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. The latest drug shortage: amoxicillin for children!
Why Is There an Amoxicillin Shortage?
Amoxicillin is one of the most basic medicines in the pharmacy. It is a form of penicillin and was discovered in 1958. Amoxicillin has been in continuous use since 1972. One of the first brand names for amoxicillin was Amoxil.
Doctors prescribe amoxicillin for a wide range of bacterial infections including strep throat, ear infections in children, pneumonia, sinusitis, urinary tract infections, dental abscesses and a variety of skin infections. You do not get more basic than amoxicillin!
The FDA has a drug shortage page on its website. When you go to the database you will discover that amoxicillin powder for suspension is “currently in shortage.” We suspect that the shortage is wider than that. The liquid form of amoxicillin that is specifically formulated for young children is also in short supply.
RSV Is Overwhelming Hospitals:
The demand for amoxicillin has surged because of the widespread outbreak of RSV (respiratory syncytial virus). This respiratory illness is straining pediatric hospitals across the country. That in turn has led to the amoxicillin shortages.
Why, you ask? RSV is a viral infection. Antibiotics like amoxicillin do not work against viruses. True, but viral infections may lead to bacterial infections.
There is also another explanation, though. It is hard to distinguish between a viral infection and a bacterial infection. Some doctors may be prescribing amoxicillin because they assume a case of pneumonia is bacterial in origin and they want to do something helpful, even if it caused by RSV. Whatever the reason, there is a huge spike in demand and hospitals are having a hard time finding adequate supplies.
Coronavirus Drug Shortages and China:
No one is talking about a possible coronavirus drug shortage. But we know that supply lines have been strained because of COVID-19.
According to Rosemary Gibson in her article in MarketWatch (April 28, 2021):
“Right now, the U.S. has virtually no capacity to manufacture antibiotics. That’s because China currently controls roughly 90% of the global supply of inputs needed to make the generic antibiotics that treat bronchitis, pneumonia, pediatric ear infections, and life-threatening conditions such as sepsis.
“At the peak of last year’s COVID-19 hospitalizations in the U.S., these generic antibiotics—including azithromycin—were urgently needed to treat secondary bacterial infections. However, the U.S. faced a potential shortage, since the key materials for azithromycin and other drugs are supplied by China.”
A Japanese article in Nikkei Asia (April 5, 2022) is titled:
“The great medicines migration
How China took control of key global pharmaceutical supplies”
In this report we are told:
“China has a huge production scale advantage as well. For some APIs [active pharmaceutical ingredients], Chinese companies have more than twice the capacity of their Indian counterparts. The average Chinese production capacity of amoxicillin, an antibiotic for bacterial infections, is 14,000 tonnes. In India it is just 5,000, according to research by KPMG India and the Confederation of Indian Industry (CII).”
China And COVID-19:
China is still having significant production problems because of the coronavirus. The zero COVID-19 policy has impacted a number of industries. It is not clear how it has impacted the pharmaceutical supply chain.
An expert in supply-chain problems, Bindiya Vakil, shared this insight with FiercePharma (Nov. 1, 2022).
“’What we don’t appreciate as much is that our drug supply is highly vulnerable because a lot of the source materials that go into developing the active pharmaceutical ingredients come from China,’ Vakil said in an interview. ‘India is a huge market for generic manufacturing that we rely on in the U.S. And India is heavily dependent on China for those source materials that they transform into the APIs. We don’t have independence in our drug supply at all.'”
Amoxicillin Made in the USA?
There is one company in the US that has recently restarted amoxicillin manufacturing. USAntibiotics in Bristol, Tennessee, was supposed to begin production a couple of months ago. How fast it can help resolve the shortage remains to be seen.
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:
Questions@Peoplespharmacy.com
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.
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.
Quality Concerns:
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.
The FDA announcement reads in part:
“…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.”