Comparison of anticoagulation control and outcomes between usual medical care and pharmacist-led anticoagulation service in ambulatory patients taking warfarin at tertiary hospital in Ethiopia: a quasi-experimental study.

BACKGROUND: We aimed to compare anticoagulation control and outcomes between usual medical care (UMC) and pharmacist-led anticoagulation services (PLAS) in patients receiving warfarin at the Tikur Anbessa Specialized Hospital (TASH), Addis Ababa, Ethiopia. METHODS: A quasi-experimental study was conducted, including 350 (66.7%) and 175 (33.3%) patients from the UMC and PLAS groups, respectively, from 525 patients. The time in therapeutic range (TTR) was determined using the Rosendaal method, with a TTR ≥ 65% set as the cut-off for optimal anticoagulation. The two-sample Wilcoxon rank-sum (Mann-Whitney U) test was used to compare continuous variables between groups. Categorical variables were compared between groups using Pearson's chi-square test or Fisher's exact test. Logistic regression and negative binomial regression analyses were conducted to identify the factors associated with suboptimal TTR and secondary outcomes, respectively, at the p values < 0.05, and 95% confidence interval (CI). RESULTS: Compared with the UMC group, the patients in the PLAC group showed a significantly higher median (IQR) TTR [60.89% (43.5-74.69%) vs. 53.65% (33.92-69.14%), p < 0.001]. A significantly higher optimal TTR (≥ 65%) was achieved in the PLAC group (41.7% vs. 31.7%) than in the UMC group (p = 0.002). The odds of having a poor TTR were reduced by 43% (AOR = 0.57, 95% CI = 0.36-0.88, p = 0.01) among patients in the PLAC group compared to those in the UMC group. There were no statistically significant differences in the secondary outcomes between the groups, except for all-cause emergency visits (p = 0.003). The incidence of bleeding events decreased by 3% (IRR = 0.97, 95% CI = 0.96-0.99, p < 0.001) for every increase in INR monitoring frequency. The incidence of thromboembolic events increased by a factor of 15.13 (IRR = 15.13, 95% CI = 1.47-155.52, p = 0.02) among patients with a high-risk CHA2DS2-VASc score compared with those with a moderate score. CONCLUSION: Patients in the PLAC group had a significantly higher median TTR than those in the UMC group did. There were no statistically significant differences in the secondary outcomes between the groups, except for fewer all-cause emergency department visits in the PLAC group.

Changes in Time in Therapeutic Range Within a Warfarin Anticoagulation Clinic Following Introduction of Direct Oral Anticoagulants.

Background: As direct oral anticoagulants (DOACs) have become widely recommended as first-line anticoagulation therapy, patients who remain on warfarin are likely those unable to afford, adhere to, or utilize DOAC therapy due to the presence of a contraindication. It is currently unknown how availability of DOACs have affected populations being managed at warfarin (VKA) anticoagulation clinics. Methods: This was a retrospective chart review assessing warfarin-treated patients at an outpatient anticoagulation clinic. The primary endpoint was the 6-month time in therapeutic range (TTR) before and after DOACs were recommended as first-line therapy by clinical guidelines. Study periods were January to June 2015, before DOACs were recommended over VKA, and January to June 2022, when DOACs were often recommended over VKA. TTR, demographic changes, and the presence of contraindications to DOAC therapy in the clinic population between the two time periods were assessed. Results: No difference in 6-month TTR was observed between study periods (59% in 2015 vs 63% in 2022; P = .45). Patient demographics did not significantly vary, which may be due to the clinic retaining 45% of patients between both time periods. Contraindications to DOAC therapy were identified in 39% of the 2015 group and 49% of the 2022 group (P = .18). The most common contraindication was indication for anticoagulation. Conclusion: Availability of DOACs did not seem to significantly affect the population or management of warfarin-treated patients at an outpatient anticoagulation clinic, however, contraindications and potential challenges to use of DOAC therapy are present in many patients.

Comparison of medical documentation between pharmacist-led anticoagulation clinics and physician-led anticoagulation clinics: A retrospective study.

Background and objectives: High-quality documentation is critical in medical settings for providing safe patient care. This study was done with the objective of assessing the standard of medical records in anticoagulation clinics and investigating the distinctions between notes written by pharmacists and physicians. Methods: A retrospective cross-sectional analysis of data from electronic health records (EHRs) was performed on patients who received anticoagulation and were observed at anticoagulation clinics from October to December 2020. Patients were monitored in two anticoagulation clinics, one administered by pharmacists and the other by physicians. The quality of the documentation was assessed using a score, and the note was assigned one of five categories according to its score: very good, good, average, poor, and very poor. The data was analyzed using Stata/SE 13.1. P value<0.05 was considered significant in all analytical tests. Results: A total of 331 patients were included. While 160 patients (48.3%) were followed by the physician-led clinic, 171 (51.6%) were by the pharmacist-led clinic. The average age of the patients was 54 ± 15. 60.73% of them were female, and 90.3% of them were Saudi nationals. Warfarin was the most widely used anticoagulant (70%), followed by rivaroxaban (15.7%). Compared to physicians, pharmacists demonstrated very strong documentation (54% vs. 18%). The examination of the variables considered in the study revealed that physicians had significantly less drug-drug interaction documentation (17 vs. 71 times) or drug-food interaction documentation (23 vs. 71 times) than pharmacists. In terms of follow-up frequency, pharmacists were found to adhere to the clinic protocol (150 times) more frequently than physicians (104 times). However, there was no significant difference in therapeutic plan documentation between the two groups. (p = 0.416). Conclusion: Pharmacists were more comprehensive in their documentation than physicians in anticoagulation clinics. Unified clinic documentation can ensure consistent documentation within EHRs across all disciplines.

Prevalence of antiphospholipid antibody syndrome misclassification in an academic health system.

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

Trombosis venosa abdominal en una población adulta seguida en una clínica de anticoagulación / Abdominal venous thrombosis in an adult population followed in an anticoagulation clinic

Resumen Introducción: La trombosis venosa abdominal es inusual y es una de las formas menos estudiada de la enfermedad tromboembólica venosa. Objetivo: Describir las características epidemiológicas, los factores de riesgo, las complicaciones y el manejo anticoagulante en pacientes con diagnóstico de trombosis venosa abdominal, atendidos en una clínica de anticoagulación en Cali, Colombia. Materiales y método: Estudio descriptivo en el que se identificaron 83 pacientes con diagnóstico de trombosis venosa abdominal, manejados en la clínica de anticoagulación de la Fundación Valle del Lili, entre los años 2011 y 2019. La edad promedio fue de 53.3 ± 17.4 años y el 59% eran de sexo femenino. Fue más frecuente en las venas mesentéricas (19%), seguidas de la vena porta (18%). Los antecedentes incluyen cáncer, hipertensión arterial y estado hipercoagulable/trombofilia. Conclusiones: La trombosis venosa abdominal es una patología poco frecuente. El principal compromiso se presenta en la vena mesentérica. La enoxaparina es el manejo más frecuente. Los pacientes requieren en su mayoría anticoagulación extendida.

Abstract Introduction: Abdominal venous thrombosis is rare condition and is one of the least studied forms of venous thromboembolic disease. Objective: To describe the epidemiological characteristics, risk factors, complications and anticoagulant management in patients with a diagnosis of abdominal venous thrombosis, treated at an anticoagulation clinic in Cali, Colombia. Materials and method: Descriptive study, 83 patients with diagnosis of abdominal venous thrombosis were identified, managed in the anticoagulation clinic of Fundación Valle del Lili, between the years 2011 and 2019. The average age was 53.3 ± 17.4, and 59% female. More frequent in mesenteric veins (19%), followed by portal vein (18%). Personal antecedent includes cancer, high blood pressure, and hypercoagulable/thrombophilia status. Conclusions: Abdominal vein thrombosis is a rare disease. The main compromise occurs at the level of the mesenteric vein. Enoxaparin is the most common management. Most patients require extended anticoagulation.

Challenges of Anticoagulation Management Service and Need of Establishing Pharmacist-Led Anticoagulation Clinic in Tertiary Care Teaching Hospital, Ethiopia: A Qualitative Study.

Pupose: To explore the challenges of anticoagulation management (AMS) and assess the need for establishing a pharmacist-led anticoagulation clinic (PLAC) at Tikur Anbessa Specialized Hospital (TASH) in Addis Ababa, Ethiopia. Methods: We conducted a qualitative study at TASH. Using a semistructured interview guide, we interviewed 15 physicians from different specialties, heads of pharmacy and laboratory departments. We also included 20 patients to explore their general perceptions, and experiences with and challenges of AMS; and the need to implement PLAC in the hospital. Results: Only three physicians responded that they had protocols for initiating and maintaining warfarin dosing. Having protocols for venous thromboembolism (VTE) risk assessment, VTE prophylaxis and treatment, bleeding risk assessment, and contraindication to anticoagulant therapy were reported by seven, six, four, and three participants, respectively. Lack of trained healthcare professionals and a separate AMS clinic, inconsistency in INR testing and anticoagulant availability, and longer appointment times were the biggest challenges of the existing AMS, according to 80% of respondents. Fourteen patient respondents indicated that their satisfaction with the AMS was affected by long wait times and inconsistent availability of anticoagulants and INR testing. The head of the laboratory stated that the facilities for INR testing are inadequate and affect the quality of AMS and customer satisfaction, and supplemented by the head of the pharmacy by adding irregularities of supplies and inadequate counseling on anticoagulants. Respondents suggested that there is a need to establish a PLAC with well-adopted standard operating procedures, qualified manpower, adequate training of assigned staff, and sustained supply of anticoagulants and INR testing. Conclusion: The hospital's AMS is not optimal to provide adequate services during the study period. Based on these findings and recommendations, the supporting literature, and the experiences of other facilities, the PLAC was established in TASH.

Caracterización de una población pediátrica seguida en una clínica de anticoagulación / Description of a pediatric population followed at an anticoagulation clinic

Resumen Introducción: En la población pediátrica, el 95% de las tromboembolias venosas son secundarias a un factor de riesgo; la presencia de catéter venoso central es el factor de riesgo más importante para el desarrollo de trombosis venosa profunda en esta población. Los estudios en población adulta sobre el uso de anticoagulantes se han extrapolado a la población pediátrica, y por ello es importante tener en cuenta las características diferenciales entre ambas poblaciones. Método: Se realizó un estudio descriptivo en el que se revisaron 2300 registros clínicos de pacientes seguidos por la Clínica de Anticoagulación institucional desde 2011 hasta 2019, buscando identificar pacientes menores de 18 años que hubieran recibido manejo anticoagulante ambulatorio. Resultados: Se encontraron 43 pacientes menores de 18 años, el 60% de sexo femenino, con una edad promedio de 9.8 ± 5.2 años. El antecedente patológico más prevalente fueron las valvulopatías (28%). Las principales indicaciones para recibir manejo anticoagulante incluyeron cardiopatías congénitas (21%), prótesis valvular cardíaca mecánica (21%, 5 aórticas y 4 mitrales) y trombosis venosa profunda (14%). La warfarina se utilizó en el 72% de los pacientes. El 81% de los pacientes recibieron tratamiento anticoagulante extendido. Las principales complicaciones durante el tratamiento anticoagulante fueron sangrado ginecológico y cutáneo, así como trombocitopenia. Conclusiones: Las cardiopatías congénitas y las valvulopatías cardíacas son las principales indicaciones para considerar el manejo anticoagulante en la población pediátrica. La warfarina es el medicamento más utilizado en forma ambulatoria en esta población. La adherencia adecuada y el seguimiento ambulatorio en esta población requieren herramientas adicionales para lograr un excelente tratamiento anticoagulante.

Abstract Introduction: In pediatric patients, 95% of venous thromboembolisms are secondary to a risk factor; the presence of central venous catheter is the most important risk factor for the development of deep vein thrombosis in this population. Studies about anticoagulation treatment in adult patients have been extrapolated to the pediatric population, it is important to consider the differential characteristics between these two populations. Method: A descriptive study was conducted; there were reviewed 2300 clinical records of patients followed by the institutional anticoagulation clinic from 2011 to 2019, looking for underage patients who have received ambulatory anticoagulation treatment management. Results: 43 patients under the age of 18 years old were found. 60% were female and the average age was 9.8 ± 5.2 years. The most prevalent pathological antecedent was valve disease (28%). The main indications for anticoagulant treatment included congenital heart disease (21%), mechanical heart valves (21%, 5 aortic and 4 mitral) and deep vein thrombosis (14%). Warfarin was found in 72% of patients. 81% of patients received extended anticoagulation therapy. The main complications during anticoagulant treatment included gynecological and cutaneous bleeding, as well as thrombocytopenia. Conclusions: Congenital heart disease and heart valve disease are the main indications for considering anticoagulation treatment in the pediatric population. Warfarin is the most formulated anticoagulant in this outpatient population. Adequate adherence and outpatient follow-up in requires additional tools to achieve excellent anticoagulant treatment.

Improving preprocedure antithrombotic management: Implementation and sustainment of a best practice alert and pharmacist referral process.

BACKGROUND: Electronic medical record-based interventions such as best practice alerts, or reminders, have been proposed to improve evidence-based medication prescribing. Formal implementation evaluation including long-term sustainment are not commonly reported. Preprocedural medication management is often a complex issue for patients taking antithrombotic medications. METHODS: We implemented a best practice alert (BPA) that recommended referral to an anticoagulation clinic before outpatient elective gastrointestinal (GI) endoscopies. Eligible patients were taking an oral anticoagulant (warfarin or direct oral anticoagulant [DOAC]) and/or antiplatelet medications. Patients referred to the anticoagulation clinic were compared to those managed by the ordering provider. Outcomes assessed included guideline-adherent drug management before endoscopy, documentation of a medication management plan, guideline-adherent rates of bridging for high-risk patients taking warfarin, and evaluation for sustained use of BPA. RESULTS: Eighty percent of patients (553/691) were referred to the anticoagulation clinic during the initial 13-month study period. Most referrals came from gastroenterologists (397/553; 71.8%) followed by primary care providers (127/554; 22.9%). Patients referred had improved rates of guideline-adherent medication management compared to those who were not referred (97.4% vs 91.0%; P = .001). Documentation of medication plan was significantly higher in the referred group (99.1% vs 59.4%; P ≤ .001). There were no differences in rates of appropriate bridging for patients taking warfarin. Implementation of the BPA also resulted in sustained, consistent use over an additional 18 months following the initial study period. CONCLUSION: Implementation of a BPA before elective outpatient GI endoscopies was associated with improved rates of guideline-adherent medication management and documented management plan, while streamlining preprocedural medication management.

Implementation and Evaluation of Virtual Anticoagulation Clinic Care to Provide Incessant Care During COVID-19 Times in an Indian Tertiary Care Teaching Hospital.

Background: COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-II) has become a global pandemic disrupting public health services. Telemedicine has emerged as an important tool to deliver care during these situations. Patients receiving Vitamin K antagonists (VKA) require structured monitoring which has posed a challenge during this pandemic. We aimed to evaluate the impact of Virtual anticoagulation clinic (VAC), a Telehealth model on the quality of anticoagulation, adverse events, and patient satisfaction vis-a-vis standard Anticoagulation clinic (ACC) care. Materials and methods: A bidirectional cohort study was conducted in the Department of Cardiology, JSS Hospital, Mysore. Two hundred and twenty-eight patients in the VAC and 274 patients in the ACC fulfilling inclusion criteria were the subjects of the study. Telehealth tools like WhatsApp and telephone were used. Time in therapeutic range (TTR), Percentage of International normalized ratio in range (PINRR), and adverse events were analyzed and compared between the VAC group and the ACC group, between pre-COVID and COVID ACC groups, and between the VAC group and the same pre-COVID cohort. Patient satisfaction was assessed by a questionnaire at the end of 8 months. Descriptive statistics were used for the patient characteristics and inferential statistics for the comparisons between pre-VAC and VAC care. Results: The mean TTR was 75.4 ± 8.9% and 71.2 ± 13.4% in the VAC group and ACC group, respectively (p < 0.001). The mean PINRR was 66.7 ± 9.4% and 62.4 ± 10.9% in the VAC group and ACC group respectively, (p < 0.001). There was no significant difference in TTR between the VAC group and the same pre-COVID cohort. The TTR differential between the pre-COVID and COVID ACC groups was significant. In either group, no major adverse events were seen. The most common tools used for data exchange were WhatsApp (83%) and SMS (17%). Seventy-four percent of patients were extremely satisfied with the overall VAC care. Conclusions: Virtual anticoagulation clinic, a telehealth model can be used as an alternative option to deliver uninterrupted anticoagulation care during pandemic times.

Budget Impact Analysis of Anticoagulation Clinics in Patients with Atrial Fibrillation under Chronic Therapy with Oral Anticoagulants.

OBJECTIVES: To assess budget impact of the implementation of an anticoagulation clinic (AC) compared to usual care (UC), in patients with non-valvular atrial fibrillation (NVAF). METHOD: A decision tree was designed to analyze the cost and events rates over a 1-year horizon. The patients were distributed according to treatment, 30% Direct Oral Anticoagulant (DOAC) regimens and the rest to warfarin. The thromboembolism and bleeding were derived from observational studies which demonstrated that ACs had important impact in reducing the frequency of these events compared with UC, due to higher adherence with DOACs and proportion of time in therapeutic range (TTR) with warfarin. Costs were derived from the transactional platform of Colombian government, healthcare authority reimbursement and published studies. The values were expressed in American dollars (USD). The exchanged rate used was COP $3.693 per dollar. RESULTS: During 1 year of follow-up, in a cohort of 228 patients there were estimated 48 bleedings, 6 thromboembolisms in AC group versus 84 bleedings, and 12 thromboembolisms events in patients receiving UC. Total costs related to AC were $126 522 compared with $141 514 in UC. The AC had an important reduction in the cost of clinical events versus UC ($52 085 vs $110 749) despite a higher cost of care facilities ($74 436 vs $30 765). A sensibility analysis suggested that in the 83% of estimations, the AC produced savings varied between $27 078 and $135 391. CONCLUSIONS: This study demonstrated that AC compared with UC, produced an important savings in the oral anticoagulation therapy for patients with NVAF.

Outpatient management of chronic warfarin therapy at a pharmacist-run anticoagulation clinic during the COVID-19 pandemic.

As a result of infection control regulations during the coronavirus disease 2019 (COVID-19) pandemic, anticoagulation clinics have been required to adjust their practices in order to continue providing safe and effective services for their patients. In accordance with a guidance document issued by the Anticoagulation Forum, The Brooklyn Hospital Center (TBHC) anticoagulation clinic in Brooklyn, New York implemented measures including telemedicine follow-ups instead of in-person clinic visits, extending the interval of INR testing, and reviewing eligible candidates for transition from warfarin to direct oral anticoagulants. This study describes the outcomes of one hospital-based clinic location in the 3 months before and after COVID-19 became a significant concern in the New York City area. The primary outcome of time-in-therapeutic range (TTR) for patients receiving warfarin was 60.6 % and 65.8 % in the pre-COVID and post-COVID groups, respectively (p = 0.21). For secondary outcomes, there was no difference in percent of therapeutic INRs (51.5 % pre-COVID v. 44.8 % post-COVID, p = 0.75) or percent of INRs ≥ 4.5 (2.3 % pre-COVID v. 4 % post-COVID, p = 0.27). Based on the data reported in this study, the short-term changes implemented at TBHC's anticoagulation clinic did not appear to cause reductions in safety and efficacy of chronic warfarin therapy management.

[Argentine Consensus in effective management of anticoagulation clinics for the use of vitamin k antagonists]. / Consenso Argentino en gestión efectiva de clínicas de anticoagulación para el uso de antagonistas de la vitamina k.

Treating an anticoagulated patient with vitamin K antagonists (VKA) remains a challenge, especially in areas where dicoumarins are still the first drug of choice due to the cost of other oral anticoagulants. Anticoagulation clinics have proven to be the most efficient and safe way to avoid thrombotic and hemorrhagic complications and to keep patients in optimal treatment range. However, they require adequate infrastructure and trained personnel to work properly. In this Argentine consensus we propose a series of guidelines for the effective management of the anticoagulation clinics. The goal is to achieve the excellence in both the clinical healthcare and the hemostasis laboratory for the anticoagulated patient. The criteria developed in the document were agreed upon by a large group of expert specialists in hematology and biochemistry from all over the country. The criteria presented here must always be considered when indicating VKA although they had to be adapted to the unequal reality of each center. Taking these premises into consideration will allow us to optimize the management of the anticoagulated patient with VKA and thus minimize thrombotic and hemorrhagic intercurrences, in order to honor our promise not to harm the patient.

El tratamiento de un paciente anticoagulado con antagonistas de la vitamina K (AVK) sigue siendo un desafío, especialmente en regiones donde, por el costo, los dicumarínicos son todavía la alternativa más buscada a la hora de elegir un anticoagulante oral. Las clínicas de anticoagulación han demostrado ser la forma más eficiente y segura de evitar complicaciones trombóticas y hemorrágicas y de mantener al paciente en rango óptimo de tratamiento. Sin embargo, requieren de una adecuada infraestructura y personal capacitado para que funcionen eficientemente. En este consenso argentino se propone una serie de parámetros para la gestión efectiva de una clínica de anticoagulación. El objetivo es lograr una elevada calidad desde el punto de vista clínico-asistencial a través de un laboratorio de hemostasia de excelencia. Los criterios desarrollados en el documento fueron consensuados por un amplio grupo de expertos especialistas en hematología y en bioquímica de todo el país. Estos criterios deben adaptarse a la irregular disponibilidad de recursos de cada centro, pero siempre se los debe tener en cuenta a la hora de indicar el tratamiento anticoagulante con estas drogas. Tener en consideración estas premisas nos permitirá optimizar la atención del enfermo anticoagulado con AVK y de esta forma minimizar las intercurrencias trombóticas y hemorrágicas a las que está expuesto, para así honrar nuestra promesa de no dañar al paciente.

Consenso argentino en gestión efectiva de clínicas de anticoagulación para uso de antagonistas de la vitamina K / Argentine consensus in effective management of anticoagulation clinics for the use of vitamin K antagonists

Resumen El tratamiento de un paciente anticoagulado con antagonistas de la vitamina K (AVK) sigue siendo un desafío, especialmente en regiones donde, por el costo, los dicumarínicos son todavía la alternativa más buscada a la hora de elegir un anticoagulante oral. Las clínicas de anticoagulación han demostrado ser la forma más eficiente y segura de evitar complicaciones trombóticas y hemorrágicas y de mantener al paciente en rango óptimo de tratamiento. Sin embargo, requieren de una adecuada infraestructura y personal capacitado para que funcionen eficientemente. En este consenso argentino se propone una serie de parámetros para la gestión efectiva de una clínica de anticoagulación. El objetivo es lograr una elevada calidad desde el punto de vista clínico-asistencial a través de un laboratorio de hemostasia de excelencia. Los criterios desarrollados en el documento fueron consensuados por un amplio grupo de expertos especialistas en hematología y en bioquímica de todo el país. Estos criterios deben adaptarse a la irregular disponibilidad de recursos de cada centro, pero siempre se los debe tener en cuenta a la hora de indicar el tratamiento anticoagulante con estas drogas. Tener en consideración estas premisas nos permitirá optimizar la atención del enfermo anticoagulado con AVK y de esta forma minimizar las intercurrencias trombóticas y hemorrágicas a las que está expuesto, para así honrar nuestra promesa de no dañar al paciente.

Abstract Treating an anticoagulated patient with vitamin K antagonists (VKA) remains a challenge, especially in areas where dicoumarins are still the first drug of choice due to the cost of other oral anticoagulants. Anticoagulation clinics have proven to be the most efficient and safe way to avoid thrombotic and hemorrhagic complications and to keep patients in optimal treatment range. However, they require adequate infrastructure and trained personnel to work properly. In this Argentine consensus we propose a series of guidelines for the effective management of the anticoagulation clinics. The goal is to achieve the excellence in both the clinical healthcare and the hemostasis laboratory for the anticoagulated patient. The criteria developed in the document were agreed upon by a large group of expert specialists in hematology and biochemistry from all over the country. The criteria presented here must always be considered when indicating VKA although they had to be adapted to the unequal reality of each center. Taking these premises into consideration will allow us to optimize the management of the anticoagulated patient with VKA and thus minimize thrombotic and hemorrhagic intercurrences, in order to honor our promise not to harm the patient.

Evaluation of Anticoagulant Effects of Clinical Pharmacist Management in Anticoagulation Clinic / 中国药房

OBJECTIVE：To eva luate the anticoagulant effect of clinical pharmacist management in clinic. METHODS ：Retro- spective analysis was performed on medical records of 481 patients in anticoagulant clinic of Nanjing Drum Tower Hospital （herein- after referred as “our hospital ”）from Aug. 2019 to Jan. 2020. The general information （gender，age，patient grading ）of patients ， anticoagulant drug ，anticoagulant causes ，anticoagulant examination [prothrombin time ，international standardized ratio results （INR）]，warfarin dose ，NOACs usage and ADR were recorded. RESULTS ：Totally 481 patients visited anticoagulant clinic of our hospital for 1 587 times in total. The case number of primary ，secondary and tertiary patients were 401，547 and 639，respectively. 470 patients received warfarin ，and 11 patients received NOACs （including 6 cases of riva roxaban，5 cases of dabigatran etexi - . The valve replacement was the main cause of anticoagu - lation（65.28％），followed by atrial fibrillation （14.97％）， valve ring repairment （12.47％）. The main detection method NDYG2017012） of prothrombin time was POCT （83.44％）. Their average dose of warfarin was （3.03±1.28）mg. The average INR of outpa - tients receiving warfarin was 1.99±0.56，and time within treat - E-mail：xiaochongzi78@sina.com ment range （TTR）was 72.79％. The average INR of the first grade was 2.12±0.84 and the TTR was 44.33％；the average INR of the second grade was 1.95±0.52 and the TTR was 72.34％； the average INR of the third grade was 1.94±0.33 and the TTR was 90.42％. There were 102 cases（6.43％）of small bleeding ， and 2 cases（0.13％）of clinical related non major bleeding ；no major bleeding and thromboembolism was observed. CONCLU - SIONS：Clinical pharmacists of anticoagulant clinic in our hospital formulate scientific management and provide individualized con - sultation for patients through implementing hierarchical management of patients. Patients show mild symptoms and low incidence of adverse reactions ；the patients taking warfarin have higher TTR ；clinical pharmacist management has significant anticoagulant effect.

Anticoagulation with rivaroxaban in a hematology unit: clinical profile, events and discontinuation rates in real-life patients with nonvalvular atrial fibrillation.

AIM: To assess the clinical profile and thromboembolic and bleeding events in patients with nonvalvular atrial fibrillation (AF) who were attended in a hematology unit. METHODS: Retrospective study of AF patients that started treatment with rivaroxaban between February 2012 and June 2016 in a hematology unit from a tertiary hospital in Spain. RESULTS: Overall, 243 patients (mean age 78.4 ± 10.1 years; 47.5% women, CHA2DS2-VASc 3.7 ± 1.5) were included. After a mean follow-up of 16.5 ± 12.7 months, rivaroxaban was discontinued in only 2.4% of patients. During the follow-up, seven (2.0 events/100 patient-years) patients had a thromboembolic event and six patients (1.7 events/100 patient-years) a major bleeding. CONCLUSION: Rivaroxaban was effective and safe among AF patients treated in a hematology unit, with very low discontinuation rates.

Conservative Management of Overanticoagulation in Patients With Low-Moderate Risk for Bleeding Complications.

Despite long-standing experience with warfarin, anticoagulation clinic services are often confronted with the challenging clinical situation of patients with overanticoagulation. This requires repeat international normalized ratio (INR) monitoring and in some cases administration of vitamin K to minimize the risk of bleeding. A study was performed to determine the safety and efficacy of outpatient management in order to provide guidance on the management of patients with prolonged INRs. Patients on stable warfarin therapy for more than 1 month attending a dedicated academic hospital anticoagulation clinic who had an INR ≥5 were identified over a 1-year period. Follow-up INR results and outcomes were recorded for 30 days. One hundred and ninety-five episodes of overanticoagulation in 148 patients were identified. Patients were classified as low risk (n = 85, 57.4%) and moderate risk of bleeding (n = 63, 42.6%). The mean index INR was 7.22 (1.88). Management with low-dose oral vitamin K (n = 32, 16.4%) did not significantly result in a more rapid correction of the INR when compared to conservative management (n = 163, 83.6%; P = .103). Follow-up INR testing was performed at a mean of 11.1 (8.9) days from the index measurement. A mean of 1.6 (0.9) follow-up INR tests were performed per episode. During the 30-day follow-up, there was 1 (0.5%) episode of major bleeding and 1 (0.5%) death. The management of asymptomatic outpatients with overanticoagulation is associated with a low risk of major bleeding within 30 days. Conservative management of overanticoagulation is as effective as utilizing low-dose oral vitamin K.

Cost-Effectiveness of Warfarin Medication Therapy Adherence Clinic versus Usual Medical Clinic at Kuala Lumpur Hospital.

BACKGROUND: Systematic anticoagulation management clinic is recommended to manage patients on chronic warfarin therapy. In Malaysia, the service was introduced as warfarin medication therapy adherence clinic (WMTAC), which is managed by pharmacists with a physician advisory. OBJECTIVES: To assess the cost-effectiveness of WMTAC in comparison with usual medical clinic (UMC), which is managed by medical officers in Kuala Lumpur Hospital, a tertiary referral hospital in Malaysia. METHODS: Data from a 6-month retrospective cohort study comparing the two clinics and the mean percentages of time in the therapeutic range for the patients were used to estimate the cost-effectiveness. The mean clinic costs were estimated using the time-motion study. A Markov model with a 6-monthly cycle was used to simulate lifetime cost-effectiveness from the perspective of the health care service provider. The base-case analysis assumed a cohort of patients with atrial fibrillation, 57 years of age with comorbid illnesses. The transition probabilities of these clinic outcomes were obtained from a literature search. Future costs and effectiveness were discounted by 3% to convert to present values. All costs were in Malaysian ringgit standardized for the year 2007. RESULTS: The mean 6-month treatment cost was lower for the WMTAC, which was significantly lower (P < 0.001). The UMC was found to be dominated by the WMTAC for both intermediate and lifetime analyses. The sensitivity analysis showed that clinic consultation costs had a major impact on the cost-effectiveness analysis. CONCLUSIONS: WMTAC is a more cost-effective option than UMC in Kuala Lumpur Hospital.

Effect of increased time in the therapeutic range on atrial fibrillation outcomes within a centralized anticoagulation service.

BACKGROUND: Clinical pharmacy anticoagulation services have improved the quality of anticoagulant therapy and are associated with lower rates of bleeding and thromboembolism compared to usual care. Several studies have found that higher time-in-therapeutic range (TTR) during warfarin therapy is associated with better warfarin outcomes. However, whether increasing TTR over time within an established anticoagulation service is associated with further reduction in bleeding and thromboembolic outcomes is unknown. METHODS: This was a retrospective cohort study of patients with atrial fibrillation conducted at an integrated healthcare delivery system with a centralized, pharmacist-managed anticoagulation service. Clinical outcomes (clinically-relevant bleeding, ischemic stroke or systemic embolism, and all-cause mortality) and TTR were compared between two distinct time periods: 1/1/2006 through 12/31/2007 (control group) and 1/1/2012 through 12/31/2013 (observation group) with regression modeling to adjustment for potential confounders. RESULTS: There were 3641 and 4764 patients in the control and observation groups, respectively. The mean age was 74.3 years and 54.4% of the cohort was female. Mean TTR was higher in the observation group (70.5% vs. 63.4%, p < 0.001). The composite outcome of clinically-relevant bleeding, thromboembolism and all-cause mortality occurred in 4.6% and 3.6% of the control and observation groups, respectively (adjusted odds ratio = 0.69; 95% confidence interval 0.54-0.87). Individual rates of stroke/systemic embolism and all-cause mortality were each lower in the observation group (both p < 0.05) while clinically-relevant bleeding was not significantly different (p = 0.256). CONCLUSION: Increased TTR within a clinical pharmacy anticoagulation management service was associated with a lower risk of the composite outcomes of bleeding, thromboembolism and death in a large atrial fibrillation population receiving warfarin.

Expanding anticoagulation management services to include direct oral anticoagulants.

Despite the ease of use of direct oral anticoagulants (DOACs), these agents remain high risk medications and their clinical efficacy can be impacted by factors such as patient adherence, drug procurement barriers, bleeding leading to discontinuation, and prescribing that deviates from approved dosing regimens. Clinical monitoring of patients on DOACs should be performed by clinicians who specialize in anticoagulation and are familiar with the nuances of DOAC dosing, monitoring, and other components of anticoagulation management including peri-procedural management and care transitions. Although data for centralized warfarin management have consistently demonstrated improved clinical outcomes compared to traditional management by individual community providers, there are no published data addressing the impact of centralized management of DOACs on clinical outcomes or anticoagulation control. In addition, there is currently no consensus on how to incorporate patients on DOACs into this centralized model, despite recommendations for systematic follow-up by both the Anticoagulation Forum and the Institute for Safe Medication Practices. Based on the national recommendations and an identified institutional need, the Brigham and Women's Hospital Anticoagulation Management Service implemented a pilot program to expand services to include patients newly initiated on, or transitioned to, a DOAC. We describe our model for expansion of the AMS to include patients on DOACs.

Incorporating Comprehensive Management of Direct Oral Anticoagulants into Anticoagulation Clinics.

Anticoagulation clinics emerged as a means to optimize warfarin effectiveness and minimize bleeding risks. Anticoagulation clinics have traditionally been warfarin-based models due to the need for frequent blood-level monitoring, drug interactions, dietary considerations, and periprocedural management with warfarin. These models have demonstrated improved anticoagulation control and reduced bleeding complications for patients taking warfarin. Direct oral anticoagulants (DOACs) emerged with the perception of improved convenience due to the lack of blood-level monitoring and lack of dietary considerations. Despite the advantages of DOAC therapy, new challenges exist with their management, warranting ongoing monitoring. Such challenges include prescribing and dosing issues, drug adherence, drug interactions, and high drug cost. Comprehensive anticoagulation centers are needed to manage and monitor all oral anticoagulants including DOACs. The objectives of this review are to describe the challenges and opportunities that exist in the management of DOACs and to describe a practice model that integrates a DOAC management service into the traditional anticoagulation clinic.