Understanding the financial impact of beyond use date in a publicly funded cancer system.
Bibliographic record
Abstract
13 Background: According to USP 797 and the National Association of Pharmacy Regulatory Authorities standards, the Beyond Use Date (BUD) based on sterility for single-dose vials is 6 hours, after which the contents must be discarded. In Ontario, centres have traditionally based BUD on stability data, not sterility data. This change presents concern about potential drug waste so an analysis was done to estimate the financial impact to the 76 systemic treatment facilities in Ontario. Methods: Using an administrative database that records the daily total dose of drugs administered by facility, annual drug waste cost was calculated using daily dose administered, cost per milligram, and available vial size(s) for 26 publicly funded drugs. Two different methods were used to determine the amount of drug waste. Method 1 used the largest vial size matched to the closest amount of drug required. Method 2 used the optimal vial size mix, when there are multiple vial sizes, to minimize wastage across all configurations of vial size. Some assumptions made include: 1) each facility had access to all available vial sizes, and 2) single-dose vial contents were true to the stated quantity as per the manufacturer. Results: The 10 facilities with the highest waste estimates are summarized in the table. The total waste estimates for all facilities are $25,927,861 (method 1) and $12,945,353 (method 2). Waste estimates were also calculated by drug, with rituximab, bevacizumab and pemetrexed having the highest waste costs. These drugs are only available in vials with a large range in size (100 and 500 mg), but could waste more than drugs with more size options or less variance between sizes. Conclusions: Assigning a BUD based on 6 hour sterility standards will have significant financial implications to facilities in Ontario. Development of mitigation strategies should be explored to provide guidance to Ontario and other jurisdictions on how to curtail the budget impact.[Table: see text]
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.013 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.001 |
| Bibliometrics | 0.002 | 0.003 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.003 | 0.002 |
| Open science | 0.001 | 0.002 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.006 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".