Characterization of Antithrombotic Regimens for Patients with Nonvalvular Atrial Fibrillation and Obesity Discharged from Cardiology Wards.

Background: Despite data derived from observational studies, optimal anticoagulation strategies have yet to be established for patients with nonvalvular atrial fibrillation and obesity. Objective: To describe direct oral anticoagulant (DOAC) regimens prescribed for adult patients with nonvalvular atrial fibrillation who weighed more than 120 kg. Methods: This single-centre, retrospective cohort study, conducted in the Saskatchewan Health Authority - Regina Area, involved adult patients with body weight greater than 120 kg who had an indication for oral anticoagulation to treat nonvalvular atrial fibrillation and were discharged by a cardiologist between June 2019 and July 2021. Results: A total of 62 patients were included (median weight 135 kg). At discharge, DOACs were prescribed for 57 (92%) of the patients and warfarin for 5 (8%). In numeric terms, patients receiving warfarin were at higher risk of thromboembolism or thrombosis; however, the small sample size limited the ability to draw conclusions. Conclusions: Practice patterns in the Saskatchewan Health Authority - Regina Area indicated substantial use of DOACs for patients with body weight greater than 120 kg; however, for those with the highest weights, warfarin was still in use.

Contexte: Malgré les données dérivées d'études observationnelles, les stratégies d'anticoagulation optimales n'ont pas été consolidées pour les patients atteints de fibrillation auriculaire non valvulaire et d'obésité. Objectif: Décrire les schémas thérapeutiques d'anticoagulants oraux (ACO) prescrits aux patients adultes atteints de fibrillation auriculaire non valvulaire et qui pesaient plus de 120 kg. Méthodes: Cette étude de cohorte rétrospective monocentrique menée dans l'office de la santé de la Saskatchewan à Regina a porté sur des patients adultes pesant plus de 120 kg qui avaient une indication de traitement anticoagulant oral pour traiter la fibrillation auriculaire non valvulaire et qui ont été renvoyés par un cardiologue entre juin 2019 et juillet 2021. Résultats: Au total, 62 patients ont été inclus (poids médian, 135 kg). Au congé, des ACO ont été prescrits à 57 (92 %) des patients et de la warfarine à 5 (8 %) d'entre eux. En termes numériques, les patients traités par warfarine présentaient un risque plus élevé de thromboembolie ou de thrombose; cependant, la petite taille de l'échantillon a limité la capacité de tirer des conclusions. Conclusions: Les modèles de pratique de l'office de la santé de la Saskatchewan à Regina indiquaient une utilisation importante des ACO pour les patients dont le poids corporel était supérieur à 120 kg; cependant, pour les personnes ayant le poids le plus élevé, la warfarine était toujours utilisée.

Anticoagulation Interventions by Pharmacists in Acute Care.

Background: Clinical pharmacy key performance indicators (cpKPIs) relate to activities performed by pharmacists that have been shown to improve patient outcomes. Within Saskatchewan Health Authority (SHA) Regina, most cpKPIs are incorporated into the organization's clinical practice standards, which provide guidance in prioritizing care, especially for high-risk medications, including anticoagulants. To track pharmacists' interventions associated with clinical practice standards, a locally developed electronic data-capture system (known as AIM High) was implemented. Objectives: To quantify and describe pharmacists' anticoagulation interventions on 16 wards with dedicated ward-based clinical pharmacists and to compare intervention rates between the cardiology and internal medicine wards to further evolve the organization's practice model. Methods: Data from the electronic data-capture system were retrospectively analyzed for a 5-year period (January 2016 to December 2020). Results: A total of 94 201 interventions were recorded in the AIM High system (average 362 interventions per week or 26 interventions per pharmacist per week). Of these, 15 661 (16.6%) cited the anticoagulation standard (average 60 anticoagulation interventions per week or 4 anticoagulant interventions per pharmacist per week). For the cardiology and internal medicine wards, 4183 of 11 888 (35.2%) and 9034 of 54 843 (16.5%) interventions cited the anticoagulation standard, respectively. The top 4 types of anticoagulation interventions were dose changed (n = 4372 or 27.9%), drug started or restarted (n = 3867 or 24.7%), patient education (n = 3094 or 19.8%), and drug discontinued (n = 2944 or 18.8%). Conclusion: Dedicated ward-based clinical pharmacists were following clinical practice standards incorporating the majority of cpKPIs to complete anticoagulation interventions. The types of anticoagulation interventions evolved over time and were influenced by the patient population.

Contexte: Les indicateurs clés de performance en pharmacie clinique (ICPEPC) se rapportent à des activités exécutées par des pharmaciens qui ont fait leurs preuves dans l'amélioration des résultats pour les patients. À la Saskatchewan Health Authority (SHA) Regina, la plupart des ICPEPC sont intégrés aux normes de pratique clinique de l'organisme. Celles-ci fournissent des conseils pour hiérarchiser les soins liés aux médicaments, en particulier ceux associés aux médicaments à haut risque, notamment les anticoagulants. Un système électronique de saisie de données développé localement, le « AIM High ¼, a été mis en place afin de suivre les interventions des pharmaciens associées aux normes de pratique clinique. Objectifs: Quantifier et décrire les interventions des pharmaciens en matière d'anticoagulation dans 16 services avec des pharmaciens cliniciens dédiés et comparer les taux d'intervention entre les services de cardiologie et de médecine interne en vue de faire évoluer davantage le modèle de pratique de l'organisation. Méthodes: Les données du système électronique de saisie des données ont été analysées rétrospectivement sur une période de 5 ans (de janvier 2016 à décembre 2020). Résultats: Au total, 94 201 interventions ont été enregistrées dans le système (moyenne de 362 interventions par semaine ou 26 interventions par pharmacien par semaine). Parmi celles-ci, 15 661 (16,6 %) citent la norme d'anticoagulation (moyenne de 60 interventions d'anticoagulation par semaine ­ soit 4 interventions d'anticoagulation par pharmacien par semaine). Pour les services de cardiologie et de médecine interne, 4183 (35,2%) des 11 888 et 9034 (16,5 %) des 54 843 interventions citent respectivement la norme d'anticoagulation. Les 4 principaux types d'interventions d'anticoagulation étaient le changement de dose (n = 4372 ou 27,9 %), le traitement commencé ou redémarré (n = 3867 ou 24,7 %), l'éducation du patient (n = 3094 ou 19,8 %) et l'arrêt du médicament (n = 2944 ou 18,8 %). Conclusion: Les pharmaciens cliniques dédiés au service suivaient les normes de pratique clinique incorporant la majorité des ICPEPC pour mener à bien les interventions d'anticoagulation. Les types d'interventions d'anticoagulation ont évolué au fil du temps et ont été influencés par la population de patients.

Pharmacokinetics of apixaban and tacrolimus or cyclosporine in kidney and lung transplant recipients.

Apixaban is frequently used off-label in transplant recipients. However, a potential drug interaction exists with the calcineurin inhibitors. We conducted an open-label drug-drug interaction study to determine the pharmacokinetics of apixaban in lung and kidney transplant recipients who were taking a calcineurin inhibitor. A single dose of apixaban 10 mg was administered orally to kidney and lung transplant recipients maintained on either tacrolimus or cyclosporine, and pharmacokinetic parameters were compared to a reference cohort of 12 healthy subjects who used the same apixaban dose and pharmacokinetic blood sampling. Fourteen participants were enrolled (n = 6 kidney, n = 8 lung), with 10 maintained on tacrolimus and four on cyclosporine. Data from 13 participants was usable. Participants were taking triple therapy immunosuppression and had a mean (SD) of 12 (3) medications. Participants receiving tacrolimus and cyclosporine had area under the plasma concentration-time curve from time zero to infinity (AUC0-inf ) geometric least square means (90% confidence interval [CI]) of 4312 (95% CI 3682, 5049) and 5388 (95% CI 3277, 8858), respectively. Compared to healthy subjects, the associated geometric mean ratios (GMRs) for apixaban maximum plasma concentration (Cmax ), AUC from time zero to the last quantifiable concentration (AUC0-tlast ) and AUC0-inf were 197% (95% CI 153, 295), 244% (95% CI 184, 323), and 224% (95% CI 170, 295) for transplant recipients on tacrolimus. The GMR (90% CI) Cmax , AUC0-tlast , and AUC0-inf of apixaban for patients on cyclosporine were 256% (95% CI 184, 358), 287% (95% CI 198, 415), and 280% (95% CI 195, 401). Kidney and lung transplant recipients receiving tacrolimus had higher apixaban exposure. A similar trend was noted for patients receiving cyclosporine, but additional patients are needed to confirm this interaction. Future studies are needed before apixaban can be safely recommended in this population, and the impact of dose staggering should be investigated. This study highlights the importance of pharmacokinetic studies in actual patient populations.

Canadian Stroke Best Practice Recommendations: Secondary Prevention of Stroke Update 2020.

The 2020 update of the Canadian Stroke Best Practice Recommendations (CSBPR) for the Secondary Prevention of Stroke includes current evidence-based recommendations and expert opinions intended for use by clinicians across a broad range of settings. They provide guidance for the prevention of ischemic stroke recurrence through the identification and management of modifiable vascular risk factors. Recommendations address triage, diagnostic testing, lifestyle behaviors, vaping, hypertension, hyperlipidemia, diabetes, atrial fibrillation, other cardiac conditions, antiplatelet and anticoagulant therapies, and carotid and vertebral artery disease. This update of the previous 2017 guideline contains several new or revised recommendations. Recommendations regarding triage and initial assessment of acute transient ischemic attack (TIA) and minor stroke have been simplified, and selected aspects of the etiological stroke workup are revised. Updated treatment recommendations based on new evidence have been made for dual antiplatelet therapy for TIA and minor stroke; anticoagulant therapy for atrial fibrillation; embolic strokes of undetermined source; low-density lipoprotein lowering; hypertriglyceridemia; diabetes treatment; and patent foramen ovale management. A new section has been added to provide practical guidance regarding temporary interruption of antithrombotic therapy for surgical procedures. Cancer-associated ischemic stroke is addressed. A section on virtual care delivery of secondary stroke prevention services in included to highlight a shifting paradigm of care delivery made more urgent by the global pandemic. In addition, where appropriate, sex differences as they pertain to treatments have been addressed. The CSBPR include supporting materials such as implementation resources to facilitate the adoption of evidence into practice and performance measures to enable monitoring of uptake and effectiveness of recommendations.

Use of low-dose acetylsalicylic acid for cardiovascular disease prevention: A practical, stepwise approach for pharmacists.

Low-dose acetylsalicylic acid (ASA) is recommended in patients with established cardiovascular disease. However, the role of ASA in those without cardiovascular disease (i.e., primary prevention) is less clear, which has led to discordance among Canadian guidelines. In 2018, 3 double-blind, randomized controlled trials were published that evaluated ASA 100 mg daily versus placebo in patients without established cardiovascular disease. In the ASPREE trial, ASA did not reduce the risk of all-cause death, dementia, or persistent physical disability in patients ≥70 years of age but increased the risk of major bleeding. In the ARRIVE trial, ASA failed to lower the risk of a composite of cardiovascular events but increased any gastrointestinal bleeding in patients at intermediate risk of cardiovascular disease. In the ASCEND trial, ASA significantly reduced the primary composite cardiovascular outcome in patients with diabetes for a number needed to treat of 91 over approximately 7.4 years. Yet major bleeding was increased with ASA for a number needed to harm of 112. Therefore, in most situations, ASA should not be recommended for primary cardiovascular prevention. However, there are additional indications for ASA beyond cardiovascular disease. Thus, a sequential algorithm was developed based on contemporary evidence to help pharmacists determine the suitability of ASA in their patients and play an active role in educating their patients about the potential benefits (or lack thereof) and risks of ASA. Can Pharm J (Ott) 2020;153:xx-xx.

Use of Direct Oral Anticoagulants Versus Traditional Therapies for Acute Venous Thromboembolism After Direct Discharge From the Emergency Department or After Hospitalization: An Audit of 16 Canadian Hospitals.

PURPOSE: This study compares and describes the use of direct oral anticoagulants (DOACs) versus traditional therapies (parenteral anticoagulant with or without warfarin) for acute venous thromboembolism (VTE) between individuals discharged directly from the emergency department (ED) versus those hospitalized. This study also reports patterns based on discharge from an academic, community, or rural-based site. METHODS: This retrospective medical records study included patients discharged with acute VTE (2015-2016) from 16 institutions across 4 provinces. Patients with atypical clots, other indications for anticoagulants, or an anticipated lifespan <3 months or those who were pregnant or breastfeeding were excluded. FINDINGS: Overall, 590 individuals (30.0%) discharged from the ED and 809 (53.8%) discharged after hospitalization were studied. Hospitalized patients were significantly older, had more comorbidities (cancer, pulmonary disease, and heart failure), and were more likely to have pulmonary embolism than deep vein thrombosis. DOAC use was significantly higher in the ED cohort versus the hospitalized cohort (51.4% vs 44.3%; P < 0.004) and more common for those having lower risk of pulmonary embolisms (simplified Pulmonary Embolism Severity Index score of 0 compared with ≥1) in the ED (58.0% and 26.5%; P < 0.0001) and hospitalized cohorts (57.1% and 35.7%; P < 0.0001). Use of DOACs was lowest in academic settings (46.2%) and highest in rural sites (56.7%). Follow-up patterns were different, with specialists and VTE clinics being most common in academic sites and family physicians being most common in rural practices. IMPLICATIONS: DOACs were used in less than half of all patients, with more use in EDs and rural sites. Follow-up patterns (VTE clinic or specialist vs family physician) varied and likely contributed to therapy selection. Over time, use of DOACs is likely to increase, and patient factors (eg, those younger with fewer comorbidities) and health care contact (eg, place of discharge or availability of an ambulatory VTE clinic) will likely continue to influence practice patterns.

Jurisdictional Guidance on DOAC Use-Will It Affect Practice? A Comparison of European, American, and Canadian Product Monographs.

Objective: To identify clinically relevant areas of concordance and discordance between product monographs for 4 direct oral anticoagulants (DOACs) approved by regulatory authorities in Europe, the United States, and Canada. Data Sources: For each DOAC (apixaban, dabigatran, edoxaban, rivaroxaban), manufacturer product monographs were retrieved from the European Medicines Database, US Food and Drug Administration, and Health Canada Drug Product Database. Data Extraction: Monographs for each DOAC were independently reviewed by 2 investigators to identify areas of concordance and discordance. Discordance existed if it was deemed that a potentially clinically relevant difference existed. A heat map summarizing the data was created to identify areas of complete concordance, partial concordance (concordance between 2 of 3 monographs), and complete discordance. Data Synthesis: The areas of concordance were indications for use, use in extremes of weight, and switching to/from the DOAC. Areas of discordance included the following: differing recommendations for use/dosing with renal dysfunction; contraindication or use with caution with drug interactions, pregnancy, and hepatic/renal dysfunction; and timing of DOAC with spinal/epidural anesthesia after a procedure or traumatic puncture. Relevance to Patient Care and Clinical Practice: Concordance was most evident for uncomplicated patients with atrial fibrillation or venous thromboembolism, whereas discordance emerged for those having characteristics/factors wherein clinicians may seek clarification within product monographs (eg, impaired renal/hepatic function, drug interactions). As such, clinicians must be familiar with product information within their country of practice. Conclusion: Variability between jurisdictions was evident, and variability of DOAC use is likely to increase with expanding worldwide uptake.

Measuring Competency of Pharmacy Residents: A Survey of Residency Programs' Methods for Assessment and Evaluation.

BACKGROUND: The Canadian Pharmacy Residency Board (CPRB) specifies the competencies that pharmacy residents must attain and the need for assessment and evaluation. Methods of assessment and evaluation are left to the discretion of individual programs. There is a scarcity of published literature compiling and comparing the strategies used by Canadian residency programs. OBJECTIVES: To determine curricular components used for assessment and evaluation; to describe the tools used by programs; to characterize the scheduling, frequency, and repetition of curricular components; and to determine the individuals or groups involved. METHODS: Coordinators of hospital pharmacy residency programs with CPRB accreditation or accreditation pending were surveyed to collect information about the assessment and evaluation of select CPRB standards. RESULTS: From the 37 eligible residency programs, 20 unique responses (54%) were received. All respondents were general practice programs (100%) in predominantly multicentre organizations (70%). Programs were similar in terms of assessment components used, with all respondents citing care plan review, direct observation of patient care, journal clubs, creation of project timelines, and ethics submission. The predominant evaluation components were within-department presentations (100%), written manuscripts (95%), drug information rotations (85%), and longitudinal evaluations (75%). Standardized forms (70%-100%) defined by Bloom's taxonomy (65%) and the CPRB "levels and ranges" document (60%) were the principle means used. Assessments for patient care and for provision of education were generally carried out immediately (80% and 95%, respectively), whereas project management skills were assessed predominantly at final evaluation (75%). Self-assessment and assessment by pharmacy team members occurred for every competency, whereas patients (0%-10%) and allied health professionals (5%) were less frequently involved. CONCLUSIONS: The assessment and evaluation strategies reported by programs were congruent. The results provide a summary of national practices and will allow existing and developing programs to examine their approach to assessment and evaluation for alignment with national standards.

CONTEXTE: Le Conseil canadien de résidence en pharmacie (CCRP) précise les compétences que les résidents en pharmacie doivent acquérir ainsi que le besoin d'observation et d'évaluation. Les méthodes d'observation et d'évaluation sont laissées à la discrétion de chacun des programmes. La littérature publiée qui compile et compare les stratégies utilisées par les programmes en résidence canadiens est rare. OBJECTIFS: Déterminer les composantes des programmes utilisés pour l'observation et l'évaluation des normes; décrire les outils utilisés par ces programmes; établir l'horaire, la fréquence et la répétition des éléments qui constituent ces programmes et déterminer les personnes ou les groupes concernés. MÉTHODES: Les coordinateurs des programmes de résidence en pharmacie hospitalière ayant un agrément ou dont l'agrément est en cours de procédure ont été interrogés afin qu'ils fournissent des informations concernant l'observation et l'évaluation des normes CCRP sélectionnées. RÉSULTATS: Des 37 programmes de résidence admissibles, 20 réponses individuelles (54 %) sont parvenues aux investigateurs. Tous les répondants représentaient des programmes de pratique générale (100 %) dans des organismes majoritairement multicentriques (70 %). Les programmes étaient similaires en termes de points à observer : tous les répondants citaient l'examen des plans de soins, l'observation directe des soins aux patients, les clubs de journaux, la création d'échéanciers pour la réalisation de projets et la proposition de documents sur l'éthique. Les critères d'évaluation prédominants consistaient en des présentations au sein du département (100 %), la rédaction de manuscrits (95 %), des rotations reliées au service d'information pharmacothérapeutique (85 %) et les évaluations longitudinales (75 %). Les formulaires standardisés (70 %­100 %) définis par la taxonomie de Bloom (65 %) et le document Levels and ranges (niveaux de performance des compétences) du CCRP (60 %) étaient les ressources de base utilisées. L'observation des soins aux patients et de la formation avait généralement lieu immédiatement (respectivement 80 % et 95 %,), tandis que les compétences en matière de gestion de projet étaient majoritairement évaluées en dernier (75 %). L'auto-observation et l'observation effectué par des membres de l'équipe de pharmacie portaient sur chaque compétence, tandis que les patients (0 % ­ 10 %) et les autres professionnels de la santé (5 %) participaient plus rarement à cette observation. CONCLUSIONS: Les stratégies d'observation et d'évaluation rapportées par les programmes concordaient. Les résultats fournissent un résumé des pratiques nationales et permettront aux responsables des programmes existants et en cours d'élaboration d'étudier l'approche de l'observation et de l'évaluation pour l'aligner sur les normes nationales.

Anticoagulant therapies for acute venous thromboembolism: a comparison between those discharged directly from the emergency department versus hospital in two Canadian cities.

OBJECTIVE: To compare the characteristics/management of acute venous thromboembolism (VTE) for patients either discharged directly from the emergency department (ED) or hospitalised throughout a year within two urban cities in Canada. DESIGN: Retrospective medical record review. SETTING: Hospitals in Edmonton, Alberta (n=4) and Regina, Saskatchewan (n=2) from April 2014 to March 2015. PARTICIPANTS: All patients discharged from the ED or hospital with acute deep vein thrombosis or pulmonary embolism (PE). Those having another indication for anticoagulant therapy, pregnant/breast feeding or anticipated lifespan <3 months were excluded. PRIMARY AND SECONDARY OUTCOMES: Primarily, to compare proportion of patients receiving traditional therapy (parenteral anticoagulant±warfarin) relative to a direct oral anticoagulant (DOAC) between the two cohorts. Secondarily, to assess differences with therapy selected based on clot burden and follow-up plans postdischarge. RESULTS: 387 (25.2%) and 665 (72.5%) patients from the ED and hospital cohorts, respectively, were included. Compared with the ED cohort, those hospitalised were older (57.3 and 64.5 years; p<0.0001), more likely to have PE (35.7% vs 83.8%) with a simplified Pulmonary Embolism Severity Index (sPESI) ≥1 (31.2% vs 65.2%), cancer (14.7% and 22.3%; p=0.003) and pulmonary disease (10.1% and 20.6%; p<0.0001). For the ED and hospital cohorts, similar proportions of patients were prescribed traditional therapies (72.6% and 71.1%) and a DOAC (25.8% and 27.4%, respectively). For the ED cohort, DOAC use was similar between those with a sPESI score of 0 and ≥1 (35.1% and 34.9%, p=0.98) whereas for those hospitalised lower risk patients were more likely to receive a DOAC (31.4% and 23.8%, p<0.055). Follow-up was most common with family physicians for those hospitalised (51.5%), while specialists/VTE clinic was most common for those directly discharged from the ED (50.6%). CONCLUSIONS: Traditional and DOAC therapies were proportionately similar between the ED and hospitalised cohorts, despite clear differences in patient populations and follow-up patterns in the community.

Anticoagulant therapies for acute venous thromboembolism among a cohort of patients discharged from Canadian urban and rural hospitals.

OBJECTIVE: To determine anticoagulant therapy at hospital discharge for patients with acute venous thromboembolism (VTE) and secondarily, to describe factors affecting choice of therapy. DESIGN: A retrospective chart review. SETTING: Canadian hospitals in Edmonton, Alberta (n=4), Regina, Saskatchewan (n=2) and rural Alberta (n=3) from April 2014 to March 2015. PARTICIPANTS: All patients discharged with an acute VTE were screened. Those with atypical clots, another indication for anticoagulation, pregnancy/breast feeding or lifespan <3 months were excluded. PRIMARY AND SECONDARY OUTCOMES: Primarily, we identified the proportion of patients discharged from hospital with acute VTE that were prescribed either traditional therapy (parenteral anticoagulant±warfarin) or a direct oral anticoagulant (DOAC). Secondarily, management based on setting, therapy choice based on deep vein thrombosis (DVT) versus pulmonary embolism (PE), clot burden and renal function was compared. DOAC dosing was assessed (when prescribed), length of hospital stay based on therapy was compared and planned follow-up in the community was described. RESULTS: Among the 695 patients included, most were discharged following a diagnosis of PE (82.9%) on traditional therapy (parenteral anticoagulant±warfarin) (70.2%) with follow-up by either a family doctor (51.5%) or specialist/clinic (46.9%) postdischarge. Regional variation was most evident between urban and rural sites. Of those prescribed a DOAC (28.3%), the majority were dosed appropriately (85.8%). DOAC use did not differ between those with DVT and PE, was proportionately higher for less severe clots and declined with worsening renal function. Patients prescribed DOACs versus traditional therapy had a shorter length of stay (4 vs 7 days, respectively). CONCLUSIONS: Uptake of DOAC therapy for acute VTE was modest and may have been influenced by the timing of the audit in relation to the approval of these agents for this indication. Future audits should occur to assess temporal changes and ongoing appropriateness of care delivery.