November-December 2019, Volume 16, Issue 6
Reducing the Likelihood of Harm Associated With Use of Anticoagulant Therapy
Published on: October 04, 2019
To improve safe prescribing of anticoagulation, the Joint Commission published an impressive document1 in 2019 that contains a wealth of information on, and links to, protocols and guidelines for various anticoagulation issues, including appropriate drug selection and dosing, reversal and management of major bleeding, perioperative management, laboratory monitoring, and patient education. While this comprehensive document might initially seem difficult to navigate, it is a great resource for anyone interested and involved in establishing hospital- and systems-wide anticoagulation guidelines and quality improvement activities.
The Joint Commission has explained that this focus on anticoagulation management arose in response to an increase in adverse events (AEs) associated with anticoagulation use. In a collective investigation of emergency department visits between 2013 and 2014 for any outpatient adverse drug events, anticoagulation was responsible for 17.6 percent of visits.2 The most common cause of anticoagulation-associated AEs is medication errors,3 and the use of anticoagulants ranks as the second leading cause of all prescribing errors.4
Furthermore, the landscape of anticoagulation has changed as direct oral anticoagulants (DOACs) have been adopted rapidly and widely as initial therapy for patients with venous thromboembolism and atrial fibrillation, largely replacing traditional agents including warfarin5,6; as a result, there has also been a rise in DOAC-associated AEs and prescribing errors. The Pennsylvania Patient Safety Reporting System investigated DOAC use between January 2011 and August 2017 and identified 1,811 reported AEs, 265 of which resulted in patient harm.7 The most frequent error type without harm was duplicate anticoagulation therapy (33.3%), and others included dose omission, wrong dose, and procedure cancellation. As expected, the most frequent harmful event was bleeding (70.2%), with close to 40 percent of harmful events occurring in patients who were 80 years or older. Other studies have reported an increasing frequency of DOAC prescribing errors, including incorrect medication dose, lack of dose adjustment for pharmacokinetic problems, and prescription in a patient with a contraindication.8,9
Joint Commission National Safety Goals to Reduce Harm Associated With Anticoagulant Therapy
The Joint Commission publishes annual National Patient Safety Goals (NPSGs) designed to identify patient safety priorities and to propose solutions to prevent potential hazards; in 2019, they added six new “Elements of Performance” (EPs) to define goals for health care institutions to improve the safety of anticoagulation therapy (Table). The new document is referred to as NPSG.03.05.0110 and was effective as of July 1, 2019. EPs 1 through 3 include the use of approved protocols and evidence-based practice guidelines for medication selection, reversal and management of bleeding, and perioperative care. EP 4 requires a written policy about laboratory testing to monitor and adjust anticoagulation. EP 5 addresses institutional safety practices, including the development of processes for identifying and responding to adverse drug events. EP6 focuses on patient education, ensuring that patients are aware of medication dose and schedule, follow-up plan, and potential drug interactions and adverse reactions.
Along with the main publication of requirements,10 the Joint Commission also published a compendium of resources,1 including seminal guidelines and publications, to help institutions achieve these patient-safety goals. The list includes online clinical support tools from the Anticoagulation Forum’s Centers of Excellence Resource Center, among others.11 Entering the search term for a given EP (e.g., “EP1”) into the search field of their website11 provides a collection of resources designed to help organizations meet the selected EP. Available materials include clinical protocols, order sets, patient education materials, and “examples of excellence” that highlight successful efforts in organizations across the United States. Also included are newer efforts to build accessible, user-friendly online resources to assist providers such as the ManageAnticoag App (tools.acc.org/ManageAnticoag) created by the American College of Cardiology.12 This application guides users through algorithms for periprocedural anticoagulation interruption and restart (EP 3), addresses acute anticoagulation-induced bleeding (EP 2), and provides a real-time clinical decision tool to support safe anticoagulation prescribing practices. The Joint Commission has also published a “Sentinel Event Alert” with an abbreviated list of recommendations to assist institutions in developing DOAC safe prescribing practices.13
The Systems-based Hematologist
With the creation of these new care standards, health systems must now institute efforts to ensure compliance with safe anticoagulation prescribing practices and provide hematologists with the opportunity to lead these efforts.
In 2015, ASH partnered with a consulting firm, Lewin Group, to investigate the future of nonmalignant hematology, seeking opportunities for nonmalignant hematologists to “optimally contribute in the emerging 21st century health ecosystem.”14 In doing so, they identified a new career role — the “systems-based hematologist,” which refers to “a specialty-trained physician, employed by a hospital, medical center, or health system, who optimizes individual patient care, as well as the overall system of heath care delivery for patients with blood disorders.”14
The implementation of the new Joint Commission safety goals presents a prime opportunity for further investment in systems-based hematology across the United States. Multiple institutions have reported improved safe prescribing practices and cost savings with the implementation of multidisciplinary anticoagulation stewardship teams,15,16 and the Anticoagulation Forum recently published very user-friendly new resources to support the development of system-level initiatives to improve anticoagulation safety.17 The full report from the Lewin Group highlights the professional role of “Medical Director for Hemostasis/Thrombosis Stewardship,” who would be equipped to create and lead such programs.18
As anticoagulation management has become increasingly complex, having a trained hematologist at the helm can ensure the creation of safe and effective care plans and policies that improve anticoagulation care delivery.
In conclusion, there are three key lessons we should keep in mind. First, the Joint Commission has published six new goals to encourage improvement in the safety of anticoagulation therapy.1,10 Second, a comprehensive document by the Joint Commission lists and links to a wealth of resources, to assist individual hematologists and institutions implement safe anticoagulation prescribing practices.1 Third, the Anticoagulation Forum produced a nice, user-friendly document to assist with implementation of good anticoagulation practices.17 Finally, systems-based hematology is an emerging field in which hematologists work within health care systems to meet these and other patient safety goals to improve hematologic care delivery.
Six New Elements of Performance (EPs) in the Joint Commission’s NPSG.03.05.0110
|EP 1||Appropriate drug selection and dosing 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||Management of bleeding 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.|
|EP 3||Perioperative management The hospital uses approved protocols and evidence-based practice guidelines for perioperative management of all patients on oral anticoagulants.|
|EP 4||Laboratory testing The hospital/organization has a written policy addressing the need for baseline and ongoing laboratory tests to monitor and adjust anticoagulant therapy.|
|EP 5||Adverse event reporting, continuing quality improvement The hospital/organization addresses anticoagulation safety practices through the following:
- Establishing a process to identify, respond to, and report adverse drug events, including adverse drug event outcomes
- Evaluating anticoagulation safety practices, taking actions to improve safety practices, and measuring the effectiveness of those actions in a time frame determined by the organization
|EP 6||Education of patients The hospital/organization provides education to patients and families specific to the anticoagulant medication prescribed, including the following:
- Adherence to medication dose and schedule
- Importance of follow-up appointments and laboratory testing (if applicable)
- Potential drug-drug and drug-food interactions
- The potential for adverse drug reactions
© The Joint Commission, 2019. Reprinted with permission.
The Joint Commission. NPSG 03.05.01 Support Resources. Effective July 1, 2019.
Shehab N, Lovegrove MC, Geller AI, et al. US emergency department visits for outpatient adverse drug events, 2013-2014. JAMA. 2016;316:2115-2125.
Piazza G, Nguyen TN, Cios D, et al. Anticoagulation-associated adverse drug events. Am J Med. 2011;124:1136-1142.
Cousins D, Crompton A, Gell J, et al. The top ten prescribing errors in practice and how to avoid them. The Pharmaceutical Journal. 2019;302:7922.
Barnes GD, Lucas E, Alexander GC, et al. National trends in ambulatory oral anticoagulant use. Am J Med. 2015;128:1300-1305.e2.
Huisman MV, Rothman KJ, Paquette M, et al. The changing landscape for stroke prevention in AF: Findings from the GLORIA-AF Registry Phase 2. J Am Coll Cardiol. 2017;69:777-785.
Valentine D, Gaunt MJ, Grissinger M. Identifying patient harm from direct oral anticoagulants. Pa Patient Saf Advis. 2018;15.
Viprey M, Jeannin R, Piriou V, et al. Prevalence of drug-related problems associated with direct oral anticoagulants in hospitalized patients: a multicenter, cross-sectional study. J Clin Pharm Ther. 2017;42:58-63.
Tran E, Duckett A, Fisher S, et al. Appropriateness of direct oral anticoagulant dosing for venous thromboembolism treatment. J Thromb Thrombolysis. 2017;43:505-513.
The Joint Commission. R3 report issue 19: National Patient Safety Goal for anticoagulant therapy. Effective July 1, 2019.
Centers of Excellence Resource Center. Anticoagulation Forum.. 2017.
ManageAnticoag. American College of Cardiology.
The Joint Commission. Sentinel Event Alert 61: Managing the risks of direct oral anticoagulants. 2019: Jul 30.
Wallace PJ, Connell NT, Abkowitz JL. The role of hematologists in a changing United States health care system. Blood. 2015;125:2467-2470.
Reardon DP, Atay JK, Ashley SW, et al. Implementation of a hemostatic and antithrombotic stewardship program. J Thromb Thrombolysis. 2015;40:379-382.
Wychowski MK, Ruscio CI, Kouides PA, et al. The scope and value of an anticoagulation stewardship program at a community teaching hospital. J Thromb Thrombolysis. 2017;43:380-386.
Anticoagulation Forum. Core elements of anticoagulation stewardship programs. 2019.
Lewin Group, Inc. Systems-based clinical hematologist project: business case portfolio. August 2014.
Conflict of Interests
Dr. May and Dr. Moll indicated no relevant conflicts of interest.
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