A novel decision tree for performing risk assessments of biologics in a health-system setting

Abstract

Objective

To develop and implement a biological drug risk assessment decision tree that expands upon National Institute for Occupational Safety and Health (NIOSH) risk assessment evaluation procedures with the addition of molecular property parameters for exposure assessment.

Data Sources

A literature review was performed using PubMed^® (Keywords: peptide, protein, biologics, occupational exposure, risk assessment, molecular weight, molecular weight and penetration, skin, nasal absorption, ocular absorption, inhalation bioavailability. Period: 1991 to 2024).

Data Summary

A thorough literature review showed a wide range of molecular weight cut-offs for absorption of biological drugs through various pathways (dermal, mucosal, inhalation). Large molecules greater than 1000 Daltons in size were found to have little to no bioavailability through these pathways, hence this weight was established as the size threshold within the risk assessment decision tree. Practical application of this decision tree by the investigational drug service in a large academic institution led to the reclassification of 89% of medications with previous hazardous designation.

Conclusions

In response to the increasing prevalence of biological drugs and limited guidelines on occupational handling, a protein-based biologics risk assessment decision tree, expanding on existing NIOSH evaluation procedures and incorporating molecular weight parameters was developed. Adoption of a risk assessment tool can help standardize and streamline biologics handling practice, which can improve operational efficiency without compromising staff safety.