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 Formulary Chapter 16: Paediatrics - Full Chapter
Notes:

*** WORK WILL BE TAKING PLACE ON THIS CHAPTER w/c 24/01/21***


PLEASE NOTE: THIS CHAPTER IS STILL UNDER CONSTRUCTION 

Where medicines are included in the BSWformulary (for any indication) and are in the BNF for Children (BNF-C), they can be prescribed for a licensed indication within the manufactrer's recommendations using any formulation.

Where medicines are not included and therefore non-formulary (despite being in the BNF-C) they  must be approved for use by the local Formulary team by submitting a Non-Formulary Medicine Request Form or an IFR application for individual patient requests where exceptionality can be shown.

Paediatric drugs are frequently used outside of the SPC since many manufacturers fail to conduct the relevant trials needed to secure licensed use in paediatrics. Prescribers take full responsibility for prescribing products outside the license. However all prescribing should be carried out in the best interest of the child irrespective of license status.

Traffic Light Status Information for Paediatric Chapter

Red Traffic Light

Amber with Shared Care Agreement (SCA)

  • In BNF-C within indication and dose range
  • Unlicensed or Off label use of drug (as per BNF-C definition Guidance on prescribing: BNFC and marketing authorisation)     
  • Require specialist initiation and stabilisation. Ongoing division of responsibility for drug and disease monitoring between specialist and GP detailed in SCA

Amber No Shared Care Agreement (SCA) needed

  • In BNF-C within indication and dose range
  • Considered suitable for GP prescribing following specialist initiation or recommendation. 

Green Traffic Light

  • In BNF-C within indication and dose range
  • Considered suitable for initiation in both primary and secondary care. 


Useful resources

RCPCH and NPPG joint position statement -using standardised strengths of unlicensed liquid medicines

RCPCH and NPPG joint position statement - choosing an oral liquid medicine for children

 

 Details...
16.04  Expand sub section  Central Nervous System (paediatric)
Melatonin
(Circadin MR 2mg®)
(Oral)
View adult BNF View SPC online
First Choice
traffic lightRed
  • 2mg MR
  • Melatonin MR 2mg tablets are licensed for use in adults over 55 years. Use in children is an 'off label' use. 
  • Melatonin guidance due Q1 2021.

 

 
Controlled Drug Methylphenidate
(Concerta® XL, Xaggitin XL, Medikinet XL, Equasym® XL)
(Modified release tablets and capsules)
View adult BNF View SPC online
First Choice
traffic lightAmber 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,54mg: 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
traffic lightAmber with Shared Care
  • 5mg,10mg, 20mg
 
Controlled Drug Lisdexamfetamine (Elvanse®)
(Capsules)
View adult BNF View SPC online
Second Choice
traffic lightAmber 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
 
Melatonin 5mg/5ml
(Oral solution or suspension (alcohol free))
View adult BNF View SPC online
Second Choice
traffic lightRed
  • Melatonin 5mg/5ml oral solution or suspension (alcohol free) Unlicensed DrugUnlicensed only in line with melatonin policy see here - link to add - 22/02/2020

 

 
 
Atomoxetine
(Oral)
View adult BNF View SPC online
Third Choice
traffic lightAmber with Shared Care
  • 10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg capsules
  • 4mg/1ml oral solution
 
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
traffic lightAmber 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
 
Hyoscine hydrobromide (Scopoderm®)
(Topical patch)
View adult BNF View SPC online
Formulary
traffic lightAmber
  • 1.5mg patch
  • Unlicensed indication
  • Only licensed from 10 years for travel sickness.
 
 
Levetiracetam
(Tablets and oral solution)
View adult BNF View SPC online
Formulary
traffic lightAmber
  • 250mg, 500mg, 750mg and 1g (category 3 MHRA)
  • Oral solution SF 100mg/ml
  • Granules in sachets 250mg, 500mg and 1000mg Desitrend (second line use only)
 
 
Levetiracetam
(Intravenous infusion)
View adult BNF View SPC online
Formulary
traffic lightRed
  • 100mg/ml 5ml vial
 
 
Controlled Drug Midazolam Maleate Oromucosal
(Epistatus®)
View adult BNF View SPC online
Formulary
traffic lightAmber with Shared Care
  • Epistatus® Oromucosal solution prefilled single syringe 10mg/1ml  (licensed in adolescents from 10 years to less than 18 years
  • unlicensed unlicensed Epistatus® Oromucosal solution 10mg/ml prefilled syringes: 2.5mg/0.25ml, 5mg/0.5ml, 7.5mg/0.75ml.  Individually wrapped in a pack of 4.
  • Do not prescribe Oromucosal solution 10mg/ml multidose 5ml bottle. In primary care, all patients should use the pre-filled syringe format as this is what the specialist primary care nursing team can provide training on for carers/schools/nurseries/after-school clubs etc.
  • Prescribe by BRAND (NB Buccolam brand is a different salt, STRENGTH and volume) 
  • See Shared Care Guidelines: Use of Oromucosal Midazolam as an intervention for prolonged seizures and prevention od Status Epilepticus

Red Swindon only - when used for sedation and pre-med in theatres

 
 
Pizotifen
(Tablets)
View adult BNF View SPC online
Formulary
traffic lightAmber
  • 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 Valproate
(Various formulations)
View adult BNF View SPC online
Formulary
traffic lightAmber
  • Crushable tablets 100mg
  • E/C tablets 200mg, 500mg
  • M/R tablets 200mg, 300mg, 500mg 
  • M/R capsules 150mg, 300mg
  • LiquidSF 200mg/5ml

COVID-19 MHRA have issued guidance - Valproate Pregnancy Prevention Programme: temporary advice for management during coronavirus (COVID-19)

 
Link  Valproate use by women and girls
 
Sodium Valproate
(Intravenous injection)
View adult BNF View SPC online
Formulary
traffic lightRed
  • 400mg

COVID-19 MHRA have issued guidance - Valproate Pregnancy Prevention Programme: temporary advice for management during coronavirus (COVID-19)

 
Link  Valproate use by women and girls
 
Trihexyphenidyl
(Tablets and oral solution)
View adult BNF View SPC online
Formulary
traffic lightAmber
  • 2mg and 5mg tablets
  • 5mg/5ml (200ml)
  • Not licensed for this indication and 'Not Recommended' for children in the SPC but is listed in the BNF-C
 
 
Guanfacine (Intuniv®)
(Tablets)
View adult BNF View SPC online
Formulary
traffic lightRed
  • 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.
 
Link  NICE NG87 Attention deficit hyperactivity disorder: diagnosis and management Sept 2019
 
Sulthiame
(Unlicensed product)
View adult BNF View SPC online
Unlicensed Drug Unlicensed
traffic lightRed
  • 50mg tablets

RUH ONLY - as adjunctive therapy in pharmaco-resistant paediatric epilepsy where other AEDs have failed at optimal 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

Traffic LightRed

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

Traffic LightAmber

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

Traffic LightAmber 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.  

Traffic LightGreen

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

Traffic LightSelf

Suitable for patient to be directed to buy themselves  

Traffic LightGrey

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

Traffic LightBlack

(In use from Oct 2020) Used where a decision has been made by the BSW APC not to routinely commission this preparation for its licensed indications. Do not prescribe.   

Traffic LightRed 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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