Standard operating procedure

Contraindications, Cautions & Risk Stratification SOP

A consistent, recorded method for deciding whether hormone replacement therapy can be prescribed by this service, needs modification or specialist advice first, or means the patient must be referred

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What's inside

This standard operating procedure is fully drafted and structured, ready to brand and complete for your service. It covers:

  • 1. Purpose
  • 2. Scope
  • 3. Definitions and abbreviations
  • 4. Responsibilities
  • 5. Information required before stratification
  • 6. Mandatory screening questions
  • 7. Verifying history and measurements for remote prescribing
  • 8. Risk stratification
  • 9. Specialist advice and the oncology agreement pathway
  • 10. Medicines interaction check
  • 11. When to refer rather than prescribe
  • 12. Recording the risk category and rationale
  • 13. Reassessment
  • 14. Safety netting and patient information
  • 15. Records
  • 16. Training and competence
  • 17. Monitoring and audit
  • 18. Related documents
  • 19. Review and version control
  • 20. Appendix A - Risk Stratification Record
  • 21. Disclaimer

CQC fundamental standard

Regulation 9 (Person-centred care)
This document is written to evidence that standard. Health and Social Care Act 2008 (Regulated Activities) Regulations 2014.

Legislation & standards it maps to

  • National Institute for Health and Care Excellence (NICE) guideline NG23, Menopause: identification and management (as last updated).
  • NICE clinical guideline CG164, Familial breast cancer: classification, care and managing breast cancer and related risks in people with a family history of breast cancer (as last updated).
  • NICE guideline NG136, Hypertension in adults: diagnosis and management (as last updated).
  • British Menopause Society (BMS) and Women's Health Concern, 2020 recommendations on hormone replacement therapy in menopausal women, and BMS Tools for Clinicians (including Migraine and HRT).
  • British Gynaecological Cancer Society (BGCS) and British Menopause Society, Management of menopausal symptoms following treatment of gynaecological cancer (August 2024).
  • UK Cancer Genetics Group (UKCGG), Primary care guidance for hormone replacement therapy in women at increased risk of breast cancer (version 1.0, January 2025).
  • The Summary of Product Characteristics for each hormone replacement therapy product prescribed, and Medicines and Healthcare products Regulatory Agency (MHRA) safety information on HRT.
  • General Medical Council (GMC), Good practice in proposing, prescribing, providing and managing medicines and devices, including the sections on remote prescribing and on sharing information with other healthcare professionals.
  • High level principles for good practice in remote consultations and prescribing (joint statement of the UK healthcare regulators, 2019).
  • Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, in particular Regulation 9 (Person-centred care), Regulation 11 (Need for consent), Regulation 12 (Safe care and treatment), Regulation 17 (Good governance) and Regulation 20 (Duty of candour).
  • Equality Act 2010; UK General Data Protection Regulation and Data Protection Act 2018; Records Management Code of Practice (2023).
  • Care Quality Commission (CQC) assessment framework: the five key questions (safe, effective, caring, responsive and well-led) and the quality statements of the single assessment framework, and the sector-specific framework for primary care and community services when it replaces them.

Who it applies to

All prescribing clinicians (who may be registered with the General Medical Council, the Nursing and Midwifery Council or the General Pharmaceutical Council), the Clinical Lead, the Registered Manager, and administrative and patient-support staff who handle pre-consultation information, including self-employed and locum clinicians, whether care is delivered in person or remotely

Glossary

Plain-English explanations of the technical terms and legislation used in this document.

Angioedema
Swelling under the skin, often of the face, lips or throat; the hereditary form can be triggered by oestrogen.
Anticoagulant
A medicine that thins the blood to treat or prevent clots.
Antiphospholipid syndrome
An immune condition that makes blood more likely to clot.
Aromatase inhibitor
A tablet used after some breast cancers that lowers oestrogen levels.
Body mass index (BMI)
A measure of weight relative to height, used to judge whether weight is in a healthy range.
BRCA1 and BRCA2 (breast cancer genes 1 and 2)
Genes that, when altered, greatly increase the risk of breast and ovarian cancer.
British Gynaecological Cancer Society (BGCS)
The UK professional society for specialists in cancers of the female reproductive organs.
British Menopause Society (BMS)
The UK specialist society for healthcare professionals working in menopause care, which publishes clinical guidance.
British National Formulary (BNF)
The standard UK reference on medicines, doses and interactions.
Care Quality Commission (CQC)
The independent regulator of health and social care services in England.
Contraindication
A reason a medicine should not be used for a particular person.
Data Protection Act 2018
The UK law, alongside the UK General Data Protection Regulation, governing how personal information is handled.
Duty of candour
The legal duty to be open and honest with patients when something goes wrong that causes, or could cause, significant harm.
Endometrial hyperplasia
Thickening of the womb lining that can occur with unopposed oestrogen and can progress to cancer.
Enzyme-inducing medicine
A medicine that makes the liver break down other medicines faster, making them less effective.
Equality Act 2010
The law protecting people from discrimination because of characteristics such as sex, gender reassignment, age and disability.
General Medical Council (GMC)
The regulator of doctors in the UK.
General Pharmaceutical Council (GPhC)
The regulator of pharmacists and pharmacy technicians in Great Britain.
General practitioner (GP)
The patient's family doctor.
Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
The regulations setting the fundamental standards that registered care providers must meet.
Hormone replacement therapy (HRT)
Medicines that replace the hormones, mainly oestrogen, that fall during the menopause.
Hypertriglyceridaemia
A high level of a type of fat called triglyceride in the blood.
Levonorgestrel intrauterine system (LNG-IUS)
A hormonal coil placed in the womb; the 52 mg device can protect the womb lining during HRT.
Medicines and Healthcare products Regulatory Agency (MHRA)
The UK regulator of medicines and medical devices, which runs the Yellow Card scheme.
National Institute for Health and Care Excellence (NICE)
The body that publishes national clinical guidance in England.
NICE CG164
NICE guidance on familial breast cancer, including how to classify risk from family history and when to refer.
NICE NG136
NICE guidance on diagnosing and managing high blood pressure in adults.
NICE NG23
NICE guidance on identifying and managing the menopause.
Nursing and Midwifery Council (NMC)
The regulator of nurses and midwives in the UK.
Off-label
Using a licensed medicine in a way not covered by its licence, such as in a condition its SmPC lists as a contraindication.
Oophorectomy
Surgical removal of the ovaries.
Porphyria
A group of rare inherited disorders affecting how the body makes haem, which some medicines can trigger.
Premature ovarian insufficiency (POI)
Loss of normal ovarian function before the age of 40.
Progestogen
A hormone given with oestrogen to protect the womb lining; includes micronised progesterone and synthetic types.
Records Management Code of Practice (2023)
National guidance on how long health and care records are kept and how they are managed.
Standard Operating Procedure (SOP)
A written step-by-step instruction for carrying out a task consistently and safely.
Summary of Product Characteristics (SmPC)
The official document describing how a medicine should be used, including its contraindications and interactions.
Thrombophilia
A condition that increases the tendency of blood to clot.
Transdermal
Given through the skin, for example as a patch, gel or spray.
Transient ischaemic attack (TIA)
A temporary interruption of blood flow to the brain causing stroke-like symptoms that resolve; a warning sign of stroke.
UK Cancer Genetics Group (UKCGG)
A UK professional group for cancer genetics specialists that publishes guidance.
UK General Data Protection Regulation
The UK's main data protection law.
Venous thromboembolism (VTE)
A blood clot in a vein, such as in the leg or lung.
Yellow Card scheme
The MHRA system for reporting suspected side effects of medicines.

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  4. Add the optional updates subscription and we keep it current as guidance changes.

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