Letter: Pharmacy on the Frontlines of COVID-19 Pandemic

Letter to the Editor:

On April 8, 2020, the Office of the Assistant Secretary for Health issued new guidance under the Public Readiness and Emergency Preparedness Act authorizing licensed pharmacists to order and administer coronavirus disease 2019 (COVID-19) tests that FDA has authorized.

US Health and Human Services (HHS) Secretary Alex Azar stated, "Giving pharmacists the authorization to order and administer COVID-19 tests to their patients means easier access to testing for Americans who need it. Pharmacists play a vital role in delivering convenient access to important public health services and information."

Despite this new federal guidance largely opening up the landscape for testing at pharmacies, several states still must clear the way by removing barriers, such as biohazard waste requirements and Clinical Laboratory Improvement Amendments (CLIA)-waiver authorizations.

We applaud HHS’ announcement and could not agree more with HHS Assistant Secretary Brett Giroir, MD, that the accessibility of community pharmacies “makes pharmacists the first point of contact with a health care professional for many Americans.” Working under this premise, we have demonstrated the value of pharmacy and cultivated pharmacist practice skills for point-of-care testing services for more than a decade, even before the 2009 H1N1 pandemic.

Early in our work, we saw the need for a comprehensive program for pharmacists and pharmacy technicians that improved comfort and confidence with offering disease state management programs that utilize CLIA-waived point-of-care tests. Further, we realized that that the best way to prepare pharmacists to respond in a pandemic was to build the capacity and hone test-related skills for everyday use.

Since 2012, we have trained more than 6000 pharmacists to provide community-based care using CLIA-waived point-of-care testing—the same type of tests that are now becoming available for COVID-19. Through the National Association of Chain Drug Stores’ (NACDS) Community Pharmacy-based Point-of-Care Testing Certificate Program—a program that we developed with other experts—we have not only trained pharmacists to order and administer these tests, but have also built a nationwide network of more than 750 pharmacist trainers ready to educate and train their peers.

These trainers are primed to share specimen collection techniques and specimen processing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) testing to pharmacy students and frontline pharmacists now. Further, since 2016, the Accreditation Council for Pharmacy Education has included point-of-care testing skills as part of the Doctor of Pharmacy curriculum, ensuring students graduate ready to provide patients with needed care.

Community pharmacies across the nation already offer point-of-care testing services for influenza, group A streptococcus, HIV, and hepatitis C. Now, COVID-19 testing and serological assays for SARS-CoV-2 are being folded into existing point-of-care services and workflows through outdoor, mobile, or drive-through operations.

The pharmacy workforce has training resources at its fingertips and is ready to take on COVID-19 testing. However, additional action is needed in some states to remove barriers to care such as biohazardous waste requirements and CLIA-waiver authorizations.

SARS-CoV-2 is unlikely to go away anytime soon. After the initial wave of infections, there are likely to be additional waves as we loosen social distancing. National Institute of Allergy and Infectious Diseases Director Anthony Fauci, MD, and others have also predicted that SARS-CoV-2 is likely to emerge as a seasonal pathogen like influenza.

The work that we have already put in to train pharmacists and provide them with new resources specific to COVID-19 testing is important now and will continue to be even more valuable in the foreseeable future.

A recent joint statement released by 12 national pharmacy organizations called for states to move swiftly to allow pharmacists to order, collect specimens, conduct and interpret tests, and when appropriate, initiate treatment for infectious diseases, including COVID-19. With the announcement from HHS, barriers at the federal level have been removed that would have impeded pharmacist testing for SARS-CoV-2 testing.

Fortunately, an appropriately trained pharmacy workforce already exists with the infrastructure to train more individuals and roll out pharmacy testing for SARS-CoV-2. This workforce can and should be mobilized.

A key reason this group was trained was to be prepared to serve in times of need like this. With additional state action to remove testing restrictions, pharmacists will be able to continue their work to serve on the frontlines of health care during this pandemic.

Michael E. Klepser, PharmD

Professor

Ferris State University College of Pharmacy

Donald G. Klepser, PhD, MBA

Associate Dean for Academic Affairs

University of Nebraska Medical Center College of Pharmacy