The Cost of Pre-Analytical Errors in INR Testing at a Tertiary-Care Hospital Laboratory: Potential for Significant Cost Savings.

BACKGROUND: Preanalytical errors account for most laboratory errors. Although the frequencies of preanalytical errors are well characterized in the literature, little is known regarding the costs of these errors to the laboratory. OBJECTIVE: To analyze costs associated with preanalytical errors associated with the international normalized ratio (INR) test. METHODS: We performed a retrospective analysis of INR requests associated with preanalytical error codes from January 2009 through September 2013. Preanalytical error types were those related to order entry (no specimen collected) and those unrelated to order entry (insufficient specimen quantity or specimen-integrity concerns). We calculated the cost of analysis of a specimen and the cost of investigating errors. RESULTS: During the study period, there were 557,411 INR requests, 13.1% of which were associated with a preanalytical error code. The total annual cost of INR testing was USD $379,222.50. Investigation and reporting of preanalytical errors not related to order entry represented 10.5% of our annual INR testing budget (USD $39,939.00). CONCLUSIONS: Minimizing preanalytical errors has the potential to result in significant cost savings.

Time-driven activity-based cost analysis for outpatient anticoagulation therapy: direct costs in a primary care setting with optimal performance.

OBJECTIVES: To determine how overall cost of anticoagulation therapy for warfarin compares with that of Novel Oral Anticoagulants (NOACs). Also, to demonstrate a scientific, comprehensive, and an analytical approach to estimate direct costs involved in monitoring and management of anticoagulation therapy for outpatients in an academic primary care clinic setting, post-initiation of therapy. METHODS: A population-based cross-sectional study was conducted in conjunction with observations of patient care processes between August 2014 and January 2015. The study was conducted in an academic primary care outpatient setting at Mayo Clinic's warfarin anticoagulation clinic, Rochester, MN. The anticoagulation clinic serves patients 18 years of age or older in Warfarin therapy management, for any indication, after referral from the patient's primary care provider. The study included anticoagulation clinic enrollment data on a population of 5,526 patients. Time-Driven Activity-Based Costing (TDABC) technique was applied. Detailed process flow maps which showed process steps for all the anticoagulation program components and care continuum phases were created. Staff roles associated with each of the process steps were identified and displayed on the maps. Process times and costs were captured and analyzed. The main outcome was direct cost of monitoring and management of anticoagulation therapy, post-initiation of therapy. RESULTS: The cost of warfarin management for patients who display unstable International Normalized Ratio (INR) is more than three times those who display stable INR over time. (Comparator to distinguish stability: Frequency of point-of-care visits needed by patients.) For complex anticoagulation patients, total cost of medication and monitoring for warfarin anticoagulation therapy is similar to that for NOACs. CONCLUSION: Despite warfarin being significantly less expensive to purchase than NOACs, overall warfarin management incurs higher costs due to laboratory monitoring and provider time than NOACs. NOAC treatment, therefore, may not be more expensive than warfarin therapy management for complex anticoagulation patients.

Health Care Resource Utilization and Costs Among Newly Diagnosed and Oral Anticoagulant-Naive Nonvalvular Atrial Fibrillation Patients Treated with Dabigatran or Warfarin in the United States.

BACKGROUND: Warfarin has a long history of use to reduce the risk of stroke in patients with atrial fibrillation (AF), but it requires frequent laboratory monitoring to maintain international normalized ratio levels in the therapeutic range. Dabigatran, a novel oral anticoagulant (OAC), has demonstrated efficacy in reducing the risk of stroke and systemic embolism and does not require laboratory monitoring. OBJECTIVE: To compare health care resource utilization (HCRU) and costs of OAC-naive patients newly diagnosed with nonvalvular atrial fibrillation (NVAF), using dabigatran or warfarin. METHODS: This retrospective observational study used data from medical and pharmacy claims extracted from the HealthCore Integrated Research Database representing commercial and Medicare Advantage members. Adults aged > 18 years with a medical diagnosis claim of NVAF were identified between October 1, 2010, and December 31, 2011. The date of first observed OAC prescription claim was the index date. Patients were followed for up to 12 months after the index date. Patients were assigned to the dabigatran or warfarin treatment groups based on their first OAC prescription fills. To reduce potential for selection bias, the cohorts were matched on baseline characteristics using propensity score matching. HCRU was measured and compared between groups on a per-patient-per-month (PPPM) basis for all-cause HCRU, as well as stroke, myocardial infarction, and bleed-specific HCRU. Pharmacy, medical, and total costs were also compared and adjusted to 2012 U.S. dollars. Generalized linear models were conducted to compare all-cause health care costs between cohorts. RESULTS: After propensity score matching, 1,648 patients were included in the analysis (824 each in the dabigatran and warfarin treatment groups). In the post-index period, patients in the dabigatran group had significantly fewer all-cause PPPM physician office visits (mean [SD] 1.29 [± 0.95] vs. 2.02 [± 1.53], P < 0.001) and outpatient visits (mean [SD] 2.17 [± 2.90] vs. 3.52 [± 3.32], P < 0.001) compared with those in the warfarin group. There were no between-group differences in outcomes for the number of stroke, myocardial infarction, or bleeding-related office visits. All-cause medical costs for the dabigatran cohort were lower than the warfarin cohort; however, the difference did not reach statistical significance ($2,696 [SD ± $6,699] vs. $2,893 [± $6,819], P = 0.179). All-cause pharmacy costs were higher in the dabigatran group versus the warfarin group ($455 [± $429] vs. $328 [± $517], P < 0.001). The dabigatran cohort also had significantly higher stroke-related ($32 [± $71] vs. $20 [± $55], P = 0.006) and nonstroke-related pharmacy costs ($423 [± $422] vs. $308 [± $515], P < 0.001). Despite higher pharmacy costs for the dabigatran cohort, both treatment groups had statistically similar all-cause total costs ($3,151 [± $6,744] vs. $3,221 [± $6,869], P = 0.701). CONCLUSIONS: This real-world study showed that among patients newly diagnosed with NVAF who were OAC naive, dabigatran use was associated with significantly less HCRU in terms of physician and outpatient visits but higher pharmaceutical costs in up to 12 months of follow-up. Similar to other real-world studies, this research supports the finding that higher pharmacy costs for dabigatran users was offset by lower medical costs, making total health care costs comparable between dabigatran and warfarin. DISCLOSURES: This work was supported by Boehringer Ingelheim Pharmaceuticals, which is the manufacturer of dabigatran, one of the products included in the analysis of this work. The authors were responsible for all content and editorial decisions. Jain and Tan are employed by HealthCore, a research consultancy which was funded by Boehringer Ingelheim Pharmaceuticals for work on this study. Fu was employed by HealthCore at the time of this study. Lim, Wang, Elder, and Sander are employees of Boehringer Ingelheim Pharmaceuticals. Study concept and design were contributed by Wang, Sander, and Tan, along with Fu and Jain. Fu, Tan, and Jain collected the data, and data interpretation was performed by Lim, Wang, and Sander, along with Jain, Tan, and Fu. The manuscript was written by Jain, Elder, Tan, and Wang, along with Lim and Fu, and revised by Jain, Wang, Elder, and Tan. Some of the results of this study were presented at Quality of Care and Outcomes Research in Cardiovascular Disease and Stroke (QCOR) 2014 Scientific Sessions on June 2-4, 2014, in Baltimore, Maryland.

Rivaroxaban vs. warfarin on extended deep venous thromboembolism treatment: A cost analysis.

Background Standard treatment for deep venous thromboembolism involves parenteral anticoagulation overlapping with a vitamin K antagonist, an approach that is effective but associated with limitations including the need for frequent coagulation monitoring. The direct oral anticoagulant rivaroxaban is similarly effective to standard therapy as a single-drug treatment for venous thromboembolism and does not require routine coagulation monitoring. The aim of this analysis was to project the long-term costs and outcomes for rivaroxaban compared to standard of care (tinzaparin/warfarin). Methods A total of 184 patients who were under anticoagulant therapy with warfarin or rivaroxaban for extended deep venous thromboembolism were retrospectively evaluated; 59 received rivaroxaban and 125 received warfarin therapy. Assessments were made on age, gender, place of residence, the duration of anticoagulation, mean international normalized ratio value, the effective rate of international normalized ratio (time in the therapeutic range), bleeding-related complication rate, duration of hospitalization due to complications, the number of annual outpatient department admission, cost for drug, cost for hospitalization, cost for outpatient department admission and international normalized ratio measurements. Results The annual outpatient cost is higher in warfarin group (147.09 ± 78 vs. 62.32 ± 19.79 USD p < 0.001). But annual drug cost is higher in rivaroxaban group (362.6 vs. 71.55 ± 31.01 USD p < 0.001). Overall cost of rivaroxaban group is higher than warfarin group (476.25 ± 36.78 vs. 364.82 ± 174.44 USD). Warfarin is not cost-effective when non-drug costs (342.5 ± 174.44 vs. 113.65 ± 36.77) and hospital costs (173.85 ± 122.73 vs. 64.9 ± 23.55 USD) were analyzed. Conclusion This analysis suggests that rivaroxaban has lower costs than warfarin in terms of outpatient department admission and hospital costs due to complications; however, warfarin was more economic when all cost parameters were considered. Time in the therapeutic range was found as 56% for warfarin that should be taken into account while analyzing costs and benefits.

The Cost Differential Between Warfarin Versus Aspirin Treatment After a Fontan Procedure.

BACKGROUND: The use of aspirin versus warfarin for treatment of patients after a Fontan procedure remains contentious. Current preference-based models of treatment across Australia and New Zealand show variation in care that is unlikely to reflect patient differences and/or clinical risk. METHODS: We combine data from the Australian and New Zealand Fontan Registry and a home INR (International Normalised Ratio) monitoring program (HINRMP) from the Royal Children's Hospital (RCH) Melbourne, to estimate the cost difference for Fontan recipients receiving aspirin versus warfarin for 2015. We adopt a societal perspective to costing which includes cost to the health system (e.g. medical consults, pathology tests) and costs to patients and carers (e.g. travel and time), but excludes costs of adverse events. Costs are presented in Australian 2015 dollars; any costs from previous years have been inflated using appropriate rates from the Australian Bureau of Statistics. RESULTS: We find that warfarin patients face additional costs of $825 per annum, with the majority ($584 or 71%) of those borne by the patient or family. If aspirin is as clinically as effective as warfarin, Fontan recipients could be enjoying far less costly, invasive and time-consuming treatment. While achieving such clinical consensus can be difficult, economics shows us that there are large costs associated with a failure to achieve it.

Point-of-care testing INR: an overview.

Oral anticoagulant therapies with the anti-vitamin K drugs (AVK), warfarin, acenocoumarol and phenprocoumon, are employed in primary and secondary anti-thrombotic prophylaxis in patients with venous thromboembolism, atrial fibrillation and cardiac mechanical valves. However, a monitoring test such as the International Normalized Ratio (INR) is required. The periodic monitoring of this therapy entails discomfort for the patients. Telemedicine and telecare can provide significant aid in the management of this therapy allowing patients to perform the test at home or anywhere else with a portable device, i.e. point-of-care testing (POCT), and to send the result to a thrombosis (TC) via web. Patients can receive dose adjustment sent back by the TC. The effectiveness of this type of management is equal or superior to the traditional AVK monitoring in terms of hemorrhagic and thrombotic events. Analysis of the costs with a horizon of 10 years reveals that both self-testing and self-management are cost-effective. The aim of this overview is to describe the pros and cons of the use of POCT as an alternative in the monitoring of AVK. In particular, description of the POCT, decentralization, quality of the therapy, safety and costs will be examined.

Cost-effectiveness of pharmacogenetic-guided dosing of warfarin in the United Kingdom and Sweden.

We aimed to assess the cost-effectiveness of pharmacogenetic-guided dosing of warfarin in patients with atrial fibrillation (AF) in the United Kingdom and Sweden. Data from EU-PACT, a randomized controlled trial in newly diagnosed AF patients, were used to model the incremental costs per quality-adjusted life-year (QALY) gained by pharmacogenetic-guided warfarin dosing versus standard treatment over a lifetime horizon. Incremental lifetime costs were £26 and 382 Swedish kronor (SEK) and incremental QALYs were 0.0039 and 0.0015 in the United Kingdom and Sweden, respectively. The corresponding incremental cost-effectiveness ratios (ICERs) were £6 702 and 253 848 SEK per QALY gained. The ICER was below the willingness-to-pay threshold of £20 000 per QALY gained in 93% of the simulations in the United Kingdom and below 500 000 SEK in 67% of the simulations in Sweden. Our data suggest that pharmacogenetic-guided dosing of warfarin is a cost-effective strategy to improve outcomes of patients with AF treated with warfarin in the United Kingdom and in Sweden.

At-Home Versus In-Clinic INR Monitoring: A Cost-Utility Analysis from The Home INR Study (THINRS).

BACKGROUND: Effective management of patients using warfarin is resource-intensive, requiring frequent in-clinic testing of the international normalized ratio (INR). Patient self-testing (PST) using portable at-home INR monitoring devices has emerged as a convenient alternative. As revealed by The Home INR Study (THINRS), event rates for PST were not significantly different from those for in-clinic high-quality anticoagulation management (HQACM), and a cumulative gain in quality of life was observed for patients undergoing PST. OBJECTIVE: To perform a cost-utility analysis of weekly PST versus monthly HQACM and to examine the sensitivity of these results to testing frequency. PATIENTS/INTERVENTIONS: In this study, 2922 patients taking warfarin for atrial fibrillation or mechanical heart valve, and who demonstrated PST competence, were randomized to either weekly PST (n = 1465) or monthly in-clinic testing (n = 1457). In a sub-study, 234 additional patients were randomized to PST once every 4 weeks (n = 116) or PST twice weekly (n = 118). The endpoints were quality of life (measured by the Health Utilities Index), health care utilization, and costs over 2 years of follow-up. RESULTS: PST and HQACM participants were similar with regard to gender, age, and CHADS2 score. The total cost per patient over 2 years of follow-up was $32,484 for HQACM and $33,460 for weekly PST, representing a difference of $976. The incremental cost per quality-adjusted life year gained with PST once weekly was $5566 (95 % CI, -$11,490 to $25,142). The incremental cost-effectiveness ratio (ICER) was sensitive to testing frequency: weekly PST dominated PST twice weekly and once every 4 weeks. Compared to HQACM, weekly PST was associated with statistically significant and clinically meaningful improvements in quality of life. The ICER for weekly PST versus HQACM was well within accepted standards for cost-effectiveness, and was preferred over more or less frequent PST. These results were robust to sensitivity analyses of key assumptions. CONCLUSION: Weekly PST is a cost-effective alternative to monthly HQACM and a preferred testing frequency compared to twice weekly or monthly PST.

Comparison of two approaches of INR-follow-up and determinants of INR-stability.

INTRODUCTION: Patients with atrial fibrillation (AF) and treated with coumarins need a close follow-up of the international normalized ratio (INR)-values. This can be done by the general practitioner (GP) or by a haematologist in an outpatient hospital clinic. OBJECTIVE: To compare both ways of follow-up and to investigate determinants of stable INR-patterns. METHODS: Cross-sectional single-centre study in patients with AF treated at the UZ Brussel, a university hospital in Brussels. Of the 113 patients included in the study, 71 had their INR followed-up by their GP and 42 similar patients were followed-up by a haematologist. Data of these 113 patients were further analysed to identify possible determinants for stable INR-values. RESULTS: The time in therapeutic range (TTR) did not significantly differ between both groups. However, patients in the GP-group had significantly more INR-values under 2.0 compared to patients from the haematologist-group (P = 0.044), whereas patients in the haematologist-group had significantly more INR-values above 3.0 compared to patients from the GP-group (P = 0.038). Reimbursement costs of both ways of follow-up were comparable, but the out-of-pocket costs for the patient were lower in the GP-group. The time since AF diagnosis was the only significant determinant predicting a higher TTR. CONCLUSION: Both approaches of follow-up seem to lead to the same TTR, yielding no reason to advocate one approach above the other. However, the patient costs were lower when followed-up by the GP.

Security and cost comparison of INR self-testing and conventional hospital INR testing in patients with mechanical heart valve replacement.

BACKGROUND: International normalized ratio (INR) self-testing can improve the management of anticoagulation therapy with warfarin for the patients following mechanical heart valve replacement. Several reviews and studies have demonstrated self-management as an option to improve patient's outcome considerably after mechanical heart valve replacement. We sought to analyze the security, economy and discuss the prospect of self-testing of anticoagulation therapy in patients following mechanical heart valve replacement in China, and evaluate the accuracy and stability of CoaguChek XS portable INR-testing device. METHODS: This was a prospective self-controlled clinical study conducted with 526 patients receiving oral warfarin anticoagulation therapy after mechanical heart valve replacement in the period of Mar.1, 2012 - Nov.1, 2012 in Cardiovascular Surgery Department of West China Hospital of Sichuan University. The same patient performed INR testing with CoaguChek XS portable coagulometer (group1) and central lab (group 2) in parallel. The follow-up time was 6 months. Meanwhile, a questionnaire was handed out to survey the expenses required for the re-examination visits to the hospital, time, and anticoagulation complications. RESULTS: No severe anticoagulation complications occurred in all the patients. No significant difference of the INR results were observed between group 1 and group 2, they showed significant relevance, r = 0.953(p < 0.05). Compared with the conventional method of INR testing in hospital, the portable coagulometer is convenient, quick and less traumatic. Self-testing of anticoagulation therapy reduced the cost and the time required for re-examination. CONCLUSIONS: Results of CoaguChek XS monitor are precise and have a good consistency and stability as compared with traditional laboratory testing. For the patients receiving anticoagulation therapy after mechanical heart valve replacement, the self-testing of anticoagulation therapy with portable coagulometer is a safe choice, and it has a promising future application in China.

Anticoagulation control and cost of monitoring of older patients on chronic warfarin therapy in three settings in North East England.

BACKGROUND: novel oral anticoagulants may be particularly cost-effective when INR control (TTR) with warfarin is poor or monitoring difficult. SETTING: the Newcastle upon Tyne monitoring service, set in hospital or general practice and a domiciliary-based service for housebound patients. OBJECTIVES: to examine anticoagulation stability and costs of monitoring. SUBJECTS: three hundred and twenty-six atrial fibrillation patients, 75 years and over, with target INR of two to three, accessing hospital (n = 100), general practice (n = 122) and domiciliary (n = 104) service. METHODS: age, co-morbidities, length of warfarin treatment, medications, INR values and dose changes from January to December 2011 were recorded, and costs analysed. RESULTS: home-monitored patients had taken warfarin for longer, mean 5.2 years, than hospital (3.7) or general practice (3.1) patients. Age and total number of drugs prescribed chronically were negatively related to TTR. INR measurements and dose changes were negatively associated with the duration of treatment, positively correlated with co-morbidities. The mean TTR was 78% in hospital, 71% in general practice and 68% in domiciliary monitored patients. INR was monitored more often in hospital and domiciliary groups than in general practice and more dose changes occurred in the domiciliary group than in others. Costs of warfarin and monitoring were £128 per patient per year for hospital, £126 for general practice and £222 for domiciliary patients. CONCLUSIONS: further exploration of the clinical effectiveness of novel anticoagulants in dependent patients is warranted to determine to what extent trial outcomes so far achieved in a fitter elderly population are influenced by the chronic co-morbidities of old age.

Impact of a new method of warfarin management on patient satisfaction, time, and cost.

STUDY OBJECTIVE: International normalized ratio self-testing with online remote monitoring and management (STORM2) is an alternative to anticoagulation clinic management, but the patient's perspective of this method has not been evaluated in the United States; thus we sought to evaluate the impact of STORM2 on patient satisfaction, time, and cost. DESIGN: Prospective pre- and postintervention study. SETTING: Freestanding clinical research center. PATIENTS: Forty-three patients treated with long-term warfarin therapy and monitored initially in the anticoagulation clinic setting and then with STORM2, referred from 11 medical practices. INTERVENTION: Patients were asked to complete a survey and the Duke Anticoagulation Satisfaction Scale (DASS) before (at baseline) and after at least 3 months of STORM2 (at follow-up). MEASUREMENTS AND MAIN RESULTS: Patient satisfaction and time were assessed by survey and the DASS. Costs were measured from the patient's perspective. Overall 90% of responders preferred STORM2 to traditional clinic management. The DASS questions indicated that patients were more satisfied with their anticoagulation treatment and more likely to recommend oral anticoagulation to a friend after experiencing STORM2. In addition, patients found STORM2 to be less complicated and more convenient than traditional clinic management. For each traditional monthly visit, patients drove 20 miles and expended a total of 1.8 hours; using 55¢/mile for mileage reimbursement and $15/hour for lost wages, the cost for each visit was $38. The total cost for four STORM2 visits per month was $10, for a net savings of $28 per patient per month. A total of 76% of patients were willing to pay additional money to eliminate a monthly clinic visit. CONCLUSION: STORM2 is more convenient, less complicated, preferred by patients, and saves patients time and money compared with clinic management.

The economic costs of routine INR monitoring in infants and children--examining point-of-care devices used within the home setting compared to traditional anticoagulation clinic monitoring.

INTRODUCTION: The use of point-of-care (POC) devices within the home for routine INR monitoring has demonstrated reliability, safety and effectiveness in the management of infants and children requiring long-term warfarin therapy. However, a comprehensive cost-analysis of using this method of management, compared to attending anticoagulation clinics has not been reported. The aim of this study was to compare the estimated societal costs of attending anticoagulation clinics for routine INR monitoring to using a POC test in the home. MATERIALS AND METHODS: This study used a comparative before-and-after design that included 60 infants and children managed via the Haematology department at a tertiary paediatric centre. Each participant was exposed to both modes of management at various times for a period of ≥3 months. A questionnaire, consisting of 25 questions was sent to families to complete and return. Data collected included: the frequency of monitoring, mode of travel to and from clinics, total time consumed, and primary carer's income level. RESULTS: The home monitoring cohort saved a total of 1 hour 19 minutes per INR test compared to attending anticoagulation clinics and had a cost saving to society of $66.83 (AUD) per INR test compared to traditional care; incorporating health sector costs, travel expenses and lost time. CONCLUSIONS: The traditional model of care requires a considerable investment of time per test from both child and carer. Home INR monitoring in infants and children provides greater societal economic benefits compared to traditional models.

Economic appraisal of dabigatran as first-line therapy for stroke prevention in atrial fibrillation.

BACKGROUND: Dabigatran is an oral anticoagulant direct thrombin inhibitor recently registered in South Africa (SA) to reduce the risk of stroke and systemic embolism in patients with atrial fibrillation (AF). Owing to the price disparity between warfarin (the current gold standard for treatment of patients with AF) and dabigatran, we conducted an economic appraisal of the use of dabigatran compared with warfarin from a payer perspective in the South African private healthcare setting. OBJECTIVES: To estimate the cost-effectiveness (CE) and budget impact of dabigatran compared with warfarin for the prevention of stroke in AF patients. Methods. A previously published Markov model was populated with SA cost and mortality data to estimate the CE and budget impact analysis of dabigatran over a lifetime horizon. The model population consisted of a cohort of patients of whom those aged younger than 80 years used dabigatran 150 mg twice daily and those older than 80 years 110 mg twice daily. Modelled outcomes included total cost, quality-adjusted life years (QALYs) and incremental CE ratio (ICER), with the effectiveness measured by QALYs gained. RESULTS: Dabigatran compared with warfarin as first-line treatment was estimated to have an ICER of R93 290 and an average incremental cost per beneficiary per month of R0.39 over a 5-year period. Conservative assumptions were made regarding the number of international normalised ratio monitoring tests for patients on warfarin, and the ICER is estimated to decrease by as much as 15.7% under less stringent assumptions. A robust sensitivity analysis was also performed. CONCLUSION: Dabigatran as first-line treatment compared with warfarin for the use of stroke prevention in patients with AF is deemed cost-effective when used in accordance with its registered indication in the SA private sector.

Cost-effectiveness of routine coagulation testing in the evaluation of chest pain in the ED.

INTRODUCTION: Approximately 5% of all US emergency department (ED) visits are for chest pain, and coagulation testing is frequently utilized as part of the ED evaluation. OBJECTIVE: The objective was to assess the cost-effectiveness of routine coagulation testing of patients with chest pain in the ED. METHODS: We conducted a retrospective chart review of patients evaluated for chest pain in a community ED between August 1, 2010, and October 31, 2010. Charts were reviewed to determine the number and results of coagulation studies ordered, the number of coagulation studies that were appropriately ordered, and the number of patients requiring a therapeutic intervention or change in clinical plan (withholding of antiplatelet/anticoagulant, delayed procedure, or treatment with fresh frozen plasma or vitamin K) based on an unexpected coagulopathy. We considered it appropriate to order coagulation studies on patients with cirrhosis, known/suspected coagulopathy, active bleeding, use of warfarin, or ST-elevation myocardial infarction. RESULTS: Of the 740 patients included, 406 (55%) had coagulation studies ordered. Of those 406, 327 (81%) patients with coagulation studies ordered had no indications for testing. One of the 327 patients (0.31%; 95% confidence interval, 0.05%-1.7%) tested without indication had a clinically significant coagulopathy (internationalized normalization ratio >1.5, partial thromboplastin time >50 seconds), but none (0%; 95% confidence interval, 0%-1.2%) of the patients with coagulation testing performed without indication required a therapeutic intervention or change in clinical plan. The cost of coagulation testing in these 327 patients was $16780. CONCLUSIONS: Coagulation testing on chest pain patients in the ED is not cost-effective and should not be routinely performed.

Potential benefits of warfarin monitoring by a clinical pharmacist in a long term care facility.

The primary objective of this study was to determine whether warfarin therapy monitoring by a pharmacist would benefit a long-term care facility, by maintaining patients within therapeutic INR range more consistently than the current practice of physician monitoring.Secondary objectives included whether adverse events resulting from non-therapeutic INR levels differed significantly between groups and whether pharmacist interventions resulted in decreased overall costs to the facility. A retrospective chart review was conducted on all patients treated with warfarin for a minimum of 14 days within a Long-Term Care (LTC) facility to compare Time within Therapeutic Range (TTR) between staff treated patients versus pharmacist treated patients. A total of 552 INRs were obtained for all patients during the study period: 499 (90.4%) under staff supervision and 53 (9.6%) under clinical pharmacist supervision. Of the 499 tests performed by the River Garden staff, 203 were within the desired range, compared with 29 of the 53 tests performed by the clinical pharmacist being in range. For the primary endpoint, a total of 1483 INRs were imputed, corresponding to the number of days between true INR measurements. INRs attributable to clinic staff management were within the therapeutic range 47.1% of the time, whereas INRs attributable to clinical pharmacist management were within the therapeutic range 58.7% of the time (P < 0.0001 for the comparison). Warfarin can be effectively monitored by a clinical pharmacist and routinely lead to appropriate INR levels in the nursing home setting, while potentially saving the facility healthcare dollars.

Bridging for an isolated subtherapeutic INR: an evaluation of clinical practice patterns, outcomes, and costs from an anticoagulation clinic.

No formal recommendations support bridging patients taking warfarin for a subtherapeutic international normalized ratio (INR). This study aimed to: (1) characterize practices at one anticoagulation clinic, (2) evaluate adverse events, and (3) compare cost of bridging versus withholding bridging for subtherapeutic INR. A retrospective chart review of 320 patients having 546 isolated subtherapeutic INR episodes included patients with an INR below their therapeutic range, preceded by two INRs within or above range. Bridged episodes required more frequent follow-up visits to achieve therapeutic INR (2.5 ± 1.0 vs. 2.2 ± 0.6; P = 0.097), but fewer days until the INR returned to therapeutic range (6.8 ± 5.0 vs. 18.9 ± 16.0; P < 0.0001). The strongest predictor of bridging was the magnitude the INR fell below the therapeutic range, where those with a severely-low INR were 30-fold more likely to be bridged (P < 0.0001), and moderately-low INR episodes were 6-fold more likely to be bridged compared with mildly-low INR (P < 0.0001). Those at high thromboembolic risk were more likely to be bridged than at low-risk (OR 3.39 [1.50-7.68]; P = 0.0034). Increasing age reduced the likelihood of being bridged (OR 0.97 [0.95-0.99]; P = 0.0118). Adverse events were infrequent in both the bridged and non-bridged; thrombosis (2.0 vs. 0.7%), major bleeding (2.0 vs. 1.3%), minor bleeding (4.1 vs. 3.1%) and bruising (18.4 vs. 3.6%). Incremental cost difference of bridging was significantly greater for total cost ($967.13) and its components, direct medical ($951.32), transportation ($2.73) and productivity cost ($13.08). It is unclear if bridging for an isolated subtherapeutic INR reduces thrombosis risk, but it is associated with higher costs.

Hospital budget implications of substituting dabigatran for warfarin in an anticoagulation service.

The aim of our study was to assess hospital budget implications of substituting dabigatran for warfarin in patients enrolled in a large anticoagulation service. The study population was identified using criteria from randomized controlled trials of dabigatran. We obtained labor costs ($483 per patient) from the hospital's anticoagulation service budget, laboratory costs of international normalized ratio (INR) tests ($267 per patient), and wholesale costs of warfarin 5 mg tablets ($31 per patient) and dabigatran 150 mg capsules ($2464 per patient). A total of 1774 (93.5%) of 1898 patients were eligible to substitute dabigatran for warfarin. The annual projected hospital expense for anticoagulation with dabigatran was $4,371,136, attributable to drug cost alone. The annual projected cost of warfarin management was $1,385,494. This was comprised of $856,842 for labor, $473,658 for INR testing, and $54,994 for the drug cost of warfarin. Substitution will result in increased expense due to drug cost.

Cost effectiveness of warfarin versus aspirin in patients older than 75 years with atrial fibrillation.

BACKGROUND AND PURPOSE: Oral anticoagulants are effective at reducing stroke compared with aspirin in atrial fibrillation patients older than 75 years. Although the benefits of reduced stroke risk outweigh the risks of bleeding, the cost effectiveness of warfarin in this patient population has not yet been established. METHODS: An economic evaluation was conducted alongside a randomized, controlled trial; 973 patients ≥75 years of age with atrial fibrillation were recruited from primary care and randomly assigned to either take warfarin or aspirin. Follow-up was for a mean of 2.7 years. Costs of thrombotic and hemorrhagic events, anticoagulation clinic visits, and primary care utilization were determined. Clinical benefits were expressed in terms of a primary event avoided: fatal/nonfatal disabling stroke, intracranial hemorrhage, or systemic embolism. A cost-utility analysis was performed using quality-adjusted life years as the benefit measure. RESULTS: Total costs over 4 years were lower in the warfarin group (difference, -£165; 95% CI, -£452-£89), primarily driven by the difference in primary event costs. The primary event rate over 4 years was lower in the warfarin group (0.049 versus 0.099), and the quality-adjusted life years score was higher (difference, 0.02; 95% CI, -0.07-0.11). With lower costs and a higher quality-adjusted life years score, warfarin is the dominant treatment, but the differences in both costs and effects are small. CONCLUSIONS: Warfarin is cost-effective compared with aspirin in atrial fibrillation patients age ≥75 years. These data support the anticoagulant therapy option in this high-risk patient population. However, the small differences in costs and effects indicate the importance of exploring patient preferences.