Developing a flowchart to evaluate the use of Closed System Drug-Transfer Devices with monoclonal antibodies: Focus on the clinical trial setting.

OBJECTIVE: Available guidelines are ambiguous about safe handling monoclonal antibodies (MABs) and whether or not to use a Closed System Drug-Transfer Device (CSTD). In this article we want to describe a standardized working method on handling MABs in a clinical trial setting. DATA SOURCES: The current workflow at the clinical trial unit of the Ghent University Hospital was critically analyzed, after which an extensive literature review was performed using the National Institute for Occupational Safety and Health Working Group guidelines and the database PubMed (Keywords: monoclonal antibodies, closed system transfer devices, safety guidelines, safe handling, management, administration, (bio)compatibility, volume loss, contamination, clinical trial unit. Period: 2020-2022). DATA SUMMARY: Literature data are ambiguous. CSTDs can reduce cross-contamination and minimize exposure to potential hazardous drugs for healthcare professionals. However, in recent years more questions have been raised about their in-use compatibility and their impact on final product quality. This makes the debate on implementing CSTDs a hot topic in daily pharmacy practice and demands a holistic and standardized approach when deciding whether or not to use a CSTD when handling MABs. In a clinical trial setting, where safety data are frequently not available and the compatibility of CSTDs and investigational product is often unknown, this poses additional challenges that need to be taken into account. CONCLUSION: We developed a flowchart which standardizes the use of a CSTD when handling MABs. It allows other healthcare professionals and clinical trial sponsors to define and evaluate the necessary criteria when standardizing the position of a CSTD in their safe handling procedures.

Assessment of the Adherence to ESPGHAN 2018 Guidelines in the Neonatal Intensive Care Unit of the Ghent University Hospital: A Retrospective Study.

Parenteral nutrition (PN) is a standard of care for preterm infants in the first postnatal days. The European Society of Paediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN) has updated their guideline recommendations on PN in 2018. However, data on actual 2018 guideline adherence in clinical practice are sparse. In this retrospective study, conducted at the neonatal intensive care unit (NICU) of Ghent University Hospital, we analyzed the ESPGHAN 2018 PN guideline adherence and growth for 86 neonates admitted to the NICU. Analyses were stratified by birth weight (<1000 g, 1000 to <1500 g, ≥1500 g). We documented the provisions for enteral nutrition (EN) and PN, and we tested the combined EN and PN provisions for ESPGHAN 2018 adherence. The nutrition protocols showed a high adherence to PN guidelines in terms of carbohydrate provisions, yet lipid provisions for EN and PN often exceeded the recommended maximum of 4 g/kg/d; although, PN lipid intakes maxed out at 3.6 g/kg/d. Protein provisions tended to fall below the recommended minimum of 2.5 g/kg/d for preterm infants and 1.5 g/kg/d for term neonates. The energy provisions also tended to fall below the minimum recommendations, especially for neonates with a birth weight (BW) < 1000 g. Over a mean PN duration of 17.1 ± 11.4 d, the median weekly Fenton Z-scores changes for length, weight, and head circumference were positive for all BW groups. Future studies have to assess how protocols adapt to current guidelines, and how this affects short- and long-term growth across different BW groups. In conclusion, the reported findings provide real-world evidence regarding the effect of ESPGHAN 2018 PN guideline adherence, and they demonstrate how standardized neonatal PN solutions can safeguard stable growth during NICU stays.