Experts have repeatedly emphasized the importance of increased testing for COVID-19 in an effort to maintain some control over this pandemic. With this goal in mind, on April 8, 2020, the Office of the Assistant Secretary for Health (“OASH”) took a step to meet current testing demands by issuing guidance for licensed pharmacists regarding their ability to assist with COVID-19 testing. Specifically, OASH authorized licensed pharmacists to order and administer COVID-19 tests, which include serology tests, that the Food and Drug Administration has authorized.
Importantly, OASH directed that pharmacists qualify as “covered persons” under the Public Readiness and Emergency Preparedness Act (“PREP Act). The PREP Act authorizes the Secretary of the Department of Health and Human Services (“HHS”) to issue a PREP Act declaration, which provides immunity from liability for any loss caused, arising out of, relating to or resulting from the administration or use of countermeasures to diseases, threats and conditions determined in the Declaration to constitute a present or credible risk of a future public health emergency. The Secretary of HHS issued such a declaration for the COVID-19 pandemic under the PREP Act on March 10, 2020.
Therefore, pharmacists ordering and administering COVID-19 tests pursuant to OASH’s guidance will receive immunity under this Act. This means that courts must dismiss claims brought against pharmacists for any loss that relates to any stage of design, development, testing, manufacture, labeling, distribution, formulation, labeling, packing, marketing, promotion, sale, purchase, donation, dispensing, prescribing, administration, licensing or use of these tests. This immunity does not cover willful misconduct by pharmacists.
HHS’s declaration and guidance should assist in increasing the United States’ capacity to perform testing. In fact, several pharmacies, including Walgreens, CVS Health and Target, have already indicated that they will offer drive-thru testing sites.
Footnotes:
- https://www.hhs.gov/sites/default/files/authorizing-licensed-pharmacists-to-order-and-administer-covid-19-tests.pdf
- https://www.federalregister.gov/documents/2020/03/17/2020-05484/declaration-under-the-public-readiness-and-emergency-preparedness-act-for-medical-countermeasures
