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Sexual health progestogen-only intra-uterine device (IUD)

This patient group direction (PGD) must only be used by registered healthcare professionals who have been named and authorised by their organisation to practice under it.

The most recent and in date final signed version of the PGD should be used.

To access the equality impact assessment for this policy, please see the overarching equality impact assessment.

Authorisations

This PGD template has been peer reviewed by the Reproductive Health PGDs short life working group in accordance with their Terms of Reference. It has been approved by the Faculty for Sexual and Reproductive Health (FSRH) in February 2023.

  • Dr Cindy Farmer, Vice President, Professional Learning and Development FSRH.
  • Michelle Jenkins, Advanced Nurse Practitioner, Clinical Standards Committee FSRH.
  • Elaine Scott, Senior Quality Matron British Pregnancy Advisory Service (BPAS).
  • Kalpesh Thakrar, Lead Pharmacist British Pregnancy Advisory Service (BPAS).
  • Tanya Lane, Designate Clinical Excellence Lead for Contraception and Sexual Health, Registered Nurse, MSI Reproductive Choices.
  • Kate Devonport, National Unplanned Pregnancy Association (NUPAS).
  • Chetna Parmar, Pharmacist Adviser Umbrella.
  • Heather Randle, Royal College of Nursing (RCN).
  • Carmel Lloyd, Royal College of Midwives (RCM).
  • Clare Livingstone, Royal College of Midwives (RCM).
  • Kirsty Armstrong, National Pharmacy Integration Lead, NHS England.
  • Dipti Patel, Local Authority Pharmacist.
  • Emma Anderson, Centre for Postgraduate Pharmacy Education (CPPE).
  • Alison Crompton, Community Pharmacist.
  • Lisa Knight, Community Health Services Pharmacist.
  • Portia Jackson, Lead Pharmacist iCaSH, Cambridgeshire Community Services NHS Trust.
  • Bola Sotubo, NHS North East London ICB Pharmacist.
  • Tracy Rogers, Director, Medicines Use and Safety, Specialist Pharmacy Service.
  • Sandra Wolper, Associate Director Specialist Pharmacy Service.
  • Jo Jenkins, Lead Pharmacist PGDs and Medicine Mechanisms Specialist Pharmacy Service.
  • Rosie Furner (Working Group Co-ordinator), Specialist Pharmacist Medicines Governance, Medicines Use and Safety, Specialist Pharmacy Service.

Organisational authorisation

  • Dr Diarmid Sinclair, Acting Medical Director.
  • Stephen Davies, Chief Pharmacist.
  • Steve Forsyth, Chief Nurse.
  • Anil Rajpal, Senior Pharmacist.
  • Tina Proctor, Nurse Consultant Senior representing of professional group using the PGD.

Contents

  1. Characteristics of staff
  2. Clinical condition or situation to which this patient group direction applies
  3. Description of treatment
  4. Key references
  5. Appendices

1 Characteristics of staff

1.1 Qualifications and professional registration

Current contract of employment within a Local Authority or NHS commissioned service or an NHS Trust or organisation. “Staff contracted by RDaSH for the provision of service commissioned from RDaSH”. Registered healthcare professional listed in the legislation as able to practice under patient group directions.

1.2 Initial training

The registered healthcare professional authorised to operate under this patient group direction (PGD) must have undertaken appropriate education and training and successfully completed the competencies to undertake clinical assessment of patients ensuring safe provision of the medicines listed in accordance with local policy.

Recommended requirement for training would be successful completion of a relevant contraception module or course accredited or endorsed by the Faculty of Sexual and Reproductive Healthcare (FSRH), Centre for Pharmacy Postgraduate Education (CPPE) or a university or as advised in the RCN training directory. Individuals working under this PGD should hold an in date FSRH letter of competence intrauterine techniques (LoC IUT) which has been achieved or recertified within the last 5 years.

Immediate postpartum intrauterine contraception (PPIUC) insertion training is not part of the FSRH LoC IUT. The insertion procedure for immediate PPIUC is different to that of standard IUC insertion and should only be performed by those who have been trained in this technique. Theoretical training information for PPIUC can be found in the FSRH member’s training hub and clinicians should follow or develop local pathways for practical training.

PGD users should have read thoroughly and be familiar with the FSRH IUC guidance (opens in new window).

Individual has undertaken appropriate training for working under PGDs for the supply and administration of medicines. Recommended training, e-learning for healthcare patient group direction e-learning programme (opens in new window).

Individuals working under this PGD will be required to administer local anaesthesia in line with local protocols and PGDs.

The healthcare professional has completed locally required training (including updates) in safeguarding children and vulnerable adults or level 2 safeguarding or the equivalent.

The healthcare professional must ensure that they have an up-to-date certificate for basic life support (BLS) and anaphylaxis as required by the employing trust or organisation.

1.3 Competency assessment

1.4 Ongoing training and competency

  • Individuals operating under this PGD are personally responsible for ensuring they remain up-to-date with the use of all medicines and guidance included in the PGD, if any training needs are identified these should be addressed and further training provided as required.
  • FSRH LoC IUT must be recertified every 5 years.
  • Organisational PGD and medication training as required by employing trust or organisation.

The decision to administer any medication rests with the individual registered health professional who must abide by the PGD and any associated organisational policies.

2 Clinical condition or situation to which this patient group direction applies (contraception)

2.1 Criteria for inclusion

  • Individual (age from menarche to 55 years) presenting for contraception.
  • Informed consent given.

2.2 Criteria for exclusion

  • Informed consent not given.
  • Individuals under 16 years of age and assessed as not competent using Fraser guidelines.
  • Individuals 16 years of age and over and assessed as lacking capacity to consent.
  • Known hypersensitivity to the active ingredient or to any constituent of the product, see summary of product characteristics.
  • Risk of pregnancy.
  • Any reported unprotected sexual intercourse (UPSI) within the last 3 weeks.
  • Over 48 hours and less than 4 weeks postpartum (note the LNG-IUD can be fitted immediately post-partum, post termination of pregnancy, ectopic pregnancy or miscarriage).
  • Postpartum sepsis.
  • Post-abortion sepsis.
  • Gestational trophoblastic disease with decreasing or, persistently elevated beta-human chorionic gonadotropin levels or malignancy.

Refer to the Faculty of Sexual and Reproductive Healthcare clinical guideline intrauterine contraception (opens in new window) and clinical guidance “switching” for specific guidance about starting and switching IUC.

Insertion of new device (no current IUC in situ):

  • any reported unprotected sexual intercourse (UPSI) since day 5 of a natural cycle, and within the last 3 weeks
  • if any UPSI is greater than 3 weeks ago where menstruation has not since occurred, negative pregnancy test required prior to insertion

Changing to a new device (current IUC in situ and in date):

  • any reported unprotected sexual intercourse (UPSI) within the last 7 days

Changing to a new device (current IUC in situ but out of date):

  • any reported unprotected sexual intercourse (UPSI) within the last 3 weeks
  • if UPSI is greater than 3 weeks ago, negative pregnancy test required prior to insertion

2.2.1 Cardiovascular disease

  • Development of ischaemic heart disease, transient ischaemic attack or stroke whilst using the LNG-IUD.
  • For individuals with pre-existing arrhythmia, Eisenmenger physiology, single ventricle (or Fontan) circulation, long QT syndrome or impaired ventricular function, a vasovagal reaction could pose a serious risk of a significant cardiac event and therefore IUC procedures should be undertaken in a hospital setting.

2.2.2 Cancers

  • Current or past history of breast cancer.
  • Malignant liver tumour (hepatocellular carcinoma).
  • Cervical cancer (awaiting treatment).
  • Endometrial cancer.
  • Cervical cancer (resulting in radical trachelectomy).

2.2.3 Gastro-intestinal conditions

  • Severe decompensated cirrhosis.
  • Benign liver tumour (hepatocellular adenoma).

2.2.4 Infections

  • Current or recurrent pelvic inflammatory disease (PID).
  • Known chlamydial infection either symptomatic or asymptomatic.
  • Known gonorrhoea infections either symptomatic or asymptomatic.
  • Current purulent cervicitis or vaginitis.
  • Known pelvic tuberculosis.
  • HIV infection with CD4 less than 200cells/mm3.

2.2.5 Anatomical abnormalities

  • Distorted uterine cavity, congenital or acquired abnormality distorting the uterine cavity, including fibroids, incompatible with LNG-IUD insertion.

2.2.6 Other conditions

  • Unexplained vaginal bleeding suspicious of a serious medical condition, present before commencing the method.
  • Organ transplant with complications.
  • Acute porphyria.
  • Previous endometrial ablation.
  • Previous uterine perforation.

2.3 Cautions including any relevant action to be taken

  • If the individual is less than 16 years of age an assessment based on Fraser guidelines must be made and documented.
  • If the individual is less than 13 years of age the healthcare professional should speak to local safeguarding lead and follow the local safeguarding policy.
  • Individuals taking anticoagulants or antiplatelets, refer to FSRH CEU statement management of women taking anticoagulants or antiplatelet medications who request intrauterine contraception or subdermal implants (opens in new window).
  • Liaison with an individual’s MDT or clinical specialist may be required with certain conditions (for example, inherited bleeding disorders, cardiac disease, taking anticoagulants, Ehlers-Danlos syndromes (EDS), Postural tachycardia syndrome (PoTS).
  • Individuals at risk of an adrenal crisis will usually need to increase their steroid dose prior to, and for 24 hours after, IUC insertion and should ideally have their IUC procedure scheduled for early morning.
  • If an individual with PoTS has a history of postural syncope, advice should be sought from their cardiologist, as it may be recommended that insertion should be undertaken in a hospital setting.
  • Individuals with cardiac arrhythmias (other than long QT) discuss with relevant clinician.
  • Discuss with appropriate medical or independent non-medical prescriber any medical condition or medication of which the healthcare professional is unsure or uncertain.

2.4 Action to be taken if the individual is excluded or declines treatment

  • Explain the reasons for exclusion to the individual and document in the consultation record.
  • Record reason for decline in the consultation record.
  • Where required refer the individual to a suitable health service provider if appropriate and, or provide them with information about further options.

3 Description of treatment

3.1 Name, strength and formulation of drug

3.2 Legal category

POM.

3.3 Black triangle

Jaydess Levonorgestrel 13.5mg intrauterine system is a black triangle product.

This information was accurate at the time of writing. See product SPCs at electronic medicines compendium (opens in new window) for indication of current black triangle status.

3.3 Route of administration

3.3.1 Intra-uterine

Insert using aseptic or no-touch technique as per FSRH guidance on intrauterine contraception (opens in new window), or immediate PPIUC technique.

3.4 Off label use

Best practice advice is given by the FSRH and is used for guidance in this PGD and may vary from the summary of product characteristics (SPC).

This PGD specifically includes inclusion criteria and dosage regimens which are outside the market authorisation for many of the available products but which are included within FSRH guidance:

  • when used for contraception only, any 52mg LNG-IUD maybe retained until contraception no longer required in individuals over 45 years of age at time of insertion
  • initial insertion after day 7 of the menstrual cycle if it is reasonably certain that the individual is not pregnant
  • postpartum insertion within 48 hours of birth or between 4 and 6 weeks
  • extended use of all 52mg LNG-IUDs to eight years for contraception (excluding Mirena which is within licence)

Medicines should be stored according to the conditions detailed in the storage section below. However, in the event of an inadvertent or unavoidable deviation of these conditions the local pharmacy or Medicines Management team must be consulted. Where medicines have been assessed by pharmacy and medicines management in accordance with national or specific product recommendations as appropriate for continued use this would constitute off-label administration under this PGD. The responsibility for the decision to release the affected medicines for use lies with pharmacy and medicines management.

Where a medicine is recommended off-label consider, as part of the consent process, informing the individual, parent or carer that the medicine is being offered in accordance with national guidance but that this is outside the product licence.

3.5 Dose and frequency of administration

  • One LNG-IUD to be inserted (after removal of previous LNG-IUD if required).
  • Insert on day 1 to 5 of the menstrual cycle with no need for additional protection.
  • The LNG-IUD can be inserted at any time after day 5 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 LNG-IUD.
  • For guidance on changing from one contraceptive method to another (opens in new window), and when to start after an abortion and postpartum (opens in new window), refer to the Faculty of Sexual and Reproductive Healthcare (FSRH) guidelines.
  • Insert within 48 hours of birth (Immediate postpartum intrauterine contraception (PPIUC)). The insertion procedure for immediate PPIUC is different to that of standard IUC insertion and should only be performed by those who have been trained in this technique.

Frequency of LNG-IUD insertion:

  • Levonorgestrel 13.5mg intrauterine delivery system (Jaydess), effective for up to 3 years.
  • Levonorgestrel 19.5mg intrauterine delivery system (Kyleena), effective for up to 5 years.
  • Levonorgestrel 52mg intrauterine delivery system (Levosert), effective for up to 8 years if individual is under the age of 45 years at time of insertion, or until the age of 55 if individual is over the age of 45 years at time of insertion.
  • Levonorgestrel 52mg intrauterine delivery system (Mirena), effective for up to 8 years, or until the age of 55 if individual is over the age of 45 years at time of insertion. This duration also applies to individuals who already have a device in situ.
  • Levonorgestrel 52mg intrauterine delivery system (Benilexa One-Handed), effective for up to 8 years if individual is under the age of 45 years of age at time of insertion or until the age of 55 if individual is over the age of 45 years at time of insertion.

3.6 Duration of treatment

For as long as individual requires contraception and has no contraindications to its use.

3.7 Quantity to be supplied

Single LNG-IUD is to be inserted per episode of care

3.8 Storage

Medicines must be stored securely according to national guidelines.

3.9 Drug interactions

All concomitant medications should be checked for interactions.

A detailed list of drug interactions is available in the individual product SPC, which is available from electronic medicines compendium (opens in new window), the British National Formulary (BNF) (opens in new window) and FSRH CEU Guidance: Drug Interactions with Hormonal Contraception (opens in new window).

Refer to a prescriber if any concern of a clinically significant drug interaction.

3.10 Identification and management of adverse reactions

A detailed list of adverse reactions is available in the SPC, which is available from the electronic medicines compendium (opens in new window) and the British National Formulary (BNF) (opens in new window).

The LNG-IUD is generally well tolerated. The following possible adverse effects are commonly reported with LNG-IUD (but may not reflect all reported adverse effects):

  • headache
  • disturbance of bleeding patterns
  • changes in mood
  • weight change
  • loss of libido
  • breast tenderness
  • acne

Insertion complications may include infection, expulsion, or perforation. Individuals should be advised on the signs that these may have occurred and the action to take if they become concerned.

3.11 Additional facilities and supplies

  • Access to working telephone.
  • Suitable waste disposal facilities.
  • Immediate access to in-date anaphylaxis kit (IM adrenaline 1:1000) and emergency drugs including atropine and oxygen according to local protocol.

3.12 Management of and reporting procedure for adverse reactions

  • Healthcare professionals and patients or carers are encouraged to report suspected adverse reactions to the Medicines and Healthcare products Regulatory Agency (MHRA) using the Yellow Card reporting scheme (opens in new window)
  • Record all adverse drug reactions (ADRs) in the patient’s medical record
  • Report via organisation incident policy
  • Note certain LNG-IUDs have additional Risk Minimisation materials (RMMs) to support safe use, organisations should ensure any RMMs supplied for the product(s) used within their organisation are considered. See product profile at electronic medicines compendium (opens in new window) for further information

3.13 Written information and further advice to be given to individual

  • Provide patient information leaflet (PIL) provided with the original pack.
  • Explain mode of action, side effects, risks and benefits of the medicine.
  • Advise about the risks of the medication including failure rates and serious side effects and the actions to be taken.
  • Advise about the possible symptoms of serious sequelae, for example, infection, ectopic pregnancy, expulsion and perforation and when to seek clinical advice.
  • Individuals should be advised that current use of progestogen-only contraceptives is associated with a small increased risk of breast cancer which reduces with time after stopping.
  • Teach individual how to check threads and to seek clinical advice if threads not felt.
  • Advise when replacement of the LNG-IUD will be due.
  • Offer condoms and advice on safer sex practices and possible need for screening for sexually transmitted infections (STIs)
  • Ensure the individual has contact details of local service and sexual health services.

3.14 Advice and follow-up treatment

  • The individual should be advised to seek medical advice in the event of an adverse reaction.
  • Individual to seek further advice if they have any concerns.

3.15 Records

  • The consent of the individual and:
    • if individual is under 13 years of age record action taken
    • if individual is under 16 years of age document capacity using Fraser guidelines, if not competent record action taken
    • if individual over 16 years of age and not competent, record action taken
  • Name of individual, address, date of birth.
  • GP contact details where appropriate.
  • Relevant past and present medical history, including medication and family history.
  • Any known allergies.
  • Details of insertion procedure to include:
    • name of registered health professional
    • date of insertion
    • name and brand of LNG-IUD inserted
    • batch number and expiry date of product in line with local procedure
    • bimanual examination and speculum findings
    • uterine sounding
    • use of no touch technique
    • name of assistant and their role
    • Analgesia or local anaesthetic used
    • problems encountered during insertion
  • Advice given, including advice given if excluded or declines treatment.
  • Individual has been advised on the date(s) for next appointment as required.
  • Details of any adverse drug reactions and actions taken.
  • Advice given about the medication including side effects, benefits, and when and what to do if any concerns.
  • Any referral arrangements made
  • Any administration outside the terms of the product marketing authorisation and additional advice given relating to this and advice given (for example, additional contraception for 7 days).
  • Recorded that administration is via patient group direction (PGD)

Records should be signed and dated (or a password controlled e-records) and securely kept for a defined period in line with local policy.

All records should be clear, legible and contemporaneous.
A record of all individuals receiving treatment under this PGD should also be kept for audit purposes in accordance with local policy.

4 Key references

Accessed November 2023, February 2024, and May 2024.

5 Appendices

5.1 Appendix A Example registered health professional authorisation sheet

Document control

PGD development group

  • Reference number: 2.3.
  • Date PGD template comes into effect: August 2023.
  • Review date: February 2026.
  • Expiry date: July 2026.

Change history

  • Version 1.0, August 2020: New template.
  • Version 1.1, November 2020: Additional of Jaydess Levonorgestrel 13.5mg intrauterine system as a black triangle product and Acute porphyria added as exclusion.
  • Version 1.2, March 2021: Levosert licence revised to usage period from 5 to 6 years for when indication is for contraception. Dose and frequency of administration section amended to read as Levonorgestrel 52mg intrauterine system (Levosert), effective for up to 6 years or until contraception no longer required if individual is over the age of 45 years of age at time of insertion.
  • Version 1.3, September 2022: Benilexa One-Handed 52mg levonorgestrel-releasing intrauterine system added to name, strength and formulation of drug and dose and frequency of administration sections. E-learning for healthcare patient group direction e-learning added to training section.
  • Version 2.0, April 2023: Updated template. Amendments to exclusion, cautions, dose and frequency of administration and adverse effects sections to align with updated FSRH IUC guidance. Minor formatting and wording changes to align with other SPS PGD reproductive health templates.
  • Version 2.1, September 2023: Added “or until contraception no longer required if individual is over the age of 45 years of age at time of insertion” to frequency of insertion for Levonorgestrel 52mg intrauterine delivery system (Benilexa One-Handed).
  • Version 2.2, April 2024: Additional indication of postpartum intrauterine contraception (PPIUC). Updated duration of treatment for Mirena to 8 years, removed from off-label use, and added FSRH statement to reference section. Added note re low risk of breast cancer. Updated SLWG.
  • Version 2.3, July 2024: Statement added to off-label use section regarding extended use of 8 years for all 52mg products in line with FSRH statement. Updated “dose and frequency of administration” section. Uterine perforation added as exclusion. Updated references. Updated SLWG members.

Page last reviewed: December 12, 2024
Next review due: December 12, 2025

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