April 24, 2013 -- A new study of the effects of oncology drug shortages, published in the April 1 edition of the American Journal of Health-System Pharmacy (AJHP), reveals that cancer patients are paying a high price in terms of delayed and altered treatment. Shortages of oncology medications, including methotrexate, liposomal doxorubicin, fluorouracil, leucovorin, and paclitaxel, have increased in recent years.
The National Survey on the Effect of Oncology Drug Shortages on Cancer Care, by Ali McBride, Pharm.D., M.S., BCPS, specialty practice pharmacist in hematologic malignancies/stem cell transplant, The James Cancer Hospital and Solove Research Institute, et al., found that cancer drug shortages often result in disruptions in the timing of chemotherapy treatments, alterations in the dose or regimen administered, or missed doses when alternative agents are unavailable.
Ninety-three percent of the 243 survey participants reported delays in chemotherapy administration or changes in treatment regimens due to shortages. Eighty-five percent reported increased costs associated with shortages, and 10 percent reported reimbursement challenges.
Generic injectable drugs, including oncology and anti-infective therapies, are most prone to shortages. According to the Food and Drug Administration, oncology drug shortages tend to result from quality issues at the manufacturing site, including contamination by items such as glass shards or fungi.
The study found that oncology drug shortages affect both the safety and quality of cancer care. According to the authors, equivalent therapeutic substitutions for certain medications are often unavailable or unknown. Health care providers who turn to the alternative medicines in the face of shortages risk suboptimal treatment responses. Alternative therapies also may not be as effective as frontline therapies or may carry an increased risk of adverse effects, according to the study.
Patient care is not the only element affected by oncology drug shortages. When first-choice therapies are unavailable, other—often more expensive—drugs must be purchased.
The study also revealed the time costs involved when pharmacists and other hospital staff must find and purchase substitutes. At 34 percent of responding institutions, at least 1,000 hours of additional labor annually was needed to manage shortages. Near-miss errors due to shortages were reported by 16 percent of participants. Forty-four percent of responding institutions revealed that the conduct of clinical trials was affected by drug shortages.