MedsScan Issue 2, 2025

These reviews provide updates on the international literature on therapeutics. Expert pharmacy practitioners — via AdPha’s Specialty Practice Groups — scan major peer-reviewed journals in areas relevant to Australian pharmacy practice and present precis on major clinical trials, important pharmacoepidemiology studies and pharmacoeconomic research, and other updates relevant to practice. Interested readers are encouraged to explore the original publications in greater detail.

CLINICAL TRIALS

MedsScan Editor for Clinical trials SPG: June Challen

Key concepts for transitioning from animal models to non-animal models in biomedical research

All medical products are required to undergo research and testing to ensure they are safe and effective for human use and commercialisation. This evaluation is typically conducted using animals. The 3Rs (replacement, reduction and refinement) are accepted internationally as critical components of the ethical, humane and responsible care and use of animals for scientific purposes. The 3Rs are explained as follows: replacement refers to methods that permit a given purpose of an activity or project to be achieved without the use of animals; reduction includes methods for obtaining comparable levels of information from the use of fewer animals in scientific procedures or for obtaining more information from the same number of animals; while refinement includes methods that alleviate or minimise potential pain and distress in animals and enhance animal wellbeing.

This article discusses the transition from the use of animals in research to the use of microphysiological systems such as organ-on-a-chip technologies and organoids. These systems use human-derived or humanised cells, tissues or data. These models are becoming increasingly sophisticated and have the potential to surpass the performance of traditional animal models at anticipating the safety and efficacy of novel medical products. The author suggests a five-pillar model to advance the transition away from animal-based models which includes awareness, access, education, application and rewards.

While the models present compelling opportunities, the author acknowledges barriers to widespread implementation, including scalability and limits of vascularisation relating to organoids. The article adopts an ethical lens to address advancing the transition to these engineered microphysiological systems and potential future use cases.

Sharoni E. Which concepts are key to transitioning from nonhuman animal models to engineered microphysiological systems in biomedical research? AMA J Ethics 2024; 26: E709–E715.

Implementation of clinical research into practice and the role of clinical trial networks

This paper discusses the importance of clinical trials being designed to ensure that evidence generated is appropriate to be applied to improve practice. Late phase trials can provide evidence that guides adoption of clinical interventions. Trial planning, design, conduct and reporting of trials are addressed, with the focus on maximising the impact of trials upon pharmacy practice.

In terms of trial planning, co-design of trials with both clinicians and consumers, choosing relevant endpoints and the appropriateness of delivering the intervention being studied are considered. Decisions made regarding design and conduct of the clinical trial should focus on appropriate population groups with appropriate comparators which could include standard of care. Other design considerations are discussed including trial burden, embedding trials into registries and the inclusion of health economic end points.

The article also explores previously published guidance on these issues by the Australian Clinical Trials Alliance (ACTA).1 This document describes implementability as follows: “characteristics of the design, execution and reporting of a clinical trial, typically a late-phase trial, that determine the capacity for the evidence generated by that clinical trial to be used for implementation. Implementability is a feature of trial design and execution that is not contingent on the results of a trial, whereas appropriate implementation is critically dependent on both the results and implementability”.1 (p4)

The role of trial networks in providing access to appropriate trial sites and trial participants is addressed as well as supporting and facilitating the application of trial findings to improve clinical practice.

References

  1. Australian Clinical Trials Alliance (ACTA). Guidance on implementability. South Melbourne: ACTA; 2019. Available from: https://clinicaltrialsalliance.org.au/wp-content/uploads/2020/02/ACTA-Guidance-on-Implementability-Report.pdf.

Teede HJ, Best K, Bloomfield FH, Cass A, Cohen P, Crengle S, et al. Implementability and impact in clinical research and the role of clinical trial networks. Med J Aust 2024; 221: 410–413.

Considerations for open-label randomised clinical trials

Randomised, blinded trials have long been recognised as the gold standard in medical research. Randomisation has been the commonly accepted method of ensuring an unbiased estimate of the treatment effect. The aim of blinding is to reduce bias in the reporting of benefits and side effects.

An open-label trial is defined as one that is not fully blinded where both participants and clinicians are aware of the assigned treatment.  However, it can be possible to conduct an open-label trial as if it were fully blinded. This paper discusses circumstances where a fully blinded trial is not possible, such as where there are obvious differences in the administration of treatment arms.

The authors provide guidance on how best to design, conduct and then finally analyse such trials.  Blinding should be attempted as often as possible. Higgins et al., provide suggestions on how to attempt to blind participants. Provision of a blinding plan can also be considered. The possible use of blinded outcome assessors is an option to reduce the potential for biased results and consideration can also be given to using objective endpoints.

The importance of trial conduct such as allocation concealment, identical timings for collection of endpoints for the randomised arms and the implementation of an unblinded Data Monitoring Committee that maintains confidentiality of interim data and results are discussed. This paper provides useful recommendations for researchers who may not be able to conduct a fully blinded study. 

Higgins KM, Levin G, Busch R. Consideration for open-label randomized clinical trials: design, conduct and analysis. Clin Trials 2024; 21: 681–688.

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CRITICAL CARE

MedsScan Editors for Critical care SPG: Melissa Faehrmann and Grainne Hughes

TIGHT K Randomised Clinical Trial

Special Contributor: Lidia Zec

Atrial fibrillation after cardiac surgery (AFACS) affects about 30% of patients post-coronary artery bypass graft (CABG) surgery, and is associated with increased morbidity, mortality, length of stay (LOS) and healthcare costs. Post-CABG potassium supplementation targeting a level >4.5 mmol/L is routine, but supporting evidence is limited. This study aimed to evaluate whether targeting a lower threshold for potassium supplementation is non-inferior to current practice.

This was a prospective, multicentre, randomised clinical non-inferiority open-label trial performed at 23 cardiac surgery units in the United Kingdom and Germany between October 2020–November 2023. Patients scheduled for isolated CABG were randomised to either a tight control (>4.5 mmol/L) or relaxed control (>3.6 mmol/L) group. Supplementation was given per local protocols. The primary endpoint was clinically detected and electrocardiographically confirmed new onset AFACS in the first 120 hours post-CABG or until hospital discharge (whichever occurred first). The secondary endpoints included other dysrhythmias, clinical outcomes and cost related to intervention.

The primary endpoint was met by 219 of 837 patients (26.2%) in the tight group and 231 of the 830 patients (27.8%) in the relaxed group (unadjusted risk difference 1.7%, 95% confidence interval [CI] -2.6% to 5.9%, p = 0.44). When adjusted for age, sex and site, the risk difference was 2.2% (95% CI -1.9% to 6.4%, p = 0.29). There was no difference between the groups in the incidence of dysrhythmias, mortality or LOS. Per patient cost for potassium was significantly lower in the relaxed group (mean difference $111.89). 

The authors concluded that relaxed potassium supplementation was non-inferior to tight potassium supplementation in the prevention of AFACS up to five days post-CABG. The study suggests that targeting a lower threshold for potassium supplementation is appropriate, reducing healthcare costs and patient risks from unnecessary interventions. Pharmacists in cardiac care units should consider this evidence in their daily practice and when developing/reviewing post-operative CABG guidelines.

O’Brien B, Campbell NG, Allen E, Jamal Z, Sturgess J, Sanders J, et al. Potassium supplementation and prevention of atrial fibrillation after cardiac surgery: The TIGHT K randomized clinical trial. JAMA 2024; 332: 979–988.

Comparing enteral to parenteral phosphate replacement for critically ill patients with hypophosphataemia

Special Contributor:  Benjamin Coghlan

Hypophosphataemia is common, but there are no evidence-based management guidelines. In intensive care unit (ICU) patients, phosphate is often replaced intravenously (even in mild cases) to prevent complications such as reduced myocardial and diaphragm contractility, muscle weakness and death.

This prospective, randomised, parallel-group, unblinded, noninferiority clinical trial was conducted in an Australian ICU. Patients with serum phosphate 0.3–0.75 mmol/L were randomised, using an electronic medical record (EMR), to receive enteral or intravenous phosphate. The primary outcome was serum phosphate at 24 hours, with a noninferiority margin of 0.2 mmol/L based on previous literature. Secondary outcomes included cost, environmental savings and fluid balance.

One hundred and forty-five patients were eligible for analysis, with similar demographic and biochemical characteristics between the enteral and intravenous groups. After 24 hours, mean serum phosphate was 0.89 mmol/L in the enteral group and 0.82 mmol/L in the intravenous (IV) group (adjusted mean difference 0.07 mmol/L, 95% CI -0.02 to -0.17 mmol/L), meeting noninferiority targets. Both groups received a median of two replacements. Median phosphate replacement doses were 2 g enterally and 20 mmol IV (sodium/potassium dihydrogen phosphate). There were no differences in daily fluid balance, ICU length of stay, bloodstream infections, new atrial fibrillation or mortality. Intravenous phosphate is ten-times more expensive than enteral phosphate; the study centre estimates annual cost savings of $21,930. Enteral phosphate also reduced healthcare waste and carbon emissions.

The authors concluded that enteral phosphate is noninferior to intravenous replacement for mild-moderate hypophosphataemia in ICU patients. The study only measured biochemical outcomes, without assessing patient-centred outcomes such as muscle weakness, cardiac arrhythmias or delayed weaning from mechanical ventilation. EMR randomisation could be considered in future research projects, as it enabled 24/7 recruitment to rapidly achieve sample size. Pharmacists should consider recommending enteral phosphate for mild-moderate hypophosphataemia, where appropriate, as an effective, less costly and more environmentally sustainable alternative to intravenous phosphate.

Nguyen CD, Panganiban HP, Fazio T, Karahalios A, Ankravs MJ, Macisaac CM, et al. A randomised noninferiority trial to compare enteral to parenteral phosphate replacement (on biochemistry, waste, and environmental impact and healthcare Cost) in critically ill patients with mild to moderate hypophosphatemia. Crit Care Med 2024; 52: 1054–1064.

SAFE-ICU: antifungal dosing in critically ill patients

Special Contributor: Georgia Clark

Optimal antifungal therapy is crucial for survival in critically ill patients with invasive fungal infections. However, critical illness can significantly alter drug pharmacokinetics, making it difficult to achieve effective drug exposures with conventional dosing. There is limited prior research evaluating antifungal concentrations in critically ill patients, mostly from small studies. This led to the SAFE-ICU study to assess current dosing adequacy in this population.

This large, prospective, open-label, multicentre pharmacokinetic study enrolled 339 critically ill adults from 30 ICUs across 12 countries. Patients receiving antifungals, for treatment or prophylaxis, had three blood samples taken (30-minutes post dose, 3–6 hours post-dose and 30 minutes before next scheduled dose) on each of two occasions (day 1–3 and day 4–7) within the first week of therapy to estimate the 24-hour area under the curve and assess total drug concentrations. Dosing adequacy was evaluated against predefined pharmacokinetic/pharmacodynamic (PK/PD) targets from the identified fungus’ minimum inhibitory concentration (MIC).

Antifungal therapy was primarily used as treatment (80.8%). Triazoles, echinocandins and polyene antifungals were evaluated in the study.  Target attainment varied widely across agents. While PK/PD target attainment was high for prophylaxis (>80% for most drugs), it was notably low for treatment with voriconazole (57.1%), posaconazole (63.2%), micafungin (64.1%) and amphotericin B (41.7%). Overall, over a quarter of patients failed to reach predefined PK/PD targets early in treatment.

The study reveals that contemporary antifungal dosing frequently results in suboptimal exposures in critically ill patients, highlighting the impact of critical illness on drug distribution and elimination. This highlights the urgent need for optimised, potentially individualised, dosing strategies guided by therapeutic drug monitoring to improve outcomes and manage toxicity risk. Identifying the causative pathogen and it’s MIC is recommended but it’s often not readily available, limiting guided dosing.

Roberts JA, Sime FB, Lipman J, Hernández-Mitre MP, Baptista JP, Brüggemann RJ, et al. Are contemporary antifungal doses sufficient for critically ill patients? Outcomes for an international, multicenter pharmacokinetics study for Screening Antifungal Exposure in Intensive Care Units – the SAFE–ICY study. Intensive Care Med 2025; 51: 302–317.

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DISPENSING AND DISTRIBUTION

MedsScan Editors for Dispensing and distribution SPG: Anna Wood and Ashley Crawford

National assessment of how dispensing errors have changed in community pharmacy with technological advancements

Dispensing errors have the potential to lead to significant patient harm, and any opportunity to improve the safety of medicines dispensing has a potential to lead to positive health outcomes for patients, economic benefits and decreased pressure on the hospital system. Technology is changing the way dispensing occurs and is often promoted as a panacea for safer medicines management, but with new technology there can be risks of new error types.

This study was a retrospective review of national registry data self-reported by Finnish community pharmacies between 2015–2020 to understand trends in dispensing errors. During this time there have been significant changes in the dispensing processes within Finland, including the introduction of electronic prescribing in 2017 and the mandatory requirement to utilise the Medicines Verification System (MVS) in 2019. The MVS requires pharmacies to scan a 2D barcode on the medicine packaging during dispensing and was designed to reduce the likelihood of counterfeit medicines being used in the European Union. Finnish pharmacies have also used this MVS system to match the electronic prescription to the barcoded product to reduce selection and transcribing errors of medications at the time of dispensing.  

The study analysed over 19 000 dispensing errors, with a statistically significant decrease in the number of dispensing errors reported per annum occurring in the final year of the study, 2020, when compared with the results from 2018. The most reported error type was incorrect product strength, which reduced by 10% as a proportion of all errors, from 2015–2020. The authors have hypothesised that the introduction of both electronic prescriptions and the MVS contributed to the downward trend in the number of dispensing errors reported during the study.

While a significant decrease in the number of self-reported dispensing errors occurred across this timeframe, the implemented technology did not prevent all errors, with human factors still contributing to dispensing mistakes. Systematic approaches, adapted to local processes, are required to support dispensing risk management. Additionally for the Australian context, this study reiterates the positive impact 2D barcode scanning can have in improving both medicines traceability and potentially reducing errors in dispensing, and provides more evidence to support striving for a standardised approach to the uptake of this technology.

Mäkinen E, Holmström A-R, Airaksinen M, Schoultz A. Trends in dispensing errors reported in Finnish community pharmacies in 2015–2020: a national retrospective register-based study. BMC Primary Care 2024; 25: 183.

Do automated dispensing cabinets improve medicines availability and prevent omission errors?

The traceability of imprest medicines which are stored within an automated dispensing cabinet (ADC) has been one of the major selling points of the technology, leading to hospitals being able to store medicines that had traditionally been dispensed for individual patient use in a ward-based environment. Additionally, the real time data generated by ADCs about demand and current stock availability should help to improve the availability of medicines at the bedside, however there is still a lack of evidence demonstrating these theoretical benefits.  

This study sought to assess the impact of a broad scale introduction of ADCs into a large teaching hospital in the United Kingdom, specifically with respect to omitted doses for medicines which should be available within the imprest list for the ward. There was a particular interest in the time to first dose antimicrobials, due to the clinical significance of delays in antimicrobial treatment. This hospital had integrated the ADCs with their electronic medical record, which is not reflective of the digital maturity of all hospitals who use ADCs. The study compared a 3-month period (July–September) in 2022 with the same period in 2023, following a broad implementation of ADCs between February–July 2023.

The researchers identified that there was no significant difference in the number of omission errors occurring for medicines kept on the imprest list for the ward pre- and post-implementation of ADCs. Overall, the omission rates both pre- and post-implementation were lower than reported in the literature. More omission errors occurred following the implementation of the ADCs and it was noted that these predominantly occurred during the hours when the pharmacy was closed. It was hypothesised that ADC refill optimisation by pharmacy staff and greater promotion of how to access medicines after hours may improve the omission rates seen. The omission rates of antimicrobials seen were very small, with limited conclusions able to be made about the impact of the technology on this.

The study occurred very soon after the implementation of the ADCs, however the authors have not highlighted that potentially the adaptation to the technology for both pharmacy staff replenishing it and nursing staff accessing it, may not reflect the utilisation of the technology longer term as familiarity increases. Additionally, it was interesting the study chose to only assess the omission rates for items included on the ward imprest, rather than holistically, as the benefits of ADCs are purportedly associated with facilitating access to a greater range of medicines across the hospital.

Jeffrey E, Walsh Á, Lai K. Automated dispensing cabinets and the effect on omitted doses of ward stock medicines; can implementation reduce delays to first dose antimicrobials? Explor Res Clin Soc Pharm 2025; 18: 100583.

Pharmacist insights on supporting patients with vision impairment

Medication dispensing and counselling are core pharmacist activities that play a critical role in ensuring safe and effective medicine use. It is essential that pharmacists consider individual patient factors to ensure that information is communicated in a way that is accessible and easily understood. One important factor that requires consideration is vision impairment, particularly as medication-related information is often conveyed through visual formats such as medication labels and consumer medicine information leaflets.

This study explored barriers and facilitators to medication dispensing and counselling for patients with vision impairment from the perspective of pharmacists practicing in Saudi Arabia, aiming to identify potential targets for future interventions. The Theoretical Domains Framework (TDF) was used to guide development of semi-structured interview questions and subsequent analysis of findings. TDF integrates numerous different behavioural change theories into 14 domains that collectively influence professional behaviour and practice.

Twenty-six pharmacists, from a variety of backgrounds and practice settings, participated in interviews conducted throughout 2019 and early 2020. Findings revealed several barriers to providing optimal care to visually impaired patients including challenges in identifying affected patients, insufficient targeted education and training, and constraints related to pharmacy layout and workload. Whilst all 14 TDF domains were found to be relevant for developing future interventions to enhance care, the ‘knowledge’ and ‘skills’ domains were highlighted as key targets.

Application of these findings to an Australian healthcare context would require further investigation to address differences in pharmaceutical care provision between Saudi Arabia and Australia which may influence pharmacist processes and behaviours. Any interventions should be developed in collaboration with patients and other care providers to ensure that the needs of patients with vision impairment are best met.

Kentab YB, Barry HE, Al-Aqeel SA, Hughes CM. Improving medication dispensing and counselling for patients with vision impairment: a qualitative study of pharmacist-reported barriers and facilitators. BMC Health Serv Res 2024; 24: 534.

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EDUCATION AND EDUCATIONAL VISITING

MedsScan Editors for Education and educational visiting SPG: Diana Bortoletto and Michelle Hansen

Supporting the pharmacy learner: how preceptors shape learner identity

Professional identity formation (PIF) is a critical component of developing into a confident and effective pharmacist. Little is known about how preceptors influence this process during experiential placements. This qualitative study explored how experienced preceptors support PIF among pharmacy students and residents.

Twenty-two experienced preceptors from five North American pharmacy programs participated in in-depth interviews. Participants practiced in various pharmacy practice settings and precepted a range of learners, including introductory pharmacy practice and advanced pharmacy practice experiences. Thematic analysis was applied.

Four key themes emerged which were categorised as either extrinsic or intrinsic methods: integrating learners into the healthcare team; progressively handing over responsibility; and intrinsic methods: helping learners navigate emotional challenges during practice experiences; and supporting learners in finding the right fit within the profession.

Practical strategies ranged from early delegation of patient interactions and impacting patients’ lives, encouraging learners to speak up in interprofessional meetings, encouraging ‘thinking aloud’ during clinical reasoning, to modelling vulnerability when discussing emotionally charged experiences. Preceptors also tailored rotations to match learner interests and used career conversations to help students articulate the kind of pharmacist they wish to become.

This study is highly relevant for Australian pharmacy educators, preceptors and curriculum designers. It suggests that PIF can be intentionally cultivated during placements. Embedding strategies to foster identity, not just competence, may better prepare future pharmacists for the challenges of real-world practice. These findings may inform preceptor training frameworks and support initiatives aligned with the evolving goals of Australian experiential education.

Kennie-Kaulbach N, Cooley J, Williams C, Riley B, Anksorus H, O’Sullivan TA. How preceptors support pharmacy learner professional identity formation. Am J Pharm Educ 2024; 88: 100740.

Practising ethics: workshop boosts hospital pharmacists’ ethical reasoning confidence

Ethical challenges are common in hospital pharmacy, often related to complex medication management options whilst working within multidisciplinary teams.  Many pharmacists feel ill-equipped to navigate them, which may cause moral distress.  This mixed-methods study evaluated the impact of a tailored 1-hour interactive education delivered to hospital pharmacists and interns across three Queensland hospitals. The workshop included case-based discussions on patient autonomy, privacy and medication management dilemmas, framed by structured ethical decision-making models. The aim was to assess its effectiveness in improving ethical reasoning skills and confidence.

Pre- and post-workshop surveys (N = 33 and N = 26 respectively) assessed participants’ confidence and approach to hypothetical scenarios. Semi-structured interviews (N = 9) further explored workshop impact.

Post-workshop, participants reported significantly improved confidence in identifying applicable regulatory frameworks (p = 0.011), ethical issues (p = 0.002) and applying ethical reasoning to real-life dilemmas (p = 0.004). Confidence in locating support for ethical questions, clinical and non-clinical, increased markedly (p = 0.002 and p = 0.003 respectively). Nearly all participants (94%) agreed that the session provided them with useful tools and frameworks to guide ethical decisions. Qualitative feedback underscored the value of peer discussion and the desire for ongoing ethics education.

This study highlights a valuable model for embedding practical ethics education into Australian hospital pharmacy practice. Tailored, scenario-based training can enhance pharmacists’ readiness to navigate ethical complexity and may reduce the risk of moral distress. Wider implementation, especially for early career pharmacists, could foster a culture of ethical awareness and confidence across pharmacy settings.

McCleery N, La Caze A, Winckel K, Hattingh HL. Evaluation of an interactive education workshop on hospital pharmacists’ ethical reasoning: an observational study. BMC Med Ethics 2024; 25: 81.

Considering the patient view in workplace-based assessment

Workplace-based assessments are widely used in healthcare education to evaluate learner development and provide feedback. Traditionally, these assessments rely on supervisor and peer evaluations. However, in healthcare environments where person-centred care is central, it is important to also consider the patient perspective as a valuable source of assessment information.

A single-site qualitative study was conducted at a pharmacist-led clinic in Canada to explore views on involving patients in learner assessment and feedback. Semi-structured interviews were undertaken with ten pharmacy learners and ten patients. The transcripts underwent thematic analysis which identified themes and sub themes.

All patients were open to providing feedback to pharmacy learners with communication, medication therapy expertise and professionalism identified as the key areas they could provide comment on. Pharmacy learners recognised that patients could offer insights on medication therapy expertise, collaboration, health advocacy, professionalism and communication. While some pharmacy learners identified limitations in the scope of patient feedback, particularly in clinical areas, the overlap in the results between the cohorts suggests that pharmacy learners would be accepting of patient feedback in defined areas.

The workplace-based assessment tools commonly used within pharmacy in Australia focus on perspectives of supervisors and peers. This study identifies the contribution patients can have in learner feedback and further exploration into how to embed patient perspectives into pharmacy assessment and training is warranted.

Nemir A, Reardon J, Wilbur K. Bringing the patient voice into workplace-based assessment of pharmacy learners: an interpretive description study. Am J Pharm Educ 2025; 89: 101353.

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GENERAL MEDICINE

Medscan Editor for General medicine SPG: Christina Hanciu

Semaglutide: not just for weight loss

Special Contributor: Wei Mann Chew

Approximately 144 000 people are living with heart failure in Australia, and there are about 170 heart failure-related hospitalisations every day. This study aimed to investigate whether semaglutide exerts beneficial effects in obese patients with heart failure with preserved ejection fraction (HFpEF), beyond its use for weight loss.

This was a randomised, controlled double-blind trial in adults with a left ventricular ejection fraction over 45% assigned once weekly semaglutide 2.4 mg or placebo over a period of 52 weeks. At the conclusion of the study, participants receiving semaglutide demonstrated a greater change in heart failure-related symptoms as noted by the change in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS) from baseline, 16.6 in treatment arm, 8.7 in placebo arm (estimated difference 7.8 points, 95% confidence interval [CI] 4.8 to 10.9, p < 0.001), and improved physical capacity, 20.3 metres greater than placebo in a 6-minute walk distance from baseline. These participants also achieved a 13.3% reduction in body weight from baseline (estimated difference, −10.7 percentage points, 95% CI −11.9 to −9.4, p < 0.001).

This study highlights the benefits semaglutide exerts in obese individuals with HFpEF, reducing symptoms and reducing body weight which may improve quality of life and disease burden. There were a number of limitations to the study including the study population was mainly white/Caucasian, the small study population and the length of the study may not have captured endpoints such as hospitalisations and mortality. In addition to being used to treat type 2 diabetes mellitus, the Therapeutic Goods Administration has also approved semaglutide to be used as a chronic weight management treatment and as an adjunct treatment to reduce risk of cardiovascular events in overweight and obese patients. Hospital pharmacists may help to identify obese patients who would benefit from semaglutide and also consider cost of treatment when recommending treatment for patients without type 2 diabetes mellitus.

Kosiborod MN, Abildstrøm SZ, Borlaug BA, Butler J, Rasmussen S, Davies M, et al. Semaglutide in patients with heart failure with preserved ejection fraction and obesity. N Engl J Med 2023; 389: 1069–1084.

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GERIATRIC MEDICINE

MedsScan Editors for Geriatric medicine SPG: Gauri Godbole and David Nguyen

New Australian guidelines for psychotropic medicine use in residential aged care

Psychotropic medications are widely prescribed in Australian residential aged care facilities (RACFs), often despite known adverse effects and limited clinical benefits for some populations. In response, new national guidelines were released in 2023, emphasising appropriate prescribing and deprescribing strategies. Successfully integrating these guidelines into everyday practice requires understanding implementation barriers and facilitators across the aged care sector.

Semi-structured interviews were conducted with 33 stakeholders across four RACFs, including residents, family members, pharmacists, nurses, nurse practitioners, occupational therapists and physicians (general practitioners and geriatricians). This study used the Consolidated Framework for Implementation Research (CFIR) to analyse data, categorising influences into external policy, organisational culture and individual attitudes.

Key implementation challenges included workforce pressures, regulatory constraints and limited digital health adoption. Four strategies to promote adherence were identified; recognising workforce challenges affecting medication management, building on recent deprescribing efforts for gradual improvement, leveraging local data to tailor interventions to RACF needs, and enhancing team collaboration to align staff perspectives.

Some potential limitations include findings not being generalisable beyond the four RACFs included and the reliance on self-reported perspectives which may have introduced bias in participant responses. Significant findings highlighted modifiable barriers to guideline implementation, with an emphasis on a multifaceted approach that supports frontline staff and improves prescribing standards.

Shrestha S, Cross AJ, Steeper M, Martini A, Cenin D, Smith J, et al. Implementing Australia's new guidelines for appropriate psychotropic medication use in residential aged care: applying the Consolidated Framework For Implementation Research. Australas J Ageing 2025; 44: e70013.

Treatment options for older patients with non-ST segment elevation acute coronary syndrome

Special contributor: Carol Chan

The prevalence of non-ST segment elevation acute coronary syndromes (NSTE ACS) in older patients is increasing. Despite advancements in managing non-ST elevation myocardial infarction (NSTEMI) improving survival rates, most evidence focuses on younger patients. There is limited evidence on optimal management in older patients. This meta-analysis aims to provide an evaluation of invasive (i.e. coronary angiography, coronary revascularisation by either percutaneous coronary intervention or coronary artery bypass graft) versus conservative treatment strategies in older patients over the age of 70 with NSTE ACS.

The researchers conducted a comprehensive search of PubMed/MEDLINE, Embase, the Cochrane Library and Clinicaltrials.gov up to 1 September 2024; as well as searching the websites of prominent cardiology-related journals. Seven randomised trials were included in the final review, encompassing 2998 patients (1490 invasive vs 1508 conservative management group). 

The meta-analysis found no statistically significant differences between the two strategies for the risk of all-cause death (risk ratio [RR] 1.03), cardiovascular death (RR 1.04), stroke (RR 0.78) and major bleeding (RR 1.23).  However, the invasive strategy was associated with a significantly reduced risk of myocardial infarction (RR 0.74) and unplanned revascularisation (RR 0.29) compared to the conservative strategy.

These findings suggest that although invasive treatment strategies reduce the risk of myocardial infarction and unplanned revascularisation without a significant increase in stroke or major bleeding, they do not improve overall survival or reduce major complications in older patients. This highlights the need for individualised treatment decisions incorporating patient preference, co-morbidities and quality of life. Older age alone should not preclude invasive management. 

Ahmed M, Ahsan A, Shafiq A, Hashmi TM, Ahmed R, Alam M, et al. Invasive versus conservative treatment strategy in older patients with non-ST segment elevation acute coronary syndromes: a meta-analysis of randomized controlled trials. J Am Geriatr Soc 2025; [online ahead of print]. 

Pharmacists' experiences with the electronic National Residential Medication Charts: benefits, barriers and the burden of transition

The electronic National Residential Medication Chart (eNRMC) has been implemented in Australian residential aged care facilities (RACFs) to improve medication safety and streamline workflows. Understanding the experiences of end-users with the eNRMC is essential to help facilitate optimisation and wider adoption.

A qualitative descriptive study using semi-structured interviews was conducted with 12 Australian pharmacists. Participants were recruited through purposive and snowball sampling. Interviews were held online to explore positive and negative experiences and potential areas for improvement. A thematic analysis was undertaken using the Framework Method.

Three key themes emerged after the analysis: improvements in medication management, limitations of eNRMC Software, and facility’s transition to eNRMC software. Pharmacists reported enhanced multidisciplinary communication, improved medication safety and increased workflow efficiency through real-time updates, electronic alerts and reduced administrative tasks. However, limitations included poor software integration, restricted edit permissions for pharmacists and variable reporting functions. Transition barriers included inadequate engagement of general practitioners (GPs), insufficient training and increased burden on prescribers, which pharmacists reported has led to charting errors and resistance to adoption.

Pharmacists broadly supported the eNRMC but noted significant implementation challenges, particularly related to software design and user permissions. The restricted ability for pharmacists to update charts limited their role in medication safety with increased reliance of prescribers to maintain charts. The findings are consistent with existing literature, highlighting the benefits of electronic prescribing and medication chart systems. However, they also highlight the potential limitations and barriers to broader implementation, especially at transitions of care where access to editing eNRMC’s is limited to GPs.

Tan J, Tan J, de Souza L, Wang Q, Wong A, Mcmaugh J, et al. Exploring Australian pharmacists’ experiences with the electronic National Residential Medication Chart: a qualitative descriptive study. Int J Clin Pharm 2025; [online ahead of print].

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ONCOLOGY AND HAEMATOLOGY

MedsScan Editor for Oncology and haematology SPG: Alborz Soroush

Comparing the standard of care to encorafenib and cetuximab with modified FOLFOX6 chemotherapy for patients with BRAF V600E-mutant metastatic colorectal cancer

The BREAKWATER phase 3 trial assessed the effectiveness and safety of encorafenib 300 mg daily plus cetuximab (EC) with modified FOLFOX6 chemotherapy (EC+mFOLFOX6) compared to the standard of care (SOC) for patients with previously untreated BRAF V600E-mutant metastatic colorectal cancer (mCRC). The BRAF V600E mutations occur in 8–12% of mCRC patients and results in worse outcomes and treatment resistance to standard chemotherapy.​ The research included 460 participants who received EC+mFOLFOX6 (n = 231) or SOC (n = 229). ​

The trial achieved one of its dual primary endpoints by showing a higher objective response rate (60.9% versus 40.0%) in the EC+mFOLFOX6 treatment group (odds ratio [OR] 2.443, P = 0.0008). ​The EC+mFOLFOX6 group showed a longer median duration of response compared to the SOC group (13.9 months versus 11.1 months). ​The early overall survival analysis indicated that EC+mFOLFOX6 provided a 0.47 hazard ratio [HZ] benefit but failed to reach statistical significance during this initial assessment. ​The safety profiles matched established drug reactions since grade 3/4 adverse events occurred in 74.0% of EC+mFOLFOX6 patients and 61.0% of SOC patients. ​Patients most often experienced nausea, as well as anaemia and diarrhoea as their main adverse reactions.

The research demonstrates how combining targeted therapy agents, encorafenib and cetuximab, with chemotherapy provides clinical advantages for treating BRAF V600E-mutant mCRC patients as a potential first-line therapy. ​The analysis of key clinical subgroups demonstrated consistent benefits for all groups including patients who had liver metastases. ​Patients tolerated the combination treatment well, since adverse events remained at a manageable level. ​Additional research on progression-free survival and overall survival continues. ​

The research indicates that EC+mFOLFOX6 could establish itself as a first-line standard treatment for this aggressive cancer subtype, while fulfilling the unmet requirement for initial treatments. Currently, EC is approved in second-line settings in BRAF V600E mutation patients in Australia. Although there have been some requests to access this treatment combination through non-clinical trial channels in some centres, there are no compassionate or special arrangements supply by companies in Australia to provide cetuximab and encorafenib in first-line settings at the time of writing.

Kopetz S, Yoshno T, Van Cutsem E, Eng C, Km TW, Wasan HS, et al. Encorafenib, cetuximab and chemotherapy in BRAF-mutant colorectal cancer: a randomized phase 3 trial. Nat Med 2025; 31: 901–908.

The postMONARCH trial represents a phase III double-blind randomised study which assesses  abemaciclib combined with fulvestrant for hormone receptor-positive (HR+) human epidermal growth factor receptor 2-negative (HER2-negative) advanced breast cancer patients who had received previous cyclin-dependent kinase 4/6 (CDK4/6) inhibitors plus endocrine therapy in both adjuvant and metastatic setting. The study included 368 patients who received either abemaciclib plus fulvestrant or placebo with fulvestrant. ​The main study outcome measured progression-free survival (PFS) as its primary endpoint, together with objective response rate (ORR) and safety evaluation as secondary endpoints. ​

Abemaciclib (150 mg twice daily) combined with fulvestrant (500 mg by intramuscular injection once per day on days 1 and 15 of cycle 1, then once every 4 weeks) demonstrated superior PFS results to placebo with fulvestrant (HR of 0.73, (95% confidence interval [CI] 0.57–0.95, P = 0.017). ​Patients treated with abemaciclib experienced a median PFS duration of 6 months compared to 5.3 months in the placebo group, while the 6-month PFS rate reached 50% versus 37% respectively. ​The abemaciclib treatment arm achieved a higher ORR than the control group with 17% versus 7% (P = 0.015). ​The subgroup analyses showed consistent benefits across clinical and genomic subgroups including those with estrogen receptor 1 or PIK3CA mutations. The adverse event profile of abemaciclib matched previous observations with diarrhoea being the most prevalent adverse effect. ​

The study demonstrated that patients can receive CDK4/6 inhibition with abemaciclib after they progress on previous CDK4/6i regimens. The modest absolute PFS improvement combined with acceptable safety results makes abemaciclib plus fulvestrant an appropriate choice for HR+, HER2-negative advanced breast cancer patients. However, ​currently the PBS-subsidised treatment with CDK 4/6 inhibitors is limited to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under locally advanced or metastatic disease is no longer available).

This trial demonstrated the necessity for additional research to develop better post-CDK4/6i treatment approaches through investigations of new combination therapies and biomarkers for selecting patients.

Kalinsky K, Bianchina G, Hamilton E, Graff SL, Park KH, Jeselsohn R, et al. Abemacoclib plus fulvestrant in advanced breast cancer after progression on CDK4/6 inhibition: results from the phase III postMONARCH trial. J Clin Oncol 2024; 43: 1101–1112.

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LEADERSHIP AND MANGAGEMENT

MedsScan Editors for Leadership and management SPG: Jessica Toleman and Ed Anderson

Leadership walkarounds: method to improve organisational culture?

This systematic review explores the impact of leadership walkarounds (LWs) on operational, cultural and clinical outcomes in healthcare, offering key insights for pharmacy leadership. LWs, modelled after management-by-walking-around (MBWA) and Lean practices like Gemba Walks, facilitate direct engagement between senior leaders and frontline staff to enhance safety culture and operational efficiency.

For pharmacy leaders, LWs present an opportunity to proactively identify medication safety risks, streamline workflows and strengthen staff engagement. The review found that organisations implementing structured and feedback-driven LWs reported improved safety climate, increased staff participation in decision-making and enhanced communication between leadership and frontline workers. Pharmacists and pharmacy technicians could benefit from LWs by using them as a platform to voice concerns about medication errors, workflow inefficiencies and patient safety risks.

Longer exposure to LWs, combined with structured follow ups, correlated with stronger improvements in organisational culture and operational efficiency. However, the review found limited evidence directly linking LWs to clinical outcomes. Only one study demonstrated a decline in catheter-associated urinary tract infections (CAUTI) following LW implementation, suggesting that more research is needed to establish measurable patient safety benefits.

For pharmacy leadership, the findings underscore the value of LWs in fostering a culture of continuous improvement, strengthening frontline engagement and enhancing medication safety. To maximise impact, pharmacy leaders should integrate LWs into existing quality improvement initiatives, ensuring that staff feedback is acted upon to drive meaningful change.

Foster M, Mazur L. Impact of leadership walkarounds on operational, cultural and clinical outcomes: a systematic review. BMJ Open Qual 2023; 12: e002284.

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RURAL AND REMOTE HEALTH

MedsScan Editors for Rural and Remote Health SPG: Kelly Beswick and Pascale Dettwiller

The usefulness of telehealth for diabetic patients in regional areas

There is a dearth of literature on telehealth-delivered services exploring rural populations. With type 2 diabetes mellitus prevalence in rural areas on the rise, this study focused on a type 2 diabetes cohort living in regional, rural and remote locations in Queensland and aimed to describe the clinical characteristics and longitudinal clinical outcomes of this group attending an urban-based Diabetes Telehealth Service (DTS), servicing more than 40 non-urban regional sites.

Data were sourced retrospectively using longitudinal patient data collected from the metro hospital in Brisbane providing the DTS from 2016–2020. All data (from N = 374 records) included demographics (excluding ethnicity to maintain confidentiality) and clinical measures as part of the patient’s routine care. The primary outcome measure was the change in glycated haemoglobin (HbA1c) and secondary outcomes explored cardiovascular risk factors, body weight and body mass index. Descriptive and statistical analyses were performed to understand the association between variables, and data was stratified by gender.

A significant decrease in HBA1c was observed in the whole cohort, with male patients (b = -0.943, p > 0.01) experiencing a larger decrease than female patients (b = -0.634, p > 0.05). This decrease was maintained over the 24-month follow up period, and the rate slowed after the first three months. Changes in the secondary measures were recorded but not statistically significant.

This is a real-world data study from an existing model of care exploring longitudinal outcome data from a tertiary telehealth model of care in a rural type 2 diabetes cohort in Queensland. It validates the model of care, although more granular data need to be obtained to qualify its effectiveness over time.

Tornvall I, Bennetts D, Balasooriya NN, Comans T, Russell AW, Menon A. Characteristics and longitudinal clinical outcomes of people with type 2 diabetes in regional areas accessing a tertiary telehealth service: a retrospective cohort study. J Telemed Telecare 2025: [online ahead of print].

Improving access to dementia training for rural and remote healthcare workers

This article explored barriers and enablers to accessing dementia training for health and aged care workers in rural and remote Australia. This research builds on critical workforce priorities identified by the Royal Commission into Aged Care Quality and Safety,1 highlighting the need for better dementia training to support high-quality, person-centred care across all settings.

A qualitative, exploratory study design was used. Six roundtable discussions were held across five states, involving 66 participants from a range of roles including nursing, allied health, personal care, management and medicine. Participants shared their experiences accessing dementia training, the barriers they faced and what made training more accessible and effective.

Key outcomes included the identification of time pressures, technology limitations and a lack of local training opportunities as major barriers. Participants strongly preferred flexible, blended models combining online and face-to-face learning. There was also an emphasis on the need for a ‘whole person approach’, recognising the physical, emotional and social needs of people living with dementia.

The findings are highly relevant to pharmacists working in community, aged care and hospital settings. Pharmacists are well placed to contribute to person-centred dementia care by identifying inappropriate prescribing, promoting non-pharmacological alternatives, and supporting safer, more tailored use of medicines. Incorporating a ‘whole person’ lens can help pharmacists move beyond symptom management and work more collaboratively with interdisciplinary teams. Improved dementia training would better equip pharmacists to take on expanded clinical and advocacy roles in dementia care, aligning with emerging models of integrated, person-centred healthcare. Importantly, the article provides a clear set of recommendations to guide those designing future dementia education, helping ensure training is accessible, relevant and effective for the aged care and health workforce.

References

  1. Royal Commission into Aged Care Quality and Safety. Final report: care, dignity and respect. Canberra: Commonwealth of Australia; 2021.

Thompson SC, Valentine J, Gusterson K, Fyfe KP, Beilby A, Woods JA, et al. Engaging health and aged care workers in rural and remote Australia around factors impacting their access to and participation in dementia training. Geriatrics (Basel) 2025; 10: 28.

Improving implementation of healthcare interventions in rural areas: insights for pharmacists

Special contributor: Caitlin Hardman

Individuals residing in rural and regional areas often face significant health disparities, including higher mortality rates and limited access to healthcare services, compared to their metropolitan counterparts. Prompted by the persistent health disparities experienced by rural populations, this study explored the key staff-reported factors that influence the implementation of evidence-based interventions (EBIs) in rural and regional healthcare settings.

For pharmacists practising in these areas, this research provides critical insights that can support the successful delivery of care. Through a rapid review of 39 studies, predominantly from Australia and the United States of America, the authors identified four main themes affecting implementation: intervention-level factors (such as complexity and compatibility with existing practices), staff-level factors (including confidence and training), patient-level considerations (like cultural beliefs and health literacy) and finally, broader system-level issues (such as staffing, funding, and geography). While many identified barriers and facilitators align with those reported in other healthcare contexts, this review highlighted that some factors are amplified in regional and rural areas.

Recognising these barriers and enablers allows pharmacists to tailor interventions more effectively to their community’s needs. For example, adapting service delivery methods, engaging in team-based care, or using culturally appropriate communication can increase acceptance and sustainability. Incorporating these insights into practice can empower pharmacists to play a crucial role in bridging the gap between evidence and implementation. Pharmacists can leverage these barriers and facilitators and apply them to improve health outcomes for rural and remote communities with sustainable EBIs within their practice areas.

Chapman A, Buccheri A, Mohotti D, Wong Shee A, Huggins CE, Alston L, et al. Staff-reported barriers and facilitators to the implementation of healthcare interventions within regional and rural areas: a rapid review. BMC Health Serv Res 2025; 25: 331.

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SURGERY AND PERIOPERATIVE MEDICINE

MedsScan Editor for Surgery and perioperative medicine SPG: Caitlin Mulqueen

Perioperative management of direct oral anticoagulants: is it really that straightforward?

Direct oral anticoagulants (DOACs) are indicated for stroke prevention in patients with atrial fibrillation and for the prevention and treatment of venous thromboembolism. Approximately 4 million patients in the United States are currently being treated with a DOAC and an estimated 20% of these patients undergo a surgical or nonsurgical procedure annually. This review aimed to summarise current evidence relating to the perioperative management of DOACs.

A total of 99 articles were included in the review. Current evidence generally recommends DOACs are (excluding the use of dabigatran in renal impairment): (1) continued in patients undergoing a minimal bleeding risk procedure (e.g. minor dental or dermatologic procedure), (2) withheld 1 day preoperatively and restarted 1 day postoperatively in patients undergoing a low to moderate bleeding risk procedure (e.g. laparoscopic cholecystectomy, gastrointestinal endoscopy) and (3) withheld 2 days preoperatively and restarted 2 days postoperatively in patients undergoing a high bleeding risk procedure (e.g. major orthopaedic or cancer surgery). These recommendations are thought to be associated with low rates of thromboembolism (<0.5%), major bleeding (1–2%) and procedure cancellation. When the recommended periods of interruption are unable to be adhered to prior to emergent or urgent procedures, DOAC-specific reversal agents can be utilised to reverse the effect of the DOAC preoperatively. Preoperative DOAC levels may also be utilised in determining if a reversal agent is required.

There were however, significant limitations associated with this review including limited available evidence with wide variability and the absence of a formal quality assessment of the included articles. Whilst this review supports the standardisation of perioperative DOAC management, it is important to note that many patient- and procedure-specific factors impact the period of DOAC interruption perioperatively. Therefore, it is important that an individualised perioperative DOAC management plan is formulated for each patient, involving all relevant members of their health care team. Further high-quality evidence is required to support the recommendations in this review

Douketis JD, Spyropoulos AC. Perioperative management of patients taking direct oral anticoagulants: a review. JAMA 2024; 332: 825–834.

Comparing the incidence of adverse events between tapentadol and oxycodone postoperatively

Oxycodone is one of the most frequently used opioids for postoperative pain globally. In the past decade, however, there has been a significant increase in tapentadol use for this indication due to its perceived lower incidence of opioid-related adverse drug events (ORADEs). This multicentre, retrospective propensity-matched cohort study was conducted across three hospitals in New South Wales, Australia. It aimed to compare the incidence of ORADEs in those receiving tapentadol alone, to those receiving oxycodone alone, in the acute postoperative period.

A total of 1530 patients receiving tapentadol were matched to a total of 2775 patients receiving oxycodone. In the matched cohorts, tapentadol and oxycodone were associated with a similar overall incidence of adverse events (14.4% versus 12.6%, 95% confidence interval [CI] -0.35–3.95%, p = 0.1), including gastrointestinal adverse events (5% versus 5.3%, p = 0.774). Tapentadol was, however, associated with an increased incidence of delirium (2.7% versus 1.3%, p = 0.003) and cardiac arrythmias (3.4% versus 2.2%, p = 0.029) in comparison to oxycodone. Tapentadol was also associated with an increased median length of hospital stay in comparison to oxycodone (5 days versus 4 days, p < 0.001).

The limitations of this study should be noted. Only ORADEs that occurred during a patient’s hospital stay were captured. ORADEs that may have occurred after a patient’s hospital stay, such as constipation, were not considered. Furthermore, the hospital coding used by the study to capture ORADEs was not specific to opioids. Therefore, adverse events caused by other medications or medical conditions may have been incorrectly categorised as an ORADE. Further research is required to validate the findings of this study and evaluate the impact of tapentadol on an extensive range of patient outcomes, including persistent postoperative opioid use.

Liu S, Patanwala AE, Naylor JM, Stevens JA, Bugeja B, Begley D, et al. Tapentadol versus oxycodone for opioid-related adverse drug events and clinical outcomes after inpatient surgery. J Pain 2024; 25: 466–475.

Revisiting preoperative recommendations for renin-angiotensin system inhibitors

Special contributor: Roya Roohizadegan

Surgical patients at increased risk of postoperative complications are often prescribed renin-angiotensin system (RAS) inhibitors for hypertension, chronic kidney disease or heart failure. RAS inhibitors are commonly withheld preoperatively to prevent intraoperative hypotension, which may increase the risk of myocardial injury and death in older patients. This multi-centre, randomised, open-label trial aimed to evaluate whether withholding RAS inhibitors preoperatively impacted the rate of myocardial injury and postoperative complications.

A total of 262 patients, aged 60 years or older, taking a RAS inhibitor and undergoing elective non-cardiac surgery were randomised to either discontinue (n = 130), according to the pharmacokinetic profile, or continue (n = 132) their RAS inhibitor. The primary endpoint was the occurrence of myocardial injury, based on plasma high-sensitivity troponin-T (hs-TnT) levels. Myocardial injury occurred in 48.3% of patients who discontinued their RAS inhibitor, compared with 41.3% of patients who continued their RAS inhibitor. This difference was not statistically significant (odds ratio [for continuing] 0.77; 95% CI 0.45–1.31, p = 0.33). Hypotension adverse events were similar when RAS inhibitors were discontinued, compared to continued (9.7% versus 8.5%, p = 0.80). Hypertensive adverse events, however, were more frequent when RAS inhibitors were discontinued (12.9% versus 5.4%, p = 0.05).

This trial discontinued RAS inhibitors based on their pharmacokinetic profile, which is an innovative approach; for example, stopping for 48 hours prior if RAS inhibitor with ≥24-hour action and stopping the morning of the day before surgery (24 hours prior) for all others. There were, however, several limitations including the small sample size, open-label design, non-adherence rates to treatment after randomisation and postoperative trial protocol deviations for clinical concern. The results may also not be applicable to patients taking RAS inhibitors for conditions other than hypertension. Further studies are required.

Ackland GL, Patel A, Abbott TEF, Begum S, Dias P, Crane DR, et al. Discontinuation vs. continuation of renin–angiotensin system inhibition before non-cardiac surgery: the SPACE trial. Eur Heart J 2024; 45: 1146–1155.

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TECHNICIANS AND ASSISTANTS

MedsScan Editor for Technicians and assistants SPG: Bryan Walker

Do continuing professional development standards help improve practice?

Health practitioners in Australia and around the globe use continuing professional development (CPD) standards to improve and extend their competency, expertise and knowledge. But is there any statistical evidence showing that CPD provides all these metrics? This systematic review aimed to investigate the impact of CPD standards on improving competencies.

The authors searched major scientific databases and identified 87 abstracts and 37 articles, published from 2015–2022, finding that formal CPD requirements provide motivation for completion for healthcare professionals and improve their knowledge and behaviour. The review found that CPD effectiveness is improved when learning is interactive and it found no difference between the effectiveness of online CPD compared to face-to-face offerings. There was some evidence that mandated CPD is more effective than self-directed, with people in mandated programs having significantly higher compliance rates with guidelines. Finally, the review found no direct evidence to support an optimal amount of CPD to improve clinical behaviour or patient outcomes, although regularity may help improve retention.  

Nationally and internationally, health practitioners have regulations that require CPD completion. The benefits of having CPD requirements are the improvement of knowledge and behaviour, and the improvement of clinical skills and patient outcomes is increasing. Communication, business skills, self-confidence, self-esteem, career progression and better workforce retention are all goals Australia tries to achieve in pharmacy technician and assistant roles. This is an overlooked opportunity to include pharmacy technician assistants, with only minor adjustments needed in our present framework, to achieve an outcome that benefits everyone.

Main PAE, Anderson S. Evidence for continuing professional development standards for regulated health practitioners in Australia: a systematic review. Hum Resour Health 2023; 21: 23.

How to best advance a pharmacy technician workforce in the United States and beyond

The United States healthcare system is under significant strain due to COVID-19 and continuing challenges regarding cost, quality and access, technological advances, supply chain problems and staff retention. Thus, pharmacy practice is undergoing a significant transformative change to help cope with these pressures and the authors of this article argue that pharmacy technicians and assistants are a vital part of this transformation. 

To do this, the authors outlined the best approach would be to ensure pharmacy technicians and assistants have uniform training, registration and certification to provide consistency across the United States and help support uniform patient safety standards. With pharmacy technicians assistants assuming the responsibility of drug preparation and distribution, pharmacists can assume direct patient care and medication management services in all clinical settings.

The question now is what models should be used to move the profession forward? So far, we have programs such as technicians and assistants recording medication histories, assisting pharmacists with medication therapy management and administering immunisations. Some indications show a move to interprofessional collaborative teams to increase effectiveness in patient care. This format would allow advanced pharmacy technician and assistant roles to be included and new career pathways to be developed. Examples include initiating a patient visit, taking vital signs, facilitating care transitions, flagging potential drug interactions with the pharmacists and identifying possible problems obtaining medication in a retail or community setting. We also now have pharmacy accuracy checking technicians (PACT) in Australia, New Zealand and the United Kingdom.

Increasing the education requirements would also help retain workers. In the United States, a chart describing the variety of assistants throughout the health professions shows that most require an associate’s degree or a post-secondary training program. Pharmacy technicians and assistants were paid the least because they only needed a high school diploma. Compared to a physical therapist, an associate’s degree and a USD $15,000 increase in pay are required.

Here in Australia and in the United States, there must be encouragement to develop a versatile and motivating pharmacy technician and assistant workforce with the implementation of increased education standards, new approaches to patient care and more technician/assistant involvement through pay incentives.

Wheeler JS, Gray JA, Gentry CK, Farr GE. Advancing pharmacy technician training and practice models in the United States: historical perspectives, workforce development needs, and future opportunities. Res Social Adm Pharm 2020; 16: 587–590.

Students leading the way: collaborative education design to increase pharmacy technician and assistant workforce in the United States

In the United States, demand for pharmacy services has increased dramatically; however, the ability to retain the proper number of trained staff has decreased, with high rates of staff turnover and low pay rates often cited as particular challenges. This article took the approach of working with a higher learning facility to establish a knowledge-based college course created with the collaborative effort of the State board of pharmacy, local community college and a healthcare system in Connecticut, USA. The aim included that students involved would have relevant experience that would prepare them for the workplace.

A partnership exists between the Connecticut Pharmacists Association (CPA) and community colleges throughout Connecticut to provide a course over 14 weeks, including 56 hours of live, remote synchronous didactic interactions and 78 hours of online asynchronous web-based simulation assignments and assessments. The CPA designed the materials following the curriculum provided by the Pharmacy Technician Certification Board (PTCB), a federal organisation created to provide consistency and uniformity with educational training and credentialing throughout the USA. Course content included pharmacy-specific medical terminology, reading and interpreting prescriptions, patient and medication safety and pharmacy law. Students also learned conversion factors, calculating dosages and intravenous flow rates, and solving compounding problems. Once the course was completed, the student could pursue an optional 80-hour paid experimental learning program at various sites. The student directly applies to the healthcare system and is accepted based on didactic performance and flexible student availability.

This collaborative approach could be very beneficial for Australia’s need to increase the pharmacy technician and assistant workforce by creating a framework that brings together several groups that, at least before the pandemic, may or may not have worked together to help solve a crisis that impacts the health profession.

Yik R, Salvo MC. Pharmacy technician education and training: highlighting the partnership among a state pharmacy association, local community college, and healthcare system. Am J Health Syst Pharm 2025; zxae410 [online ahead of print].

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WOMEN'S AND NEWBORN HEALTH

MedsScan Editor for Women’s and newborn health: Kate Luttrell

Nirsevimab for Prevention of Hospitalisations Due to RSV in Infants

Special contributor: Megan Clark

Background: Respiratory syncytial virus (RSV) is a common cause of respiratory infection in infants and children, following a seasonal pattern peaking in winter (June–July) in the temperate climate regions of Australia. Conversely, it affects children during the wet season (December–March) in tropical climate regions across the north of Australia including areas of Western Australia, the Northern Territory and Queensland.1 Infants are more susceptible to RSV because of their smaller airways and decreased reserve for managing airway inflammation and secretions. Until 2024, RSV prevention therapy in Australia was limited to palivizumab (Synagis), a humanised immunoglobulin G (IgG1) monoclonal antibody, administered to high-risk infants intramuscularly every four weeks for the duration of the RSV season, and its use is limited to high-risk infants due to cost.2

Aim: Nirsevimab, an RSV neutralising monoclonal antibody with extended half-life was evaluated for prevention of RSV infection leading to hospitalisation and compared to standard care, specifically in infants who were ineligible for local palivizumab programs.

Method: The HARMONIE trial was a phase 3b, open label, two group randomised trial in 235 sites across France, Germany and the United Kingdom. Infants aged up to 12 months, entering their first RSV season were randomised in a 1:1 ratio to receive a single dose of nirsevimab (weight based) or standard care. It was stratified by country and postnatal age (<3months, 3–6 months, >6 months). The pre-determined event driven analysis point was after 61 episodes of hospitalisation for RSV lower respiratory tract infections (LRTI) for all sites combined.

Efficacy outcome subgroup analysis was carried out by age and weight at randomisation, whether the patient was born preterm or at term, gender, and whether nirsevimab was administered before or during the RSV season. Very severe RSV LRTI was defined as oxygen saturation < 90% at any time during hospitalisation, and oxygen supplementation.

Results: At the pre-determined event driven analysis of the primary outcome, a total of 8058 infants had been enrolled (4037 to nirsevimab, 4021 to placebo), including approximately one-quarter who were neonates at nirsevimab administration (age < 28 days).

The efficacy outcome, hospitalisation for RSV-associated LRTI occurred in 11 patients administered nirsevimab (1 event per 1000 person months), and in 60 patients who received standard care (6 events per 1000 person months), demonstrating superiority for time to event. The subgroup analyses (age stratification, country stratification) each showed similar results to the overall study population, and superiority throughout.

Very severe RSV-associated LRTI occurred in 5 patients administered nirsevimab (<1 event per 1000 person months), and in 19 patients who received standard care (2 events per 1000 person months). Co-administration with routine immunisations was permitted and the safety profile was favourable, with low severity reactions.

One serious treatment related event occurred: West syndrome and seizures occurring 23 days after nirsevimab injection. The relationship between nirsevimab and the adverse effect could not be excluded but it is reflective of the baseline population rate of West syndrome.

Key limitation: This study was conducted in the northern hemisphere, in countries with a distinct seasonal RSV infection pattern. It is important to investigate the efficacy of nirsevimab on RSV infection prevention where these seasonal peaks differ (i.e. across northern Australia), and whether re-dosing is beneficial in infants (including high risk subgroups) to prevent RSV infection as they get older.

Impact on practice: Importantly, this trial recruited lower risk infants (those not eligible for local palivizumab programs). The high-risk cohort had previously been reviewed.3 Additionally, the post-immunisation procedure reflected a real-world setting (as best as possible in a large, randomised controlled trial setting). Administration was encouraged with routine childhood immunisations and routine healthcare appointments, and the trial had a narrow outcome of RSV LRTI hospitalisation.

Nirsevimab has been incorporated into state-wide immunisation programs in Australia but is yet to make it on the National Immunisation Program. The next step is determining optimal timing of doses for patients in neonatal units, particularly those who are looking down the barrel of a long stay, and when is best to protect them from RSV infections resulting from community exposure, including in our paediatric wards.

It will be interesting to observe whether nirsevimab can contribute to the management of high-risk patients during hospital RSV outbreaks in ward areas, and intensive care units (including neonatal, paediatric and combination adult/paediatric).

References

  1. John-Sebastian E, Sikazwe C, Xie R, Yi-Mo D, Sullivan SG, Michie A, et al. Off-season RSV epidemics in Australia after easing of COVID-19 restrictions. Nat Commun 2022; 13: 2884.
  2. Wong SK, Abby L, Lanctôt LK, Paes B. Adherence and outcomes: a systematic review of palivizumab utilization. Expert Rev Respir Med 2018; 12: 27–42.
  3. Griffin MP, Yuan Y, Takas T, Domachowske JB, Madhi SA, Manzoni P, et al. Single-dose nirsevimab for prevention of RSV in preterm infants. N Engl J Med 2020; 383: 415–425.

Drysdale SB, Cathie K, Flamein F, Knuf M, Collins AM, Hill HC, et al. Nirsevimab for prevention of hospitalizations due to RSV in infants. N Engl J Med 2023; 389: 2425–2435.

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