European journal of hospital pharmacy : science and practice最新文献

Objectives: This paper combines the concepts of design thinking and benchmarking in an aseptic manufacturing context. Design thinking is a problem-solving approach that aims to understand user needs, generate ideas, prototypes and test solutions. There are no published examples in the Irish healthcare setting. There are also no national legislative frameworks in Ireland for compounding medicine in unlicensed hospital aseptic compounding units (ACUs). This study aims to apply design thinking principles to the development of a benchmarking process in the absence of existing frameworks.

Methods: A literature review of design thinking research and international best practice guidelines regarding sterile product manufacture documentation was undertaken to develop an initial prototype benchmarking tool. Design thinking principles were implemented by recruiting and empathising with key senior stakeholders (N=5). Semistructured interviews were conducted with these stakeholders to aid the defining, ideation and optimisation of the prototype tool. The optimised tool was then prototyped and tested in practice by end users (N=11), within an Irish ACU. End users were interviewed regarding their experience of using the tool. Transcripts of interviews were coded, and thematic analysis was undertaken to generate overarching themes to support its further development.

Results: The design thinking approach enabled the development of a benchmarking tool, which was optimised by empathising with key stakeholders. Through the process of empathising, defining, ideation, prototyping and testing, a useful benchmarking tool was developed which was deemed appropriate and accepted by its users.

Conclusions: Design thinking provides a platform for collaboration to deliver innovation and drive quality improvement in healthcare settings. The design thinking process was successful in delivering a user-centred tool for documentation procedures in an aseptic unit, which was accepted for use by end users. When exisiting guidleines and regulations are considered, design thinking shows promise as an innovation tool in Irish aseptic units, manufacturing facilities and the wider healthcare context.

Objective: We report our experience with the use of ceftaroline in combination with daptomycin or vancomycin for methicillin resistant coagulase negative Staphylococcus bacteraemia.

Methods: A multicentre retrospective study was carried out at three institutions of adult patients with methicillin resistant S. epidermidis or S. lugdunensis bacteraemia who were managed with either daptomycin or vancomycin in combination with ceftaroline.

Results: Twelve patients met the inclusion criteria. All patients who received combination therapy had sterile blood cultures on the subsequent blood cultures drawn following ceftaroline initiation. Those who received ceftaroline combination within 7 days had a faster time to blood culture sterilisation than those who received ceftaroline combination therapy after 7 days (6 (3-7) days vs 17 (12-19) days, p=0.031).

Conclusions: The results from this case series support the use of ceftaroline combination therapy in patients with methicillin resistant coagulase negative Staphylococcus bacteraemia whose blood cultures failed to sterilise with vancomycin or daptomycin alone.

Background: Immune-mediated inflammatory diseases (IMIDs) are a group of disorders characterised by acute or chronic inflammation. Adalimumab and infliximab are the cornerstones of their pharmacotherapy. This study aimed to determine whether variations in the volume and citrate content of different subcutaneous adalimumab formulations result in differences in pain perception during administration.

Methods: A retrospective, cross-cohort study was conducted. Patients who had experienced a change in subcutaneous adalimumab formulation in the past year were recruited. Pain perception was evaluated using a visual analogue scale ranging from 1 to 10 points. Patients were assigned to three groups based on the type of formulation change they experienced: reduction in citrate and volume, reduction in volume only or reduction in citrate only. Data were analysed via ANOVA to determine if there were differences in perceived pain among the three patient groups.

Results: A total of 68 patients were included, of whom 39 (57.4%) experienced a reduction in both volume and citrate, 20 (29.4%) experienced only a reduction in volume and 9 (13.2%) experienced only a reduction in citrate. Analysis showed that all three groups experienced a reduction in perceived pain during administration: 2.46±0.24, 0.3±0.57 and 0.66±1.11 points, respectively (p<0.001).

Conclusions: Our results show that in all three scenarios, perceived pain was reduced. If both volume and citrate are reduced, this effect is greater. Therefore, it is recommended to use formulations with the lowest citrate buffer concentration and the lowest possible volume to minimise pain during adalimumab administration.

Background: Adults who are critically ill frequently require multiple intravenous infusions through limited vascular access, making Y-site co-infusion unavoidable. However, much of the primary compatibility literature uses concentrations, diluents and visual-only methods that do not reflect contemporary intensive care unit (ICU) practice, risking false reassurance at the bedside.

Objective: To create an ICU-specific, concentration-matched Y-site compatibility chart aligned to standardised infusion concentrations and to identify compatible, conditional, incompatible and no-data drug-pairs.

Methods: We performed a PRISMA (preferred reporting items for systematic reviews and meta-analyses) guided, method-stratified synthesis (1970-2025) of in-vitro Y-site evidence from PubMed, Trissel's and Micromedex. Classifications privileged instrumented endpoints (pH, turbidimetry, sub-visible particles, high-performance liquid chromatography) over visual inspection. Drug-drug pairs were mapped to our tertiary adult ICU formulary; medicines with an established ward standard were deemed ICU standardised.

Outcomes: compatible (C), compatible in saline only (Csf), conditional (concentration/diluent dependent; applied only when at least one medicine was ICU standardised), incompatible-physical (Ie/Ip/It) or chemical (Iq)-or no data (ND).

Results: Among 4465 mapped drug-pairs, 43.94% were compatible (C 42.37%, Csf 1.57%); 2.53% were conditional; 8.24% were incompatible-predominantly physical; and 45.29% lacked eligible evidence. High-risk clusters included lipid emulsions (eg, propofol, clevidipine), extreme-pH agents (eg, amiodarone, furosemide), phenytoin and calcium salts. For morphine hydrochloride, evidence was sparse (76% ND, 21% compatible, 1% conditional, 2% incompatible). Amiodarone exemplified concentration non-concordance; with an ICU concentration of 15 mg/mL, 34% of amiodarone drug-pairs had compatibility that was concentration dependent.

Conclusions: At standardised ICU concentrations, fewer than half of potential Y-site pairings are unequivocally compatible and nearly half have no concentration-matched data. A conservative, method-stratified framework anchored to exact concentration and diluent mitigates risk and exposes evidence gaps. Applying a conservative, method-stratified framework anchored to exact concentration and diluent mitigates risk while revealing priority evidence gaps-especially for lipid emulsions, calcium-containing solutions, extreme-pH drugs and opioids. Embedding the chart within the electronic prescribing and medicines administration (EPMA) system can deliver checks, standardise line allocation, reduce uncertain Y-site mixing and prioritise dedicated lumens for high-risk agents.

Objectives: Medication errors are a leading source of preventable harm in healthcare, affecting approximately 1 in 30 patients, with a substantial proportion resulting in severe outcomes. In response, the European Association of Hospital Pharmacists convened a Special Interest Group (SIG) to propose comprehensive and sustainable strategies for reducing these errors across Europe, employing a systems approach.

Methods: 89 anonymised medication error reports, and empirical data from the SIG members' daily practice, were analysed to identify root causes, classified into system-level and individual errors. Expert subgroups then linked root causes to targeted preventive measures. A literature review was conducted, searching PubMed and Embase databases, to assess existing standards and identify gaps in medication safety practices, which informed the analysis.

Results: Analysis revealed that governance deficiencies and inconsistent implementation of existing legal standards contribute significantly to medication errors. System-level issues, including inadequate oversight, understaffing and insufficient technical infrastructures, along with individual errors from cognitive lapses, were prevalent. The literature review supported these findings and highlighted the variability in medication safety practices across systems, underscoring the importance of strategic improvements in healthcare policies.

Conclusions: Findings highlight the critical need for robust governance, comprehensive policy frameworks and enhanced safety cultures to prevent medication errors. Automation and improved human-machine interfaces are recommended to mitigate active failures and enhance system reliability. This systems-thinking approach, supported by strengthening legislation and better resource allocation, is essential for reducing medication errors and improving patient safety.

Background: Enoxaparin, a low molecular weight heparin, is widely used for venous thromboembolism treatment and prevention. While routine anti-factor Xa (anti-Xa) monitoring is not generally required, it may be valuable in high-risk populations such as patients with obesity or renal impairment.

Objective: To evaluate the impact of clinical variables on therapeutic enoxaparin dosing and assess the effectiveness of anti-Xa monitoring in real-world clinical practice.

Methods: A retrospective, single-centre, descriptive study was conducted in adults admitted to hospital and receiving therapeutic enoxaparin with correctly timed peak anti-Xa measurements (4 hours after dose) between December 2021 and January 2023. Demographic, clinical and dosing data were extracted from medical records. Predictors of peak anti-Xa concentration were identified using multiple linear regression. Dose-concentration correlations were examined overall and by obesity status.

Results: A total of 146 patients were included (mean age 67±12.3 years; 56.2% male; mean body mass index 29.6±7.5 kg/m²; 30.1% with obesity). Enoxaparin dose (p<0.001) and obesity (p=0.007) were independent predictors of peak anti-Xa concentration; renal impairment and critical illness were not. The correlation between dose and concentration was strong in patients without obesity (r=0.56) but weak in those with obesity (r=0.16). Only 46.6% achieved therapeutic concentrations; 40.4% were subtherapeutic and 12.9% supratherapeutic. Among patients with out-of-range values, dose adjustments were made in 67.9%, but follow-up anti-Xa measurement occurred in only 45.3%; 79.2% of these achieved target concentrations.

Conclusion: Obesity significantly influences enoxaparin pharmacokinetics, reducing predictability of anti-Xa concentrations with actual body weight dosing. Targeted anti-Xa monitoring in high-risk groups, particularly patients with obesity, and structured dose-adjustment protocols may improve therapeutic achievement and safety.

Objectives: Enzyme replacement therapy (ERT) with alglucosidase alfa is the cornerstone of treatment for Pompe disease, a rare disorder caused by acid α-glucosidase (GAA) deficiency. Since 2008, home infusions have been provided in the Netherlands. However, the short shelf-life of the ready-to-administer infusions poses challenges for manufacturing and dispensing pharmacies. This study assessed the stability of ready-to-administer alglucosidase alfa infusions by determining enzyme activity and cellular uptake of two concentrations during 11 days of storage.

Methods: Alglucosidase alfa infusions (2 and 4 mg/mL in 0.9% sodium chloride) were prepared and samples were drawn on days 1 to 7 and 11. Enzyme activity was determined using 4-methylumbelliferyl-α-D-glucoside (4MU-αGlc) and glycogen as substrates. Additionally, enzyme uptake in cultured fibroblasts was investigated.

Results: There was no difference in enzyme activity after 11 days as compared with day 1 using 4MU-αGlc (2 mg/mL: 352 vs 331 nmol/h/mL; 4 mg/mL: 657 vs 662 nmol/h/mL) or glycogen (2 mg/mL: 183 vs 176 nmol/h/mL; 4 mg/mL: 352 vs 357 nmol/h/mL). Uptake of alglucosidase alfa in fibroblasts remained stable over 11 days, with activity ranging from 90 to 104 nmol/h/mL at 2 mg/mL and from 233 to 238 nmol/h/mL at 4 mg/mL. Linear regression analysis confirmed no statistically significant association between time and enzyme activity or uptake.

Conclusions: Ready-to-administer alglucosidase alfa infusion in 0.9% sodium chloride at 2-4 mg/mL is stable for 11 days when stored at 2-8°C or -20°C and protected from light. Extending the stability could enhance efficiency and flexibility for infusion preparation and home delivery, while minimising pharmaceutical waste.