Long before the coronavirus pandemic, crucial medicines have been in short supply. We have been tracking drug shortages since 2014. In any given year, anywhere from 100 to 300 different medications have been hard to obtain. That includes antibiotics, anesthetics, drugs to treat cancer and mental illness. If you did not see “60 Minutes” on May 22, 2022, you really need to watch this segment titled: “In Short Supply: Medical Middlemen: Broken system making it harder for hospitals and patients to get some life-saving drugs.” Coronavirus drug shortages are making matters worse.
Infant Formula in Short Supply!
You have no doubt read about the shortage of infant formula. Do you know what led to this disaster? Abbott Nutrition has a plant in Sturgis, Michigan. The company makes Similac, EleCare and Alimentum there.
There have been reports of babies getting sick, though it is not clear if the infant formula was responsible. The Sturgis plant has had quality control issues going back more than a decade, though. A whistle-blower apparently notified the FDA that bacterial contamination could be a problem. The controversy eventually led to a recall and eventually the shortages that have made headlines in recent weeks.
The bottom line is that there are relatively few manufacturers of infant formula in the US. When there are disruptions in the supply chain, they can have a profound impact on the whole system.
Abbott is promising to get its production lines going again within a couple of weeks. There will be new safeguards to reassure parents that the infant formulas are safe. If there is a lesson to be learned, though, it is that it does not take much to disrupt the manufacture and distribution of critical products, especially medicines.
Where Does Your Medicine Come From?
If we asked you where your undies come from or where your shoes were made, you could look for a label with that information. Easy-Peasy!
Try to figure out where your pills are made. It can be a challenge. For example, if you take the blood pressure pill valsartan, you might discover that the medicine is marketed by Jubilant Cadista Pharmaceuticals, Inc. out of Salisbury, Maryland. But if you look a bit farther (with your magnifying glass), you might discover that they were manufactured by Jubilant Generics, Ltd., in Roorkee, India.
That is only possible if your pharmacy dispenses the pills in the original 90-tablet bottle from the manufacturer. If the pharmacist took the pills out of a big bottle and put them in a smaller amber pharmacy bottle, you will probably never see a country of origin on the label.
Don’t believe us? Grab one of your amber pharmacy bottles and see if you can find where your pills were manufactured. If you can, please take a photo and attach it to an email:
Your pharmacy might fill your cholesterol-lowering drug rosuvastatin from Biocon Pharma. Unless you look up the manufacturer online, you might not have a clue that it is a biopharmaceutical company based in Bangalore, India.
Most Medicines Are Made Abroad!
It wasn’t that long ago that Americans swallowed pills that were actually made in the United States. That all started to change about 20 years ago. Now, the vast majority of medications we take are made in whole or in part outside of our borders.
This happened in large measure because manufacturing costs, especially materials and labor, are far less expensive in places like China, India, Slovakia or Brazil. The generic drug industry relies on low prices to sell its products.
A Cardiologist Is Mad As Hell About Coronavirus Drug Shortages!
We recently heard from a cardiologist about a critical medicine in his tool box. It is called iodine contrast material:
“As a cardiologist, I am outraged that there is a critical shortage of contrast media for heart CT scans. We use this during coronary angiograms to visualize arteries and see where there may be blockages. It tells whether a patient needs surgery or stents, and also helps us see if there are blood clots in the lungs.
“All of these require urgent treatment, so not having contrast puts lives at risk. A country that can’t manage access to such essential medications is sick!”
You can sense the frustration coming from this cardiologist. The United States is highly dependent on foreign suppliers for indispensable medical supplies, including the iodine solution that provides contrast on CT scans. In the most recent shortage, a factory in Shanghai, China, shut down to slow the spread of COVID. As a result, hospitals in the US are running out.
The FDA states on its website
“Not Available/Stock Out. Anticipate full stock by July 2022.
“Impacted by Covid-related shutdown in China; supply increasing through May and June with a return to stocking levels in July 2022”
That is not very reassuring for health professionals or patients who need this contrast material to make an accurate diagnosis.
Unfortunately, drug shortages are not rare events. Even before the pandemic, many health care systems reported difficulties accessing critical medications. Without significant changes in the way we manage our supply chains, shortages are likely to continue.
The FDA Loves Generic Drugs:
The FDA has embraced generic drugs. On its website the agency brags that generic drugs save Americans billions of dollars every year.
Four years ago, the U.S. Government Accountability Office (GAO) reported that:
“more than 40 percent of finished drugs and 80 percent of active pharmaceutical ingredients are produced overseas.”
These “APIs” are the defining compounds in all our medications.
Sadly, no one knows for sure what the actual numbers are. That’s because there is a blanket of secrecy over where the chemicals in our medicines are actually made. For reasons that mystify us, it is very hard to find out who makes what, where.
Inspections Are Harder Abroad!
Is there a downside to the huge shift in the pharmaceutical supply chain? Over the past decade or so, we have heard from many readers who complain that their medications appear to be of substandard quality.
Should you wish to learn more about quality concerns of generic drugs you can listen to our free podcast with Katherine Eban, author of Bottle of Lies: The Inside Story of the Generic Drug Boom.
When manufacturing is located abroad, the FDA has a harder time inspecting pharmaceutical facilities to ensure quality. That is especially true now. The FDA has pulled most of its inspectors from China, India and other countries because of the coronavirus pandemic.
Coronavirus Drug Shortages:
There is another complication when the pharmaceutical supply chain originates overseas. In a crisis such as a worldwide pandemic, there can be shortages of essential medicines.
FiercePharma is an online news service that tracks the pharmaceutical industry on a daily basis.
In an April 13, 2020 report it shared this concern:
“The novel coronavirus has put an enormous strain on the pharmaceutical supply chain, with spot shortages of certain meds increasingly common. Now, with thousands of COVID-19 patients flooding U.S. hospitals, drugs used during treatment and ventilation are growing scarce.”
Critical medications like the anesthetic propofol and the sedative midazolam have been in short supply. Some antibiotics and albuterol asthma inhalers have also been problematic. Coronavirus drug shortages are making life difficult for both physicians and patients.
Here is what the FDA has to say about the coronavirus drug shortages:
“Coronavirus Disease (COVID-19): The FDA continues to take steps to monitor the supply chain. The Drug Shortage Staff within the FDA’s Center for Drug Evaluation and Research (CDER) has asked manufacturers to evaluate their entire supply chain, including active pharmaceutical ingredients, finished dose forms, and any components that may be impacted in any area of the supply chain due to the COVID-19 outbreak. For the latest information from the FDA on COVID-19 see our website at: Coronavirus Disease 2019 (COVID-19).
When it comes to coronavirus drug shortages, though, the FDA doesn’t have a lot of answers. Although the agency lists drug shortages at this link, it does not tell doctors, pharmacists or patients what they can do about coronavirus drug shortages.
In point of fact, the FDA doesn’t know what you should do about any drug shortages. It would be as if you were in desperate need of toilet paper and the FDA listed the names of all the companies that were out of toilet paper.
Thanks for nothing. If no one else is supplying toilet paper, knowing which companies are out does not help you one little bit.
Coronavirus Drug Shortages and Shipping:
It’s not just the manufacturing process that has been affected.
According to FiercePharma (March 31, 2020):
“The production of Chinese active pharmaceutical ingredients (APIs) slipped by 10 percent to 20 percent during the early days of the COVID-19 outbreak in China but is quickly recovering. The bottleneck in the global supply chain for APIs is now shipping, particularly ocean freight.”
Did you read that last sentence carefully and appreciate the implications? FiercePharma stated that drugs from China could be in short supply because of a bottleneck due to a lack of ocean freight!
We have been bugging the FDA for years to learn how active pharmaceutical ingredients get from China to India. We worried about temperature and humidity and wanted to know if drugs are shipped by truck, airplane or cargo ship.
This is the first time we have heard that medications might be shipped via ocean freight. We wonder whether they are in temperature and humidity-controlled containers. We have spoken with insiders who state that a lot of meds are indeed shipped by cargo ship. Containers have skyrocketed in price. Are generic manufacturers spending money to maintain their precious products within the FDA very stringent specifications? We have no idea, but it worries us.
There is another problem linked to our dependence upon foreign pharmaceutical manufacturing. Quality may suffer during a pandemic. As previously mentioned, that is partly because FDA inspectors have been called home from China and India. The honor system has replaced FDA oversight.
Coronavirus drug shortages may encourage U.S. lawmakers to reevaluate the appeal of less expensive foreign-made medicines. Maybe it is time to reward companies for making medicines at home where they can be regularly inspected by the FDA.
Share Your Thoughts About Coronavirus Drug Shortages:
Have you ever experienced a recall of one of your prescriptions? Blood pressure drugs like irbesartan, losartan and valsartan were recalled because of nitrosamine contamination. So was ranitidine (Zantac).
A generic manufacturer, Avet Pharmaceuticals, Inc. had to recall the antibiotic tetracycline.
“…due to low out of specification dissolution test results.
“Low dissolution results in less tetracycline available in the body to fight infection. This can lead to treatment failures. For patients with compromised immune systems and the elderly, who may be taking tetracycline to treat a serious infection such as pneumonia, there is a reasonable probability that if there is not enough tetracycline in the body to fight the infection, this could result in rapid progression of the infection and death.”
This tetracycline is distributed under the Heritage Pharmaceutics Inc. label. The parent company, Emcure, is “One of India’s Leading Pharmaceutical Companies.”
Share your thoughts about drug shortages and drug quality in the comment section below.
If you care about drug shortages and quality medicines, take a few moments to watch the extraordinary report from 60 Minutes: “In Short Supply: Medical Middlemen: Broken system making it harder for hospitals and patients to get some life-saving drugs.”