Kabisatpathy ’14: a guide in the COVID testing maze

Saswat Kabisatpathy ’14 is helping pharmacists navigate the uncharted landscape of COVID-19. 

When the Department of Health and Human Services (HHS) released a statement April 8 authorizing licensed pharmacists to order and administer COVID-19 tests, a door opened for pharmacists to make an unprecedented, highly-visible difference in America’s recovery from the coronavirus pandemic. Rapid, widespread testing could be the key to safely reopening businesses and letting the labor force go back to work.

Walking through the door could lead to a national reassessment of pharmacists’ role in healthcare and reimbursement. But it could also lead a pharmacist to disaster.

“There’s a lot of misinformation out there,” said Kabisatpathy, chief operations officer with Rx Clinic Pharmacy in Charlotte, N.C. “We’ve gone on a real journey the last couple of weeks learning about what is going on.”

Kabisatpathy and Amina Abubakar, owner of Rx Pharmacy, recently presented a webinar in conjunction with the National Community Pharmacists Association steering pharmacists through the confusing maze of COVID-19 testing and the rapidly-changing Food and Drug Administration (FDA) policies. Having experienced their own initial challenges with testing manufacturers, the Rx Clinic Pharmacy team wanted to educate others so that they would avoid these pitfalls themselves. They’ve done three such webinars, drawing an audience of more than 1,000 pharmacists and other healthcare professionals. 

“A lot of people are offering pharmacists COVID-19 testing kits, claiming they are FDA-approved,” Kabisatpathy said. “But some kits aren’t suitable for use in pharmacies. Some are suitable for use only in certain pharmacies. And none at present are FDA-approved.” 

The webinar outlined the three main tests on the market:

• Polymerase Chain Reaction (PCR)/Molecular Testing: nasal or throat swab, best used before or during symptoms, quick results (10-15 minutes), difficult to perform in a provider office.    
• Antigen Testing: nasal or throat swab, not reliable until symptoms exist, narrow testing window, can be performed in a provider office.
• Antibody Testing: blood sample (fingerprick), tests immunity response, testing window of 10-14 days after infection for initial antibody, testing window of 21-20 days after infection, can determine if maximum immunity response has occurred.

The difficulty facing pharmacists is deciding the best option, when the urgency of a devastating pandemic has created a flood of possibilities. 

“Because the government has such a high priority to get Americans back to working, and we know based on immunology that the antibody test could be the pathway to do this, the FDA allows tests to come into market,” Abubakar said. “They do not stop any manufacturer who wanted to make them as long as the manufacturer notifies the FDA.”

If the manufacturer has successfully applied for an Emergency Use Authorization (EUA), a pharmacist with a Clinical Laboratory Improvement Amendments (CLIA) waiver can perform the test. But if a manufacturer has only notified the FDA, their test is considered “high complexity” and a pharmacy would need a CLIA certificate. While some of these tests coming to the market are simple Point-of-Care tests, high complexity categorization affords the FDA an opportunity for further validation by the testing locations (clinical laboratories or medical facilities). 

“It is important that pharmacists do not simply purchase what is being presented to them,” Kabisatpathy said. “They need to do their own due diligence around these products and what is being allowed by the appropriate governing bodies.”

The challenge for pharmacists already overwhelmed with patient care, protecting staff, educating patients, guarding the supply line, and many other critical tasks is to decide whether the COVID-19 testing is appropriate for their pharmacies and, if so, to educate themselves so as not to end up with unusable products or unreliable results. 

“The government saw an avenue for pharmacists to play a key role, get results, and get people back to work,” Kabisatpathy said. “COVID-19 is going to revolutionize how healthcare is delivered in America. My goal in this landmark timeframe is to help pharmacists showcase the value that we provide to our patients – this opportunity allows us to the shape the future of our profession beyond just the current crisis.”