PATIENT GROUP DIRECTION
FOR THE SUPPLY OF PROGESTOGEN ONLY ORAL
EMERGENCY CONTRACEPTION (POEC)
BY COMMUNITY PHARMACISTS
Start date: December 2005
Expiry date: December 2007
Issued by: Primary Healthcare Directorate
Patient Group Direction for the supply of Progestogen Only Oral Emergency Contraception
(POEC) by Community Pharmacists
Start Date: December 2005
Expiry Date: December 2007
1
GREENWICH TEACHING PRIMARY CARE TRUST
PATIENT GROUP DIRECTION FOR THE SUPPLY OF
PROGESTOGEN ONLY ORAL EMERGENCY CONTRACEPTION
(POEC) BY COMMUNITY PHARMACISTS
1. Clinical Condition
1.1 Define Clinical Situation
Women requiring progestogen only oral emergency contraception (POEC), between
the ages of 14 and 20 years.
A standard assessment Proforma (Appendix 1) must be completed for each client
to assess eligibility for supply.
1.2 Inclusion Criteria.
Initial Supply - FOR WOMEN NOT ON HORMONAL METHOD OF
CONTRACEPTION
 Woman presents within 72 hours of unprotected sexual intercourse (UPSI) or
failure of a contraceptive method AND
 Presenting within 4 weeks since last menstrual period (LMP), termination of
pregnancy or miscarriage OR
 First episode of UPSI since childbirth.
Initial Supply – FOR WOMEN ON HORMONAL METHOD OF
CONTRACEPTION (See Appendix 2 for “Missed pill/patch advice” and
“Expiry of parenteral hormonal contraception”).
 Woman presents within 72 hours of first episode of UPSI since potential
method/user failure AND
 Presenting within 4 weeks since last withdrawal bleed, termination of
pregnancy or miscarriage OR
 First episode of UPSI since expiry of parenteral contraception.
Subsequent Supply – A second supply may ONLY be made within the same
menstrual cycle where the client has vomited within 3 hours of taking the tablets.
Where an anti-emetic is required, the patient should be referred - after consulting with
the patient.
Fraser/Gillick Competence should be assessed in those less than 16 years.
1.3 Exclusion criteria
 Previous issue of emergency contraception within the cycle in question.
 Experienced problems with EHC previously, e.g. vomiting or failure.
 Absolute contraindications to POEC:- actual or possible established pregnancy
- unexplained vaginal bleeding
- current breast cancer
- hypersensitivity to ingredients
 More than 72 hours since UPSI
Patient Group Direction for the supply of Progestogen Only Oral Emergency Contraception
(POEC) by Community Pharmacists
Start Date: December 2005
Expiry Date: December 2007
2
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
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Cycle length of client is less than 23 days or more than 35 days
Suffering from a condition that affects absorption e.g. Crohns disease
Acute or severe liver disease
Porphyria
Currently taking drugs with clinically significant interactions e.g. enzymeinducing drugs (BNF Appendix 1) or taking the herbal product St Johns Wort.
1.4 Circumstances when to refer to a doctor
 Excluded from supply under any of the above criteria
 LMP abnormal to the patient
 Last withdrawal bleed abnormal to the patient
 Requests emergency IUD
 Where there is doubt a patient should have hormonal contraception or if the
patient chooses the option of seeing a doctor or Family Planning Clinic.
 When dealing with, or suspected, STD need to refer to a doctor or Family
Planning Clinic
2. Characteristics of practitioners authorised to supply the named
treatment
2.1 Professional qualifications of health care professional
 Emergency contraception may ONLY be supplied by a pharmacist who
has undertaken the relevant training. Medicine counter staff must be trained
to refer each request for emergency contraception to that pharmacist.
 The registered pharmacist must have valid registration with the RPSGB.
 The pharmacist must have satisfactorily completed the approved training,
which will include Child Health Protection (either the training or the forum)
and the updated CPPE pack on ‘Emergency Hormonal Contraception’.
 The service can only be provided in a pharmacy which must have a suitable
area for consultation with. This may be a quiet screened area within the shop,
where privacy can be maintained, or a separate room.
 The pharmacy will be required to designate window space giving information
on emergency contraception. It may be an advantage for the pharmacy to offer
a pregnancy testing service.
 The pharmacist must ensure their professional indemnity cover is either
provided by the National Pharmaceutical Association or other organisation
which has confirmed that this activity will be included in the policy.
2.2 Requirements for training and continuing education
See Appendix 3 for details of training.
3. Description of treatment within the PGD
For product details see Appendix 4.
Patient Group Direction for the supply of Progestogen Only Oral Emergency Contraception
(POEC) by Community Pharmacists
Start Date: December 2005
Expiry Date: December 2007
3
4. Consent
The patient will be deemed to have given consent once they have signed the supply
form (Appendix 1).
4.1 Action if patient declines treatment
Advise that they can make an appointment to see their GP or Family Planning Clinic
if they wish.
5. Follow-up treatment
Patients will be encouraged to make an appointment with their GP or Family Planning
Clinic for further advice, and for future methods of contraception.
6. Information to be given to the patient
See Appendix 5 for Advice and Counselling
7. Supply Records




Record on proforma (Appendix 1) the name of the client and whether supply
made or client referred.
Obtain signature of client on proforma
The community pharmacist should record the supply as they would for a
private prescription. They should also include the batch number and
manufacturer’s expiry date.
The product should also be labelled with the appropriate instructions and
recorded on the PMR as a supply under a PGD.
8. Records of receipt and issue of medicines
A copy of the supply form should be retained at the pharmacy.
9. Reporting of adverse reactions
Any adverse reactions reported by the patient should be reported to the Pharmacist.
Who will decide whether the reaction is to be reported to the Committee of Safety of
Medicines (CSM), using the Yellow Card scheme.
10. Professional accountability
Each Pharmacist supplying medication under this Patient Group Direction is
personally and professionally accountable for his/her own actions as laid down by the
RPSGB Code of Conduct.
Patient Group Direction for the supply of Progestogen Only Oral Emergency Contraception
(POEC) by Community Pharmacists
Start Date: December 2005
Expiry Date: December 2007
4
11. Management and monitoring of this Patient Group Direction
11.1 The authors of the Patient Group Direction are:
_____________________
Date………………..
Kuldeep Kaur, Community Services Pharmacist, Greenwich TPCT
_____________________
Date…………………
Dr. Jane Dickson, Senior Clinical Medical Officer, Sexual & Reproductive Health
Service
______________________
Date………………….
Denise Rabbette, Head of Medicines Management, Greenwich TPCT
_____________________
Date………………..
Dr John Livingstone, Authorising Doctor, PEC Chair
______________________
Date………………..
Joanne Kiangala, Community Pharmacy Lead, Greenwich TPCT
11.2 Authorised on behalf of Greenwich Teaching Primary Care Trust
_____________________
Date……………
Hilary Shanahan, Chair Clinical Governance, Greenwich Teaching PCT
Patient Group Direction for the supply of Progestogen Only Oral Emergency Contraception
(POEC) by Community Pharmacists
Start Date: December 2005
Expiry Date: December 2007
5
12. Professionals Agreement
12.1 Name, Designation and Base
I agree to supply POEC (Levonelle-1500) and I am qualified and trained to do so. I
have read and understood the PGD and agree to supply under these instructions.
I have current professional indemnity cover, which has confirmed that this activity is
covered by the policy. The Trust will accept responsibility only for the accuracy and
clinical content of the PGD.
Name
Signature
Date
Registration Number
Base:
Patient Group Direction for the supply of Progestogen Only Oral Emergency Contraception
(POEC) by Community Pharmacists
Start Date: December 2005
Expiry Date: December 2007
6
13. References
13.1
The Prescription Only Medicines (Human Use) Amendment Order 2000,
Statutory Instrument 2000 No 1917
13.2
Patient Group Directions (England Only), National Health Service Executive,
HSC 2000/026
13.3 Guide to consent for examination or treatment. Department of Health, 2005,
www.doh.gov.uk/consent
13.4. Code for Professional Practice. Nursing and Midwifery Council, 2002.
13.5. Summary of Product Characteristics – Levonelle1500, Schering Healthcare
Ltd
13.6. British National Formulary – September 2005
Patient Group Direction for the supply of Progestogen Only Oral Emergency Contraception
(POEC) by Community Pharmacists
Start Date: December 2005
Expiry Date: December 2007
7
Appendix 1
Standard Proforma for Client Assessment and Record Sheet
1. Client’s History
Date of first day of last menstrual period
Length of normal menstrual cycle
therefore
usual or irregular
Has client had Levonelle since last LMP?
Pharmacy Stamp
day of cycle
Yes
No
Client’s name
Client’s address
Date of consultation
Age/date of birth
Postcode
GP name (must be registered with a GP in
Greenwich)
2. Criteria for Inclusion
There has been a failure of a contraceptive method?
Yes
No
Advice was given if missed contraceptive pill?
Yes
No
Since the LMP, has the client only had UPSI
within the last 72 hour period?
Yes
No
All options for emergency contraception discussed?
Yes
No
Client prefers hormonal method?
Yes
No
3. If further advice is required please contact any of the support centres or
refer client to any Family Planning Clinic or to her GP
Criteria for Referral (exclusion)
Has the client used any form of emergency
contraception within this cycle?
(If ‘yes’ refer – apart from if vomited within 3 hours)
Yes
No
Is the client taking any drugs with clinically
significant interactions (see BNF Appendix 1)?
(If ‘Yes’ refer)
Yes
No
Is the client pregnant or likely to be pregnant?
(If ‘Yes’ refer)
Yes
No
Patient Group Direction for the supply of Progestogen Only Oral Emergency Contraception
(POEC) by Community Pharmacists
Start Date: December 2005
Expiry Date: December 2007
8
Was her period more than 4 weeks ago?
(If ‘Yes’ carry out a pregnancy test or refer)
Yes
No
Was her period in any way abnormal?
(If ‘Yes’ refer)
Yes
No
Did UPSI occur more than 72 hours ago?
(If ‘Yes’ refer)
Yes
No
Does the client have breast cancer?
(If ‘Yes’ refer)
Yes
No
Does the client have severe liver disease?
(If ‘Yes’ refer)
Yes
No
Mode of action discussed?
Yes
No
Failure rate discussed?
Yes
No
Side-effects discussed?
Yes
No
Follow-up discussed?
Yes
No
Future contraception discussed?
Yes
No
4. Counselling Check-list
5. Action Taken
Supply
Yes
No
Batch number / expiry date
Referral (please state name and address of person referred to)
Advice given
Client’s signature
Date………………………
__________________________
Pharmacist’s Signature
Date…………………….
___________________________
Patient Group Direction for the supply of Progestogen Only Oral Emergency Contraception
(POEC) by Community Pharmacists
Start Date: December 2005
Expiry Date: December 2007
9
Appendix 2
Missed Pill/Patch Advice
Combined Oral Contraceptives
How late are you?
Less than 12 hours
late
Just take the late pill
at once and carry on
with your pills as
usual
More than 12 hours
late#
Take the most recently
delayed/missed pill now (no more
than 2 pills at any one time).
Discard any other missed pills.
Use condoms for the next seven
days and carry on with your pills
as usual.*
How many pills are left
after the last one that was
late or missed?
7 or more
Take the usual
break at the end
of the pack
Less than 7
Don’t have the
break, go straight
into the next pack
# If 2 or more pills are missed from the first 7 days of a pill packet – use Levonelle.
If 4 or more pills are missed from the second 7 days of a pill packet – use
Levonelle.
If 2 or more pills are missed from the last 7 days of a pill packet – continue
immediately onto the next pill packet without a break – Levonelle not needed.
*EHC is recommended for episodes of UPSI occurring in this 7 day period where
additional precautions are required.
Patient Group Direction for the supply of Progestogen Only Oral Emergency Contraception
10
(POEC) by Community Pharmacists
Start Date: December 2005
Expiry Date: December 2007
Are you within 72 hours of UPSI? If so, use Levonelle.
If you are more than 72 hours but less than 120 hours, and you have missed 2 or more
pills, refer to Family Planning Clinic or GP for late Levonelle or an IUD. (If she is
certain that she is in the middle week of the pack you need only refer if she has missed
4 or more pills).
Also
Vomited pills count as missed if they were vomited within 3 hours of taking them.
Pills taken during a course of antibiotics, or in the seven days after, count as missed.
Progestogen only pills
If any pill is taken more than 3 hours late – supply Levonelle, and use condoms for the
next seven days.
If the condom breaks or is not used, supply EHC and continue with pills as usual, use
condoms for seven more days.
Vomited pills count as missed if they were vomited within 3 hours of taking them.
Expiry of parenteral hormonal contraception
A supply may be made provided that the first UPSI since the injection expired was not
more than 72 hours ago.
Depo-Provera expires 89 days (12 weeks and 5 days) after the last injection.
Noristerat expires 56 days after the last injection.
Medical advice about on-going contraception should be sought urgently, and the
woman must be advised to arrange a pregnancy test 3 weeks after the supply, as
regular periods may take some time to resume after the use of parenteral hormonal
contraception.
Evra – delayed/detached patches
Evra is the new transdermal patch. Each patch is worn for seven days and patches
should be applied for 3 consecutive weeks followed by one patch free week.
There is a risk of pregnancy when patches become detached or the change of patch is
delayed.
The guidance given by the manufacturer is:
- For detached patches there is no need for additional contraception if the
patch is replaced within 24 hours. After 24 hours additional
precautions are needed for 7 days.
- If the change of patch is delayed then additional precautions are needed
for 7 days where, in week one the delay is over 24 hours or in weeks 2
& 3 the delay is over 48 hours.
EHC is recommended for all episodes of UPSI occurring in the 7 day period
where addition precautions are required.
Patient Group Direction for the supply of Progestogen Only Oral Emergency Contraception
11
(POEC) by Community Pharmacists
Start Date: December 2005
Expiry Date: December 2007
Appendix 3
Training requirements
Theory
1. All pharmacists will have an in depth knowledge of the summaries of
product characteristics accompanying Levonelle 1500.
2. All pharmacists will have read and clearly understand this Patient Group
Direction.
Requirements for continuing education and training
3. All pharmacists will ensure that they maintain their competency to work under this
Patient Group Direction.
4. The pharmacist must have satisfactorily completed the approved training, which
will include Child Health Protection (either the training or the forum); and be able
to prove this if arriving from another.
5. All pharmacists must have completed the updated CPPE pack on ‘Emergency
Hormonal Contraception’.
Requirements for locum/relief pharmacists
1. For locums/relief pharmacists who work for longer than a 4 week period
continuously – all of the above training requirements apply.
2. For a locum/relief pharmacist who works less than a 4 week period
continuously – Only the theory requirements apply. But they must also go
through a locum induction programme with the contractor.
3. If a locum/relief pharmacist is not able to or refuses to work under the
PGD – they must clearly signpost the other pharmacies that are willing to
provide this service.
Patient Group Direction for the supply of Progestogen Only Oral Emergency Contraception
12
(POEC) by Community Pharmacists
Start Date: December 2005
Expiry Date: December 2007
Appendix 4
Description of Treatment Within the Protocol
3.1Name,
pharmaceutical
form, strength:
3.2 Dose and frequency
3.3 Route of administration
3.4 Legal Category
3.5 Storage and handling
requirements
3.6 Specific side effects
3.7 Specific advice to client
Levonelle 1500 tablets, containing 1 tablet containing
Levonorgestrel 1500 micrograms
1 tablet to be taken as a single dose as soon as possible (and not
later than 72 hours) after UPSI. If vomiting occurs within 3 hours of
taking the tablet another tablet should be taken immediately.
Oral
POM
Store at room temperature and out of direct sunlight.
Menstrual irregularities (the next period may be early or late),
nausea, low abdominal pain, fatigue, headache, dizziness, breast
tenderness, vomiting.
See Appendix 5
Patient Group Direction for the supply of Progestogen Only Oral Emergency Contraception
13
(POEC) by Community Pharmacists
Start Date: December 2005
Expiry Date: December 2007
Appendix 5
Advice and Counselling
General Advice
The risks and benefits of the method should be discussed including:
 Mode of action
 Side-effects
 Failure rate
 Action to take if vomiting occurs
Also that:
 Emergency hormonal contraception does not provide protection against
pregnancy for the rest of the menstrual cycle. Other contraceptive methods will
be needed.
 Emergency hormonal contraception will not bring on a period straight away
but can alter the timing of the next menstrual period, which may be early or
late, usually within 3 days of the expected time. If the next period does not
occur within 3 weeks of taking EHC, the client should seek a pregnancy
test.
 Repeated use of EHC is likely to cause disruption to the menstrual cycle and is
less effective than other forms of regular contraception.
 A dose, information and advice sheet (Patient Information Leaflet) and support
pack must be given with the supply.
Additional Advice
 Breast-feeding – clients who are breastfeeding should be advised that very
small amounts of levonorgestrel might appear in breast milk. This is not
thought to be harmful to the baby, but if clients are concerned, the tablet
should be taken immediately after a breast-feed. In this way, the tablet is taken
well before the next breast-feed, thus reducing the amount of active ingredient
the baby may take in with the breast milk.
Patient Group Direction for the supply of Progestogen Only Oral Emergency Contraception
(POEC) by Community Pharmacists
Start Date: October 2005
Expiry Date: October 2007
14