Assessing the risk to health care staff from long-term exposure to anticancer drugs - the case of monoclonal antibodies

Author:

Halsen Gabriele1,Krämer Irene2

Affiliation:

1. Berufsgenossenschaft für Gesundheitsdienst und Wohlfahrtspflege (BGW), Bonner Strasse 337, 50968 Cologne, Germany

2. Department of Pharmacy, University Medical Center, Johannes Gutenberg-University, Langenbeckstraße 1, 55131 Mainz, Germany,

Abstract

Today the occupational health and safety risk involved when handling most anticancer drugs is well recognized and, as a result of regulatory requirements, safety measures have been established. There is little knowledge about the occupational hazard posed by handling monoclonal antibodies assigned to ATC Class L01XC. The aim of our study was to evaluate the occupational risk of monoclonal antibodies. Using the information obtained in a systematic review of the literature, the potentially dangerous properties of the active drug substances were assessed using a specially devised algorithm. As a result, all monoclonal antibodies in question were categorized as substances with developmental toxicity. In addition, gemtuzumab ozogamicin was categorized as mutagenic. In view of the high molecular weights and the proteinogenic nature of monoclonal antibodies, the route of exposure for health care staff is limited to inhalation, unless there is an accident. Employers should implement the necessary administrative and engineering controls. Employees should adhere to the standards in order to avoid occupational exposure. The hazard assessment algorithm devised and the evaluation procedure may also be used for other drugs considered to be dangerous.

Publisher

SAGE Publications

Subject

Pharmacology (medical),Oncology

Reference43 articles.

1. FDA. Summary statement gemtuzumab ozogamicin NDA 21-174, www.fda.gov/ohrms/dockets/ac/00/backgrd/3592b2a.pdf. (accessed December 2009)

2. Niosh. List of new FDA drugs and warnings fitting NIOSH criteria for hazardous drugs 2006, www.cdc.gov/niosh (NIOSH Docket 105) (accessed May 2009).

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