CPSR researcher leads effort to ensure drugs carefully monitored to prevent stroke, minimize complications
With a new generation of novel direct oral anticoagulant drugs (NOACs or DOACs) now being prescribed to millions of patients around the world, Canadian experts call for careful patient monitoring – guided by a new evidence-based practice tool – to ensure that these drugs are used properly to maximize stroke prevention and minimize bleeding complications.
The authors describe their recommended monitoring approach in the June 30, 2015 issue of the Annals of Internal Medicine, where they introduce a new anticoagulant monitoring checklist that clinicians can use whenever patients receiving DOACs are seen for follow-up. It is designed as a knowledge-translation tool to promote standardized patient assessments, safety monitoring, medication adherence, and counseling.
“Anticoagulation for atrial fibrillation is one of the most powerful stroke prevention interventions, but it entails potential risks for patients and clinicians,” says Dr. David Gladstone, lead author of the paper and Medical Director of the Regional Stroke Prevention Clinic at Sunnybrook Health Sciences Centre. “We hope that practice tools like this, if used regularly, will help to reduce the incidence of preventable strokes and preventable bleeding.”
The checklist distills the essentials of published recommendations into a practical one-page worksheet to streamline assessments for busy clinicians. It is organized around the “A-B-C-D-Es” of anticoagulant safety monitoring and counseling: “Adherence”, “Bleeding”, “Creatinine Clearance”, “Drug Interactions”, and “Examination”.
An accompanying page of quick-reference tables summarizes dosing, drug interactions, and instructions on how many doses to hold before a surgical procedure. The checklist reminds clinicians to be on the lookout for the common reversible risk factors for bleeding in anticoagulated patients, and to ensure correct DOAC dosing and renal function monitoring.
Direct oral anticoagulants (apixaban, dabigatran, edoxaban, and rivaroxaban) have safety advantages over warfarin and are being recommended by practice guidelines for eligible patients with atrial fibrillation, supported by randomized trials involving over 75,000 patients. However, in practice these drugs are being prescribed lifelong to older, sicker patients who are at greater risk for bleeding and non-adherence. Most guidelines, however, have lacked specific recommendations about medication monitoring and how best to follow patients taking these drugs in the long run.
The checklist places special emphasis on adherence to treatment and provides tips for how to counsel patients. “Medication adherence is important for all drugs, but is especially critical for DOACs because they are short-acting anticoagulants. If one or more doses are missed, patients will no longer be maximally protected against stroke,” says Dr. Gladstone, also an associate professor of Medicine at the University of Toronto. “Physicians, nurses, and pharmacists have an important role to play in helping patients achieve and maintain optimal daily medication adherence and avoid prolonged or unnecessary interruptions in therapy.”
“DOACs are being used increasingly in patients with atrial fibrillation to prevent stroke,” says Dr. James Douketis, President of Thrombosis Canada and a co-author of the paper. “The DOAC monitoring tool will provide a user-friendly roadmap for healthcare professionals on how to monitor patients who are receiving the newer anticoagulants so that their risks of both stroke and bleeding are minimized.”
Given the wide variability in current DOAC monitoring practices, the checklist is poised to set a new standard for anticoagulant follow-up care. The checklist is intended for use by any clinician caring for patients taking these anticoagulants, including primary care physicians, specialists, pharmacists, nurses, physician assistants, and trainees.
The checklist is endorsed as a practice tool by Thrombosis Canada, the Canadian Cardiovascular Society, the Canadian Stroke Consortium, and the Canadian Cardiovascular Pharmacists Network. The checklist will become available on June 30 for free download from the Thrombosis Canada website at www.thrombosiscanada.ca .
The authors are a team of multidisciplinary clinicians from the University of Toronto and McMaster University.
Dr. Gladstone 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 CIHR 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.