![]() ![]() Pharmacies along with other private sector facilities and organizations should strive to maximize PPE through normal supply chains, exercising CDC-recommended conservation guidelines. 24 Pharmacists in pharmacies with limited staff may be concerned about exposure and impact on staffing issues. ![]() 24, 25 An anterior nares specimen collected by the patient has been recommended by CDC to decrease the exposure and required PPE. Some pharmacists may have difficulty securing proper personal protective equipment (PPE). 23Įven with HHS authority for testing, challenges exist for the widespread implementation of pharmacist SARS-CoV-2 diagnostic testing. 22 On May 19, 2020, an advisory opinion provided clarification that the federal guidance preempts any state and local legal requirements that prevent pharmacists from ordering and administering FDA-approved SARS-CoV-2 tests. 21 On April 8, 2020, HHS Secretary, Alex Azar, issued a guidance giving pharmacists the authority to order and administer tests for SARS-CoV-2 under the Public Readiness and Emergency Preparedness (PREP) Act. 18, 19, 20 Furthermore, pharmacies ranked fourth in most number of CLIA-waived locations in 2015, with more than 10,000 sites, and can play a critical role in expanding SARS-CoV-2 testing with the use of CLIA-waived POC tests. Pharmacists are fundamental in the solution to expand SARS-CoV-2 testing in the United States because of their accessibility to patients, relationships with other health care providers, skills and ability for patient assessment, POC testing, and referral. 17 determined that POC testing in community-based pharmacies could benefit patients. ![]() 13, 14, 15, 16 In addition, pharmacists are already using POC devices to test for Streptococcal pharyngitis and influenza that are similar to the devices in use for SARS-CoV-2 testing. ![]() 12 In addition, employees may be required to have a least 1 or even 2 negative tests for SARS-CoV-2 before returning to work, increasing testing demand.Įvidence exists for the quality, safety, and effectiveness of pharmacist-administered Clinical Laboratory Improvement Amendments (CLIA)–waived point-of-care (POC) tests for infectious diseases, including Streptococcal pharyngitis, influenza, Helibactor pylori, HIV, and hepatitis C. 11 With increasing demands to reopen the country and noncompliance with Centers for Disease Control and Prevention (CDC) recommendations to prevent infection, such as washing your hands, avoiding close contact, and covering your mouth and nose with a mask when around others, there is an even greater need now for expanded testing. The inadequate response of the United States to develop and distribute such tests left states initially with few options except for expedited vaccine and drug development and physical distancing. 9 Although the tests are detecting the presence of SARS-CoV-2, the tests are commonly called COVID-19 tests. Serologic tests have been developed to identify the immune response to SARS-CoV-2 through the identification of antibodies. 9, 10 Molecular-based tests identify the presence of viral RNA, and antigen tests detect the presence of the nucleocapsid protein antigen and are used to determine active infection. 8 There are currently 3 types of in vitro tests available for the detection of current or previous SARS-CoV-2 infection: (1) molecular-based (reverse transcription polymerase chain reaction), (2) antigen, and (3) serologic (antibody) tests. Testing is 1 of the cornerstones of controlling the spread of infection. Each in vitro diagnostic test requires an EUA for distribution unless developed by state laboratories. 6 An EUA allows FDA to facilitate the availability of countermeasures more rapidly during a public health emergency, including for SARS-CoV-2 testing. Health and Human Services (HHS) Secretary determined that COVID-19 posed significant public health threats, and multiple Emergency Use Authorizations (EUA) were subsequently issued by the Food and Drug Administration (FDA). 1 The World Health Organization declared COVID-19 a pandemic on March 11, 2020, and as of August 1, 2020, there were almost 5 million cases, with more than 52 million people who have been tested for SARS-CoV-2 (positivity rate of 10%) in the United States. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the strain of coronavirus that causes coronavirus disease (COVID-19), is spread through human-to-human contact. ![]()
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