Cancer drug shortages cause treatment, research problems

Frequent shortages of oncology drugs in a recent 1-year period led to delays in chemotherapy and changes in therapy, complications in clinical research, increases in the risks of medication errors and adverse outcomes, and higher medication costs, according to new survey findings.

Senior study author James M. Hoffman, PharmD, of St. Jude Children's Research Hospital in Memphis, Tennessee, and colleagues distributed a 34-item online survey on oncology drug shortages to 1,672 members of the Hematology/Oncology Pharmacy Association and other organizations. The category of “oncology drugs” covered all medications essential in the care of cancer patients, including supportive-care agents. The survey focused on a 12-month period ending in October 2011.

After analyzing 243 completed questionnaires, almost all (97%) from pharmacists, Hoffman's group learned the following:
  • The oncology medications most frequently reported to be in short supply during the preceding 12 months were fluorouracil, leucovorin, liposomal doxorubicin, and paclitaxel.
  • Nearly all survey respondents (98%) reported having dealt with a shortage of at least one chemotherapy agent or other essential cancer-related drug in the previous 12 months.
  • Nearly all respondents (93%) reported delays in chemotherapy administration or changes in treatment regimens due to drug shortages.
  • The majority (85%) reported increased costs, and 10% reported reimbursement challenges related to the shortages.
  • The carrying out of clinical trials was affected by drug shortages at 44% of the represented institutions.
  • One-third of the represented institutions (34%) needed at least 1,000 hours of additional labor per year to manage shortages.
  • Changes in therapy leading to near-miss errors were reported by 16% of the respondents, and 6% reported one or more actual medication errors attributable to a drug shortage.

 “Unlike medications for other diseases, there are few, if any, therapeutically equivalent alternatives available for many oncology drugs in short supply,” noted Hoffman in a statement from St. Jude.

As explained in the statement, prior research has indicated that most medication shortages occur in the supply chain of generic injectable drugs, particularly agents that combat cancer and infections. In 2012, the FDA was allowed to implement additional measures to prevent and ease drug shortages, including requiring manufacturers to report anticipated supply problems of key medications. However, cautioned Hoffman, additional action is needed to address continuing shortages.

The study findings appear in American Journal of Health-System Pharmacy (2013;70[7]:609-617).

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