Joint Commission Sentinel Event Alert #61 - Managing the Risks of Direct Oral Anticoagulants

PUBLISHED: Aug 1, 2019
Relevant to: Ambulatory Care, Clinical Lab, Critical Access Hospitals, Dialysis Facilities, Home Health, Hospice, Hospitals, Long Term Care, Medical Office, Office-Based Surgery, Pharmacy, Rural Health Clinics

The Joint Commission has issued Sentinel Event Alert #61 which reviews strategies for managing the risks associated with use of direct oral anticoagulants (DOAC). According to TJC, anticoagulants, as a medication class, are among those most frequently involved in error resulting in death or serious harm. However, TJC believes that with appropriate preparation and treatment the potentially deadly consequences of DOACs can be avoided.

The benefit of DOACs is that they are easy to use for patients. However, there is challenge in stopping bleeding events in patients on DOACs. While there are readily available reversal agents for traditional anticoagulants like warfarin (Coumadin®) and heparin, DOACs have lesser known and sometimes lesser available reversal agents. Different DOACs require different reversal agents and some DOACs do not have FDA-approved reversal agents at all.

TJC has issued this Sentinel Event Alert to increase awareness about adverse events related to DOACs, provide guidance on safe use and management of DOACs and ensure that all healthcare settings are aware of the patient safety concerns related to DOACs.

TJC encourages the following to improve patient safety with use of DOACs:

  • Organizations should cultivate DOAC name awareness: apixaban (Eliquis®), betrixaban (Bevyxxa®), dabigatran (Pradaxa®), edoxaban (Savaysa®), and rivaroxaban (Xarelto®). Specifically, pharmacists, emergency department clinicians and other providers involved in situations where rapid reversal of life-threatening bleeding may be required should be familiar with these medications.
  • Organizations must adopt evidence-based protocols and practice guidelines for drug initiation and maintenance, reversal of anticoagulation and management of bleeding events.
  • Risks, benefits, side effects, potential antidotes or reversal agents should be known for all anticoagulants. This information should also be provided to patients/families/caregivers as appropriate.
  • Organizations should adopt standard baseline and ongoing laboratory tests to monitor and adjust anticoagulant therapy., including DOACs.
  • Note: Although DOACs are designed to be given at fixed doses and do not require routine coagulation monitoring, in some instances, the interpretation of coagulation laboratory results is important for optimal management of DOAC toxicity or reversal.
  • Include the indication for use for the DOAC’s indications for use on the patient’s prescription, in the instructions for the patient, and in the electronic medical record (EMR).
  • Organizations should routinely evaluate anticoagulation safety practices and take actions to improve safety practices wherever possible.

Included with today’s notice are example polices related to patient safety and the use of anticoagulants, including DOACs.

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