Transcript PAIN - West Midlands Strategic Clinical Network and Senate

Optimising Anticoagulation in
the
New Oral Anticoagulant Clinic
for People with AF
Satinder Bhandal
Consultant Anticoagulation Pharmacist
February 2015
Buckinghamshire Health Care NHS Trust
Algorithm: Stroke prevention of people with nonvalvular AF
National Clinical Guideline Centre. Atrial fibrillation: the management of atrial fibrillation. June 2014. Available at: http://guidance.nice.org.uk/CG180/Guidance
(accessed June 2014
The Statistics
Annual data
• Estimate 16,100 strokes are averted including 4,400
fatal strokes by current warfarin treatment
• 54% of people requiring anticoagulation receive it
• 8.74% of people requiring anticoagulation have
declined it or it is recorded it is contra-indicated
• Another 46% need anticoagulation
Cost & Benefits of Antithrombotic Therapy in England: An Economic Analysis
based on GRASF-AF (NHS Improving Quality Report – November 2014)
AF and NICE
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Dabigatran and rivaroxaban approved 2012
Apixaban approved 2013
Need to implement NICE guidance
Need to ensure patients benefit from these
new drugs
• Ensure safe prescribing
• Need to reduce avoidable strokes
• Manage the entry of these new drugs
Challenges
• Politics
• Lack of experience with NOACs
– On job learning
• Lack of clarity on place of NOACs
• Demanding / mis-informed patients
• Securing funding
Commissioning a Specialist
Anticoagulant Decision Unit
• Convened a meeting of all the key
stakeholders
• Agreed criteria for NOAC use
• Agreed who could initiate NOACs
• Agreed to commission a specialist service
• Agreed referral pathways
• Agreed responsibilities of GPs and specialist
clinic
Objectives
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The NOACs
Bucks NOAC Care Pathways
Safety checks for ALL anticoagulants
Shared decision making
Counselling
Avoiding Pitfalls
Meta-analysis of stroke or systemic embolism
Relative Hazard Ratio
(95% CI)
Category
W vs Placebo
ICH
W vs Dabigatran 110
W vs Rivaroxaban
W vs Wlow dose
W vs Dabigatran 150
W vs Aspirin
W vs Apixaban 5
W vs Aspirin + Clop
0
W vs Ximelagatran
Major bleeding
W vs Dabigatran 110
W vs Dabigatran 110
W vs Rivaroxaban
W vs Rivaroxaban
W vs Dabigatran 150
W vs Dabigatran 150
W vs Apixaban 5
0
0.3 0.6 0.9 1.2 1.5 1.8 2.0
W vs Apixaban 5
0.3 0.6 0.9 1.2 1.5 1.8 2.0
Favours warfarin
Favours other Rx
0
0.3 0.6 0.9 1.2 1.5 1.8 2.0
Favours warfarin
Modified from
Camm AJ. EHJ
2009;30:2554-5
Favours other Rx
GP diagnoses patient
with AF and refers to
NOAC service
New AF patient from primary
care
NOAC clinic risk assess patient & decides on
anticoagulation option with patient in line with Bucks
criteria
•Start warfarin
•Prescribe
•Counsel patient
•Alert Card
•Information Pack
Refer into usual A/C clinic
•Start NOAC,
•Prescribe
•Counsel patient,
•Anticoagulant Alert Card
•Information pack
If warfarin and NOAC
unsuitable, consider referral to
cardiologist
•Second contact by phone at 2 weeks:
Address issues/concerns/compliance
Discharge to GP for continuation
•If switching NOAC, repeat above stages
•If switched to warfarin, refer to A/C clinic
Patient with AF identified requiring A/C
Non- urgent refer to NOAC clinic
Recent TIA or stroke
• Stroke Team starts A/C
•Refers to NOAC Clinic clinic
Hospital Referral
Pathway
CHA2DS2VASC>/= 6 but no TIA or
stroke: refer to NOAC clinic for urgent
initiation 72hours
NOAC clinic risk assess patient & agrees anticoagulation with patient in line
with Bucks criteria
•Start warfarin
•Prescribe
•Counsel patient
•Anticoagulation Alert Card
•Information pack
•Start/continue NOAC
•Prescribe
•Counsel patient
•Anticoagulant Alert Card
•Information Pack
If warfarin and NOAC
unsuitable, consider
referral to Cardiologist
The Consultation
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Open and welcoming
Involve relative / carer
Why the patient is here
30 minute structured consultation
Educate on stroke risks
Purpose of information gathering
Shared decision making
Information about anticoagulants
Follow up arrangements
Helpline
Safety Checks
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Age
Weight
BP
U&Es
FBC
LFTs
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PMH
Bleeding history
Drug History
Over the counter
medicines
Stroke risk assessment with CHA2DS2-VASc
CHA2DS2-VASc criteria
Score
Congestive heart failure/
left ventricular dysfunction
1
Hypertension
1
Age 75 yrs
2
Diabetes mellitus
1
Stroke/transient ischaemic
attack/TE
2
Vascular disease
(prior myocardial infarction,
peripheral artery disease or
aortic plaque)
1
Age 65–74 yrs
1
Sex category
(i.e. female gender)
1
CHA2DS2-VASc
total score
Rate of stroke/other TE
(%/year)*
0
0.0
1
1.3
2
2.2
3
3.2
4
4.0
5
6.7
6
9.8
7
9.6
8
6.7
9
15.2
* Theoretical rates without therapy: assuming that warfarin provides a 64% relative reduction in
(2.7% ARR), based on Hart et al.
TE = thromboembolism
1 Lip GYH et al. Stroke 2010;41:2731–2738.
2 Hart RG et al. Ann Intern Med 2007;146:857–67.
TE risk
Balancing the risk – the HASBLED
score
One point for each of:
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Hypertension is SBP >160mmHg
Abnormal renal function (Cr >200 or dialysis/transplant)
Abnormal liver function (cirrhosis or Bil*2 + ALT/ALP*3)
Stroke
Bleeding (history or predisposition e.g. bleeding diathesis or anaemia)
Labile INR (TTR<60%)
Elderly (>65yrs)
Drugs: Alcohol >8 units per week
Drugs that increase bleeding risk: NSAIDs, Aspirin, SSRI
The Risk of Stroke Versus Risk of
Bleeding
• Some of the risk factors for bleeding are modifiable
(which is a very good reason to do the assessment
and take action prior to anticoagulation)
- Hypertension
- Labile INR (for some)
- Drugs
- Alcoholic drinks
• Explain risks versus benefits in plain English to
patient / carer
The Shared Decisions
First agree to anticoagulate!
Agree the right drug for the patient
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Stroke risk
Bleeding risk
Extreme age
Extreme weight
Co-morbidities
Renal function
Liver function
Risk of ICH
TTR
• Risk of side effects
• Need for MDS
• Lack of licensed
antidotes for NOACs
• Mitral stenosis or
mechanical heart valve
• Adherence with
complex regimens
• Compliance issues
Locally Agreed Criteria for NOAC Use
NEW PATIENTS
• High risk of interactions with warfarin leading to unacceptable
INR fluctuations which cannot be addressed.
• Co-morbidities which make INR control challenging e.g.
unstable severe COPD or recurrent cellulitis
• Regular INR monitoring is difficult or impractical after
exploring all possible alternatives eg. immobile patients
requiring home visits from phlebotomy
• Adherence to variable and complex warfarin dosage regimens
is likely to be poor
• Secondary prevention of Af patients with recent stroke or TIA.
To be referred by secondary care stroke service
Locally Agreed Criteria for NOAC Use (2)
EXISTING WARFARIN PATIENTS
• Poor INR control (TTR < 65%) despite evidence of compliance
• Allergy to or intolerable side effects from warfarin which
would require warfarin withdrawal
Characteristic
Drug choice
Mechanical valve or
valvular AF
Severe renal impairment
(CrCl <30 ml/min)
NOACs contra- indicated
NOACs not recommended
Dabigatran contraindicated. Apixaban and rivaroxaban – Use with
caution.
Dyspepsia or upper GI
Apixaban Preferred
symptoms
Dyspepsia occurs in 10% of patients on dabigatran
Recent GI bleed
Apixaban Preferred. Higher rates of GI bleeding with dabigatran &
rivaroxaban compared to warfarin.
Recent ischaemic stroke on Dabigatran (at a dose of 150mg bd) is the only NOAC shown to be
warfarin
superior to warfarin in reducing ischaemic stroke
Recent ACS
Rivaroxaban or Apixaban Preferred
Moderate or severe heart
failure
Dabigatran Preferred.
Peripheral oedema reported with rivaroxaban. No data available for
apixaban.
Poor compliance with twice Rivaroxaban Preferred as only NOAC that is once daily administration
daily dosing
Patient requiring a
Rivaroxaban or apixaban preferred.
compliance aid e.g. dosette Dabigatran not stable in a compliance aid
box
Initiation of ANY anticoagulant
needs full counselling
Doses for AF(1)
(see SPC for full dosing and prescribing information)
Dabigatran
• 150 mg BD
• 110 mg BD e.g. if high risk
of bleeds, CrCl 30 - 50
ml/min, over 75 &
considered a moderate risk
of a bleed, over 80, very low
body weight
• Do not added to Dosette
box
• Best with or after food
Rivaroxaban
• 20 mg OD
• If CrCl 15 – 49 ml/min 15 mg
OD
• Best taken with or after
food
Doses for AF (2)
(see SPC for full dosing and prescribing information)
Apixaban
• 5 mg BD
• All patients with creatinine clearance 15 - 29ml/min
should receive 2.5 mg twice daily of apixaban.
• In addition if they meet two of the following criteria they
should receive the lower dose: serum creatinine 133
micromol/L, age ≥ 80years or body weight ≤ 60kg.
Checking Renal function
CrCl = (140 – age) x weight (kg) x 1.2 for men
Serum creatinine
• NOTE: eGFR does not allow for weight
• Use IBW or actual if underweight
Counselling
Patient explanation
Condition / Purpose of medicine /Duration
If NOAC, lack of antidote
How to take in relation to food & regimen
Monitored dosage aids – warfarin and dabigatran not in dosette
Compliance
Action if missed dose
Alert Card
Informing healthcare professionals (surgery /dental/injections/pregnancy/meds)
Interactions – pain relief /OTC medicines
Side-effects/ Warning signs/ Emergency
Alcohol /Diet
Follow up arrangements
Telephone Follow up
Questions for Patient or Carer
Have you had a chance to start taking your medicine yet?
How are you getting on with it?
Are you having any problems with you new medicine or concerns?
Do you understand why you need anticoagulation?
Do you think you are getting any side-effects or unexpected effects?
Have you missed any doses or changed when you take it?
Do you have anything else you would like to know or
anything you would like me to go over again?
Anticoagulants Prescribed
Anticoagulant Prior to
Consultation
Nil
Warfarin
NOAC
76 (66%)
33 (29%)
5 (4%)
Drug After
Consultation
Patients
Nil
Warfarin
Apixaban
Dabigatran
Rivaroxaban
2
49 (41%)
5 (4%)
29 (25%)
33 (28%)
Drugs
Stopped
Warfarin
Due to Poor TTR /
Labile INR
Apixaban
Dabigatran
Rivaroxaban
Patients
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Patient feedback questionnaire
If a friend or relative needed similar treatment, would you
be happy to recommend the standard of care in the clinic?
70
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10
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Extremely likely
Likely
Neither likely or
unlikely
Unlikely
Extremely
unlikely
Don't know
If a friend or relative needed similar treatment, would you be happy to recommend the standard of
care in the clinic?
Did you have confidence and trust in the pharmacist?
90
80
70
60
50
40
30
20
10
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Yes definitely
Yes, to some extent
Did you have confidence and trust in the pharmacist?
No, not really
Were you involved as much as you wanted to be in
decisions about your treatment?
90
80
70
60
50
40
30
20
10
0
Yes definitely
Yes, to some extent
No, not really
Were you involved as much as you wanted to be in decisions about your treatment?
Did a member of staff explain the purpose of the
medicines you were to take at home in a way you could
understand?
90
80
70
60
50
40
30
20
10
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Yes , completely
Yes to some extent
No
I did not need an
explanation
I had no medicines
Did a member of staff explain the purpose of the medicines you were to take at home in a way you could
understand?
Did a member of staff tell you about medication side
effects to watch for when you went home?
80
70
60
50
40
30
20
10
0
Yes , completely
Yes to some extent
No
I did not need an
explanation
Did a member of staff tell you about medication side effects to watch for when you went home?
Avoiding the Pitfalls (1)
• NOACs are anticoagulants
- Major side effect is bleeding
• Omitted doses cause patient harm
- Short Half Lives all about 12 hours
• Only ONE anticoagulant at a time
- No LMWH, fondaparinux or warfarin
Avoiding the Pitfalls (2)
• Avoid antiplatelets
- same rules as with warfarin
- include OTC medicines
• Report any potential side effects to NOAC
team
• Prescribe correct dose for renal function
calculated using Cockcroft & Gault
Summary
• Specialist NOAC clinic pathways in Bucks
• Consultation style to facilitate patient
education
• Patient risk assessment
• Shared decision making
• Counselling
• Avoiding pitfalls