Abstract Background Compared with vitamin K antagonists, direct acting oral anticoagulants (DOACs) have fixed dosing, limited drug interactions, and do not require therapeutic drug level monitoring. ...Dose adjustments are recommended for moderate renal dysfunction, low body weight, and select drug interactions. Objectives The aim of our study is to determine if DOAC dose reductions were appropriate based on the manufacturer labeling recommendations for each agent. We also followed patients’ treatment outcomes. Methods We retrospectively reviewed patients administered a DOAC at a reduced dose between January 2011 and August 2014. The primary outcome was adherence to current manufacturer dose recommendations. The secondary outcome measures were the incidence of thromboembolic events or any bleeding episodes, regardless of severity, while on therapy. Results Of 224 patients included in the analysis, 43.3% of patients fit criteria for a dose adjustment according to manufacturer recommendations. Only 3 out of 28 (10.7%) patients treated with apixaban met two out of three clinical criteria required for a dose reduction per manufacturer recommendations. Only 54.7% of rivaroxaban treated patients and 32.2% of dabigatran treated patients had renal insufficiency requiring a dose reduction. Half of our patient population received aspirin therapy, with 6.3% of patients on triple antithrombotic therapy (dual antiplatelet agents plus an anticoagulant). A past medical history significant for bleeding was prevalent in patients treated with a reduced dose DOAC (32.1%, 20.4%, and 25.4% of patients in the apixaban, rivaroxaban, and dabigatran treated groups, respectively). Thromboembolic events occurred in 10.7%, 3.6%, and 5.1% of patients in the apixaban, rivaroxaban, and dabigatran groups, respectively. Frequency of bleeding complications, regardless of severity, was 17.9%, 18.2%, and 23.7% of patients in the apixaban, rivaroxaban, and dabigatran groups, respectively. Conclusion We found that dose-adjusted DOAC therapy was often prescribed in a dose that was lower than package insert recommendations.
Abstract Renal impairment increases risk of stroke and systemic embolic events and bleeding in patients with atrial fibrillation. Direct oral anticoagulants have varied dependence on renal ...elimination, magnifying the importance of appropriate patient selection, dosing, and periodic kidney function monitoring. In randomized controlled trials of nonvalvular atrial fibrillation, direct oral anticoagulants were at least as effective and associated with less bleeding compared with warfarin. Each direct oral anticoagulant was associated with reduced risk of stroke and systemic embolic events and major bleeding compared with warfarin in nonvalvular atrial fibrillation patients with mild or moderate renal impairment. Renal function decline appears less impacted by direct oral anticoagulants, which are associated with a better risk-benefit profile than warfarin in patients with declining renal function over time. Limited data address the risk-benefit profile of direct oral anticoagulants in patients with severe impairment or on dialysis.
Hospital Costs of Acute Pulmonary Embolism Fanikos, John, RPh, MBA; Rao, Amanda, BS; Seger, Andrew C., PharmD ...
The American journal of medicine,
02/2013, Letnik:
126, Številka:
2
Journal Article
Recenzirano
Odprti dostop
Abstract Objective Pulmonary embolism places a heavy economic burden on health care systems, but the components of hospital cost have not been elucidated. We evaluated hospitalized patients with the ...primary diagnosis of pulmonary embolism. Our goal was to determine the total and component costs associated with their hospital care. Methods We included patients hospitalized at Brigham and Women's Hospital from September 2003 to May 2010. Patient demographics, characteristics, comorbidities, interventions, and treatments were obtained from the electronic medical record. Costs were obtained using the hospital's accounting software and categorized into the areas providing direct patient supplies or care. Results We identified 991 hospitalized patients with acute pulmonary embolism. In-hospital mortality was 4.2%, and 90-day mortality after hospital discharge was 13.8%. The median length of hospital stay was 3 days, and the mean length of hospital stay was 4 days. The mean total hospitalization cost per patient was $8764. Nursing costs, which included room and board, were $5102. Pharmacy ($966) and radiology ($963) costs were similar. Pharmacy costs ($966) were dominated by the use of low-molecular-weight heparin ($232). Radiology costs ($963) were dominated by the use of diagnostic imaging examinations ($672). During the observation period, an average of 160 patients with pulmonary embolism were admitted each year, requiring an annual hospital expense ranging from $884,814 to $1,866,489. Conclusions Pulmonary embolism has a high case fatality rate and remains an expensive illness to diagnose and treat. Nursing costs comprise the largest component of costs.
Anticoagulation-associated Adverse Drug Events Piazza, Gregory, MD; Nguyen, Thanh Nha, PharmD; Cios, Deborah, PharmD ...
The American journal of medicine,
12/2011, Letnik:
124, Številka:
12
Journal Article
Recenzirano
Abstract Purpose Anticoagulant drugs are among the most common medications that cause adverse drug events (ADEs) in hospitalized patients. We performed a 5-year retrospective study at Brigham and ...Women's Hospital to determine clinical characteristics, types, root causes, and outcomes of anticoagulant-associated ADEs. Methods We reviewed all inpatient anticoagulant-associated ADEs, including adverse drug reactions (ADRs) and medication errors, reported at Brigham and Women's Hospital through the Safety Reporting System from May 2004 to May 2009. We also collected data about the cost associated with hospitalizations in which ADRs occurred. Results Of 463 anticoagulant-associated ADEs, 226 were medication errors (48.8%), 141 were ADRs (30.5%), and 96 (20.7%) involved both a medication error and ADR. Seventy percent of anticoagulant-associated ADEs were potentially preventable. Transcription errors (48%) were the most frequent root cause of anticoagulant-associated medication errors, while medication errors (40%) were a common root cause of anticoagulant-associated ADRs. Death within 30 days of anticoagulant-associated ADEs occurred in 11% of patients. After an anticoagulant-associated ADR, most hospitalization expenditures were attributable to nursing costs (mean $33,189 per ADR), followed by pharmacy costs (mean $7451 per ADR). Conclusion Most anticoagulant-associated ADEs among inpatients result from medication errors and are, therefore, potentially preventable. We observed an elevated 30-day mortality rate among patients who suffered an anticoagulant-associated ADE and high hospitalization costs following ADRs. Further quality improvement efforts to reduce anticoagulant-associated medication errors are warranted to improve patient safety and decrease health care expenditures.
Abstract As expected with all antithrombotic agents, there is a risk of bleeding complications in patients receiving direct oral anticoagulants (DOACs) because of the DOAC itself, acute trauma, ...invasive procedures, or underlying comorbidities. For many bleeding events, a prudent course of action will be to withdraw the DOAC, then “wait and support” the patient, with the expectation that the bleeding event should resolve with time. Likewise, DOAC therapy may be interrupted ahead of a planned procedure, the stopping time being dependent on the agent involved and the patient's renal function. However, urgent reversal of anticoagulation is required in patients with serious or life-threatening bleeding or in those requiring urgent surgery or procedures. Novel specific reversal agents, either under development or recently approved, will need to be incorporated into local anticoagulation reversal protocols. For dabigatran-treated patients, idarucizumab recently has been approved for clinical use in cases of life-threatening or uncontrolled bleeding or when patients require emergency surgery or urgent procedures, both associated with a high risk of bleeding. As clinical experience with individual specific reversal agents grows, their roles in managing major bleeding events in DOAC–treated patients will become better defined. Future research, as well as ongoing use of idarucizumab, should help establish when it is appropriate to re-dose with idarucizumab, co-administer with prothrombin complex concentrates, or re-initiate DOAC after idarucizumab use. Ongoing trials should help identify the appropriate doses and expected durations of effect for andexanet alfa and ciraparantag, which are likely to vary depending on the individual oral anticoagulants.
Abstract As expected with all antithrombotic agents, there is a risk of bleeding complications in patients receiving direct oral anticoagulants (DOACs) because of the DOAC itself, acute trauma, ...invasive procedures, or underlying comorbidities. For many bleeding events, a prudent course of action will be to withdraw the DOAC, then “wait and support” the patient, with the expectation that the bleeding event should resolve with time. Likewise, DOAC therapy may be interrupted ahead of a planned procedure, the stopping time being dependent on the agent involved and the patient’s renal function. However, urgent reversal of anticoagulation is required in patients with serious or life-threatening bleeding or in those requiring urgent surgery or procedures. Novel specific reversal agents, either under development or recently approved, will need to be incorporated into local anticoagulation reversal protocols. For dabigatran-treated patients, idarucizumab recently has been approved for clinical use in cases of life-threatening or uncontrolled bleeding or when patients require emergency surgery or urgent procedures, both associated with a high risk of bleeding. As clinical experience with individual specific reversal agents grows, their roles in managing major bleeding events in DOAC—treated patients will become better defined. Future research, as well as ongoing use of idarucizumab, should help establish when it is appropriate to re-dose with idarucizumab, coadminister with prothrombin complex concentrates, or re-initiate DOAC after idarucizumab use. Ongoing trials should help identify the appropriate doses and expected durations of effect for andexanet alfa and ciraparantag, which are likely to vary depending on the individual oral anticoagulants.
Patients with renal impairment require dose adjustments for direct oral anticoagulants (DOACs), though there is uncertainty regarding their use in severe chronic kidney disease. Inappropriately dosed ...DOACs may increase risk of ischemic events when under-dosed, or risk of bleeding when over-dosed. The purpose of this study was to describe DOAC selection, dosing strategies, and associated clinical outcomes in patients with moderate to severe renal impairment at our institution. This was a single-center retrospective analysis of adult outpatients with moderate to severe renal impairment (estimated creatinine clearance <50 mL/min, including need for hemodialysis) who were prescribed a DOAC by a cardiologist between June 1, 2015 and December 1, 2018. Outcomes evaluated included the percentage of patients who received appropriate and inappropriate DOAC dosing, prescriber reasons for inappropriate DOAC dosing if documented, and incidence of thrombotic and bleeding events. A total of 207 patients were included. Overall, 61 (29.5%) patients received inappropriate dosing, with 43 (70.5%) being under-dosed and 18 (29.5%) being over-dosed as compared to FDA-labeled dosing recommendations for atrial fibrillation or venous thromboembolism (VTE). By a median follow-up duration of 20 months, stroke occurred in 6 (3.3%) patients receiving DOACs for atrial fibrillation, and VTE occurred in 1 (4.3%) patient receiving a DOAC for VTE. International Society on Thrombosis and Haemostasis major or clinically relevant nonmajor bleeding occurred in 25 (12.1%) patients. Direct oral anticoagulants were frequently prescribed at off-label doses in patients with moderate to severe renal impairment, with a tendency toward under-dosing.
Thromboembolism afflicts millions of patients annually in the United States and is associated with a significant cost burden. Oral anticoagulants provide clinicians with options for management of ...these diseases and their use continues to grow. Accordingly, regulatory, legislative, and nonprofit organizations have set performance standards with the goal of improving patient outcomes, ensuring patient safety, and reducing costs. Recent efforts in quality improvement have introduced changes surrounding regulatory requirements, surveillance, litigation, and oversight that clinicians should be familiar with. This article summarizes key updates related to the management of anticoagulant therapy as it relates to thrombosis prevention and treatment.
Clinical uncertainty exists regarding which assay should be designated as the standard monitoring coagulation test for intravenous unfractionated heparin (UFH). Several studies have compared the use ...of activated partial thromboplastin time (aPTT) and antifactor-Xa (anti-Xa) and have come out with varying results. The correlation between these 2 tests varied, markedly from strong to weak. Some have demonstrated that monitoring with anti-Xa heparin assay leads to fewer dose adjustments, resulting in fewer laboratory tests, while others have not. In the current study, we evaluated the correlation between aPTT and anti-Xa values to guide clinical management of UFH, with the intention to develop a new correlation nomogram.
Abstract Purpose Up to 15% of clinician-ordered doses of injectable pharmacological prophylaxis to prevent venous thromboembolism are not administered. Patient refusal accounts for nearly 50% of ...these omitted doses. We conducted a prospective cohort study to determine whether a patient education program would improve medication adherence to clinician-ordered injectable prophylactic anticoagulation. Methods We identified 528 hospitalized patients ordered to receive injectable pharmacological venous thromboembolism prophylaxis. We evaluated the impact of pharmacist-led patient education sessions on medication adherence (defined as the ratio of doses administered to doses scheduled) compared with our historical cohort. Results Individualized patient education sessions were conducted within 24 hours of the initial order for prophylactic anticoagulation in 99% of patients. Adherence to clinician-ordered pharmacological venous thromboembolism prophylaxis was higher after the patient education program than in our historical cohort (94.4% vs 89.9%, P <.0001). The proportion of patients receiving 100% of scheduled doses of injectable pharmacological venous thromboembolism prophylaxis was higher after our novel patient education program than in our historical cohort (73.7% vs 62.4%, P = .001). Patient refusal as a reason for omitted doses was less frequent after the patient education program (29.3% vs 43.7%, P = .001). Conclusion Pharmacist-led individualized patient education sessions were associated with higher medication adherence to clinician-ordered injectable pharmacological venous thromboembolism prophylaxis and a reduction in patient refusal as a reason for omitted doses. A randomized controlled trial to evaluate the impact of a patient education program on medication adherence to pharmacological venous thromboembolism prophylaxis is warranted.
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