Study: Cancer Drug Shortages Endanger Patients, Blamed on Manufacturing Issues

Cancer_Drug_ShortageCancer doctors say that shortages of key cancer medications are affecting their patients and the issues have to do with pharmaceutical plant manufacturing problems, according to a new study.

Most cancer specialists—83 percent—said that they experienced a drug shortage in the past six months, which is interfering with care in patients who are struggling to survive, according to USA Today. Some 92 percent said that these shortages impacted patient care. The survey involved 245 doctors and the study results were just presented at the annual meeting of the American Society of Clinical Oncology.

The new survey also found that 38 percent of doctors changed treatment from a generic drug to a more expensive and brand-name drug, which can significantly increase treatment costs, according to USA Today. The study was co-authored by Keerthi Gogineni at the University of Pennsylvania School of Medicine.

For example, said the researchers, in one case, a commonly used oral medication cost 140 times more than the generic intravenous version, wrote USA Today.

In 2011, 251 drug shortages were reported; 121 were reported in 2012, according to the U.S. Food and Drug Administration (FDA), wrote Bloomberg News. This February, the University of Utah Drug Information Service—an organization that tracks drug shortages—reported national and regional U.S. shortages of 320 drugs, the highest number since 2010, according Bloomberg News.

The issue is significant, notes Bloomberg News. Cancer specialists responding to the survey said that when they were unable to provide the best drug for their patients—no matter the cost—they were left with very difficult options, most of which could be less efficacious, could permit cancer to spread, could cause patients to go without treatment, could impact how cancer was controlled, and could jeopardize patient survival:

  • 79 percent were forced into a different chemotherapy regimen
  • 43 percent had to delay treatment
  • 37 percent had to choose among patients
  • 29 percent omitted doses
  • 20 percent reduced doses
  • 17 percent sent their patients to other doctors.

 

Cancer researcher William Li, executive director of the Angiogenesis Foundation, which sponsors research of blood vessel growth, told Bloomberg News that some hospitals actually use a lottery system to determine which patients receive medication.

The chemotherapy drugs that were most commonly reported to be in short supply were:

  • Leucovorin, a colorectal cancer drug, 68 percent
  • Liposomal doxorubicin, used to treat ovarian cancer, multiple myeloma, and other cancers, 63 percent
  • 5-FU, used in a variety of gastrointestinal cancers, 19 percent
  • Bleomycin, used in testicular cancer, Hodgkin lymphoma, and other cancers, 18 percent
  • Cytarabine, used to treat acute myeloid leukemia, non-Hodgkin lymphoma, and other cancers, 7 percent

Although it is not known how these disruptions affect patient health, “There is a lot of improvisation when trying to make educated guesses about what is the safest alternative,” Gogineni says, according to Bloomberg News. But a study last December from St. Jude Children’s Research Hospital did find an association between drug shortages and higher relapse rates in young people diagnosed with Hodgkin lymphoma who were enrolled in a national clinical trial. In fact, the number of patients free of cancer after two years dropped from 88 percent prior to the shortage to 75 percent when the shortage forced physicians to make treatment substitutions.

“When there’s a limited supply of drug, and you’re methodically going down the list of patients, that’s incredibly uncomfortable,” Dr. Gogineni said. “Those are not decisions we like to make,” according to MarketWatch.

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