Pharmacy orgs urge HHS to authorize pharmacists to provide COVID-19 prophylaxis treatment
A group of pharmacy organizations is urging the Department of Health and Human Services to allow pharmacists to provide COVID-19 prophylaxis treatment to ensure patients have timely access.
Efforts from the group, which includes the American Pharmacists Association and National Community Pharmacists Association, come after the Food and Drug Administration recently authorized the first post-exposure prophylaxis for COVID-19 emergency use.
In addition to requesting authorization, the groups encouraged HHS to coordinate with insurers to ensure adequate reimbursement is available to support access to these services when provided by pharmacists.
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In a letter to HHS Secretary Xavier Becera, the groups said “On August 2, the Food and Drug Administration authorized the first post-exposure prophylaxis for COVID-19 emergency use. This is a welcome announcement as cases due to the Delta variant of COVID-19 are surging across the country. To ensure timely patient access to this therapy, we recommend that HHS immediately amend its PREP Act declaration for COVID-19 to allow pharmacists to order and administer Regen-Cov (casirivimab and imdevimab) and future products authorized for time sensitive COVID-19 prophylaxis or treatment."
The groups further stated, "The emergency use authorization issued by FDA indicates that “for post-exposure prophylaxis, either subcutaneous injection or intravenous infusion can be used.” FDA also recommends administering post-exposure prophylaxis “as soon as possible after exposure to SARS-CoV-2.”
The groups indicated that when patients access care from a pharmacist, directing the patient to another provider for initiation of prophylaxis would unnecessarily delay treatment, if post-exposure prophylaxis occurs at all.
The letter also stated, "Initiation of therapy is particularly likely to be delayed in rural and underserved communities that lack access to infusion services and other healthcare providers. HHS can support timely administration of prophylaxis by authorizing pharmacists to order and administer Regen-COV."