Scarcity of several high-profile prescription drugs, such as the antibiotic amoxicillin and the ADHD treatment Adderall, have had some patients searching pharmacies and rationing pills, and now parents in some areas are having to hunt to find over-the-counter pain- and fever-reducing medications for their sick kids. According to experts, this isn’t unusual, because even when demand is not sky-high, drugs shortages happen regularly in the U.S. It’s just that usually, it isn’t so noticeable.
Ass CNN reports, drug shortages “hit a lot of different patient populations with different drugs and whatnot, but many of those don’t get a lot of headline news because they’re very niche,” said David Margraf, a pharmaceutical research scientist with the Resilient Drug Supply Project at the University of Minnesota’s Center for Infectious Disease Research and Policy.
At any time, the reasons why shelves may be empty vary from place to place and from drug to drug. Each shortage has its own particular factors. “They’re all a different tale,” Margraf said. “There’s commonalities between them, but each one is a little bit different and it’s very tedious trying to figure out what’s going on sometimes.”
Some drugs are generally more vulnerable to shortage due to a lack of economic incentives to produce them. Sometimes, manufacturing disruptions, labor issues or ingredient shortages will reduce availability. While the US is a major developer of new medications for the world, it is also heavily dependent on other countries for the manufacturing of those drugs.
Then there’s the problem getting the raw ingredients that go in to making drugs, as they are sourced from just two countries, China and India, says Bindiya Vakil, chief executive officer of Resilinc, a company that maps and monitors pharmaceutical supply chains with the aim of giving an early warning to clients when trouble is on the way. Any disruption in China or India, such as work stoppage at a factory due to China’s strict zero Covid policy, which was only recently eased, may have a ripple effect on the supplies of many products, including medications.
Even with normal levels of production, high demand during a tough cold and flu season – like the one the US is experiencing – can make it hard for families to find what they’re looking for. That’s what’s happening right now, as pain and fever medications for children, especially liquid formulations, are in short supply in some places because of a trio of viral illnesses – flu, RSV and Covid-19 – hitting the United States at the same time, creating unprecedented demand. Many pediatricians say they can’t remember ever seeing so many kids this sick at the same time.
With children’s medications, drug manufacturers say they are running full-tilt, and they planned for some increase in sales over the winter months. But they didn’t know it would be this bad or start this early. According to the Consumer Healthcare Products Association, which represents producers of over-the-counter medications, major US manufacturers of children’s medications – including Perrigo in Michigan and Johnson & Johnson in Pennsylvania – are “operating facilities 24 hours a day, 7 days a week” to keep up.
The US Food and Drug Administration also says it is keeping a close eye on the situation and “talking daily” with manufacturers to find ways to increase supply. “The ibuprofen and acetaminophen and children’s formulations, we’re monitoring those really closely at this time,” said an FDA official who spoke to CNN on the condition of anonymity because they were not authorized to share details of the agency’s work.
“There are not any manufacturing problems, so there’s not anything that’s slowing production down or causing these shortages as far as manufacturing. In fact, manufacturers are working very closely with us and increasing supply so that we can get the demand where the priority needs to be,” the official said, also stating that the FDA is able to help increase supply by identifying new sources of raw materials to facilitate additional production. The agency can also assist with identifying additional manufacturing sites and “expediting review of anything related to increase in production.”
In the United States, there are groups tracking and watching shortages and potential shortages.
The American Society of Health-Systems Pharmacists, a nonprofit representing pharmacists that work in hospitals, tracks drug shortages in the US by taking reports of shortages from anyone and then checking with manufacturers to verify them. It defines drug shortages as supply issues that affect how a pharmacy prepares or dispenses a drug product or influences patient care if providers have to seek an alternative.
The FDA tracks drug shortages too, taking reports directly from manufacturers, but it defines them differently than the pharmacists’ group. The agency considers a drug to be in shortage when the total supply of all versions of a commercially available product cannot meet the current demand and a registered alternative manufacturer will not meet the current or projected demands, leaving patients in a lurch.
According to CNN, the White House says drug shortages are a priority for President Biden’s administration, too. It points to Biden’s Executive Order on America’s Supply Chains, signed in February 2021, which directed the secretary of the Department of Health and Human Services to identify and report risks in the supply chain for pharmaceuticals and their active ingredients and to make recommendations to address those risks.
Most of the drugs that seem to disappear are inexpensive generics given by injection. These “sterile injectables” have stringent manufacturing requirements that make them costly to produce, and they have slimmer profit margins, so there’s less economic incentive for companies to make them.
Other generics – like many antibiotics – are vulnerable to shortages, too. Experts say that’s what happened recently to some formulations of amoxicillin. Companies produce generic drugs to order. They don’t keep stocks on shelves in a warehouse. Some manufacturers say this year’s orders didn’t anticipate the high demand. Even when companies realize there’s a shortfall, it may take weeks or months for them to make and ship more product.
“Really, it comes down to economics,” said Vimala Raghavendran, senior director of the Pharmaceutical Supply Chain Center at the U.S. Pharmacopeia, a nonprofit that at sets quality standards for dietary supplements, food and medications.
There are some systems in place to stay ahead of shortages. The FDA requires manufacturers to notify it if there is anything that would disrupt the manufacturing or supply of a drug, and in many cases, that allows the agency to head off problems. However, companies are not currently required to notify the FDA of increased demand.
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