Today, the Department of Health and Human Services (HHS) announced an amendment to the COVID-19 Public Readiness and Emergency Preparedness (PREP) Act declaration to allow licensed pharmacists to order and administer select COVID-19 therapeutics, including subcutaneous monoclonal antibodies.
The amendment broadly addresses COVID-19 therapeutics given orally, subcutaneously, or intramuscularly, including current and future medications that are approved, authorized, cleared, or licensed to treat or prevent COVID-19. Licensed pharmacists, licensed or registered pharmacy interns, and qualified pharmacy technicians who meet the criteria in the amendment are also authorized to administer certain COVID-19 therapeutics.
ASHP led a joint effort with other pharmacy organizations urging HHS to issue an additional PREP Act Declaration permitting qualified pharmacists to order and administer therapeutics for prophylaxis or treatment of COVID-19. This comes after the Food and Drug Administration recently authorized the first post-exposure prophylaxis for COVID-19 emergency use.
“We applaud the PREP Act declaration amendment and look forward to continuing to work with HHS and the White House to further leverage the knowledge and skills of our pharmacy workforce to bring an end to this pandemic," said Tom Kraus, ASHP's vice president of government relations. "The PREP Act declaration allowing pharmacists to order and administer COVID-19 therapeutics will significantly expand patient access to needed treatments and post-exposure prophylaxis, particularly in medically underserved areas. ASHP has been excited to partner with HHS and the White House on this effort which will result in broader patient access to COVID-19 therapies that can prevent severe illness."
Several states, including Arkansas, Mississippi, and Oregon implemented statewide standing orders or protocols to allow pharmacists to independently order and administer REGEN-COV COVID-19 monoclonal antibodies. The amended PREP Act declaration standardizes the authority for pharmacists to order and administer COVID-19 therapeutics nationwide.