The week of March 16, reports of hydroxychloroquine (HCQ) shortages began to circulate around the U.S. following a sudden surge in interest regarding the drug’s potential use as a therapy for COVID-19. As clinical trials are launched to investigate this and other treatments already approved for rheumatic diseases, rheumatologists and their patients are worried about the availability of HCQ to fill existing prescriptions for lupus and other diseases.
On March 20, the ACR co-authored a letter to Vice President Mike Pence, head of the U.S. COVID-19 Task Force, calling for the U.S. Food and Drug Administration (FDA) to monitor and report any drug shortages and ensure HCQ supplies are protected for patients with autoimmune diseases. The letter co-authors were the Lupus Foundation of America, the American Academy of Dermatology and the Arthritis Foundation.
“Ever since the release of the French study examining the utility of HCQ in COVID-19 patients, interest in HCQ skyrocketed to the point that its supply has evaporated,” says Alfred Kim, MD, PhD, a rheumatologist and assistant professor of medicine at the Washington University School of Medicine, St. Louis. “In the St. Louis region, right after the study came out, most of the pharmacies had several hundred pills of HCQ in stock, but their suppliers were either out or had very low stock. Starting Monday, we have had increasing number of patients who cannot get their prescriptions refilled.”
Dawn Smith-Popielski, a patient in St. Louis who takes HCQ for Sjögren’s syndrome, says she is close to needing a refill and is worried about its availability through her mail-order pharmacy.
“I am more alarmed by the response of friends on Facebook suddenly talking about HCQ and wondering how they can get it. These are people who don’t have an autoimmune disease and do not necessarily know that taking this drug requires regular monitoring with lab tests and eye exams,” she says. Ms. Smith-Popielski says she had severe ophthalmologic symptoms until starting HCQ two years ago.
Supply Shortages Reported
Angus Worthing, MD, a rheumatologist at Arthritis and Rheumatism Associates, Washington, D.C., and Chevy Chase, Md., also received calls from patients late last week saying that pharmacies were out of HCQ. Supplies need to be maintained for patients who have prescriptions, he says.
“People with systemic autoimmune diseases need to refill their drugs. Just about everyone with systemic lupus takes HCQ as a preventive drug,” says Dr. Worthing, who strongly supports the ACR speaking on behalf of rheumatologists to ensure the FDA closely monitors and reports any drug shortages. “In talking to my patients who have concerns about COVID-19, I am going through the current drugs they take one by one and addressing their questions. When I tell them that HCQ doesn’t suppress their immune systems, it calms their concerns.”
Madelaine Feldman, MD
Madelaine Feldman, MD, a rheumatologist at The Rheumatology Group, New Orleans, also received calls from patients saying that local pharmacies could not refill their HCQ prescriptions. She says her staff was only able to find one pharmacy, an independent store in Mississippi, that had HCQ in stock.
“It is important for lupus patients, probably even those who are in remission, to continue taking their HCQ,” says Dr. Feldman, who states that hospitals in New Orleans have been using HCQ as part of the cocktail of medications given COVID-19 patients for weeks, draining the supply for her patients. “I don’t feel confident that my patients will be able to get their medications. Every day, I look at my practice’s electronic health record, and the portal is full of messages asking where patients can refill their HCQ [prescriptions] because their drugstore is out of it.”
Veena K. Ranganath, MD, MS
Public Health Crisis
Rheumatologist Veena K. Ranganath, MD, MS, associated clinical professor of medicine at the University of California, Los Angeles, also reports HCQ shortages at local pharmacies. “My lupus patients really need these medications. I worry that we will see an increase in flares later, and that if they have a really bad flare, we’ll have to prescribe high-dose prednisone, which will increase their risk of contracting viral infections. I worry for my patients,” she says.
Several clinical trials are investigating the treatment—including one led by researchers at Columbia University in New York that will begin recruiting 1,600 patients this month—are underway in the U.S. and other countries.3
On March 19, the FDA announced that it will play a critical role in government-wide responses to the COVID-19 pandemic, including surveillance of drug supplies and working with clinical trial investigators to study potential therapies, such as HCQ, chloroquine (an older anti-malarial drug) and several IL-6 inhibitors approved for use in RA and other rheumatic diseases. For now, rheumatologists still have serious concerns about the availability of their patients’ medications.
“This is creating a public health crisis: The overutilization of HCQ for a condition—COVID-19—where the data currently do not justify its use has overwhelmed the supply chain currently designed for patients with systemic autoimmune diseases, such as SLE or RA,” says Dr. Kim. “Compounding the situation is the speed at which this interest exploded. Obviously, the supply chain could not catch up. This has put lupus patients, particularly, in health jeopardy, because this is the most important drug we have in our arsenal to treat lupus.”
Susan Bernstein is a freelance journalist based in Atlanta.
References
- Thomas K, Grady D. Trump’s embrace of unproven drugs to treat coronavirus defies science. The New York Times. 2020 Mar 20.
- Gautret P, Lagier JC, Parola P, et al. Hydroxychloroquine and azithromycin as a treatment of COVID-19: Results of an open-label, non-randomized clinical trial. Int J Antimicrob Agents. 2020 Mar 20:105949. [Epub ahead of print]
- Oelsner E, Columbia University Irving Medical Center. Hydroxychloroquine post-exposure prophylaxis for coronavirus disease (COVID-19) (NCT04318444). Clinicaltrials.gov. 2020 Mar 25.
- U.S. Food and Drug Administration. FDA news release: Coronavirus (COVID-19) update: FDA continues to facilitate development of treatments. 2020 Mar 19.
