Pharmacy Student Monitoring of Direct Oral Anticoagulants.

BACKGROUND: Best practice recommendations are lacking. Thus far, literature has described pharmacist-led DOAC monitoring. OBJECTIVE: The purpose of this study is to describe a DOAC monitoring program involving pharmacy students. METHODS: This was an observational analysis of a quality improvement initiative. A clinical pharmacist preceptor identified clinic patients taking DOACs by running a report using the electronic medical record. Pharmacy students conducted chart reviews, called pharmacies for 6-month refill histories, and interviewed and educated patients. Findings were communicated to the care team and interventions were performed as applicable with the preceptor. RESULTS: Of 90 patients included, the mean age was 63 years, 54% were female, and 65.6% were black or African American. Rivaroxaban and apixaban were used most commonly. Sixty-two percent of DOACs were prescribed for atrial fibrillation/flutter, while 32.2% for venous thromboembolism. The mean MPR was 77.1%, with 27.7% of patients having an MPR ≤60%. Of the 136 student-led interventions, 25.2% involved medication access, 24.4% adherence education, 20.7% processing refills, 14.8% laboratory monitoring recommendations, 8.9% switching or recommending switching to another anticoagulant, and 4.4% stopping a nonsteroidal anti-inflammatory drug or aspirin. CONCLUSION: Pharmacy students can help to ensure medication safety and effective use of DOACs.

Overview of a pharmacist anticoagulation certificate program.

BACKGROUND AND PURPOSE: To describe the design of an ongoing anticoagulation certificate program and annual renewal update for pharmacists. EDUCATIONAL ACTIVITY AND SETTING: Components of the anticoagulation certificate program include home study, pre- and posttest, live sessions, case discussions with evaluation and presentation, an implementation plan, and survey information (program evaluation and use in practice). Clinical reasoning skills were assessed through case work-up and evaluation prior to live presentation. An annual renewal program requires pharmacists to complete home study and case evaluations. FINDINGS: A total of 361 pharmacists completed the anticoagulation certificate program between 2002 and 2015. Most (62%) practiced in ambulatory care and 38% in inpatient care settings (8% in both). In the past four years, 71% were working in or starting anticoagulation clinics in ambulatory and inpatient settings. In their evaluations of the program, an average of 90% of participants agreed or strongly agreed the lecture material was relevant and objectives were met. SUMMARY: Pharmacists are able to apply knowledge and skills in management of anticoagulation. This structured practice-based continuing education program was intended to enhance pharmacy practice and has achieved that goal. The certificate program in anticoagulation was relevant to pharmacists who attended the program.

Pharmacological and clinical differences between low-molecular-weight heparins: implications for prescribing practice and therapeutic interchange.

Thanks to their predictable pharmacokinetics and ease of use, low-molecular-weight heparins (LMWHs) have established uses in the prevention and treatment of thrombotic diseases and as a replacement for unfractionated heparin (UFH). Although LMWHs as a class have similar antithrombotic effects, they comprise a diverse group of agents with distinct biochemical and pharmacological profiles. In light of the ongoing pressure to contain pharmacy costs, the diversity among the LMWHs and their benefits over UFH are important considerations in clinical practice.

Translating evidence-based guidelines into performance measures for venous thromboembolism and acute coronary syndrome.

PURPOSE: The evolution of evidence-based quality measures in healthcare, specific performance measures that have been developed by various groups for the prevention and treatment of venous thromboembolism (VTE), the objectives and potential benefits of a national quality improvement initiative designed to improve the care of high-risk patients with acute coronary syndrome (ACS), the reporting of performance data to the public to guide consumer choice, and the recent growth in pay-for-performance programs are described. SUMMARY: Efforts to develop evidence-based quality measures began in the mid to late 1990s and have led to the creation of various safe practices, indicators, standards, and quality measures and initiatives. The prevention and treatment of VTE and the management of ACS have been the focus of some of these initiatives. Reporting of data for two surgery-related VTE process measures to the Centers for Medicare and Medicaid Services began January 1, 2007, and two additional measures may be used in the future. The Joint Commission and National Quality Forum have proposed eight core measures for the prevention and care of VTE that could eventually be used in hospital accreditation decisions. A national quality improvement initiative, CRUSADE, provides participating hospitals with feedback about performance in caring for high-risk patients with non-ST-segment elevation ACS. Reporting of performance data to the public facilitates healthcare decision making by consumers. The use of pay-for-performance programs that provide incentives and rewards for meeting quality goals has grown rapidly in recent years. CONCLUSION: The various initiatives under way using evidence-based performance measures to evaluate quality of care for VTE and ACS have the potential to improve patient outcomes.

The clinical challenge of bridging anticoagulation with low-molecular-weight heparin in patients with mechanical prosthetic heart valves: an evidence-based comparative review focusing on anticoagulation options in pregnant and nonpregnant patients.

BACKGROUND: Recent labeling changes for enoxaparin, a low-molecular-weight heparin (LMWH), have prompted a reexamination of its role in patients with mechanical prosthetic heart valves (MPHVs). Healthcare providers are faced with the challenge of weighing favorable trial results with LMWHs and balancing their clinical experiences with these agents as a bridge to oral anticoagulation in patients with prosthetic heart valves. This review will provide evidence-based guidance on issues surrounding the use of LMWH that require bridging anticoagulant therapy in the setting of cardiac surgery (MPHVs), cardiovascular disease, and during temporary interruption of oral anticoagulants in patients requiring periprocedural bridging therapy. METHODS: A Medline search was conducted of articles appearing in the medical literature published in English between 1992 and 2004. Approximately 120 clinical trials, case reports, editorials, and/or guideline statements were retrieved and reviewed by the authors as to their relevance for the subject under review, ie, bridging anticoagulation in patients with MPHVs. Approximately 80 of these publications were selected for detailed review, analysis, and discussion in a consensus format. RESULTS: This review addresses the controversy surrounding the divergence between the new labeling recommending against the use of LMWH in patients with MPHVs as well as the ongoing clinical experience and evidence in the medical literature. The clinical challenges in the use of LMWH and unfractioned heparin (UFH) in pregnant patients with MPHVs are presented; the evidence for LMWHs in nonpregnant patients with prosthetic valves is described; and the role of LMWH for bridging immediately after mechanical valve surgery and its periprocedural and perioperative uses are discussed. Based on an expert consensus panel, clinical algorithms for the use of LMWH in pregnant and nonpregnant patients with MPHVs are also illustrated. CONCLUSIONS: Based on the available data sets, clinical trials, reviews, and registry data, the evidence suggests that LMWH compared to UFH may be a safe and effective agent in patients with MPHVs. Future large-scale, randomized trials are warranted.

The clinical effectiveness initiative: a pharmacy analysis to improve outcomes and costs of drug therapy.

Selecting the most appropriate therapeutic regimens is one of the most complex and critical aspects of pharmacy management today, but the process is fraught with biases. Clinical pharmacists must offer balanced and unbiased opinions concerning therapies that provide the best cost-benefit ratio for their organizations. This article describes the use of existing administrative databases to develop robust clinical resource utilization data, identify internal bias and barriers to efficient drug therapy selection, and devise medical management strategies that provide desirable clinical outcomes through cost-consequence analysis.

Challenges in variation and responsiveness of unfractionated heparin.

Unfractionated heparin (UFH) has been in clinical use for more than half a century. Despite its undoubted contribution to the treatment and prevention of thrombosis, heparin is significantly limited by its variable biochemical composition and unpredictable pharmacokinetics. The situation is compounded by the fact that methods for monitoring heparin do not necessarily reflect its therapeutic effect. The activated partial thromboplastin time (aPTT) is a method for monitoring heparin therapy that is simple, cheap, and readily available. However, it is also poorly standardized and is affected by numerous factors-both analytic and preanalytic-that are unrelated to the heparin effect. Establishing an appropriate therapeutic range for the aPTT is challenging for smaller clinical laboratories, and the antifactor Xa method of measuring heparin levels is not widely available. The College of American Pathologists published consensus guidelines in an effort to improve the laboratory monitoring of UFH therapy. However, it seems unlikely that the laboratory problems associated with monitoring UFH will be resolved. Unfractionated heparin is highly antigenic and carries a significant risk of heparin-induced thrombocytopenia (HIT). Even in the absence of thrombocytopenia or thrombosis, the presence of heparin-associated antibodies may predict adverse clinical outcomes and strengthen the rationale for the ultimate replacement of UFH. Fortunately, alternatives to UFH, such as low-molecular-weight heparins, direct thrombin inhibitors, and more specific factor Xa inhibitors, are becoming available for clinical use. The pharmacokinetics of these agents are more predictable and rely much less on laboratory monitoring. Nonheparin agents also eliminate the risk of HIT. The emergence of these newer anticoagulants makes the continued use of UFH increasingly difficult to justify.

Anticoagulant prophylaxis in medical patients: an objective assessment.

Venous thromboembolism (VTE) is a clinically silent and potentially fatal disease that manifests as deep vein thrombosis (DVT) and pulmonary embolism. Venous thromboembolism remains a serious public health challenge, with an ever-increasing odds ratio of occurrence given the aging population in the United States. This article reviews the epidemiology of VTE; risk factor identification and stratification as a means of advancing awareness, prevention, and detection of VTE; and prophylaxis options and their outcomes, particularly administration of unfractionated heparin (UFH) 5000 U subcutaneously every 12 versus 8 hours in the at-risk medical patient population. The important studies comparing outcomes of these different UFH dosing regimens compared with placebo and low-molecular-weight heparins also are discussed. Consensus recommendations shaping contemporary clinical practice guidelines in this setting are highlighted. A systemwide approach to treatment of all medical patients who are risk stratified and receiving appropriate pharmacologic prophylaxis is recommended.

Evaluation of a novel point-of-care enoxaparin monitor with central laboratory anti-Xa levels.

BACKGROUND: Measurement of enoxaparin's anticoagulant activity has been limited to specialized coagulation laboratories and has been impractical for areas needing rapid results, such as during coronary angioplasty. A new point-of-care device, Rapidpoint ENOX, was recently developed to measure clotting times with enoxaparin use. OBJECTIVES: To correlate ENOX times with anti-Xa levels among patients receiving enoxaparin. METHODS: A total of 166 patients receiving enoxaparin for the prevention of deep venous thrombosis or as treatment during acute coronary syndromes or angioplasty were prospectively studied. Citrated and non-citrated whole-blood (CWB and NCWB) samples were obtained at baseline and peak enoxaparin activity. ENOX times were measured with whole-blood, and the Stachrom anti-Xa assay was performed on the plasma from the remainder of the samples. The Pearson correlation coefficient was used to assess the relationship between these two assays. RESULTS: There was a strong linear correlation between the ENOX times and the anti-Xa activities for both CWB (r=0.89, p<0.001) and NCWB (r=0.82, p<0.001) when considering all 332 samples (baseline and peak). When baseline samples were excluded, the correlation remained strong for CWB ENOX times and anti-Xa levels (r=0.84, p<0.001), but was only moderate for NCWB (r=0.73, p<0.001). A CWB ENOX time of /=200 s corresponded to anti-Xa levels >/=0.8 IU/ml in 96% (93/96) of patients. CONCLUSIONS: Rapidpoint ENOX times correlate strongly to anti-Xa activities measured by the Stachrom Heparin Assays for citrated whole-blood samples. This novel test can be used for rapid bedside measurements of enoxaparin anticoagulant activity.

"Bridging" therapy with low molecular weight heparin in pregnant patients and patients with mechanical prosthetic heart valves.

A substantial body of published, peer-reviewed, trial and cohort study-based evidence, institutional data sets and expert clinical experience/opinion supports the safe and effective use of enoxaparin for anticoagulation management of non-pregnant patients with prosthetic mechanical heart valves. A comparable body of data and trial results exists, also supported by a significant and authoritative base of expert opinion, for enoxaparin-based VTE prevention and treatment of at-risk pregnant patients who do not have mechanical heart valves. In pregnant women with prosthetic mechanical heart valves, no recommendations on the use of LMWHs can be made until the availability of more data (Lovenox Injection (package insert). Available at www.aventis-us.com/PIs/lovenox. Accessed July 30, 2003. Aventis Pharmaceuticals 2003).