On March 25, the American Medical Association, American Pharmacist Association and Americans Society of Health-System Pharmacists issued a statement in response to media reports that physicians and pharmacists were hoarding supplies of the drugs for their own use.
As of March 31, 2020, there are no drugs approved specifically to effectively treat COVID-19, the disease caused by the novel coronavirus, SARS-CoV-2. But that doesn’t stop people—the public and more surprisingly, physicians—from stockpiling some of the drugs that might be used to treat the disease. Examples include hydroxychloroquine and chloroquine, which are used to treat malaria, but also lupus and rheumatoid arthritis.
Chloroquine and hydroxychloroquine are particularly prominent on this issue, despite the questionable effectiveness of the drugs to treat the disease. On March 29, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for both drugs to treat the disease.
In a statement by the Department of Health and Human Services (HHS), the EUA allowed for the drugs to be “donated to the Strategic National Stockpile to be distributed and prescribed by doctors to hospitalized teen and adult patients with COVID-19, as appropriate, when a clinical trial is not available or feasible.”
Sandoz, a division of Novartis, is donating 30 million doses of hydroxychloroquine to the stockpile and Bayer is donating 1 million doses of chloroquine.
“Let’s see how it works,” President Trump said at a press conference on Sunday, March 29, referring to efforts by New York State. “It may. It may not.”
Scientists and physicians have expressed concern over the effort, citing lack of efficacy data and worries that it will make it more difficult for patients who need the drugs for other conditions to get it. Hydroxychloroquine is used to treat malaria, lupus and rheumatoid arthritis. An increasing number of lupus and arthritis patients have reported difficulties in filling their prescriptions and there are reports that some physicians are hoarding the drug for themselves.
On March 25, the American Medical Association, American Pharmacist Association and Americans Society of Health-System Pharmacists issued a statement in response to media reports that physicians and pharmacists were hoarding supplies of the drugs for their own use.
The statement said, in part, “We are aware that some physicians and others are prophylactically prescribing medications currently identified as potential treatments for COVID-19 (e.g., chloroquine or hydroxychloroquine, azithromycin) for themselves, their families or their colleagues; and that some pharmacies and hospitals have been purchasing excessive amounts of these medications in anticipation of potentially using them for COVID-19 prevention and treatment. We strongly oppose these actions.”
A March 24 New York Times article indicated that stockpiling has become such a concern that the pharmacy boards in Idaho, Kentucky, Ohio, Nevada, Oklahoma, North Carolina and Texas have issued emergency restrictions or guidelines on how pharmacies can dispense the drugs, with more states expected to follow.
“This is a real issue and it is not some product of a few isolated bad apples,” said Jay Campbell, executive director of the North Carolina Board of Pharmacy.
The president of the American Medical Association, Patrice Harris, told the New York Times, “The AMA is calling for a stop to any inappropriate prescribing and ordering of medications, including chloroquine or hydroxychloroquine, and appealing to physicians and all health care professionals to follow the highest standards of professionalism and ethics.”
The Idaho board barred pharmacies from dispensing chloroquine and hydroxychloroquine unless the prescription showed what disease the drugs were being used to treat. It also placed a 14-day limit on the amount of the drug. Texas launched a similar rule, but included another malaria drug, mefloquine, and the antibiotic azithromycin (also known as Zithromax Z-Pak).
French researchers had published an article in the International Journal of Antimicrobial Agents that described the potential use of hydroxychloroquine and azithromycin. This is also a very small study and showed a significant reduction of the viral carriage after six days of treatment and “much lower average carrying duration” compared to patients receiving other treatment. Six patients were asymptomatic and 22 had upper respiratory tract infection symptoms. Eight patients had lower respiratory tract infections. Twenty cases were treated in the study, with untreated patients acting as negative controls.
Despite the positive data in 40 coronavirus patients published in France, the French health ministry has warned against use of hydroxychloroquine for COVID-19. The company’s health minister, Olivier Veran, said it should only be used for “serious forms of hospitalization and on the collegial decision of doctors and under strict medical supervision.”
The Ohio Board of Pharmacy also barred pharmacists from providing drugs for COVID-19 unless the individual had tested positive for the disease or the request had been approved directly by the pharmacy board’s executive director.
CVS, however, issued a statement saying pharmacists were to use their “professional judgment to determine whether a prescription was valid and appropriate to dispense.” But they also told the pharmacists to defer to their states’ board regulations. Walgreens pretty much said the same thing, adding that company guidelines had been issued for chloroquine and hydroxychloroquine, allowing only a 14-day supply for new prescriptions.
Garth Reynolds, executive director of the Illinois Pharmacists Association, told ProPublica, “It’s disgraceful, is what it is. And completely selfish.”
He also pointed out that there have been examples of prescribers claiming the individual they were calling the prescriptions in for had rheumatoid arthritis, which the pharmacists doubted. “I mean,” he told ProPublica, “that’s fraud.”
Brian Brito, president of SMP Pharmacy Solutions in Miami, told ProPublica that his pharmacy had approximately 800 Plaquenil (hydroxychloroquine) tablets on March 23 and almost sold out in one hour. A physician had called and asked for 200 of the tablets, but SMP Pharmacy refused. “He was a little upset about it,” Brito said, “but he understood and he went quickly from 200 to 42 tablets, which is essentially treating two people. So yeah, they’re stockpiling it.”
Meanwhile, some lupus patients and rheumatoid arthritis patients are reporting problems refilling their prescriptions for these drugs.
“It’s unfortunate that a news conference, I think prematurely, made it sound like this was the answer, and that’s led to this panic,” said Michelle Petri, director of Johns Hopkins University School of Medicine’s Lupus Center.
Petri is referring to a March 20 press conference.
A day later, Anthony Fauci, director of the National Institute of Allergy and Infectious Disease, said “As the Commissioner of FDA and the president mentioned yesterday, we’re trying to strike a balance between making something with the potential of an effect available to the American people, at the same time that we do it under the auspices of a protocol that would give us information to determine if it’s truly safe and truly effective. But the information that you’re referring to specifically is anecdotal, it was not done in a controlled clinical trial. So you really can’t make any definitive statement about it.”
The joint statement noted, “Physicians’ and pharmacists’ first and foremost ethical obligation in situations of epidemic, disaster or terrorism is to provide urgent medical care and ensure availability and appropriate use of necessary medications. This requires close coordination with the entire health care team to help ensure patients receive the testing, treatments, follow-up care and medications they need. We applaud the innumerable selfless acts by health care professionals across the nation who are putting themselves in harm’s way to provide care to America’s patients.
