TOP - August 2012, Vol 5, No 5 published on August 22, 2012 in Drug Updates & News

At one New York medical center, half of the cancer patients required drugs that were considered in short supply in 2010 and 2011, and 10% were forced to receive an alternative, according to a study presented at the 2012 ASCO Annual Meeting (Abstract 6114).

While the investigators hope that this did not compromise efficacy, about one-third of the time the physicians felt the substitute was inferior, said Daniel J. Becker, MD, of St. Luke’s-Roosevelt and Bet h Israel M edic al Center, New York, who led the study presented at ASCO.

Becker reported that drugs considered in shortage were used for 51% of patients in 2010, and this increased significantly to 64% in 2011.

“When the shortage reached critical levels, about 10% of the patients we treated had an actual change in treatment mandated by the shortage,” he told The Oncology Pharmacist.

The researchers reviewed pharmacy records for drug shortages, defined 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, and examined records of outpatient s who r e ceived chemot h erapy from April 2010 to September 2010 (n = 335) and from April 2011 to September 2011 (n = 379). They also surveyed physicians about the efficacy and toxicity of the alternative regimen used during the shortage.

The percentage of drugs in shortage increased from 30% in 2010 to 50% in 2011, and the percentage of patients treated with a shortage drug increased from 51% to 65%. Most of the shortages occurred in breast cancer patients (48%), followed by gynecologic cancer patients (26%).

Of the 235 patients in the subgroup examined in August/September 2011 (when shortages peaked), 23 (9.8%) experienced a change in therapy, he reported. No substitutions occurred in 2010.

Three medications were unavailable at St . Luke’s-Roosevelt : paclitaxel (74%), liposomal doxorubicin (22%), and 5-fluorouracil (4%). Leucovorin was also in short supply, but the consequences were difficult to track for this project, since most patients continued to receive the drug in reduced dosages, Becker said.

As a substitute for paclitaxel, the use of docetaxel increased by 80%, while paclitaxel decreased by 69% during the most critical period. The estimated cost of a single treatment with paclitaxel for the average patient was $47, versus $858 for docetaxel, a 1704% increase, Becker pointed out.

“When we surveyed treating physicians about the change in therapy, we found that they considered the alternative regimen inferior to the standard regimen in 30% of patients and thought the alternative regimen was more toxic in around 35%,” Becker said.

Today, he added, “Many drugs are still in sh rtage , but few affect care on a daily basis . There is definitely progress, though there is still vulnerability.”

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Last modified: May 21, 2015