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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...
16.15  Expand sub section  Miscellaneous
Amikacin 
(Solution for injection)
View adult BNF View SPC online
Formulary
Red
  • 500mg/2ml

Swindon only

  • Paediatric consultant/microbiology advice only
  • Monitoring of drug levels required - NOT ROUTINELY STOCKED AT GWH

Non-formulary at BaNES and Salisbury

 
   
Ciclosporin (Verkazia®)
(Ophthalmic drops)
View adult BNF View SPC online
Formulary
Red
  • 0.1% drops (1 mg/mL eye drops, emulsion)
  • SFT only. 
  • Not on formulary at RUH or GWH
  • Note - Ensure correct product is prescribed; available products have different licensing information and TLS. 
  • Verkazia®  is licensed for the treatment of severe vernal keratoconjunctivitis (VKC) in children from 4 years of age and adolescents. 
  • Ikervis® is not licensed in paediatrics.
 
Link  NICE TA369: Ciclosporin for treating dry eye disease that has not improved despite treatment with artificial tears
   
Clonidine 
(Oral)
View adult BNF View SPC online
Formulary
Red

GWH only

  • Treatment resistant ADHD and severe Tic disorder. Paediatric consultant only.

Non-formulary at RUH/SFT

 
   
Gaviscon Infant® 
(Powder sachets)
View adult BNF View SPC online
Formulary
Green
  • 1 dose = half a dual sachet
  • Prescribe as doses
 
   
Cytotoxic Drug Mercaptopurine 
(Tablet)
View adult BNF View SPC online
Formulary
Red
    • 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)
View adult BNF View SPC online
Formulary
Red
  • Unlicensed named patient product
  • Consultant Specialist initiation only
  • For treatment of severe allergic rhinitis and severe allergic conjunctivitis not responding to standard treatment
 
   
Pizotifen 
(Tablets)
View adult BNF View SPC online
Formulary
Amber
  • 500microgram tablet
  • 1.5mg tablet
  • Pizotifen is only included for prophylaxis of migraine in paediatrics. See Chapter 4.7.4.2 for BSWformulary choices for migraine in adults.

 

 
Link  Medicines for Children PIL - Pizotifen to prevent migraine headaches
   
Sodium Bicarbonate 8.4%

View adult BNF View SPC online
Formulary
Red
  • 100ml bottle
  • Used as a diluent for dissolving some medicines e.g. omeprazole for oral/enteral use (unlicensed indication)

BaNES only

 
   
Sodium Chloride 30% oral solution

Formulary
Red
  • GWH - For Consultant prescribing only. 
 
   
Xylometazone 
(Nasal drops)
View adult BNF View SPC online
Formulary
Green
  • 500microgram per 1 ml

Swindon only

Non-formulary in BaNES and Salisbury

 
   
 ....
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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