How Federal and State Law May Affect Vaccine Administration During the COVID-19 Pandemic

Pharmacy Times® interviewed Ned Milenkovich, PharmD, JD, principal and co-chair of the Health Care Law practice group at Much Shelist, on how federal and state law may affect vaccine administration in accordance with recent declarations by the US Department of Health and Human Services (HHS), which authorize pharmacists to administer vaccines to children during the coronavirus disease 2019 (COVID-19) pandemic and to order and administer an eventual COVID-19 vaccine.

Following the HHS declaration, the American Pharmacists Association (APhA), the National Association of Chain Drug Stores (NACDS), and National Community Pharmacists Association (NCPA) released statements applauding the decision. However, there was an acknowledgement regarding the need for continued efforts toward affirmation of this declaration from state governments.

Milenkovich explained that in order to understand why such an affirmation on the state-level would remain important following this federal authorization, it would require taking a step back to discuss the Public Readiness and Emergency Preparedness (PREP) Act of 2005.

“It was actually passed during the Bush administration, and that act authorizes the secretary of the Department of Health and Human Services, in this case Alex Azar, who is the current HHS secretary, to issue a declaration that provides immunity from liability, except in the case of willful misconduct from any claims of loss arising out of the administration or use of counter measures to disease and those sorts of threats and conditions. So, a PREP Act declaration is specifically for the purpose of providing immunity from liability and is different from other emergency declarations,” Milenkovich said.

Under normal circumstances, the states govern the practice of pharmacy, including the administration of immunizations, according to Milenkovich.

“We find that in the Pharmacy Practice Act and in rules promulgated by various [state pharmacy] board members,” Milenkovich said. “We know that not all states are uniform, so the effort by the associations is probably multifaceted, but the effort is intended to get states to not only get on board with the emergency declaration by the HHS, which, by the way, is preemptive of state laws, which means they supplant state laws and the federal law actually takes effect over any state law, creating a uniformity, so to speak.”

However, Milenkovich noted this effort by the associations to have state governments affirm the federal authorization by the HHS may also have the purpose of laying the groundwork for a more expansive role for the pharmacist in the fight against COVID-19.

“We know that Secretary Azar has said in an earlier pronouncement that pharmacists should be able to obtain and administer the COVID-19 vaccine when it comes out, but subsequent to that, we saw an expansion of that basically stating that pharmacists can immunize, and pharmacy interns under the supervision of the pharmacist can immunize patients aged 3 to 18, and that's really where we see a lot of disparities,” Milenkovich said. “So there were some issues there, but at the end of the day, I think what all the associations are trying to promote, and we'll see how it ends up in the end game, but I think that what they're looking for is for pharmacy boards and states to step up and provide uniformity, allowing these health care professionals a mandate to do what they have to do with vaccination.”

The discussion also included whether there are any potential legal considerations for pharmacists and pharmacies that are planning to deliver vaccines in accordance with both of the HHS authorizations for pharmacists; how state and federal law interact in regard to immunization planning, distribution, and administration; whether federal and state systems currently seem as if they will work in accordance with one another to efficiently and effectively immunize the country upon the release of a COVID-19 vaccine; whether there are any legal implications regarding immunization planning, distribution, and administration in the country during the flu season and concurrent COVID-19 pandemic; and how the COVID-19 pandemic could potentially shape the future of the legal framework for pharmacists in relation to immunization authorization and other areas of concern.