Key pharmacy groups had a strong reaction to the FDA's decision to specifically exclude ordering and administration by pharmacists when granting an Emergency Use Authorization (EUA) to the first COVID-19 oral treatment.
The FDA authorized the Pfizer COVID-19 oral antiviral in late December but specifically prevented pharmacists from writing the prescriptions. The American Pharmacists Association, American Society of Consultant Pharmacists, American Society of Health System Pharmacists, National Alliance of State Pharmacy Associations, and the National Community Pharmacists Association had this to say:
"The Food and Drug Administration's decision to grant an emergency use authorization (EUA) for the first COVID-19 oral treatment is a welcome development in the fight against COVID-19. However, FDA created an unnecessary hurdle for access to this important new treatment option," according to the letter.
"Pharmacists have ordered and administered nearly 200 million doses of the COVID-19 vaccines and vast numbers of COVID-19 tests. They have immunized more Americans than any other category of health care provider, and they have been instrumental in the success of the COVID vaccine program. It makes absolutely no sense to restrict their ability to help patients rapidly mitigate the severity of COVID-19 symptoms just as the most aggressive strains of the virus to date are driving up hospitalizations and fatalities across the country," the groups add.
Similar language is in the EUA granted to another oral COVID-19 drug, Molnupiravir from Merck.
In both cases, the FDA states that the drugs "may only be prescribed for an individual patient by physicians, advanced practice registered nurses, and physician assistants that are licensed or authorized under state law to prescribe drugs in the therapeutic class" to which the drugs belong (i.e., anti-infectives) according to the FDA EUA letters.
"The federal government has already authorized pharmacists to order and dispense oral therapeutics under the PREP Act. The FDA's authorization nullifies that authority with no explanation or justification," the pharmacy groups point out.
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