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Published on: February 28, 2012
Prescribing patterns of target-specific oral anticoagulants: an academic hospital perspective
Stacy A Johnson1, Peter M Yarbrough, Richard S Rose
1aDepartment of Internal Medicine, University of Utah School of Medicine bGeorge E. Wahlen Department of Veterans Affairs Medical Center, Salt Lake City cDivision of Pulmonary and Critical Care Medicine, University of Utah and Intermountain Medical Center, Murray, Utah, USA.
Abstract:
Target-specific oral anticoagulants have been rapidly adopted into clinical practice for stroke prophylaxis and venous thromboembolism treatment, raising concerns about off-label prescribing practices. We conducted a retrospective review of consecutive patients prescribed dabigatran, rivaroxaban or apixaban prior to inpatient hospitalization over an 18-month period to examine the off-label prescribing frequency, contraindications and related complications. Chart review included baseline demographics, hospital admitting service, outpatient prescribing service, renal function, therapeutic indication, echocardiographic findings, contraindications, major bleeding events and vital status. We identified 160 patients who received a target-specific oral anticoagulant prior to hospitalization. Over half (53.1%) of the patients received rivaroxaban, 43.7% received dabigatran and 3.1% received apixaban. Atrial fibrillation (68.1%) and venous thromboembolism treatment (25.6%) were the most common indications. Ninety percent of patients had a U.S. Foods and Drugs Administration (FDA)-approved indication for therapy. Major bleeding events occurred in 4.4% of patients. Cardiology was the most common prescribing and admitting service (43.8 and 31.3%), and more frequently adhered to FDA-approved indications (97 vs. 84%, P = 0.01). There were no significant differences between prescribing services regarding major contraindications (P = 0.14) and major bleeding events (P = 0.77). Off-label prescription rates for target-specific oral anticoagulants were infrequent and not associated with increased adverse events.
Insights
Off-label prescribing of target-specific oral anticoagulants (TSOACs) like dabigatran, rivaroxaban, and apixaban was infrequent. These anticoagulants were not associated with increased adverse events when used off-label.
Area of Science:
- Pharmacology
- Clinical Medicine
- Drug Safety
Background:
- Target-specific oral anticoagulants (TSOACs) are increasingly used for stroke prophylaxis and venous thromboembolism (VTE) treatment.
- Concerns exist regarding the frequency and safety of off-label prescribing practices for these novel agents.
Purpose of the Study:
- To evaluate the incidence of off-label prescribing for TSOACs (dabigatran, rivaroxaban, apixaban).
- To assess contraindications and associated complications, including major bleeding events, in patients receiving TSOACs prior to hospitalization.
Main Methods:
- Retrospective chart review of 160 patients prescribed TSOACs before inpatient admission over 18 months.
- Data collected included demographics, prescribing/admitting services, renal function, indications, contraindications, and adverse events.
Main Results:
- Ninety percent of patients received TSOACs for U.S. Food and Drug Administration (FDA)-approved indications.
- Major bleeding events occurred in 4.4% of patients, with no significant differences based on prescribing service.
- Cardiology services showed higher adherence to FDA-approved indications compared to other services.
Conclusions:
- Off-label prescription rates for TSOACs were infrequent in this cohort.
- The study found no association between off-label TSOAC use and increased adverse events or major bleeding.
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