Patient Group Direction for pharmacist supply of progestogen-only
postcoital contraception (Levonelle-1500)
Clinical condition
Clinical condition
Relevant national guidance
Inclusion criteria
For patient under 16 years of age it is necessary to assess the
competence of the patient to give informed consent according to the
Fraser ruling. Recognised guidance (eg as issued by the Family
Planning Association) should be followed.
 Patient refuses treatment.
 Patient attends for postcoital contraception more than 72 hours
after first episode of unprotected sexual intercourse.
 Known pregnancy
 Suspected pregnancy where menstrual bleeding is overdue or
was ”abnormal”
 Unexplained vaginal bleeding
 Patient awareness of any medical reason why the progestogenonly oral contraceptive should not be taken
 Current severe liver disease
 Allergy to any component of Levonelle-1500.
 Medical condition that might affect levornorgestrel absorption eg
Crohn’s disease.
 Concomitant therapy with enzyme-inducing drugs: barbiturates,
primidone, phenytoin, carbamazepine, griseofulvin, rifampicin, St
Johns Wort
 Concomitant therapy with ciclosporin
 Advise immediate referral to GP or Family Planning Clinic.
 If attending within 120 hours since first episode of unprotected
sexual intercourse advise that fitting of IUD may be appropriate.
Immediate referral to GP or Family Planning Clinic required.
Exclusion criteria
Action to be followed if
patient excluded from
supply
Staff characteristics
Qualifications
Required
Additional
Requirements
Continuing Training
Requirements
Supply of postcoital contraception
Recommendations for clinical practice: emergency contraception.
Faculty of Family Planning and Reproductive Health Care. April 2003
(updated June 2003)
Female patient aged under 19 years requesting postcoital
contraception within 72 hours of first episode of unprotected sexual
intercourse (no contraception, condom breakage or leakage) in
current cycle.
Registered community pharmacist
Satisfactory completion of CPPE distance learning course ‘Emergency
hormonal contraception’ and attendance at specific training event organised
by Teenage Pregnancy Unit.
Regular update in the field of family planning, reproductive health care
(including postcoital contraception) and sexual health.
MAS/PGD06/OCTL06/ISSUE004
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Patient Group Direction for pharmacist supply of progestogen-only postcoital contraception
(Levonelle 1500)
Treatment
Name of medicine
Legal status
Licensed use
Dose of medicine
Route of administration
Frequency of dose
Total number of doses
supplied
Nature of supply
One tablet each containing levonorgestrel 1500mg (Levonelle-1500)
POM
The Summary of Product Characteristics for Levonelle-1500 states that
Levonelle-1500 is not recommended in children. Very limited data available
in women under 16 years of age.
One tablet should be taken as soon as possible preferably within 12 hours
and no later than 72 hours after unprotected intercourse.
Oral
One dose. The earlier in the 72-hour period the dose is given the greater
the efficacy. It is therefore useful if the client takes the tablet in the
pharmacy.
One dose consisting of one tablet.
Where possible encourage patient to take the tablet in the pharmacy in
your presence.
If the patient declines to do so, agree a time when it will be taken by the
patient.
Advice to be given to
the patient
Follow up treatment
Records to be
completed
Audit trail
If medication is to be taken away to take, the packet must be labelled with
the name that patient provides, date of issue, directions for use, ‘pharmacy
address’, ‘Keep Out of Reach of Children’
 Discuss mode of action of postcoital contraception
 Discuss failure rate
 Counsel patient on possible side effects (nausea and vomiting, breast
tenderness, headaches, dizziness, fatigue. Bleeding pattern may be
temporarily disturbed).
 If vomiting occurs within three hours of taking the tablet, then contact
doctor or Family Planning Clinic to obtain replacement tablet without
delay.
 Identify package insert within the Levonelle-1500 pack.
 If patient attends because of missed pill, confirm that she knows how to
proceed with remaining pill regime.
 Advise on need for ongoing and future contraception.
 Provide information on local family planning services.
 Provide information on sexually transmitted infections (STI) and local
GUM services.
 Advise STI screen, particularly if recent change of sexual partner or two
or more partners in the last twelve months.
Advise patient to attend Family Planning Clinic or their GP if their next
period is more than five days late or is unusual in any way, or, for those on
the pill, if there is no bleed in the pill-free interval.
Date of supply and dose regime used. Signature of pharmacist making
supply. Batch number of Levonelle-1500. Completion of relevant check list
All documents to be maintained and retained within the pharmacy for 3
years.
MAS/PGD06/OCTL06/ISSUE004
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Patient Group Direction for pharmacist supply of progestogen-only postcoital contraception
(Levonelle 1500)
Management
PGD developed by
Authorising Pharmacist
Central Cornwall Primary Care Trust, Prescribing Team
Jim Jiwa
PEC Pharmacist
Central Cornwall Primary Care Trust
Signature of Authorising Pharmacist
Date of PGD
Date this PGD becomes due for review
August 2008
Approved by:
Central Cornwall PCT
Nominated Doctor
Central Cornwall PCT
Pharmaceutical Adviser
Name
Dr Paul Travis
Signature
Bridget Sampson
I
This copy to be retained by the pharmacist
MAS/PGD06/OCTL06/ISSUE004
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