Abstract
Objective
To examine whether the centralised Oncology Pharmacy Unit (OPU) model, established in the late 1990s for BSA-dependent cytotoxic compounding, remains fit for purpose in a contemporary oncology context dominated by flat-dose immunotherapy and subcutaneous checkpoint inhibitor formulations, and to propose a stratified hybrid model proportional to actual preparation complexity.
Data Sources
Published clinical trial data for subcutaneous checkpoint inhibitors (IMscin001, CheckMate-67 T, IMscin002); EMA and FDA regulatory documents (2024–2025); peer-reviewed literature on flat-dose immunotherapy, time toxicity and oncology pharmacy workflow; institutional reports from IOV IRCCS Padua, NHS England, French SFPO and the Veneto Region Pharmacy Working Group.
Data Summary
Four structural inefficiencies are documented: (1) identical compounding workflows applied to pharmacologically non-equivalent preparations; (2) subcutaneous formulations with up to 80% administration time reduction routed through the full compounding circuit without clinical justification; (3) per-preparation process costs exceeding vial-sharing savings for off-patent generics; and (4) same-day compression of clinical assessment, prescribing, compounding and administration generating structural day-hospital congestion and measurable patient time toxicity. A four-level stratified hybrid model is proposed: robotic automation for high-complexity cytotoxics, simplified workflow for flat-dose IV immunotherapy, ward-based preparation for subcutaneous products, and D/D + 1 visit-to-administration day separation as an institutional standard.
Conclusion
The 1999 OPU model has outlived its pharmacological context. A stratified approach to oncology pharmacy organisation — proportional to actual preparation complexity — is operationally feasible, clinically safe and necessary to restore pharmacy resources to where they generate genuine value.
Keywords
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