Drug shortages are nothing new for the healthcare industry, but the Covid-19 pandemic caused a wave of new shortages—and with it came increased public attention.
That’s why these days, it can seem like new shortages are creeping up everywhere, from Adderall to weight loss drugs like Ozempic and Wegovy.
So, what causes drug shortages? Turns out, a lot of things.
“Every drug shortage is unique,” according to Craig Burton, SVP of policy and strategic alliances at the trade group Association for Accessible Medicines, which represents generic drugmakers.
But there are a few factors that pop up consistently: quality concerns, financial incentives, and increased demand.
Quality control: Though brand-name drugs like Adderall, Ozempic, and Wegovy get a lot of attention when there’s a shortage, the generic, low-cost injectable drugs make up the majority of shortages, according to Michael Ganio, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists.
The most common reason behind generic injectable drug shortages is quality issues at manufacturing plants, said Erin Fox, associate chief pharmacy officer of shared services at the University of Utah Health in Salt Lake City.
Making injectables is a very complex process that requires more testing than pills or solid dosage drugs, Ganio said. The FDA also heavily regulates the manufacturing of these drugs, which means there are a ton of protocols plants have to follow.
The combination of complexity and heavy regulation means there’s lots of room for mistakes, too. Something as seemingly small as using the incorrect number of vials when making a batch of an injectable drug could delay the manufacturing process, Ganio said. Other issues could be a piece of equipment not working properly or a documentation error occurring during sterility testing.
Keep reading here.—MA
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