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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:

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...
16.01  Cardiovascular system drugs
Captopril 
(Tablets and oral solution)
View adult BNF View SPC online
Formulary
Amber
  • 12.5mg, 25mg and 50mg
  • 5mg/5ml and 25mg/5ml SF solution

Swindon only

Non-formulary in BaNES and Salisbury

 
   
Chlorothiazide 
(Oral solution)
View adult BNF View SPC online
Formulary
Amber
  • Only available as an unlicensed preparation for specialist initiation only.

Swindon only

Non-formulary in BaNES and Salisbury

 
   
Enalapril 
(Tablets)
View adult BNF View SPC online
Formulary
Amber
  • 2.5mg, 5mg, 10mg and 20mg
 
   
Spironolactone 
(Oral suspension)
View adult BNF View SPC online
Formulary
Red
  • 10mg/5ml and 50mg/5ml (Note: RUH will be moving to standard solution strength in near future).

 
Link  MHRA DSU: Spironolactone and renin-angiotensin system drugs in heart failure: risk of potentially fatal hyperkalaemia—February 2016 article
   
16.02  Fibrinolytic-drugs
Alteplase Actilyse Cathflo

(Powder for reconstitution)
View adult BNF View SPC online
Formulary
Red
  • 1 vial with powder contains: 2 mg alteplase (corresponding to 1,160,000 IU)
  • Paediatric central venous catheter management
 
   
16.03  Corticosteriods
Prednisolone 
(Soluble tablets)
View adult BNF View SPC online
Formulary
Green
  • 5mg
  • For emergency treatment of Croup as per BNF-C
 
   
Triamcinolone hexacetonide

(Solution for injection)
View adult BNF View SPC online
Formulary
Red
  • 20mg/ml
  • For intra-articular administration

Swindon only

Non-formulary in BaNES and Salisbury

 
   
16.04  Hypnotics
Melatonin (Circadin MR 2mg®)
(Oral)
View adult BNF View SPC online
First Choice
Red
  • 2mg
  • 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))
View adult BNF View SPC online
Second Choice
Red
  • 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
  • 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.

 

 
   
16.05  Central Nervous System Stimulants to top
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.
 
   
16.06  Control of Epilepsy
Levetiracetam 
(Tablets and oral solution)
View adult BNF View SPC online
Formulary
Amber
  • 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
Red
  • 100mg/ml 5ml vial
 
   
Sulthiame 
(Unlicensed product)
View adult BNF View SPC online
Unlicensed Drug Unlicensed
Red
  • 50mg tablets

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

 
   
16.07  Status Epilepticus
Controlled Drug Midazolam Maleate Oromucosal
(Epistatus®)
View adult BNF View SPC online
Formulary
Amber with Shared Care
  • Epistatus® Oromucosal solution prefilled single syringe 10mg/1ml  (licensed in adolescents from 10 years to less than 18 years
  • Epistatus® Oromucosal solution 10mg/ml prefilled syringes: 2.5mg/0.25ml, 5mg/0.5ml, 7.5mg/0.75ml, (unlicensed).  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 in children under 10 years of age

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

 
   
Sodium Valproate 
(Various formulations)
View adult BNF View SPC online
Formulary
Amber
  • 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 medicines (Epilim¥, Depakote¥): contraindicated in women and girls of childbearing potential unless conditions of Pregnancy Prevention Programme are met
Link  Valproate medicines and serious harms in pregnancy: new Annual Risk Acknowledgement Form and clinical guidance from professional bodies to support compliance with the Pregnancy Prevention Programme
   
Sodium Valproate 
(Intravenous injection)
View adult BNF View SPC online
Formulary
Red
  • 400mg

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

 
Link  Valproate medicines (Epilim¥, Depakote¥): contraindicated in women and girls of childbearing potential unless conditions of Pregnancy Prevention Programme are met
Link  Valproate medicines and serious harms in pregnancy: new Annual Risk Acknowledgement Form and clinical guidance from professional bodies to support compliance with the Pregnancy Prevention Programme
   
16.08  Antibiotic guidance for Primary Care
Colistimethate Sodium
(Promixin®)
(Powder for nebuliser solution)
View adult BNF View SPC online
Formulary
Red
  • 1million-units
  • For use in paediatrics only following initiation by specialist
 
   
16.09  Lyme Disease
 note 

See BSW antimicrobial prescribing guidance for information and choice of treatment which is based on age of child.

Amoxycillin 
(Tablets and oral suspension)
View adult BNF View SPC online
Formulary
Green
  • Capsules 250mg, 500mg 
  • Suspension 125mg/5ml and 250mg/5ml
 
   
Azithromycin 
(Tablets and oral solution)
View adult BNF View SPC online
Formulary
Green
  • 250mg and 500mg
  • 200mg/5ml 
 
   
Doxycycline 
(Capsules and dispersible tablets)
View adult BNF View SPC online
Formulary
Green
  • 50mg and 100mg
 
   
16.10  Blood Glucose Monitoring to top
 note 

NICE information on Freestyle Libre 

 

Following NHS England’s (NHSE) announcement of  Flash Glucose Monitoring: National arrangements for funding of relevant diabetes patients  From 1st April 2019 the local formulary groups (BCAP, 3T's Swindon, Microguide Salisbury) have agreed to amend the status of Freestyle Libre (FSL) from red to amber (specialist recommendation). There will be some central funding made available fro FSL but reimbursement to CCGs will only be based on primary care prescribing, hence the change.

Existing Patients

  • Responsibility for prescribing FSL sensors for existing patients can now be passed from secondary care to the patients GP practice
  • The ongoing review and clinical care of existing patients will be retained by Specialist Teams

New Patients

  • FSL should not be initiated by GP's in primary care
  • Specialist Teams will identify patients meeting the criteria set out by NHSE (see link above) at the patients next routine review. Specialist Teams will provide patient education, initiate a patient contract, review benefits after 6 months and provide ongoing clinical care
  • GP's should take on the prescribing of FSL sensors when asked to do so by the Specialist Teams

Patients currently self-funding Freestyle Libre

  • These patients should be assessed to see if they meet the criteria set out by NHSE (see link above) at the patients next routine review with the Specialist Teams
  • Patients should not be referred to a specialist just to assess FSL on the NHS



Freestyle Libre 
View adult BNF View SPC online
Formulary
Amber
  • See information above
  • A Freestyle Libre Sensor lasts for 2 weeks, so one month’s supply is 2 sensors

 

 
   
16.11  Growth Hormone
Somatropin 
(Injection)
View adult BNF View SPC online
Formulary
  • Red at RUH and SFT
  • Amber with Shared Care at GWH
 
Link  GWH shared care agreement for the use of somatropin in children (2011)
Link  Human growth hormone (somatropin) for the treatment of growth failure in children
   
Testosterone 
(Injection)
View adult BNF View SPC online
Formulary
Red
  • 250mg in 1ml
 
   
16.12  Bisphosphonates
Zoledronic acid 
(Intravenous injection)
View adult BNF View SPC online
Formulary
Red
  • 800micrograms/ml (4mg) vial
  • Osteogenesis imperfecta and other low bone mass conditions as per the Bristol Childrens Hospital Guidelines
  • Six monthly infusions
 
   
16.13  Drooling Guidelines
 note 

BCAP Childrens Drooling Guidelines

Glycopyrronium (Sialanar®)
(Oral solution)
View adult BNF View SPC online
Formulary
Amber
  • 320micrograms/ml
  • Licensed for symptomatic treatment of severe sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disorders
  • For short term intermittent use
 
   
Hyoscine hydrobromide
(Scopoderm®)
(Topical patch)
View adult BNF View SPC online
Formulary
Amber
  • 1.5mg patch
  • Unlicensed indication
  • Only licensed from 10 years for travel sickness.
 
   
Trihexyphenidyl 
(Tablets and oral solution)
View adult BNF View SPC online
Formulary
Amber
  • 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
 
   
16.14  Non-steriodal Anti-Inflammatory
Piroxicam 
(Orodispersible tablets)
View adult BNF View SPC online
Formulary
Amber
  • 20mg melts

Swindon only. Third line in children unresponsive to or intolerant of Ibuprofen and Diclofenac.    

Non-formulary in BaNES and Salisbury

 
   
16.15  Miscellaneous to top
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

 
   
16.16 
 ....
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.  

netFormulary