U.S. drug shortages put people with life-threatening illness at risk

WASHINGTON, Sept. 16 (UPI) -- Adderall and monkeypox vaccine represent only the tip of the iceberg when it comes to drugs now in short supply in the United States -- some badly needed by patients who are seriously ill with life-threatening diseases.

Pharmacists tell UPI of scrambling to meet patients' urgent needs amid current shortages ranging from basics like sterile water and saline to antibiotics, sedatives and cancer-fighting medications.

They say the situation is "plaguing" them and affecting their ability to provide care to patients.

As of Thursday, the Food and Drug Administration reported 184 drug shortages nationwide. The Association of Health-System Pharmacists put the figure higher, tracking a scarcity of 210 drugs.

U.S. drug shortages may be caused by a host of issues, including manufacturing and quality problems and delays and discontinuations, along with a regulatory system seen by many healthcare providers as more reactive than proactive in making fixes.

Long-standing problem

It's a long-standing problem worsened by supply chain issues and huge demands during the COVID-19 pandemic, with many drugs languishing on the shortage lists for months or years.

In its annual report to Congress, the FDA placed a different emphasis, saying it had prevented a record 317 drug shortages in calendar year 2021 by working with drug manufacturers.

Drugmakers, too, speak of collaboration to solve the problem.

"Our top concern is patients' health and well-being, and we are committed to working closely with [the FDA], supply chain partners and healthcare providers to prevent and mitigate medicine shortages," spokesman Andrew Powaleny, of Pharmaceutical Research and Manufacturers of America, told UPI in an email.

Meanwhile, many front-line pharmacists characterize the problem as one being felt every day in large and small ways throughout the healthcare system, especially in hospitals and cancer clinics.

Hospitals may face more challenges from shortages of fluids or diluents, intravenous oncology and antibiotic medications, "and supportive care, as well as supplies such as needles that are necessary to deliver the medications," Mesfin Tegenu, CEO and chairman of RxParadigm, a Delaware-based pharmacy benefits manager, told UPI in an email.

By contrast, doctors' offices may have more challenges from shortages of drugs dispensed at the pharmacy level, such as cardiovascular and analgesic medications, he said.

Causing frustration

"Our members are frustrated with ongoing [drug] shortages that seem to have worsened in recent months," Michael Ganio, senior director of pharmacy practice and quality for the Association of Health-System Pharmacists, told UPI in a phone interview.

He added: "Some compare the current shortages to the aftermath of Hurricane Maria, which wiped out several [pharma] manufacturing sites on the island of Puerto Rico in 2017."

Most described the drug shortage issue to UPI as "scary" and unpredictable, a problem that must be closely tracked, often requiring pharmacists to think on their feet and find makeshift solutions.

"It's the juggling act on top of severe staffing shortages. I think that's what is making it worse right now. Before it was 'drug shortages on top of COVID.' Now it's 'drug shortages on top of staffing shortages,'" said Erin Fox, senior pharmacy director at University of Utah Health and adjunct professor at the University of Utah College of Pharmacy.

First, Fox cited the academic healthcare system's shortage of basic saline.

"Almost every single patient who gets admitted to the hospital is going to need saline," she told UPI in a phone interview. "So to be short is scary."

She also described a "critical shortage" of lorazepam injections -- widely used medication used to keep patients sedated in the intensive care unit, calm people's nausea from chemotherapy, stop seizures and much more.

Making substitutions

Fox said the low supply has required her hospital "to start using oral [lorazepam] tablets whenever possible" -- not ideal for patients who are nauseated or incapacitated.

"It's a very basic product that we should have access to, but it's not available," she said, explaining that the supplier of lorazepam had delays in manufacturing and shipping this summer.

Fox tracks drug shortages nationally for the Association for Health-System Pharmacists. She said she provides 50 to 100 updates a week by talking to drug companies directly, while the FDA is "more passive," waiting for companies to report supply problems as required under a 2012 law.

At Ohio State University's James Cancer Hospital in Columbus, lorazepam injections also are scarce, Julie Kennerly-Shah, associate director in the Department of Pharmacy at Ohio State's College of Medicine, told UPI in a phone interview.

So, the cancer center is now saving lorazepam injections for patients with seizure disorders and giving alternative medications to relieve nausea from chemotherapy, said Kennerly-Shah, who directs the center's hematology/oncology, pain/palliative and ambulatory care clinical services.

Even more pressing, she said, is a shortage of pentostatin, a drug that is highly effective at treating a rare form of cancer called hairy-cell leukemia.

Scary situation

"Currently, any time we have a new patient diagnosed with hairy-cell leukemia," she said, "we must contact the manufacturer and hope they have a supply of the medication" -- what she described as "a very scary situation."

Pentostatin has been on the drug shortage list since 2019, but sometimes the hospital has needed the medication urgently -- like now -- and other times it has received regular shipments.

Kennerly-Shah also noted a shortage of fludarabine, used for various types of cancer and also as part of a regimen before CD19 chimeric antigen receptor (CAR) T-cell therapy.

Since February, the hospital has had to prioritize the use of fludarabine for patients who receive bone marrow transplants, using substitute regimens for CAR T-cell patients, Kennerly-Shah said.

Other cancer centers, especially smaller ones, have reached out to Ohio State's cancer center seeking fludarabine. But, she said, "When they ask, we don't have it to give."

Kennerly-Shah said the hospital tries to be as proactive as possible, using its own internal list of drug shortages, along with the FDA and Association for Health-System Pharmacists lists, to monitor medications and anticipate when it's time to restrict supplies so pharmacists can keep a drug on hand for patients who need it the most.

"Our team meets twice weekly to review the list of medications on shortage, to define criteria for how we prioritize patients, and to recommend substitute medications when necessary, she said.

Fails to arrive

Sometimes the hospital only discovers medication supply problems when a shipment fails to arrive, she said.

"We're frequently told there's been a manufacturing challenge and we have no estimated date on when or how much supply we'll get," she said. "I think our patients deserve answers when there's not enough medication to treat their cancer."

Janelle Mann, a clinical pharmacy manager who works with providers at the Washington University School of Medicine's Siteman Cancer Center in St. Louis, said lorazepam injections and fludarabine are the latest products now being monitored.

Roughly a year ago, the Siteman center faced a shortage of Lupron, a medication mainly used to regulate hormones in prostate cancer patients, but had nearly identical therapies to offer in the same drug class, Mann told UPI in a phone interview.

So, while Siteman got through the Lupron shortage using other formulations, Mann said it was "still a struggle" to switch products because healthcare providers must establish new relationships with other drugmakers, and set up new contracts, to gain access to substitute therapies.

"Sometimes, that's our red flag, when you can't order through your manufacturer or wholesaler. It says it's out of stock," Mann said. "Or you place an order and it just doesn't show up. Either you don't get the number of vials you ordered or you'll get a notice [that] they can't fill the order request."

Then, the pharmacist needs to talk with the prescriber to decide on next steps.

"In many cases, we find suitable alternatives that the providers are comfortable with," Mann said. "We want what is best for the patients."

Rationing doses

Conserving the supply of a drug once healthcare providers know it's going to become scarce may include setting guidelines for the medication's use and rationing doses, the Association of Health-System Pharmacists' Ganio said.

That occurred this spring after GE Healthcare shuttered its facility in China that makes injectable contrast solutions used to highlight CT scan image because of local COVID-19 policies.

"As of now, that shortage has been fixed. But the underlying fragility of the system continues ... and there is no reason it couldn't happen again," Dr. Matthew Davenport, vice chair of the American College of Radiology's Commission on Quality and Safety, told UPI in a recent phone interview.

Davenport is professor of radiology and urology at Michigan Medicine in Ann Arbor.

Often, cost isn't the issue, since many of the drugs in short supply are very inexpensive, Fox said.

"It costs hospitals more in labor costs to manage these [drug shortages], paying overtime, or seeing other work just not getting done. But there aren't more expensive alternatives, usually, and the prices don't generally go up for these very low-cost medications," she said.

The frustrating part, Fox said, is the problem is not being resolved quickly -- which has "really changed" the way drugs are prescribed, prepared and administered.