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

Objective: This study aims to evaluate the risk of occupational exposure to hazardous medicinal products (HMPs) when utilising robotic compounding systems for the preparation of antineoplastic sterile medications. Specifically, it assesses the levels of HMPs present on the surfaces of ready-to-use preparations and on the gloves worn by personnel involved in the compounding process.

Methods: The study was conducted over three consecutive days during routine production with a robotic compounding system. Each day, wipe samples were collected from the surfaces of 20 HMPs preparations and from the gloves of the operator involved in the compounding process. Analyses were performed using an Ultra-High Performance Liquid Chromatography (UHPLC) system to detect and quantify 25 commonly used anticancer molecules in hospital pharmacies.

Results: Throughout the study, the robot compounded 60 bags of 19 different drugs, including 5-fluorouracil, bevacizumab, carboplatin, cisplatin, cyclophosphamide, docetaxel, doxorubicin, eribulin, etoposide, gemcitabine, irinotecan, nivolumab, oxaliplatin, paclitaxel, panitumumab, pembrolizumab, pemetrexed, trastuzumab, and vinorelbine. Only negligible amounts of gemcitabine, below the quantification limit (<0.0025 ng/cm²), were detected on the surfaces of 10 out of the 60 bags and on two of the operator's gloves.

Conclusion: The results demonstrate that surface contamination levels of HMPs in robotic compounding are exceedingly low and, in most cases, undetectable. Occupational exposure to HMPs remains consistently below 0.1 ng/cm², a threshold deemed safe according to various studies. These findings assure the safety of compounding personnel and other hospital staff involved in cancer treatment.

We present the case of a man in his 70s admitted to the intensive care unit (ICU) after mitral valve replacement and coronary artery bypass graft surgery requiring extracorporeal membrane oxygenation support due to haemodynamic instability. He received anticoagulation therapy with heparin sodium and, after 5 days, the patient presented with thrombocytopenia and deep venous thrombosis. Heparin-induced thrombocytopenia was suspected based on a positive 4T score and confirmed by antiplatelet factor 4/heparin antibodies, so argatroban was initiated as an alternative anticoagulation therapy. In the following days the patient developed severe neutropenia requiring discontinuation of argatroban and the administration of granulocyte colony-stimulating factor. According to the Naranjo Adverse Drug Reaction Probability Scale, this event would be classified as a 'probable' argatroban-related adverse event. Argatroban should be conisdered as a possible cause of neutropenia and appropriate interventions need to be implemented due to the gravity of this adverse event in the ICU.

Objectives: Inappropriate prescriptions are known to cause medication-related problems, but little is known about the prevalence of this issue in paediatric patients. This systematic review provides an overview of the prevalence of potentially inappropriate prescriptions identified through tools developed for the paediatric population and delineates the strengths and limitations of the identification tools.

Methods: Literature from PubMed, CINAHL, Cochrane database and Google Scholar was searched with a combination of medical subject headings (MeSH) and free-text terms related to inappropriate prescriptions, paediatrics and potentially inappropriate prescription tools. Studies reported in English and published from inception of the databases until May 2023 were selected based on fulfilment of eligibility criteria. All eligible articles were assessed for methodological quality and examined using thematic analysis.

Results: Twelve studies met the inclusion criteria. The majority of the studies were of high quality. Four themes emerged-namely, evaluation tools and calculation methods of inappropriate prescriptions, prevalence of potentially inappropriate medications (PIMs) and potential prescribing omissions (PPOs), and predictors of PIM and PPO in children. Among the nine tools identified, the original and modified version of the POPI tool was most commonly used. The prevalence of PIM and PPO ranged from 0.04% to 69% and from 1.5% to 55.9%, respectively. Age was the most common predictor reported, whereby PIMs and PPOs were more likely in children aged 2-6 and 6-12 years, respectively.

Conclusions: Potentially inappropriate prescriptions in paediatric patients is highly prevalent, despite the wide variation in the reported prevalence range and limited implementation of the available tools in practice. Future efforts need to be focused on the development and implementation of age-, disease- or country-specific tools to effectively evaluate and further determine the economic impact of PIMs in children.

Thrombotic microangiopathy is a serious condition that can be precipitated by exposure to certain medications. Although rare, it is life threatening and requires a high index of clinical suspicion, appropriate laboratory testing and immediate cessation of the offending agent. We present a case of a 75-year-old man with a history of ischaemic heart disease treated with clopidogrel and aspirin. One month after initiating the treatment he developed microangiopathic haemolytic anaemia and thrombocytopenia. Extensive clinical and laboratory investigations suggested thrombotic microangiopathy secondary to clopidogrel. The drug was immediately discontinued and treatment with intravenous corticosteroids was started. Within a week the patient's laboratory parameters normalised, indicating successful recovery. This case highlights the role of early detection and immediate discontinuation of suspected medication in the effective management of clopidogrel-induced thrombotic microangiopathy. Healthcare professionals should consider drug-induced thrombotic microangiopathy as a possible diagnosis in patients receiving clopidogrel who present with thrombocytopenia and microangiopathic haemolytic anaemia.

Background: In the context of the opioid epidemic, it is indispensable to reduce the use of opioids and develop new therapeutic alternatives. The combined use of ketamine, lidocaine and dexmedetomidine has been studied for opioid-free anaesthesia and the management of pain to reduce the use of opioids. An opioid-free anaesthesia mixture in one syringe for multimodal anaesthesia has been used in case series and is currently being studied in clinical trials. However, there are no data evaluating the compatibility of the admixture of these three drugs in syringes. The objective of this study was to evaluate the physicochemical stability of the combination of dexmedetomidine, ketamine and lidocaine.

Methods: The formulation combining the three active drugs was prepared at a final concentration of 1 µg/mL of dexmedetomidine, 1 mg/mL of ketamine and 10 mg/mL of lidocaine. The formulation was conditioned in syringes; three syringes were placed at 21°C and three others at 5°C. The concentration and the particle count were evaluated at predetermined time points up to 9 days. A validated stability-indicating HPLC method was developed.

Results: The study demonstrated the stability of ketamine (1 mg/mL) and lidocaine (10 mg/mL) in the injectable formulation when stored in polypropylene syringes at 5°C and 21°C for up to 9 days. However, dexmedetomidine (1 µg/mL) was stable for 9 days at 5°C, but only for 3 days when stored at 21°C. Therefore, the injectable formulation containing the three active compounds should be stored at 5°C in order to remain stable for 9 days. The particle count was below the threshold for injectable solution for 9 days at both temperatures.

Conclusion: This study demonstrated the stability of dexmedetomidine (1 µg/mL), ketamine (1 mg/mL) and lidocaine (10 mg/mL) when stored in a polypropylene syringe at 5°C for up to 9 days.

Objectives: Medication reconciliation (MR) has been identified by the French High Health Authority (HHA) as an advanced criterion for improving the quality of care. Although this activity has been widely developed and evaluated in conventional establishments, few studies have looked at its implementation in 'hospitalisation at home' (HAH) settings. HAH is considered to be an alternative to conventional hospitalisation that requires slight changes to be made to the medication process, such as the prominent role of the patient and their caregivers, the intermittent presence of numerous members of multidisciplinary staff in the home environment, and the patient's own home. So, this study aims to provide an overview of the implementation of MR in our HAH using activity indicators, and to measure the clinical impact of the pharmaceutical procedures carried out as part of this activity.

Methods: A retrospective observational study was conducted. A process and MR materials were developed based on HHA tools. The clinical impact of the pharmaceutical procedure was determined using the Clinical Economic and Organisational (CLEO) scale.

Results: 29 patients benefited from MR on admission, carried out by a pharmacy intern with a pharmacy assistant. A total of 38 unintentional discrepancies were identified. The average number of unintentional discrepancies per patient with at least one unintentional discrepancy in their MR was 2.1. The mean time to complete MR was 2.5 hours. 30 (79%) pharmaceutical procedures were accepted by the clinicians, of which 6 (20%) were considered to have a major clinical impact.

Conclusion: MR for hospitalised patients at home is valuable to ensure safe medication management at this stage of the care pathway. Despite the small sample size of our study, each pharmaceutical procedure has a significant clinical impact. This activity contributed to the certification of our home care facility by the French HHA.

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.

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.

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.

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.