No Easy Fix for U.S. Drug Shortages

Pharmaceutical shortages are jeopardizing care quality, patient safety.

Every day we are learning of glitches, hitches, and critical shortages along the U.S. healthcare supply chain, particularly around pharmaceuticals.

The well-publicized shortages of antivirals and antibiotics, and the bungled initial rollout of the COVID-19 boosters have received close attention as the nation heads into flu season.

Unfortunately, the drug shortages are more expansive than that.

A U.S. Senate report released in March found 295 active drug shortages at the end of 2022 for pharmaceuticals ranging from more than a dozen cancer drugs to Children's Tylenol and representing a 20% increase from the 246 drug shortages reported at the end of 2021.

The data, compiled by the American Society of Health System Pharmacists, also found that drug shortages worsened in 2022, growing from 114 to 160 reported shortages, a 40% increase.

These shortages have consequences for public health.

A recent survey of nearly 200 clinicians, pharmacists, and procurement specialist compiled by nonprofit ECRI and its affiliate Institute for Safe Medication Practices found growing concerns that the shortages are hurting patient care, across several specialties, including surgery and anesthetics (74%), emergency care (64%), pain management (52%), cardiology (45%), hematology and oncology (44%), infectious diseases (39%), and obstetrics and gynecology (37%).

Half of the respondents in the ECRI survey report having to delay or cancel surgical procedures and drug treatments, such as chemotherapy, one-third say they aren't able to provide optimal treatment because of drug shortages, and one quarter say they know of at least one error related to a drug, supply, or device shortages. 

"While medication and supply shortages have been widely reported across healthcare, we now know with certainty that these shortages are causing preventable harm and have the potential to cause even more if they are not addressed soon," says ECRI President / CEO Marcus Schabacker, MD, PhD.

"There are strategies hospitals can use to reduce the impact of shortages, but they are a deviation from standard practice and resource-intensive—two characteristics that themselves can increase the likelihood of preventable harm," he says.

The problems the drug supply chain faces are very much like the problem shortages of personal protective equipment and single-use clinical supplies.

There are several explanations for the shortages, including product quality and sanitation issues, drugmakers abandoning cheaper generics, and natural disasters. However, the biggest single hurdle – and the hardest to clear -- is that most of the shortages begin outside of United States, limiting our options for corrective measures.

In a Johns Hopkins podcast examining drug shortages, Mariana Socal, MD, PhD, a policy researcher and associate scientist at the University's Bloomberg School of  Health Policy and Management, noted that the "drug supply chain typically starts far away from the U.S."

"Our research has found that over 85% of all of the active ingredients needed to produce generic drugs for the U.S. are produced overseas," Socal says. "These ingredients are then transported to a second player—the facility that will then manufacture the finalized product."

Any single kink in this long, complex, multinational supply chain can derail the entire process. Until the U.S. can find a meaningful, effective solution that can safeguard the supply chain, Socal says providers will have to make do with incremental improvements.

"Other than the companies coming back online and producing the drugs we need, I'm not confident right now that we have a good long-term strategy. This is just a Band-Aid," she says. "And I'm worried for my patients that this could keep happening and could potentially worsen with each shortage, given what we're seeing now."