Standard operating procedure

HRT Supply, Shortages & Substitution SOP

How [Organisation Name] responds when a prescribed hormone replacement therapy (HRT) preparation cannot be supplied, so that patients keep treatment, Serious Shortage Protocol supplies are captured and every other change stays a clinical decision

For Women's Health & Menopause ClinicRef BS-WOM-SOP-012See a sample (PDF) →
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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. Systems and information required
  • 6. Pharmacy arrangements and the substitution rule
  • 7. Supplies made under a Serious Shortage Protocol
  • 8. Responding to a supply failure (no SSP, or SSP declined or unsuitable)
  • 9. Choosing an alternative: equivalence and endometrial protection
  • 10. Unlicensed imports and unregulated sources
  • 11. Stockpiling and prescription limits
  • 12. Communicating with patients and safety netting
  • 13. Records
  • 14. Training and competence
  • 15. Monitoring and audit
  • 16. Related documents
  • 17. Review and version control
  • 18. Appendix A - Standard patient messages
  • 19. 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

  • Human Medicines Regulations 2012, in particular regulation 214 (Sale or supply of prescription only medicines), regulation 167 (Supply to fulfil special patient needs) and regulation 226A (Sale etc by a pharmacist in accordance with a serious shortage protocol), and any Serious Shortage Protocol in force under them.
  • Department of Health and Social Care (DHSC) Medicine Supply Notifications and the Medicines Supply Tool published on the Specialist Pharmacy Service website.
  • 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.
  • National Institute for Health and Care Excellence (NICE) guideline NG23, Menopause: identification and management (as last updated).
  • British Menopause Society (BMS) Tool for Clinicians, HRT preparations and equivalent alternatives (as last reviewed).
  • 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).
  • 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, the [Clinical Lead], the Registered Manager and administrative and patient-support staff, including self-employed and locum staff, and the dispensing pharmacy [Insert Pharmacy Name] under its service level agreement

Glossary

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

Amenorrhoea
No periods or bleeding.
Body mass index (BMI)
A measure of weight relative to height.
British Menopause Society (BMS)
The UK professional society for menopause care, publisher of Tools for Clinicians.
Care Quality Commission (CQC)
The independent regulator of health and social care in England.
Data Protection Act 2018
The UK law, alongside the UK GDPR, on handling personal information.
Department of Health and Social Care (DHSC)
The government department that manages national medicine supply problems.
Duty of candour
The legal duty (Regulation 20) to be open with patients when something goes wrong.
Endometrium
The womb lining, which can thicken abnormally if oestrogen is given without enough progestogen.
Equality Act 2010
The law protecting people from discrimination.
General Medical Council (GMC)
The UK regulator of doctors.
General Pharmaceutical Council
The regulator of pharmacists and pharmacies 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 registered providers must meet.
Hormone replacement therapy (HRT)
Medicines replacing hormones, mainly oestrogen, that fall at menopause.
Human Medicines Regulations 2012
The main UK law on licensing, prescribing and supplying medicines.
Levonorgestrel intrauterine system (LNG-IUS)
A device in the womb releasing progestogen; only 52 mg devices protect the endometrium in HRT.
Medicine Supply Notification (MSN)
A DHSC notice explaining a shortage and what to do.
Medicines and Healthcare products Regulatory Agency (MHRA)
The UK regulator of medicines and devices, which runs the Yellow Card scheme.
National Institute for Health and Care Excellence (NICE)
Publisher of national clinical guidelines, including NG23 on menopause.
Nursing and Midwifery Council
The UK regulator of nurses and midwives.
Off-label
Use of a licensed medicine outside the terms of its licence.
Oestradiol
The main oestrogen used in HRT, as tablets, patches, gel or spray.
Premature ovarian insufficiency (POI)
Loss of normal ovarian function before age 40.
Progestogen
A hormone given with oestrogen to protect the womb lining.
Records Management Code of Practice (2023)
National guidance on managing and retaining health and care records.
Sequential and continuous combined HRT
Sequential: progestogen for part of each month, usually with a monthly bleed. Continuous combined: both hormones daily, intended to give no bleeds.
Serious Shortage Protocol (SSP)
A government protocol letting a pharmacist supply a set alternative during a serious shortage without contacting the prescriber, if the patient agrees.
Service level agreement (SLA)
The written contract setting out what the pharmacy does for the service.
Single assessment framework
The CQC's current assessment method, built on quality statements and five key questions.
Specialist Pharmacy Service (SPS)
A national medicines advice service hosting the Medicines Supply Tool.
Standard Operating Procedure (SOP)
A written step-by-step instruction for doing a task consistently and safely.
Summary of Product Characteristics (SmPC)
The approved document describing how a medicine should be used.
Transdermal
Absorbed through the skin, for example by patch, gel or spray.
UK General Data Protection Regulation (UK GDPR)
The UK's main data protection law.
Unlicensed medicine
A medicine without a UK marketing authorisation.
Venous thromboembolism (VTE)
A blood clot in a vein, such as a deep vein thrombosis or pulmonary embolism.
Yellow Card scheme
The MHRA system for reporting side effects and suspected fake medicines.

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