Standard operating procedure

HRT Initiation SOP

The steps between deciding that hormone replacement therapy (HRT) is appropriate and the first prescription reaching the pharmacy, including endometrial protection, information sharing with the patient's GP and what applies where the patient declines

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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. Confirming the decision to initiate
  • 6. Pre-prescription checklist
  • 7. Choosing the regimen and endometrial protection
  • 8. Sharing information with the patient's GP
  • 9. Issuing the prescription
  • 10. Safety netting and patient information
  • 11. Records
  • 12. Training and competence
  • 13. Monitoring and audit
  • 14. Related documents
  • 15. Review and version control
  • 16. Appendix A - GP Notification Letter Template
  • 17. 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) Tools for Clinicians, including Progestogens and endometrial protection, and the 2024 joint guideline on the management of unscheduled bleeding on hormone replacement therapy.
  • General Medical Council (GMC), Good practice in proposing, prescribing, providing and managing medicines and devices, including the sections on remote prescribing and sharing information with other health professionals; and GMC, Confidentiality: good practice in handling patient information.
  • Nursing and Midwifery Council (NMC), The Code; General Pharmaceutical Council (GPhC), Standards for pharmacy professionals; Royal Pharmaceutical Society, A Competency Framework for all Prescribers.
  • 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.
  • Mental Capacity Act 2005 and Equality Act 2010.
  • UK General Data Protection Regulation, Data Protection Act 2018 and the 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 (registered with the GMC, NMC or GPhC), the [Clinical Lead], the [Registered Manager], and administrative and patient-support staff at [Organisation Name], 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.

111 urgent care service
The national telephone and online service for urgent medical advice that is not an emergency.
Body mass index (BMI)
A measure of weight relative to height.
British Menopause Society (BMS)
The UK specialist society for menopause care professionals, which publishes clinical guidance.
Care Quality Commission (CQC)
The independent regulator of health and social care in England.
College of Sexual and Reproductive Healthcare (CoSRH)
The UK professional body for sexual and reproductive healthcare.
Continuous combined regimen
HRT with oestrogen and progestogen taken every day, usually with no bleeding once settled.
Data Protection Act 2018
The UK law, alongside the UK GDPR, on handling personal information.
Endometrial ablation
A procedure that destroys the womb lining to reduce heavy periods; some lining can remain.
Endometriosis
A condition where tissue like the womb lining grows elsewhere, such as in the pelvis.
Enzyme-inducing medicine
A medicine that speeds up how the liver breaks down other medicines, making them less effective.
Equality Act 2010
The law protecting people from discrimination, including because of sex, gender reassignment, age or disability.
General Medical Council (GMC)
The UK regulator of doctors.
General Pharmaceutical Council (GPhC)
The regulator of pharmacists and pharmacies in Great Britain.
General practitioner (GP)
The family doctor with whom a patient is registered, who holds the main medical record.
Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
The regulations setting the fundamental standards registered providers must meet.
Hormone replacement therapy (HRT)
Medicines that replace hormones, mainly oestrogen, that fall at the menopause.
Human Medicines Regulations 2012
The main UK law on licensing, prescribing, supplying and advertising medicines.
Lamotrigine
A medicine for epilepsy and some mood disorders whose levels can fall with oestrogen.
Levonorgestrel intrauterine system (LNG-IUS)
A device in the womb releasing a progestogen; 52 mg devices protect the womb lining during HRT.
Medicines and Healthcare products Regulatory Agency (MHRA)
The UK regulator of medicines and medical devices.
Mental Capacity Act 2005
The law on deciding whether a person can make a particular decision, and acting if they cannot.
National Institute for Health and Care Excellence (NICE)
The body publishing national health and care guidance for England.
NICE guideline NG23
Menopause: identification and management, the main national menopause guideline.
Nominated Individual
The senior person responsible to the CQC for supervising how the service is provided.
Nursing and Midwifery Council (NMC)
The UK regulator of nurses, midwives and nursing associates.
Off-label
Use of a licensed medicine outside the terms of its licence, such as a different dose or duration.
Premature ovarian insufficiency (POI)
Loss of normal ovarian function before the age of 40.
Progestogen
A hormone similar to progesterone, used in HRT to protect the womb lining.
Records Management Code of Practice (2023)
National guidance on how long health and care records are kept and how they are managed.
Registered Manager
The person registered with the CQC as responsible for the day-to-day running of the service.
Sequential (cyclical) regimen
HRT with daily oestrogen and progestogen for part of each month, usually causing a monthly bleed.
Serious Shortage Protocol (SSP)
An arrangement letting a pharmacist supply an alternative during a serious shortage without contacting the prescriber.
Standard Operating Procedure (SOP)
A written, step-by-step instruction for carrying out a task consistently and safely.
Subtotal hysterectomy
An operation removing the womb but leaving the cervix.
Transdermal
Absorbed through the skin, as with patches, gels and sprays.
Transient ischaemic attack (TIA)
A brief interruption of blood supply to the brain causing stroke-like symptoms; a medical emergency.
UK General Data Protection Regulation (UK GDPR)
The UK's main data protection law.
Unopposed oestrogen
Oestrogen taken without a progestogen by someone with a womb, which can cause womb cancer.
Venous thromboembolism (VTE)
A blood clot in a vein, usually the leg, which can travel to the lungs.
Yellow Card scheme
The MHRA system for reporting suspected side effects of medicines.

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