Policy

Systemic Immunosuppressant & Biologic Monitoring Policy

Screening before starting, shared-care arrangements, monitoring schedules and the failsafe that ensures a due test is never missed

For Dermatology & Skin SurgeryRef BS-DER-POL-007See a sample (PDF) →
£44.99
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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. Which medicines this covers
  • 6. Before starting
  • 7. Who is responsible for what
  • 8. Ongoing monitoring
  • 9. Abnormal results and adverse events
  • 10. Patient responsibilities and support
  • 11. Stopping, transferring and lapsed monitoring
  • 12. Roles and responsibilities
  • 13. Training and competence
  • 14. Records, monitoring and audit
  • 15. Version control and review
  • 16. Appendix A - Pre-treatment checklist
  • 17. Appendix B - Monitoring register core fields
  • 18. Related documents
  • 19. Disclaimer

CQC fundamental standard

Regulation 12 (Safe care and treatment)
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 12 (Safe care and treatment), Regulation 17 (Good governance) and Regulation 18 (Staffing)
  • Human Medicines Regulations 2012 (as amended)
  • Medicines and Healthcare products Regulatory Agency drug safety updates and the summary of product characteristics for each medicine
  • General Medical Council good practice in prescribing and managing medicines and devices
  • National Institute for Health and Care Excellence guidance relevant to the conditions treated
  • Data Protection Act 2018 and the UK General Data Protection Regulation

Who it applies to

All prescribers, clinicians and administrative staff involved in systemic therapy, and the clinical lead and registered manager of [Organisation Name]

Glossary

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

Action threshold
The point at which a test result means something must be done, written down in advance so nobody has to decide under pressure.
Baseline screening
The tests done before treatment starts, to check it is safe to begin and to give a reference for later.
Biologic
A modern injected medicine made from living cells that blocks one specific part of the immune system.
Cytopenia
A low count of one of the blood cell types.
Immunosuppressant
A medicine that damps down the immune system, which makes infections more likely.
Intercurrent infection
An infection that happens while the patient is on treatment for something else.
Live vaccine
A vaccine containing a weakened form of a germ, which can be dangerous for someone whose immune system is suppressed.
Neutropenia
A low count of the white blood cells that fight infection.
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.
Teratogenic
Capable of causing harm to an unborn baby.
Tuberculosis reactivation
Old, dormant tuberculosis becoming active again, a recognised risk when the immune system is suppressed.
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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