Pharmacy, Infection Control Groups Raise Concerns About COVID-19 Testing

It wasn’t enough for HHS to authorize licensed pharmacists to order and administer COVID-19 tests, according to a group of pharmacy and infection control associations, which says pharmacists need more specific guidance to ensure testing is done safely and accurately. Find out their concerns.

WASHINGTON, DC – While some pharmacy and infectious disease specialty groups say they endorse the Department of Health & Human Service’s decision last month to authorize licensed pharmacists to order and administer COVID-19 tests, they also raise some important concerns related to safety, accuracy and reporting.

A document from the American College of Clinical Pharmacy, Society of Infectious Diseases Pharmacists, Infectious Diseases Society of America, The Society for Healthcare Epidemiology of America and The Pediatric Pharmacy Association lays out those concerns.

“We applaud the leadership of HHS in calling on pharmacists to serve as members of the health care team in this emergency response effort, and for recognizing the central role of America’s pharmacies in providing front line services,” the organizations write. “As we evaluated the guidance currently available from HHS and worked to support the development of best practices, we identified several key issues related to safety, accuracy, and reporting that we believe merit further HHS consideration.”

One of the issues is the availability and use of personal protective equipment (PPE) and the testing environment for pharmacies conducting POC testing. The national Centers for Disease Control and Prevention has issued guidance for healthcare workers involved in the collection of respiratory specimens for diagnostic purposes, which would apply to point of care testing at pharmacies. Yet, the associations note, “PPE shortages are challenging the U.S. healthcare system in unprecedented ways during this pandemic. In response, the CDC has issued recommendations for PPE equipment optimization.” More guidance is needed, according to the group.

The statement also emphasizes that pharmacies taking on COVID-19 point of care testing must consider employee and public safety, and the feasibility of performing testing in the pharmacy environment. It urges that HHS consider the following concerns:

  • Drive-through prescription pickup windows operated by most pharmacies are not conducive to proper POC testing and should be avoided.
  • POC testing should be conducted outside the pharmacy itself and in an isolated driveup setting, such as a pharmacy/supermarket parking lot, to avoid unnecessary viral exposure and allow patients to remain in their cars.
  • Designated pharmacies that meet safety criteria for POC testing should be identified so that PPE can be appropriately allocated to sites where testing will be conducted.
  • Adherence to CDC recommendations for conserving PPE and increasing use of other appropriate barriers should be required until PPE is fully available.
  • Pharmacists must undergo training on the storage, disposal/recycling, and use of PPE, including fit testing prior to using N-95 respirators.

The organizations also seek further guidance on test ordering and limitations, pointing out that most of the tests that the Food and Drug Administration has granted emergency use authorization (EUA) are for use only in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988. Pharmacists need more information on which tests to order, especially since many of the assays have high rates of false negatives or false positives, according to the statement.

“Given the emergence of new tests on the market, HHS should make available on an ongoing basis information documenting clinical performance and recommending interpretation of currently approved tests,” the associations state.

The group also urges HHS to provide more guidelines to pharmacists on how to provide COVID-19 testing results to patients and their providers, writing, “Patients must be advised on the appropriate actions to take if initially mild symptoms worsen (i.e., prompting them to seek emergency department/hospital care). An additional follow-up call or e-mail from the pharmacy several days after a positive result would be valuable, given that patients with COVID-19 can rapidly decompensate after the onset of symptoms.”

Pharmacists also need guidelines for referring patients to their primary care clinician, including notification of test results, patient symptoms, and any counseling provided to the patient regarding suggested follow up, according to the associations.

The groups also emphasize how critical it is that data collected by pharmacists be used to help track the spread of disease and ask that a system be in place to allow pharmacies to report both positive and negative results to local and state health departments.

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