PGD Number
Patient Group Direction
Clinical Department/Service
Valid From
Review Date
Expiry Date
This PGD Replaces
CP 01B
Levonelle 1500 (Levonorgestrel 1.5mg tablet)
Community Pharmacy
30th September 2014
30th September 2015
30th September 2016
CP01A Levonelle 1500 (Levonorgestrel 1.5 mg
tablet)
This PGD covers the supply of Levonelle 1500 (Levonorgestrel 1.5mg tablet)
The supply will be made by Pharmacists registered with the General Pharmaceutical
Council (GPhC), working in registered community pharmacy premises, who have
undertaken additional training and are accredited by the Local Authority within which
the pharmacy premises is located. The supply will be made to women aged 14
years and over following unprotected sexual intercourse. (UPSI) in order to minimise
the potential for an unintended pregnancy.
Background
Following the transfer of Public Health functions to the Local Authorities the NHS
South of Tyne and Wear PGD (CP01A) has been reviewed and updated in line with
the most recent information available from the specific product characteristics, The
Faculty of Family Planning and Sexual Health and the Centre for Pharmacy
Postgraduate Education.
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Title
Head of
Medicines
Optimisation
North of
England
Commissionin
g Support
Unit (NECS)
(Pharmacist)
Senior
Medicines
Optimisation
Pharmacist
Service Lead
Service Lead
Service Lead
On behalf of Name (print)
Gateshead,
Janette
South
Stephenson
Tyneside &
Sunderland
Local
Authority
Gateshead,
South
Tyneside &
Sunderland
Local
Authority
Gateshead
Local
Authority
South
Tyneside
Local
Authority
Sunderland
Local
Authority
Gateshead &
South
Tyneside
Medical
Practitioner
(Lead
Associate
Specialist for
Sexual Health
Services)
Medical
Sunderland
Practitioner
Consultant
Contraception
Service
Director of
Gateshead
Public Health
Gateshead
Director of
South
Public Health Tyneside
South
Tyneside
Director of
Sunderland
Public Health
Sunderland
1. Clinical Condition
Signature
Date
Catherine
McClelland
Emma
Gibson
Janet
Chandler
Ben Seale
Dr Janet
Gallagher
Dr Sarah
Gatiss
Carole Wood
Amanda
Healy
Nonnie
Crawford
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Clinical Situation for which
medicine is to be used.
Criteria for inclusion
Unprotected sexual intercourse or failure of a
contraceptive method within 72 hours of presentation.
Client having vomited within three hours of initial dose
of Levonelle 1500, who decline the offer of an IUCD.
Women aged 14 years and over presenting within 72
hours of UPSI or potential failure of a contraceptive
method.
Potential failure includes.
 Women who have severe diarrhoea and
vomiting which may have reduced the efficacy
of oral contraception.
 Women who have taken antibiotics which may
have decreased the contraceptive effect of their
regular contraceptive method and have not
used an additional barrier method of
contraception e.g. concomitant use of enzymeinducing rifamycins (such as rifabutin and
rifampicin) and CHC
 (EHC is not required when using combined
hormonal contraception (CHC) with antibiotics
that are not enzyme inducers.) Noncompliance with dosage regime of oral
contraceptives. i.e. delayed or missed pills.
 More than 90 days have elapsed since injection
of Medroxyprogesterone.
 Having reason to believe that a barrier method
has failed.
 Failed to use an additional barrier method of
contraception when current methods have
failed.
 Can confirm that their intrauterine contraceptive
device (IUCD)/IUS or Subdermal implant has
expired and has had a failure of contraception.
Women who are taking oral contraception who have
also taken prescribed, or OTC, medication that is
known to interact with their oral contraception
(producing a reduced effect).
Women aged 14 years and over presenting within 72
hours of unprotected sexual intercourse who have
taken one dose of Levonorgestrel and have vomited
within three hours of taking the first dose of
Levonorgestrel. (Levonelle 150 or Levonelle One
Step).
Criteria for exclusion.
Women aged less than 16 years must be assessed
and considered to be Fraser competent.
UPSI more than 72 hours prior to presentation.
Aged under 14 years
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Aged under 16 years and not considered to be Fraser
competent.
Known hypersensitivity to Levonorgestrel or any
excipients contained within the product. (Levonelle
1500).
Suspected pregnancy.
Prior use of Levonorgestrel within the same cycle.
Other episode of unprotected sexual intercourse more
than 72 hours ago.
Unexplained or unusual vaginal bleeding.
Young girls not having gone through menarche.
Taking enzyme inducing drugs refer to current BNF for
list.
Taking drugs known to interact with Levonelle 1500
refer to current BNF for list.
At risk of ectopic pregnancy
Taking prescribed, or OTC, medication that is known
to interact with Levonorgestrel producing toxicity (due
to possible initiation of metabolism)
Severe hepatic dysfunction
Severe malabsorption syndrome
Cautions/need for further
advice
If client prefers IUCD, after advice about efficacy, then
refer to Contraception & Sexual Health service or GP.
However, if appropriate, still offer Levonelle 1500 to
client.
Consider risks due to ovulation timing When there is
suspected sexually transmitted disease (STI) refer to
Sexual Health Services.
Advice on Chlamydia screening service for under 25’s.
Provide information on any appropriate local ‘condom
supply schemes’
See supporting information file for specific information
relating to services available locally.
Action for excluded
patients/patient declines
Refer Contraception & Sexual Health service or GP.
See supporting information file for specific information
relating to services available locally.
2. Description of Treatment
Name of medicine
Dose
Levonelle 1500 (Levonorgestrel 1.5mg tablet).
Single tablet to be taken as soon as possible
(provided dose is taken within 72 hours of unprotected
sexual intercourse.)
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Legal classification
Route of administration
Frequency of administration
Period of administration
Quantity to
supply/administer
Follow up
Advice for patient
Warnings/Adverse events
POM
Oral
Single dose.
Single dose (with possibility of second dose if vomiting
occurs within 3 hours of first dose, providing that this
second dose is still within the 72 hour window)
One original pack containing one tablet.
POM pack should be supplied.
OTC pack should not be supplied.
Refer to Contraception & Sexual Health service or GP
if client experiences a missed or abnormal period.
When there is suspected sexually transmitted disease
(STI) refer to Sexual Health services.
Advise on Chlamydia screening service for under 25’s.
Provide information on any appropriate local “condom
supply schemes”.
Provide contraception leaflet
Signpost to local contraceptive services.
Inform client that if there is an abnormal period and/or
abdominal pain then they should contact their local
sexual health services or see their GP.
See supporting information file for specific information
relating to services available locally.
 Give patient information leaflet (PIL) and
discuss as required.
 Reason treatment required.
 Mode of action.
 Failure rate and efficacy.
 What to do if vomiting occurs within 3 hours.
(Advice may differ depending on timing of
presentation with respect to 72 hour window)
 Then explain/discuss the potential side effects,
and the likelihood of them occurring.
 Possible effects on menstrual cycle.
 What to do if period does not arrive/or is
unusual.
 Effective contraception.
 Seeking medical advice.
 Treatment administration,
 Well tolerated, however,
o Nausea and vomiting
o Breast tenderness
o Headache, Dizziness
o Fatigue.
Refer to SPC for additional details (a copy of the most
recent SPC, at the time of development of the PGD is
included in the supporting information pack. Be aware
that this may have been superseded. Up to date
SPCs can be accessed via the electronic Medicine
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Arrangements for referral
Records
Compendium (emc),
http:///www.medicines.org.uk/emc
Client to report any suspected adverse effects
believed to be associated with Levonelle 1500 to a
Healthcare Professional or direct by using the Yellow
Card system.
Clients and Healthcare Professionals can log ADRs
directly via the MHRA website
(http://yellowcare.mhra.ove.uk/)
Contraception & Sexual Health Service or GP
See supporting information file for specific information
relating to services available locally.
Records should be kept that will demonstrate;
 Details of all drugs supplied for audit purposes.
 Fraser guidance fulfilled for under 16.
 Evidence of counselling and future
contraception needs explored.
 Documentation of referral onward or advice
sought.
Records will be made on standard documentation.
See supporting information pack for copies of
documentation.
3. Staff Permitted to Supply/Administer under the PGD
Qualifications required
Additional requirements.
Pharmacist registered with the General
Pharmaceutical Council (GPhC)
Pharmacist to provide evidence of completion of
Centre for Pharmacy Postgraduate Education.
 Emergency contraception, e-learning and
assessment
 Contraception open leaning programme and
assessment.

Safeguarding children and vulnerable adults, elearning and assessment.
Pharmacists should attend CPPE Public Health
workshop Emergency Contraception and associated
pre- workshop task if accreditation to supply EHC
under PGD is requested after 1st June 2014 or have
attended a PCT training event on emergency
hormonal contraception if initial accreditation to supply
was requested prior to 1st June.
Accreditation status will be reviewed annually. This
should be in the form of a self-declaration of
competency. The declaration will be made by
submitting a signed form generated via the CPPE
website.
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(Declaration of qualifications and competence to
deliver community pharmacy services – Emergency
contraception).
Each pharmacy must have a Standard Operating
Procedure in place which covers the supply of
Levonelle 1500 via this PGD.
Education, Training
Maintenance of knowledge, skills and competencies
Continuing Professional
by engaging in continuing professional development.
Development
Each practitioner is accountable for ensuring their
skills and knowledge is kept up to date prior to
supplying under PGD.
AUTHORISATION OF NAMED HEALTH PROFESSINAL TO WORK WITHIN
PATIENT GROUP DIRECTION.
The direction must be read, agreed to and signed be each of the health
professionals who wok within it. All professions must act within their appropriate
Code of Professional Conduct.
Pharmacy Contractors must ensure that the following staff are competent to provide
care under this group direction including any training or education required.
I have read and understood this Patient Group Direction and have received
appropriate training and provided the Local Authority/Authorities within which I work
with evidence of tis. I have been authorised to supply EHC under this PGD and I
agree to work within its parameters.
Date
Name
Designation
Pharmacy
Signature
The above named professional(s) is (are) authorised to work within the parameters
of the Patient Group Direction.
Name Authorising Person: (Pharmacy Contractor / Manager / Director)
……………………………………………………………………………………………
Title of Authorising Person:……………………………………………………………
Signature:………………………………………………………………………………..
Date:………/………../…………
One copy retained by Local Authority. One copy retained by Contractor. One copy
retained by Pharmacist
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