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Pilot study : External surface contamination of gemcitabine and 5-fluorouracil on drug packaging

Kåredal, Monica LU orcid ; Özdemir, Jennie ; Tinnert, Andreas LU ; Wetterling, Maria and Hedmer, Maria LU orcid (2023) In Journal of oncology pharmacy practice
Abstract

Introduction: Antineoplastic drugs (ADs) are commonly used pharmaceuticals for anticancer treatments. It has previously been shown that the external surface of drug vials frequently is contaminated with ADs. More than a decade ago methods to prevent occupational exposure were introduced by using plastic coverage of the glass vials or packing vials in a secondary plastic container. The aim of the pilot study was to determine contamination levels of ADs on different parts of AD packaging of two different commercially available drug vials on the Swedish market and to investigate the occurrence of cross contamination of ADs. Methods: Packagings of gemcitabine (GEM) and 5-fluorouracil (5-FU) were tested by wipe sampling. Five ADs; GEM, 5-FU,... (More)

Introduction: Antineoplastic drugs (ADs) are commonly used pharmaceuticals for anticancer treatments. It has previously been shown that the external surface of drug vials frequently is contaminated with ADs. More than a decade ago methods to prevent occupational exposure were introduced by using plastic coverage of the glass vials or packing vials in a secondary plastic container. The aim of the pilot study was to determine contamination levels of ADs on different parts of AD packaging of two different commercially available drug vials on the Swedish market and to investigate the occurrence of cross contamination of ADs. Methods: Packagings of gemcitabine (GEM) and 5-fluorouracil (5-FU) were tested by wipe sampling. Five ADs; GEM, 5-FU, cyclophosphamide (CP), ifosfamide and etoposide were quantified using liquid chromatography mass spectrometry. Results: AD contaminations were detected in 69% and 60% of the GEM and 5-FU packaging samples. Highest levels, up to approximately 5 µg/sample, were observed on the glass vials. The protective shrink-wrap of 5-FU vials and the plastic container of GEM were contaminated with low levels of 5-FU and GEM, respectively, and furthermore the 5-FU vials with shrink-wrap were cross-contaminated with GEM. Cross-contamination of CP and GEM was detected on 5-FU vials with plastic shrink-wrap removed. Conclusions: External contamination of ADs are still present at primary drug packagings on the Swedish market. Protection of AD vials by plastic shrink-wrap or a secondary plastic container does not remove the external contamination levels completely. The presence of cross contamination of ADs on drug packagings was also observed.

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author
; ; ; and
organization
publishing date
type
Contribution to journal
publication status
epub
subject
keywords
Antineoplastic drugs, dermal exposure, drug preparation, occupational exposure, wipe sampling
in
Journal of oncology pharmacy practice
publisher
SAGE Publications
external identifiers
  • pmid:36916178
  • scopus:85150848738
ISSN
1078-1552
DOI
10.1177/10781552231163544
language
English
LU publication?
yes
id
0641e86f-740a-4d19-bc67-a81107fc0e38
date added to LUP
2023-05-26 13:56:08
date last changed
2024-06-16 06:04:17
@article{0641e86f-740a-4d19-bc67-a81107fc0e38,
  abstract     = {{<p>Introduction: Antineoplastic drugs (ADs) are commonly used pharmaceuticals for anticancer treatments. It has previously been shown that the external surface of drug vials frequently is contaminated with ADs. More than a decade ago methods to prevent occupational exposure were introduced by using plastic coverage of the glass vials or packing vials in a secondary plastic container. The aim of the pilot study was to determine contamination levels of ADs on different parts of AD packaging of two different commercially available drug vials on the Swedish market and to investigate the occurrence of cross contamination of ADs. Methods: Packagings of gemcitabine (GEM) and 5-fluorouracil (5-FU) were tested by wipe sampling. Five ADs; GEM, 5-FU, cyclophosphamide (CP), ifosfamide and etoposide were quantified using liquid chromatography mass spectrometry. Results: AD contaminations were detected in 69% and 60% of the GEM and 5-FU packaging samples. Highest levels, up to approximately 5 µg/sample, were observed on the glass vials. The protective shrink-wrap of 5-FU vials and the plastic container of GEM were contaminated with low levels of 5-FU and GEM, respectively, and furthermore the 5-FU vials with shrink-wrap were cross-contaminated with GEM. Cross-contamination of CP and GEM was detected on 5-FU vials with plastic shrink-wrap removed. Conclusions: External contamination of ADs are still present at primary drug packagings on the Swedish market. Protection of AD vials by plastic shrink-wrap or a secondary plastic container does not remove the external contamination levels completely. The presence of cross contamination of ADs on drug packagings was also observed.</p>}},
  author       = {{Kåredal, Monica and Özdemir, Jennie and Tinnert, Andreas and Wetterling, Maria and Hedmer, Maria}},
  issn         = {{1078-1552}},
  keywords     = {{Antineoplastic drugs; dermal exposure; drug preparation; occupational exposure; wipe sampling}},
  language     = {{eng}},
  publisher    = {{SAGE Publications}},
  series       = {{Journal of oncology pharmacy practice}},
  title        = {{Pilot study : External surface contamination of gemcitabine and 5-fluorouracil on drug packaging}},
  url          = {{http://dx.doi.org/10.1177/10781552231163544}},
  doi          = {{10.1177/10781552231163544}},
  year         = {{2023}},
}