Washington, D.C.—The Department of Health and Human Services (HHS) has announced that pharmacists—as well as pharmacy interns and technicians—are among the healthcare providers now authorized to administer vaccines and therapeutics against smallpox, monkeypox virus, and other orthopoxviruses in a declared emergency.
HHS Secretary Xavier Becerra said this month that the Public Readiness and Emergency Preparedness Act (PREP Act) declaration for smallpox medical countermeasures was amended to expand the categories of providers authorized.
“As our supply of Jynneos vaccine steadily increases, we are exceeding demand in all 50 states,” stated HHS Assistant Secretary for Preparedness and Response, Dawn O’Connell. “By expanding the pool of providers who can administer monkeypox vaccines, we can increase equitable access for people at high risk for monkeypox infections who have not yet had an opportunity to get vaccinated.”
The American Pharmacists Association (APhA) applauded the action. “APhA appreciates the trust and confidence that HHS has in pharmacists by issuing a PREP Act declaration enabling pharmacists, pharmacy interns and pharmacy technicians, as appropriate, to order and administer monkeypox vaccines and therapeutics across the country, under certain conditions,” said Ilisa Bernstein, PharmD, JD, interim executive VP and CEO of APhA. “This will provide greater access to patients in need of these vaccines and treatments to address this public health outbreak.”
“This is a win for patients,” Dr. Bernstein added. “Pharmacists are easily accessible and readily located, particularly in underserved communities. State laws vary widely in whether a pharmacist can order and administer monkeypox vaccines and therapeutics. This PREP Act declaration removes barriers for pharmacists to order and administer for patients in all states.”
Providers administering vaccines and therapeutics must meet training requirements, but, with certain limitations, they are immune from suit and liability under federal and state law “with respect to all claims for loss resulting from the administration or use of a covered countermeasure if a declaration under the PREP Act has been issued with respect to such countermeasure.”
The providers must comply with all relevant requirements and recommendations of the CDC and be consistent with the scope of the FDA’s approval, authorization, and any applicable expanded access requirements of FDA’s protocol, the announcement stated.
The new declaration especially applies to public health threats arising from smallpox (variola virus), monkeypox virus, and other orthopoxviruses, according to Mr. Becerra’s statement. In 2008, the HHS Secretary issued a declaration under the PREP Act for smallpox medical countermeasures which was amended in 2016 to provide liability coverage for “smallpox countermeasures against variola virus or other orthopoxviruses,” which includes monkeypox.
The effective time period of the declaration was extended to December 31, 2032, allowing coverage for manufacturers, distributors, and other covered persons through that date. It includes coverage “for the administration of countermeasures by subcutaneous, intradermal, or intramuscular injections, dermal/percutaneous scarification, orally or intranasally in response to a declared emergency by authorized qualified persons to be extended during the relevant emergency or December 31, 2032, whichever occurs first. A declared emergency can be any federal, state, regional, or local declaration.”
HHS noted that, at the time of the announcement, jurisdictions across the country had ordered approximately 835,700 vials of the approximately 1.1 million vials of the Jynneos vaccine HHS had allocated to prevent monkeypox. The federal government also has distributed approximately 38,000 patient courses of the drug TPOXX to treat patients infected with monkeypox. The drug is used for patients with severe disease, or at risk for severe disease, such as immunocompromised and pediatric cases. Tecovirimat (TPOXX) is approved to treat smallpox and is only available under an expanded access investigational new drug protocol to treat monkeypox infections.
Dr. Bernstein pointed out that APhA “directly advocated to the federal government on behalf of pharmacists and patients to provide this authority under the PREP Act. It is important for the government to provide a pathway for reimbursement for pharmacists to provide this needed care; however, we have yet to see what plans are in place to ensure a sustainable model for pharmacists and pharmacies to offer the monkeypox vaccine and treatments.”
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