LONDON CONTRACEPTION AND SEXUAL HEALTH

PATIENT GROUP DIRECTION (PGD) TEMPLATE

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PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF LEVONORGESTREL 52mg PROGESTOGEN ONLY INTRAUTERINE SYSTEM (IUS) (MIRENA®) BY REGISTERED NURSES IN SEXUAL AND REPRODUCTIVE HEALTH SERVICES.

PATIENT GROUP DIRECTION (PGD)

FOR THE SUPPLY AND ADMINISTRATION OFLEVONORGESTREL 52mg PROGESTOGENONLY INTRAUTERINE SYSTEM (IUS)(MIRENA®)

BY REGISTERED NURSES IN SEXUAL AND REPRODUCTIVE HEALTH SERVICES

Version Number 1.2

Change History
Version and Date / Change details
Version 1.2 / New template
FSRH IUS (2015)
FSRH Contraception choices for women with cardiac disease (2014)

Each organisation using this PGD must ensure that it is formally authorised by a pharmacist, a medical lead and a governance lead on behalf of the authorising organisation to ensure that this document meets legal requirements for a PGD.

This Patient Group Direction (PGD) must only be used by registered nurseswho have been named and authorised by their organisation to practise under it. The most recent and in date final signed version of the PGD must be used.

TABLE OF CONTENTS
CONTENTS / PAGE NUMBER
PGD for the insertion of Levonorgestrel 52mgProgestogen only intrauterine system (IUS)(Mirena®) / 1 -14
Staff Characteristics / 10
Authorisation and Signatures / To be added by approving organisation
Individual authorisation to supply and insert the IUS / To be added by approving organisation
DRUG NAME /STRENGTH/FORM
Levonorgestrel 52mg Intrauterine System (Mirena®)
CLINICAL CONDITION TO WHICH THIS DIRECTION APPLIES /
  • Contraception

INCLUSION CRITERIA /
  • Any individual (age from menarche) presenting for contraception

EXCLUSION CRITERIA / Personal Characteristics & Reproductive History
  • Known or suspected pregnancy
  • Individuals under 16 years of age and assessed as not competent using Fraser guidelines
  • Individuals aged 16 years of age and over and assessed as not competent to consent
  • Known hypersensitivity to any constituent of the IUS
  • Less than 4 weeks postpartum
  • Puerperal sepsis
  • Immediate post septic abortion
Cardiovascular Disease
  • Development of ischaemic heart disease, transient ischaemic attack or stroke whilst using the IUS
  • Pre-existing cardiac conditions
Cancers
  • Current or past history of breast cancer
  • Cervical cancer (awaiting treatment)
  • Endometrial cancer
  • Benign liver tumour
  • Malignant liver tumour (hepatoma)
Gastro – Intestinal Conditions
  • Severe decompensated cirrhosis
Infections
  • Current pelvic inflammatory disease (PID)
  • Chlamydial infection either symptomatic or asymptomatic
  • Current purulent cervicitis or gonorrhoea
  • Known pelvic tuberculosis
See next page
EXCLUSION CRITERIA / Continued from previous page
Anatomical Abnormalities
  • Distorted uterine cavity; congenital or acquired abnormality distorting the uterine cavity including fibroids that are incompatible with IUS insertion
Other Conditions
  • Systemic Lupus Erythematosus (SLE) with positive or unknown anti–phospholipid antibodies
  • Gestational trophoblastic disease with persistently elevated
β-hCG levels or malignancy
  • Undiagnosed abnormal vaginal bleeding
  • Individual wishes to see a doctor

CAUTIONS
(INCLUDING ANY ACTION TO BE TAKEN) /
  • If under 13 years of age follow local safeguarding policy
  • Ensure emergency drugs and equipment, including adrenaline are available for the treatment of anaphylaxis and emergencies according to local policy
  • Discuss with appropriate doctor/independent non-medical prescriber any medical condition or medication which the nurse is unsure/uncertain of
  • Interacting medicines-see current BNF on interactions

ACTION IF EXCLUDED /
  • Refer to appropriate doctor/independent non-medical prescriber
  • Discuss/offer alternative method
  • Document all actions taken

ACTION IF PATIENT DECLINES TREATMENT /
  • Record the refusal in the clinical record
  • Refer to appropriate doctor/independent non-medical prescriber where required
  • Discuss/offer alternative method
  • Document all actions taken

DRUG DETAILS Levonorgestrel 52mg Intrauterine System (Mirena®)
NAME, FORM & STRENGTH OF MEDICINE / Levonorgestrel 52mg intrauterine system
ROUTE/METHOD / Intrauterine
LEGAL CATEGORY / Prescription Only Medicine (POM)
USE OUTSIDE THE TERMS OF THE MARKETING AUTHORISATION / Best practice advice given by the Faculty of Sexual and Reproductive Healthcare (FSRH) is used for guidance in this PGD and may vary from the Summary of Product Characteristics (SPC)
This PGD includes unlicensed use as follows:
  • Use for 7 years in individuals over 45 years of age at insertion
  • Postpartum insertion between 4-6 weeks
  • Insertion after day 7 of the menstrual cycle

QUANTITY /
  • One intrauterine system

DOSAGE/FREQUENCY /
  • Levonorgestrel 52mg system
  • Insert on day 1-7 of the menstrual cycle with no need for additional protection
  • The IUS can be inserted at any time after day 7 of the menstrual cycle if it is reasonably certain that the individual is not pregnant. Additional contraception is then required for 7 days after insertion of the IUS
  • For guidance on changing from one contraceptive method to another, and when to start after abortion and postpartum refer to FSRH guidelines

DURATION OF TREATMENT / • For as long as the individual requires the IUS and has no contraindications
MAXIMUM OR MINIMUM TREATMENT PERIOD /
  • Maximum-five years for each intrauterine system or 7 years if inserted when the individual is over the age of 45 years

SIDE EFFECTS
Any drug may produce unwanted or unexpected adverse reactions. Detection and recording of these is of vital importance. Patients should be actively encouraged to report any suspected adverse reaction, particularly to black triangle medicines. / Refer to current Summary of Product Characteristics (SPC) of relevant product and current British National Formulary (BNF) for full list and further information.
This list may not represent all reported side effects of this medicine.
The IUS is well tolerated. Some of the common side effects are;
  • Acne
  • Breast tenderness
  • Headache
  • Disturbance of bleeding patterns
  • Changes in mood
  • Weight change
  • Loss of libido
Insertion complications may include infection, expulsion or perforation.
In the event of untoward or unexpected adverse reactions:
  • If necessary seek appropriate emergency advice and assistance
  • Document in the individual’s clinical record and inform appropriate doctor/independent non-medical prescriber
  • Complete incident procedure if adverse reaction is severe (refer to local organisational policy)
  • Use yellow card system to report serious adverse drug reactions directly to the Medicines and Healthcare products Regulatory Agency (MHRA).Yellow cards are available in the back of the BNF or obtained via Freephone 0808 100 3352 or online at
The public can report adverse effects directly to the MHRA via the yellow card scheme and should be encouraged to do so.
ADVICE TO INDIVIDUAL /
  • Provide Manufacturer’s Patient Information Leaflet (PIL) and discuss
  • Explain mode of action, side effects, and benefits of the system
  • Advise about the risks of the system including failure rates and serious side effects and the actions to be taken
  • Advise about the possible symptoms of serious sequelae e.g. infection, ectopic pregnancy,expulsion and perforation and when to seek clinical advice.
  • Teach individual how to check threads and to seek clinical advice if not felt.
  • Provide a copy of the FPA leaflet on the IUS
  • Offer condoms and advise on safer sex practices.
  • Ensure individual knows what to do if her medical condition changes in the future
  • Ensure individual has the contact details of the service

FOLLOW UP /
  • Individual to return to clinic if she has any concerns
  • Review in 3 to 6 weeks after insertion.

RECORDS / The authorised registered nursemust ensure the following is documented in the clinical record:
  • Individual’s name, address and date of birth
  • GP contact details where appropriate
  • Attendance date
  • Reason for attendance
  • Relevant past and present medical and family history, including drug history
  • Any known allergy
  • Relevant examination findings
  • Inclusion or exclusion from PGD
  • A statement that supply andinsertion is by using a PGD
  • Advice given about the system, including side effects, benefits, and when and what to do if any concerns
  • Details of any adverse drug reactions and what action taken
  • Any referral arrangements
  • Any supply/administration outside the terms of the product marketing authorisation
  • The consent of the individual
  • If individual is under 13 years of age, record action taken
  • If individual is under 16 years of age document competency using Fraser guidelines
  • If individual is 16 years of age and over and not competent, record action taken
  • Record the name/brand, dose of the medication and quantity supplied and administered
  • Record batch number and expiry date according to local policy or national guidelines
  • Record follow up and/or signposting arrangements
  • Anyother relevant information that was provided to the individual
  • Name and signature (which may be an electronic signature) of the nursesupplying or administering the medicine

REFERENCES /
  • Manufacturer’s Summary of Product Characteristics (SPC) Mirena®
Bayer PLC. Last updated June 2015

Accessed on 03/09/2015
  • Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press accessed 03/09/2015
  • National Institute for Health and Care Excellence (2013). Patient Group Directions. Medicines Practice Guidelines 2

  • Faculty of Sexual and Reproductive Healthcare(2015) Intrauterine Contraception Clinical Effectiveness Unit June 2015
  • Faculty of Sexual and Reproductive Healthcare (2009) UK Medical Eligibility Criteria for Contraceptive Use;
  • Faculty of Sexual and Reproductive Healthcare(2011) Drug interactions with hormonal contraception
  • Faculty of Sexual and Reproductive Healthcare (2010) Antiepileptic drugs and contraception: CEU statement January
  • Faculty of Sexual and Reproductive Healthcare (2013) Update on newer antiepileptic and antiretroviral drugs and interactions with hormonal contraceptives (CEU statement)
See next page
REFERENCES / Continued from previous page
  • Faculty of Sexual and Reproductive Healthcare(2012) Management of unscheduled bleeding in women using hormonal contraception
  • Faculty of Sexual and Reproductive Healthcare (2010) Service Standard for Resuscitation in Sexual Health Services
  • Faculty of Sexual and Reproductive Healthcare (2014) Contraception choices for women with cardiac disease

  • Faculty of Sexual and Reproductive Healthcare(2015) Problematic bleeding with hormonal contraception

STAFF CHARACTERISTICS
The named nurse authorised to supply and/or administer medications under the PGD must meet the following criteria: / THE NURSE MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD BEFORE WORKING ACCORDING TO IT
Registration
The nurse must be registered with the Nursing and Midwifery Council (NMC)
Education/training, qualifications and competencies
The nurse must satisfy the following criteria:
  • Qualification in contraception/sexual health (university modules/FSRH) Note: an introduction to contraception/ sexual health is not sufficient
  • Qualification/training in the insertion technique of the IUSNote: The FSRH Letter of Competence (LoC) in Intrauterine Techniques (IUT) is the gold standard
  • Has had training in the use of PGDs
  • Has had training which enables the nurse to make a clinical assessment in order to supply and administer the medication according to this PGD.
  • Has undertaken the competency training appropriate to this PGD.
  • Is competent in the assessment of individuals using Fraser guidelines
  • Has undergone regular training and updating in safeguarding children and vulnerable adults
  • Has undergone regular updating in basic life support and anaphylaxis
Maintenance of competencies
  • The nurse must ensure she/he is aware of any changes to the recommendations for these medicines
  • It is the responsibility of the nurse to keep up to date with continuing professional development and take part in audit of clinical records on a regular basis
  • The nurse must be familiar with current FSRH clinical guidelines on insertion of Intrauterine contraception

An up to date list and signatures of registered practitioners who are authorised to practiseunder this PGD is kept in by

Practitioners not listed are not authorised to practise under this PGD.

PGD DEVELOPMENT GROUP

Date PGD template comes into effect: / 07/12/2015
Review date / 07/06/2018 or earlier in the light of significant changes in best practice
Expiry date: / 07/12/2018

This template was peer reviewed and ratified by London Contraception and Sexual Health PGD Working Group:

NAME/ROLE / POSITION / DATE
Kathy French
Chair - Working Group / Independent Nurse Advisor SRHC Project Lead / 03/12/2015
Angela Bussey
Advisor - Working Group / Principal Pharmacist Medicines Information Projects.
Guy’s and St Thomas’ NHS Foundation Trust. / 07/12/2015
Lead Doctor
Sarah Pillai / Lead Associate Specialist, Contraception and Sexual Health Service, Central London Community Healthcare NHS Trust / 03/12/2015
Lead Pharmacist
Sandra Wolper / Associate Director for Specialist Pharmacy Service Hounslow and Richmond NHSTrust / 03/12/2015
Lead Nurse
Sandra Bennett / Lead Nurse
Integrated Sexual Health
Barts Health NHS Trust / 03/12/2015

The PGD template is not legally valid until it has had the relevant organisational approval.

See next page

ORGANISATIONAL AUTHORISATIONS AND OTHER LEGAL REQUIREMENTS

This page may be deleted if replaced with a format agreed according to local PGD policy with relevant approvals and authorisation.

The PGD is not legally valid until it has had the relevant organisational authorisations.

To ensure compliance with the law, organisations must add local authorisation details i.e. clinical authorisations and the person signing on behalf of the authorising organisation.

You may either complete details below or delete and use a format agreed according to local PGD policy which complies with PGD legislation and NICE MPG2 PGD 2013.

.

Name / Job title and organisation / Signature / Date
Senior doctor
Senior pharmacist
Senior representative of professional group using the PGD e.g. Lead Contraception /Sexual Health Nurse
Lead Specialist Reviewer
e.g. microbiology* if relevant / N/A
Person signing on behalf of authorising body / e.g. Director of Public Health on behalf of a local authority or a clinical governance lead on behalf of an NHS Trust.

It is the responsibility of the authorising organisation to ensure that all legal and governance requirements for authorising the PGD are met.

It is the responsibility of the provider organisation to ensure that all legal and governance requirements for using the PGD are met.

To meet legal requirements, organisations must add an Individual Practitioner Authorisation sheet or List of Authorised Practitioners. This varies according to local policy and how the service is managed but this should be a signature list or an individual agreement.

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. Individual practitioners must declare that they have read and understood the Patient Group Direction and agree to supply/administer medicines listed only in accordance with the PGD.

ORGANISATIONS MAY ALSO ADD:

  • Local training and competency assessment documentation.
  • Other supporting local guidance or information.
  • Links to local PGD Policy and other supporting guidance.

Version No: 1.2 / Expiry date: 07/12/2018
Approving Organisation Name:
Approval Committee Name: / Reference Number :
Date of authorisation: / Page 1 of 14