Photo: Crystal Cox/Business Insider
When Mary Louise Luczkowski called her longtime pharmacist Tuesday to refill her prescriptions for lupus medication, she got a surprising answer.
The small pharmacy in South Lyon, Michigan, couldn't get the pills. Luczkowski has been taking hydroxychloroquine for lupus since 2010, and this is the first time she's struggled to get her medication, she told Business Insider.
Chloroquine and the safer, more widely used variant called hydroxychloroquine have rapidly gone into shortage as demand has spiked, thanks to early reports that the pills may work to treat COVID-19, the disease caused by the novel coronavirus.
There is no peer-reviewed clinical data showing that these old generic drugs work against COVID-19. But that hasn't stopped anecdotal reports of chloroquine working in cases across the world from building up hopes for the drug, which both President Donald Trump and Tesla CEO Elon Musk both amplified.
And US prescriptions have spiked as well.
Chloroquine, which is made by one manufacturer in the US and was approved in the country in 1949, has been in shortage since March 9, according to the American Society of Health-System Pharmacists. Hydroxychloroquine, sold under the brand name Plaquenil, went into shortage on Thursday, according to the pharmacy group, with four of its eight suppliers affected.
And while it remains to be seen if these pills will work for COVID-19, they have been approved by regulators as a safe and effective medication for malaria, lupus, and rheumatoid arthritis.
Rheumatologists, patients, and medical organizations focused on lupus and arthritis are "very concerned" about the threat of shortages, said Dr. Karen Costenbader, the director of the lupus program at Brigham and Women's Hospital and the chair of the Lupus Foundation of America's medical-scientific advisory council. She said there's a need to increase supplies, and that the federal government should consider subsidizing production.
"It is imperative that our patients with autoimmune diseases like lupus continue to have access to these proven medications and for COVID-19 patients to have access to these potentially useful but yet unproven medications for their disease," Costenbader said.
The Shortage Happened Quickly as Coronavirus-Treatment Hopes Emerged
Drug manufacturers are now working to meet the demand. Amneal is working to increase production, according to a person familiar with the company's plans. Mylan said it would restart hydroxychloroquine manufacturing at a West Virginia plant. The Indian healthcare company Zydus Cadila said it's increasing production as well.
Teva Pharmaceutical Industries said it plans to donate more than 10 million tablets of hydroxychloroquine to US hospitals within a month.
"Immediately upon learning of the potential benefit of hydroxychloroquine, Teva began to assess supply and to urgently acquire additional ingredients to make more product while arranging for all of what we had to be distributed immediately," Brendan O'Grady, an executive vice president at the drugmaker, said in a statement.
Sandoz, the generics arm of the pharmaceutical company Novartis, said it had a good supply of hydroxychloroquine in the US. On Friday, Novartis committed to donate up to 130 million doses of the drug to support the global response.
Advanz Pharma said the drug was in stock, and it's monitoring the situation closely.
"Even with eight suppliers, just the huge surge in demand is absolutely creating a shortage," said Erin Fox, a drug-shortage expert and the senior pharmacy director for the University of Utah's health system.
Fox told Business Insider she made the decision Tuesday to restrict hydroxychloroquine prescriptions after a pharmacist flagged unusual prescriptions at higher dosing levels for people not previously on the medicine.
The health system, which includes four hospitals and 12 retail clinics, is preserving the drugs for patients with chronic diseases like lupus or arthritis who need them. It also wants to have a supply on hand in case the drugs are needed for hospitalized patients.
"I think it's concerning to have this huge surge," she said. "I don't think these suppliers are prepared to ramp up production."
The Food and Drug Administration does not list either drug as in shortage. Drugmakers are required to report shortages to the FDA but face no penalties if they fail to do so, Fox said.
The Shortage Will Leave Patients Without the Medicine They Need
If lupus is left uncontrolled, the disease can restrict a person's life and even turn fatal. Luczkowski knows firsthand: She had a friend with lupus who died from kidney failure after the disease progressed.
For her, the autoimmune disease often brings flares, during which she said her skin feels like it is being burned by the air and that her muscles and joints severely ache. In the unresolved scramble to get her medicine, stress, a key trigger of flares, has been particularly high.
"People rely on this medication," Fox said. "They have chronic illnesses, and they really rely on this. Once you're stable on these therapies, it's not something that is easy to switch."
Michael Rea, the CEO of Rx Savings Solution who was previously a pharmacist, said he was most concerned about the panic that could sweep over people in extreme situations like this.
"The fear, the chaos, and the panic is a far greater threat to humanity than a virus, especially for a therapy that may or may not work," he told Business Insider.
Rea advises all healthcare workers to act professionally in these times, he said.
"Don't let fear dictate your decisions," Rea said. "Only use the drug, prescribe the drug, obtain the drug if you truly need it."
Fox, who has closely studied drug shortages for about two decades, is worried there will be more to come as the furious scramble to find effective coronavirus treatments continues.
"It makes me worry about potential for other shortages as this goes on," Fox said. "In the US, we're not used to having huge numbers of patients being very, very critically ill in our hospitals. We're not used to it, and it's a completely different amount of drug people are going to need to have on hand."