Aims
The increasing use of hazardous pharmaceutical and advanced therapeutic products creates challenges in ensuring consistent occupational exposure risk management across healthcare settings. This study aimed to validate an occupational exposure risk assessment tool to guide the safe preparation of pharmaceutical and advanced therapeutic products, ensuring a consistent approach to safe preparation.
Methods
Using the risk assessment tool, a working group, representing five Australian jurisdictions and consisting of expert production pharmacists (n=8) and a clinical nurse educator (n=1), assessed the occupational exposure risk for pharmaceutical and advanced therapeutic products encountered in routine practice. Risk was scored based on hazard classification including carcinogenicity, with a score of >5 deeming the product high risk. Validation was conducted in two phases. Following review of Phase 1 findings, the expert working group refined the tool, subsequently reassessed in Phase 2 during routine practice. Validation is defined by the tool generating the same preparation recommendation as expert consensus for > 90% of products.
Results
Phase 1 assessed 51 products across multiple risk categories. Nearly half (47%; n=24/51) were identified as high risk, and the tool informed best-practice preparation recommendations for 88% (n=45/51) of products, below the predefined threshold. Following expert working group review, revisions to the tool were made to clarify scope and application across the broad range of products. Following refinement, Phase 2 assessed a further 42 products, finding an increase in identified high risk products (63%, n=27/42) and the tool generated preparation recommendations consistent with expert consensus across multiple risk categories for 98% (n=41/42) of products, exceeding the predefined validation threshold.
Conclusion
Validation of the occupational exposure risk assessment tool supports its use to provide consistent, evidence-based decision-making for the safe preparation of pharmaceutical and advanced therapeutic products and may support a national, harmonised approach to occupational exposure risk management in this setting.