After receiving multiple requests from pharmacists, pharmacies, and the National Association of Chain Drug Stores (NACDS), the Department of Health & Human Services (HHS) explained that pharmacists across the country are authorized to order and administer coronavirus disease 2019 (COVID-19) diagnostic tests under the Public Readiness and Emergency Preparedness (PREP) Act.1

The Secretary of HHS, Alex M. Azar II, clarified in a statement released on May 19 that the PREP Act preempts state licensing laws that place restrictions on pharmacists’ ability to order and administer COVID-19 tests.1

The PREP Act, which was enacted on December 30, 2005, amended the Public Health Service (PHS) Act and addressed liability immunity. It enabled the HHS Secretary to issue a declaration that provides liability immunity against claims related to the manufacture, distribution, administration, or use of medical countermeasures once the PREP Act is declared. The statement added that the exception exists for claims involving “willful misconduct” as defined in the PREP Act, as willful misconduct is not immune from liability.2

The PREP Act was declared by Azar on February 4, 2020, so from that time, all pharmacists and pharmacies are authorized to administer COVID-19 diagnostic tests and are immune from liability, as long as they do not commit acts of willful misconduct.1

However, the statement explains that the advisory opinion released by Azar is not a final agency action or a final order, does not bind the HHS or federal courts, and does not have the force or effect of law. It is based upon the PREP declaration, which the Secretary is authorized to make during times of emergency, and it will endure for the period that the declaration is enacted and is not a permanent authorization.1

The statement released by the Secretary comes on the heels of a report issued by the NACDS earlier this month that urged state and federal governments to recognize the critical role that community pharmacies play in the current COVID-19 response. The NACDS explained in the report that pharmacies are not only able to administer COVID-19 tests, but also provide valuable information to public health officials regarding how COVID-19 is affecting local populations.3

The NACDS report also emphasized the need to prepare now for accelerated access to forthcoming COVID-19 vaccines and treatments through a uniform, national pandemic immunization plan. With 90% of Americans living within 5 miles of a retail pharmacy, the report explained that pharmacies will be incredibly valuable to the success of such a plan. The report added that the aid of retail pharmacies would also allow for the vaccination of 80% of the population 7 weeks earlier than would be possible otherwise, according to a study conducted by the CDC.3

This statement from the Secretary clarifies that pharmacists across the country are not restricted by state and local authorities in their ability to order and administer COVID-19 diagnostic testing, and use and administer a covered countermeasure. Although the language does not clarify that a covered countermeasure would include forthcoming COVID-19 immunizations or treatments, it would imply that once designated a covered countermeasure by the Secretary, immunizations and treatments would be covered by the PREP Act as well.1

“In an effort to expand testing capabilities, we are authorizing licensed pharmacists to order and administer COVID-19 tests to their patients,” said Assistant Secretary for Health Brett P. Giroir, MD, in a statement included in the HHS’s advisory opinion. “The accessibility and distribution of retail and independent community-based pharmacies make pharmacists the first point of contact with a healthcare professional for many Americans. This will further expand testing for Americans, particularly our healthcare workers and first responders who are working around the clock to provide care, compassion, and safety to others.”1

REFERENCES
  1. Department of Health & Human Services (HHS). Advisory Opinion 20-02 on the Public Readiness and Emergency Preparedness Act and the Secretary’s Declaration Under the Act. HHS website. hhs.gov/sites/default/files/advisory-opinion-20-02-hhs-ogc-prep-act.pdf. Published May 19, 2020. Accessed May 21, 2020.
  2. Federal Register. Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19. Federal Register website. federalregister.gov/documents/2020/03/17/2020-05484/declaration-under-the-public-readiness-and-emergency-preparedness-act-for-medical-countermeasures. Published March 17, 2020. Accessed May 21, 2020.
  3. Hippensteele A. NACDS Urges Government to Consider Pharmacies’ Critical Role in COVID-19 Prevention. Pharmacy Times. pharmacytimes.com/ajax/nacds-urges-government-to-consider-pharmacies-critical-role-in-covid-19-prevention. Published May 18, 2020. Accessed May 21, 2020.