IDEAS AND OPINIONS
Annals of Internal Medicine
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 Society David J. Gladstone, MD, PhD; William H. Geerts, MD; James Douketis, MD; Noah Ivers, MD, PhD; Jeff S. Healey, MD; and Kori Leblanc, PharmD
A
nticoagulation for atrial fibrillation with direct oral anticoagulants (DOACs)—apixaban, dabigatran, edoxaban, and rivaroxaban—is one of the most powerful stroke prevention interventions (1) and is now being prescribed to millions worldwide. Guidelines, however, have focused primarily on patient selection and therapy initiation, with little guidance on patient follow-up and monitoring for these long-term therapies. Given the increasing use of these agents, their associated risks for bleeding and nonadherence (one quarter of patients in recent reports was less than 80% adherent [2– 4]), the absence of routine coagulation monitoring, and variable follow-up practices, we advocate regular, standardized clinical monitoring of patients receiving these agents aimed at minimizing adverse events (Table).
GOALS OF ANTICOAGULANT FOLLOW-UP VISITS Follow-up visits should focus on 3 objectives: ensuring proper DOAC use, maximizing adherence, and minimizing bleeding. Although DOACs have safety advantages over warfarin, in trials their annual major bleeding rates were 2% to 4% on average (higher with increasing age and renal dysfunction) and in practice they are prescribed lifelong to older, sicker patients at higher risk for bleeding than trial participants. Therefore, clinicians should continually seek to identify and eliminate modifiable risk factors for bleeding: unnecessary concomitant use of aspirin or nonsteroidal antiinflammatory drugs, other drug interactions, uncontrolled hypertension, syncope, falls, and incorrect DOAC dosing for age or renal function. Adherence is crucial for DOACs because they are short-acting drugs (elimination half-lives are 5 to 17 hours), unlike warfarin (which has a 40-hour half-life), and the consequences of missed doses may be devastating strokes. Although acceptable adherence is traditionally defined as 80% of prescribed doses being taken, for DOACs we should strive for a higher standard to prevent strokes. The lack of international normalized ratio monitoring, which is a convenience advantage of DOACs, is also a potential hazard because it eliminates this adherence assessment and reinforcement strategy and reduces the frequency of clinical monitoring, making it easier for patients to be lost to follow-up. Thus, a key challenge for effective DOAC
therapy in practice is to help patients maintain optimal adherence and persistence. Patient monitoring has been shown to enhance adherence to these agents (4).
AN ANTICOAGULANT MONITORING CHECKLIST Building on expert recommendations (6), we designed a practical, evidence-based point-of-care tool—a 1-page DOAC checklist available online for free download (7)—to help physicians, nurses, and pharmacists provide best-practice anticoagulant follow-up care. The checklist, which can be integrated into electronic health record systems, is a template to facilitate standardized patient assessments, counseling, and documentation for follow-up visits. It is organized into sections that correspond to key categories of DOAC monitoring: A (adherence), B (bleeding), C (creatinine clearance), D (drug interactions), E (examination), and F (follow-up). The checklist is accompanied by quick-reference tables summarizing dosing, interactions, and periprocedural management (7). A. Adherence Assessment and Counseling At every visit, we recommend saying, “Some people have trouble remembering to take their medications. In an average week, how many doses would you typically miss for one reason or another?” (8). For patients with no missed doses, provide positive reinforcement. For those who report 1 or more missed doses per week, determine why (intentional or unintentional) and provide extra counseling and personalized problem-solving. Adherence is facilitated when patients understand their diagnosis, believe in their therapy, and trust their clinician (9). Remind patients of the rationale for this treatment and the importance of daily adherence. Key counseling messages are that DOACs are “stroke prevention medications” and are short-acting; if 1 or more doses are missed, patients will not be maximally protected against stroke. Review dosing instructions and how to handle missed doses. Of note, before surgery or procedures, advise patients how many doses to hold beforehand (usually not more than 1 to 4 days' worth) to avoid excessive therapy interruptions (7, 10). Acknowledge the potential for serious bleeding, and put risks into perspective so patients understand
This article was published online first at www.annals.org on 30 June 2015. 382 © 2015 American College of Physicians
Downloaded From: http://annals.org/pdfaccess.ashx?url=/data/journals/aim/934350/ by a Fudan University User on 03/24/2017
IDEAS AND OPINIONS
How to Monitor Patients Receiving Direct Oral Anticoagulants
Table. Suggested Strategies to Minimize Practice Gaps in DOAC Management Potential DOAC Practice Gaps
Priorities for DOAC Follow-up Assessments and Measures to Mitigate Risk of Practice Gaps
Potentially preventable ischemic strokes may occur when drug administration is incorrect or drug intake adherence is poor.
Inquire about medication adherence at each visit. Routinely reinforce the rationale for strict adherence and risks of nonadherence. Advise patients that a reasonable approach to a missed dose is to take it as soon as they remember (but not 1 d of DOAC dosing is generally not recommended (i.e., skip dose only on the day of the procedure). For routine gastroscopy or colonoscopy, most patients can skip their DOAC the day before and the day of the procedure (hold for an additional day in patients receiving dabigatran with a CrCl
Annals of Internal Medicine
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 Society David J. Gladstone, MD, PhD; William H. Geerts, MD; James Douketis, MD; Noah Ivers, MD, PhD; Jeff S. Healey, MD; and Kori Leblanc, PharmD
A
nticoagulation for atrial fibrillation with direct oral anticoagulants (DOACs)—apixaban, dabigatran, edoxaban, and rivaroxaban—is one of the most powerful stroke prevention interventions (1) and is now being prescribed to millions worldwide. Guidelines, however, have focused primarily on patient selection and therapy initiation, with little guidance on patient follow-up and monitoring for these long-term therapies. Given the increasing use of these agents, their associated risks for bleeding and nonadherence (one quarter of patients in recent reports was less than 80% adherent [2– 4]), the absence of routine coagulation monitoring, and variable follow-up practices, we advocate regular, standardized clinical monitoring of patients receiving these agents aimed at minimizing adverse events (Table).
GOALS OF ANTICOAGULANT FOLLOW-UP VISITS Follow-up visits should focus on 3 objectives: ensuring proper DOAC use, maximizing adherence, and minimizing bleeding. Although DOACs have safety advantages over warfarin, in trials their annual major bleeding rates were 2% to 4% on average (higher with increasing age and renal dysfunction) and in practice they are prescribed lifelong to older, sicker patients at higher risk for bleeding than trial participants. Therefore, clinicians should continually seek to identify and eliminate modifiable risk factors for bleeding: unnecessary concomitant use of aspirin or nonsteroidal antiinflammatory drugs, other drug interactions, uncontrolled hypertension, syncope, falls, and incorrect DOAC dosing for age or renal function. Adherence is crucial for DOACs because they are short-acting drugs (elimination half-lives are 5 to 17 hours), unlike warfarin (which has a 40-hour half-life), and the consequences of missed doses may be devastating strokes. Although acceptable adherence is traditionally defined as 80% of prescribed doses being taken, for DOACs we should strive for a higher standard to prevent strokes. The lack of international normalized ratio monitoring, which is a convenience advantage of DOACs, is also a potential hazard because it eliminates this adherence assessment and reinforcement strategy and reduces the frequency of clinical monitoring, making it easier for patients to be lost to follow-up. Thus, a key challenge for effective DOAC
therapy in practice is to help patients maintain optimal adherence and persistence. Patient monitoring has been shown to enhance adherence to these agents (4).
AN ANTICOAGULANT MONITORING CHECKLIST Building on expert recommendations (6), we designed a practical, evidence-based point-of-care tool—a 1-page DOAC checklist available online for free download (7)—to help physicians, nurses, and pharmacists provide best-practice anticoagulant follow-up care. The checklist, which can be integrated into electronic health record systems, is a template to facilitate standardized patient assessments, counseling, and documentation for follow-up visits. It is organized into sections that correspond to key categories of DOAC monitoring: A (adherence), B (bleeding), C (creatinine clearance), D (drug interactions), E (examination), and F (follow-up). The checklist is accompanied by quick-reference tables summarizing dosing, interactions, and periprocedural management (7). A. Adherence Assessment and Counseling At every visit, we recommend saying, “Some people have trouble remembering to take their medications. In an average week, how many doses would you typically miss for one reason or another?” (8). For patients with no missed doses, provide positive reinforcement. For those who report 1 or more missed doses per week, determine why (intentional or unintentional) and provide extra counseling and personalized problem-solving. Adherence is facilitated when patients understand their diagnosis, believe in their therapy, and trust their clinician (9). Remind patients of the rationale for this treatment and the importance of daily adherence. Key counseling messages are that DOACs are “stroke prevention medications” and are short-acting; if 1 or more doses are missed, patients will not be maximally protected against stroke. Review dosing instructions and how to handle missed doses. Of note, before surgery or procedures, advise patients how many doses to hold beforehand (usually not more than 1 to 4 days' worth) to avoid excessive therapy interruptions (7, 10). Acknowledge the potential for serious bleeding, and put risks into perspective so patients understand
This article was published online first at www.annals.org on 30 June 2015. 382 © 2015 American College of Physicians
Downloaded From: http://annals.org/pdfaccess.ashx?url=/data/journals/aim/934350/ by a Fudan University User on 03/24/2017
IDEAS AND OPINIONS
How to Monitor Patients Receiving Direct Oral Anticoagulants
Table. Suggested Strategies to Minimize Practice Gaps in DOAC Management Potential DOAC Practice Gaps
Priorities for DOAC Follow-up Assessments and Measures to Mitigate Risk of Practice Gaps
Potentially preventable ischemic strokes may occur when drug administration is incorrect or drug intake adherence is poor.
Inquire about medication adherence at each visit. Routinely reinforce the rationale for strict adherence and risks of nonadherence. Advise patients that a reasonable approach to a missed dose is to take it as soon as they remember (but not 1 d of DOAC dosing is generally not recommended (i.e., skip dose only on the day of the procedure). For routine gastroscopy or colonoscopy, most patients can skip their DOAC the day before and the day of the procedure (hold for an additional day in patients receiving dabigatran with a CrCl
