Widespread drug shortages in the United States are at the highest level in nearly a decade, a new study found, and they are affecting treatments for cancer patients, kids with ear infections, pregnant women and others.
“There were 309 active, ongoing drug shortages — the highest number in nearly a decade and close to the all-time high of 320 shortages” at the end of the second quarter, according to the study by the the American Society of Health-System Pharmacists of more than 1,000 ASHP members.
Many Americans may be dimly aware of the shortages, if they take a medication that’s hard to get, or if a shortage hits the headlines like last winter’s reports of scarce antibiotics and fever and pain relievers for children in the “tripledemic” surge of Covid, flu and RSV infections. But it turns out that the shortages are fairly widespread, resulting in a lot of people not getting medications, and a lot of MacGyvering in hospitals and pharmacies.
“Over 99% of respondents reported they are experiencing drug shortages,” the study said.
“Most respondents categorized the current state of drug shortages as either critically impactful (32%) or moderately impactful (63%). Critically impactful was defined as rationing, delaying, or canceling treatments or procedures. More than half of respondents (57%) said shortages of antineoplastic (chemotherapy) drugs were critically
impactful.”
Here is a Food and Drug Administration site listing shortages.
Kids with ear infections
The victims of the drug shortages are many and varied, said Dr. Marion Mass, who has practiced pediatrics in Philadelphia for 24 years. She described the antibiotic shortages of last winter when “I had never seen so many sick kids in my life — ear infections out the wazoo. And then we had an antibiotic shortage.” She spoke of parents of children with ear infections who couldn’t get the first line of antibiotic defense in such cases, amoxicillin, and were given instead more powerful antibiotics, like cephalosporin, and a cascade of unwanted consequences.
“It treats more things than it needs to,” she said of cephalosporin. “But then that increases your resistance, and then we end up with plenty of kids that keep on getting bad infections, which the antibiotics don’t work for. And we end up having a whole bunch of kids that need ear tubes.”
Then you call the hospital, she said, “and ask them, ‘Hey, how soon can you take an appointment for a kid that needs ear tubes?’ The patients are telling me it is taking two or three months to get in with some of the ENT surgeons, who are the ones who put the tubes in.
“When you have a toddler, and your kid keeps getting sent home from daycare, and the kid’s in pain, and they’re screaming, and it’s nighttime, and you are going through infection after infection, and you have to wait two months to even see the general otolaryngologist. How frustrating for these parents and awful for their kids. There’s a glut of these patients needing the tubes, because we’ve created a problem with resistance because we didn’t have the antibiotics.”
Mass is cofounder of Practicing Physicians of America, promoting the interests of working physicians, is a visiting fellow at the Independent Women’s Forum, and a leader in the Free2Care coalition, a coalition of physician and patient organizations and others believing that health care is fundamentally about the physician/patient relationship.
Cancer drug shortages
She said: “We are not just talking antibiotics here. We are not talking about the stress that if you are a cancer patient, and they say there’s no chemo.
“I have talked with an oncologist who has had to decide who’s getting the drug today? Is it the 20-year-old with testicular cancer or the 28-year-old with lymphoma?
“But are they going to tell the patients? No. And the reason they’re not going to tell the patients is because you don’t want to scare your patient — they’re under enough stress.”
She talked about another doctor, this one in Michigan.
“I had a colleague that had two very, very sick patients come in at the same time. One was a child with a bad asthma attack. The other was a patient with chronic obstructive pulmonary disease. Those two patients both need the medication called albuterol, your go-to medication to open up lungs that are obstructed.
“They ran out of albuterol — they had used everything they had in the hospital. One patient got sent to the ICU and got an inferior drug, and the other one got transferred to another hospital because they had to make a choice.”
“You can’t breathe and you can’t get what you need. Are you kidding me?”
IV antibiotic shortages
It’s a story of making do, devising a stopgap solution, in some cases, she said.
In another Michigan hospital, in late winter, she said, they were short of the bags of common antibiotics for an IV pole — so nurses had to draw antibiotics with a syringe, from a vial, and sit at the patient’s bedside “and manually push the antibiotic into the patient’s arm,” she said. “And this in the setting of a nursing shortage.”
A cardiologist told her of another situation, pre-Covid. “He wasn’t able to give bicarb, which is like baking soda in water, to his patient,” she said.
“The patient had a heart rate of 20 — like they’re going to die. He asks for bicarb and he’s told there’s a national shortage. The response is he has to actually now thread a piece of wire into the guy’s neck and pace him out of it, which is kind of dangerous compared to giving bicarb in an IV, you know.”
Another place: Maternity care. She said that pitocin, used to induce labor, is in short supply, as are the anesthetics used for a Cesarean section and the medication needed to start a premature baby’s heart.
A neonatologist friend told her that the supplies to feed preemies, either through an IV or a tube in the gut, are in short supply, as are trace elements critical for preemie feeding like magnesium, calcium and phosphorous.
Critical back orders, ‘no opioids’
On Reddit, doctors and others are comparing notes. “Continuing excessive demand on Wegovy, Ozempic, Mounjaro. Critical back orders on Oxycodone and Lorazepam products. Locasamide, Suboxone shortage.”
“We are in a tadalafil back order now, it’s been going on for 3 months. I’m in Denver, Co”
“We ran out of sildenafil today and McKesson says it’s unavailable”
“Carboplatin, 5-FU, Cisplatin, vinblastine, MTX… At least Keytruda is readily available I suppose.”
“My pharmacy has has no opioids and it’s been a nightmare. Literally no oxycodone products.”
“No hydrocodone and while we’re still getting dribbles of oxy, it vanishes as soon as it comes in because all the norco patients have swapped over. Constant phone calls about it and ‘When will you have it?!’ “
“Yeah I work in specialized pharmacy in a hospital so basically all of our patients are cancer patients and patients that just had surgery so you can only imagine how much of hell it’s been. All of our patients are on pain meds and I feel so bad because there’s literally nothing we can do. So many times patients ask us crying well what am I going to do and it so stressful I can’t even. I heard it’s a possibility that they won’t make Percocet anymore but it hasn’t been confirmed. If it’s a chronic problem you may have to switch to a long acting pain medication like morphine, or methadone instead but once doctors start prescribing those more then we’ll be out of those. But if it’s just surgery and not a chronic condition they aren’t going to prescribe long acting pain meds and basically screwed.”
“I went to seven pharmacies to get Vyvanse and finally threw up my hands in defeat. Doctor switched me to Adderall this month. I actually found that at my normal pharmacy. And next week I’ll be trying to find my kid’s Concerta. I know ADHD meds are a big joke among pharmacists but our ability to function like normal humans is totally reliant on these meds. “
“We’re going back to the days of mixing thyme in some mud and packing the wound with it.”
What causes these drug shortages?
Mass said, “We have had significant drug shortages for over two decades. No one ever fixes the problem. They go round and round.”
She cited the role of Group Purchasing Organizations, which used to be “like a Costco for smaller hospitals,” through which little hospitals can get good bundled deals on supplies. While they had long existed, she said, in the 1980s they got an exemption from the prohibition on kickbacks.
“They got a safe harbor for legalized kickbacks,” she said. The idea was that a kickback was limited to no more than 3 percent of the cost of the drug, with oversight from the Department of Health and Human Services and the Office of the Inspector General. But many have heard the kickbacks grew and grew without oversight, she said.
The GPO mandates where the drugs go by its purchasing power. The drugs are distributed by the distributors — McKesson, Amerisource Bergen and Cardinal Health. But the work of manufacturers is limited by market share — if a manufacturer cannot get enough market share, it drops out, leaving fewer manufacturers. Then if there’s a crisis like the one when the hurricane hit Puerto Rico and damaged factories, the repercussions are grave.
The top three GPO’s are Vizient, with 451,849 beds; Premier, with 341,745 beds; and HPG, with 176,182 beds, according to Definitive Healthcare, a trade publication.
Two other big ones are Zinc Health Services, LLC, and Ascent Health Services, LLC. “Zinc was founded in 2020 and operates as the GPO for CVS Caremark. Ascent was founded in 2019 and operates as a GPO for Express Scripts, Prime Therapeutics, Envolve Pharmacy Solutions, and Humana Pharmacy Solutions,” according to the FTC in its May announcement of expanding its drug middlemen investigation.
Also, in February, a drug manufacturer named Akorn Pharmaceuticals, based in Lake Forest, Ill., went bankrupt and closed. It “was responsible for producing 75 generic drugs, all of which were pulled from the market when the company closed down. In some cases, the company was the sole supplier of particular products,” NBC News reported. It was one of two U.S. suppliers of liquid albuterol, NBC reported.
It was founded in 1971 as an eye care manufacturer, then expanded to “make a range of drugs such as antibiotics, pain and allergy medicines, and veterinary drugs. Its generic drugs included adenosine, which is a drug for irregular heartbeats, and lorazepam, which is used for anxiety as well as nausea and vomiting in some cancer patients. It was the sole supplier of physostigmine, an antidote for overdoses from certain medications, according to a report from the End Drug Shortages Alliance, a group dedicated to preventing drug shortages.”
Also in May, Teva Pharmaceuticals, a big Israeli manufacturer, said it would cut back on generics and focus more on other drugs, in what it called a “pivot to growth” strategy.
FDA cites reasons
The Food and Drug Administration cited several main reasons for the shortages in a 2020 paper.
- “Lack of incentives for manufacturers to produce less profitable drugs;
- “The market does not recognize and reward manufacturers for ‘mature quality systems’ that focus on continuous improvement and early detection of supply chain issues; and
- “Logistical and regulatory challenges make it difficult for the market to recover from a disruption.”
Manufacturing overseas is also a factor: A lot of drugs are made in India, Europe and China. Very few are made in the United States. That means that the U.S. does not control manufacturing and supplies. In addition, a lot of the ingredients for drugs are made overseas.
The biggest U.S. manufacturing site is Puerto Rico, and the storms there can take out a lot of manufacturing capacity. A Pfizer plant in North Carolina was struck by a tornado a month ago, damaging capacity.
Big drug companies don’t want to manufacture cheap generics — the more expensive, flashier drugs make more money than the older generics. So that can mean that there are fewer suppliers and they are farther away — so if a crisis in manufacturing in China takes place, it can affect a lot of drugs.
Earlier this year, we wrote about patients having a hard time filling prescriptions for Adderall, Vyvanse and Ritalin, commonly prescribed for Attention Deficit Hyperactivity Disorder and narcolepsy. We learned that the shortages were partly caused by increased demand, as well as some supply-chain and labor shortage issues at manufacturers affecting some production lines,
On top of increased demand, a secret 2021 settlement in an opioid case with three top U.S. drug distributors kicked in to make more limits on medications like Adderall and other controlled substances.
What’s next?
So what can be said or done that would make any difference?
Drug companies regularly suggest less regulation and higher prices, which other health industry sectors regard as undesirable.
A task force led by the FDA issued a report on shortages in 2019 with the suggestion “Create a shared understanding of the impact of drug shortages and the contracting practices that may contribute to them” and “create a rating system to incentivize drug manufacturers to invest in achieving quality management system maturity.” It also suggested promoting sustainable private sector contracts.”
Of course, it’s the money: “FDA heard from stakeholders that current contracting practices create a high degree of financial uncertainty for generic manufacturers, and thus may contribute to business decisions leading to shortages,” the report said.
Some experts suggest a national stockpile of medications. Michael Ganio, senior director of pharmacy practice and quality for the American Society of Health-System Pharmacists, told Pharma News Intelligence that it’s time to re-imagine the strategic national stockpile of medications.
“He explained that the FDA and WHO both have an essential medicines list that they find critical to have in stock. Having a 3–6 month stockpile of these medications may help effectively manage drug shortages,” Pharma News wrote. ‘I would call it more of a buffer,’ Ganio said. ‘Unlike a stockpile that sits in a warehouse and collects dust, this would be a 3–6 month buffer of these essential medications, probably maintained by the private sector, likely our wholesalers. If there was a government program to support maintaining that kind of inventory, and it was something we rotated through so that it didn’t collect dust and expire, it would give us the ability to respond to a surge in demand and gives manufacturers time to scale up.'”
In June, the the Association for Accessible Medicines published a report calling for several measures, including preventing “regulatory shenanigans,” policing “patent gamesmanship,” regulatory attention to complex generics, “placement of biosimilar medicines on a level competitive playing field” and “Increasing use of cost-saving generics for low-income patients in Medicare,” among other measures.
“Policymakers must act quickly to ensure continued saving and market-based competition, as well as prevent shortages, for future availability of affordable medicines,” the report said.
Clarity in supply chain
Mass said: “First of all, the people that are acquiring medications for hospitals should be unchained and be able to say, with impunity, what they know might be going on. I’m not going to release this person’s name, but someone who used to be in charge of the supply chain at a major, top 10 university hospital, told me, ‘Oh, we know the GPO’s are responsible. But no one will say anything because the GPO is tied to the hospitals.” (Some big hospitals have their own GPO’s, though, she said.)
Also, she said someone should investigate GPO pricing, “becaus when they’re looking at the drugs, in particular, with every drug, like you can see that it’s the exact same price across the board.” (The Federal Trade Commission announced in May that it was expanding its pharmacy benefit manager investigation to include GPO’s.)
Ganio also suggested supply chain transparency. “If there was a little more transparency into the quality, where drugs were made, and where they were coming from, the purchasing patterns could follow where better quality and more reliability lie,” he told Pharma News Intelligence.
Beyond that, Mass suggested looking at the top 20 drugs in shortage. When did. the manufacturers drop out? How is it that Oxycontin is never in shortage? And what are the barriers to entering the drug manufacturing universe?
“Sterile salt water costs $10 a bag to make but hospitals have sometimes been able to charge $700,” she said. “You would think people would be tripping over themselves to create a sterile saline plant and make sterile saltwater, right? But in 2018 there was one place in America making most of the saline when Hurricane Maria closed the plant. Everyone should have asked, why are we relying on a single plant, when there should be robust competition?
“It’s crazy. So we should be going back and looking for these things in shortage and ask, ‘When did manufacturers drop out?’ And we should also be doing a very careful inventory of the medications that are coming from abroad, and the ingredients that are coming from abroad, particularly those from China? Are they safe?”
