Delivery of Optimized Anticoagulant Therapy: Consensus Statement from the Anticoagulation Forum

David A Garcia, MD; Daniel M Witt, PharmD; Elaine Hylek, MD, Ann K Wittkowsky, PharmD CACP FASHP FCCP; Edith A Nutescu, PharmD FCCP; Alan Jacobson, MD, Director, Anticoagulation Services; Associate Chief of Staff for Research, Loma Linda Veterans Affairs Medical Center, Loma Linda, CA; Stephan Moll, MD; Geno J Merli, MD FACP; Mark Crowther, MD MSc FRCPC; Laura Earl, BSN CACP; Richard C Becker, MD; Lynn Oertel, MS ANP CACP; Amir Jaffer, MD; Jack E Ansell, MD

Disclosures

The Annals of Pharmacotherapy. 2008;42(7):979-988.

Abstract and Introduction

Objective: To provide recommendations, policies, and procedures pertaining to the provision of optimized anticoagulation therapy designed to achieve desired clinical endpoints while minimizing the risk of anticoagulant-related adverse outcomes (principally bleeding and thrombosis).
Study Selection and Data Extraction: Due to 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 who constitute 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 significant collective experience in the management of patients receiving anticoagulation therapy.
Data Synthesis: Recommendations for delivering optimized anticoagulation therapy were developed collaboratively by the authors and are summarized in 9 key areas: (I) Qualifications of Personnel, (II) Supervision, (III) Care Management and Coordination, (IV) Documentation, (V) Patient Education, (VI) Patient Selection and Assessment, (VII) Laboratory Monitoring, (VIII) Initiation and Stabilization of Warfarin Therapy, and (IX) Maintenance of Therapy. Recommendations are intended to inform the development of care systems containing elements with demonstrated benefit in improvement of anticoagulation therapy outcomes. Recommendations for delivering optimized anticoagulation therapy are intended to apply to all clinicians involved in the care of outpatients receiving anticoagulation therapy, regardless of the structure and setting in which that care is delivered.
Conclusions: Anticoagulation therapy, although potentially life-saving, has inherent risks. Whether a patient is managed in a solo practice or a specialized anticoagulation management service, a systematic approach to the key elements outlined herein will reduce the likelihood of adverse events. The need for continued research to validate optimal practices for managing anticoagulation therapy is acknowledged.

Millions of patients receive anticoagulant therapy to prevent or treat thromboembolism. High-quality evidence documenting the benefit of antithrombotic therapy for patients with mechanical heart valves, a history of venous thromboembolism, or atrial fibrillation is abundant.^[1,2,3] However, antithrombotic agents are associated with a risk of bleeding. On death certificates, anticoagulants ranked first in 2003 and 2004 in the number of total mentions of "deaths for drugs causing adverse effects in therapeutic use."^[4]

In the US, the Joint Commission has brought significant attention to the safety of antithrombotic agents by challenging hospitals to "reduce the likelihood of patient harm associated with the use of anticoagulation therapy" as 1 of 2 new National Patient Safety Goals for 2008.^[5] Warfarin, the only oral anticoagulant available in North America, is notorious for having both a narrow therapeutic index as well as numerous drug and dietary interactions.^[6,7,8,9,10] The fear of bleeding complications and the need for frequent blood sampling are among the reasons that oral anticoagulant therapy is underutilized.^{[11,12,13,14]}

The safety and effectiveness of both short- and long-term anticoagulation can be optimized by a "systematic," evidence-based approach to therapy, often in the context of dedicated anticoagulation management services (AMS).^[15,16] The benefits of AMS are well documented.^[16,17] However, the majority of anticoagulated patients in North America do not receive care from such services. Thus, recommendations for delivering optimized anticoagulation therapy (OAT) should apply to all clinicians involved in the care of outpatients receiving anticoagulation, regardless of the structure and setting in which that care is delivered.

This document is focused on outpatient care and describes policies and procedures designed to achieve desired clinical endpoints while minimizing the risk of anticoagulant-related adverse outcomes (principally, bleeding and thrombosis). Recommendations in this document are, whenever possible, supported by the best available evidence. However, for some issues, published evidence is inconclusive or unavailable. In all instances, recommendations herein represent the consensus opinion of all authors. We constitute the Board of Directors of the Anticoagulation Forum, an organization dedicated to optimizing anticoagulation care for all patients (www.acforum.org).

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Authors and Disclosures

David A Garcia, MD, Associate Professor, University of New Mexico School of Medicine; Medical Director, Anticoagulation Clinic, University of New Mexico Health Sciences Center, University of New Mexico, Albuquerque, NM

Daniel M Witt, PharmD, Clinical Assistant Professor, School of Pharmacy, University of Colorado; Manager, Clinical Pharmacy Services, Kaiser Permanente Colorado, Denver, CO

Elaine Hylek, MD, Associate Professor, School of Medicine, Boston University; Director, Anticoagulation Clinic, Boston Medical Center, Boston, MA

Ann K Wittkowsky, PharmD CACP FASHP FCCP, Clinical Professor, School of Pharmacy, University of Washington; Director, Anticoagulation Services, University of Washington Medical Center, Seattle, WA

Edith A Nutescu, PharmD FCCP, Clinical Associate Professor of Pharmacy Practice; Director, Antithrombosis Center, College of Pharmacy & Medical Center, The University of Illinois at Chicago, Chicago, IL

Alan Jacobson, MD, Director, Anticoagulation Services; Associate Chief of Staff for Research, Loma Linda Veterans Affairs Medical Center, Loma Linda, CA

Stephan Moll, MD, Associate Professor, School of Medicine, University of North Carolina, Chapel Hill, NC

Geno J Merli, MD FACP, Professor of Medicine, Jefferson Medical College, Thomas Jefferson University; Senior Vice President and Chief Medical Officer, Thomas Jefferson University Hospital, Philadelphia, PA

Mark Crowther, MD MSc FRCPC, Professor and Academic Division Director, Hematology and Thromboembolism, McMaster University; Director of Laboratory Hematology, Hamilton Regional Laboratory Medicine Program; Head of Service, Hematology, St. Joseph's Healthcare, Hamilton, Ontario, Canada

Laura Earl, BSN CACP, Practicing Nurse, University of New Mexico, Albuquerque

Richard C Becker, MD, Professor of Medicine, School of Medicine, Duke University; Director, Duke Cardiovascular Thrombosis Center, Duke Clinical Research Institute, Durham, NC

Lynn Oertel, MS ANP CACP, Clinical Nurse Specialist, Anticoagulation Management Services, Massachusetts General Hospital, Boston, MA

Amir Jaffer, MD, Division Chief of Hospital Medicine, University of Miami, Miami, FL

Jack E Ansell, MD, Chair, Department of Medicine, Lenox Hill Hospital, New York, NY

Disclosure: Dr. Garcia has served as a consultant to ARYx Therapeutics, AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, CSL Behring, Roche Diagnostics, and Sanofi-Aventis and has received research funding from Bristol-Myers Squibb and CSL Behring.

Dr. Hylek has served as a consultant to Bristol-Myers Squibb and has received research funding from AstraZeneca and Bristol-Myers Squibb.

Dr. Wittkowsky has served as a consultant for Boehringer Ingelheim and has served on the speaker's bureau for Sanofi-Aventis.

Dr. Jacobson has served as a consultant for Boehringer Ingelheim, Bristol-Myers Squibb, Farallon Medical, GlaxoSmithKline, Hemosense, Inverness Medical, ITC, Roche Diagnostics, and Sanofi-Aventis.

Dr. Moll has served as a consultant for Bayer, Bristol-Myers Squibb, Inverness, ITC, and Roche Diagnostics.

Dr. Merli has served as a consultant for Bayer, Bristol-Myers Squibb, and Sanofi-Aventis and has received research funding from Bayer, Bristol-Myers Squibb, and Sanofi-Aventis.

Ms. Earl has served as a consultant for ARYx Therapeutics, and Roche Diagnostics and has served on the speaker's bureau for Roche Diagnostics.

Dr. Becker has received research funding from AstraZeneca, Bayer, Bristol-Myers Squibb, Johnson & Johnson, Medicines Company, Regado Biosciences, and Schering-Plough Research Institute.

Ms. Oertel has served on the speaker's bureau for GlaxoSmithKline.

Dr. Jaffer has served as a consultant for AstraZeneca, Boehringer Ingelheim, Roche Diagnostics, and Sanofi-Aventis, served on the speaker's bureau for Sanofi-Aventis, and received research funding from AstraZeneca.

Dr. Ansell has served as a consultant for ARYx Therapeutics, Bayer, Bristol-Myers Squibb, Hemosense, Inverness, ITC, and Roche Diagnostics and has served on the speaker's bureau for Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, Roche Diagnostics, and Sanofi-Aventis.

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Delivery of Optimized Anticoagulant Therapy: Consensus Statement from the Anticoagulation Forum

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