Risk assessment

Testosterone Off-Label Prescribing Risk Assessment

A scored assessment of the risks of prescribing testosterone, a Schedule 4 Part 2 controlled drug, off-label or unlicensed to menopausal patients, including remotely

For Women's Health & Menopause ClinicRef BS-WOM-RA-002See a sample (PDF) →
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  • Instant download after checkout
  • 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

  • Misuse of Drugs Act 1971 and Misuse of Drugs Regulations 2001 (testosterone: Schedule 4 Part 2).
  • Controlled Drugs (Supervision of Management and Use) Regulations 2013.
  • Human Medicines Regulations 2012, regulation 217 (particulars of prescriptions) and regulation 284 (advertising of prescription only medicines).
  • 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 17 (Good governance), Regulation 18 (Staffing) and Regulation 20 (Duty of candour).
  • Mental Capacity Act 2005; Equality Act 2010.
  • General Medical Council (GMC), Good practice in proposing, prescribing, providing and managing medicines and devices, including controlled drugs and other medicines where additional safeguards are needed, and prescribing unlicensed medicines; GMC, Remote consultations.
  • Nursing and Midwifery Council (NMC), The Code; General Pharmaceutical Council (GPhC), Standards for pharmacy professionals.
  • British Menopause Society (BMS), Tool for Clinicians: Testosterone replacement in menopause (May 2026).
  • National Institute for Health and Care Excellence (NICE) guideline NG23, Menopause: identification and management (as last updated).
  • Medicines and Healthcare products Regulatory Agency (MHRA), The Blue Guide: Advertising and Promotion of Medicines in the UK; MHRA Yellow Card scheme.
  • World Anti-Doping Agency (WADA) Prohibited List (current year).
  • 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, administrative, patient-support and marketing staff of [Organisation Name] involved in assessing, prescribing, monitoring, arranging supply of or promoting testosterone treatment, including self-employed and locum clinicians.

Glossary

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

Biopsychosocial assessment
Looking at physical, psychological and relationship causes, not only hormones.
British Menopause Society (BMS)
The United Kingdom professional society for menopause clinicians.
Care Quality Commission (CQC)
The independent regulator of health and social care in England.
Clitoral enlargement
Growth of the clitoris from excess androgen; may not reverse.
Compounded medicine
A medicine made to an individual recipe rather than a licensed, quality-tested product.
Controlled drug (CD)
A medicine controlled by law because it can be misused.
Controlled Drugs Accountable Officer (CDAO)
A senior person responsible for the safe management of controlled drugs in a designated body or area.
Controlled Drugs Local Intelligence Network
A local group that shares concerns about controlled drug use and misuse.
Controlled Drugs (Supervision of Management and Use) Regulations 2013
The law requiring designated bodies to appoint a CDAO.
Designated body
An organisation that must appoint a CDAO, such as an independent hospital.
Diversion
A medicine being used by someone other than the patient.
Duty of candour
The legal duty to be open with patients when a notifiable safety incident happens.
Equality Act 2010
The law protecting people from discrimination.
FP10PCD
The form for private prescriptions of Schedules 2 and 3 controlled drugs; not used for testosterone.
General Medical Council (GMC)
The regulator of doctors.
General Pharmaceutical Council (GPhC)
The regulator of pharmacists and pharmacies in Great Britain.
General practitioner (GP)
The patient's family doctor.
Genitourinary syndrome of the menopause (GSM)
Vaginal dryness, painful sex and urinary symptoms caused by low oestrogen.
Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
The regulations setting the fundamental standards for registered providers.
Hormone replacement therapy (HRT)
Treatment replacing oestrogen, with progestogen where needed.
Human Medicines Regulations 2012
The main United Kingdom law on supplying, prescribing and advertising medicines.
Hypoactive sexual desire disorder (HSDD)
Persistent low sexual desire causing distress, not explained by another cause.
Liquid chromatography-tandem mass spectrometry (LC-MS/MS)
A precise laboratory method preferred for measuring low testosterone levels.
Medicines and Healthcare products Regulatory Agency (MHRA)
The United Kingdom regulator of medicines, which runs the Yellow Card scheme and publishes the Blue Guide on advertising.
Mental Capacity Act 2005
The law on assessing whether a person can make a decision.
Misuse of Drugs Regulations 2001
The regulations placing controlled drugs in schedules with rules for each.
National Institute for Health and Care Excellence (NICE)
The body publishing national guidance in England; NG23 is its menopause guideline.
Nominated Individual
The senior person responsible to the CQC for supervising the regulated activity.
Nursing and Midwifery Council (NMC)
The regulator of nurses and midwives.
Off-label use
Prescribing a licensed medicine outside its licence, such as a male product at a female dose.
Prescription only medicine (POM)
A medicine supplied only on prescription.
Registered Manager
The person registered with the CQC to run the service day to day.
Schedule 4 Part 2
The controlled drug schedule for anabolic steroids, including testosterone.
Selective serotonin reuptake inhibitor (SSRI)
A common antidepressant that can reduce sexual desire.
Sex hormone-binding globulin (SHBG)
A blood protein that binds testosterone and reduces how much is active.
Supraphysiological
Higher than the body would naturally produce.
Therapeutic Use Exemption (TUE)
Anti-doping permission to use a prohibited medicine for a medical need.
Transdermal
Absorbed through the skin.
Unlicensed medicine
A medicine with no United Kingdom licence, such as an import.
Virilisation
Development of masculine features such as a deeper voice.
World Anti-Doping Agency (WADA)
The body listing substances banned in sport; applied by UK Anti-Doping.
Yellow Card scheme
The MHRA system for reporting suspected medicine side effects.

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

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