PLEASE NOTE: THIS CHAPTER IS STILL UNDER CONSTRUCTION
This chapter contains information from BCAP, Microguide and 3T's but a joint finalised version has yet to be agreed. Please use the information presented here in combination with the appropriate local guidelines.
Paediatric Drugs and the Traffic Light System
This guidance applies:
only where a drug does not already have a TLS classification
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 Summary of Product Characteristics since many manufacturers fail to conduct the relevant trials needed to secure licensed use in paediatrics. Local guidance has made clear that the BNF for Children is the accepted reference.
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
Off label use of drug (as per BNF-C definition page 2)
Treatment resistant ADHD and severe Tic disorder. Paediatric consultant only.
Non-formulary at RUH/SFT
Gaviscon Infant® (Powder sachets)
1 dose = half a dual sachet
Prescribe as doses
Note: 10mg strength tablets are unlicensed specials and prohibitively expensive when sourced in primary care.
10mg strength tablets are included on the formulary only when used in paediatric patients (alternate dosing using 50mg/100mg should be considered where daily doses between 50 and 100mgs are required for adults).
Prescribing in paediatric patients should be retained by secondary care.
Oralvac Compact (Oral mucosal solution)
Unlicensed named patient product
Consultant Specialist initiation only
For treatment of severe allergic rhinitis and severe allergic conjunctivitis not responding to standard treatment
Pizotifen is only included for prophylaxis of migraine in paediatrics. See Chapter 22.214.171.124 for BSWformulary choices for migraine in adults.
Used as a diluent for dissolving some medicines e.g. omeprazole for oral/enteral use (unlicensed indication)
Sodium Chloride 30% oral solution
GWH - For Consultant prescribing only.
Xylometazone (Nasal drops)
500microgram per 1 ml
Non-formulary in BaNES and Salisbury
Section Title (top level)
Section Title (sub level)
First Choice item
Non Formulary section
Display tracking information
Link to adult BNF
Link to SPCs
Scottish Medicines Consortium
High Cost Medicine
Cancer Drugs Fund
High Cost Drug Approval System
Traffic Light Status Information
RED - Hospital only – to be prescribed by a specialist and supplied from secondary care ONLY throughout treatment.
Amber medicines are considered suitable for GP prescribing following specialist initiation or recommendation.
Shared Care - these medicines require specialist initiation and stabilisation. Ongoing division of responsibility for drug and disease monitoring between specialist and GP by a Shared Care Guideline (SCG). If no SCG in place status reverts to red.
These medicines are appropriate for initiation in both primary and secondary care. Prescribing is appropriate within licensed or local recommendations.
Suitable for patient to be directed to buy themselves
Not currently used. We intend to include this TLS in future to highlight where a decision to use this medicine is under review.
Not currently used. We intend to include this TLS in future to highlight where a decision has been made by either or both the local or national NHS not to routinely commission this preparation for its licensed indications. Do not prescribe.
Not currently used. We intend to include this TLS in future to highlight where this medicine and indication is ONLY available through a Specialist Centre according to a NICE Highly Specialised Technology or NHSE Specialised Commission Circular / Policy.