In late March, FDA issued an Emergency Use Authorization (EUA) for hydroxychloroquine.
Although the FDA approved the anti-malaria, rheumatoid arthritis, and lupus medications hydroxychloroquine sulfate and chloroquine phosphate for emergency treatment of new coronavirus disease (COVID-19), physician groups and medical experts are concerned about their use.
In late March, FDA issued an Emergency Use Authorization (EUA) for hydroxychloroquine, already approved to treat malaria, lupus, and rheumatoid arthritis, for patients who are hospitalized with COVID-19.
Already, thousands of hospitalized coronavirus patients in New York and other states are receiving the medication. Up to 4,000 seriously ill COVID-19 patients in New York are being treated with hydroxychloroquine, Fox News reported.
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Healthcare providers are often using the drug in combination with the antibiotic azithromycin (Zithromax).
President Donald Trump and his trade adviser, Peter Navarro, have promoted the drug to treat COVID-19 since the beginning of the U.S. outbreak. In fact, Trump said at a recent White House press briefing that he would ask his doctor about taking hydroxychloroquine to prevent getting COVID-19.
However, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases at the NIH, said that current studies only show anecdotal information that hydroxychloroquine works to combat COVID-19. Fauci said more testing is needed before it’s clear that the drug works against the coronavirus and is safe for COVID-19 patients, Associated Press reported.
In a joint statement, the American Medical Assocation (AMA) and the American Society of Health-Systems Pharmacists (ASHP) expressed alarm that “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. We collectively support state and federal requirements that direct a prescription must be written only for a legitimate medical purpose. We also strongly support a pharmacist’s professional responsibility to make reasonable inquiries to a prescriber to resolve any questions about a prescription,” the two groups said.
ASHP said in a new guidance that only limited clinical trial data is available to date to evaluate use of chloroquine for treatment or prevention of COVID-19.
“Additional data is needed to determine whether in vitro activity against SARSCoV-2 corresponds with clinical efficacy for treatment or prevention of COVID19,” ASHP wrote. Data regarding toxicity profile when used in patients with COVID-19 is also needed.
However, there are multiple clinical trials initiated in China and other countries to evaluate various chloroquine dosages for treatment of patients with COVID-19. “Clinical experience in treating patients with COVID-19 accumulating; reports of possible clinical benefits, including decrease in viral load and duration of illness; only limited data available to date to support efficacy and identify possible safety concerns in patients with COVID-19,” ASHP wrote.
Former FDA Commissioner Scott Gottlieb, MD, said more research must be done on the efficacy of hydroxychloroquine, with or without the antibiotic azithromycin, before it is given to patients. “If the drug combo is working its effect is probably subtle enough that only rigorous and large-scale trials will tease it out,” Gottlieb tweeted.
Former FDA Commissioner Margaret Hamburg was “surprised and perturbed” by the FDA’s EUA, ScienceInsider reported. “I understand the desire to find hope, but we need more evidence than is currently available before we encourage widespread use.”
However, a majority of independent pharmacists said that COVID-19 patients should have access to the drug. In the National Community Pharmacists Association survey of more than 400 independent pharmacies, 83.8 percent said they should be able to dispense a limited supply of the drugs as long the patient has tested positive and is under a doctor’s care.
In addition, 66.8 percent of independent pharmacists believe the states that have restricted patient access to the drugs could be endangering patient lives. Some state boards of pharmacy and at least two governors have placed restrictions on dispensing hydroxychloroquine.
“This a well-established drug that has been in use for decades for malaria as well as other conditions. We know it can be used safely with the proper oversight of a physician and pharmacist,” said B. Douglas Hoey, RPh, CEO of NCPA. "Efforts to restrict stockpiling and hoarding are appropriate and there is limited data indicating that it may be effective against COVID-19, but Americans who are infected and their doctors have a right to try.”