DRUG SHORTAGES IN USA!!

May 24, 2012 — In a recent survey of 200 oncologists in the United States, 90.5% reported experiencing shortages of key cancer drugs in their practices.

The most frequently cited drug was doxorubicin; 70.5% of respondents reported its shortage. Cytarabine and methotrexate were the 2 other drugs most commonly identified as being in short supply; they were cited by 40.0% and 30.5% of respondents, respectively.

The poll was conducted April 11 and 12 by MDLinx, an online physician service.

One in 10 of the responding oncologists reported that patients had gone into the "grey market" to find cancer drugs.

The survey results indicated that 42% of responding oncologists were concerned with the safety of imported cancer drugs approved on an emergency basis by the US Food and Drug Administration (FDA). Overall, 31.5% of clinicians were unsure about quality, whereas 26.0% had full confidence in the overseas drugs.

This survey is another indicator of the stress caused by the ongoing problem of drug shortages, especially in oncology.

The situation has apparently spawned a cottage industry of oncologist surveys.

In another survey conducted earlier this year by a consulting company with ties to the pharmaceutical industry, 82 of 206 (40%) respondents indicated that "a patient died sooner due to drug shortages."

The situation has been dire for an extended period of time, and experts have repeatedly warned about potentially catastrophic consequences.

In an essay published last year in the New England Journal of Medicine (2011;365:1653-1655), and reported at the time by Medscape Medical News, 2 experts suggested that the chronic shortage of cancer drugs would eventually cause a patient death.

Mary Gatesman, PharmD, from the Virginia Commonwealth University Health System in Richmond, and Thomas Smith, MD, from the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center in Baltimore, Maryland, said that they were "unaware of any documented death of a patient with cancer," but warned that "it is only a matter of time."

A few months later, a prominent pediatric oncologist sounded an alarm about the shortage of a preservative-free version of methotrexate, saying that "children will die" if the drug disappeared from formularies. The drug is critical to the treatment of children with acute lymphoblastic leukemia. The supply situation for this version of methotrexate subsequently improved.

The drug shortage problem has hit oncology especially hard. However, the FDA recently issued a report saying that the overall drug shortage situation had stabilized and improved.

The number of new drug shortages in the United States in 2012 is half that of the same time period last year, according to the May 4 report. There were 42 drugs newly reported as being in shortage in 2012, compared with 90 in the same period in 2011, said Margaret Hamburg, MD, the FDA commissioner, in an FDAVoice blog entry.

Dr. Hamburg wrote the blog post as an informal report to mark the 6-month anniversary of President Barack Obama's signing of an executive order to help the FDA do battle with prescription drug shortages.

The other major accomplishment in the 6 months since the executive order was the prevention of 128 shortages, according to the report.

The FDA report highlighted the improved status of 4 cancer drugs, including doxorubicin.