Residual contamination in antineoplastic drug packaging

J Oncol Pharm Pract. 2023 Dec;29(8):1862-1867. doi: 10.1177/10781552231151693. Epub 2023 Jan 19.

Abstract

Introduction: The handling of antineoplastic drugs should follow strict supervision and safety rules to minimize the occupational exposure risks to professionals involved. The external surface contamination of drug vials is recognized as a health risk. So, our goal was to determine if there is residual contamination on the vials and containers surface of the antineoplastic drugs doxorubicin (DOX) and cyclophosphamide (CP).

Methods: A cross-sectional study was conducted. Samples were collected using a uniform sampling procedure on the inner surfaces of the packages/boxes and the outer surfaces of the vials. The analyzes were executed by high-performance liquid chromatography/mass spectrometry (UHPLC-MS/MS).

Results: A total of 209 samples were analyzed, 66 of CP and 143 of DOX. CP levels were detected in nine samples (13.63%), three were below the lower limit of quantification (LLQ) and the other six had contamination levels ranging from 1.24 to 28.04 ng/filter. DOX levels were detected in 36 samples (25.17%), two were below the LLQ and the others had levels between 1.32 and 664.84 ng/filter. The majority of samples with residual contamination were in vials (80.0%), however, boxes also showed contamination.

Conclusions: The results revealed the presence of residual contamination in the vials and packages of CP and DOX drugs. Although the residues found in each sample are small, special care should be taken in the handling and disposal of the antineoplastic drugs. The use of personal protective equipment is fundamental while handling the vials and packaging of cytotoxic drugs.

Keywords: Antineoplastic drugs; anticancer drug; occupational exposure; packaging; residual contamination.

MeSH terms

  • Antineoplastic Agents* / analysis
  • Cross-Sectional Studies
  • Cyclophosphamide / analysis
  • Doxorubicin
  • Drug Contamination / prevention & control
  • Drug Packaging
  • Environmental Monitoring / methods
  • Equipment Contamination
  • Humans
  • Occupational Exposure* / analysis
  • Occupational Exposure* / prevention & control
  • Tandem Mass Spectrometry

Substances

  • Antineoplastic Agents
  • Cyclophosphamide
  • Doxorubicin