Policy

Isotretinoin & Pregnancy Prevention Policy

Pregnancy prevention requirements, mental health monitoring, sexual function and the two-prescriber safeguard for oral retinoid treatment

For Dermatology & Skin SurgeryRef BS-DER-POL-008See 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 policy is fully drafted and structured, ready to brand and complete for your service. It covers:

  • 1. Purpose
  • 2. Scope
  • 3. Policy statement
  • 4. Definitions
  • 5. Whether we prescribe it at all
  • 6. Before starting: every patient
  • 7. Additional safeguards before starting
  • 8. Pregnancy prevention programme
  • 9. Monitoring during treatment
  • 10. Records and prescription control
  • 11. Roles and responsibilities
  • 12. Training and competence
  • 13. Records, monitoring and audit
  • 14. Version control and review
  • 15. Appendix A - Pre-treatment checklist
  • 16. Appendix B - Monthly review record
  • 17. Related documents
  • 18. 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 the 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, and Gillick competence where a patient under 16 is treated

Who it applies to

All prescribers, clinicians and administrative 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 from age or circumstances.
Contraception
Methods used to prevent pregnancy. Only highly effective methods are accepted during this treatment.
Cumulative dose
The total amount of medicine taken across the whole course of treatment.
Gillick competence
The test of whether a young person under 16 understands enough to consent to their own 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 and triglycerides, 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.
Suicidal ideation
Thoughts of taking one's own life.
Teratogenic
Capable of causing serious abnormality in an unborn baby.
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.

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