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Birmingham, Sandwell, Solihull and environs APC Formulary
Maintained by Midlands and Lancashire Commissioning Support Unit
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 Formulary Chapter 1: Gastro-intestinal system - Full Chapter
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01.05.03  Expand sub section  Drugs affecting the immune response
Azathioprine
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Formulary
Amber
Tablets 25mg, 50mg
Maintenance of remission of acute ulcerative colitis and Crohn’s disease in adults– unlicensed but in line with national guidelines.

For use in Inflammatory Bowel Disease (IBD) as per effective shared care agreement (ESCA). See link below. 
Link  ESCA: Azathioprine in IBD
   
Ciclosporin
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Restricted Drug Restricted
Red
Capsules 10mg, 25mg, 50mg, 100mg, IV infusion 50mg/ml
Treatment of ulcerative colitis- for specialist use only
MHRA specify that ciclosporin must be prescribed and dispensed by brand as bioavailability differences exist between brands
 
   
Mercaptopurine
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Formulary
Amber
Tablet 50mg
Maintenance of remission of acute ulcerative colitis and Crohn’s disease in adults – unlicensed but in line with national guidelines

For use in Inflammatory Bowel Disease (IBD) as per effective shared care agreement (ESCA). See link below.  
Link  ESCA: Mercaptopurine in IBD
   
Cytotoxic Drug Methotrexate
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Formulary
Amber
  • Tablets 2.5mg (2.5mg tablets preferred as per NPSA alert)
    Cytotoxic- do not crush and disperse in water
  • Parenteral injection:Metoject®PEN is the APC preferred brand.
  • Unlicensed liquid may be available if required

    For use in active Crohn's disease (unlicensed indication supported by APC) as per effective shared care agreement (ESCA). See link below.
     
  • Link  ESCA: Methotrexate in active Crohn’s disease.
    Link  UKMI Q&A: Should patients drink alcohol whilst taking long-term low-dose methotrexate?
    Link  UKMI Q&A: What is the clinical significance of the interaction between methotrexate and penicillins? (Oct13)
       
    Tofacitinib (Xeljanz®)
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    Formulary
    Red
    CCG

    In line with NICE

     
    Link  NICE TA 547: Tofacitinib for moderately to severely active ulcerative colitis
       
    01.05.03  Expand sub section  Cytokine inhibitors
    Adalimumab (Humira®)
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    Restricted Drug Restricted
    Red
    High Cost Medicine
    Injection
    For specialist use only in line with NICE guidance below
     
    Link  NICE TA187: Crohn’s disease - infliximab (review) and adalimumab (review of TA40)
       
    Infliximab (Remicade®)
    View adult BNF View SPC online
    Restricted Drug Restricted
    Red
    High Cost Medicine
    Infusion
    For specialist use only in line with NICE guidance below
    Commissioned in paediatrics by NHSE
     
    Link  NICE TA163: Ulcerative colitis (acute manifestations) Infliximab
    Link  NICE TA187: Crohn’s disease- infliximab (review) and adalimumab (review of TA40)
    Link  NICE TA329: Ulcerative Colitis (treatment)- Infliximab, adalimumab and golimumab
       
    01.05.03  Expand sub section  Vedolizumab
    Vedolizumab (Entyvio®(infusion)
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    Restricted Drug Restricted
    Red
    High Cost Medicine
  • For specialist use only in line with NICE guidance below  
  • Link  NICE TA342: Ulcerative colitis- vedolizumab
    Link  NICE TA352: Crohn’s disease after prior therapy- vedolizumab
       
     ....
    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 children's BNF
    click to search medicines.org.uk
    Link to SPCs
    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

    Traffic Light Status Information

    Status Description

    Prescribing in children

    The APC notes that the informed use of unlicensed medicines or of licensed medicines for unlicensed applications (‘off-label’ use) is often necessary in paediatric practice.

    The APC advises GPs to consider specialist prescribing recommendations for Green and Amber medicines that are not subject to ESCAs or RICaDs in combination with the information provided in the BNFC which goes beyond that of marketing authorisations. The BNFC has been designed for rapid reference and the information presented has been carefully selected to aid decisions on prescribing.

      

    Green

    Medicines which are suitable for initiation and maintenance prescribing by primary and secondary care clinicians. These medicines should be initiated and prescribed within their licensed indications.  

    Amber

    Initiation and maintenance of prescribing by Specialists and transfer to Primary Care prescribing when appropriate, or initiation and maintenance of prescribing in Primary Care following recommendation from a Specialist.

    Some amber medicines require agreement with the local (internal) medicines committee prior to initiation; others may require a framework to support safe transfer and maintenance of care such as a RICaD or ESCA. The Formulary will be annotated to reflect these requirements.   

    Red

    Medicines for initiation and maintenance prescribing by Specialists only  

    Black

    Non-formulary medicines- medicines not recommended for routine primary care prescribing.  

    Grey

    Positive NICE TA and /or awaiting local clarification on place in therapy ; Please contact your Medicines Optimisation team for more information.  

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