Journal of Oncology Pharmacy Practice最新文献

ObjectiveAbraxane^® intravenous infusion (albumin-bound paclitaxel nanoparticles; Abraxane^® or paclitaxel nanoparticles) is a lyophilized cake formulation containing paclitaxel and human serum albumin in nanoparticulate form. Before use, it must be uniformly dispersed in saline. However, this reconstitution process often leads to foaming, necessitating careful handling and prolonging preparation time. This study aimed to investigate shaking conditions for rapid, uniform paclitaxel nanoparticle dispersion while minimizing foam formation. Additionally, we evaluated whether shaking affects nanoparticle size.MethodsAfter adding 20 mL of saline to a vial containing 100 mg of lyophilized cake, the vial was placed either vertically or horizontally on a shaker. Two shaking types were examined: linear reciprocal and orbital shaking. We varied shaking intensity and recorded the dispersion time and foam formation. Particle size was analyzed under the following three conditions: (1) control, (2) minimal dispersion time without foaming, and (3) the condition causing the most severe foaming.ResultsWhen the vial was placed horizontally and subjected to orbital shaking at 100 rpm, uniform dispersion was achieved within 6.25 min without foaming. This was approximately one-third the time required under control conditions. Further, when particle size was measured under different shaking intensities in the horizontal setup, no significant change in nanoparticle size was observed regardless of shaking strength or time after preparation.ConclusionIn the reconstitution of Abraxane^®, the optimal shaking condition identified in this study was demonstrated to not only preserve nanoparticle integrity but also reduce the time and effort required for healthcare professionals.

AimThis study evaluates the efficacy and safety of rituximab biosimilars (BRs) compared to the original rituximab (MAB) administered intravenously, particularly from the aspect of switching and switch directions.Materials and MethodsThis retrospective study included patients treated with BR and/or MAB for hematological diagnoses. For efficacy analyses, patients with DLBCL or FL receiving BR during R-CHOP were compared with two matched-control groups treated only with MAB. Patients completing fewer than two consecutive cycles of BR or MAB were excluded. Study groups were classified as BR-only or switching (S). Switching was defined as replacing rituximab between MAB and BR for at least two consecutive cycles. Switch directions are denoted as OB (MAB to BR), BO (BR to MAB), and M (multiple switches).ResultsToxicity was evaluated in 185 patients. Responses of 69 DLBCL and 33 FL patients were compared with 52 DLBCL and 11 FL patients treated only with MAB. Median follow-up was 20 months. In DLBCL, MAB had significantly higher interim ORR and CR than BR and S (p = 0.04), but not at end-of-treatment (p = 0.081, 0.125). FL responses were similar across groups. Among 1266 rituximab infusions, 32 (2.5%) IRRs occurred, 78% during first-cycle. No difference in IRR or first-cycle reactions was seen between BR and S (p = 0.175, 0.429). IRR rates in S subgroups were 1/37 (OB), 8/35 (BO), and 4/28 (M), with BO direction higher than OB (p = 0.029).ConclusionOur findings confirm that intravenous BRs and MAB are equivalent in efficacy and toxicity, while a direction-specific increase in IRRs occurs when switching from BR to MAB, warranting further prospective studies to clarify clinical significance and guide safer treatment transitions.

Many oral oncolytics inhibit rapidly dividing cells and are teratogenic. However, only a few agents are restricted under a Risk Evaluation and Mitigation Strategies (REMS) program due to embryo-fetal toxicity. The benefit of a REMS program for only select oral oncolytics is unclear.

IntroductionTo minimize the risk of hypersensitivity reactions (HSRs) caused by paclitaxel infusion, premedication with corticosteroid, H1-antagonist and H2 antagonist (ranitidine) was standard of care. Discontinuation of ranitidine in 2020 led to adjustments in premedication regimens and a new regimen without ranitidine was implemented in our center. This study aimed to compare the incidence of HSRs during paclitaxel treatment of a standard premedication regimen including ranitidine with a new premedication regimen without ranitidine and with a titrated infusion rate during the first two administrations.MethodsRetrospective data analysis was performed on two cohorts of adult patients with solid tumors who started treatment with paclitaxel and received a premedication regimen with and without ranitidine over the years 2021 and 2023 respectively (before and after ranitidine withdrawal). Univariable and multivariable logistic regression models were used to investigate any associations with H2 antagonist treatment adjusting for confounding variables.ResultsA total of 319 patients were included. 158 patients received the standard premedication regimen with ranitidine compared to 161 patients who did not received ranitidine. HSRs were observed in 10 of 1101 administrations of paclitaxel (0,90%) in ranitidine group compared to 2 of 899 (0,22%) in the ranitidine-free cohort (p = 0.048). Analysis incidence per patient also found results with statistically significant differences: 5.7% (9 of 158 patients) in the ranitidine cohort compared to 1.2% (2 of 161 patients) in the ranitidine-free cohort (p = 0.029).ConclusionsThe results of the study show the effectiveness of a premedication regimen including only dexchlorpherinamine and dexamethasone, along with a titrated infusion rate during the first two administrations, in reducing the incidence of paclitaxed-induced HSRs.

IntroductionExposure of healthcare workers to hazardous drugs may result in adverse health effects underscoring the importance of validating working procedures and safety precautions to minimise the risk. The objective was to monitor environmental contamination caused by the hazardous drug workflow: from drug vials, compounding process, to patient administration.MethodsSurface wipe samples were collected from potentially contaminated surfaces in the compounding department and in the administration department. The outside of drug vials, compounded syringes, bags, elastomeric pumps, and gloves used by the nurses for administration were also monitored. Stationary air samples were collected near the isolators and above the bench top. Personal air samples were collected from pharmacy technicians, pharmacists, and nurses. Monitoring was performed in three trials during two-months. Samples were analysed for cyclophosphamide, 5-fluorouracil, docetaxel, and paclitaxel using liquid chromatography tandem mass spectrometry.ResultsContamination was mainly found for 5-fluorouracil and cyclophosphamide on isolator surfaces, bench top, trays, and compounded products. Lower levels of contamination were measured in the administration department on trays, trolley arms and gloves of the nurses. Paclitaxel and docetaxel were incidentally detected. Air contamination was found for paclitaxel in the compounding department in one trial, and 5-fluorouracil was detected once in front of an isolator. Docetaxel was found in one air sample of a nurse.ConclusionsContamination was mainly found for 5-fluorouracil and cyclophosphamide on the products compounded in the isolators. Contamination was further spread along the workflow towards the administration department causing surfaces in between being contaminated too.

IntroductionLenvatinib (LEN) is the standard treatment for hepatocellular carcinoma (HCC). In clinical practice, gastrointestinal (GI) symptoms such as fatigue and loss of appetite often lead to dose reduction or treatment discontinuation. This study aimed to identify the predictors of patients who will experience dose reduction or treatment discontinuation owing to fatigue or GI symptoms during LEN treatment for HCC.MethodsWe retrospectively identified 99 patients who received LEN at the Ogaki Municipal Hospital (Ogaki, Japan) between April 2018 and December 2023. To investigate the risk factors for treatment discontinuation or dose reduction due to fatigue or GI symptoms during LEN administration, patients were divided into two groups based on whether treatment discontinuation or dose reduction occurred due to fatigue or GI symptoms during LEN administration (37 patients) or not (62 patients). We compared baseline characteristics between the two groups.ResultsMultivariate analysis revealed that body weight (odds ratio 4.310, 95% confidence interval 1.380-13.500; P = 0.002) was an independent risk factor that significantly contributed to treatment discontinuation or dose reduction owing to fatigue or GI symptoms during LEN administration. The cut-off value calculated using the body weight curve was 55.0 kg. Using this cutoff value, the sensitivity and specificity of body weight to detect treatment discontinuation or dose reduction due to fatigue or GI symptoms during LEN administration were 83.9% and 56.8%, respectively.ConclusionIn clinical practice, patients weighing less than 55 kg who start with a full dose will likely experience weight loss or discontinuation during treatment.

BackgroundPediatric patients often require individualized medication dosing due to variations in age, weight, and swallowing ability. Commercial ondansetron HCl dihydrate formulations are limited by rigid dosing options, unpleasant taste (dysgeusia), and challenges with administration, which can result in poor adherence. Pharmaceutical compounding technologies, particularly those incorporating automation, offer a pathway toward patient-centric solutions. Semi-solid extrusion (SSE) 3D printing enables the controlled production of customized dosage forms.MethodsThis study investigated the development and quality performance of personalized ondansetron HCl dihydrate dosage forms produced using an SSE-based automated compounding system. Three dosage forms (semi-solid gel tablet, anhydrous troche, and orodispersible film (ODF)) were formulated in various ondansetron concentrations: 0.81-7.5 mg. Formulations were developed and printed at a hospital setting demonstrating real-life hospital pharmacy conditions. Quality evaluations followed United States Pharmacopeia (USP) guidelines.ResultsThe printed ondansetron HCl dihydrate formulations met USP acceptance criteria for mass and content uniformity, syringe homogeneity, visual inspection, chemical stability, and in vitro dissolution performance. ODFs demonstrated rapid disintegration and are particularly suited for pediatric use. All dosage forms were reproducibly manufactured using the automated SSE printing platform, supporting flexible, on-demand production tailored to patient needs.ConclusionSSE 3D printing offers a reliable and scalable compounding approach for producing personalized ondansetron HCl dihydrate formulations in hospital pharmacies. By integrating automation and digital manufacturing into pharmaceutical workflows, this study demonstrates the potential of next generation compounding systems to enhance dosing precision, regulatory compliance, and patient adherence in pediatric pharmacotherapy.

IntroductionAntineoplastic drug contamination can result in severe health effects for healthcare workers exposed to them. Despite the worldwide growing concern regarding these drugs and sustained monitoring efforts in developed countries, there is almost no data about surface contamination levels in Argentina, in particular, and South America, in general.MethodsAntineoplastic drug contamination was measured in three Argentinean public hospitals (pharmacy and daycare center areas) by surface wiping and liquid chromatography coupled with tandem mass spectrometry.Results and DiscussionEleven drugs were detected, in 51 of 58 sampled surfaces, in variable concentrations from 0.00064 to 7.3 ng cm^-2, with cyclophosphamide, gemcitabine, and paclitaxel as the most prevalent drugs. This highly variable antineoplastic distribution reflects differences in facility layout, number of patients, antineoplastic drug use, etc., at each hospital. Values exceeding the 1 ng cm^-2 threshold were detected in 13 surfaces of the two hospitals handling the largest amounts of antineoplastic drugs. The cyclophosphamide 75th percentile averaged 0.030 ng cm^-2 comparable to the high values reported more than 10 years ago for developed countries, emphasizing the potential of reducing antineoplastic contamination by implementing routine monitoring and improved cleaning and handling procedures.ConclusionThis study is the first survey of multi-compound surface antineoplastic contamination in Argentinean (and South American) hospitals, providing a baseline against which future studies can be compared. Widespread antineoplastic contamination has been detected on numerous surfaces, with concentrations surpassing suggested threshold exposure levels (1 ng cm^-1) for some surfaces in two of the sampled hospitals.

ObjectiveThis study aims to develop standardized recommendations for the implementation of Automated Dispensing Systems (ADS) in oncology wards, focusing on enhancing patient safety, operational efficiency, and the integration of these systems into hospital workflows.MethodA structured methodology was employed, combining documentary analysis of ADS practices at CHUIS, synthesis of strategies for implementation, and development of evidence-based recommendations validated by a multidisciplinary panel.ResultsThe primary outcome of this study was the development of standardized recommendations tailored for ADS implementation in oncology wards. Key findings included the importance of phased planning, targeted training (60 h), and integration with existing hospital IT systems. These recommendations emphasized initial audits, stakeholder engagement, and continuous monitoring to ensure sustainable and replicable practices. Enhanced medication management processes, including reductions in cytotoxic drug costs (9%), expiration-related losses (98.3%), and stockouts (41.1%), further demonstrated the transformative potential of ADS.DiscussionThe study underscores the critical role of tailored, evidence-based strategies in facilitating successful ADS adoption. These recommendations align with international safety standards and provide a scalable framework adaptable to diverse oncology settings. Limitations include the need for further exploration of resource adaptability and long-term impact on patient outcomes. The integration of emerging technologies, such as AI, presents opportunities for future optimization.ConclusionThis research highlights the value of standardized recommendations for ADS implementation in oncology wards. By addressing operational challenges and integrating innovative solutions, this study offers a practical model for enhancing oncology pharmacy practices globally.