FDA data shows numerous drugs in shortage, including a leading antidepressant
By USA Today on 6/11/2020
When Dr. Jeremy Faust ordered medications for a coronavirus patient he planned to put on a mechanical ventilator several weeks ago, he saw warning messages pop up on his computer.
“We're very, very accustomed to seeing drug shortages and alarms coming up on our screen,” said Faust, an emergency physician at Brigham and Women’s Hospital in Boston. “But during this crisis, it’s become a lot more frequent.”
Although Faust was able to ventilate the patient as planned, he was alarmed by the warnings of new shortages at a time acute cases of the virus were surging.
A USA TODAY analysis found 28 generics in 405 dosages hit the U.S. Food and Drug Administration's list of drugs currently in shortage from January through May. All but one, chloroquine phosphate tablet, an antimalarial drug, remain on the list.
USA TODAY’s review shows that even as daily new cases of coronavirus declined nationally in May, more generics hit the FDA’s list: 11 for the month.
Doctors said at least 17 of this year’s 28 new drug shortages are directly or indirectly prompted by events the current COVID-19 pandemic has brought on – including the demand for anesthetics and other medicines used to ease intubation.
“COVID-19 has caused such a huge surge in the numbers of patients,” said Erin Fox, director of Drug Information and Support Services at the University of Utah hospital. “That's really what's driving a lot of the shortages right now, especially critical care medications.”
Among the recent additions related to the coronavirus was one of the nation’s most commonly used antidepressants, sertraline, which is marketed under the brand name Zoloft.
“We're seeing a mental health pandemic that's not going to go away,” said Charles Nemeroff, professor and chair of the Department of Psychiatry at the University of Texas at Austin’s Dell Medical School.
Drugs that hit the FDA’s shortage list for the first time in 2020
A USA TODAY analysis found 28 generics in 405 dosages hit the Food and Drug Administration's list of drugs in shortage from January through May. More than half of those shortages are directly or indirectly related to the current coronavirus pandemic based on interviews with doctors and patients.
|Name||Therapeutic Category||Date First Posted|
|Pindolol Tablets||Cardiovascular||Feb 21|
|AVYCAZ (ceftazidime and avibactam) for Injection, 2 grams / 0.5 grams||Anti-Infective||Feb 26|
|Amoxapine Tablets||Psychiatry||March 9|
|Rifapentine Tablets||Anti-Infective||March 25|
|Nizatidine Capsules||Gastroenterology||March 27|
|Hydroxychloroquine Sulfate Tablets||Anti-Infective||March 31|
|Chloroquine Phosphate Tablets*||Anti-Infective||March 31|
|Midazolam Injection, USP||Anesthesia||April 2|
|Hydrocortisone Tablets, USP||Endocrinology / Metabolism||April 2|
|Furosemide Injection, USP||Cardiovascular||April 7|
|Cisatracurium Besylate Injection||Anesthesia||April 8|
|Dexmedetomidine Injection||Anesthesia||April 10|
|Propofol Injectable Emulsion||Anesthesia||April10|
|Azithromycin Tablets||Anti-Infective||April 14|
|Sulfasalazine Tablets||Gastroenterology||April 24|
|Continuous Renal Replacement Therapy (CRRT) Solutions||Renal||April 24|
|Hydroxypropyl (Lacrisert) Cellulose Ophthalmic Insert||Ophthalmology||May 1|
|Famotidine Tablets||Gastroenterology||May 4|
|Famotidine Injection||Gastroenterology||May 5|
|Vecuronium Bromide for Injection||Anesthesia||May 6|
|Lithium Carbonate Oral Solution, USP||Psychiatry||May 6|
|Dimercaprol (Bal in Oil) Injection USP||Hematology;Other||May 11|
|Amifostine Injection||Oncology||May 21|
|Sertraline Hydrochloride Oral Solution, USP||Psychiatry||May 26|
|Sertraline Hydrochloride Tablets||Psychiatry||May 29|
|Timolol Maleate Ophthalmic Gel Forming Solution||Ophthalmology||May 29|
|Timolol Maleate Ophthalmic Solution||Ophthalmology||May 29|
*The shortage of the Chloroquine Phosphate Tablets has been resolved
SOURCE The Food and Drug Administration
The FDA adds drugs to its shortage database all the time. Dozens entered since 2012 haven’t come off, mainly due to manufacturing problems and difficulties maintaining a supply of imported ingredients that are of adequate quality. Apart from the 28 additions in 2020, another 89 were already in short supply when the year began.
What’s unusual this year is that manufacturers most frequently cite increased demand as the cause for a drug being in shortage, the FDA data shows. An agency report found that between 2013 and 2017, about 62% of drugs that went into shortage between were associated with quality issues or manufacturing problems.
“I've never experienced a shortage of multiple critical medications to this extent, all at once,” Esther Choo, an Oregon based physician who has practiced emergency medicine for more than a decade, said in May.
Choo said the ideal situation is to use “first-line” medications – those that are considered more effective and have fewer side effects. But in early May, even when faced with a relatively low volume of COVID-19 patients in Portland, Choo said doctors were making adjustments because of shortages.
“Any places that are in crisis are really likely to be working with their second- or third-line medications,” Choo said at the time.
Those medications cost doctors and nurses time to figure out the right dosing and methods of administration.
“We have a menu of medications that we normally give for intubation,” said Megan Ranney, an emergency physician, who works at the Rhode Island Hospital in Providence. “Switching that last minute can be challenging for the nurses and for the doctors.”
Even as the April wave of hospitalizations has ebbed in some hard-hit cities, the shortage of key drugs has lingering effects.
As states reopen and hospitals resume elective surgeries, doctors and experts voiced concern.
Dan Kistner, group senior vice president for the health services company, Vizient, said drugs needed for ventilators are also the ones commonly used in elective surgeries.
“Knowing that COVID is still prevalent and knowing that we're going to see other uses for these products,” said Kistner, whose group purchasing organization serves about 3,000 hospitals in the United States. “We've got to make sure we're doing everything we can to increase the supply of these drugs.“
Physicians and other health experts cited five broad categories and causes of shortages related to coronavirus.
Patients with severe COVID-19 symptoms need ventilators. But patients must be intubated first. That requires anesthesia.
“It is not natural to have a rigid plastic tube just put down your throat,” Choo said. “It's also not natural to have a machine dictate how you breathe. In order to just tolerate that treatment, we basically put them to sleep.”
Six anesthesia drugs, including four sedatives and two muscle relaxants, hit the FDA’s drug shortage database since April 2 due to skyrocketing demand.
Faust, the ER doctor, said fewer patients visited the ER during the current pandemic than before it. But, he said during an interview in May, “the ones we are seeing on average are much sicker.” Some will need to be ventilated for weeks.
According to Vizient, the demand for essential drugs used for ventilation in April increased by more than 50% compared to January. Although supply increased along with demand, the volume of drugs ordered was 1.5 times greater than units available in April.
Kistner, the Vizient executive, described anesthesia drugs as “the gas in the car” without which ventilators would not be possible to operate. “It's a one-to-one equation,” he said.
Janie Haseman / USA TODAY
Heart and kidney drugs
Besides essential drugs for sedation, a super sick COVID-19 patient who’s on ventilation may need additional drugs for other medical problems.
The list of new drugs in shortage includes two cardiovascular and renal drugs used for COVID-19 patients with underlying heart diseases or needing dialysis while using ventilators.
Continuous renal replacement therapy solution, for example, is used for patients whose kidneys stopped working and need continuous dialysis. “There're so many more critically ill patients,” Faust said. “There are a lot more patients on dialysis than usual.”
Antimalarial drugs, antibiotics and heartburn meds
Four drugs typically used for treating other conditions entered the FDA’s shortage list this year after being promoted as possible treatments for COVID-19.