Paediatric Drugs & the Traffic Light System

This guidance applies

  • only where a drug does not already have a TLS classification
  • only for paediatric patients within BCAP area
  • only for long-term use of a medicine where the patient would not otherwise visit the initiating clinician or unit at intervals of 60 days or less

Paediatric drugs are frequently used outside the makers Statement of Product Characteristics since many manufacturers fail to conduct the relevant trials need to secure licensed use in paediatrics.

Local guidance has made clear that the BNF for Children is the accepted reference.


Drug Indication  In BNF-C for indication and dose range

In BNF-C but outside indications or dose range Not in BNF-C

Licensed drug within SPC indications Amber No Shared Care Protocol (SCP) needed Red
Off label use of drug   (as per BNF-C definition page 2) Amber if SCP agreed Red
Unlicensed drug Amber if SCP agreed Red



Last updated by: Joy Craine on 03-09-2014 15:07