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 Formulary Chapter 16: Paediatrics - Full Chapter
Notes:

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)

Amber if SCP agreed

Red

Unlicensed drug

Amber if SCP agreed

Red

 RCPCH and NPPG joint position statement - 

https://www.rcpch.ac.uk/resources/using-standardised-strengths-unlicensed-liquid-medicines-children-joint-position

 Details...
16.05  Expand sub section  Central Nervous System Stimulants
Controlled Drug Methylphenidate (Concerta® XL, Xaggitin XL, Medikinet XL, Equasym® XL)
(Modified release tablets and capsules)
View adult BNF View SPC online
First Choice
Amber with Shared Care
  • Xaggitin® XL  Modified release tablet 18mg, 27mg, 36mg, 54mg - First line for new patients as the most cost-effective formulary choice locally
  • Concerta® XL Modified release tablet 18mg, 27mg, 36mg: existing patients only.
  • Equasym® XL Modified release capsule 10mg, 20mg, 30mg
  • Prescribe by brand Modified release brands provide different release profiles of methylphenidate and switching brands should only be considered following specialist advice.
 
Controlled Drug Methylphenidate 
(Immediate release tablets)
View adult BNF View SPC online
First Choice
Amber with Shared Care
  • 5mg,10mg, 20mg
 
Controlled Drug Lisdexamfetamine (Elvanse®)
(Capsules)
View adult BNF View SPC online
Second Choice
Amber with Shared Care
  • 20mg, 30mg, 40mg, 50mg, 60mg and 70mg
  • Once daily dosing
 
Link  BSW SCA For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents
Link  NICE NG87 Attention deficit hyperactivity disorder: diagnosis and management Sept 2019
   
Controlled Drug Atomoxetine 
(Capsules)
View adult BNF View SPC online
Third Choice
Amber with Shared Care
  • 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg
 
Link  BSW SCA For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents
Link  NICE NG87 Attention deficit hyperactivity disorder: diagnosis and management Sept 2019
   
Controlled Drug Dexamfetamine Sulphate

(Tablets)
View adult BNF View SPC online
Third Choice
Amber with Shared Care
  • 5mg
  • Only for those whose ADHD symptoms are responding to lisdexamfetamine but who cannot tolerate the longer effect profile.
 
Link  BSW SCA For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents
Link  NICE NG87 Attention deficit hyperactivity disorder: diagnosis and management Sept 2019
   
Guanfacine (Intuniv®)
(Tablets)
View adult BNF View SPC online
Formulary
Red
  • Use as per NICE NG87
  • Offer guanfacine to children aged 5 years and over and young people if:
    • they cannot tolerate methylphenidate or lisdexamfetamine or
    • their symptoms have not responded to separate 6-week trials of lisdexamfetamine and methylphenidate, having considered alternative preparations and adequate doses.
 
   
 ....
Key
note Notes
Section Title Section Title (top level)
Section Title Section Title (sub level)
First Choice Item First Choice item
Non Formulary Item Non Formulary section
Restricted Drug
Restricted Drug
Unlicensed Drug
Unlicensed
Track Changes
Display tracking information
click to search medicines.org.uk
Link to adult BNF
click to search medicines.org.uk
Link to SPCs
SMC
Scottish Medicines Consortium
Cytotoxic Drug
Cytotoxic Drug
CD
Controlled Drug
High Cost Medicine
High Cost Medicine
Cancer Drugs Fund
Cancer Drugs Fund
NHSE
NHS England
Homecare
Homecare
CCG
CCG
Blueteq
High Cost Drug Approval System

Traffic Light Status Information

Status Description

Red

RED - Hospital only – to be prescribed by a specialist and supplied from secondary care ONLY throughout treatment.  

Amber

Amber medicines are considered suitable for GP prescribing following specialist initiation or recommendation.  

Amber with Shared Care

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.  

Green

These medicines are appropriate for initiation in both primary and secondary care. Prescribing is appropriate within licensed or local recommendations.  

Self

Suitable for patient to be directed to buy themselves  

Grey

Not currently used. We intend to include this TLS in future to highlight where a decision to use this medicine is under review.   

Black

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.  

Red Specialist Centre

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.  

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