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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...
16.06  Expand sub section  Endocrine (paediatric)
Sodium Bicarbonate 8.4%
View adult BNF View SPC online
Formulary
traffic lightRed
  • 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
traffic lightRed
  • GWH - For Consultant prescribing only. 
 
 
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  NICE TA188 Human growth hormone (somatropin) for the treatment of growth failure in children May 2010
 
Testosterone
(Injection)
View adult BNF View SPC online
Formulary
traffic lightRed
  • 250mg in 1ml
 
 
Zoledronic acid
(Intravenous injection)
View adult BNF View SPC online
Formulary
traffic lightRed
  • 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)
View adult BNF View SPC online
Formulary
traffic lightAmber
  • 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.
 
Link  NHSE Nov 2020 Flash Glucose Monitoring: National Arrangements for Funding of Relevant Diabetes Patients
 
 ....
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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