Nov. 29, 2021 –With little fanfare, the U.S. Department of Health and Human Services (HHS) recently moved to allow licensed pharmacists to dispense Food and Drug Administration (FDA)-authorized COVID-19 therapeutics directly to patients, without a physician prescription.
This step, taken by publishing an amendment to a declaration under the Public Readiness and Emergency Preparedness Act, should help remove barriers to providing these important drugs in the five-day window after symptoms appear, which is what studies from companies developing these drugs show is the optimal period for administration of their COVID-19 oral antivirals.
“HHS’ action will cut through the red tape to get therapies out to patients,” said Coalition for Healthcare Communication Executive Director Jon Bigelow. “This is particularly important in the context of the ongoing COVID-19 pandemic, because these antivirals work best if given in a very short window after symptoms appear.”
Specifically, a notice in the Sept. 14 Federal Register explains that HHS Secretary Xavier Becerra is expanding the authorization of a “qualified person” able to order and administer antivirals to include licensed pharmacists; licensed or registered pharmacy interns and qualified pharmacy interns may administer – but not order – COVID-19 antivirals.
“The Secretary anticipates that there will be a need to increase the available pool of providers able to order and administer COVID-19 therapeutics to address rising COVID-19 cases, to expand patient access to these critical therapies, and to keep as many patients out of the hospital as possible,” the Federal Register notice states. “Pharmacists, pharmacy technicians and pharmacy interns are well positioned to increase access to therapeutics and have played a critical role in this pandemic in overseeing COVID-19 testing and vaccine administration.”
This critical role is particularly important for antiviral administration, because individuals will have just five days in which to recognize symptoms, get a COVID-19 test, receive the test results, get a prescription for the antiviral and begin taking the drug. For people with limited access to healthcare, the pharmacy could serve as a convenient place to get tested, receive a prescription for, and obtain the potentially life-saving medication.
HHS and the Biden administration – which already has secured millions of doses of the investigational antivirals to provide free to patients once they are authorized – clearly see the pharmacy as a care hub for those who may not have access to primary care physicians and as an alternative to overwhelmed physician offices. “Given their skill set and training, as well as looming provider shortages, pharmacists, pharmacy technicians, and pharmacy interns will quickly expand access to COVID-19 therapeutics,” HHS stated in the notice.
An FDA advisory committee is convening Nov. 30 to weigh in on the COVID-19 oral antiviral medication being developed by Merck and Ridgeback Therapeutics (molnupiravir) in advance of any emergency use authorization from the FDA. An antiviral treatment from Pfizer (Paxlovid), as well as others, are on the horizon.
“Therapeutics are particularly important in the fight against COVID-19 because many people haven’t been – and won’t be – vaccinated,” Bigelow noted. “Early signals are that oral antivirals may be more effective than antibody therapy infusions – but they must be administered in a timely and equitable manner.”