U.S. FDA Authorizes Pharmacists to Prescribe Paxlovid

The U.S. Food and Drug Administration (FDA) announced today it revised the oral COVID-19 treatment Paxlovid™ previous authorization to empower state-licensed pharmacists to prescribe the pill to eligible patients, subject to defined limitations.

The FDA authorizes Paxlovid to treat mild-to-moderate COVID-19 in most adults and pediatric patients.

Patrizia Cavazzoni, M.D., director for the FDA's Center for Drug Evaluation and Research, commented in a media statement issued on July 6, 2022, "Since Paxlovid must be taken within five days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients who are eligible to receive this drug for the treatment of COVID-19."

Paxlovid may not be an appropriate therapeutic option based on the current Fact Sheet for Healthcare Providers or due to potential drug interactions for which recommended monitoring would not be feasible.

Patients who have tested positive for COVID-19 and are seeking to determine their eligibility for receiving Paxlovid at locations where prescribing by state-licensed pharmacists is available should bring the following information to ensure that the state-licensed pharmacist has sufficient information to determine their eligibility to receive Paxlovid:

• Electronic or printed health records less than 12 months old, including the most recent reports of laboratory blood work for the state-licensed pharmacist to review for kidney or liver problems. State-licensed pharmacists could also receive this information through a consult with the patient's health care provider.
• A list of all medications they are taking, including over-the-counter medicines, so that the state-licensed pharmacist can screen for drugs with potentially serious interactions with Paxlovid.

Under the limitations outlined in the authorization, the state-licensed pharmacist should refer patients for clinical evaluation with a physician, advanced practice registered nurse, or physician assistant licensed or authorized under state law to prescribe drugs if any of the following apply:

• Sufficient information is not available to assess renal and hepatic function.
• Sufficient information is not available to assess for a potential drug interaction.
• Modification of other medications is needed due to a potential drug interaction.

Since December 2021, the U.S. government has distributed about 3,963,802 Paxlovid treatments in the USA.

Additional COVID-19 treatment news is posted at CoronavirusToday.

Note: The FDA announcement was manually curated for mobile readership.