As reported by the Patient Safety Network, anticoagulant medications are “known to be high-risk for adverse drug events.” Even direct oral anticoagulants (DOACs), which do not carry the same monitoring requirements as warfarin, can be associated with “an increased risk of patient harm if not prescribed and administered correctly.” In late July, The Joint Commission (JC) released a Sentinel Event Alert on managing the risks of DOACs, including Apixaban (Eliquis®), Betrixaban (Bevyxxa®), Dabigatran (Pradaxa®), Edoxaban (Savaysa®) and Rivaroxaban (Xarelto®).
In its alert, the JC describes the “serious and potentially deadly consequences related to bleeding risks for patients on DOACs” and cites data published in The Pharmaceutical Journal (February 2019) that indicates “anticoagulants have been named second of the top 10 medications involved in error incidents causing death or serious harm.”
The JC specifically warns that “some direct oral anticoagulants have no FDA-approved reversal agent at this time. Therefore, bleeding complications can be severe if these patients are not assessed according to guidelines on the management of DOACs. Intracranial hemorrhage is the most serious emergent bleeding risk.” It also notes that bleeding complications can “stem from blunt trauma and other injuries” treated in any clinical setting, such as hospitals, ambulatory care, nursing care centers, home care, pharmacy and behavioral health.
To avoid adverse events related to DOACs, the JC issues these cautions for physicians and other healthcare providers (quoted directly from the Alert):
- DOACs present different risks than heparin and warfarin and have different reversal mechanisms.
- A reversal mechanism that works for one DOAC may not work for another.
- Perioperative assessment and communication are critical.
In addition, the JC’s July 30 Sentinel Event Alert recommends specific actions to prevent patient harm, including the following:
- Create name awareness for the various kinds of DOACs.
- For each type of anticoagulant medication, use evidence-based protocols and practice guidelines for drug initiation and maintenance, reversal of anticoagulation and management of bleeding events.
- Have a written policy on the need for baseline and ongoing laboratory tests to monitor and adjust anticoagulant therapy.
- To reduce the risk of bleeding or clotting, provide education to patients and families specific to the anticoagulant medication prescribed.
- Include the particular DOAC’s indications for use on the patient’s prescription, in the instructions for the patient, and in the electronic medical record (EMR).
MLMIC encourages policyholders to review the Alert in its entirety here. Additionally, facilities, physicians and other staff should review their policies and procedures for prescribing all anticoagulants to ensure compliance with JC guidance and provide thorough education to patients on the risks and benefits of these medications.