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 Formulary Chapter 3: Respiratory system - Full Chapter
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03.07  Expand sub section  Mucolytics
Acetylcysteine 600mg
(tablet (effervescent))
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Restricted Drug Restricted
Red
Restricted - prescribing by Respiratory Team. Cardiology team may prescribe for renoprotection of patients undergoing contrast enhanced MRI. 
   
Carbocisteine 375mg
(capsules)
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Restricted Drug Restricted
Green
In secondary care restricted - Respiratory Team

In primary care review effectiveness after 4-6 weeks 
   
Carbocisteine 750mg/10ml
(sugar-free oral solution in sachet)
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Restricted Drug Restricted
Green

As second line to carbocisteine capsules where carbocisteine capsules cannot be swallowed.

In secondary care restricted - Respiratory Team

In primary care review effectiveness after 2-4 weeks


 
   
Ivacaftor (Kalydeco®)
(film-coated tablets)
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Restricted Drug Restricted
Red Specialist Centre
Restricted - prescribing by Respiratory and Paediatric consultants only after initiation in a Specialist centre and delivered as outreach as part of a provider network.

For Cystic Fibrosis in accordance with NHSE Clinical Commissioning Policy A01/P/c and SSC 1541, October 2015.

The name of the Specialist centre and consultant initiating Ivacaftor to be communicated to Pharmacy Formulary Team prior to prescribing.  
Link  NHSE Commissioning Policy A01/P/c: Ivacaftor for Cystic Fibrosis (named mutations)
   
Mannitol 40mg (Bronchitol ®)
(inhalation powder, hard capsule)
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Restricted Drug Restricted
Red
High Cost Medicine
FOR ALL PRESCRIBING - NICE compliance to be verified.

Restricted - to prescribing by Respiratory consultants in accordance with NICE TA 266.
NOTE: Unlikely to be used in BHT as all adult CF patients are treated in Oxford or London. 
Link  NICE TA266 Mannitol dry powder for inhalation for treating cystic fibrosis
   
03.07  Expand sub section  Dornase alfa
Dornase Alfa 2.5mg (2500units)/2.5mL
(nebuliser solution)
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Formulary
Red
 
   
03.07  Expand sub section  Hypertonic Sodium Chloride
Sodium Chloride 6% (Hypertonic) (MucoClear®6%)
(nebuliser solution)
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Formulary
Red
 
   
03.07  Expand sub section  Mannitol
 ....
 Non Formulary Items
Carbocisteine 125/5mL  (oral liquid)

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Non Formulary
Black
Discontinued
 
Erdosteine  (Erdotin®)

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Non Formulary
 
Lumacaftor/ivacaftor 200mg/125mg  (Orkambi®)
(Tablets)

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Non Formulary
Black
Link  NICE TA 398: Lumacaftor–ivacaftor for treating cystic fibrosis homozygous for the F508del mutation
 
Mecysteine Hydrochloride  (Visclair®)

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Non Formulary
 
  
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

Black

Not recommended for use because of lack of evidence of clinical effectiveness, cost effectiveness or safety.
Drugs which have been evaluated and rejected by the Medicines Value Group (MVG)
Drugs defined as ‘Low Priority’ by the South Central Priorities Committee
New drugs which have not as yet been evaluated by the MVG
Any drug not listed in the Buckinghamshire Formulary  

Red

Drugs which should only be prescribed in secondary care by a specialist.
Require specialist knowledge and/or equipment for patient selection and initiation
Require long term on-going monitoring and dose adjustment to ensure efficacy and minimise toxicity by a specialist
Designated as “hospital only“ by product licence, NICE, DoH or BNF
May need further evaluation by a specialist
Are hospital initiated clinical trial materials  

Red Specialist Centre

As for ‘red’ (above) with the addition of the following:
Designated by NHS England to require initiation by or in prior agreement with a Specialist Centre. Continuation where appropriate by BHT (or other secondary care provider)
Detailed requirements for Specialist Centre initiation to be described in the wording of the formulary restriction  

Amber Protocol

Drugs which should be initiated in secondary care by the specialist with follow-on prescription and monitoring according to a drug specific Shared Care Protocol(SCP). Prescribing may be continued in primary care following the SCP
Require specialist knowledge and/or equipment for patient selection and initiation
Require short or medium term (eg. 3 to 6 months) specialist monitoring of efficacy or toxicity. The need for stabilisation will vary with different drugs and patients, but is usually a minimum of 2 months (see principles for shared care)
Require significant long term monitoring
Require ongoing communication between the GP and the specialist
Have clearly defined consultant, GP and patient responsibilities documented in a shared care protocol (see responsibilities for amber protocol drugs)  

Amber Initiation

Drugs suitable for primary care prescribing following specialist initiation
Require specialist knowledge and/or equipment for patient selection
Monitoring does not require specialist knowledge or equipment
If the drug is one with which the primary care prescriber is unfamiliar the specialist is expected to provide sufficient information on the drug indication, dose, duration , monitoring and any further necessary dose adjustments
Require the first prescription to be written by the specialist  

Amber Recommended

Drugs suitable for primary care prescribing following specialist recommendation
As for amber initiation except that:- The first prescription may be written by the GP after specialist recommendation.  

Green

Drugs for which primary care prescribers would normally take full responsibility for prescribing and monitoring
Drugs not included in the Traffic Light list but included on joint formulary.
New drugs classified as red or amber but as greater experience regarding their safety and efficacy is established may move to Green after re-consideration by the MVG and APC.  

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