Washington, D.C.—More than 90 key pharmacy and public health associations are requesting assurance from the United States Department of Health & Human Services (HHS) that expanded flexibility for pharmacy personnel—granted as part of the COVID-19 pandemic response—will continue into late 2024.

"Clarification from HHS that pharmacy personnel flexibilities granted through the PREP Act will remain in place through October 1, 2024, as established for other healthcare providers, is essential for effective, proactive community planning and to support certainty for public access," according to the letter sent to HHS Secretary Xavier Becerra in June. "Current and ongoing ambiguities leave pharmacy personnel, their community and public health partners, and the American people they serve in an untenable position."

Signers of the letter include the American Pharmacists Association, the National Community Pharmacists Association, the National Association of Chain Drug Stores (NACDS), and many others.

The groups pointed out that, because of the authorizations granted under the Public Readiness and Emergency Preparedness (PREP) Act and other key federal actions:

• Pharmacists and pharmacy staff have administered more than 250 million COVID-19 vaccinations to date.
• Approximately two out of three COVID-19 vaccine doses are provided at a pharmacy.
• More than 40% of those vaccinated at pharmacies were from racial and ethnic minority groups.
• More than 40% of children aged 5 to 11 years who received a COVID-19 vaccination did so at a pharmacy.
• Half of pharmacy COVID-19 vaccination sites are located in areas with high social vulnerability.
• Pharmacists and pharmacy staff have provided more than 11,000 mobile COVID-19 vaccination clinics across the country.
• Pharmacies have provided more than 45 million COVID-19 tests, across more than 20,000 testing sites nationwide, and 70% of such sites are in areas with moderate-to-severe social vulnerability.
• Pharmacies and retail health clinics provide access to COVID-19 antivirals at thousands of locations nationwide.

The letter also cited a poll conducted by Morning Consult and commissioned by the NACDS, which found that 70% of Americans support extending the policies that have allowed them to access essential services from their pharmacies during the pandemic. Those who received a COVID-19 vaccination from a pharmacist or pharmacy staff are even more supportive; 85% support extending these policies.

"The[se] authorities granted have been instrumental to supporting the role of pharmacists, pharmacy staff, and pharmacies to expand access and foster equity throughout the pandemic," the groups noted in the letter.

The letter requests the following from the Biden Administration:

• That the Secretary issue a declaration under the PREP Act clarifying that the relevant pharmacists, pharmacy staff, and pharmacy authorities granted in various amendments to the Secretary's existing declaration extend through October 1, 2024, even in the event the emergency declaration is rescinded because a credible risk of such an emergency remains, including: all of those outlined in section V(d) of the Declaration under the PREP Act for medical countermeasures against COVIDÐ19: Ordering and administration of COVID-19, flu, and pediatric vaccines; ordering and administration of COVID-19 testing and therapeutics; that qualified persons include all pharmacy personnel: pharmacists, technicians, and interns; and pharmacists and interns acting pursuant to V(j) with respect to reciprocity across state lines.

• That the Administration clearly states that all relevant countermeasures, personnel, and activities/authorizations outlined above are covered through October 1, 2024, irrespective of regional, state, or local declarations. Connecting PREP Act declaration authorizations to states' declared emergencies, for example, undercuts the effectiveness of these flexibilities to mount an equitable, comprehensive, nationwide response. Consider, for example, that COVID-19 emergency orders have expired in the majority of states.

• That the Administration provides assurance that any expiration date of activities authorized under the PREP Act declaration would not be shortened prior to, or extended beyond, the October 1, 2024, expiration date without at least 90 days' notice. Advance notice of any expiration is critical given the extensive operational changes and considerations that would need to be untangled and ramped down.

In a footnote, the letter discussed the pharmacybased Test-to-Treat initiative, promoted by the Biden Administration to help enhance access to COVID-19 antivirals through hundreds of pharmacy–based collocated clinics. "While this program is a step in the right direction to promote a more seamless patient journey and better access to care, opportunity exists to further leverage the full force of pharmacies to address access and equity through pharmacist assessment and initiation of COVID-19 antivirals as authorized in September 2021 via the Ninth Amendment to the current PREP Act declaration," the authors noted.

"Unexpectedly, the emergency use authorizations (EUAs) issued by FDA for the two COVID-19 oral antiviral medications needlessly omitted pharmacists as authorized prescribers. In addition to those pharmacy locations able to participate in the Test-to-Treat initiative, thousands of pharmacies are also providing important access to COVID-19 therapeutics by providing a dispensing access point, and are also providing patient and prescriber education, coordinating with prescribers on appropriate use, initiation within the 5-day symptom window, dosing adjustments, infection control procedures, and more," the authors added.

"Pharmacists, pharmacy staff, and pharmacies have demonstrated their tremendous value, importance, and collaboration in helping to maintain reliable access to needed countermeasures throughout the pandemic," the organizations concluded. "Access granted by authorizations within the current PREP Act declaration must be maintained and clarified to support an ongoing, effective, and robust response for the American people."

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