More-than-typical shortages of common over-the-counter and prescription drugs have caused headaches for sick Americans and those managing chronic diseases. Public attention has focused on widespread shortages linked to increased demand for medicines used to treat common respiratory diseases, such as flu and respiratory syncytial virus. Those ailments spiked nationwide after a pandemic hiatus. "Demand shortages have been kind of a new challenge for us since the pandemic," said Valerie Jensen, associate director of the drug shortage staff at the FDA. In addition to shortages of cold and flu medication, Jensen pointed to surging demand last year for Adderall and the diabetes drug Ozempic. “We've had some unusual circumstances.” Most shortages were caused by supply-chain issues for which public policy solutions might exist. But while long-term changes might help the supply chain function better, they wouldn't necessarily stop a real-time shortage in its tracks. Erin Fox, a senior pharmacy director at University of Utah Health who directs its Drug Information and Support Services, says her team is tracking 290 active shortages with only a handful spurred by consumer demand. What’s going on: — Supply disruptions: Contamination at manufacturing facilities is among the most common problems, although delays and discontinuations also contribute, according to the FDA. Supply shortages are often linked to companies cutting corners, said Ilisa Bernstein, who spent the past 10 years of her more than 30-year FDA tenure dealing with shortage-related compliance issues. “When you cut corners, you have problems, and when you have problems, you have to fix them,” said Bernstein, now interim CEO at the American Pharmacists Association. Fixing those problems often means shutting down the manufacturing line. — Haves and have-nots: Some of the drug shortages are actually signs of misallocation. Certain parts of the country might have more supply than they need, while other parts of the country are low on or out of stock. Reallocation is easy enough for big national pharmacies like Walmart but harder for hospitals or independent pharmacies. — Stockpiling and hoarding: “When FDA announces a shortage, orders really go up,” said Marta Wosińska, a health care economist and visiting fellow at the USC-Brookings Schaeffer Initiative on Health Policy. “The behavioral response exacerbates the problem,” said Wosińska, who has also worked at the FDA. Wholesalers buying drugs in anticipation of a shortage can trigger a shortage or make it harder to end an ongoing one. Why it’s so hard to end drug shortages: Health care manufacturing is complex, with slim profit margins for makers of the generics most often in short supply. As a result, generic drug manufacturers are reluctant to produce more product than they know they can sell, according to Wosińska. What could help: — More transparency from pharma: Fox, Bernstein and Wosińska told Erin that to address shortages, drug companies need to be more transparent about where the drug supply is at any given time. Without better data about the drugs’ location, it’s impossible to send them from areas of the country that have enough supply to those that don’t. Companies are already required to notify the FDA about supply or manufacturing disruptions, Jensen explained, noting that the agency used that information to prevent hundreds of shortages over the past five years. But there's no similar requirement for reporting increased demand. "We do think that would be helpful," Jensen said of advanced warnings. "What that would do is help us to use our tools earlier and hopefully prevent shortages before they occur," she said. But for now, that disclosure is voluntary. "It would take legislation to require them to actually have to notify us of increased demand," Jensen said. — Drug compounding: Custom formulations of drugs made by pharmacists, a process known as drug compounding, can rapidly address shortages of certain drugs. In response to a shortage of the antibiotic amoxicillin, for example, the FDA relaxed some rules for compounding the drug to create more supply. Bernstein’s group sent a letter to the FDA this month asking the agency to issue similar guidance to allow for compounding for ibuprofen and acetaminophen. — An update of the essential medicines product list: An executive order issued by former President Donald Trump in 2020 required the FDA to create a list of essential medicines to have on hand with an adequate supply at all times. The problem, Wosińska said, is the list is geared toward responding to infectious diseases and chemical, biological, radiological and nuclear threats. We should expand the list to include products also critical in non-crisis times, such as baby formula, antipsychotic drugs and mood stabilizers, Wosińska wrote in a Brookings Institution paper last year.
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