Volume 9, Issue 1

Objectives Critically ill paediatric patients often receive a large number of parenteral drugs via only a few available intravenous accesses. This poses the risk of incompatibilities. The aim of our study was to investigate the compatibility of etacrynic acid and theophylline with other parenteral drugs used in a paediatric cardiological intensive care unit. These include ampicillin and sulbactam, cefazolin, furosemide, glucose 50 % solution, meropenem, pantoprazole, paracetamol, potassium chloride 7.46 % solution and sodium bicarbonate 8.4 % solution. Methods Drugs were mixed in various concentrations representing infant and adult dosage. The physicochemical compatibility was investigated over a period of up to 96 h using several methods. This was done by visual inspection, pH determination, turbidimetric measurements at 350 nm, 410 and 530 nm and content determination via high performance liquid chromatography. Results Fifty drug combinations were tested. No incompatibilities were found in 37 drug combinations, indicating these as physicochemically compatible. Depending on the concentration, 13 drug combinations namely etacrynic acid + theophylline, etacrynic acid + ampicillin + sulbactam, etacrynic acid + cefazolin, theophylline + cefazolin and theophylline + meropenem were evaluated as incompatible. Conclusions These results will enable healthcare professionals and pharmacists to optimise infusion therapy for paediatric patients and substantially reduce the risk of incompatibilities regarding etacrynic acid and theophylline.

Objective Trastuzumab biosimilar SB3 (Ontruzant ® ), a HER2 binding monoclonal antibody, is available as powder for concentrate for solution for infusion. According to the summary of product characteristics, the reconstituted solution (21 mg/mL) is physicochemically stable for 7 days when stored refrigerated at 2–8 °C. The objective of this focused study was to determine the extended physicochemical stability of trastuzumab SB3 reconstituted with water for injection and stored in the original glass vials under refrigeration or at room temperature over a period of 28 days. Methods Ontruzant ® vials were reconstituted with sterile water for injection and stored light protected at 2–8 °C in the refrigerator or at room temperature (15–25 °C, Ph. Eur.) over a maximum period of 28 days. At predefined time points (day 0, 7, 14, (21), 28) samples were withdrawn and analyzed by size-exclusion high-performance liquid chromatography with photodiode array detection, ultraviolet spectroscopy, and pH measurement. Test solutions were inspected for colour changes, clarity, and visible particles at each sampling time point. Results According to the size-exclusion chromatography assay, trastuzumab SB3 monomer concentrations exceeded 95 % of the initially measured concentrations over the entire study period. pH values and trastuzumab concentrations measured by UV remained unchanged. No colour changes or visible particles were detected. Results were independent from storage temperature. Conclusions According to the stability indicating methods used, physicochemical stability of reconstituted trastuzumab SB3 Ontruzant ® solution in original glass vials is given over a period of 28 days either stored refrigerated or at room temperature. Results have to be substantiated by IE-HPLC or icIEF. To avoid microbiological instability storage under refrigeration is recommended.

Training and certification of personnel in capsule preparation are essential procedures, overseen by the pharmacist who delegates these tasks. These procedures aim not only to ensure the efficacy and safety of operations but also to establish a clear chain of responsibility. They align with established best practices. Certification grants formal authorization to qualified individuals to perform specific tasks. For new hires, a comprehensive training program is designed to facilitate their integration and empower them from the onset. We propose training objectives structured around a competency-based approach, highlighting objective evaluation criteria applicable in real-world practical settings. These training objectives address critical aspects such as the handling of hazardous substances, weighing and mixing of powders, and capsule filling. They also emphasize the importance of documentation and traceability. Specialized preparations and tools are offered to facilitate the assessment of learning outcomes.