Drug Shortages Lead to Substantial Increase in Costs; Mandate Treatment Changes
(CHICAGO, IL) — Shortages in oncology drugs “increased at an alarming rate” in just one year and affected the majority of outpatients with cancer being treated at a single New York City university hospital, according to a study reported at the 2012 American Society of Clinical Oncology Annual Meeting.
“Drug shortages have substantial economic costs and mandate treatment changes that may affect efficacy and toxicity,” said Daniel Jacob Becker, MD, of St. Luke's-Roosevelt and Beth Israel Medical Center, Continuum Cancer Centers of New York, NY, on behalf of the study investigators.
Drug shortages have complex origins, including planned interruptions in manufacturing for maintenance, FDA enforcement actions, and discontinued production of bulk source materials. Although shortages in cancer agents have increased considerably over the past 5 years, limited quantitative analyses of their scope and effects are available. This study assessed effects of drug shortages on outpatient medication use at the hospital. Pharmacy records were examined for drug shortages, which is defined by the American Society of Health-System Pharmacists 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.”
Outpatient records for all patients treated with infusional anti-neoplastic and/or supportive medications from April to September 2010 and from April to September 2011 were examined. Subgroup analysis was performed in August/September 2011, “the peak of medication availability problems at our hospital,” Dr. Becker said.
In 2010, 12 medications were in shortage; in 2011, it was 22. Drugs considered in shortage were used for 170 patients (50.8%) in 2010 and 241 (63.6%) in 2011 (P=0.0005), they reported. During August/September 2011, of 235 patients treated, there were 23 (9.8%) documented therapy changes due to shortages vs. no changes among 211 patients treated in August/September 2010 (P<0.0001).
Among those treated in August/September 2010, 24 patients (11.4%) received paclitaxel and 19 (9.0%) received docetaxel, but the following year, paclitaxel shortages led to 11 (4.7%) patients being administered paclitaxel and 38 (16.2%) docetaxel, which was a 69% decrease for paclitaxel (P=0.009) and an 80% increase for docetaxel (P=0.024). Estimated cost for a single treatment with paclitaxel for 1 patient with BSA 1.75mg/m2 was $47.59 vs. $858.39 for docetaxel — a 1,704% increase.
The FDA has taken steps to encourage manufacturers to warn the agency of impending disruptions in production but one of the challenges is that manufacturing levels are not “actively monitored” by the FDA, Becker said. “It's volunteer reporting on the part of companies that have the shortage,” he said. “There is some question about how quickly the information gets to the FDA website when there's a shortage. These shortages have nebulous beginnings and endings. There's really no consensus definition of what constitutes a shortage.”