Surface contamination of the outer and blister packages of oral anticancer drugs: A multicenter study

J Oncol Pharm Pract. 2020 Jan;26(1):141-145. doi: 10.1177/1078155219850305. Epub 2019 May 27.

Abstract

Introduction: All guidelines necessitate wearing personal protective equipment during dispensing of oral anticancer drugs. This study aims to measure the degree of contamination on the press-through-package strips of oral anticancer drugs in Japan.

Method: Surface contamination of the external packaging of anticancer drugs was examined by performing wipe tests at four hospitals and two community pharmacies. The following commercially available drugs were examined: Xeloda®, TS-1®, and methotrexate tablets and SA-1® and Rheumatrex® capsules.

Results: The wipe tests' results revealed that the contamination levels of Xeloda® and TS-1® tablets and SA-1® capsules were within their detection limits. In some facilities, the contamination levels on the press-through-package strips of Rheumatrex® capsules were 3.27 × 10-1, which is close to its detection limit. However, across all facilities, the contamination level of methotrexate tablets was above its detection limit.

Conclusion: The results of this study suggested that adherence to oral anticancer drugs may not occur during manufacture or transportation. However, it may be due to the presence of pollutants in the facilities. Prevention of pollution in facilities might eliminate the need to wear personal protective equipment during dispensing of oral anticancer drugs.

Keywords: A multicenter study; surface contamination of oral anticancer drugs; the wipe tests.

Publication types

  • Multicenter Study

MeSH terms

  • Antineoplastic Agents / administration & dosage*
  • Antineoplastic Agents / analysis
  • Drug Contamination / prevention & control*
  • Drug Packaging / methods*
  • Drug Packaging / standards
  • Environmental Monitoring / methods
  • Environmental Monitoring / standards
  • Equipment Contamination / prevention & control*
  • Humans
  • Japan / epidemiology
  • Occupational Exposure / prevention & control*
  • Occupational Exposure / standards
  • Pharmacies / standards

Substances

  • Antineoplastic Agents