Covid Challenges and Opportunities for Pharmacists – Testing

All too often, the kudos, honorable mentions and stories about the challenges of front line health care workers during the Covid-19 Pandemic omits pharmacists. This blog is the first in a series designed to highlight the challenges pharmacists faced and overcame as they adopted their role as a front line health care worker during the pandemic. As pharmacists have done in the past, they addressed each of these challenges and continued to provide enhanced patient care even in the toughest of times. Accolades are indeed deserved.

Picture going to work in the pharmacy, fully realizing that you will probably be encountering individuals infected with the Covid-19 virus. The first challenge was dealing with the unknown. What do I need to do to ensure the safety of myself, my colleagues and my family? Do I need to buy the N95 mask? Do I need to wash my clothes every night after work to protect my family? What if I get sick and I don’t have any sick days? What will my employer do? Will I be paid if I need to quarantine for 10 days? Will I have a Plexiglas divider installed? If so, how soon? If I need a Covid test, will I have to pay for it or will my employer?

These were questions being asked by all front line health care providers as the pandemic began. I started watching social media in the early days of the pandemic as pharmacist chat groups on Facebook sprung up overnight, asking these questions. The overall tone of the discussion was – what will my employer do to assure my safety? Employers had to address this matter and many others in a very short period of time as discussed in this blog.

In April 2020, the U.S. Office of the Assistant Secretary for Health issued guidance authorizing licensed pharmacists to test for COVID-19. This authorization superseded all state scopes of practice and generated a whole host of new challenges.

Before pharmacists could begin testing, they needed to:

1. Become familiar with the general federal, state, and local agency testing considerations, restrictions, regulations and requirements.
2. Contact state boards of pharmacy, local and state health departments, and the state survey agencies that oversee laboratories for the most current information on Covid testing.
3. Prepare a system that documents each patient encounter.
4. Evaluate their supplies of personal protective equipment (PPE).
5. Ensure an adequate supply of PPE is maintained: N95 or higher-level respirator, or surgical face mask if those products are not available; eye protection; gloves; and a gown.
6. Acquaint themselves with recommendations for how to handle patients who may have the virus.
7. Implement a medical waste disposal protocol.
8. Develop a workflow that ensures the safety of the pharmacy staff and the patient.
9. Train pharmacist staff in their new duties.
10.  Establish an appointment scheduling system.
11.  Establish a prescription delivery system for patients who choose not to come to the pharmacy.
12.  Develop a tele-pharmacy program to continue to provide communication and consultant services to those who choose not to come to the pharmacy.
13.  Decide which testing options to choose: partnering with a laboratory or point of care testing.
14.  Decide which tests to offer: Molecular, antibody and/or antigen.
15.  Determine how and who to bill for testing services: Medicaid, Medicare, health plans, insurance companies, Health Resources and Services Administration (HRSA) Covid-19 Uninsured Program and Coverage Assistance Fund.

Non-management pharmacists, technicians and staff just had to wait until their employer addressed each one of these action items. The independent pharmacy owners and employers in chain, grocery, mass merchandise, hospital and health systems had to address each one of these challenges quickly, since the public was already lining up at their doors upon hearing that pharmacies will be offering testing.

The decision of which, of two, testing options to offer was a major one because so many factors came into play. Testing options included:

Partnering with a laboratory

In partnering with a laboratory, pharmacies collected respiratory samples and then sent them to the lab that actually performed the diagnostic test.

For pharmacies with no drive through windows this was a logistical nightmare. A person had to stand outside or under a tent in a parking lot or other remote location so possibly infected patients didn’t have to leave their cars and the pharmacy’s patients and customers who came into the pharmacy for their prescription and drug store needs were protected. The next challenge was staffing this location outside the pharmacy to have maximum hours of testing available and having adequate PPE, masks, gowns, goggles, and gloves, to protect the staff. If the pharmacy had a drive through window, it was a little simpler where a self test could be administered with pharmacy staff observing the procedure and then having the swabs dropped into a collection box that could then be sent to the lab.

The pharmacy needed to establish a communication plan for reporting results to the patient, primary care provider, and authorities as mandated by state and local requirements. Note that some agencies required reporting of both positive and negative test results, while others only required reporting of positive results. There were even some jurisdictions that required that the results be submitted manually.

Point of care (POC) testing

Point of care (POC) testing, which unlike the first alternative, is pharmacies testing at or near the place where a specimen is collected, and providing results within minutes rather than hours. A whole host of new challenges come with this option in addition to the ones mentioned above. Pharmacies needed to:

1. Obtain a CLIA (Clinical Laboratory Improvement Amendments) Certificate of Waiver.
2. Select a testing device that has been granted EUA (Emergency Use Authorization) by the FDA. The COVID-19 testing device must be authorized to be performed in a patient care setting, since FDA classifies pharmacies as patient care settings.
3. Enroll in the program as an independent clinical laboratory to receive reimbursement from Medicare.
4. Meet state and federal regulatory requirements.
5. Adhere to all federal reporting requirements.
6. Implement CDC Guidelines for Collecting and Handling Clinical Specimens.
7. Develop an Exposure Control Plan required by OSHA demonstrating compliance with the Bloodborne Pathogen Standard protecting employees potentially exposed to Covid-19.

What an amazing accomplishment that in just a matter of weeks, pharmacists were able to address each one of these challenges in addition to conducting the regular daily tasks of filling prescriptions, providing pharmacist care and offering services and products to the communities they served. By adopting Covid-19 testing, the role of the pharmacist in patient care has been greatly expanded during this pandemic.

Vaccinations produced a whole new series of challenges and even greater opportunities for pharmacists to be recognized as front-line responders for Covid-19 patient care. This will be discussed in the next blog post.