After we wrote about the ongoing problem of drug shortages, we heard from one of our readers.
“I start chemotherapy tomorrow and was to take adriamycin (generic doxorubicin),” she begins. But:
My oncologist called today to say there is a shortage so I have to have an alternative … I have enough stress right now with the diagnosis of breast cancer, surgery recovery and now this. What is the real answer to this shortage? I am told cancer patients all over the country are being told the same.
Indeed, several chemotherapy drugs are among those most in demand, Cynthia Reilly, director of the practice development division at the American Society of Health-System Pharmacists, tells the Health Blog. The group keeps a list of all medications and vaccines in short supply; it now numbers more than 140. (When the WSJ wrote about shortages in 2002, the list stood at 40.) The FDA has its own list, but it’s shorter than ASHP’s because it tracks only drugs deemed medically necessary.
Drug shortages occur for a range of reasons that vary by medication: the unavailability of raw ingredients, FDA enforcement actions that halt production, voluntary recalls, poor inventory ordering, a change in product formulation and even rumors of an impending shortage, which can cause hoarding, according to the Institute for Safe Medication Practices. When drugs are made only by a few suppliers, any one manufacturer can have a huge impact, Michael Link, president-elect of the American Society of Clinical Oncology, tells the Health Blog.
According to the ASHP’s entry on doxorubicin products, one producer reported an unexpected increase in demand, another suffered manufacturing issues and a third didn’t offer a reason.
Vincristine, used to treat leukemia and pediatric cancers, among others, has also been affected by increased demand and manufacturing problems, according to ASHP. One maker of etoposide, for testicular cancer and small-cell lung cancer, was beset by manufacturing delays, while others couldn’t provide an explanation, ASHP says. And cisplatin, which Link says is very important for use against testicular cancer, is also on the ASHP’s list.
“These are drugs that have become mainstays of curative therapy” for both pediatric and adult cancers, Link says. And for many of them, there are no good workarounds or alternatives — randomized trials have shown them to improve outcomes when added to standard treatment, he says. “When we’re forced to treat patients without that drug, we know we are giving suboptimal treatment,” he says. “And it’s adding stress at a time when [patients] can ill afford it.”
Link and Reilly were among the attendees at a drug shortages summit convened earlier this month by their organizations, the ISMP and the American Society of Anesthesiologists. Manufacturers and representatives of regulatory agencies also attended. In addition to establishing working groups to study longer-term solutions to the problem, the group explored some short-term measures, including pushing back expiration dates when they are arbitrary, Link says.
Image: iStockphoto
