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How to Monitor Patients Receiving Direct Oral Anticoagulants for Stroke Prevention in Atrial Fibrillation: A Practice Tool Endorsed by Thrombosis Canada, the Canadian Stroke Consortium, the Canadian Cardiovascular Pharmacists Network, and the Canadian Cardiovascular SocietyHow to Monitor Patients Receiving Direct Oral Anticoagulants

David J. Gladstone, MD, PhD; William H. Geerts, MD; James Douketis, MD; Noah Ivers, MD, PhD; Jeff S. Healey, MD; and Kori Leblanc, PharmD
[+] Article, Author, and Disclosure Information

This article was published online first at www.annals.org on 30 June 2015.

From the University of Toronto Department of Medicine; Sunnybrook Regional Stroke Prevention Clinic, Hurvitz Brain Sciences Program, Dr. Thomas and Harriet Black Rapid TIA Clinic, and Anticoagulant Management Clinic and Thromboembolism Service, Sunnybrook Health Sciences Centre; University of Toronto Stroke Program; Family Practice Health Centre, Women's College Research Institute, and Institute for Health Systems Solutions and Virtual Care, Women's College Hospital; and University Health Network and OpenLab, University Health Network, Toronto, Ontario, Canada, and McMaster University, Population Health Research Institute, and Canadian Stroke Prevention Intervention Network, Hamilton, Ontario, Canada.

Acknowledgment: The authors thank Dr. Ken Gruchalla (Health Canada) for valuable comments on an earlier draft and Najla Nina Zahr (OpenLab, University Health Network, Toronto) for graphic design assistance for the checklist. The authors also thank numerous external reviewers, clinic nurses, and members of national professional organizations for the feedback received on earlier drafts. Dr. Gladstone thanks the Division of Neurology and Department of Medicine of Sunnybrook Health Sciences Centre and the University of Toronto.

Grant Support: This article and the accompanying checklist were conceived, developed, authored, and revised by the authors as an investigator-initiated academic project, independent of industry, and refined through pilot-testing in outpatient clinics. Dr. Gladstone's research program is supported by the Bastable-Potts Chair in Stroke Research at Sunnybrook Health Sciences Centre, the Sunnybrook Department of Medicine Research Committee, the University of Toronto Department of Medicine Eaton Scholar Award, the Sam Sorbara Charitable Foundation, and the Heart and Stroke Foundation Canadian Partnership for Stroke Recovery. Dr. Ivers is funded by a Canadian Institutes of Health Research New Investigator Award in Community-Based Primary Health Care and a New Investigator Award from the Department of Family and Community Medicine, University of Toronto.

Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M15-0143.

Requests for Single Reprints: David J. Gladstone, MD, PhD, Regional Stroke Prevention Clinic, Sunnybrook Health Sciences Centre, A442-2075 Bayview Avenue, Toronto, Ontario M4N 3M5, Canada; e-mail, david.gladstone@sunnybrook.ca.

Current Author Addresses: Dr. Gladstone: Regional Stroke Prevention Clinic, Sunnybrook Health Sciences Centre, A442-2075 Bayview Avenue, Toronto, Ontario M4N 3M5, Canada.

Dr. Geerts: Sunnybrook Health Sciences Centre, Room D764, 2075 Bayview Avenue, Toronto, Ontario M4N 3M5, Canada.

Dr. Douketis: St. Joseph's Healthcare Hamilton, Room F-544, 50 Charlton Avenue East, Hamilton, Ontario L8N 4A6, Canada.

Dr. Ivers: Women's College Hospital Family Practice, 76 Grenville Street, Toronto, Ontario M5S 1B2, Canada.

Dr. Healey: Room C3-121, DBCVSRI Building, Hamilton Health Sciences, General Site, 237 Barton Street East, Hamilton, Ontario L8L 2X2, Canada.

Dr. Leblanc: Pharmacy Department, 585 University Avenue, Clinical Services Building, BCS-080, Toronto, Ontario M5G 2N2, Canada.

Author Contributions: Conception and design: D.J. Gladstone, K. Leblanc.

Analysis and interpretation of the data: D.J. Gladstone, J. Douketis, N. Ivers, K. Leblanc.

Drafting of the article: D.J. Gladstone, W.H. Geerts, J. Douketis, N. Ivers, K. Leblanc.

Critical revision of the article for important intellectual content: D.J. Gladstone, W.H. Geerts, J. Douketis, J.S. Healey, K. Leblanc.

Final approval of the article: D.J. Gladstone, W.H. Geerts, J. Douketis, N. Ivers, J.S. Healey, K. Leblanc.

Administrative, technical, or logistic support: N. Ivers, K. Leblanc.

Collection and assembly of data: D.J. Gladstone, N. Ivers, K. Leblanc.

Ann Intern Med. 2015;163(5):382-385. doi:10.7326/M15-0143
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Direct oral anticoagulants are making anticoagulation simpler for patients with atrial fibrillation who need protection from strokes. However, clinicians still have an important role to play in patient monitoring to ensure that these drugs are used as safely and effectively as possible. The authors of this guide provide a framework for monitoring patients receiving these drugs.

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Posted on July 8, 2015
Alex C. Spyropoulos, MD, Darren M. Triller, PharmD, Susan Wymer BSN, RN, MS, Peter A. Kouides, MD, Jack Ansell, MD, Kelly Rudd, PharmD
North Shore-LIJ Health System
Conflict of Interest: None Declared
We applaud Gladstone et. al. (June 30, 2015) for producing the Anticoagulant Monitoring Checklist (AMC). The instrument was greatly needed, as the explosion of available direct oral anticoagulants (DOACs) has not been accompanied by the types of cohesive guidance available for warfarin.1,2 Patients prescribed DOACs may not be clinically managed by organized services designed for vitamin K antagonists, possibly creating additional opportunities for preventable errors and adverse events.
While the AMC is well designed and fills an important void, its ultimate value and success will depend upon its incorporation into practice and its objectively measured impact on clinical outcomes. The authors state that it may be “useful as a data collection instrument”, but its present format does not lend itself to digital data capture or integration into electronic health records (EHRs).
The Electronic Health Record Task Force of the New York State Anticoagulation Coalition recently published a consensus statement on features of EHRs deemed necessary to support high quality management of patients prescribed anticoagulants.3 That document built upon the earlier consensus of the Anticoagulation Forum1 and, together, they provide an organized and exhaustive profile of clinical activities and EHR features required to provide quality care to anticoagulated individuals.
We suggest that, to accelerate digitalization and to catalyze its uptake into clinical practice, all AMC elements be mapped to specific domains of the previous documents1,2 and that all discrete data elements be fully characterized in a companion data dictionary. Electronic Health Record vendors have already begun incorporation of elements of the EHR Consensus document into clinical software (http://www.ptofcare.com/anticoagulation-EHR-Recommendations/ ) and the Anticoagulation Forum recently incorporated EHR users groups into conference proceedings to facilitate clinician dialogue with software programmers (13th National Conference on Anticoagulant Therapy, Washington DC). The deliberate indexing of the AMC elements to the EHR Consensus and the creation of a data dictionary will allow vendors to incorporate the AMC seamlessly into widely used packages, expanding its use and allowing objective evaluation of its performance.
Also, we also question the use of the term “monitoring”, and recommend “assessment” instead, as monitoring implies use of a quantitative lab test or other parameter. Such tests are not routinely used now, but may become integral to DOAC management in the future.
The AMC is a timely and valuable resource, and the developers are commended for their vision and execution. We look forward to its widespread adoption and integration into the EHR environment.

1. Garcia DA, Witt DM, Hylek E, et al. Delivery of optimized anticoagulant therapy: consensus statement from the Anticoagulation Forum. Ann Pharmacother. Jul 2008;42(7):979-988.
2. Nutescu EA, Wittkowsky AK, Burnett A, Merli GJ, Ansell JE, Garcia DA. Delivery of optimized inpatient anticoagulation therapy: consensus statement from the anticoagulation forum. Ann Pharmacother. May 2013;47(5):714-724.
3. Spyropoulos AC, Viscusi A, Singhal N, et al. Features of electronic health records necessary for the delivery of optimized anticoagulant therapy: consensus of the EHR Task Force of the New York State Anticoagulation Coalition. Ann Pharmacother. Jan 2015;49(1):113-124.

Alex C. Spyropoulos, MD, FACP, FCCP, FRCPC
System Director - Anticoagulation and Clinical Thrombosis Services
North Shore-LIJ Health System
Lenox Hill Hospital
100 E 77th Street
New York, NY 10065

Darren M. Triller, PharmD
Senior Director, Drug Safety
Albany, New York

Susan Wymer BSN, RN, MS
Senior Data Analyst
Albany, New York

Peter A. Kouides, MD
Medical & Research Director, Mary M. Gooley Hemophilia Center
Rochester General Hospital
Rochester, NY

Jack Ansell, MD
Professor of Medicine
Hofstra North Shore-LIJ School of Medicine
Hempstead, NY

Kelly Rudd, PharmD
Anticoagulation & Clinical Pharmacy Service Coordinator
Bassett Healthcare
Cooperstown, New York

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