Drug shortages hit a record high

According to a new bulletin published by the American Society of Health-System Pharmacists (ASHP), the number of ongoing and active drug shortages in the United States is currently 323 — the highest number recorded since ASHP began tracking data in 2001. The number of drug shortages has also been over 300 for over a year now.

The drugs in short supply include both basic and life-saving products, such as oxytocin, pain and sedation treatments, chemotherapy, and more. The top five drug classes with the highest number of active shortages are central nervous system drugs, antimicrobials, hormone agents, chemotherapy drugs, and fluids/electrolytes.

Currently, some of the reasons for drug shortages reported by manufacturers include supply and demand issues, manufacturing issues, business decisions, and raw material issues. However, 60% of manufacturers either said that the reason for the shortage was unknown or they didn't provide a reason. 

According to STAT+, increased FDA surveillance of drug manufacturers may also be impacting shortages. In 2023, FDA conducted 13,305 domestic inspections and 2,716 foreign inspections, an increase from the 7,147 domestic inspections and 186 foreign inspections conducted in 2021.

As FDA inspectors identify manufacturing issues, companies may have to slow or halt production until the problems are addressed. Last year, the agency found serious issues at Intas Pharmaceuticals, a key chemotherapy supplier located in India, and did not allow the company to distribute most of its medications in the United States, except for some chemotherapy treatments in short supply.

Some domestic manufacturing plants are also struggling with ongoing issues. For example, a tornado damaged Pfizer's manufacturing plant in North Carolina last July, and it still has not fully recovered. The plant had produced almost 30% of the sterile injectable medicines Pfizer sells to U.S. hospitals, and some production lines are not expected to fully return until the end of 2025.

Separately, the U.S. Drug Enforcement Administration (DEA) last August issued quota changes for controlled substances, moving from annual amounts to quarterly amounts and reducing the amount of a medication that a manufacturer is required to have in its inventory. However, DEA did not consider requirements for producing injectable medicines and the potential impact on supply.

"From what I understand about drug manufacturing, schedules are laid out at least a year in advance. Machinery used to make injectable products often takes a three-week period to switch out to another product," said Erin Fox, director of the University of Utah Drug Information Service, which provided the data in ASHP's bulletin. "By forcing manufacturers to make very small batches on a quarterly basis, this will result in significant manufacturing inefficiencies and shortages."

Efforts to combat drug shortages

Last week, HHS released a white paper outlining potential steps to prevent and mitigate persistent drug shortages.

In the paper, the agency proposed creating two nongovernmental organizations that would assess drugmakers' and hospitals' drug supply-related issues. The Manufacturing Resiliency Assessment Program would develop metrics to evaluate drugmakers' practices for monitoring shortages and improving their manufacturing performance. A separate Hospital Resilient Supply Program would provide incentives and penalties for hospitals based on their drug purchasing practices.

In addition, CMS has proposed new incentives for around 500 small hospitals to maintain a six-month buffer stock of essential medicines as part of its Inpatient Prospective Payment System rule for fiscal year 2025.

According to Fox, the federal government's current efforts to address ongoing drug shortages are "exciting and hopeful." However, she also noted that "we need a way forward to choose companies that are doing a better job and investing in quality."

"It's the only way we will claw our way out of this," Fox said. "Meanwhile, I think things will get worse before they get better." (Silverman, STAT+ [subscription required], 4/11; Reed, Axios, 4/11; ASHP drug shortage status report, accessed 4/11; Muoio, Fierce Healthcare, 4/10)

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