Risk assessment

Compounded & Bioidentical Hormone Request Risk Assessment

A scored assessment of the risks arising when patients request, or arrive already taking, compounded bioidentical hormone preparations, hormone implants or saliva and serum hormone testing

For Women's Health & Menopause ClinicRef BS-WOM-RA-003See a sample (PDF) →
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  • Editable Microsoft Word (.docx)
  • Mapped to the CQC standards
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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 - Regulation 9 (Person-centred care), 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) and Regulation 20 (Duty of candour).
  • Human Medicines Regulations 2012 - regulation 167 (Supply to fulfil special patient needs) and Part 14 (Advertising), including regulation 284 (advertisements to the public for prescription-only medicines).
  • Medicines and Healthcare products Regulatory Agency (MHRA) Guidance Note 14, The supply of unlicensed medicinal products ("specials").
  • Medicines and Healthcare products Regulatory Agency Blue Guide, Advertising and promoting medicines in the UK, Appendix 6 (advertising guidance for providers of medicinal treatment services).
  • UK Code of Non-broadcast Advertising and Direct & Promotional Marketing (the CAP Code), section 12, including rule 12.12 (prescription-only medicines must not be advertised to the public).
  • Digital Markets, Competition and Consumers Act 2024, Part 4, Chapter 1 (unfair commercial practices).
  • National Institute for Health and Care Excellence (NICE) guideline NG23, Menopause: identification and management (as last updated).
  • British Menopause Society Consensus Statement, Bioidentical HRT (April 2026), and British Menopause Society Tool for Clinicians, Testosterone replacement in menopause (May 2026).
  • General Medical Council, Good practice in proposing, prescribing, providing and managing medicines and devices (2024), and the equivalent professional standards of the Nursing and Midwifery Council and the General Pharmaceutical Council.
  • UK General Data Protection Regulation, Data Protection Act 2018 and the 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 clinical, patient-support, administrative and marketing staff of [Organisation Name], including self-employed, sessional and locum clinicians, and prescribing clinicians registered with the General Medical Council, the Nursing and Midwifery Council or the General Pharmaceutical Council.

Glossary

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

Advertising Standards Authority (ASA)
The United Kingdom's independent regulator of advertising, which enforces the CAP Code.
Body-identical hormones
Licensed hormones with the same chemical structure as those the body makes, such as oestradiol and micronised progesterone, made to pharmaceutical standards.
British Menopause Society (BMS)
The United Kingdom specialist society for health professionals working in menopause care, which publishes consensus statements and Tools for Clinicians.
CAP Code
The UK Code of Non-broadcast Advertising and Direct & Promotional Marketing, written by the Committee of Advertising Practice (CAP) and enforced by the ASA.
Care Quality Commission (CQC)
The independent regulator of health and social care services in England.
Compounded bioidentical hormone replacement therapy (cBHRT)
Hormone preparations made up by specialist pharmacies to an individual prescription, which have not been through the regulator's licensing assessment for quality, safety and effectiveness.
Consequence
In this assessment, how severe the harm would be if the hazard occurred, scored 1 to 5.
Data Protection Act 2018
The United Kingdom law that sits alongside the UK GDPR and governs how personal information is handled.
Dehydroepiandrosterone (DHEA)
A hormone made by the adrenal glands, sometimes included in compounded preparations; not recommended by the BMS for routine use.
Digital Markets, Competition and Consumers Act 2024
The law that, from April 2025, prohibits misleading and unfair commercial practices towards consumers.
Duty of candour
The legal duty on providers to be open and honest with patients when a notifiable safety incident occurs (Regulation 20).
Endometrial hyperplasia
Thickening of the lining of the womb, which can develop into cancer; a risk when oestrogen is taken without adequate progestogen.
Endometrial protection
Use of a progestogen alongside oestrogen in a patient with a womb to prevent the womb lining from over-thickening.
Equality Act 2010
The law that protects people from discrimination on grounds including sex and gender reassignment.
Falsified medicine
A fake medicine that pretends to be genuine and may contain the wrong ingredients, the wrong dose or harmful substances.
General Medical Council (GMC)
The regulator of doctors in the United Kingdom.
General Pharmaceutical Council (GPhC)
The regulator of pharmacists, pharmacy technicians and registered pharmacies in Great Britain; its online register shows whether a pharmacy is legitimate.
General practitioner (GP)
A family doctor who holds the patient's main medical record.
Hormone replacement therapy (HRT)
Medicines that replace the hormones, mainly oestrogen, that fall at menopause.
Human Medicines Regulations 2012
The main United Kingdom law on the licensing, supply and advertising of medicines.
Levonorgestrel intrauterine system (LNG-IUS)
A small device placed in the womb that releases a progestogen; only 52 mg devices are used to protect the womb lining during HRT.
Likelihood
In this assessment, how probable it is that the harm will occur, scored 1 to 5.
Medicines and Healthcare products Regulatory Agency (MHRA)
The United Kingdom regulator of medicines and medical devices, which runs the Yellow Card scheme and publishes the Blue Guide.
MHRA Blue Guide
The MHRA's guidance on advertising and promoting medicines in the United Kingdom; Appendix 6 covers services that may lead to prescribing.
Micronised progesterone
A licensed body-identical form of progesterone, taken by mouth, used to protect the womb lining during HRT.
National Institute for Health and Care Excellence (NICE)
The body that publishes evidence-based guidance for health and care in England, including NG23 on menopause.
Nursing and Midwifery Council (NMC)
The regulator of nurses and midwives in the United Kingdom, and of nursing associates in England.
Pellet implant
A small hormone pellet inserted under the skin that releases hormone over several months and cannot easily be removed.
Premature ovarian insufficiency (POI)
Loss of normal ovarian function before the age of 40.
Prescription-only medicine
A medicine that can only be supplied against a prescription from an appropriate practitioner and must not be advertised to the public.
Regulated body-identical hormone replacement therapy (rBHRT)
Licensed body-identical HRT authorised by the MHRA; the BMS term for regulated products, as opposed to compounded ones.
Records Management Code of Practice (2023)
National guidance on how long health and care records should be kept and how they should be managed.
Regulation 284
The part of the Human Medicines Regulations 2012 that bans advertising to the public likely to lead to the use of a prescription-only medicine.
Residual risk
The risk that remains once controls and further actions are in place.
Safety netting
Clear advice to a patient about which symptoms to watch for, what to do and how quickly to seek help.
Saliva hormone testing
Measuring hormone levels in saliva, promoted by some clinics to tailor doses but not supported by evidence or national guidance.
Sex hormone-binding globulin (SHBG)
A blood protein that carries sex hormones; measured with testosterone to help interpret results.
Special (unlicensed medicine)
A medicine made or imported without a United Kingdom licence to meet an individual patient's special clinical need, used only where no licensed product is suitable (MHRA Guidance Note 14).
Standard operating procedure (SOP)
A written step-by-step instruction for carrying out a task consistently and safely.
Supraphysiological
Hormone levels higher than the body would normally produce.
Transvaginal ultrasound
An internal scan used to measure the thickness of the womb lining.
UK General Data Protection Regulation (UK GDPR)
The United Kingdom's main data protection law on how personal information is collected, used and shared.
Venous thromboembolism (VTE)
A blood clot in a vein, such as in the leg (deep vein thrombosis) or lung (pulmonary embolism).
Yellow Card scheme
The MHRA's system for reporting suspected side effects, and suspected fake or faulty medicines.

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