Patient Group Direction PGD for ellaOne 30 mg (ulipristal ... · be made for IUD insertion as per current guidance. Ulipristal acetate is a lipophilic compound and may theoretically

Patient Group Direction PGD for ellaOne 30 mg (ulipristal acetate) Emergency contraception

Document Number: 3SXH-PGD-013

Clinical Sponsor: Contraceptive & Sexual Health Service

Created date: 04/01/2012 Version: 2.0 Status: Final Reviewed date: 05/01/2015 Next Review date: 05/01/2017

Approved by: Non-medical Prescribing Committee

Patient Group Direction for Ulipristal acetate tables 30mg (ellaOne) Number: 2SXH-PGD-013 Version: 2.0 Status Final Dated: 02/12/2013

Note: This document is electronically controlled. The master copy is maintained by the owner department. If this document is printed it becomes uncontrolled.

Printed on 29/07/16 at 17:06 Page 2 of 13

Table of Contents

1. Document Definition .................................................................................................... 3 1.1 Revision History ........................................................................................................................ 3 1.2 Review and Approval History .................................................................................................... 3 1.3 References ............................................................................................................................... 3 1.4 Glossary/Definitions .................................................................................................................. 4 1.5 Statutory Position ...................................................................................................................... 4 1.6 Comments ................................................................................................................................ 4 1.7 Equality Impact Statement ........................................................................................................ 4

2. Patient Group Direction (PGD) for ellaOne 30mg (ulipristal acetate) ...................... 4 3. Authorisation ............................................................................................................... 5 4. Services ........................................................................................................................ 5 5. Clinical Condition ........................................................................................................ 6 6. Drug Details ................................................................................................................. 7 7. Staff Characteristics .................................................................................................... 9 8. Referral Arrangements and Audit Trail......................................................................10 9. Patient Group Direction Peer Reviewed By..............................................................11 10. Individual Authorisation.............................................................................................12 11. Appendix 1..................................................................................................................13




1. Document Definition

1.1 Revision History

Version Status CR No. or Reason for change Date Author

1.0 Draft New document 31/12/2011 WCHS

1.0 Draft Incorporated initial review comments 04/01/2012 Ann Tyndall

1.0 Draft Final review 08/02/2012 Ann Tyndall

1.0 Issued After final review 28/02/2012

1.2 Review and Approval History

Version Reviewer/Approver R/A Scope Date

1.0 WCHS Pharmacy Lead R Review current document 03/01/2012

1.0 Review by MIU R Content, completeness and accuracy 04/01/2012 18/01/2012

1.0 Review by Dr Mona Selman-Abdullan, C&SH

R Content, completeness and accuracy 09/01/2012

1.0 Review by Julie Paterson, C&SH

R Content, completeness and acc 17/01/2012

1.0 NMP Committee A Ratification, current and compliant 28/02/2012

2.0 Review by SWISH R Content, Completeness and accuracy 16/12/2014

2.0 NMP Committee A Ratification, current and compliant 05/01/2015

1.3 References

Ref Number Document title Document Location

1 BNF September 2014 www.medicinescomplete.com

Intranet/hard copy

1 BNF for Children 2013-14 www.medicinescomplete.com

Intranet/hard copy

2 Summary of Product Characteristics Accessed

http://www.medicines.org.uk/emc/default.aspx


3 NICE Clinical knowledge summaries

http://cks.nice.org.uk/#azTab Internet

http://www.medicinescomplete.com/

http://www.medicinescomplete.com/




http://cks.nice.org.uk/#azTab




1.4 Glossary/Definitions

PGD – Patient Group Direction UPSI – Unprotected Sexual Intercourse IUD – Intrauterine device CASH –Contraceptive and Sexual Health OOH – Out of hours service MIU – Minor Injury Unit

1.5 Statutory Position

Nursing and Midwifery Council

1.6 Comments

Any comments on this document should, in the first instance, be addressed to the author.

1.7 Equality Impact Statement

Great Western Hospitals NHS Foundation Trust aims to design and implement services, policies and measures that meet the diverse needs of its service, population and workforce, ensuring that none are placed at a disadvantage over others. This document has been assessed against the Trust’s Equality Impact Assessment Tool. This document has been assessed as relevant/ not relevant to the duty.

2. Patient Group Direction (PGD) for ellaOne 30mg (ulipristal acetate)

YOU MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF

THIS PGD BEFORE YOU ATTEMPT TO WORK ACCORDING TO IT.




3. Authorisation – Signed copy held in Pharmacy Department

LEAD DOCTOR

Name: Dr Chinthapalli

Position: Trust Medical Prescribing Committee

Signature: Date:

LEAD NURSE/ALLIED HEALTH PROFESSIONAL

Name: Helen Winter

Position: Lead Chemotherapy Nurse / Matron

Signature: Date:

LEAD PHARMACIST

Name: Jane Coleborn

Position: Chief Pharmacist

Signature: Date:

ORGANISATIONAL AUTHORISATION BY:

Name: Hilary Walker

Position: Chief Nurse

Signature: Date:

4. Services

Great Western Hospital NHS Foundation Trust – Acute

Swindon Integrated Sexual Health (SWISH)

Great Western Hospital NHS Foundation Trust - Community

Minor Injury Units




5. Clinical Condition

INDICATION Patient at risk of unwanted pregnancy

INCLUSION CRITERIA

Ulipristal acetate emergency contraception to be used when a patient presents 72-120hrs after a single episode of UPSI/contraceptive failure and declines an IUD.

Levonelle (levonorgestrel) continues to be available up

to 72 hours. Minor Injury Unit Patients aged 16 and over Contraceptive and Sexual Health service Patients aged 16 and over If the patient is still worried about the risk of pregnancy and is not within the exclusion criteria, this PGD can be used.

NB: the BNF states that ellaOne is licensed in over 18s only. However, the information received from the manufacturer (29th July 2011) states that ‘Our regulatory department has confirmed that ellaOne can be used in women under 18 years old and use in this age group would not be outside of the product licence.’ After consideration of this and the trial data, it has been decided that this PGD can be used in those over 16 years of age.

EXCLUSION CRITERIA

No valid consent Pregnancy or possible pregnancy – advise patient of

need to test to exclude pregnancy. Unprotected intercourse more than 120 hours earlier in

the same menstrual cycle. Hypersensitivity to Ulipristal acetate or to any of the

excipients (these include lactose monohydrate) Severe asthma insufficiently controlled by oral

glucocorticoid Hepatic/ renal impairment Requests from third parties should be excluded. Patients under 16 years old. If she had Levonelle or ellaOne in this cycle. (Unless

there has been vomiting within 3 hours of taking ellaOne and therefore another ellaOne tablet is appropriate and can be given under this PGD).

See interactions – not to be given to women taking liver enzyme-inducing drugs and for 28 days after these drugs are stopped. It should also not be given to women taking drugs that increase gastric pH.(see interactions)




CAUTIONS/NEED FOR FURTHER ADVICE

If patient becomes pregnant after taking ellaOne then they need to seek medical advice

Regular attendees Any other problems Refer to a doctor or CASH clinic. Consideration should

be made for IUD insertion as per current guidance. Ulipristal acetate is a lipophilic compound and may

theoretically be excreted in breast milk. A risk to the breast-fed child cannot be excluded. After intake of ellaOne, breastfeeding is not recommended for 1 week. Breast milk should be expressed and discarded during this time. Caution in women with hereditary problems of galactose intolerance, the LAPP lactase deficiency or glucose-galactose malabsorption

FURTHER ADVICE/ACTION IF PATIENT DECLINES OR IS EXCLUDED

Document reason for exclusion or refusal and action taken in patient record

Refer to a doctor or CASH clinic. Consideration should be made for IUD insertion as per current guidance.

Patients presenting to MIU following rape or sexual assault should be encouraged to inform the Sexual Assault Referral Centre (SARC) – New Swindon Sanctuary www.newswindonsanctuary.co.uk – 0808 168 0024 (24hour helpline) or similar support

Patients under 16 should be referred to their GP or OOH for treatment

6. Drug Details

NAME FORM & STRENGTH OF MEDICINE

Ulipristal acetate 30mg tablet

ROUTE/METHOD Oral – stat dose taken on premises

DOSAGE One 30mg tablet taken between 72 and 120 hours after UPSI.

If vomiting occurs within 3 hours of taking the tablet, another tablet should be obtained and taken as soon as possible.

ellaOne must be taken as supervised consumption on the premises.

FREQUENCY Single dose per menstrual cycle unless vomited within 3 hours of taking the first tablet.

DURATION OF TREATMENT Single dose

MAXIMUM TREATMENT PERIOD

Only once per menstrual cycle

QUANTITY TO SUPPLY/ADMINISTER

1 x 30mg tablet as original pack

http://www.newswindonsanctuary.co.uk/




STORAGE Store below 25°c and keep blister in original packet to protect from light.

POTENTIAL SIDE EFFECTS Common

Abdominal pain / discomfort Irregular vaginal bleeding, pelvic pain, breast tenderness Headache, dizziness Nausea, vomiting Mood disorders Myalgia, back pain Fatigue

INTERACTIONS Refer to a Doctor if taking any of the following:

Rifampicin, phenytoin, Phenobarbital, carbamazepine, ritonavir, St John’s wort (or if taken in the last 2-3 weeks) – efficacy of ellaOne may be reduced

Proton pump inhibitors (omeprazole, lansoprazole, pantoprazole, rabeprazole and esomeprazole), antacids or H2-receptor antagonists (cimetidine, ranitidine, famotidine, nizatidine) – efficacy of ellaOne may be reduced

Ketoconazole, itraconazole, telithromycin, clarithromycin – may increase exposure to ulipristal acetate

Ulipristal acetate may interfere with the action of

progestogen-containing medicinal products:

Contraceptive action of combined hormonal contraceptives and progestogen-only contraception may be reduced

Concomitant use of ulipristal acetate and emergency contraception containing levonorgestrel is not recommended

See appendix 1 for starting contraception after taking ellaOne. NB starting contraception immediately after ulipristal acetate is off licence.

ADVICE TO PATIENT/CARER

If vomiting occurs within 3 hours, a second dose is required.

Contraceptive action of oral and parental progesterone may be reduced by ellaOne. After using ellaOne, the woman is to be advised to resume their oral hormonal contraception. It is recommended that a reliable barrier method is used for 14 days for the combined hormonal contraceptive, 9 days for the progestogen-only pill and 16 days for Qlaira. (see also appendix 2 for starting contraception)

Advise patient that emergency contraception is an occasional method and regular contraception should be discussed.




ADVICE TO PATIENT/CARER

Continued………

Emergency contraceptive methods are not abortifacient and this should be emphasised when counselling prior to use.

Advise patient that their next period may occur earlier or later than expected by a few days. If there is any doubt about whether menstruation has occurred, a pregnancy test should be performed ≥ 3 weeks after UPSI has occurred. Advise the patient that she could still become pregnant. If pregnancy (ectopic pregnancy should also be considered) has occurred, she will need to inform the GP or CASH clinic that she has taken ellaOne as this needs to be reported to the manufacturer of ellaOne for inclusion in their European register to monitor outcomes of exposure during pregnancy.

Give the patient information leaflet to take away.

If deemed appropriate, patients should be offered a Chlamydia screening. Up until their 25th birthday this is part of the Chlamydia Screening Programme and after this age patients should be referred to their GP, CASH clinic or GUM clinic for screening.

Patients should be provided with condoms if available

FOLLOW UP Advise the patient to attend their GP surgery or CASH services regarding future contraception.

If the next period is absent or abnormal, she should consider the possibility of pregnancy and be advised how to obtain a test.

Follow-up appointment for a pregnancy test

If pregnancy occurs after treatment with ellaOne, the possibility of an ectopic pregnancy should be considered.

7. Staff Characteristics

PROFESSIONAL QUALIFICATIONS

Registered health professional with a current registration

SPECIALIST COMPETENCIES OR QUALIFICATION

Must fit all the following criteria: have undertaken appropriate training for working under

patient group directions for the supply and administration of medicines

have received mandatory yearly update on anaphylaxis and resuscitation in adults and children and are competent in the recognition and management of anaphylaxis

have been assessed as competent to work with this PGD have undertaken training in the role, care and

administration of the medicine specified in this PGD have access to a current copy of the BNF.

CONTINUING EDUCATION & TRAINING

It is the responsibility of the individual to keep up to date with continued professional development




8. Referral Arrangements and Audit Trail

REFERRAL ARRANGEMENTS

Refer to a doctor or CASH clinic. Consideration should be made for IUD insertion as per current guidance.

RECORDS/AUDIT TRAIL Patient’s name, address, date of birth and consent given NHS number Date and time administered Contact details of GP Diagnosis Dose and form administered including batch number and

expiry date Advice given to patient Signature, designation and name of staff who

administered or supplied the medication. Details of any adverse drug reaction and actions taken

including documentation in the patient’s medical record Referral arrangements (including self care) Patient information leaflet offered Advice given to patient/parents/guardian (including side

effects) Any additional advice sought from a doctor or other

health professional Clinical details to be transferred to the patient’s GP

practice in a confidential approved manner if medicine given outside GP practice environment (if appropriate)

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




9. Patient Group Direction Peer Reviewed By

NAME POSITION DATE

Ann Tyndall Wiltshire Community Health Services Pharmacy Lead

04/01/2012

Jane Ingham Manager Minor Injury Units 04/01/2012

Sharron Hibberd ENP MIU Chippenham Hospital 18/01/2012

Dr Mona Selman-Abdullah Contraceptive & Sexual Health Service 09/01/2012

Julie Paterson

NOW RETIRED

Manager Contraceptive & Sexual Health Service

17/01/2012

Claire Watts Senior Sister SWISH 09/12/2014

Thomas Wareing

Rotational Pharmacist – Medicines Information

28/11/2014




10. 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 in accordance with this PGD.

Name of Professional Signature Authorising Manager Date




11. Appendix 1

Summary of additional contraceptive requirements when starting contraception

Method Circumstances (day of menstrual

cyclea/method of emergency

contraception)

Requirements for additional

contraception (condoms/

avoidance of sex)

Combined oral contraceptive pills (except Qlaira®)

Days 1–5

Day 6 onwards/Quick starting after POEC

Quick starting after UPA EC

Not required

7 days

14 days

Qlaira combined oral

contraceptive pillb

Day 1



Not required

9 days

16 days

Combined vaginal

ringb/transdermal patchb

Day 1



Not required

7 days

14 days

Progestogen-only pill (traditional/desogestrel)

Days 1–5



Not required

2 days

9 days

Progestogen-only implant

Days 1–5



Not required

7 days

14 days

Progestogen-only injectable

Days 1–5

Day 6 onwards/Quick starting after POECc

Quick starting after UPA ECc

Not required

7 days

14 days

Levonorgestrel-releasing intrauterine system

Days 1–7

Day 8 onwardsc

Not required

7 days

Copper-bearing intrauterine device

Any start dayc Not required

a: Day 1 defined as first day of menstrual bleeding; does not apply to withdrawal or unscheduled bleeding in women already established on hormonal contraception.

b: Recommendations according to Summary of Product Characteristics; currently no Faculty guidance on these methods.

c: See text for restrictions on quick starting these methods.

EC, emergency contraception; POEC, progestogen-only emergency contraception; UPA, ulipristal acetate.

Taken from Faculty of Sexual and Reproductive Healthcare Clinical Guidance – Quick Starting Contraception (Sept 2010) – available at http://www.fsrh.org/pdfs/CEUGuidanceQuickStartingContraception.pdf accessed 21st November 2011

NB: starting contraception immediately after ulipristal acetate is off licence.

http://www.fsrh.org/pdfs/CEUGuidanceQuickStartingContraception.pdf%20accessed%2021st%20November%202011

Documents

Patient Group Direction PGD for ellaOne 30 mg (ulipristal ... · be made for IUD insertion as per current guidance. Ulipristal acetate is a lipophilic compound and may theoretically