Standard operating procedure

HRT Review, Titration & Annual Review SOP

How every patient on hormone replacement therapy (HRT) is reviewed at 3 months and then at least annually, how treatment is titrated and changed safely, and how repeat prescribing is controlled so that continuation stays an active, recorded decision

For Women's Health & Menopause ClinicRef BS-WOM-SOP-003See a sample (PDF) →
£29.99
One-off purchase · no VAT · instant download
  • Instant download after checkout
  • Editable Microsoft Word (.docx)
  • Mapped to the CQC standards
  • Optional 3-monthly updates

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. Equipment, systems and information required
  • 6. Review schedule
  • 7. Conducting every review
  • 8. The 3-month review
  • 9. The annual review
  • 10. Unscheduled bleeding identified at review
  • 11. Titration and regimen changes
  • 12. Repeat prescribing and overdue reviews
  • 13. Stopping HRT
  • 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. 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).
  • British Menopause Society (BMS), Management of unscheduled bleeding on hormone replacement therapy (HRT), joint guideline with the Royal College of Obstetricians and Gynaecologists, British Gynaecological Cancer Society, British Society of Gynaecological Endoscopy, College of Sexual and Reproductive Healthcare and Getting It Right First Time (2024, as updated); and BMS Tools for Clinicians, including Progestogens and endometrial protection.
  • General Medical Council (GMC), Good practice in proposing, prescribing, providing and managing medicines and devices, including the sections on remote prescribing and on medicines requiring additional safeguards; and the equivalent professional standards of the Nursing and Midwifery Council (NMC) and the General Pharmaceutical Council (GPhC).
  • GMC, Remote consultations guidance and decision flowchart.
  • 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).
  • Human Medicines Regulations 2012, including the requirements for prescription-only medicines and regulation 226A (Serious Shortage Protocols).
  • UK General Data Protection Regulation and Data Protection Act 2018; Records Management Code of Practice (2023).
  • Equality Act 2010.
  • 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, Nursing and Midwifery Council or General Pharmaceutical Council), the [Clinical Lead], the Registered Manager, and administrative and patient-support staff at [Organisation Name], including self-employed and locum clinicians, whether reviews are delivered in person or remotely

Glossary

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

Body mass index (BMI)
A measure of weight relative to height, used to judge whether weight is in a healthy range.
British Gynaecological Cancer Society
The UK professional society for specialists who treat gynaecological cancers.
British Menopause Society (BMS)
The UK specialist society for healthcare professionals working in menopause care, which publishes guidelines and Tools for Clinicians.
British Society of Gynaecological Endoscopy
The UK professional society for specialists in keyhole and camera-based gynaecological procedures, such as hysteroscopy.
Care Quality Commission (CQC)
The independent regulator of health and social care services in England.
College of Sexual and Reproductive Healthcare (CoSRH)
The UK professional body that sets standards and guidance for contraception and sexual health care.
Continuous combined HRT
HRT where oestrogen and progestogen are both taken every day, aiming for no bleeding.
Data Protection Act 2018
The UK law, alongside the UK GDPR, governing how personal information must be handled.
Duty of candour
The legal duty (Regulation 20) to be open and honest with a patient when something goes wrong with their care that causes, or could cause, significant harm.
Endometrium
The lining of the uterus (womb).
Equality Act 2010
The law that protects people from discrimination, including on grounds of sex and gender reassignment.
General Medical Council (GMC)
The body that registers and regulates doctors in the UK.
General Pharmaceutical Council (GPhC)
The body that registers and regulates pharmacists and pharmacy technicians in Great Britain.
Getting It Right First Time
A national programme that works to improve the quality and consistency of hospital care.
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 providers of regulated care must meet, enforced by the CQC.
Hormone replacement therapy (HRT)
Medicines that replace the hormones (mainly oestrogen) that fall during the menopause.
Human Medicines Regulations 2012
The main UK law on how medicines are licensed, prescribed, supplied and advertised.
Levonorgestrel intrauterine system (LNG-IUS)
A small device placed in the uterus that releases a progestogen; the 52 mg type protects the lining of the uterus during HRT.
Lynch syndrome and Cowden syndrome
Inherited conditions that increase the risk of certain cancers, including cancer of the endometrium.
Medicines and Healthcare products Regulatory Agency (MHRA)
The UK government agency that regulates medicines and medical devices and runs the Yellow Card scheme.
Micronised progesterone
A progestogen that is chemically identical to the body's own progesterone, used for endometrial protection.
mmHg
Millimetres of mercury, the unit used for blood pressure readings.
National Institute for Health and Care Excellence (NICE)
The body that publishes evidence-based national guidance on health and care in England.
NICE guideline NG12
Suspected cancer: recognition and referral, which sets out when to refer people with possible cancer symptoms, including postmenopausal bleeding.
NICE guideline NG23
Menopause: identification and management, the national guideline on diagnosing and treating the menopause.
NICE guideline NG136
Hypertension in adults: diagnosis and management, the national guideline on high blood pressure.
Nominated Individual
The senior person responsible to the CQC for supervising how a service is provided.
Nursing and Midwifery Council (NMC)
The body that registers and regulates nurses and midwives in the UK.
Off-label use
Using a licensed medicine or device in a way not covered by its licence, for example for longer than licensed.
Oestrogen and oestradiol
Oestrogen is the main female sex hormone; oestradiol is the form most often used in HRT.
Polycystic ovary syndrome (PCOS)
A common hormonal condition affecting the ovaries, which increases the risk of endometrial problems.
Premature ovarian insufficiency (POI)
When the ovaries stop working normally before the age of 40.
Progestogen
A hormone given with oestrogen in HRT to protect the lining of the uterus.
Records Management Code of Practice (2023)
National guidance on how health and care records should be managed and how long they should be kept.
Registered Manager
The person registered with the CQC as responsible for the day-to-day running of the service.
Royal College of Obstetricians and Gynaecologists
The UK professional body for doctors specialising in pregnancy, childbirth and women's reproductive health.
Sequential combined HRT
HRT where oestrogen is taken every day and a progestogen is added for part of each month, usually causing a monthly bleed.
Serious Shortage Protocol (SSP)
A national protocol that allows a pharmacist to supply a different quantity, strength or product during a serious medicine shortage without contacting the prescriber.
Standard Operating Procedure (SOP)
A written, step-by-step instruction describing how a task is carried out consistently and safely.
Transient ischaemic attack (TIA)
A 'mini-stroke': a brief interruption of blood supply to the brain causing temporary stroke-like symptoms. It needs emergency assessment.
Transvaginal ultrasound (TVUS)
An internal ultrasound scan using a probe placed in the vagina, used to measure the thickness of the lining of the uterus.
UK General Data Protection Regulation (UK GDPR)
The UK's main data protection law governing how personal information is collected and used.
Urgent suspected cancer pathway
The fast-track referral route for patients whose symptoms could be caused by cancer.
Venous thromboembolism (VTE)
A blood clot in a vein, such as a deep vein thrombosis in the leg or a pulmonary embolism in the lung.
Yellow Card scheme
The MHRA system for reporting suspected side effects of medicines and problems with medical devices.

How it works

  1. Buy securely with Stripe - instant, no VAT, no account needed.
  2. Download your editable Word file from the link we email you straight away.
  3. Complete the placeholders for your service, then have it approved before use.
  4. Add the optional updates subscription and we keep it current as guidance changes.

Related documents

PolicyWomen's Health Scope of Service Policy£44.99
PolicyMenopause Assessment & Diagnosis Policy£44.99
PolicyHRT Prescribing Policy£44.99
PolicyTestosterone Prescribing in Women Policy£44.99

Need the whole set?

Buy the full Women's Health & Menopause Clinic pack and save versus buying documents individually.

View the Women's Health & Menopause Clinic pack →