New (Novel) Oral Anticoagulants (NOACs)

Guidance for medical examiners when assessing a patient for either a general topic or condition – New (Novel) Oral Anticoagulants (NOACs).

Also known as Direct-acting Oral Anticoagulants (DOACs)

Aeromedical implications

Effect of treatment on aviation

  • anticoagulation complications
  • short half-life

Approach to medical certification

Based on treatment

Appropriate indication for use

  • Non-valvular atrial fibrillation
  • Venous thrombo-embolic disease (VTE) treatment or prevention of recurrent VTE (Rivaroxaban only and when only clinically appropriately indicated)

Demonstrated stability

  • Absence of side effects
  • Good compliance essential

Risk assessment protocol - information required

New cases and renewal

Clinical status

  • Clinical status
    • absence of side-effects
    • normal renal function
  • Management
    • pharmacy printout for prior 12 months (less if a new case).

Indicative outcomes

  • Treatment and the use of NOACs or Vitamin K antagonists (eg. Warfarin) should be determined by the treating physician.
  • If stable on Warfarin without complications then switching to a NOAC is not recommended by current clinical guidelines. Unstable INRs due to non-compliance is not a reason to change to a NOAC. Poor compliance with a NOAC can lead to no anticoagulation effect due to their short half-life
  • Assessment involves consideration of likely compliance. Where good compliance is not demonstrated, the risk must be evaluated as if not treated with anticoagulant. Aeromedical risks usually require restrictions to be applied to Medical Certificates
  • VTE treatment Minimum of 3 weeks ground trial
  • Guidelines strongly support patient education to ensure compliance and regular review by the prescribing doctor for renal function checks, especially creatinine clearance and drug-drug interactions

Favourable

  • Satisfactory criteria met
    • Class 1 and 3- multi-crew operations/proximity restrictions only respectively
    • Class 2 – unrestricted
  • Demonstrated compliance.

Unfavourable

  • Significant side-effects
  • Non-compliance or no demonstrated compliance

Pilot and controller information

  • While NOACs have fewer food and drug interactions, all NOACs have some drug-drug interactions. Other medications can significantly affect how NOAC's work
  • While NOACs have a favourable risk-benefit profile, all NOACs are still anticoagulants and serious bleeding is still possible. Hence, Class 1 and Class 3 certificate holders who satisfactorily meet the criteria will be certified for multi-crew operations or with proximity restriction respectively
  • Any occurrence of significant side-effects such as serious bleeding or thrombotic effects mandate grounding and reporting to the DAME
  • NOACs have a short half-life, such that even missing one dose can lead to loss of anticoagulation and a two or three times increase in the risk of recurrent events
  • While monitoring of NOAC drug activity or levels is currently only available at major hospitals, more widespread monitoring of NOACs may be available in the near future and could form part of this risk assessment protocol
  • Dispensing records are accepted as demonstration of compliance. Blood tests not readily available

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Disclaimer

The clinical practice guidelines is provided by way of guidance only and subject to the clinical practice guidelines disclaimer.

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