Clinical Situation

Purpose of this Document
This document describes the content of any Patient Group Direction (PGD)
used in conjunction with the All – Wales National Enhanced Service for
Progestogen Only Emergency Contraception (POEC).
Local Health Boards (LHB) are responsible for producing and authorising the
PGD that it to be used for POEC supply from a pharmacy in their LHB area.
The clinical content of the PGD operating in any LHB will be the same and is
set out in this document.
Pharmacists must read this document and sign an agreement to work within
its terms. Pharmacists must also familiarise themselves with the format of the
PGD available in each pharmacy at which they work.
Management of the content of the National Patient Group Direction
The content of the PGD shall be determined nationally. Variation to the
content of the PGD can only be made with the agreement of the Welsh
Assembly Government and only following consultation with Community
Pharmacy Wales. Local Health Boards shall include the content of the
national PGD, so far as it relates to the provision of the service, in their own
Any pharmacist involved in the use of the PGD must read and agree to act
only within the conditions specified there within. The pharmacist must sign an
agreement to that effect and return this to the NHS Wales Shared Services
Clinical Situation
Patient presenting in person at the community pharmacy
requesting emergency contraception for their own use.
Inclusion Criteria
Patient is aged 13 or over.
Unprotected sexual intercourse (UPSI)/contraception
failure within the last 72 hours.
UPSI within the last 96 hours where, for reasons of
unavailability of access to services within the 96 hour
period following UPSI, it is impracticable for the patient
to be referred for insertion of an Intra Uterine Device
(IUD) or prescription of Ullipristal (see section entitled
‘Action if Excluded’).
UPSI/contraception failure within the last 96 hours where
patient has vomited within 3 hours of taking dose of
levonorgestrel for emergency hormonal contraception.
Patient gives their consent to providing the relevant
clinical information to the pharmacist once pharmacist
has assessed their capacity to understand the nature
and purpose of the treatment
Exclusion Criteria
Longer than 96 hours since UPSI
Patient is under 13 years.
Patient who the pharmacist has assessed as not having
capacity to understand the nature and purpose of
Patient who does not give their consent to providing the
relevant clinical information to the pharmacist.
Patients who are/or may be pregnant.
Patients who have delivered a baby within last 3 weeks
(POEC not required in these circumstances).
Patients taking ciclosporin.
Patients with unexplained vaginal bleeding
Patients with Severe hepatic dysfunction
Patients with Severe malabsorption syndromes e.g.
severe diarrhoea, Crohn’s disease
Hypersensitivity to levonorgestrel or any of the tablet
ingredients/excipients (potato starch, maize starch,
colloidal silica anhydrous, magnesium stearate, talc,
lactose monohydrate).
Patients with rare hereditary problems of galactose
intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption as Levonelle® 1500 contains
Requests made by third parties on behalf of the patient
Action if Excluded
All excluded patients should be referred to a Family
Planning/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
If unprotected sex was within the last 120 hours the
patient may be suitable for insertion of an IUD or
prescription of Ullipristal. Referral should be made in a
suitable timeframe to allow this to happen. Only in
circumstances where it is impracticable for the patient to
be referred, within the 120 hour period following UPSI, to
a service providing IUD insertion or prescription of
Ullipristal, should a supply of levonorgestrel be made
more than 72 hours after UPSI.
Characteristics of Persons and Premises Authorised Under the PGD
A pharmacist whose name is currently on register held
by the General Pharmaceutical Council (GPhC)
The pharmacist must have completed level 2 child
protection training
The pharmacists must have a certificate demonstrating
compliance 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 undertake regular continuing
professional development (CPD) and maintain own level
of competence and knowledge in this clinical area to
provide the service.
A premises specified in a Service Level Agreement
(SLA) between the pharmacy contractor and the Local
Health Board
Description of Treatment
Name of Medicine
Levonorgestrel (Levonelle® 1500)
Legal Status
Prescription Only Medicine (PoM)
Tablet 1500microgram (mcg)
Take ONE tablet (1500mcg) as a single oral dose as
soon as possible after UPSI (preferably within 12 hours
but no later than 72 hours unless as specified above).
If the patient is using an enzyme inducing medication
(refer to BNF Chapter 7.3.5 Emergency Contraception
for details) then TWO tablets of levonorgestrel 1500 mcg
should be taken as a single dose (total dose 3000mcg
levonorgestrel). This is an unlicensed indication for
Route of
Frequency of
Single dose of 1500mcg
Single dose of 3000mcg if the patient is using enzyme
inducing medication
If patient has vomited within 3 hours of taking a dose of
levonorgestrel the dose can be repeated.
Total Daily Dose
Duration of
Total Treatment
Use Outside
3000mcg (if patient is taking enzyme inducing
Single oral dose
One or two 1500mcg tablet(s)
Levonelle® 1500 is not recommended for women under
Terms of Summary 16 years of age.
of Product
The use of 2 Levonelle® 1500 tablets if the patient is
taking enzyme-inducing drugs is an unlicensed
indication. However, this is the recommendation in the
current BNF.
Use between 72 and 96 hours after UPSI
EHC may be considered for use between 72 and 96
hours after UPSI, but women should be informed of the
limited evidence of efficacy and that such use falls
outside the licence of the product.
If >72 hours but <less 120 hours from UPSI, advise that
the option of an insertion of an IUD is the recommended
first –line treatment but that POEC is supported by
evidence from a World Health Organisation trial.
Use of POEC does NOT stop a woman from having the
IUD fitted as well but may ensure some protection whilst
more effective protection is sought.
Use more than once in a cycle
The product SPC advises against this because of the
possibility of disturbance of the cycle. However, use
more than once is supported by guidance from the
Faculty of Sexual and Reproductive Healthcare.
Adverse Reactions
Explain to patient that advice differs from patient
information leaflet and the reason for this.
Very common
Bleeding not related to menses, headache, nausea, low
abdominal pain, fatigue
Breast tenderness, delay of menses > 7 days, irregular
bleeding and spotting, dizziness, diarrhoea, vomiting.
Procedure for
Adverse Reactions
This list is not exhaustive. Please refer to the Summary
of Product Characteristics (SPC) for further information.
Side effects should be recorded in the patient
medication record (PMR).
Refer to a GP where necessary.
Consider reporting via the MHRA yellow card reporting
Verbal Advice to
Advise on likely side effects, action needed if vomiting
occurs, delayed menses and the failure rate.
All patients should be advised on the option of an
emergency IUD.
Explain that:
 the next period may be early or late
 if the patient is taking an oral contraceptive or uses a
contraceptive patch, but emergency contraception is
indicated, that a barrier method of contraception
may need to be used in addition to her usual method
until she has taken the pill or applied the patch
correctly for the appropriate time as advised in the
most recent version of the British National
 if the patient is not taking an oral contraceptive or
using a contraceptive patch , a barrier method of
contraception should be used until appropriate
advice about ongoing contraception has been given
 the patient should contact their GP if any lower
abdominal pain occurs (possibility of an ectopic
 if the patient has not had their period within 5 days
of their expected date of menstruation, abnormal
bleeding occurs or pregnancy is suspected, they
should attend a Family Planning Clinic or GP with a
urine sample to confirm or exclude pregnancy.
 highlight that levonorgestrel (Levonelle® 1500) is
used for emergency contraception only. Suggest
where appropriate that patient makes an
appointment with their GP, Family Planning Clinic or
Sexual Health Services to discuss their on-going
contraceptive needs.
Advise patient that they can be tested and treated for
sexually transmitted infections if necessary and signpost the patient to locally available services.
If the patient is breast-feeding advise that levonorgestrel
(Levonelle® 1500) is not thought to be harmful. However
potential exposure of the baby to levonorgestrel can be
reduced if the mother takes the tablet immediately after
Written information
for Patient
The following must be provided:
A Levonelle® 1500 Patient Information Leaflet (PIL)
A leaflet on currently available forms of contraception
Information on family planning and sexual health
services available within the Health Board area
Follow Up
None required
The pharmacist must ensure maintenance of records of
each supply including the date of supply, batch number
and expiry date for each pack supplied.
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
emergency hormonal contraception proforma for each
The pharmacist will be required to complete the National
Electronic Claim and Audit Form (NECAF) for each
This form is to be completed on each
occasion the Emergency Contraception
National Enhanced Service is provided.
Pharmacy Stamp
Completed forms should be retained for 10
years or until the client is 25 years age
whichever is longer.
Date of Consultation
Patient Reference No
Patient’s Age/Date of Birth
Patient’s Postcode (complete as much as possible)
Is the patient presenting in person?
If the patient is under 16 years of age, are they
deemed Fraser competent?
Is the patient 13 years of age or over?
Was Last Menstrual Period (LMP) normal
Date of Last Menstrual Period (LMP)
Has the patient had other episode(s) of UPSI in
this cycle prior the episode for which she is
Is the patient presenting more than 72 hours but
less than 96 hours after UPSI
Date and time of UPSI
Has POEC been taken already in this cycle?
Does the patient have a known allergy to
levonorgestrel or any other ingredient of
Levonelle® 1500?
Does the patient have severe hepatic
Does the patient have any severe absorption
difficulties e.g. severe vomiting or diarrhoea?
Does the patient have any severe malabsorption
syndrome e.g. Crohn’s disease?
Does the patient have porphyria?
Is the patient taking ciclosporin?
Hours since UPSI
Has the patient delivered a baby within the last 3
Regular contraception
Does the patient have unexplained vaginal
Is the patient taking enzyme inducing medication?
(refer to BNF Chapter 7.3.5 Emergency
Contraception for details)
Reason for request
(EHC not
Condom Failure 
0 – 24
Previous POEC use (months)
25 – 48 
3-5 
49 - 72 
6+ 
Both oral and IUD emergency contraception options discussed
72 +
Never 
Treatment Plan
Levonelle® 1500 one tablet as single dose
Levonelle® 1500 two tablets as single dose (enzyme inducers)
No supply – patient presenting too late for treatment
No supply – POEC not required
In these circumstances Pharmacists may use their professional judgement in determining whether to make
a supply of levonorgestrel for an unlicensed indication
Child protection issues considered/discussed
Discuss mode of action
Discuss failure rate
Confirm next period my be early or late
Discuss need for follow up including pregnancy test if next
menstrual period is more than 5 days late of lighter than usual
Discuss need to return if further UPSI
Action to take if vomiting within 3 hours
Discuss if appropriate unlicensed use and obtain consent
Discuss need for future contraception
Discuss risk of STIs
Provide information on family planning and sexual health services
available within the Health Board area
Supervise dose on premises
Details of Supply
Batch Number
Expiry Date
Dose taken on the premises
I have been counselled on the use of emergency hormonal contraception and understand the advice given to me by the pharmacist
Patient Name
Patient Address
Patient Signature/Initials
The action specified was based on the information given to me by the patient, which to the best of my knowledge, is correct.
Pharmacist Signature
Pharmacist GPhC Registration Number
Fraser Guidance for Issuing Contraceptive Advice to those under 16
Fraser guidelines refer to the Department of Health guidance issued in 1986
on the provision of contraceptive advice and treatment to young people under
16 years of age (also formerly known as ‘Gillick Competence’).
A doctor or any other professional would be justified in giving contraceptive
advice and treatment to a young person under 16 without parental knowledge
and consent provided if they were satisfied
The young person, although under 16, understands
the advice from the healthcare professional seen
The young person cannot be persuaded to tell their
parents they are seeking contraceptive advice
The young person is likely to have intercourse with
or without contraceptive treatment
The young person’s physical or mental health is
likely to suffer unless they receive contraceptive
advice or treatment
It is in the young person’s best interests to give
contraceptive advice or treatment
Pharmacist Signature
Fraser guidelines for contraception Ref: Turner, J. (1985) “discretion to act in the interests of the girl –
the Gillick Judgement. Journal of Medical Defence Union. Vol: Winter; 6-7. Fraser Guidelines