Innovations in pharmacovigilance studies of medicines in older people.

Pharmacovigilance is defined by the World Health Organization as "the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem". Pharmacovigilance studies are critical for detecting and assessing adverse events of medicines that may not have been observed in clinical trials. This activity is especially important in older people who are often excluded from clinical trials as they have multiple chronic conditions and use multiple medicines for longer durations than the clinical trials. In this narrative review we describe innovative methods in pharmacovigilance studies of medicines in older people that leverage the increasing availability of digital health technologies, electronic health records and real-world health data to identify and quantify medication related harms in older people.

What is impacting clinical pharmacists' participation in an interprofessional ward round: a thematic analysis of a national survey.

The ward round (WR) is an important opportunity for interprofessional interaction and communication enabling optimal patient care. Pharmacists' participation in the interprofessional WR can reduce adverse drug events and improve medication appropriateness and communication. WR participation by clinical pharmacists in Australia is currently limited. This study aims to explore what is impacting clinical pharmacists' participation in WRs in Australian hospitals. A self-administered, anonymous national survey of Australian clinical pharmacists was conducted. This study describes the outcomes from qualitative questions which were analyzed thematically in NVivo-2020 according to Braun and Clarke's techniques. Five themes were constructed: "Clinical pharmacy service structure", "Ward round structure", "Pharmacist's capabilities", "Culture" and "Value". A culture supportive of pharmacist's contribution with a consistent WR structure and flexible delivery of clinical pharmacy services enabled pharmacists' participation in WR. Being physically "absent" from the WR due to workload, workflow, and self-perception of the need for extensive clinical knowledge can limit opportunities for pharmacists to proactively contribute to medicines decision-making with physicians to improve patient care outcomes. Bidirectional communication between the interprofessional team and the pharmacist, where there is a co-construction of each individual's role in the WR facilitates consistent and inter-dependent collaborations for effective medication management.

A comparison of survival models for prediction of eight-year revision risk following total knee and hip arthroplasty.

BACKGROUND: There is increasing interest in the development and use of clinical prediction models, but a lack of evidence-supported guidance on the merits of different modelling approaches. This is especially true for time-to-event outcomes, where limited studies have compared the vast number of modelling approaches available. This study compares prediction accuracy and variable importance measures for four modelling approaches in prediction of time-to-revision surgery following total knee arthroplasty (TKA) and total hip arthroplasty (THA). METHODS: The study included 321,945 TKA and 151,113 THA procedures performed between 1 January 2003 and 31 December 2017. Accuracy of the Cox model, Weibull parametric model, flexible parametric model, and random survival forest were compared, with patient age, sex, comorbidities, and prosthesis characteristics considered as predictors. Prediction accuracy was assessed using the Index of Prediction Accuracy (IPA), c-index, and smoothed calibration curves. Variable importance rankings from the Cox model and random survival forest were also compared. RESULTS: Overall, the Cox and flexible parametric survival models performed best for prediction of both TKA (integrated IPA 0.056 (95% CI [0.054, 0.057]) compared to 0.054 (95% CI [0.053, 0.056]) for the Weibull parametric model), and THA revision. (0.029 95% CI [0.027, 0.030] compared to 0.027 (95% CI [0.025, 0.028]) for the random survival forest). The c-index showed broadly similar discrimination between all modelling approaches. Models were generally well calibrated, but random survival forest underfitted the predicted risk of TKA revision compared to regression approaches. The most important predictors of revision were similar in the Cox model and random survival forest for TKA (age, opioid use, and patella resurfacing) and THA (femoral cement, depression, and opioid use). CONCLUSION: The Cox and flexible parametric models had superior overall performance, although all approaches performed similarly. Notably, this study showed no benefit of a tuned random survival forest over regression models in this setting.

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.

Implementation and Evaluation of a Digitally Enabled Precision Public Health Intervention to Reduce Inappropriate Gabapentinoid Prescription: Cluster Randomized Controlled Trial.

BACKGROUND: Digital technologies can enable rapid targeted delivery of audit and feedback interventions at scale. Few studies have evaluated how mode of delivery affects clinical professional behavior change and none have assessed the feasibility of such an initiative at a national scale. OBJECTIVE: The aim of this study was to develop and evaluate the effect of audit and feedback by digital versus postal (letter) mode of delivery on primary care physician behavior. METHODS: This study was developed as part of the Veterans' Medicines Advice and Therapeutics Education Services (MATES) program, an intervention funded by the Australian Government Department of Veterans' Affairs that provides targeted education and patient-specific audit with feedback to Australian general practitioners, as well as educational material to veterans and other health professionals. We performed a cluster randomized controlled trial of a multifaceted intervention to reduce inappropriate gabapentinoid prescription, comparing digital and postal mode of delivery. All veteran patients targeted also received an educational intervention (postal delivery). Efficacy was measured using a linear mixed-effects model as the average number of gabapentinoid prescriptions standardized by defined daily dose (individual level), and number of veterans visiting a psychologist in the 6 and 12 months following the intervention. RESULTS: The trial involved 2552 general practitioners in Australia and took place in March 2020. Both intervention groups had a significant reduction in total gabapentinoid prescription by the end of the study period (digital: mean reduction of 11.2%, P=.004; postal: mean reduction of 11.2%, P=.001). We found no difference between digital and postal mode of delivery in reduction of gabapentinoid prescriptions at 12 months (digital: -0.058, postal: -0.058, P=.98). Digital delivery increased initiations to psychologists at 12 months (digital: 3.8%, postal: 2.0%, P=.02). CONCLUSIONS: Our digitally delivered professional behavior change intervention was feasible, had comparable effectiveness to the postal intervention with regard to changes in medicine use, and had increased effectiveness with regard to referrals to a psychologist. Given the logistical benefits of digital delivery in nationwide programs, the results encourage exploration of this mode in future interventions.

Post-market utilization patterns of Alzheimer's disease treatments in South Korea: comparison with countries with universal health coverage.

PURPOSE: This study aimed to compare the utilization of Alzheimer's disease (AD) treatments, donepezil, galantamine, rivastigmine, and memantine, in Korea with Australia and other countries with universal health coverage. METHODS: Reimbursement criteria and the patent status of four AD treatments in Korea and Australia were reviewed. The monthly spending and utilization of the treatments were extracted from the national electronic database in Korea and Australia. The defined daily dose per 1000 elderly population per day (DDD/1000e/day) were calculated from July 2008 to June 2019. Annual cost trends of Norway and England were compared with Korea and Australia. RESULTS: With the highest share of the use of donepezil in both countries, the cost and utilization of AD treatments in Korea increased more rapidly and remained higher than Australia. The cost of AD treatments in Korea increased by 15.5% every year during the study period, while the spending of the same drugs in Australia decreased by 10.5% annually. The utilization in DDD/1000e/day of AD treatments in Korea increased by 18.3% annually compared with 1.4% in Australia. When compared with Norway and England, countries with similar universal health coverage (UHC) system and elderly polupation, the cost of AD treatments in Korea was still higher with the opposite trend from other countries. CONCLUSIONS: Despite the similar UHC systems, there were considerable differences in the post-market utilization of AD treatments in Korea from Australia and other countries. This results can be attributed to differences in re-assessment system, pricing and reimbursement policies, and prescribing culture. This study provides a baseline to explore more comprehensive cross-country studies on rational use of medicines.

Potentially inappropriate medication use and related hospital admissions in aged care residents: The impact of dementia.

AIMS: To determine the prevalence of potentially inappropriate medication (PIM) use at hospital admission and discharge, and the contribution to hospital admission among residential aged care facility residents with and without dementia. METHODS: We conducted a secondary analysis using data from a multihospital prospective cohort study involving consecutively admitted older adults, aged 75 years or older, who were taking 5 or more medications prior to hospital admission and discharged to a residential aged care facility in South Australia. PIM use was identified using the 2015 Screening Tool for Older Persons' Prescription and 2019 Beers criteria. An expert panel of clinicians with geriatric medicine expertise evaluated the contribution of PIM to hospital admission. RESULTS: In total, 181 participants were included, the median age was 87.5 years and 54.7% were female. Ninety-one (50.3%) had a diagnosis of dementia. Participants with dementia had fewer PIMs, according to at least 1 of the 2 screening criteria, than those without dementia, at admission (dementia: 76 [83.5%] vs no dementia: 84 [93.3%], P = .04) and discharge (78 [85.7%] vs 83 [92.2%], P = .16). PIM use was causal or contributory to the admission in 28.1% of study participants (n = 45) who were taking at least 1 PIM at admission. CONCLUSIONS: Over 80% of acutely admitted older adults took PIMs at hospital admission and discharge and for over a quarter of these people the admissions were attributable to PIM use. Hospitalisation presents an opportunity for comprehensive medication reviews, and targeted interventions that enhance such a process could reduce PIM use and related harm.

Potentially inappropriate prescribing in people with dementia: An Australian population-based study.

OBJECTIVE: To investigate the prevalence of potentially inappropriate prescribing (PIP) using the Screening Tool of Older Person's Prescriptions (STOPP) criteria in people with dementia compared with people without dementia. METHODS: A retrospective cohort study was conducted using the Pharmaceutical Benefits Scheme 10% sample of pharmacy claims. People with dementia were defined as those dispensed a medicine for dementia (cholinesterase inhibitors, memantine, or risperidone for behavioural and psychological symptoms of dementia) between 1 January 2005 and 31 December 2015, aged 65 years or older at 1 January 2016 and alive at the end of 2016. An age- and gender-matched comparison cohort of people not dispensed medicines for dementia was identified. PIP prevalence was determined between 1 January 2016 and 31 December 2016. RESULTS: In total, 8280 people dispensed medicines for dementia and 41 400 comparisons not dispensed medicines for dementia were included: 63% were female and the median age was 82 years. PIP prevalence was 79% among people with dementia compared with 70% among the comparison group (P < .0001). Use of anticholinergics, long-term use of high-dose proton pump inhibitors, and use of benzodiazepines were the most common instances of PIP in people with dementia. After adjustments for age, gender, comorbidity, and number of prescribers, people with dementia were more likely to be exposed to PIP than comparisons (adjusted OR 1.44, 95% CI, 1.35-1.53, P < .0001). CONCLUSIONS: PIP was more common in people dispensed medicines for dementia than comparisons. These results highlight the need for effective interventions to optimize prescribing in people with dementia.

Implementation of medication-related indicators of potentially preventable hospitalizations in a national chronic disease management program for older patients with multimorbidity.

INITIAL ASSESSMENT: Older people are at increased risk of medication-related potentially preventable hospitalizations (MR-PPH) due to the presence of multiple chronic conditions (multimorbidity) and subsequent polypharmacy. CHOICE OF SOLUTION: A pilot study was conducted, using evidence-based indicators to detect older patients in a chronic disease management program (CDMP) at risk of hospitalization due to sub-optimal medication use. IMPLEMENTATION: Previously validated indicators for MR-PPH were applied to patients with multimorbidity, aged 65 years or older and who were enrolled in a national community-based CDMP. Nurse-led telephone interviews and case note abstraction were used as data sources. EVALUATION: Nineteen patients triggered the MR-PPH indicators 85 times with a median of four per patient. Sub-optimal medication management was identified 34 times (40%) with a median of two per patient. The most common reasons for sub-optimal medication management were exposure to medications associated with falls, underuse of angiotensin-converting enzyme inhibitor/angiotensin-2 receptor blocker medications for cardiovascular disease and low rates of hemoglobin A1c and renal monitoring in patients with diabetes. LESSONS LEARNED: This study has shown the utility of MR-PPH indicators within a CDMP to identify and monitor sub-optimal medication-related care. Implementation and ongoing monitoring of these types of indicators can support the development of targeted programs to reduce the ongoing risk of adverse events in the older population and improve the overall quality of life.

Antipsychotic polypharmacy in older Australians.

ABSTRACTBackground:Antipsychotics are commonly used, and the rate of use is highest, among those aged 65 years or over, where the risk of adverse events is also high. Up to 20% of younger adults use more than one antipsychotic concurrently; however there are few studies on the prevalence of antipsychotic polypharmacy in older people. We aimed to analyze antipsychotic use in elderly Australians, focusing on the prevalence of antipsychotic polypharmacy and the use of medicines to manage adverse events associated with antipsychotics. METHODS: A cross-sectional study was conducted using Australian Department of Veterans' Affairs (DVA) administrative claims data for the period 1 March 2014 to 30 June 2014. Veterans dispensed at least one antipsychotic medicine during the study period was included. We determined the number of participants dispensed antipsychotic polypharmacy and the number of participants dispensed medicines to manage antipsychotic side effects. RESULTS: There were 7,412 participants with a median age of 86 years. Fifty-one percent (n=3,784) were women and 48% (n=3,569) lived in residential aged-care. Fifty one participants (0.7%) were dispensed anticholinergic medicines indicated for the management of antipsychotic-associated extrapyramidal movement disorders and eight (0.1%) were dispensed medicines for the management of hyperprolactinemia. Five percent of participants (n=365) received dual antipsychotics. Dual antipsychotic users were more likely to be under the care of a psychiatrist or to have had a mental health hospitalization than those using a single antipsychotic. CONCLUSIONS: Antipsychotic polypharmacy occurred in one in 20 elderly persons, indicating that there is room for improvement in antipsychotic use in elderly patients.

Reducing hypnotic use in insomnia management among Australian veterans: results from repeated national interventions.

BACKGROUND: The Australian Government Department of Veterans' Affairs (DVA) Veterans' Medicines Advice and Therapeutics Education Services (Veterans' MATES) programme conducted two intervention (March 2009, follow-up intervention June 2012) both of which aimed to reduce hypnotic use among Australian veterans. We evaluated the effectiveness of the interventions, and estimated the associated health consequences. METHODS: Both interventions targeted veterans who had been dispensed hypnotics prior to the intervention. Patient-specific prescriber feedback containing patient details and the volume of hypnotics dispensed, along with tailored educational information, was mailed to general practitioners. Veterans, pharmacists and directors of care in residential aged care facilities were mailed tailored educational information. Interrupted time-series and segmented regression modelling were used to determine the effect of the two interventions on the rate of hypnotics dispensing. The cumulative patient-months of hypnotic treatment avoided as a result of the interventions was calculated. We estimated improvements in health consequences of as a result of hypnotic treatment avoided based on the results of cohort studies in the same population identifying the association between hypnotic and sedative use on the outcomes of falls, and confusion. RESULTS: After the first Veterans' MATES intervention in March 2009, hypnotic use declined by 0.2% each month, when compared to the baseline level (p = 0.006). The intervention effect was attenuated after one year, and use of hypnotics was found to increase by 0.2% per month after March 2010. Following the second intervention in June 2012, there was a further significant decline in use of 0.18% each month over the 12 months of follow up (p = 0.049). The cumulative effect of both interventions resulted in 20,850 fewer patient-months of treatment with hypnotics. This cumulative reduction in hypnotic use was estimated to lead to a minimum of 1 fewer hospital admissions for acute confusion and 7 fewer hospital admissions due to falls. CONCLUSIONS: The Veterans' MATES insomnia interventions which involved multiple stakeholders were effective in reducing hypnotic use among older Australians. Repetition of key messages led to sustained practice change.

What is polypharmacy? A systematic review of definitions.

BACKGROUND: Multimorbidity and the associated use of multiple medicines (polypharmacy), is common in the older population. Despite this, there is no consensus definition for polypharmacy. A systematic review was conducted to identify and summarise polypharmacy definitions in existing literature. METHODS: The reporting of this systematic review conforms to the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) checklist. MEDLINE (Ovid), EMBASE and Cochrane were systematically searched, as well as grey literature, to identify articles which defined the term polypharmacy (without any limits on the types of definitions) and were in English, published between 1st January 2000 and 30th May 2016. Definitions were categorised as i. numerical only (using the number of medications to define polypharmacy), ii. numerical with an associated duration of therapy or healthcare setting (such as during hospital stay) or iii. Descriptive (using a brief description to define polypharmacy). RESULTS: A total of 1156 articles were identified and 110 articles met the inclusion criteria. Articles not only defined polypharmacy but associated terms such as minor and major polypharmacy. As a result, a total of 138 definitions of polypharmacy and associated terms were obtained. There were 111 numerical only definitions (80.4% of all definitions), 15 numerical definitions which incorporated a duration of therapy or healthcare setting (10.9%) and 12 descriptive definitions (8.7%). The most commonly reported definition of polypharmacy was the numerical definition of five or more medications daily (n = 51, 46.4% of articles), with definitions ranging from two or more to 11 or more medicines. Only 6.4% of articles classified the distinction between appropriate and inappropriate polypharmacy, using descriptive definitions to make this distinction. CONCLUSIONS: Polypharmacy definitions were variable. Numerical definitions of polypharmacy did not account for specific comorbidities present and make it difficult to assess safety and appropriateness of therapy in the clinical setting.

Preoperative medication use and postoperative delirium: a systematic review.

BACKGROUND: Medications are frequently reported as both predisposing factors and inducers of delirium. This review evaluated the available evidence and determined the magnitude of risk of postoperative delirium associated with preoperative medication use. METHODS: A systematic search in Medline and EMBASE was conducted using MeSH terms and keywords for postoperative delirium and medication. Studies which included patients 18 years and older who underwent major surgery were included. The methodological quality of included studies was assessed independently by two authors using the Newcastle-Ottawa quality assessment scale for cohort studies. RESULTS: Twenty-nine studies; 25 prospective cohort, three retrospective cohort and one post hoc analysis of RCT data were included. Only four specifically aimed to assess medicines as an independent predictor of delirium, all other studies included medicines among a number of potential predictors of delirium. Of the studies specifically testing the association with a medication class, preoperative use of beta-blockers (OR = 2.06[1.18-3.60]) in vascular surgery and benzodiazepines RR 2.10 (1.23-3.59) prior to orthopedic surgery were significant. However, evidence is from single studies only. Where medicines were included as one possible factor among many, hypnotics had a similar risk estimate to the benzodiazepine study, with one significant and one non-significant result. Nifedipine use prior to cardiac surgery was found to be significantly associated with delirium. The non-specific grouping of psychoactive medication use preoperatively was generally higher with an associated two-to-seven-fold higher risk of postoperative delirium, while only two studies included narcotics without other agents, with one significant and one non-significant result. CONCLUSIONS: There was a limited number of high quality studies in the literature quantifying the direct association between preoperative medication use and postsurgical delirium. More studies are required to evaluate the association of specific preoperative medications on the risk of postoperative delirium so that comprehensive guidelines for medicine use prior to surgery can be developed to aid delirium prevention. TRIAL REGISTRATION: This systematic review has been registered on PROSPERO International prospective register of systematic reviews (Registration number: CRD42016051245 ).

Use of proton pump inhibitors among older Australians: national quality improvement programmes have led to sustained practice change.

OBJECTIVE: To evaluate the impact of national multifaceted initiatives to improve use of proton pump inhibitors (PPIs) on the use of PPIs among older Australians. DESIGN: Interrupted time series analysis using administrative health claims data from the Australian Government Department of Veterans' Affairs (DVA). SETTING: Australia. PARTICIPANTS: All veterans and dependents who received PPIs between January 2003 and December 2013. INTERVENTION(S): National, multifaceted interventions to improve PPI use were conducted by the Australian Government Department of Veterans' Affairs Veterans' MATES programme and Australia's NPS MedicineWise in April 2004, June 2006, May 2009 and August 2012. MAIN OUTCOME MEASURE(S): Trends in monthly rate of use of any PPI among the veteran population, and the monthly rate of use of low strength PPIs among all veterans dispensed a PPI. RESULTS: Interventions in 2004, 2006, 2009 and 2012 slowed the rate of increase in PPI use significantly, with the 2012 intervention resulting in a sustained 0.04% decrease in PPI use each month. The combined effect of all four interventions was a 20.9% (95% CI 7.8-33.9%) relative decrease in PPI use 12 months after the final intervention. The four interventions also resulted in a 42.2% (95% CI 19.9-64.5%) relative increase in low strength PPI use 12 months after the final intervention. CONCLUSIONS: National multifaceted programmes targeting clinicians and consumers were effective in reducing overall PPI use and increasing use of low strength PPIs. Interventions to improve PPI use should incorporate regular repetition of key messages to sustain practice change.

Suboptimal medication-related quality of care preceding hospitalisation of older patients.

OBJECTIVE: To examine the prevalence of suboptimal medication-related processes of care before the hospitalisation of older patients. DESIGN AND SETTING: We conducted a retrospective cohort study using a clinical indicator set related to medication management that has been validated by an expert panel as consisting of suboptimal aspects of medication use that clinicians should be able to foresee and avoid. Australian Government Department of Veterans' Affairs administrative claims data between 1 July 2007 and 30 June 2012 were analysed according to these clinical indicators to assess medication-related processes of care preceding hospitalisation. PARTICIPANTS: Veterans with one or more hospitalisations in Australia for a condition defined by the clinical indicator set. MAIN OUTCOME MEASURE: Prevalence of suboptimal medication-related processes of care before hospitalisation as a proportion of all hospitalisations defined by diagnoses in the clinical indicator set. RESULTS: During the 5-year study period, there were 164,813 hospitalisations with primary diagnoses for conditions included in the clinical indicator set, encompassing 83,430 patients. The overall proportion of hospitalisations that were preceded by suboptimal medication-related processes of care was 25.2% (41,546 hospitalisations); 34.5% of patients (28,807 patients) had at least one hospitalisation and 10.4% (8640 patients) had two or more hospitalisations preceded by suboptimal medication-related processes of care. At least one in 10 hospitalisations for chronic heart failure, ischaemic stroke, asthma, gastrointestinal ulcer or bleeding, fracture, renal failure or nephropathy, hyperglycaemia or hypoglycaemia were preceded by suboptimal medication-related processes of care. CONCLUSIONS: This study highlights conditions for which there are evidence-practice gaps in medication management in the older population. Routine prospective monitoring of these evidence-based, validated, medication-related clinical indicators provides a means for quality improvement in the management of common chronic conditions.

An international comparison of spontaneous adverse event reports and potentially inappropriate medicine use associated with dabigatran.

PURPOSE: The objective of this study was to analyse spontaneous adverse event (SAE) reports associated with the oral anticoagulant dabigatran from Australia, Canada and USA and to examine concomitant medicine use. METHODS: Spontaneous adverse event national databases from Australia, Canada and the USA were used to examine all reports of adverse events associated with dabigatran from 1st August 2005 to 31st March 2013. Disproportionality analysis was conducted for the quantitative detection of signals using the USA database. Concomitant medicine use was examined to identify potentially inappropriate medicines, which may place the patient at increased risk for adverse events. RESULTS: There were a total of 1039, 1333 and 13 788 SAE reports associated with dabigatran from Australia, Canada and USA, respectively. Gastrointestinal (GI) disorders were the most commonly reported adverse event, ranging from 27.5% for Australia and up to 40.5% for USA. Of these, GI haemorrhage accounted for 81.5% of Australian, 71.5% of Canadian and 42% of the USA adverse event reports for GI disorders. Positive signals were confirmed in the USA data (GI haemorrhage; PRR 18.18, χ2 40993.51 and ROR 19.55 95% CI 18.77-20.36). Use of concomitant medicines with the potential to increase bleeding risk across all three countries ranged from 34.1% for Australia to 51.1% for the USA. CONCLUSIONS: A large proportion of adverse events were associated with concomitant therapies, which may have placed the patient at increased risk of harm. This highlights the need for pharmacovigilance by the prescribing clinician to minimise risk and ensure the safe and effective integration of dabigatran into routine clinical practice.

Exploration of 'micro' level factors that affect the involvement of clinical pharmacists in interprofessional ward rounds in hospitals: Through the lens of social cognitive theory.

BACKGROUND: Macro and meso level factors that influence the participation by clinical pharmacists in ward rounds include pharmacy management culture, commitment to ward rounds and adequate time for ward rounds being included in workload models. The 'micro' level factors that affect the involvement of clinical pharmacists in ward rounds have not been widely explored. OBJECTIVE: Explore 'micro' level factors to gain insight into clinical pharmacists' participation in interprofessional ward rounds in inpatient settings through the lens of social cognitive theory. METHOD: A qualitative focused ethnographic study with five clinical pharmacists, four medical practitioners, one allied health professional and one nurse was conducted in three metropolitan hospitals in Southern Australia. Seven hours of semi-structured interview (n = 11) and 76-h of observations (n = 5) were conducted. A qualitative descriptive analysis was conducted (guided by Spradley) followed by reflexive thematic-analysis (according to Braun and Clarke's technique). RESULTS: Three micro level factors influencing clinical pharmacist participation in ward rounds are: (1) Cognitive mindset of clinical pharmacists, (2) Behavioural conduct of clinical pharmacists, and (3) Social rules of the ward. Clinical pharmacists that did not participate in ward round reconciled their moral distress by transferring information without clinical judgement or interpretation of the patient scenario to medical practitioners. Clinical pharmacists that did participate in ward rounds demonstrated credibility by making relevant recommendations with a holistic lens. This enabled clinical pharmacists to be perceived as trustworthy by medical practitioners. Positive experiences of participating in ward rounds contributed to their cognitive upward spiral of thoughts and emotions, fostering continued participation. CONCLUSION: Clinical pharmacists participate in ward rounds when they develop a positive mindset about ward round participation and perceive ward rounds as an enabler to the establishment of trusted professional relationships with medical practitioners. This trusted relationship creates an environment where the pharmacist develops confidence in making relevant recommendations.

Bridging evidence-practice gaps: improving use of medicines in elderly Australian veterans.

BACKGROUND: The Australian Government Department of Veterans' Affairs (DVA) funds an ongoing health promotion based program to improve use of medicines and related health services, which implements interventions that include audit and feedback in the form of patient-specific feedback generated from administrative claims records. We aimed to determine changes in medicine use as a result of the program. METHODS: The program provides targeted patient-specific feedback to medical practitioners. The feedback is supported with educational material developed by a clinical panel, subject to peer review and overseen by a national editorial committee. Veterans who meet target criteria also receive educational brochures. The program is supported by a national call centre and ongoing national consultation. Segmented regression analyses (interrupted time series) were undertaken to assess changes in medication use in targeted veterans pre and post each intervention. RESULTS: 12 interventions were included; three to increase medicine use, seven which aimed to reduce use, and two which had combination of messages to change use. All programs that aimed to increase medicine use were effective, with relative effect sizes at the time of the intervention ranging from 1% to 8%. Mixed results were seen with programs aiming to reduce inappropriate medicine use. Highly specific programs were effective, with relative effect sizes at the time of the intervention of 10% decline in use of NSAIDs in high risk groups and 14% decline in use of antipsychotics in dementia. Interventions targeting combinations of medicines, including medicine interactions and potentially inappropriate medicines in the elderly did not change practice significantly. Interventions with combinations of messages targeting multiple components of practice had an impact on one component, but not all components targeted. CONCLUSIONS: The Veterans' MATES program showed positive practice change over time, with interventions increasing use of appropriate medicines where under-use was evident and reduced use of inappropriate medicines when single medicines were targeted. Combinations of messages were less effective, suggesting specific messages focusing on single medicines are required to maximise effect. The program provides a model that could be replicated in other settings.

Precision public-health intervention for care coordination: a real-world study.

BACKGROUND: Health emergencies disproportionally affect vulnerable populations. Digital tools can help primary care providers find, and reach, the right patients. AIM: To evaluate whether digital interventions delivered directly to GPs' clinical software were more effective at promoting primary care appointments during the COVID-19 pandemic than interventions delivered by post. DESIGN AND SETTING: Real-world, non-randomised, interventional study involving GP practices in all Australian states. METHOD: Intervention material was developed to promote care coordination for vulnerable older veterans during the COVID-19 pandemic, and sent to GPs either digitally to the clinical practice software system or in the post. The intervention material included patient-specific information sent to GPs to support care coordination, and education material sent via post to veterans identified in the administrative claims database. To evaluate the impact of intervention delivery modalities on outcomes, the time to first appointment with the primary GP was measured; a Cox proportional hazards model was used, adjusting for differences and accounting for pre-intervention appointment numbers. RESULTS: The intervention took place in April 2020, during the first weeks of COVID-19 social distancing restrictions in Australia. GPs received digital messaging for 51 052 veterans and postal messaging for 26 859 veterans. The digital group was associated with earlier appointments (adjusted hazard ratio 1.38 [1.34 to 1.41]). CONCLUSION: Data-driven digital solutions can promote care coordination at scale during national emergencies, opening up new perspectives for precision public-health initiatives.