HELP OUR PHARMACISTS TO JOIN THE FIGHT

Hon. Steven S. Honigman

Medical experts and government leaders agree that to fight the spread of the coronavirus and speed the time when the economy can reopen, effective, widespread and sustained testing is essential. 

Governor Murphy has said, “In order to further mitigate the spread of COVID-19 and manage our health care resources and personal protective equipment supply, we need to implement more aggressive testing techniques.” New Jersey’s Health Commissioner Judith Persichilli has added, “Rapid testing will help provide more real-time data on the impact of COVID-19 in our state.” New York State Governor Cuomo has also urged, “The key to reopening is going to be testing. Testing of antibodies, testing for diagnostic results – and testing on a scale that we have not done before.”  

Ready access to rapid diagnostic tests for all symptomatic cases or those with a reasonable suspicion of COVID-19 exposure, and widespread serological testing to understand underlying rates of infection and to identify those who have developed immunity and could potentially return to work or school without fear of becoming infected, are the foundation for the National Plan to Enable Comprehensive COVID-19 Case Finding and Contact Tracing in the US issued on Monday by the Johns Hopkins Bloomberg School of Public Health.

Tuesday morning, Dr. Robert Redfield, the Director of the Centers for Disease Control and Prevention, said that for certain critical infrastructure grounds, serological tests looking for the antibodies in a person’s blood that the immune system makes in response to an infection “may help accelerate some of these group reopening [and] would give great confidence for some of the public to return to work. Significantly, the CDC Director added, “It may help hospitals, if they look at the next wave, which I believe we will have in late fall or winter, they may be able to identify a group of health care professionals that are no longer likely to be susceptible. That may have an impact on how the health care system can take care of coronavirus-specific individuals.”

And a few days ago, the New York Times published an Op-Ed column from Vice President Biden declaring that, “there needs to be widespread, easily available and prompt testing” and “we should be ready to scale up a second form of testing: rapid serology tests to tell who has already been infected with the coronavirus and has antibodies.” 

It is time to help our nation’s pharmacists to join this fight.

On April 8, HHS Secretary Azar said that, “Giving pharmacists the authorization to order and administer COVID-19 tests to their patients means easier access to testing for Americans who need it.”

In consequence, HHS has authorized licensed pharmacists to order and administer 

COVID-19 tests to their patients. HHS recognizes that 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, and this authorization will further expand testing for Americans, particularly healthcare workers and first responders.

Significantly, the pharmacy channel will open tens of thousands of professional 

healthcare testing destinations throughout the United States. And the testing itself will be a welcome small business stimulus by providing income and jobs to independent and community pharmacists and their employees during this crisis.

The FDA has issued a Policy for Diagnostic Tests for Coronavirus Disease-2019 during the

Public Health Emergency. A key provision of that policy declares, “Considering that serology tests are less complex than molecular tests and are solely used to identify antibodies to the virus, FDA does not intend to object to the development and distribution by commercial manufacturers or development and use by laboratories of serology tests to identify antibodies to SARS-CoV-2,” where the test has been validated, notification is provided to FDA, and certain specified information is included in the test reports and disclosures to the patients who are tested.

The tests that comply with the FDA’s policy are simple finger-prick serology tests to identify antibodies to SARS-CoV-2 that produce results within minutes. They are not tests of high complexity.

These actions are needed right away:  

• Enlisting pharmacists to administer rapid serological tests should become a cornerstone of the Northeastern Governors’ plan to reopen our states. Governor Murphy and the Board of Pharmacy can lead the way on this critical point.
• President Trump should encourage the Governors and Boards of Pharmacy of every State to follow the lead of his own Health and Human Services Secretary and authorize their licensed pharmacists to order and administer the point of care rapid serology tests.
• New Jersey’s Department of Health administers the federal the CLIA (the Clinical Laboratory Improvement Amendment) program that monitors laboratory facilities. Expediting CLIA application processing by the NJDOH will be needed to bring the tests and their results on board as soon as possible.  
• Finally, from a public health perspective, assuring that all New Jersey Residents will be able to be tested and retested without charge is crucial to motivating residents without medical insurance to participate in the testing regime – and each person’s participation will benefit everyone.  Governor Murphy should work with Medicare and the health insurance companies who serve New Jersey to guarantee that nobody will have to pay for their test by providing the right reimbursement to the pharmacists for administering them

               Medical facilities, their heroic medical and healthcare workers and first responders are already strained beyond capacity. Professionally-trained and licensed pharmacists are ready to stand shoulder to shoulder with them. Give them the tools to join the fight.

The Honorable Steven S. Honigman is a former General Counsel of the Navy and a member of the board of directors of the EastWest Institute. He is working with Dr. Steven Victor, Kenneth DeRoberts, Ritesh Shah, Rph and New Jersey’s Legacy Pharmacy Group of community pharmacies to distribute and use SARS-Co-V-2 IgG/IgM rapid tests in accordance with the FDA’s Policy.