Originally published by our sister publication Pharmacy Practice News

By Gina Shaw

The rising number of drug shortages in the United States poses a significant risk not only to the health and safety of patients but to national security, according to testimony at a March 22 hearing before the Senate Homeland Security and Governmental Affairs Committee.

Drug shortages increased by nearly 30% in 2022 compared with 2021, with the average shortage lasting about 18 months, noted a report released with the hearing by the committee’s Democratic majority, led by Sen. Gary Peters (D-Mich.).

“Since 2018, we have been tracking over 200 active and ongoing shortages. For many months in that timeframe, there were over 250 active and ongoing shortages, and at the end of 2022, we were monitoring 295 active and ongoing shortages,” said Erin Fox, PharmD, the associate chief pharmacy officer for shared services at University of Utah Health, in Salt Lake City, in testimony before the committee.

Of the products, 17 basic critical care drugs, most of which are injectable products, have remained in shortage for more than decade, according to the report, and nearly one-third of these are antimicrobial agents. Among the antimicrobials in long-term shortage are ampicillin-sulbactam and vancomycin. 

“Nearly half of the antimicrobial agents listed on the FDA’s Essential Medicines list … ‘have no domestic API [active pharmaceutical ingredient] manufacturing,’” the report said.

“The Department of Defense (DOD) has acknowledged that it is ‘wholly dependent”’ on the commercial market for pharmaceutical products to ensure the ‘health, safety, and wellbeing of DOD personnel,’” the report noted, adding that a 2021 Department of Homeland Security (DHS) Key Threats Assessment found that medical products sourced from abroad or that depend on global supply chains will remain especially vulnerable to disruptions “due to sustained demand, foreign government actions to secure supplies of such goods for their country’s use, and the length of time required to reconstitute these production capabilities elsewhere.”

The hearing and accompanying report cited several reasons for increasing drug shortages, including:

Few incentives for manufacturers to produce difficult-to-make generic injectable drugs with low-profit margins. “The low prices for some of these products are due to a “race to the bottom”—the result of pressure from hospitals that are paid for most hospital stays with capitated payments and group purchasing organizations (GPOs) that contract on behalf of hospitals,” Dr. Fox said. “Manufacturers cannot be expected to produce products at a loss.”

Overreliance on foreign and geographically concentrated sources for critical drugs and APIs and limited domestic manufacturing capabilities. (Between 2010 and 2015, the number of Chinese-based API manufacturers registered with the FDA more than doubled, from 188 in 2010 to 445 in 2015.)

Lack of end-to-end visibility into the drug and API supply chain for the FDA and other government entities, as well as for industry and other key players. “The FDA is currently unable to assess the percentage of life-supporting and life-sustaining medications that have fewer than three manufacturers or rely on only one API supplier because the FDA does not have a list of life-supporting and life-sustaining drugs,” the report said.

Lack of rewards or incentives for manufacturers to invest in quality. “Sixty-two percent of shortages between 2013 and 2017 were due to manufacturing or quality problems based on the most current aggregate data from FDA that outlines reasons,” Dr. Fox testified.

Michael Ganio, PharmD, the ASHP senior director of pharmacy practice and quality, who attended the meeting but did not testify, told Pharmacy Practice News that efforts to strengthen the supply chain should avoid overfocus on the location of suppliers. “Based on our experience, location is less relevant than the fact that there are one or two nodes where there could be a problem,” he said. “There’s a risk of drug shortages whenever you have just one or two suppliers of anything, anywhere in the world.”

Efforts to strengthen the pharmaceutical supply chain should begin with a reassessment of what medications are most critical, Dr. Fox said. “FDA’s list of essential medicines should not be the starting point for identifying critical medicines that may need their supply chains strengthened because it is not comprehensive for essential medical care and in many cases the selections do not make sense from a clinical perspective or resource allocation perspective. It is also critical that the government supplement any updates to the list with supply-side analytics to identify vulnerabilities.”

The majority report’s recommendations for addressing the continued risk of shortages included:

  • investment in domestic advanced manufacturing capabilities for critical generic drug products regularly in shortage;
  • regular medical supply chain risk assessments between government agencies;
  • requirements that manufacturers of life-supporting and life-sustaining drug products report increased demand and export restrictions to the FDA;
  • ensuring that the FDA’s supply chain data can be used to monitor supply chain vulnerabilities and conduct predictive modeling;
  • better coordination of public and private efforts to predict and mitigate supply chain vulnerabilities; and
  • mandatory recall authority for the FDA for all drugs that pose a serious threat to health.

“We support any measures that would incentivize quality,” Dr. Ganio said. “We know from the 2019 report on drug shortages issued by the FDA, as well as from our own experiences, that many shortages can be traced to quality issues.”

He said ASHP has been in close communication with Mr. Peters’ office as well as a number of other legislators. “There’s a lot of interest right now in addressing this issue, especially as we’ve just emerged from a winter where we had several high-profile shortages.”

Drs. Fox and Ganio reported no relevant financial disclosures.