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.
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.
In addition, physicians should discourage people from misusing non-pharmaceutical chloroquine phosphate (a chemical used in home aquariums) after a Phoenix-area man reportedly died and another became critically ill after taking it in an attempt to prevent getting coronavirus.
“Due to the current limitations of the research and lack of clinical data, the Texas Medical Association does not support the use of hydroxychloroquine as a treatment for COVID-19 patients, outside of two exceptions: 1) prescribed as an investigational drug as part of a clinical trial; and 2) applied for compassionate use in inpatient settings,” the TMA COVID-19 Task Force said in a statement. “TMA recognizes that this stance may change, pending results from several active clinical trials of hydroxychloroquine for prophylaxis or treatment of SARS-CoV-2 infection, and treatment of patients with mild, moderate, and severe COVID-19.”
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.”