Healthcare expenditure and its socio-demographic and clinical predictors in Australians with poorly controlled asthma.

INTRODUCTION: Asthma has substantial and increasing health and economic burden worldwide. This study aimed to estimate healthcare expenditure and determine the factors that increase expenditure in Australians with poorly controlled asthma. METHODS: Individuals ≥18 years of age with poorly controlled asthma, as determined by a score ≥1.5 on the Asthma Control Questionnaire, were included in the study. Healthcare utilization costs from medical services and medications were estimated over an average follow-up of 12 months from administratively linked data: the Medicare Benefits Schedule and Pharmaceutical Benefits Scheme. A generalized linear model with gamma distribution and log link was used to predict participants' key baseline characteristics associated with variations in healthcare costs. RESULTS: A total of 341 participants recruited through community pharmacies were included. The mean (standard deviation, SD) age of participants was 56.6 (SD 17.6) years, and approximately 71% were females. The adjusted average monthly healthcare expenditure per participant was $AU386 (95% CI: 336, 436). On top of the average monthly costs, an incremental expenditure was found for each year increase in age ($AU4; 95% CI: 0.78, 7), being unemployed ($AU201; 95% CI: 91, 311), one unit change in worsening quality of life ($AU35; 95% CI: 9, 61) and being diagnosed with depression and anxiety ($AU171; 95% CI: 36, 306). CONCLUSIONS: In a cohort of Australian patients, characterized by poor asthma control and co-morbidities individuals impose substantial economic burden in terms of Medicare funded medical services and medications. Programs addressing strategies to improve the quality of life and manage co-morbid anxiety and depression and encourage asthma patients' engagement in clinically tolerable jobs, may result in significant cost savings to the health system.

Effect of an ongoing pharmacist service to reduce medicine-induced deterioration and adverse reactions in aged-care facilities (nursing homes): a multicentre, randomised controlled trial (the ReMInDAR trial).

OBJECTIVE: To assess the effectiveness of a pharmacist-led intervention using validated tools to reduce medicine-induced deterioration and adverse reactions. DESIGN AND SETTING: Multicenter, open-label parallel randomised controlled trial involving 39 Australian aged-care facilities. PARTICIPANTS: Residents on ≥4 medicines or ≥1 anticholinergic or sedative medicine. INTERVENTION: Pharmacist-led intervention using validated tools to detect signs and symptoms of medicine-induced deterioration which occurred every 8 weeks over 12 months. COMPARATOR: Usual care (Residential Medication Management Review) provided by accredited pharmacists. OUTCOMES: Primary outcome was change in Frailty Index at 12 months. Secondary outcomes included changes in cognition, 24-hour movement behaviour by accelerometry, grip strength, weight, adverse events and quality of life. RESULTS: 248 persons (median age 87 years) completed the study; 120 in the interventionand, 128 in control arms. In total 575 pharmacist, sessions were undertaken in the intervention arm. There was no statistically significant difference for change in frailty between groups (mean difference: 0.009, 95% CI: -0.028, 0.009, P = 0.320). A significant difference for cognition was observed, with a mean difference of 1.36 point change at 12 months (95% CI: 0.01, 2.72, P = 0.048). Changes in 24-hour movement behaviour, grip strength, adverse events and quality of life were not significantly different between groups. Point estimates favoured the intervention arm at 12 months for frailty, 24-hour movement behaviour and grip strength. CONCLUSIONS: The use of validated tools by pharmacists to detect signs of medicine-induced deterioration is a model of practice that requires further research, with promising results from this trial, particularly with regards to improved cognition.

Rethinking the gold standard - The feasibility of randomized controlled trials within health services effectiveness research.

BACKGROUND: An evidence-based randomized controlled trial for a novel Pharmacy Asthma Service was tested in 3 Australian states. Positive asthma outcomes were achieved after the 12-month intervention, albeit in both the intervention and comparator arms. The current investigation uses a mixed methods approach to 1) qualitatively explore how comparator arm pharmacists implemented the trial protocol and 2) quantitatively examine how this may have impacted patient outcomes in this trial. METHODS: Post-intervention semi-structured qualitative interviews were conducted with 20 pharmacists, representing 21 of 37 (57%) comparator arm pharmacies that completed the trial. Based on these interviews, pharmacies were classified as 'adherent' to the trial protocol (reporting no interventions other than general practitioner referral) or 'non-adherent' (reporting at least one extra intervention to the trial protocol), or 'inconclusive'. These subgroups were compared descriptively in relation to patient outcomes. RESULTS: Overall, 33% (n = 8/24) of the comparator pharmacies who were interviewed (n = 21) or determined to have monitoring by a project officer to ensure adherence to the protocol (n = 3) were classified as adherent), 58% (n = 14/24) as non-adherent, 8% inconclusive (n = 2/24). While all patients commenced with uncontrolled asthma (Asthma Control Questionnaire score (ACQ) > 1.5), after 12 months the mean ACQ score for patients from adherent comparator pharmacies ('true control') was 1.8 (still uncontrolled asthma) compared to a score of 1.4 (controlled asthma) in the non-adherent comparator group. Quality of life significantly improved in the non-adherent comparator group over the 12 months of the trial. CONCLUSION: The majority of pharmacists in the comparator arm who were interviewed, introduced their own interventions, which may have influenced the outcomes of the trial. The naturalistic setting of the study was not protective against these confounders. These findings question the feasibility of comparator arms within primary care settings and that alternative study designs should be considered when designing future intervention studies in pharmacy practice.

Medication Regimen Complexity Index Prediction of Adverse Drug Reaction-Related Hospital Admissions.

BACKGROUND: The relationship between the medication regimen complexity index (MRCI) and adverse drug reaction (ADR)-related hospital admissions has not yet specifically been investigated. OBJECTIVE: To evaluate the MRCI and compare with medication count for prediction of ADR-related hospital admissions in older patients. METHODS: This was a retrospective analysis of a prospectively collected convenience sample of 768 unplanned medical admissions of Australians aged 65 years old and older. The sample consisted of 115 (15.0%) ADR-related unplanned hospital admissions and 653 (85.0%) non-ADR-related unplanned medical admissions. The MRCI score was calculated from the medical records and analyzed to predict ADR-related hospital admissions. RESULTS: The cohort had a median age of 81 years, 5 comorbidities, and 11 medications, with a slight majority of women. The MRCI score was not significantly different in patients who had ADR-related admissions compared with other medical admissions-38.5 versus 34.0, respectively; Wilcoxon Rank Sum test W = 33 522; P = 0.067. The medication count was significantly different between the ADR-related admissions compared with other medical admissions: 12 versus 10; W = 32 508; P = 0.021. However, the medication count was not a strong predictor of ADR-related admissions; unadjusted odds ratio = 1.044; 95% CI = 1.006-1.084. CONCLUSION AND RELEVANCE: The MRCI score did not discriminate between ADR-related admissions and other medical admissions despite taking time to calculate with potential for inconsistent application. Medication count is more readily applicable with marginally greater relevance in this cohort; however, both measures do not appear to be useful when used alone for clinicians to identify patients at risk of ADRs.

Reducing medicine-induced deterioration and adverse reactions (ReMInDAR) trial: study protocol for a randomised controlled trial in residential aged-care facilities assessing frailty as the primary outcome.

INTRODUCTION: Many medicines have adverse effects which are difficult to detect and frequently go unrecognised. Pharmacist monitoring of changes in signs and symptoms of these adverse effects, which we describe as medicine-induced deterioration, may reduce the risk of developing frailty. The aim of this trial is to determine the effectiveness of a 12-month pharmacist service compared with usual care in reducing medicine-induced deterioration, frailty and adverse reactions in older people living in aged-care facilities in Australia. METHODS AND ANALYSIS: The reducing medicine-induced deterioration and adverse reactions trial is a multicentre, open-label randomised controlled trial. Participants will be recruited from 39 facilities in South Australia and Tasmania. Residents will be included if they are using four or more medicines at the time of recruitment, or taking more than one medicine with anticholinergic or sedative properties. The intervention group will receive a pharmacist assessment which occurs every 8 weeks. The pharmacists will liaise with the participants' general practitioners when medicine-induced deterioration is evident or adverse events are considered serious. The primary outcome is a reduction in medicine-induced deterioration from baseline to 6 and 12 months, as measured by change in frailty index. The secondary outcomes are changes in cognition scores, 24-hour movement behaviour, grip strength, weight, percentage robust, pre-frail and frail classification, rate of adverse medicine events, health-related quality of life and health resource use. The statistical analysis will use mixed-models adjusted for baseline to account for repeated outcome measures. A health economic evaluation will be conducted following trial completion using data collected during the trial. ETHICS AND DISSEMINATION: Ethics approvals have been obtained from the Human Research Ethics Committee of University of South Australia (ID:0000036440) and University of Tasmania (ID:H0017022). A copy of the final report will be provided to the Australian Government Department of Health. TRIAL REGISTRATION NUMBER: Australian and New Zealand Trials Registry ACTRN12618000766213.

Development and Validation of an Atrial Fibrillation Knowledge Assessment Tool (AFKAT).

Assessing and improving public knowledge of atrial fibrillation (AF) could increase its detection rate and the subsequent use of stroke prevention therapies. However, there is no validated AF knowledge assessment tool applicable to the general population, including those at risk of AF. Therefore, we aimed to develop and validate such a tool. The tool was developed from a literature review and discussion with subject matter experts. Content validity was ensured by a ten-member panel of experts comprising cardiologists and pharmacists. An online validation survey was conducted and reported based on the Checklist for Reporting Results of Internet E-Surveys (CHERRIES). The survey evaluated the tool performance by construct validity, internal consistency reliability, item discrimination, difficulty index and ease of readability. The survey participants included 14 general medical specialists, 20 fourth-year and 33 second-year undergraduate pharmacy students, and 122 members of the general public. The tool had satisfactory content validity, with a scale content validity index of 0.8. The mean percentage knowledge scores for general medical specialists and fourth-year pharmacy students were higher than second-year pharmacy students, followed by the general public (92.9%, 87.6%, 68.5% and 53.4%, respectively; p-value < 0.001), supporting construct validity. The tool had good internal consistency reliability (Cronbach's alpha = 0.91). The item-total correlation was in the preferred range of 0.23 to 0.71. The Atrial Fibrillation Knowledge Assessment Tool is a valid instrument and can be used to investigate AF knowledge of the general population.

Adherence to Oral Anticoagulants in Atrial Fibrillation: An Australian Survey.

BACKGROUND: The aim of this study was to investigate the proportion of patients who have suboptimal adherence to oral anticoagulant (OAC), identify the predictors of adherence, and determine whether patient-related factors vary across adherence levels in Australia. METHODS: Respondents were recruited for an online survey using Facebook. Survey instruments included the Morisky Medication Adherence Scale, the Anticoagulation Knowledge Tool, the Perception of Anticoagulant Treatment Questionnaires, and a modified Cancer Information Overload scale. Predictors of medication adherence were identified using ordinal regression analysis. RESULTS: Of the 386 responses eligible for analysis, only 54.9% reported a high level of adherence. Participants aged 65 years or younger were less likely to have high adherence compared to older participants (odds ratio [OR], 0.54; 95% confidence interval [CI], 0.33-0.88; P = .013), while females were more likely to be highly adherent compared to males (OR, 1.69; 95% CI, 1.08-2.64; P = .023). The analyses showed that age, gender, treatment satisfaction, information overload, concerns about making mistake when taking OACs, and cost of medication were significant predictors of adherence. CONCLUSION: Self-reported suboptimal adherence to OAC is common among patients with atrial fibrillation. A focus on supporting people who are at higher risk of suboptimal adherence is needed to maximize the benefit of OAC therapy in this population.

Potential use of NOACs in developing countries: pros and cons.

PURPOSE: Although vitamin K antagonists (VKAs) are effective for long-term thromboprophylaxis in atrial fibrillation (AF), their limitations have led to widespread underutilisation, especially in the developing world. Novel oral anticoagulants (NOACs) have emerged as promising alternatives to VKAs, although there are some particular considerations and challenges to their introduction in developing countries. This review summarises the current state of antithrombotic management of AF in the developing world, explores the early evidence for the NOACs and describes some of the special considerations that must be taken into account when considering the role of the NOACs within developing countries' health care systems. METHODS: A literature search was conducted via PubMed and Google Scholar to find articles published in English between the years 2000 to 2014. Search terms used were "atrial fibrillation", "oral anticoagulants", "warfarin", "NOACs", "dabigatran", "rivaroxaban", "apixaban", "edoxaban", "time in therapeutic range", "International Normalized Ratio" "cost-effectiveness", "stroke", "adverse-drug reactions" and "drug-drug interactions", together with the individual names of developing countries as listed by the World Bank. We reviewed the results of randomized clinical trials, relevant retrospective and prospective studies, case-studies and review articles. RESULTS: Many developing countries lack or have sporadic data on the quality of AF management, making it difficult to anticipate the potential impact of NOACs in these settings. The utilisation of anticoagulants for AF appears highly variable in developing countries. Given the issues associated with VKA therapy in many developing countries, NOACs offer some potential advantages; however, there is insufficient evidence to advocate the widespread replacement of warfarin at present. VKAs may continue to have a role in selected patients or countries, especially if alternative monitoring strategies can be utilised. CONCLUSION: The evaluation of the introduction of NOACs should consider safety, budget concerns and the quality of oral anticoagulation care achieved by each country. Prospective registries will be important in developing countries to better elucidate the comparative safety, efficacy and cost-effectiveness of NOACs and VKAs as NOACs are introduced into practice.

The benefits of pharmacist-delivered warfarin education in the home.

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.

Training Australian pharmacists for participation in a collaborative, home-based post-discharge warfarin management service.

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.