The PREP Act Declaration and How the COVID-19 Pandemic Changed the Perception and Role of Pharmacy Technicians

Pharmacy technicians are a critical part of the pharmacy team and have been increasingly leaned on for support during the COVID-19 pandemic. As of September 15, 2022, pharmacists and pharmacy staff have administered more than 266 million doses of COVID-19 vaccines through the Federal Retail Pharmacy Program.¹ According to an announcement from the White House in December 2021, more than 2 of 3 COVID-19 vaccine doses were administered at a local pharmacy.² Not only are these vaccines more accessible through pharmacies, but they are also more equitable, with at least 40% of pharmacies located in areas that are underserved and have high social vulnerability index values.³

In March 2020, the US Department of Health and Human Services (HHS) secretary issued a Public Readiness and Emergency Preparedness (PREP) Act declaration that provided liability protections to manufacturers, distributors, states, localities, territories, tribes, and licensed health care professionals (including pharmacy professionals) who administered covered countermeasures, including COVID-19 therapeutics authorized under emergency use authorization status by the FDA.⁴ Results from a poll conducted by business intelligence company Morning Consult and commissioned by the National Association of Chain Drug Stores showed that 70% of all Americans support extending these policies and 68% support making them permanent.⁵

On June 7, 2022, organizations representing patients, public health advocates, pharmacists, pharmacy staff, and pharmacies sent a letter to Xavier Becerra, secretary of the HHS, requesting further clarification from the HHS that pharmacy personnel flexibilities granted through the PREP Act would remain in place through October 1, 2024, as established for other health care providers. Further, the pharmacy-based organizations asked for the declaration to hold true even in the event that the emergency declaration is rescinded because a credible risk of such an emergency remains. This includes the following medical countermeasures⁶:

• Ordering and administering COVID-19, flu, and pediatric vaccines
• Ordering and administering COVID-19 testing and therapeutics
• Ensuring qualified pharmacy personnel (eg, pharmacists, technicians, and interns) are part of this provision

The letter also stated that extension of the PREP Act for pharmacy personnel was “essential for effective, proactive community planning and to support continued certainty for public access” to COVID-19 resources. Nearly 100 pharmacy organization and societies signed the letter issued to Becerra.⁶

The COVID-19 PREP Act declaration has been amended several times to expand liability proatections, including prior amendments to cover licensed health care professionals who cross state borders and federal response teams.^7,8 It preempts state requirements, such as more limited licensing or scope of practice requirements, that may prohibit a qualified person (eg, pharmacist, pharmacy technician, or registered pharmacy intern) to prescribe, dispense, or administer COVID-19 countermeasures.⁴ Expanded roles of qualified persons covered under the Ninth Amendment to the COVID-19 PREP Act declaration are described in the Table.⁴

Expanding Pharamcy Personnel Roles to Meet Demand

We must do our best to provide the “vaccine willing” with access to public health services. Busy pharmacy settings and increased workloads can hinder success in offering these services and limits the time to engage with vaccine-hesitant persons and respond to their inquiries. As a result, we must evaluate how to do more with the available resources; this includes using everyone in the pharmacy team at the top of their licensure and abilities. Pharmacy technicians can support vaccination services and play an import role in addressing patients’ needs, as demands have increased during the COVID-19 pandemic. In a recent systematic review, DeMarco et al assessed the published literature to better define the emerging roles of pharmacy technicians in patient screening and vaccine administration.⁹ They determined that the expanded role of pharmacy technicians in delivering vaccination services contributes to improved workflow and patient outcomes. Moreover, pharmacy technicians can increase vaccination services efficiently and safely, thereby meeting the needs of more patients.

Pharmacy personnel have successfully provided COVID-19 services—including vaccinations, testing, and therapeutics—in more than 41,000 pharmacies across the United States.¹ Because most Americans live within 5 miles of a pharmacy, pharmacy personnel are essential to the effective deployment of COVID-19 vaccines.¹ The PREP Act not only expanded access to services being provided by licensed pharmacists, qualified pharmacy technicians, and pharmacy interns, it also cultivated a strong public health and pharmacy collaboration that leveraged the strength of community partners to better serve the public. Because of their essential role in the national response to the ongoing COVID-19 pandemic, it is imperative that the expanded scope of pharmacy personnel becomes permanent.⁶

The Case for Permanent Change

Have you asked a friend or colleague where they received their most recent vaccination? Most likely, the answer is “at the pharmacy.” The convenience and individualized care associated with a pharmacy has no comparison. Being able to take your family to the trusted pharmacy staff in your community is invaluable, especially as we see more and more consolidation of the health care system and decreased access to quality care. In some communities, the pharmacy is the only source for patients to access their health care needs. In some cases, individuals may live miles from another health care provider and need additional care and services due to lack of transportation.

It would be detrimental to take services away from the public. Extending the PREP Act declaration through October 2024 is a good start; however, families and communities now rely on the neighborhood pharmacy to provide expanded services, and if they are taken away, it could have devasting effects on public health and safety. We must think about not only surviving this pandemic but also thriving and being prepared for the next one.

The impact of expanded coverage for pharmacy personnel under the PREP Act declaration is clear. Because we need to be prepared and respond to future crises, making these changes permanent is a top priority for the profession of pharmacy. Let’s all talk to our state and federal legislators about making this the standard of care. It’s not only good for pharmacy, it’s also good for public health.

About The Author

Christina M. Madison, PharmD, FCCP, AAHIVP, is the founder and CEO of The Public Health Pharmacist, PLLC, in Las Vegas, Nevada.

References

1. The Federal Retail Pharmacy Program for COVID-19 vaccination. CDC. Reviewed September 19, 2022. Accessed September 13, 2022. https://www.cdc.gov/vaccines/covid-19/retail-pharmacy-program/index.html

2. President Biden announces new actions to protect Americans against the Delta and Omicron variants as we battle COVID-19 this winter. News release. The White House; December 2, 2021. Accessed September 25, 2022. https://www.whitehouse.gov/briefing-room/ statements-releases/2021/12/02/fact-sheet-president-biden-announces-new-actions-to-protect-americans-against-the-delta-and-omicron-variants-as-we-battle-covid-19-this-winter/

3. COVID-19: federal efforts to provide vaccines to racial and ethnic groups. United States Government Accountability Office. February 2022. Accessed September 25, 2022. https://www.gao.gov/assets/gao-22-105079.pdf

4. Expanding access to COVID 19 therapeutics. Department of Health and Human Services. Reviewed September 21, 2021. Accessed September 25, 2022. https://www.phe.gov/Preparedness/legal/prepact/Pages/PREPact-NinethAmendment.aspx

5. NACDS releases poll: 70% of adults back extension of policies giving access to pharmacies’ pandemic services. National Association of Chain Drug Stores. March 11, 2022. Accessed September 25, 2022. https://www.nacds.org/news/nacds-releases-poll-70-of-adults-back-extension-of-policies-giving-access-to-pharmacies-pandemic-services/

6. Re: request for clarifications to maintain public access to pandemic-related services at the nation’s pharmacies. National Association of Chain Drug Stores. June 7, 2022. Accessed September 25, 2022. https://www.nacds.org/ pdfs/COVID-19-Flexibilites-Clarifications-Sign-On-Letter-June-2022.pdf

7. Ninth amendment to declaration under the Public Readiness and Emergency Preparedness Act for medical countermeasures against COVID-19. Federal Register. September 14, 2021. Accessed September 25, 2022. https://www.federalregister.gov/documents/2021/09/14/2021-19790/ ninth-amendment-to-declaration-under-the-public-readiness-and-emergency-preparedness-act-for-medical

8. PREP Act immunity from liability for COVID-19 vaccinators. Department of Health and Human Services. Reviewed April 13, 2021. Accessed September 25, 2022. https://www.phe.gov/emergency/events/COVID19/COVIDVaccinators/Pages/PREP-Act-Immunity-from-Liability-for-COVID-19-Vaccinators.aspx

9. DeMarco M, Carter C, Houle SKD, Waite NM. The role of pharmacy technicians in vaccination services: a scoping review. J Am Pharm Assoc (2003). 2022;62(1):15-26.e11. doi:10.1016/j.japh.2021.09.016