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Objective: In aged-care facilities (ACFs) monitoring of warfarin can be logistically challenging and International Normalised Ratio (INR control) is often suboptimal. We aimed to determine whether an integrated information and communications technology system and the use of point-of-care (POC) monitors by nursing staff could improve the INR control of aged-care facility residents who take warfarin., Methods: Nursing staff identified residents who were prescribed warfarin in participating ACFs. A computer program (MedePOC) was developed to store and transmit INR results from the ACFs to general practitioners (GPs) for dosage adjustment. Nursing staff received training in the use of the CoaguChek XS point-of-care INR monitor and the MedePOC software. Following a run-in phase, eligible patients were monitored weekly for up to 12 weeks. The primary outcome was the change in the time in therapeutic range (TTR) in the intervention phase compared to the TTR in the 12 months preceding the study. All GPs, nursing staff and patients were surveyed for their experiences and opinions of the project., Key Findings: Twenty-four patients and 19 GPs completed the trial across six ACFs. The mean TTR for all patients improved non-significantly from 58.9 to 60.6% (P=0.79) and the proportion of INR tests in range improved non-significantly from 57.1 to 64.1% (P=0.21). The mean TTR improved in 14 patients (58%) and in these patients the mean absolute improvement in TTR was 23.1%. A post hoc analysis of the INR data using modified therapeutic INR ranges to reflect the dosage adjustment practices of GPs suggested that the intervention did lead to improved INR control. The MedePOC program and POC monitoring was well received by nursing staff., Conclusions: Weekly POC INR monitoring conducted in ACFs and electronic communication of the results and warfarin doses resulted in non-significant improvements in INR control in a small cohort of elderly residents. Further research involving modification to the communication strategy and a longer follow-up period is warranted to investigate whether this strategy can improve INR control and clinical outcomes in this vulnerable population., (© 2013 The Authors. IJPP © 2013 Royal Pharmaceutical Society.)

Background: Point-of-care international normalized ratio (INR) monitoring devices simplify warfarin management by allowing selected patients to monitor their own therapy in their homes. Patient self-testing (PST) has been shown to improve the clinical outcomes of warfarin therapy compared to usual care., Objective: To compare management of warfarin therapy using PST combined with online supervision by physicians via a custom system with usual warfarin management, which involved laboratory testing and physician dosing., Methods: Interested patients were recruited via community pharmacies to participate in a warfarin PST training program. Participants were required to have a long-term indication for warfarin, have been taking warfarin for at least 6 months, and have Internet access in their home. The training involved two sessions covering theoretical aspects of warfarin therapy, use of the CoaguChek XS, and the study website. Following training, patients monitored their INR once weekly for up to 3 months. Patients and physicians utilized a secure website to communicate INR values, dosage recommendations, and clinical incidents. Physicians provided a 6-12 month history of INR results for comparison with study results. The percentage of time spent within the therapeutic INR range (TTR) was the primary outcome, with participants acting as their own historical controls. The percentage of INR tests in range and participant satisfaction were secondary outcomes., Results: Sixteen patients completed training requirements. The mean age of participants was 69.8 (SD 10.1) years. TTR improved significantly from 66.4% to 78.4% during PST (P=.01), and the number of tests within the target range also improved significantly (from 66.0% at prior to the study to 75.9% during PST; P=.04). Patients and physicians expressed a high degree of satisfaction with the monitoring strategy and online system., Conclusions: PST supported by an online system for supervision was associated with improved INR control compared to usual care in a small group of elderly patients. Further research is warranted to investigate the clinical outcomes and cost-effectiveness of online systems to support patients monitoring medications and chronic conditions in the home.

What Is Known and Objective: Warfarin is recognized as a high-risk medication for adverse events, and the risks are particularly heightened in the period immediately following a patient's discharge from hospital. This qualitative study aimed to explore the experiences of Australian patients and healthcare professionals of warfarin management in the post-discharge period and identify the benefits and deficiencies of existing systems, to inform the development of a model for a new collaborative post-discharge warfarin management service., Methods: Healthcare professionals, professional organization representatives and patients recently discharged from hospital taking warfarin (consumers) were recruited via purposive, criterion-based sampling within two Australian states. Semi-structured telephone interviews were conducted between August and October 2008 using standard discussion guides. Data were manually analyzed to identify emergent themes using a phenomenological approach., Results: Forty-seven participants were involved in the telephone interviews. Three major themes emerged: (i) appropriate warfarin education is integral to effective warfarin management, (ii) problems occur in communication along the continuum of care and (iii) home-delivered services are valuable to both patients and healthcare professionals., Discussion: Although high-quality warfarin education and effective communication at the hospital-community interface were identified as important in post-discharge warfarin management, deficiencies were perceived within current systems. The role of home-delivered services in ensuring timely follow-up and promoting continuity of care was recognized. Previous studies exploring anticoagulation management in other settings have identified similar themes. Post-discharge management should therefore focus on providing patients with a solid foundation to minimize future problems., What Is New and Conclusion: Addressing the three identified facets of care within a new, collaborative post-discharge warfarin management service may address the perceived deficiencies in existing systems. Improvements may result in the short- and longer-term health outcomes of patients discharged from hospital taking warfarin, including a reduction in their risk of adverse events., (© 2011 Blackwell Publishing Ltd.)

Background: Warfarin remains a high-risk drug for adverse events, especially following discharge from the hospital. New approaches are needed to minimize the potential for adverse outcomes during this period., Objective: To evaluate the clinical outcomes of a collaborative, home-based postdischarge warfarin management service adapted from the Australian Home Medicines Review (HMR) program., Methods: In a prospective, nonrandomized controlled cohort study, patients discharged from the hospital and newly initiated on or continuing warfarin therapy received either usual care (UC) or a postdischarge service (PDS) of 2 or 3 home visits by a trained, HMR-accredited pharmacist in their first 8 to 10 days postdischarge. The PDS involved point-of-care international normalized ratio (INR) monitoring, warfarin education, and an HMR, in collaboration with the patient's general practitioner and community pharmacist. The primary outcome measure was the combined incidence of major and minor hemorrhagic events in the 90 days postdischarge. Secondary outcome measures included the incidences of thrombotic events, combined hemorrhagic and thombotic events, unplanned and warfarin-related hospital readmissions, death, INR control, and persistence with therapy at 8 and 90 days postdischarge., Results: The PDS (n=129) was associated with statistically significantly decreased rates of combined major and minor hemorrhagic events to day 90 (5.3% vs 14.7%; p=0.03) and day 8 (0.9% vs 7.2%; p=0.01) compared with UC (n=139). The rate of combined hemorrhagic and thrombotic events to day 90 also decreased (6.4% vs 19.0%; p=0.008) and persistence with warfarin therapy improved (95.4% vs 83.6%; p=0.004). No significant differences in readmission and death rates or INR control were demonstrated., Conclusions: This study demonstrated the ability of appropriately trained accredited pharmacists working within the Australian HMR framework to reduce adverse events and improve persistence in patients taking warfarin following hospital discharge. Widespread implementation of such a service has the potential to enhance medication safety along the continuum of care.

Background: Shorter periods of hospitalisation and increasing warfarin use have placed stress on community-based healthcare services to care for patients taking warfarin after hospital discharge, a high-risk period for these patients. A previous randomised controlled trial demonstrated that a post-discharge service of 4 home visits and point-of-care (POC) International Normalised Ratio (INR) testing by a trained pharmacist improved patients' outcomes. The current study aims to modify this previously trialled service model to implement and then evaluate a sustainable program to enable the smooth transition of patients taking warfarin from the hospital to community setting., Methods/design: The service will be trialled in 8 sites across 3 Australian states using a prospective, controlled cohort study design. Patients discharged from hospital taking warfarin will receive 2 or 3 home visits by a trained 'home medicines review (HMR)-accredited' pharmacist in their 8 to 10 days after hospital discharge. Visits will involve a HMR, comprehensive warfarin education, and POC INR monitoring in collaboration with patients' general practitioners (GPs) and community pharmacists. Patient outcomes will be compared to those in a control, or 'usual care', group. The primary outcome measure will be the proportion of patients experiencing a major bleeding event in the 90 days after discharge. Secondary outcome measures will include combined major bleeding and thromboembolic events, death, cessation of warfarin therapy, INR control at 8 days post-discharge and unplanned hospital readmissions from any cause. Stakeholder satisfaction will be assessed using structured postal questionnaire mailed to patients, GPs, community pharmacists and accredited pharmacists at the completion of their study involvement., Discussion: This study design incorporates several aspects of prior interventions that have been demonstrated to improve warfarin management, including POC INR testing, warfarin education and home visits by trained pharmacists. It faces several potential challenges, including the tight timeframe for patient follow-up in the post-discharge period. Its strengths lie in a strong multidisciplinary team and the utilisation of existing healthcare frameworks. It is hoped that this study will provide the evidence to support the national roll-out of the program as a new Australian professional community pharmacy service., Trial Registration: Australian New Zealand Clinical Trials Registry Number 12608000334303.

Objective: To describe the development, implementation and outcomes of an anticoagulation education program for pharmacists participating in a community-based post-discharge warfarin management service., Setting: Australian community pharmacy practice., Method: Three education modules were developed in collaboration with medical experts and delivered electronically and via hands-on training sessions to pharmacists in three Australian states. Educational outcomes were assessed via a short answer assignment and evaluation of their warfarin dosing recommendations for five hypothetical scenarios. Consumer and pharmacist perceptions of the adequacy of the training were surveyed using a structured postal questionnaire., Main Outcome Measure: Pharmacists' score in the short answer assignment and evaluation of their responses to the hypothetical warfarin dosing scenarios., Results: Sixty-two pharmacists successfully completed the training program with a mean score for the short answer assignment of 14.3 out of 15 (95.3%; 95% CI 13.8-14.7). The pharmacists' warfarin management recommendations were very similar to those of two experienced medical specialists. Pharmacists and consumers expressed confidence in the adequacy of the training program., Conclusion: This education program successfully up-skilled a cohort of pharmacists for involvement in a post-discharge warfarin management service. These findings support formalization and further development of the program to facilitate widespread implementation of home-based post-discharge warfarin care.

Aim: To evaluate the accuracy of the CoaguChek XS international normalised ratio (INR) monitor compared with the laboratory method., Methods: The accuracy and ease of use of the recently marketed CoaguChek XS portable INR monitor was evaluated in 17 patients involved in a trial of warfarin home monitoring. INR results from the monitor were compared with those from the laboratory method. Clinical applicability was measured by discrepant INR values, defined in the literature by expanded and narrow agreement criteria, and by the proportion of INR values differing by >15% and by >20% from those derived by the laboratory method., Results: Participants provided 59 comparison INR measurements for analysis. The paired results were highly correlated (r = 0.91). Expanded and narrow agreement between paired INR values occurred 100% of the time. Only three CoaguChek XS (5.1%) results differed by >15% compared with the laboratory method; no results differed by >20% or were discrepant by >0.5 INR units., Conclusions: In the hands of patients the CoaguChek XS showed good correlation with laboratory determination of INR and compared well with expanded and narrow clinical agreement criteria. Both patients and doctors were highly satisfied with the accuracy and ease of use of the CoaguChek XS.

The use of warfarin in the elderly, particularly for stroke prevention in chronic atrial fibrillation, is steadily increasing. Although the benefits of warfarin are greatest in the elderly, so are the risk of adverse outcomes and the difficulties of anticoagulant management. Clinical systems need to improve to counter this therapeutic dilemma, as warfarin is likely to remain the only widely available oral anticoagulant for the foreseeable future. Aspects that require attention are: the careful selection of patients in whom treatment with warfarin is appropriate; initiating therapy in a low dose (e.g., 2.5-5 mg/day); thorough education of patients and carers; close monitoring, especially with any change in the patient's regular drug therapy; involving patients more in the management of their warfarin therapy (self-monitoring/management in suitable patients); and ongoing review of the appropriateness of therapy as circumstances change.

Objective: The aim of this project was to assess whether rural pharmacist involvement in the management of patients receiving warfarin has the potential to lead to safer and more effective anticoagulation, and is valued and welcomed by patients and their general practitioners (GPs)., Methods: A convenience sample of rural pharmacists was trained in the use of the CoaguChek S International Normalized Ratio (INR) monitor and then conducted pharmacy-based testing for approximately 3 months. Two types of testing were performed in the pharmacy: (i) comparison testing was defined as pharmacy-based tests taken within 4 h of conventional laboratory testing or (ii) additional testing, which was a pharmacy-based test with no direct comparison laboratory test taken. Pharmacists, GPs and patients completed anonymous satisfaction surveys after the completion of the pharmacy-based testing., Results: Pharmacists from 16 rural pharmacies were trained to use the CoaguChek S monitor. During the trial period, 518 INR tests were performed in the pharmacies on 137 different patients. A total of 120 tests were evaluated against results from laboratory testing. The pharmacy-based INR values were significantly correlated with the laboratory INR values (mean of 2.32+/-0.77 and 2.32+/-0.59 respectively; r=0.88, P<0.0001). A total of 398 additional pharmacy-based tests were conducted in the pharmacy and 8.5% of the additional tests resulted in a subsequent dosage change. The monitoring was well received by pharmacists, GPs and patients., Conclusions: The results of the trial were very positive. The CoaguChek S monitor in pharmacy-based testing performed accurately compared with conventional laboratory testing. Further research needs to be conducted on the impact of community pharmacy-conducted INR monitoring on patient care and outcomes.

Background: Despite evidence that antithrombotics are effective in reducing the risk of stroke in atrial fibrillation (AF), they remain underused., Objective: To perform a controlled trial of a comprehensive educational program promoting the rational prescribing of antithrombotics for stroke prevention in AF., Methods: The intervention was conducted in Southern Tasmania, Australia, using Northern Tasmania as a control area. General practitioners were sent locally produced guidelines on stroke risk stratification and antithrombotic drug use in AF, which were followed by academic detailing visits. Outcomes were measured using evaluation feedback from the general practitioners, and drug utilization data were provided by a series of patients presenting to the hospital with an admission diagnosis of AF and dispensing of antithrombotic therapy under the Australian Pharmaceutical Benefits Scheme., Results: During the educational intervention, 272 guidelines were mailed and, subsequently, 162 general practitioners were visited and the guidelines discussed. Hospital admission data before and after the intervention revealed a significant increase in the use of warfarin in patients at high risk of stroke (33% vs 46% of eligible patients; p < 0.05). Analysis of prescription data for warfarin also indicated that the increase in use of warfarin within the intervention region was significantly greater than for the control region (p < 0.001)., Conclusions: The educational program described here led to a significant increase in the prescribing of warfarin for stroke prevention in patients with AF.

Warfarin is a recognised high-risk drug for adverse events. Patients from rural and remote regions are at increased risk of these events because of problems of access to health care providers and services, and there is some reluctance to prescribe warfarin to patients in rural areas because of the difficulties in monitoring anticoagulated patients. The availability of portable international normalised ratio (INR) monitors is particularly attractive in rural or remote settings because of the lack of access to pathology services. Pharmacists and other health professionals in rural areas are ideally placed to assist general practitioners in the management of their anticoagulated patients through the use of portable INR monitors. The present article describes three cases of successful outcomes of pharmacist-assisted anticoagulation monitoring in the rural setting. Innovative service delivery models like these are needed to meet the needs of the increasing number of rural Australians requiring warfarin therapy.

Objectives: A number of studies have reported that the risk of bleeding associated with warfarin is highest early in the course of therapy. This study examined the effect of a programme focused on the transition of newly anticoagulated patients from hospital to the community., Design: Open-label randomized controlled trial., Setting: Home-based follow-up of patients discharged from acute care hospital in southern Tasmania, Australia., Subjects: A total of 128 patients initiated on warfarin in hospital and subsequently discharged to general practitioner (GP) care were enrolled in the study. Sixty were randomized to home monitoring (HM) and 68 received usual care (UC)., Interventions: HM patients received a home-visit by the project pharmacist and point-of-care international normalized ratio (INR) testing on alternate days on 4 occasions, with the initial visit two days after discharge. The UC group was solely managed by the GP and only received a visit 8 days after discharge to determine anticoagulant control., Results: At discharge, 42% of the HM group and 45% of the UC group had a therapeutic INR. At day 8, 67% of the HM patients had a therapeutic INR, compared with 42% of UC patients (P < 0.002). In addition, 26% of UC patients had a high INR, compared with only 4% of HM patients. Bleeding events were assessed 3 months after discharge and occurred in 15% of HM patients, compared with 36% of the UC group (P < 0.01)., Conclusions: This programme improved the initiation of warfarin therapy and resulted in a significant decrease in haemorrhagic complications in the first 3 months of therapy.

Objective: To compare the accuracy and clinical usefulness of the near-patient testing CoaguChek S INR monitor in rural medical practice. DESIGN, SETTING AND MAIN OUTCOME MEASURES: General practices were identified through Australian university departments of rural health. Study investigators trained general practitioners and/or practice nurses in the use of the CoaguChek S INR monitor. General practices obtained a fingerprick sample for testing with the INR monitor to compare with conventional pathology testing for accuracy. An evaluation questionnaire was administered to users of the machine to assess ease of use and clinical usefulness., Results: A total of 169 patients from 15 general practice sites provided 401 paired (CoaguChek S and laboratory) INR results. The CoaguChek S was found to be accurate when compared to laboratory INR (r = 0.89), despite complicating variables such as multiple users of the monitor and multiple laboratories used for comparison with the CoaguChek S INR. Overall, 88% of dual INR measurements were within 0.5 INR units of each other. For laboratory INR /= 3.6, 97%, 90% and 57% of readings were within 0.5 INR units, respectively. Clinical agreement occurred 93% and 90% of the time against published expanded and narrow criteria, respectively., Conclusions: The routine use of near-patient testing, with appropriate training and quality assurance programs, has the potential to increase the safety and efficacy of warfarin therapy in rural and remote communities.

The accuracy and reproducibility of the CoaguChek S, and its clinical agreement with conventional laboratory international normalized ratio (INR) determination, were evaluated in an outpatient anticoagulation clinic setting. Forty-three patients provided 248 paired INR measurements for analysis. The paired results were highly correlated (r = 0.90). The mean coefficient of variation for the CoaguChek S for a random sample of 21 patients with three repeated tests each, was 4%. Clinical applicability was also measured by discrepant INR values, as defined in the literature by expanded and narrow agreement, and by INR values resulting in a different clinical decision by a blinded haematology registrar. Expanded agreement and narrow agreement between the two INR values occurred 90 and 88% of the time, respectively. The stricter criteria set down by the clinician resulted in 73% of paired results producing the same dosage decision. The CoaguChek S displayed good correlation with laboratory determination of INR and compared relatively well with expanded and narrow clinical agreement criteria.

Background: The benefits of antithrombotic therapy in chronic atrial fibrillation (AF) have been established in clinical trials, but there is a paucity of data on outcomes in practice., Aims: The objective was to establish a large ongoing database of patients with non-valvular AF, to enable the accurate determination of clinical outcomes., Methods: A retrospective review of the medical records for consecutive patients who had AF documented on electrocardiogram at the major teaching hospital in Tasmania between 1 January 1997 and 30 June 1999 was performed. An extensive range of demographic and clinical variables was recorded for all patients with chronic or paroxysmal non-valvular AF., Results: The 505 patients (60% males) included in the database had a median age of 76 years. According to risk stratification criteria, 79% of the patients with previously diagnosed chronic or paroxysmal AF had a high risk of developing stroke at the time of admission to hospital care. However, only one-third (34%) of these patients were receiving warfarin (or warfarin plus aspirin), with almost one-quarter (24%) receiving no antithrombotic agent. The annual incidence of ischaemic strokes was 3.4% (1.5-6.4%; 95% CI) when taking warfarin, compared to 7.0% (5.2-9.4%) for patients not taking warfarin and 7.8% (5.4-11.1%) for patients taking aspirin. The annual incidence of bleeding complications in patients taking warfarin was 14.2% (10.0-19.5%) overall and 3.4% (1.5-6.4%) for major bleeds. In patients not taking warfarin, the overall annual incidence of bleeds was 8.4% (6.3-10.9%) and 3.9% (2.5-5.7%) for major bleeds., Conclusions: Warfarin is underused in patients with AF. In clinical practice, warfarin confers a similar stroke risk reduction to that observed in trials, with an increase in incidence of only minor bleeding complications. Aspirin did not appear to reduce the risk of stroke.