Risk assessment

Isotretinoin Safety Risk Assessment

A scored assessment of the teratogenic, psychiatric and monitoring risks created by prescribing oral isotretinoin

For Dermatology & Skin SurgeryRef BS-DER-RA-003See a sample (PDF) →
£34.99
One-off purchase · no VAT · instant download
  • 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. Pregnancy and teratogenicity hazards
  • 6. Psychiatric hazards
  • 7. Sexual function and other adverse effect hazards
  • 8. Monitoring and continuity hazards
  • 9. Commercial and demand hazards
  • 10. Action plan
  • 11. Monitoring and review
  • 12. Roles and responsibilities
  • 13. Related documents
  • 14. Declaration
  • 15. Disclaimer

CQC fundamental standard

Regulation 11 (Need for consent)
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 11 (Need for consent), Regulation 12 (Safe care and treatment), Regulation 13 (Safeguarding) and Regulation 17 (Good governance)
  • Human Medicines Regulations 2012 (as amended)
  • Medicines and Healthcare products Regulatory Agency drug safety updates on oral retinoids, including the pregnancy prevention programme and requirements on psychiatric and sexual adverse effects
  • The summary of product characteristics for the specific product prescribed
  • General Medical Council good practice in prescribing and managing medicines and devices
  • Mental Capacity Act 2005

Who it applies to

All prescribers and staff involved in oral retinoid treatment, and the clinical lead and registered manager of [Organisation Name]

Glossary

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

Childbearing potential
Able to become pregnant. Assessed for each patient individually rather than assumed.
Cumulative dose
The total amount of medicine taken across the whole course of treatment.
Isotretinoin
A strong oral medicine for severe acne, derived from vitamin A, which causes serious harm to an unborn baby.
Lipids
Fats in the blood, such as cholesterol, which this medicine can raise.
Medically supervised pregnancy test
A pregnancy test done and read by the clinic, not one the patient reports doing at home.
MHRA
The Medicines and Healthcare products Regulatory Agency, the UK medicines regulator.
Pregnancy prevention programme
The set of rules that must be followed, including regular pregnancy tests and contraception, before this medicine can be prescribed.
Residual risk
The risk that is left once the existing controls are working.
Shared care
An arrangement where two organisations each take responsibility for agreed parts of a patient's treatment.
Summary of product characteristics (SPC)
The manufacturer's official document setting out how a medicine must be used and monitored.
Suicidal ideation
Thoughts of taking one's own life.
Teratogenic
Capable of causing serious abnormality in an unborn baby.
Two-prescriber agreement
A second prescriber independently agreeing that treatment is appropriate before it is started.
Yellow Card scheme
The official way of reporting a suspected side effect of a medicine to the UK medicines regulator.

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

PolicyMinor Surgery & Skin Lesion Excision Policy£44.99
PolicyLocal Anaesthesia Policy£44.99
PolicySpecimen Handling & Histopathology Policy£44.99
PolicySuspected Skin Cancer Recognition & Urgent Referral Policy£44.99

Need the whole set?

Buy the full Dermatology & Skin Surgery pack and save versus buying documents individually.

View the Dermatology & Skin Surgery pack →