2.8. Anticoagulants and protamine
2.8.1. Parenteral anticoagulants
Restrictions:
Restricted to specialist use where other options are not suitable or available in accordance with local protocol (to be updated).
Restrictions:
Restricted to initiation and prescribing by specialists in the Scottish Pulmonary Vascular Unit or similar specialists for use in chronic thromboembolic pulmonary hypertension.
Restrictions:
Restricted to specialist initiation only. For The treatment and prevention of VTE in patients with solid tumours use is restricted to initiation by healthcare professionals experienced in the treatment of VTE and use according to local protocol.
Prescribing Notes:
When dalteparin is used in the extended treatment of VTE and prevention of recurrence in patients with solid tumours, prescribers are reminded that a dose reduction is required following the first month of treatment, and where there is a transfer of care, the need for this dose reduction should be communicated clearly. For further dosing information, see the product literature or BNF.
Restrictions:
Restricted to specialist initiation only.
Prescribing Notes:
- Enoxaparin is a biological medicine and should be prescribed by brand name
- Inhixa® is the preparation of choice for pre-filled syringes
Restrictions:
Restricted to specialist initiation only. Restricted to use for the treatment of unstable angina or non-ST segment elevation myocardial infarction (NSTEMI) or ST segment elevation myocardial infarction (STEMI) in accordance with agreed local protocols.
2.8.2. Oral anticoagulants
Prescribing Notes:
Apixaban is the preferred DOAC for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurring DVT and PE in adults.
For other indications of apixaban, please refer to the Total Formulary
Restrictions:
Restricted to use for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA).
Prescribing Notes:
- Edoxaban is the preferred DOAC for use in the prevention of stroke in patients with atrial fibrillation (as described above).
- For other indications of edoxaban, see the Total Formulary.
Restrictions:
Restricted to use in accordance with the prescribing notes below
Prescribing Notes:
Prevention of stroke in atrial fibrillation
Use for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation, with one or more risk factors (see below), is restricted to:
- newly diagnosed patients
- those currently receiving warfarin who have poor INR control despite evidence that they are complying as described in NHSGGC Atrial Fibrillation guideline
- patients with allergy or intolerable side effects from coumarin anticoagulants
- patients for whom warfarin has been clinically excluded as a therapeutic option but anticoagulation is deemed safe and appropriate.
Patients who are well controlled on warfarin should remain on warfarin therapy.
Risk factors may include: prior stroke or transient ischaemic attack (TIA); age ≥75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA class ≥II)
Further supporting information for prescribers can be found in the Prescribing Resources section of this website
VTE prophylaxis in orthopaedic surgery
- The use for the primary prevention of venous thromboembolic events (VTE) in adults undergoing elective hip or knee replacement surgery is non-formulary.
Restrictions:
Restricted to use in accordance with the prescribing notes below
Prescribing Notes:
Prevention of stroke in atrial fibrillation
Use for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation and with one or more risk factors is restricted to:
- newly diagnosed patients
- those currently receiving warfarin who have poor INR control despite evidence that they are complying
- patients with allergy or intolerable side effects from coumarin anticoagulants
- patients for whom warfarin has been clinically excluded as a therapeutic option but anticoagulation is deemed safe and appropriate
Risk factors include:
- previous stroke, transient ischaemic attack, or systemic embolism
- left ventricular ejection fraction <40%
- symptomatic heart failure, ≥ New York Heart Association (NYHA) Class 2
- age ≥75 years
- age ≥65 years associated with one of the following: diabetes mellitus, coronary artery disease or hypertension
Patients well controlled on warfarin should remain on warfarin therapy.
The National Consensus Statement was developed in April 2012 (click here) and may continue to provide useful advice in patients poorly controlled on warfarin and use in that patient group is described in the NHSGGC Atrial Fibrillation guideline.
Further supporting information for prescribers can be found in the Prescribing Resources section of this website
A number of cases of serious and fatal haemorrhage have been reported in elderly patients with renal impairment who were receiving dabigatran. Renal function should be assessed in all patients before starting dabigatran and at least once a year in patients older than 75 years or those with a suspected decline in renal function. Dabigatran is contraindicated in patients with severe renal impairment (creatinine clearance <30 mL/min). See Drug Safety Update December 2011 (click here)
Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE
Use is restricted to patients who fail to tolerate other therapeutic options or where other agents are not appropriate, where the intended duration of treatment is 3-6 months. Where indefinite duration is indicated, the treatment of choice should be or apixaban or low molecular weight heparin followed by warfarin.
VTE prophylaxis in orthopaedic surgery
- The use for the primary prevention of venous thromboembolic events (VTE) in adults undergoing elective hip or knee replacement surgery is non-formulary.
Restrictions:
Restricted to use for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) and prevention of recurrent DVT and PE.
Prescribing Notes:
For the prevention of stroke in patients with atrial fibrillation, see the Prefered List
Restrictions:
Prevention of stroke in atrial fibrillation
Use for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation and with one or more risk factors is restricted to:
- those currently receiving warfarin who have poor INR control despite evidence that they are complying
- patients with allergy or intolerable side effects from coumarin anticoagulants
- patients for whom warfarin has been clinically excluded as a therapeutic option but anticoagulation is deemed safe and appropriate
Risk factors may include: congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack.
Patients well controlled on warfarin should remain on warfarin therapy. Rivaroxaban is not included in the Formulary for use in newly diagnosed patients.
Further advice can be accessed via the NHSGGC Atrial Fibrillation guideline.
Further supporting information for prescribers can be found in the Prescribing Resources section of this website
Treatment of VTE
- Rivaroxaban for the treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE) and prevention of further DVT and PE is restricted to use in patients requiring anticoagulation where the intended duration of treatment is 3 to 6 months and in whom apixaban is deemed unsuitable.
VTE prophylaxis in orthopaedic surgery
- The use in VTE prophylaxis in orthopaedic surgery is restricted to specialist use only in accordance with local protocol.
Use in combination with aspirin in Coronary Artery Disease
- Rivaroxaban co-administered with aspirin for the prevention of artherothrombotic events in adults is restricted to initiation by, or on the advice of a consultant only in patients with stable coronary artery disease that do not require dual antiplatelet therapy.
A Medicines Update blog for the use of rivaroxaban in combination with aspirin for coronary artery disease was published March 2019 and is available here.
It should be noted that use of rivaroxaban in combination with aspirin for the prevention of atherothrombotic events in patients with peripheral artery disease (PAD) alone was not considered by SMC and the use in this setting is non-Formulary.
Prescribing Notes:
The following indications are not recommended for use by the SMC and are non-Formulary:
- Acute Coronary Syndrome: The use of rivaroxaban for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers is not recommended for use within NHS Scotland and is therefore non-Formulary.
2.8.3. Protamine sulphate
2.8.4. Reversal of anticoagulation
Restrictions:
Restricted to use only on the advice of a Consultant Haematologist for the reversal of anticoagulation in adults treated with a direct factor Xa inhibitor where there is life-threatening or uncontrolled bleeding. In addition, use should be in accordance with the local protocol (in development).
Restrictions:
See Prescribing Notes below.
Prescribing Notes:
Restricted to specialist use only when rapid reversal of anticoagulation effect of dabigatran is required for emergency surgery/ urgent procedures or in life-threatening or uncontrolled bleeding in line with national guidance.