Formulary


	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

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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

In BNF-C but outside indications or dose range
Not in BNF-C
Off label use of drug (as per BNFC definition Guidance on prescribing: BNF for Children and marketing authorisation)
Unlicensed drug

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

Central Nervous System (paediatric)

Melatonin
(Circadin MR 2mg^®)
(Oral)

First Choice

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.

Methylphenidate
(Concerta® XL, Xaggitin XL, Medikinet XL, Equasym® XL)
(Modified release tablets and capsules)

First Choice

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.

BSW SCA For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents

NICE NG87 Attention deficit hyperactivity disorder: diagnosis and management Sept 2019

Methylphenidate
(Immediate release tablets)

First Choice

5mg,10mg, 20mg

BSW SCA For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents

NICE NG87 Attention deficit hyperactivity disorder: diagnosis and management Sept 2019

Lisdexamfetamine (Elvanse®)
(Capsules)

Second Choice

20mg, 30mg, 40mg, 50mg, 60mg and 70mg
Once daily dosing

BSW SCA For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents

NICE NG87 Attention deficit hyperactivity disorder: diagnosis and management Sept 2019

Melatonin 5mg/5ml
(Oral solution or suspension (alcohol free))

Second Choice

Melatonin 5mg/5ml oral solution or suspension (alcohol free) Unlicensed only in line with melatonin policy see here - link to add - 22/02/2020

Atomoxetine
(Oral)

Third Choice

10mg, 18mg, 25mg, 40mg, 60mg, 80mg, 100mg capsules
4mg/1ml oral solution

BSW SCA For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents

NICE NG87 Attention deficit hyperactivity disorder: diagnosis and management Sept 2019

Dexamfetamine Sulphate
(Tablets)

Third Choice

5mg
Only for those whose ADHD symptoms are responding to lisdexamfetamine but who cannot tolerate the longer effect profile.

BSW SCA For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents

NICE NG87 Attention deficit hyperactivity disorder: diagnosis and management Sept 2019

Hyoscine hydrobromide (Scopoderm®)
(Topical patch)

Formulary

1.5mg patch
Unlicensed indication
Only licensed from 10 years for travel sickness.

Levetiracetam
(Tablets and oral solution)

Formulary

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)

Formulary

100mg/ml 5ml vial

Midazolam Maleate Oromucosal
(Epistatus®)

Formulary

Epistatus^® Oromucosal solution prefilled single syringe 10mg/1ml (licensed in adolescents from 10 years to less than 18 years)
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

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

Pizotifen
(Tablets)

Formulary

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.

Medicines for Children PIL - Pizotifen to prevent migraine headaches

Sodium Valproate
(Various formulations)

Formulary

Crushable tablets 100mg
E/C tablets 200mg, 500mg
M/R tablets 200mg, 300mg, 500mg
M/R capsules 150mg, 300mg
Liquid^SF 200mg/5ml

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

Valproate use by women and girls

Sodium Valproate
(Intravenous injection)

Formulary

400mg

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

Valproate use by women and girls

Trihexyphenidyl
(Tablets and oral solution)

Formulary

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)

Formulary

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.

NICE NG87 Attention deficit hyperactivity disorder: diagnosis and management Sept 2019

Sulthiame
(Unlicensed product)

Unlicensed

50mg tablets

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

....

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.
	(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.
	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.