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 Formulary Chapter 3: Respiratory system - Full Chapter
Notes:

*Important*

The NENC ICB Respiratory Network recommends that all inhalers should be prescribed by brand for patient safety, to ensure that the correct device is dispensed to support correct technique and avoid patient confusion and medication errors.

Choice of inhaler device should be based on patient ability to use. Devices should be chosen based on availability for the type of drug to be prescribed and the patient’s ability to use it.

Refer to local guidelines for information on preferred options.

Note: All new patients should be started on the updated formulary choices as per local/national guidelines.

When inhalers are removed from the formulary, existing, stable, patients should continue to receive the non-formulary device. Treatment should not be changed unless a full face to face review has been conducted.

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03.07  Expand sub section  Mucolytics
Acetylcysteine
(Mucolytic)
View adult BNF View SPC online View childrens BNF
Formulary
Green
  • 600mg effervescent tablets.
  • Green Green for licensed indications.
  • Green plus For use on specialist advice in the treatment of idiopathic pulmonary fibrosis.
  • For the prevention of x-ray contrast media induced renal damage Red Traffic Light.

 

 
 
Carbocisteine
View adult BNF View SPC online View childrens BNF
Formulary
Green
  • 375mg capsules.
  • 750mg/10ml oral solution in sachets: first choice liquid preparation for adult patients.
  • 250mg in 5ml syrup.
 
 
Sodium Chloride 0.9%
View adult BNF View SPC online View childrens BNF
Formulary
Green
  • Nebuliser solution: 10ml 
 
 
Ivacaftor
View adult BNF View SPC online View childrens BNF
Formulary
Red
High Cost Medicine
  • Approved for the treatment of cystic fibrosis in patients who have a faulty mutation in the CFTR gene in line with NHS England Clinical Commissioning Policy. 
  • Only available from:
    • South Tees Hopsitals NHS Foundation Trust
    • The Newcastle upon Tyne Hospitals NHS Foundation Trust
 
Link  Commissioning statement: Ivacaftor, tezacaftor/ivacaftor, lumacaftor/ivacaftor and elexacaftor/tezacaftor/ivacaftor for cystic fibrosis
Link  MHRA Drug Safety Update (Feb 2022): Ivacaftor, tezacaftor, elexacaftor (Kaftrio▼) in combination with ivacaftor (Kalydeco): risk of serious liver injury; updated advice on liver function testing
 
Lumacaftor and IvacaftorBlack Triangle (Orkambi®)
View adult BNF View SPC online View childrens BNF
Formulary
Red
High Cost Medicine
NHS England
  • Ivacaftor 125mg/lumacaftor 100mg & ivacaftor 200mg/lumacaftor tablets
  • Ivacaftor 95mg/lumacaftor 75mg, ivacaftor 125mg/lumacaftor 100mg &
    ivacaftor 188mg/lumacaftor 188mg granules in sachet
  • Approved for the treatment of cystic fibrosis in patients 1 year and older who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene in line with NHS England Specialised Commissioning Policy (SSC2538)
  • Only available from:
    • South Tees Hopsitals NHS Foundation Trust
    • The Newcastle upon Tyne Hospitals NHS Foundation Trust
 
Link  Commissioning statement: Ivacaftor, tezacaftor/ivacaftor, lumacaftor/ivacaftor and elexacaftor/tezacaftor/ivacaftor for cystic fibrosis
Link  NICE TA398: Lumacaftor–ivacaftor for treating cystic fibrosis homozygous for the F508del mutation
 
Tezacaftor and ivacaftor  (Symkevi®)
View adult BNF View SPC online View SMC online View childrens BNF
Formulary
Red
High Cost Medicine
NHS England
  • Ivacaftor 75g/tezacaftor 50mg tablet & ivacaftor 100mg/tezacaftor 150mg tablet
  • Approved for the treatment of cystic fibrosis in line with NHS England Commissioning Policy
  • Only available from:
    • South Tees Hopsitals NHS Foundation Trust
    • The Newcastle upon Tyne Hospitals NHS Foundation Trust

 

 
Link  Commissioning statement: Ivacaftor, tezacaftor/ivacaftor, lumacaftor/ivacaftor and elexacaftor/tezacaftor/ivacaftor for cystic fibrosis
 
Tezacaftor with ivacaftor and elexacaftor (Kaftrio®)
View adult BNF View SPC online View SMC online View childrens BNF
Formulary
Red
High Cost Medicine
NHS England
  • Ivacaftor 75g/tezacaftor 50mg/elexacaftor 100mg & Ivacaftor 37.5mg/tezacaftor 25mg/elexacaftor 50mg tablet
  • Approved for the treatment of cystic fibrosis in line with NHS England Commissioning Policy
  • Only available from:
    • South Tees Hopsitals NHS Foundation Trust
    • The Newcastle upon Tyne Hospitals NHS Foundation Trust

 

 
Link  Commissioning statement: Ivacaftor, tezacaftor/ivacaftor, lumacaftor/ivacaftor and elexacaftor/tezacaftor/ivacaftor for cystic fibrosis
Link  MHRA Drug Safety Update (Feb 2022): Ivacaftor, tezacaftor, elexacaftor (Kaftrio▼) in combination with ivacaftor (Kalydeco): risk of serious liver injury; updated advice on liver function testing
 
03.07  Expand sub section  Dornase alfa
Dornase Alfa
View adult BNF View SPC online View childrens BNF
Formulary
Red
High Cost Medicine
 
 
03.07  Expand sub section  Hypertonic Sodium Chloride
Hypertonic sodium chloride 7% (Nebusal®)
(For nebulisation)
View adult BNF View SPC online View childrens BNF
Formulary
Green plus
 
 
03.07  Expand sub section  Mannitol
Mannitol inhalation (Bronchitol ®)
View adult BNF View SPC online View childrens BNF
Formulary
Red
High Cost Medicine
  • Only approved for use in accordance with NICE guidance. 
 
Link  NICE TA266: Cystic fibrosis - mannitol dry powder for inhalation
 
Mannitol inhalation
(0mg, 5mg, 10mg, 20mg, 40mg capsules for inhalation)
View adult BNF View SPC online View childrens BNF
Formulary
Red
  • Approved for bronchial provocation testing in patients unable to tolerate the taste of methacholine.
 
 
 ....
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
NHSE
NHS England
Homecare
Homecare
CCG
CCG

Traffic Light Status Information

Status Description

Red

Drugs for hospital use only. The responsibility for initiation and monitoring treatment should rest with an appropriate hospital clinician and the drug should be supplied through the hospital throughout the duration of treatment. In some very exceptional circumstances (e.g. due to distance from the hospital, storage, supply or mobility/transport problems) it may be appropriate for the GP to be asked to prescribe a Red drug. This should be negotiated on an individual patient basis and should only be done with the GP’s prior informed agreement where the roles of the GP and hospital services are clearly defined and agreed. The GP should not feel under pressure to prescribe in these circumstances. For all RED drugs automatically added to the formulary in response to a positive NICE TA: Prescribers need to ensure that local Trust new drug governance procedures and pharmacy processes are followed before any prescribing.  

Amber

Drugs initiated by hospital specialist, but where continuing treatment by GPs may be appropriate under a shared care arrangement. The specialist should send the GP a copy of the shared care agreement to sign. The GP should sign the shared care agreement, or indicate they do not want to be part of such an agreement, and return a copy back to the specialist. Shared care guidelines are available or are being developed for most of the drugs listed as Amber. If no shared care guideline is available, the hospital specialist should provide the patient’s GP with sufficient information and support to allow treatment to be continued and managed safely in primary care.  

Green plus

Drugs normally recommended or initiated by a specialist (hospital or GP with an extended role https://www.rcgp.org.uk/gpwer), but can be safely maintained in primary care with very little or no monitoring required. In some cases there may be a further restriction for use outlined - these will be defined in each case. Provision of additional information, or an information leaflet, may be appropriate in some cases to facilitate continuing treatment by GPs.  

Green

Drugs where prescribing by GPs is appropriate. Can be initiated and prescribed in all care settings, and if appropriate, discontinued without recourse to secondary care.  

Black

NOT APPROVED: Drugs that have been considered by NTAG or the NENC ICB Medicines Subcommittee (or other approved body) and are not approved for prescribing within the North East and North Cumbria.   

Brown

UNDER REVIEW: drugs whose current formulary status or RAG status is currently under review.  

Not Recomended

NOT REVIEWED: Drugs that haven not been reviewed yet. This usually means that an application is in progress. These drugs are not normally considered appropriate for prescribing in the North East and North Cumbria until such time that a decision is taken on their formulary status.  

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