Sometime before the end of this year, a federal task force is expected to release a report on the effect of drug shortages on the nation’s health care system. It should be an eye-opener for Congress and for the general public, as emerging evidence paints a picture of a drug delivery infrastructure stretched to the breaking point.
When a break occurs in the supply chain, as has happened more often in recent years, it is patients who suffer. We are not talking about the drugs meant to treat rare diseases, though those can also be affected. It is the so-called everyday medications and vaccines that prevent or treat everything from the flu to childhood cancer.
And it is children who are being put at risk by the latest drug shortage. Doctors across the country are warning of a shortage of the drug vincristine, which helps treat a murder’s row of childhood cancers, including leukemias, lymphomas and brain tumors.
The drug used to be produced by two companies — Pfizer and Teva Pharmaceutical Industries. Over the summer, however, Teva made what the Food and Drug Administration termed a “business decision” and stopped making the drug.
In itself, Teva’s decision was not unusual. Many drugs are dropped from production as they become less profitable to investors. But that doesn’t make them any less valuable to patients.
And that is certainly the case with vincristine, which has no apparent substitute, a flaw that became glaring when Pfizer, the only remaining manufacturer of the drug, ran into production problems.
“This is truly a nightmare situation,” Yoram Onguru, a pediatric oncologist at Baltimore’s Herman and Walter Samuelson Children’s Hospital at Sinai, told the New York Times. “Vincristine is our water. It’s our bread and butter. I can’t think of a disease in childhood cancer that doesn’t use vincristine.”
It’s not just cancer drugs. The American Society of Health-System Pharmacists, which tracks drug production, has a list of current shortages that runs 213 entries long.
“The rate of new shortages is slowing but long-term active and ongoing shortages are not resolving,” the society notes on its website. “The most basic products required for patient care are short: local anesthetics, pain medications (and) nausea medications.”
Even the most mundane of medical supplies are often at risk. When Hurricane Maria hit Puerto Rico in the fall of 2017 last fall, it didn’t just devastate the island. It destroyed one of the country’s few production centers of intravenous bags.
A lack of IV bags made it more difficult to treat an especially virulent strain of flu in the winter of 2018. Hospitals, unable to provide patients with a saline drip, were forced to offer sufferers Gatorade.
“It’s unprecedented to have this kind of large-scale, nationwide drug shortage of such a basic item in U.S. health care,” John Armistead, chief pharmacist at the Florida-based Lee Health, said at the time. “So it’s quite dramatic.”
As we continue to learn, however, drug shortages are no longer unprecedented. Rather, they are becoming routine.
So what to do? Congress, as it awaits the report from the task force appointed to study the issue and provide recommendations, would do well to consider the solutions the American Hospital Association has been urging for the past several years. Those recommendations include:
Requiring pharmaceutical companies to be more transparent about what drugs they are manufacturing and where the work is being done;
Making sure there is a redundancy in the manufacture of “critical” products, such as vincristine and IV bags;
Requiring manufacturers of critical medications and supplies to have a “reasonable” contingency plan in case of a production shutdown;
Using incentives to push other manufacturers to step in when there is a drug shortage.
All reasonable suggestions, all worth debate. And all worth debating now, because the next shortage is likely around the corner, and no patient should be put in the situation facing those needing vincristine:
“You either have to skip a dose or give a lower dose,” Onguru told the Times. “Or beg, borrow or steal.”