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

Conceptual Model for the Future of Oral Anticoagulation Management

Given that approximately 60% of patients receiving warfarin in the United States do not have access to high-quality anticoagulation clinics and are managed through routine medical care, self-monitoring can provide a valuable alternative to these patients. With the expansion of novel oral anticoagulants, it is expected that overall warfarin use will decrease. However, warfarin will continue to be used for years to come for many patient subsets. Future models of warfarin management will have to shift to ones that are more efficient and allow for a better quality of life and enhanced clinical outcomes. It is expected that for those patients treated with warfarin, models of self-monitoring will play a key role (Figure 1).

Figure 1.

Current and future state of oral anticoagulation management. Use of oral anticoagulants will shift from warfarin as the sole oral anticoagulant to include novel oral anticoagulants and warfarin in a subset of patients. For those patients who will continue to be treated with warfarin, self-monitoring will play a central role. Patient-centered interventions are needed to overcome existing barriers to widen adoption and implementation of patient self monitoring in the United States.

Patient involvement in their own care could be especially useful in patients at highest risk for complications due to access barriers to high-quality care.[81] Inherent in this model of care is the new paradigm of patient-professional partnership in which patients are their own caregivers and health care professionals act as consultants and coaches to support them in this role.[66] Effective providers to patients with chronic disease must deliver not only good treatment and sound advice, but also the motivation, tools, knowledge, and skills patients need to effectively self-monitor their condition.[82,83] Although some early programs (e.g., asthma self-management) often lacked an explicit theoretical underpinning, newer self-management education programs are grounded in the social-cognitive[84,85] and self-efficacy theories.[86,87] The social-cognitive theory describes an interaction among behavioral, personal, and environmental factors, all of which can be manipulated to improve a person's health. Increasing knowledge and self-efficacy are prerequisites for behavior change, which, through improved anticoagulant use, may influence health outcomes.

We propose that anticoagulation patient self-monitoring be understood within the broader concept of social-cognitive and self-efficacy theories (Figure 2).[84–87] In this model, patient-centered education is intended to educate and motivate, overcome barriers (environmental factor), enhance self-efficacy (personal factor), and improve skills (behavioral factor) of high-risk patients receiving warfarin therapy. This departure from standard self-testing skill-based interventions is expected to overcome the barriers to self-monitoring in high-risk, longterm anticoagulated patients.

Figure 2.

Conceptual framework for anticoagulation self-monitoring and outcomes.

The need for accessible, high-quality treatment alternatives will be even more critical in the era of novel oral anticoagulants. The high cost, relatively high clinical trial dropout rates due to adverse effects,[88] lack of wide-ranging indications, and the absence of long-term safety data will likely prohibit initial widespread adoption of these new drugs. This will be especially true among minority and disadvantaged populations in which warfarin is expected to remain a mainstay therapy because of financial and access barriers.


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