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You can add a new worry to the health concerns caused by Covid-19: a sustained shortage of medicines needed to combat the coronavirus and countless other illnesses.

Across the U.S. and Europe, 29 out of 40 drugs used to combat the coronavirus are currently in short supply. And those shortages are expected to grow even worse as the number of Covid-19 cases and hospitalizations surge in the coming winter months, according to a new report by the Center for Infectious Disease Research and Policy at the University of Minnesota.

Moreover, the problem is likely to be exacerbated by the vagaries of the global pharmaceutical supply chain, which is heavily dependent on China for active pharmaceutical ingredients and on manufacturers based in India. As of now, 43% — or 67 of 156 — of acute care medicines used to treat various illnesses are running low. This group includes such staples as antibiotics, blood thinners, and sedatives.

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“The supply chain has already been stressed over the past few years, but as we go through the fall and into the winter, we’re going to have some real challenges” thanks to Covid-19, said Michael Osterholm, director of CIDRAP and co-principal investigator of the center’s Resilient Drug Supply Project.

Indeed, the pandemic has exposed many of the vulnerabilities in the U.S. drug supply chain, according to the report. “Covid-19 tends to strike hard in a discrete geographic area, and when it creates a new hot spot, the hospitals in that area usually see a dramatic spike in admissions and ventilator use,” the researchers wrote.

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As examples, they foresee the possibility of a five-fold jump in demand for midazolam, a commonly used sedative, and a 10-fold increase in the use of a muscle relaxant known as cisatracurium. There were ongoing shortages of such medicines in the spring as the number of Covid-10 cases in the New York area skyrocketed.

Over the next several months, though, such shortages could easily grow if there is a surge in multiple parts of the country around the same time, a scenario that has started to play out.

“This time, we may approach a surge not with five or six hot spots, but maybe something like 30 or more hot spots,” explained Stephen Schondelmeyer, another co-principal investigator at the CIDRAP Resilient Drug Supply Project. “If they’re all having a surge at the same time, we don’t have the ability to shift supplies around as we tried to do in the spring.”

The concerns arise after years in which the U.S. pharmaceutical supply chain has been regularly hindered by shortages. And this occurs at great cost, according to the report. Overall, U.S. health systems spend more than $500 million a year on estimated costs related to drug shortages, with approximately $200 million in direct costs and up to $360 million on indirect costs.

The reasons for shortages often vary. In some cases, a drug maker walks away from a product, claiming it is no longer profitable, leaving an insufficient number of alternate suppliers. At times, some manufacturers complain that regulatory requirements are too costly to pursue and choose to withdraw from a particular market.

Last year, however, the U.S. saw 186 new shortages, 82% of which were classified as due to “unknown” reasons largely because of “the intentional opacity and secrecy of the upstream supply chain,” the CIDRAP researchers wrote.

In a report issued last year, the FDA noted that the number of ongoing shortages has been steadily rising — reaching about 110 — after peaking in 2011 and then declining until 2018. The agency examined a sample of 163 drugs for which shortages first occurred between 2013 and 2017, and found 63% of the shortages arose after supply disruptions associated with product quality or manufacturing problems. Another 18% occurred for unknown reasons, 12% were due to unanticipated increases in demand, 5% followed natural disasters, and 3% were attributed to product discontinuations.

The FDA has responded by approving more generics, but a recent study found that the proportion of approvals for drugs that could address those concerns has actually remained steady. Last year, the agency also considered creating a system to rate manufacturing facilities run by drug makers, but the idea has not gained traction.

As noted previously, however, the pandemic has highlighted concerns that the U.S. remains vulnerable to shortages of numerous medicines —  but especially antibiotics — if geopolitical disputes arise with China. Consequently, there has been increasing talk in the U.S. of creating an America First program to find ways to spur domestic production of APIs and finished medicines.

In May, the federal government awarded a $354 million contract to a new company to make generics that are in short supply during the pandemic. But achieving this goal may be easier said than done, if only because it can take time to build a sufficient number of facilities before domestic production could meet demand for key medicines or ingredients. For that to happen, pharmaceutical companies will likely demand incentives, since production is generally cheaper in other countries.

“America First is not something that’s going to happen overnight,” said Osterholm. “We have to start looking at this from a national security standpoint, because we don’t want to be totally dependent on supplies from another country. But we’re not having the discussion in this country.”

  • With 63% of shortages found by the FDA to be due to quality or manufacturing problems in other countries, production of those pharmaceuticals should move to America or reliable other nations. For product reliability – increased cost of pharmaceuticals is to be expected. Simply because you can’t have your cake and eat it too.

  • State Duma deputy vaccinated with Sputnik V infected with coronavirus
    today at 07:30
    State Duma Deputy Valery Gartung, who participated in the test of the Russian vaccine against the coronavirus Sputnik V, fell ill with COVID-19. This was announced on Wednesday, October 21 by TASS.

    From this it follows that my medicine is the only reliable remedy

    Russia missed its bread card
    Appeal from Rishat Rafailievich Akhmetvaleev!
    I appeal to everyone who is interested in the treatment of Covid-19!
    With me, the world will win an unconditional victory over Covid-19!
    I can cure the disease completely free of charge because I have very strong immunity, which you could use to make a medicine.
    researchers from Utrecht University
    managed to isolate from immune cells
    an experimental monoclonal antibody that neutralizes not only SARS-CoV-2, which is the causative agent of COVID-19, but also another SARS-CoV virus. Monoclonal antibodies are produced by immune cells
    I can cure coronavirus for free
    But no one in Russia pays attention to me, and I decided to switch to drug manufacturers in other countries

  • State Duma deputy vaccinated with Sputnik V infected with coronavirus

    today at 07:30
    State Duma Deputy Valery Gartung, who participated in the test of the Russian vaccine against the coronavirus Sputnik V, fell ill with COVID-19. This was announced on Wednesday, October 21 by TASS.

    From this it follows that my medicine is the only reliable remedy

    Russia missed its bread card
    Appeal from Rishat Rafailievich Akhmetvaleev!
    I appeal to everyone who is interested in the treatment of Covid-19!
    With me, the world will win an unconditional victory over Covid-19!
    I can cure the disease completely free of charge because I have very strong immunity, which you could use to make a medicine.
    researchers from Utrecht University
    managed to isolate from immune cells
    an experimental monoclonal antibody that neutralizes not only SARS-CoV-2, which is the causative agent of COVID-19, but also another SARS-CoV virus. Monoclonal antibodies are produced by immune cells
    I can cure coronavirus for free
    But no one in Russia pays attention to me, and I decided to switch to drug manufacturers in other countries

  • Scary, and kind of makes one have empathy for those in our human family who live in Africa and Central America and thus don’t have access to the standard of living considered usual in the rich western countries. This is a heck of a way to achieve a needed decline in human population, isn’t it?

  • Ed:

    Interesting topic to pick. Few facts need to be shared.

    1) FDA has no clue how long it takes to get an ANDA approved. Best guess is 36-48 months. FDA just likes to toot its horn as they stack up number for the calendar year. That is telling the world a blatant lie.
    2) They want to rate manufacturing facilities when less than five people at FDA have any manufacturing experience. They should rate their own processes and will find out that they live by “QUALITY BY AGGRAVATION/ANALYSIS” rather than QbD which they want the industry to practice. They have no clue.
    3) FDA has been trying to reduce shortages fro the last few years and have nothing to show.

    US needs a focused concerted plan but they do not know how, what and where. Linked might be of interest as it is a ROAD MAP.
    A road map for driving pharmaceutical manufacturing back to the USA by 2025
    https://bit.ly/3nxOlIz

    It might be worth considering.

    Be safe and well.

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