Orhan Ziya, Tuba Reçber, Emirhan Nemutlu, Merve Güdül Bacanlı
{"title":"广泛使用的抗肿瘤药物的瓶面和交叉污染的定量分析:生产和职业安全的关键评估。","authors":"Orhan Ziya, Tuba Reçber, Emirhan Nemutlu, Merve Güdül Bacanlı","doi":"10.1177/10781552251381167","DOIUrl":null,"url":null,"abstract":"<p><p>IntroductionThe global rise in cancer incidence has led to an increased demand for antineoplastic agents, intensifying occupational risks associated with drug handling.MethodsThis study aimed to quantitatively assess both surface contamination and cross-contamination on the vials of six frequently used cytotoxic drugs in Türkiye, 5-fluorouracil (5-FU), doxorubicin, etoposide, gemcitabine, ifosfamide, and cyclophosphamide, using a standardized wipe sampling method followed by LC-MS/MS analysis. This study quantitatively assess both surface contamination on 65 vials of six frequently used cytotoxic drugs and cross-contamination on an extended set of 75 vials (including oxaliplatin), using a standardized wipe sampling method followed by LC-MS/MS analysis.ResultsOut of 65 vials, 63.08% were contaminated with the active pharmaceutical ingredient (API), while 49.33% of 75 vials exhibited cross-contamination with other APIs. Notably, contamination was present in 100% of 5-FU and gemcitabine samples, with the highest recorded level reaching 2276.920 ng/cm<sup>2</sup> (133199.848 ng/vial).ConclusionsWe explicitly state that this is the first study in Türkiye to assess both surface and cross-contamination on cytotoxic drug vials at a national level. These findings underscore significant disparities in manufacturing hygiene practices and highlight an urgent need for regulatory oversight to mitigate healthcare worker exposure risks. The study advocates mandatory contamination reporting, stricter decontamination protocols, and enhanced batch control measures in drug production facilities.</p>","PeriodicalId":16637,"journal":{"name":"Journal of Oncology Pharmacy Practice","volume":" ","pages":"10781552251381167"},"PeriodicalIF":0.9000,"publicationDate":"2025-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Quantitative analysis of vial surface and cross-contamination of widely used antineoplastic drugs in Türkiye: A critical assessment for manufacturing and occupational safety.\",\"authors\":\"Orhan Ziya, Tuba Reçber, Emirhan Nemutlu, Merve Güdül Bacanlı\",\"doi\":\"10.1177/10781552251381167\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>IntroductionThe global rise in cancer incidence has led to an increased demand for antineoplastic agents, intensifying occupational risks associated with drug handling.MethodsThis study aimed to quantitatively assess both surface contamination and cross-contamination on the vials of six frequently used cytotoxic drugs in Türkiye, 5-fluorouracil (5-FU), doxorubicin, etoposide, gemcitabine, ifosfamide, and cyclophosphamide, using a standardized wipe sampling method followed by LC-MS/MS analysis. This study quantitatively assess both surface contamination on 65 vials of six frequently used cytotoxic drugs and cross-contamination on an extended set of 75 vials (including oxaliplatin), using a standardized wipe sampling method followed by LC-MS/MS analysis.ResultsOut of 65 vials, 63.08% were contaminated with the active pharmaceutical ingredient (API), while 49.33% of 75 vials exhibited cross-contamination with other APIs. Notably, contamination was present in 100% of 5-FU and gemcitabine samples, with the highest recorded level reaching 2276.920 ng/cm<sup>2</sup> (133199.848 ng/vial).ConclusionsWe explicitly state that this is the first study in Türkiye to assess both surface and cross-contamination on cytotoxic drug vials at a national level. These findings underscore significant disparities in manufacturing hygiene practices and highlight an urgent need for regulatory oversight to mitigate healthcare worker exposure risks. The study advocates mandatory contamination reporting, stricter decontamination protocols, and enhanced batch control measures in drug production facilities.</p>\",\"PeriodicalId\":16637,\"journal\":{\"name\":\"Journal of Oncology Pharmacy Practice\",\"volume\":\" \",\"pages\":\"10781552251381167\"},\"PeriodicalIF\":0.9000,\"publicationDate\":\"2025-09-24\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Oncology Pharmacy Practice\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1177/10781552251381167\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Oncology Pharmacy Practice","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1177/10781552251381167","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"ONCOLOGY","Score":null,"Total":0}
Quantitative analysis of vial surface and cross-contamination of widely used antineoplastic drugs in Türkiye: A critical assessment for manufacturing and occupational safety.
IntroductionThe global rise in cancer incidence has led to an increased demand for antineoplastic agents, intensifying occupational risks associated with drug handling.MethodsThis study aimed to quantitatively assess both surface contamination and cross-contamination on the vials of six frequently used cytotoxic drugs in Türkiye, 5-fluorouracil (5-FU), doxorubicin, etoposide, gemcitabine, ifosfamide, and cyclophosphamide, using a standardized wipe sampling method followed by LC-MS/MS analysis. This study quantitatively assess both surface contamination on 65 vials of six frequently used cytotoxic drugs and cross-contamination on an extended set of 75 vials (including oxaliplatin), using a standardized wipe sampling method followed by LC-MS/MS analysis.ResultsOut of 65 vials, 63.08% were contaminated with the active pharmaceutical ingredient (API), while 49.33% of 75 vials exhibited cross-contamination with other APIs. Notably, contamination was present in 100% of 5-FU and gemcitabine samples, with the highest recorded level reaching 2276.920 ng/cm2 (133199.848 ng/vial).ConclusionsWe explicitly state that this is the first study in Türkiye to assess both surface and cross-contamination on cytotoxic drug vials at a national level. These findings underscore significant disparities in manufacturing hygiene practices and highlight an urgent need for regulatory oversight to mitigate healthcare worker exposure risks. The study advocates mandatory contamination reporting, stricter decontamination protocols, and enhanced batch control measures in drug production facilities.
期刊介绍:
Journal of Oncology Pharmacy Practice is a peer-reviewed scholarly journal dedicated to educating health professionals about providing pharmaceutical care to patients with cancer. It is the official publication of the International Society for Oncology Pharmacy Practitioners (ISOPP). Publishing pertinent case reports and consensus guidelines...