Groups urge Pence to address hydroxychloroquine shortages after demand spikes for COVID-19
The American College of Rheumatology, the Lupus Foundation of America, the Arthritis Foundation and the American Academy of Dermatology have issued a joint statement calling on Vice President Mike Pence to address shortages of hydroxychloroquine and chloroquine, following comments from White House regarding their potential use in treating COVID-19.
“There are already shortages and there is a lot of concern from people with lupus, the lupus community and other rheumatic disease patients,” Karen Costenbader, MD, MPH, 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, told Healio Rheumatology. “We need increased production of these medications so there is a supply that allows people already taking these medications to continue to have access, as well as for COVID-19 patients to receive them — and hopefully larger studies and trials show benefit for COVID-19.”
In a press briefing last week, President Donald Trump erroneously implied that the FDA had approved hydroxychloroquine to treat patients infected with the novel coronavirus. FDA Commissioner Stephen Hahn, MD, soon after clarified that the agency must first conduct a clinical trial to determine whether the drug, which is currently approved for lupus, rheumatoid arthritis and malaria, is safe and effective in patients with COVID-19, and at what dosage.
In the days following that announcement and correction, shortages of hydroxychloroquine and chloroquine have been reported, as increased demand has threatened already-limited supplies of the drug for patients with rheumatic and dermatologic diseases who rely on them, according to the joint statement.
“We haven’t done any systematic surveys yet, but we have received emails from our members who reported that their patients have gone to the pharmacy and have been unable to fill their prescriptions because the pharmacists are out and they are not getting timely shipments from the wholesalers,” ACR President-elect David Karp, MD, PhD, told Healio Rheumatology.
In their letter, leaders of the four organizations urged Pence to work with patient and physician representatives to ensure the continued availability of these drugs for the tens of thousands of people who require them to avoid disability, illness and death.
“In many cases, there are no alternatives to hydroxychloroquine or chloroquine,” read the letter. “For patients with lupus, hydroxychloroquine is the only medication shown to increase survival. Hydroxychloroquine is the cornerstone of therapy, used in most patients unless a contraindication exists. Already today, many of our patients are not able to fill their prescriptions, due to major shortages of hydroxychloroquine, with validated reports across the country of pharmacies having depleted their supplies and half of the drugs’ manufacturers reporting backorders.”
Although the groups expressed support for rigorous clinical trials investigating hydroxychloroquine and chloroquine for COVID-19, they stressed the importance of maintaining access for patients who currently use them.
They called on Pence and the White House to work with the pharmaceutical industry, pharmacies and the FDA and take the following actions:
- Increase monitoring and timely reporting of shortages and mitigate the shortage that has resulted from an increased demand;
- Use existing authorities to increase production and supply;
- Ensure current supplies are allocated for patients taking them for indicated uses and that any increase in supply be available for continued access, not diverted for use in COVID-19;
- Communicate to the public, health care professionals and other stakeholders accurate and timely information regarding these drugs, their role in treating their current indications and the status of their use for COVID-19, including ongoing clinical trials and what is known or not known about the safety and efficacy in COVID-19;
- Implementing restrictions to minimize unnecessary prescribing or stockpiling of hydroxychloroquine and chloroquine solely for use in COVID-19;
- Monitor and prevent unreasonable price increases or cost sharing for the drugs;
- Give patients who take these medications for indicated uses ongoing access to refills of a 90-day supply to prepare them for an emergency in case of a sudden shortage, and establish policies to assist with cost-sharing related to emergency supplies; and
- Limit prior authorization and use management practices that may delay access to these drugs for those with indicated diseases.
The danger associated with individuals self-medicating with hydroxychloroquine or chloroquine to treat or prevent COVID-19 was illustrated this week, when reports surfaced of an Arizona man who died after ingesting chloroquine phosphate. According to NBC News, the man and his wife took the toxic substance, which was not the medication form of chloroquine but instead a parasite treatment for fish tanks, after watching President Trump discuss the potential benefits of chloroquine in COVID-19.
The man’s wife, who is under critical care, told reporters they were afraid of getting sick and believed the substance would protect them from being infected by the coronavirus.
“This underscores the fact that, although we in rheumatology think of hydroxychloroquine as one of the safest medications that we use — because we know how to use it and what the correct doses are — people should not be taking it on their own without medical supervision, just like any medication,” Karp said. “In particular, as this unfortunate incident shows, chloroquine phosphate is the less safe drug compared with hydroxychloroquine. It’s still used when patients don’t respond well to hydroxychloroquine, but when we do use it, we are very cautious.”
According to Karp, that physicians should “get the word out” that individuals should not be taking these medications on their own. He added that the ACR would be releasing clinical guidance on hydroxychloroquine for members “very soon.”
Victoria Werth, MD, professor of dermatology and medicine at the University of Pennsylvania, chief of dermatology at the Corporal Michael J. Crescenz VA Medical Center in Philadelphia, and member of the Lupus Foundation of America Medical-Scientific Advisory Council, echoed this sentiment, stressing that general public should understand that such drugs and treatments should only be administered via a physician’s orders.
“Studies of antimalarials as a treatment for the coronavirus are ongoing, and any use should be determined by a person’s health care provider,” Werth told Healio Rheumatology. “Non-medicinal preparations are not safe to take, and the public should not self-treat.” – by Jason Laday
Disclosures: Costenbader, Karp and Werth report no relevant financial disclosures.