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Biomedical subjects

Edith A Nutescu

Publications and source records attributed to Edith A Nutescu.

At least 19 recordsLinked to original sources
PubMed2007

Basic terminology in obtaining reimbursement for pharmacists' cognitive services.

PURPOSE: A basic overview and definitions of commonly used billing and reimbursement terminology that pharmacists will need to know to obtain reimbursement for cognitive services are provided. SUMMARY: Currently, the profession of pharmacy has been gathering momentum in its efforts to seek and obtain reimbursement for cognitive services. However, there have been major barriers in seeking reimbursement, including the lack of understanding by third-party payers of the pharmacist's role in patient care and the pharmacist's in-depth knowledge of pharmacotherapy, the lack of appropriate billing codes for pharmacists' services, and the lack of detailed knowledge and understanding by pharmacy practitioners of nondistributive reimbursement mechanisms, processes, and terminology. The types of services provided are usually described by the American Medical Association's Current Procedural Terminology (CPT) codes for the face-to-face provision of patient care services by a pharmacist. As of January 1, 2006, pharmacists have been able to indicate the appropriate diagnosis code from the International Classification of Diseases, 9th Revision (ICD-9) (ICD-10 will replace the ICD-9 on October 1, 2007), and CPT code when billing under a major medical plan that recognizes the pharmacist as a patient care service provider. Understanding the billing and reimbursement terminology will aid pharmacist communication with third-party payers, Medicare, and Medicaid. A glossary of the most commonly encountered terms in billing and reimbursement procedures for cognitive services is provided. Also included are lists of Web-based reimbursement resources and references on reimbursement for cognitive services by the pharmacist. CONCLUSION: An understanding of terminology is important in receiving reimbursement for cognitive services.

Drug Therapy↗
PubMed2006

Choosing the appropriate antithrombotic agent for the prevention and treatment of VTE: a case-based approach.

OBJECTIVE: To review the risk of venous thromboembolism (VTE) in various patient populations and evaluate the agents available for the prevention and treatment of VTE using a case-based approach. DATA SOURCES: A MEDLINE search (1995-July 2006) was conducted to identify relevant literature. Additional references were reviewed from selected articles. STUDY SELECTION AND DATA EXTRACTION: Articles related to the prevention of VTE in orthopedic surgery, general surgery, and medically ill patients, as well as the treatment of VTE, were reviewed. DATA SYNTHESIS: Pharmacologic options for the prevention and treatment of VTE include warfarin, unfractionated heparin (UFH), low-molecular-weight heparins (LMWH), and fondaparinux. Current guidelines support the use of warfarin, LMWH, or fondaparinux for VTE prophylaxis following lower limb major orthopedic surgery. For VTE prophylaxis in hospitalized medical patients or patients undergoing general surgery, use of UFH and LMWH is supported; however, recent data on fondaparinux suggest that it is also effective in these patient populations. The use of UFH or LMWH (both in conjunction with warfarin) for treatment of acute deep venous thrombosis or nonmassive pulmonary embolism is recommended. Recent data suggest that fondaparinux (in conjunction with warfarin) is also effective for the treatment of VTE. A variety of pharmacokinetic, pharmacodynamic, and pharmacoeconomic factors differentiate each agent for the various indications. CONCLUSIONS: Currently, a "one-size-fits-all" anticoagulant is not available for treatment of VTE. A variety of patient factors, including type of surgery, medical indication, thrombotic risk factors, bleeding risk, history of heparin-induced thrombocytopenia, and a variety of comorbid conditions can affect the safety, efficacy, and selection of appropriate VTE therapy.

Aged↗
PubMed2006

Sex difference in the antiplatelet effect of aspirin in patients with stroke.

BACKGROUND: There is substantial interpatient variability in response to aspirin after an ischemic stroke or transient ischemic attack (TIA), as assessed by ex vivo effects of aspirin on platelet aggregation. The factors contributing to this variability are not well defined. OBJECTIVE: To determine whether demographic, social, or clinical characteristics are associated with ex vivo response to aspirin in patients with a history of stroke or TIA. METHODS: Eighty-one patients who were taking aspirin for secondary stroke prevention and underwent ex vivo platelet aggregation studies were identified. The medical records of eligible patients were reviewed by clinicians who specialize in the management of stroke patients. Characteristics were compared between 45 patients who had a complete response to aspirin and 36 patients who exhibited an incomplete (partial) response to aspirin based on the results of platelet aggregation testing. RESULTS: The median (range) aspirin dose was similar in complete (325; 81-1950 mg/day) and partial (325; 81-1300 mg/day) responders. There was no association between aspirin response and age, race, body mass index, medical history, smoking status, or use of statin or hormone replacement therapy. However, sex was significantly associated with response to aspirin, with more women in the partial versus complete responder group (75% vs 49%; p = 0.02). CONCLUSIONS: Our data suggest that aspirin may be less effective at inhibiting platelet aggregation in women compared with men who have a history of ischemic stroke or TIA.

Adult↗
PubMed2006

New anticoagulant agents: direct thrombin inhibitors.

Decades of research have been devoted to developing effective, safe, and convenient anticoagulant agents. In recent years, much emphasis has been placed on the development of direct thrombin inhibitors (DTIs) that offer benefits over agents like heparin and warfarin including the inhibition of both circulating and clot-bound thrombin; a more predictable anticoagulant response, because they do not bind to plasma proteins and are not neutralized by platelet factor 4; lack of required cofactors, such as antithrombin or heparin cofactor II; inhibiting thrombin-induced platelet aggregation; and absence of induction of immune-mediated thrombocytopenia. Various injectable DTIs are currently available and used for many indications. In addition, research is now focusing on oral DTIs that seem promising and offer various advantages, such as oral administration, predictable pharmacokinetics and pharmacodynamics, a broad therapeutic window, no routine monitoring, no significant drug interactions, and fixed-dose administration.

Administration, Oral↗
PubMed2006

Different contributions of polymorphisms in VKORC1 and CYP2C9 to intra- and inter-population differences in maintenance dose of warfarin in Japanese, Caucasians and African-Americans.

OBJECTIVE: To investigate pharmacokinetic and pharmacodynamic factors associated with population differences in warfarin doses needed to achieve anticoagulation, in particular the possible involvement of genetic variability in vitamin K epoxide reductase (VKOR) and CYP2C9. METHODS: Warfarin maintenance dose, unbound plasma S-warfarin concentration [Cu(S)] and INR were determined in 157 Caucasians, 172 Japanese, and 36 African-Americans stably anticoagulated patients. In a subset (n = 166), fully carboxylated plasma normal prothrombin levels (NPT) were also measured. Genotyping for seven CYP2C9 (CYP2C9*1 through 6 and *11) and seven VKORC1 variants were performed in 115 Caucasians and 64 Japanese patients and 66 healthy African-Americans. Multivariate analysis was performed to identify covariates associated with warfarin requirement. RESULTS: The relationship between NPT and Cu(S) indicated Japanese are more susceptible to inhibition of NPT production by S-warfarin than the other two populations. VKORC1 1173 C > T had a greater frequency in Japanese (89.1%) than Caucasians (42.2%) and African-Americans (8.6%). CYP2C9 variants with reduced metabolizing ability were less frequent in Japanese compared to the other two populations. The median warfarin dose was significantly higher in Caucasians than Japanese patients (5.5 versus 3.5 mg/day), however, when matched for CYP2C9*1 homozygosity, no difference in dose was observed between VKORC1 genotype-matched groups. Furthermore, VKORC1 1173C > T and CYP2C9 (*2/*3/*11) genotypes, age and weight were identified as independent covariates contributing to interpatient variability in warfarin dosage. CONCLUSIONS: Both VKORC1 and CYP2C9 polymorphisms contribute to inter-population difference in warfarin doses among the three populations, but their contribution to intra-population variability may differ within each population.

Aryl Hydrocarbon Hydroxylases↗
PubMed2006

Outcomes of oral anticoagulant therapy managed by telephone vs in-office visits in an anticoagulation clinic setting.

BACKGROUND: Anticoagulation management by a dedicated anticoagulation clinic improves patient outcomes compared to routine medical care. Telephone-based anticoagulation management has been described but has not been compared to management with traditional office-based visits. The objective of this study was to compare warfarin-related monitoring outcomes, clinical end points, and the use of health-care resources as a result of warfarin-related complications in anticoagulation clinic patients whose management was conducted by telephone or in-office-based visits. SETTING: Two university-affiliated anticoagulation clinics in Seattle, WA, and Chicago, IL. METHODS: A retrospective, observational cohort design was used to investigate anticoagulation clinic patients who were managed by telephone encounters compared to those managed during face-to-face in-office encounters. RESULTS: A total of 234 patients were evaluated; 117 patients managed by telephone were compared to 117 patients managed in office-based clinic visits. Monitoring outcomes (ie, time in therapeutic range and clinic visits per patient-year) were similar between groups. Differences in major bleeding (5.67% vs 5.62% per patient-year, respectively) and thromboembolic events (1.42% vs 2.81% per patient-year, respectively) between telephone-managed and face-to-face-managed patients did not reach statistical significance. The same was true for differences in the frequency of emergency department visits and hospital admissions to manage complications of warfarin therapy. CONCLUSIONS: Telephone-based management of oral anticoagulation through a pharmacist-staffed anticoagulation clinic yielded clinical outcomes that were at least as favorable as those associated with traditional office-based visits. Telephone follow-up can be successfully used to manage warfarin therapy in patients who are unable to present in person to an anticoagulation clinic.

Administration, Oral↗
PubMed2006

Warfarin and its interactions with foods, herbs and other dietary supplements.

Despite its complex pharmacokinetic and pharmacodynamic profile, warfarin is still one of the most widely used oral anticoagulant agents. Attaining optimal anticoagulation with this agent is clinically challenging in view of its many food and drug interactions. Inappropriate anticoagulation control can expose patients to an increased risk of bleeding or thromboembolic complications, due to over and underanticoagulation, respectively. Fluctuations in dietary vitamin K intake can have a significant effect on the degree of anticoagulation in patients treated with warfarin. In addition, the explosion in use of various dietary supplements and herbal products can lead to undesired outcomes on anticoagulant levels. The aim of this review is to discuss the scope and the potential clinical impact of the most commonly reported food, dietary supplement and herbal interactions with warfarin therapy. Practical steps for patients and providers to minimise these interactions are highlighted.

Administration, Oral↗
PubMed2006

Drug evaluation: the directly activated Factor Xa inhibitor otamixaban.

Otamixaban, under development by sanofi-aventis, is a directly activated Factor X (FXa) inhibitor that is currently in phase IIb clinical trials for acute coronary syndrome and myocardial infarction. Preclinical studies with otamixaban demonstrated high selectivity of the compound for FXa. Otamixaban effectively inhibited thrombin generation without interfering with existing thrombin activity. Intravenously administered otamixaban was well tolerated in both male and female patients, independent of age. Otamixaban exhibited a well-described dose-exposure relationship, a low inter-patient variability in plasma exposure, and was both rapidly distributed in the plasma and quickly eliminated. The rapid decrease in otamixaban plasma concentrations following the termination of an infusion is an advantage over other FXa inhibitors that have longer half-lives. Otamixaban exhibited an improved pharmacodynamic profile over conventional anticoagulant therapies such as heparin. During clinical trials with otamixaban, no major drug interactions were observed with agents that were likely to be used in combination therapy. Otamixaban is a promising agent that merits further consideration for clinical trials in patients with coronary thrombosis.

Animals↗
PubMed2006

Easing the economic burden of acute coronary syndromes: cost-effectiveness of emerging therapies.

Although only part of the entire treatment regimen, antithrombotic therapy represents a large portion of the total costs associated with acute coronary syndromes (ACS) treatment. Unfractionated heparin (UFH), the mainstay of antithrombotic therapy, carries the risk of bleeding and associated interventions, and must be closely monitored. UFH therapy also has an increased risk of heparin-induced thrombocytopenia (HIT) and osteoporosis. These drawbacks prompted the development of newer antithrombotic agents, particularly low molecular weight heparins (LMWH) and factor Xa inhibitors. LMWH have several clinical advantages over UFH and has been demonstrated to be more effective than UFH in ACS. Because UFH is inexpensive, newer therapies need to demonstrate economic attractiveness over UFH. In addition to acquisition costs, it is important to consider the cost of all key components throughout the continuum of care. Health economic analyses show that the clinical advantages of the LMWH enoxaparin are also likely to result in net cost-saving benefits, due to reductions in diagnostic catheterization, percutaneous transluminal coronary angioplasty, and intensive care unit length of stay. Fondaparinux, an indirect inhibitor of factor Xa, does not require routine monitoring or multiple daily dosing, and is unlikely to interact with HIT antibodies. Large randomized clinical trials have shown that fondaparinux is at least as safe and efficacious as enoxaparin or UFH in the prevention of venous thromboembolism (VTE) and treatment of deep vein thrombosis or pulmonary embolism. Data from 2 recently published trials are similarly indicating noninferiority of fondaparinux in ACS patients. Health economic analysis of fondaparinux treatment is currently limited to VTE scenarios but point to a cost benefit associated with fondaparinux compared with enoxaparin.

Acute Disease↗
PubMed2005

Anticoagulation monitoring part 2: Unfractionated heparin and low-molecular-weight heparin.

OBJECTIVE: To review the availability, mechanisms, limitations, and clinical application of point-of-care (POC) devices used in monitoring anticoagulation with unfractionated heparin (UFH) and low-molecular-weight heparins (LMWHs). DATA SOURCES: Articles were identified through a MEDLINE search (1966-August 2004), device manufacturer Web sites, additional references listed in articles and Web sites, and abstracts from scientific meetings. STUDY SELECTION AND DATA EXTRACTION: English-language literature from clinical trials was reviewed to evaluate the accuracy, reliability, and clinical application of POC monitoring devices. DATA SYNTHESIS: The activated partial thromboplastin time (aPTT) and activated clotting time (ACT) are common tests for monitoring anticoagulation with UFH. Multiple devices are available for POC aPTT, ACT, and heparin concentration testing. The aPTT therapeutic range for UFH will vary depending upon the reagent and instrument employed. Although recommended by the American College of Chest Physicians Seventh Conference on Antithrombotic and Thrombolytic Therapy, establishing a heparin concentration-derived therapeutic range for UFH is rarely performed. Additional research evaluating anti-factor Xa monitoring of LMWHs using POC testing is necessary. CONCLUSIONS: Multiple POC devices are available to monitor anticoagulation with UFH. For each test, there is some variability in results between devices and between reagents used in the same device. Despite these limitations, POC anticoagulation monitoring of UFH using aPTT and, more often, ACT is common in clinical practice, particularly when evaluating anticoagulation associated with interventional cardiology procedures and cardiopulmonary bypass surgery.

Anticoagulants↗
PubMed2005

Anticoagulation monitoring part 1: warfarin and parenteral direct thrombin inhibitors.

OBJECTIVE: To review the availability, mechanisms, limitations, and clinical application of point-of-care (POC) devices used in the management of warfarin and parenteral direct thrombin inhibitors. DATA SOURCES: Scientific articles were identified through a MEDLINE search (1966-August 2004), manufacturer Web sites, additional references listed in articles and Web sites, and abstracts from scientific meetings. STUDY SELECTION AND DATA EXTRACTION: English-language literature from clinical trials was reviewed to evaluate the accuracy, reliability, and clinical application of POC monitoring devices. DATA SYNTHESIS: The prothrombin time expressed as the international normalized ratio (PT-INR) is a well-established test for monitoring warfarin anticoagulation. Multiple devices are available for POC testing. Because there is no universally accepted standard, the performance of each device is typically tested against a standard test performed in a reference laboratory. Performance of currently available devices, as measured by correlations to a standard reference laboratory PT-INR, may be considered very good and acceptable for use in patient care. Utilization of patient self-testing and patient self-monitoring of warfarin anticoagulation using POC devices is increasing. Parenteral direct thrombin inhibitors are typically monitored using a standard laboratory activated partial thromboplastin time. Some research has shown that POC monitoring of direct thrombin inhibitors using the ecarin clotting time is helpful for patients undergoing cardiopulmonary bypass surgery, although that test is not readily available. CONCLUSIONS: POC testing for anticoagulation therapy has been available for >20 years. Multiple POC devices are available to monitor warfarin. There is some variability in results between devices and between reagents used in the same device. Despite these limitations, POC monitoring of warfarin via the PT-INR is an integral part of clinical practice. Additional research evaluating POC monitoring of direct thrombin inhibitors is necessary.

Anticoagulants↗
PubMed2005

Concomitant drug, dietary, and lifestyle issues in patients with atrial fibrillation receiving anticoagulation therapy for stroke prophylaxis.

Atrial fibrillation is a common cardiac arrhythmia and the leading risk factor for stroke. In those at moderate to high risk of stroke, oral anticoagulation therapy with warfarin (a vitamin K antagonist) significantly reduces not only the frequency of such events but also their severity and the associated risk of death. However, achieving optimal anticoagulation with this agent is clinically challenging in view of its complex pharmacokinetic and pharmacodynamic profile. In this regard, concomitant drug therapy (both prescription and over-the-counter medications, including herbal products, vitamins, and various nutritional supplements), along with alcohol intake, dietary factors, and changes in lifestyle, can significantly affect anticoagulation control and thereby expose patients to the risk of bleeding or thromboembolic complications (due to over- and underanticoagulation, respectively). Therefore, it is recommended that intensified monitoring of anticoagulation be performed at initiation and discontinuation of concomitant drug therapy, and in the case of significant dietary and lifestyle changes. Moreover, many patients receive inadequate education and are unaware of such risks and their implications, highlighting the need for better awareness and education on this important aspect of anticoagulation therapy.

Journal Article↗
PubMed2005

Factors that influence prescribing within a therapeutic drug class.

RATIONALE, AIMS AND OBJECTIVES: The decision to prescribe one drug instead of another within the same therapeutic class may be influenced by a variety of drug-related, direct, or indirect factors; but little is known about which considerations are most important in such choices. The low-molecular-weight heparins (LMWHs) represent a class of drugs that are commonly used and for which therapeutic equivalence has been debated in the literature. The purpose of this study was to identify and compare factors perceived by doctors and clinical pharmacists to be influential in prescribing decisions among LMWHs. METHODS: Doctors and clinical pharmacists were interviewed to elicit information and to rank factors that influence the prescribing and use of LMWHs in community hospitals in the United States. For each factor, the mean and median of the rating were determined along with the frequency distribution across ratings. The non-parametric Mann-Whitney U-test was used to examine differences between doctors and clinical pharmacists. RESULTS: Both groups considered efficacy, formulary status, and policies restricting drug use to be highly influential in the decision to use one LMWH instead of another. Compared to clinical pharmacists, doctors rated personal experience as more influential, whereas they rated drug cost and prescribing guidelines lower. CONCLUSIONS: These findings suggest that doctors and clinical pharmacists differentiate between LMWHs based on differences between products and because of hospital administrative programs (such as drug formularies). This information may be of value in designing programs to alter medication use.

Choice Behavior↗
PubMed2005

Barriers to patient self-testing of prothrombin time: national survey of anticoagulation practitioners.

Oral anticoagulation with warfarin requires routine monitoring of prothrombin time, expressed as the international normalized ratio (INR). Patient self-testing for INR is common in Europe but not in the United States. In order to determine the frequency of INR self-testing among patients whose anticoagulant therapy is managed in U.S. anticoagulation clinics, to describe the processes that support this self-testing, and to identify the barriers as experienced by anticoagulation clinic providers, a three-part survey was mailed to 538 anticoagulation specialists in the United States. The response rate was 43.7%. Policies and procedures of almost 60% of anticoagulation clinics prohibited INR self-testing for enrolled patients. In addition, less than 1% of patients being managed by U.S. anticoagulation clinics use self-testing to obtain INR results. Primary barriers were the cost of self-testing instruments (78.7% of respondents), cost of reagent cartridges (60.4%), and fear that self-testing might lead to unintended self-management (35.7%). Over 75% of respondents believed that some reimbursement for the cost of self-testing devices and supplies would increase the likelihood that anticoagulation clinics would recommend INR self-testing.

Ambulatory Care Facilities↗
PubMed2005

A pharmacologic overview of current and emerging anticoagulants.

For over 50 years, anticoagulant options for the treatment and prevention of thrombosis have been limited mainly to traditional agents such as unfractionated heparin and oral vitamin K antagonists such as warfarin. These traditional agents are fraught with limitations that complicate their clinical use. A variety of novel anticoagulants with improved pharmacologic and clinical profiles have recently been introduced or are in development, offering benefits over traditional therapies. Specifically, progress has been made in the development of low-molecular-weight heparins, factor Xa inhibitors, and direct thrombin inhibitors. Because of their convenience and ease of use, some of these novel compounds are competing with the traditional anticoagulants and are needed additions to the antithrombotic arsenal.

Anticoagulants↗