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.

Extravasation of monoclonal antibodies commonly used in oncology: Classification, management and the role of the pharmacist.

INTRODUCTION: Extravasation by conventional cytotoxics has been well documented. While monoclonal antibodies are not considered to have the necrotic potential of some cytotoxic medicines, they require appropriate management in case of extravasation. However, fewer data are available on their classification and appropriate management when extravasation occurs. As monoclonal antibodies are being more commonly used in current daily oncology practice, this is an issue that cannot be ignored. METHODS: A scientific literature review on PubMed was conducted. All findings were critically appraised independently by 6 clinical pharmacists in order to provide a classification according to the extravasation hazard. RESULTS: A classification of non-conjugated and conjugated monoclonal antibodies according to extravasation hazard has been elaborated for different molecules frequently used in oncology. In addition, general management, in case extravasation of monoclonal antibodies occurs, has been proposed and the role of the pharmacist in the extravasation process has been described. CONCLUSION: A classification of hazard extent of extravasation of monoclonal antibodies with concurrent management based on literature data and expert consensus has been elaborated. In addition, the role of the oncology pharmacist is crucial in terms of follow-up and documentation of the extravasated monoclonal antibody and management is described.

The impact of logarithmic dose banding of anticancer drugs on pharmacy compounding efficiency at Ghent University Hospital.

BACKGROUND: Dose banding (DB) (dose rounding with predetermined variation with prescription) enables in-advance preparation of high-turnover anticancer drugs with potential benefit for pharmacy compounding work flow. OBJECTIVES: To analyse the impact of potential situations on the efficiency of DB in the pharmacy (safe and maximum storage), calculate preparation lead times and the potential full-time equivalent (FTE) benefit. METHODS: Candidate intravenous anticancer drugs were selected for logarithmic DB according to prescribing frequency, infusion volume and stability (usage data 2015 of the tertiary Ghent University Hospital, Belgium). With a selected DB set already stored, a 2-week time study (April/November 2015) provided lead times (between prescription and transfer) for just-in-time and DB preparations. A 'maximal' storage (using all drugs with a relative incidence of ≥2% recurrent monthly prescription) and a 'safe' storage scenario (lowest monthly prescribing pattern) were used to calculate the potential future FTE change. RESULTS: Mean lead times for DB storage and just-in-time preparation were 17.1 min (95% CI 13.5 to 21.0) and 26.5 min (23.3 to 29.8). For 21 164 yearly preparations with already 5292 in DB (25%), 11 157 and 6 862 could be batch-produced in advance in a maximum storage and safe storage scenario, respectively. The existing FTE in 2015 of 5.41 could then be reduced to 4.91 and 5.27. CONCLUSION: Further development of DB could contribute to pharmacy compounding efficiency.