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1.
AAPS J ; 26(3): 61, 2024 05 15.
Article in English | MEDLINE | ID: mdl-38750400

ABSTRACT

The aim of this study was to investigate the in-use compatibility of eight commercially available closed system transfer device brands (CSTDs) with a formulated model antibody drug conjugate (ADC). Overall, in-use simulated dosing preparation applying the CSTD systems investigated raised concerns for several product quality attributes. The incompatibilities observed were mainly associated with increased visible and subvisible particles formation as well as significant changes in holdup volumes. Visible and subvisible particles contained heterogeneous mixtures of particle classes, with the majority of subvisible particles associated with silicone oil leaching from CSTD systems during simulated dose preparation upon contact with the ADC formulation. These observations demonstrate that CSTD use may adversely impact product quality and delivered dose which could potentially lead to safety and efficacy concerns during administration. Other product quality attributes measured including turbidity, color, ADC recovery, and purity by size exclusion HPLC, did not show relevant changes. It is therefore strongly recommended to test and screen the compatibility of CSTDs with the respective ADC, in a representative in-use simulated administration setting, during early CMC development, i.e., well before the start of clinical studies, to include information about compatibility and to ensure that the CSTD listed in the manuals of preparation for clinical handling has been thoroughly assessed before human use.


Subject(s)
Immunoconjugates , Immunoconjugates/chemistry , Immunoconjugates/administration & dosage , Drug Compounding/methods , Chemistry, Pharmaceutical/methods , Particle Size
2.
Article in Japanese | WPRIM (Western Pacific) | ID: wpr-811006

ABSTRACT

Objective: The importance of occupational exposure control in cancer therapy is widely recognized, and measurement of anti-cancer drug exposure during preparation, as well as comprehensive measures, including administrative control, patients’ excrements, and environmental pollution, among others, are becoming important. The Osaka Women’s and Children’s Hospital introduced the closed system drug transfer device (CSTD) for administering anticancer drugs, and conducted consistent exposure measures from preparation to disposal. We simultaneously conducted an awareness survey on anti-cancer drug exposure measures for health care workers,observed the changes in their awareness and behavior, and examined the issues that constantly challenge anti-cancer drug exposure measures.Method: We surveyed doctors, nurses, and pharmacists who handle anticancer drugs belonging to the Osaka Women’s and Children’s Hospital from March 2018 to October 2018. The questionnaire was anonymous and was collected within one week after distribution. In the questionnaire survey, we obtained permission to present the contents on paper and orally.Results: The questionnaire response rate was approximately 70%. Following the training and introduction sessions, the participants had an improved understanding of Hazardous Drugs and CSTD. The introduction of the workshops on anti-cancer drug exposure measures and CSTD encouraged the nurses to reflect on the exposure measures and revisit the manuals on in-hospital treatment with anti-cancer drugs; however, there was little or no change in the behavior of the pharmacists.Discussion: Since nurses work primarily in the field of patient care, their awareness of anti-cancer drugs has gradually declined, and it was observed that procedures for exposure control were not being followed. In order to ensure that anti-cancer drug exposure measures are properly observed, pharmacists need to take initiatives and conduct in-hospital workshops once every six months. It is also necessary to educate the medical staff about electronic devices in order to ensure their easy participation in workshops and encourage e-learning.

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