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.

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.

Prochlorperazine is a commonly used medicine to treat nausea and vomiting. The only liquid formulation in the UK was discontinued in November 2022 due to safety concerns. One alternative option available is to use crushed tablets instead. Crushing and mixing tablets in water to produce a liquid is a widespread practice in paediatrics. However, there is often little evidence to support this practice.In this case report, a patient established on liquid prochlorperazine mesilate who was switched to crushed prochlorperazine maleate tablets experienced significant harm. The child's vomiting became uncontrolled and led to multiple healthcare attendances and a prolonged hospital admission. Control was re-established by increasing the prochlorperazine dose to accommodate for loss of drug during preparation. Care should be taken when converting prochlorperazine mesilate liquid doses to crushed prochlorperazine maleate tablets, and the doses used should not be treated as equivalent.

Objective: Elastomeric devices or pumps are a valuable tool to deliver outpatient parenteral therapy and have been used for administration of chemotherapy, antibiotics and pain medication. A key determinant of effective treatment is to consider the stability of medicines within these devices. It is widely known that an increase in temperature positively correlates to an increase in drug degradation. The objective of our work was to measure the temperature within soft shell elastomeric devices, under simulated outpatient treatment conditions in summer and winter months, and to determine the maximum temperature reached within these periods of use.

Methods: Thermocouples were inserted within soft shell Easypump II (B Braun Medical, Sheffield, UK) elastomeric pumps and the temperature was monitored under simulated outpatient conditions during cold and warm weather with different fill volumes. Temperature monitoring was also conducted with varying levels of insulation around the devices.

Results: Our results show that internal temperatures remained below 32°C±1°C in winter and summer months, including during times defined as a heatwave. Fill volume and ambient temperature were shown to be significant factors affecting the internal temperatures reached.

Conclusion: A soft shell Easypump II elastomeric pump, if used within its carry pouch, will maintain the internal solution below a temperature of 32°C±1°C if patients correctly adhere to handling guidance. Our results show that further improvements to the insulation material used in carry pouches can significantly restrict the rate of temperature rise within the pumps and will give more assurance in relation to preventing degradation especially considering the increases in extreme weather conditions observed in recent years due to global warming.

Objectives: Diabetic ketoacidosis (DKA) is a serious complication in patients treated with sodium-glucose co-transporter 2 inhibitors (SGLT2i). The aim of this study was to investigate the relationship between SGLT2i and the risk of DKA, and to identify high-risk groups and characteristics that should be emphasised.

Methods: A retrospective case series study was conducted to collect medical records of inpatients diagnosed with DKA and using SGLT2i before the onset of the disease from September 2022 to September 2023 in a tertiary hospital in Shanghai. Cases that met the inclusion criteria were retrieved through the electronic medical record system. Information was collected to compare the risk of DKA in patients with different characteristics.

Results: A total of 21 patients (12 men and 9 women) met the criteria for SGLT2i-associated DKA. The mean diabetes duration was 10.4 years, with 47.6% (10/21) of patients diagnosed with euglycaemic DKA. The drug treatment regimen most commonly used was the combination of SGLT2i and metformin, representing 52.4% (11/21) of cases. The most common clinical symptoms were nausea, vomiting, abdominal pain and malaise. Common predisposing factors were acute infections, acute pancreatitis (predominantly hyperlipidaemic type), dietary inappropriateness, acute cardiovascular and cerebrovascular events and surgery. 71.4% of patients (15/21) had multiple risk factors.

Conclusion: The use of SGLT2i in diabetic patients is associated with an increased risk of DKA, particularly in the presence of predisposing factors such as infection. Furthermore, long diabetes duration, decreased pancreatic β-cell function and the combined use of metformin may also contribute to the risk of DKA in patients treated with SGLT2i. The findings of this study provide valuable insights for better identification and management of DKA risks associated with SGLT2i in clinical practice.