주사 항암제 조제 시 주사바늘을 이용한 조제 방식 대비 폐쇄형 약물전달장치 사용의 효과 비교 연구
Comparative Effectiveness of Closed System Drug Transfer Devices versus Traditional Compounding Devices for Injectable Antineoplastic Agents
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Background : Closed system drug transfer devices (CSTDs) are recommended in the US, Europe, and Japan, to reduce the risks associated with the compounding of anticancer drugs. However their high cost limits their use in South Korea. This study aimed to evaluate the effectiveness of CSTD use in reducing leakage, compounding time, and user satisfaction compared to traditional compounding devices for in jectable antineoplastic agents in a tertiary hospital. Methods : Needle compounding was compared with two closed system drug transfer devices (CSTDs), CSTD A and CSTD B, from different companies that utilize distinct methods. Four pharmacists compounded cyclophosphamide and doxorubicin, employing CSTD A’s multi vial adaptor exclusively for doxorubicin. Drug leakage onto gloves, the compounding board, and IV bags was analyzed using liquid chromatogra phy-tandem mass spectrometry. Additionally, satisfaction surveys were completed by four pharmacists and six nurses, employing a 5-point scale. The Mann-Whitney U test (p < 0.05) was used to compare leakage and preparation time. Results : For cyclophosphamide, needle compounding showed more leakage than CSTD A on the com pounding board (257.54 vs. 0.09 ng/cm2) and IV bags (29.33 vs. 0 ng/cm2). It also showed more leakage than CSTD B on gloves (550.64 vs. 0.07 ng/cm2) and the compounding board (257.54 vs. 0 ng/cm2). For doxorubicin, needle compounding had significantly more leakage on the compounding board compared to CSTD A (9.88 vs. 0 ng/cm2), whereas CSTD B displayed more leakage than needle compounding on the compounding board (12.13 vs. 9.88 ng/cm2) and IV bags (52.79 vs. 0 ng/cm2), although this difference was not statistically significant. Needle compounding was faster than both CSTDs for both cyclophospha mide and doxorubicin. Pharmacists favored CSTD A (4.01), while nurses preferred CSTD B (4.06). Conclusion : CSTDs significantly reduced drug leakage compared to needles. Although CSTDs in creased compounding time, overall satisfaction supported their usage. These findings highlight the need for the adoption of CSTDs in South Korea to ensure safety, despite their higher costs.
Abstract
Background : Closed system drug transfer devices (CSTDs) are recommended in the US, Europe, and Japan, to reduce the risks associated with the compounding of anticancer drugs. However their high cost limits their use in South Korea. This study aimed to evaluate the effectiveness of CSTD use in reducing leakage, compounding time, and user satisfaction compared to traditional compounding devices for in jectable antineoplastic agents in a tertiary hospital. Methods : Needle compounding was compared with two closed system drug transfer devices (CSTDs), CSTD A and CSTD B, from different companies that utilize distinct methods. Four pharmacists compounded cyclophosphamide and doxorubicin, employing CSTD A’s multi vial adaptor exclusively for doxorubicin. Drug leakage onto gloves, the compounding board, and IV bags was analyzed using liquid chromatogra phy-tandem mass spectrometry. Additionally, satisfaction surveys were completed by four pharmacists and six nurses, employing a 5-point scale. The Mann-Whitney U test (p < 0.05) was used to compare leakage and preparation time. Results : For cyclophosphamide, needle compounding showed more leakage than CSTD A on the com pounding board (257.54 vs. 0.09 ng/cm2) and IV bags (29.33 vs. 0 ng/cm2). It also showed more leakage than CSTD B on gloves (550.64 vs. 0.07 ng/cm2) and the compounding board (257.54 vs. 0 ng/cm2). For doxorubicin, needle compounding had significantly more leakage on the compounding board compared to CSTD A (9.88 vs. 0 ng/cm2), whereas CSTD B displayed more leakage than needle compounding on the compounding board (12.13 vs. 9.88 ng/cm2) and IV bags (52.79 vs. 0 ng/cm2), although this difference was not statistically significant. Needle compounding was faster than both CSTDs for both cyclophospha mide and doxorubicin. Pharmacists favored CSTD A (4.01), while nurses preferred CSTD B (4.06). Conclusion : CSTDs significantly reduced drug leakage compared to needles. Although CSTDs in creased compounding time, overall satisfaction supported their usage. These findings highlight the need for the adoption of CSTDs in South Korea to ensure safety, despite their higher costs.