Experts call U.S. drug shortages ‘national security issue’ that predates pandemic

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

Fears that the United States would experience unprecedented prescription medication shortages during the COVID-19 pandemic were unfounded, despite concerns fueled in part by supply chain issues that affect other consumer products, experts told UPI.

As of Friday, the Food and Drug Administration was reporting shortages of 169 medications, but that was not out of the ordinary.

That number is fairly typical and perhaps even lower than the nation has seen over the past 20 years, Stephen Schondelmeyer, a professor of pharmacy at the University of Minnesota in Minneapolis, told UPI.

Which is not to say there have not been drug supply issues unique to the pandemic, 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 also is co-principal investigator with the Resilient Drug Supply Project at the University of Minnesota’s Center for Infectious Disease Research and Policy.

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

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

In addition, the American Society of Health-System Pharmacists, an organization for professionals who oversee drug inventories at hospitals across the country, has recommended reforms that would maintain the security of the nation’s medication supply.

Not a ‘COVID-19’ problem

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

Similarly, supplies of the horse de-wormer ivermectin were affected by rumors of its potential benefits against the virus, which persisted even in the face of research findings to the contrary, he said.

In addition, drugs used in hospitalized patients, including the anesthetic propofol and the opioid pain-killer fentanyl were in short supply in New York City in spring 2020, said Michael Ganio, senior director for pharmacy practice and quality with the American Society of Health-System Pharmacists.

These shortages occurred when hospitals there increased usage by 600% to treat people intubated because of COVID-19, Ganio said in a phone interview.

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

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

Supply and demand

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

In addition, hydrocortisone tablets — which manage the symptoms of inflammatory conditions such as asthma, COPD and rheumatoid arthritis — and certain forms of the pain reliever lidocaine remain in short supply, the agency reports.

Conversely, recent shortages of drugs such as the anti-psychotic haloperidol, which is 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, it says.

Most of these shortages have been caused by manufacturing problems, including equipment malfunctions in processing plants that have either disrupted production or caused quality problems, Ganio said.

A prominent example of the latter is the Baltimore processing plant that produced contaminated batches of a COVID-19 vaccine soon after it was cleared for use, Schondelmeyer said.

Other drug supplies have been affected by product recalls, most famously the smoking cessation treatment varenicline, or Chantix, last year.

The manufacturer Pfizer issued a voluntary recall after several lots 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 — problems in these regions can impact supply, Ganio said.

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

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

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

Domestic production

Closer to home, in the aftermath of Hurricane Maria in 2017, production of saline solution, which has dozens of medical uses, was severely impacted in Puerto Rico, from which much of the supply in the United States comes, Ganio said.

Problems at a manufacturing facility in Kansas in 2019 led to supply disruptions with commonly used opioid pain relievers, he said.

These incidents show that while improving domestic production capacity could mitigate some shortages, should events lead to the closure of manufacturing facilities stateside — such as a resurgence in the pandemic, for example, supplies would be affected, Ganio and Schondelmeyer said.

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

About 80% of drugs dispensed nationally are manufactured overseas, with most brand-name drugs imported from Europe and cheaper, generic alternatives coming from Asia, Schondelmeyer said.

However, shortages have occurred with generic drugs, which are less expensive to make, he said.

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

Because of these issues, regulatory agencies such as the FDA and the Federal Trade Commission should take steps to require suppliers to be more transparent about where drugs, and their ingredients, are sourced, Ganio and Schondelmeyer said.

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

“They need to ask their pharmacists and push legislators to get regulatory agencies to take action — the FDA doesn’t even know where all of the drugs sold in the U.S. are produced,” he said.

Not unique to U.S.

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

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

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

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

If consumers are impacted by shortages in generic prescription medications they use, they can ask their doctors to specify brand-name products, but these can be more expensive, and not all insurance companies will cover these costs, Fox added.

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

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

However, although ongoing shortages of 150 or more drugs in the United States — and elsewhere — are nothing new, they should be viewed as “acceptable” either, Schondelmeyer added.

“What shortages tell us is that our system is broken,” he said. “We need to be as ever-vigilant as we can so that patients don’t end up without the medicine they need when they need it.”

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