For Charles Penley, MD, a partner at Tennessee Oncology, in Nashville, the drug shortage hit home in the spring and summer of last year. What had been a concern for years suddenly bubbled over when supplies of some of the most commonly used cancer drugs evaporated without warning. Staffers scrambled to track down suppliers while physicians occasionally made do with alternative treatments.
“We had to change some things for our practice to stay on top of it,” says Penley, who chairs the Government Relations Committee of the American Society of Clinical Oncology (ASCO). “We assigned a staff member the responsibility of making sure the anticipated needs of each clinic could be met.”
It wasn’t easy. The practice includes more than 50 physicians at multiple sites. “We have places where patients and drugs must come together in a timely manner,” says Penley. The practice’s formulary committee worked out substitution policies where appropriate. When leucovorin and fluorouracil (sold under brand names like Adrucil and Carac) were in shortage, for example, doctors would occasionally substitute capecitabine (Xeloda).
“Xeloda is not a general substitute for leucovorin,” cautions Penley. “Leucovorin and 5-FU [fluorouracil] are often given in combination, and 5-FU was also in short supply. Xeloda was substituted for our colon cancer patients. We also used levoleucovorin [Fusilev], a stereoisomer of leucovorin, which is used primarily in pediatric patients but rarely in adults.” And since levoleucovorin dosing differs from leucovorin dosing, the former could not be substituted in a one-to-one ratio for the latter.
“The dosage calculations for our chemotherapy regimens had to be changed to reflect the different dosing when levoleucovorin was used,” says Penley. “This caused headaches for our IT department, given that all our chemotherapy regimens are in our electronic health records.”
For practices like Penley’s, drug shortages have become a constant thorn. And while shortages have eased in recent months, Tennessee Oncology still keeps a wary eye on the fragile stockpile of medications.
Under the new U.S. Food and Drug Administration Safety and Innovation Act, the FDA will come up with its own early-warning system designed to flag shortages. Drug manufacturers are required to give the feds six-month advance notice when they know one of their drugs will be in short supply. And the agency can use that time to prevent a problem — or at least notify providers that a problem is developing.