Delivery of Optimized Inpatient Anticoagulation Therapy

Consensus Statement From the Anticoagulation Forum

Edith A Nutescu PharmD FCCP; Ann K Wittkowsky PharmD CACP FASHP FCCP; Allison Burnett PharmD PhC; Geno J Merli MD FACP; Jack E Ansell; David A Garcia MD

Disclosures

The Annals of Pharmacotherapy. 2013;47(5):714-724. 

In This Article

Abstract and Introduction

Abstract

Objective: To provide recommendations for optimized anticoagulant therapy in the inpatient setting and outline broad elements that need to be in place for effective management of anticoagulant therapy in hospitalized patients; the guidelines are designed to promote optimization of patient clinical outcomes while minimizing the risks for potential anticoagulation-related errors and adverse events.

Data sources: The medical literature was reviewed using MEDLINE (1946-January 2013), EMBASE (1980-January 2013), and PubMed (1947-January 2013) for topics and key words including, but not limited to, standards of practice, national guidelines, patient safety initiatives, and regulatory requirements pertaining to anticoagulant use in the inpatient setting. Non–English-language publications were excluded. Specific MeSH terms used include algorithms, anticoagulants/administration and dosage/adverse effects/therapeutic use, clinical protocols/standards, decision support systems, drug monitoring/methods, humans, inpatients, efficiency/organizational, outcome and process assessment (health care), patient care team/organization and administration, program development/standards, quality improvement/organization and administration, thrombosis/drug therapy, thrombosis/prevention and control, risk assessment/standards, patient safety/standards, and risk management/methods.

Study selection and data extraction: Because of this document's scope, the medical literature was searched using a variety of strategies. When possible, recommendations are supported by available evidence; however, because this paper deals with processes and systems of care, high-quality evidence (eg, controlled trials) is unavailable. In these cases, recommendations represent the consensus opinion of all authors and are endorsed by the Board of Directors of the Anticoagulation Forum, an organization dedicated to optimizing anticoagulation care. The board is composed of physicians, pharmacists, and nurses with demonstrated expertise and experience in the management of patients receiving anticoagulation therapy.

Data synthesis: Recommendations for delivering optimized inpatient anticoagulation therapy were developed collaboratively by the authors and are summarized in 8 key areas: (1) process, (2) accountability, (3) integration, (4) standards of practice, (5) provider education and competency, (6) patient education, (7) care transitions, and (8) outcomes. Recommendations are intended to inform the development of coordinated care systems containing elements with demonstrated benefit in improvement of anticoagulation therapy outcomes. Recommendations for delivering optimized inpatient anticoagulation therapy are intended to apply to all clinicians involved in the care of hospitalized patients receiving anticoagulation therapy.

Conclusions: Anticoagulants are high-risk medications associated with a significant rate of medication errors among hospitalized patients. Several national organizations have introduced initiatives to reduce the likelihood of patient harm associated with the use of anticoagulants. Health care organizations are under increasing pressure to develop systems to ensure the safe and effective use of anticoagulants in the inpatient setting. This document provides consensus guidelines for anticoagulant therapy in the inpatient setting and serves as a companion document to prior guidelines relevant for outpatients.

Introduction

An estimated 4 million patients in the US and almost 7 million worldwide are receiving long-term therapy with oral anticoagulants, primarily warfarin or other coumarin derivatives, for prevention and treatment of venous and arterial thromboembolism.[1,2] Hospitalized patients may be treated with anticoagulants for traditional ambulatory indications such as stroke prevention in those with atrial fibrillation, as well as for conditions encountered primarily in the inpatient setting, including venous thromboembolism (VTE) prophylaxis and treatment and acute coronary syndrome. Inpatients are exposed to a wide variety of anticoagulants, including unfractionated heparin, low-molecular-weight heparins, factor-Xa inhibitors, and direct thrombin inhibitors. Anticoagulants are high-risk medications associated with a significant rate of medication errors[3,4] and adverse effects associated with this drug class are the leading cause of hospitalization among older adults.[5] Among hospitalized patients, anticoagulants are associated with approximately 7% of all medication errors,[6,7] resulting in a 20% increased risk of death.[7] Similarly, the Joint Commission's Sentinel Event Database showed that 7.2% of all adverse medication events from January 1997 to December 2007 were related to anticoagulants.[8]

In 2008, the Joint Commission introduced National Patient Safety Goal 03.05.01 (formerly 3E) with the intent of "reducing the likelihood of patient harm associated with the use of anticoagulant therapy."[9] Hospitals were required to "develop and implement standardized anticoagulation practices" to reduce adverse drug events and improve patient outcomes. Other entities, such as the Institute for Safe Medication Practices[10] and the Centers for Medicare and Medicaid Services,[11] have also introduced initiatives with similar overarching goals of reducing anticoagulant-related errors and improving patient outcomes. With health care regulators increasingly focused on anticoagulants, hospitals are under increasing pressure to develop systems that optimize the safety and efficacy of anticoagulants in the inpatient setting.

This document provides consensus guidelines for optimized anticoagulant therapy in the inpatient setting. It is a companion document to our prior guidelines, "Delivery of Optimized Anticoagulant Therapy: Consensus Statement from the Anticoagulation Forum."[12] Although the prior document suggested that its recommendations should "apply to all clinicians involved in the care of patients receiving anticoagulation, regardless of the structure and setting in which that care is delivered," there are some anticoagulation-related challenges that are unique to the inpatient arena. The present guidelines discuss broad elements that need to be in place for effective management of anticoagulant therapy in hospitalized patients. They are designed to promote optimization of patient clinical outcomes while minimizing the risks for potential anticoagulation-related errors and adverse events. Recommendations in this document are, whenever possible, based on best available evidence. However, for some issues, published evidence is inconclusive or unavailable. In all instances, recommendations set forth represent the consensus opinion(s) of all authors and are endorsed by the Anticoagulation Forum's Board of Directors. The Anticoagulation Forum is an organization dedicated to optimizing anticoagulation care for all patients (www.acforum.org). The Board of Directors is composed of physicians, pharmacists, and nurses with demonstrated expertise and experience in the management of hospitalized patients receiving anticoagulant therapy. The medical literature was reviewed for topics and key words including, but not limited to, standards of practice, national guidelines, patient safety initiatives, and regulatory requirements pertaining to anticoagulant use in the inpatient setting. Non–English-language publications were excluded. Specific MeSH terms used include algorithms, anticoagulants/administration and dosage/adverse effects/therapeutic use, clinical protocols/standards, decision support systems, drug monitoring/methods, humans, inpatients, efficiency/organizational, outcome and process assessment (health care), patient care team/organization and administration, program development/standards, quality improvement/organization and administration, thrombosis/drug therapy, thrombosis/prevention and control, risk assessment/standards, patient safety/standards, and risk management/methods.

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