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Birmingham, Sandwell, Solihull and environs APC Formulary
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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 SC

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 SC

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 SC
  • 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®)
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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 suitable for routine use within primary care. Initiation and maintenance of prescribing by Specialists, GPs and other qualified clinicians.   

    Amber Initiation

    Amber Specialist Initiation: Initiation and maintenance of prescribing by Specialists and transfer to Primary Care prescribing when appropriate. This may be supported by a RICaD, annotated within the formulary entry.  

    Amber Recommended

    Amber Specialist Recommendation: Initiation and maintenance of prescribing in Primary Care following recommendation from a Specialist.  

    Amber SC

    Amber Shared Care: Initiation and maintenance of prescribing by Specialists and transfer to Primary Care prescribing, in accordance with an ESCA, annotated within the formulary entry.  

    Red

    Medicines for initiation and maintenance prescribing by Specialists only.  

    Black

    Non-formulary Medicines which APC/Trust DTC has actively reviewed and do not recommend for use.  

    Grey

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

    The term 'Specialist' refers to Consultants, General Practitioners and Independant Prescribers with a Specialist Interest.  

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