Coronavirus Outbreak Raising Fear of Drug Shortages

By Pat Anson, PNN Editor

As the coronavirus spreads around the world, so are fears about drug supply shortages. While the prescription or over-the-counter medication you take may not come directly from China – the epicenter of the outbreak – chances are one of its ingredients does.

According to a recent study, nearly two-thirds of the world’s supply of acetaminophen comes from China. Known as paracetamol outside the United States, acetaminophen is a key ingredient in hundreds of over-the-counter pain relievers and cough, cold and flu medicines – from Excedrin and Tylenol to Theraflu and Alka-Seltzer Plus. It’s also used in opioid pain medications such as Vicodin.

While there’s no sign yet of an acetaminophen shortage, quarantines, travel restrictions and supply disruptions in China caused by the COVID-19 virus are causing some concern.

“One of the ugly secrets of the pharmaceutical industry is that the vast majority of raw materials that go into a prescription drug are produced overseas, mostly in China and India,” Geoffrey Joyce, PhD, chair of the Department of Pharmaceutical and Health Economics at the USC School of Pharmacy told the Los Angeles Times. “The coronavirus shutting down China or India for an extended period of time is likely to have a substantial impact on the supply of many drugs.”

Another academic expert made an even more alarming prediction.

“You’re going to see shortages,” William Comanor, PhD, a professor of health policy and economics at UCLA told The Times. “Tell your readers to stock up on generics!”

Vague Warning from FDA

There is already a shortage of at least one drug, although the head of the Food and Drug Administration didn’t identify what it was in an unusually vague statement released last night.

“A manufacturer has alerted us to a shortage of a human drug that was recently added to the drug shortages list. The manufacturer just notified us that this shortage is related to a site affected by coronavirus. The shortage is due to an issue with manufacturing of an active pharmaceutical ingredient used in the drug,” said FDA Commissioner Stephen Hahn, MD.

“It is important to note that there are other alternatives that can be used by patients. We are working with the manufacturer as well as other manufacturers to mitigate the shortage. We will do everything possible to mitigate the shortage.”

The FDA has contacted over 180 drug manufacturers around the world to remind them they have a legal obligation to notify the agency of any supply disruptions. About 20 pharmaceutical drugs that the FDA calls “non-critical” either come directly from China or have ingredients that come from there.

“We have been in contact with those firms to assess whether they face any drug shortage risks due to the outbreak. None of these firms have reported any shortage to date,” Hahn said.

The FDA is taking Chinese drug manufacturers at their word. Because of federal travel restrictions, FDA inspectors are not currently traveling to China to see for themselves.

Hahn’s statement also warned about manufacturing problems at dozens of Chinese facilities that make “essential” medical devices – but again without identifying what those devices are.

“We are aware that several of these facilities in China are adversely affected by COVID-19, citing workforce challenges, including the necessary quarantine of workers. While the FDA continues to assess whether manufacturing disruptions will affect overall market availability of these products, there are currently no reported shortages for these types of medical devices within the U.S. market,” said Hahn.

Face Mask Shortages

As for personal protective equipment --- such as face masks, gloves and surgical gowns – Hahn said the FDA has “heard reports of increased market demand and supply challenges” but was unaware of widespread shortages. China makes about half of the world’s supply of surgical masks but has stopped virtually all exports.

“Before the outbreak of the epidemic, we used to export 600,000-700,000 surgical masks a month, but now the amount is zero," David Peng, manager of a Chinese medical supplier, told the Chicago Tribune.

Walgreens, Home Depot, Lowe’s and other retailers in the U.S. are scrambling to meet demand for masks or have sold out.

The CDC has been urging healthy people not to use masks and other protective gear because they want those products available at healthcare facilities if the coronavirus outbreak becomes severe. Regular hand washing is the preferred alternative.

“CDC does not recommend that people who are well wear a facemask to protect themselves from respiratory illnesses, including COVID-19. You should only wear a mask if a healthcare professional recommends it,” the CDC says.

“A facemask should be used by people who have COVID-19 and are showing symptoms. This is to protect others from the risk of getting infected. The use of facemasks also is crucial for health workers and other people who are taking care of someone infected with COVID-19 in close settings (at home or in a health care facility).”

Who is most at risk of coronavirus? Unfortunately, its people who are already sick and have compromised immune systems, as Dr. Lynn Webster explained in a recent column.

“The people with increased risk for experiencing severe symptoms, and possibly dying of COVID-19, are seniors and those with chronic illness. Of course, many people in chronic pain are part of both risk groups. The mortality rate of COVID-19 has been reported to be about two percent,” Webster said. “People with chronic pain may be more susceptible to viruses in general, because chronic pain can change the way our immune systems work.”

For more information from CDC on the coronavirus outbreak, including symptoms, prevention and answers to frequentely asked questions, click here.