Modification to EUAs for Oral Antivirals Needed to Achieve Potential of “Test to Treat” Initiative
Today, 14 pharmacy organizations urged the Biden administration to remove barriers preventing pharmacists from ordering oral antivirals and expand patient access to the “Test to Treat” initiative announced last week during the State of the Union.
In a letter sent to President Biden, the groups called for the removal of a limitation placed on the emergency use authorization (EUA) of COVID-19 antivirals by the Food and Drug Administration (FDA). The limitation prevents pharmacists from ordering the medications. The groups stressed that limitations in the EUAs for COVID-19 oral antivirals mean that patients in rural and underserved communities will be less likely to benefit from the test to treat approach.
“Despite your statement during the State of the Union, Americans who test positive at a pharmacy will only be able to access time-sensitive oral antivirals, on the spot, from a limited number of pharmacies with in-house access to non-pharmacist prescribers, primarily in metropolitan areas,” the groups noted.
Many states license pharmacists to order medications, either independently or in collaboration with a physician. In September, the Department of Health and Human Services authorized pharmacists in all 50 states to order oral treatments for COVID-19. The EUAs issued in December by the FDA specifically prevent pharmacists from ordering oral antivirals.
Pharmacists are clinically trained medication experts and are the primary healthcare professionals responsible for ensuring safe medication use, including identifying and mitigating drug interactions associated with oral antiviral medications for COVID-19.
Signatories
American Society of Health-System Pharmacists (ASHP)
Academy of Managed Care Pharmacy (AMCP)
American Association of Colleges of Pharmacy (AACP)
American College of Apothecaries (ACA)
American College of Clinical Pharmacy (ACCP)
American Pharmacists Association (APhA)
American Society of Consultant Pharmacists (ASCP)
College of Psychiatric and Neurologic Pharmacists (CPNP)
Hematology/Oncology Pharmacy Association (HOPA)
National Alliance of State Pharmacy Associations (NASPA)
National Association of Boards of Pharmacy (NABP)
National Community Pharmacists Association (NCPA)
National Pharmaceutical Association (NPhA)
Society of Infectious Diseases Pharmacists (SIDP)