Anticoagulation Patient Self-monitoring in the United States

Considerations for Clinical Practice Adoption

Edith A. Nutescu, Pharm.D.; Sacheeta Bathija, B.Pharm.; Lisa K. Sharp, Ph.D.; Ben S. Gerber, M.D., M.P.H.; Glen T. Schumock, Pharm.D., M.B.A.; Marian L. Fitzgibbon, Ph.D.


Pharmacotherapy. 2011;31(12):1161-1174. 

In This Article

Systematic Management Models

Systematic management models such as anticoagulation management services and anticoagulation clinics have emerged in order to optimize warfarin effectiveness and to minimize warfarin-related complications. Patients managed by specialized anticoagulation clinics have attained better safety and effectiveness outcomes, as well as better anticoagulation control, than patients who receive routine medical care.[13–17] In addition, pharmacist-managed anticoagulation clinics have been reported to achieve superior anticoagulation control in their patients, reduce anticoagulation-related emergency department visits and hospitalizations, and provide a significant financial benefit when compared with routine medical care and nurse-managed anticoagulation clinics.[18] Provision of coordinated care management anticoagulation models has been endorsed by the National Quality Forum[19] in conjunction with the Agency for Healthcare Research and Quality[20] as one of 30 National Safe Practices for Better Health Care, in addition to the Anticoagulation Forum[21] and the American College of Chest Physicians.[1] Despite favorable outcomes and endorsement by national guidelines and regulatory groups, it is estimated that only 30–40% of patients in the United States who are receiving warfarin can access management through a specialized anticoagulation clinic because of time, distance, and financial and other care-access constraints.[12,21]

Most anticoagulation clinics are structured for patients to come to the clinic for in-person testing and evaluation, thus making this model of care difficult to access and time consuming especially for patients who are employed and who have distance and time barriers. In addition, even when managed by specialized clinics, on average the INR is within the target range of 2–3 (or 2.5–3.5 for those with prosthetic heart valves) only 52–66% of the time,[1,15–17] leaving further room for improvement in anticoagulation control. Poor anticoagulation control during long-term warfarin therapy is associated with an increased risk for thromboembolic events, major bleeding, and death.[22–27] In addition, patients with unstable anticoagulation require more frequent monitoring, increasing the cost of anticoagulation management.[1]

Because of the potentially severe sequelae and increased cost of care as a result of nontherapeutic anticoagulation, improving a patient's time within the therapeutic INR range is a priority for clinicians and health systems who are managing patients receiving warfarin therapy. Data suggest that minority (African-Americans and Hispanics) and underserved patients may be at particular risk for poor outcomes as a result of nontherapeutic anticoagulation.[28–31] Thus, instituting "accessible" and "convenient" measures to further improve anticoagulation control is of particular importance, especially in these high-risk patient groups.


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