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

Introduction: The COVID-19 pandemic has led to unforeseen and novel manifestations, as illustrated by the management of drug shortages through the development of hospital production of sterile pharmaceutical preparations (P2S). Visual inspection of P2S is a release control whose methods are described in monographs of the European Pharmacopoeia (2.9.20) and the United States Pharmacopeia (1790). However, these non-automated visual methods require training and proficiency testing of personnel. The main objective of this work was to compare the reliability and speed of analysis of two visual methods and an automated method for detecting visible particles by image analysis in P2S. Furthermore, these methods were used to evaluate sources of particulate contamination during pre-production processes (washing, disinfection, depyrogenation) and production (filling, capping).

Materials and methods: Three pharmacy technicians examined 41 clear glass vials of type I, 10 and/or 50 mL through manual visual inspection (MVI), semi-automated (SAVI), and automated (AVI) inspection. The vials were distributed as follows: (i) 16 vials of water for injection containing either glass particles (224 µm or 600 µm), stopper fragments, or textile fibres; (ii) five sterile injectable specialties; (iii) 20 vials of water for injection prepared under different pre-production conditions.

Results and discussion: MVI and SAVI detected 100% of visible particles compared with 28% for AVI, which showed a deficiency in detecting textile fibres. All three methods correctly analysed P2S that did not contain visible particles. The three methods detected particles in vials maintained under International Organization for Standardization (ISO) 9 pre-production conditions. However, detections by (i) MVI and SAVI, and by (ii) AVI of particles contained in vials maintained under ISO 8 pre-production conditions were deemed satisfactory and unsatisfactory, respectively.

Conclusion: The importance of visual inspection of P2S requires rapid, sensitive, and reliable detection methods. In this context, MVI and SAVI have proven to be more effective than AVI for a more competitive financial, training, and implementation investment.

We present a case of drug-induced immune thrombocytopenia (DITP) proven to be due to ceftriaxone instead of assumed tuberculostatic treatment in a patient with miliary tuberculosis. It is important to identify the culprit drug in DITP to avoid discontinuing essential treatment, especially when more than one drug is implicated. In these cases additional analysis (drug-dependent platelet antibody testing) should be considered to prevent unnecessary replacement of a first-line regimen of tuberculostatic treatment with an alternative treatment regime.

Objectives: Adverse drug reactions (ADRs) are among the leading standalone causes of morbidity and hospitalisation and contribute substantially to an increase in healthcare expenditure. Repeat ADR events, although difficult to quantify, are a recognised problem that lead to preventable suffering for the patient. The current approaches for the prevention of ADR recurrence in low/middle-income countries range from inefficient to non-existent. There is very little literature that focuses on the preventability of ADRs in such settings. This study aimed to develop the ADR Alert Card, an economical innovation designed as a stop gap in preventing ADR recurrence, and to evaluate its utility by validating the system through input from medical professionals.

Methods: The ADR Alert Card was validated and registered with the Copyrights Office of the Government of India. To obtain the opinion of healthcare professionals and gauge the status quo in prevention of ADR recurrence, we conducted an online descriptive cross-sectional study over a period of 6 months.

Results: The survey received 218 responses. Demographics varied, ranging across different healthcare specialties and years of experience. Our study found that existing practice in ADR recurrence prevention was inadequate, and most healthcare workers were unaware of an alternative approach. Unique solutions were provided by the respondents, with the majority favouring a card format for preventing recurrence.

Conclusions: After being introduced to the ADR Alert Card, there was an overwhelming consensus on the utility and practicality of this card in preventing ADR recurrence.

Objectives: The role of the hospital pharmacist is evolving, and in many countries pharmacists play an increasingly patient-centred role in healthcare. This study aimed to investigate the development of Danish hospital clinical pharmacy services from 2008 to 2023 and compare their current state to the European Association of Hospital Pharmacists (EAHP) statements of clinical pharmacy services.

Methods: Four Danish reports describing the current state of clinical pharmacy in Danish hospitals released in 2008, 2013, 2019 and 2023 were analysed and compared. The reports' data were obtained through questionnaires sent to all hospital pharmacies in Denmark. Data on staff resources and the clinical pharmacy services provided by all hospital pharmacies were extracted, analysed using descriptive statistics and compared with the EAHP statements of hospital clinical pharmacy services.

Results: The number of clinical pharmacists increased by 85% from 2008 to 2023, and the number of pharmaconomists (Danish title of a healthcare professional with responsibilities comparable to a pharmacy technician) increased by 59% from 2013 to 2023. In 2023, there were 2.77 pharmaconomists for every pharmacist employed. The pharmaconomist ratio/100 beds increased from 1.93 in 2013 to 3.92 in 2023. The pharmacist ratio/100 beds increased from 0.54 in 2008 to 1.41 in 2023. In 2023, the main patient-level services provided by pharmacists were medication reviews, medication histories and reconciliation, and dispensing and administration. The main pharmaconomist services were dispensing and administration, medication histories and reconciliation, and prescription reviews. The time spent on clinical pharmacy services shifted towards patient-level services over the years. Furthermore, clinical pharmacy services shifted towards greater fulfilment of the EAHP statements.

Conclusions: By providing an overview and comparing Danish clinical pharmacy services to the EAHP statements, we have identified areas for further development, such as the hospital pharmacist being an integral part of all patient care teams, to guide future research and practice.

The objectives were to summarise the evidence and clinical experts' views comparing the use of decentralised produced chimeric antigen receptor (CAR) T-cell therapies versus commercially available products, regarding drug costs, time to finalised product and other reported advantages, disadvantages, challenges and facilitators. A literature review according to the PRISMA guidelines was conducted in Medline, Embase and Trip databases. Publications were included if they reported information on cost estimates, time to finalised products and other outcomes of interest of a decentralised CAR T-cell production strategy. A structured interview guide was developed and used for qualitative expert interviews. Five experts were purposively selected, and interviews were either conducted face-to-face or online, and recorded for the purpose of transcription. Transcripts were analysed and categories and codes extracted. Reporting is based on the COREQ checklist for reporting qualitative research. Costs of decentralised produced CAR T-cells appear to be lower by a factor two to 14, compared with commercial products. But there is high uncertainty about this estimate, because it is unclear whether cost components included are comparable and due to the heterogeneity of the studies. The most commonly reported advantages were proximity to patients and decreased product risks and costs, whereas the continuing dependency on centrally manufactured reagents and specific characteristics of 'fresh' CAR T-cells are reported as disadvantages. Compliance with regulatory requirements is mentioned as the biggest challenge. The availability of closed-system production devices is reported as one main facilitator, as are clear commitment, secured financing and knowledge transfer from already experienced centres. Apparent cost differences open a field for healthcare decision-makers to discuss and justify investment costs for implementation of a complementing decentralised production programme and to realise other associated benefits of such a strategy, such as flexibility, patient proximity and expanding patient access.

This case report investigates elevated serum concentrations of inhaled tobramycin in a patient with chronic kidney disease. The patient, a man in his early 80s with complex comorbidities, underwent tobramycin inhalation therapy for chronic respiratory infections caused by Pseudomonas aeruginosa Despite the strategic localised treatment approach, unexpectedly high plasma tobramycin concentrations were observed. After a dosage adjustment guided by a pharmacokinetic-pharmacodynamic model, a final inhalation dose of 300 mg of tobramycin was determined at a 24-hour interval. This case report underscores the need for rigorous monitoring of plasma tobramycin levels in patients with renal impairment undergoing inhaled tobramycin therapy, advocating for enhanced pharmacokinetic models to improve the safety and efficacy of the treatment.

Objectives: The product information and literature does not provide confirmation of compatibility for co-administration of all commonly used drug pairs in obstetrics. However, there is a need for co-administration of these drugs over one lumen for this group of patients. Therefore, this study focuses on Y-site compatibility. Since different conditions between clinical and laboratory settings can lead to discrepancies in results, a novel approach for drug intravenous compatibility testing was designed to reflect clinical conditions. The aim was to study the compatibility of nine commonly used drug pairs in obstetrics and to evaluate the clinical value of the designed method.

Methods: The clinical situation was reflected by using different temperature ranges (20°C and 37°C), actual Y-site flow ratios, clinically relevant drug pairs and an observation time of 120 min. The clinically relevant drugs pairs include atosiban, nicardipine, amoxicillin/clavulanic acid, oxytocin, remifentanil, labetalol and magnesium sulpfate. Drug pairs were visually assessed according to the European Pharmacopoeia (Ph. Eur.) and pH was measured. When incompatibility of a drug pair seemed likely based on literature review or observed abnormalities during visual assessment, subvisual analysis was performed using a particle counter. Y-site compatibility applied for drug pairs when no visual changes occurred or when no additional particles were formed during the observation time.

Results: Eight of the nine combinations showed no visual changes or noticeable changes in pH during the observation time. The amoxicillin/clavulanic-acid-oxytocin combination showed a colour change at 37°C at the actual Y-site flow ratio. However, subvisual particle counting showed no formation of additional particles.

Conclusions: Y-site compatibility was established for all tested drug pairs. The new clinical approach for analysing Y-site compatibility provides a high certainty of outcomes for clinical practice. In this way, clinical complications and use of several additional intravenous catheters can be avoided.

Objectives: Interleukin-17 (IL-17) contributes to the pathogenesis of psoriasis. Secukinumab, ixekizumab, and brodalumab are monoclonal antibodies anti-IL-17 antibodies, approved for the treatment of moderate/severe plaque psoriasis.The aim of the study was to describe the effectiveness and safety of anti-IL-17 agents in moderate/severe plaque psoriasis in clinical practice. We also analysed anti-IL-17 therapies' survival, dose adjustment, and clinical patients' factors associated with their effectiveness and safety.

Methods: A retrospective, longitudinal study was conducted at a tertiary hospital. We included patients with moderate/severe psoriasis treated with anti-IL-17 agents. The effectiveness was evaluated with Psoriasis Area and Severity Index (PASI) score and safety through the adverse drug reactions (ADRs) collected.

Results: 38 patients were studied (median age=47.4 years, 71.0% male). The mean number of biological therapies that patients received was 2.6, and anti-IL-17 therapy was the first biological therapy for 36.8% of patients. The median years in treatment were 2.5 (95% CI 1.95 to 2.98) for secukinumab, 1.2 (95% CI 0.36 to 1.47) for ixekizumab, and 0.7 (IQR 0.71) for brodalumab. The median PASI score after 6 months of treatment was 0 (IQR 0) and 85.3% of patients achieved a PASI of 90 (84.0% with secukinumab, 87.5% with ixekizumab, and 100% with brodalumab). Dose adjustment was associated with the line of treatment (p=0.034 for naïve patients), age (p=0.044 for younger patients), and concomitant pathologies (p=0.015 without more diseases).24 patients suffered from ADRs, mainly infections of the upper respiratory tract, and there were no statistically significant differences between the three therapies.

Conclusions: Anti-IL-17 agents constitute an effective treatment for patients with moderate/severe plaque psoriasis and for longer. Dose reductions were associated with fewer lines of treatment, younger patients and absence of concomitant pathologies. ADR were minor and similar among the anti-IL-17.