NHS Bath and North East Somerset, Swindon and Wiltshire CCG Royal United Hospitals Bath NHS Foundation Trust Great Western Hospitals NHS Foundation Trust Salisbury NHS Foundation Trust
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.
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)
Melatonin MR 2mg tablets are approved for use only to aid sleep cycle synchronisation in children with sensory impairment, autistic spectrum disorder, in other neurodisability/neuropsychiatric/neurodevelopmental disorders (including ADHD when behaviour measures have been insufficient) and also to induce sleep in children undergoing sleep EEG.
Melatonin MR 2mg tablets are licensed for use in adults over 55 years. Use in children is an 'off label' use.
Melatonin 5mg/5ml (Oral solution or suspension (alcohol free))
Second Choice
Melatonin 5mg/5ml oral solution or suspension (alcohol free) Unlicensedonly in line with melatonin policy see here - link to add - 22/02/2020
Melatonin is approved for use only to aid sleep cycle synchronisation in children with sensory impairment, autistic spectrum disorder, in other neurodisability/neuropsychiatric/neurodevelopmental disorders (including ADHD when behaviour measures have been insufficient) and also to induce sleep in children undergoing sleep EEG.
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Key
Notes
Section Title (top level)
Section Title (sub level)
First Choice item
Non Formulary section
Restricted Drug
Unlicensed
Display tracking information
Link to adult BNF
Link to SPCs
Scottish Medicines Consortium
Cytotoxic Drug
Controlled Drug
High Cost Medicine
Cancer Drugs Fund
NHS England
Homecare
CCG
High Cost Drug Approval System
Traffic Light Status Information
Status
Description
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.
Unlicensed 
