Anticoagulation clinic models of care

J Thromb Thrombolysis (2015) 39:410–425 DOI 10.1007/s11239-015-1193-7

Proceedings of the 13th National Conference on Anticoagulant Therapy

Ó Springer Science+Business Media New York 2015

Anticoagulation clinic models of care

Patient education/public awareness

A1 Transition from traditional anticoagulation clinic services to telephonic management: pilot study. Brian Cryder A2 INR management of an anti-phospholipid syndrome patient with point-of-care INR testing Aaron Dush A3 A pilot study: mobile health technology to enhance selfmanagement and anticoagulation adherence in older adults Jung-Ah Lee A4 Mobile technology-based system for smart anticoagulation management—preliminary observations Michael Miyamoto A5 Design and implementation of an ambulatory anticoagulation therapy program using a RN—pharmacy model Mary M Morin A6 Monitoring patient compliance with INR testing using and automated telephone reminder call process in the anticoagulation management service (AMS) Irina Seliverstov A7 Development of a pediatric-centered anticoagulation service at a tertiary care children’s hospital Karen Texter A8 Useful tools for developing a target-specific oral anticoagulant clinic Katherine E Werner

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Inpatient anticoagulation management B1

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Warfarin versus rivaroxaban in long term acute care patients with nonvalvular atrial fibrillation: a budget impact analysis Brian Bell Antifactor xa levels correlating to body mass index and creatinine clearance with enoxaparin thromboprophylaxis MaryAnne Cronin Decreasing rivaroxaban medication incidents by pharmacy staff education of the ‘‘LEARN’’ acronym at a community hospital Barbara Greenberg-Schwartz

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Investigation of adverse interactions between herbal drugs and natural blood clotting system Manish Adhyapak Assessing the need for continual warfarin education using a follow-up survey—a report from the Michigan anticoagulation quality improvement initiative Steven T. Heidt Evaluation of patient’s knowledge in use of oral anticoagulation therapy. Fernanda Silva

Patient self-testing D1 Patients’ preferred method of blood draw for INR measurement—the PREFER study Gary B Liska D2 Comparative efficacy of NOACs and warfarin with patent self-testing: bridging the gap Jeff P Wittekiend D3 Implementation costs of patient self-testing and point-of-care testing for warfarin populations in America: the payer perspective Jeff P Wittekiend D4 Improving staff productivity and INR control in patient home testing with a 2-way communication device Ted M. Crum D5 Patient characteristics and determinants of anticoagulation quality in 15,868 patients performing patient self-management of oral anticoagulation with vitamin K antagonists in real-life practice: a survey of the International Self-Monitoring Association of Oral Anticoagulated Patients Christian Schaefer

Quality improvements E1

Patient characteristics influencing warfarin time in therapeutic range in the Hematology Anticoagulation Clinic at The Johns

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Hopkins Hospital Martin Bishop Improving patient and family education in the Anticoagulation Management Service (AMS) Lynn B. Oertel Initial findings of a root cause analysis of adverse events in anticoagulation patients: results from the michigan anticoagulation quality improvement initiative (MAQI2) Christopher M. Graves Developing a system wide competency assessment tool for the Department of Veterans Affairs anticoagulation clinics Kenneth Kellick A post-hoc analysis of dalteparin versus oral anticoagulant (VKA) therapy for the prevention of recurrent venous thromboembolism (rVTE) in patients with cancer and renal impairment Seth Woodruff

411 F14 Initial experience with an outpatient DVT protocol utilizing rivaroxaban. Adam Porath F15 Activated partial thromboplastin time guided dabigatran dose reduction and switch to alternative novel anticoagulant Olga Sherman

Transitions of care G1 Promoting patient safety during transitions of care in the anticoagulation management service Diane DeTour G2 Facilitating anticoagulation for safer transitions: outcomes from an emergency department deep vein thrombosis discharge program. Lynda Thomson

Target specific oral anticoagulants (novel agents) F1 Is there a need for laboratory testing in the management of patients on target specific oral anticoagulants (TSOACs)? Walter Crumpler F2 Evaluation of persistence in patients on target specific oral anticoagulants (TSOACs) with a pharmacist managed anticoagulation clinic in a veteran population Linh Chan F3 The frequency of potential drug interactions involving dabigatran, rivaroxaban, and apixaban in a veteran population Mehgan Hassanzadah F4 Anticoagulation decision making: case reports describing the process at the VA Loma Linda Healthcare System for selecting the most favorable target specific oral anticoagulant (TSOAC) for an individual patient Walter Crumpler F5 Trends in anticoagulant utilization: data from the michigan anticoagulation quality improvement initiative Zachary Hale F6 The shift of warfarin patients to new anticoagulants: data from the michigan anticoagulation quality improvement initiative Brian Haymart F7 Safety and efficacy of rivaroxaban in obese and morbidly obese patients undergoing total joint replacement MaryAnne Cronin F8 Identification of risk factors for inappropriate prescribing and use of target-specific oral anticoagulants Molly Howard F9 A community hospital’s experience with prothrombin complex concentrates for the reversal of bleeding in patients receiving rivaroxaban. Anjali Kakwani F10 Impact of a pharmacist-managed target-specific oral anticoagulation service Brian Kurtz F11 NOAC antidotes—too little, too late? Wendy Leong F12 Evaluating prescriber practices of holding target-specific oral anticoagulants around invasive procedures Krista Luck F13 A multi-modal approach for the reversal of rivaroxabaninduced coagulopathy—A case report on the management of a severe gastrointestinal bleed Christopher Malabanan

Warfarin dosing management H1 Comprehensive dosing protocol Tiffany Duell H2 Warfarin is a safer choice than NOACs in the elderly (LTC) Wendy Leong H3 The impact of race on the association between a novel genotypeguided personalized warfarin service and clinical outcomes in an ethnically diverse population Beenish Manzoor H4 Influence of the African-American race on warfarin dosing Talitha Pulvino H5 Incidence of bleeding in patients with left ventricular thrombi post-myocardial infarction on triple antithrombotic therapy with a lowered International Normalized Ratio (INR) range—a case series Germaine Wong

A1 Transition from traditional anticoagulation clinic services to telephonic management: pilot study Brian Cryder1,2, Margaret Felczak1,2, Adwoa Darkwa2, Hiral Patel2, Justine Janociak2, Rami Rihani2 1

Midwestern University, Chicago College of Pharmacy, Downers Grove, IL, USA, 2Advocate Medical Group, Chicago, IL, USA Our study sought to evaluate the performance of a local telephonic system of warfarin management for stable patients who currently utilized traditional anticoagulation management services. The study was a retrospective, observational cohort consisting of three groups (1) patients transitioned from an office-based anticoagulation clinic to telephonic management (TM), (2) patients continuously enrolled in office-based anticoagulation clinic (AC), (3) patients continuously managed by internal medicine physicians without specialized anticoagulation services (PM). Primary outcomes included time in therapeutic range (TTR) and number of extreme INR values (\1.5 or [4.5). Data was collected for the 6 months period prior to transition (baseline phase) and the 6 months period after transition (active phase). Included patients completed [3 months of warfarin therapy

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412 and [60 % TTR in the baseline phase. All groups demonstrated significantly decreased TTR from baseline to active phase, with the TM and AC groups showing similar magnitude of reduction (-10.61 to 77.85 and -12.66 to 78.07 % respectively) but the PM group producing a greater drop (-20.08 to 61.60 %). The TM and AC groups had similar rates of extreme INR levels that did not significantly change from baseline to active phase; PM had significantly higher numbers of extreme INRs in three of the four measurements. Secondary outcome measures showed no differences between the three groups in rates of hemorrhagic and thrombotic events or hospitalizations. Stable patients transitioned from traditional officebased anticoagulation clinic to a telephonic based model of management performed equally as well as those who continued traditional enrollment.

A2 INR management of an anti-phospholipid syndrome patient with point-of-care INR testing Aaron D. Dush1, H. Paige Stewart1, Kendra Klaczak2 1 Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at The Ohio State University, Columbus, OH, USA, 2The Ohio State University School of Pharmacy, Columbus, OH, USA

Case Report: Anti-phospholipid syndrome (APS) is a clinical condition that can increase risk of thrombotic complications. Antiphospholipid antibodies (APA) are auto immune antibodies directed against phospholipid binding proteins. Warfarin management in APS patients can be challenging. It has been documented that the international normalized ratio (INR) can be falsely elevated in APS patients. This elevation is hypothesized to be from a reaction of the APA with the thromboplastin used to measure the protime. False elevations can be seen in both venipuncture (VP) and point-of-care (POC) INRs, but is usually more apparent in patients with APS with POC testing. The James Anticoagulation Management Service manages APS patients via VP INR. Our patient is a 31 year old female with stage 4 chronic kidney disease, systemic lupus erythmatosis, hypertension and APS with persistent positive lupus anticoagulant. The patient was started on warfarin therapy for serologic evidence of increased disease activity concerning for high risk of thromboembolism related to APS. The patient’s INR was managed by VP. However, the patient is a very difficult needle stick and in some instances an INR could not be obtained. Correlation of VP and POC INR was established using a chromogenic factor X (cFX) level. On the day of correlation, her POC INR was 2.5, VP INR was 2.1 (goal 2.0–3.0) and her cFX was 34 % (goal 20–40 %). After correlation, it was deemed appropriate to obtain future INR results via POC with an increased goal INR of 2.5–3.0 to account for false elevation due to APS.

A3 A pilot study: Mobile health technology to enhance selfmanagement and anticoagulation adherence in older adults Jung-Ah Lee1, Alpesh Amin1, Lorraine Evangelista1, Mark Bachman1, Alison Moore2, Annie Nguyen3, Javier Garcia-Rivas1 1 University of California Irvine, Irvine, CA, USA, 2UCLA, Los Angeles, CA, USA, 3Univesity of Southern California, Los Angeles, CA, USA

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13th National Conference on Anticoagulant Therapy Background: Mobile health applications have been found to improve self-management in patients with chronic conditions, particularly children and adults. Older adults are a group that can potentially benefit from mobile health interventions. Objective: To design and test Mobile Applications for Seniors to enhance Safe anticoagulation therapy (MASS), a mobile-based health technology intervention, composed of several culturally appropriate and age-sensitive tools and components to promote independence and self-care in older adults (including Hispanic elders) on anticoagulation treatment (AT). Methods: The pilot study uses a single-arm, experimental, pre-post design to test the feasibility of a 12-week intervention using the MASS in 20 older adults ([=55 years) on AT by examining changes from baseline to 3 months follow-up in emotional well-being, knowledge, attitude, and adherence to AT. Preliminary Results: The MASS development was completed. The components of the MASS app include (1) Education about anticoagulation therapies and safety tips, (2) Medication self-monitoring and reminders, (3) Vitamin K content of foods including common Hispanic foods, (4) Monitoring of signs and symptoms of bleeding, (5) Monitoring INR, (6) Connecting with people whom older adults trust (e.g., family caregivers, friends), and (7) Resources. Currently 8 participants are enrolled and the recruitment has progressed. The results of this feasibility study including 3 months follow-ups will be presented at the conference. Conclusion: The preliminary results will be used to modify the health app to make the design more elder friendly and to identify challenges and benefits from the health app on self-management in older adults with chronic conditions.

A4 Mobile technology-based system for smart anticoagulation management: preliminary observations Michael I. Miyamoto1, Phac Le Tuan1, Roger A. Winkle2 1 UncleCare, Inc., San Jose, CA, USA, 2Silicon Valley Cardiology, Palo Alto, CA, USA

Despite[60 years of use, the management of warfarin anticoagulation remains labor intensive and high-risk, often relying on phone and mail communications between providers and patients. To improve the safety, efficiency, and convenience of this process, we created an anticoagulation management software system based on mobile technology, consisting of a patient-facing mobile app, a cloud-based provider interface, and a back-end database connecting the two. After receipt of an INR value and a patient status update (e.g. new medications, missed doses, bleeding) reported via the mobile app, the clinic provider formulates the new warfarin dose regimen, which is pushed to the patient’s mobile device. The daily doses are converted into easy to follow, daily to-do items, allowing for daily dose reminders. The next scheduled INR reminder also appears as a to-do item. The system has been deployed in a pilot project in a cardiology practice, in 26 patients, since February, 2,014. Patient and provider acceptance has been excellent, despite an average patient age of 71 ± 14 years (mean ± SD). The need for phone calls to communicate patient instructions has been eliminated in [70 % of cases, resulting in reduced clinic work requirements and enhanced patient convenience and satisfaction, while TTR (over 9 months) in this pilot group has been well-maintained (75 ± 22 %). This novel, mobile-based system may, therefore, significantly improve the remote management of these inherently high-risk patients, with reduced clinic work requirements. If validated in larger patient samples, this system may increase clinic capacities, facilitate patient self-testing, and reduce perceived work barriers to achieving more appropriate anticoagulation prescription rates.


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A5 Design and implementation of an ambulatory anticoagulation therapy program using a RN: pharmacy model Mary M. Morin1, Cheryl A. Weimer2 Sentara Medical Grou, Norfolk, VA, USA, 2Sentara Medical Group, Norfolk, VA, USA

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Title: Design and Implementation of an Ambulatory Anticoagulation Therapy Program Using a RN-Pharmacy Model Objectives: 1. Describe the development and implementation of a comprehensive nonacute anticoagulation therapy management program, within a large integrated healthcare system. 2. Compare and contrast the impact of a RN-Pharm D anticoagulation therapy management model, to management within a physician practice. 3. Describe the innovative strategies used to evolve the RN-Pharm D model within the ambulatory setting. Description: A system senior leadership team assigned the nurse executive of a multi-practice medical group to lead an initiative regarding anticoagulation therapy management. The goal of this initiative was to standardize anticoagulation processes within the nonacute care venues of our healthcare system. This initiative was due to two safety events. The system’s medical group, long-term care facilities, and home health were included. Management of anticoagulation patients within our healthcare system was fragmented, lacking standardized procedures. Standardization of protocols, patient/caregiver education, and staff education/training specific to the management of anticoagulation patients improves patient outcomes. The areas focused on included: (1) anticoagulation protocols for warfarin and novel agents, (2) patient/caregiver education, (3) staff education/training and (4) documentation. This aligned with our organization’s strategic goals; caring for defined patient populations and improving health and safety. This initiative has achieved development of evidence based protocols, standardized patient/caregiver education, standardized staff education/training, standardized workflows/documentation, and improved patient access.

A6 Monitoring patient compliance with INR testing using and automated telephone reminder call process in the Anticoagulation Management Service (AMS) Irina Seliverstov, Lynn Oertel, Walter Moulaison Anticoagulation Management Hospital, Boston, MA, USA

Service,

Massachusetts

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Background: Quality healthcare outcomes depend upon patient compliance with INR testing. An automated telephone reminder system replaced a completely paper and mail process to inform patients about missed INR tests. Electronic tracking within the patient record facilitates the ability to list, reschedule and create electronic telephone messages which are then collated for distribution to patients in their primary language each evening. A 5-tiered approach escalates the tone and consequence of continued non-compliance. Objective: (1) To determine the effectiveness of replacing print with telephone reminder calls for the first two stages of the AMS noncompliance process and (2) To evaluate cost variances. Methods: For 1 month, each day, patients identified as two business days late for scheduled INR tests were tracked along the non-compliance continuum. Call reports were evaluated to determine variation of response by language. The cost variance for mailings versus automated calls was calculated based on the number of reminders.

Results: On average, 365 tier one and 92 tier two reminder calls were delivered weekly. The response to the initial call was 74.9 % improving to 91.2 % after the second call was delivered. English speaking patients demonstrated no difference in behavior responding to reminder calls from other languages. Annualized process costs decreased by 73 %. Conclusion: Patients feel positive and respond in a timely manner to straightforward, personalized automated telephone reminders which are more cost effective compared with mailed reminders. Cost advantages depend on the scale of operation with cost of unit of output generally decreasing with increasing scale.

A7 Development of a pediatric-centered anticoagulation service at a tertiary care children’s hospital Karen M. Texter2,3, Jean Giver1, Riten Kumar1,3, Bryce Kerlin1,3 1 Nationwide Children’s Hospital, Division of Hematology, Columbus, OH, USA, 2Nationwide Children’s Hospital, Division of Cardiology, Columbus, OH, USA, 3The Ohio State University, Columbus, OH, USA

Background: Pediatric anticoagulation management is challenging. Dedicated anticoagulation services have been demonstrated to improve patient care for adults. We describe our initial experience establishing a system-wide Anticoagulation Clinic (AC) at a major tertiary care children’s hospital. Methods: A hematology and cardiology collaborative AC was established in May 2013. The AC assumed care for all patients on anticoagulation within our hospital system. The AC utilized point of care testing (POCT) in a dedicated clinic space combined with telephone management. Data was collected for 1 year before and after establishing the AC. Results: Since inception, the AC has managed 290 patients, 33 % with hematologic diagnoses and 67 % with cardiac diagnoses. Average pediatric age was 12.9 (±6.2) years, (N = 124/290, 42 %). 58 % were adult survivors (age range 20–54 years) of pediatric conditions continuing to receive care within our system. Most patients were treated with warfarin (83 %) or enoxaparin (17 %). The patients are geographically dispersed, living in a total of 5 states and 152 zip codes. Baseline monitoring compliance was 63 %, increasing to 72 % at 1 year. Rate of chronic noncompliance with lab monitoring was 17 % at baseline, decreasing to 6 % at 1 year. Conclusions: A successful AC can be established in the pediatric setting, although the needs are more complex due to varied diagnoses, ages, and geographic distribution. Nonetheless, AC implementation improves anticoagulation care efficiency in the pediatric setting. Next steps include provision of POCT in our network of regional labs and utilization of eMR methods to track adverse events and clinic efficiency.

A8 Useful tools for developing a target-specific oral anticoagulant clinic Katherine E. Werner Cheyenne VAMC, Cheyenne, WY, USA With the advent of Target-Specific Oral Anticoagulants (TSOACs) came new challenges in the management of oral anticoagulants. Many

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414 clinics were not prepared for these challenges and the need to standardize care similar to with vitamin K antagonist (VKA) management existed to promote patient safety. National Patient Safety goal 3e recommends those managing anticoagulants use standardized practices to reduce the likelihood of patient harm associated with the use of anticoagulation therapy. The development of standardized education for staff & patients on the TSOACs, clinical decision making tools, and promotion of safe use were necessary similar to what exists with the VKAs. At the Veterans Health Administration (VHA), the Pharmacy Benefits Management Services (PBM) reviews new molecular entities plus creates Criteria for Use (CFU). For dabigatran a clinical guidance document was also published advocating for specific education and monitoring requirements. Following this publication, a medication use evaluation (MUE) of local use of dabigatran revealed poor compliance at the facility with safety monitoring, so recommendations were made to initiate a pharmacy-run monitoring program to determine manpower needs, establish a work model for management, and decrease ADRs for those on TSOACs. With little guidance available other than the ESC Guidelines for TSOACs at the time, even this resource did not include specific clinical situations such as perioperative management or bleeding. For anticoagulation providers, a more specific follow-up plan is needed which lead to the development of our TSOAC decision tree tool. To standardize staff trained in TSOAC management a competency tool was also developed.

B1 Warfarin versus rivaroxaban in long term acute care patients with nonvalvular atrial fibrillation: a budget impact analysis Brian Bell1, Kyle Frantz1,2, Brayton Jones1, Deborah Zeitlin1 1 Butler University, Indianapolis, IN, USA, 2Select Specialty Hospital, Indianapolis, IN, USA

Study Objective: To retrospectively assess past treatment and management expenses at Select Specialty Hospital—Indianapolis and determine overall patient costs when comparing warfarin to rivaroxaban treatment. The hypothesis is there will be a potential cost savings by switching nonvalvular atrial fibrillation patients from warfarin to rivaroxaban. Methods: Patient data and hospital treatment costs at Select Specialty Hospital—Indianapolis will be retrospectively analyzed via hospital medical records. Data collection on costs accrued by the hospital will include direct cost of medications to the hospital, cost of routine and acutely ordered lab testing, and other management expenses based on patients’ length of stay. Study Subjects: Included patients must have been treated with either warfarin or rivaroxaban for nonvalvular atrial fibrillation on or after July 1, 2011. Patient stay must extend beyond 7 days, and patients must have a CHA2DS2VASC score of [2. Patients with contraindications to either warfarin or rivaroxaban or a history of recurrent stroke and ineligible to be rechallenged on therapy will be excluded. Results: Data collection is underway at this time. The results will be presented at The 13th National Anticoagulation Forum Conference.

B2 Antifactor Xa levels correlating to body mass index and creatinine clearance with enoxaparin thromboprophylaxis MaryAnne Cronin, Ayal Segal, Eugene Krauss Syosset Hospital, Syosset, NY, USA

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13th National Conference on Anticoagulant Therapy Background: Thromboprophylaxis with enoxaparin following total joint arthroplasty is well documented, but effective doses for obese and morbidly obese patients remains controversial. Methods: This was an observational prospective study of 725 total joint arthroplasty patients. The sample included 11 % normal BMI (\25), 26 % overweight (25–29), 45 % obese (30–39), 18 % morbidly obese (40 and greater). Patients received enoxaparin 40 mg SC daily for total hip arthroplasty and 30 mg SC q12 h for total knee arthroplasty. All patients with creatinine clearance \ 30 mL/min received 30 mg SC daily; patients with morbid obesity (BMI [40) received enoxaparin 40 mg SC q12 h. AntiFactor Xa levels were drawn 4 h after the 4th dose to obtain steady state peak serum levels. Pearson and Spearman correlations were calculated to test the relationship of Age, BMI, and CrCl to AntiFactor Xa level. Results: A statistically significant inverse correlation was found to exist between BMI and AntiFactor Xa levels (r = -0.34, p \ 0.0001) and between creatinine clearance and AntiFactor Xa levels (r = -0.32, p \ 0.0001) across hip and knee groups. No significant association was found between BMI and VTE, or between AntiFactor Xa level and VTE. Regardless of dose, the rate of deep vein thrombosis (DVT) was 0.5 %; rate of pulmonary embolism (PE) was 0.41 %. Conclusion: BMI and creatinine clearance are significantly correlated with AntiFactor Xa level. Both have an inverse relationship to AntiFactor Xa such that as BMI increases, AntiFactor Xa level decreases and as creatinine clearance increases, AntiFactor Xa level decreases.

B3 Decreasing Rivaroxaban medication incidents by pharmacy staff education of the ‘‘LEARN’’ acronym at a community hospital Barbara Greenberg-Schwartz, Rph CCHP, Sandra Richardson, PharmD Monmouth Medical Center, Southern Campus, Dept of Pharmacy Services, Barnabas Health, Lakewood, NJ, USA Background: Rivaroxaban was approved by P&T in 4/2012. However lack of specific monitoring criteria to evaluate under/over coagulation when prescribers follow manufacturer’s guidelines for its specific indications is concerning. Furthermore there are three dosages requiring renal/liver impairment adjustments for indications. Due to these issues more than half of rivaroxaban orders required pharmacy modifications and/or interventions. In an effort to decrease medication incidents the clinical pharmacist devised a program to educate the pharmacy staff on appropriate rivaroxaban prescribing. Objective: Decrease Rivaroxaban medication incidents through pharmacy staff education utilizing the ‘‘LEARN’’ acronym Methods: The ‘‘LEARN’’ acronym was developed using monitoring criteria based on best practice guidelines/evidence based medicine ‘‘LEARN’’ means L: Liver disease contraindication E: Evening meal enhances absorption A: Anticoagulant-Avoid duplicate therapy. Per Corporate Anticoagulation policy, pharmacists can automatically discontinue duplicate anticoagulant agents prior to starting rivaroxaban R: Renal Function Assessment N: Numerous Indications/dosages To assist with ‘‘LEARN’’ Sentri7Ò is utilized to identify patients receiving Rivaroxaban by screening daily labs/medications/drug interactions. Results:’’ LEARN’’ was rolled out as an in-service with mandatory post-test in 6/2012. Results post ‘‘LEARN’’ Q2/2012 showed minimum medication incidents at 8.5 % through Q1/2013. However during Q2 and Q3/2013 medication incidents increased to 31.7 %

13th National Conference on Anticoagulant Therapy which lead to staff reeducation in q3/2013.Errors included inaccurate renal and hepatic dosing adjustments, incorrect dosage based on indication and duplication of anticoagulation agents. After reeducation medication incidents in Q4/2013 and Q1/2014 decreased to 21.8 %. In Q2/2014 medication incidents remained at 22 %. Conclusion: An acronym incorporated with staff education/testing has lead to decreased medication incidents and safer prescribing

C1 Investigation of adverse interactions between herbal drugs and natural blood clotting system Manish Adhyapak1, Manvendra Kachole2 1

Vivekanand College, Aurangabad, India, 2Dr. B.A.M.University, Aurangabad, India Throughout the world, herbal medicines are consumed by most of the patients without considering their adverse effects. Many herbal medicines/plant extracts have been reported to interact with blood clotting system. In continuation to this effort, thirty medicinal plant extracts were allowed to interact with citrated human blood and the clotting time was measured after re-calcification in vitro using Lee and White method. The aqeous leaf extract of Syzygium cumini and Camellia sinensis ceased the clotting process. In response to the Prothrombin Time Test and Activated Partial Thromboplastin Time Test, the extract of Camellia sinensis showed normal APTT and marginally prolonged the PTT to 16.7 s (control- 15.2 s) while Syzygium cumini showed normal PTT but significantly prolonged the APTT to 66.9 s (control- 20.7 s). This suggests that, Camellia sinensis acts on the extrinsic pathway while Syzygium cumini on the intrinsic pathway. There are some common herbal formulations that are frequently used by the patients which contain above plant materials, like, Syzygium cumini in anti-diabetic formulations, while the extract of Camellia sinensis is consumed frequently as beverage in many part of the world. Hence, patients having known bleeding tendency or haemophilia disease should take into account the interaction potential of these plants with the natural blood clotting system, specially, the patients suffering from intrinsic pathway factor deficiency should keep a limit on the consumption of Syzygium cumini while extrinsic pathway factor deficiency patients should limit Camellia sinensis. Also, the medical practitioners should consider the patient’s food consumption history before doing any major surgical procedures.

C2 Assessing the need for continual warfarin education using a follow-up survey: a report from the Michigan anticoagulation quality improvement initiative Steven T. Heidt1, Constantina Alexandris-Souphis1, Xiaokui Gu1, Geoffrey D. Barnes1, Brian Haymart1, Stephanie Watts2, Renee Kozlowski2, Jay H. Kozlowski2, James B. Froehlich1, Eva KlineRogers1 University of Michigan, Ann Arbor, MI, USA, 2Huron Valley-Sinai Hospital, Commerce, MI, USA

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Background: Education of warfarin patients is important in ensuring compliance and safety. A previous analysis of patients within the

415 Michigan Anticoagulation Quality Improvement Initiative (MAQI2) registry exposed knowledge gaps in patient understanding, including the need for a consistent diet and necessity to seek medical attention. This study evaluates a subset of the original cohort, assessing warfarin knowledge 6 months after warfarin initiation. Methods: MAQI2 is a Blue Cross Blue Shield of Michigan sponsored quality improvement consortium of six anticoagulation management services. We received completed initial surveys from 146 patients at two MAQI2 sites which included the previously validated Oral Anticoagulation Knowledge (OAK) Test. Six months after warfarin initiation, 85 patients from a single site were asked to repeat the survey. Patients completed surveys voluntarily with no monetary benefit. Signed-rank tests were used to compare initial and follow-up results. Results: Of the 85 patients initially surveyed, 40 completed follow-up surveys (47.1 %) after 6 months of anticoagulation therapy. Scores on the OAK Test were significantly lower on follow-up (14.85 ± 2.59) when compared to the initial OAK Test (16.2 ± 2.52, p \ .0001). Patients answered four clinically relevant questions incorrectly more often upon follow-up (2.5 ± 0.99) as compared to the initial evaluation (2.95 ± 1.06, p = 0.0038). Discussion: Though initial patient education efforts are relatively effective, patients do not retain this level of knowledge. Patient education efforts need to be continually reinforced, and may be augmented via periodic patient education newsletters or reminders provided alongside warfarin dosing instructions.

C3 Evaluation of patient’s knowledge in use of oral anticoagulation therapy Fernanda Souza e Silva1, Rafaela de Oliveira Manzato1, De´bora C. P. T. Cunha1, Fabiana Bolela1,2, Renata Stackfleth1,3, Rosana A. S. Dantas1 1

University of Saõ Paulo at Ribeiraõ Preto College of Nursing, Ribeiraõ Preto, Brazil, 2Hospital Estadual, Ribeiraõ Preto, Brazil, 3 Hospital das Clıńicas da Faculdade de Medicina de Ribeiraõ Preto, Ribeiraõ Preto, Brazil The oral anticoagulation therapy (OAT) is indicated for treatment or prophylaxis of venous thrombosis or pulmonary, the use of artificial heart valve and arrhythmia mainly. OAT requires strict controls requiring frequent blood tests, correct use of medication, and changes in lifestyle. The health team has an important role in training of OAT users and evaluation of knowledge. The use of instruments such as a structured questionnaire helps understand the knowledge of users quickly and effectively allowing for appropriate intervention. The aim of our study was to develop questionnaire and evaluate the knowledge of users of OAT. The questions were developed and evaluated by five experts. The draft instrument (43 questions) was applied to 50 patients in the pilot phase. Some changes were carried out and 500 patients answered the final version of the instrument (32 questions). The average age of participants was 57 years (SD13), with low educational levels (mean 6 years) and 56 % were women. We observed lower than 50 % of right answers for important questions such as the name of the blood test for anticoagulation control (43.6 %), intake alcoholic drinks (43.6 %), the optimal therapeutic range (38.9 %) and interaction with homemade medicines (33.4 %). Most of them gave the right answers for the name of the oral anticoagulant (96.4 %) and time under OAT (86.6 %). These results showed us that many patients

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416 under OAT need to learn more about this important therapy in order to prevent serious complications.

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D3 Implementation costs of patient self-testing and point-of-care testing for warfarin populations in America: the payer perspective Jeffrey P. Wittekiend

Patients’ preferred method of blood draw for INR measurement: the PREFER study

Cogent Reimbursement Services, Austin, TX, USA

Gary B Liska, Victoria Pigott, Ken Kupfer

In 2012, Boehringer-Ingelheim released a comprehensive study examining anticoagulation therapies in Australia, investigating the clinical and economic impact of warfarin and NOAC administration and management in a range of settings. One segment focused on implementation and operating costs to the payer per patient of warfarin administration in two clinical contexts: anticoagulation management via patient INR self-testing (PST) and via point-of-care (POC) testing in a physician’s office. This segment of the study found a significant increase in annualized per-patient costs in both contexts when compared to lab testing: $836.99 in the former case and $175.02 in the latter. However, the Australian statistical model diverges from the realities of the American market in several important respects regarding the manner in which anticoagulation care is reimbursed by American payers. Our hypothesis is that correcting for these differences will demonstrate that per-patient conversion costs for payers reimbursing American physicians are much lower than for their Australian counterparts. Indeed, our results demonstrate that, under a typical American reimbursement scheme, conversion from lab testing to POC or PST testing would mean decreased costs of $61.20 per patient per year in the former case and increased cost of $630.77 per patient per year in the latter case. Though clinical considerations must also be incorporated into the broader anticoagulation conversation, the results of our investigation into differential provision costs will provide valuable guidance to payers as the anticoagulation landscape continues to shift and evolve in the coming years.

Alere Inc., San Diego, CA, USA Background: Warfarin became commercially available in 1955. The drug’s approval included the need for chronic monitoring of INR to measure the intensity and thus anticoagulant therapeutic effect. To date, no study has asked patients about their preferred method of monitoring. Hypothesis Patients should prefer self-testing (PST) over venipuncture (Lab) or point-of-care INR testing in a clinic, or physician’s office (POC). Methods and Design: An online survey (2008–2014) asked patients taking warfarin to grade questions on a scale of 1–10 related to their experience of warfarin therapy and INR monitoring. Results: In 12,579 subjects, higher satisfaction, higher confidence, and less worry were a consistent response for PST as compared to either Lab, or POC, statistically significant with p values \0.0001 in all areas of comparison. For example, the response to ‘‘I am comfortable with the method used to test my blood’’ was (mean) 9.24, 7.92, and 6.21, the response to ‘‘I am confident being on warfarin’’ was 8.32, 6.91, and 6.24, and the response to ‘‘I worry about my INR levels’’ was 4.08, 6.26, and 5.64, for PST, POC, and Lab, respectively. Conclusion: This study supported the hypothesis that patient selftesting is the patient’s preferred method of INR monitoring, the benefit of which may include adherence to testing and remaining on warfarin.

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Comparative efficacy of NOACs and warfarin with patent selftesting: bridging the gap

Improving staff productivity and INR control in patient home testing with a 2-way communication device

Jeffrey P. Wittekiend

Ted M. Crum

Cogent Reimbursement Services, Austin, TX, USA

Cleveland Clinic, Cleveland, OH, USA

In recent years, several studies have compared the clinical efficacy of NOACs and warfarin, primarily relying on point-of-care (POC) INR testing in a physician’s office or lab testing for anticoagulation (AC) management in the latter group. Additional studies have compared clinical efficacy and time in therapeutic range (TTR) for warfarin management through point-of-care/lab testing and patient self-testing (PST). This study undertakes to aggregate and extrapolate the results of these two bodies of research, allowing a clinical comparison between NOACs and warfarin with patient selftesting that has been missing from the conversation heretofore. Our results bore out our initial hypothesis that well-managed warfarin in a PST setting is clinically equivalent or superior to NOACs in a clinical trial setting. Relying on established statistical relationships between TTR and adverse event rates, we tested this hypothesis by comparing adverse event (primarily stroke/systemic embolism, major bleed, and all-cause mortality) reductions between POC and PST testing and between NOACs and warfarin with POC testing. These results will provide valuable guidance to payers, physicians, and patients as they consider the range of anticoagulation therapies available today.

Rationale: A novel communication device for home INR testing can improve efficiency and patient outcomes in an anticoagulation clinic. Objectives This study was conducted to determine the effectiveness of a 2-way communication device based on patient INR results and provider time required per encounter. Methods: The FlexLife AVS is a device which can transfer information between inputs using cellular technology. Patients begin INR testing by answering common questions about their warfarin therapy on the FlexLife device, such as ‘‘Did you miss any doses recently?’’ After answering the series of questions, the patient performs an INR fingerstick. The FlexLife device then sends the questions, responses, and INR result to a secure website or EMR. The time required for providers to complete an encounter was measured with a stopwatch. 30 patients were enrolled beginning in October 2012. A second group of 30 patients were enrolled beginning in March 2014. Results: The time required for completing an anticoagulation encounter including completion of EMR documentation was decreased from 12.5 min (clinic visit) to 2.6 min (FlexLife), more than quadrupling provider efficiency. Providers were able to manage 5 patients/h (clinic) or 20 patients/h (FlexLife). FlexLife patients required an

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13th National Conference on Anticoagulant Therapy average of 1.7 min when INR results were in therapeutic range and 4.7 min when INR results were not in therapeutic range. The percentage of all INR results within the therapeutic range was 68.5 % (FlexLife AMS) and 59.1 % (clinic visit). The discontinuation rate with FlexLife AMS was\5 %. Reasons for discontinuation included cost (insurance copays for INR testing) and inability to perform testing. Conclusions: Managing warfarin patients with the FlexLife AMS system resulted in better INR control compared to usual care and a significant increase in provider productivity.

D5 Patient characteristics and determinants of anticoagulation quality in 15’868 patients performing patient self-management of oral anticoagulation with vitamin K antagonists in real-life practice: a survey of the international self-monitoring association of oral anticoagulated patients Christian Schaefer1, Michael Nagler2,3, Walter A. Wuillemin2,4 1

International Self-Montioring Association of Oral Anticoagulated Patients (ISMAAP), Geneva, Switzerland, 2Luzerner Kantonsspital, Lucerne, Switzerland, 3Maastricht University Medical Center, Maastricht, Netherlands, 4University of Berne, Berne, Switzerland Background: Even though patient self-management (PSM) of oral anticoagulation with vitamin K antagonists (VKA) is a recommended treatment scheme for patients requiring long-term anticoagulation, some aspects are still under debate. Evidence from randomized controlled trials and real-life data confirm efficacy and safety to be at least as good as standard care with VKA. However, it is not clear, which patients benefit the most from PSM and what predictors for an excellent anticoagulation control are. Methods: Data from a large survey of the International SelfMonitoring Association of Orally Anticoagulated Patients (ISMAAP) were used. INR values, bleeding and thromboembolic events were recorded as outcome variables. Various patient characteristics were obtained as potential predictors for these outcomes. Results: Here we report preliminary data. Details of the analysis will be presented at the conference. Questionnaires were completed by 15’868 patients from Germany, corresponding to an observation period of 148’554 patient-years (median 10 years; IQR 6–14). Median age was 72 years (IQR 60–84 years), 30.1 % were female. Indications for oral anticoagulation were as follows: mechanical heart valve (46.4 %), atrial fibrillation (34.2 %), venous thromboembolism (16.3 %) and others (2.9 %). The median percentage of INR values within the therapeutic range (%TIR) was 80.8 % (IQR 65.4–92.3). The incidence of major bleedings was 5.3 per 100 patient-years, the incidence of thromboembolic events was 2.2 per 100 patient-years. Conclusion: Patient self-management appears to be safe and effective across a broad range of age categories and patient characteristics. The impact of different patient characteristics on anticoagulation control will be presented.

E1 Patient characteristics influencing warfarin time in therapeutic range in the Hematology Anticoagulation Clinic at The Johns Hopkins Hospital Martin A. Bishop1, Michael B. Streiff2 The Johns Hopkins Hospital, Baltimore, MD, USA, 2Johns Hopkins University School of Medicine, Baltimore, MD, USA

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417 Anticoagulation (AC) clinics use percentage of time in therapeutic INR range (% TTR) to characterize the quality of management for patients treated with warfarin. The standard method for calculating % TTR is by linear interpolation, first described by Rosendaal et al. % TTR is used as a surrogate clinical outcome for warfarin patients as rates for bleeding or thrombosis are often quite low. In order to guide policy and procedure changes, the purpose of this quality improvement (QI) study was to characterize the AC patient population at The Johns Hopkins Hospital (JHH) and investigate differences between groups of patients with higher and lower quality management using % TTR. This QI study is a retrospective chart review of 525 patients treated with warfarin and managed by pharmacists in the Hematology AC Management Clinic at JHH from June 28, 2013–November 1, 2014. We recorded patient characteristics, calculated % TTR-related data, and compare parameters between patients groups. This study is ongoing. Preliminary data analysis indicates patients with a primary AC provider (single provider for [50 % of their AC visits) have a significantly higher %TTR (53.96 vs 46.49 %, p = 0.0019). In warfarin patients managed in the Hematology AC Management Clinic at JHH, we hypothesize there will be improved management by an increased % TTR in patients with a primary AC provider and more frequent follow-up. These differences will inform changes in the AC Clinic policies and procedures. If differences are found, an IRB-approved research study will be conducted at several other clinic sites within the Johns Hopkins enterprise.

E2 Improving patient and family education in the Anticoagulation Management Service (AMS) Lynn B. Oertel, Christine O’Leary, Jamie Ronin Massachusetts General Hospital, Boston, MA, United States Background/significance: Warfarin is a high-risk drug and education is critical to improve safety and quality of care. A patient-centered process to improve warfarin education in AMS was undertaken. Objectives: To identify ‘weak links’ in the way information specific to warfarin is conveyed, and to evaluate knowledge retention and deficits in the information provided in our patienteducation process. Implementation: A committee of staff nurses evaluated the existing warfarin education process. An initial assessment of patient knowledge retention was conducted by telephone using a scripted list of 11 multiple-choice questions, followed by 4 open-ended questions. Results guided modification of slide show content and emphasis was placed on how material aligned with ‘‘A Guide to Warfarin’’, a published teaching guide. Patients and families were actively engaged in the evaluation process. A second telephone assessment was performed to determine if safety information was better understood. Plain Language experts were then consulted to remove extraneous information or confusing phrases. Performance improvement outcome: This improvement initiative enhanced a comprehensive warfarin education slide show based on input from patients and families, nursing and plain language experts. Improvements included: why patient referred and AMS role, pill identification and how to obtain refills, visual concept of INR goal range, and review questions to assess understanding. Implications for practice and future research: Input from patients, families, nurses and plain language experts is beneficial for developing warfarin education information that is presented in clear, concise terms. Further patient evaluation is underway to determine if understanding and knowledge of warfarin therapy has improved.

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competency assessment in lieu of board certification or other on-site training programs. Objectives: The objectives of the project are to develop new modules consistent with new anticoagulation guidelines as well as new clinical information. In lieu of other board certifications these modules are designed to keep clinical and non-clinical staff knowledgeable about anticoagulation concepts. The project was divided up into two enduring modules that would be installed on the Department of Veterans Affairs Talent Management System (TMS). Implementation: The basic anticoagulation module is designed for health care staff minimally involved in caring for patients receiving anticoagulant therapy and presents core concepts. The advanced enduring module targets prescribers and other clinical staff involved in caring for patients receiving anticoagulant therapy. Topics include day to day clinical scenarios. Supplementary modules will be ‘swappable’ lecture recording(s) to keep the enduring modules up to date as new agents, and new concepts emerge. Conclusion: Discussion This new online content will be available in 2015 for all VA clinical and non-clinical staff. This novel approach is designed to keep basic concepts in the enduring material, yet allow the flexibility of inserting supplemental modules as new information/ technology/principles emerge.

Initial findings of a root cause analysis of adverse events in anticoagulation patients: results from the Michigan anticoagulation quality improvement initiative (MAQI2) Christopher M. Graves1, Xiaokui Gu1, Brian Haymart1, Steven L. Almany2, Gregory D. Krol3, Scott Kaatz4, James B. Froehlich1, Geoffry D. Barnes1, Eva Kline-Rogers1 1

University of Michigan, Ann Arbor, MI, USA, 2Oakland University William Beaumont School of Medicine, Royal Oak, MI, USA, 3Henry Ford Hospital, Detroit, MI, USA, 4Hurley Medical Center, Flint, MI, USA Background: A number of factors can lead to adverse events (AE) in patients taking warfarin. Performing a root cause analysis (RCA) of serious adverse events is one systematic way of determining these causes. Methods: Multidisciplinary teams were formed at three participating MAQI2 high volume sites with organized anticoagulation services. Medical records from patients who suffered serious adverse events (major bleeds, embolic stroke, venous thromboembolism) were reviewed to determine the root cause. More than 200 patients had an AE and underwent screening by trained RNs. Of these, 48 required full review. All potential contributing factors (co-morbidities, patient physical limitations, concurrent meds, current protocols) were assessed to determine the main factor that caused the AE. Results: Full RCA was completed in 48 cases from 3 sites. The main contributing factor was identified in 42/48 (88 %) cases. Most AEs, 31/42 (78 %), were due to patient-specific factors such as co-morbidities, patient physical limitations, or language barriers. Patient to provider and provider to provider communication accounted for 10/42 (24 %) of events and was the second most common cause. Other causes included protocol non-adherence and technology/equipment issues. After each detailed review, the multidisciplinary team recommended changes that addressed the primary cause. Conclusions: The majority of severe adverse events for patients taking warfarin were related to non-modifiable patient related issues. The remaining adverse events were primarily due to patient to provider and provider to provider communication issues. Methods for improving communication need to be addressed and studied, and methods for more effective patient education should be investigated.

E4 Developing a system wide competency assessment tool for the Department of Veterans Affairs anticoagulation clinics Kenneth Kellick1, Janet Dailey2, Lisa Longo2, Brooke Bergmann3, Carol Ingle4, Arthur Allen5, Patricia Schoch6 Department of Veterans Affairs, Buffalo, NY, USA, 2Department of Veterans Affairs, Chicago, IL, USA, 3Department of Veterans Affairs, Chicago, IL, USA, 4Department of Veterans Affairs, Daytona, FL, USA, 5Department of Veterans Affairs, Cleveland, OH, USA, 6 Department of Veterans Affairs, Reno, NV, USA 1

Background and Objectives: In 2009, the Department of Veterans affairs developed several training modules for practitioners who deal with patients on anticoagulation. The modules were basic (for nonclinicians) and advanced (for clinicians.) These modules were used along with clinic hours/peer review may be elected as part of

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E5 A post-hoc analysis of dalteparin versus oral anticoagulant (VKA) therapy for the prevention of recurrent venous thromboembolism (rVTE) in patients with cancer and renal impairment Seth Woodruff, Guillaume Feuge`re, Paula Abreu, Joseph Heissler, Frank Jen Pfizer Inc, New York, NY, USA Purpose: To compare the safety and efficacy of dalteparin versus VKA for prevention of rVTE in patients with cancer and renal impairment. Methods: Data from patients entered into a 6-month, phase 3, randomized, open-label controlled trial were analyzed. Renal impairment (creatinine clearance [CRCL] \60 mL/min) was defined as moderate (CRCL C30–\60 mL/min) or severe (CRCL \30 mL/min). Patients received 200 IU/kg dalteparin SC qd month 1, and 150 IU/kg SC qd months 2–6; or VKA qd, and 200 IU/kg dalteparin SC qd days 1–5 and until INR was 2.0–3.0. Primary endpoints were rate of rVTE and bleeding. Cox proportional hazard models were used to analyze the data. Results: Overall, 162/676 (24 %) patients had renal impairment at baseline (74 dalteparin; 88 VKA). Age (median 71.0 vs. 73.9 years), weight (median 64 vs 65 kg), and CRCL (moderate: 65 vs 82 patients; severe: 9 vs 6 patients) were comparable between groups. 2/74 (3 %) and 15/88 (17 %) of patients treated with dalteparin and VKA, respectively, experienced C1 rVTE (hazard ratio 0.15 [95 % CI 0.03–0.65] in favor of dalteparin; P = 0.01). Overall, C1 bleeding (major and minor) episodes were experienced by 15/74 (20 %) dalteparin-treated patients and 21/87 (24 %) VKA-treated patients (P = 0.65). Major bleeding was experienced by 7/74 (9.5 %) dalteparin-treated patients and 6/87 (6.9 %) VKA-treated patients (P = 0.65). Conclusions: In patients with cancer and renal impairment, dalteparin was significantly better than VKA in preventing rVTE. Rates of bleeding were similar for patients treated with dalteparin and VKA.


F1 Is there a need for laboratory testing in the management of patients on target specific oral anticoagulants (TSOACs)?

419 Conclusion: An anticoagulation service plays an important role in optimizing persistence in TSOAC therapy. They can provide longitudinal follow-up, reinforce disease state and bleeding education, assess and reinforce compliance and persistence considerations, reconcile drug interactions, and monitor renal and liver function.

Walter Crumpler, Linh Chan, Alan Jacobson VA Loma Linda Healthcare System, Loma Linda, CA, USA Background: TSOACs were introduced as anticoagulants that can be given in a fixed dose without routine laboratory monitoring. A recent article published by Reilly and colleagues found that stroke and bleeding outcomes were correlated with dabigatran plasma concentrations, however there were no clinical break points identified to clearly indicate dose adjustments. This led to a series of articles raising concerns as to the safety and efficacy of TSOACs when utilized without laboratory testing. In our clinical experience with these agents, we have come across three main settings where knowledge of TSOAC anticoagulant effect would be helpful. Need to verify absence of drug: Prior to invasive procedures and surgery it would be helpful to have objective verification that no anticoagulant was present and there would be no increase in bleeding risk due to a prolonged half-life or inadvertent ingestion of TSOAC preoperatively. Verification of drug absence would also be useful in a patient prescribed a TSOAC who presents with ischemic stroke and is being considered for thrombolytic therapy. Verification of therapeutic levels: in the presence of interacting drugs (inducers or inhibitors), renal or liver dysfunction, or in patients of extremes of weight or the very elderly. Verification of excess anticoagulation effect: in the case of bleeding or if a reversal agent is being considered. Conclusion: The current lack of readily available laboratory testing for TSOACs complicates management in a number of clinical settings, may adversely affect safety and efficacy and reduces the population of patients eligible for TSOAC therapy.

F2 Evaluation of persistence in patients on target specific oral anticoagulants (TSOACs) with a pharmacist managed anticoagulation clinic in a veteran population Linh Chan, Walter Crumpler, Alan Jacobson VA Loma Linda Healthcare System, Loma Linda, CA, USA Background: Maintaining adherence and persistence with warfarin therapy remains a challenge. In clinical trials, persistence with warfarin treatment ranges from 75 to 79 % at 1 year and persistence in clinical practice is much lower. Higher persistence rates were reported in a study published in Circulation in 2013 by Zalesak and colleagues. All patients on TSOACs at VA Loma Linda are followed by the anticoagulation service. We evaluated the persistence in patients treated with TSOACs and the various factors that led to the discontinuation of therapy. Methods: TSOAC data is recorded in a database which was queried for the period of January 2011–November 2014 (46 months). The persistence rates of TSOAC patients were measured at 3, 6, 12, and [15 months. Results: 352 patients have been initiated on TSOACs over the study period. Persistence rates were 92.3 % at 3 months, 85.2 % at 6 months, 81.8 % at 12 months, 77.1 % at [15 months. 83 patients discontinued TSOAC therapy: 20 completed the prescribed duration of therapy, 21 stopped due to ADRs, 16 stopped due to hospice care and only 3 transitioned back to warfarin. 23 patients moved or were otherwise lost to follow-up.

F3 The frequency of potential drug interactions involving dabigatran, rivaroxaban, and apixaban in a veteran population Mehgan Hassanzadah2, Walter Crumpler1, Linh Chan1, Alan Jacobson1, Hyma Gogineni2, Gollapudi Shankar2, Tony Chau1 1

VA Loma Linda Healthcare System, Loma Linda, CA, USA, Western University of Health Sciences, College of Pharmacy, Pomona, CA, USA

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Introduction: A purported advantage of target specific oral anticoagulants (TSOACs) is fewer drug–drug interactions. Although the number of interacting medications is much less than for warfarin, the potential for significant interactions still remains. These interactions involve Cytochrome P450 3A4 (CYP 3A4) and P-glycoprotein (P-gp) inducers and inhibitors and may affect both the safety and effectiveness of TSOACs. Objective: To determine the total and individual frequency of coprescribed strong inducers or inhibitors that might interact with TSOACs. Methods: This is a retrospective cohort study of veteran patients who received at least one warfarin and one co-prescription of TSOAC interacting medications during fiscal year 2013. Current use of warfarin was used as a surrogate to identify a patient population with the potential to receive anticoagulation therapy with TSOACs. The data was analyzed using descriptive statistics. Results: Of 3,885 patients prescribed warfarin, 15.08 % of the patients were also prescribed at least one strong interacting medication. 1.34 % were prescribed a strong inducer and 13.75 % prescribed a strong inhibitor. Diltiazem was the most frequent, prescribed to 11.17 %. Conclusion: These results highlight the need for careful and ongoing drug reconciliation for patients prescribed TSOACs. Failure to recognize and adjust for a strong inducer would reduce effectiveness and potentially leave the patient at elevated stroke risk. Failure to recognize and adjust for a strong inhibitor would potentially increase bleeding risk. More diligence is needed on monitoring for drug interactions, medication reconciliation, and patient education during baseline and long-term use with TSOACs.

F4 Anticoagulation decision making: case reports describing the process at the VA Loma Linda Healthcare System for selecting the most favorable target specific oral anticoagulant (TSOAC) for an individual patient Walter Crumpler, Linh Chan, Alan Jacobson VA Loma Linda Healthcare System, Loma Linda, CA, USA Background: TSOACs have unique attributes that need to be considered, in addition to patient’s thromboembolic and bleeding risk, when selecting anticoagulation for the individual patient. Here we present four cases to illustrate the nuances in selecting an appropriate anticoagulant.

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420 Case Reports: Case 1 is a 79 yo male on apixaban 5 mg twice daily for AF with a history of stroke, HTN, and seizures treated with carbamazepine. A TSOAC is contraindicated in this case due to the interaction with carbamazepine, a strong inducer. Apixaban was discontinued and warfarin started. Case 2 is an 84 yo male with a history of AF, thrombocytopenia, Child-Pugh Score B, CHF, HTN, recurrent strokes and thrombocytopenia. We started apixaban but with concern as to which dose was most appropriate based on thrombocytopenia and liver disease. Case 3 is 77 yo male on warfarin for AF with a history of stroke, HTN, DM, MI, DVT, and dyspepsia. Transportation issues made it difficult for routine laboratory testing. He was transitioned to rivaroxaban. Case 4 is a 57 yo male on enoxaparin for upper extremity DVT with history of pancytopenia due to underlying liver cirrhosis (Child-Pugh Score C). He was transitioned to dabigatran because it is not metabolized in the liver. Conclusion: Indication, patient’s thromboembolic/bleeding risk, dyspepsia, kidney and liver function, and drug interactions need to be considered when selecting the most appropriate anticoagulant for an individual. Laboratory testing of TSOAC effect would be useful in many of these settings.

F5 Trends in anticoagulant utilization: data from the michigan anticoagulation quality improvement initiative Zachary Hale1, Xiaokui Gu1, Eva Kline-Rogers1, Steven L. Almany2, Gregory D. Krol3, Jay H. Kozlowski4, Scott Kaatz5, Brian Haymart1, Geoffrey D. Barnes1, James B. Froehlich1 1 University of Michigan, Ann Arbor, MI, USA, 2Oakland University William Beaumont School of Medicine, Royal Oak, MI, USA, 3Henry Ford Hospital, Detroit, MI, USA, 4Huron Valley Sinai Hospital, Commerce, MI, USA, 5Hurley Medical Center, Flint, MI, USA

Background: Since the FDA approval of 3 target specific oral anticoagulants (TSOACs), some established warfarin patients are transitioning to these anticoagulants. Maintenance of treatment with these agents is not well documented, nor is the rate of warfarin reinitiation. Methods: Starting in 2010, trained abstractors from five Michigan Anticoagulation Quality Improvement Initiative (MAQI2) clinics have collected data on patients that switch from warfarin to a TSOAC. We identified atrial fibrillation patients who transitioned to a TSOAC and had at least one follow-up visit. TSOAC agent selection, duration, discontinuation rate and reasons, transitions between TSOACs, and warfarin re-initiation were evaluated. Kaplan–Meier regression analysis was performed to estimate durations. Results: Since 2010, 309 patients met selection criteria. Of these, 184(58.8 %) were started on Dabigatran, 87(27.8 %) on Rivaroxaban, and 38(12.1 %) on Apixaban. The probability that a patient remained on a TSOAC at 12 and 24 months was 72 and 60 %, respectively. The most common reasons for TSOAC discontinuation were bleeding 22(20.4 %), resolution of indication 18(16.7 %), GI symptoms 7(6.5 %), and falls 6(5.6 %). At 12 months, 30(9.7 %) switched back to warfarin and 7(2.3 %) switched to another TSOAC. The most common TSOAC–TSOAC transition reasons were GI symptoms 12(33 %) (Dabigatran only), and cost 5(13.8 %). Conclusion: These data suggest that TSOACs are well tolerated when patients switch from warfarin, with the majority of patients remaining on TSOACs at 12 months, and very few transitioning back to warfarin. Bleeding was the most common reason for TSOAC discontinuation, and GI symptoms appeared to be a compliance issue among Dabigatran patients.

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F6 The shift of warfarin patients to new anticoagulants: data from the Michigan anticoagulation quality improvement initiative Brian Haymart1, Xiaokui Gu1, Eva Kline-Rogers1, Steven L. Almany2, Gregory D. Krol3, Jay H. Kozlowski4, Scott Kaatz5, Zachary Hale1, Geoffrey D. Barnes1, James B. Froehlich1 1 University of Michigan, Ann Arbor, MI, USA, 2Oakland University William Beaumont School of Medicine, Royal Oak, MI, USA, 3Henry Ford Hospital, Detroit, MI, USA, 4Huron Valley Sinai Hospital, Commerce, MI, USA, 5Hurley Medical Center, Flint, MI, USA

Background: With the FDA approval of 3 target-specific oral anticoagulants (TSOACs), warfarin patients are now switching to these new agents, but little is known about this transition. The Michigan Anticoagulation Quality Improvement Initiative (MAQI2) is a consortium of 6 anticoagulation management services. The objective of this study is to use MAQI2’s clinical registry to learn more about this transition. Methods: Data from 5 MAQI2 sites were analyzed to determine how many patients were switched, to which TSOAC they were switched, and the reasons for switching. Results were stratified by year and restricted to patients with atrial fibrillation (AF) as the only indication for anticoagulation. Results: Of the 3,575 MAQI2 patients on warfarin for AF, 364(10 %) switched to a TSOAC. During 2010 and 2011, 161 switched to dabigatran. In 2012, 39 switched [dabigatran 21(54 %), rivaroxaban 18(46 %)]. In 2013, 92 patients switched [dabigatran 13(14 %), rivaroxaban 59(64 %), apixaban 20(22 %)]. In 2014, 72 patients have switched [dabigatran 6(8.3 %), rivaroxaban 35(49 %), apixaban 31(43 %)]. At least one reason for switching was identified in 195 patients. Patient convenience was an identified reason for 111(57 %) patients. Clinical reasons was an identified reason in 100(51 %) patients [e.g. 46(24 %) switched due to unstable INRs]. Seventeen (9 %) switched for compliance reasons. Conclusion: Only 10 % of AF patients in the MAQI2 registry have switched to a TSOAC. The distribution of selected TSOAC over time has shifted away from dabigatran towards rivaroxaban and apixaban, fairly equally. Patient convenience and clinical reasons, especially out of range INRs, were the main identified reasons for switching.

F7 Safety and efficacy of rivaroxaban in obese and morbidly obese patients undergoing total joint replacement MaryAnne Cronin, Ayal Segal, Barry Simonson, Sanjeev Suratwala, Eugene Krauss Syosset Hospital, Syosset, NY, USA Rivaroxaban is a relatively new therapeutic option for thromboprophylaxis following total joint replacement surgery, but published data outcomes specific to patients who are obese and morbidly obese are limited. Two hundred eighty-one consecutive adult patients meeting criteria received Rivaroxaban 10 mg PO once daily for 12 days following total knee arthroplasty and for 35 days following total hip arthroplasty, beginning 24 h after surgery and/or 6 h after discontinuation of epidural analgesia. Fifty-eight percent of patients were obese and morbidly obese (Group 1, BMI greater than or equal to 30) and 42 % were normal or overweight (Group 2, BMI less than 30). Patients were excluded if they had a calculated creatinine clearance less than 30 mL/min, moderate to severe hepatic dysfunction, or

13th National Conference on Anticoagulant Therapy taking concurrent medications known to interact with Rivaroxaban. Patients were monitored for deep vein thrombosis (DVT) or pulmonary embolus (PE), and for major bleeding. The Chi square test was used to compare outcomes between BMI groups, where possible. The mean age was 65.1 ± 10.1 in Group 1 and 66.6 ± 10.1 in Group 2. The majority of the sample was female (60.4 % in Group 1 and 64.1 % in Group 2). There was no significant association between abnormal bleeding events and BMI (P \ 0.5507). Two PEs occurred in Group 1 (1.2 %) and one PE occurred in Group 2 (0.9 %). One bleeding event occurred in Group 2 (0.85 %). Rivaroxaban is both safe and effective for thromboprophylaxis following total joint replacement surgery in patients who are obese and morbidly obese.

F8 Identification of risk factors for inappropriate prescribing and use of target-specific oral anticoagulants Molly Howard1,2, Andrew Lipshutz1,2, Breanne Roess1,2, Emily Hawes1,2,3, Zachariah Deyo1,2, Jena Burkhart1, Betsy Shilliday2,3 1 Department of Pharmacy, University of North Carolina (UNC) Healthcare, Chapel Hill, NC, USA, 2UNC Eshelman School of Pharmacy, University of North Carolina, Chapel Hill, NC, USA, 3 UNC School of Medicine, University of North Carolina, Chapel Hill, NC, USA

Background: The Target Specific Oral Anticoagulants (TSOACs) require specific dosing, monitoring, and patient education to ensure safe and appropriate use. A previous quality improvement initiative at this institution identified a need for patient and prescriber education, as the majority of patients prescribed a TSOAC did not have appropriate labs drawn at medication initiation and 26 % of patients interviewed reported inappropriate TSOAC storage or administration. The objective of this quality improvement project is to identify patient- and process-related factors that correlate with increased risk of inappropriate prescribing, monitoring, and patient use of TSOACs. Methods: A retrospective chart review is being conducted to identify patients started on TSOAC therapy in four clinics within an academic medical center. Data collected on each patient includes demographics, choice of agent, dose, indication, baseline renal and hepatic function, concomitant medications, and documented adverse effects including bleeding and thrombosis. Patients are contacted via telephone to provide standardized TSOAC education and assessment of medication use, adherence, and adverse effects. Follow-up for further monitoring and counseling is provided on a patient- and clinic-specific basis as appropriate. Data will be analyzed based on patient demographics, setting of TSOAC initiation, initiating prescriber, choice of agent, and indication for use to identify factors correlating with inappropriate use. Results: Data collection is ongoing and will be completed by March 2015. Findings will be available for presentation at the Anticoagulation Forum. At the time of abstract submission, chart review has been completed for 144 TSOAC patients, and telephone interviews have been successfully completed with 57 of those patients.

F9 A community hospital’s experience with prothrombin complex concentrates for the reversal of bleeding in patients receiving rivaroxaban Anjali Kakwani, Heidi Hornstein Atlantic Health System, Summit, NJ, USA

421 Background: The oral factor Xa inhibitors rivaroxaban and apixaban carry a risk of major hemorrhage, yet no specific reversal agent is available. Prothrombin complex concentrates (PCCs) may be considered for reversal; however their effect on clinical outcomes has not been evaluated. Methods: We evaluated all cases of PCCs used at our institution for the reversal of bleeding in patients taking oral factor Xa inhibitors. Results: Five patients received PCCs for the reversal of rivaroxaban related hemorrhage. Two patients received 50 U/kg PCCs for gastrointestinal hemorrhages, two patients received approximately 50 U/ kg PCCs for subdural hemorrhages, and one patient received 10 U/kg PCC for splenic contusion following trauma. Three patients received three factor PCC and two patients received nonactivated four factor PCC. Coagulation assays were obtained before and after administration of PCCs in three patients, all of which showed an improvement in coagulation assays. Two patients experienced adverse effects following PCCs. One patient developed bilateral intramuscular deep vein thromboses of the lower extremities 2 days following 10 units/kg of nonactivated four factor PCC. The other patient developed an extensive proximal lower extremity DVT and pulmonary embolism 8 days following administration of 50 units/kg of three factor PCC. Discussion: We describe five patients who received PCCs for the reversal of the anticoagulant effects of rivaroxaban. Two patients developed thromboembolic complications following the administration of PCCs. Further randomized controlled studies are needed to evaluate clinical outcomes and thromboembolic effects associated with the use of PCCs for the reversal of oral factor Xa inhibitors.

F10 Impact of a pharmacist-managed target-specific oral anticoagulation service Brian Kurtz, Elizabeth Renner, Erin Mouland University of Michigan, Ann Arbor, MI, USA Purpose: Anticoagulation services role in the management of targetspecific oral anticoagulants (TSOACs), including dabigatran, rivaroxaban, and apixaban, is unclear. In 2013, the University of Michigan Outpatient Anticoagulation Service developed a pharmacist-managed TSOAC-monitoring service to ensure appropriate use of TSOACs, including appropriate medication selection, dosing, and monitoring. Here we evaluate the impact of this service by describing drug-related problems identified and therapy changes made by pharmacists. Methods: Patients are enrolled upon receiving a referral from a University of Michigan physician. Physicians refer for monitoring of a pre-selected TSOAC or for assistance in prescribing a TSOAC. After receiving a referral, patients are contacted via telephone to provide patient-specific anticoagulation education and confirmation of therapy affordability. After a 2 weeks follow-up appointment, calls are scheduled every 3–6 months to re-evaluate dosing, adherence, and adverse effects. Additionally, pharmacists make recommendations on antiplatelet therapy and order laboratory tests if clinically indicated. Results: To date, 91 patients have been enrolled in the service. Of the 91 patients, 74 were referred for TSOAC monitoring and 17 for pharmacist assistance in initial therapy selection. Sixty-seven patients have had at least one follow-up. Pharmacists recommended modification to anticoagulation therapy for 11 patients (14.9 %) on a TSOAC medication at the initial visit. Changes were recommended to anticoagulation or antiplatelet therapy for 33 patients (36.2 %) during the course of therapy. Conclusion: A pharmacist-managed TSOAC service assists providers in improving anticoagulation care by ensuring proper drug selection,

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422 dosing based on patient-specific factors, therapy affordability, and by providing ongoing education to patients.

F11 NOAC antidotes: too little, too late? Wendy A. Leong1, Joseph A. Caprini2, Jawed Fareed3 1 Burnaby Research & University of British Columbia, Vancouver, BC, Canada, 2Evanston Northwestern Healthcare & Feinberg School of Medicine, Northwestern University, Chicago, IL, USA, 3Loyola University Medical Center, Dept of Pharmacology, Chicago, IL, USA

Background: Restrictions for high-bleeding-risk patients [e.g. age [75 years, CrCl \50 mL/min, major drug interactions] should have been mandatory in the original 2008 NOAC product monographs (i.e. no lab monitoring or antidotes). Soon after the NOAC 2011 atrial fibrillation approval, international safety advisories were issued (260 fatal bleeds). Noac bleeding: Unproven strategies for major NOAC bleeding include: (1) neutralization (e.g. charcoal); (2) hemodialysis (i.e. inappropriate in hemodynamic instability); and (3) unreliable lab tests (e.g. PTT). Noac antidotes: NOAC antidotes may be useful for major life-threatening situations (e.g. ICH, overdoses). Three NOAC investigational antidotes are: 1. Andexanet (Portola): for NOACs and enoxaparin; 2. Idarucizumab (‘‘DabiFab’’ by Boehringer Ingelheim): for dabigatran; 3. Aripazine (Perosphere): for NOACs, UH, LMWH & fondaparinux. Limitations: The anticipated limitations of NOAC antidotes include: 1. Timing (Too Late): approval delayed until 2016; 2. No Lab Monitoring (Too Little): to measure NOAC anticoagulation intensity; 3. Immunogenicity: mAb ADRs may include anaphylaxis, serum sickness, infections, etc; 4. Cost: each treatment may exceed $400.00 US that may limit availability. Conclusion: NOAC investigational antidotes may not be approved until 2016 & may be limited by high drug cost, parenteral administration and mAb ADRs. The delay to antidotes & accurate lab monitoring has already proven to be deadly (260 fatal NOAC bleeds), due to NOAC overprescribing & indiscriminate use in high-bleedingrisk patients. Clinicians are advised to restrict NOAC prescribing to lower-bleed-risk patients; to choose traditional anticoagulants for high-risk patients; & to screen all patients with a standardized NOAC Safety Checklist.

F12 Evaluating prescriber practices of holding target-specific oral anticoagulants around invasive procedures Krista K. Luck, Autumn D. Carroll Mission Hospital Anticoagulation Service, Asheville, NC, USA Purpose: Assess adherence with guideline-derived protocol for holding practices of target-specific oral anticoagulants (TSOACs) around invasive procedures at Mission Hospital in Asheville, NC. Primary Endpoint: the percentage of patients whose peri-procedural hold times for rivaroxaban, apixaban, or dabigatran were consistent with guideline-derived protocol. Secondary endpoints include the percentage of patients on TSOACs undergoing an invasive procedure with bleeding and/or thromboembolic events in predetermined subgroups: age C75 years, dose prescribed not adjusted for patient’s

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13th National Conference on Anticoagulant Therapy renal function, drug interactions and concomitant therapy with parenteral anticoagulants or antiplatelet therapy. This retrospective, electronic chart review was conducted for a randomized sample of 130 patients ages 18 and older who underwent an invasive procedure between October 30, 2012, and April 30, 2014, and were taking a TSOAC peri-operatively. Descriptive statistics were used to determine percent of patients meeting primary and secondary end points. Fifty patients were included with a mean age of 71 years and 27 patients (54 %) were male. The most common TSOAC used in patients was rivaroxaban (58 %). Most patients (86 %) did not receive appropriate holding instructions based on guideline-derived protocol. The majority of identified deviations (82 %) were related to delayed resumption of the TSOAC in the post-operative period. In conclusion, the TSOAC holding instructions provided to the majority of patients undergoing invasive procedures deviated from current protocol. During data collection, Mission Hospital approved this protocol for system-wide use. The results will be shared as part of prescriber education, and eventually the protocol will be fully integrated into the peri-operative process.

F13 A multi-modal approach for the reversal of rivaroxaban-induced coagulopathy: a case report on the management of a severe gastrointestinal bleed Christopher Malabanan, Mohamed Fouad, Nilesh Patel, Justin McNamee, Terrance McGovern St. Joseph’s Regional Medical Center, Paterson, NJ, USA Objective: To report a multi-modal approach with four factor prothrombin complex concentrate (4F-PCC) and fresh frozen plasma (FFP) to blunt rivaroxaban-induced coagulopathy. Case Summary: A 73-year-old female presented to the emergency department (ED) complaining of a 2 days history of vomiting and epigastric abdominal pain. Pertinent medications taken prior to admission include rivaroxaban and aspirin. Lab values and clinical presentation were significant for a major bleeding episode. 4F-PCC at approximately 30 U/Kg followed by FFP at 13 mL/Kg were used to reverse rivaroxaban-induced coagulopathy. Conventional coagulation tests and thrombelastography (TEG) were used to assess reversibility. No embolic complications were reported post intervention. Discussion: Rivaroxaban alters thrombin generation parameters such as the endogenous thrombin potential (ETP), thrombin peak, the lagtime and time to peak. Individually, 4F-PCC and FFP have normalized thrombin generation parameters and may complement each other to reverse clinically significant bleeding due to rivaroxaban. Additionally, some recent data indicate a potential role for TEG to assess rivaroxaban-induced coagulopathy. Conclusions: 4F-PCC in combination with FFP has shown positive outcomes for blunting the anticoagulant effect of rivaroxaban in our patient. Further prospective clinical studies are needed to determine the exact role that each modality contributes in reversing the anticoagulant effect of rivaroxaban.

F14 Initial experience with an outpatient DVT protocol utilizing rivaroxaban Adam D. Porath, Michelle L. Rand Renown Regional Medical Center, Reno, NV, USA

13th National Conference on Anticoagulant Therapy Objectives: To develop a safe and effective protocol to treat patients diagnosed with deep vein thrombosis (DVT) with rivaroxaban in the outpatient setting. Methods: Beginning in June of 2013, outpatients diagnosed with DVT within Renown Health were eligible to be referred the Anticoagulation Program for treatment with rivaroxaban as an alternative to Emergency Department referral. Data from the first 106 patients referred for treatment were examined to determine if the protocol was a safe and effective alternative. Results: A total of 106 consecutive patients were evaluated between June 2013 and November 2014. Of these, 60 (56 %) patients were referred from either primary care or urgent care settings. The remaining 46 patients were referred from the emergency department. The majority of these patients (98 %) established care with the Anticoagulation Program. Eleven patients (10 %) originally started on rivaroxaban were switched to an alternative anticoagulant. 89 % of patients were also seen at a 3 weeks follow up appointment. 96 % of patients have completed therapy or remain on indefinite anticoagulation. Five patients (4.7 %) have been lost to long term follow up. 13 patients (12 %) had a hospital admission for any cause in the 6 months after diagnosis. Three of these patients were admitted for bleeding complications and one patient was admitted for a subsequent pulmonary embolism. 15 patients (14 %) had visits for any reason to an emergency department subsequent to their diagnosis. Conclusion: A protocol utilizing rivaroxaban for the outpatient treatment of DVT has been successfully implemented and may be a safe and effective alternative to Emergency Department referral.

F15 Activated partial thromboplastin time guided dabigatran dose reduction and switch to alternative novel anticoagulant Olga Sherman1, Lawrence Baruch1,2 James J Peters VA Medical Center, Bronx, NY, USA, 2Mount Sinai Medical Center, New York, NY, USA 1

Purpose: To report a case of aPTT guided dose reduction and discontinuation of dabigatran. The aPTT provides a qualitative estimation of dabigatran concentration. At the expected median peak plasma concentration, the aPTT is approximately 2–3 times control, and at trough 1.3 times control. In patients treated with dabigatran, trough aPTT [80 s was associated with an increased risk of bleeding. An elderly man with nonvalvular atrial fibrillation treated with dabigatran 150-mg twice daily (recommended dose for his creatinine clearance of 48.8 ml/min) presented to our anticoagulation clinic. He reported weight loss, decreased appetite, and abdominal discomfort. There was no evidence of bleeding. He was not prescribed any medications that increase dabigatran concentration. His aPTT at projected peak and trough dabigatran concentration, were 108.1 and 99.5 s, respectively. Three weeks later at trough dabigatran, aPTT was 114.1 s, ecarin clotting time (ECT), 157 s, and dabigatran concentration, 260.3 ng/ml; values consistent with elevated dabigatran concentration. As trough values were consistent with peak dabigatran levels, the dabigatran dose was decreased to 75-mg twice daily. Three weeks later he reported an improvement in his abdominal discomfort. The trough aPTT was 76.8 s. About 9 months later, peak and trough aPTT were 117 and 84.5 s, respectively. ECT and dabigatran concentration were consistent with elevated dabigatran concentration. As the trough aPTT was [80 s and the other parameters were suggestive of elevated dabigatran concentration, he was believed to be at elevated bleeding risk; dabigatran was discontinued and rivaroxaban 15-mg daily was initiated.

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G1 Promoting patient safety during transitions of care in the Anticoagulation Management Service (AMS) Diane DeTour, Lynn Oertel, Walter Moulaison Anticoagulation Management Hospital, Boston, MA, USA

Service,

Massachusetts

General

Background: Patients undergoing anticoagulant therapies are at risk for poor healthcare outcomes due to medical errors during transitions of care. The use of electronic interfaces between hospital admission, discharge, transfer (ADT), laboratory operations and the AMS anticoagulation management software, provide important communication key to the prevention of adverse events. Objective: (1) To demonstrate how interface warnings inform AMS nurses of potential or future danger as patients move from one care setting to another. (2) To demonstrate the impact of managing interface warnings on nurse work. Methods: Representative data was collected, evaluated, processed and collated from the ‘‘failed to interface’’ hold monitor and daily tracking lists by AMS nurses for a 1 week period. Results: Interface transactions include: INR results for patients not in an ‘active’ status (daily average 10), admissions (daily average 5.9) and discharges (daily average 11.9), and failed execution of messages to patients or physicians. Monitoring interface transactions may create additional workload however, more significantly, it allows nurses to evaluate, intervene and provide safe transition management in real time. Conclusion: Technology can assist in the identification of potential deficiencies in transitions of care. Interface warnings notify the AMS nurse that a patient is moving within the system and provides an opportunity to be in touch with patients and care providers to promote understanding and bridge gaps in anticoagulant care. Well organized workflow tools and processes deliver information directly to AMS nurses making it possible to seamlessly and effectively monitor and act on alerts.

G2 Facilitating anticoagulation for safer transitions: outcomes from an emergency department deep vein thrombosis discharge program Lynda Thomson, Glenn Oettinger, Robert Pugliese, Geno Merli Thomas Jefferson University Hospital, Philadelphia, PA, USA With the recent advent of the target specific oral anticoagulants, patients presenting to the ED with an acute uncomplicated DVT may be eligible for outpatient treatment with appropriate screening and patient selection. The objective of this study was to implement and evaluate a transition-of-care program for outpatients presenting to the ED with an acute uncomplicated DVT. We will outline the program implementation process, named Jeff Fast, describe the key components of the process and the results of our outcomes. Data was collected for patients treated by the ED for acute DVT pre- and postprogram implementation. Follow-up calls were placed after discharge for all patients enrolled in the Jeff-FAST program; data was collected on follow-up appointments, anticoagulation adherence, readmission rates, and patient satisfaction. Program implementation was successful. By the 30-day follow-up call, 100 % of patients had a followup outpatient appointment, with an average time to the follow-up of 4.4 days (range 1–7 days). Zero patients at the 3–5 and 30-day calls

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424 had any issues with their anticoagulant, nor reported any significant hemorrhagic associated adverse events. One patient was re-admitted after discharge with a PE. Patient satisfaction has been high, with all patients at the 30-day call indicating they would recommend the program. The educational components of this program were essential to ensuring a successful transition-of-care program for patients with acute uncomplicated DVT. Reassessment of the program is ongoing and dynamic to allow any necessary changes to the program to ensure it remains current, sustainable, and patient/provider friendly.

H1 Comprehensive dosing protocol

13th National Conference on Anticoagulant Therapy a mean dose of 22.9 mg/week (range 3.5–49.0); a mean of 22.5 dosage adjustments; 64.3 % INRs in the therapeutic range; 16.5 % INRs \2.0; 13.2 % INRs between 3.1 and 3.9; 4.8 % of INRs between 4.0 and 6.0; & 1.2 % INRs [6.0. Twenty-eight warfarin DI were documented in 11 patients (91.7 %), including acetaminophen (75.0 %) & antibiotics (66.1 %). Fifty ADRs in 10 patients were reported (e.g. 49 minor bleeds). Conclusion: This evaluation demonstrated complex anticoagulation management in the elderly. Warfarin was prescribed for AF (75.0 %), VTE prophylaxis (17.7 %) & PE (8.3 %); with a target INR 2.0–3.0 (100 %); a mean dose of 22.9 mg/week (range 3.5–49.0); a mean of 22.5 dosage adjustments; 28 warfarin DI in 11 patients (91.7 %); plus 50 ADRs. Warfarin is drug-of-choice in the elderly (LTC), and safer than NOACs due to accurate INR monitoring & readily-available antidotes.

Tiffany K. Duell, Lisa K. Brattin, Heidi M. Conklin, Michelle R. Slattum Salem Health, Salem, OR, USA

H3

According to the Oregon State Board of Nursing, it would be considered an act of prescribing if a nurse made a judgment decision on dosing medications. Prescribing is out of scope of practice for nurses. We collaboratively developed this comprehensive warfarin dosing protocol so that nurses could dose warfarin within their scope of practice. Our nineteen page protocol includes dosing algorithms for induction of therapy, established patients and post-procedure bridges for INR goals of 1.5–2.5, 2–3 and 2.5–3.5. It also addresses dosing protocols for missed doses, diet changes and medication changes. Our dosing protocol was designed so that a nurse could flip to an appropriate algorithm after obtaining the INR result and responses to our questions regarding changes in diet and medications. According to the algorithm, the nurse would then determine if the patient needs a change in dose for that day and/or a weekly dosing adjustment. The length of time until the next appointment is also specified. For example, if a patient has an INR goal of 2–3, has been on 5 mg daily and their INR is 4.1, according to the algorithm, the nurse would hold warfarin for 1 day then decrease the weekly dose by 15 percent or 2.5 mg Monday and Friday and 5 mg others. The next appointment would be within 1 week. By implementing this comprehensive dosing protocol, we were able to maintain a nurse driven Anticoagulation Clinic that operates within the scope of practice for nurses.

The impact of race on the association between a novel genotypeguided personalized warfarin service and clinical outcomes in an ethnically diverse population

H2 Warfarin is a safer choice than NAOCs in the elderly (LTC) Wendy A. Leong Burnaby Research & University of British Columbia, Vancouver, BC, Canada Background: Although anticoagulation is complicated in the elderly, warfarin is safer than NOACs due to accurate INR monitoring & antidotes. Methods: Warfarin patients age [80 years who were referred to a community-based LTC anticoagulation service with point of care INR testing, certified anticoagulation pharmacists, evidence-based protocols & case management were randomly selected for retrospective chart review in 2007. Results: Twelve charts were reviewed with 92 % females & 8 % males; a mean age of 85.7 years; a mean weight 69.1 kg; a mean of 12 medications; & a mean anticoagulation service duration of 13.4 months. Warfarin was prescribed for AF (75.0 %), VTE prophylaxis (17.7 %) & PE (8.3 %); with a target INR 2.0–3.0 (100 %);

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Beenish S. Manzoor, Julio Duarte, James Lee, William Galanter, Surrey Walton, Nina Galanter, Thomas Stamos, David Peace, John Garofalo, Jerry Krishnan, Jerry Bauman, Larisa Cavallari, Edith Nutescu University of Illinois at Chicago, Chicago, IL, USA Objective: The aim of this study was to examine the impact of race on the association between a novel genotype-guided personalized warfarin (PGx) service and anticoagulation related clinical outcomes. Methods: Multivariate linear and logistic models were used to examine differences across race in the association between the PGx service and several clinical outcomes adjusted for confounders and using inverse probability treatment weight propensity scoring. Results: A total of 339 patients on the PGx service (mean age 56 ± 16 years; 61 % African American; 55 % female) and 299 controls (mean age 54 ± 16 years; 74 % African American, 64 % female) were included. Time in therapeutic INR range was significantly higher in African-Americans in the PGx group compared to Caucasians over the initial 7 days of therapy (b: 5.52 days, 95 % CI 1.4, 9.6), while at 14 and 30 days there was no difference. The proportion of INRs at extremes (\1.5 and [4) was lower in AfricanAmericans in the PGx group compared to Caucasians (b: -25.56, 95 % CI -31.6, -19.6). The length of low molecular weight heparin therapy was also lower in African-Americans in the PGx group compared to Caucasians (b: -7.77, 95 % CI -9.2, -6.4). Additionally, relative to Caucasians, African-Americans in the PGx group were 2.17 times more likely to have an INR in therapeutic range at discharge (OR 2.17, 95 % CI 1.0, 4.7). Conclusion: A novel genotype-guided personalized warfarin service was positively associated with anticoagulation related clinical outcomes, and this association was stronger in African-American patients.

H4 Influence of the African-American race on warfarin dosing Talitha L. Pulvino, Madiha Baig, Rashida Jones Temple University School of Pharmacy, Philadelphia, PA, USA

13th National Conference on Anticoagulant Therapy The decision of initial warfarin dosing can be challenging despite guideline recommendations based on the expected maintenance dose. There are data supporting the use of age and some comorbidities in this decision but additional information could be helpful. Genetic testing is not standard nor is it recommended at this time. The existence of another easily identifiable criterion to determine an appropriate starting dose of warfarin could benefit clinicians. There is a small amount of literature examining the influence of race on warfarin dosing, however studies include a limited number of Black or African-American patients. This study aimed to examine the effect of the Black/African-American race on warfarin dosing in one anticoagulation clinic. Retrospective data was collected from paper and electronic medical records of patients enrolled in the clinic over a 6 years period. The weekly warfarin dose was collected for resulting INRs between 2.0 and 3.0, allowing for single fluctuations up to ±0.4 from the target along with the following patient information: sex, average weight, moderate to severely interacting drugs, and comorbidities. The mean weekly warfarin dose was 41.5 mg for Black/ African-American patients (n = 91) compared to 35.6 mg for the other races combined (n = 29) (p = 0.1076). Multiple linear regression modeling identified age (p = 0.0032) and indication of DVT/PE (p = 0.0280) as significantly affecting the warfarin dose but not race (p = 0.2464). Although the results were not statistically significant, a trend toward higher doses by an additional 5.9 mg/week was seen in the Black/African-American population.

425 Patients who develop left ventricular (LV) thrombi after myocardial infarction (MI) require triple antithrombotic therapy (TAT) with warfarin and dual antiplatelets (DAPT). Guidelines suggest anticoagulation for 3 months using a lowered INR range of 2.0–2.5 to attenuate bleeding risk, although strong evidence for this is lacking. We present a case series of patients on TAT post-MI to evaluate the safety and efficacy of this approach. From February 2013 to May 2014, ten patients (all male, average age 47.8 years) received TAT consisting of aspirin, clopidogrel and warfarin after MI and were followed for 6 months after TAT initiation. Eight of ten underwent coronary stenting. Of nine stents inserted, six were bare metal and three were Everolimus-eluting. All received at least minimum duration of DAPT. Duration of warfarin was guided by resolution of thrombi demonstrated by repeat transthoracic echocardiograms (TTE), performed an average of 94.8 ± 49.1 days after the index TTE. Three patients utilized lowered INR target ranges (1.8–2.2 and 1.8–2.5) while the remainder used the conventional 2.0–3.0 range. The time-in-therapeutic ranges (TTR) for lowered and conventional groups at approximately 95 days were 37.6 and 40.7 % respectively. Two patients using the conventional range had INR values greater than 5; another one developed major bleeding (gastrointestinal tract), necessitating the cessation of warfarin and clopidogrel. No thromboembolic events were reported in either group. From this series, utilization of a lowered INR range appeared to be safer with zero bleeding events and as efficacious in preventing cerebrovascular accidents within the 6-month period, compared to conventional group.

H5 Incidence of bleeding in patients with left ventricular thrombi post-myocardial infarction on triple antithrombotic therapy with a lowered International Normalized Ratio (INR) range: a case series Germaine Wong, Grace Chang, Doreen Tan Khoo Teck Puat Hospital, Singapore, Singapore

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