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This Patient Group Direction (PGD) must only be used by registered community pharmacists who have been named and authorised by their organisation to practice under it. The PGD must only be used in conjunction with a local authority commissioned service specification for Emergency Contraception. The most recent and in date final signed version of the PGD should be used.

Patient Group Direction

for the supply and/or administration of

Levonorgestrel 1500microgram tablets

by registered community pharmacists for

Emergency Hormonal Contraception

in Cheshire and Merseyside

Version number: 1.0

Change history

Version number / Change details / Date

PGD development

Name / Job title and organisation
Members of the PGD working group / Dr Ifeoma Onyia / Consultant in Public Health, Halton Borough Council
Dr Nicola Mullin / Consultant in Sexual and Reproductive Health, Countess of Chester Hospital NHS Foundation Trust
Helen Stubbs / Senior Pharmacist, Cheshire and Merseyside Commissioning Support Unit
Jane Knight / Sexual Health Commissioner, Warrington Borough Council
Dr Jane Wilkinson / GP, GP Champion for Chlamydia & Sexual Health: Western Cheshire
Melanie Carrol / Chief Officer, Wirral Local Pharmaceutical Committee
Margaret Geoghegan
Helen Cartwright / Commissioning Improvement Lead, champs Public Health Collaborative Service
Adam Major / Commissioning Improvement Manager, champs Public Health Collaborative Service

PGD authorisation

Name / Job title and organisation / Signature / Date
Senior doctor / Dr Nicola Mullin / Consultant in Sexual and Reproductive Health, Countess of Chester Hospital NHS Foundation Trust / / 01/04/14
Senior pharmacist / Helen Stubbs / Senior Pharmacist, Cheshire & Merseyside Commissioning Support Unit / / 01/04/14
Person signing on behalf of authorising body
/ Commissioning Organisation

Community Pharmacist agreement to practise under the

Levonorgestrel 1500microgram tablets Patient Group Direction for Community Pharmacists

I have read and understood the Patient Group Direction and agree to supply and/or administer this medicine only in accordance with this PGD

Full Name (print)
GPhC number
Signature
Date

Training and competency of registered community pharmacists

Requirements of registered community pharmacists working under the PGD
Qualifications and professional registration / Community Pharmacists currently registered with the General Pharmaceutical Council (GPhC), who are working in a pharmacy contracted to NHS England (Mersey) or NHS England (Cheshire, Warrington and Wirral)
Initial training / Training must be in accordance with the Local Authority service specification, including the Pharmacist Self-declaration of Competence in Emergency Hormonal Contraception (EHC), and Safeguarding.
Competency assessment / The pharmacist must satisfy the requirements of Self-declaration of Competence for Community Pharmacy for Emergency Contraception
The Pharmacist should have achieved the competency levels specified in the NICE Competency Framework for Health Professionals using Patient Group Directions
http://www.nice.org.uk/mpc/goodpracticeguidance/GPG2.jsp
Ongoing training and competency / The pharmacist must maintain a regular Self-assessment Declaration of Competency every two years or sooner if appropriate.
It is the responsibility of the pharmacist to undertake Continuing Professional Development and to make this information available on request.

Clinical condition

Clinical condition or situation to which this PGD applies / Prevention of pregnancy from unprotected sexual intercourse (UPSI) e.g. no contraception used or failure of usual method
Inclusion criteria / ·  A woman of child bearing age, presenting within 72 hours of UPSI.
·  A woman presenting after 72 and up to 120 hours for whom ulipristal acetate is contraindicated, (use of levonorgestrel after 72 hours is outside the Product Licence but is allowed under this PGD)
·  Failure of normal contraceptive method (see Appendix C)
·  Severe diarrhoea and/or vomiting which may have reduced oral contraceptive efficacy
·  A woman being referred for an intrauterine device (IUD)
·  Women who have previously been supplied with levonorgestrel during the cycle in question
·  Under 18 year olds a risk assessment should be undertaken to ensure the child is not at risk of harm. If a risk is identified, a referral to social services should be made in line with the Child Protection Procedures of the Commissioning Organisation.
o  Under 16 year olds are included provided they meet the criteria of the Fraser Guidelines on consent to medical treatment.
o  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 Commissioning Organisation.
Exclusion criteria / ·  A woman presenting following most recent UPSI more than 120 hours (NB – IUD may still be an option)
·  No valid consent,
·  Confirmed pregnancy
·  Knowingly supplying to a third party on behalf of client
·  Known hypersensitivity to levonorgestrel or any ingredient contained in the product (note tablets contain lactose) or has experienced any severe clinical problems with progestogens, apart from nausea
·  Less than 21 days postpartum
·  A woman who is being referred for ulipristal acetate. If the woman wishes to take ulipristal acetate and is less than 72 hours since UPSI, don’t give levonorgestrel refer to nearest Community Sexual and Reproductive Health Clinic.
Cautions (including any relevant action to be taken)
Cautions (including any relevant action to be taken) continued
Cautions (including any relevant action to be taken) continued / ·  An IUD is the most effective means of post coital contraception and this option must be discussed with the woman. In instances where an IUD is acceptable to the woman, continue to supply levonorgestrel in case the IUD fitting is not done or proves unsuitable.
·  If levonorgestrel is used more than once in a cycle, advise the woman that she may have a delayed period or irregular bleeding.
·  Currently taking any medicine which induces hepatic enzymes:
Anti-epileptics
Carbamazepine
Eslicarbazepine
Oxcarbazepine
Phenobarbital
Phenytoin
Primidone
Rufinamide
Topiramate
Antimicrobials:
Rifampicin
Rifabutin
Also
Antiretrovirals
St John’s Wort
Bosentan
Modafinail
Aprepitant
For enzyme inducers this exclusion also covers women who have stopped the medicines listed that induce hepatic enzymes within the last 28 days.
·  Women currently taking anticoagulant drugs: the anticoagulant effects may be altered following treatment with levonorgestrel. Women must be advised to give extra attention to anticoagulant monitoring.
·  Failure of levonorgestrel and ectopic pregnancies: the Medicine and Health Care Products Regulatory Agency (MHRA) has advised that the possibility of an ectopic pregnancy must be considered in particular in women with a previous history of ectopic pregnancy, fallopian tube surgery or pelvic inflammatory disease.
·  Women with a history of any of the following should be issued with levonorgestrel and referred for clinical advice:
·  Unexplained vaginal bleeding
·  Vomiting associated with previous taking
·  Acute active porphyria
·  If the woman vomits within 2 hours of taking levonorgestrel the course may be repeated, provided that the new dose is still within 120 hours of the most recent episode of UPSI in that cycle. Anti-emetics may be recommended. Alternatively the woman may be referred for an IUD.
·  If the new dose would be later than 120 hours after the most recent episode of UPSI in that cycle, it may still be possible to fit an IUD. Refer to a Community Sexual and Reproductive Health doctor or GP if you believe the woman fits this criteria.
·  Medicines containing levonorgestrel may increase the risk of ciclosporin toxicity
·  Note: non liver enzyme inducing antibiotics DO NOT interact with levonorgestrel.
Arrangements for referral for medical advice / Know the referral pathway into local sexual and reproductive health services or how to contact the local lead doctor for sexual and reproductive health for medical advice.
Action to be taken if patient excluded / Document exclusion criteria, discuss alternative measures and refer to a Community Sexual and Reproductive Health doctor or GP as appropriate. For those presenting more than 120 hours after UPSI an IUD may be an option. Warn the woman that a delay in starting treatment may compromise its efficacy
Visitors from countries outside the EU are entitled to access this free service on the NHS.
Action to be taken if patient declines treatment / Record decision in the patient clinical record
Discuss alternative and refer to a Community Sexual and Reproductive Health clinic or GP

Details of the medicine

Name, form and strength of medicine / Levonorgestrel 1500microgram tablet
Legal category / POM
Indicate any oHYPERLINK "http://publications.nice.org.uk/patient-group-directions-gpg2/appendix-a-glossary"ff-label use (if relevant) / May be taken from 72+ to 120 hours following UPSI
Route/method of administration / Oral
The earlier in the 120 hour period the tablet is taken the greater the efficacy.
It is recommended that the woman takes the tablet(s) whilst in the pharmacy
If the tablet(s) are not taken in the pharmacy:
Advise the woman to take the tablet(s) as soon as possible
Highlight the presence of a patient information leaflet in the pack(s)
The pack(s) should be labelled with the woman’s name, date of issue, directions for use, the pharmacy address and ‘keep out of reach of children’.
Dose and frequency / Levonorgestrel 1500micrograms or 3mg if a double dose is required, as a single course
Quantity to be administered and/or supplied / Either
·  One tablet to be taken as a single dose as soon as possible after UPSI or
·  Two tablets to be taken as a single dose as soon as possible after UPSI for a patient taking enzyme-inducing drugs (or within 28 days of stopping) or with severe malabsorption problem.
This advice is outside the terms of the product licence but is in accordance with the Clinical Effectiveness Unit of the Faculty of Sexual and Reproductive Healthcare Guidance (FSRH)
Maximum or minimum treatment period / As often as required, although women returning for repeat dosage should be advised to seek a reliable ongoing method of contraception from their GP or Community Sexual and Reproductive Health clinic
Adverse effects / Vomiting 1%, nausea 14%
Alteration in timing of next period
For less frequent undesirable effects affecting<1% of patients see patient Information Leaflet, Summary of Product Characteristics and current BNF
Records to be kept
Records to be kept (continued) / ·  A consultation proforma for the “Supply and Administration of EHC” must be fully completed and signed for all consultations, irrespective of whether a supply is made. The following details will be recorded:
o  That valid informed consent has been given
o  Patient’s name, address (optional) and date of birth
o  Name of GP
o  Dose given
o  Date of supply
o  Manufacturer, brand, batch number and expiry date
o  A record of the counselling about encouragement to consider an IUD
o  Advice given
o  Advice given if patient excluded or declines treatment
o  Details of any ADRs and actions taken
o  Signature, GPHC number and name of pharmacist who administered or supplied the medication
o  Document if the dose is administered on the premises
o  The supply must be entered in the Patient Medication Record (PMR)
o  All records should be clear, legible and contemporaneous.
This can be a paper or electronic version (or both)
·  A “Fraser Ruling Assessment of Competency” form must be completed for all women under 16 years of age
·  Consultation and Fraser Ruling proformas must be signed by the pharmacist and the woman

Patient information

Written information to be given to patient or carer / Give woman a copy of any relevant patient information leaflet and discuss as required e.g. failure rate (1-3 women out of100 will become pregnant despite taking EHC. An IUD has negligible failure rate)
Supply woman with appropriate leaflets and information about local Sexual and reproductive Health Services
Follow-up advice to be given to patient or carer / ·  Explain other available treatment option including an IUD.
·  Explain treatment and administration including advice if vomiting occurs.
·  Advise the patient that the drug given at this consultation for this episode of UPSI, will have no effect for previous risks (UPSI) i.e. more than 120 hours ago.
·  Advise that if vomiting should occur within 2 hours of taking levonorgestrel to seek immediate advice from a Community Sexual and Reproductive Health clinic, pharmacist or GP.
·  Advise patient that she could still become pregnant, If next period is delayed by more than 7 days or is abnormal in any way (light, heavy or painful), woman should seek medical advice.
·  If a pregnancy has occurred, following failure of levonorgestrel treatment, the patient should contact a Community Sexual and Reproductive Health clinic or GP for further advice.
·  Seek medical advice if there is any lower abdominal pain because this could signify an ectopic pregnancy, although women who become pregnant after taking EHC are not at higher risk of ectopic pregnancy compared to women who have not taken EHC.
·  Stress the need to use a reliable ongoing method of contraception.
·  Discuss sexually transmitted infection risk and condom use.
·  If further dose(s) are given in the same cycle, the woman should be advised that levonorgestrel may cause disturbance of subsequent cycles.
·  For breast feeding mothers: a very small amount of levonorgestrel is excreted in breast milk, although there is no evidence that this is harmful.
·  Emergency contraception is an occasional method. It should in no instance replace a regular method of contraception.
·  There is no evidence to date that the hormones used postcoitally carry any risk of teratogenicity should the method fail and a pregnancy occur.

Appendices

Appendix A Key references

1.  Emergency Contraception Guidelines, Faculty of Sexual & Reproductive Health Clinical Effectiveness Unit (2012) http://www.fsrh.org
2.  Faculty of Sexual & Reproductive Healthcare Guideline “Missed pill recommendations” May 2011
3.  GPhC Guidance – Consent 2012, Raising Concerns 2012 , and Confidentiality 2012
http://www.pharmacyregulation.org/standards/guidance
4.  Summary of Product Characteristics for Levonelle 1500® available on www.medicines.org.uk accessed 3rd February 2013.
5.  Current BNF chapter 7.3.1
6.  Drug Interactions with ellaOne® Faculty of Sexual & Reproductive Healthcare Clinical Guidance (updated 2012)
7.  NICE Good Practice Guidance on Patient Group Directions and the Competency framework for healthcare professionals using Patient Group Directions http://www.nice.org.uk/mpc/goodpracticeguidance/GPG2.jsp

Appendix B - Clinical Condition Notes