Development of Quality Indicators to Assess Oral Anticoagulant Management in Community Pharmacies for Patients with Atrial Fibrillation.

BACKGROUND: Few studies have evaluated the quality of oral anticoagulant management by community pharmacists. There is no complete set of quality indicators available for this purpose. OBJECTIVE: To develop a set of specific quality indicators to assess oral anticoagulant management by community pharmacists for patients with atrial fibrillation (AF). METHODS: Quality indicators were developed in 3 phases. In phase 1, potential quality indicators were generated based on clinical guidelines and a literature review. In phase 2, a modified RAND appropriateness method involving 2 rounds was implemented with 9 experts, who judged the appropriateness of quality indicators generated in phase 1 based on the extent to which they were accurate, based on evidence, relevant, representative of best practices, and measurable in community pharmacies. Phase 3 consisted of a feasibility assessment in 5 community pharmacies on 2 patients each. RESULTS: The final set included 38 quality indicators grouped into 6 categories: documentation (n = 29), risk assessment (n = 3), clinical control (n = 1), clinical follow-up (n = 15), choice of therapy (n = 11), and interaction management (n = 8). The quality indicators referred to process of care (n = 34), clinical outcomes (n = 2), or structure of care (n = 2). There were 24 quality indicators related to vitamin K antagonists (VKAs), and 17 were related to direct oral anticoagulants (DOACs). To assess quality indicators, a questionnaire was developed for completion by community pharmacists for each patient, which included 17 questions about VKA patients and 12 questions about DOAC patients. CONCLUSIONS: A first set of quality indicators is now available to assess the quality of oral anticoagulant management by community pharmacists for patients with AF. DISCLOSURES: This research was supported by the Réseau Québécois de recherche sur le médicament (RQRM); the Blueprint for Pharmacy in collaboration with Pfizer Canada; and the Cercle du Doyen of the Faculty of Pharmacy, University of Montreal. The study sponsors were not involved in the study design, data collection, data interpretation, the writing of the article, or the decision to submit the report for publication. Chartrand received a scholarship from the Fonds de Recherche du Québec en Santé (FRQ-S), the Réseau Québécois de recherche sur l'usage des médicaments with Pfizer, and the Faculty of Pharmacy, University of Montreal. Guénette holds a Junior-1 Clinician Researcher Award from the FRQ-S in partnership with the Société québécoise d'hypertension artérielle. Williamson holds a Junior-1 Career Award from the FRQ-S. Côté reported being a medical speaker for Bayer, Boehringer Ingelheim Canada, and Pfizer Canada. The other authors reported no conflicts of interest. Study concept and design were contributed by Lalonde, Chartrand, and Martin. Chartrand, Martin, and Lalonde collected the data, along with Brouillette, Côté, Huot, Landry, Martineau, Perreault, Williamson, and White-Guay. Data interpretation was performed by Chartrand, Gagnon, and Lalonde, along with Guénette and Martin. The manuscript was primarily written by Chartrand, along with Guénette and Lalonde, and revised by Chartrand, Guénette, and Lalonde, along with the other authors. A portion of this study's results was presented at the 4th RQRM Annual Meeting on September 22-23, 2014, in Orford, Quebec, Canada, in the form of an abstract, which was published in the Journal of Population Therapeutics and Clinical Pharmacology, 2014;21(2):e312.

Evaluation of a continuous quality improvement program in anticoagulant therapy: Feasibility, satisfaction and perception.

BACKGROUND: The ACO Program (Programme ACO), a continuous quality improvement program (CQIP) in anticoagulation therapy, was offered in community pharmacies as a pilot project. OBJECTIVE: To evaluate the participants' appreciation for the various activities of the program. METHODS: Participants had access to training activities, including an audit with feedback, online training activities (OTA), clinical tools and support from facilitators. Cognitive behavioural learning determinants were evaluated before and 5 months after the beginning of the program. Participants' satisfaction and perception were documented via online questionnaires and a semistructured interview. RESULTS: Of the 52 pharmacists in the ACO Program, 47 participated in this evaluation. Seventy-seven percent of the participants completed at least 1 OTA and 6% published on the forum. The feeling of personal effectiveness rose from 8.01 (7.67-8.35) to 8.62 (8.24-8.99). The audit and feedback, as well as the high-quality OTA and their lecturers, were the most appreciated elements. DISCUSSION: There was a high OTA participation rate. The facilitators seemed to play a key role in the CQIP. The low level of participation in the forum reflects the known phenomenon of social loafing. Technical difficulties affecting the platform and data collection for the audit with feedback constituted limitations. CONCLUSION: The CQIP in anticoagulation therapy is appreciated by community pharmacists and is associated with an improved feeling of personal effectiveness.

Management and adherence to VTE treatment guidelines in a national prospective cohort study in the Canadian outpatient setting. The Recovery Study.

Documenting patterns and outcomes of venous thromboembolism (VTE) management and degree of adherence by clinicians to treatment guidelines could help identify remediable gaps in patient care. Prospective, clinical practice-based data from Canadian outpatient settings on management of VTE, degree of adherence with treatment guidelines and frequency of recurrent VTE and bleeding during follow-up was obtained in a multicentre, prospective observational study. From 12 Canadian centres, we assessed 868 outpatients with acute symptomatic VTE who received the low-molecular-weight heparin (LMWH) enoxaparin alone or with vitamin K antagonists (VKA), at baseline and at six months (or at the end of treatment, whichever came first). Index VTE was limb deep venous thrombosis (DVT) in 583 (67.2%) patients, pulmonary embolism (PE) with or without DVT in 262 (30.2%) patients, and unusual site DVT in 23 (2.6%) patients. VTE was unprovoked in 399 (46.0%) patients, associated with cancer in 74 (8.5%) patients, transient risk factors in 327 (37.7%) patients and hormonal factors in 68 (7.8%) patients.With regard to guideline adherence, 58 (7.3%) patients received <5 days LMWH and 114 (14.5%) had overlap <1 day. Among patients with cancer-related VTE, 59.5% were prescribed LMWH monotherapy and 43.2% received such treatment for >3 months. Only 38.1% of patients with transient VTE risk factors had received thromboprophylaxis. Our study provides useful information on clinical presentation, management and related outcomes in Canadian outpatients with VTE. Our results suggest there may be important gaps in use of thromboprophylaxis to prevent VTE and use of LMWH monotherapy to treat cancer-related VTE.

Implementation and evaluation of a pharmacy-led thromboprophylaxis campaign in a community hospital.

In hospitalized patients, venous thromboembolism (VTE) is an important cause of morbidity and mortality. Despite evidence demonstrating efficacy and safety of pharmacological thromboprophylaxis in the prevention of VTE, its use remains low. The aim of this study is to compare the incidence of use of thromboprophylaxis before and after a pharmacy-led thrombosis prevention campaign in medical patients hospitalized in a community hospital. A pharmacy-led multifaceted thromboprophylaxis campaign including continuing education activities for physicians and pharmacists and individualized academic detailing activities supported by clinical tools were implemented over an 8-week period. In a quasi-experimental study, the incidence of pharmacological thromboprophylaxis was evaluated using a retrospective chart review and compared before and after the campaign in medical patients at high and non-high risk of VTE as defined by the American College of Chest Physicians criteria. The medical charts of 461 patients were reviewed; 66 and 58 patients were at high-risk of VTE prior to and after the campaign, respectively. After the campaign, thromboprophylaxis ordering in high-risk patients increased from 15.2 to 43.1% (adjusted OR: 6.8; 95% CI: 2.5-18.0). Thromboprophylaxis ordering in non-high risk patients was 1.8% before the campaign and 6.0% after. This increase was not statistically significant (adjusted OR: 4.6; 95% CI: 1.0-20.4). The incidence of pharmacologic thromboprophylaxis in hospitalized medical patients at high-risk of VTE increased significantly after the campaign but remained sub-optimal. Longer or a different campaign may be needed to ensure long-term optimal thromboprophylaxis use.

Primary care practices and determinants of optimal anticoagulation management in a collaborative care model.

BACKGROUND: In a collaborative care model (CCM) for managing oral anticoagulant therapy, patients are followed at a pharmacist-managed anticoagulation service and, once stabilized, are transferred to their primary care physician. The objective of this study was to describe physicians' clinical practices and the practice characteristics associated with better international normalized ratio (INR) control in a CCM. METHODS: A telephone questionnaire about their practices was administered to 121 physicians exposed to a CCM. The physicians followed 121 patients for a mean of 14.5 weeks. The percentage of time within the exact INR target range was computed and dichotomized (> or = or < median time within target range). Determinants of better INR control were identified using logistic regression models. RESULTS: The survey revealed that, after discharge from the pharmacist-managed anticoagulation service, patients are followed mainly by physicians and their secretaries. Physicians do not often consult other health professionals. Few report using technological resources to obtain INR results (39.7%), document medical follow-up (6.6%), or detect drug (32.2%) and food (9.9%) interactions. The median percentage of time within the exact INR target range was 84%. Determinants of better INR control include using computerized support to monitor patients (odds ratio [OR] 9.16, 95% CI 1.77-47.4) and detect drug interactions (OR 3.49, 95% CI 1.71-7.10) and consulting specialists (OR 5.92, 95% CI 1.49-32.48). CONCLUSIONS: Primary care physicians are poorly supported by technological and human resources to monitor patients on oral anticoagulant. Even in a CCM, interprofessional collaboration and better technological support may be associated with optimal INR control.

Is long-term pharmacist-managed anticoagulation service efficient? A pragmatic randomized controlled trial.

BACKGROUND: Some pharmacist-managed anticoagulation services (PMAS) provide initial follow-up to patients on oral anticoagulant, who are transferred to their physician once they are stabilized. This may be as effective as and less expensive than long-term PMAS follow-up. METHODS: Once PMAS patients were stabilized and ready for discharge, they were randomized to be transferred to their physician or stay with the PMAS. Quality of international normalized ratio (INR) control, incidence of complications, health-related quality of life, use of health care services, and direct incremental cost of PMAS follow-up were evaluated. RESULTS: One hundred thirty-eight physicians and 250 patients participated. Patients were initially followed at the PMAS for a mean of 11.3 weeks and afterwards were followed by their physician (n = 122) or by the PMAS pharmacists (n = 128) for a mean of 14.9 and 14.5 weeks, respectively. Pharmacist-managed anticoagulation services' and physician's patients were within the exact target range 77.3% and 76.7% of the time (95% CI of the difference -4.9% to 6.0%) and within the extended range 93.0% and 91.6% of the time (95% CI -2.1% to 4.7%), respectively. Pharmacist-managed anticoagulation services patients have seen their family physician less often (95% CI -3.1 to -0.1 visit per year). Number of INR tests, incidence of complications, and health-related quality of life were similar in both groups. The incremental cost of PMAS follow-up was estimated at CAN$123.80 per patient year. CONCLUSION: Once PMAS patients are well stabilized, maintaining a PMAS follow-up or transferring them to their physician is associated with excellent INR control. However, long-term PMAS follow-up may be more expensive.

Dosage of enoxaparin among obese and renal impairment patients.

BACKGROUND: Enoxaparin dosage for obese patients and patients with renal impairment remains controversial. OBJECTIVE: To compare anti-factor Xa activity (anti-Xa) among obese and renal impairment patients to patients with healthy weight and adequate renal function. DESIGN: Open, prospective, nonrandomized clinical trial. SETTING: A major community teaching hospital. PATIENTS: A total of 233 patients with prescription of enoxaparin. INTERVENTIONS: Enoxaparin 1.5 mg/kg once daily or 1 mg/kg twice daily except those on dialysis, who received 75% of the dose. MEASUREMENTS: Anti-Xa was measured 4 h post-injection on day 2 or 3. RESULTS: Mean (95% confidence interval (95% CI)) anti-Xa was equal to 1.14 IU/mL (1.07-1.21) and 1.14 IU/mL (1.08-1.20) among patients who received one (n=92) and two injections (n=122) per day, respectively. Anti-Xa increases with body mass index (BMI) (0.01 IU/mL for each kg/m2; 95% CI: 0.002-0.017), but the increase is insufficient to reach supratherapeutic anti-Xa. Anti-Xa decreases with higher creatinine clearance (CrCl) (-0.003 IU/mL for each mL/min; 95% CI: -0.006 to -0.001). On the twice-daily regimen, this is sufficient to reach supratherapeutic anti-Xa. The odd ratio (OR) (95% CI) of having a nontherapeutic anti-Xa is equal to 2.28 (1.25-4.16) when enoxaparin is administered twice daily and to 3.03 (1.16-7.86) among severe renal impairment patients (< or =30 mL/min). CONCLUSIONS: Based on Anti-Xa, no dosage adjustments are required in obese patients. In renally impaired patients, adjustments may be necessary when enoxaparin is administered twice daily.

Pharmacoeconomic analysis of fondaparinux versus enoxaparin for the prevention of thromboembolic events in orthopedic surgery patients.

INTRODUCTION: Fondaparinux is a novel synthetic antithrombotic that has been evaluated for the prevention of venous thromboembolism (VTE). In four large trials in patients who underwent major hip or knee surgery, fondaparinux was found to have a good safety profile and be more effective than enoxaparin. To generate Canadian pharmacoeconomic data for fondaparinux, an internationally developed cohort deterministic model was used to estimate the costs and consequences of prophylaxis with fondaparinux compared with enoxaparin in the Canadian orthopedic surgical setting. DESIGN AND SETTING: A health economic advisory group was assembled to guide the pharmacoeconomic evaluation. Efficacy and safety data for fondaparinux relative to enoxaparin were abstracted from a meta-analysis of four randomized trials. Canadian cost data to populate the model were obtained from a resource-use survey of four large Canadian hospitals, from the Canadian Institute for Health Information (CIHI), and from the Canadian economic literature. Case-mix information obtained from CIHI was incorporated into the cohort deterministic model, which predicted the number of VTEs and bleeds following prophylaxis with fondaparinux or enoxaparin within 90 days of surgery, and the associated overall cost difference. The stability of the base-case findings was evaluated with sensitivity analyses. STUDY PERSPECTIVE: Canadian healthcare system perspective. MAIN OUTCOME MEASURES AND RESULTS: Assuming a case mix of 50,693 major hip or knee surgeries performed in Canada in 1999/2000 (as reported by CIHI), the model predicted that prophylaxis with fondaparinux would avoid an additional 16 symptomatic VTEs per 1000 patients over the first 90 days, with an average cost savings of Can 55 dollars per patient. These findings were stable when key economic and clinical parameters were varied, including bleeding events. CONCLUSIONS: Our results suggest that in Canada, prophylactic fondaparinux compared with enoxaparin avoids VTEs and is associated with lower costs in patients who undergo major hip or knee surgery.

Reliability, validity and ease of use of a portable point-of-care coagulation device in a pharmacist-managed anticoagulation clinic.

UNLABELLED: In a pharmacist-managed anticoagulation clinic, portable point-of-care coagulation devices may facilitate patient monitoring by providing rapid INR measurement. Few studies, however, have validated this type of device. OBJECTIVE: To evaluate the reliability, validity and ease of use of the CoaguChek S, a new portable coagulation device. METHODS: A total of 100 patients followed at a pharmacist-managed anticoagulation clinic attended two study visits. INRs were measured using the CoaguChek S and the standard laboratory technique. RESULTS: Reliability: The test-retest reliability (precision) of the CoaguChek S, estimated by the intraclass correlation coefficient (ICC) and a 95% confidence interval (95% CI), was high (0.98 (0.98-0.99)) and comparable to the standard laboratory technique (0.99 (0.98-0.99)). Interrater reliability was also high (0.97 (0.95-0.98)). Reliability coefficients did not vary with the test-strip lot number nor the CoaguChek S operator. VALIDITY: When compared with standard laboratory procedure, the ICC (95% CI) was equal to 0.93 (0.91-0.95). The mean difference (95% CI) between INR measured by the laboratory and the CoaguChek S was equal to -0.02 units (-0.06-0.03). The mean absolute and relative absolute differences (95% CI) were equal to 0.24 units (0.21-0.27) and 9% (8%-10%), respectively. Differences tended to increase for INRs greater than 3 units as seen by a mean difference (95% CI) of -0.17 units (-0.35-0.02). This represented a mean absolute difference (95% CI) of 0.44 units (0.33-0.55) and a mean relative absolute difference of 12% (9%-15%). Concordance between therapeutic decisions based on CoaguChek S and laboratory results was high (Kappa = 0.68). In 34 cases (18%), the therapeutic decision would have been different. However, in 15 of these discordant observations, the difference between the CoaguCheck S and laboratory INR was