EMERGENCY CONTRACEPTION PROTOCOL

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INSERT THE NHFT LOGO OF YOUR COMMITTEE IN THE HEADER OF THE FIRST PAGE OF THE DOCUMENT (see Appendix 2 – PB001 – Policy for the Production and Management of all Policies within NHFT)

EMERGENCY CONTRACEPTION PROTOCOL Integrated Sexual Health Services

Policy Details NHFT document reference Version Date Ratified Ratified by Implementation Date Responsible Director Review Date Related Policies & other documents Freedom of Information category

MMPR001/11/11 21.01.2014 21/01/2014 Medicines Management Committee 01/02/2014 Medical Director 21/01/2016 MMP001 – Control of Medicines Policy Policy

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version MMPR001 Emergency Contraception (Jan14-Jan16).doc

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Implementation Date: 01/02/2014

TABLE OF CONTENTS 1.

DOCUMENT CONTROL SUMMARY ...................................................... 3

2.

INTRODUCTION. .................................................................................... 4

3.

PURPOSE ............................................................................................... 4

4.

DEFINITIONS .......................................................................................... 4

5.

DUTIES. ................................................................................................... 4 5.1. 5.2. 5.3. 5.4.

6.

The Medicines Management Committee......................................... 4 Medical Director .............................................................................. 4 Clinical Director's ............................................................................ 4 Contraceptive service staff .............................................................. 4

PROTOCOL PROCESS .......................................................................... 5 6.1 Client attends Clinic / Venue ............................................................. 5

EMERGENCY IUD........................................................................................... 6 ELLAONE (ULIPRISTAL ACETATE 30 MG) .................................................. 6 7.TRAINING..................................................................................................... 7 7.1 Mandatory Training ............................................................................ 7 7.2 Specific Training not covered by Mandatory Training ........................ 7 8.

MONITORING COMPLIANCE WITH THIS DOCUMENT ........................ 7

9.

REFERENCES AND BIBLIOGRAPHY: .................................................. 8

10. RELATED TRUST POLICY ..................................................................... 8

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version MMPR001 Emergency Contraception (Jan14-Jan16).doc

2 of 8

Implementation Date: 01/02/2014

1.

DOCUMENT CONTROL SUMMARY

Document Title

Emergency Contraception Protocol

Document Purpose (executive brief)

The purpose of this protocol is to describe the process for Contraceptive Services staff to provide emergency contraception within the clinics

Status: - New / Update/ Review Areas affected by the policy

Review Directorate of Sexual health staff and patients Contraceptive Services Protocol Group Contraceptive Services Protocol Group Medicines management Committee meeting 21.1.2014

Policy originators/authors Consultation and Communication with Stakeholders including public and patient group involvement Archiving Arrangements and register of documents Equality Analysis

The Trust policy lead is responsible for the archiving of this policy and will hold archived copies on a central register See MMP001 – Control of Medicines Policy

(including Mental Capacity Act 2007)

Training Needs Analysis

See section 7

Monitoring Compliance and See section 8 Effectiveness Meets national criteria with regard to NHSLA N/A NICE N/A NSF N/A Mental Health Act N/A CQC N/A Other Further comments to be considered at the time of ratification for this policy (i.e. national policy, commissioning requirements, legislation)

If this policy requires Trust Board ratification please provide specific details of requirements

2. INTRODUCTION. ISHS welcome all clients and we respect all personal beliefs and life choices. We aim to serve everyone equally and we work hard to eliminate any disadvantages faced in respect to gender, age, ethnicity, disability, sexuality or any health inequalities. Carers/interpreters/chaperones are welcome to attend the consultation at the request of the client. The trust is happy to provide this service, although prior notification may be required. ISHS will be provided to meet individual clients’ needs. 3. PURPOSE The aim of this protocol is to describe the process for Integrated Sexual Health Services (ISHS) staff to provide emergency hormonal contraception within the clinics and satellite venues. 4. DEFINITIONS NHFT - Northamptonshire Healthcare NHS Foundation Trust ISHS Integrated Sexual health Services MMC- Medicines Management Committee BP – Blood pressure LMP – Last Menstrual Period CVD – Cardiovascular disease BMI – Body Mass Index FPA- Family Planning Association INP- Independent Nurse Prescriber FSRH – Faculty of sexual & reproductive healthcare 5.

DUTIES. 5.1. The Medicines Management Committee Will review and approve the protocol 5.2. Medical Director Is responsible for the dissemination of this protocol as appropriate to their Clinical Director's and Clinical Tutor's 5.3. Clinical Director's Are responsible for the dissemination and implementation of the protocol in their service areas as appropriate 5.4. Contraceptive service staff Are responsible for following this protocol when providing contraceptive injections within the clinics

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version MMPR001 Emergency Contraception (Jan14-Jan16).doc

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Implementation Date: 01/02/2014

6.

PROTOCOL PROCESS 6.1 Client attends Clinic / Venue Discuss with the client the reason for needing Emergency Contraception (EC) Record history (new, review, U16) in client record ensuring and recording valid consent is obtained. Minimum History to be documented: • Risk of existing pregnancy – last normal period, normal cycle length, shortest cycle • Normal contraceptive method, reason for UPSI • Number and timing of all episodes of UPSI since last period • Previous EC use within this cycle • Medical History • Drug history including use of enzyme inducing drugs and warfarin • If IUD considered take history relevant to IUD (see IUD protocol) Discuss eligible options i.e. Levonelle, ellaOne, IUD. Adequate information of suitable methods should be given to the patient for her to make her choice of method. Levonelle and ellaOne can be issued under PGD. (PGD Numbers: PGD 100 & 164) If Levonelle or ellaOne cannot be given under PGD or the patient needs an IUD then refer the patient to a doctor or Independent Nurse Prescriber or an IUD fitting nurse. Complete Emergency Contraception-oral template if issuing oral EC. If patient is unsuitable for emergency contraception, then record why. Proceed using relevant protocol e.g. Unplanned pregnancy / relevant contraception.

6.2 Providing Information for clients: Your Guide to Emergency Contraception Go through the leaflet with the client making sure she understands the following • The mechanism of action • Efficacy • Side effects including nausea, possible sickness and menstrual disturbance • There is no evidence of teratogenicity with Levonelle on available data • There is limited data of the effect of ellaOne use in pregnancy therefore ellaOne should not be used if there has been previous UPSI or use of Levonelle in the same menstrual cycle The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version MMPR001 Emergency Contraception (Jan14-Jan16).doc

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Implementation Date: 01/02/2014

Advice on additional contraception if continuing hormonal contraception after administration of oral EC. Contraception for the rest of the menstrual cycle Future contraception If Levonelle is given outside product licence inform this to patient and document in patient records

• • • •

6.3 Future Contraception • Discuss and give leaflet on future contraception. Combined hormonal contraception & the Progestogen-only pill can be quick started after administration of EC. The woman should be informed of the theoretical risks, additional contraception and the importance of pregnancy testing. Document discussion appropriately. If future contraception is not relevant, record this. •

Offer condoms ensuring patient understands how to use them as per protocol



Advice on safer sex and follow up for STI screening

6.4 Repeat and return visits Timing of next appointment, as appropriate, is at the discretion of the doctor or nurse but is usually 3 weeks to exclude pregnancy and discuss contraception and sexual health screening. 6.5 Additional information





• •

EMERGENCY IUD Copper IUD can be inserted as emergency contraception for up to 5 days after 1st act of UPSI in a cycle or up to 5 days of earliest expected date of ovulation. Emergency IUD should ideally be fitted at the time of presentation. Where this is not possible, arrangements should be made for the patient to attend as soon as possible within the legal timeframe. Oral EC should be advised at the initial visit, in case, for any reason it is not possible to subsequently fit the IUD. The IUD can be removed at next normal menses, if not required for ongoing contraception ELLAONE (ULIPRISTAL ACETATE 30 MG) ellaOne is the oral emergency contraceptive licensed for use up to 120 hours of UPSI. ellaOne may be used in the following circumstances:  Patient requesting EC and has had UPSI in the previous 72-120 hours. It can be used under 72 hours, at the clinicians’ discretion, if the patient has had UPSI at a fertile time of the cycle.  No UPSI more than 120 hours ago  Declines or is not suitable for emergency IUD

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version MMPR001 Emergency Contraception (Jan14-Jan16).doc

6 of 8

Implementation Date: 01/02/2014

      

No contraindications to ellaOne If the patient is breast feeding she should not give the baby breast milk for 1 week ellaOne should not be used more than once in a cycle or if there has been another UPSI >120 hours ago if Levonelle has already been given in the same menstrual cycle In women taking liver enzyme inducers or within 28 days of stopping taking this medication In women currently taking drugs that increase gastric pH (antacids, Histamine H2 antagonists, proton pump inhibitors)

LEVONELLE  Levonelle can be given up to 120 hours after UPSI (unlicensed use) by prescribers and PGD (PGD 100) 7.TRAINING 7.1 Mandatory Training There is no mandatory Training associated with this protocol 7.2 Specific Training not covered by Mandatory Training Ad hoc training sessions based on an individual’s training needs as defined within their annual appraisal or job description. All nurses and doctors working under this protocol will hold a relevant family planning qualification

8. MONITORING COMPLIANCE WITH THIS DOCUMENT The table below outlines the Trusts’ monitoring arrangements for this document. The Trust reserves the right to commission additional work or change the monitoring arrangements to meet organisational needs. Aspect of compliance or effectiveness being monitored Duties Protocol process followed

Method of monitoring

Individual responsible for the monitoring

Monitoring frequency

Group or committee who receive the findings or report

To be addressed by the monitoring activities below. Contraceptive Audit of 50 Consultant for Every 2 Services patients Contraceptive years Protocol records from and Group; across the reproductive Operational service healthcare Group;

Group or committee or individual responsible for completing any actions Contraceptive Services Operational Group

MMC Where a lack of compliance is found, the identified group, committee or individual will identify required actions, allocate responsible leads, target completion dates and ensure an assurance report is represented showing how any gaps have been addressed.

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version MMPR001 Emergency Contraception (Jan14-Jan16).doc

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Implementation Date: 01/02/2014

9. REFERENCES AND BIBLIOGRAPHY: Emergency Contraception Guidance, FSRH, Jan 2012 Ulipristal Acetate (ellaOne®) October FSRH 2009 Drug Interactions and Hormonal Contraception, FSRH, January 2011 Quickstarting Contraception, FSRH, September 2010 Statement on Drug Interactions between Hormonal contraception and Ulipristal Products: ellaOne® November 2012 Quickstarting Contraception, FSRH, September 2010 The UK Medical Eligibility for Contraceptive Use, FSRH, May 2010 Ulipristal (ellaOne) FAQs: Faculty statement from the CEU, FSRH, December 2009 CEU Statement – Update on use of Ulipristal Acetate (ellaOne) in breastfeeding women, March 2013 NMC Standards for medicines management, August 2008 PGD101, Levonelle 1500, July 2010 PGD 164 ellaOne, September 2012 Levonelle SPC, medicines.org.uk ellaOne SPC, medicines.org.uk 10. RELATED TRUST POLICY MMP001 – Control of Medicines Policy

The current version of any policy, procedure, protocol or guideline is the version held on the NHFT internet. It is the responsibility of all staff to ensure that they are following the current version MMPR001 Emergency Contraception (Jan14-Jan16).doc

8 of 8

Implementation Date: 01/02/2014

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