Publications

  • American Journal of Hematology 04/2015; DOI:10.1002/ajh.24042 · 3.48 Impact Factor
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    ABSTRACT: Thromboembolism afflicts millions of patients annually in the United States and is associated with a significant cost burden. Recent advances in oral anticoagulation have provided clinicians with more options for management of these diseases. Accordingly, regulatory, legislative, and policy-making organizations have intervened with the aim of improving patient outcomes, ensuring patient safety, and reducing costs. There have been a number of recent developments in surveillance, litigation, and regulatory oversight that clinicians should recognize. In this review article we summarize key updates related to the management of anticoagulant therapy as it relates to thrombosis prevention and treatment.
    Journal of Thrombosis and Thrombolysis 03/2015; 39(3). DOI:10.1007/s11239-015-1198-2 · 2.17 Impact Factor
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    ABSTRACT: Despite rigorous expert review, medications often fall into routine use with unrecognized and unwanted complications. Use of some medications remains controversial because information to support efficacy is conflicting, scant, or nonexistent. Medication use evaluation (MUE) is a performance improvement tool that can be used when there is uncertainty regarding whether a medication will be beneficial. It is particularly useful when limited evidence is available on how best to choose between two or more medications. MUEs can analyze the process of medication prescribing, preparation, dispensing, administration, and monitoring. MUEs can be part of a structured or mandated multidisciplinary quality management program that focuses on evaluating medication effectiveness and improving patient safety. Successful MUE programs have a structure in place to support completion of rapid-cycle data collection, analysis, and intervention that supports practice change.
    Pharmacotherapy 12/2014; 34(S1). DOI:10.1002/phar.1506 · 2.20 Impact Factor
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    ABSTRACT: Our objective is to evaluate different pharmacologic strategies for VTE (venous thromboembolism) prophylaxis following orthopedic surgery at a tertiary academic medical center. This was a retrospective, observational study assessing the efficacy and safety of different strategies for VTE prophylaxis in elective total knee arthroplasty and total hip arthroplasty surgery patients. We evaluated warfarin at two different INR (international normalized ratio) goal ranges (1.5-2.5 and 1.8-2.3) and aspirin 325 mg once or twice daily. The main efficacy outcome was a composite of symptomatic deep vein thrombosis or pulmonary embolism. The main safety outcome was incidence of major or minor bleeding. From January 2010 to June 2010, there were 190 patients in the warfarin group with INR range 1.5-2.5, 214 patients in the warfarin group with INR range 1.8-2.3, and 48 patients in the aspirin group. Of the three strategies, two primary events occurred in each of the warfarin groups (1.6% vs. 1.4%; P = 0.31). There were no primary events in the aspirin group. Rates of major or minor bleeding were 4.2% in warfarin group INR 1.5-2.5 and 4.7% in warfarin group INR 1.8-2.3 (P = 0.19), and 2.1% in the aspirin arm (P = 0.29). There were no differences in the incidence of VTE in any of the treatment arms.
    Journal of Pharmacy and Pharmacology 06/2014; 2(6):371-375. · 2.16 Impact Factor
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    ABSTRACT: Submassive pulmonary embolism (PE) is characterized by hemodynamic stability with evidence of right ventricular dysfunction or myocardial necrosis, and represents a heterogeneous population at risk for adverse outcomes. Although patients with this subtype of PE are at higher risk of death, it is unclear whether escalation of care with fibrinolytic therapy mitigates this risk. The controversial role of fibrinolytic therapy for submassive PE is driven by a paucity of data, conflicting results from clinical trials, and lack of reliable positive predictive markers of mortality in this population. When compared with anticoagulation therapy alone, systemic fibrinolytic therapy leads to a more rapid improvement in pulmonary artery hemodynamics, restoration of right ventricular function, improved lung perfusion, and fewer episodes of clinical deterioration. The clinical significance of these findings remains uncertain because fibrinolytic therapy has not been demonstrated to improve mortality or reduce recurrent PE in patients with submassive PE. However, it is unclear whether this reflects methodological limitations such as small sample size and rescue fibrinolytic therapy in those assigned placebo, the absence of benefit in all patients with submassive PE, or the benefit is limited to an undefined, high-risk subset. The decision to administer adjunctive fibrinolytics in patients with submassive PE should be made on an individual basis, with serious consideration given to those with severe PE-related clinical manifestations and an acceptable risk of bleeding.
    12/2013; 1(4):236-246. DOI:10.1007/s40138-013-0027-1
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    ABSTRACT: Biologics are the fastest growing segment of annual United States (US) drug expenditure. Biologics are complex proteins derived from living sources that are important therapy for a variety of diseases. The US is now poised to introduce biosimilars, which are copies of biologics that are not manufactured by the innovator company and are approved under an abbreviated regulatory process. Biosimilars are intended to offer comparable safety and efficacy to the reference biologic at a lower cost. Because of the complexity of producing biologics, the manufacturing process for biosimilars may differ from that of the reference biologic, which may result in subtle changes in biological characteristics and clinical activity. Questions exist regarding whether these slight differences allow the products to be interchanged with the reference product and if unique adverse events will occur with use. While the Biologics Price Competition and Innovation Act outlined the abbreviated approval pathway for biosimilars, guidance from the US Food and Drug Administration (FDA) is needed on specific details of the approval process. The FDA has recently provided guidance about the scientific and quality requirements for demonstrating biosimilarity, but a number of unanswered questions still remain, including concerns about immunogenicity, product naming, and the exact cost savings from biosimilars. Emergency Medicine practitioners must have a sound understanding of these issues to ensure patient safety and avoid complications in care.
    12/2013; 1(4). DOI:10.1007/s40138-013-0023-5
  • 43rd Annual Critical Care Congress; 12/2013
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    ABSTRACT: To evaluate whether using an immunoglobulin G (IgG)-specific platelet factor 4 (PF4) test reduces the rate of positive PF4 results and has an impact on prescribing practices of nonheparin anticoagulants (direct thrombin inhibitors and fondaparinux) in patients assessed for heparin-induced thrombocytopenia (HIT). Single-center prospective cohort study with a historical control group. Large academic medical center. A total of 672 patients assessed for HIT. Patients were assessed for HIT by using either an IgG-specific PF4 enzyme-linked immunosorbent assay (ELISA; 336 patients) or a nonspecific PF4 ELISA (336 patients; historical control group). No significant difference was noted in the proportion of patients with a low, intermediate, or high risk of HIT based on the 4Ts pretest clinical scoring system. The PF4 ELISA was positive in 6.9% versus 11.3% of patients (p=0.04) in the IgG-specific and nonspecific cohorts, respectively. A smaller proportion of patients were prescribed a direct thrombin inhibitor in the IgG-specific cohort (19.4% vs 25.9%; p=0.04). No significant difference in fondaparinux use was noted between the cohorts. The duration of direct thrombin inhibitor therapy, bleeding events, hospital length of stay, and in-hospital mortality was similar in both cohorts. Use of an IgG-specific PF4 ELISA was associated with a lower rate of positive PF4 test results. Direct thrombin inhibitor prescribing was also significantly lower during the time period where the IgG-specific PF4 ELISA was used, with no significant differences noted in safety outcomes.
    Pharmacotherapy 11/2013; 33(11). DOI:10.1002/phar.1322 · 2.20 Impact Factor
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    ABSTRACT: Rivaroxaban is the first agent available within a new class of anticoagulants called direct factor Xa inhibitors. Rivaroxaban is approved for use in the United States for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, for the prevention of deep vein thrombosis in patients undergoing total hip replacement and total knee replacement, for the treatment of deep vein thrombosis and pulmonary embolism, and for the reduction in risk of recurrence of deep vein thrombosis and pulmonary embolism (with additional indications under review). Rivaroxaban dose and frequency of administration vary depending on the indication. As of result of predictable pharmacokinetics and pharmacodynamics, a fixed dose of rivaroxaban is administered without routine coagulation testing. Rivaroxaban has a short half-life, undergoes a dual mode of elimination (hepatic and renal), and is a substrate for P-glycoprotein. Rivaroxaban has a lower potential for drug interactions compared with warfarin. Despite the advantages of a once/day fixed-dose oral agent, in many clinical situations limited evidence is available to guide optimal management of rivaroxaban therapy. In this article, we review the available evidence and provide recommendations where possible for such situations including the desire to monitor the anticoagulation intensity, use in special patient populations, managing drug interactions, and transitioning across anticoagulant agents. Potential strategies for reversing rivaroxaban's anticoagulant effect are reviewed. Health systems will need to perform a systematic safety evaluation and ensure that numerous hospital policies related to anticoagulation are updated to include rivaroxaban. A comprehensive approach to education is needed for clinicians, patients, and technical support personnel involved in patient interactions to ensure safe use.
    Pharmacotherapy 11/2013; 33(11). DOI:10.1002/phar.1289 · 2.20 Impact Factor
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    John Fanikos
    Journal of Medical Economics 08/2013; DOI:10.3111/13696998.2013.831353
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    ABSTRACT: Anticoagulants remain the primary strategy for the prevention and treatment of thrombosis. Unfractionated heparin, low molecular weight heparin, fondaparinux, and warfarin have been studied and employed extensively with direct thrombin inhibitors typically reserved for patients with complications or those requiring intervention. Novel oral anticoagulants have emerged from clinical development and are expected to replace older agents with their ease of use and more favorable pharmacodynamic profiles. Hemorrhage is the main concerning adverse event with all anticoagulants. With their ubiquitous use, it becomes important for clinicians to have a sound understanding of anticoagulant pharmacology, dosing, and toxicity.
    06/2013; 1(2):83-97. DOI:10.1007/s40138-013-0014-6
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    ABSTRACT: Dabigatran was expected to replace warfarin for stroke prevention in patients with nonvalvular atrial fibrillation (AF) who are warfarin naive, difficult to maintain in therapeutic range, or at risk of warfarin-related bleeding complications. We hypothesized that the number of patients with nonvalvular AF referred to Anticoagulation Management Services would decrease sharply and that most would switch from warfarin to dabigatran. We evaluated the number of patients with nonvalvular AF referred to 2 large services, Anticoagulation Management Service 1 and Anticoagulation Management Service 2, 12 months before and after market entry of dabigatran. We also evaluated the number of patients who switched from warfarin to dabigatran. Anticoagulation Management Service 1 follows 1,225 patients with nonvalvular AF with mean CHADS2 and CHA2DS2-VASc scores of 2.0 and 3.5, respectively. Anticoagulation Management Service 2 follows 1,137 patients with nonvalvular AF with mean CHADS2 and CHA2DS2-VASc scores of 2.0 and 3.3, respectively. In the 12 months preceding market entry of dabigatran, patients with nonvalvular AF constituted 537 (31.4%) of the referrals sent to Anticoagulation Management Service 1 and increased to 793 (32.3%) in the following 12 months. For Anticoagulation Management Service 2, patients with nonvalvular AF constituted 617 (30.7%) of referrals before market entry of dabigatran and decreased to 495 (25.2%) of referrals. Eighty-one patients (6.6%) from Anticoagulation Management Service 1 and 44 (3.9%) from Anticoagulation Management Service 2 have switched from warfarin to dabigatran. The frequency of initial prescription of dabigatran for stroke prevention in AF and the frequency of transition from warfarin to dabigatran have been less than expected.
    The American journal of cardiology 05/2013; 112(3). DOI:10.1016/j.amjcard.2013.03.046 · 3.43 Impact Factor
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    ABSTRACT: Venous thromboembolism (VTE) is a common complication of cancer and chemotherapy. We evaluated the baseline clinical characteristics, thromboprophylaxis patterns, frequency and timing of VTE, and clinical outcomes in 1000 adult hospitalized patients with active cancer. Overall, symptomatic VTE occurred in 5.4% of hospitalized patients with cancer. The VTE occurred in 2.3% of patients with cancer during hospitalization and in 3.4% between hospital discharge and day 90. Few (13.9%) hospitalized patients with cancer received extended duration pharmacological prophylaxis after hospital discharge. Cancer was the most frequent known cause of death in both the groups. In conclusion, VTE was common in hospitalized patients with cancer, especially after discharge. Inhospital death and death between discharge and day 90 were frequent in hospitalized patients with cancer who developed VTE.
    Clinical and Applied Thrombosis/Hemostasis 03/2013; 19(5). DOI:10.1177/1076029613481844 · 1.58 Impact Factor
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    John R Fanikos, Julie K Atay, Jean M Connors
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    ABSTRACT: Three agents have recently been approved to reduce the risk of stroke and embolism, and one agent is in phase 3 trials. These drugs cause less serious bleeding and are simpler to manage, compared with warfarin, but they are not without their risks.
    P&T 03/2013; 38(3):173-7. · 1.07 Impact Factor
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    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.
    The American journal of medicine 02/2013; 126(2):127-132. DOI:10.1016/j.amjmed.2012.07.025 · 5.30 Impact Factor
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    ABSTRACT: Study Objective To evaluate whether using an immunoglobulin G (IgG)‐specific platelet factor 4 (PF4) test reduces the rate of positive PF4 results and has an impact on prescribing practices of nonheparin anticoagulants (direct thrombin inhibitors and fondaparinux) in patients assessed for heparin‐induced thrombocytopenia (HIT). DesignSingle‐center prospective cohort study with a historical control group. SettingLarge academic medical center. PatientsA total of 672 patients assessed for HIT. InterventionPatients were assessed for HIT by using either an IgG‐specific PF4 enzyme‐linked immunosorbent assay (ELISA; 336 patients) or a nonspecific PF4 ELISA (336 patients; historical control group). Measurements and Main ResultsNo significant difference was noted in the proportion of patients with a low, intermediate, or high risk of HIT based on the 4Ts pretest clinical scoring system. The PF4 ELISA was positive in 6.9% versus 11.3% of patients (p=0.04) in the IgG‐specific and nonspecific cohorts, respectively. A smaller proportion of patients were prescribed a direct thrombin inhibitor in the IgG‐specific cohort (19.4% vs 25.9%; p=0.04). No significant difference in fondaparinux use was noted between the cohorts. The duration of direct thrombin inhibitor therapy, bleeding events, hospital length of stay, and in‐hospital mortality was similar in both cohorts. Conclusion Use of an IgG‐specific PF4 ELISA was associated with a lower rate of positive PF4 test results. Direct thrombin inhibitor prescribing was also significantly lower during the time period where the IgG‐specific PF4 ELISA was used, with no significant differences noted in safety outcomes.
    Pharmacotherapy 01/2013; 33(11). · 2.20 Impact Factor
  • Deborah Cios, John Fanikos
    Circulation 04/2012; 125(14):e542-4. DOI:10.1161/CIRCULATIONAHA.111.087718 · 14.95 Impact Factor
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    Journal of the American College of Cardiology 03/2012; 59(13). DOI:10.1016/S0735-1097(12)61898-1 · 15.34 Impact Factor
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    ABSTRACT: 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. 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. 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). 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.
    The American journal of medicine 03/2012; 125(3):258-64. DOI:10.1016/j.amjmed.2011.09.012 · 5.30 Impact Factor
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    ABSTRACT: 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. 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. 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). 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.
    The American journal of medicine 12/2011; 124(12):1136-42. DOI:10.1016/j.amjmed.2011.06.009 · 5.30 Impact Factor

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