Introduction. Background to this event. Raising awareness 09/11/2015

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1 Introduction Primary Care Medicines Governance HSCB Background to this event New class of medicines Availability of training Increasing volume of prescriptions Reports of medication incidents Raising awareness HSCB aware of the safety issues from medication incident reports Collaboration with ABPI cardiovascular therapy group to increase awareness of the issues and improve patient safety & clinical outcomes 1

2 Key role of the community pharmacist Patients taking the NOACs will attend their GP practice less often that patients taking warfarin no INR monitoring Acknowledge the key role of the community pharmacist as the healthcare professional with regular contact with the patient Format Focuses on community pharmacy practice ABPI will cover the key drug characteristics for each of the NOACs HSCB will cover safety issues Resources Local Northern Ireland ABPI cardiovascular therapy group representatives Learning outcomes Describe the characteristics of the NOACs Describe potential sources of medication errors for NOACs Describe how community pharmacists can contribute to safe & appropriate use of NOACs 2

3 NOACs available in UK Apixaban (Eliquis ) 2011 Dabigatran (Pradaxa ) 2008 Edoxaban (Lixiana ) 2015 Rivaroxaban (Xarelto ) 2008 How do they work? Apixaban Edoxaban Rivaroxaban 3

4 What is their place in therapy? Alternative to warfarin & heparin for the treatment & prevention of venous thromboembolism (some patient exceptions apply): Atrial fibrillation DVT PE After hip/knee surgery Acute coronary syndromes Guidance in N.I. Date of NICE Technical Appraisal NIF Northern Ireland Formulary Stroke prevention AF Apixaban Feb 2013 Dabigatran Mar 2012 NIF NIF Treatment DVT/PE June 2015 Dec 2014 Edoxaban Sept 2015 Aug 2015 NIF NIF Prevent VTE after hip/knee Jan 2012 Sept 2008 NIF NIF Acute coronary syndrome Rivaroxaban May 2012 NIF July 2012/13 NIF Apr 2009 NIF Mar 2015 NICE approval What does it say for Atrial Fibrillation? The drugs must be made available for prescribing within their licensed indications & should be included in local formularies Patients must be actively involved with their clinician in decision making about their anticoagulant treatment options and agree the therapy that is best for them (AF) 4

5 Northern Ireland Formulary All NOACs can be prescribed in primary care The cardiovascular chapter has been updated & is due later in 2015 NOACs that had a NICE TA at the time of the review are included in the formulary Some NOAC indications are not included as they are considered too specialist e.g. ACS Medication incidents a) Drug interactions b) Over-dosing c) Under-dosing d) Non- compliance Themes e) Switching from warfarin to NOAC 5

6 Drug interactions Co-prescription of contra-indicated medicines e.g. other anticoagulants Co-prescription of medicines known to increase bleeding risk e.g. antiplatelets, NSAIDs Management of interactions anecdotal reports of the NOAC being held whilst patient on an interacting medicine Co-prescribing with anticoagulants & anti-platelets NOAC Contra-indicated Anticoagulants Caution antiplatelets Apixaban (Eliquis ) Dabigatran (Pradaxa ) Edoxaban (Lixiana ) Rivaroxaban (Xarelto ) LMWH e.g. enoxaparin, dalteparin Heparin (unless for catheter patency) Other NOACs Warfarin (unless during switch) Not routinely used in combination unless advised by a specialist Aspirin Clopidogrel Dipyridamole Ticagrelor Prasugrel Double dosing Treatment of VTE (DVT or PE) Rivaroxaban and apixaban have an initial dose followed by a maintenance dose NOAC Initial dose Maintenance dose Rivaroxaban 15mg BD for 3 weeks 20mg daily Apixaban 10mg BD for 1 week 5mg BD 6

7 Under-dosing Each NOAC has dose recommendations for the various indications based on patient factors e.g. renal function Important to follow the licensed dose as this is proven in clinical trials to provide efficient anticoagulant cover Evidence of intentional and unintentional under-dosing HSE Ireland Under-dosing Reviewed prescription data from 2013 >80% NOAC Rx for atrial fibrillation 16% rivaroxaban Rx were for 10mg daily Recommended dose is 20mg daily reducing to 15mg daily in renal impairment Non - compliance Anticoagulant effect fades rapidly hours after the last dose intake Strict therapy compliance is crucial for adequate protection 7

8 Issues to consider Patients with experience of missing warfarin doses No routine blood monitoring to test compliance Periods of illness or GI upset Re-ordering prescriptions Collection of prescriptions Collection of owings Ensuring adequate supply over holiday periods Optimising compliance Prescribers & pharmacists need to consider all means to optimize compliance: Frequency of dosing regimen Patient/family/carer education Clear follow up schedule MDS/ compliance aids Smartphone apps Switching from warfarin to NOAC 1. Warfarin is stopped 2. INR is monitored until it has fallen below a certain level (depends on NOAC) 3. NOAC is started 8

9 Who & what? GP, pharmacist, patient, carer, care home Remove warfarin from repeat Rx Cancel patients INR monitoring Issue Rx for NOAC Ensure that everyone is clear about when the NOAC should start Advise that warfarin is returned to community pharmacy for disposal What are we doing to reduce risk? 9

10 Raising awareness Training events Newsletter articles Raising awareness of the newer oral anticoagulants letter + poster for pharmacies & clinical areas (March 2014) Avoiding dosing errors HSC letter re dosing incidents Consideration to introduction of starter packs Full initial 3 weeks supply from hospital at discharge Ensuring that duration of therapy and start dates are included Sharing learning adverse incidents Medicines Safety Matters (GPs & CPs October 2015) Interactions Switching Dosing errors Concordance Patient counselling 10

11 Patient counselling resources Promoting the importance of patient counselling and increasing patient awareness Signpost to resources Request that all GP practices counsel patients when they start a NOAC & ensure patient is carrying the alert card Pharmacies can also support on-going patient education Q - Use of a counselling check list for primary care? Patient held alert card Show patient the alert card in pack with first supply Importance of carrying their patient alert card Patient held alert card Ideally there would be a nationally agreed generic card in the future Areas in UK are either: Using product specific cards only Using yellow oral anticoagulant alert card with product cards Using a local/area designed alternative with product cards HSCB plan to roll out use of the yellow oral anticoagulant alert card to NOAC patients in primary care 11

12 generic NOAC alert card options EHRA card Northern England Cardiac network Extending the use of the warfarin oral anticoagulant alert card to use with NOACs Mr James Brown 25 The Green, Belfast BT Mrs Brown NOAC name Atrial fibrillation N/A 15/7/15 lifelong Grange Medical Practice Prescription analysis Analysis of our N.I. prescription data using the 2D barcode HSCB has previously looked a prescribing using the 2D barcode Similar to work in HSE Ireland Identify potentially inappropriate or unsafe doses, drug combinations etc. 12

13 E- health solutions Examine potential to add warning flags to electronic prescribing and dispensing systems in both primary and secondary care which promote medicines safety Examine decision support for prescribing, administration and supply of NOACs Safety monitoring Monitor incident data for new and emerging risks Pharmacists play a key role in sharing their experiences of incidents and near misses Reporting to HSCB can be in person or anonymous (online anonymous coming soon) Ideas? 13

14 Role of the Community Pharmacist Patient contact Patients taking the NOACs will attend their GP practice less often that patients taking warfarin no INR monitoring Acknowledge the key role of the community pharmacist as the healthcare professional with regular contact with the patient Key role to support safe use a) Clinical check Doses Drug interactions b) Supporting compliance c) Patient education d) Reporting medication incidents e) Yellow card ADRs 14

15 Clinical check - doses ABPI workshops have covered the appropriate dose ranges for the NOACs Medication incident reporting has highlighted how there is under-dosing and over-dosing Clinical check - interactions Contra-indicated anticoagulants Patients being switched from warfarin or another NOAC Patients prescribed LMWH Cautionary check on all antiplatelets & drugs known to increase bleeding risk Possible inadvertent prescribing Aspirin, NSAIDs, herbal products + OTC advice SSRIs, SNRIs Supporting compliance Patient education Use of reminders e.g. smart phone app Use of monitored dosage systems Use of other compliance aids e.g. Pradaxa medication device 15

16 Identifying non-compliance Checking re-order frequencies Owings not collected Discussions with patient/carer Reasons? Dosing regimen Side effects Concerns Episodes of bruising or bleeding not reported to GP Patient education key messages covered in PILs Understand importance of treatment Administration Dosing interval Missed doses Interactions e.g. OTC NSAIDs Food & alcohol Surgical/Dental procedures Adverse/side effects & early intervention Advice to patients PILs You should: Report signs of bleeding and bruising Have regular blood tests to check your kidney function Take your NOAC with food and a glass of water Take the dose advised by the doctor Carry your anticoagulant alert card with you Show your alert card to pharmacists, dentists, doctors if attending for treatment 16

17 Advice to patients - PILs You should not: Take aspirin or NSAIDs unless prescribed by your doctor Miss a dose of NOAC unless advised to do so Take extra doses or change your dose of NOAC without first discussing with the doctor Run out of NOAC tablets. Ask your GP for a repeat prescription in good time. Advice to patients - PILs Be aware: If you think you may be pregnant whilst taking NOAC, contact your doctor at once Tell the GP surgery of any changes of address, telephone number Yellow card scheme Reporting adverse reactions via yellow card Encouraging patients to report via yellow card New Yellow card phone app 17

18 References How to support patients taking new oral anticoagulant medicines. Pharm J Clinical pharmacist Journal Nov 2013 EHRA Practical Guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation: executive summary Updated European Heart Rhythm Association Practical Guide on the use of non-vitamin K antagonist anticoagulants in patients with non-valvular atrial fibrillation uropace.euv309 Medicines SPC Copy of slides 18

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