New Sentinel Event Alert Highlights Risks of Direct Oral Anticoagulants

The Joint Commission (TJC) this week issued a new Sentinel Event Alert (SEA #61) warning of the risks to patients posed by direct oral anticoagulants (DOAC).

According to the alert, DOACs provide ease of use for patients, but they can lead to bleeding risks that could be serious and potentially life-threatening. Stopping such bleeding events can be complex and different from those used on patients on warfarin and heparin, which have more widely available reversal agents. Reversal agents for DOACs are lesser known and may not be available in all care settings, and some DOACs have no FDA-approved reversal agent. The most serious type of bleeding risk is intracranial hemorrhage.

SEA #61 provides guidance on the safe use and management of DOACs, which include Apixaban (Eliquis®), Betrixaban (Bevyxxa®), Dabigatran (Pradaxa®), Edoxaban (Savaysa®), and Rivaroxaban (Xarelto®). Effective July 1, 2019, TJC revised its National Patient Safety Goal NPSG.03.05.01 on anticoagulation to help organizations design systems to prevent quality and safety issues related to DOAC prescribing, monitoring, and treatment of severe bleeding.

The alert advises caregivers to avoid using the wrong intervention for DOACs. Using evidence-based practice guidelines for DOACs can reduce the likelihood of prescribing errors. Perioperative assessment and communication are critical to determine whether there is bleeding risk, the accreditor notes in the SEA. There should be communication about the specifics of the DOAC at transitions of care. Especially important is to avoid therapeutic duplication; providers who are not familiar with all DOACs may accidentally prescribe a second anticoagulant.

The Joint Commission suggests taking the following actions to prevent mix-ups with DOACs:

  • Create name awareness of the various DOACs among providers, including pharmacists, emergency department (ED) clinicians, and others who may be called on to deal with life-threatening bleeding problems.
  • Use evidence-based protocols and practice guidelines for drug initiation and maintenance, anticoagulation reversal, management of bleeding events, and perioperative management for each DOAC.
  • Have a written policy in place requiring baseline and ongoing lab tests to monitor and adjust anticoagulant therapy.
  • Each particular DOAC’s indications for use should be included on the patient’s prescription, in instructions for the patient, and in the electronic medical record.
  • Address anticoagulation safety practices by evaluating them and setting goals to improve measures, and establishing a process to identify, respond to, and report adverse drug events.
  • Provide education to patients and families about the anticoagulant medication prescribed, including adherence to medication dose and schedule, follow-up appointments, potential drug-drug interactions (and interactions with herbs or supplements), the potential for adverse drug reactions and how to spot them, and when to contact a physician or visit the ED.