Update April 22:
Per the National Institutes of Health (NIH) COVID-19 Treatment Guidelines, which cites insufficient clinical data, the Texas Medical Association COVID-19 Task Force recommends against using hydroxychloroquine plus azithromycin to treat COVID-19, “except in the context of a clinical trial.” As indicated by NIH, CDC, and FDA, no drug has been proven to be safe and effective for treating COVID-19, nor has been proven to be an effective pre- or post-exposure prophylaxis treatment for COVID-19.
The Texas State Board of Pharmacy (TSBP) is limiting prescriptions of chloroquine, hydroxychloroquine, mefloquine, and azithromycin amid reports that hospitals and prescribers are stocking up on some of those drugs even though they are not proven to treat COVID-19 effectively.
Under a TSBP temporary rule, prescriptions for those drugs will be allowed only if the scrips come with “a written diagnosis from the prescriber consistent with the evidence for its use.” The rule, issued March 20, also limits new prescriptions for those drugs to a 14-day supply and prohibits refills without a new prescription or medication order.
“The Texas Medical Association supports the guidance by the Texas State Board of Pharmacy, which places medical limitations on the prescribing of hydroxychloroquine as a means to conserve this drug for patients for whom it is medically necessary,” the TMA COVID-19 Task Force said in a statement.
Chloroquine and hydroxychloroquine are approved by the Food and Drug Administration (FDA) for marketing for rheumatoid arthritis and lupus, and are also known as malaria drugs. Recent reports have indicated that hospitals are obtaining much more of the medications, which have shown promise as COVID-19 treatments in foreign clinical trials. President Donald Trump recently touted the promise of chloroquine and hydroxychloroquine, and Premiere Data found major ordering spikes by hospitals for both drugs between March 1-17.
However, the FDA has not approved them for marketing for use in treating COVID-19 or coronavirus. And a Phoenix-area man has reportedly died after taking a form of chloroquine in an attempt to prevent getting coronavirus.
The TMA Task Force statement also reminds physicians that as of early April, “there are no drugs or other therapeutics approved by the U.S. Food and Drug Administration to prevent or treat COVID-19. Current clinical management therefore emphasizes infection prevention and control measures and supportive care, including supplemental oxygen and mechanical ventilatory support when indicated.”
TSBP is one of five state pharmacy boards that have curbed prescriptions for chloroquine and hydroxychloroquine, according to Becker’s Hospital Review.
The FDA says it’s working to expedite “the development and availability of critical medical products to prevent and treat this novel virus, including repurposing existing therapies that may help treat patients with COVID-19.”
On Wednesday, the American Medical Association (AMA), American Pharmacists Association, and American Society of Health-System Pharmacists issued a statement strongly opposing “prophylactically prescribing medications currently identified as potential treatments for COVID-19 (e.g., chloroquine or hydroxychloroquine, azithromycin) for themselves, their families, or their colleagues” or purchasing excessive amounts of those medications “in anticipation of potentially using them for COVID-19 prevention and treatment.”
The statement said the organizations 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. If a prescription is not for a legitimate medical purpose, it should not be written, and it should not be dispensed.”
The three groups cautioned hospitals, health systems, and individual practitioners that “no medication has been FDA-approved for use in COVID-19 patients, and there is no incontrovertible evidence to support off-label use of medications for COVID-19. Stockpiling these medications – or depleting supplies with excessive, anticipatory orders – can have grave consequences for patients with conditions such as lupus or rheumatoid arthritis if the drugs are not available in the community. … Being just stewards of limited resources is essential.”
However, the statement added, the organizations are “further concerned by the confusion that may result from various state government agencies and boards issuing emergency rules limiting or restricting access to chloroquine, hydroxychloroquine, or other emerging therapies or requiring new procedures for physicians and other health care professionals and patients. If these bodies promulgate new rules, we urge that they emphasize professional responsibility and leave room for professional judgment.”