Occupational Drug Hazards: When NIOSH Listing Affects Your Product and What Can Be Done About It
June 12, 2017
The National Institute for Occupational Safety and Health (NIOSH) maintains a list of drugs considered hazardous in healthcare settings. This list was originally compiled from hazardous drug lists maintained by the Pharmaceutical Research and Manufacturers of America (PhRMA) and major healthcare institutions.

The hazardous classification is based on concerns for potential carcinogenicity/genotoxicity, teratogenicity/developmental toxicity, reproductive toxicity, and low dose organ toxicity; however, in its compilation, risk assessments were not conducted to address the likelihood of hazard to workers from the handling of the drugs listed in the NIOSH alert.

Although the NIOSH list of hazardous drugs was never meant to serve as the basis for limiting access to such drugs, this has been an unintended result of its existence.

Recent Case Study

Exponent scientists recently assisted a client with review and analysis of the preclinical safety data that served as the basis for the classification of their product as a hazardous drug of concern due to potential adverse reproductive effects. This analysis found that:

  • The developmental toxicity findings had been incorrectly interpreted with respect to their relationship to treatment.
  • The feasible pathways for occupational systemic exposure were extremely limited.
  • The amount of drug required to achieve the developmental toxicity No Observed Effect Level (NOEL) was improbable in a healthcare setting. 

The results of this analysis were presented to NIOSH on the client’s behalf. As a direct result of this presentation and discussion with NIOSH personnel, NIOSH agreed that the client’s product did not meet the NIOSH definition of a hazardous drug and the product was immediately delisted.

How Exponent Can Help

Exponent scientists have extensive expertise in the areas of developmental/reproductive toxicity and genotoxicity/carcinogenesis, as well as mechanistic biology. We can assist clients in the review and interpretation of data from safety studies that serve as the basis for listing a pharmaceutical product as a potential occupational hazard. When such data do not warrant classification, Exponent scientists can also assist clients in the preparation and presentation of relevant arguments to NIOSH and other regulatory agencies.

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