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Pan Mersey
Area Prescribing Committee
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 Formulary Chapter 1: Gastro-intestinal system - Full Chapter
Notes:

Review date: June 2020

Non-formulary drugs: Any drug or formulation not listed in the formulary is deemed to be non-formulary.

Off-label use: Drugs are included in the formulary for their licensed indications – where inclusion of off-label use is considered to be included in the formulary this is specifically stated in the formulary entry for the drug N.B. also see Paediatrics note below.

Paediatrics: Drugs are included in the formulary for paediatric use for their BNF for Children recommended indications (indicated by symbol View childrens BNF) which may be off-label, unless otherwise stated. All drugs are deemed to have the same RAG status as they have for adults unless stated otherwise.

NHS England Specialised Commissioning
Drugs carrying the NHS England logo are commissioned by them. Links to key documents, national programmes of care, and clinical reference groups are found below.

NHSE NHS England Specialised Commissioning: Key documents

NHSE NHS England Specialised Commissioning: National programmes of care and clinical reference groups

 Details...
01.05.03  Expand sub section  Drugs affecting the immune response
 note 

Ciclosporin

Patients should be stabilised on a particular brand of oral ciclosporin. Prescribing and dispensing of ciclosporin should be by brand name.

Switching between formulations without close monitoring may lead to clinically important changes in blood-ciclosporin concentration. If it is necessary to switch to a different brand the patient should be monitored closely.

Oral tacrolimus products

Prescribe and dispense by brand name only, to minimise the risk of inadvertent switching between products, which has been associated with reports of toxicity and graft rejection.

Inadvertent switching between oral tacrolimus products has been associated with reports of toxicity and graft rejection. To ensure maintenance of therapeutic response when a patient is stabilised on a particular brand, oral tacrolimus products should be prescribed and dispensed by brand name only. There are 3 different oral formulations of tacrolimus:

  • Adoport®, Prograf®, Capexion®, Tacni® and Vivadex® are immediate-release capsules taken twice daily, once in the morning and once in the evening;
  • Modigraf® granules are used to prepare an immediate-release oral suspension which is taken twice daily, once in the morning and once in the evening;
  • Advagraf® is a prolonged-release capsule that is taken once daily in the morning.

Switching between different oral formulations of tacrolimus requires careful supervision and therapeutic monitoring by an appropriate specialist

Tacrolimus is RED for ulcerative colitis and Crohn's disease.

Azathioprine
View adult BNF View SPC online View childrens BNF
Formulary
Purple

Tablets 25 mg, 50 mg
10mg/ml suspension (unlicensed Special for paediatrics)

Azathioprine is metabolised to mercaptopurine.

Red   Paediatrics (NHS England commissioned)

 
Link  Pan Mersey Shared Care Framework for Azathioprine
Link  St Helen’s & Knowsley Hospitals’ Shared Care Framework
   
Mercaptopurine
View adult BNF View SPC online View childrens BNF
Formulary
Purple
Red Triangle Take care when prescribing and dispensing
Oral suspension and tablets are not bioequivalent with respect to peak plasma concentration; intensified haematological monitoring is advised when switching formulations [SPS (2018)]
Tablets 50 mg, 10 mg (unlicensed special for paediatric use)
Oral supension 100 mg/5 ml (licensed [Nova] for paediatric use - expensive)

Red Paediatrics (NHS England Commissioned)

 
Link  Pan Mersey Shared Care Framework for Mercaptopurine
Link  St Helen’s & Knowsley Hospitals’ Shared Care Framework
   
Ciclosporin
View adult BNF View SPC online View childrens BNF
Formulary
Red

Capsules 25 mg, 50 mg, 100 mg
Oral solution 100mg/ml (adults and paediatrics)

Prescribe by brand name

For acute and chronic ulcerative colitis and Crohn's disease

 
Link  Pan Mersey Shared Care Framework for Ciclosporin
Link  St Helen’s & Knowsley Hospitals’ Shared Care Framework
   
Ciclosporin
View adult BNF View SPC online View childrens BNF
Formulary
Red
Concentrate for intravenous infusion (oily) 50 mg/mL

Acute ulcerative colitis 
   
Methotrexate
View adult BNF View SPC online View childrens BNF
Formulary
Purple

Tablets 2.5 mg

Subcutaneous injection 50 mg/mL prefilled pen, 7.5mg, 10mg, 12.5mg, 15mg, 17.5mg, 20mg, 22.5mg, 25mg, 27.5mg, 30mg

Subcutaneous injection 25mg/mL pre-filled syringes, 7.5mg, 12.5mg, 15mg, 17.5mg, 20mg, 22.5mg, 25mg

BLACK 10mg tablets. Do not prescribe – see link below

The dose is always a weekly dose.
If oral methotrexate is prescribed only use the 2.5 mg strength. NPSA Patient Safety Alert No.13 June 2006

Red Paediatrics (NHS England commissioned)

Red Injection – intramuscular or intravenous injection 2.5mg/ml, 25mg/ml 100mg/ml

Red Oral solution sugar-free 2mg/ml paediatrics only

 
Link  Pan Mersey APC (2018). METHOTREXATE: safe prescribing and dispensing
Link  Pan Mersey Shared Care Framework for Methotrexate
Link  St Helen’s & Knowsley Hospitals’ Shared Care Framework
   
Tacrolimus
View adult BNF View SPC online View childrens BNF
Formulary
Red

See BNF for individual brands.
Suspension 2.5mg in 5ml (unlicensed special for paediatrics)

For acute and chronic ulcerative colitis and Crohn's disease.

Prescribe by brand name

Tacrolimus is RED for ulcerative colitis and Crohn's disease. Please see other relevant chapters of this formulary for use in other indications.

 
   
01.05.03  Expand sub section  Cytokine inhibitors
 note 

NHS NHSE drug: cytokine inhibitors in paediatrics are commissioned by NHS England

Infliximab
View adult BNF View SPC online View childrens BNF
Formulary
Red
Intravenous infusion, powder for reconstitution, 100-mg
Remicade® - Originator Brand
Flixabi ®, Inflectra®, Remisima® - Biosimilar Brands

Prescribe by brand

Crohn's disease
Acute ulcerative colitis 
Link  NICE TA163: Ulcerative colitis (acute manifestations) Infliximab
Link  NICE TA187: Crohn’s disease - infliximab (review) and adalimumab (review of TA40)
Link  NICE TA329: Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy
Link  NICE Biosimilars Position Statement
Link  MHRA Drug Safety Update - Biosimilar Products
Link  London Medicines Evaluation Network - Answers to commonly asked questions about biosimilar versions of infliximab
   
Adalimumab
View adult BNF View SPC online View childrens BNF
Formulary
Red

Injection 40-mg prefilled pen or prefilled syringe, 40 mg/0.8-mL vial

Crohn's disease

Ulcerative Colitis

Amgevita® biosimilar brand

Hulio® biosimilar brand

Hyrimoz® biosimilar brand

Imraldi® biosimilar brand

Humira® originator brand  

Prescribe by brand name

 
Link  NICE TA187: Crohn’s disease - infliximab (review) and adalimumab (review of TA40)
Link  NICE TA329: Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy
   
Golimumab
View adult BNF View SPC online
Formulary
Red
Injection 50-mg prefilled pen or prefilled syringe, 100-mg prefilled pen

Ulcerative colitis moderate - severe

Paediatrics: no BNFc entry - seek specialist advice 
Link  NICE TA329: Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy
   
Tofacitinib
View adult BNF View SPC online View childrens BNF
Formulary
Red

Film-coated tablets 5mg

For ulcerative colitis

 
Link  Pan Mersey APC (2019): TOFACITINIB film-coated tablets (Xeljanz®▼) for moderately to severely active Ulcerative Colitis
Link  NICE TA547: Tofacitinib for moderately to severely active ulcerative colitis
   
Ustekinumab
View adult BNF View SPC online
Formulary
Red

Injection; Pre-filled syringe 45mg, 90mg

Concentrate for solution for infusion; 130mg 

Crohn's Disease; moderate to severe

Grey for Ulcerative Colitis

 
Link  Pan Mersey (2019): USTEKINUMAB solution for injection (Stelara®) for ulcerative colitis
Link  NICE TA456 (2017): Ustekinumab for moderately to severely active Crohn’s disease after previous treatment
   
Vedolizumab
View adult BNF View SPC online
Formulary
Red
Concentrate for intravenous infusion, powder for reconstitution 300-mg vials

Ulcerative Colitis & Crohn's Disease

Paediatrics: no BNFc entry - seek specialist advice 
Link  NICE TA352: Vedolizumab for treating moderately to severely active Crohn’s disease after prior therapy
Link  NICE TA342: Vedolizumab for treating moderately to severely active ulcerative colitis
   
 ....
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
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

Traffic Light Status Information

Status Description

Green

Medicines considered suitable for non-specialist prescribing in primary or secondary care.  

Amber Recommended

Requires specialist assessment to enable patient selection.  Amber Recommended medicines must meet criteria: (1) Requires specialist assessment to enable patient selection (2) Following specialist assessment, the medicine is suitable for prescribing in Primary Care.  

Amber Initiated

Amber Initiated. Requires specialist initiation of prescribing. Prescribing to be continued by the specialist until stabilisation of the dose is achieved and the patient has been reviewed. Amber Initiated medicines must meet criteria: (1) Requires specialist assessment to enable patient selection (2) Medicine is suitable for on-going prescribing in Primary Care (3) Requires short to medium term specialist prescribing and monitoring of efficacy or toxicity until the patient’s dose and condition is stable   

Amber Retained

Amber Patient Retained. Requires specialist initiation of prescribing. Prescribing to be continued by specialist until stabilisation of the dose is achieved and the patient had been reviewed. Patient remains under the care of specialist (ie not discharged) as occasional specialist input may be required. Amber Patient Retained medicines must meet criteria: (1)Requires specialist assessment to enable patient selection (2)Medicine is suitable for on-going prescribing in Primary Care (3) Requires short to medium term specialist prescribing and monitoring of efficacy or toxicity until the patient’s dose and condition is stable (4) May require occasional specialist input indefinitely and therefore the patient should not be discharged from specialist care   

Amber

Medicines recommended or initiated by specialists in primary or secondary care. Non-specialist prescribing in primary care may follow according the RAG criteria. In process of being superceded by Amber Recommended, Amber Initiated and Amber Patient Retained.  

Purple

Shared Care. Medicines are considered suitable for Primary Care prescribing and/or management, following specialist initiation of therapy, with on-going communication between the Primary Care prescriber and specialist, within the framework of a Shared Care Agreement. Medicines designated as requiring Shared Care require on-going input from both Specialist and Primary Care clinicians and patients should not be discharged from Specialist care. Where prescribing and monitoring are required under shared care, it is implicit that the responsibility for both of these tasks rests with the prescriber. A Shared Care Agreement will always be available for Shared Care medicines and this document will include a Shared Care Agreement pro-forma which will be completed by all involved clinicians. This pro-forma will record agreement to take on defined aspects of care e.g. monitoring and/or on-going prescribing for the individual patients. A policy detailing clinician responsibilities in Shared Care Agreements must be referred to in all cases of Shared Care. All drugs to be included in this category must meet Shared Care criteria 1 to 3: SC1 Requires specialist assessment to enable patient selection and also initiation, stabilisation and review of treatment and the patient`s condition. SC2 Prescribing and/or management of the drug in Primary Care with specialist support and input, within the framework of the Shared Care Agreement is safe and convenient and that there is an appropriate mechanism for individual patient access in Primary Care. SC3 Requires specific long-term monitoring (blood test or other measurement) for adverse effects and / or efficacy of the drug to be completed in Primary Care, and requires on-going specialist support for the dose changes or management of adverse effects. Monitoring is required on a regular basis (typically four times a year). Implicit in any shared care agreement is the understanding that participation is at the discretion of the Primary Care prescriber subject to their clinical confidence.   

Red

Primary care prescribing of these medicines is NOT recommended. These treatments should be initiated by specialists only; ongoing prescribing is retained within secondary care.   

Black

Not recommended for use. Deviation from the policy may be considered on an individual basis where exceptional circumstances exist.   

Grey

Not recommended for use at this time. Deviation from the policy may be considered on an individual basis where exceptional circumstances exist. Further guidance will be issued when more information or evidence is made available.  

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