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Background: Cytotoxic medicine contamination of preparation and administration areas of oncology healthcare facilities poses a risk to staff facing repeated low‐level exposure over time. The use of closed‐system transfer devices (CSTDs) during preparation and administration of cytotoxic products may reduce the levels of contamination. The primary aim was to determine the levels of cytotoxic medicine contamination in preparation and administration areas of hospitals that use CSTDs compared to those that do not. Aim: The primary aim was to determine the levels of cytotoxic medicine contamination in preparation and administration areas of hospitals that use CSTDs compared to those that do not. Method: A retrospective, cross‐sectional study across four Australian hospitals was conducted. Cytotoxic medicine contamination was determined via surface wipe sampling on six specified surfaces. The samples were tested for cyclophosphamide, docetaxel, etoposide, ifosfamide, irinotecan, methotrexate, paclitaxel, pemetrexed, topotecan, and vinblastine. This project was exempt due to the local policy requirements that constitute research by the South Eastern Sydney Local Health District Human Research Ethics Committee (Reference no: ETH01899). The justification for this ethics exemption was as follows: this was a study involving sample testing only and did not include human participants or participation. Results: Environmental contamination with cytotoxic medications was observed at all hospitals, regardless of the CSTD used. Of the 24 samples tested, the agent most frequently seen was ifosfamide with 29% (n = 7), followed by cyclophosphamide 13% (n = 3), and methotrexate 8% (n = 2). There was no statistically significant difference between hospitals that used CSTDs compared to hospitals that did not (25% vs 42%, p = 0.67). Contamination was more extensive in preparation areas than administration areas, and was observed on the biological safety cabinets (BSC) worktop, packaging bench, and floor in front of the BSCs. Conclusion: All sites had contamination present for cytotoxic medicines. There was no statistically significant difference in the proportion of contaminated surfaces between sites that used CSTDs versus sites where CSTDs were not used. Only ifosfamide contamination was identified in pharmacy areas that used CSTDs. Safe work practices and staff training are encouraged to further minimise exposure risk. [ABSTRACT FROM AUTHOR]

Aims: The potential harm associated with medication errors is widely reported, but data on actual harm are limited. When actual harm has been measured, assessment processes are often poorly described, limiting their ability to be reproduced by other studies. Our aim was to design and implement a new process to assess actual harm resulting from medication errors in paediatric inpatient care. Methods: Prescribing errors were identified through retrospective medical record reviews (n = 26 369 orders) and medication administration errors through direct observation (n = 5137 administrations) in a tertiary paediatric hospital. All errors were assigned potential harm severity ratings on a 5‐point scale. Multidisciplinary panels reviewed case studies for patients assigned the highest three potential severity ratings and determined the following: actual harm occurrence and severity level, plausibility of a link between the error(s) and identified harm(s) and a confidence rating if no harm had occurred. Results: Multidisciplinary harm panels (n = 28) reviewed 566 case studies (173 prescribing related and 393 administration related) and found evidence of actual harm in 89 (prescribing = 22, administration = 67). Eight cases of serious harm cases were found (prescribing = 1, administration = 7) and no cases of severe harm. The panels were very confident in 65% of cases (n = 302) where no harm was found. Potential and actual harm ratings varied. Conclusions: This harm assessment process provides a systematic method for determining actual harm from medication errors. The multidisciplinary nature of the panels was critical in evaluating specific clinical, therapeutic and contextual considerations including care delivery pathways, therapeutic dose ranges and drug–drug and drug–disease interactions. [ABSTRACT FROM AUTHOR]

Objective: To provide a greater understanding of the tolerability, safety and clinical outcomes of onasemnogene abeparvovec in real‐world practice, in a broad population of infants with spinal muscular atrophy (SMA). Methods: A prospective cohort study of children with SMA treated with onasemnogene abeparvovec at Sydney Children's Hospital Network, Australia was conducted from August 2019 to November 2021. Safety outcomes included clinical and laboratory evaluations. Efficacy assessments included World Health Organisation (WHO) motor milestones, oral and swallowing abilities, and requirements for respiratory support. The implementation of a model of care for onasemnogene abeparvovec administration in health practice is described. Results: 21 children were treated (age range, 0.65–24 months; body weight range, 2.5–12.5 kg) and 19/21 (90.4%) had previous nusinersen. Transient treatment‐related side effects occurred in all children; vomiting (100%), transaminitis (57%) and thrombocytopaenia (33%). Incidence of moderate/severe transaminitis was significantly greater in infants weighing ≥8 kg compared with <8 kg (p < 0.05). Duration of prednisolone following treatment was prolonged (mean 87.5 days, range 57–274 days). 16/21 (76%) children gained at least one WHO motor milestone. Stabilisation or improvement in bulbar or respiratory function was observed in 20/21 (95.2%) patients. Implementation challenges were mitigated by developing standard operating procedures and facilitating exchange of knowledge. Interpretation: This study provides real‐world evidence to inform treatment decisions and guide therapeutic expectations for onasemnogene abeparvovec and combination therapy for SMA in health practice, especially for children weighing ≥8 kg receiving higher vector loads. Proactive clinical and laboratory surveillance is essential to facilitate individualised management of risks. [ABSTRACT FROM AUTHOR]

Background Double-checking the administration of medications has been standard practice in paediatric hospitals around the world for decades. While the practice is widespread, evidence of its effectiveness in reducing errors or harm is scarce. Objectives To measure the association between double-checking, and the occurrence and potential severity of medication administration errors (MAEs); check duration; and factors associated with doublechecking adherence. Methods Direct observational study of 298 nurses, administering 5140 medication doses to 1523 patients, across nine wards, in a paediatric hospital. Independent observers recorded details of administrations and double-checking (independent; primed--one nurse shares information which may influence the checking nurse; incomplete; or none) in real time during weekdays and weekends between 07:00 and 22:00. Observational medication data were compared with patients' medical records by a reviewer (blinded to checking-status), to identify MAEs. MAEs were rated for potential severity. Observations included administrations where double-checking was mandated, or optional. Multivariable regression examined the association between doublechecking, MAEs and potential severity; and factors associated with policy adherence. Results For 3563 administrations double-checking was mandated. Of these, 36 (1.0%) received independent double-checks, 3296 (92.5%) primed and 231 (6.5%) no/incomplete double-checks. For 1577 administrations double-checking was not mandatory, but in 26.3% (n=416) nurses chose to double-check. Where double-checking was mandated there was no significant association between double-checking and MAEs (OR 0.89 (0.65-1.21); p=0.44), or potential MAE severity (OR 0.86 (0.65-1.15); p=0.31). Where double-checking was not mandated, but performed, MAEs were less likely to occur (OR 0.71 (0.54-0.95); p=0.02) and had lower potential severity (OR 0.75 (0.57-0.99); p=0.04). Each double-check took an average of 6.4 min (107 hours/1000 administrations). Conclusions Compliance with mandated double-checking was very high, but rarely independent. Primed double-checking was highly prevalent but compared with single-checking conferred no benefit in terms of reduced errors or severity. Our findings raise questions about if, when and how double-checking policies deliver safety benefits and warrant the considerable resource investments required in modern clinical settings. [ABSTRACT FROM AUTHOR]

The shift towards microservisation which can be observed in recent developments of the cloud landscape for applications has led towards the emergence of the Function as a Service (FaaS) concept, also called Serverless. This term describes the event-driven, reactive programming paradigm of functional components in container instances, which are scaled, deployed, executed and billed by the cloud provider on demand. However, increasing reports of issues of Serverless services have shown significant obscurity regarding its reliability. In particular, developers and especially system administrators struggle with latency compliance. In this paper, following a systematic literature review, the performance indicators influencing traffic and the effective delivery of the provider's underlying infrastructure are determined by carrying out empirical measurements based on the example of a File Upload Stream on Amazon'sWeb Service Cloud. This popular example was used as an experimental baseline in this study, based on different incoming request rates. Different parameters were used to monitor and evaluate changes through the function's logs. It has been found that the so-called Cold-Start, meaning the time to provide a new instance, can increase the Round-Trip-Time by 15%, on average. Cold-Start happens after an instance has not been called for around 15 min, or after around 2 h have passed, which marks the end of the instance's lifetime. The research shows how the numbers have changed in comparison to earlier related work, as Serverless is a fast-growing field of development. Furthermore, emphasis is given towards future research to improve the technology, algorithms, and support for developers. [ABSTRACT FROM AUTHOR]

Background: Many studies have explored the effect of electronic medication management systems (EMMS) on doctors' and nurses' work, but few have focused specifically on pharmacists' work. Aim: This study examined how implementation of a commercial EMMS affected the work of pharmacists in an Australian paediatric hospital. In particular, the study investigated whether any pharmacy tasks changed or were eliminated, or whether new tasks emerged following EMMS introduction. Methods: Two rounds of semistructured interviews with pharmacists, one 4 months and the other 1 year after EMMS implementation, were conducted. In total, 17 pharmacists were interviewed, comprising inpatient, outpatient and oncology pharmacists, as well as pharmacy managers. Results: EMMS implementation eliminated a small number of tasks, changed some tasks and created many new work tasks for pharmacists. These new tasks included helping doctors and nurses to use the EMMS, duplicated data entry and the review of additional information. Pharmacists held the view that their workload had increased and that additional pharmacists were necessary to cope with the new work requirements associated with the EMMS. Some problems were perceived to be the result of implementation of a US‐designed EMMS that did not fully support Australian pharmacy workflows. Conclusion: Implementation of an EMMS in a paediatric hospital affected pharmacists' work in a variety of ways, predominately by introducing new tasks. Anticipating how workflows will change with EMMS implementation is challenging. Undertaking regular reviews of workflow and planning for an increased burden on pharmacy staff is likely to improve the transition from paper to electronic medication management. [ABSTRACT FROM AUTHOR]

Background To date, there is no national or international consensus on which key performance indicators ( KPIs) should be used to measure hospital pharmacy performance. Aim To explore hospital pharmacists' perspectives on the role of KPIs and to use their perspectives to suggest a set of KPIs for use in Australian hospital pharmacy practice. Methods The study comprised of two parts. Part A involved semi-structured interviews with hospital pharmacists from major Sydney metropolitan hospitals; interviews were conducted until theme saturation was attained. Part B involved an online survey comprising Likert-scale responses and open-ended questions; the survey was distributed nationally to pharmacists via the Society of Hospital Pharmacists of Australia ( SHPA) eNewsletter and Facebook page. Results Part A: 19 hospital pharmacists were interviewed. Part B: 49 online surveys were received (after excluding incomplete submissions). Overall, the emergent themes identified that hospital pharmacists agreed that KPIs are a valuable tool for individual and departmental performance measurement; the use of KPIs was challenged by data collection difficulties, a lack of engagement from staff, and a lack of clarification regarding the intended use of KPIs and their relevance. The study identified a consolidated set of seven KPIs, proposed as standard measures for hospital pharmacy practice. Conclusion There is a perceived need to develop national standardised KPIs to demonstrate the value of pharmacy services at the individual and departmental levels. However, there are challenges that will need to be addressed before the implementation of a set of consolidated KPIs that encompasses the full scope of pharmacy activities. [ABSTRACT FROM AUTHOR]

Aim: Intravenous immunoglobulin (IVIG) is an expensive therapy used in immunodeficiency and autoimmune disorders. Increasing demands and consequent shortages result in a need for usage to conform to guidelines.Method: We retrospectively evaluated IVIG use for neuroimmunological indications and adherence to existing guidelines in a major Australian paediatric hospital between 2000 and 2014.Results: One-hundred and ninety-six children (96 male, 100 female; mean age at disease onset 6y 5mo [range 3mo-15y 10mo], mean age at first IVIG dose 7y 2mo [range 3mo-16y 5mo]) received IVIG for neuroimmunological indications during the study period (28.1% had Guillain-Barré syndrome), representing 15.5% of all hospital indications. In total, 1669 IVIG courses were administered (total 57 221g, median 78g/patient, range 12-5748g). The highest median numbers of courses were in chronic inflammatory demyelinating polyneuropathies, opsoclonus-myoclonus ataxia syndrome, suspected immune-mediated epilepsies, and Rasmussen's encephalitis. Adverse reactions occurred in 25.5% of patients, but these were mostly minor. Outcome at follow-up was best in anti-N-methyl-d-aspartate receptor (anti-NMDAR) encephalitis, Guillain-Barré syndrome, and myasthenia gravis, and worst in Rasmussen's encephalitis and epilepsies. The total cost of IVIG was US$2 595 907 (median $3538/patient, range $544-260 766). Of patients receiving IVIG, 45.4% to 57.1% were given the therapy for 'weak' indications or indications 'not listed' in international guidelines. Some entities commonly treated with IVIG in current practice, such as anti-NMDAR encephalitis and transverse myelitis, are not listed in most guidelines.Interpretation: Our study demonstrates that IVIG is generally well tolerated but expensive, and discloses discrepancies between guidelines and clinical practice in paediatric neurology, suggesting both the need for greater adherence to current recommendations, and for recommendations to be updated to accommodate emerging indications. [ABSTRACT FROM AUTHOR]

Introduction: Hospitals play a significant and important role in funding high-cost medicines so patients can access treatments they need. High-cost medicines are often specialty medicines, which contribute to a significant and increasing portion of the hospital budget. It is imperative that these expensive medicines are governed and managed with a fair, standardized evidence-based process. We aim to provide a framework for Drugs and Therapeutics Committees (DTCs). Methods: During 2021, Guiding Principles were developed following a literature review and survey of current practices by DTCs in Australia. An Expert Advisory Group (EAG) was convened, comprising individuals with expertise in quality use of medicines, evidence-based medicine and medicines governance. The guiding principles were drafted by the EAG, in consultation with a range of stakeholders and relevant external organizations. All feedback was collated, reviewed and discussed to refine the content of the final Guiding Principles released in January 2022. Results: Seven overarching principles provide key recommendations for the governance of high-cost medicines: (i) A definition of high‑cost medicines should be determined and clearly articulated for use by each medicines governance committee. (ii) Review of high-cost medicines requires members with relevant expertize to facilitate good and effective decision-making. (iii) The committee should engage directly with the applicant prior to review to ensure a full understanding of the rationale for the request. (iv) consistent, robust and transparent procedure for the assessment of high-cost medicine applications should be defined and implemented for use by each medicines governance committee to ensure fair process. (v) Ethical considerations fundamentally underpin deliberations around high-cost medicines. (vi) The decisions and outcomes of the decision making should be transparent and appropriately communicated to the various audiences. (vii) The high-quality assessment of high-cost medicines requires appropriate training and resourcing. Conclusions: These national Guiding Principles promote consistent, evidence-based use of high-cost medicines and provide a framework for DTCs to assess and achieve effective governance for the quality use of high‑cost medicines. [ABSTRACT FROM AUTHOR]

Objectives: To examine changes in technology-related errors (TREs), their manifestations and underlying mechanisms at 3 time points after the implementation of computerized provider order entry (CPOE) in an electronic health record; and evaluate the clinical decision support (CDS) available to mitigate the TREs at 5-years post-CPOE., Materials and Methods: Prescribing errors (n = 1315) of moderate, major, or serious potential harm identified through review of 35 322 orders at 3 time points (immediately, 1-year, and 4-years post-CPOE) were assessed to identify TREs at a tertiary pediatric hospital. TREs were coded using the Technology-Related Error Mechanism classification. TRE rates, percentage of prescribing errors that were TREs, and mechanism rates were compared over time. Each TRE was tested in the CPOE 5-years post-implementation to assess the availability of CDS to mitigate the error., Results: TREs accounted for 32.5% (n = 428) of prescribing errors; an adjusted rate of 1.49 TREs/100 orders (95% confidence interval [CI]: 1.06, 1.92). At 1-year post-CPOE, the rate of TREs was 40% lower than immediately post (incident rate ratio [IRR]: 0.60; 95% CI: 0.41, 0.89). However, at 4-years post, the TRE rate was not significantly different to baseline (IRR: 0.80; 95% CI: 0.59, 1.08). "New workflows required by the CPOE" was the most frequent TRE mechanism at all time points. CDS was available to mitigate 32.7% of TREs., Discussion: In a pediatric setting, TREs persisted 4-years post-CPOE with no difference in the rate compared to immediately post-CPOE., Conclusion: Greater attention is required to address TREs to enhance the safety benefits of systems., (© The Author(s) 2024. Published by Oxford University Press on behalf of the American Medical Informatics Association.)