Impact of leucovorin shortage on patient treatment.

Abstract

e17566 Background: Shortages of intravenous leucovorin were initially reported in late 2008, and availability plummeted nationally and at Continuum Cancer Centers of New York (CCCNY) in late 2011. NCCN guidelines recommend either the use of levoleucovorin or low dose leucovorin during the shortage. The impact of the leucovorin shortage on patient therapy remains unknown. Methods: We reviewed patient charts for all outpatients treated with leucovorin at CCCNY between April and September of 2010, 2011, and 2012. We recorded patient characteristics, and leucovorin use (dose, number of treatments); and calculated descriptive statistics. We classified each dose as either low (20-40 mg/m2) or high (200-500mg/m2) and compared leucovorin use between years with Chi Square and ANOVA tests. We also reviewed pharmacy purchasing data to evaluate the economic effect of the leucovorin shortage. Results: We identified 55 patients treated with 313 doses of leucovorin in 2010, 99 patients treated with 582 doses in 2011 and 118 patients treated with 742 doses in 2012. No patients received levoleucovorin. Patient characteristics, disease and stage were similar between years with colorectal cancer accounting for 78%, 69%, and 70% of patients in 2010, 2011, and 2012 (p=0.87). Low dose leucovorin was used in 30.0% of doses in 2010, 30.4% in 2011, and 99.1% in 2012 (p<0.0001). The mean dose/treatment (SD) was 459 mg (296), 499 mg (328), and 47 mg (89), in 2010, 2011, 2012, respectively (p<0.0001). Among patients treated for colon cancer we found no association between stage (III vs. IV) and use of low dose leucovorin in 2010 or 2011. Quantity of leucovorin purchased at one hospital decreased by 63% from 171.75 g in 2010 and 157.50g in 2011 to 63.00 g in 2012. The price of leucovorin was similar at 0.017 $/mg in 2011 and 0.013 $/mg in 2012. Conclusions: Worsening leucovorin drug shortage was associated with a profound change in leucovorin use at CCCNY between 2011 and 2012. In accordance with NCCN guidelines, physicians used more low dose leucovorin. The price of leucovorin remained constant despite limited supply. Additional patient follow up is warranted to evaluate the outcomes of patients treated during the shortage.