Rising rate of drug shortages touted as national security threat

A Senate Homeland Security Committee examined growing health care shortages amid reports of hospital rationing.

Rising shortages of cheap but essential drugs are forcing hospitals to make 'horrific' choices and pose a threat to national security, according to report and testimony at court hearing Senate Homeland Security on Wednesday.

A report prepared for the hearing found that drug shortages increased nearly 30% last year compared to 2021, with an average shortage lasting 18 months and some lasting 15 years. They include common antibiotics, anesthetics and sterile fluids used to keep IV medication tubing clean. opaque supply and the fact that as much as 80 to 90 percent of some products are made overseas, said Sen. Gary Peters, Democrat of Michigan and Chairman of the Senate Homeland Security and Governmental Affairs Committee. p>

“Taken together, these underlying causes not only present serious concerns to the provision of adequate patient care, but they also pose serious threats to national security” , said Mr. Peters.

Dr. Andrew Shuman, a cancer surgeon from Michigan, told senators during the hearing that shortages in his field have come to "represent a tragedy unfolding in slow motion."

Dr. Shuman, who holds leadership positions with the University of Michigan Hospital System and the Ann Arbor Veterans' Health System, said a cheap and established cancer drug called etoposide was recently out of stock. He had to weigh which patients, young and old, with lung, brain and testicular cancer, should receive the limited number of doses.

"As As a doctor who has dedicated my life to fighting cancer, it's hard to express how awful this is,” Dr. Shuman said. should not try desperately to squeeze out the last few drops when a life may be at stake,” Dr. Shuman said.

An expert described US efforts . Pharmacopeia, a non-profit organization focused on secure drug supply, to map the dynamics and causes of shortages. This group has found that there is a higher risk of shortages of drugs at low prices, with a complex manufacturing process or quality problems marked by a history of recalls, said Vimala Raghavendran, vice president of product development computers for the U.S.P.

These factors can add up in an interesting way: many of the cheaper products tend to be made in parts of India and China where they are inexpensive to produce, but the concentration of facilities creates an additional layer of vulnerability to issues such as natural disasters or political unrest.

Ms. Raghavendran said efforts to diversify production sites were important, but cautioned that bringing manufacturing to the United States would not be the only way to solve the problem. She noted the recent bankruptcy of a US generic drug manufacturer. The abrupt closure of Akorn Pharmaceuticals last month was linked to a worsening shortage of albuterol.

Witnesses also highlighted the need for a greater transparency in drug supply. Policymakers are "flying blind" when it comes to sources of critical ingredients, often called APIs, or active pharmaceutical ingredients, Raghavendran said.

While the Food and Drug Administration obtains data on these active ingredients, the agency acknowledged to Senate staff that the data was not kept in a usable format, but rather "buried in PDF files in drug applications." individual".