycle calculator in appendix 1)
Criteria for inclusion:
Patient is aged 13 years or over and presents
in person at the community pharmacy between
72 and 120 hours of unprotected sexual
intercourse (UPSI) or failure of a contraceptive
method. (Under 16 year olds are included
provided they meet the criteria of the Fraser
Guidelines on consent to medical treatment.
The patient has capacity to understand the
nature and purpose of the treatment and gives
their consent to providing the relevant clinical
information. In addition, if patient is under 13
years of age a referral to social services
should be made in line with the Child
Protection Procedures of the Health Board.)
Remember a more effective alternative is a
copper intra-uterine device (Cu-IUD)
Levonorgestrel 1500mcg is still recommended
for patients who present at up to 72 hours
following unprotected intercourse.
NB: If patient has vomited within 3 hours of
taking a dose of ulipristal 30mg a further
supply can be given provided patient is still
within 120hours of UPSI.
Patient gives their consent to providing the
relevant clinical information to the pharmacist
once the pharmacist has assessed their
capacity to understand the nature and purpose
of the treatment
Emergency contraception decision support
guide for pharmacists (see appendix 2)
Criteria for exclusion:
Patients aged 12 years or under.
Patient who the pharmacist has assessed as
not having capacity to understand the nature
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and purpose of treatment.
Patients who do not agree to share relevant
clinical information or there is no valid consent.
Requests made by third parties on behalf of
patient.
UPSI occurred more than120 hours ago.
UPSI occurred less than 72 hours after UPSI,
advise patient that levonorgestrel (Levonelle®
1500) is recommended - refer to levonorgestrel
PGD
Previously had one or more episodes of UPSI
in current menstrual cycle (whether treated
with levonorgestrel or not).
Patient used ulipristal for emergency hormonal
contraception in current menstrual cycle (NB:
unless vomiting occurred within 3 hours of
previous dose, in which case another dose can
be supplied).
Concomitant use with emergency
contraception containing levonorgestrel is not
recommended.
Patients who are/or think may be pregnant
(pregnancy should be excluded before ellaOne
is administered)
Patients whose last menstrual period (LMP)
was more than 4 weeks ago (Note: some
women have a longer cycle than 28 days so
manage accordingly)
Patients whose last LMP was abnormal/unusual
Patients who have delivered a baby within last
3 weeks (EHC not required in these
circumstances).
Women who wish to continue breast feeding
(see cautions section below)
Concomitant use of ulipristal (EllaOne®) with
CYP3A4 inducers.
(Ulipristal acetate (UPA) is not advised in
women using enzyme-inducing drugs or who
PGD EHC Ulipristal v1
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have taken them within the last 28 days
(Faculty of Sexual and Reproductive Health
(FSRH)). BNF also indicates that effectiveness
of ulipristal may be reduced for up to 4 weeks
after stopping enzyme inducer(s)).
 Antiepileptics: phenytoin,
fosphenytoin,carbamazepine,
oxcarbazepine, phenobarbital primidone
 Antivirals: ritonavir
 HIV infection: efavirenz, nevirapine,
 rifampicin, rifabutine
 Herbal medicines containing Hypericum
perforatum (St. John's wort).
Avoid concomitant use with:
 Drugs that affect gastric pH: Antacids,
H2 antagonists and proton pump
inhibitors.
Patients with:
 Known hypersensitivity to ulipristal or
any excipients, or patient has previously
experienced any severe clinical
problems with hormonal contraception.
 Rare hereditary problems of galactose
intolerance, the Lapp lactase deficiency
or glucose-galactose malabsorption are
excluded from treatment with ulipristal
(ellaOne®) under this PGD, as this
medicine contains lactose monohydrate.
 Severe asthma (where asthma is not
controlled despite oral glucocorticoid
treatment)
 Unexplained vaginal bleeding
 Renal or hepatic impairment (in absence
of specific studies, no specific dose
recommendations can be made)
Cautions (including any relevant
action to be taken)
Severe malabsorption syndromes e.g.
severe diarrhoea, Crohn’s. The FSRH
advise that oral contraception may be less
reliable in women with inflammatory bowel
disease who have malabsorption due to severe
small bowel disease or resection, or who have
vomiting or severe diarrhoea for more than 24
hours. Refer to Sexual health services for
IUD/follow up
Breast feeding. After taking ulipristal
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(ellaOne®), breastfeeding is not recommended
for 7 days. The manufacturers advise that
women who are breast feeding should feed
their baby immediately before taking the tablet,
then pump and discard the breast milk for the
next 7 days in order to stimulate lactation.
Breast feeding can be resumed after 7 days. If
the woman is unable or unwilling to comply
with this advice she is excluded from treatment
with ulipristal (ellaOne®) under this PGD- refer
to GP or Community Sexual Health Clinic.
Potential for other medicines to affect
ulipristal (also see Appendix 1 of the current
British National Formulary and SPC):
 progestogens: possible reduced
contraceptive effect
 vinblastine and quinidine (micromedex).
CYP3A4 enzyme inhibitors.
Ulipristal acetate is metabolized by CYP3A4 in
vitro. In vivo results show that administration
of ulipristal acetate with a potent and a
moderate CYP3A4 inhibitor increased Cmax
and AUC of ulipristal acetate with a maximum
of 2- and 5.9-fold, respectively. The effects of
CYP3A4 inhibitors are unlikely to have any
clinical consequences.
Although the use of ellaOne does not
contraindicate the continued use of regular
hormonal contraception, ellaOne may reduce
its contraceptive action. Therefore, after using
emergency contraception, it is recommended
that subsequent acts of intercourse be
protected by a reliable barrier method until the
next menstrual period starts. If a woman
wishes to initiate hormonal contraception as a
regular contraception method, she can do so
immediately after using ellaOne, but the
woman should use a reliable barrier method
until the next menstrual period.
The UK manufacturer’s SPC (May14) states
that in vitro ulipristal acetate may be an
inhibitor of P-glycoprotein (P-gp) at clinically
relevant concentrations. Results in vivo with
the P-gp substrate fexofenadine were
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inconclusive. If further states that the effects of
the P-gp substrates are unlikely to have any
clinical consequences.
 BNF advises to give digoxin at least 1.5
hours before or after ulipristal
 BNF advises to give dabigatran at least
1.5 hours before or after ulipristal.
 BNF advises to give fexofenadine at
least 1.5 hours before or after ulipristal
Action if excluded:
All excluded patients should be referred to a
Sexual Health Clinic or GP practice.
Patient aged 12 years or under - the Child
Protection Team must be contacted for
children of 12 years and under, who present
having had sexual intercourse
Consider the supply and administration of
levonorgestrel 1500mg (refer to levonorgestrel
PGD)
If unprotected sex was within the last 5 days
(120 hours) the patient may be suitable for IUD
(intrauterine device) insertion. Referral should
be made in a suitable timeframe to allow this to
happen.
Advise women using liver enzyme-inducing
drugs that an IUD is the only option.
Seek further advice:
To be completed by LHB according to local
arrangements. Know the referral pathway into
local sexual and reproductive health services
or how to contact the local lead doctor for
sexual and reproductive health for medical
advice.
Description of Treatment
Name of Medicine
Approved name:
ulipristal acetate 30mg tablet
ellaOne®
Proprietary name:
Legal status:
Prescription Only Medicine (POM)
Form:
Tablet
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Strength:
Dosage:
Route of Administration:
Frequency of Administration:
30mg
One tablet as a single oral dose.
Oral
30mg tablet as a single dose between 72 and
120 hours after UPSI.
NB: If patient has vomited within 3 hours of
taking a dose of ulipristal the dose can be
repeated.
Total treatment quantity:
Adverse reactions:
One or two 30mg tablet(s)
Side effects (BNF) may include;
 Nausea,vomiting, diarrhoea,abdominal pain
 Dizziness
 Fatigue
 Headache
 Temporary disturbance of menstrual cycle
(bleeding, spotting, next period early or
late)
 Back pain
 Muscle spasms
 Less common; tremor, hot flush, uterine
spasm, breast tenderness, dry mouth,
blurred vision, pruritis and rash.
(This list is not exhaustive. Please refer to
current SPC for further information.)
Reporting procedure of adverse
reactions:
Side effects should be recorded in the patient
record/notes.
Refer to a GP where necessary.
Consider reporting via the MHRA yellow card
reporting scheme.
Verbal advice for patient:
Advice on likely side effects, action needed if
vomiting occurs and delayed menses.
All patients should be advised on the option of
an emergency intra-uterine device (IUD) as
an alternative. An IUD is more effective than
hormonal emergency contraception especially
when there are multiple risks or the patient is
towards the end of the 120 hour time limit.
Explain that:
 the next period may be early or late
 that a barrier method of contraception
needs to be used until the next period
 the patient should contact their GP if
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
any lower abdominal pain occurs
(possibility of an ectopic pregnancy)
if the patient has not had their period
within 7 days of their expected date of
menstruation, abnormal bleeding occurs
or pregnancy is suspected, they should
attend a sexual health clinic with a urine
sample to confirm or exclude
pregnancy.
Highlight that ulipristal (ellaOne®) is used for
emergency contraception only. Suggest
where appropriate that patient makes an
appointment with their GP or sexual health
clinic to discuss their on-going contraceptive
needs. Remind the patient that the use of
ulipristal (ellaOne®) does not provide ongoing
contraceptive protection and that she must
continue to use another method for the
remainder of the cycle.
Patients taking oral contraceptives. Those
taking combined oral contraceptives (COC) or
progestogen only pills (POP) should be
advised to continue taking their pills but to also
use additional barrier method contraceptive
precautions until their next period. This is
because ulipristal (ellaOne®) will reduce the
efficacy of regular hormonal contraception.
Advise patient that they can be tested and
treated for sexually transmitted infections if
necessary and sign-post the patient to locally
available services.
If the patient is breast-feeding advise as noted
in cautions section.
Written information for patient:
The following must be provided:
 An ellaOne® Patient Information Leaflet
 A leaflet on currently available forms of
contraception
 Information on local sexual health
services
 Information about local genitourinary
medicine (GUM) services
Follow Up:
With Sexual health service 3 weeks later for
pregnancy testing and contraceptive/sexual
health advice.
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Arrangements for referral for medical
advice:
Refer to a GP or sexual health clinic as
necessary.
Records of supply for audit:
Maintain a record of the supply, batch number
and expiry and any advice given (complete
EHC community pharmacy proforma)
The pharmacist must document Fraser
Competence for clients under (or appearing to
be under) 16 years of age.
The pharmacist will be required to complete
the National Electronic Claim and Audit Form
(NECAF) for each consultation.
NB: Records may need to be shared with LHB
representatives subject to appropriate patient
confidentiality protocols.
Staff
Professional qualifications:
Training:
Community Pharmacists currently registered
with the General Pharmaceutical Council
(GPhC).
The Pharmacist must have completed the
Wales Centre for Pharmacy Professional
Education’s (WCPPE) All Wales procedure for
accreditation to provide the Emergency
Contraception Enhanced Service.
http://www.wcppe.org.uk/assessment/enhance
d-services/ehc-accreditation/emergencyhormonal-contraception
The pharmacists must have a certificate
demonstrating compliance with the National
Competence and Training Framework for the
service
The pharmacist’s name must be included in
the All Wales Pharmacy Database for the
service.
The pharmacist where required by the Local
Health Board, has successfully completed an
enhanced Criminal Records Bureau (CRB)
check
The pharmacist must handle all requests for
emergency hormonal contraception in a
sensitive and non-judgmental manner, and act
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in accordance with guidance issued by the
General Pharmaceutical Council on consent,
raising concerns and confidentiality.
The pharmacist must be competent to assess
a patient’s capacity to understand the nature
and purpose of the treatment in order to give or
refuse consent.
Competency assessment:
The pharmacist must satisfy the requirements
of WCPPE.
Continuing education:
The pharmacist must undertake regular CPD
and maintain own level of competence and
knowledge in this clinical area to provide the
service.
The pharmacist must have access to and be
familiar with the latest Summary of Product
Characteristics for ulipristal (ellaOne®) and
BNF.
Special Considerations / Additional
Information:
Pharmacy premises must respect a patient’s
right to confidentiality and safety and provide
an acceptable level of privacy.
References:
PGD EHC Ulipristal v1
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
British National Formulary 66 Sept 2013

Summary of Product Characteristics
ellaOne®
http://www.medicines.org.uk/emc/medici
ne/22280 (accessed 7 July 2014)

Emergency Contraception Guidelines,
Faculty of Sexual & Reproductive Health
Clinical Effectiveness Unit (2012)
http://www.fsrh.org (accessed 14 March
2014)

Drug Interactions with Hormonal
Contraception. Faculty of Sexual &
Reproductive Healthcare Clinical
Guidance (updated 2012)
http://www.fsrh.org/pdfs/CEUguidancedr
uginteractionshormonal.pdf (accessed 7
July 2014)

GPhC Guidance – Consent 2012,
Raising Concerns 2012 , and
Confidentiality 2012
http://www.pharmacyregulation.org/stan
3 December 2014
dards/guidance (accessed 18 Mar 2014)

NICE Good Practice Guidance on
Patient Group Directions
http://www.nice.org.uk/mpc/goodpractic
eguidance/GPG2.jsp (accessed 17
March 2014)
This Patient Group Direction is to be read, agreed and signed by all registered community
pharmacists authorised to operate the PGD. One copy should be given to each named
community pharmacist; the original signed copy should be kept by the nominated member of
staff with responsibility for PGDs within the pharmacy. This will usually be the Superintendent
Pharmacist or Responsible Pharmacist.
I confirm that I have read and understood the content of this patient group direction and that I am
willing and competent to work under it within my professional code of conduct.
Name of Pharmacist:
GPhC Registration Number:
Pharmacy location:
Signature:
Date:
Signed copy to be returned to:
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Appendix 1:
Cycle length (in days)
Calculating the mid cycle range for varying cycle lengths.
1
2
3
4
5
6
7
8
Day
9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32
26
28
30
32
Mid cycle is shown in dark blue. Women who
present having had UPSI during the mid cycle
period must be advised of the risk of EC failure
supplied and also be referred for IUD insertion
Note: Coils can be fitted up to 5 days post UPSI and also up to 5 days after the earliest possible ovulation, so UPSI on day 8/ 9/10/11 etc (of a 28 day cycle ) can still have a
coil up to day 19 even if they have had repeated UPSI. (Bar chart could be used to help show this)
Appendix 2 Emergency contraception decision guide for community pharmacists (based on FSRH review document
http://www.fsrh.org/pdfs/FSRH_ECDecisionGuide.pdf)