External contamination of antineoplastic drug containers from a Canadian wholesaler

J Oncol Pharm Pract. 2020 Mar;26(2):423-427. doi: 10.1177/1078155219868525. Epub 2019 Aug 25.

Abstract

Introduction: Contamination of hospitals' surfaces with antineoplastic drugs is documented despite safe handling practices. The exterior of commercial containers is often contaminated during the manufacturing process and can cross-contaminate hospitals' surfaces. The aim was to investigate the contamination of the exterior of antineoplastic drug vials available in Canada in 2018.

Methods: Cross-sectional study. All available antineoplastic drugs vials from a single wholesaler were targeted. Containers were sampled upon their receipt by the pharmacy staff, before they were cleaned. One wipe was used to sample the external surface of five vials from a single batch from the same manufacturer. Nine antineoplastic drugs were quantified by ultra-performance liquid chromatography-tandem mass spectrometer: cyclophosphamide, docetaxel, 5-fluorouracil, gemcitabine, ifosfamide, irinotecan, methotrexate, paclitaxel, vinorelbine.

Results: Twenty-one samplings were done (105 containers from nine different manufacturers): cyclophosphamide = 2, docetaxel = 1, gemcitabine = 2, 5-fluorouracil = 2, ifosfamide = 2, irinotecan = 3, methotrexate = 6, paclitaxel = 2, vinorelbine = 1. One of these samplings was done on blister packaging, the remainder were done on glass vials. A total of 15/21 samples (71%) were positive to at least one drug (docetaxel, 5-fluorouracil, ifosfamide, and vinorelbine). A maximum of 272 ng/vial was quantified (gemcitabine). Cross contamination with other antineoplastic drugs was detected on 16/21 (76%) samples.

Conclusion: The majority of samples were positive to at least one antineoplastic drug, confirming that the exterior of antineoplastic drugs containers is still an important source of contamination. Manufacturers should reduce this contamination. Vials should be washed upon receipt, before they are stored in pharmacy. Gloves must be worn at all times to avoid occupational exposure.

Keywords: Antineoplastic drugs; environmental surveillance; hazardous drugs; occupational exposure.

MeSH terms

  • Antineoplastic Agents / analysis*
  • Canada
  • Chromatography, Liquid
  • Cross-Sectional Studies
  • Drug Packaging*
  • Environmental Monitoring / methods*
  • Equipment Contamination / prevention & control*
  • Hospitals
  • Humans
  • Occupational Exposure / analysis

Substances

  • Antineoplastic Agents