NORTHAMPTONSHIRE INTEGRATED SEXUAL HEALTH SERVICES IUD/IUS PROTOCOL Policy Details NHFT document reference MMPr005 Version Final Date Ratified 19.01.16 Ratified by Medicines Management Committee Implementation Date January 2016 Responsible Director Medical Director Review Date January 2018 Related Policies & other documents MMP001 Control of Medicines Policy Freedom of Information category Protocol MMPr005 IUD-IUS Protocol (Jan16-Jan18) 1 of 11 Implementation Date: January 2016
TABLE OF CONTENTS 1. DOCUMENT CONTROL SUMMARY... 3 2. INTRODUCTION... 4 3. PURPOSE... 4 4. DEFINITIONS... 4 5. DUTIES... 4 5.1. The Medicines Management Committee... 4 5.2. Medical Director... 5 5.3. Clinical Director's... 5 5.4. NISH staff... 5 6. PROTOCOL PROCESS... 5 6.1. Initial assessment appointment... 5 6.1.1. Minimum history and documentation... 5 6.1.2. Examination / investigation:... 6 6.1.3. Minimum information for clients... 6 6.2. IUD / IUS fitting... 7 6.3. Follow up... 8 6.4. IUD / IUS removal... 9 6.5. Lost threads procedure... 9 7. TRAINING... 10 7.1. Mandatory Training... 10 7.2. Specific Training not covered by Mandatory Training... 10 8. MONITORING COMPLIANCE WITH THIS DOCUMENT... 11 9. REFERENCES AND BIBLIOGRAPHY... 11 10. RELATED TRUST POLICY... 11 2 of 11 Implementation Date:
1. DOCUMENT CONTROL SUMMARY Document Title Document Purpose (executive brief) Status: - New / Update/ Review Areas affected by the policy Policy originators/authors Consultation and Communication with Stakeholders including public and patient group involvement IUD/IUS Protocol The purpose of this protocol is to describe the process for Contraceptive trained staff to provide fitting and removal of IUD/IUS within the clinics. Review Health Service Gill Black - Senior Nurse Darren Cousins - Consultant Medicines Management Committee meeting Archiving Arrangements and register of documents Equality Analysis (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 CG30 NSF N/A Mental Health Act N/A CQC N/A Other N/A 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 The Risk Department is responsible for the archiving of this protocol and will hold archived copies on a central register. See MMP001 Control of Medicines Policy MMPr005 IUD-IUS Protocol (Jan16-Jan18) 3 of 11 Implementation Date: January 2016
2. INTRODUCTION The Health Service (NISH) welcomes 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. Intrauterine methods include the copper bearing intrauterine device (IUD) and the Levonorgestrel-releasing intrauterine system (IUS). The IUD and the IUS provide long term reversible contraception. The IUS is also licensed for treatment of idiopathic menorrhagia and for protection from endometrial hyperplasia during oestrogen replacement therapy. 3. PURPOSE The aim of this protocol is to describe the process for NISH staff to provide IUD/IUS within the statutory contraceptive clinics. 4. DEFINITIONS MMC - Medicines Management Committee BP - Blood pressure LMP - Last Menstrual Period IUD - Copper bearing Intrauterine Device IUS - Intrauterine System STI - Sexually Transmitted Infection EPR - Electronic Patient Record SLE - Systemic Lupus Erythematosus PID - Pelvic Inflammatory Disease GUM - Genito-urinary medicine FPA - Family Planning Association BLS - Basic Life Support FSRH - Faculty of Sexual and Reproductive Healthcare USS - Ultrasound scan BMI - Body mass index PMH - Personal Medical History GP - General Practitioner NHFT - Northamptonshire Healthcare NHS Foundation Trust 5. DUTIES 5.1. The Medicines Management Committee Will review and approve the protocol. 4 of 11 Implementation Date:
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. NISH staff Are responsible for following this protocol when fitting and removing IUD/IUS within the clinics 6. PROTOCOL PROCESS 6.1. Initial assessment appointment All patients requesting an intrauterine method must be offered an initial assessment appointment with the nurse either in person or on telephone. The purpose of this appointment is to Ensure the chosen method is an appropriate choice for the client Identify medical conditions that may affect the insertion Exclude any coincidental problems that require further assessment first (e.g. abnormal bleeding, pelvic pain, fibroids) Ensure that any client with an abnormality is appropriately assessed by a doctor prior to booking the insertion appointment Offer appropriate STI screening and testing Counsel the client about the method Arrange interim contraception Advise clients of the procedure to organise the insertion appointment If IUS is requested for non contraceptive reasons, advise patient to obtain referral letter from their GP. The letter needs to be sent by the GP to the consultant in advance of the fitting. to obtain a prescription for IUS from their GP and to bring the device to the fitting appointment. 6.1.1. Minimum history and documentation Complete appropriate History template and the IUD / IUS counselling template on Lilie EPR. A clinical history (including sexual history) should be taken as part of the routine assessment for intrauterine contraception to assess suitability for use of the method and identify those at higher risk of STIs. Age LMP PMH: relevant medical history (including epilepsy and for IUS, current liver disease, severe arterial disease, SLE, breast cancer) 5 of 11 Implementation Date:
Gynaecological history (including menstrual pattern, history of abnormal vaginal bleeding, treatment to cervix, trophoblastic disease or known uterine anomalies) Obstetric history (parity, history of ectopic pregnancy etc.) Sexual History and STI risk assessment (current or recurrent PID / STI) Any known allergies 6.1.2. Examination / investigation: BP Tests for STI: In asymptomatic patients offer Chlamydia and Gonorrhoea screening If age<25 years, new partner, more than 1 partner in last 12 months, must be screened for Chlamydia and Gonorrhoea Obtain valid consent for screening by self taken vulvovaginal swab. Complete the relevant template on Lilie EPR. If client has any symptoms then she must be referred to GUM. If client is at low risk of STI she may opt out of screening. This must be documented in her records. 6.1.3. Minimum information for clients Efficacy including risk of ectopic in event of failure Mode of action Insertion procedure, availability of local anaesthetic Safety: risks of infection, expulsion, perforation Side effects: Expected changes to bleeding patterns Progestogenic side effects with IUS Duration of use Safer sex Advice about interim contraception (condom use alone is not considered acceptable as interim contraception) FPA IUD / IUS leaflet Advice on when to book fitting appointment. It is ideal to arrange fitting with a normal period. If this is not possible then client should be advised to abstain from day 1 of period until device can be fitted. If client is having a device exchanged and the current device is still in date then the client should be advised to abstain for at least 7 days prior to exchange. If client is having a device exchanged and the current device is not in date then the client should be advised to abstain for at least 3 weeks prior to exchange for 6 of 11 Implementation Date:
an IUS or book an appointment with a normal period for IUD. If a patient has had an unsuccessful attempt at insertion of the device an appointment for insertion with the consultant must be arranged no sooner that 4 weeks since the initial attempt at fitting. Explain to client she will have to stay in clinic for 10-20 minutes after device is fitted Client may bring a friend or partner with her 6.2. IUD / IUS fitting The following are minimum clinic requirements for IUD / IUS fitting: 2 clinical members of staff present Approved clinic premises and a doctor available on the premises in case of an emergency Availability of emergency equipment including emergency drug box and oxygen Staff up to date with BLS & Anaphylaxis training Staff familiar with emergency procedure protocol. The clinician fitting the device should Review the indication and suitability of the method. Ensure there is no change in history since counselling. If there is a change then document this. Check LMP and rule out pregnancy. Check the results of any STI tests done. Obtain valid consent to carry out the procedure Inform the clients of the device they have had fitted and its licensed duration of use Appropriate advice after fitting Complete IUD / IUS insertion/exchange template on Lilie EPR IUD / IUS must be fitted by trained doctors / nurses only; who hold a certificate/letter of competence in Intra-uterine techniques from the FSRH. Trainee in clinic: If trainee doctor or nurse is to be present, obtain permission/consent from client first. Role of the trainee doctor/nurse should be clearly informed. Chaperones and assistants: An assistant must be present during all fittings, whose role is to assist the fitter if required and assist in the management of any adverse event occurring during the procedure. Women may in addition request a chaperone, who need not be a trained health professional and may be a friend or relative. All patients should be informed of the availability of local anaesthetic. 7 of 11 Implementation Date:
Prepare equipment required i.e. Dressing pack, Allis forceps, uterine sound, scissors, sterile paper and gloves, IUD / IUS and sharps bin, Hegars dilators sizes 1-6 must be readily available if required. Check pulse & BP prior to fitting and document this. Procedure to fit IUD/IUS should be commenced using universal precautions and infection control guidelines. A no touch technique should be used when sounding the uterine cavity and inserting intrauterine contraception. Follow Manufacturer s instructions for insertion. Check the batch number and expiry date of the device and of local anaesthetic if used. Check B/P and pulse after fitting and document this. Document the type of device inserted, batch number, date to be inserted by and the removal date. IUS: Give patient the IUS record card with the date of insertion and removal date recorded and document that you have done so. If the card is not given in error or if patient forgets to take the card with her then document what action has been taken to ensure that the patient receives her card. Give IUD / IUS aftercare information sheet and the manufacturer s product information leaflet to the patient. Complete the IUD / IUS insertion letter to the GP with client consent. This letter will be scanned to the patient s records before it is sent to the GP by the admin team. Advise follow up appointment for six weeks. If an emergency IUD has been inserted then Chlamydia screening may be done at time of fitting. Offer prophylactic antibiotics to cover Chlamydia Trachomatis. Failed insertion: If an attempt at insertion of the device has failed an appointment for insertion with the consultant must be arranged no sooner that 4 weeks since the initial attempt at fitting 6.3. Follow up Routine follow up appointment is usually at 6 weeks post fitting. Complete IUD / IUS interim visit template on Lilie EPR. Assess satisfaction with method. Review and record menstrual pattern. 8 of 11 Implementation Date:
Record any pelvic pain or unusual discharge Exclude infection and expulsion via history and examination Ask client if she can feel her threads and re-teach if necessary. Further routine follow up is not required but advise patient to return if she has any problems. Clients should be seen towards the end of the lifespan of their device to discuss ongoing contraception. It is the clients responsibility to contact the service regarding this. 6.4. IUD / IUS removal Document the reason for removal. Obtain valid consent IUD / IUS can be removed by a trained nurse / doctor. If client wishes to conceive, remove IUD / IUS at any time, in any clinic. Offer pre-conception advice. If not wishing to conceive, arrange to start alternative contraception and remove device after new method takes effect or ask client to abstain for 7 days before removal of device Postmenopausal: Removal advised 1 year after LMP if > 50 years and 2 years after LMP if < 50 years. IUS for idiopathic menorrhagia: If a woman does not need contraception and has an IUS in situ for treatment of idiopathic menorrhagia only, this will not need removal / changing after 5 years unless her periods have become a problem in which case she will need referring by her GP. 6.5. Lost threads procedure Need to exclude pregnancy, expulsion, malposition Perform pregnancy test if necessary If positive, consider possibility of ectopic pregnancy, arrange urgent USS via NGH/KGH. 9 of 11 Implementation Date:
If negative assess need for emergency contraception Client may be referred to a doctor if available in clinic. Arrange an ultrasound scan. If device has been inserted by our service this can be done by referring to USS department at NGH / KGH. If device has been inserted elsewhere advise client to have USS arranged by her GP. Arrange alternative contraception. If USS confirms device intrauterine, removal can be arranged in consultant clinic. Ensure no risk of pregnancy before booking for removal. NB GP referrals for lost threads should be advised to have USS via GP prior to attending clinic. 7. TRAINING 7.1. Mandatory Training Training required to fulfil this policy will be provided in accordance with the Trust s Training Needs Analysis. Management of training will be in accordance with the Trust s Statutory and Mandatory Training Policy Annual basic life support. Annual anaphylaxis training. 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 Letter of Competence(LoC) in Intrauterine Techniques from the FSRH. 10 of 11 Implementation Date:
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 To be addressed by the monitoring activities below. Audit of 50 patients records from across the service Consultant for Contraceptiv e and reproductive healthcare Every 2 years Group or committee who receive the findings or report Contraceptive Services Protocol Group; MMC Group or committee or individual responsible for completing any actions Contraceptive Services Operational Group; 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. 9. REFERENCES AND BIBLIOGRAPHY Intrauterine Contraception, November 2007, CEU Available at: http://www.fsrh.org/pdfs/ceuguidanceintrauterinecontraceptionapr15 (updatedoct15).pdf UKMEC, 2009, Available at http://www.fsrh.org/pdfs/ukmecsummarysheets2009.pdf Your guide to the IUD, FPA, June 2015 and Your Guide to the IUS FPA June 2015 10. RELATED TRUST POLICY MMP001-Control of Medicines Policy MMPr006 Protocol for training using placebo training devices 11 of 11 Implementation Date: