Anyone who had a kid with RSV this winter, their own infection or ADHD diagnosis, or a relative with cancer likely discovered that getting drugs to treat the problem has become a problem itself.
A massive drug shortage has left people calling around to get prescriptions filled, settling for half dosages or going without needed medications.
Shortages began cropping up a decade ago but worsened during the coronavirus pandemic, with surges in demand for drugs to treat infections and constraints on supply by manufacturers who shuttered plants or limited exports.
Johns Hopkins University experts recently held a panel discussion about the scope of the shortages, the reasons and the possible remedies. Here are some answers to common questions based on what they had to say:
So, what is in short supply?
The U.S. Food and Drug Administration reports shortages of 207 prescription medications for a variety of reasons, from manufacturing issues to quality control, discontinuation of production or a surge in demand.
This has included some basics like versions of the painkiller acetaminophen, the antibiotic amoxicillin, Adderall for ADHD and a variety of life-saving cancer drugs.
“There are 15 indispensable chemotherapy drugs in short supply,” said Dr. Amanda Fader, an associate professor in the department of gynecology and obstetrics and the Sidney Kimmel Comprehensive Cancer Center at Hopkins Medicine.
She said hospitals around the country are ensuring that they “use every drop,” share resources and use proven alternatives when necessary to ensure every patient is treated. Sometimes that means a longer course of care or extra side effects, however.
What are the main reasons for shortages?
There are many reasons, but quality control is a big one, said Tinglong Dai, a supply chain expert and professor in the Hopkins Carey Business School.
He said most drugs, including nearly all generic drugs, are each made in just two or three dedicated factories overseas. Some are made in a single factory, mostly in China or India. Cancer drugs trace specifically to India.
The FDA doesn’t have the capacity to inspect several thousand overseas facilities frequently, so small quality control problems become large problems and the plant can be shut down with no backup.
Federal reports show quality control is responsible for at least half of the shortages, he said. (Quality is an issue in the United States, too, with the recent baby formula shortage due to a recall for contamination at a Michigan plant, and Emergent BioSolutions in Baltimore had to toss millions of ruined doses of COVID-19 vaccines.)
There are also other reasons, said Dr. Mariana Socal, an associate scientist with the Johns Hopkins Bloomberg School of Public Health, whose research focuses on improving pharmaceutical access and affordability
Some addictive drugs are tightly regulated by the U.S. Drug Enforcement Administration, potentially cutting off supplies. Sometimes a manufacturer doesn’t see enough demand, and profit, to keep making a drug.
But she said spot shortages of common drugs such as Tylenol and ibuprofen were due to spikes in demand during the winter surge in respiratory infections. Caught off guard, there were no extra supplies in the system to account for the demand, or the medications were in the wrong places.
The pandemic caused some other countries to hoard supplies, she said, especially if plants closed temporarily.
“India suspended exports of Tylenol during the pandemic,” Socal said. “They wanted the supply in their country.”
That wasn’t just finished products, but drug ingredients, which are also predominantly produced overseas. And this lack of domestic supplies and capabilities makes ramping up manufacturing quickly in the United States difficult, she said.
What can be done about supplies?
The experts said understanding the supply chain is crucial. U.S. manufacturers can begin to set up more of the complex production facilities and identify a ready supply of ingredients.
Time-consuming, but a start, they said. Faster approval of new drugs to diversify treatment options would be another path.
Using federal dollars to stockpile more medications, and incentivizing manufacturers to keep making some drugs and more doses of certain high-use drugs, would also help, said Dr. Joshua Sharfstein, vice dean for public health practice and community engagement and the former principal deputy commissioner of FDA.
Sharfstein said many drugs are expensive but some are really cheap, and perhaps those could cost a bit more to pay for these more robust supplies.
He also said working with other countries that import drugs to officially share inspection duties and information with the FDA could help the quality control issues.
He added there must be one federal agency empowered to take these and other necessary steps in times of shortages. That may include an easier path to safely import drug supplies from other countries, such as Canada or Mexico, and a more seamless way to move medications to parts of the country where they are needed during spot shortages.
That’s a “spread the wealth” system, one that hospitals are currently taking it upon themselves to do with those chemotherapy drugs.
Maybe, Sharfstein said, there could be an emergency manufacturing facility able to produce a variety of drugs when they are short.
Fader pointed to legislation in the U.S. Congress, including the Drug Shortage Prevention Act, giving more power to the FDA to require manufacturers to alert it earlier of potential shortages. It would also require the FDA to notify providers about drug supplies and give guidance to manufacturers for better predicting demand.
She said shortages of life-saving drugs are unacceptable.
“We’re one of the worst chemotherapy drug shortages in U.S. history,” she said. “This has escalated to the level of a public health crisis.”