• Posted March 23, 2023

Drug Shortages Rose by 30% in 2022, U.S. Senate Report Shows

Americans are facing shortages of drugs critical for cancer treatment, breathing problems and more -- shortages that increased nearly 30% between 2021 and 2022, a new report shows.

The report, commissioned by the U.S. Senate and discussed during a Senate committee hearing on Wednesday, found a record five-year high of 295 active drug shortages.

The problem isn't likely to get better soon because of how the system is regulated and the fact that many drugs or their ingredients are made outside the United States, the report noted.

"Since 2007, the FDA [U.S. Food and Drug Administration] identified an average of over 100 separate drug shortages per year. In 2011, the FDA identified a whopping 267 drugs in short supply and despite possessing the most innovative medical industry in the world, the U.S. is unable to maintain a consistent supply of the most crucial medicines,"ranking committee member Sen. Rand Paul (R-Ky) said during the hearing before the Senate's Homeland Security and Governmental Affairs Committee.

These shortages are a risk to national security and make the U.S. medical supply vulnerable, according to testimony Wednesday at the hearing, CNN reported.

"Even drugs needed to treat childhood and adult cancers, including some that have simply no alternative treatment, are regularly in shortage. And while some shortages may only be an inconvenience, others have had devastating impacts on patient care,"said Sen. Gary Peters (D-Mich.), who commissioned the new report, CNN reported.

Though 295 drugs were in shortage last year, the latest number is 130, according to the FDA.

The average length of a shortage is 1.5 years, though some drugs are in short supply for much longer. About 15 critical drug products have been scarce for a decade, CNN reported.

Albuterol sulfate is among them. Used for breathing problems, the FDA has reported it as in short supply since October while the American Society of Health-System Pharmacists has been warning of a shortage since last summer.

A major supplier to U.S. hospitals closed this month, CNN reported, likely exacerbating the issue.

Other drugs in short supply include the attention-deficit/hyperactivity disorder (ADHD) drug Adderall.

Medications like the antibiotic amoxicillin are also more likely to face shortages because they're generic and lower-priced, according to the nonprofit U.S. Pharmacopeia, which presented its analysis at the hearing, CNN reported. U.S. Pharmacopeia works to strengthen global supply chains.

"Manufacturers only receive pennies per dose for some of these drugs,"testified Dr. Vimala Raghavendran, senior director of the pharmaceutical supply chain center at U.S. Pharmacopeia.

Experts blame market consolidation as another contributor to shortages, CNN reported.

In addition, there's a lack of transparency.

About 80% of manufacturing facilities for ingredients for drugs sold in the U.S. market are in other countries, typically in China or India, where work stoppages can have a major effect. On top of that, no U.S. agency tracks those manufacturers, so shortages can come as a surprise.

"Policymakers are flying blind in our understanding of U.S. reliance on other countries for critical ingredients used in the manufacture of medicines,"Raghavendran noted.

Among the transparency issues are that the public is often uninformed about quality results and inspections, though reasons for a shortage may be known to federal regulators, CNN reported.

"FDA sees really clear quality differences between products and manufacturing sites, but this information is confidential, and it's not available to people making the purchases. Buyers can't easily see the reliability of manufacturing operations,"Erin Fox, associate chief pharmacy officer at the University of Utah, testified during the hearing.

She called on the U.S. government to develop a rating system for pharmaceutical manufacturing reliability, CNN reported. This could help health systems choose reliable suppliers, Fox suggested.

For now, it's up to the health systems to deal with drug shortages.

Dr. Andrew Shuman, a head and neck surgeon who works at the U.S. Department of Veterans Affairs and is an associate professor at University of Michigan Health, called shortages of cancer drugs "a tragedy that's happening in slow motion."

"Not every hospital has that resource. Patients should not have better access to scarce drugs based on the hospital they go to,"Shuman noted during his testimony at the Senate hearing, CNN reported.

More information

The U.S. Food and Drug Administration has more on drug shortages.

SOURCE: CNN