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What’s New in the Patient Safety World

October 2019

Sentinel Event Alert on DOAC’s

 

 

Primarily because of the increased use of DOAC’s (direct oral anticoagulants), the Joint Commission established a new National Patient Safety Goal (NPSG.03.05.01) that became effective July 1, 2019 (TJC 2018). The elements of performance (EP’s) are:

 

·       EP 1: The [hospital/organization] uses approved protocols and evidence-based practice guidelines for the initiation and maintenance of anticoagulant therapy that address medication selection; dosing, including adjustments for age and renal or liver function; drug-drug and drug-food interactions; and other risk factors as applicable.

 

·       EP 2: The [hospital/organization] uses approved protocols and evidence-based practice guidelines for reversal of anticoagulation and management of bleeding events related to each anticoagulant medication.

 

·       The other 6 EP’s deal with lab tests and monitoring of patients on anticoagulants, perioperative management, safety practices, patient/family education, and, for specific agents, the hospital/organization uses only oral unit-dose products, prefilled syringes, or premixed infusion bags when these types of products are available and uses programmable pumps to provide consistent and accurate dosing.

 

Well, it didn’t take long for The Joint Commission to issue a Sentinel Event Alert on managing the risks of direct oral anticoagulants (TJC 2019), It points out that, while DOACs offer ease of use to patients, stopping bleeding events in patients on DOACs is more complicated. Different strategies are required than those for patients on warfarin and heparin.

 

The alert focuses on the different reversal mechanisms for DOAC’s compared to those for heparin or warfarin. It also notes that a DOAC-specific reversal agent may not be effective in treating another kind of DOAC.

 

It also emphasizes that perioperative assessment and communication are critical. Before surgery and outpatient procedures such as cardiac catheterization, interventional radiology and colonoscopies —perioperative assessment is critical to assess bleeding risk. Communication about the specifics of a DOAC also is critical at transitions of care for many reasons. Especially important is avoiding therapeutic duplication.

 

It has the following 6 recommended actions for hospitals/organizations to take:

 

-        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, and perioperative management

-        Have a written policy on the need for baseline and ongoing laboratory tests to monitor and adjust anticoagulant therapy

-        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).

-        Address anticoagulation safety practices

-        Because DOACs are easy to use and rising in popularity, patients with DOAC prescriptions may not fully understand the risks of these medications. To reduce the risk of bleeding or clotting, provide education to patients and families specific to the anticoagulant medication prescribed,

 

See the actual Sentinel Event Alert for details on each of those actions.

 

 

The alert also provides links to other Joint Commission resources, as well as resources from ISMP (Institute for Safe Medication Practices), the American College of Cardiology, and others. Some other useful studies on DOAC’s we’d like to point out are from the Pennsylvania Patient Safety Authority (Valentine 2018), the British Medical Journal (Vinogradova  2018),

 

 

References:

 

 

TJC (The Joint Commission). R3 Report. National Patient Safety Goal for anticoagulant therapy. Issue 19, Dec. 7, 2018

https://www.jointcommission.org/assets/1/18/R3_19_Anticoagulant_therapy_Rev_FINAL1.PDF

(TJC 2018)

 

 

TJC (The Joint Commission). Sentinel Event Alert 61: Managing the risks of direct oral anticoagulants, July 30, 2019

https://www.jointcommission.org/sentinel_event_alert_61_managing_the_risks_of_direct_oral_anticoagulants/

(TJC 2019)

 

 

Valentine D, Gaunt MJ, Grissinger M. Identifying Patient Harm from Direct Oral Anticoagulants. Pa Patient Saf Advis 2018; 15(2).

http://patientsafety.pa.gov/ADVISORIES/Pages/201806_DOACs.aspx

(Valentine 2018)

 

 

Vinogradova Y, Coupland C, Hill T, Hippisley-Cox J. Risks and benefits of direct oral anticoagulants versus warfarin in a real world setting: cohort study in primary care. BMJ 2018; 362: Published 04 July 2018

https://www.bmj.com/content/362/bmj.k2505

 

 

 

 

 

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