Impact of oncology drug shortages on patient treatment.

Abstract

6114 Background: Cancer drug shortages increased considerably over the past 5 years, but quantitative analyses of the scope and effects are limited. We assessed the effects of drug shortages on outpatient medication use in a single New York City university hospital. Methods: We examined pharmacy records for drug shortages, defined by the ASHP as supply issues that affect “how the pharmacy prepares or dispenses a drug product or influences patient care when prescribers must use an alternative agent.” We examined outpatient records for all cancer patients treated with infusional antineoplastic and/or supportive medications from 4/2010-9/2010 and from 4/2011-9/2011, and performed subgroup analysis on Aug/Sept 2011, the peak of medication availability problems at our hospital. We compared proportions of patients treated with specific medications in 2010 and 2011 with Pearson’s chi-square test. Results: Twelve medications were in shortage during the study period in 2010 and 22 in 2011. Between 4/1/10 and 9/30/10, 335 cancer patients were treated, and 379 patients were treated between 4/1/11 and 9/30/11. Median patient age was 60 years. Cancer site of origin was comparable between years: breast (40%), GI (15%), lymphoma (10%), GU (8%), and lung (7%). Drugs considered in shortage were used for 170 (50.8%) patients in 2010 and 241 (63.6%) patients in 2011 (p=0.0005). Of 235 patients treated in Aug/Sept 2011, there were 23 (9.8%) documented therapy changes due to shortages, compared with 0 changes among 211 patients treated in Aug/Sept 2010 (p<0.0001). Among patients treated in Aug/Sept 2010 24 (11.4%) patients received paclitaxel and 19 (9.0%) received docetaxel. Among patients treated in Aug/Sept 2011, 11 (4.7%) received paclitaxel and 38 received docetaxel (16.2%), a 69% decrease for paclitaxel and 80% increase for docetaxel from 1 year prior (p=0.009, and p=0.024, respectively). The estimated cost of a single treatment with paclitaxel for 1 patient with BSA 1.75 was $47.59 versus $858.39 for docetaxel, a 1704% increase. Conclusions: Oncology drug shortages affected the majority of patients in our center and increased at an alarming rate. Drug shortages have substantial economic costs and mandate treatment changes that may affect efficacy and toxicity.