Non-vitamin K antagonist oral anticoagulants (NOACs) YOUR FACILITY Presenter Month YYYY Presenter: add your facility, name and month / year

This session will provide an: Introduction to high-risk medicines Overview of NOACs (also known as ‘DOACs’ – Direct Oral Anticoagulant), including: NOACs available Indications Contraindications Adverse effects Prescribing, administering and supply Specific NOAC risks

‘A-PINCH’ A – Anti-infectives P – Potassium & other concentrated electrolytes I – Insulins N – Narcotics and other sedatives C – Cytotoxic agents H – Heparins and other anticoagulants ‘A-PINCH’ is an acronym used as a starting point to identify high-risk medicines. As anticoagulant medicines, NOACs are part of this acronym.

Features of High-Risk Medicines: More likely to cause harm if involved in an error Narrow therapeutic window Multiple interactions with other medications Potent medications Complex dosage and monitoring schedules Wide variation in effect All anticoagulants can cause harm if involved in an error

Anticoagulant medicines: Are used extensively in clinical practice Act through targeting a number of different proteins that may limit or prevent thrombus formation Have a narrow therapeutic index and over or under anticoagulation can result in significant adverse patient outcomes Choice of anticoagulant will be based on a variety of patient factors and indication for treatment Until introduction of NOACs, warfarin was the only oral anticoagulant available All anticoagulants can cause harm if involved in an error

There are currently three NOACs registered in Australia: One direct thrombin inhibitor: Dabigatran (Pradaxa®) Three NOACs are registered in Australia. They work on different parts of the clotting cascade.

Two Factor Xa inhibitors: Apixaban (Eliquis®) Rivaroxaban (Xarelto®)

NOAC indications include: Reduces risk of stroke in non-valvular atrial fibrillation Prevention of VTE following hip or knee replacement Treatment and ongoing prevention of VTE Important to note: there is currently no reversal agent registered in Australia for these medicines

Contraindications to NOAC therapy include: Renal impairment a reduced dose may be used in moderate renal impairment, depending on renal function, NOAC and indication Disorders of haemostasis Clinically significant active bleeding Prosthetic heart valve Liver disease Pregnant and breastfeeding women Children under 18 years

NOAC adverse effects Dabigatran Apixaban Rivaroxaban Common bleeding anaemia nausea dyspepsia gastritis abdominal pain GI bleeding peripheral oedema itch, skin blisters muscle spasm Infrequent increased liver enzymes thrombocytopenia Rare allergic reactions

NOAC dosing Unlike warfarin: NOAC doses are fixed based upon patient factors, such as renal function and indication of therapy Dose frequency is either daily, or twice daily depending on indication Duration of therapy is dependent on the indication for therapy

NOAC monitoring Unlike warfarin: There is no need to routinely measure patient blood levels and make dose adjustments according to a ‘therapeutic range’ However: NOACs are excreted renally. Renal function should be monitored: at least annually if the patients condition changes Patients should also be routinely assessed for signs of bleeding and for other bleeding risk factors (e.g. persistent hypotension; other medicines; platelet counts) Point one: provide an example: monitoring International Normalised Ration (INR) for patients on warfarin

Prescribing NOACs on the National Inpatient Medication Chart (NIMC) Check all charts in case an anticoagulant medicine has already been ordered The NOAC should be prescribed in either a ‘Regular Medication’ order space, or following VTE risk assessment, on the ‘VTE prophylaxis section’ NIMC Regular medicine order space NIMC VTE prophylaxis section

Prescribing therapeutic dose NOACs on the NIMC Use a NIMC ‘regular medicine’ order space Include the ‘Indication’ in the order: allows the medicine to be reviewed in terms of why it was ordered reduces the risk of misinterpretation of the order e.g. medicines with look-a-like names or incorrect doses and for medicines which have different doses for different indications Remove this slide if the relevant NOAC chart is not in use in your facility

Prescribing VTE prophylaxis dose NOACs on the NIMC Use the NIMC VTE prophylaxis section The ‘Indication’ is preprinted in this section If VTE therapy is required e.g. for a pre-existing DVT, it should be charted in a regular medicines order space Remove this slide if the relevant NOAC chart is not in use in your facility

Documenting NOAC education on the NIMC NOAC education can be documented on the NIMC in the ‘Warfarin Education Section’ Warfarin should be crossed out and the name of the NOAC inserted. Remove this slide if the relevant NOAC chart is not in use in your facility

NOAC administration instructions: Dabigatran (Pradaxa®) Swallow whole with or without food Do not chew or open capsule Keep in original packaging Do not transfer capsule to a dose administration aid Apixaban (Eliquis®) Can be used in dose administration aids Rivaroxaban (Xarelto®) 10 mg tablet may be taken with or without food 15 mg and 20 mg tablet should be taken with food Images courtesy of MIMS Australia PRESENTATION NAME – PRESENTER NAME

Accessing NOAC supplies NOACs are short-acting medicines. Dose omission may put the patient at risk of thrombosis Inform the ward pharmacist when a patient is admitted or commenced on a NOAC If the prescribed NOAC is not available as imprest supply, and the Pharmacy Department, is closed the NOAC should be sourced by: Contacting the After-Hours Pharmacist Sourcing it through the After-Hours Supply Contact the relevant medical officer if a dose is still not available The chart shouldn’t simply be marked as ‘N’ (not available) The presenter should adjust this slide according to facility procedures

General NOAC safety considerations: For all patients receiving anticoagulants clinicians should be alert to signs of bleeding Patients taking anticoagulants are at increased risk of bleeding if they fall (refer to local fall protocol) All patients (and/ or their carer) receiving or going home on an anticoagulant require education on their medicines The presenter should adjust this slide according to facility procedures

Specific NOAC risks Specific incidents that have been identified associated with NOAC use: Failure to recognise these medicines as anticoagulants For example, venous thromboembolism (VTE) prophylaxis (enoxaparin) prescribed along with a NOAC Anticoagulants prescribed on different charts Intravenous heparin is prescribed on an IV heparin chart and a NOAC is prescribed on the NIMC

Specific NOAC risks Failure to realise clinical significance of NOACs For example, doses omitted and documented ‘N’ (not available) If there is any doubt whether a dose has been given, contact the medical officer, don’t simply omit Mismanaged during the perioperative period For example, the NOAC is ceased too early prior to a procedure Risk of drug interactions Specific interactions and medicines that increase bleeding risk

In summary: NOACs (anticoagulants) are a high-risk medicine As with all medicines, if the patient’s condition changes NOAC use may need to be reviewed NOACs need to be sourced, or the medical officer notified if not available For all anticoagulants, check that duplicate anticoagulant therapy hasn’t inadvertently been prescribed

References Australian Commission on Safety and Quality in Health Care. NIMC User Guide. 2014. MIMS Australia. Pradaxa Full Product Information. 2015. MIMS Australia. Xarelto Full Product Information. 2015. Therapeutic Goods Administration. Approved Product Information. Apixaban (Eliquis) 2015 Presenter can include additional local resources on this slide

Policy and resources: Australian Commission on Quality and Safety in Health Care, NIMC User Guide http://www.safetyandquality.gov.au/publications/nimc-user-guid/ Government of Western Australia. Living with a New Oral Anticoagulant (NOAC) http://www.watag.org.au/wamsg/docs/Living_with_a_NOAC_2015.pdf NSW Clinical Excellence Commission High-Risk Medicines Webpage http://www.cec.health.nsw.gov.au/programs/high-risk-medicines NSW Health Policy on High-Risk Medicine Management http://www0.health.nsw.gov.au/policies/pd/2015/PD2015_029.html National Prescribing Service (NPS) http://www.nps.org.au/medicines/heart-blood-and-blood-vessels Presenter can include additional local resources on this slide

Thank you Questions For further information: CEC-MedicationSafety@health.nsw.gov.au www.cec.health.nsw.gov.au