| Formulary Chapter 3: Respiratory system - Full Chapter
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| 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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| Chapter Links... |
 NICE NG244: Asthma pathway (BTS, NICE, SIGN) |
| County Durham and Tees Valley Paediatric Asthma Inhaler Guide |
 North of Tyne, Gateshead and North Cumbria - Asthma in Children Summary Guideline |
| North of Tyne, Gateshead and North Cumbria - Paediatric Asthma Inhaler Guidance (Children under 5 years) |
| NICE NG115: Chronic obstructive pulmonary disease in over 16s: diagnosis and management |
| MHRA Drug Safety Update (July 2018): Pressurised metered dose inhalers (pMDI): risk of airway obstruction from aspiration of loose objects |
| NENC COPD Guideline |
| NICE NG245: Asthma: diagnosis, monitoring and chronic asthma management |
| NICE TA10: Asthma inhaler devices (children under 5) |
| NICE TA38: Asthma inhaler devices (older children) |
| North Cumbria - Paediatric doses of inhaled corticosteroids |
| Details... |
| 03.07 |
Mucolytics |
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Acetylcysteine
(Mucolytic)
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Formulary
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- 600mg effervescent tablets.
- Green for licensed indications.
 For use on specialist advice in the treatment of idiopathic pulmonary fibrosis.- For the prevention of x-ray contrast media induced renal damage
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Carbocisteine
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Formulary
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- 375mg capsules.
- 750mg/10ml oral solution in sachets: first choice liquid preparation for adult patients.
- 250mg in 5ml syrup.
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Sodium Chloride 0.9%
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Formulary
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Ivacaftor
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Formulary
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- 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
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Commissioning statement: Ivacaftor, tezacaftor/ivacaftor, lumacaftor/ivacaftor and elexacaftor/tezacaftor/ivacaftor for cystic fibrosis
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
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Lumacaftor and Ivacaftor (Orkambi®)
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Formulary
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- 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
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Commissioning statement: Ivacaftor, tezacaftor/ivacaftor, lumacaftor/ivacaftor and elexacaftor/tezacaftor/ivacaftor for cystic fibrosis
NICE TA988: Ivacaftor–tezacaftor–elexacaftor, tezacaftor–ivacaftor and lumacaftor–ivacaftor for treating cystic fibrosis
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Tezacaftor and ivacaftor (Symkevi®)
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Formulary
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- 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
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Commissioning statement: Ivacaftor, tezacaftor/ivacaftor, lumacaftor/ivacaftor and elexacaftor/tezacaftor/ivacaftor for cystic fibrosis
TA988: Ivacaftor–tezacaftor–elexacaftor, tezacaftor–ivacaftor and lumacaftor–ivacaftor for treating cystic fibrosis
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Tezacaftor with ivacaftor and elexacaftor (Kaftrio®)
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Formulary
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- 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
|
Commissioning statement: Ivacaftor, tezacaftor/ivacaftor, lumacaftor/ivacaftor and elexacaftor/tezacaftor/ivacaftor for cystic fibrosis
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
TA988: Ivacaftor–tezacaftor–elexacaftor, tezacaftor–ivacaftor and lumacaftor–ivacaftor for treating cystic fibrosis
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| 03.07 |
Dornase alfa |
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Dornase Alfa
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Formulary
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| 03.07 |
Hypertonic Sodium Chloride |
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Hypertonic sodium chloride 7% (Nebusal®)
(For nebulisation)
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Formulary
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| 03.07 |
Mannitol |
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Mannitol inhalation (Bronchitol ®)
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Formulary
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- Only approved for use in accordance with NICE guidance.
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NICE TA266: Cystic fibrosis - mannitol dry powder for inhalation
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Mannitol inhalation
(0mg, 5mg, 10mg, 20mg, 40mg capsules for inhalation)
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Formulary
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- Approved for bronchial provocation testing in patients unable to tolerate the taste of methacholine.
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Key |
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Restricted Drug |
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Unlicensed |
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Link to adult BNF
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Link to children's BNF
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Link to SPCs
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Cytotoxic Drug |
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Controlled Drug |
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High Cost Medicine |
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NHS England |
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Homecare |
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ICB |
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Low carbon footprint |
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Medium carbon footprint |
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High carbon footprint |
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| Status |
Description |
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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. |
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Drugs initiated by hospital specialist, but where continuing treatment by GPs may be appropriate under a shared care arrangement. These medicines are considered suitable for primary care prescribing following specialist initiation of therapy and stabilisation, with ongoing communication between the primary care prescriber and specialist as set out in the associated shared care guideline (SCG). Shared care should be initiated by the specialist, which includes consultant, suitably trained specialist non-medical prescriber or GPwER within a secondary, tertiary, or primary care clinic.
The specialist should send the primary care prescriber a copy of the NENC Clinical Effectiveness and Governance (CEG) Subcommittee approved SCG to sign. The primary care prescriber should sign the SCG or indicate reasons why they are unable to accept the agreement and return a copy back to the specialist, as soon as possible.
SCGs are available or are being developed for most of the drugs listed as AMBER. |
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Drugs normally recommended or initiated by a hospital specialist who is a prescriber, a GP with an extended role [GPwER], or a specialist within primary care which can be safely maintained in primary care and monitored in primary care. In some cases, a further restriction for use may be defined. The primary care prescriber must be familiar with the drug to take on prescribing responsibility or must obtain the required information from the specialist. Therefore, provision of additional information, or an information leaflet, may be appropriate in some cases to facilitate continuing treatment by primary care prescriber or provide information re stopping criteria.
These are considered suitable for primary care prescribing following specialist assessment and recommendation of therapy, with ongoing communication between the primary care prescriber and specialist, if necessary.
In some case these drugs require specialist initiation and short to medium term monitoring of efficacy or toxicity until the patient’s dose is stable. Following specialist review the patient may be transferred to primary care for ongoing prescribing. Ongoing prescribing by primary care can include, if required, additional dose titrations and assessment of efficacy, with ongoing communication between the primary care prescriber and specialist, if necessary.
If the drug requires urgent initiation, it is expected that the specialist undertakes the initial prescribing responsibility for an appropriate period of time, usually a minimum of 28 days. A GREEN+ drug can only be recommended to primary care for initiation if does not need to be initiated within 28 days. |
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Medicines suitable for initiation, ongoing prescribing and discontinuation in all care settings, subject to appropriate communication between those responsible. |
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UNDER REVIEW: drugs whose current formulary status or RAG status is currently under review. |
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Drugs that have been considered by the NENC Clinical Effectiveness and Governance (CEG) Subcommittee (or other approved body) and are not approved for prescribing within the North East and North Cumbria ICS. These may also include all medicines with a “not NHS” or “DLCV” classification in the BNF, those agents as included within the NICE “Do not do” list, and those agents included with the NHS England: Items which should not routinely be prescribed in primary care. |
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