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Guidance values for surface monitoring of antineoplastic drugs in German pharmacies

Rudolf Schierl1, Antje Böhlandt, Dennis Nowak

  • 1Institute and Outpatient Clinic for Occupational, Social and Environmental Medicine, Ludwig-Maximilians-University Munich, Ziemssenstrasse 1, D-80336 Muenchen, Germany. Rudolf.Schierl@med.uni-muenchen.de

The Annals of Occupational Hygiene
|July 22, 2009
PubMed
Abstract

Insights

Surface monitoring in German pharmacies found antineoplastic drug contamination. Threshold guidance values (TGVs) were proposed to assess and improve occupational safety for handling cytotoxic drugs like platinum and 5-fluorouracil.

Area of Science:

  • Occupational Health
  • Environmental Monitoring
  • Pharmaceutical Sciences

Background:

  • Antineoplastic drugs are vital in cancer therapy but pose risks due to their cytotoxic, carcinogenic, mutagenic, or teratogenic properties.
  • Evaluating personal exposure to these hazardous drugs is crucial for healthcare worker safety.
  • Surface monitoring has been established as a reliable method for assessing contamination levels in pharmacy settings.

Purpose of the Study:

  • To statistically describe a dataset of surface contamination from antineoplastic drugs in German pharmacies.
  • To propose Threshold Guidance Values (TGVs) to aid in the interpretation of surface monitoring results.
  • To provide a benchmark for evaluating and improving occupational safety practices.

Main Methods:

  • Wipe sampling was conducted in 102 German pharmacies.
  • Concentrations of platinum (PT) and 5-fluorouracil (FU) were measured using validated analytical techniques (voltammetry for PT, GC/MS for FU).
  • Data were stratified by location and statistically analyzed to establish TGVs.

Main Results:

  • Contamination by PT and FU was detected on all surfaces, with higher levels on storage shelves and floors.
  • Median contamination levels ranged from 0.20-1.70 pg cm⁻² for PT and 2.50-10.00 pg cm⁻² for FU.
  • The 75th percentiles were 3.92 pg cm⁻² for PT and 28.90 pg cm⁻² for FU, forming the basis for TGV 2.

Conclusions:

  • The proposed TGVs (TGV 1 at median, TGV 2 at 75th percentile) facilitate the interpretation of contamination monitoring results.
  • Results below TGV 1 indicate good working practices, while exceeding TGV 2 necessitates optimization of handling procedures.
  • Implementing TGVs aids in reducing occupational exposure and enhances pharmacy personnel's ability to benchmark and improve safety.

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