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 Formulary Chapter 3: Respiratory system - Full Chapter
Notes:

Review date: March 2022

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

Chapter Links...
 Details...
03.07  Expand sub section  Mucolytics
 note 

 

Acetylcysteine (NACSYS®)
View adult BNF
First Choice
Green

Effervescent tablets 600mg

Prescribe by brand name.

Black For interstitial pulmonary fibrosis

 
Carbocisteine
View adult BNF View SPC online View childrens BNF
First Choice
Green
Capsules 375 mg;
Oral liquid 250 mg/5 mL
Sachets 750mg/10ml 
Hypertonic sodium chloride
View adult BNF View SPC online View childrens BNF
Formulary
Amber Recommended

Nebuliser solution 3%, 6%, 7%, ampoules

 
   
Acetylcysteine
View adult BNF View SPC online View childrens BNF
Formulary
Red
Injection 200mg in 1mL (administered orally)

For management of distal intestinal obstruction syndrome (DIOS)in cystic fibrosis and meconium ileus. 
   
Dornase alfa
View adult BNF View SPC online View childrens BNF
Formulary
Red
Nebuliser solution 1000 units (1 mg)/mL
(For use undiluted with jet nebulisers only; ultrasonic nebulisers are unsuitable)

NHS NHSE commissioned drug - see Specialised Commissioning: Key documents
N.B. Existing prescribing may remain in primary care until any repatriation to hospitals under NHS England commissioned service takes place. 
   
Ivacaftor (Kalydeco®)
View adult BNF View SPC online View childrens BNF
Formulary
Red
Film coated tablets 150mg
Granules sachets 50mg, 75mg

NHS NHSE commissioned drug - see Specialised Commissioning: Key documents
 
Link  IVACAFTOR (Kalydeco) NHS England specialised commissioning resources: the clinical reference group responsible for cystic fibrosis has published a commissioning policy that defines access to a particular service for a cohort of patients.
   
Lumacaftor and Ivacafotor (Orkambi®)
View adult BNF View SPC online View childrens BNF
Formulary
Red
Film coated tablets 200mg lumacaftor/125mg ivacaftor

NHS NHSE commissioned drug - see Specialised Commissioning: Key documents
 
Link  NICE TA398: Lumacaftor–ivacaftor for treating cystic fibrosis homozygous for the F508del mutation
   
Mannitol
View adult BNF View SPC online
Formulary
Red
Mannitol 40 mg inhalation powder, hard capsule

NHS NHSE commissioned drug - see Specialised Commissioning: Key documents


Paediatrics: no BNFc entry - seek specialist advice 
Link  TA266 Mannitol dry powder for inhalation for treating cystic fibrosis National Institute for Health and Clinical Excellence Technology Appraisal
   
Oscillating positive expiratory pressure device
Formulary
Amber Initiated

Acapella®

Flutter®

Lungflute®

Pari O-PEP®

RC-Cornet®

Recommended for consideration when selecting an appropriate airway clearance technique in those with CF and non-CF bronchiectasis. OPEP treatment should be provided only after individual assessment by an appropriately skilled therapist.

Treatment should not be initiated by GPs or other non-specialists.

 
   
 ....
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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