By Marie Rosenthal, MS
Originally published by our sister publication, Pharmacy Practice News
The Department of Health and Human Services amended the COVID-19 Public Readiness and Emergency Preparedness (PREP) Act declaration to allow licensed pharmacists to order and administer selected COVID-19 therapeutics, including subcutaneous monoclonal antibodies (mAbs).
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/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, according to the HHS.
“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,” said Tom Kraus, ASHP’s vice president of government relations, who added the amendment will allow “broader patient access to COVID-19 therapies that can prevent severe illness.”
ASHP had led ajoint effort with other pharmacy organizations urging the HHS to act after the FDA authorized the first antibody (casirivimab-imdevimab [Regen-Cov, Regeneron]) to be used for post-exposure prophylaxis for COVID-19 emergency use in August, saying that allowing pharmacists to administer COVID-19 could ensure that patients receive timely access to treatment. The FDA recommends administering post-exposure prophylaxis as soon as possible after exposure.
“Initiation of therapy is particularly likely to be delayed in rural and underserved communities that lack access to infusion services and other health care provers,” the joint letter told the HHS; pharmacists can provide that access.
Several states, including Arkansas, Mississippi and Oregon implemented statewide standing orders or protocols to allow pharmacists to independently order and administer casirivimab-imdevimab.
Scope-of-practice rules vary widely from state to state. Most states did not grant pharmacists unrestricted authority to prescribe mAbs or any other therapy for COVID-19 infection independently. In fact, Florida, New Hampshire, Washington, D.C., and Puerto Rico do not typically allow pharmacists to administer medications to patients under any circumstances. Some states permit pharmacists to administer certain medications or restrict the routes of administration for pharmacist-administered drugs. Some require pharmacists to have a collaborative practice agreement with a prescribing practitioner to administer medications.
The amended PREP Act declaration standardizes the authority for pharmacists to order and administer COVID-19 therapeutics nationwide, Mr. Kraus explained.
“HHS has previously made clear that state scope-of-practice laws cannot prohibit covered persons from providing the services authorized in a PREP Act declaration,” he said.
Throughout the pandemic, pharmacists have been helping with staffing shortages, and in some states pharmacists are already administering mAbs because of nursing shortages. They also have been involved in COVID-19 testing and vaccination, often running the programs for the facilities.
Although the ability to deliver mAbs will be welcome for many state and local health systems that are overrun by the current delta variant surge, a permanent solution is needed, especially for states with limited access to health care providers, according to Mr. Kraus.
“Pharmacy’s rapid response to the COVID-19 health emergency—setting up testing sites, overseeing mass vaccination clinicals and administering vaccines—underscores the essential role pharmacists can play in pandemic preparedness,” Mr. Kraus said. “Over the last year, several states have acted to authorize reimbursement for pharmacists’ patient care services, but Medicare does not have a similar payment mechanism.
“The ASHP continues to advocate for federal and state laws that will expand patient access to pharmacists and help shore up the nation’s public health infrastructure against future pandemics,” he said.
Watch Dr. Carrie Adams, of Meritus Health, who offers tips for providing Regen-Cov for post-exposure prophylaxis.
