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OBJECTIVES: Good warfarin knowledge is important for optimal patient outcomes, but barriers exist to effective education and warfarin knowledge is often poor. This study aimed to explore the educational outcomes of home-based warfarin education provided by trained pharmacists. METHODS: In a prospective, non-randomised, controlled cohort trial, patients received either usual community-based post-discharge care or a post-discharge warfarin management service, including warfarin education by trained pharmacists during two or three home visits. Patients' warfarin knowledge was assessed at 8 and 90 days post-discharge using the Oral Anticoagulation Knowledge test. KEY FINDINGS: One hundred and thirty-nine patients were recruited into the usual care group between November 2008 and August 2009, and 129 into the intervention group between May and December 2009. Pharmacist-delivered warfarin education was associated with a significant difference between the intervention patients' baseline and day 8 mean warfarin knowledge scores of 64.5% (95% confidence interval (CI) 61.0-68.5%) and 78.0% (95% CI 74.5-81.5%; P < 0.001), respectively. The intervention patients also scored significantly higher than the usual care patients at day 8 (65.0%, 95% CI 61.5-68.0%; P < 0.001), but not at day 90. CONCLUSIONS: Use of an existing healthcare framework overcame several systemic barriers by facilitating warfarin education in patients' homes. While the intervention was associated with better short-term warfarin knowledge, follow-up may be required to optimise its benefits. Widespread implementation of home-based warfarin education by pharmacists has the potential to contribute significantly to improved outcomes from warfarin therapy.

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BACKGROUND: Despite continual improvements in the management of acute coronary syndromes, adherence to guideline-based medications remains suboptimal. We aim to improve adherence with guideline-based therapy following acute coronary syndrome using an existing service that is provided by specifically trained pharmacists, called a Home Medicines Review. We have made two minor adjustments to target the focus of the existing service including an acute coronary syndrome specific referral letter and a training package for the pharmacists providing the service. METHODS/DESIGN: We will be conducting a randomized controlled trial to compare the directed home medicines review service to usual care following acute coronary syndromes. All patients aged 18 to 80 years and with a working diagnosis of acute coronary syndrome, who are admitted to two public, acute care hospitals, will be screened for enrolment into the trial. Exclusion criteria will include: not being discharged home, documented cognitive decline, non-Medicare eligibility, and presence of a terminal malignancy. Randomization concealment and sequence generation will occur through a centrally-monitored computer program. Patients randomized to the control group will receive usual post-discharge care. Patients randomized to receive the intervention will be offered usual post-discharge care and a directed home medicines review at two months post-discharge. The study endpoints will be six and twelve months post-discharge. The primary outcome will be the proportion of patients who are adherent to a complete, guideline-based medication regimen. Secondary outcomes will include hospital readmission rates, length of hospital stays, changes in quality of life, smoking cessation rates, cardiac rehabilitation completion rates, and mortality. DISCUSSION: As the trial is closely based on an existing service, any improvements observed should be highly translatable into regular practice. Possible limitations to the success of the trial intervention include general practitioner approval of the intervention, general practitioner acceptance of pharmacists' recommendations, and pharmacists' ability to make appropriate recommendations. A detailed monitoring process will detect any barriers to the success of the trial. Given that poor medication persistence following acute coronary syndrome is a worldwide problem, the findings of our study may have international implications for the care of this patient group. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12611000452998.

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OBJECTIVE: To characterise the nature of the drug-related problems with warfarin therapy identified in pharmacist-conducted medication reviews during a collaborative post-discharge warfarin management service, with a focus on potentially serious drug interactions. SETTING: Australian community pharmacy practice. METHOD: Medication review reports submitted by pharmacists to patients' general practitioners as part of the service were reviewed and the type and clinical significance of the warfarin-associated drug-related problems, and the pharmacists' recommendations were classified. The prevalence of prescribing of 'potentially hazardous' warfarin drug interactions was investigated and compared with the frequency of documentation of these interactions in the medication review reports. MAIN OUTCOME MEASURE: The number and nature of warfarin-associated drug-related problems identified and the rate of documentation of 'potentially hazardous' warfarin drug interactions in the reports from pharmacist-conducted medication reviews. RESULTS: A total of 157 warfarin-associated drug-related problems were documented in 109 medication review reports (mean 1.4 per patient, 95% CI 1.3-1.6, range 0-5). Drug selection and Education or information were the most commonly identified warfarin-associated drug-related problems; most drug-related problems were of moderate clinical significance. Eight of 23 potentially serious warfarin drug interactions (34.8%) were identified in the medication review reports. CONCLUSION: Pharmacists addressing drug selection and warfarin education drug-related problems during medication reviews may have contributed to the positive outcomes of the post-discharge service. Warfarin drug interactions were frequently identified; however, well-recognised potentially hazardous interactions were under-reported. Improved communication along the continuum of care would permit improved targeting of drug-related problem reporting, especially in relation to preventable drug interactions.

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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.

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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.

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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.

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BACKGROUND: Statins are recommended for all patients with known coronary heart disease. This pilot study investigated statin initiation by a Western Australian general practitioner cohort and the influence of prescriber and patient characteristics on prescribing. METHODS: A structured vignette questionnaire was posted to members of the Fremantle GP Network. Respondents indicated their prescribing decisions for nine hypothetical patients who had recently suffered a myocardial infarction. Data analysis utilised logistic regression analyses and a generalised linear model with a logit link function. RESULTS: Fifty-five GPs responded (16.0% response rate). In over 20% of cases a statin was not prescribed. Male (OR 4.71; 95% CI: 1.24-17.87) and GPs with fewer years in practice (4.50; 1.21-16.77) were more likely to prescribe appropriately. Younger patients (2.21; 1.38-3.53), and those with diabetes (1.74; 1.09-2.76) or hypercholesterolaemia (4.81; 2.88-8.03) were more likely to receive therapy. DISCUSSION: Prescribing practices failed to comply with current guidelines in a significant number of cases. Further research to confirm these findings is warranted.

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AIMS: A number of factors have been hypothesized to increase the risk of amiodarone-induced pulmonary toxicity (AIPT). This study aimed to confirm these risk factors and determine whether a cohort of tertiary hospital patients diagnosed with AIPT demonstrated comparable characteristics. METHODS: Phase I of this study involved compilation of a database of adverse reactions to amiodarone reported to the Australian and US drug agencies, and identification of risk factors for AIPT using logistic regression analysis. In Phase II, AIPT cases were identified via a retrospective review of medical records of patients discharged from Fremantle Hospital and Health Service, Western Australia (FHHS) between 2000 and 2005 with diagnosed interstitial lung disease. Data were collected regarding these patients' risk factors for AIPT and compared with those previously identified in Phase I. RESULTS: A total of 237 cases of AIPT were identified from agency data. Patients aged > 60 years and those on amiodarone for 6-12 months (odds ratio 18.28, 95% confidence interval 6.42, 52.04) were determined to be at the highest risk of AIPT. Australian data also suggested increased risk in patients who had received cumulative doses of 101-150 g. The seven AIPT cases identified among the FHHS patients were all at high risk of AIPT based on their age and duration of amiodarone therapy. CONCLUSION: Contrary to previous findings, only patient age and the duration of amiodarone therapy were confirmed as significant risk factors for AIPT. Targeted monitoring of these patients may facilitate early identification and management of AIPT.

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OBJECTIVE: To describe a case of a hypersensitivity reaction to oral amiodarone in a patient with a previous reaction to an iodinated radiocontrast agent. CASE SUMMARY: A 55-year-old man experienced facial urticaria after intraarterial injection of iohexol, an iodinated radiocontrast agent, during coronary angiography, which was successfully treated with intravenous hydrocortisone and promethazine. The procedure revealed significant triple vessel disease, and the patient subsequently underwent coronary artery bypass grafting in October 2006. Postoperatively, the patient experienced 2 episodes of fast atrial fibrillation, the first of which was treated successfully with intravenous amiodarone. The second episode resulted in the commencement of therapy with oral amiodarone 400 mg 3 times daily. Within one hour after the first dose, the patient experienced lip swelling and tingling, which was again treated with intravenous promethazine. Amiodarone was stopped; the patient remained in sinus rhythm and was discharged without further incident. DISCUSSION: Amiodarone is a class III antiarrhythmic agent frequently used in the management of atrial fibrillation after cardiac surgery. The approved product information lists known hypersensitivity to iodine as a contraindication to its administration, but no other cases of amiodarone hypersensitivity in a patient with a previous reaction to an iodinated radiocontrast agent have been published. Conversely, it has been suggested that the drug may be safely used in such patients. The Naranjo probability scale supported a probable adverse reaction of hypersensitivity associated with amiodarone therapy in this patient. CONCLUSIONS: Prescribers should exercise caution in the administration of amiodarone to patients with a true, documented history of hypersensitivity to an iodinated compound.

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OBJECTIVE: To quantify the changes in synovial expression of mediators of macrophage chemotaxis, matrix degradation, and macrophage infiltration in the synovial membrane of patients with rheumatoid arthritis (RA) achieving American College of Rheumatology (ACR) defined remission and radiological arrest. METHODS: Knee synovial biopsies were taken from a selected group of 18 patients with RA before and after treatment and immunostained with antibodies specific for CD68; the chemokines macrophage inflammatory protein (MIP)-1a and monocyte chemoattractant protein (MCP)-1; matrix metalloproteinases (MMP-1 and 3) and their inhibitors, the tissue inhibitors of metalloproteinases (TIMP-1 and 2); as well as isotype-specific negative controls. Immunostaining was quantified using a computer assisted color video image analysis system. Radiographs were performed before and after treatment and the Larsen score determined. Patients were arbitrarily divided into 2 groups: the radiological arrest group (defined as change in Larsen score pound 5 from baseline) and radiological progressors (defined as change in Larsen score > 5). Patients were classified according to ACR response criteria. RESULTS: In the 8 patients who achieved ACR defined remission, there were tendencies toward reductions in the synovial lining layer (LL) expression of MIP-1a by 36% (p = 0.1) and MCP-1 by 48% (p = 0.1). Significant reductions occurred in the expression of MMP-1, by 53% in the LL (p = 0.008) and 59% in synovial sublining layer (SL) (p = 0.02) and MMP-3, by 76% in LL (p = 0.02), and 72% in SL (p = 0.008), but not in TIMP expression. In this group of patients there were reductions in MMP:TIMP ratios, in particular the MMP-1:TIMP-1 ratio in the LL (p = 0.05), MMP-3:TIMP-1 ratio in the LL (p = 0.05) and SL (p = 0.008), and MMP-3:TIMP-2 ratio in the LL (p = 0.04) and SL (p = 0.08). In this group of patients CD68+ macrophage infiltration was significantly reduced in the LL by 59% (p = 0.008) and in the SL by 52% (p = 0.008), which corresponded with the reductions in chemokine expression. In the remaining 10 patients who did not achieve full remission there were no significant changes in the variables studied. In the group achieving ACR 50% or 70% response there was a reduction in CD68 expression that approached significance (p = 0.06 in LL and SL), but there was no significant change in the other variables. There were no significant changes in the patients with an ACR 20% response. In the radiological arrest group (12 patients) there was a 41% reduction in LL expression of MIP-1a (p = 0.05) and MMP-1 (p = 0.06). Reductions in MMP:TIMP expression were also noted, in particular in MMP-1:TIMP-1 expression in the LL (p = 0.04) and MMP-3:TIMP-1 in the SL (p = 0.01). There were corresponding reductions in CD68 expression by 49% (p = 0.009) in LL and by 42% (p = 0.0005) in SL. In the radiological progressors (6 patients) there were no significant reductions in mediator expression. CONCLUSION: In RA, ACR defined remission is associated with reductions in MMP-1 and 3 expression, with a corresponding reduction in macrophage infiltration and a tendency to reduction in MIP-1a expression. Radiological arrest is associated with reductions in MMP-1 expression, and significant reductions in macrophage infiltration, MIP-1 expression, and MMP:TIMP ratio.

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