New FDA Guidance on the Test-to-Treat COVID-19 Anti-Virals

On December 22, 2021, the Federal Food and Drug Administration (FDA) made news headlines by issuing an emergency use authorization for the use of Pfizer’s ritonavir-boosted nirmatrelvir (Paxlovid) for the treatment of COVID-19. This was followed a day later by the emergency use authorization of Merck’s drug molnupiravir (Lagevrio), also for the treatment of COVID-19. Both drugs came at a critical time in the pandemic and could be used for treatment within 5 days of symptom onset for patients with mild to moderate COVID-19 who were at high risk of disease progression.

The FDA authorization came with additional verbiage allowing pharmacists in all 50 states to prescribe Paxlovid without an order from a physician. The initial labeling for Paxlovid had specific wording allowing state-licensed pharmacists to prescribe the antiviral for COVID-19, as long as they had current significant medical history to understand the patient’s hepatic/renal function and their current medication history. The label also issued guidance for pharmacists on how to refer patients’ care to other providers, should the pharmacy not be equipped to manage care under their clinical scope. The ability for pharmacists to provide care for COVID-19 through the prescribing of these antivirals depended on a positive test result or “current diagnosis of mild-to-moderate coronavirus disease 2019 (COVID-19)” according to the FDA. In February 2023, the FDA changed the guidelines to include the ability for pharmacists to prescribe to individuals “who are at high risk for progression to severe COVID-19, including hospitalization or death.”

As of May 25, 2023, Paxlovid is approved by the FDA for the “treatment of mild-to-moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.” A letter from the FDA states that pharmacists can continue to prescribe Paxlovid, since an Emergency Use Authorization (EUA) still exists and has not been revoked. This EUA has been supplemented with additional information due to Paxlovid’s full approval, but the EUA package insert still includes the ability of pharmacists to prescribe Paxlovid, provided that they still meet the prescribing . There is no indication that pharmacist prescribing will continue if the EUA is revoked.

The revised Letter of Authorization for Paxlovid allows pharmacists to prescribe these antivirals for patients who are suspected of having COVID-19 through their symptomatic or contact history and allows pharmacists to utilize their clinical judgement when treating these individuals. This streamlines the process for treating high-risk individuals who may not have received their testing results, enabling them to initiate therapy as long as they meet the other requirements for prescribing. In many pharmacy chains, while the pharmacy often collected the specimen, COVID-19 testing and result interpretation was outsourced to laboratories. In some instances, results were communicated between the patients and their specific laboratory, keeping the pharmacist unaware of the patient’s status and unable to initiate antiviral therapy if required. With the new changes to the authorized labeling, the pharmacists’ scope has now expanded in terms of COVID-19 antivirals.  It will be interesting to see how this may expand a pharmacists’ scope elsewhere.

Posted June 2023