Atlanta, GA—The CDC has issued guidance on personal protective equipment for pharmacy staff conducting COVID-19 testing and other close-contact patient care procedures where they could be exposed to coughing and sneezing.
While the guidance also applies to pharmacists who perform influenza and strep testing, those instructions are especially critical now that the federal government has authorized licensed pharmacists to order and administer COVID-19 tests approved by the FDA.
That news came from the Office of the Assistant Secretary for Health, who cited the Public Readiness and Emergency Preparedness Act in expanding pharmacists’ role in the novel coronavirus outbreak.
Brett P. Giroir, MD, who announced the change, explained, “In an effort to expand testing capabilities, we are authorizing licensed pharmacists to order and administer COVID-19 tests to their patients. 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. This will further expand testing for Americans, particularly our healthcare workers and first responders who are working around the clock to provide care, compassion and safety to others.”
“Giving pharmacists the authorization to order and administer COVID-19 tests to their patients means easier access to testing for Americans who need it,” added Health & Human Services Secretary Alex Azar. “Pharmacists play a vital role in delivering convenient access to important public health services and information. The Trump Administration is pleased to give pharmacists the chance to play a bigger role in the COVID-19 response, alongside all of America’s heroic healthcare workers.”
The order states, “Therefore, as an Authority Having Jurisdiction under the Secretary’s March 10, 2020 declaration under the Public Readiness and Emergency Preparedness Act (PREP Act), OASH issues this guidance authorizing licensed pharmacists to order and administer COVID-19 tests, including serology tests, that the Food and Drug Administration (FDA) has authorized. See 85 Fed. Reg. 15,198, 15,202 (March 17, 2020); see also Pub. L. No. 109-148, Public Health Service Act § 319F-3, 42 U.S.C. § 247d-6d and 42 U.S.C. § 247d-6e.1 By doing so, such pharmacists will qualify as “covered persons” under the PREP Act. And they may receive immunity under the PREP Act with respect to all claims for loss caused by, arising out of, relating to, or resulting from, the administration or use of FDA-authorized COVID-19 tests. 42 U.S.C. § 247d-6d(a)(1).”
Testing priorities are listed here.
Approved tests are listed here.
Guidance from the CDC also said that pharmacies that are participating in public health testing for COVID-19 should communicate with local and state public health staff to determine exactly who meets the criteria for testing. It emphasizes that state and local health departments will inform pharmacies about procedures to collect, store, and ship specimens appropriately, including during after-hours or on weekends/holidays. Some pharmacies are including self-collection options.
How to collect respiratory specimens is in this CDC document.
Public health officials advise that pharmacy staff using respirators must be familiar with proper use and follow a complete respiratory protection program that complies with OSHA Respiratory Protection standard (29 CFR 1910.134). Staff should also have training in the how to put on and remove PPE, the CDC notes.
« Click here to return to Weekly News Update.
While the guidance also applies to pharmacists who perform influenza and strep testing, those instructions are especially critical now that the federal government has authorized licensed pharmacists to order and administer COVID-19 tests approved by the FDA.
That news came from the Office of the Assistant Secretary for Health, who cited the Public Readiness and Emergency Preparedness Act in expanding pharmacists’ role in the novel coronavirus outbreak.
Brett P. Giroir, MD, who announced the change, explained, “In an effort to expand testing capabilities, we are authorizing licensed pharmacists to order and administer COVID-19 tests to their patients. 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. This will further expand testing for Americans, particularly our healthcare workers and first responders who are working around the clock to provide care, compassion and safety to others.”
“Giving pharmacists the authorization to order and administer COVID-19 tests to their patients means easier access to testing for Americans who need it,” added Health & Human Services Secretary Alex Azar. “Pharmacists play a vital role in delivering convenient access to important public health services and information. The Trump Administration is pleased to give pharmacists the chance to play a bigger role in the COVID-19 response, alongside all of America’s heroic healthcare workers.”
The order states, “Therefore, as an Authority Having Jurisdiction under the Secretary’s March 10, 2020 declaration under the Public Readiness and Emergency Preparedness Act (PREP Act), OASH issues this guidance authorizing licensed pharmacists to order and administer COVID-19 tests, including serology tests, that the Food and Drug Administration (FDA) has authorized. See 85 Fed. Reg. 15,198, 15,202 (March 17, 2020); see also Pub. L. No. 109-148, Public Health Service Act § 319F-3, 42 U.S.C. § 247d-6d and 42 U.S.C. § 247d-6e.1 By doing so, such pharmacists will qualify as “covered persons” under the PREP Act. And they may receive immunity under the PREP Act with respect to all claims for loss caused by, arising out of, relating to, or resulting from, the administration or use of FDA-authorized COVID-19 tests. 42 U.S.C. § 247d-6d(a)(1).”
Testing priorities are listed here.
Approved tests are listed here.
Guidance from the CDC also said that pharmacies that are participating in public health testing for COVID-19 should communicate with local and state public health staff to determine exactly who meets the criteria for testing. It emphasizes that state and local health departments will inform pharmacies about procedures to collect, store, and ship specimens appropriately, including during after-hours or on weekends/holidays. Some pharmacies are including self-collection options.
How to collect respiratory specimens is in this CDC document.
Public health officials advise that pharmacy staff using respirators must be familiar with proper use and follow a complete respiratory protection program that complies with OSHA Respiratory Protection standard (29 CFR 1910.134). Staff should also have training in the how to put on and remove PPE, the CDC notes.
« Click here to return to Weekly News Update.
