Safe handling of monoclonal antibodies: Too large to be hazardous?

It has been argued that the larger molecular weight of hazardous monoclonal antibodies may prevent their dermal absorption via occupational exposure. However, this assertion does not seem to be supported by direct evidence. Although the larger molecular weight may render monoclonal antibodies less probable to achieve therapeutic systemic level through dermal absorption, the concern in occupational health is whether these drugs can possibly attain a detectable level through repeated dermal exposure. Currently, there is no direct evidence to support a particular molecular weight above which a drug cannot achieve a detectable level following repeated occupational exposure. Therefore, the precautionary principle would dictate that repeated exposure of healthcare workers to hazardous monoclonal antibodies should be kept to a minimum.

Hazards in determining whether a drug is hazardous.

The US National Institute for Occupational Safety and Health list and evaluation criteria have provided an important foundation to help institutions identify and create a list of hazardous formulary drugs. However, further guiding principles were needed to make the adoption feasible at our organization. First, we developed separate directives for determining the inherent hazardous toxicity of a drug and for the requirements for safe handling based on dosage forms (exposure risks) of these drugs. Secondly, we created a systematic approach in determining the scope of the drugs reviewed by US National Institute for Occupational Safety and Health. Thirdly, we streamlined our review process by defining which drugs needed to be evaluated by our organization. Finally, we considered the pros and cons of creating a tiered system for classifying hazardous drugs beyond those recommended by US National Institute for Occupational Safety and Health.