HHS: Pharmacists May Order and Administer COVID-19 Testing
On April 8, 2020, the United States Department of Health and Human Services (HHS) announced that it would allow licensed pharmacists to order and administer coronavirus disease 2019 (COVID-19) tests to their patients. The HHS guidance directs pharmacists to review Food and Drug Administration’s (FDA’s) emergency use authorizations (EUAs) for diagnostic and therapeutic medical devices to diagnose and respond to public health emergencies. Additional information is available from the FAQs on Diagnostic Testing for SARS-CoV-2 page on the FDA website.
“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 health care professional for many Americans,” said HHS Assistant Secretary for Health Brett P. Giroir, MD, in the statement. “This will further expand testing for Americans, particularly our health care workers and first responders who are working around the clock to provide care, compassion, and safety to others.”
The policy change was widely praised by national and local pharmacy organizations, including the American Society of Health-System Pharmacists, National Community Pharmacists Association, National Alliance of State Pharmacy Associations, the American Association of Colleges of Pharmacy, and the Academy of Managed Care Pharmacy, according to Drug Topics.
COVID-19 Pandemic Nearing Peak on National Level
The number of COVID-19 fatalities per day trended down over the weekend, which could indicate that the virus has reached its peak on a national level. Nevertheless, experts are warning that peaks in the number of active cases will differ by state, according to CNN.
Other developments over the last few days include:
- World Health Organization (WHO) reports that at least 70 COVID-19 vaccines are in development, and three have entered human trials, as reported in TIME.
- FDA has issued a final guidance document on its temporary policy related to personal protective equipment use during human drug compounding at state-licensed pharmacies or federal facilities that are not registered with FDA as outsourcing facilities.
- FDA has posted a letter to stakeholders to not use ivermectin intended for animals for treatment of COVID-19.
- FDA issued an EUA for decontaminating compatible N95 or N95-equivalent respirators for reuse by health care providers in hospitals.
Daily updates on the spread of the virus, including a state-by-state breakdown of known infections and fatalities, are available from the Centers for Disease Control and Prevention. International information is available from WHO.
NABP continues to collect information about how boards of pharmacy are responding to COVID-19 in the Coronavirus Updates section of the NABP website. Pharmacists are also encouraged to check their state board(s) of pharmacy websites for jurisdiction-specific information. Additional resources for pharmacists and other health care providers are available from the American Pharmacists Association’s (APhA’s) Pharmacists’ Guide to Coronavirus.
NABP e-Profiles Available for Businesses
Board of pharmacy licensed businesses, including, but not limited to, pharmacies, wholesale distributors, third-party logistics providers, manufacturers, and redistributors, can now visit the NABP website to create NABP e-Profiles for their businesses. Business NABP e-Profiles contain information relevant to a licensee’s demographics, licensure, business hours, services offered, inspection and accreditation histories, and ownership information.
NABP encourages boards of pharmacy to direct facility licensees to create e-Profiles and provide the e-Profile IDs to the board. State boards who do so will be better positioned to take advantage of data sharing, be able to access real-time updates of inspection and accreditation data, and see decreases in data inconsistencies and errors and reduced processing time for the boards and NABP.
Instructions for creating an NABP e-Profile are available in the help section of the NABP website. For questions or additional information, contact NABP Customer Engagement at 847/391-4406.
APhA Offers Weekly Webinars on COVID-19
To help pharmacists follow the latest relevant developments during the COVID-19 pandemic, APhA is offering weekly webinars each Thursday from 1-2 PM ET. Pharmacists may register for upcoming webinars on the APhA website. Each webinar is recorded and made available on YouTube and via links on the APhA website.
During the April 9, 2020 webinar, NABP Executive Director/Secretary Carmen A. Catizone, MS, RPh, DPh, spoke about the changes that are happening related to pharmacists’ scope of practice and other pharmacy practice areas like prescription dispensing amidst the pandemic.