Data show drug shortages are bigger than ever

The number of drugs in shortage is bigger and lasting longer than ever, says Amy Sonderman, senior director of US advocacy and stakeholder engagement at USP.

At the recent Trade & Channel Strategies in Philadelphia last month, Sonderman shared key insights from USP’s 2023 annual drug shortage report. USP, also known as US Pharmacopeia, is a nonprofit organization that sets quality standards for pharmaceutical medicines.

Data showed that at the end of 2023, 125 active drugs were in shortage.

“We’re not talking about chemotherapies, even though the fact that we had a chemotherapy shortage is a crisis. We are talking about every category and class of drug. Shortages transcend across every disease state,” she told delegates at the conference.

Amy Sonderman, senior director of US advocacy and stakeholder engagement, USP

The report showed that the average duration of a drug shortage is more than three years compared to two years in 2020, and drugs in shortage affected a wide range of therapeutic classes, with 53% being injectables.

Additionally, data from the report revealed that the average price of sterile injectables medicines in shortage was nearly 8.5 times less than injectables that were not in shortage, while solid oral medicines in shortage cost 5 times less than those not in shortage.

“Again, all these factors lead to discontinuations, and what we saw in 2023 was that discontinuations increased by 40%,” Sonderman said.

“We knew that in Washington, there’s been a lot of proposals around trying to prevent and mitigate drug shortages,” she continued.

“We wanted to be a partner that could supply evidence-based proposals to some of what Congress was thinking, and what the administration was thinking around a coordinated approach to prevent these shortages.”

4 root causes of drug shortages

According to the report, USP used its Medicine Supply Map, created in 2021, to identify four factors that contribute to a drug shortage. The firm also worked with the FDA’s drug shortage database.

“Essentially it is a set of data that we’ve been able to collect that have been able to flag the root causes of drug shortages that would lead us to see when the next potential disruption or just a vulnerable environment would be for a drug shortage,” Sonderman said.

The first factor is low prices. Particularly older generic drugs that are priced low are vulnerable of to drug shortage, she noted.

Sonderman shared data from IQVIA that showed that 60% of oral solid dose products in shortage cost less than $4 a unit.

“You go to Starbucks and pay $6 for a cup of coffee, but a vial of cisplatin is $4,” she emphasized.

The second factor is manufacturing complexity. Drugs with higher manufacturing complexity, such as cisplatin, have an increased risk of shortage. “Not every generic manufacturer is able to ramp up production of these products,” she said.

The third factor is product concentration. “There is very heavily concentrated production of APIs and sterile injectables that are made primarily in India and China. Meaning if there is any sort of geopolitical crisis, if there is an environmental issue, it could wipe out an entire production of these lifesaving products.”

Lastly, quality concerns. This doesn’t necessarily mean the quality concerns of the product itself, she noted. For example, one may experience a risk-based inspection of their facility. “It’s not the FDA coming in and testing your product and telling you it’s not high quality. There could be a range of quality concerns,” Sonderman said.

Solutions

Sonderman proposes risk identification, incentivizing reliance, and fostering invocation to address drug shortages.

“We need to know where the pockets of these vulnerable drugs are,” she said.

“We need to reward manufacturers who are doing the right thing. Manufacturers who have a diverse geographic, contract suppliers, API manufacturers, suppliers who are able to hold several months of buffer stock of API, of finished dosed product, and manufacturers who are doing what they can to build reliability and resilience into their supply lines,” she continued.

Furthermore, public-private partnerships were suggested by Sonderman to help manufacturers adopt newer technologies and ramp up production quicker.

She said while proposals have come out of Congress, a lot of them have been piecemeal.

“We need Congress to work with the administration, and we need input from the private sector, from thought leaders, from industry, from all disciplines of practitioners and patients,” she said.

That’s why in 2023, USP created a coalition of public interest partners that actively advocates on Capitol Hill to push for reform.

“We want congressional leaders, and policy makers in the agencies and in the administration to know that this situation is not going away. It probably will just get worse.”

Quotes have been lightly edited for clarity.

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