Risk assessment

Remote HRT Prescribing Risk Assessment

A scored assessment of the risks created by assessing and prescribing hormone replacement therapy without ever seeing the patient in person

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  • Editable Microsoft Word (.docx)
  • Mapped to the CQC standards
  • Optional 3-monthly updates

What's inside

This risk assessment is fully drafted and structured, ready to brand and complete for your service. It covers:

  • 1. Scope and purpose
  • 2. Assessment details
  • 3. Legal and regulatory framework
  • 4. Risk assessment methodology
  • 5. Hazards, controls and risk rating
  • 6. Action plan
  • 7. Roles and responsibilities
  • 8. Monitoring and review
  • 9. Related documents
  • 10. Sign-off
  • 11. 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

  • Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, in particular Regulation 9 (Person-centred care), Regulation 10 (Dignity and respect), Regulation 11 (Need for consent), Regulation 12 (Safe care and treatment), Regulation 13 (Safeguarding service users from abuse and improper treatment), Regulation 16 (Receiving and acting on complaints), Regulation 17 (Good governance), Regulation 18 (Staffing), Regulation 19 (Fit and proper persons employed) and Regulation 20 (Duty of candour).
  • 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.
  • The Human Medicines Regulations 2012, including the requirements for prescription only medicines and for prescriptions (regulations 214 and 217) and supply under a serious shortage protocol (regulation 226A).
  • General Medical Council (GMC), Good practice in proposing, prescribing, providing and managing medicines and devices (2021, as updated), including its guidance on remote prescribing and on sharing information with other healthcare professionals; and the professional standards of the Nursing and Midwifery Council and the General Pharmaceutical Council that apply to non-medical prescribers.
  • High level principles for good practice in remote consultations and prescribing, agreed by UK healthcare regulators including the Care Quality Commission, the General Medical Council, the Nursing and Midwifery Council and the General Pharmaceutical Council.
  • General Pharmaceutical Council, Guidance for registered pharmacies providing pharmacy services at a distance, including on the internet (February 2025).
  • National Institute for Health and Care Excellence (NICE) guideline NG23, Menopause: identification and management (as last updated), and NICE guideline NG12, Suspected cancer: recognition and referral.
  • British Menopause Society, Royal College of Obstetricians and Gynaecologists and partner organisations, Management of unscheduled bleeding on hormone replacement therapy (joint guideline, 2024).
  • UK General Data Protection Regulation, Data Protection Act 2018 and the Records Management Code of Practice (2023).
  • Mental Capacity Act 2005 and Equality Act 2010.

Who it applies to

All clinical, administrative and patient-support staff of [Organisation Name] involved in the remote assessment, prescribing, review and supply of hormone replacement therapy, including self-employed, locum and sessional clinicians

Glossary

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

Advanced electronic signature
A secure digital signature linked to the prescriber that shows an electronic prescription is genuine and has not been changed.
Amenorrhoea
The absence of periods.
Body mass index (BMI)
A measure of weight relative to height, used to identify whether a person is underweight, a healthy weight or overweight.
British Menopause Society (BMS)
The UK specialist society for healthcare professionals working in menopause care, which publishes clinical guidance.
Care Quality Commission (CQC)
The independent regulator of health and adult social care services in England.
College of Sexual and Reproductive Healthcare (CoSRH)
The professional body for sexual and reproductive healthcare, formerly the Faculty of Sexual and Reproductive Healthcare, which publishes contraception guidance.
Consequence (C)
How serious the harm would be if a hazard led to an incident, scored from 1 to 5.
Continuous combined HRT
HRT in which oestrogen and progestogen are taken every day without a planned monthly bleed.
Data Protection Act 2018
The UK law that sits alongside the UK GDPR and governs how personal information must be handled.
Data Protection Impact Assessment (DPIA)
A check carried out before using a system or process to identify and reduce risks to people's personal data.
Duty of candour
The legal duty to be open and honest with patients when something goes wrong with their care that causes, or could cause, significant harm.
Endometrial protection
Giving a progestogen alongside oestrogen to stop the womb lining thickening, which can lead to hyperplasia or cancer.
Equality Act 2010
The law that protects people from discrimination and requires reasonable adjustments for disabled people.
General Medical Council (GMC)
The body that registers and regulates doctors in the UK.
General Pharmaceutical Council (GPhC)
The body that regulates pharmacists, pharmacy technicians and registered pharmacies in Great Britain.
General practitioner (GP)
A family doctor who holds a patient's main medical record.
Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
The regulations setting out the fundamental standards that registered providers of health and social care must meet.
Healthcare Improvement Scotland, Healthcare Inspectorate Wales, Regulation and Quality Improvement Authority
The bodies that regulate independent healthcare services in Scotland, Wales and Northern Ireland respectively.
High level principles for good practice in remote consultations and prescribing
Ten shared principles agreed by UK healthcare regulators that all prescribers should follow when consulting or prescribing remotely.
Hormone replacement therapy (HRT)
Medicines containing oestrogen, usually with a progestogen, used to relieve menopause symptoms and protect long-term health.
Human Medicines Regulations 2012
The main UK law controlling how medicines are made, advertised, prescribed and supplied.
Information Commissioner's Office (ICO)
The UK regulator for data protection and information rights.
Levonorgestrel intrauterine system (LNG-IUS)
A small device placed in the womb that releases a progestogen; the 52 mg device can provide contraception and endometrial protection.
Likelihood (L)
How probable it is that a hazard will cause harm, scored from 1 to 5.
Liveness verification
An online check that the person presenting identification is real and present, not a photograph or recording.
Medicines and Healthcare products Regulatory Agency (MHRA)
The UK regulator of medicines and medical devices, which runs the Yellow Card scheme.
Mental Capacity Act 2005
The law setting out how to assess whether a person can make a decision and how to act in their best interests if they cannot.
National Institute for Health and Care Excellence (NICE)
The national body that publishes evidence-based guidance on health and care in England.
NICE NG12
NICE guideline Suspected cancer: recognition and referral, which sets out when to refer people with possible cancer symptoms.
NICE NG23
NICE guideline Menopause: identification and management, the main national guidance on menopause care and HRT.
Nominated Individual
The senior person responsible to the Care Quality Commission for supervising how the regulated activity is managed.
Nursing and Midwifery Council (NMC)
The body that registers and regulates nurses, midwives and nursing associates 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 the licensed duration.
Patient safety incident
Any unintended or unexpected event that did or could have led to harm to a patient receiving care.
Premature ovarian insufficiency
Loss of normal ovarian function before the age of 40.
Records Management Code of Practice (2023)
National guidance on how long health and care records should be kept and how they should be managed.
Red flag
A symptom or sign that may indicate serious illness and needs urgent assessment.
Regulated activity
A type of care or treatment that the law requires a provider to be registered with the Care Quality Commission to deliver.
Residual risk
The risk that remains after controls and further actions are in place.
Royal College of Obstetricians and Gynaecologists (RCOG)
The professional body for doctors specialising in women's reproductive health, pregnancy and childbirth.
Sequential HRT
HRT in which a progestogen is taken for part of each month, usually causing a monthly withdrawal bleed.
Serious Shortage Protocol (SSP)
A government protocol that allows a pharmacist to supply an alternative medicine 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
Removal of the womb that leaves the cervix in place, so a progestogen is still needed with oestrogen.
Suspected cancer pathway
An urgent referral route for people whose symptoms could indicate cancer.
Transdermal
Absorbed through the skin, for example HRT patches, gels or sprays.
Transient ischaemic attack (TIA)
A temporary interruption of blood supply to the brain causing stroke-like symptoms that resolve; a warning sign of stroke and a medical emergency.
Transvaginal ultrasound
An internal ultrasound scan used to measure the thickness of the womb lining.
UK General Data Protection Regulation (UK GDPR)
The UK's main data protection law governing how personal information is collected, used and kept secure.
Unscheduled bleeding
Vaginal bleeding on HRT that does not follow the expected bleeding pattern for the regimen.
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 suspected side effects of medicines.

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