America's Secretive Drug Shortage Explained—By a Pharmacist Fighting Back

The United States health care system is under pressure as escalating drug shortages grip the nation. However, the reasons behind over half of these shortages are shrouded in mystery.

In the first quarter of 2023, there were 309 active national drug shortages, the highest they have been since 2014, according to estimates by the University of Utah Drug Information Service.

Each of these drug shortages affects at least half a million consumers on average, the U.S. Office of the Assistant Secretary for Planning and Evaluation estimates, and many shortages have resulted in the rationing of health care necessities.

"The most concerning shortages right now are chemotherapy shortages, particularly because there are almost never good alternatives," Erin Fox, associate chief pharmacy officer at the University of Utah, told Newsweek. "For some shortages, patients are having therapy delayed or their doses reduced. There are other shortages of critically needed antibiotics, such as Bicillin-LA."

In a survey of 345 members of the American Society of Health-System Pharmacists, 344 respondents said that they had been affected by shortages of these critical drugs.

"There are also a number of shortages of generic injections that are mostly used inside hospitals," Fox said. "There are generally alternatives, but these take a lot of work as far as changing the electronic health record and educating staff about the changes and stocking new products."

These alternatives may also be more expensive.

"Hospitals are really struggling with drug shortages," Fox said. "The costs to manage these shortages are challenging, particularly since they require more labor, and there are definitely labor shortages. Further, hospitals have no mechanism from wholesalers to understand how much of a product they can access and when it will arrive.

"It's basically Hunger Games when you are ordering— the more resources you have, the better you will do."

In 2022, Fox's team at the University of Utah investigated the reasons behind each of these drug shortages, as reported by their manufacturers. The second and third most significant causes were supply and demand and manufacture, which represented 19 and 18 percent of the shortages, respectively.

"In the case of [chemotherapy drugs] cisplatin, carboplatin, and methotrexate, one company had serious quality problems at their factory in India," Fox said. "This created a situation where other companies couldn't increase their manufacturing quickly enough. For Ozempic and Wegovy, the issue is manufacturing isn't meeting demand."

However, in 56 percent of cases, the reasoning for the drug shortage was either unknown or would not be provided by the manufacturers.

"So much of drug manufacturing is not transparent," Fox said. "Companies are allowed to have all of the following as a trade secret: the name of the company doing the actual production; a list of drugs made in a factory; the source of the raw material; the market share of production; the total amount of production; and sales. All of these secrets make it challenging to actually figure out what is truly happening with these different shortages."

Fox and her team have been following national drug shortages in the U.S. since 2001. "On average, most shortages last a year or more, but many last multiple years," she said.

So what can be done to solve this crisis? "The best proposal I have seen is the one from Brookings' Marta Wosinska," Fox said.

Wosinska's proposal involves the following:

1. Supporting manufacturing upgrades to improve quality

"This isn't just a handout to drug companies, though, it is tied to them meeting specific quality metrics."

2. Purchasers need access to data to make better choices for selecting generic products.

"FDA says they are all equal, but FDA also has non-public data that shows the manufacturing facilities are not equal and some have much higher quality than others. Access to a rating system helps hospitals choose wisely with some federal policies to encourage this behavior...At the end of the day, clinicians need to know what they can access, how much, and when and all three of those elements are extremely challenging."

3. Implementing a safety net

"Nothing is perfect, so there would be targeted government stockpiles of the most at-risk and critical products."

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