Royal Free London NHS. NHS Foundation Trust. Bunis Packham

Royal Free London NHS . NHS Foundation Trust Bunis Packham Nurse Consultant Thrombosis & Anticoagulation Royal Free London Hospital NHS Foundation Tr...
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Royal Free London NHS . NHS Foundation Trust

Bunis Packham Nurse Consultant Thrombosis & Anticoagulation Royal Free London Hospital NHS Foundation Trust

Improving Adherence in patients on DOAC

Aim of the session Quiz NICE guidance NOAC referral process NOAC service Audit data Case scenarios Questions

Royal Free London NHS . NHS Foundation Trust

How we got there Undertaking a medication history and successfully reconciling medicines Involving patients in decisions about prescribed medicines and supporting adherence: Implementing NICE, NPSA & NPC guidance The benefits of medicines reconciliation on patient outcomes Improving medicines management practice at discharge from hospital Patient views on non medical prescribing/PGD cost effectiveness

Aim of Service Achieve and maintain safety and effectiveness Increase patient adherence and attendance to follow up appointments, Reduce over and under anticoagulation and prolong associated hospital stay Provide a comprehensive and individualised patient care Ensure continuity and improve communication, information and education for patients, relatives, carers and primary health care

An estimated 50% of medicines for chronic Conditions are not taken as prescribed

Ill-health and reduced quality of life Reduced life expectancy Avoidable healthcare cost Economic loss to society

QUIZ 1. What is the most serious side effect of NOACs? a) GI b) rashes c)bleeding d) renal failure 2. What is the half life of the NOACs in normal renal function? a) 12h b) 24h c) 36h d) 48h 3. What percentage of patients stop NOACs due to side effects? a) 5% b) 10% c) 20% d) 50% 4. The dose of Dabigatran must be appropriate for which of the following: a) RF b) LFTs c) Sex d) Age e) weight

Quiz 5.The dose of Rivaroxaban must be appropriate for which of the following: a) RF b) LFTs c) Sex d) Age e) weight 6. The dose of Apixaban must be appropriate for which of the following: a) RF b) LFTs c) Sex d) Age e) weight

NICE guidelines [CG180] Published date: June 2014 Interventions to prevent stroke

• Anticoagulation may be with apixaban, •

dabigatran etexilate, rivaroxaban or a vitamin K antagonist. Offer anticoagulation to people with a CHA2DS2VASc score of 2 or above, taking bleeding risk into account. [new 2014]

NICE guidelines [CG180] Published date: June 2014 Atrial fibrillation: the management of atrial fibrillation

• Treatment and care should take into account individual needs and preferences • Patients should have the opportunity to make informed decisions about their care and treatment, in partnership with their healthcare professionals

Pharmacology Dabigatran1-3

Rivaroxaban4,5

Apixaban6,7

Mode of action

Factor II

Factor X

Factor X

Half life

12-14 hrs

7-11 hrs

12 hrs

Metabolism

Esterase catalysed hydrolysis

CYP P450 dependant and independent mechanisms

CYP P450

Excretion

80% Renal

1/3 Renal 2/3 Hepatic

1/4 Renal 3/4 Non Renal

Form

Capsule

Tablet

Dosing in AF DVT/PE

B.D. LMWH 7 days BD dose

O.D. 15mg BD dose 21 days 20mg once a day

150 mg Dose

110 mg (>80 yrs, verapamil or increased bleeding risk)

Tablet B.D. 10mg BD dose 5 days 5mg BD dose 5 mg

20 mg 15 mg (CrCL 30-49 ml/min)

B.D. = twice daily; O.D. = once daily

2.5 mg (2 or more: >80yr; weight 1.5 mg/dL)

Clinical Trial Data for information only - no clinical conclusions should be drawn. Please refer to individual product SPCs for further information. 1. Ezekowitz MD et al. Am Heart J 2009;157:805–10; 2. Connolly SJ et al. N Engl J Med 2009;361:1139–51; 3. Connolly SJ et al. N Engl J Med 2010;363:1875–1876; 4. Rocket Investigators. Am Heart J 2010;159:340-347; 5. Patel MR et al. NEJM 2011;365:883–91; 6. Lopes et al. Am Heart J 2010;159:331-9; 7. Granger et al. N Eng J Med 2011;365:981-92.

Pharmacology TTR: 64% RE-LY 55% ROCKET AF 62% ARISTOTLE

Dabigatran1-3

Rivaroxaban4,5

Apixaban6,7

Factor II

Factor X

Factor X

Ischaemic Stroke Prevention vs warfarin

Superior @ 150mg Non-inferior @ 110mg

Non-inferior (ITT analysis)

Bleeding risk V warfarin

↓ bleeding @ 110mg ↑ GI bleeding @ 150mg ↓ ICH

Generally same as ↓ bleeding warfarin No ↑ GI bleeding ↑ GI bleeding ↓ ICH ↓ ICH

Dosing

B.D.

O.D.

Non-inferior

B.D.

Doses for AF (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 add to Dosette box Ideally after food

Interactions Potential for P-gp interactions, e.g. amiodarone, verapamil, quinidine, ketoconazole, clarithromycin, rifampicin, phenytoin and carbamazepine SSRIs and SNRIs increased the risk of bleeding in RE-LY in all treatment groups Concomitant treatment with systemic and ketoconazole, cyclosporine, itraconazole, tacrolimus and dronedarone is contraindicated5

Rivaroxaban Rivaroxaban

20 mg OD If CrCl 15 – 49 ml/min 15 mg OD Must taken with or after food

Interaction

Caution with strong CYP3A4 inducers e.g. rifampicin, phenytoin, carbamazepine Avoid concomitant treatment with strong inhibitors of both CYP3A4 and P-gp e.g. ketoconazole, itraconazole, voriconazole or HIV protease inhibitors

Apixaban 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

Interactions Avoid concomitant use with strong inhibitors of both CYP3A4 and Pgp e.g. ketoconazole, itraconazole, voriconazole or HIV protease inhibitors Caution with strong CYP3A4 inducers e.g. rifampicin, phenytoin, carbamazepine, phenobarbital or St. John’s Wort as they may lead to reduced Apixaban concentrations6

NOAC clinic referral process • Anticoagulation clinic accepts referral from within the organisation, GPS and external organisation • EPR referral – not on warfarin referral • EPR letter referral

Referral requirement • Patient should have base line of HB, LFT and creatinine levels at least within the last month • If the patient has been commenced on the NOAC already please give the patient blood request form. Ask patient to organise the blood test to be done a week before they attend the NOAC clinic

Royal Free London NHS . NHS Foundation Trust

Involving patients in decisions about prescribed medicines Communication skills central Patient involvement – patients differ in how much involvement they want Patient perspective is different from professional perspective Information – patients cannot decide on involvement and decision unless they have information

Royal Free London NHS . NHS Foundation Trust

Perspective of guideline Patient’s right to be involved in decisions about their care Patient’s right not to take medicines Medicine-taking is a complex behaviour Patient’s act according to their own understanding of their problem and the medicine, and the place of this problem in their lives. Dynamic process – ongoing evaluation and decisions by patient

Royal Free London NHS . NHS Foundation Trust

Increasing patient involvement Clearly explain the condition and the pros and cons of treatment….what does this treatment do? Clarify what the patient hopes the treatment will achieve Talk and listen to the patient and note any non-verbal cues rather than make assumptions about patients’ preferences about treatment Help patients to make decisions based on likely benefits and risks rather than misconceptions.

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

Foundation For the Service • Adopting a safety culture • Trained, competent professionals, supervised until competency is achieved • Implementing policies, protocols, guidelines • Auditing the process, investigating any adverse events and quickly learning from mistakes • Revising guidelines and protocols in order to achieve safety and gold standards

Aim ;Quality must be seen from patient’s

perspective

• Access to service • Working in partnership • Right to be involved in the decision making process • Patient’s right not to take the medication • Ongoing support via telephone support line • Dynamic process

Medication History • What is the relevance of medication history in patients on anticoagulation therapy? • What does medication history inform the anticoagulation nurse?

Case scenario 1 • 86 year old gentleman diagnosed with PE and DVT • Dementia , wife is the main carer and she has MS • Not able to manage LMWH require D/N • Cr 77 weight 74 crcl 64 Last HB:14 • Patient is on Phenytoin

Case Scenario 2 • 88 year old female • Reason for A/C: Atrial Fibrillation • CHA2DS2VASc score 4 ( age sex htn) • • • • •

Has bled 1 age Stroke risk 8.5% Recent result: Cr 69 weight 57 CrCl 50mL/min HB: 14 Which NOAC and why?

Pharmacology Dabigatran1-3

Rivaroxaban4,5

Apixaban6,7

Mode of action

Factor II

Factor X

Factor X

Half life

12-14 hrs

7-11 hrs

12 hrs

Metabolism

Esterase catalysed hydrolysis

CYP P450 dependant and independent mechanisms

CYP P450

Excretion

80% Renal

1/3 Renal 2/3 Hepatic

1/4 Renal 3/4 Non Renal

Form

Capsule

Tablet

Dosing in AF DVT/PE

B.D. LMWH 5 days BD dose

O.D. 15mg BD dose 21 days 20mg once a day

150 mg Dose

110 mg (>80 yrs, verapamil or increased bleeding risk)

Tablet B.D. 10mg BD dose 5 days 5mg BD dose 5 mg

20 mg 15 mg (CrCL 30-49 ml/min)

B.D. = twice daily; O.D. = once daily

2.5 mg (2 or more: >80yr; weight 1.5 mg/dL)

Clinical Trial Data for information only - no clinical conclusions should be drawn. Please refer to individual product SPCs for further information. 1. Ezekowitz MD et al. Am Heart J 2009;157:805–10; 2. Connolly SJ et al. N Engl J Med 2009;361:1139–51; 3. Connolly SJ et al. N Engl J Med 2010;363:1875–1876; 4. Rocket Investigators. Am Heart J 2010;159:340-347; 5. Patel MR et al. NEJM 2011;365:883–91; 6. Lopes et al. Am Heart J 2010;159:331-9; 7. Granger et al. N Eng J Med 2011;365:981-92.

Case scenario 2 • 84 year old female • Reason for A/C: Atrial Fibrillation • CHA2DS2VASc score 6 ( stroke age sex htn) Has bled 2 age & stroke Discharged on Rivaroxaban 20mg • Seen in anticoagulation clinic about 3 weeks later Cr 87 weight 48kg , CrCl 33 mL/min

Case Scenario 3 • 81 year old female • Reason for A/C: Atrial Fibrillation • CHA2DS2VASc score 6 ( age stroke, htn, sex) HAS BLED 3 ( age stroke INR)

• Has been commenced on warfarin very unstable . TTR of 56%

• Weight 52kg Cr 113 Cockcroft Gault 28mL/min • What do we do ?

Pharmacology Dabigatran1-3

Rivaroxaban4,5

Apixaban6,7

Mode of action

Factor II

Factor X

Factor X

Half life

12-14 hrs

7-11 hrs

12 hrs

Metabolism

Esterase catalysed hydrolysis

CYP P450 dependant and independent mechanisms

CYP P450

Excretion

80% Renal

1/3 Renal 2/3 Hepatic

1/4 Renal 3/4 Non Renal

Form

Capsule

Tablet

Dosing in AF DVT/PE

B.D. LMWH 7 days BD dose

O.D. 15mg BD dose 21 days 20mg once a day

150 mg Dose

110 mg (>80 yrs, verapamil or increased bleeding risk)

Tablet B.D. 10mg BD dose 5 days 5mg BD dose 5 mg

20 mg 15 mg (CrCL 30-49 ml/min)

B.D. = twice daily; O.D. = once daily

2.5 mg (2 or more: >80yr; weight 1.5 mg/dL)

Clinical Trial Data for information only - no clinical conclusions should be drawn. Please refer to individual product SPCs for further information. 1. Ezekowitz MD et al. Am Heart J 2009;157:805–10; 2. Connolly SJ et al. N Engl J Med 2009;361:1139–51; 3. Connolly SJ et al. N Engl J Med 2010;363:1875–1876; 4. Rocket Investigators. Am Heart J 2010;159:340-347; 5. Patel MR et al. NEJM 2011;365:883–91; 6. Lopes et al. Am Heart J 2010;159:331-9; 7. Granger et al. N Eng J Med 2011;365:981-92.

Patients Numbers on NOAC (July 2014- June 2015)

NOAC: Dose Variation (July 2014- June 2015)

NOAC Use in Elderly Population

NOAC: Side Effects

NOAC: Gender

QUIZ 1. What is the most serious side effect of NOACs? a) GI b) rashes c)bleeding d) renal failure

2. What is the half life of the NOACs in normal renal function? a) 12h b) 24h c) 36h d) 48h

3. What percentage of patients stop NOACs due to side effects? a) 5% b) 10% c) 20% d) 50% 4.

The dose of dabigatran must be appropriate for which of the following: a) RF b) LFTs c) Sex d) Age e) weight

Quiz 5.The dose of Rivaroxaban must be appropriate for which of the following: a) RF b) LFTs c) Sex d) Age e) weight 6. The dose of Apixaban must be appropriate for which of the following: a) RF b) LFTs c) Sex d) Age e) weight

References • Department of Health. Pharmacy in England, building on strengths - delivering the • •

future. 1-141. 2008 Friedman and Marr (1995) A supervisory model of professional competence: A joint service/education initiative Horne R 2006 Compliance, adherence and concordance implications for asthma treatment. Chest 130(1 Suppl)65S-72S

• • Improving Patients’ Access to Medicines: A Guide to Implementing Nurse and •

Pharmacist Independent Prescribing within the NHS in England-2006 [email protected]

• NICE 2009 Medicines Adherence: involving patients in decisions about • •

prescribed medicines and supporting adherence NICE 2015 Medicine Optimisation NPSA Alert 18 2007 Anticoagulation

• World Health Organization. Adherence to long-term therapies; evidence for action. • • •

2003. WHO. www.npc.co.uk www.npsa.nhs.uk/patientsafety/medication www.patientsafetyfirst.nhs.uk

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