Modified Paxlovid EUA for COVID-19

by Sarah Koehler | Jul 12, 2022 | Audits, Blog, Certificates, Classification, Compliance, Consulting Group, De Novo, Documents, Engineering, EUA, FDA, Guidance, Inspections, Pharma, Pharmaceuticals, Quality, Quality Systems, Recall, Registration, Regulatory, Requirements, Risk Management, Safety, Standardization, Standards, Testing, Tools, Updates, Verification

21st Century Cures Act, FDA regulatory changes,

Coronavirus (COVID-19) has been prevalent in the United States for over 2 years, on July 6^th, the Food and Drug Administration (FDA) modified the Emergency Use Authorization (EUA) for Paxlovid for COVID-19 treatment. Paxlovid is a co-packaged, nirmatrelvir tablet and ritonavir tablet for oral use to assist with the treatment of COVID-19 in adult and pediatric patients with positive SARS-CoV-2 testing¹. The nirmatrelvir inhibits the SARS-Cov-2 protein to stop the virus whereas the ritonavir slows down the breakdown of nirmatrelvir to help it remain in the body for a longer period.

Paxlovid is now authorized for a state-licensed pharmacist to prescribe to eligible patients however there are certain limitations to ensuring appropriate treatment². Pharmacists have played a large role in combating the COVID-19 pandemic from testing to prescribing. Paxlovid should be taken five days after a patient develops symptoms. The modifications of the EUA for Paxlovid allow pharmacists to prescribe treatment promptly for some patients who are eligible at their time of COVID-19 testing.

It is best to look for a test-to-treat testing site or seek care from a healthcare provider for COVID-19 with Paxlovid, so results are immediate versus waiting for other test methods to come back. To determine the eligibility for Paxlovid, patients must provide a list of all medications they are taking including over the counter and their recent health records². This allows the pharmacist or physician to take the best path for COVID-19 treatment based on drug interaction and health history.

If your company needs assistance with Emergency Use authorization or drug determinations, EMMA International has experts available to assist you. Contact us by phone at 248-987-4497 or by email at info@emmainternational.com.

_{1FDA (December 2021) Coronavirus (COVID-19) Update: FDA Authorizes First Oral Antiviral for Treatment of COVID-19, retrieved on July 11, 2022, from https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-pharmacists-prescribe-paxlovid-certain-limitations}

Sarah Koehler

Sarah is a Quality Engineer at EMMA International. She has experience in quality assurance, change management, laboratory controls, and process/equipment validation within the pharmaceutical and medical device industry. Sarah has earned a Bachelor of Science in Chemical Engineering from Western Michigan University.