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... |
16.01 |
Gastro-Intestinal (paediatric) |
|
|
Docusate Sodium
|
Formulary

|
- Paediatric 12.5mg/5ml Oral Solution (licensed from age 6months)
- 50mg in 5ml oral solution SF (licensed from age 12years)
- 120mg micro enema (licensed from age 12years)
- 100mg capsules (licensed from age 12years)
|
|
Esomeprazole
(gastro-resistant granules for oral suspension, sachet)
|
Formulary

|
- 10mg
- Licensed for Children 1 – 11 years with a bodyweight of ≥10 kg
- Used locally for patients with enteral tubes or patients who have not tolerated MUPS
|
|
Gaviscon Infant®
(Powder sachets)
|
Formulary

|
- 1 dose = half a dual sachet
- Prescribe as doses
|
|
Mercaptopurine
(Tablet)
|
Formulary

|
- Note: 10mg strength tablets are unlicensed specials and prohibitively expensive when sourced in primary care.
- Use by gastroenterology specialists.
- 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.
|
|
Omeprazole
(4mg/mL Suspension)
|
Restricted

|
- Omeprazole 4mg/mL powder for oral suspension (Rosemont)
- RESTRICTED USE - Only for use following specialist recommendation for paediatric patients under 1 year of age or under 10kg whereby dispersible tabs/esomeprazole sachets are not appropriate (i.e. prescribed dose under 5mg or feeding tube in situ).
- To support review process of infants receiving doses ≥5mg or those with feeding tubes in situ at 12 months to transition to more cost effective PPI alternatives see link below.
- Omeprazole suspension is NOT included on the formulary for use outside this cohort (see here).
|
Guidance on use of PPIs in Children from (SFT)
|
16.02 |
Cardiovascular (paediatric) |
|
|
Alteplase Actilyse Cathflo
(Powder for reconstitution)
|
Formulary

|
- 1 vial with powder contains: 2 mg alteplase (corresponding to 1,160,000 IU)
- Paediatric central venous catheter management
|
|
Captopril
(Tablets and oral solution)
|
Formulary

|
- 12.5mg, 25mg and 50mg
- 5mg/5ml and 25mg/5ml SF solution
- Swindon only
- Non-formulary in BaNES and Salisbury
|
|
Clonidine
(Tablets/Oral solution)
|
Formulary

|
- GWH only for treatment resistant ADHD and severe Tic disorder. Paediatric consultant only.
- Non-formulary at RUH/SFT
- 25mcg tablets
- 50mcg/5ml oral solution
|
|
Enalapril
(Tablets)
|
Formulary

|
- 2.5mg, 5mg, 10mg and 20mg
|
|
Propranolol
(Oral)
|
Formulary

|
- Tablets 10mg, 40mg
- Liquid
|
|
Chlorothiazide
(Oral solution (various strengths))
|
Unlicensed

|
- Only available as an unlicensed preparation for specialist initiation only.
- Swindon only
- Non-formulary in BaNES and Salisbury
|
|
Spironolactone
(Oral suspension)
|
Unlicensed

|
|
MHRA DSU: Spironolactone and renin-angiotensin system drugs in heart failure: risk of potentially fatal hyperkalaemia—February 2016 article
|
16.03 |
Respiratory (paediatric) |
|
|
Colistimethate Sodium
(Promixin®)
(Powder for nebuliser solution)
|
Formulary

|
- 1million-units
- For use in paediatrics only following initiation by specialist
|
|
Prednisolone
(Soluble tablets)
|
Formulary

|
- 5mg
- For emergency treatment of Croup as per BNF-C
|
|
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

|
|
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

|
|
|
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
- LiquidSF 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

|
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

|
RUH ONLY - as adjunctive therapy in pharmaco-resistant paediatric epilepsy where other AEDs have failed at optimal doses.
|
|
16.05 |
Infections (paediatric) |
|
|
|
Amikacin
(Solution for injection)
|
Formulary

|
- Swindon only
- 500mg/2ml
- Paediatric consultant/microbiology advice only
- Monitoring of drug levels required - NOT ROUTINELY STOCKED AT GWH
- Non-formulary at BaNES and Salisbury
|
|
Amoxicillin
(Tablets and oral suspension)
|
Formulary

|
- Capsules 250mg, 500mg
- Suspension 125mg/5ml and 250mg/5ml
|
|
Azithromycin
(Tablets and oral solution)
|
Formulary

|
- 250mg and 500mg
- 200mg/5ml
|
COVID-19 Therapeutic Alert - Antimicrobials (azithromycin and doxycycline) Not Beneficial in the Management of COVID-19 (SARS-CoV-2) Positive Patients
|
Doxycycline
(Capsules and dispersible tablets)
|
Formulary

|
|
COVID-19 Therapeutic Alert - Antimicrobials (azithromycin and doxycycline) Not Beneficial in the Management of COVID-19 (SARS-CoV-2) Positive Patients
|
16.06 |
Endocrine (paediatric) |
|
|
Sodium Bicarbonate 8.4%
|
Formulary

|
- 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

|
- GWH - For Consultant prescribing only.
|
|
Somatropin
(Injection)
|
Formulary
|
|
GWH shared care agreement for the use of somatropin in children (2011)
NICE TA188 Human growth hormone (somatropin) for the treatment of growth failure in children May 2010
|
Testosterone
(Injection)
|
Formulary

|
|
|
Zoledronic acid
(Intravenous injection)
|
Formulary

|
- 800micrograms/ml (4mg) vial
- Osteogenesis imperfecta and other low bone mass conditions as per the Bristol Childrens Hospital Guidelines
- Six monthly infusions
|
|
Freestyle Libre®
(Sensors)
|
Formulary

|
- ONLY to be initiated following specialist recommendation in people with diabetes who fit the NHSE criteria for funding (link below).
- Freestyle Libre should NOT be initiated by non-specialists in primary care.
- Freestyle Libre should not be initiated in people with Type 2 Diabetes (T2D) in line with NHSE policy. Exceptions are people with T2D on dialysis or with Cystic Fibrosis, and people with insulin treated T2D living with a learning disability which is recorded on the GPs learning disability register.
- Specialist teams must provide clinical oversight of a person’s use of Freestyle Libre. Including education for people initiated on Freestyle Libre , a prescribing contract, review of benefits after 6 months and ongoing follow up and review, alongside wider diabetes management.
- Continuing prescription for long-term use of Freestyle Libre post initial 6 months is contingent upon evidence of agreeing with NHSE conditions for use and that on-going use of Freestyle Libre is demonstrably improving an individual’s diabetes self-management. For example improvement of HbA1c or Time In Range; improvement in symptoms such as DKA or hypoglycaemia; or improvement in psycho-social wellbeing.
- A Freestyle Libre Sensor lasts for 2 weeks; one month’s supply is 2 sensors
Freestyle Libre 2 - Jan 2021 Update - NHSE link to follow when published
- The new Freestyle Libre 2 sensor has the added feature of real-time glucose alarms that notify people if glucose goes too low or too high.
- To manage workload & product supply, Freestyle Libre 2 will be offered to patients who meet the eligibility criteria for Flash at their next routine appointment with their specialist diabetic healthcare professional. In the current climate, we respectfully request that people wait until their next routine appointment with their specialist in 2021 to enquire about the FreeStyle Libre 2 system.
- Specialist diabetes teams will support people to use the new features included in Freestyle Libre 2 system to better manage their diabetes by supplying an information booklet and signposting to New Starter Clinic online education and support and will supply those using the old Freestyle Libre scanning device with a new Freestyle Libre 2 scanner. People using the Flash App should check that it is updated to the latest version (version 2.5 or above). Details on device compatibility can be found in the compatibility guide on the Abbott website.
|
NHSE Nov 2020 Flash Glucose Monitoring: National Arrangements for Funding of Relevant Diabetes Patients
|
16.07 |
Obs, Gyn, and UT (paediatric) |
|
|
16.08 |
Malignant Disease and Immunosuppression (paediatric) |
|
|
Mercaptopurine
(Tablet)
|
Formulary

|
- Note: 10mg strength tablets are unlicensed specials and prohibitively expensive when sourced in primary care.
- Oncology specialist use.
- 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.
|
|
16.09 |
Nutrition and Blood (paediatric) |
|
|
SMA Althera
|
First Choice

|
- Only to be prescibed in line with BSW CMPA guidance (below)
- SMA Althera (suitable from birth) is first line extensively hydrolysed formula (eHF) milk
- Aptamil Pepti, Alimentum, Nutramigen are alternative eHF options where SMA Althera is not tolerated or on the advice of a dietitian/ allergy specialist.
|
BSW Cow’s Milk Protein Allergy (CMPA) Diagnosis and Management
|
SMA Alfamino
|
Formulary

|
- Only to be prescibed in line with BSW CMPA guidance (below)
- AAF are significantly more expensive that eHF. A small number of infants will need an AAF but this should usually be prescribed on the advice of a Consultant Paediatrician, allergy specialist or Paediatric Dietitian
- SMA Alfamino (suitable from birth) is first line Amino Acid-based Formula (AAF) milk
- Neocate LCP, Neocate Junior, Neocate Syneo, Nutramigen Puramino and Elecare are alternative AAF options where SMA Alfamino is not tolerated or on the advice of a dietitian/ allergy specialist.
|
BSW Cow’s Milk Protein Allergy (CMPA) Diagnosis and Management
|
16.10 |
Musculoskeletal (paediatric) |
|
|
Piroxicam
(Orodispersible tablets)
|
Formulary

|
- Swindon only.
- 20mg melts
- Third line in children unresponsive to or intolerant of Ibuprofen and Diclofenac.
- Non-formulary in BaNES and Salisbury
|
|
Triamcinolone hexacetonide
(Solution for injection)
|
Formulary

|
- Swindon only.
- 20mg/ml
- For intra-articular administration
- Non-formulary in BaNES and Salisbury
|
|
16.11 |
Eye (paediatric) |
|
|
Ciclosporin
(Verkazia®)
(Ophthalmic drops)
|
Formulary

|
- 0.1% drops (1 mg/mL eye drops, emulsion)
- Verkazia® is licensed for the treatment of severe vernal keratoconjunctivitis in children from 4 years of age and adolescents.
- Ensure correct product is prescribed. Other ciclosporin eyedrops are available but have different licensing information and TLS. Ikervis® contains the same ingredient but is not licensed in paediatrics.
|
NICE TA369: Ciclosporin for treating dry eye disease that has not improved despite treatment with artificial tears
|
16.12 |
Ear, Nose and Oropharynx (paediatric) |
|
|
Oralvac Compact
(Oral mucosal solution)
|
Formulary

|
- Unlicensed named patient product
- Consultant Specialist initiation only
- For treatment of severe allergic rhinitis and severe allergic conjunctivitis not responding to standard treatment
|
|
Xylometazone
(Nasal drops)
|
Formulary

|
- Swindon only
- 500microgram per 1 ml
- Non-formulary in BaNES and Salisbury
|
|
16.13 |
Skin (paediatric) |
|
|
16.14 |
Immunological Products and Vaccines (paediatric) |
|
|
16.15 |
Anaesthesia (paediatric) |
|
|
16.16 |
Miscellaneous |
|
|
Glycopyrronium
(Sialanar®)
(Oral solution)
|
Formulary

|
- 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
|
BCAP Treatment of Sialorrhoea / Drooling in paediatrics: Cost-effective treatment options 2017
NICE NG62 Cerebral palsy in under 25s: assessment and management Jan 2017
|
LAT gel [Lidocaine 4%, Adrenaline 0.1% and Tetracaine 0.5%,
(3ml sterile gel )
(Topical)
|
Unlicensed

|
- Used in accident and emergency departments
|
|
16.17 |
Continence and Stoma (paediatric) |
|
|
|
.... |
Key |
|
|
Cytotoxic Drug
|
|
Controlled Drug
|
|
High Cost Medicine
|
|
Cancer Drugs Fund
|
|
NHS England |
|
Homecare |
|
CCG |
|
High Cost Drug Approval System |
|
Traffic Light Status Information
|
|
|