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 Formulary Chapter 2: Cardiovascular system - Full Chapter
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02.08.02  Expand sub section  Oral anticoagulants
 note 

NHSE Operational note: Commissioning recommendations for national procurement for direct-acting oral anticoagulant(s) (DOACs)

County Durham and Darlington DVT Pathway Information

Tees Warfarin Guidelines for Primary Care

Warfarin
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Formulary
  • 500 microgram, 1mg, 3mg & 5mg tablets Green Traffic Light.
  • 1mg/1ml oral suspension - - for use in paediatric patients on mechanical support using ventricular assistance devices, and for patients with mechanical heart valves or irregular heart rythms who have not been weaned Green Traffic Light.
 
Link  MHRA Drug Safety Update (July 2016): Warfarin: reports of calciphylaxis
Link  MHRA Drug Safety Update (Oct 2020): Warfarin and other anticoagulants: monitoring of patients during the COVID-19 pandemic
 
Phenindione
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Formulary
Green
 
 
Acenocoumarol (Sinthrome®)
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Formulary
Green
  • 1mg tablets
 
 
Andexanet alfaBlack Triangle (Ondexxya®)
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Formulary
Red

 

    • 200mg powder for solution for infusion

 

    • Approved for reversing anticoagulation from apixaban and rivaroxaban in adults with life-threatening or uncontrolled bleeding in line with NICE

 

 
Link  NICE TA697: Andexanet alfa for reversing anticoagulation from apixaban or rivaroxaban
 
Apixaban
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Formulary
Green
  • Only approved for use in accordance with NICE guidance. 
 
Link  NICE TA245: Apixaban for the prevention of venous thromboembolism after total hip or knee replacement in adults
Link  NICE TA275: Apixaban for preventing stroke and systemic embolism in people with nonvalvular atrial fibrillation
Link  NICE TA341: Apixaban for the treatment and secondary prevention of deep vein thrombosis and/or pulmonary embolism
Link  MHRA Drug Safety Update Dec 2014: New oral anticoagulants apixaban (Eliquis▼), dabigatran (Pradaxa) and rivaroxaban (Xarelto▼)
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 June 2020: Direct-acting oral anticoagulants (DOACs): reminder of bleeding risk, including availability of reversal agents
 
Dabigatran
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Formulary
Green
  • Only approved for use in accordance with NICE guidance. 
 
Link  MHRA Drug Safety Update Dec 2014: Dabigatran (Pradaxa): contraindicated in patients with prosthetic heart valve(s) requiring anti-coagulant treatment
Link  MHRA Drug Safety Update Dec 2014: New oral anticoagulants apixaban (Eliquis▼), dabigatran (Pradaxa) and rivaroxaban (Xarelto▼)
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 June 2020: Direct-acting oral anticoagulants (DOACs): reminder of bleeding risk, including availability of reversal agents
Link  NICE TA157: Dabigatran etexilate for the prevention of venous thromboembolism after hip or knee replacement surgery in adults
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
 
Edoxaban
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Formulary
Green
  • Only approved for use in accordance with NICE guidance. 
 
Link  MHRA Drug Safety Update June 2019: Direct-acting oral anticoagulants (DOACs): increased risk of recurrent thrombotic events in patients with antiphospholipid syndrome
Link  NICE TA354: Edoxaban for treating and for preventing deep vein thrombosis and pulmonary embolism
Link  NICE TA355:Edoxaban for preventing stroke/systemic embolism in non‑valvular atrial fibrillation
 
RivaroxabanBlack Triangle
(For CAD/PAD)
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Formulary
Green plus
  • 2.5mg tablets

 

  • Rivaroxaban co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events.
  • Approved for use in accordance with NICE TA607
 
Link  MHRA Drug Safety Alert June 2020: Direct-acting oral anticoagulants (DOACs): reminder of bleeding risk, including availability of reversal agents
Link  MHRA Drug Safety Update Dec 2014: New oral anticoagulants apixaban (Eliquis▼), dabigatran (Pradaxa) and rivaroxaban (Xarelto▼)
Link  MHRA Drug Safety Update July 2019: Rivaroxaban (Xarelto▼): reminder that 15 mg and 20 mg tablets should be taken with food
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 Oct 2018: Rivaroxaban (Xarelto▼) after transcatheter aortic valve replacement: increase in all-cause mortality, thromboembolic and bleeding events in a clinical trial
Link  NICE TA607: Rivaroxaban for preventing atherothrombotic events in people with coronary or peripheral artery disease
 
Rivaroxaban
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Formulary
Green

  • 2.5mg, 10mg, 15mg & 20mg tablets

  • 1mg/1ml granules for oral suspension

    • approved for the treatment of VTE in children



  • Only approved for use in accordance with NICE guidance. 

 
Link  MHRA Drug Safety Update Dec 2014: New oral anticoagulants apixaban (Eliquis▼), dabigatran (Pradaxa) and rivaroxaban (Xarelto▼)
Link  MHRA Drug Safety Update July 2019: Rivaroxaban (Xarelto▼): reminder that 15 mg and 20 mg tablets should be taken with food
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 June 2020: Direct-acting oral anticoagulants (DOACs): reminder of bleeding risk, including availability of reversal agents
Link  MHRA Drug Safety Update Oct 2018: Rivaroxaban (Xarelto▼) after transcatheter aortic valve replacement: increase in all-cause mortality, thromboembolic and bleeding events in a clinical trial
Link  NICE TA170: Rivaroxaban for the prevention of venous thromboembolism after total hip or total knee replacement in adults
Link  NICE TA256: Rivaroxaban for the prevention of stroke and systemic embolism in people with atrial fibrillation
Link  NICE TA261: Rivaroxaban for the treatment of deep vein thrombosis and prevention of recurrent deep vein thrombosis and pulmonary embolism
Link  NICE TA287: Rivaroxaban for treating pulmonary embolism and preventing recurrent venous thromboembolism
Link  NICE TA335: Rivaroxaban for preventing adverse outcomes after acute management of acute coronary syndrome
 
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
02.08.02  Expand sub section  Antidotes to top
 ....
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
Cytotoxic Drug
Cytotoxic Drug
CD
Controlled Drug
High Cost Medicine
High Cost Medicine
NHSE
NHS England
Homecare
Homecare
CCG
CCG

Traffic Light Status Information

Status Description

Red

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.  

Amber

Drugs initiated by hospital specialist, but where continuing treatment by GPs may be appropriate under a shared care arrangement. The specialist should send the GP a copy of the shared care agreement to sign. The GP should sign the shared care agreement, or indicate they do not want to be part of such an agreement, and return a copy back to the specialist. Shared care guidelines are available or are being developed for most of the drugs listed as Amber. If no shared care guideline is available, the hospital specialist should provide the patient’s GP with sufficient information and support to allow treatment to be continued and managed safely in primary care.  

Green plus

Drugs normally recommended or initiated by a specialist (hospital or GP with an extended role https://www.rcgp.org.uk/gpwer), but can be safely maintained in primary care with very little or no monitoring required. In some cases there may be a further restriction for use outlined - these will be defined in each case. Provision of additional information, or an information leaflet, may be appropriate in some cases to facilitate continuing treatment by GPs.  

Green

Drugs where prescribing by GPs is appropriate. Can be initiated and prescribed in all care settings, and if appropriate, discontinued without recourse to secondary care.  

Black

NOT APPROVED: Drugs that have been considered by NTAG or the NENC ICB Medicines Subcommittee (or other approved body) and are not approved for prescribing within the North East and North Cumbria.   

Brown

UNDER REVIEW: drugs whose current formulary status or RAG status is currently under review.  

Not Recomended

NOT REVIEWED: Drugs that haven not been reviewed yet. This usually means that an application is in progress. These drugs are not normally considered appropriate for prescribing in the North East and North Cumbria until such time that a decision is taken on their formulary status.  

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