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1.
Artigo em Inglês | MEDLINE | ID: mdl-38733515

RESUMO

Anticoagulation therapy is standard for conditions like atrial fibrillation, venous thromboembolism, and valvular heart disease, yet it is unclear if there are ethnoracial disparities in its quality and delivery in the United States. For this scoping review, electronic databases were searched for publications between January 1, 2011 - March 30, 2022. Eligible studies included all study designs, any setting within the United States, patients prescribed anticoagulation for any indication, outcomes reported for ≥ 2 distinct ethnoracial groups. The following four research questions were explored: Do ethnoracial differences exist in 1) access to guideline-based anticoagulation therapy, 2) quality of anticoagulation therapy management, 3) clinical outcomes related to anticoagulation care, 4) humanistic/educational outcomes related to anticoagulation therapy. A total of 5374 studies were screened, 570 studies received full-text review, and 96 studies were analyzed. The largest mapped focus was patients' access to guideline-based anticoagulation therapy (88/96 articles, 91.7%). Seventy-eight articles made statistical outcomes comparisons among ethnoracial groups. Across all four research questions, 79 articles demonstrated favorable outcomes for White patients compared to non-White patients, 38 articles showed no difference between White and non-White groups, and 8 favored non-White groups (the total exceeds the 78 articles with statistical outcomes as many articles reported multiple outcomes). Disparities disadvantaging non-White patients were most pronounced in access to guideline-based anticoagulation therapy (43/66 articles analyzed) and quality of anticoagulation management (19/21 articles analyzed). Although treatment guidelines do not differentiate anticoagulant therapy by ethnoracial group, this scoping review found consistently favorable outcomes for White patients over non-White patients in the domains of access to anticoagulation therapy for guideline-based indications and quality of anticoagulation therapy management. No differences among groups were noted in clinical outcomes, and very few studies assessed humanistic or educational outcomes.

2.
J Thromb Thrombolysis ; 55(1): 185-188, 2023 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-35442003

RESUMO

Direct oral anticoagulants (DOACs) are standard of care for venous thromboembolism (VTE) treatment and stroke prevention in atrial fibrillation (AF). Adding antiplatelet therapy (APT) to an oral anticoagulant (OAC) causes a 2-fold increase in major bleeding. As such, recent guidelines recommend limiting the duration and indication of combined therapy in patients already on an OAC. Despite these recommendations, approximately one-third of anticoagulated patients are prescribed concomitant APT. University of Utah Health patients receiving DOAC + APT between August 1, 2019 and November 30, 2019 were included. These were categorized into four groups by APT indication: primary atherosclerotic cardiovascular disease (ASCVD) prevention, ASCVD-no percutaneous coronary intervention (PCI), ASCVD-PCI ≤ 12 months prior, ASCVD-PCI > 12 months prior. The primary outcome was the proportion of DOAC patients receiving concomitant APT for each indication. During the study period, 347 patients received DOAC + APT, primarily for AF (59.1%) or VTE (33.1%), and the most common DOAC was apixaban (76.7%).The most common indication for APT was ASCVD-no PCI (47.3%), followed by ASCVD-PCI > 12 months prior (30.8%), primary ASCVD prevention (18.7%), and ASCVD-PCI ≤ 12 months prior (1.7%). Five patients (1.4%) were on APT with unclear indication. Based on recent guidelines limiting indications and duration of APT added to anticoagulation, over 95% of patients in this single-center study warranted re-assessment of APT indication, with stable ASCVD and primary prevention being prime targets for APT de-prescribing. This study highlights the tremendous potential to improve patient safety and reduce bleeding harm.


Assuntos
Fibrilação Atrial , Tromboembolia Venosa , Humanos , Inibidores da Agregação Plaquetária/efeitos adversos , Tromboembolia Venosa/tratamento farmacológico , Tromboembolia Venosa/prevenção & controle , Tromboembolia Venosa/complicações , Anticoagulantes/efeitos adversos , Hemorragia/induzido quimicamente , Hemorragia/tratamento farmacológico , Fibrilação Atrial/tratamento farmacológico , Fibrilação Atrial/complicações , Administração Oral
3.
J Thromb Thrombolysis ; 56(4): 511-513, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37548901

RESUMO

Warfarin patient self-management (PSM) is when a patient independently manages their warfarin therapy using a decision-support tool provided by their anticoagulation provider. Clinical trials of PSM, conducted predominantly in Europe, have consistently demonstrated superior efficacy without compromising safety. However, the evidence-based practice of PSM is rarely utilized in the United States (U.S.). We describe initiatives completed to implement a successful PSM program among experienced warfarin-taking patients in a U.S. academic health system by overcoming perceived barriers. The results showed PSM resulted in similar or improved INR control, and an estimated 68% reduction in pharmacist workload.


Assuntos
Autogestão , Varfarina , Humanos , Varfarina/uso terapêutico , Coeficiente Internacional Normatizado , Anticoagulantes/uso terapêutico , Coagulação Sanguínea , Farmacêuticos
4.
J Thromb Thrombolysis ; 56(4): 568-577, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37596426

RESUMO

This scoping review summarizes the extent and characteristics of the published literature describing digital population management dashboards implemented to improve the quality of anticoagulant management. A standardized search protocol was executed to identify relevant manuscripts published between January 1, 2015 and May 31, 2022. The resulting records were systematically evaluated by multiple blinded reviewers and the findings from selected papers were evaluated and summarized. Twelve manuscripts were identified, originating from 5 organizations within the US and 2 from other countries. The majority (75%) described implementation in the outpatient setting. The identified papers described a variety of positive results of dashboard use, including a 24.5% reduction of questionable direct oral anticoagulant dosing in one organization, a 33.3% relative improvement in no-show appointments in an ambulatory care clinic, and a 75% improvement in intervention efficiency. One medical center achieved a 98.4% risk-appropriate venous thromboembolism risk prophylaxis prescribing rate and 40.6% reduction in anticoagulation-related adverse event rates. The manuscripts primarily described retrospective findings from single-center dashboard implementation experiences. Digital dashboards have been successfully implemented to support the anticoagulation of acute and ambulatory patients and available manuscripts suggest a positive impact on care-related processes and relevant patient outcomes. Prospective studies are needed to better characterize the implementation and impact of dashboards for anticoagulation management. Published reports suggest that digital dashboards may improve the quality, safety, and efficiency of anticoagulation management. Additional research is needed to validate these findings and to understand how best to implement these tools.

5.
Blood ; 132(21): 2230-2239, 2018 11 22.
Artigo em Inglês | MEDLINE | ID: mdl-30463993

RESUMO

Oral anticoagulants are commonly prescribed but high risk to cause adverse events. Skilled drug interaction management is essential to ensure safe and effective use of these therapies. Clinically relevant interactions with warfarin include drugs that modify cytochrome 2C9, 3A4, or both. Drugs that modify p-glycoprotein may interact with all direct oral anticoagulants, and modifiers of cytochrome 3A4 may interact with rivaroxaban and apixaban. Antiplatelet agents, nonsteroidal anti-inflammatory drugs, and serotonergic agents, such as selective serotonin reuptake inhibitors, can increase risk of bleeding when combined with any oral anticoagulant, and concomitant use should be routinely assessed. New data on anticoagulant drug interactions are available almost daily, and therefore, it is vital that clinicians regularly search interaction databases and the literature for updated management strategies. Skilled drug interaction management will improve outcomes and prevent adverse events in patients taking oral anticoagulants.


Assuntos
Anticoagulantes/farmacologia , Interações Medicamentosas , Varfarina/farmacologia , Administração Oral , Anticoagulantes/administração & dosagem , Anticoagulantes/metabolismo , Indutores do Citocromo P-450 CYP2C9/farmacologia , Indutores do Citocromo P-450 CYP3A/farmacologia , Inibidores das Enzimas do Citocromo P-450/farmacologia , Sistema Enzimático do Citocromo P-450/metabolismo , Humanos , Varfarina/administração & dosagem , Varfarina/metabolismo
6.
J Thromb Thrombolysis ; 49(3): 492-496, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-31776847

RESUMO

Concurrent antiplatelet therapy (APT) is common during warfarin therapy but is less well-documented during direct oral anticoagulant (DOAC) therapy. Combined anticoagulant and APT use has been associated with increased bleeding risk without providing additional protection against thrombosis. This study aimed to describe single-center prescribing rates of DOAC + APT as well as compare bleeding rates between DOAC monotherapy and DOAC + APT cohorts. Patients receiving DOAC therapy were evaluated for APT use at the time of hospital discharge. Patients were categorized into DOAC monotherapy and DOAC + APT cohorts. Primary outcomes included DOAC + APT prescribing rate as well as rates of major bleeding and clinically relevant non-major bleeding (CRNMB) within six months after hospital discharge. Secondary outcomes included rates of thromboembolism and all-cause mortality. Of 407 patients receiving DOAC therapy, 78 (19.2%) also received APT at hospital discharge. Common indications for APT included secondary cardiovascular event prevention (57.7%) and primary cardiovascular event prevention (29.5%). The indication for APT could not be determined in 12.8% of patients. The major bleeding rate was 1.3% for DOAC + APT and 1.2% for DOAC monotherapy (p = 0.95). The CRNMB rate was 10.2% for DOAC + APT and 6.4% for DOAC monotherapy (p = 0.23). Thromboembolism and mortality were infrequent in both cohorts. DOAC + APT was documented in approximately 1 of 5 patients. Adding APT to DOAC therapy did not significantly increase the major bleeding or CRNMB rates compared to DOAC monotherapy but the sample size limits drawing conclusions about the safety of these regimens. Targeting primary prevention or unclear indications for APT could be a focus of future interventions.


Assuntos
Anticoagulantes , Prescrições de Medicamentos , Hemorragia , Inibidores da Agregação Plaquetária , Tromboembolia , Varfarina , Administração Oral , Idoso , Anticoagulantes/administração & dosagem , Anticoagulantes/efeitos adversos , Quimioterapia Combinada , Feminino , Hemorragia/sangue , Hemorragia/induzido quimicamente , Hemorragia/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Inibidores da Agregação Plaquetária/administração & dosagem , Inibidores da Agregação Plaquetária/efeitos adversos , Estudos Retrospectivos , Tromboembolia/sangue , Tromboembolia/tratamento farmacológico , Tromboembolia/epidemiologia , Varfarina/administração & dosagem , Varfarina/efeitos adversos
7.
J Thromb Thrombolysis ; 48(4): 623-628, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31317300

RESUMO

Certain patient populations (pregnancy, cancer, renal impairment, and obesity) may be at higher risk of adverse events during low molecular weight heparin (LMWH) therapy and may benefit from anti-Xa monitoring. Yet, evidence supporting a standardized approach to anti-Xa monitoring correlated to clinical outcomes is lacking. Patients with at least one documented anti-Xa level and receiving LMWH within a 6-month period were identified. In a 6-month period, 224 adult LMWH patients with 359 anti-Xa levels were identified. Anti-Xa monitoring was most commonly performed in patients with active cancer receiving venous thromboembolism (VTE) treatment doses (57.4%) or obese patients receiving VTE prophylaxis (48.1%). Anti-Xa monitoring during renal impairment and pregnancy were infrequent (0.9% and 1.8%, respectively). Most (71.9%) anti-Xa levels were therapeutic, but only 45% were drawn correctly in relation to LMWH administration time. Compared to those with therapeutic anti-Xa levels, patients with out-of-range levels were four times as likely to receive a LMWH therapy change (odds ratio, 4.16; 95% confidence interval, 2.53-6.84). However, when levels were supratherapeutic or subtherapeutic, the LMWH doses remained unchanged in one-third to one-half of patients, respectively. Anti-Xa monitoring was most commonly performed in patients with cancer or obesity and was more common with VTE prophylaxis dosing. The majority of levels were therapeutic, indicating that anti-Xa monitoring may be unnecessary even in high-risk patient populations. Many out-of-range anti-Xa levels did not prompt a change in LMWH therapy. Further research is still needed to determine if anti-Xa- guided LMWH dosing improves clinical outcomes.


Assuntos
Inibidores do Fator Xa/sangue , Heparina de Baixo Peso Molecular/administração & dosagem , Adulto , Idoso , Anticoagulantes/uso terapêutico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias/tratamento farmacológico , Obesidade/tratamento farmacológico , Gravidez , Tromboembolia Venosa/tratamento farmacológico , Tromboembolia Venosa/prevenção & controle
8.
J Thromb Thrombolysis ; 48(4): 596-602, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31273515

RESUMO

Warfarin remains the most commonly prescribed oral anticoagulant in the United States, but it has disadvantages such as dietary interactions and frequent laboratory monitoring. Direct oral anticoagulants (DOACs) have been introduced as safer and equally effective alternatives to warfarin. This study assessed patient preference for warfarin or DOAC based on a willingness to pay more for potential DOAC benefits. Current warfarin patients with atrial fibrillation or venous thromboembolism enrolled in the University of Utah Health Thrombosis Service were given a one-time electronic survey that assessed preferences between warfarin and DOACs using scenarios comparing effectiveness, safety, and convenience. When DOACs were preferred, patients were asked how much more they would be willing to pay monthly for the perceived advantages associated with DOACs. With 123 completed surveys, 68% of patients preferred to stay on warfarin. No particular factor influenced patient preference (lack of routine laboratory monitoring, lower risks of major bleeding, and fewer dietary interactions). Reduced stroke risk was associated with the highest value (willing to pay an additional $21). Considering all factors, patients preferring DOACs would pay a median $18 extra per month for the additional benefits. Prior exposure to DOACs was associated with preference for DOACs. Many patients currently taking warfarin preferred to stay on warfarin when given the choice, despite DOAC benefits. Willingness to pay extra for DOAC advantages did not exceed $20 in the majority of survey respondents. Previous DOAC exposure influences patient preference and perceived value for DOACs.


Assuntos
Substituição de Medicamentos , Inibidores do Fator Xa/uso terapêutico , Preferência do Paciente/estatística & dados numéricos , Varfarina/uso terapêutico , Fibrilação Atrial/tratamento farmacológico , Custos de Medicamentos , Substituição de Medicamentos/estatística & dados numéricos , Inibidores do Fator Xa/economia , Humanos , Preferência do Paciente/economia , Inquéritos e Questionários , Tromboembolia Venosa/tratamento farmacológico , Varfarina/economia
9.
J Thromb Thrombolysis ; 48(3): 506-510, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31230262

RESUMO

Preferred anticoagulation therapy for venous thromboembolism (VTE) has shifted from warfarin to direct oral anticoagulants (DOACs). Adherence to DOAC prescribing information is an important quality measure as off-label doses have been associated with increased risk of adverse events (AEs). To identify the prevalence, outcomes, and patient characteristics associated with off-label DOAC dosing during VTE treatment. Patients receiving DOAC for VTE treatment discharged from University of Utah Health (UUH) over a 90-day period were identified. Dosing was classified as "labeled" or "off-label" based on concordance with manufacturer prescribing information. AEs (thromboembolic events, bleeding, death) occurring within 90 days after discharge were identified. Out of 195 patients, 154 (79.0%) received labeled dosing, 31 (15.9%) received off-label dosing, and 10 (5.1%) were indeterminate. Two-thirds of off-label doses were higher than recommended and three-fourths occurred during extended treatment (more than 90 days post-VTE). Off-label dosing rates dropped to 5.6% when 6-month dose reductions were not required. Off-label dosing was associated with apixaban use and extended phase treatment (p < 0.001). No association was found between off-label dosing and age, renal function, prescriber rationale for dose selection, or Thrombosis Clinic referral. AEs were experienced by 18 (11.7%) and 3 (9.7%) patients in the labeled and off-label groups, respectively (p = 0.77). Bleeding events comprised 46.2% of AEs. The rate of off-label DOAC dosing for VTE at UUH was within rates reported in prior studies, occurred primarily with extended-duration apixaban, and did not result in a higher rate of AEs.


Assuntos
Inibidores do Fator Xa/administração & dosagem , Uso Off-Label , Tromboembolia Venosa/tratamento farmacológico , Inibidores do Fator Xa/efeitos adversos , Feminino , Hemorragia/induzido quimicamente , Humanos , Masculino , Pessoa de Meia-Idade , Padrões de Prática Médica , Pirazóis/uso terapêutico , Piridonas/uso terapêutico , Estudos Retrospectivos
11.
J Thromb Thrombolysis ; 41(1): 206-32, 2016 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-26780747

RESUMO

Venous thromboembolism (VTE) is a serious medical condition associated with significant morbidity and mortality, and an incidence that is expected to double in the next forty years. The advent of direct oral anticoagulants (DOACs) has catalyzed significant changes in the therapeutic landscape of VTE treatment. As such, it is imperative that clinicians become familiar with and appropriately implement new treatment paradigms. This manuscript, initiated by the Anticoagulation Forum, provides clinical guidance for VTE treatment with the DOACs. When possible, guidance statements are supported by existing published evidence and guidelines. In instances where evidence or guidelines are lacking, guidance statements represent the consensus opinion of all authors of this manuscript and are endorsed by the Board of Directors of the Anticoagulation Forum.The authors of this manuscript first developed a list of pivotal practical questions related to real-world clinical scenarios involving the use of DOACs for VTE treatment. We then performed a PubMed search for topics and key words including, but not limited to, apixaban, antidote, bridging, cancer, care transitions, dabigatran, direct oral anticoagulant, deep vein thrombosis, edoxaban, interactions, measurement, perioperative, pregnancy, pulmonary embolism, reversal, rivaroxaban, switching, \thrombophilia, venous thromboembolism, and warfarin to answer these questions. Non- English publications and publications > 10 years old were excluded. In an effort to provide practical information about the use of DOACs for VTE treatment, answers to each question are provided in the form of guidance statements, with the intent of high utility and applicability for frontline clinicians across a multitude of care settings.


Assuntos
Anticoagulantes/uso terapêutico , Tromboembolia Venosa/tratamento farmacológico , Administração Oral , Anticoagulantes/efeitos adversos , Feminino , Humanos , Masculino , Guias de Prática Clínica como Assunto , Gravidez , Tromboembolia Venosa/sangue
13.
Pharmacotherapy ; 44(3): 224-230, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-38088033

RESUMO

STUDY OBJECTIVE: The objective of the study was to assess clinical outcomes (composite of any venous thromboembolism [VTE], any bleeding, and mortality) associated with anti-Xa monitoring in the 30 days following enoxaparin initiation for VTE prophylaxis. DESIGN: Retrospective cohort study. SETTING: Hospital within an academic healthcare system. PATIENTS: Propensity score-matched hospitalized adults receiving enoxaparin for VTE prophylaxis. INTERVENTION: Low-molecular-weight heparin anti-Xa monitoring. MEASUREMENTS AND MAIN RESULTS: During the 13-month study period, a total of 6611 patients received enoxaparin for VTE prophylaxis, 301 in the anti-Xa monitored group and 6310 in the unmonitored group (4.6% received monitoring). The mean age was 52.9 years and 52% of patients were male. The mean body mass index was 31 kg/m2 and the mean creatinine clearance was 109 mL/min. Twenty percent of patients had active cancer. The most common indication for enoxaparin prophylaxis was hospitalization for medical illness (52%) followed by nonorthopedic surgery (37%). The adjusted odds ratio for the primary outcome comparing monitored to unmonitored patients was 1.26 (95% confidence interval, 0.75-2.11). None of the between-group differences in the individual components of the composite outcome were statistically significant. CONCLUSIONS: Thirty-day clinical outcomes in patients receiving enoxaparin for VTE prophylaxis were not improved by anti-Xa monitoring. Our results support current evidence-based guideline recommendations against anti-Xa monitoring for patients receiving enoxaparin for VTE prophylaxis.


Assuntos
Enoxaparina , Tromboembolia Venosa , Adulto , Humanos , Masculino , Pessoa de Meia-Idade , Feminino , Enoxaparina/uso terapêutico , Tromboembolia Venosa/prevenção & controle , Tromboembolia Venosa/tratamento farmacológico , Estudos Retrospectivos , Anticoagulantes/uso terapêutico , Heparina de Baixo Peso Molecular
15.
Thromb Res ; 232: 163-167, 2023 12.
Artigo em Inglês | MEDLINE | ID: mdl-36446659

RESUMO

PURPOSE: Antiphospholipid Antibody Syndrome (APS) is a complex autoimmune disorder that includes a combination of laboratory criteria and clinical events (thrombosis, pregnancy complications). Accurate classification is essential, as APS patients may have limited oral anticoagulant options and requires indefinite anticoagulation. The prevalence of inaccurate APS misclassification is unknown. This study sought to determine the proportion of patients in an academic health-system who formally met APS criteria. METHODS: This retrospective cohort study included any patient within the University of Utah Health system who had an International Classification of Diseases-10 code for APS, between January 1, 2016 and June 30, 2020. Manual chart review was performed to assess the appropriateness of the APS classification by laboratory and clinical criteria. RESULTS: Of the 184 patients identified, 59 (32.1 %) formally met APS criteria, while 69 (37.5 %) did not meet criteria. The remaining 56 (30.4 %) patients lacked enough information in their medical records to decide on appropriateness of APS classification. The most prevalent reason for inappropriate APS classification in the 69 patients identified was incorrect interpretation of lab values as positive (62; 89.9 %), followed by lack of repeat confirmation testing (32; 46.4 %). CONCLUSION: The results of this single-center study indicate that only one-third of patients with presumed APS met classification criteria. This was predominantly due to incorrect collection or interpretation of APS laboratory data. One-third had insufficient medical record data to determine APS classification, which impairs clinical decision-making. This suggests more education or implementation of anticoagulation stewardship is needed to ensure accurate APS classification and proper management of anticoagulation therapy.


Assuntos
Síndrome Antifosfolipídica , Trombose , Gravidez , Feminino , Humanos , Síndrome Antifosfolipídica/diagnóstico , Síndrome Antifosfolipídica/epidemiologia , Síndrome Antifosfolipídica/complicações , Prevalência , Estudos Retrospectivos , Anticoagulantes/uso terapêutico , Trombose/etiologia
16.
JMIR Hum Factors ; 8(4): e28618, 2021 Oct 26.
Artigo em Inglês | MEDLINE | ID: mdl-34698649

RESUMO

BACKGROUND: Exposure to life-threatening drug-drug interactions (DDIs) occurs despite the widespread use of clinical decision support. The DDI between warfarin and nonsteroidal anti-inflammatory drugs is common and potentially life-threatening. Patients can play a substantial role in preventing harm from DDIs; however, the current model for DDI decision-making is clinician centric. OBJECTIVE: This study aims to design and study the usability of DDInteract, a tool to support shared decision-making (SDM) between a patient and provider for the DDI between warfarin and nonsteroidal anti-inflammatory drugs. METHODS: We used an SDM framework and user-centered design methods to guide the design and usability of DDInteract-an SDM electronic health record app to prevent harm from clinically significant DDIs. The design involved iterative prototypes, qualitative feedback from stakeholders, and a heuristic evaluation. The usability evaluation included patients and clinicians. Patients participated in a simulated SDM discussion using clinical vignettes. Clinicians were asked to complete eight tasks using DDInteract and to assess the tool using a survey adapted from the System Usability Scale. RESULTS: The designed DDInteract prototype includes the following features: a patient-specific risk profile, dynamic risk icon array, patient education section, and treatment decision tree. A total of 4 patients and 11 clinicians participated in the usability study. After an SDM session where patients and clinicians review the tool concurrently, patients generally favored pain treatments with less risk of gastrointestinal bleeding. Clinicians successfully completed the tasks with a mean of 144 (SD 74) seconds and rated the usability of DDInteract as 4.32 (SD 0.52) of 5. CONCLUSIONS: This study expands the use of SDM to DDIs. The next steps are to determine if DDInteract can improve shared decision-making quality and to implement it across health systems using interoperable technology.

17.
Thromb Res ; 194: 240-245, 2020 10.
Artigo em Inglês | MEDLINE | ID: mdl-33213849

RESUMO

BACKGROUND: Direct oral anticoagulants (DOACs) have emerged as safe and effective alternatives to Vitamin-K antagonists for treatment and prevention of arterial and venous thrombosis. Due to their novelty, pharmacokinetic DOAC drug-drug interactions (DDIs) that result in clinical adverse events have not been well-documented. OBJECTIVE: This study aims to systematically review reported pharmacokinetic DDIs resulting in clinical adverse events through documented observational evidence to better inform clinicians in clinical practice. METHODS: A comprehensive literature review of EMBASE, MEDLINE, and Ovid HealthStar was conducted through March 10th, 2020. Two independent reviewers screened and extracted data from eligible articles according to pre-established inclusion and exclusion criteria. Articles reporting bleeding or thrombotic outcomes in non-controlled (observational) settings resulting from suggested pharmacokinetic DOAC DDIs were included. RESULTS: A total of 5567 citations were reviewed, of which 24 were included following data extraction. The majority were case reports (n = 21) documenting a single adverse event resulting from a suspected DOAC DDI, while the remaining papers were a case series (n = 1) and cohort studies (n = 2). The most commonly reported interacting drugs were amiodarone and ritonavir (bleeding), and phenobarbital, phenytoin, and carbamazepine (thrombosis). Bleeding events more often resulted from a combined mechanism (P-glycoprotein AND CYP3A4 inhibition), whereas thrombotic events resulted from either combined OR single P-glycoprotein/CYP3A4 induction. CONCLUSION: Current literature evaluating the real-world risk of DOAC DDIs is limited to few case reports and retrospective observational analyses. Clinicians are encouraged to continue to report suspected drug interactions resulting in adverse events.


Assuntos
Anticoagulantes , Preparações Farmacêuticas , Administração Oral , Anticoagulantes/efeitos adversos , Interações Medicamentosas , Hemorragia/induzido quimicamente , Hemorragia/tratamento farmacológico , Humanos , Estudos Observacionais como Assunto , Estudos Retrospectivos
18.
Ann Pharmacother ; 43(11): 1824-35, 2009 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-19737994

RESUMO

OBJECTIVE: To provide an evidence-based review and clinical summary of postthrombotic syndrome (PTS). DATA SOURCES: A literature review was performed via MEDLINE (1950-July 1, 2009) and International Pharmaceutical Abstracts (1970-June 2009) searches using the terms post-thrombotic syndrome, post-phlebitic syndrome, deep vein thrombosis, and compression stockings. DATA SYNTHESIS: PTS is best characterized as a chronic syndrome of clinical signs and symptoms including pain, swelling, parasthesias, and ulceration in the affected limb following deep vein thrombosis (DVT). It occurs in up to half of patients with symptomatic DVT, usually within the first 2 years. Although the pathophysiology of PTS is not well understood, a thrombus may cause venous hypertension and valvular incompetence resulting in edema, tissue hypoxia, and in severe cases, ulceration. Risk factors for PTS include recurrent ipsilateral DVT, obesity, and poor quality of anticoagulant therapy. PTS diagnosis is based on the presence of typical signs and symptoms and may be made using one of several clinical scoring systems. Prevention of PTS should focus on DVT prevention and the use of elastic compression stockings following DVT, while fibrinolysis remains under investigation as an effective method for PTS prevention. The treatment of PTS may include either pharmacologic or mechanical modalities, although none of these regimens has been rigorously tested. Pharmacists have the opportunity to provide more comprehensive antithrombotic management by educating patients and providers on PTS, recommending appropriate preventive therapy, assisting patients in obtaining and adhering to this therapy, and assisting providers with the management of PTS. CONCLUSIONS: Providers should be proactive in preventing PTS, with pharmacists taking an active role in optimal DVT prevention, identifying patients at risk for PTS, and counseling and directing preventive therapies.


Assuntos
Síndrome Pós-Trombótica/diagnóstico , Síndrome Pós-Trombótica/prevenção & controle , Meias de Compressão , Gerenciamento Clínico , Humanos , Síndrome Pós-Flebítica/diagnóstico , Síndrome Pós-Flebítica/etiologia , Síndrome Pós-Flebítica/prevenção & controle , Síndrome Pós-Trombótica/etiologia , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/tendências , Fatores de Risco , Meias de Compressão/normas , Meias de Compressão/tendências , Trombose Venosa/complicações , Trombose Venosa/diagnóstico , Trombose Venosa/terapia
19.
J Am Pharm Assoc (2003) ; 49(1): 78-85, 2009.
Artigo em Inglês | MEDLINE | ID: mdl-19196602

RESUMO

OBJECTIVE: To evaluate a workflow model and define factors affecting patient visit length in an anticoagulation clinic primarily treating an urban patient population. DESIGN: Workflow analysis. SETTING: Anticoagulation clinic in Memphis, TN, between November 2005 and April 2006. PATIENTS: 240 and 246 patient visits were assessed pre- and postintervention, respectively. INTERVENTION: For 7 weeks, pharmacists documented factors affecting visit length and problems addressed during the visit, which were classified as anticoagulation or non-anticoagulation related. Following data analysis, changes were made to address inefficiencies in the clinic workflow. Postintervention data were collected for 7 weeks to assess the impact of these interventions. MAIN OUTCOME MEASURES: Patient visit length and factors affecting patient visit length. RESULTS: Factors affecting visit length were overbooking, pharmacist preceptor availability, attending physician availability, and repeat venipuncture. To target these inefficiencies, changes were made to the clinic schedule and workflow and a patient-provider agreement was implemented. These interventions decreased the frequency of the visit length factors significantly. As a result, pharmacist providers addressed significantly more total problems (anticoagulation problems plus nonanticoagulation problems) without an increase in visit length. CONCLUSION: Periodically evaluating workflow efficiency and making changes, if indicated, is important. In this study, we identified areas for improvement in anticoagulation clinic efficiency and implemented specifically targeted interventions. The resolution of workflow issues created a more streamlined patient visit. This provided more time for pharmacists to address important health issues specific to our indigent patient population. Other clinicians can apply this model to their practice setting to evaluate and make improvements to workflow efficiency as a means of providing highquality patient care.


Assuntos
Instituições de Assistência Ambulatorial/organização & administração , Anticoagulantes/uso terapêutico , Eficiência Organizacional , Farmacêuticos/organização & administração , Análise e Desempenho de Tarefas , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Modelos Organizacionais , Visita a Consultório Médico , Médicos/organização & administração , Pobreza , Papel Profissional , Tennessee , Estudos de Tempo e Movimento , População Urbana , Recursos Humanos
20.
Pharm Pract (Granada) ; 17(4): 1709, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31897264

RESUMO

BACKGROUND: Direct oral anticoagulants (DOACs) are preferred for stroke prevention in atrial fibrillation (AF). However, off-label doses have been associated with increased risk of adverse events. OBJECTIVE: The objective of this study was to compare the frequency and outcomes of labeled versus off-label DOAC dosing in patients with AF. METHODS: This retrospective cohort study included adults diagnosed with nonvalvular AF (NVAF), discharged from University of Utah Health on DOAC therapy between 7/1/2017 and 9/30/2017. The primary outcome was off-label DOAC dosing frequency, defined as dosing inconsistent with manufacturer labeling. Secondary outcomes included variables associated with off-label dosing and a composite of adverse events (major bleeding, thromboembolism, and all-cause mortality) in the 90 days following the index hospital discharge. RESULTS: Of 249 included patients, 16.1% were discharged with off-label dosing. Factors associated with off-label dosing included advanced age, lower body mass index, decreased renal function, use of rivaroxaban, and hepatic impairment. The majority of off-label patients (70%) received lower-than-recommended DOAC dosing. Prescriber rationale for off-label prescribing was documented in 25% of patients and included anti-Xa guided dosing, high risk for bleeding or thromboembolism, and prior history of on-therapy adverse events. The rate of adverse events between labeled and off-label DOAC doses was not statistically different (10.0% vs. 6.7%, p=0.299), although this is likely due to small sample size. CONCLUSIONS: Off-label DOAC prescribing for stroke prevention in NVAF at University of Utah Health was consistent or lower than previously published studies. Off-label dosing most often involved under-dosing of rivaroxaban. Future research should investigate the role of provider rationale and insight in optimizing DOAC therapy outcomes.

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