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

Introduction: Invasive fungal infections (IFI) can contribute to increased mortality and morbidity rates after heart transplant in adults. The most common causes are Aspergillus and Candida species. There is uncertainty on how effective antifungal prophylaxis is against Candida spp infections and limited guidance on the prevention of Aspergillus spp infections. This systematic review and meta-analysis will assess the literature to see if antifungal prophylaxis reduces the incidence of IFI after heart transplant in adults.

Methods and analysis: This systematic review protocol follows the Preferred Reporting Items for Systematic reviews and Meta Analysis guidelines. A systematic search of the Cochrane Library, Web of Science, Scopus, Embase, MEDLINE, and Proquest databases will be undertaken. Reference lists of retrieved publications and conference abstracts will also be searched. Title, abstract and full-text screening will be undertaken by two reviewers. Discrepancies will be resolved by a third reviewer. Studies with paediatric patients, multi-organ transplants, or patients with a second heart transplant will be excluded, along with those who do not have clear definitions and diagnostic criteria for IFI. Risk of bias will be assessed using the Cochrane Risk of Bias 2 tool and the Risk of Bias in Non-randomised Studies of Interventions tool. A meta-analysis will be carried out, but if studies are not deemed to be sufficiently similar, only a narrative synthesis will be undertaken.

Ethics and dissemination: Ethical approval is not required for this systematic review as primary data will not be collected. The results of the review will be disseminated through publication in an academic journal and scientific conferences.

Prospero registration number: CRD42024516588.

Objective: To determine the pharmaceutical interventions in patients eligible for phase I cancer clinical trials, focusing specifically on exclusion criteria related to medication or relevant interactions.

Method: Descriptive, observational study conducted at a comprehensive cancer centre. Patients undergoing screening for phase I clinical trials (March 2019-December 2022) were included. The pharmacist reviewed concomitant medication and provided a recommendation.

Results: The concomitant medication of 512 patients eligible to participate in 84 phase I clinical trials was analysed. In 230 (44.9%) patients, the clinical trial treatment included oral medication. The median number of concomitant medications was 5 (IQR 3-8) per patient.A total of 280 pharmaceutical interventions were performed in 140 (27.3%) patients: 240 (85.7%) were due to interactions in 124 (24.2%) patients, and 40 (14.3%) were due to exclusion criteria in 34 (6.6%) patients. Interactions and exclusion criteria were detected in 18 (3.5%) patients. The main groups of drugs involved were 68 (24.3%) antacids and antiulcer drugs, 28 (10.0%) antidepressants and 26 (9.3%) opioids. Acceptance analysis of the recommendation was applicable in 215 cases; in 208 (96.7%), the pharmaceutical intervention was accepted.Differences were identified for exclusion criteria (7 vs 27) and interactions (37 vs 87) between parenteral and oral clinical trial medication (p<0.001).

Conclusion: The pharmacist's review of concomitant medication during the screening period in phase I clinical trials enables the detection of prohibited medication or relevant interactions, potentially avoiding screening failures and increasing the efficacy and safety of treatments.

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.

Background: The use of dose administration aids in automated ward dispensing devices requires the repackaging of medications, which may impact their stability compared with the original manufacturer's packaging.

Objectives: This study aimed to assess the physical and chemical stability of clozapine tablets for up to 84 days after repackaging.

Methods: A total of 900 tablets of clozapine 100 mg (Viatris) were repackaged and stored under five different conditions to conduct physical and chemical stability tests on days 0, 28, 56 and 84. The results were compared with control tablets in their original packaging. Visual inspections of tablet appearance were performed. Physical tests included assessments of mass uniformity, friability and resistance to crushing, following the standards of the European Pharmacopoeia 11th edition. The chemical stability was determined using ultra-high performance liquid chromatography with tandem-mass spectrometry detection (UHPLC-MS/MS) to measure clozapine concentration, N-desmethyl-clozapine, and monitor clozapine degradation to detect formation of any degradation products other than N-desmethyl-clozapine.

Results: Visual examination showed changes in the appearance of tablets only in those stored under UV light. Mass uniformity met standards for all tablets over 84 days. None passed the friability test due to tablet cracking after tumbling. A gradual deterioration in tablet hardness was observed with the resistance to crushing test. In terms of chemical stability, N-desmethyl-clozapine was undetected in any of the tablets stored under all conditions, and the mean concentration of clozapine remained within the target range over 84 days.

Conclusion: N-desmethyl-clozapine was not detected and clozapine concentrations remained stable under all storage conditions. The tablets were compliant with the mass uniformity test in each condition. However, the tablets were cracked in the friability test and gradual deterioration in tablet hardness was observed. In the light of these results, the Vinatier Hospital pharmacy has chosen to establish a shelf life for clozapine tablets of 84 days.

Objective: To identify and promote hospital pharmacy initiatives to improve the management of patients with hereditary angioedema (HAE) within the Spanish healthcare system.

Method: A panel of experts comprising hospital pharmacists, an allergist and a nurse/member of the Spanish Hereditary Angioedema Association (Asociación Española de Angioedema Familiar) highlighted initiatives to improve care for patients with HAE after identifying, evaluating and prioritising them. Prioritisation was assessed based on the impact on patient care and the feasibility of their implementation on a scale of 1-5.

Results: Seven key areas of activity for the role of hospital pharmacists in the management of patients with HAE were identified: evaluation and selection of medicines; hospital pharmacy dispensation and telepharmacy; pharmacotherapy follow-up and telemedicine; coordination with other healthcare teams involved in the care of patients with HAE; patient health education and training; research on HAE; and continuous education and training of hospital pharmacy service personnel. Ten initiatives with a mean impact score of 5 and a mean feasibility score of ≥4.1 were considered as high-priority initiatives. Half of the initiatives belong to the area concerning patient education and training (50%), followed by care coordination initiatives (30%) and continuous education and training (20%).

Conclusions: Ten high-priority initiatives for the management of patients with HAE were identified by a panel of experts. The implementation of such initiatives by the hospital pharmacy service should enhance the management of patients with HAE in the Spanish healthcare system.

Objectives: Large language models (LLMs) with advanced language generation capabilities have the potential to enhance patient interactions. This study evaluates the effectiveness of ChatGPT 4.0 and Gemini 1.0 Pro in providing patient instructions and creating patient educational material (PEM).

Methods: A cross-sectional study employed ChatGPT 4.0 and Gemini 1.0 Pro across six medical scenarios using simple and detailed prompts. The Patient Education Materials Assessment Tool for Print materials (PEMAT-P) evaluated the understandability, actionability, and readability of the outputs.

Results: LLMs provided consistent responses, especially regarding drug information, therapeutic goals, administration, common side effects, and interactions. However, they lacked guidance on expiration dates and proper medication disposal. Detailed prompts yielded comprehensible outputs for the average adult. ChatGPT 4.0 had mean understandability and actionability scores of 80% and 60%, respectively, compared with 67% and 60% for Gemini 1.0 Pro. ChatGPT 4.0 produced longer outputs, achieving 85% readability with detailed prompts, while Gemini 1.0 Pro maintained consistent readability. Simple prompts resulted in ChatGPT 4.0 outputs at a 10th-grade reading level, while Gemini 1.0 Pro outputs were at a 7th-grade level. Both LLMs produced outputs at a 6th-grade level with detailed prompts.

Conclusion: LLMs show promise in generating patient instructions and PEM. However, healthcare professional oversight and patient education on LLM use are essential for effective implementation.

Background: The healthcare sector contributes significantly to global greenhouse emissions, with inhalers being major contributors.

Objective: To develop a framework for reducing the environmental footprint of inhalers in Spain by implementing greener prescription practices.

Methods: A multidisciplinary working group was formed, including hospital pharmacists, pulmonologists, and environmental experts. We created a comprehensive database on the environmental impact of inhalers marketed in Spain, incorporating product specifications and environmental data from the Spanish Agency of Medicines and Medical Devices and pharmaceutical companies. We developed a decision-making algorithm integrating clinical and environmental criteria and performed scenario projections to estimate potential benefits of transitioning from pressurised metered-dose inhalers (pMDIs) to dry powder inhalers (DPIs) and other eco-friendly alternatives. Scenarios included global and individual projections, as well as comparisons between sustainable prescriptions and waste-management strategies.

Results: The national database revealed significant variability in the carbon footprint across inhaler types, with pMDIs showing the highest emissions. A shift of 10% from pMDIs to DPIs could reduce CO₂ emissions by approximately 40 000 tonnes/year, and a 50% shift by up to 200 000 tonnes. The decision-making algorithm effectively combined clinical and environmental considerations, facilitating the selection of more sustainable inhalers.

Conclusion: The study highlights the importance of incorporating environmental criteria into inhaler prescribing choices to reduce healthcare's carbon footprint. Transitioning from pMDIs to DPIs when clinically indicated offers considerable environmental benefits without compromising patient health. The developed decision-making algorithm provides a practical tool for healthcare professionals, balancing clinical efficacy with sustainability. Future research should refine these practices and explore their application in other medical devices.