By Edward C. Li, PharmD, BCOP, Drugs & Biologics Editor and Jennifer Hinkel, NCCN e-Bulletin Editor-in-Chief
NCCN conducted a survey in August 2009 to investigate how oncology practices and providers have been affected by recent and ongoing shortages of two items commonly used in oncology practice. A shortage of intravenous leucovorin, used to augment the efficacy of fluorouracil and as a rescue to avoid significant toxicities with high-dose methotrexate protocols, was initially reported in late 2008, but is now resolved according to the FDA. However, American Society of Health-System Pharmacists (ASHP) still lists IV leucovorin as being affected in their drug shortages bulletin. A second, ongoing shortage of technetium-99m (Tc-99m), a radioisotope used in several imaging and diagnostic procedures for cancer, continues to affect global availability for this radioisotope. This shortage is due to an unplanned shutdown of a reactor used to produce materials needed for the manufacture of Tc-99m.
The shortages of leucovorin and Tc-99m have a potential to disrupt workflow or delay care, which can possibly lead to negative patient outcomes. This is especially concerning for potentially curative situations as in the case of treating early stage colorectal cancer with a fluorouracil/leucovorin-based regimen. Moreover, Tc-99m is used in various imaging tests to detect, diagnose, or monitor cancer. Abstaining from or delaying the use of essential imaging could pose serious risks to patients. One strategy to cope with these shortages would be to use alternative agents or imaging tests, but depending on the alternative, this could lead to inferior outcomes or an increase in cost for the healthcare system. NCCN’s survey last month sought to gain some preliminary insight as to the seriousness of these shortages on patient care.
Results from the NCCN survey indicated a scattered impact of the shortages on physicians, pharmacists, and other clinicians. Survey responses included data from 718 individuals, 64% of whom were practicing physicians with a cancer specialty, 15% of whom were advanced practitioners and nurses, and 12% of whom were practicing oncology pharmacists. Overall, most respondents were either not impacted by the shortages or were able to meet demand despite the shortages (77% for leucovorin, 86% for Tc-99m). Mild-moderate and severe difficultly in meeting demand was 18% and 5% (respectively) for leucovorin, and 12% and 2% (respectively) for Tc-99m.
Of importance were the strategies employed to meet the needs of patients because of the shortages. For leucovorin, the predominant strategy was to obtain the drug from an alternate source, followed by substituting leucovorin with levoleucovorin. Omitting leucovorin from the regimen or changing to a regimen that does not use leucovorin was employed commonly for patients receiving chemotherapy for metastatic colorectal cancer, but not as commonly if a patient was receiving adjuvant chemotherapy. For Tc-99m, most clinicians used an alternate imaging study or procedure and/or delayed the use of the procedure requiring Tc-99m. In some cases, a different radioisotope was used instead of Tc-99m or the overall use of a test of procedure requiring Tc-99m was reduced.
These survey results provide an interesting perspective at how oncology clinicians are affected by shortages. As this shortage problem persists, patient outcomes will likely be the focus. While the overall ability of clinicians to meet the demands of patients was good in our survey, many believe that these shortages will have a negative impact on patient outcomes (overall, 58% and 64% for leucovorin and Tc-99m, respectively).