US drug shortages predate pandemic and are a ‘national security issue’, experts say

Experts describe long-term drug supply problems in the United States as a “national security issue”. File photo by Brian Kersey/UPI | License picture

NEW YORK, March 21 (UPI) — Fears that the United States would experience unprecedented shortages of prescription drugs during the COVID-19 pandemic were unfounded, despite worries fueled in part by supply chain issues that affect other products from consumption, experts told UPI.

On Friday, the Food and Drug Administration was reporting shortages of 169 drugs, but that was not unusual.

Although the number seems high to a layman, it’s fairly typical and possibly even lower than what the nation has seen in the past 20 years, according to Stephen Schondelmeyer, a professor of pharmacy at the University of Minnesota in Minneapolis.

That’s not to say there haven’t been pandemic-specific drug supply issues, he and others said.

“We had shortages long before, we continue to have them in COVID, and we will continue to have them after COVID,” said Schondelmeyer, who is also co-principal investigator of the Resilient Drug Supply Project at the University’s Center for Infectious. of Minnesota. Disease research and policy.

“Our drug supply system and shortages of these products is a national security issue because these drugs don’t work until patients have them and can’t use them properly,” he said during of a telephone interview. “Shortages can harm and even kill people who need these drugs.

Schondelmeyer is not the only expert to characterize the issue in this way. The federal Office of the Assistant Secretary for Preparedness and Response, under President Biden, called last summer for policy changes that would address shortages in a national security context.

Additionally, the American Society of Health-System Pharmacists, an organization of professionals who oversee drug inventories in hospitals nationwide, recommended reforms that would keep the nation’s drug supply secure.

Not a “COVID-19” problem

In 2020, some people — including doctors — racked up doses of the antimalarial drug hydroxychloroquine when it was touted as a potential cure for COVID-19, despite a lack of scientific evidence, Schondelmeyer said.

Similarly, supplies of ivermectin, a dewormer for horses, have been hit by rumors about its potential benefits against the virus, which have persisted even in the face of research findings to the contrary, he said.

Additionally, drugs used in hospitalized patients, including the anesthetic propofol and the opioid painkiller fentanyl, were in short supply in New York City in the spring of 2020, according to Michael Ganio, senior director of practice and quality of pharmacy at the American Society of Health. – System pharmacists.

Those shortages occurred when hospitals increased their utilization by 600% to treat people intubated with COVID-19, Ganio said in a phone interview.

Supplies of such products have rebounded as medical professionals learned how to better manage hospitalized patients with severe COVID-19, he said.

“These shortages are not new issues, although the pandemic has exacerbated them in some ways,” Ganio said.

Supply and demand

Drugs currently in short supply include azithromycin eye drops, which are used to treat eye infections, and heparin, a blood thinner used in hospitalized patients at risk of life-threatening clots, according to the FDA.

Also, hydrocortisone tablets – which manage symptoms of inflammatory conditions such as asthma, COPD and rheumatoid arthritis – and some forms of the painkiller lidocaine remain in short supply, the agency reports.

Conversely, recent shortages of drugs such as the antipsychotic haloperidol, used to treat mental health conditions such as schizophrenia and bipolar disorder, and prednisolone eye drops, a steroid used to treat inflammation caused by allergies, have been resolved. .

Most of those shortages were caused by manufacturing issues, including equipment malfunctions at processing plants that either disrupted production or caused quality issues, Ganio said.

A stark example of the latter is the Baltimore processing plant that produced contaminated batches of a COVID-19 vaccine shortly after it was cleared for use, according to Schondelmeyer.

Other drug supplies were affected by product recalls, including varenicline, or Chantix, a smoking cessation treatment, last year.

Manufacturer Pfizer issued a voluntary recall after several batches of the drug were found to be contaminated, the FDA said.

In other cases, when drugs or their key ingredients are imported from other countries — China and India are the most common sources — issues in those regions can impact supply, Ganio said. .

For example, production was halted in India last summer when that country was ravaged by the wave of the COVID-19 pandemic fueled by the Delta variant, and a recent resurgence of infections in China could lead to similar issues. did he declare.

Perhaps most troubling, shortages of the chemotherapy drug vincristine, which is used to treat leukemia, Hodgkin’s disease, neuroblastoma and small cell lung cancer, primarily in children, developed when manufacturers ceased production due to declining profits, according to Schondelmeyer.

“So doctors had to tell parents of children with cancer that they couldn’t be treated,” Schondelmeyer said.

“Made in USA” is not the answer

Closer to home, in the aftermath of Hurricane Maria in 2017, the production of saline solution, which has dozens of medical uses, was badly affected in Puerto Rico, where much of the supply in the United States, according to Ganio.

Problems at a Kansas manufacturing plant in 2019 led to supply disruptions of commonly used opioid painkillers, he said.

These incidents show that while improving domestic manufacturing capacity could alleviate some shortages, if events resulted in the closure of manufacturing facilities in the United States – such as a resurgence of the pandemic, for example, supplies would be affected, said Ganio and Schondelmeyer.

Instead, they argue, the United States must take steps to “diversify” its drug supply chain.

About 80% of drugs distributed domestically are made overseas, with most branded drugs imported from Europe and cheaper generic alternatives from Asia, Schondelmeyer said.

However, shortages have occurred with generic drugs, which are cheaper to manufacture, he said.

Also, they can be influenced by factors outside of medicine, such as when China threatened to put up “trade barriers” on many products the country exports to the United States, including pharmaceuticals, amid an ongoing trade dispute, he said.

Because of these issues, regulators such as the FDA and the Federal Trade Commission should take steps to require suppliers to be more transparent about the origin of drugs and their ingredients, according to Ganio and Schondelmeyer.

“Every consumer should know where the drugs they are consuming come from,” Schondelmeyer said.

“They need to ask their pharmacists and push lawmakers to get regulatory agencies to act — the FDA doesn’t even know where all the drugs sold in the United States are produced,” he said.

Not unique to the United States

Not only are most consumers unaware of where their drugs are made, very few are even aware of shortages when they occur, Schondelmeyer said.

Indeed, these supply issues are often “managed” by pharmacists and distributors, who find alternative generic drugs when they spot shortages of drugs in high demand, he said.

“Most of the time, patients will get the treatment they need — currently most of the burden of drug shortages is borne by health system pharmacies inside hospitals,” said Erin R. Fox. , senior director of pharmacy at the University of Utah Health at Salt. Lake City told UPI in an email.

“However, the pharmacy has to work hard to use different products [and] it takes a lot of time and effort to implement as a change,” she said.

If consumers are affected by shortages of the generic prescription drugs they use, they can ask their doctors to specify brand name products, but these may be more expensive, and not all insurance companies will cover these costs, Fox added.

Even with local implications, drug shortages are a global problem, and while supply problems in the so-called developing world – such as Africa – are of concern, high-income countries in Europe have also reported them. , said Ganio.

And, of course, Canada, which sources many of its drugs from the same places as the United States, has also experienced this, he said.

However, while ongoing shortages of 150 or more drugs in the United States — and elsewhere — aren’t new, they should be considered “acceptable” either, Schondelmeyer added.

“What shortages tell us is that our system is broken,” Schondelmeyer said.

“We need to be as vigilant as possible so that patients don’t end up without the drugs they need when they need them,” he said.

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