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

Background: Upon admission to the hospital, patients' home medications are often substituted with those from the hospital formulary. An alternative is Patients' Own Medication (POM), allowing patients to bring their own medications from home. If POM runs out or new medications are prescribed, the hospital supplies identical medications for use after discharge. This may cause an imbalance between the home and hospital medication budgets. Using POM in the hospital results in overpayment from the home medication budget. In contrast, using hospital-provided medication after discharge results in overpayment from the hospital medication budget. This imbalance could hinder the implementation of POM. However, hospitals can adjust the amount of medication supplied to offset overpayment from the home medication budget. Therefore, this study simulates the impact of two medication supply strategies on the balance between overpaid costs from the home and hospital medication budgets.

Methods: A total of 200 patients (>18 years) were included across two hospitals. In supply strategy 1, both new and resupplied medications were provided for 14 days. In strategy 2, new medications were provided for 14 days, while resupplied medications were provided for 28 to 30 days. The primary outcome was the difference in overpaid costs between the two budgets, calculated per patient per admission.

Results: For strategy 1 (the provision of resupply medication for 14 days), the median cost difference per patient per admission was -€3.48 (range -€198.27 to €293.40), indicating a small overpayment by the hospital. When resupply medication was provided for 28 to 30 days, the median overpayment per patient per admission increased slightly to -€4.12 (range -€315.87 to €293.40).

Conclusion: Implementing POM results in only a small difference in overpaid costs between home and hospital medication budgets, regardless of the supply strategy. Consequently, this does not hinder the implementation of POM in hospitals.

Objectives: To assess the container closure integrity of needle-free Closed System Transfer Device (CSTD) components (ChemoClave and ChemoLock) combined with Luer-Lock (LL) syringes and IV bags as a terminal closure/access device. The UK NHS Yellow Cover Document (YCD) requires containment data for final storage devices of aseptic chemotherapy drugs when prepared in advance in pharmaceutical technical services (PTS). Assessment of both physical and microbial integrity of all combinations was performed: syringe adapter/LL syringes and vented bag adaptor/IV bags. All container combinations were subject to an additional vibrational challenge, with three-axis vibrational data logging representing a typical transportation excursion.

Methods: Container integrity testing was performed according to YCD requirements "Protocols for the Integrity Testing of Syringes" for ChemoClave and ChemoLock syringe adapters (CH2000S/CL2000S) and for ChemoClave and ChemoLock vented bag spikes (CH-14/CL-14) as terminal closure devices. Microbiological integrity was assessed according to Method 1, Part 1.4 using Brevundimonas diminuta at 32°C for 14 days. Physical integrity was assessed using the following dye intrusion methods: YCD Method 3 and European Pharmacopoeia 3.2.9 "Rubber closures for containers". Readout for dye intrusion was reported visually and using a spectrophotometer. Positive (n=2) and negative (n=1) controls were assessed according to YCD for both arms of the test.

Results: ChemoClave and ChemoLock syringe adapters and vented bag spikes/IV bags were shown to be free of microbiological contamination (n=160) and free of dye intrusion (n=80 in total). The data support both ChemoClave and ChemoLock CSTD components as closure for aseptic preparations of pharmaceutical drug products in PTS. 100% closure integrity was demonstrated.

Conclusions: ChemoClave and ChemoLock CSTD components showed 100% container integrity in accordance with YCD requirements as terminal closure for LL syringes and IV bags in PTS. ChemoClave and ChemoLock syringe adapters and vented bag spike components can be used for the preparation of chemotherapeutic drug products prepared in advance in UK PTS.

Objectives: To assess which of the formulae for estimating renal function (Cockcroft-Gault (CG), Chronic Kidney Disease Epidemiology Collaboration CKD-EPI) and Modification of Diet in Renal Disease (MDRD)) provides the most accurate prediction of minimum vancomycin concentration (Cmin) and to evaluate whether they can be interchanged to optimise vancomycin dosage.

Methods: An observational and retrospective study was undertaken in hospitalised adult patients treated with intravenous vancomycin. Patients with serum creatinine (Scr) >2 mg/dL and <0.5 mg/dL, body mass index >40 kg/m², need for extracorporeal clearance techniques and unstable renal function were excluded. Bayesian analysis was used to obtain individual pharmacokinetic parameters. Vancomycin clearance (CLvan) was calculated by means of CG (eCLvan_CG), CKD-EPI (eCLvan_CKD-EPI) and MDRD (eCLvan_MDRD) and used to obtain Cmin estimates (eCmin). eCmin and observed Cmin were compared using an intraclass correlation coefficient (ICC). A post-hoc analysis by subgroups (age, sex, weight, Scr and estimated glomerular filtration rate (eGFR)) was performed. From each eCLvan, the area under the curve (AUC) was calculated and categorised as AUC <400 mg*hour/L, AUC 400-600 mg*hour/L and AUC >600 mg*hour/L. The kappa coefficient was applied to study AUC concordance.

Results: A total of 228 patients (69.3% men) were included. eCmin_CG had a statistically significant better agreement with Cmin (ICC >0.7) and showed good agreement in almost all subgroups. Patients with Scr >1.1 mg/dL were the only subgroup in which eCmin_MDRD and eCmin_CKD-EPI had an adequate ICC with no statistically significant differences compared with eCmin_CG. eCmin_MDRD had a similar ICC to eCmin_CG in the eGFR <60 mL/min and age 46-75 years subgroups. Kappa values showed regular agreement in all subgroups: 0.32 (AUC <400 mg*hour/L), 0.24 (AUC 400-600 mg*hour/L) and 0.41 (AUC >600 mg*hour/L).

Conclusions: The CG formula provides the most accurate prediction of vancomycin Cmin. In patients with eGFR <60 mL/min and aged 46-75 years, MDRD also shows a good predictive capacity. However, in low weight and elderly patients, Cmin predictions are superior with CG. Therefore, renal function estimation equations should not be considered interchangeable for vancomycin dose adjustments.

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.