Drug shortages jeopardize patient access to quality hospital care

"Hospitals are doing everything they can to ensure that patients have access to the medications they need, even if it means sourcing them from outside traditional suppliers and paying more for the same drugs," he said.

Buying drugs outside of existing contracts during a shortage also means the costs for those drugs are typically higher than usual. The challenges extend beyond obtaining the drugs. Shortages have introduced a labor-intensive process of finding sources for the drugs, outside normal suppliers. Adapting means retraining staff to use alternative medications and recalibrating doses, all of which add to the existing strain of workforce shortages in the healthcare sector.

"This need for additional staff training and expertise makes it exponentially harder and more costly to deliver care," Krishnamurthy added.

Supplies of generic drugs are lagging

A significant portion of the drugs in shortage are generic, sterile injectable drugs, which have seen a decline in production due to insufficient profit margins. This has led to a lack of incentives for manufacturers to continue production, further worsening the supply crisis. 

Often, generic drug makers just stop production without any notice, sometimes throwing the healthcare system into crisis, with organizations forced to rapidly find alternatives.

"Congress is aware of this issue, and there are proposals in place to address it, but the problem persists," Krishnamurthy said.

Pharmaceutical supply chain impacted by natural disasters and COVID

Natural disasters and global disruptions in the supply chain have also played a role in aggravating the shortages. Krishnamurthy cited examples, including a recent, massive saline shortage caused by a hurricane that hit Puerto Rico, where a large portion of the U.S. supply comes from.

Medical imaging iodine contrast agents also became very scarce after China shut down all factories in Shanghai, China, for months to contain a large resurgence of COVID-19 in 2022. The shuttering of GE Healthcare's main X-ray contrast factory there caused large ripples across the world at hospitals. He said these events have forced hospitals to ration supplies and delay critical procedures, compromising patient care.

The problem, according to Krishnamurthy, is not just the existence of drug shortages, but the exponential increase in the number of drugs affected. "When shortages affect drugs used daily across hospitals, it creates a cascading effect that becomes unsustainable for patient care," he said.

AHA advocacy efforts to prevent drug shortages

The AHA is supporting the Drug Shortage Prevention Act of 2023, which is currently being reviewed by the Senate Committee on Health, Education, Labor, and Pensions. 

This bill would require drug manufacturers to notify the U.S. Food and Drug Administration (FDA) if there is an increased demand, export restriction, or other circumstance that may result in a shortage of certain critical drugs. Currently, drug manufacturers are required to notify the FDA in the event of a discontinuation or interruption in the supply of prescription drugs that are life-supporting, life-sustaining, or used for a debilitating disease or condition, including those used in medical emergencies, surgeries, or public health emergencies.

The bill would also require drug makers to notify the FDA if there is an increased demand, export restriction, or other circumstance that may result in a meaningful shortfall or delay in meeting the demand for such drugs. Manufacturers must notify the FDA as soon as possible, but no later than 10 days after the onset of the relevant circumstance. The notice must include the reasons for the increased demand, the expected duration, and any other information the FDA requires. The bill's requirements apply to both prescription and nonprescription drugs.

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