guidance on use of direct oral anti-coagulants (doacs) and ... · menorrhagia patients with...

Jointly approved by Ipswich and East Suffolk CCG and East Suffolk and North Essex NHS Foundation Trust (Ipswich site only)

Guidance on use of Direct Oral Anti-Coagulants (DOACs) and warfarin in non-valvular Atrial Fibrillation

Contents

1. Introduction Page 2

2. Assessing need for anticoagulation Page 2

2.1 Calculation of CHA2DS2-VASc Page 2

2.2 Calculation of HAS-BLED Page 3

2.3 Patient risk tool Page 4

3. Choice of anticoagulation Page 5

3.1 Flow chart decision aid Page 5

3.2 Further considerations Page 7

(Includes contraindications, interactions and adverse drug reactions)

4. Summary table of DOACs for the prevention of stroke and systemic embolism in 2

non-valvular atrial fibrillation

5. Initiation of anticoagulants and switching patients between anticoagulants Page 14

5.1 Initiation of warfarin Page 14

5.2 Initiation of DOAC Page 14

5.3 Switching from DOAC to warfarin Page 14

5.4 Switching from warfarin to DOAC Page 15

6. Monitoring (including self-monitoring) Page 16

7. Prescriber DOAC Initiation Checklist Page 17

Appendix 1 Patient alert cards and patient information leaflets Page 18 Abbreviations

AF – Atrial Fibrillation

DOAC – Direct oral anticoagulant

TTR – Time in therapeutic range

eGFR – Estimated glomerular filtration rate

PE – Pulmonary Embolism

DVT – Deep Vein Thrombosis

AMS – Anticoagulation Monitoring Service

(Ipswich and East Suffolk CCG would like to thank NHS East of England Prescribing Advisory Committee for sharing their Atrial Fibrillation Anticoagulation Resources)

Additional resources

http://www.mhra.gov.uk http://www.medicines.org.uk http://www.sign.ac.uk/pdf/AF_publication.pdf http://www.nice.org.uk/ http://cks.nice.org.uk/atrial-fibrillation#!scenarioclarification:6 https://www.prescqipp.info/resources/category/165-af-anticoagulation-resources (login required)

http://www.mhra.gov.uk/

http://www.medicines.org.uk/

http://www.sign.ac.uk/pdf/AF_publication.pdf

http://www.nice.org.uk/

http://cks.nice.org.uk/atrial-fibrillation#!scenarioclarification:6

https://www.prescqipp.info/resources/category/165-af-anticoagulation-resources

Produced by Medicines Management Team Ipswich and East Suffolk Clinical Commisioning Group in conjunction with The Ipswich Hospital Thrombosis Group. Version 2.0 April 2019. Next review due April 2021

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1. Introduction

NICE has issued Technology Appraisals (TA) for dabigatran (Pradaxa®), rivaroxaban

(Xarelto®▼), apixaban (Eliquis®▼) and edoxaban (Lixiana® ▼) for the prevention of stroke and

systemic embolism in non-valvular atrial fibrillation (TA249, TA256, TA275 and TA355).

This guidance has been produced to:-

Help identify those patients who are most likely to benefit from dabigatran, rivaroxaban,

apixaban or edoxaban.

Provide advice on choice and use of these drugs in the safest possible manner.

2. Assessing need for anticoagulation

2.1 Calculation of CHA2DS2-VASc score

Estimates risk of stroke in patients

CHA2DS2-VASc for new AF patients only –

to determine if oral anticoagulation is indicated for patients with newly diagnosed non-valvular atrial

fibrillation

Risk factor Score (if present)

Congestive heart failure 1

Hypertension (or treated hypertension) 1

Age ≥ 75 years 2

Diabetes mellitus 1

Previous stroke, TIA or thrombo-embolism 2

Vascular disease (M, PAD, aortic plaque) 1

Age 65 – 74 years 1

Female sex 1

Total

Oral anticoagulation is recommended for patients with a score of ≥ 2.

Oral anticoagulation should be considered for male patients with a score of 1.

For additional guidance around anticoagulation, please use the Advice and Guidance function for any additional queries. This should be used first line over completing an electronic referral.


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2.2 Calculation of HAS-BLED score

Estimates risk of major bleeding for patients on anticoagulation.

Source: European Society of Cardiology guidelines for the management of atrial fibrillation


4

2.3 Patient risk tool (Reproduced with permission from NHS East of England Prescribing Advisory Committee)

This tool should be used to facilitate informed discussion with patients in order to highlight the potential risks of

treating/not treating an individual.


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3. Choice of anticoagulation

Direct oral anticoagulant (DOAC)

o Apixaban - an oral direct factor Xa inhibitor.

o Dabigatran - a direct thrombin inhibitor.

o Edoxaban - an oral direct factor Xa inhibitor.

o Rivaroxaban - an oral direct factor Xa inhibitor.

Vitamin K antagonists e.g. Warfarin

Factors to consider include:

Bleeding risk, especially gastro-intestinal bleeding risk.

Compliance.

Consideration of the patient’s current INR control on warfarin.

Drug interactions.

Lack of reversibility for majority of the new agents.

Monitoring.

Renal function – a creatinine clearance (CrCl) calculator can be found at

https://www.mdcalc.com/creatinine-clearance-cockcroft-gault-equation

Unknown long-term safety profile of the new agents.

If patients on warfarin are struggling to stay in range, arrange an appointment to discuss their

compliance and lifestyle in order to help improve their time in therapeutic range (TTR). It may be

beneficial to ensure the patient remains on warfarin until their TTR improves, as it can be

adequately monitored, and may be a more appropriate choice long term for that individual patient.

NB. All patients considered for a DOAC must meet NICE criteria. Warfarin remains a

suitable oral anticoagulant for most patients.

3.1 Flow chart decision aid

Considerations for anticoagulation in non valvular AF:-

Please use this flow chart in combination with the information in further considerations (section

3.2), which will apply to specific patients, and discuss the option of anticoagulation in conjunction

with the patient risk tool (section 2.3). Once a drug has been chosen, please check its suitability

for that individual patient by checking contraindications, interactions and adverse drug reactions

(section 3.2) and discuss choice with the individual patient to ensure that the drug is the most

appropriate for that patient and any co-existing conditions.

https://www.mdcalc.com/creatinine-clearance-cockcroft-gault-equation


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Is the patient's CrCl < 15ml/min?

No long term anticoagulation

required

Consider warfarin

Does the patient have a contraindication

to a DOAC? (See Page 9)

Has the patient got a history of non-

compliance or any other reasons which

may lead to missed doses?

Is there a reason why a DOAC would be

advantageous (e.g. intracranial

haemorrhage risk) or patient preference

for a DOAC? (section 4)

Yes

No

Yes

Yes

Yes

No

No

No

No

Yes – offer anticoagulation

Consider warfarin

Consider warfarin

Consider warfarin

Is the patient's CHAD-VASC score ≥2

(female) or ≥ 1 (male)

Consider the following factors in conjunction with the information in further considerations (see section 3.2)

Apixaban – Suitable for

patients with a high risk of GI bleed/current GI side effects or HAS-BLED >3 and patients with menorrhagia

patients with impaired renal function (CrCl>15ml/min)

Dabigatran – Suitable for

patients aged under 80

patients with a low risk of GI bleed or HAS-BLED <3 and patients with menorrhagia

patients with good renal function (CrCl>30ml/min)

Edoxaban - Suitable for

patients with a high risk of GI bleed/current GI side effects or HAS-BLED >3 and patients with menorrhagia

patients with impaired renal function (CrCl>15ml/min)

patients with compliance issues (once a day dose)

Rivaroxaban - Suitable for:

patients with a low risk of GI bleed or HAS-BLED <3,

patients with impaired renal function (CrCl >15ml/min)

patients with compliance issues (once a day dose) Make sure the best choice, least costly DOAC is chosen


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3.2 Further considerations

Initiation of DOACs:

This guidance does not and should not override the NICE TA’s. A clinician may initiate

dabigatran, rivaroxaban, apixaban or edoxaban for any patient within the Technology

Appraisals’ criteria.

For the prevention of stroke and systemic embolism in patients with non-valvular AF who also have 1 or more risks factor(s) (including previous stroke/TIA, age≥75yrs, hypertension, diabetes mellitus, or congestive heart failure), prescribing may be initiated by GPs with appropriate expertise in anticoagulation.

Reversal of DOACs:

Currently, the only DOAC with a reversal agent is dabigatran (Praxbind) which should be used in

emergency situations in hospital only.

Missed doses of DOACs:

The protective effect of DOACs may wear off 12-24 hours after taking. For this reason, it is

important that DOACs should be taken regularly at the dose prescribed, and may not be suitable

for patients who have difficulty with compliance.

Apixaban, Edoxaban or Rivaroxaban: If a dose is missed the patient should take their missed dose immediately and continue on the following day with their usual daily dose. The dose should not be doubled within the same day to make up for a missed dose.

Dabigatran: A forgotten dabigatran dose may still be taken up to 6 hours prior to the next scheduled dose. From 6 hours prior to the next scheduled dose on, the missed dose should be omitted. No double dose should be taken to make up for missed individual doses.

Monitored Dosage Systems (MDS):

All DOACs except dabigatran are suitable for use within monitored dosage systems.

Compliance:

Rivaroxaban and edoxaban have once daily dosing which may be preferable for some patients.

If time in therapeutic range of warfarin is of a poor level, prescribing a DOAC will not help to

resolve this. It may also be more appropriate for a patient to remain on warfarin, depending on

their conditions and other medications.

Duration:

Requirement for ongoing treatment in AF should be reviewed at least annually, or more frequently

dependent on events affecting the patient’s bleed risk or anticoagulation.


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Elderly patients:

Ensure renal function is monitored so dosage can be amended where required, and monitor

requirement of any other concurrent medications which may need to be stopped due to changes

in condition.

Patients at extremes of weight:

There is a lack of available data on the extremes of weight (<50kg, >120kg) and the numbers of

patients in these extremes. Therefore, until further studies are completed, these patients should

be treated with warfarin.

Monitoring:

Periodic monitoring of weight, renal function and any other factors which may affect dose choice

should take place to ensure the patient is still receiving the appropriate dose (see section 6).

Contraindications for DOACs:

All DOACs share the following common contraindications:

Hypersensitivity to any of the ingredients;

Active bleeding;

Women who are pregnant or breastfeeding;

A prosthetic heart valve (patients should be anticoagulated with warfarin lifelong)

Hepatic impairment or liver disease associated with coagulopathy and clinically relevant bleeding risk;

Lesion or condition considered a significant risk of major bleeding (including current or recent gastrointestinal ulceration, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent surgery/haemorrhage);

Concomitant treatment with another anticoagulant agent;

Patients aged under 18.


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In addition, the drugs have the following specific contraindications:

Drug Name

Additional Specific

Contraindications

Apixaban Dabigatran Edoxaban Rivaroxaban

Active cancer

(efficacy & safety

not established)

Elevated liver

enzymes (more than

twice the upper

normal limit)

Elevated liver

enzymes (more than

twice the upper

normal limit)

Elevated liver

enzymes (more than

twice the upper

normal limit)

Uncontrolled severe

hypertension

Uncontrolled severe

hypertension

Moderate to severe

mitral stenosis

Severe hepatic

impairment

Hepatic impairment

or liver disease

which has any

impact on life

expectancy

Severe hepatic

impairment

People who have

liver cirrhosis with

moderate or severe

impairment (Child-

Pugh B or C)

CrCl<15ml/min CrCl<15ml/min CrCl<15ml/min

CrCl<30ml/min

Lactose intolerant

patients

Lactose intolerant

patients

Patients undergoing

dialysis

Patients undergoing

dialysis

Body weight under

50kg

This list is not exhaustive, always check the latest Summary of Product Characteristics (SPC) available via

www.medicines.org.uk

Interactions for DOACs:

All DOACs share the following common interactions – consider alternative therapy if patient is

concurrently taking any of the following:

Nonsteroidal anti-inflammatory drugs (NSAIDs) — increased risk of bleeding. The risk is thought to be greatest with dabigatran and NSAIDs that have a half-life greater than 12 hours (e.g. piroxicam). If concurrent use is unavoidable, an NSAID with a short half-life such as ibuprofen (2 hours) is preferred.

Other anticoagulants (e.g. heparin, warfarin, DOACS) —increased risk of bleeding. Avoid concomitant use except when switching to or from warfarin treatment.

Antiplatelets (aspirin, clopidogrel, ticlopidine, glycoprotein IIb/IIIa-receptor antagonists, sulfinpyrazone, prasrugrel and ticagrelor) — increased risk of bleeding.

Carbamazepine, phenytoin, phenobarbital, rifampicin, and St John's Wort — plasma concentration of reduced by all of these drugs as they are strong inducers of CYP3A4.



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In addition, the drugs have the following specific drug interactions:

Drug Name Apixaban Dabigatran Edoxaban Rivaroxaban

Specific Interactions

Itraconazole, ketoconazole, voriconazole,

posaconazole, and HIV protease

inhibitors (e.g. ritonavir)

Ciclosporin, dronedarone, itraconazole,

ketoconazole, and tacrolimus

Ciclosporin, dronedarone,

erythromycin, and ketoconazole

(Not contraindicated, but the manufacturer

has advised that the dose should be

reduced to 30 mg daily)

Ketoconazole, itraconazole, voriconazole, posaconazole,

dronedarone, or HIV protease inhibitors —

all strong inhibitors of CYP3A4 and P-

glycoprotein (P-gp) -plasma concentration

of increased.

Verapamil (Not contraindicated, but the manufacturer

has advised that the dose should be

reduced to 110 mg twice daily)

Amiodarone (Not contraindicated, but the manufacturer

has advised close monitoring for bleeding

or anaemia)

Selective serotonin reuptake

inhibitors (SSRIs) or serotonin

norepinephrine re-uptake

inhibitors (SNRIs)

— increased risk of bleeding


has advised caution when co-administering)




inhibitors (SNRIs)



has advised caution when co-administering especially if other risk factors which increase plasma levels are also

present)




inhibitors (SNRIs)







inhibitors (SNRIs)








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Adverse Drug Reactions of DOACs:

Drug name Apixaban Dabigatran Edoxaban Rivaroxaban

Common adverse reactions

Bleeding, bruising, nausea and anaemia.

Bleeding, indigestion, nausea, diarrhoea,

abdominal pain, anaemia,

Bleeding,bruising, anaemia, nausea, rash, hepatobiliary

disorders (increased blood bilirubin and gamma-glutamyl transferase) and abnormal liver function test

Increased risk of MI, GI haemorrhage

Anaemia, dizziness, headache, fainting,

bleeding events, hypotension,

haematoma, stomach pain, GI bleed,

increased transaminases,

dyspepsia (heartburn), nausea,

constipation, diarrhoea, vomiting,

pruritus (itching), rash, bruising, pain in the extremities, fever,

and swelling, especially of the

ankles and feet, post

procedural bleeding.

Less common adverse reactions

Hypotension, rash, thrombocytopenia.

Hepatobiliary disorders, vomiting, dysphagia, gastro-

intestinal ulcer, gastro-oesophageal reflux, oesophagitis, thrombocytopenia,

pruritis

Anaphylactic reaction, other

internal haemorrhage.

Increased bilirubin, abnormal hepatic

function, tachycardia (rapid heartbeat).





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4. Summary table of DOACs for the prevention of stroke and systemic embolism in non-

valvular atrial fibrillation.

Apixaban

(Note that the trials compared different

levels of INR rates – time in therapeutic

range (TTR) was 66% in ARISTOTLE)

Dabigatran

(Note that the trials compared different levels

of INR rates – time in therapeutic range (TTR)

was 64% in RE-LY

Edoxaban


of INR rates – time in therapeutic range (TTR))

was 68% in ENGAGE-AF)

Rivaroxaban


of INR rates – time in therapeutic range (TTR)

was 55% in ROCKET AF)

Efficacy in stroke prevention compared

to warfarin

Overall superior

Superior for haemorrhagic stroke

No difference for ischaemic and uncertain

type stroke

Overall no difference

Superior (150mg twice daily dose)

Non-inferior (110mg bd dose)

Non inferior at 30mg/60mg dose

Superior for haemorrhagic stroke

Overall no difference

Non inferior

Reduced risk of bleeding

compared to warfarin

Evidence for reduced risk of bleeding

Evidence for reduced bleeding risk at lower

dose. NB Increased risk of GI bleed compared to warfarin at higher dose

(which is the usual dose). Overall reduced intra cranial haemorrhage

(ICH)

Evidence for significantly reduced risk of bleeding

NB Higher risk of GI bleed with edoxaban

than warfarin

Equivalent to warfarin (except reduced ICH)

Dialysable

No Yes, but will need to be carried out for at least 6 hours in order to ensure adequate drug clearance

No No

Renal Function

Manufacturer states cannot be used if

CrCl<15ml/min, however locally we are advising

not to use if CrCl<30ml/min (If CrCl 15-29 reduce dose to

2.5mg twice daily)

Cannot be used if CrCl <30ml/min


CrCl<15ml/min, however locally we are advising not to use if CrCl<30ml/min.

(If CrCl 15-50ml/min reduce dose to 30mg

once daily)


CrCl<15ml/min, however locally we are advising

not to use if CrCl <30ml/min (If CrCl 15-49

reduce dose to 15mg once daily)

Liver Function

Use in caution in mild or moderate impairment or if

with elevated liver enzymes. No dose

adjustment is required.

Cannot be used in severe impairment.

Contraindicated in patients with hepatic disease

associated with coagulopathy and

clinically relevant bleeding risk.

Contraindicated in patients with any level of

hepatic impairment.

Use in caution in mild or moderate impairment.

(maximum recommended daily dose is 60mg)

Use in caution with elevated liver enzymes.

Cannot be used in severe impairment.



clinically relevant bleeding risk.



clinically relevant bleeding risk including cirrhotic

patients.


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Apixaban Dabigatran Edoxaban Rivaroxaban

Use in patients with

swallowing difficulties

May be crushed and mixed with water,

dextrose 5% or apple juice/puree and given

orally (off-license). May be crushed and suspended in water or dextrose 5% and

administered through naso-gastric tube (off-

license)

Capsule should not be opened

No information available. May be taken with or

without food.

May be crushed and mixed with apple puree or water and given orally (off-license). May be crushed

and put suspended in water and administered

through naso-gastric tube (off-licence)

Suitability for monitored dosage

systems (MDS)

Suitable Not suitable Suitable Suitable

Dosage for stroke prevention

5mg BD 150mg BD 60mg OD 20mg OD

Circumstances for reduced dose

Reduce to 2.5mg BD if: serum creatinine

>1.5mg/dL (133 micromole/L) and ≥80yrs or <60kg

CrCl 15-29ml/min

Reduce to 110mg BD if:

≥80yrs

taking verapamil. Consider reducing to 110mg BD based on individual assessment of clotting and bleeding risks if:

75-79yrs

moderate renal impairment (CrCl 30-49ml/min)

has gastritis, esophagitis or gastroesophageal reflux

increased risk of bleeding

Reduce to 30mg OD if: CrCl 15-50ml/min <60kg taking P-gp inhibitors -

ciclosporin, dronedarone, erythromycin or ketoconazole

Reduce to 15mg OD if: CrCl 15-49ml/min and

bleeding risk outweighs benefit.

For interactions, cautions and contraindication see tables in section 3.2 and Summary of Product Characteristics (SPC) available via www.medicines.org.uk




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5. Initiation of anticoagulation and switching patients between anticoagulants

5.1 Initiation of warfarin

If warfarin is considered to be the best option for the patient:

Counsel the patient on warfarin, side effects, interactions and lifestyle measures. There is

no need to supply an alert card and information leaflet if referring the patient to the

anticoagulant monitoring service (AMS) as they will provide this. Prescribe warfarin 1mg

and 3mg tablets and inform patient not to initiate until they have been seen by AMS.

Send referral via NHS net to AMS in order for them to schedule an appointment with the

patient. At this appointment, the patient will be given a starting regime and blood test dates.

For AF, duration of treatment is usually long term.

Alternatively if you wish to initiate, provide the patient with an alert card and information

leaflet. A typical initiation dose for atrial fibrillation is 5mg for 4 days, with an INR check on

day 5, and then repeated again at day 8. The best days to start to facilitate this are a

Monday, Thursday or Friday to avoid test requirements at the weekend. INR blood tests

will be advised by AMS after each INR blood test via the patient dose letter. For AF, target

INR should be between 2.5 to 3. Ensure that a referral is sent via NHS net to AMS clearly

stating that warfarin has been commenced, the dose the patient has been advised to take

and the date of their first blood test.

There is no set dose of warfarin, but doses usually range between 0.5mg-10mg depending

on the individual. Occasionally doses up to 20-30mg can be required. Warfarin doses

should be taken at the same time each day and evening, after 18:00, is recommended.

Refer to the Summary of Product Characteristics (SPC) or BNF for further information.

Contact AMS via NHS net for any further advice.

5.2 Initiation of a DOAC

If a DOAC is considered the best option for the patient:

Counsel the patient on the DOAC (see checklist in section 7) supply Alert Card and

Patient information booklet and prescribe drug of choice.

GP to follow guidance on future monitoring (see section 6)

5.3 Switching from a DOAC to warfarin

Patients currently taking a DOAC

Counsel patient on warfarin, supply Alert Card and Information Leaflet or ask the AMS team to see at an outpatient appointment. Prescribe warfarin 1mg and 3mg tablets, inform patient to continue DOAC and not take warfarin until advised by the AMS team.

Send referral via NHS net to AMS informing them that the patient is to switch to warfarin and the reason why.

Check INR - Important Note - INRs will need to be taken either 12 or 24 hours after the


15

last dose DOAC, depending on dose, prior to taking the next dose as they will affect the INR result. If the patient takes their DOAC in the evening, the dose will need to be moved to the morning to enable blood tests to be taken.

AMS will inform the patient of warfarin starting regime and dates of INR, they will continue their DOAC until their INR is over 2.0, the AMS team will inform the patient when to stop their DOAC.

5.4 Switching from warfarin to a DOAC

Conversion from warfarin to DOAC recommended for patients:

Allergic to vitamin K antagonists

TTR < 65% after 6 months (providing no evidence of non-compliance).

Conversion from a warfarin to DOAC may be considered for patients:

With history of stroke or TIA (not haemorrhagic) while taking warfarin (providing no

evidence of non-compliance).

Where there are barriers to safe INR monitoring and dose adjustments (e.g.lifestyle

factors, cognitive function)

Other patients who are well controlled and tolerant of warfarin are not recommended

to change.

Patients currently taking warfarin:

Counsel patient on DOAC (see checklist in section…), supply Alert Card and Information

leaflet. Prescribe drug of choice and inform patient to continue warfarin and not to take

DOAC until advised by the AMS team.

Send letter via NHS net to AMS informing them that the patient is switching to a DOAC,

which DOAC you have selected for the patient and reason why.

Check INR – depending on the result the AMS team will co-ordinate when to stop

warfarin and start DOAC.

GP to follow guidance on future monitoring (see section 6).

i) Dabigatran and apixaban can be given as soon as INR ≤2.

ii) Rivaroxaban can be given as soon as INR ≤3

iii) Edoxaban can be given as soon as INR is ≤2.5.

If initiated by secondary care a letter must be sent to GP informing them of this and the

reasons why a DOAC was chosen.


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6. Monitoring

Monitoring of DOACs

It is essential to monitor renal function; if renal function declines then exposure to dabigatran,

rivaroxaban, apixaban and edoxaban will increase. There have been MHRA warnings relating

to the risk of haemorrhage if renal function is not closely monitored.

For all patients prior to initiation, check;

o HASBLED, CHA2DS2-VASc, eGFR, U+Es, FBC’s, clotting screen and LFTs.

After initiation check renal function at 1, 3, and 6 months for all patients.

Then after 6 months;

If CrCl ≥60ml/min continue to check renal function every 12 months.

If CrCl 30-59ml/min continue to check renal function every 6 months.

If CrCl <30ml/min continue to check renal function every 3 months.

If patient is on dabigatran and CrCl drops below 30ml/min; or rivaroxaban, apixaban or

edoxaban and CrCl drops below 15ml/min stop drug and recheck HASBLED. If patient still

requires anticoagulation seek advice from the anticoagulant clinic.

At least one annual clinical review

o check HAS-BLED

o CHA2DS2VaSc check patient still has a score of ≥2 (males≥1)

o Check patient compliance

o Check CrCl, FBC’s, clotting screen and LFTs

It may also be appropriate to review renal function during acute illness, which may also require a

dose modification.

Warfarin self-testing

The routine prescribing of machines and testing strips for INR monitoring is NOT

recommended, and should be reserved for exceptional circumstances where it is not practicable

for a patient to attend an anticoagulant clinic. Patients who decide to self-test are responsible

for the purchase of the device and any consumables associated with this.


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7. Prescriber DOAC Initiation Checklist

Date: Patient name: Age: Indication: Weight: CHA2DS2-VASC: HAS-BLED: Initiation Checklist Please tick to confirm or include any

further comment Have all arms of the decision flow chart been considered?

Have baseline FBC, LFT, renal function and clotting screen been taken?

Does the patient meet NICE criteria?

Patient has non-valvular AF

AND

Patient has one or more risk factors

i) Prior stroke or transient ischaemic attack

ii) Age 75 years or older

iii) Hypertension

iv) Diabetes mellitus

v) Symptomatic heart failure)

Prescribed medication:

Medication has been checked for:

Correct dosage for the indication and patient circumstance

Patient’s liver function

Concurrent medication which may have contraindications

Concurrent conditions which may be contraindicated

The patient has been counselled on:

Indication

Drug mode of action

Dose (treatment and maintenance)

Frequency and timing of dose

Monitoring

Duration of treatment

Risks, benefits and side effects

Potential for drug interactions

Action for missed dose

Action for unexpected bleed

Action in the event of fall/injury

(especially head injury)

Patient Alert Card and who to show this

to (medical professionals etc)

Surgical procedures

Alcohol intake

How to obtain further supplies

What to do with any remaining /untaken

anticoagulant

Who to contact for further

advice/information


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Appendix 1: Patient Alert Cards & Patient Information Booklets

All patients started on a new oral anticoagulant should be given a patient alert card. This should

be filled in when the patient is initiated on a new oral anticoagulant and should form part of the

initial patient counselling. Patient information booklets are also available and these provide

useful information for the patient about atrial fibrillation and their medication.

Patient alert cards can be found inside the medication packaging. Patient information booklets can be obtained directly from the manufacturers. Both can be printed from the websites listed below:

Apixaban

Alert card - http://medicinesauthority.gov.mt/file.aspx?f=3187

Patient information booklet - https://www.eliquis.co.uk/hcp/resources/patient-materials/patient-

information-booklets-nvaf

Dabigatran

Alert card - https://www.medicines.org.uk/emc/rmm/401/Document

Patient information booklet - https://www.pradaxa.co.uk/assets/patients-

support/materials/downloads/spaf-patient-support-booklet.pdf

Patient starter card - https://www.pradaxa.co.uk/assets/patients-

support/materials/downloads/patient-starter-card.pdf

Edoxaban

Alert card - https://www.medicines.org.uk/emc/rmm/227/Document

Patient information booklet - https://lixiana.co.uk/documents/lixiana_patient_material_english.pdf

Rivaroxaban

Alert card -

http://www.antithrombose.de/datafiles/images/downloads/Patientenausweis_engl_Ansichts_RZ.

pdf

Patient information booklet - https://www.xarelto-info.co.uk/static/documents/af-patient-

brochure.pdf

https://eliquis.co.uk/Images/5829_FINAL_Patient%20Alert%20Card_WEB_.pdf

http://medicinesauthority.gov.mt/file.aspx?f=3187

https://www.eliquis.co.uk/hcp/resources/patient-materials/patient-information-booklets-nvaf

https://www.eliquis.co.uk/hcp/resources/patient-materials/patient-information-booklets-nvaf

http://www.pradaxa.co.uk/downloads/patient-alert-card.pdf

https://www.medicines.org.uk/emc/rmm/401/Document

https://www.pradaxa.co.uk/assets/patients-support/materials/downloads/spaf-patient-support-booklet.pdf

https://www.pradaxa.co.uk/assets/patients-support/materials/downloads/spaf-patient-support-booklet.pdf

https://www.pradaxa.co.uk/assets/patients-support/materials/downloads/patient-starter-card.pdf

https://www.pradaxa.co.uk/assets/patients-support/materials/downloads/patient-starter-card.pdf

https://www.medicines.org.uk/emc/rmm/227/Document

https://lixiana.co.uk/documents/lixiana_patient_material_english.pdf

http://www.xarelto-info.co.uk/site-resources/pdfs/Patient_Alert_Card_15and20mg.pdf

http://www.antithrombose.de/datafiles/images/downloads/Patientenausweis_engl_Ansichts_RZ.pdf

http://www.antithrombose.de/datafiles/images/downloads/Patientenausweis_engl_Ansichts_RZ.pdf

https://www.xarelto-info.co.uk/static/documents/af-patient-brochure.pdf

https://www.xarelto-info.co.uk/static/documents/af-patient-brochure.pdf

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