Request for information about recommendations to reduce adverse reproductive outcomes in healthcare workers exposed to antineoplastic drugs

January 2015
NIOSH Docket Number 279, CDC-2015-0003

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) intends to evaluate the scientific data on reproductive effects in healthcare workers who work with antineoplastic drugs. The majority of antineoplastic drugs are known to have adverse reproductive effects in laboratory studies in animals and in patients who have been treated with these drugs. Effects such as low birth weight, malformations, spontaneous abortions, and effects on fertility have been associated with these drugs in patient populations. Similar adverse effects have been reported in healthcare workers who work with these drugs on a daily basis. Pharmacy and nursing personnel have been the most often studied healthcare workers, but all workers who may be exposed to antineoplastic drugs may be at risk. These include workers in transportation, receiving departments, environmental services and waste disposal. In addition, operating room personnel and workers in home health care and veterinary practices may also be at risk of adverse reproductive effects.

NIOSH has summarized effects in laboratory studies and in patients who have been treated with these drugs. NIOSH has also performed an in-depth summary and review of all English language published reports on reproductive effects in healthcare workers. Based on this information, NIOSH has made recommendations aimed at protecting the reproductive health of both men and women who may be exposed to these drugs during the course of their employment. NIOSH requested comments on the quality and thoroughness of the presented data and the recommendations supported by these data.

To view the notice and related materials, visit http://www.regulations.govexternal icon and enter CDC-2015-0003 in the search field and click “Search.”

Reference Documents

Federal Register Notice: 80 FR 3601 CIB pdf icon[PDF – 202 KB]

Reproductive Risks Associated with Hazardous Drug Exposures in Healthcare Workers and Recommendations for Reducing Exposures pdf icon[PDF – 505 KB]

Page last reviewed: March 26, 2015