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

Objectives: Critically ill newborn infants often require simultaneous administration of multiple intravenous (IV) solutions through the same catheter lumen, making compatibility of these solutions crucial in neonatal intensive care units (NICUs). This study aimed to investigate the physical compatibility of insulin aspart, lidocaine, alprostadil and vancomycin with individualised two-in-one parenteral nutrition (PN).

Methods: The study was conducted at the hospital pharmacy's drug compounding facility of the University Medical Centre Utrecht. Two PN formulations were prepared with different electrolyte concentrations (PN1 with high electrolytes and PN2 with low electrolytes), each with either 0% or 30% w/v glucose, resulting in four solutions for testing. Each solution was then mixed with the selected IV drugs in a 1:1 ratio. Compatibility was assessed through visible particle testing, pH measurements and subvisible particle testing at multiple time points (T=0, T=1, T=4 hours).

Results: No visible particles were detected in any combinations. However, insulin and lidocaine combinations exceeded the subvisible particle threshold of 6000 particles ≥10 µm per container volume at T=0 hours, with insulin also exceeding the threshold in a specific PN combination at T=4 hours. pH measurements indicated minimal shifts in the PN solutions, suggesting significant buffering capacity.

Conclusion: Alprostadil and vancomycin IV solutions are physically compatible with two individualised neonatal PN solutions, with high as well as low glucose concentrations. Combinations of PN with lidocaine or insulin form subvisible particles, which could have clinical implications if administered in large volumes over extended periods of time. In clinical scenarios where there is no other option but to administer lidocaine or insulin through the same catheter lumen as PN using a Y-site connector, the use of an in-line filter is advised. Our study adds important compatibility data that can guide clinical practice in NICU settings. However, the broader application of these results requires careful consideration of the unique characteristics of each neonatal PN solution and drug combination.

Objectives: This study addressed the gaps in the disclosure of statin-associated adverse drug reactions (ADRs) in China's official database and the inadequacy of cases reported relative to the population size in public ADR databases.

Methods: To address these limitations, we conducted a retrospective trial-based analysis using data from Chinese journals to comprehensively assess statin-associated ADRs from 1992 to 2023, focusing on liver (2895 studies, n = 163 810) and muscle (2888 studies, n = 161 714) related outcomes.

Results: For large sample size clinical trial analysis (n≥100), our analysis encompassed data from 31 763 participants for muscle-related ADRs (incidence rate: 0.004-0.006, common effect model; 0.002-0.006, random effects model) and 31 281 participants for liver-related ADRs (incidence rate: 0.004-0.006, common effect model; 0.003-0.006, random effects model), covering various statins, including atorvastatin, simvastatin, rosuvastatin, fluvastatin, pitavastatin, pravastatin and lovastatin. Notably, muscle-related ADRs, particularly rhabdomyolysis, were most prevalent with fluvastatin, lovastatin and pravastatin, showing rates of 0.90%, 0.74% and 0.53%, respectively. Pitavastatin and atorvastatin were frequently associated with liver-related ADRs such as abnormal liver function and elevated enzymes, with rates of 5.36% and 1.819%, respectively.

Conclusions: This study underscores significant variations in ADR incidence among different statins in the Chinese population, providing critical insights for healthcare professionals and policymakers to enhance patient safety and optimise clinical decisions regarding statin therapy.

Background: Intravitreal and intracameral administration of melphalan and topotecan (TPT) has shown its efficacy in the treatment of retinoblastoma over the last few years. Due to rapid hydrolysis, melphalan must be administered within the hour following reconstitution. With improved stability at room temperature and reduced ocular toxicity, TPT seems to be a promising candidate for production of prefilled syringes in terms of safety and efficiency of preparation and treatment administration. Due to the lack of TPT stability data, the stability of TPT at 20 µg/mL and 200 µg/mL in prefilled syringes was evaluated in three different storage conditions.

Methods: The stability of TPT in prefilled syringes was assessed via reversed-phase liquid chromatography coupled to a diode array detector analytical platform. The physicochemical stability of TPT in prefilled syringes in both concentrations, stored at 30±2°C with a relative humidity (RH) of 65±5%, 5±3°C, and -20±5°C, was evaluated over 12 months including visual inspection and pH measurement.

Results: TPT solution in syringes at 20 µg/mL and 200 µg/mL was stable at 5±3°C and -20±5°C for up to 12 months, with no precipitate and no significant change in pH and concentration. A TPT-related degradant, 8-methoxy-TPT, was detected at <0.5% only in 30±2°C (65±5% RH) after 3 months.

Conclusion: This study demonstrated that TPT solutions at 20 µg/mL and 200 µg/mL conditioned in BBraun Omnifix syringes could be stored at 5±3°C for 12 months for safe and secure administration to patients.

Objective: Achieving glycaemic control is essential to avoid disease progression and diabetes-related complications. Non-adherence and discontinuity in diabetic therapy are major barriers to optimal glycaemic control. The aim of this study was to evaluate adherence, persistence and therapy switching over 1 year in real-life conditions in patients with type 2 diabetes within an Italian region.

Methods: A retrospective, observational, non-interventional study was conducted, analysing patients treated with Anatomical Therapeutic Chemical (ATC) Classification A10B drugs dispensed by pharmacies under the local health authority (ASL) of the Umbria region from 1 January 2022 to 31 December 2023. Adherence was measured using the Proportion of Days Covered (PDC), while persistence was calculated as the duration between the start and end of therapy.

Results: A total of 6928 patients with type 2 diabetes were analysed. After 1 year, the overall adherence rate was 0.78, with 58% (4017/6928) of patients having adherence greater than 0.80. The lowest adherence was observed in patients treated with metformin +dipeptidyl peptidase 4 (DPP4) inhibitors, with a mean adherence of 0.71 and 36% (142/395) of patients achieving adherence greater than 0.80. Conversely, the highest adherence was seen in patients on sodium-glucose co-transporter 2 (SGLT2) inhibitors, with a mean adherence of 0.91 and 97% (473/487) of patients achieving adherence greater than 0.80. Persistence data showed concerning results, with less than 10% of patients remaining on treatment for 1 year across all drug classes. Among patients initially treated with metformin (n=4427), there was a substantial loss to follow-up, with 3582 patients (81%) discontinuing treatment within the first year.

Conclusions: The 1 year data on adherence and persistence for antidiabetic drugs revealed concerning trends. These findings underscore the need for targeted interventions, involving clinicians and pharmacists, to improve adherence and persistence in patients with type 2 diabetes, ultimately ensuring better disease management and reducing long-term healthcare costs.

Objectives: There have been cases of cardiotoxicity induced by osimertinib in patients with non-small-cell lung cancer (NSCLC). However, limited data exist for a comprehensive cardiotoxicity profile analysis for osimertinib use in NSCLC patients. The aim of this study was to report the entire profile of cardiotoxicities after the initiation of osimertinib in consecutive patients with epidermal growth factor receptor (EGFR) mutation at a single health system.

Methods: The data were retrospectively collected from electronic medical records for all patients who were started on osimertinib for NSCLC at West Virginia University Health System. Prevalence of heart failure (HF), atrial fibrillation, and prolonged QT before and after starting osimertinib were calculated.

Results: This study had 116 participants and the median age was 72 years. The frequency of each new cardiotoxicity was between 6% and 9%, and the overall percentage of patients who had developed any of the four cardiotoxicities while on osimertinib was 19.9%. The median time of follow-up was 477 days and the median time on osimertinib for all patients was 390 days. The strongest risk factor in predicting a new onset cardiac event was hypertension with a hazard ratio (HR) of 6.35 (confidence interval (CI) 1.48 to 27.23, p=0.013) and HR 5.36 (CI 1.23 to 23.39, p=0.025) in univariate and multivariate analysis respectively.

Conclusion: Osimertinib appears to be associated with an increase in cardiac abnormalities. Given the association between this medication exposure and the observed cardiac toxicities, use of osimertinib may entail closer cardiac monitoring of electrocardiogram (ECG) and echocardiogram abnormalities.

Objectives: Acceleration of the haemostasis process after dermatological surgery predominantly relies on mechanical methods, such as the use of sutures or staples. To our knowledge, there is currently no commercialised haemostatic agent for this specific application. Due to the protein precipitation properties of the 50% (w/v) aluminium chloride hexahydrate solution, its physicochemical stability and maintenance of sterility over a 6 month period were assessed.

Methods: Aluminium chloride hexahydrate was dissolved in sterile water to obtain a 50% (w/v) solution, which was subsequently sterilised through filtration. The solution was then placed in brown glass vials and kept at 20-25°C. The physicochemical stability and sterility of the solution were assessed at four different time points (D0, M1, M3 and M6). At each time point, pH and osmolality were measured, the chloride concentration of the sample was evaluated using the Mohr method, and aluminium identification was carried out through a precipitation method. In addition, the sterility of the solution was also assessed at each time point, according to the European Pharmacopoeia method.

Results: The pH, osmolality and chloride concentration values remained stable and were concordant with the expected values throughout the study. Aluminium was identified in each sample. The sterility of the solution was maintained over the study period.

Conclusions: The physicochemical stability and sterility of the 50% (w/v) aluminium chloride hexahydrate solution were maintained for 6 months. These results indicate that the solution can be prepared in advance.

Objective: Drug-related problems (DRPs) are a frequent reason for visits to the emergency department (ED). However, data about the characteristics associated with early revisits are limited. We aimed to identify clinical phenotype clusters of patients admitted to emergency rooms due DRPs to identify those patients with the highest risk of new visits.

Methods: We included consecutive patients admitted to EDs due DRPs (February 2021 to December 2022), including DRP admissions in 2023 as validation cohort. We employed K-means clustering to group patients according to adjusted morbidity groups (GMA), age, and number of drugs at admission. To determine the optimal number of cluster centres, we used the elbow method. The impact of 30-day revisits in each cluster was assessed.

Results: 1611 patients (mean (SD) age 75.0 (15.1) years) were included. We identified six clusters, with 30-day revisits rates ranging from 14.8% to 24.5%. The main groups of drugs implicated in the DRP episodes were diuretics (190 patients; 11.8%). The most common DRP diagnoses were constipation (191; 11.9%) and gastrointestinal bleeding (158; 9.8%). Six clusters of patients were identified. Significantly higher 30-day revisits in patients identified in cluster 4 (24.5% vs 17.5%; p=0.007). The highest revisit rate was observed in the cluster including patients with a higher number of drugs and GMA status.

Conclusions: Patients admitted to the ED due DRPs exhibit varying revisit rates across different clinical phenotypes. K-means clustering aids in identifying patients who derive the greatest rates of readmission, and is a useful tool to prioritise interventions in these units.

Brentuximab vedotin (BV) is an antibody-drug conjugate, consisting of a CD30-directed antibody, conjugated by a protease-cleavable linker to a microtubule disrupting agent auristatin E (MMAE). Although the safety datasheet of BV does not warn of severe toxic effects of extravasation, we report a third case of a patient with anaplastic large cell lymphoma who developed severe epidermal necrosis after extravasation. The reason for what happened could be attributed to the fact that MMAE belongs to the group of vinca alkaloids so it should be handled like other tissue-necrotising chemotherapeutics. Reporting of all cases of extravasation involving new conjugated chemotherapeutic drugs is of the utmost importance to be able to develop updated guidelines. Hospital pharmacists can provide information on how to manage extravasation, assess the potential risk, and have a crucial role in drafting hospital protocols.

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.