‘This Is Truly A Nightmare Situation’: Where There’s No Substitute, Drug Shortages Cripple Life-Saving Care
A shortage of a chemotherapy drug used to treat cancer in children highlights the serious perils of the rampant shortage problem facing the industry. "It’s our bread and butter," said Dr. Yoram Unguru, a pediatric oncologist. "There is no substitution ... You either have to skip a dose or give a lower dose — or beg, borrow or plead." While the FDA has been trying to address the issue of shortages it's fallen short in its efforts to grant addition approval of generics. Meanwhile, companies are trying other methods to combat the problem.
The New York Times:
Faced With A Drug Shortfall, Doctors Scramble To Treat Children With Cancer
A critical drug that serves as the backbone of treatment for most childhood cancers, including leukemias, lymphomas and brain tumors, has become increasingly scarce, and doctors are warning that they may soon be forced to consider rationing doses. Persistent shortages of certain drugs and medical supplies have plagued the United States for years, but physicians say the loss of this medication, vincristine, is uniquely problematic, as there is no appropriate substitute. (Rabin, 10/14)
Stat:
FDA Bid To Bolster Generics, Combat Shortages Isn't Working — Yet
Although the Food and Drug Administration has maintained that additional generic approvals should promote competition and alleviate shortages, the proportion of approvals for drugs that could address those concerns has actually remained steady, according to a new report. From July 2016 to December 2018, the total number of generic drug applications approved by the agency gradually increased during most quarters, from 133 to 262. Of the 1,832 generics approved during that time, 20.4% faced limited competition at the time of the approval, and 39.1% had experienced a shortage in the previous five years. (Silverman, 10/14)
The Wall Street Journal:
Drugmaker To Test Machine Learning To Prevent Drug Shortages
Merck KGaA plans to use analytics and machine learning to predict and prevent drug shortages, a move that could also save it money. Currently, the Germany-based pharmaceuticals company needs to stockpile medications to make sure it has enough on hand, meaning some of them expire before they can be used. Merck said its supply-and-demand forecasts are about 85% accurate today. (Castellanos, 10/14)
