THE PAEDIATRIC RAG LIST INCLUDES THOSE DRUGS AND INDICATIONS SPECIFIC TO USE IN CHILDREN ONLY.

For those drugs/indications which may be used in both children and adults, check the adult RAG/DNP/grey list. This includes all “off label” use of licensed medicines.

RAG list entries may be subject to a lag period to allow for implementation by Trusts/localities. Please check with your individual Trust or locality.

If an indication is not stated then the designated status relates to licensed indications only.

Some indications in paediatrics may be “off-label”, for example licensed medicines used for an unlicensed indication or at an unlicensed dose. Medicines may be used off-label if there is a recognised evidence base and/or it is standard treatment, in terms of paediatric medicines. Inclusion of guidance in the BNF for Children provides a suitable evidence base.

Exceptions may arise and it is to be remembered that the RAG list is advisory and cannot be expected to include every possible use of every drug.  Primary care prescribers and specialist teams are encouraged to discuss individual patient circumstances and consider where prescribing is best managed taking into account monitoring requirements, drug interactions, frequency of routine patient visits to the specialist and the specialist nature of the condition being treated.  Clinical judgement should be used to arrive at the most reasonable outcome. However, if it is not possible to reach a consensus or a specific issue has arisen, please submit an application to the Clinical Reference Group to assess or re-assess the RAG status.

Please read the Guidelines on Defining Red, Amber, Green, DNP, and Grey Status for further detail on assigning a RAG status prior to submitting any queries or applications to GMMMG.

In line with NHS England guidance, GM do not routinely support prescribing for conditions which are self-limiting or amenable to self-care. For further details see GM commissioning statement.

Red Amber Green Classifications

Classification Guidance
Red

Drugs considered to be specialist medicines and prescribing responsibility for these medicines should normally remain with the consultant or specialist clinician. These drugs should not be initiated or prescribed in primary care. It is recommended that the supply of these specialist medicines should be organised via the hospital pharmacy or specialist service. This may include arranging for supply via a home care company.

Amber

Drugs suitable for shared care arrangements under a shared care protocol.
Prescribing and monitoring responsibilities may be transferred from specialist teams to primary care prescribers in line with a shared care protocol. Shared care arrangements will usually be supported by a GMMMG shared care protocol (SCP). See here for a list of GMMMG approved SCPs.

Green

Drugs that are suitable for initiation and ongoing prescribing within primary care.

Green (specialist initiation)

Drugs that are suitable for ongoing prescribing within primary care following initiation by a specialist service. Little or no monitoring is required.

Green (specialist advice)

Drugs that are suitable for initiation by primary care following written or verbal advice from a specialist service. Little or no monitoring is required.

DNP

Products which are not recommended for prescribing in any setting. “Do Not Prescribe” status may relate to a specific medicine, or to prescribing for a particular indication. This is in addition to all medicines with a “not NHS” or “Drugs of Low Clinical Value” classification in the BNF, and those medicines with a NICE “Do not do” recommendation.

Grey

Products which are not suitable for routine prescribing but suitable for exceptional use in a defined patient population. Prescribers should ensure that more suitable alternatives have been considered and ruled out as not being appropriate before recommending or prescribing a medicine with a GREY list status. In these cases a RAG of RED, AMBER or GREEN will also be assigned to clarify in which care setting prescribing responsibility lies.

Other

Criteria for inclusion on DNP/grey lists:

  • Criterion 1: Products of low clinical effectiveness, where there is a lack of robust evidence of clinical effectiveness or there are significant safety concerns.
  • Criterion 2: Products which are clinically effective but where more cost-effective products are available, including products that have been subject to excessive price inflation.
  • Criterion 3: Products which are clinically effective but, due to the nature of the product or condition being treated, are deemed a low priority for NHS funding.
Drug (proprietary examples) BNF chapter Indications and rationale Formulary drug RAG status Information Responsible commissioner Date added
Alpha-1 antitrypsin 9 Alpha-1 anti-trypsin deficiency: Type 1 diabetes mellitus in children. Red NHSE
Amiodarone 2 Red

MHRA DSU: Amiodarone (Cordarone X): reminder of risks of treatment and need for patient monitoring and supervision

ICS
Amisulpride 4 Atypical antipsychotics (Oral) use in children. Licensed Indications & unlicensed indications supported by NICE. Amber ICS
Amisulpride 4 Atypical antipsychotics (Oral). All other unlicensed indications incl short-term use. Red ICS
Anti reflux milks (infant formula) 9 Criterion 3 DNP DNP

See GMMMG guidance: Cow’s milk protein allergy: prescribing infant formula in primary care.

Sep 2022
Antipsychotics 4 When used by the eating disorder service Red ICS
Aripiprazole 4 Atypical antipsychotics (Oral) use in children. Licensed Indications & unlicensed indications supported by NICE. Amber

Shared care protocols available for:
– bipolar disorder
– OCD
– Psychosis and schizophrenia

ICS
Aripiprazole 4 Atypical antipsychotics (Oral). All other unlicensed indications incl short-term use. Red ICS
Aripiprazole 4 Tourette's Syndrome and other tic disorders in children and adolescents Red

For new patients only

ICS
Asfotase alfa 9 Paediatric-onset hypophosphatasia No Red

NICE HST23: Asfotase alfa for treating paediatric-onset hypophosphatasia

NHSE Jul 2023
Atomoxetine 4 ADHD amber once patient stabilised Amber

Shared care protocol: Atomoxetine for ADHD in children and adolescents

ICS
Azathioprine 1 Inflammatory bowel disease Amber

Shared care protocol: Azathioprine for IBD in paediatrics

ICS
Aztreonam lysine nebules 5 Cystic fibrosis April 13: commissioned by NHS England Red NHSE
Betaine 9 Homocystinuria Red

NHSE highly specialised criteria only

NHSE
Chloral hydrate 4 All indications No Red

MHRA DSU: Chloral hydrate, cloral betaine (Welldorm): restriction of paediatric indication, Oct 2021

ICS Jul 2023
Ciclosporin 8 Childhood nephrotic syndrome Red NHSE
Ciclosporin 0.1% eye drops (Verkazia®) 11 For treatment of vernal keratoconjunctivitis in patients aged 4 to 18 years old and who are subject to active follow-up (e.g. reviewed every 6 months) Green (specialist initiation) ICS
Citalopram 4 For use in paediatric indications where a shared care protocol is available. Amber

Shared care protocols available for:

  • OCD and body dysmorphic disorder
  • anxiety disorders
  • depression
ICS
Clobazam 4 Antiepileptic. As per NICE guidance Green (specialist advice) ICS
Clonazepam 4 Antiepileptic. As per NICE guidance Green (specialist advice) ICS
Clonidine 4 Tourette's Syndrome and other tic disorders in children and adolescents Red

For new patients only

ICS
Cloral betaine 4 All indications No Red

MHRA DSU: Chloral hydrate, cloral betaine (Welldorm): restriction of paediatric indication, Oct 2021

ICS Jul 2023
Clozapine 4 Atypical antipsychotics (Oral) use in children Red ICS
Colistimethate – nebulised 5 Colomycin®, Promixin® for cystic fibrosis Red

For new patients

NHSE
Dexamfetamine 4 ADHD amber once patient stabilised Amber

Shared care protocol: Dexamfetamine for ADHD in children and adolescents

ICS
Domperidone 1 Gastro indications Amber

Shared care protocol: Domperidone for Paediatric Gastro-oesophageal Reflux Disease (GORD)

ICS
Dornase alfa (Pulmozyme®) 3 Cystic fibrosis Amber NHSE
Emollient bath additives 13 Criterion 1
When used for the management of eczema in children. This recommendation does not apply to the use of standard emollients when used in the bath as a soap substitute
DNP DNP

NICE CG57: Do not offer emollient bath additives to children with atopic eczema

Oct 2018
Emollient bath additives containing antimicrobials 13 Criterion 1
Only for short term use in patients with infected eczema
Grey Green ICS
Ethinylestradiol (tablets) 6 Pubertal induction for use only when estradiol matrix patches are unsuitable or not tolerated Grey Amber

Shared care protocol: Ethinylestradiol for the induction of delayed puberty

ICS
Flecainide 2 For use in paediatric patients, although unlicensed in children - well established therapy and in the children's BNF. Red

RED until patient stabilised, then GREEN

ICS
Fluoxetine 4 For use in paediatric indications where a shared care protocol is available. Amber

Shared care protocols available for:

  • SSRIS for the treatment of OCD and body dysmorphic disorder in children and adults
  • SSRIs for the treatment of anxiety disorders in children and adolescents
  • SSRIs for the treatment of depression in children and adolescents
ICS
Fluvoxamine 4 For use in paediatric indications where a shared care protocol is available. Amber

Shared care protocols available for:

  • SSRIS for the treatment of OCD and body dysmorphic disorder in children and adults
  • SSRIs for the treatment of anxiety disorders in children and adolescents
ICS
Goserelin 6 Precocious puberty Red ICS
Growth hormone (Somatropin) 6 For children. Amber

Shared care protocol: Growth hormone in paediatrics

ICS
Guanfacine 4 ADHD Amber

Shared care protocol: Guanfacine for childhood and adolescent ADHD

ICS
Haloperidol 4 Tourette's Syndrome and other tic disorders in children and adolescents Red

For new patients only

ICS
Hydrocortisone granules (Alkindi) 6 For management of adrenal insufficiency, only in patients requiring doses <5mg. Alkindi should not be used in combination with hydrocortisone tablets to make up dose increments ≥5mg. Grey Green (specialist initiation)

MHRA advice: risk of acute adrenal insufficiency in children when switching from hydrocortisone tablet formulations to granules

ICS
IV Formulations 0 Unless part of an agreed local pathway. Red

Commissioner depends on drug and indication

ICS or
NHSE
Leuprorelin 6 Precocious puberty Red ICS
Liraglutide 6 Obesity in people aged 12-17 years DNP DNP

NICE TA749: Liraglutide for managing obesity in people aged 12 to 17 years. Insufficient evidence to support an evidence submission.

May 2022
Lisdexamfetamine 4 ADHD amber once patient stabilised (> 3 months) Amber

Shared care protocol: Lisdexamfetamine for ADHD in children and adolescents

ICS
Lithium 4 Paediatric use Red ICS
Melatonin 4 Sleep disorders, ADHD. Unlicensed specials only to be used in exceptional circumstances. Doses greater than 6mg are RED Amber

Shared care protocol: Melatonin for children and adolescents

ICS
Melatonin 1 mg/mL oral solution (Colonis brand licensed product) 4 Not suitable for use in children and adolescents aged 0-18 due to safety & efficacy concerns. DNP DNP

See summary of product characteristics

Metformin 6 Type 2 diabetes Green (specialist initiation) ICS
Methylphenidate 4 ADHD amber once patient stabilised Amber

Shared care protocol: Methylphenidate for ADHD in children and adolescents

ICS
Midazolam (buccal) 4 Epilepsy Green (specialist initiation) ICS
Modafinil 4 Sleepiness associate with narcolepsy Red ICS
Nadolol 2 Prolonged QT syndrome Red ICS
Nutritional Supplement Drinks 9 When used by the eating disorder service Green ICS
Olanzapine 4 Atypical antipsychotics (oral). Licensed Indications & unlicensed indications supported by NICE. Amber

Shared care protocols available for:

  • bipolar disorder
  • OCD
  • Psychosis and schizophrenia
ICS
Olanzapine 4 Atypical antipsychotics (oral). All unlicensed indications not supported by NICE, including eating disorders. Red ICS
Omalizumab 3 Allergic asthma prophylaxis. Red NHSE
Omalizumab 3 Severe chronic spontaneous urticaria Yes Red ICS
Omeprazole MUPS tablets 1 GORD Green

Medicines for children: omeprazole for GORD

nhs.uk: how to help a choking child

ICS
Paliperidone 4 Atypical antipsychotics (oral) use in children. Licensed Indications & unlicensed indications supported by NICE. Red

Pending production of a shared care protocol

ICS
Paliperidone 4 Atypical antipsychotics (oral). Unlicensed indications not supported by NICE Red ICS
Palivizumab 5 RSV Red NHSE
Paraldehyde 4 Status epilepticus Red ICS
Peanut protein powder (Palforzia) 3 Criterion 1
Peanut allergy
Only for use in people aged 18 and over if treatment started between the ages of 4 to 17, as per NICE guidance.
Grey Red

NICE TA769: Palforzia for treating peanut allergy in children and young people

ICS Jun 2022
Phenazone / lidocaine eardrops (Otigo) 12 Acute otitis media.
Use only if an immediate oral antibiotic prescription is not given, and there is no eardrum perforation or otorrhoea
Green

NICE NG91: Otitis media (acute): antimicrobial prescribing.

ICS Sep 2022
Poractant alfa (Curosurf®) 3 Pulmonary surfactant Red NHSE
Potassium Phosphate 9 When used by the eating disorder service Red ICS
Quetiapine 4 Atypical antipsychotics (oral) use in children. Licensed Indications & unlicensed indications supported by NICE. Amber

Shared care protocols available for:

  • Bipolar disorder
  • OCD
  • Psychosis and   schizophrenia
ICS
Quetiapine 4 Atypical antipsychotics (oral). All other unlicensed indications incl short-term use. Red ICS
Risperidone 4 Atypical antipsychotics (oral) use in children. Licensed Indications & unlicensed indications supported by NICE. Amber

Shared care protocols available for:

  • Bipolar disorder
  • OCD
  • Psychosis and   schizophrenia
ICS
Risperidone 4 Atypical antipsychotics (oral). All other unlicensed indications incl short-term use. Red ICS
Risperidone 4 Tourette's Syndrome and other tic disorders in children and adolescents Red

For new patients only

ICS
Secukinumab 13 Biologics/cytokine modulators Red

NICE TA734: Secukinumab for treating moderate to severe plaque psoriasis in children and young people

NHSE Jul 2022
Semaglutide 6 Obesity in people aged 12-17 years DNP DNP

NICE TA910

Dec 2023
Sertraline 4 For use in paediatric indications where a shared care protocol is available. Amber

Shared care protocols available for:

  • depression
  • anxiety disorders
  • OCD & body dysmorphic disorder
ICS
Somatrogon 6 Growth disturbance
Red pending availability of a shared care protocol
Red

NICE TA863: Somatrogon for treating growth disturbance in children and young people aged 3 years and over

ICS Jun 2023
SSRIs 4 When used by the eating disorder service Amber ICS
Stiripentol 4 Paediatric patients Red ICS
Sulpiride 4 Tourette's Syndrome and other tic disorders in children and adolescents Red

For new patients only

ICS
Testosterone injection 6 Delayed puberty Green (specialist initiation) ICS
Tobramycin – nebulised 5 Tobi®, Bramitob® for cystic fibrosis Red

For new patients

NHSE
Tofacitinib 10 Biologics/cytokine modulators Red

NICE TA735: Tofacitinib for treating juvenile idiopathic arthritis

NHSE Jul 2022
Triptorelin 6 Precocious puberty Red ICS