New Anticoagulants Require Patient Engagement to Avoid Harmful Events


At a meeting with the Vizient Patient Safety Organization (PSO) Medication Safety Advisory Team, facilitators asked the question, “What keeps you up at night?” The responses from the assembled group (mostly pharmacists) were quick and consistent—direct oral anticoagulant (DOAC) medications.

"We are seeing concerning events related to the direct oral anticoagulants in our PSO database,” said Ellen Flynn, RN, MBA, JD, CPPS, associate vice president, safety at Vizient.  

Management of anticoagulant therapy has typically been high volume, high risk and problem prone. In fact, a Joint Commission national patient safety goal focused on improving patient safety related to anticoagulation therapy has existed for almost 10 years. Although standardized practices, enhanced education and closer monitoring of patients in anticoagulant clinics have improved safety for patients on Warfarin (the most common older anticoagulant), the need for frequent blood tests to maintain a safe, therapeutic range for blood clotting places high demands on patients who take this medication.

With no requirements for regular blood testing, no dietary limitations, fewer drug interactions and a rapid onset of action, the new DOACs—Rivaroxaban, Apixaban, Dabigatran and Edoxaban—offer an attractive alternative for patients. Data from 2016 in the Vizient Clinical Data Base (CDB) revealed that as the number of patients on Warfarin decreased, the number of patients on the DOACs rose. However, use of the DOACs added more complexity to the anticoagulation management picture.

“We reviewed a variety of PSO-reported events related to the use of DOACs,” Flynn said. “These included instances where providers unintentionally duplicated therapy because they did not realize the patient was already on an anticoagulant and/ or they did not conduct thorough medication reconciliation. In other cases, discharge instructions were unclear due to confusion between paper and electronic prescriptions.”

Speculation is there were opportunities missed to prevent these events because the patients may not have been well informed about their medication and/or engaged in the process. Drug interactions went unnoticed and the patients were not educated on (nor did they know to ask about) the seriousness of these interactions.  

Problems or errors seem less likely to detect before the patient incurs harm with the DOACs (than with Warfarin) because the patient is not monitored as frequently by their provider or anticoagulation clinic. The patient might also be less engaged in their care.  Patients did not always understand their discharge instructions, including the importance of tapering their medication and/or the potential complications that might occur if not accurately followed.

Flynn also noted opportunities for improvement related to monitoring and dosing issues for older, more medically complex patients. Other examples involved perioperative management and reversal of the anticoagulation effect for surgery. There were even issues with the patient being able to acquire the required medication post discharge because of the drug’s cost. Complying with the provider’s recommendations related to anticoagulation therapy is critical and lack of compliance could result in serious patient harm, such as stroke.

Teaming Up to Ensure Safety

The Vizient PSO is bringing together a multidisciplinary team of experts to help deliver tools to Vizient members that will increase patient safety, health care quality and outcomes related to the DOAC anticoagulants. 

“We are listening closely to our members as they tell us not to create another tool kit that will just sit on a shelf,” Flynn said. “Providers need actionable tools that help them improve care for this patient population, and the Vizient PSO is working to figure out what those tools will be.”

In the meantime, Flynn said it is essential that (prior to starting treatment), both providers and patients confirm there are no adverse interaction issues or duplications of medication. In addition, there must be a clear plan to monitor the patient, either through an anticoagulant clinic or with the provider.

Flynn said the DOACs are high alert medications and raising awareness of them in an organization by placing them on a high alert medication list is critical. In addition, organizations should conduct ongoing concurrent monitoring of these medications’ use and report findings to nurses, physicians and pharmacists. Organizations should also share findings from the review of safety events with front line providers, pharmacists and nurses. To take it a step further, an organization can also report near miss and actual events to their Patient Safety Organization to promote national learning and accelerate the pace of improvement related to these medications.

To access the Vizient patient safety alert, “Discharge Care of Patients on Direct Oral Anticoagulants,” click here. For more information on how the Vizient PSO strives to achieve patient safety, or to learn how to join Vizient’s PSO, click here.