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 Formulary Chapter 2: Cardiovascular system - Full Chapter
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02.05.01  Expand sub section  Vasodilator antihypertensive drugs
Ambrisentan 5mg
(tablet)
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Restricted Drug Restricted
Red Specialist Centre
Restricted - prescribing by Respiratory consultants only after initiation in a Specialist centre. May be continued in BHT via shared care between Specialist centre and BHT via a network model.

For pulmonary arterial hypertension in accordance with NHSE Specialised Commissioning Policy A11/P/b, June 2014: National policy for targeted therapies for the treatment of pulmonary hypertension in adults.

The name of the Specialist centre and consultant initiating drug to be communicated to Pharmacy formulary team prior to prescribing.  
Link  NHSE Commissioning Policy A11/P/b: National Policy for targeted therapies for the treatment for the treatment of pulmonary hypertension in adults
   
Bosentan 62.5mg, 125mg
(tablet)
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Restricted Drug Restricted
Red Specialist Centre
Restricted - prescribing by Respiratory consultants only after initiation in a Specialist Centre. May be continued in BHT via shared care between Specialist centre and BHT via a network model.

For pulmonary arterial hypertension in accordance with NHSE Specialised Commissioning Policy A11/P/b, June 2014: National policy for targeted therapies for the treatment of pulmonary hypertension in adults.

The name of the Specialist centre and consultant initiating drug to be communicated to Pharmacy Formulary Team prior to prescribing.  
Link  NHSE Commissioning Policy A11/P/b: National Policy for targeted therapies for the treatment for the treatment of pulmonary hypertension in adults
   
Diazoxide 300mg/20mL
(injection)
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Restricted Drug Restricted
Red
Restricted - for ITU only 
   
Hydralazine Hydrochloride 20mg
(injection)
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Formulary
Red
 
   
Hydralazine Hydrochloride 25mg, 50mg
(tablet)
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Formulary
Green
 
   
Iloprost 100micrograms/1mL
(injection)
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Restricted Drug Restricted
Red

Red Traffic Light 1. Restricted - prescribing by Consultant vascular surgeons, rheumatologists and dermatologists only.
See Iloprost Infusion Protocol (BHTCG 684FM)

Red Specialist Centre 2. Restricted - prescribing by Respiratory Consultants only after initiation in a Specialist Centre. May be continued in BHT via shared care between Specialist centre and BHT via a network model.

For pulmonary arterial hypertension in accordance with NHSE Specialist Commissioning Policy A11/P/b, June 2014: National policy for targeted therapies for the treatment of pulmonary hypertension in adults. The name of the Specialist centre and consultant initiating drug to be communicated to Pharmacy Formulary team prior to prescribing.

 
Link   NHSE Commissioning Policy A11/P/b: National Policy for targeted therapies for the treatment for the treatment of pulmonary hypertension in adults
Link  Iloprost Infusion Protocol (BHTCG 684FM)
   
Iloprost 10micrograms/mL (Ventavis®)
(nebuliser solution)
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Restricted Drug Restricted
Red Specialist Centre
Restricted - prescribing by Respiratory consultants only after initiation in a Specialist Centre. May be continued in BHT via shared care between Specialist centre and BHT via a network model.

For pulmonary arterial hypertension in accordance with NHSE Specialised Commissioning Policy A11/P/b, June 2014: National Policy for targeted therapies for the treatment of pulmonary hypertension in adults.

The name of the Specialist centre and consultant initiating drug to be communicated to Pharmacy Formulary Team prior to prescribing. 
Link   NHSE Commissioning Policy A11/P/b: National Policy for targeted therapies for the treatment for the treatment of pulmonary hypertension in adults
   
Macitentan 10mg
(film-coated tablet)
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Restricted Drug Restricted
Red Specialist Centre

Restricted - prescribing by Respiratory consultants only after initiation in a Specialist Centre. May be continued in BHT via shared care between Specialist Centre and BHT via a network model.

For pulmonary arterial hypertension in accordance with NHSE Specialised Commissioning Policy A11/P/b, June 2014: National policy for targeted therapies for the treatment of pulmonary hypertension in adults.

The name of the Specialist Centre and consultant initiating drug to be communicated to Pharmacy Formulary Team prior to prescribing.


 
Link  NHSE Commissioning Policy A11/P/b: National Policy for targeted therapies for the treatment for the treatment of pulmonary hypertension in adults
   
Minoxidil 5mg
(tablet)
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Formulary
Amber Initiation
Use as 4th choice after Diazoxide, Hydralazine and Sodium Nitroprusside. 
   
Riociguat 0.5mg, 1mg, 1.5mg, 2mg, 2.5mg
(tablet)
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Restricted Drug Restricted
Red Specialist Centre
FOR ALL PRESCRIBING - a completed and approved HIGH COST DRUG compliance form is required. NHS England criteria to be verified if form not available.

Restricted - prescribing by Respiratory Consultants after initiation by Specialist Centre for pulmonary arterial hypertension, in accordance with NHSE SSC 1688, January 2017, and NHSE Clinical Commissioning Policy 16055/P.

Name of Specialist Centre organisation and consultant to be communicated to the BHT Formulary Team before prescribing is initiated in BHT. 
Link  NHSE Clinical Commissioning Policy 16055/P: Riociguat for pulmonary arterial hypertension
   
Sildenafil 20mg, 25mg
(tablet)
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Restricted Drug Restricted
Red Specialist Centre
Restricted - prescribing by Respiratory consultants only after initiation in a Specialist Centre. May be continued in BHT via shared care between Specialist Centre and BHT via a network model.

For pulmonary arterial hypertension in accordance with NHSE Specialised Commissioning Policy A11/P/b, June 2014: National policy for targeted therapies for the treatment of pulmonary hypertension in adults.

The name of the Specialist Centre and consultant initiating drug to be communicated to Pharmacy Formulary Team prior to prescribing.

See also 7.4.5 for use in erectile dysfunction 
Link  NHSE Commissioning Policy A11/P/b: National Policy for targeted therapies for the treatment for the treatment of pulmonary hypertension in adults
   
Sildenafil 800micrograms/1mL
(injection)
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Restricted Drug Restricted
Red
For treatment of pulmonary arterial hypertension.
FIRST DOSE MUST BE GIVEN IN HOSPITAL - risk of first-dose hypotension.
Restricted - only for patients who are unable to swallow the tablets with initiation by Respiratory consultants in secondary or tertiary care. See European Society of Cardiology guideline on diagnosis and treatment of pulmonary arterial hypertension, European Heart Journal 2004. 
   
Sodium Nitroprusside 50mg
(intravenous infusion)
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Formulary
Red
Note: Powder for dilution and use as an infusion

unlicensedunlicensed - Medium Risk 
   
Tadalafil 20mg
(tablet)
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Restricted Drug Restricted
Red Specialist Centre
Restricted - prescribing by Respiratory consultants only after initiation in a Specialist Centre. May be continued in BHT via shared care between Specialist centre and BHT via a network model.

For pulmonary arterial hypertension in accordance with NHSE Specialised Commissioning Policy A11/P/b, June 2014: National policy for targeted therapies for the treatment of pulmonary hypertension in adults.

The name of the Specialist centre and consultant initiating drug to be communicated to Pharmacy Formulary Team prior to prescribing.

See also 7.4.5 for use in erectile dysfunction. 
Link  NHSE Commissioning Policy A11/P/b: National Policy for targeted therapies for the treatment for the treatment of pulmonary hypertension in adults
   
 ....
 Non Formulary Items
Iloprost 50micrograms/0.5mL
(injection)

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Non Formulary
Black

unlicensedunlicensed - high risk


Licensed preparation available.

 
Sitaxentan Sodium  (Thelin®)

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Non Formulary
 
Tolazoline

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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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