Understanding the financial impact of beyond use date in a publicly funded cancer system.

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]

Review of studies examining microbial contamination of vials used for preparations done with closed-system drug transfer devices

“…However, when applying the 6-hour BUD, some opened vials are wasted, and this has a financial impact for healthcare centres 11 12. Some centres use closed-system drug transfer devices (CSTD) to prepare hazardous drugs in order to increase workers’ protection.…”