Draft National Template
Patient Group Direction for the supply of:
levonorgestrel 1500mcg by Community Pharmacists
This direction was prepared 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 EC Levonorgestrel v1
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2 December 2014
Patient Group Direction for the Supply of:
levonorgestrel 1500mcg
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:
levonorgestrel 1500mcg
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 EC Levonorgestrel v1
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2 December 2014
Clinical Condition
Emergency contraception of unprotected
sexual intercourse (UPSI) or failure of other
contraceptive method;
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
within 72 hours of unprotected sexual
intercourse (UPSI) or failure of a contraceptive
method
Or
Presents in person at the community pharmacy
between 72 and 96 hours following
unprotected sexual intercourse (UPSI) or
failure of a contraceptive method and where
ulipristal is contraindicated and it is
impracticable for the patient to be referred for
insertion of an IUD.
(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).
NB: If patient has vomited within 3 hours of
taking a dose of levonorgestrel 1500mcg a
further supply can be given provided patient is
still within 96 hours of UPSI.
Patient gives their consent to providing the
PGD EC Levonorgestrel v1
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2 December 2014
relevant clinical information to the pharmacist
once pharmacist has assessed their capacity
to understand the nature and purpose of the
treatment
Emergency contraception decision support
guide for pharmacists (see appendix 2)
BNF note: Levonorgestrel is effective if taken
within 72 hours of unprotected intercourse and
may also be used between 72 and 96 hours
after unprotected intercourse (unlicensed use)
Criteria for exclusion:
Patients aged 12 years or under
Patient who the pharmacist has assessed as
not having capacity to understand the nature
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 than 72 hours ago (refer
to ulipristal acetate PGD) or UPSI occurred
between 72 and 96 hours ago and ulipristal
acetate is contra-indicated
Patients who are/or think may be pregnant
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 (EC not required in these
circumstances)
Patients taking ciclosporin
Patients taking anticoagulants
Patients with unexplained vaginal bleeding
PGD EC Levonorgestrel v1
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2 December 2014
Patients with severe hepatic dysfunction
Patients with severe malabsorption syndrome
e.g. porphyria
Hypersensitivity to levonorgestrel or any of the
tablet ingredients/excipients
Patients with rare hereditary problems of
galactose intolerance, the Lapp lactase
deficiency or glucose-galactose malabsorption
are excluded from treatment with
levonorgestrel under this PGD as this medicine
may contain lactose monohydrate.
Cautions (including any relevant
action to be taken):
Severe malabsorption syndromes e.g.
severe diarrhoea, Crohn’s. The Faculty of
Sexual and Reproductive Health (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
Repeat use within a menstrual cycle is not
advisable
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.
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. Only in circumstances where it is
impracticable for the patient to be referred,
should a supply of levonorgestrel be made
more than 72 hours after UPSI.
Seek further advice:
PGD EC Levonorgestrel v1
To be completed by LHB according to local
arrangements. Know the referral pathway into
local sexual and reproductive health services
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2 December 2014
or how to contact the local lead doctor for
sexual and reproductive health for medical
advice.
Description of Treatment
Name of Medicine
Approved name:
Levonorgestrel 1500mcg
Proprietary name:
Legal status:
Prescription Only Medicine (POM)
Form:
Tablet
Strength:
Dosage:
1500mcg
Take ONE tablet 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 should be taken as a single dose
(total dose 3000mcg). This is an unlicensed
indication for levonorgestrel.
Oral
1500mcg as a single dose
Route of Administration:
Frequency of Administration:
3000mcg if patient using enzyme inducing
medication
NB: If patient has vomited within 3 hours of
taking a dose of levonorgestrel the dose can
be repeated.
Total daily dose:
1500mcg
Or
3000mcg (if patient taking enzyme inducing
medication)
Duration of treatment:
Total treatment quantity:
Use outside terms of summary of
product characteristics:
PGD EC Levonorgestrel v1
Single oral dose
One or two 1500mcg tablets
Levonorgestrel is not recommended in children
and very limited data are available in women
under 16 years of age.
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2 December 2014
The use of two levonorgestrel 1500mcg tablets
if the patient is taking enzyme-inducing drugs
is an unlicensed indication. However this is
recommended in the current BNF.
Use between 72 and 96 hours after UPSI
See Ulipristal acetate PGD.
If ulipristal is contraindicated levonorgestrel
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 license of the
product.
If >72 hours but <96 hours after UPSI advise
that the option of insertion of an IUD is the
recommended option but that levonorgestrel is
supported by evidence from a World Health
Organisation trial.
Use of levonorgestrel does NOT stop a woman
from having the IUD fitted therefore women
should be supplied levonorgestrel AND be
referred for an IUD.
Use more than once in a cycle
Use more than once in a cycle is not advised
because of the possibility of cycle disturbance.
However it is supported by guidance from the
Faculty of Sexual and Reproductive
Healthcare.
Explain to patient that advice differs from
patient information leaflet and the reasons for
this.
Very common
Adverse reactions:






PGD EC Levonorgestrel v1
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Bleeding not related to menses
Delay of menses
Headache
Nausea
Low abdominal pain
Fatigue
2 December 2014
Common






Breast tenderness
Delay of menses >7 days
Irregular bleeding and spotting
Dizziness
Diarrhoea
Vomiting
(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 72 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
any lower abdominal pain occurs
(possibility of an ectopic pregnancy)
 if their next menstrual period is more
than 5 days overdue, 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 levonorgestrel 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
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2 December 2014
levonorgestrel does not provide ongoing
contraceptive protection and that she must
continue to use another method for the
remainder of the cycle.
Advise patient that they can be tested and
treated for sexually transmitted infections if
necessary and sign-post to locally available
services.
If the patient is breast feeding advise that
levonorgestrel is not thought to be harmful.
However potential exposure of the baby to
levonorgestrel can be reduced if the mother
takes immediately after feeding.
Written information for patient:
The following must be provided:
 A product Patient Information Leaflet
(PIL)
 A leaflet on currently available forms of
contraception
 Information on local sexual health
services
Follow Up:
With sexual health service 3 weeks later for
pregnancy testing and contraceptive/sexual
health advice.
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:
PGD EC Levonorgestrel v1
Community Pharmacists currently registered
with the General Pharmaceutical Council
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2 December 2014
(GPhC).
Training:
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
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 the specific levonorgestrel
PGD EC Levonorgestrel v1
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product supplied 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:

British National Formulary 67 March
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
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:
PGD EC Levonorgestrel v1
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PGD EC Levonorgestrel v1
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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)