HHS Empowers Pharmacists to Administer COVID-19 Vaccine

The public readiness and emergency pre- paredness act (prep act) of 2005 authorizes the secretary of the US Department of Health and Human Services (HHS) to issue an emergency declaration that provides immunity from liability, except for willful misconduct, for claims of loss arising out of the administration or use of countermeasures for conditions, diseases, and threats determined to constitute a present or credible risk of a future public health emergency to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures.

Any PREP Act emergency declaration is specif- ically for the purpose of providing immunity from liability and is different from, and not dependent on, other emergency declarations.

On April 8, 2020, HHS Secretary Alex Azar issued such an emergency declaration allowing pharmacists to become so-called covered persons under the PREP Act and allowing them to procure, dispense, and administer the coronavirus disease 2019 (COVID- 19) vaccine when it becomes commercially available without risk of liability. On September 3, 2020, the assistant secretary for health issued guidance authorizing state-licensed pharmacists to order and administer, and state-licensed or registered pharmacy interns acting under the supervision of the qualified pharmacist to administer, COVID-19 vaccinations to individuals 3 years of age and older. On October 21, 2020, Azar expanded the emergency declaration to also allow pharmacy technicians to order and administer also.

FEDERAL GOVERNMENT PREEMPTS STATE LAWS

Normally, states govern the practice of pharmacy, including the pharmacist administration of vaccines. In the case of the HHS emergency declaration, the federal government has the power to preempt state laws and authorize health care workers to undertake activities, state laws notwithstanding. Not all state laws are uniform when it comes to immunization laws and regulations, so such an emergency authorization not only enables states to get on board with the HHS emergency declaration, but also provides an opportunity to lay the groundwork for a more expansive role for pharmacists in the longer term.

UNDERSTANDING LEGAL CONSIDERATIONS

Pharmacists should understand the legal considerations associated with the PREP Act and any HHS guidance. They must know whether they qualify as a “covered person” for the purposes of using the so-called countermeasures under the emergency declaration and understand what they need to qualify. The pharmacist should also understand how a given state board of pharmacy responds to the federal directive when it comes to the PREP Act and Azar’s emergency declaration, along with any amendments and guidance. Both federal and state government actors recognize the public health threat of COVID-19 and should be working collaboratively and in the public interest. Nevertheless, it is incumbent on pharmacists to under- stand what compliance obligations are required amid such circumstances.

When it comes to COVID-19 vaccines, pharmacists must also adhere to the HHS guidance that Azar issued. For example, to qualify for the protections under the PREP Act, a pharmacist is required to use an FDA-approved COVID-19 vaccine, administer it in accordance with the Advisory Committee on Immunization Practices vaccination schedule, complete 20 hours of training approved by the Accreditation Council for Pharmacy Education, complete basic cardiopulmonary resuscitation training, adhere to the record-keeping and reporting requirements of the jurisdiction in which they practice, provide disclosures in the case of minors, and follow select CDC guidelines.

OPPORTUNITIES FOR PERMANENTLY EXPANDED ROLES

Regardless of the liability preclusion of the PREP Act, invoking pharmacists as a covered person for the purposes of administering a COVID-19 vaccine represents an opportunity for the federal government to recognize pharmacists and pharmacy staff members as front-line health care workers who can make a meaningful difference in combating the disease. The federal government has worked with states many times in the past, including during natural disasters such as earthquakes and hurricanes, where there had been a temporary relaxation of licensure laws. The opioid crisis is another example in which the Drug Enforcement Administration worked closely with state boards of pharmacies to contain drug diversion, as well as recommending the dispensing of naloxone opioid-reversal drugs, when the majority of states developed standing orders and pharmacists were able to dispense in emergency situations.

Although the PREP Act is intended to extend liability to health care professionals who give aid during a national emergency and crisis situation, it also affords a real opportunity for the pharmacy profession to step forward in a meaningful way to assist patients on a permanent and unfettered basis. Pharmacists represent the first line of defense against many health conditions. Few other health care professionals have such broad access to patient populations and extended exposure to patients, garnered such trust from their patients, and have direct access to the medical community.

Although the PREP Act emergency declaration is poised to be in effect until October 1, 2024, pharmacists and their staff members have an invaluable, built-in pilot opportunity to demonstrate that they are independently capable of administering a broad array of vaccines, including those for COVID-19, without the need for overregulation or delegation by other health care professionals. In a world where health care resources are scarce, pharmacists should be able to assist patients in ways previously contemplated but impeded through various unnecessary barriers.

Ned Milenkovich, PharmD, JD, is the co-chairman of the health care practice at Much Shelist, PC in Chicago, Illinois, and the former vice chairman of the Illinois State Board of Pharmacy.