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 Formulary Chapter 2: Cardiovascular system - Full Chapter
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02.08.02  Expand sub section  Oral anticoagulants
Acenocoumarol 1mg
(tablet)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Amber Protocol

Restricted - for use in accordance with Anticoagulants, oral (warfarin, acenocoumarol, phenindione) when doses adjusted by Anticoagulation service & prescribed by GP Shared Care protocol (BHTCG 797FM)

 
Link  Anticoagulants, oral (warfarin, acenocoumarol, phenindione) when doses adjusted by Anticoagulation service & prescribed by GP - Shared Care protocol (BHTCG 797FM)
   
Apixaban 2.5mg, 5mg
(tablet)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted

NOTE: Tablets can be dissolved/crushed and administered via nasogastric/PEG tubes.


Amber For treatment of DVT and PE and prevention of recurrent DVT and PE in adults unsuitable for warfarin, for whom dalteparin would otherwise be considered, in accordance with NICE TA 341 and the Dabigatrin, Rivaroxaban, Apixaban and Edoxaban for DVT and PE - Amber Initiation guideline (BHTCG 295FM).

Initiation by or on the advice of  consultant Haematologists or DOAC pharmacists with continuation by GPs.  Any consultant may refer DVT/PE cases to Haematology / DOAC service for a decision about treatment after dalteparin has already been initiated. 

 
Green For preventing stroke and systemic embolism in adults with non-valvular atrial fibrillation in accordance with Dabigatran, Rivaroxaban, Edoxaban and Apixaban for Atrial Fibrillation guideline (BHTCG 313FM).

 
Link  MHRA Drug Safety Update - June 2019: Direct-acting oral anticoagulants (DOACs): increased risk of recurrent thrombotic events in patients with antiphospholipid syndrome
Link  Dabigatran, Rivaroxaban, Edoxaban and Apixaban for Atrial Fibrillation - Primary/Secondary Care guideline (BHTCG 313FM)
Link  Dabigatrin, Rivaroxaban, Apixaban and Edoxaban for Deep Vein Thrombosis and Pulmonary Embolism - Amber Initiation guideline (BHTCG 295FM)
Link  Rivaroxaban & Apixaban - Management of Overdose, Bleeding & Emergency/Elective Surgery (BHTCG 240FM)
Link  NICE TA 275: Apixaban for preventing stroke and systemic embolism in people with nonvalvular atrial fibrillation
Link  NICE TA 341: Apixaban for the treatment and secondary prevention of deep vein thrombosis and/or pulmonary embolism
   
Dabigatran etexilate 110mg, 150mg
(capsule)
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Restricted Drug Restricted

Amber For treatment of DVT and PE and prevention of recurrent DVT and PE in adults unsuitable for warfarin, for whom dalteparin would otherwise be considered, in accordance with NICE TA 341 and the Dabigatrin, Rivaroxaban, Apixaban and Edoxaban for DVT and PE - Amber Initiation guideline (BHTCG 295FM).

Initiation by or on the advice of  consultant Haematologists or DOAC pharmacists with continuation by GPs.  Any consultant may refer DVT/PE cases to Haematology / DOAC service for a decision about treatment after dalteparin has already been initiated. 

 
Green For preventing stroke and systemic embolism in adults with non-valvular atrial fibrillation in accordance with Dabigatran, Rivaroxaban, Edoxaban and Apixaban for Atrial Fibrillation guideline (BHTCG 313FM).

 
Link  MHRA Drug Safety Update - June 2019: Direct-acting oral anticoagulants (DOACs): increased risk of recurrent thrombotic events in patients with antiphospholipid syndrome
Link  Dabigatran - Management of Overdose, Bleeding & Emergency/Elective Surgery (BHTCG 34FM)
Link  Dabigatran, Rivaroxaban, Edoxaban and Apixaban for Atrial Fibrillation - Primary/Secondary Care guideline (BHTCG 313FM)
Link  Dabigatrin, Rivaroxaban, Apixaban and Edoxaban for Deep Vein Thrombosis and Pulmonary Embolism - Amber Initiation guideline (BHTCG 295FM)
Link  NICE TA249: Dabigatran for Stroke prevention in AF
Link  NICE TA327: Dabigatran etexilate for the treatment and secondary prevention of deep vein thrombosis and/or pulmonary embolism
   
Dabigatran etexilate 75mg, 110mg
(capsule)
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Restricted Drug Restricted
Red
Restricted - to prescribing by Orthopaedic team for use in accordance with the VTE Policy and VTE Risk Assessment for Total Hip and Knee Replacement (THR and TKR).
 
Link  MHRA Drug Safety Update - June 2019: Direct-acting oral anticoagulants (DOACs): increased risk of recurrent thrombotic events in patients with antiphospholipid syndrome
Link  Dabigatran - Management of Overdose, Bleeding & Emergency/Elective Surgery (BHTCG 34FM)
   
Edoxaban 15mg, 30mg, 60mg
(tablet)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted

Amber For treatment of DVT and PE and prevention of recurrent DVT and PE in adults unsuitable for warfarin, for whom dalteparin would otherwise be considered, in accordance with NICE TA 341 and the Dabigatrin, Rivaroxaban, Apixaban and Edoxaban for DVT and PE - Amber Initiation guideline (BHTCG 295FM).

Initiation by or on the advice of  consultant Haematologists or DOAC pharmacists with continuation by GPs.  Any consultant may refer DVT/PE cases to Haematology / DOAC service for a decision about treatment after dalteparin has already been initiated. 

 
Green For preventing stroke and systemic embolism in adults with non-valvular atrial fibrillation in accordance with Dabigatran, Rivaroxaban, Edoxaban and Apixaban for Atrial Fibrillation guideline (BHTCG 313FM).

 
Link  MHRA Drug Safety Update - June 2019: Direct-acting oral anticoagulants (DOACs): increased risk of recurrent thrombotic events in patients with antiphospholipid syndrome
Link  Dabigatran, Rivaroxaban, Edoxaban and Apixaban for Atrial Fibrillation - Primary/Secondary Care guideline (BHTCG 313FM)
Link  Dabigatrin, Rivaroxaban, Apixaban and Edoxaban for Deep Vein Thrombosis and Pulmonary Embolism - Amber Initiation guideline (BHTCG 295FM)
Link  NICE TA 354:Edoxaban for treating and for preventing deep vein thrombosis and pulmonary embolism
Link  NICE TA355: Edoxaban for preventing stroke and systemic embolism in people with non-valvular atrial fibrillation
   
Phenindione 10mg, 25mg, 50mg
(tablet)
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Restricted Drug Restricted
Amber Protocol

Restricted - Initiation by Haematology team / Anticoagulant monitoring service, with continuation by GPs in accordance with the Anticoagulants, oral (warfarin, acenocoumarol, phenindione) when doses adjusted by Anticoagulation service & prescribed by GP - Shared Care protocol (BHTCG 797FM), when warfarin, all four NOACs and acecoumarol are unsuitable as a 7th line oral anticoagulant.

 
Link  Anticoagulants, oral (warfarin, acenocoumarol, phenindione) when doses adjusted by Anticoagulation service & prescribed by GP - Shared Care protocol (BHTCG 797FM)
   
Rivaroxaban 10mg
(tablet)
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Formulary
Red

Restricted: COVID-19 VTE prevention.  Unlicensed use.            


In COVID-19 patients, Rivaroxaban 10mg can be used as an alternative to dalteparin in appropriate patients for discharge VTE prophylaxis.                                                              


Use in accordance with guideline: VTE - Venous Thromboembolism In Patients 16 Years Or Above On Wards During Covid-19 - Secondary Care Guideline (BHTCG 66FM)

 
Link  VTE - Venous Thromboembolism In Patients 16 Years Or Above On Wards During Covid-19 - Secondary Care Guideline (BHTCG 66FM)
   
Rivaroxaban 10mg, 15mg, 20mg
(tablet)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted

Amber For treatment of DVT and PE and prevention of recurrent DVT and PE in adults unsuitable for warfarin, for whom dalteparin would otherwise be considered, in accordance with NICE TA 341 and the Dabigatrin, Rivaroxaban, Apixaban and Edoxaban for DVT and PE - Amber Initiation guideline (BHTCG 295FM).

Initiation by or on the advice of  consultant Haematologists or DOAC pharmacists with continuation by GPs.  Any consultant may refer DVT/PE cases to Haematology / DOAC service for a decision about treatment after dalteparin has already been initiated. 

 
Green For preventing stroke and systemic embolism in adults with non-valvular atrial fibrillation in accordance with Dabigatran, Rivaroxaban, Edoxaban and Apixaban for Atrial Fibrillation guideline (BHTCG 313FM).

 
Link  MHRA Drug Safety Update - July 2019: Rivaroxaban (Xarelto▼): reminder that 15mg and 20mg tablets should be taken with food
Link  Dabigatran, Rivaroxaban, Edoxaban & Apixaban for Atrial Fibrillation - Primary/Secondary Care guideline (BHTCG 313FM)
Link  Dabigatrin, Rivaroxaban, Apixaban and Edoxaban for Deep Vein Thrombosis and Pulmonary Embolism - Amber Initiation guideline (BHTCG 295FM)
Link  MHRA Drug Safety Update - June 2019: Direct-acting oral anticoagulants (DOACs): increased risk of recurrent thrombotic events in patients with antiphospholipid syndrome
Link  MHRA Drug Safety Update - October 18: Rivaroxaban (Xarelto▼) after transcatheter aortic valve replacement: increase in all-cause mortality, thromboembolic and bleeding events in a clinical trial
Link  NICE TA256: Rivaroxaban for the prevention of stroke and systemic embolism in patients with AF
Link  NICE TA261: Rivaroxaban for treatment of DVT
Link  NICE TA287 Pulmonary embolism and recurrent venous thromboembolism - rivaroxaban
Link  Rivaroxaban & Apixaban - Management of Overdose, Bleeding & Emergency/Elective Surgery (BHTCG 240FM)
   
Rivaroxaban 2.5mg
(tablet)
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Restricted Drug Restricted
Amber Initiation

Restricted - prescribing by Consultant Cardiologists with continuation by GPs for: 


1. Prophylaxis of atherothrombotic events following an acute coronary syndrome (ACS) with elevated cardiac biomarkers (in combination with aspirin alone or aspirin and clopidogrel) in accordance with NICE TA 335. To be used for a MAXIMUM of one year and stopped by the GP at the same time as clopidogrel unless the consultant clearly specifies at discharge that treatment is for a different time period (for a small cohort of patients each year).


2. Prophylaxis of atherothrombotic events in patients with coronary artery disease or symptomatic peripheral artery disease at high risk of ischaemic events (in combination with aspirin) in accordance with NICE TA 607. Duration of treatment  and review of bleeding risks to be clearly communicated to the GP by the consultant at discharge.

 
Link  Antiplatelets and Rivaroxaban 2.5 mg for Secondary Prevention of OVE - Primary/Secondary Care guideline (BHTCG 708FM)
Link  MHRA Drug Safety Update - June 2019: Direct-acting oral anticoagulants (DOACs): increased risk of recurrent thrombotic events in patients with antiphospholipid syndrome
Link  MHRA Drug Safety Update - October 18: Rivaroxaban (Xarelto▼) after transcatheter aortic valve replacement: increase in all-cause mortality, thromboembolic and bleeding events in a clinical trial
Link  NICE TA 335: Rivaroxaban for preventing adverse outcomes after acute management of acute coronary syndrome
Link  NICE TA 607: Rivaroxaban for preventing atherothrombotic events in people with coronary or peripheral artery disease
   
Warfarin Sodium 1mg, 3mg, 5mg
(tablet)
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Restricted Drug Restricted
Amber Protocol

WARNING: Warfarin sodium 5mg and warfarin sodium 500micrograms must never be written on the same prescription.
Only original packs to be dispensed
Restricted - for use in Outpatient prescribing and Discharge clinics only and in accordance with Anticoagulants, oral (warfarin, acenocoumarol, phenindione) when doses adjusted by Anticoagulation service & prescribed by GP - Shared Care protocol (BHTCG 797FM).

 
Link  Anticoagulants, oral (warfarin, acenocoumarol, phenindione) when doses adjusted by Anticoagulation service & prescribed by GP - Shared Care protocol (BHTCG 797FM)
Link  Warfarin (over anticoagulation protocol) (BHTCG 191FM)
   
Warfarin Sodium 500micrograms
(tablet)
View adult BNF View SPC online View childrens BNF  Track Changes
Restricted Drug Restricted
Amber Protocol

WARNING: Warfarin sodium 5mg and warfarin sodium 500micrograms must never be written on the same prescription.
Only original packs to be dispensed
Restricted - for use in Outpatient prescribing and Discharge clinics only and in accordance with Anticoagulants, oral (warfarin, acenocoumarol, phenindione) when doses adjusted by Anticoagulation service & prescribed by GP - Shared Care protocol (BHTCG 797FM).

 
Link  Anticoagulants, oral (warfarin, acenocoumarol, phenindione) when doses adjusted by Anticoagulation service & prescribed by GP - Shared Care protocol (BHTCG 797FM)
Link  Warfarin (over anticoagulation protocol) (BHTCG 191FM)
   
02.08.02  Expand sub section  Stroke prevention in AF
02.08.02  Expand sub section  VTE treatment
02.08.02  Expand sub section  VTE prophylaxis in hip/knee surgery
 ....
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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