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Patient Group Direction (PGD) for the Administration of:

INTRA-UTERINE PROGESTOGEN-ONLY SYSTEM (LEVONORGESTREL) (Mirena)

Prescription Only Medicine (POM)

YOU MUST BE AUTHORISED BY NAME UNDER THE CURRENT VERSION OF THIS PGD BEFORE YOU ATTEMPT TO WORK ACCORDING TO IT CLINICAL CONDITION OR SITUATION TO WHICH DIRECTION APPLIES Long-acting reversible contraception to healthy women aged 13 Indication years of age and over wishing to prevent pregnancy, following full method teaching, including mode of action, efficacy and side effects.

Inclusion Criteria for Initial Insertion

Exclusion Criteria

Approval Date: 9/12/09

Informed consent has been given in accordance with current PCT guidelines for the supply of the medicine. Insertion up to day 7 of menstrual cycle, OR At any time in the cycle if the patient has abstained since LMP, OR After 3 weeks abstinence following a negative pregnancy test, OR At any time in the cycle if using effective contraception (not condoms) Medical and family history has been taken and there is no reason for exclusion. Treatment of clients aged 16 years or younger must meet Fraser guidelines Informed consent has not been given for administration of the medicine. Fraser competence not confirmed. Any risk of pregnancy Requires emergency contraception Previous adverse reaction to Mirena or any of its components Allergy to Levonorgestrel or other Mirena components Uterine fibroids or uterine anatomical abnormalities distorting the uterine cavity. Less than 4 weeks post partum or post TOP Recent puerperal sepsis Post septic abortion Current venous thromboembolism (on anticoagulants) New diagnosis of ischaemic heart disease in a current user. New diagnosis of migraine with aura in a current user. Unexplained vaginal bleeding suspicious of serious condition Gestational trophoblastic neoplasia with abnormal hCG Current endometrial or cervical cancer Ovarian cancer Current pelvic inflammatory disease (PID) Known pelvic tuberculosis Current purulent cervicitis or untreated chlamydia or gonorrhoea High risk of exposure to STI

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Current liver disorders e.g. active viral hepatitis, liver tumours (benign or malignant), severe cirrhosis. Current or history of breast cancer. Past attack of bacterial endocarditis or of severe pelvic infection in a woman with an anatomical lesion of the heart. Women with a prosthetic heart valve On highly active antiretroviral therapy (HAART)

Cautions/Need for Further Advice

Increased risk of STIs - the risk of sexually transmitted infection should be assessed on an individual basis. If there is deemed to be a significant risk then swabs should be taken prior to IUS insertion. Previous episodes of PID and desire for future pregnancy should be relevant considerations. Any blood disorder that may affect clotting ability or response to infection e.g. leukaemia History of asthma or epilepsy - fitting procedure may precipitate attack. Possibility of anaemia or electrolyte imbalance - may make bradycardia/cervical shock more likely.

Action if Patient Declines or is Excluded

Arrange carefully timed repeat appointment if appropriate and provide adequate contraception until appointment If IUS is unsuitable arrange appropriate alternative Refer to doctor if necessary.

DESCRIPTION OF TREATMENT Name, Form & Strength of Mirena. Levonorgestrel Intrauterine System (IUS) Medicine

Route/Method

Dosage & Frequency

Intrauterine system consisting of T shaped frame carrying 52mg of Levonorgestrel. The initial release rate is 20 micrograms/24 hours. See guidelines for insertion The IUS is inserted into the uterine cavity using a sterile technique A nurse/HCA should be present to assist who is up-to-date with basic life support. The pulse rate should be taken pre and post insertion Assessment by the nurse/HCA and fitter should include general demeanor, colour,capilary refill, changes in breathing and presence of sweating/clamminess Headscarves should be removed and tight clothing loosenes The patient should wait directly outside the treatment room for 10 minutes after fitting before being allowed home A Mirena may be changed for a new one at any time in the cycle.The patient must abstain from sex for 7 days prior to fitting in case of unsuccessful insertion Single administration of 52mg Levonorgestrel every 5 years. Can be removed earlier at patient’s request

Duration of Treatment

Approval Date: 9/12/09

See above PGD No 71 - Mirena Coil Review Date: 9/12/11now extended to 31/03/2012 Page 2


Maximum or Minimum Treatment Period

Treatment can continue for as long as required for contraception, or until exclusion develops.

Quantity to Administer Managing and Reporting Adverse Events

Possible Side Effects

One Levonorgestrel 52mg coil Report any adverse drug reactions to the Lead Doctor and also follow the PCT incident reporting procedure. In addition use the Yellow Card System to report serious adverse drug reactions directly to the CSM and complete a critical incident form. Yellow Cards and guidance on their use are available at the back of the BNF or can be accessed via the CSM website http://www.mhra.gov.uk/ and follow safety information. It is the responsibility of the clinician identifying the suspected ADR to report it. In case of method failure pregnancy may be ectopic Irregular bleeding and spotting is common in the first 6 months after insertion. By 1 year after insertion amenorrhoea or oligomenorrhoea is usual. Other side effects include: peripheral or abdominal oedema, weight gain, depressive mood, nervousness, mood lability, headache, abdominal pain, pelvic pain, nausea, acne, back pain, dysmenorrhoea, vaginal discharge, cervicitis, breast tenderness, mastalgia. Risks during insertion of infection, expulsion, perforation and bradycardia This list is not exhaustive. Refer to current BNF and individual product SPC for complete list

Additional Facilities

Nurse or HCA to assist The following drugs should be immediately accessible: Atropine for intraveous use (0.6 mg/ml) Adrenaline for intramuscular use (1 in 1000 or 1mg/ml) for anaphylaxis Clear algorithms on display for management of emergencies eg bradycardia anaphylaxis Sphygmomanometer Oxygen Bag/valve/mask IUD/S insertion pack Instillagel Rectal diazepam if history of epilepsy Patients own asthma treatment if history of asthma Patient information leaflets

Special Considerations / Additional information Advice to Patient

Approval Date: 9/12/09

At initial counselling visit the following should be discussed: Effectiveness rate

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Duration of effectiveness Mode of action Risks of insertion and future possible side effects e.g. change in period pattern, post insertion bleeding/pain, future possible complications Assessment of STI risk and swab taking if necessary Give FPA patient information leaflet Give manufacturers leaflet following insertion When to seek medical attention after insertion If pregnancy does occur possible 1 in 20 risk of ectopic therefore to seek immediate medical attention Procedure for insertion and removal Timing of insertion contraceptive cover required for insertion and appointment date and time Advice against fitting if unwell, feverish etc. Abstain from sex for 7 days prior to procedure if IUS change Fraser guidelines should be applied as appropriate (see guidelines) At the time of fitting the following should be discussed: Written informed consent should be obtained with explanation of risks including incidence How and when to check for threads and to seek medical attention and use condoms if threads absent. Possibility of pain and bleeding after insertion. Increased expulsion rate, particularly within 1st 3 months of insertion. (Offer condoms). When to seek help (symptoms of perforation and infection). Supplement with patient information leaflet.

Follow up

Approval Date: 9/12/09

6 weeks post insertion to check for infection/expulsion/ perforation. Offer condoms to 6 week check (optional)

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REFERRAL ARRANGEMENTS AND AUDIT TRAIL Referral Arrangements Records/Audit Trail

See action if patient declines or is excluded In all cases manual records and computerised records including communication to the General Practitioner should include: Patient’s name, address, date of birth and consent given. If consent is either refused or withdrawn, this decision should also be documented. Contact details of GP Batch details, expiry date and manufacturer, including brand name Advice given to patient (including side effects, and risks) Date administered Signature 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 Record for each patient:LMP Pregnancy test if relevant Contraceptive cover if relevant Previous swabs taken and results Informed consent and risks Size and position of uterus Blood Pressure Baseline and post insertion pulse Sterile technique Sound insertion length Use of tenaculum Ease of insertion and problems encountered IUS type/batch number/expiry date Letter to GP (if authorised) Follow up arrangements Condom cover 6 weeks ~(optional) Use and amount of instillagel, batch number and expiry

STAFF CHARACTERISTICS

Approval Date: 9/12/09

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Qualifications Specialist Training or Qualifications

Registered nurse with recognised post graduate qualification in contraception and Sexual Health currently working within NHS Kirklees 1st level registered nurse 2 years experience in CASH prior to training for IUCD/IUS fitting Recognised post registration CASH qualification Advanced practioner accreditation(RCN/Margaret Pyke) for insertion of IUD/IUS and bimanual examination Practical training of nurse done by Doctor with Faculty recognised Training Qualification (LOC FIN DOC) Cytology Training ENB N84 or equivalent Has undertaken appropriate training and is competent to undertake the clinical assessment of patients according to the indications listed in this PGD. Has undertaken appropriate training and is competent for working under PGDs for the supply and administration of medicines Has undertaken training appropriate to this PGD – e.g. updates in Contraception and Sexual health at recommended intervals Has undertaken training and is competent in the recognition and treatment of anaphylaxis. Has undertaken training and is competent in resuscitation skills. Accepts personal responsibility for working within the PGD, understands the legal implications of doing so and works within the scope of the PGD. Keep updated via departmental meetings and updates

Continuing Training & Education

Approval Date: 9/12/09

Up to date with advanced life support training The practitioner should be aware of any change to the recommendations for the medicine listed. It is the responsibility of the individual to keep up-to-date with continued professional development and to work within the limitations of their scope of practice. Attends updates in administration of medicines through the use of patient group directives at recommended intervals including updates on anaphylaxis and resuscitation. Practitioner should have access to current BNF, Faculty of Contraception and Sexual Health Guidance (including current UK Medical Eligibility Criteria For Contraceptive Use), and updated DH advice where appropriate.

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References/Resources and Comments

o o o o o o o

Approval Date: 9/12/09

SPC from Electronic Medicines Compendium http://www.medicines.org.uk/ BNF No 57 http://www.bnf.org/bnf/ Faculty of Family Planning & Reproductive Healthcare UK Medical Eligibility Criteria for Contraceptive (UKMEC 2005/2006) Faculty of Sexual & Reproductive Healthcare Clinical Guidance, Intrauterine Contraception, November 2007 FFPRHC Clinical Guidance. The Use of Contraception Outside the Terms of Product Licence. July 2005 Royal College of Nursing ‘Fitting Intrauterine DevicesTraining Guidance for nurses’ NICE guidelines on Long Acting Reversible Contraception October 2005

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This PGD is an updated version of CaSH Services PGD No 9, ‘Levonorgestrel Intra Uterine System (Mirena)’, July 2007. It was updated for use within NHS Kirklees CaSH Services by the individuals listed below: Name

Position

Dawn Broadbent Shirley Tabner Lucianne Ricketts

CaSH Team Leader CaSH Clinical Lead Senior Medicines Management Adviser, Stratey and Operational Develeopment Specialist Technician, Community and Support Services

Lisa Meeks

Approval Date: 9/12/09

Date November 2009 November 2009 November 2009 November 2009

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Individual Authorisation for the Administration of Mirena Coil by appropriately qualified Nurses Working in CaSH Services Within NHS Kirklees. 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 I have read and understood the Patient Group Direction and agree to supply/administer this medicine ONLY in accordance with this PGD. In signing this declaration the registered healthcare professional is willing to be professionally accountable for this work as defined in their Code of Professional Conduct. Name of Professional Signature Authorising Manager and signature

Approval Date: 9/12/09

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Date


Staff who are no longer required to supply/administer under this PGD should be removed from it. This can be done by crossing through the relevant name, adding date and initials. Authorising Managers For PCT staff this will be the team leader, or relevant clinical manager. 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.

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

Organisation Kirklees Primary Care Trust Director of Patient Care Name : Sheila Dilks & Professions Signature:

Date:

Assistant Director of Name: Neill McDonald Medicines Management and Prescribing Signature:

Medical Director

Name: Dr Judith Hooper

Signature:

PEC Chair

Date:

Name: Dr David Anderson

Signature:

Approval Date: 9/12/09

Date:

Date:

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