patient group direction (pgd) for - psnc main...

PATIENT GROUP DIRECTION (PGD) FOR:

Levonorgestrel 1500mg Tablets POM

PGD PH Levonorgestrel Final Version Dec 2016 v0.2 Valid from: 1.1.2017 Review date: 1.11.2018 Expiry date: 31.12.2018

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YOU MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD BEFORE YOU ATTEMPT TO WORK ACCORDING TO IT

Clinical Condition

Indication Prevention of pregnancy from unprotected sexual intercourse (UPSI) (no contraception, missed pills, failed condom / barrier method).

Inclusion criteria

Female 13 years or above presenting within 72 hours of unprotected sexual intercourse,

OR: EHC indicated for missed combined oral contraceptive pills if:

Pill free interval between packets lengthened to 9 days or more, e.g. by missing any two of the first or last seven pills in a packet combined with a 7 day pill free period. (see appendix 1)

Severe GI upset that may have affected contraceptive efficacy (See current BNF).

(Please note that use of broad-spectrum antibiotics and failure to use barrier method of contraception is no longer an indication for EHC. Also if pills are missed from day 8-14 of the pack, and the previous 7 pills have been taken correctly and consistently there is no longer an indication for EHC after 4 missed pills mid pack, as long as pills are taken correctly afterwards, however please refer to FSRH guidance*). OR: EHC is indicated for missed progestogen only contraceptive pills if:

A pill is missed (by more than 3 hours or 12 hours if Cerazette®) and there has been UPSI or barrier failure before efficacy has been re-established (i.e. 48 hrs after restarting).

Severe GI upset which may have affected contraceptive efficacy (see BNF: Diarrhoea and Vomiting).

Antibiotics do not affect progestogen only contraceptives. OR: EHC is indicated for late medroxyprogesterone depots (Depo- Provera®/SAYANA PRESS®) if:

14 weeks and 1 day has elapsed since the last injection and UPSI has occurred in the last 3 days (not applicable if UPSI occurred within 14 weeks of last DMPA). *NOTE: FSRH states that given the difficulties in accurately determining risk of pregnancy and the consequences of an unintended pregnancy, all requests for EHC should be considered and care individualised.

If aged under 16 years must be accompanied by a responsible adult/parent or must satisfy Fraser Guidelines (Gillick competent) – Please refer to Department of Health (DH) document “Best practice




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guidance for Doctors and other Health Professionals on the provision of advice and treatment to young people under 16 on contraception, sexual and reproductive health” Gateway Ref 3382

The child should be seen individually if assessed as Gillick competent. If aged under 16 years and not Fraser Guidelines (Gillick competent)

and accompanied by an adult/parent and EHC is indicated as above, dispense EHC and a referral to the specialist service should also be made for assessing risk.

If under 18 years of age or adult with learning disabilities ascertain as far as if possible that there are no unaddressed child protection or vulnerable adult issues

Exclusion criteria

Hypersensitivity to levonorgestrel or any ingredient contained in the product.

Current breast cancer.

Unexplained or unusual vaginal bleeding.

Acute severe liver disease.

Acute porphyria.

Severe intestinal malabsorption syndromes, e.g. Crohn’s Disease.

UPSI more than 72 hours ago.

If aged under 16 years and is not accompanied by an adult/parent and does not satisfy Fraser Guidelines as above.

Aged under 13 years

Those below 13 years must be referred to GP/ Multi-Agency Safeguarding Hub (MASH) if safeguarding issue is suspected.

Refuses immediate supervised consumption of levonorgestrel 1500mcg.

Cautions/Need for further advice

If > 72 hours since episode of unprotected intercourse, a post-coital IUCD, ullapristal or levonelle (unlicensed) may be a possible recommended option. Referral to the GP or Integrated Contraception and Sexual Health (iCASH) service [family planning] should be urgently made. Patient could already be pregnant (other episode of unprotected sexual intercourse in this cycle or in last three weeks if amenorrhoea/irregular periods, prior use of EHC since last menstrual period, last period more than 4 weeks ago if normally regular) and although there is no current evidence that progesterone causes defects to the foetus, this cannot be guaranteed. Pregnancy > 21 days can be excluded with a negative test, ideally using first morning urine. Note that this will not necessarily show positive for earlier pregnancies. Women seeking emergency contraception who have used cytochrome P450 3A4 (CYP3A4) enzyme inducers within the last 4 weeks, should: • Preferably use a non-hormonal emergency contraceptive i.e. a copper IUD




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• If this is not an option, double the usual dose of levonorgestrel from 1.5mg to 3mg and advise them to have a pregnancy test to exclude pregnancy Examples of enzyme inducers include drugs used to treat: • Epilepsy (e.g. barbiturates, primidone, phenytoin, carbamazepine) • Tuberculosis (e.g. rifampicin, rifabutin) • HIV (e.g. ritonavir, efavirenz) • Fungal infections (e.g. griseofulvin) • St John’s wort (Hypericum perforatum)

Action if patient excluded

Refer to appropriate doctor/independent prescriber

Discuss/offer alternative contraceptive method

Document all actions taken

Action if patient declines

Document refusal and course of action taken following advice.

Refer as appropriate.

Drug Details

Name, form & strength of medicine, legal status

Levonorgestrel 1500 microgram tablet

POM

Route/Method Oral tablet

Dosage 1 tablet (1500 micrograms) to be taken as a single dose as soon as possible after unprotected sexual intercourse (but within 72 hours).

To be consumed on site and witnessed by pharmacist or nurse. For women who are currently on or have taken liver enzyme inducing drugs within the last 4 weeks they should preferably use a non-hormonal emergency contraceptive i.e. a copper intrauterine device however if this is not an option, double the usual dose of levonorgestrel from 1500 micrograms to 3000 microgram (two x 1500 microgram tablets) and recommend that they have a pregnancy test if their menstrual bleed does not occur at its usual time.

Must be consumed on site even if patient has accepted referral for copper coil provided within the 72 hours window

Frequency Single dose (of one or two tablets as indicated in dosage)




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Duration of treatment/number of times treatment may be administered

Usually one dose in any single menstrual cycle is advised because of the possibility of disturbance of the cycle, except in the case of vomited tablets. See below.

Where a patient returns having vomited the dose within 3 hours of taking it, a replacement supply should be issued, as long as the dose remains within 72 hours of the episode of unprotected sexual intercourse. If it is outside the 72 hours then the patient should be referred to doctor or iCASH.

Quantity to supply/administer

One 1500 microgram tablet

Only for women who are currently on or have taken liver enzyme inducing drugs within the last 4 weeks two 1500 microgram tablets

Side effects and potential adverse drug reactions

Headache, dizziness

Nausea and vomiting

Lower abdominal pain

Bleeding not related to menses - Bleeding patterns may be temporarily disturbed, but most women will have their next menstrual period within 7 days of the expected time. Please refer to SPC or BNF for full details Report adverse drug reactions to the MHRA using the yellow card system https://yellowcard.mhra.gov.uk/

Advice to patient/carer

Explain treatment and course of action

Give the patient a copy of the product information leaflet and discuss as required

Advise to resume any regular oral contraception

Stress the need to abstain from sexual intercourse or to consistently and carefully use a reliable barrier method until next menstrual bleed

Seek medical advice if there is severe lower abdominal pain

Offer the patient a supply of condoms if part of local protocol

Offer advice regarding regular contraception, including the use of long acting reversible contraceptives

Follow up Ensure patient is aware of local arrangements e.g. integrated sexual health clinics and GP for ongoing contraception

If next menses is delayed by more than 5 days/ no normal bleed within the next three weeks or if bleed is unusual in any way (light/heavy, painful etc.) pregnancy should be excluded using an early morning urine sample

If pregnancy occurs, following failure of levonorgestrel treatment, patient should contact GP/iCASH for follow up to exclude ectopic pregnancy.

Provide patient with patient information sheet

For patients who are taking CYP3A4 liver enzyme inducers or

https://yellowcard.mhra.gov.uk/




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who taken these within the last 4 weeks provide the patient information leaflet available at https://assets.publishing.service.gov.uk/media/57d7d2d840f0b6533a000046/Levonorgestrel_patient_sheet.pdf

Staff Characteristics

Class of Qualified Health Professional for whom PGD is applicable

1. Registered Nurse on the NMC Register.

2. Pharmacist registered with the GPhC.

Qualifications 1. First level nursing qualification with current NMC Registration.

2. Degree in pharmacy with current GPhC registration.

Additional requirements considered relevant to the medicines to be supplied/administered according to this PGD

All named nurses/pharmacists should be able to demonstrate:

Training and experience in sexual health & emergency contraception

The ability to identify the risk of pregnancy.

Adequate standards of documentation that meet the requirements listed below under Method of Recording.

That they have undertaken appropriate training and successfully completed the competencies to undertake the clinical assessment of individuals leading to diagnosis that requires treatment according to the indications listed in this PGD.

That they have undertaken appropriate training for working under PGDs for the supply and administration of medicines.

Continuing training & education

A commitment to continuing professional development in the speciality, including maintenance of PREP/CPD requirements and a Personal and Professional Portfolio.

Referral Arrangements and Audit Trail

Referral arrangements GP or iCASH services

Method of Recording supply/administration sufficient to enable audit trail

Patient assessment form to be completed for all cases and retained for 15 years, OR comprehensive record made in patient notes or PMR. The following should be clearly documented in the patient’s health record where available or in the PMR or on PharmOutcomes with the patient’s consent:

Patient’s name, address, date of birth and consent given.

Contact details of GP (if registered)

Details of any adverse drug reaction and actions taken including

https://assets.publishing.service.gov.uk/media/57d7d2d840f0b6533a000046/Levonorgestrel_patient_sheet.pdf

https://assets.publishing.service.gov.uk/media/57d7d2d840f0b6533a000046/Levonorgestrel_patient_sheet.pdf




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documentation in the patient’s health record

The date, medication name, dose and form administered, signature/name of the health professional providing treatment

That the product information leaflet has been given to the patient

That the patient has been given advice on how long they should abstain from sexual intercourse or use barrier method

That the patient has been given verbal and written advice on how to access GP or an integrated sexual health service (iCASH)

Details of any referral

References/Resources and comments

Summary of Product Characteristics – Levonorgestrel 1500mg tablet. Bayer http://www.medicines.org.uk/emc/medicine/16887 Last update 9.10.1422.08.16

Joint Formulary Committee (2016) British National Formulary. September 2016 edition. London: British Medical Association and the Royal Pharmaceutical Society https://www.evidence.nhs.uk/formulary/bnf/current

Levonorgestrel-containing emergency hormonal contraception: advice on interactions with hepatic enzyme inducers and contraceptive efficacy MHRA Drug Safety Update September 2016

https://www.gov.uk/drug-safety-update/levonorgestrel-containing-emergency-hormonal-contraception-advice-on-interactions-with-hepatic-enzyme-inducers-and-contraceptive-efficacy

Faculty of Sexual and Reproductive Healthcare Clinical Guideline Emergency Contraception January 2012 Update http://www.fsrh.org/pdfs/CEUguidanceEmergencyContraception11.pdf

Nursing and Midwifery Council (2008) Standards for Medicines Management http://www.nmc-uk.org/Documents/NMC-Publications/NMC-Standards-for-medicines-management.pdf

Nursing and Midwifery Council (2015) The Code: Professional standards of practice and behaviour for nurses and midwives https://www.nmc.org.uk/globalassets/sitedocuments/nmc-publications/nmc-code.pdf

National Institute for Health and Care Excellence. Medicines Practice Guidance. Patient Group Directions August 2013 http://www.nice.org.uk/guidance/mpg2

Royal Pharmaceutical Society of GB (2008) Patient group Directions - A Resource pack for pharmacists

“Best practice guidance for Doctors and other Health Professionals on the provision of advice and treatment of young people under 16 on contraception, sexual and reproductive health” Gateway Ref 3382

http://www.medicines.org.uk/emc/medicine/16887

https://www.evidence.nhs.uk/formulary/bnf/current




http://www.fsrh.org/pdfs/CEUguidanceEmergencyContraception11.pdf

http://www.nmc-uk.org/Documents/NMC-Publications/NMC-Standards-for-medicines-management.pdf

http://www.nmc-uk.org/Documents/NMC-Publications/NMC-Standards-for-medicines-management.pdf

http://www.nice.org.uk/guidance/mpg2




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http://webarchive.nationalarchives.gov.uk/20130107105354/http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_4086914.pdf

Please direct comments specifically relating to information on this PGD to the Prescribing and Medicines Management Team NEL Commissioning Support Unit 01603 257132

http://webarchive.nationalarchives.gov.uk/20130107105354/http:/www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/dh_4086914.pdf






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This patient group direction must be agreed to and signed by all health care professionals involved in its use. Norfolk County Council will hold the original signed copy. The PGD must be easily accessible in the clinical setting.

This PGD has been agreed to be appropriate, necessary and an advantage to patient care by Norfolk County Council PGD Development and Authorisation Group

Organisation Norfolk County Council

This PGD was developed by the following on behalf of Norfolk County Council Public Health

Lead Doctor Dr Augustine Pereira Consultant in Public Health Medicine NCC

Signature: Date: 21.12.2016

Lead Nurse Sue Marshall Registered Nurse


Lead Pharmacist Françoise Price Senior Clinical Pharmacist NEL (Anglia) CSU


Patient Group Direction prepared and peer reviewed by

Name Position Date

Françoise Price Senior Clinical Pharmacist NEL CSU 10.11.2016

Tony Dean CEO Norfolk Local Pharmaceutical Committee 8.11.2016

Augustine Pereira Consultant in Public Health Medicine 24.10.2016

Tracey Milligan Public health nurse 24.10.2016

Sarah Barnes Sexual Health Commissioner and registered nurse

24.10.2016

Sue Marshall Clinical governance manager 10.11.2016

NCC PGD Development and Authorisation Group

Body with delegated authority to develop and review PGDs on behalf of NCC

24.10.2016 and via email communication

Patient Group Direction Authorisation

This PGD is authorised by Norfolk County Council Dr Augustine Pereira Chair Consultant in Public Health Medicine and Chair of the PGD group Signature: Date: 21.12.2016




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Individual Authorisation

PGDs DO NOT REMOVE INHERENT PROFESSIONAL OBLIGATIONS OR ACCOUNTABILITY.

It is the responsibility of each professional to practice only within the bounds of their own competence and in accordance with their own Code of Professional Conduct.

Note to Authorising Managers: authorised staff should be provided with an individual copy of the clinical content of the PGD and a photocopy of the document showing their authorisation. I have read and understood the Patient Group Direction and agree to supply/administer this medicine only in accordance with this PGD.

Name of Professional Signature Authorising Manager Date




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Appendix 1 Indications for emergency contraception following potential failure of hormonal and intrauterine methods of contraception

Method Situation leading to possible contraceptive failure

Indications for emergency contraception

Hormonal methods of contraception Failure to use additional contraceptive precautions when starting the method

UPSI or barrier failure during time that additional precautions required as indicated within CEU guidance

Combined hormonal contraception, progestogen-only pill and progestogen-only implant

Failure to use additional contraceptive precautions whilst using liver enzyme-inducing drugs or in the 28 days after use

EC is indicated if there is UPSI or barrier failure during, or in the 28 days following, use of liver enzyme inducing drugs. Offer the Cu-IUD (unaffected by liver enzyme-inducing drugs) or a double dose (3 mg) of LNG. UPA is not recommended with liver enzyme inducing drugs

Combined oral contraceptive pill (other than Qlaira®)

Missed pills. If two or more active pills are missed

EC is indicated if the pills are missed in Week 1 and there has been UPSI or barrier failure during Week 1 or the pill-free interval If the pill-free interval is extended an emergency IUD can be considered up to 15 days after taking the 21st pill in the last packet providing the preceding pills have been taken correctly

Progestogen-only pill Late or missed pill (>27 hours since last traditional POP or >36 hours since last desogestrel-only pill)

EC is indicated if a pill is late or missed and there has been UPSI or barrier failure before efficacy has been re-established (i.e. 48 hours after restarting). Timing of ovulation after missed pills cannot be accurately predicted. An emergency IUD is therefore only recommended up to 5 days after UPSI

Progestogen-only injectable

Late injection (>14 weeks since last injection of DMPA or >10 weeks since NET-EN)

UPSI during time that additional precautions required as indicated within CEU guidance

Intrauterine methods (Cu-IUD and LNG-IUS)

Removal without immediate replacement; partial or complete expulsion; threads missing and IUD/IUS location unknown

If UPSI has occurred in the 5 days prior to removal, perforation, partial or complete expulsion. Depending on the timing of UPSI and time since IUD known to be correctly placed, it may be appropriate to fit another IUD for EC

CEU, Clinical Effectiveness Unit; Cu-IUD, copper-bearing intrauterine device; DMPA, depot medroxyprogesterone acetate; EC, emergency contraception; LNG-IUS, levonorgestrel intrauterine system; NET-EN, norethisterone enantate; POP, progestogen-only pill; UPA, ulipristal acetate; UPSI, unprotected sexual intercourse

Reproduced from Faculty of Sexual and Reproductive Healthcare Clinical Guidance Emergency Contraception Clinical Effectiveness Unit August 2011 (updated January 2012) http://www.fsrh.org/pdfs/CEUguidanceEmergencyContraception11.pdf

http://www.fsrh.org/pdfs/CEUguidanceEmergencyContraception11.pdf




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Appendix 2 Norfolk Sexual Health Clinical Care Pathway Level 1

N.B. National Chlamydia Screening Programme for clients age 15 – 24 is available from THT 01603 226666. Additional

Chlamydia testing (outside NCSP) is via referral into GP/iCASH services. Also signpost to online chlamydia testing at www.areyougettingit.com

Emergency Hormone

Contraception

Client Request

Consultation and Assessment Offer chlamydia screening or testing if appropriate. See NB

Offer Pregnancy test

Client accept Copper coil.

Dispense Levonelle as

back- up.

Consult & Provide EHC under PGD

Onward Referral

GP/CASH

Refer future contraception

Inform: Require repeat pregnancy test

after 3/52 if appropriate

National Chlamydia Screening Programme*

(Clients age 15 -24)

Clients 15 -24

Pregnancy Testing

Client Request for screening/information

-ve result: No follow

up

For all consultations & treatments complete details on Pharm Outcomes or include within quarterly report via CSU portal

template

*Screening/Information offered

+ve result: Client attends with treatment

number.

Complete CTS1 form & promote full

STI screening & partner notification

Administer most appropriate

antibiotic under PGD

Client Request

Pregnancy Test Offered. Offer chlamydia

screening or testing if

appropriate. See N.B.

Inform: Require repeat pregnancy test after 3/52 if appropriate

+ve result: Onward referral

-ve pregnancy result

Refer re future contraception

GP/Maternity Services

Marie Stopes

*Through the National Chlamydia Screening Programme clients can also be tested for Gonorrhoea using the same testing kit.

-ve result Discuss EHC option & benefit of copper coil

http://www.areyougettingit.com/




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Onward referrals: Chlamydia Screening Programme: 01603 226666 iCASH clinics: http://www.icash.nhs.uk/our-

services/norfolk

Contraception: C Card www.areyougettingit.com Oak Street Norwich Tel: 0300 300 3030

Marie Stopes: 0845 300 80 90 www.mariesstopes.org.uk Vancouver House Kings Lynn Tel: 0300 300 3030

Matrix Project (for sex workers) 01603 883423 Breydon Clinic, Northgate Hospital, Great Yarmouth Tel: 0300 300 3030

Multi-Agency Safeguarding Hub (MASH) http://www.norfolk.gov.uk/mash 0344 800 8020

Norfolk Safeguarding Children Board http://www.norfolklscb.org/

Terence Higgins Trust, oak Street, Norwich. Tel: 01603 226666

Mancroft Advice Project (young people) [email protected] 01603 766994 Norwich 01493 854839 Gt Yarmouth

Drug & Alcohol: over 18’s 0300790 0227 www.norfolkrecoverypartnership.org Under 18’s [email protected] 01603 626123

NHS Choices & search for services:

http://www.nhs.uk/worthtalkingabout/Pages/sex-worth-talking-about.aspx

Rape Crisis: 0808 802 9999 The Harbour Centre: 0845 456 4810 www.theharbourcentre.co.uk

http://www.icash.nhs.uk/our-services/norfolk

http://www.icash.nhs.uk/our-services/norfolk

http://www.areyougettingit.com/

http://www.mariesstopes.org.uk/

http://www.norfolk.gov.uk/mash

http://www.norfolklscb.org/

mailto:[email protected]

http://www.norfolkrecoverypartnership.org/

mailto:[email protected]



http://www.theharbourcentre.co.uk/