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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...
16.01  Expand sub section  Gastro-Intestinal (paediatric)
Docusate Sodium
View adult BNF View SPC online
Formulary
traffic lightGreen
  • 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)
View adult BNF View SPC online
Formulary
traffic lightGreen
  • 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)
View adult BNF View SPC online
Formulary
traffic lightGreen
  • 1 dose = half a dual sachet
  • Prescribe as doses
 
 
Mercaptopurine
(Tablet)
View adult BNF View SPC online
Formulary
traffic lightRed
  • 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)
View adult BNF View SPC online
Restricted Drug Restricted
traffic lightAmber
High Cost Medicine
  • 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).  
 
Link  Guidance on use of PPIs in Children from (SFT)
 
 ....
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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