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
Ill-health and reduced quality An estimated 50% of of life medicines Reduced life for chronic expectancy Conditions are Avoidable not taken as healthcare cost prescribed 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 CHA 2 DS 2 - VASc 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 Dabigatran 1-3 Rivaroxaban 4,5 Apixaban 6,7 Mode of action Factor II Factor X Factor X Half life 12-14 hrs 7-11 hrs 12 hrs CYP P450 dependant and Esterase catalysed Metabolism independent CYP P450 hydrolysis mechanisms 1/3 Renal 1/4 Renal Excretion 80% Renal 2/3 Hepatic 3/4 Non Renal Tablet Form Capsule Tablet B.D. O.D. B.D. Dosing in AF LMWH 7 days 15mg BD dose 21 days 10mg BD dose 5 days DVT/PE BD dose 20mg once a day 5mg BD dose 5 mg 150 mg 20 mg 2.5 mg (2 or more: Dose 110 mg (>80 yrs, verapamil or 15 mg (CrCL 30-49 ml/min) >80yr; weight <60 kg; increased bleeding risk) Cr >1.5 mg/dL) B.D. = twice daily; O.D. = once daily 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 Dabigatran 1-3 Rivaroxaban 4,5 Apixaban 6,7 55% ROCKET AF 62% ARISTOTLE Factor II Factor X Factor X Ischaemic Stroke Superior @ Non-inferior (ITT Non-inferior Prevention vs 150mg analysis) warfarin Non-inferior @ 110mg Bleeding risk V ↓ bleeding @ Generally same as ↓ bleeding warfarin 110mg warfarin No ↑ GI bleeding ↑ GI bleeding @ ↑ GI bleeding ↓ ICH 150mg ↓ ICH ↓ ICH Dosing B.D. O.D. B.D.
Doses for AF (see SPC for full dosing and prescribing information) Dabigatran Dabigatran Interactions Interactions � Potential for P-gp interactions, � 150 mg BD e.g. amiodarone, verapamil, � 110 mg BD e.g. if high risk quinidine, ketoconazole, clarithromycin, rifampicin, of bleeds, CrCl 30 - 50 phenytoin and carbamazepine ml/min, over 75 & considered a moderate � SSRIs and SNRIs increased the risk of a bleed, over 80, risk of bleeding in RE-LY in all very low body weight treatment groups � Concomitant treatment with � Do not add to Dosette box systemic and ketoconazole, � Ideally after food cyclosporine, itraconazole, tacrolimus and dronedarone is contraindicated 5
Rivaroxaban Interaction Interaction Rivaroxaban Rivaroxaban � Caution with strong CYP3A4 � 20 mg OD inducers e.g. rifampicin, � If CrCl 15 – 49 ml/min phenytoin, carbamazepine 15 mg OD � Avoid concomitant treatment with � Must taken with or strong inhibitors of both CYP3A4 and P-gp e.g. ketoconazole, after food itraconazole, voriconazole or HIV protease inhibitors
Apixaban Apixaban Apixaban Interactions Interactions � 5 mg BD � Avoid concomitant use with strong inhibitors of both CYP3A4 and P- � All patients with creatinine gp e.g. ketoconazole, itraconazole, clearance 15 - 29ml/min should voriconazole or HIV protease receive 2.5 mg twice daily of inhibitors Apixaban. � In addition if they meet two of � Caution with strong CYP3A4 the following criteria they inducers e.g. rifampicin, should receive the lower dose: phenytoin, carbamazepine, serum creatinine 133 phenobarbital or St. John’s Wort as they may lead to reduced micromol/L, age ≥ 80years or Apixaban concentrations 6 body weight ≤ 60kg
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 CHA 2 DS 2 -VASc CHA 2 DS 2 -VASc criteria Score CHA 2 DS 2 -VASc Rate of stroke/other TE total score (%/year)* Congestive heart failure/ 1 left ventricular dysfunction 0 0.0 Hypertension 1 1 1.3 Age ≥ ≥ 75 yrs 2 ≥ ≥ 2 2.2 Diabetes mellitus 1 3 3.2 Stroke/transient ischaemic 2 attack/TE 4 4.0 Vascular disease 1 5 6.7 (prior myocardial infarction, 6 9.8 peripheral artery disease or aortic plaque) 7 9.6 Age 65–74 yrs 1 8 6.7 Sex category 1 9 15.2 (i.e. female gender) * Theoretical rates without therapy: assuming that warfarin provides a 64% relative reduction in TE risk (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.
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
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