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Residual contamination in antineoplastic drug packaging
Luciana Stein E Silva1, Cibele da Silva Barbosa Machado1, Rafael Linden2
1Post Graduate Program in Health Sciences: Gynecology and Obstetrics, Medical School, Universidade Federal do Rio Grande do Sul, Porto Alegre, RS, Brazil.
Residual contamination of antineoplastic drugs cyclophosphamide (CP) and doxorubicin (DOX) was detected on vials and packaging. This highlights the need for strict handling protocols and personal protective equipment for healthcare professionals.
Area of Science:
- Oncology
- Pharmaceutical Sciences
- Occupational Health
Background:
- Antineoplastic drug handling requires strict safety measures to minimize occupational exposure risks.
- External surface contamination of drug vials poses a significant health hazard to healthcare professionals.
- Previous studies have indicated potential contamination risks associated with cytotoxic agents.
Purpose of the Study:
- To determine residual contamination on vials and packaging of doxorubicin (DOX) and cyclophosphamide (CP).
- To assess the extent and location of surface contamination for these widely used antineoplastic drugs.
Main Methods:
- A cross-sectional study design was employed.
- Samples were collected from inner package surfaces and outer vial surfaces using a standardized procedure.
- High-performance liquid chromatography/mass spectrometry (UHPLC-MS/MS) was utilized for quantitative analysis.
Main Results:
- A total of 209 samples were analyzed (66 CP, 143 DOX).
- Cyclophosphamide (CP) contamination was found in 13.63% of samples, with levels up to 28.04 ng/filter.
- Doxorubicin (DOX) contamination was detected in 25.17% of samples, with levels up to 664.84 ng/filter.
- Residual contamination was predominantly found on vials (80.0%) but also present on packaging.
Conclusions:
- Residual contamination of CP and DOX exists on both drug vials and their packaging.
- While contamination levels per sample were low, meticulous handling and disposal are crucial.
- Consistent use of personal protective equipment is essential when managing cytotoxic drug vials and packaging.
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