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.

Treatment dosing of low-molecular-weight heparins and the dose cap dilemma: considerations for patients in Canada.

BACKGROUND: In Canada, there is a dose cap for weight-based treatment with low-molecular-weight (LMW) heparins. OBJECTIVE: To review whether capping of LMW heparin doses is warranted for patients with obesity. METHODS: English-language publications concerning the use of LMW heparin in Canada were reviewed, and the literature regarding use of these drugs at treatment doses in patients with obesity was assessed. RESULTS: Five pharmacokinetic or pharmacodynamic studies meeting the inclusion criteria were identified. The evidence in those studies pointed toward no excess accumulation of LMW heparin in patients with obesity. In addition, 5 trials involving patients with acute coronary syndromes and 6 trials involving patients with venous thromboembolism and other indications were identified, but only 7 of these 11 trials included sufficient information for review. Subgroup analysis of patients with acute coronary syndrome whose LMW heparin dose was not capped showed no increased risk of bleeding for obese patients treated with enoxaparin. For patients with venous thromboembolism and other indications, the best evidence was for dalteparin, with anti-Xa levels used as a surrogate end point. In this setting, excess accumulation did not occur when there was no dose cap. DISCUSSION: There is little literature dedicated to the dosing of LMW heparin for obese patients. In particular, there are few data for those with body weight above 150 kg. Despite the limitations of these studies, there appears to be little justification for capping the doses of these drugs. On the basis of the available literature, it is suggested that treatment doses of LMW heparin be based on body weight up to 150 kg.

Advantages of a Warfarin Protocol for Long-term Care Pharmacists: a Retrospective Cohort Study.

BACKGROUND: Warfarin is an anticoagulant prescribed to 12% of long-term care residents to reduce the risk of thrombo-embolism. This study used indicators to compare warfarin management by pharmacists to usual care. METHODS: This was a retrospective cohort study comparing a pharmacist-managed warfarin protocol with usual care of qualified warfarin recipients at long-term care facilities (two protocol, one control) in Calgary, Alberta. We compared the proportion of international normalized ratio (INR) tests in the range 2.0 to 3.0, time in range, number of tests, and frequency of bleeding at protocol and control sites. Our primary outcome, time in INR therapeutic range, is an indicator for assuring care quality. A cross-sectional survey at these sites compared health professionals' perceptions of workload and effectiveness of warfarin management. RESULTS: Of the 197 residents' charts reviewed in the study period, those on protocol had 45.0 INR tests while those on usual care had 52.7 tests (p = .034, 95% CI for the difference: 0.6 to 14.6 INR tests). No significant difference was found for time in therapeutic range, number of tests in range, or major bleeding events. Of 178 health professionals surveyed, those from protocol facilities were more satisfied with warfarin management (p = .013). Workload and safety were perceived similarly at all sites. INTERPRETATION: Our results suggest that a pharmacist-managed warfarin protocol is as effective as usual care and has advantages pertaining to work satisfaction, knowledge of drug interactions, consistent documentation, and fewer INR tests. Further research on teamwork and coagulation management in long-term care facilities is recommended.

Patient satisfaction with services provided by multidisciplinary anticoagulation clinics.

STUDY OBJECTIVE: To assess patients' perception of care delivery by anticoagulation clinics (ACs) throughout Alberta, Canada. DESIGN: Prospective postal survey. SETTING: Therapy provision by an AC to ambulatory-based patients for a minimum of 3 months across the province. PATIENTS: A total of 1687 patients (67.9%) receiving warfarin therapy from 6 ACs for a minimum of 3 months responded. MEASUREMENT AND MAIN RESULTS: The 25-item survey had responses grouped into domains of patient preference, knowledge, and service delivery. A 5-point Likert scale enabled each response to be assigned a numerical value from 1 (strongly disagree) to 5 (strongly agree). Overall, the mean response for patient satisfaction was 4.54, indicating most patients were satisfied with the AC care they received. Among those who had received care outside of an AC, 70.4% preferred AC care compared with 18.4% for family physician care. Mean responses for knowledge and service delivery exceeded 4.0, demonstrating positive responses in favor of AC care. CONCLUSIONS: This study demonstrates that most patients were greatly satisfied with AC care and preferred the care received from an AC to that provided by their family physician. Service delivery across Alberta is well perceived by patients.

Evaluation of a multi staged professional development course for practising pharmacists in anticoagulation management.

BACKGROUND: With the evolution of pharmacist prescriptive authority in Alberta, Canada, professional development courses need to impact change in daily practice. We designed a multi stage course targeting anticoagulation management with several components: (1) a print-based course to develop foundational knowledge; (2) a 2-day workshop; (3) a 3-day experiential programme; (4) distance mentorship to practice site; and (5) two full-day mentorship meetings. OBJECTIVE: To assess the impact of a comprehensive anticoagulation professional development course on practising pharmacists' knowledge, confidence and daily practice, with documentation of resources for the mentorship phases. METHODS: A mixed method of evaluation using surveys to assess pharmacist knowledge and confidence and semi-structured interviews to assess the impact on practice. Surveys were conducted prior to and following the workshop, after the experiential training and 4-6 months following completion of the workshop. Interviews were conducted following the experiential training and 4-6 months after the workshop. RESULTS: Enrolment for the complete multi stage course was limited to 12 pharmacists, while another 59 completed the course to the end of the workshop. Pharmacists completing the entire course had improved knowledge scores following the workshop, and between the workshop and 3-day experiential. These scores declined at 4-6 months. Improvements in confidence occurred throughout the course. At the final interview, all pharmacists indicated a positive impact on their practice. Mentorship was feasible and imperative to offer security to facilitate practice change. CONCLUSIONS: Overall, this comprehensive multi stage course improved knowledge, confidence and practice for pharmacists.