A Closer Look at COVID-19 Testing at Pharmacies

As of April 8, 2020, pharmacists have been given authorization to order and administer COVID-19 tests under the guidance of the Public Readiness and Emergency Preparedness (PREP) Act. This includes nasal and serology tests. On May 19, 2020, the Office of General Counsel (OGC) released a document answering whether PREP Act preempts state licensing laws that restrict pharmacists to order and administer these tests. The conclusion is that the PREP Act preempts any state or local laws that would restrict “a qualified person”, a licensed pharmacist under PREP Act, from ordering or administering FDA-authorized COVID-19 tests. A practicing pharmacy must apply for a Clinical Laboratory Improvement Amendment (CLIA) certificate of waiver before they can accept human samples for diagnostic testing. In some states, such as Pennsylvania, pharmacies must obtain a state-specific CLIA waived lab license in addition to the federal CLIA waiver. In the Emergency Use Authorization (EUA), the FDA specifies which patient care settings are authorized for the tests. If the FDA authorizes a test as a point-of-care test, the test is CLIA waived for the duration of the emergency declaration and can be used in pharmacies. The Department of Health and Human Services Centers for Medicare & Medicaid Services manages the process to obtain CLIA waivers.

Pharmacists may administer tests which are authorized for use in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance. Tests allowed include the ID NOW COVID-19, Accula SARS-COV-2 Test, Xpert Xpress SARS-CoC-2 test, and serology tests. A complete list of COVID-19 tests given Emergency Use Authorizations (EUA) and their authorized settings can be found here. The FDA is allowing development and distribution of serological tests without going through the EUA process. However, these tests to identify to SARS-CoV-2 must be validated, and the FDA must be notified of the validation.

Tests using patient saliva are currently available by prescription only and intended for at-home collection and mail in for results.

APhA is also offering COVID-19 Specimen Collection Training, COVID-19 educational videos (link 1 link 2), and COVID-19 fraudulent medical device and scam guidance to train pharmacists and keep them up to date and aware of the latest science and data pertaining to COVID-19. Many pharmacies are already offering testing at no cost to eligible individuals who meet criteria set by the CDC. Most pharmacies require patients to preregister in advance to be directed to the nearest testing location. Testing can deliver results in as little as 15 minutes.

With 90% of Americans living within 5 miles of a community pharmacy, testing can become much more accessible, which can lead to earlier identification and improved outcomes relating to COVID-19.  Hopes are that many more patients will be tested and can take appropriate measures to reduce the spread of COVID-19. Is your pharmacy prepared to participate and offer COVID-19 point-of-care testing?

 

 

Posted May 2020

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