Although drugmakers are not required to tell the FDA or the ASHP why a drug is in shortage, an FDA review revealed more than 60 percent of drug shortages from 2013 to 2017 were because of quality problems, according to the ASHP.
A Vizient study in 2021 found facilities with many manufacturing violations were more likely to have a shortage, and an expert from Washington University in St. Louis said May 9 that more than 1 in 4 generic prescriptions were made by companies with recent FDA warning letters.
Some of the most vulnerable medications include injectable solutions — including chemotherapies — and generics because they are made in a “just-in-time” model, according to Erin Fox, PharmD.
Generic drugmakers “don’t have a lot of redundancies, they don’t have a stockpile,” said Dr. Fox, associate chief pharmacy officer for shared services at Salt Lake City-based University of Utah Health. “So even if one company has a problem, it almost always immediately results in a shortage.”
In March, drug shortage experts testified before a Senate subcommittee about the risk of drug shortages, which have hit a 10-year high, and many expressed concerns about quality issues and where active pharmaceutical ingredients are sourced. For example, in 2022, the FDA inspected only 6 percent of the 2,800 overseas manufacturing facilities that produce ingredients for the U.S. drug supply, the ASHP said.
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